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November 1, 2014

Monthly Update for November 2014

Bergeson & Campbell, P.C.


EPA Proposes To Remove 72 Chemicals From Approved Pesticide Inert Ingredients List: On October 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. 79 Fed. Reg. 63120. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA developed an alternative strategy designed to reduce the risks posed by hazardous inert ingredients in pesticide products more effectively than by disclosure rulemaking. EPA outlined its strategy in a May 22, 2014, letter to the petitioners, which is available online. Many of the 72 inert ingredients targeted for removal are on the list of 371 inert ingredients identified by the petitioners as hazardous. The 72 chemicals are not currently being used as inert ingredients in any pesticide product and include:

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Ingredients that are directly responsible for controlling pests such as insects or weeds are called active ingredients. An inert ingredient is any substance that is intentionally included in a pesticide that is not an active ingredient. Comments are due November 21, 2014. General information on inert ingredients can be found online.

EPA Issues Direct Final Rule Promulgating 52 SNURs: On October 27, 2014, EPA promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 52 chemical substances that were the subject of premanufacture notices (PMN). 79 Fed. Reg. 63821. Nine of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. The rule requires persons who intend to manufacture (including import) or process any of these 52 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. This rule is effective on December 26, 2014. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before November 26, 2014. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 26, 2014, EPA will withdraw the relevant sections of this direct final rule before its effective date.

EPA Denies TSCA Section 21 Petition On Polyvinyl: On October 31, 2014, EPA announced its decision to deny a petition submitted under TSCA Section 21 seeking a rulemaking under TSCA Section 6 on polyvinyl chloride (PVC), vinyl chloride, and phthalates used as plasticizers. 79 Fed. Reg. 64722. The Center for Biological Diversity (CBD) petitioned EPA for such a rulemaking and, in the alternative, a Section 4 rulemaking seeking additional data on these chemical substances. EPA denied the petition stating that the petition reflected a “nearly complete lack of detail as to the TSCA risk management that it is seeking,” among other stated deficiencies. The Section 4 “alternative” was denied on the grounds that the petitioner did not set forth sufficient facts for EPA to find that the toxicity information available to EPA is insufficient to “permit a reasoned evaluation of the health or environmental effects of these chemical substances…”

GAO Report Concludes Residue Monitoring Flawed: On November 6, 2014, the Government Accountability Office (GAO) issued a report concluding that the U.S. Department of Agriculture’s (USDA) monitoring of pesticide residue levels is flawed. GAO contends that several high volume pesticides are not routinely monitored, and that the results of monitoring do not disclose that these chemicals are not monitored. The report further notes that the U.S. Food and Drug Administration (FDA) tests less than one-tenth of one percent of imported food shipments for pesticide residue. The modest testing, according to GAO, cannot elicit a statistically significant estimate of residue levels on the food FDA regulates. The report is available online.

EPA Issues Partial Exemption Of Certain Chemical Substances From Reporting Additional Chemical Data: On November 10, 2014, EPA issued a direct final rule amending the list of chemical substances that are partially exempt from reporting additional information under the Chemical Data Reporting (CDR) rule. 79 Fed. Reg. 66655. EPA has determined that, based on the totality of information on the chemical substances listed in the document, EPA has low current interest in their CDR processing and use information. The chemicals are:

68-04-21,2,3-Propanetricarboxylic acid, 2-hydroxy-, sodium salt (1:3)
77-92-91,2,3-Propanetricarboxylic acid,2 -hydroxy-
866-84-21,2,3-Propanetricarboxylic acid, 2-hydroxy-, potassium salt (1:3)
8013-07-8Soybean oil, epoxidized
66071-94-1Corn, steep liquor

EPA reached this conclusion after considering factors, including the risk of adverse human health or environmental effects, information needs for CDR processing and use information, and the availability of other sources of comparable processing and use information. This direct final rule is effective January 9, 2015, without further notice, unless EPA receives adverse comment on or before December 10, 2014. If EPA receives written adverse comments, EPA will withdraw the applicable partial exemption in the direct final rule before its effective date.


FDA CDRH Issues Draft Guidance For Industry: On October 3, 2014, FDA Center for Devices and Radiological Health (CDRH) issued two draft guidance documents dealing with Laboratory Developed Tests (LDT). 79 Fed. Reg. 59776 and 79 Fed. Reg. 59779. The “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and the “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” documents are intended to address LDTs that are considered an in vitro diagnostic device subset. Both documents indicate FDA is currently targeting those LDTs for clinical use and design, manufactured and used within a single laboratory. The Framework draft guidance will provide “a risk-based oversight” to ensure proper controls are in place and the complementary notification and medical device reporting guidance will address specifics. Comments for both are due by February 2, 2015. For more details, see here and here.

FDA CDRH Issues Final Guidance On Distinguishing Medical Device Recalls From Medical Device Enhancements: On October 14, 2014, FDA CDRH issued a final guidance entitled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” The guidance is intended to clarify for manufacturers when a modification to a device would require a recall or would be considered an enhancement. In addition to the final guidance, FDA held a webinar on November 5, 2014, to offer an opportunity to explain the guidance and answer any specific questions. For more details on the guidance document and for the webinar transcript, see Distinguishing Medical Device Recalls from Medical Device Enhancements and online.

FDA CDRH Announces Additional eCopy Program Resources: On October 20, 2014, FDA CDRH announced updates to the eCopy Program for Medical Device Submissions webpage. The updates include five new video tutorials and a new tool that allows users to “confirm that the eCopy [they] created meets the requirements.” For more details see online.

