Monthly Update for January 2016


TSCA/FIFRA/IRIS/NTP/TRI

EPA Seeks Comment And New Information On Risk Assessments For Pending PMNs For Chlorinated Paraffins: On December 23, 2015, the U.S. Environmental Protection Agency (EPA) requested "new available data on certain chlorinated paraffins" in different industries for different uses, and comment on risk assessments for long- and medium-chain chlorinated paraffins prepared in the context of EPA's review of certain premanufacture notices (PMN) submitted under Section 5 of the Toxic Substances Control Act (TSCA) New Chemicals Program. 80 Fed. Reg.79886. According to EPA, chlorinated paraffins are used primarily in metal working fluids and sealants, resins, and coatings. EPA is currently reviewing these "new" chemical notices (for chemicals that have been in the market place for decades) and is requesting new available data on a range of environmental releases. This information will, according to EPA, inform the risk assessments for chlorinated paraffins submitted as TSCA new chemical notices. Comments are due by February 22, 2016.

EPA Launches Pesticide Worker Protection Dashboard: EPA recently launched a new Pesticide Worker Protection Dashboard (Dashboard). EPA states this Dashboard is "focused on the universe of agricultural operations regulated and farm workers and pesticide handlers covered by the Worker Protection Standard." EPA states that the Dashboard provides charts and graphs presenting certain key enforcement and compliance information related to the Worker Protection Standard (WPS) program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, the Dashboard has screens that show the number of WPS inspections conducted, the number of violations found during inspections, the types of violations found, and the types and numbers of enforcement actions taken. Since the Dashboard is interactive, users can find answers to questions such as: how many facilities in the United States employ workers or handlers covered by the WPS; how many inspections are reported; and how many violations have been found, and what enforcement actions have been taken by states, tribes, and/or EPA.

EPA states that Dashboard information from states and tribes is compiled from data on state and tribal inspections and regulatory actions submitted annually (Form: 5700-33H) to EPA. This form provides information regarding the number of WPS inspections conducted, the types and numbers of violations found, and the number and types of regulatory actions taken during the year. EPA inspection data are obtained from EPA's Integrated Compliance Information System (ICIS) database. Other information is compiled from data from the U.S. Department of Agriculture's (USDA) National Agricultural Statistics Service's Agricultural Statistics, 2007 and 2012 Census of Agriculture database. EPA makes several caveats to the data presented, including: (1) EPA does not require regional offices to enter all regulatory actions into ICIS, so many "informal" actions are not recorded; (2) the data included in the Dashboard do not reflect all compliance monitoring/inspections or enforcement activities, nor the full extent of enforcement activity within a state or tribe; and (3) tribal inspections and enforcement actions conducted under sovereign tribal authority and regulations are not EPA reviewed or reported, and are not included in the Dashboard. The Dashboard shows data from 2010 to 2014 to provide context at the national level, or within a state or tribe. EPA plans to update the information annually when new data are available (e.g., after annual state and tribal reporting forms are submitted to EPA). The Dashboard provides interesting information and should be monitored, as many groups will likely use it in support of their unique interests. More information on the WPS is available at Agricultural Worker Protection Standard.

EPA Issues Final Rule On Minimum Risk Pesticide Exemption: On December 28, 2015, EPA issued a final rule clarifying the active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption from registration under FIFRA. 80 Fed. Reg. 80653. The rule codifies the inert ingredients list by adding, where available, specific chemical identifiers for all eligible active and inert ingredients in minimum risk pesticide products. According to EPA, the specific identifiers will make it easier for manufacturers, the public, and federal, state, and tribal inspectors to determine the chemical substances that are permitted in minimum risk pesticide products. EPA also modified the labeling requirements in the exemption to require products to list ingredients on the label with a designated label display name and to provide the producer's contact information on the product's label. The rule is effective on February 26, 2016. The compliance date for the requirements to label ingredients and to provide company contact information is February 26, 2019.

EPA Addresses TSCA Section 21 Petition Relating To Inventory Equivalency: On January 12, 2016, EPA published its response to a TSCA Section 21 petition submitted by the Biobased and Renewable Products Advocacy Group (BRAG®) (managed by Bergeson & Campbell, P.C.'s (B&C®) affiliate, B&C® Consortia Management, L.L.C.). 81 Fed. Reg. 1365. The petition requested that EPA initiate a TSCA rulemaking to establish a process to amend the list of natural sources of oil and fat in the Soap and Detergent Association (SDA) nomenclature system by considering the chemical equivalence of additional natural sources. EPA denied the petition for rulemaking under TSCA Section 21, but in so doing, EPA identified several approaches, other than the requested rulemaking, that may achieve the same goals.