FDA FSMA Holds Public Meeting On Four Proposed Rulemakings: On October 20, 2014, FDA Center for Food Safety and Applied Nutrition (CFSAN) announced that a Food Safety Modernization Act (FSMA) public meeting would be held on November 13, 2014, on the Supplemental Notices of Proposed Rulemaking. The meeting purpose was to seek comments on the new content of the recent proposed revisions to “Proposed Supplemental Rule for Produce Safety,” “Proposed Supplemental Rule for Preventative Controls for Human Food,” “Proposed Supplemental Rule for Preventive Controls for Animal Food,” and “Proposed Supplemental Rule for Foreign Supplier Verification Program” (FSVP) rules. For more details on the proposals and the meeting, see online.

FDA CFSAN Posts On-line Tool For Seafood Industry: On October 24, 2014, FDA CFSAN announced that a new online tool was available to assist the seafood industry with proper labeling of seafood products. The online module includes details on labeling requirements, laws and regulations as well as guidance documents and additional tips to industry on identifying mislabeled seafood. For more details, see online.

FDA CDRH Holds Industry Basics Webinar: On November 4, 2014, FDA CDRH held a webinar for Industry to cover the basic concepts of the medical device regulations. The presentations covered five principle concepts, including Investigational Device Exemptions, 510(k) Program, De Novo, Corrective and Preventive Actions (CAPA), and Electronic Medical Device Reporting (eMDR). For copies of the presentations, see online.


EPA To Host Webinar On RCRA Hazardous Waste Electronic Manifest System: EPA will host a webinar on Thursday, November 20, 2014, from 2:00 to 3:30 p.m. (EST) to update stakeholders on the implementation of the Hazardous Waste Electronic Manifest Program (e-Manifest) under the Resource Conservation and Recovery Act (RCRA). EPA states that the webinar will provide an update on the regulations implementing the e-Manifest and other important aspects of the system. In addition, EPA intends to update stakeholders on potential changes to the technical architecture for the e-Manifest system. EPA will provide logistical information on the webinar prior to the November 20 scheduled date. Since the inception of the RCRA regulatory program in 1980, RCRA-regulated entities transporting hazardous waste have been required to complete a paper hazardous waste manifest for each shipment of hazardous wastes. On October 5, 2012, however, President Obama signed into law the Hazardous Waste Electronic Manifest Establishment Act (HWEMEA), which authorizes EPA to implement a national electronic manifest system. Commonly referred to as “e-Manifest,” this national system is envisioned to be implemented by EPA in partnership with industry and states. The HWEMEA requires that the e-Manifest system be up and running by October 5, 2014. In addition, HWEMEA set an October 5, 2013, deadline for EPA to issue a final rule authorizing use of electronic manifests. EPA missed this deadline, however, and did not promulgate the final rule until February 7, 2014. 79 Fed. Reg. 7517. The registration link for the webinar is here.

EPA Clarifies Position Regarding Alternative Uses Of CRT Glass: EPA has clarified that using cathode ray tube (CRT) glass as a substitute in ceramic tile manufacturing may be considered legitimate recycling, while using the leaded glass as alternative daily cover in landfills is considered disposal of the material, according to letters EPA issued to Sims Recycling Solutions and Sony Electronics, Inc. on September 10, 2014. EPA would exclude recycling CRT glass in ceramic tiles from solid and hazardous waste regulations under RCRA, while disposing of these materials would require compliance with certain RCRA requirements, according to EPA. Sims Recycling Solutions sought the clarification on how CRT glass used in ceramic tile production would be treated. Sony Electronics, Inc. sought the clarification for alternate daily cover in landfills. EPA concluded the CRT glass provides a useful contribution, produces a valuable product or intermediate, is managed as a valuable commodity, and has concentrations of lead and cadmium that meet standards set by the European Union (EU). EPA also concluded that using CRT glass as alternate daily cover in landfills would not constitute recycling, meaning it would be regulated under certain RCRA regulations. EPA’s letter on the use of CRTs in ceramic tile production is available online. The EPA’s letter on the use of CRTs as alternate daily cover at landfills is available online.


U.S. And China Reach Historic Accord On Climate Change: In a surprise announcement that capped months of secret negotiations, on November 11, 2014, President Obama and Chinese President Xi Jinping announced an historic pact that commits each country to ambitious goals to cap greenhouse gas (GHG) emissions. Under the agreement, the U.S. will slash its GHG emissions between 26 and 28 percent below 2005 levels by 2025, which far outpaces the 17 percent reduction goal President Obama set in 2009. China agreed that its GHG emissions would peak by 2030 or earlier. This is the first-ever commitment by China to stop its GHG emissions from growing by 2030. The White House hopes that the agreement will help inject momentum into the global climate negotiations slated to take place next year in Paris at the Framework Convention on Climate Change (FC3). The U.S. intends to submit its 2025 goals to the FC3 as an “Intended Nationally Determined Contribution” no later than the first quarter of 2015. Specifically, the U.S. and China agreed to the following:

  • Expand Joint Clean Energy Research and Development: This is a renewed and expanded commitment to the U.S.-China Clean Energy Research Center (CERC). This will include:
    • Extending the CERC mandate for an additional five years from 2016-2020;
    • Renewing funding for the three existing tracks: building efficiency, clean vehicles, and advanced coal technologies with carbon capture, use, and sequestration (CCUS); and
    • Launching a new track on the interaction of energy and water (the energy/water nexus).
  • Advance Major Carbon Capture, Use and Storage Demonstrations: Expanding the work under the Climate Change Working Group (CCWG) and under the CERC, and partnering with the private sector, the U.S. and China will undertake a major carbon capture and storage project in China that supports a long term, detailed assessment of full-scale sequestration in a suitable, secure underground geologic reservoir. The U.S. and China will make equal funding commitments to the project and will seek additional funding commitments from other countries and the private sector. In addition, both sides will work to manage climate change by demonstrating a new frontier for carbon dioxide (CO2) use through a CCUS project that will capture and store CO2 while producing fresh water, thus demonstrating power generation as a net producer of water instead of a water consumer. This CCUS project with Enhanced Water Recovery will eventually inject about one million tons of CO2 and create approximately 1.4 million cubic meters of fresh water per year, the White House estimated.
  • Enhance Cooperation on Hydroflurocarbons (HFC): Building on the historic Sunnylands agreement between President Xi and President Obama regarding HFCs, the U.S. and China will enhance bilateral cooperation to begin phasing down the use of high global warming potential HFCs, including through technical cooperation on domestic measures to promote HFC alternatives and to transition government procurement toward climate-friendly refrigerants.
  • Launch a Climate-Smart/Low-Carbon Cities Initiative: Urbanization is a major trend in the 21st century, and cities worldwide account for a significant percent of global GHG emissions. In response, the U.S. and China are establishing a new initiative on Climate-Smart/Low-Carbon Cities under the U.S.-China CCWG. Under the initiative, the two countries will share city-level experiences with planning, policies, and use of technologies for sustainable, resilient, low-carbon growth. This initiative will eventually include demonstrations of new technologies for smart infrastructure for urbanization. As a first step, the U.S. and China will convene a Climate-Smart/Low-Carbon Cities Summit where leading cities from both countries will share best practices, set new goals, and celebrate city-level leadership.
  • Promote Trade in Green Goods: The U.S. announced that Commerce Secretary Penny Pritzker and Energy Secretary Ernest Moniz will lead a Smart Cities/Smart Growth Business Development Mission to China April 12-17, 2015, focused on green infrastructure, energy efficiency, and environmental trade sectors. The mission will highlight the benefits of sustainable urbanization, technologies to support China’s air pollution and climate goals, and green buildings opportunities.
  • Demonstrate Clean Energy on the Ground: The U.S. will undertake a number of additional pilot programs, feasibility studies, and other collaborative efforts to promote China’s energy efficiency and renewable energy goals. These will include expansion of cooperation on “smart grids” that enable efficient and cost-effective integration of renewable energy technology, as well as the implementation through a U.S. and Chinese private sector commercial agreement of a first-of-its-kind 380 megawatt (MW) concentrating solar plant in China.

The announcement was greeted with opposition by GOP leaders. Congressional Republicans pledged to do everything they could to undo the Obama Administration’s emissions targets for power plants. The U.S.-China announcement is a “nonbinding charade,” stated Senator Jim Inhofe (R-OK), the leading Republican critic on climate policy. Inhofe, the likely incoming Chair of the Senate Environment and Public Works Committee who has long disputed the science on global warming, vowed to use his perch in Congress to restrain the Administration on energy and climate policy. “This announcement is yet another sign that the president intends to double-down on his job-crushing policies no matter how devastating the impact for America’s heartland and the country as a whole,” stated Speaker of the House John Boehner of Ohio. Senator Mitch McConnell of Kentucky, the soon-to-be majority leader, was no less critical. “This unrealistic plan, that the president would dump on his successor, would ensure higher utility rates and far fewer jobs,” he stated.

EPA Issues NODA And Supplemental Proposal On Clean Power Plan: On October 30, 2014, EPA issued a Notice of Data Availability (NODA) (79 Fed. Reg. 64543) and on November 4, 2014, EPA issued a Supplemental Proposal (79 Fed Reg. 65481). On June 18, 2014, EPA issued arguably the most ambitious and contentious rule in its history: the Clean Power Plan. 79 Fed. Reg. 34829. The proposed rule takes direct aim at the coal industry by requiring a 30 percent reduction in CO2 emissions from existing fossil fuel-fired power plants by 2030, using 2005 as the baseline year. The Clean Power Plan proposal is a centerpiece of President Obama’s Climate Change Action Plan and would, for the first time, impose regulatory limits on carbon pollution from existing power plants, the largest source of GHG emissions in the U.S. The proposal does not establish specific emission limits for existing utilities. Instead, the Clean Power Plan has two main parts: state-specific emission rate-based CO2 enforceable state goals to cut carbon pollution per megawatt hour of electricity generated, and guidelines to help states develop plans for meeting the goals. The goal is a target states must meet by 2030, while starting to make meaningful progress toward reductions by 2020. States would be required to develop plans to meet the goals, although EPA is not prescribing a specific set of measures for states to incorporate into their plans. EPA believes this approach will give states flexibility in what measures they put into the plans. Each state’s goal is a rate — a single number for the future carbon intensity of the state. Each state’s goal also would reflect that CO2 emissions from fossil fuel-fired power plants are determined both by how efficiently and how much they operate. The proposed rule would give states ten to 15 years to achieve the reductions, and states will be able to choose how to meet the goal through whatever measures reflect their particular circumstances. States can develop their own plans or develop regional, multi-state approaches. In the NODA, EPA provides additional information on three main issues raised by stakeholders and also solicits comment on these issues: the emission reduction compliance trajectories created by the interim goal for 2020 to 2029, certain aspects of the building block methodology, and the way state-specific CO2 goals are calculated. Comments are due by December 1, 2014. Comments on the Supplemental Proposal are due December 19, 2014.