EPA Seeks Comment On Draft Guidelines For Human Exposure Assessment: On January 7, 2016, EPA requested comment on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). 81 Fed. Reg. 774. According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the National Academy of Sciences (NAS) and EPA's Science Advisory Board (SAB). The draft Guidelines build on topics covered in the 1992 exposure guidelines, including planning and scoping for an assessment, data acquisition and use, modeling, and considerations of uncertainty in exposure assessment. The draft Guidelines also include new material on planning and conducting an observational human exposure measurement study and considerations of lifestages and sensitive populations in exposure assessments. EPA states that the draft Guidelines "present the most current science used in EPA exposure assessments and incorporates information about the Agency's current policies." The draft Guidelines state that the focus is on human exposure to chemical agents (stressors) in the non-occupational environment. The exposed populations (e.g., receptors) to which the draft Guidelines refer are adults and children or other vulnerable groups within the human population. The draft Guidelines are organized in chapters, each of which explores a component of the exposure assessment process. The draft Guidelines represent EPA's efforts to incorporate developments in the risk assessment area since the first version of this guidance was released in 1992. The documents used as the primary source for this update are listed on pages 1 and 2 of the new guidelines. The organization from the earlier version is retained for the most part in the current version. The original version consisted of seven chapters plus references while the recent version includes two new chapters: Chapter 4, Consideration of Lifestages, Vulnerable Groups and Populations of Concern in Exposure Assessments, and Chapter 7, Planning and Implementing an Observational Human Exposure Measurement Study. These topics were briefly mentioned in the 1992 version. EPA states that it is seeking public comment prior to external peer review. The draft Guidelines will undergo review during an expert peer review meeting that an independent contractor will convene, organize, and conduct. EPA's effort in revising the guidelines appears to consist of careful editing of the older text and integration of selected material from the sources listed on page 1. On first inspection, there appears to be little or no new/original writing that resulted from this merger of existing sources. Given that most of the cited sources were peer reviewed when developed, it is unclear if the peer reviewers for the 2015 document will focus on science issues or subjects like organization, readability, usefulness, and related features. Comments are due February 22, 2016.

EPA Files Reply In Support Of Its Motion For Voluntary Vacatur And Remand: On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), EPA filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor Dow AgroSciences LLC (DowAgro) for Enlist Duo herbicide under FIFRA. DowAgro responded to the motion by agreeing that remand is appropriate but opposing vacatur as an effort to circumvent the normal cancellation process, while the petitioners Center for Food Safety, et al. (CFS) filed a response supporting the motion for vacatur. More information on the DowAgro and CFS responses is available in our blog entry DowAgro and Center for Food Safety File Responses to EPA's Motion for Voluntary Vacatur and Remand. In its reply, EPA rejects the argument by DowAgro that it is trying to "short-circuit" the normal cancellation procedures under FIFRA. Citing recent Ninth Circuit precedent on vacatur, EPA argues that "vacatur would be more protective of the environment during the time in which EPA evaluates the new information, and Dow has failed to demonstrate any disruptive consequences of vacatur." EPA also takes issue with certain statements by CFS that it characterizes as "erroneous or irrelevant." EPA contradicts assertions by CFS that EPA overlooked important evidence concerning the synergistic effects of Enlist Duo's principal ingredients, that EPA determined that Enlist Duo will not protect endangered non-target plants, that EPA has violated the Endangered Species Act (ESA), and that EPA is approaching synergistic effects as a new issue. EPA also objects to the efforts of CFS to introduce an extra-record newspaper article. This case will continue to be watched closely, as there is widespread industry concern about EPA's effort to use a judicial process in lieu of normal adjudicatory procedures and about EPA's substantive approach to evaluating synergistic efficacy data. In this regard, it is noteworthy that the issue of potential synergistic effects is relatively narrow and does not appear to be among the purported deficiencies in the EPA decision originally cited by the petitioners.

EPA Makes Available Biological Evaluations For Pilot Chemicals: On December 11, 2015, the Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three "pilot" chemicals that are being evaluated: chlorpyrifos, diazinon, and malathion. For each chemical, the following supporting documents are now available: problem formulation; fate and effects characterizations; and related appendices. The provisional models are available here. EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process. The entire draft BEs for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016. The BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and USDA in response to NAS' April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, that examined topics pertaining to tools and approaches for assessing the effects of proposed FIFRA actions on endangered and threatened species and their critical habitats, and provided recommendations. More information is available at our blog.

Federal Agencies Challenge Tox Testing Developers: On January 8, 2016, EPA, the National Institutes of Health's National Center for Advanced Translational Sciences (NCATS), and the National Toxicology Program (NTP) threw down the gauntlet, as it were, and challenged toxicity testing developers to develop testing procedures that capture chemical metabolites. The Transform Tox Testing Challenge seeks to incentivize the development of modified high throughput screens to enable testing to predict chemical metabolite toxicity, a limitation that current testing protocols share. Participants are asked to propose commercially viable test methods for the federal agencies participating in the Challenge. The Challenge is in three stages. Stage 1, call for proposals, is from January 8, 2016, to April 8, 2016. Up to ten submissions will be selected and semi-finalists will be awarded $10,000 and invited to participate in the next stage of the competition. Stage 2, protocol development, is "to be determined." Stage 3, product testing, is also "to be determined." The winner is eligible for a reward of $400,000 to complete the development of the method. Semi-finalists will be announced on May 16, 2016. NTP's press release provides more information.

EPA Sued Over Guidance Classifying Seeds Coated With Neonicotinoid Insecticides As FIFRA Treated Articles Exempt From Registration: On January 6, 2016, a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (NGO) filed a complaint against EPA in the United States District Court for the Northern District of California. The petitioners allege that EPA has allowed "the ongoing sale and use of unregistered pesticide products" because EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be "treated articles" exempt from registration under 40 C.F.R. § 152.25(a). Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the "treated article" exemption and was in effect an unlawful rule issued without prior notice and comment. According to petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the "treated article" exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves. Based on this analysis, petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA. Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered. Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption. Petitioners also request that the District Court enjoin EPA from: (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself. The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the "treated article" exemption by including seeds coated with neonicotinoid insecticides are of significant concern. Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use.

EPA Opens Public Comment Period On First Of Four Preliminary Risk Assessments For Insecticides Potentially Harmful To Bees: On January 15, 2016, EPA opened a 60-day public comment period for its preliminary pollinator risk assessment for imidacloprid, a neonicotinoid insecticide. 81 Fed. Reg. 2212. After the comment period ends, EPA states that it may revise the pollinator assessment based on comments received and, if necessary, take action to reduce risks from the insecticide. The preliminary risk assessment identified a residue level for imidacloprid of 25 ppb, above which effects on pollinator hives are likely to be seen and below which effects are unlikely. These effects may include reduction in numbers of pollinators as well as the amount of honey produced.

The imidacloprid assessment is the first of four preliminary pollinator risk assessments for the neonicotinoid insecticides. Preliminary pollinator risk assessments for three other neonicotinoids, clothianidin, thiamethoxam, and dinotefuran, are scheduled to be released for public comment in December 2016. A preliminary risk assessment for all ecological effects for imidacloprid, including a revised pollinator assessment and impacts on other species such as aquatic and terrestrial animals and plants, will also be released in December 2016. EPA is planning to hold a webinar on the imidacloprid assessment in early February. The times and details will be posted online. Comments are due on or before March 15, 2016.

CWA/CAA

EPA Decides Not To Regulate Four Contaminants: On January 4, 2016, EPA announced final regulatory determinations not to issue national primary drinking water regulations for four of the 116 contaminants listed on the Third Contaminant Candidate List. 81 Fed. Reg. 13. The Safe Drinking Water Act, as amended in 1996, requires EPA to make regulatory determinations every five years on at least five unregulated contaminants. A regulatory determination is a decision about whether or not to begin the process to propose and promulgate a national primary drinking water regulation for an unregulated contaminant. On October 20, 2014, EPA published its preliminary determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos, and terbufos sulfone and begin the process to regulate strontium. EPA requested public comment on the determinations, process, rationale, and supporting technical information. EPA received comments from 14 individuals or organizations on the preliminary regulatory determinations. After review and consideration of the public comments, EPA decided not to regulate dimethoate, 1,3-dinitrobenzene, terbufos, and terbufos sulfone. EPA, however, is delaying the final regulatory determination on strontium to consider additional data and decide whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water.