EPA Expands List Of Acceptable Substitutes For Ozone-Depleting Substances: On October 21, 2014, EPA issued a Determination of Acceptability expanding the list of acceptable substitutes for ozone-depleting substances (ODS) under EPA’s Significant New Alternatives Policy (SNAP) program. 79 Fed. Reg. 62863. The rule lists as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, and fire suppression and explosion protection sectors. EPA’s SNAP program under Clean Air Act (CAA) Section 612 authorizes EPA to develop lists of both acceptable and unacceptable substitutes for ODSs. Substitutes are used in a wide variety of industrial sectors, including refrigeration, cleaning solvents, and fire suppression. They are also regulated under the international Montreal Protocol, a treaty originally drafted to protect the ozone layer that has also become a venue to discuss limiting substances, including HFCs, with a high global warming potential. New substitutes include trans-1-chloro-3,3,3-trifluoropop-1-ene in non-mechanical heat transfer and in flexible poloyurethane foams. The list also includes R-450A for refrigeration and air conditioning, and methylal and hydrofluoroolefin-1336-mzz for a variety of foam blowing uses, according to the notice. The Determination was effective on October 21, 2014.

Federal Agencies Release Sustainability And Climate Change Adaption Plans: On October 31, 2014, federal agencies released plans for reducing GHG emissions and preparing for climate change impacts such as flooding, sea level rise, severe weather, and temperature extremes. These Sustainability Plans and Climate Change Adaptation Plans coincide with the fifth anniversary of President Obama’s 2009 Executive Order on Environmental, Energy and Economic Performance, which set aggressive energy, climate, and environmental targets for agencies. The plans are available online.

U.S. Fines Hyundai And Kia $100 Million In Record CAA Case: On November 3, 2014, EPA and the U.S. Department of Justice announced an historic settlement with automakers Hyundai and Kia that will resolve alleged CAA violations based on their sale of close to 1.2 million vehicles that will emit approximately 4.75 million metric tons of GHGs in excess of what the automakers certified to EPA. In a consent decree lodged in federal court, the automakers agreed to pay a $100 million civil penalty, the largest in CAA history, to resolve violations concerning the testing and certification of vehicles sold in the U.S. The companies also agreed to spend approximately $50 million on measures to prevent any future violations and to forfeit 4.75 million GHG emission credits that the companies previously claimed, which are estimated to be worth over $200 million. EPA and the California Air Resources Board (CARB) claim that the car companies sold close to 1.2 million cars and SUVs from model years 2012 and 2013 whose design specifications did not conform to the specifications the companies certified to EPA, which led to the misstatements of GHG emissions. Hyundai and Kia also allegedly gave consumers inaccurate information about the real-world fuel economy performance of many of these vehicles. Hyundai and Kia reportedly overstated the fuel economy by one to six miles per gallon, depending on the vehicle, EPA claims. Similarly, they understated the emissions of GHGs by their fleets by approximately 4.75 million metric tons over the estimated lifetime of the vehicles.


Belgium Publishes Decree On The Nanomaterial Register: The Belgian Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale, a Report to the King, and the Opinion of the Council of State were published in the September 24, 2014, issue of the Official Gazette. Substances defined as nanomaterials, and mixtures containing them, must be registered by the Belgian Federal Public Service for Health, Food Chain Safety and the Environment if at least 100 grams of the substance or mixture is placed on the market during the year covered by the registration, and if the entity putting the substance on the market produced this substance or mixture, or puts it on the market for professional users only. Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of the Royal Decree. Nanomaterials subject to declaration requirements must be registered by January 1, 2016, if they are already on the market by this date. After January 1, 2016, all nanomaterials concerned must be registered before being placed on the market. Mixtures subject to declaration requirements must be registered by January 1, 2017, if they are already on the market by this date. After January 1, 2017, all mixtures concerned must be registered before being placed on the market.

PCAST Calls For Nanotechnology Community To Take On National Nanotechnology Grand Challenges: On October 10, 2014, the Office of Science and Technology Policy (OSTP) announced that the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fifth Assessment of the National Nanotechnology Initiative, which concludes that the nanotechnology community is at an important turning point. PCAST recommends that the federal government accelerate its activities aimed at facilitating the commercialization of federally sponsored research, “thereby enabling the Nation to reap the benefits of this investment.” To help focus the commercialization process, PCAST calls for the nanotechnology community to take on a series of national nanotechnology Grand Challenges. Specific nanotechnology Grand Challenges would provide a way to turn scientific advances into products that leverage existing opportunities and meaningfully address existing needs. In the report, PCAST recommends that the federal government establish and execute a process for engaging the nanotechnology community to identify specific Grand Challenges that best support these goals. PCAST also provides some specific recommendations regarding the formulation of the Grand Challenges and innovation prizes and public-private partnerships to support them, as well as a focus on manufacturing challenges. Finally, the report details several program management updates to leadership initiatives, advisory input, evaluation metrics, and other areas to ensure the continuing success of the National Nanotechnology Initiative.

EPA Promulgates SNUR For Functionalized Carbon Nanotubes (Generic): On October 27, 2014, EPA promulgated SNURs for 52 chemical substances, including “functionalized carbon nanotubes (generic)” (see related item above). 79 Fed. Reg. 63821. According to the Federal Register notice, the PMN states that the substance will be used as a thin film for electronic device applications. The notice states that, as described in the PMN, EPA “does not expect significant occupational exposures due to the use of impervious gloves, where there is potential for dermal exposure, and because the PMN is used in liquid form and is not spray applied.” In addition, EPA does not expect environmental releases during the use identified in the PMN submission. EPA states that it has determined, however, “that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects.” The rule is effective on December 26, 2014. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, must be received by November 26, 2014.

Summary Of IARC Working Group Meeting On Some Nanomaterials And Some Fibers Published: The International Agency for Research on Cancer (IARC) Working Group met on September 30-October 7, 2014, to review the carcinogenicity of fluoro-edenite, silicon carbide (SiC) fibers and whiskers, and carbon nanotubes (CNT). A summary of the evaluations has now been published in The Lancet Oncology. The summary states:

Fluoro-edenite fibrous amphibole was classified as carcinogenic to humans (Group 1) on the basis of sufficient evidence in humans that exposure to fluoro-edenite causes mesothelioma. Sufficient evidence of carcinogenicity was also reported in experimental animals, with increased incidences of mesotheliomas observed in one study in male and female rats given fibrous fluoro-edenite by intraperitoneal or intrapleural injection. The results of the few available mechanistic studies were consistent with proposed mechanisms of fibre carcinogenicity.