FDA

FDA Proposes Two New Rules: On December 22, 2015 the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued two proposed rules. The two rules, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products and Sunlamp Products: Proposed Amendment to Performance Standard, aim to establish age restrictions for users and to address concerns about safety risks associated with indoor exposure to ultraviolet (UV) radiation. 80 Fed. Reg. 79493 and 80 Fed. Reg. 79505. Sunlamps and indoor tanning equipment are currently regulated as Class II medical devices. FDA is proposing restricting the use to minors and to update technical requirements to reflect current science. The comment period for both rules ends March 21, 2016.

FDA Creates New Office: On December 21, 2015, FDA Center for Food Safety and Applied Nutrition (CFSAN) announced the creation of a new Office of Dietary Supplemental Programs (ODSP). ODSP will allow the agency to address the growing market for dietary supplements and to continue to protect human health by providing better access to government resources and regulatory capabilities. The current Acting Director is Bob Durkin.

FDA Extends Comment Period: On December 28, 2015, FDA's CFSAN announced the extension of the comment period for the use of the term "natural" on the food label. 80 Fed. Reg. 80718. FDA is extending the comment period from February 10, 2016, to May 10, 2016, in response to requests from interested parties to allow more time to prepare comments.

FDA Revokes Food Additives Approval: On January 4, 2016, FDA's CFSAN revoked its food additive regulation for the use of three long-chain perfluorinated compounds as water repellents in paper and paperboard due to safety concerns. 81 Fed. Reg. 5. The rule was effective January 4, 2016. For more details, see online.

FDA CDRH Strategic Priorities: On January 14, 2016, FDA's CDRH announced its strategic priorities for 2016 - 2017. The three primary objectives are to "establish a National Evaluation System for medical devices," to "partner with patients," and to "promote a culture of quality and organizational excellence." In addition, the announcement contained details on how CDRH had met its strategic priorities for 2014 ? 2015, including a list of accomplishments for the two-year period.

NANOTECHNOLOGY

Danish EPA Posts Several Publications Regarding Nanomaterials: In December 2015, the Danish Environmental Protection Agency (Danish EPA) published the following publications, in English, concerning nanomaterials:

  • Better control of nanomaterials -- summary of the 4-year Danish initiative on nanomaterials: The "Better control of nanomaterials" initiative intended to create an overview of the possible risks of using nanomaterials, focusing on consumers and the environment. The report states: "Generally, there is still a need for more information on where nanomaterials are used, on which nanomaterials that are used and on the extent to which consumers and the environment are exposed to them." The report claims that industry has expressed general satisfaction with the creation of the Danish nano product register, yet states: "Initial experience from the first entries into the Danish register, however, seems to indicate that despite these efforts, it is difficult for many Danish companies to deal with nanomaterials and that it is difficult to obtain the necessary information from the manufacturers and supplie[r]s who are typically located abroad."
     
  • Nano-enabled environmental products and technologies -- opportunities and drawbacks: The report highlights how nano-enabled technologies could reduce health and environmental problems. The project focused specifically on solutions where the properties of nanomaterials are used to address health and environmental problems, including: (1) purification of water and wastewater; (2) remediation of soil and groundwater; (3) cleaning of air; (4) reduction of energy consumption; and (5) for improving hygiene in the health care sector by using the antibacterial properties of certain nanomaterials. According to the report, "there appears to be broad consensus among stakeholders that life cycle considerations are relevant to provide an overall view of health and environmental pros and cons of nanoproducts," but "surprisingly few" life cycle assessments have been conducted and published. The report states that existing studies indicate that one of the main trade-offs is whether the sometimes energy-intensive nanomaterial production phase and the use of sometimes scarce metals are outweighed by the benefits obtained in the use phase, where a considerably lower amount of material and more energy-efficient solutions are often applied, as compared to conventional technologies.
     
  • Carbon nanotubes: Types, products, market, and provisional assessment of the associated risks to man and the environment: The report provides a detailed overview of the variability and physico-chemical complexity of carbon nanotubes and how they are produced, purified, and surface modified. In addition, the report includes an overview of the different commercial uses of carbon nanotubes now and in the future, and describes carbon nanotube-exposure in relation to consumers, the environment, and workers. Finally, the report summarizes the existing knowledge of effects on humans and the environment and uses this information in a preliminary risk assessment.

EC Promulgates Final Novel Foods Regulation: The European Commission (EC) published the final novel foods regulation in the December 11, 2015, issue of the Official Journal of the European Union. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. Engineered nanomaterial means "any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale." Properties that are characteristic of the nanoscale include those related to the large specific surface area of the materials considered; and/or specific physico-chemical properties that are different from those of the non-nanoform of the same material. The regulation states that the European Food Safety Authority (EFSA) should verify that, where a novel food consists of engineered nanomaterials, "the most up-to-date test methods are used to assess their safety." When test methods are applied to engineered nanomaterials, applicants must provide an explanation of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made to respond to the specific characteristics of those materials.

IRSST Publishes Best Practices Guidance For Nanomaterial Risk Management In The Workplace: On December 11, 2015, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), a leading occupational health and safety research center in Canada, published the second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace. IRSST intends the Guidance to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial levels in different work environments, risk assessment, and the application of various risk management approaches. IRSST states that the Guidance provides practical information and prevention tools for the safe handling of nanomaterials in laboratories and pilot plants, as well as industrial facilities that produce or incorporate them. The Guidance recommends a preventive approach designed to minimize occupational exposure to nanomaterials. According to IRSST, given the different exposure pathways, the many factors that can affect nanomaterial toxicity and the health risks, its approach "is essentially based on hazard identification, different risk assessment strategies and a hierarchy of control measures, incorporating knowledge specific to nanomaterials when available." The second edition of the Guidance incorporates new information in the scientific literature. In addition, IRSST has included appendices describing initiatives in Québec workplaces; examples of at-risk situations described in the literature; preventive measures and data on their relative efficacy; and the implementation of measures to control exposure. IRSST notes that "solutions for any particular workplace must be developed on a case-by-case basis taking into account the risk assessment of each workstation."

The Netherlands Publishes Report On Nanotechnologies In Medical Devices: The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years. According to the report, knowledge is evolving on the safety evaluation of nanomaterials in general, and thus also when used in medical devices. The report states that current state-of-the-art guidance provides a "suitable base" for assessing the risk of nanomedical devices. The report states: "Nanomaterials exhibit specific characteristics that may or may not lead to toxic effects. As for all medical products, risk assessment of nanomedical products needs to be performed on a case-by-case basis. The potential for release, leading to a higher or lower exposure to nanomaterials, is considered the most important feature driving the extent of the risk assessment to be performed."

EC Requests Scientific Opinion On Three Coatings For Titanium Dioxide (Nano) As UV-Filter In Dermally Applied Cosmetic Products: On December 17, 2015, the Scientific Committee on Consumer Safety (SCCS) posted a request for a scientific opinion on three coatings for titanium dioxide (nano) as a UV-filter in dermally applied cosmetic products. According to the request, the EC received data from industry to assess the safety of the following coatings for titanium dioxide (nano form) used as a UV-filter in dermally applied cosmetic products: cetyl phosphate; manganese dioxide; and triethoxycaprylylsilane. The EC asks whether the SCCS considers safe the use of these materials as coatings for titanium dioxide (nano) used as UV-filter in dermally applied products, and whether the SCCS has any other scientific concerns. The deadline for SCCS's opinion is June 2016.

NIST Intends To Fund New Manufacturing Innovation Institutes: On December 22, 2015, the U.S. Commerce Department National Institute of Standards and Technology (NIST) announced that it issued a notice of intent to fund up to two institutes as part of the National Network for Manufacturing Innovation (NNMI). For the first institutes, the Commerce Department will provide up to $70 million per institute over five to seven years. Commerce funding must be matched by private and other non-federal sources. The Commerce Department expects the institutes to become self-sustainable within the time period of the award. The Commerce Department notes that this will be the first NNMI solicitation in which the funding agency has not predetermined an institute's area of focus. The Commerce Department states that NIST "is open to receiving proposals in any topic of interest to industry, particularly those relevant to manufacturing robotics and biopharmaceutical manufacturing." The NNMI Institutes bring together manufacturers, universities, community colleges, federal agencies, and state organizations with the goal of bridging the gap between basic research and product development. They are intended to accelerate innovation by focusing investment in industrially relevant, pre-competitive manufacturing technologies with broad applications. According to the press release, NIST plans to issue a solicitation for up to two new institutes in January 2016. The date and location of a Proposer's Day will be announced on www.grants.gov and at www.manufacturing.gov.