According to the summary, SiC particles are manufactured mainly by the Acheson process, with SiC fibers being unwanted byproducts. The summary states:

Occupational exposures associated with the Acheson process were classified as carcinogenic to humans (Group 1) on the basis of sufficient evidence in humans that they cause lung cancer. Since the correlation between exposures to SiC fibres and cristobalite made it difficult to disentangle their independent effects, the Working Group concluded that fibrous SiC is possibly carcinogenic to humans (Group 2B) based on limited evidence in humans that it causes lung cancer. No data on cancer in humans exposed to SiC whiskers were available. In experimental animals, there was sufficient evidence for the carcinogenicity of SiC whiskers, with mesotheliomas observed in three studies in female rats treated by intrapleural implantation, intrapleural injection, or intraperitoneal injection, and in one inhalation study in rats that did not include concurrent controls. Although not unanimous, the Working Group classified SiC whiskers as probably carcinogenic to humans (Group 2A) rather than possibly carcinogenic to humans (Group 2B), on the basis that the physical properties of the whiskers resemble those of asbestos and erionite fibres, which are known carcinogens. In addition, the results of available mechanistic studies were consistent with proposed mechanisms of fibre carcinogenicity. The majority of the Working Group considered that differences in the nature of SiC fibres and SiC whiskers warranted separate evaluations.

The Working Group reviewed single-walled CNTs (SWCNT) and multi-walled CNTs (MWCNT). The summary states that no human cancer data were available, “indicating inadequate evidence for the carcinogenicity of CNTs in humans.” The Working Group reviewed studies in rodents and in cultured human lung or mesothelial cells. The summary states:

As a whole, the Working Group acknowledged that the above mechanisms are all relevant to humans. However, a majority did not consider the mechanistic evidence for carcinogenicity — especially concerning chronic endpoints — to be strong for any specific CNT. Furthermore, the lack of coherent evidence across the various distinct CNTs precluded generalisation to other types of CNTs. Thus, MWCNT-7 was classified as possibly carcinogenic to humans (Group 2B); and SWCNTs and MWCNTs excluding MWCNT-7 were categorised as not classifiable as to their carcinogenicity to humans (Group 3).

Australian Pesticides And Veterinary Medicines Authority Hosts Symposium On Nanotechnology Regulation: On October 28, 2014, the Australian Pesticides and Veterinary Medicines Authority (APVMA) held a nanotechnology regulation symposium on developing a regulatory framework for nanotechnologies in Australian agriculture and animal husbandry. The program was based on a draft report entitled Regulatory Considerations for Nanopesticides and Veterinary Nanomedicines. The report addresses relevant aspects of nanotechnology, including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The draft report suggests that “a pragmatic approach, based on the durability of formulated product, may be the way forward.” According to the draft report, nanoparticles require a very different approach for fate and effect assessment to that for conventional agricultural and veterinary (AgVet) chemicals. The report recommends a minimum set of characterization criteria for nano-AgVet chemicals. APVMA intends to release a final document by the end of January 2015.

Lynn L. Bergeson Speaks At SNO 2014 Conference: During the Sustainable Nanotechnology Organization’s (SNO) 2014 Conference, held November 2-4, 2014, in Boston, Massachusetts, Lynn L. Bergeson presented the session “Current Developments in Nanotechnology Law and Policy.” SNO, a non-profit, international professional society dedicated to advancing sustainable nanotechnology through education, research, and promotion of responsible development of nanotechnology, intended the conference to bring together scientific experts from academia, industry, and government agencies to present and discuss current research findings on the subject of nanotechnology and sustainability. The conference emphasized not only the environmental aspects of sustainability, but also the societal and economic sustainability issues. The conference program addressed the critical aspects of sustainable nanotechnology, such as life cycle assessment, green synthesis, green energy, industrial partnerships, environmental and biological fate, and the overall sustainability of engineered nanomaterials. SNO, together with Sustainable Nanotechnologies (SUN) and GUIDENANO, two large European Union FP7 nanosafety projects, will convene the SUN-SNO-GUIDENANO Sustainable Nanotechnology Conference 2015 on March 9-11, 2015, in Venice, Italy. The conference program will address the critical aspects of sustainable nanotechnology such as life cycle thinking; environmental release and fate of engineered nanomaterials (ENM); environmental, occupational, and consumer exposure to ENMs; environmental and human health impacts of ENMs; safe production, handling, and disposal of ENMs; regulatory and industrial decision support for sustainable nanotechnology; nanotechnology applications for sustainability; societal implications of nanotechnology; and curriculum and training for sustainable nanotechnology.

CRIS Will Hold First Open House In November: The Center for Research on Ingredient Safety (CRIS), which was established at Michigan State University (MSU) in partnership with the Grocery Manufacturers Association in April 2014, will hold its first open house on November 20-21, 2014. Members and prospective members will have the opportunity to meet MSU President Lou Anna K. Simon, hear presentations, and participate in round table discussions. CRIS will be modeled after already existing centers of expertise at other academic institutions, which focus on allergen and microbiological safety. As an independent, academic, science-based center, CRIS will serve as a reliable and unbiased source for information, research, training, and analysis on the safe use of chemical ingredients in consumer packaged goods, including foods, beverages, cosmetics, and household consumer products. Founding members of CRIS include Cargill, Kellogg’s, Unilever, ConAgra Foods, Campbell’s, McCormick, General Mills, Hormel Foods, PepsiCo, Hershey’s, Coca-Cola, EcoLab, Bumble Bee Foods, LLC, Mondelez International, Kraft Foods, and Bush’s Best. Registration for the open house will close November 14, 2014.


BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C Consortia Management, L.L.C. (BCCM), 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

USDA Proposes Amended Voluntary Labeling Program For Biobased Products: On October 27, 2014, USDA proposed to amend the regulations for the Voluntary Labeling Program for Biobased Products under USDA’s BioPreferred Program. 79 Fed. Reg. 63846. As explained in the Federal Register notice, the proposed amendments are needed to address certain legislative requirements in the 2014 Farm Bill that cannot be implemented without further guidance. Specifically, the proposed amendments allow for USDA promotion of biobased products regardless of date of entry into the marketplace, which overrides previous provisions that excluded mature market products. The proposal includes USDA promotion of biobased products, including forest products that incorporate “innovative approaches” per the direction of Congress. The proposal also revises the definition of “biobased product” to include forest products that meet biobased content requirements, regardless of the product’s market share, age, or whether it is new.

The major provisions of the proposed rule include:

  • Changes to Definitions: USDA proposes to delete definitions of “BioPreferred Product,” “Designated Item,” and “Mature Market Products.” USDA proposes to revise the definitions of “Biobased Product,” “Certification Mark Artwork,” and “Intermediate Ingredient or Feedstock,” and to add new definitions for “Designated Product Category,” “Forest Product,” “Qualified Biobased Product,” and “Renewable Chemical.”
  • Changes to “Criteria for Product Eligibility to Use the Certification Mark”: USDA proposes to describe the biobased content criteria for complex assemblies and to update the voluntary labeling program rules to include these products. USDA also proposes to present the criteria for determining whether a product is using “innovative approaches.”
  • Changes to “Initial Approval Process”: USDA proposes to address situations in which a manufacturer seeks certification for a product that is similar in biobased ingredients and contact to a previously certified product. The proposal also clarifies that manufacturers of certified products are subject to periodic auditing and potential suspension or revocation of certification if violations are found. USDA also proposes to revoke a certification if an error is discovered during the USDA approval process.
  • Changes to “Oversight and Monitoring”: USDA proposes specific auditing efforts that will be used for the voluntary labeling program. USDA plans to audit the program on an ongoing basis with specific audit activities scheduled every other calendar year.

The proposed rule is open for comment for 60 days, with a comment deadline of December 26, 2014. More information is available in the USDA press release on the voluntary labeling program proposal.

USDA Proposes Amended Guidelines For Biobased Products For Federal Procurement: USDA issued a second rulemaking related to its BioPreferred program on October 27, 2014. 79 Fed. Reg. 63841. That proposed rule would update the Guidelines for Designating Biobased Products for Federal Procurement under the USDA BioPreferred program, consistent with the 2014 Farm Bill. As noted in the Federal Register announcement, the proposed guidelines would not affect products already designated for federal procurement preference. Like the proposal for changes in the USDA Voluntary Labeling Program (see above), this proposal includes criteria for evaluating “innovative approaches,” which are critical to determining what products should be included in the program. It also includes a revised definition for “biobased product,” new definitions for “forest product” and “renewable chemical,” and deletion of the definition for “forestry materials.” The proposed guidelines would mandate that federal agencies report amounts and types of biobased products purchased and establish targeted biobased-only procurement requirements. Comments are due December 26, 2014.


EPA Calls For Nominations For 20th Annual Presidential Green Chemistry Challenge Award: On November 13, 2014, EPA announced its call for nominations for the 2015 Presidential Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment. The Presidential Green Chemistry Challenge Awards promote the environmental and economic benefits of developing and using novel green chemistry. These prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use. EPA’s Office of Chemical Safety and Pollution Prevention sponsors the Presidential Green Chemistry Challenge Awards in partnership with the American Chemical Society Green Chemistry Institute® and other members of the chemical community, including industry, trade associations, academic institutions, and other government agencies. Nominations for innovative technologies in six categories are due to the Agency by December 31, 2014See the 2015 Presidential Green Chemistry Challenge Awards nomination package. The categories are: academic; small business; greener synthetic pathways; greener reaction conditions and designing greener chemicals; and a new category for climate change. The awardees will be honored at a ceremony in Washington, D.C., in July 2015. Since the inception of the awards 20 years ago, EPA has received more than 1,500 nominations and presented awards to 98 technologies. It has resulted in the reduction of more than 826 million pounds of hazardous chemicals and solvents, savings of 21 billion gallons of water, and elimination of 7.8 billion pounds of CO2 releases to air.