Proceedings Available On 2015 U.S.-EU Joint Workshop On Bridging Nanoehs Research Efforts: In December 2015, the proceedings from the March 12-13, 2015, U.S.-European Union (EU) joint workshop on "Bridging NanoEHS Research Efforts" were posted online. The workshop was sponsored by the EC and the National Nanotechnology Initiative (NNI). It brought together European and American scientists engaged in nanotechnology environmental, health, and safety (nanoEHS) research to identify areas of shared nanoEHS interest and mechanisms for collaboration to advance the science. The report includes information on the following:

  • NanoEHS Scrimmage:
     
    • Purpose and Goals;
       
    • Scrimmage Steps;
       
    • Results of the nanoEHS Scrimmage; and
       
    • Discussion of the Results and Recommendations.
       
  • Community of Research (COR) Breakout Sessions and Plenary Reports:
     
    • EcoToxicity COR;
       
    • Human Toxicity COR;
       
    • Databases and Computational Modelling for nanoEHS COR;
       
    • Exposure through Product Life COR;
       
    • Risk Assessment COR;
       
    • Risk Management and Control COR; and
       
    • Characterization COR.
       
  • Research Strategies:
     
    • Quality Assurance for the Characterization of Nanomaterials and Implementation of Labelling Requirements for Food and Consumer Products;
       
    • U.S. Progress Review on the Coordinated Implementation of the NNI 2011 EHS Research Strategy;
       
    • Research Needs and Data Gaps;
       
    • Regulatory Research Roadmap; and
       
    • EU Closer to the Market Roadmap.
       
  • Collaborations and Funding Opportunities"
     
    • U.S. Funding Opportunities;
       
    • NANoREG Progress Report, ProSafe, and NANoREG II; and
       
    • EU Funding Opportunities.
       
BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C's consulting affiliate, BCCM, manages 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.

LEGISLATIVE DEVELOPMENTS

Senate Passes TSCA Reform Bill: On December 17, 2015, the Senate unanimously passed by voice vote the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). B&C prepared a detailed analysis of the bill as compared with S. 697 passed by the Senate Environment and Public Works (EPW) Committee in June (Lautenberg2). This detailed review also briefly compares S. 697 to H.R. 2576, the TSCA Modernization Act of 2015, which passed the House of Representatives on June 23, 2015, to identify areas of alignment and dissonance. The memorandum is available online. Our review of Lautenberg2 is available online. B&C's 2016 Forecast memorandum provides further analysis and discussion of likely legislative next steps regarding TSCA reform and other significant legislative and regulatory initiatives.

Obama Disapproves Resolutions Blocking Clean Air Act Rules: On December 19, 2015, President Obama issued a "pocket veto" of two resolutions that would have blocked implementation of two EPA rules that curb emissions of greenhouse gas emissions from new and existing power plants. The resolutions -- S.J. Res. 23 and S.J. Res. 24 -- are joint resolutions providing for Congressional disapproval under Chapter 8 of Title 5 of the United States Code of EPA's rules. S.J. Res. 23 would nullify EPA's carbon pollution standards for new, modified, and reconstructed power plants (80 Fed. Reg. 64510; Oct. 23, 2015). S.J. Res. 24 would nullify the rule establishing emission limits on existing power plants (80 Fed. Reg. 64662; Oct. 23, 2015). The rules are the foundation of Obama's Clean Power Plan. Obama withheld his approval of the resolutions, resulting in a "pocket veto" of them. Under Article 7 of the Constitution, if the President refuses to approve or return the bill within ten days (not including Sunday), the bill automatically becomes law. If, in the interim, Congress has adjourned, the bill dies and the legislation must be reintroduced and passed again when Congress reconvenes. In a statement announcing the veto of S.J. Res. 23, Obama stated that "y blocking these standards from taking effect, [the resolutions] would delay our transition to cleaner electricity generating technologies by enabling continued build-out of outdated, high-polluting infrastructure. Because it would overturn carbon pollution standards that are critical to protecting against climate change and ensuring the health and well-being of our Nation, I cannot support the resolution. To leave no doubt that the resolution is being vetoed, in addition to withholding my signature; I am returning S.J. Res. 23 to the Secretary of the Senate, along with this Memorandum of Disapproval."

House Passes Bill Blocking Streams Rule; White House Threatens Veto: By a vote of 235-188, the House of Representatives on January 12, 2016, passed legislation that would block -- at least temporarily -- the Department of Interior (DOI) from promulgating in final a rule intended to protect streams from coal mining waste. The Supporting Transparent Regulatory and Environmental Actions in Mining Act (STREAM Act, H.R. 1644) would amend the Surface Mining Control and Reclamation Act of 1977 to direct DOI to make publicly available online and in the Federal Register, 90 days before publication, any draft, proposed, supplemental, final, or emergency rule, or any environmental analysis, economic assessment, policy, or guidance, and each scientific product upon which DOI has relied in developing the rule. The vote is largely symbolic, however, on January 11, the White House issued a Statement of Administration Policy promising to veto the legislation. "The Administration strongly opposes H.R. 1644, which would delay for at least three years updated regulations to protect streams from the effects of destructive surface coal mining practices," the White House stated. "Such a needless delay of these important safeguards would impact the communities and economies that depend on clean water and a healthy environment," stated the White House.

MISCELLANEOUS

Five New Substances Of Very High Concern Added To The REACH Candidate List: On December 17, 2015, the European Chemicals Agency (ECHA) added five new substances of very high concern (SVHC) to the Candidate List under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation due to the carcinogenic, toxic to reproduction, persistent, bioaccumulative and toxic (PBT), and very persistent and very bioaccumulative (vPvB) properties of the substances. The decision to include perfluorononan-1-oic acid and its sodium and ammonium salts was taken with the involvement of the Member State Committee. The Candidate List of SVHCs for authorization now contains 168 substances. Substances included in the Candidate List for authorization and their SVHC properties are:

No Substance
Name
EC
Number
CAS Number Reason for
Inclusion
Examples
of Use(s)
1 Nitrobenzene 202-716-0 98-95-3 Toxic for reproduction (Article 57 c) Manufacture of other substances
2 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) 223-383-8 3864-99-1 vPvB (Article 57 e) UV-protection agents in coatings, plastics, rubber and cosmetics
3 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) 253-037-1 36437-37-3 vPvB (Article 57 e) UV-protection agents in coatings, plastics, rubber and cosmetics
4 1,3-propanesultone 214-317-9 1120-71-4 Carcinogenic (Article 57 a) Electrolyte fluid of lithium ion batteries
5 Perfluorononan-1-oic-acid and its sodium and ammonium salts 206-801-3 375-95-1
21049-39-8
4149-60-4
Toxic for reproduction (Article 57 c) PBT (Article 57 d) Processing aid for fluoropolymer manufacture/
lubricating oil additive/
surfactant for fire extinguishers/
cleaning agent/
textile antifouling finishing agent/
polishing surfactant/
waterproofing agents and in liquid crystal display panels
(Source: ECHA website)

California Adds Two Chemical Classes To Biomonitoring List: The Scientific Guidance Panel (SGP) of the California Environmental Contaminant Biomonitoring Program (Biomonitoring California) has added two classes of chemicals to the state's list of priority chemicals for its Biomonitoring program. The classes of chemicals are ortho-phthalates and perfluoroalkyl and polyfluoroalkyl substances (PFAS). The purpose of Biomonitoring California is to determine levels of environmental chemicals in a representative sample of Californians, establish trends in the levels of these chemicals over time, and help assess the effectiveness of public health efforts and regulatory programs to decrease exposures to specific chemicals. More information is available online.

DOJ And DOL Enter Into MOU Regarding Workplace Safety Violations: On December 17, 2015, the U.S. Department of Justice (DOJ) and the U.S. Department of Labor (DOL) announced that they had entered into a Memorandum of Understanding (MOU) regarding criminal prosecutions of worker safety laws. The MOU establishes a process and framework for notification, consultation, and coordination between the DOJ and DOL to aid both agencies in effectively implementing workplace safety laws. DOJ will examine cases brought to it by the Occupational Safety and Health Administration, the Mine Safety and Health Administration, and the Wage and Hour Division to determine whether other charges could be prosecuted, such as witness tampering and violations of clean water and wire fraud laws. The MOU signals the agencies' enhanced emphasis on worker safety and a new willingness to criminalize workplace safety failures. The MOU is available online. The DOJ's letter to U.S. attorneys 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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