OSHA Denies Request To Extend Deadline; Agrees To Provide Enforcement Discretion On June 1, 2015, Deadline: On October 31, 2014, the Occupational Safety and Health Administration (OSHA) responded to an August 2014 petition from the American Coatings Association (ACA) and other trade associations to extend the June 1, 2015, regulatory deadline in OSHA’s Hazard Communication Standard (HCS) for updating labels and Safety Data Sheets (SDS). Although OSHA denied the ACA petition, it agreed to provide formulated product manufacturers with relief from the June 1, 2015, deadline in the form of an enforcement policy letter and a compliance directive rather than reopening the rule itself. ACA and eight other trade associations petitioned OSHA to extend the HCS compliance date for chemical product formulators to June 1, 2017, arguing that compliance with the deadline for many manufacturers of formulated products has been virtually impossible because manufacturers of raw materials are not required to provide SDSs that conform to the new standard until June 1, 2015. Because formulators may not receive updated SDS from their suppliers until June 1, 2015, ACA argued that its members “cannot develop accurate hazard classifications and produce complete labels and SDSs for their formulated products that are compliant with the new HCS classification scheme in time to meet the June 1, 2015 deadline.” In the October 31 letter, OSHA stated that it will exercise its enforcement discretion in cases where a regulated entity has performed due diligence and made a good faith effort to obtain the necessary information to comply with the June 1, 2015, deadline but is unable to do so. To this end, OSHA stated that regulated entities should document all efforts to obtain the required information, including attempts to contact their suppliers, and efforts to find other suppliers and to find relevant data themselves. This same enforcement discretion would apply to distributors that can demonstrate they received the hazard communication materials under this policy. ACA states that at an October 31, 2014, meeting OSHA confirmed that SDSs and labels do not have to be compliant with the new HCS requirements on June 1, 2015, so long as a company can demonstrate good faith efforts to comply. OSHA also stated that enforcement officers would consider the multitude of steps needed to create an SDS and label in determining what a reasonable time frame for compliance is. Based on the letter from OSHA and the discussions that occurred during the meeting, a company may avail itself of OSHA’s enforcement discretion and not be in compliance on June 1, 2015, if a company can show its labels and data sheets are in compliance with the current version of the HCS, the company is making good faith efforts to comply with the upcoming June 1, 2015, deadline and can demonstrate that because of circumstances beyond their control, they cannot comply by that date, and the company can provide a plan of implementation that will put them in compliance with the new HCS requirements within a reasonable period of time following June 1, 2015.


Senate GOP And Republican Caucuses Elect Leaders For 114th Congress: On November 13, 2014, the Senate Republican conference elected the following leadership team for the 114th Session of Congress: Mitch McConnell (R-KY) as Senate Republican Leader, John Cornyn (R-TX) as Senate Republican Whip, John Thune (R-SD) as Senate Republican Conference Chair, John Barrasso (R-WY) as Senate Republican Policy Chair, Roy Blunt (R-MO) as Senate Republican Vice Conference Chair, and Roger Wicker (R-MS) as National Republican Senatorial Committee Chair. Senate Democrats elected Harry Reid (D-NV) to the Minority Leader post and added Dick Durbin of Illinois, Chuck Schumer of New York, Patty Murray of Washington, and Amy Klobuchar of Minnesota to the leadership team. In a surprise move, Elizabeth Warren of Massachusetts was added to the newly created post of Strategic Policy Adviser to the Democratic Policy and Communications Committee, putting her in a much more prominent position in the Senate hierarchy.

House GOP Elects Leaders For 114th Congress: Ohio Republican John Boehner was elected by the GOP on November 13, 2014, to another two years as Speaker of the House. The full House must vote on Speaker position, but with Republicans in the majority his position is secured. Majority Leader Kevin McCarthy (CA) was also reelected to his post. Majority Whip Steve Scalise (LA), Conference Chair Cathy McMorris Rodgers (WA) and House GOP Campaign Chair Greg Walden (OR) were also re-elected by voice vote. In the only contested leadership race, Luke Messer (IN) was elected as Republican Policy Committee Chair. House Democrats have yet to elect their leadership.

Congressional Committee Chairmanships To Change After Mid-Term Elections: Congress returned to Washington after the mid-term elections, with Republicans in charge of both houses. The GOP will likely use the lame-duck session of Congress to establish leaders and committee chairs and implement strategies for blunting President Obama’s initiatives in the last two years of his presidency. Below are the most likely changes to committee leadership positions in those committees that impact environmental and product safety issues.

Senate Committees: With Republicans recapturing the Senate majority, GOP lawmakers now take the helm of several committees of interest. For the most part, those Republican Senators who were ranking members are likely to move into the chairman roles.

Environment and Public Works Committee: Senator James Inhofe of Oklahoma will take over the EPW reins from Barbara Boxer of California. His committee will have the primary role in overhauling TSCA. Inhofe was lauded by late Senator Frank Lautenberg for his assistance in working with stakeholders on TSCA reform. In a public statement, Inhofe stated that although TSCA’s current risk-based review process protects human health and the environment, he is open to changes to the law “ut only if those changes modernize chemical reviews, increase public understanding of the process, and strengthen protections for human health and the environment.” He set forth several principles that he believes any TSCA revisions must follow. These are:

  • The use of data and methods based on the best available science and risk-based assessment.
  • Including cost/benefit considerations for the private-sector and consumers.
  • Protecting proprietary business information, as well as information that should be protected for security reasons.
  • Prioritizing reviews for existing chemicals.
  • Eliminating provisions that encourage litigation or citizen suits.
  • Avoiding provisions that compel product substitution.

Inhofe is an unabashed skeptic of climate change and has sponsored numerous bills aiming to “rein in” EPA. He is also likely to be critical of many of EPA’s most prominent rules, including those on power-plant emissions, fracking, water quality, and other issues.

Budget: Jeff Sessions of Alabama will take over the Budget Committee. He is a fiscal conservative, a budget hawk, and a vocal critic of the Obama Administration’s spending policies.

Finance: Senator Orrin Hatch of Utah takes the helm of the Finance Committee and will have significant influence on the prospects for major tax and trade reform. He is a conservative politician, but one who has demonstrated the ability and willingness to reach across the aisle to Democrats.

Energy and Natural Resources: Lisa Murkowski of Alaska takes over this committee and is most likely to battle federal control of mining and drilling interests.

House Committees: Republicans retained control of the House in the mid-term elections, but because of retirements and party-imposed term limits on committee chairmen, more than half a dozen committees will be getting new chairmen. Under House rules, GOP members can only serve three terms as the senior member of a committee, unless they are granted a waiver by the Republican Steering Committee. Major House committees getting new leaders next year are:

Agriculture: With Oklahoma Representative Frank Lucas term-limited, Michael Conaway of Texas is the most likely replacement. Conaway now chairs the Ethics Committee.

Budget: Georgia Representative Tom Price is in line to succeed Paul Ryan as chairman of the Budget Committee. Price worked closely with Ryan in assembling prior GOP budgets and he is likely to take a similar approach in crafting this year’s budget.

Natural Resources: Utah Representative Rob Bishop is taking over this committee. He has pushed for more oil and gas leases on federal land and has accused the Obama Administration of using the Antiquities Act to designate unilaterally public acreage as national monuments off limits to developers.

Oversight and Government Reform: In a bit of good news for the Obama Administration, Representative Jason Chaffetz of Utah is considered the favorite to succeed term-limited Representative Darrell Issa of California. Chaffetz will likely be challenged by Michael Turner and Jim Jordan. Chaffetz, who chairs the Oversight panel’s national security subcommittee, has led the investigation into security breaches involving the Secret Service, giving him a high-profile. He is less confrontational than Issa and has reached out to Democrats on the panel, including ranking minority member Elijah Cummings of Maryland. Issa has been a major burr under the Obama Administration’s saddle, leading investigations on the Internal Revenue Service, the attacks in Benghazi, Libya, and other topics. Along the way he has alienated not just Democrats but also fellow Republicans with his confrontational and overbearing style. Chaffetz has made it clear he would do things differently. A strong conservative, he is liked by fellow Republicans and viewed as being dogged but not shrill in his committee role.

Ways and Means: Paul Ryan is moving from the Budget Committee to what is arguably the most powerful House committee chairmanship.

House Passes Legislation Authorizing Construction Of Keystone XL Pipeline: Wasting little time after their return to Washington, on November 14, 2014, the House passed legislation to authorize construction of the Keystone XL pipeline, setting the stage for a showdown in the Senate. Introduced by Representative William Cassidy (R-LA), the bill (H.R. 5682) was approved 252-161, with 31 Democrats joining Republicans in backing a construction permit for the controversial project, which would bring oil sands from Canada to refineries in the United States. The Senate is scheduled to vote the week of November 17, 2014, on a similar Keystone bill sponsored by Mary Landrieu (R-LA). If the Senate also passes Keystone legislation, President Obama would be put in a difficult position. Signing a bill could boost Landrieu in her runoff battle in Louisiana against Cassidy, but it would also be seen as a gross insult to environmental groups who have fought for years to kill the project. Vetoing the bill, which the White House has signaled is likely, would set the stage for a new Keystone fight in January, when Senate Republicans might have enough votes to override a presidential veto altogether.


EU Launches Chemical Information Searching Tool: On October 28, 2014, the European Commission released a new online site, ChemAgora, to enable searches for chemical information from multiple databases. Searches can be conducted by chemical name or partial name, by Chemical Abstracts Service Registry Number, by International Chemical Identifier Number, and by chemical structure (a drawing of the molecule). The Commission’s Joint Research Center searches 12 databases and offers links to the specific pages where more information about the chemical is available. ChemAgora’s website is

UN Report Urges Rapid End To Use Of Fossil Fuels: The unrestricted use of fossil fuels must end soon if the world is to avoid dangerous climate change. That is the central message of a stark new report from the United Nations (UN) Intergovernmental Panel on Climate Change (IPCC). The IPCC urges that by 2050, most of the world’s electricity must and can be produced from low carbon sources. Fossil fuels, without carbon capture and storage (CCS), should be phased out “almost entirely” by 2100, the report states. The report was issued on November 2, 2014, in Copenhagen, after a week of intense debate between scientists and government officials. The report states the world faces “severe, pervasive and irreversible” impacts without effective action on carbon. The report suggests renewables will have to grow from their current 30 percent share to 80 percent of the power sector by 2050. In the longer term, the report states “fossil fuel power generation without CCS is phased out almost entirely by 2100.” Three previous reports from the IPCC, issued over the past year, have outlined the causes, impacts, and potential solutions to climate change. The most recent report distills these three reports into one, with the intention of informing politicians engaged in attempts to deliver a new global treaty on climate by the end of 2015. It re-states many familiar positions:

  • Warming is “unequivocal” and the human influence on climate is clear;
  • Since the 1950s, the observed changes are unprecedented over decades to millennia;
  • The period from 1983 to 2012 was likely the warmest 30-year period of the last 1,400 years;
  • Warming impacts are already being seen around the globe; and
  • Without concerted action on carbon, temperatures will increase over the coming decades and could be almost 5C above pre-industrial levels by the end of this century.

Politicians have agreed that a rise of 2 degrees Celsius is the threshold of danger. In this report, the IPCC authors outline a number of routes to keep to that level by the end of the century. Countries will need to adapt rapidly, but almost all scenarios see near zero emissions by 2100.

EPA Expands Administrative Enforcement Process To Include Ship Air Pollution Fines: On November 6, 2014, EPA issued a direct final rule to expand its administrative civil penalty procedures to include air pollution penalties assessed under the Act to Prevent Pollution from Ships. 79 Fed. Reg. 65897. EPA’s administrative enforcement proceedings apply EPA’s enforcement of environmental statutes including the CAA and the Clean Water Act. It was established to provide “uniform procedural rules” for administrative enforcement adjudications conducted by EPA’s administrative law judges or regional judicial officers. EPA stated that applying its administrative enforcement proceedings to ship air pollution, based on engine and fuel standards, “will provide for the efficient and effective adjudication, including administrative appeals, of such proceedings consistent with statutory requirements.” It will also provide “consistency and uniformity” in all of EPA’s administrative penalty proceedings. EPA considers the rule noncontroversial. If adverse comments are received by December 8, 2014, EPA will withdraw the rule. EPA also proposed the same rule on November 6, 2014. 79 Fed. Reg. 65910. Comments are due by December 8, 2014.

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.