Monthly Update for February 2017
EPA Proposes Regulation Of TCE Use In Vapor Degreasing Under TSCA Section 6(a): On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing. 82 Fed. Reg. 7432. The proposed rule would prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing, prohibit commercial use of TCE in vapor degreasing, require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain, and require limited recordkeeping. Comments are due by March 20, 2017. More information is available on Bergeson & Campbell, P.C.’s (B&C®) website.
EPA Proposes TSCA Section 6(a) Rule For Methylene Chloride And NMP: On January 19, 2017, EPA proposed under TSCA Section 6(a) risk management restrictions on methylene chloride and N-methylpyrrolidone (NMP). 82 Fed. Reg. 7464. EPA proposed, among other restrictions, to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal. EPA also proposed similar restrictions for NMP, along with alternative proposals. Under the first approach proposed for NMP, EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of NMP for all consumer and commercial paint and coating removal, with exemptions for certain coating removal uses that EPA proposes are critical to national security. EPA is also proposing to prohibit the commercial use of NMP for paint and coating removal, with exemptions for certain coating removal uses that EPA proposes are critical to national security. These exemptions include the condition that any exempt paint and coating removal products containing NMP be packaged in containers with a volume no less than five gallons. Unlike the option proposed for methylene chloride, these exemptions do not include the use of NMP in furniture refinishing. EPA is also proposing to require manufacturers (including importers), processors, and distributors, except for retailers, of NMP for any use to provide downstream notification of these prohibitions throughout the supply chain, and to require limited recordkeeping. Under the second approach proposed for NMP, EPA is proposing a reformulation, personal protective equipment (PPE)), and labeling approach. This would require product reformulation to limit the concentration of NMP in paint and coating removal products; testing of product formulations to identify specialized gloves that provide protection; relabeling of products to provide additional information to consumers; an occupational dermal and respiratory protection program for commercial use of NMP in paint and coating removal, downstream notification when distributing NMP for other uses, and limited recordkeeping. Under this approach, no exemption is proposed for coating removal identified as critical for national security because paint and coating removal products containing NMP would continue to be available for these national security uses under this option, even without establishing a national security exemption. Comments are due by April 19, 2017.
EPA Proposes Chemical Risk Evaluation Process Under New TSCA: On January 19, 2017, EPA proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. 82 Fed. Reg. 7562. The process would not consider costs or other nonrisk factors. Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. The proposed rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA proposes that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests. Comments are due by March 20, 2017. An in-depth memorandum on the proposed risk evaluation process, as well as memoranda regarding EPA’s proposed requirements for TSCA Inventory notification and prioritization process for reviewing existing chemicals, is available online.
EPA Proposes Procedures To Prioritize Chemicals For TSCA Risk Evaluation: On January 17, 2017, EPA proposed procedures to establish a risk-based screening process and criteria that EPA will use to identify chemical substances under TSCA as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. 82 Fed. Reg. 4825. The proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations. EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to TSCA. EPA incorporated all of the elements required by new TSCA, but also supplemented those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation. EPA requests comments on all aspects of the proposed rule. Comments are due March 20, 2017. More information is available online.
EPA Schedules Public Meeting On Risk Evaluation Scoping Efforts: On January 19, 2017, EPA proposed to convene a public meeting on its efforts to establish the scope of risk evaluations under development for the ten chemical substances designated on December 19, 2016, for risk evaluations under TSCA. 82 Fed. Reg. 6545. The meeting was convened on February 14, 2017.
EPA Issues Guidance On Substantiation Requirements For CBI Claims Under TSCA: On January 19, 2017, EPA issued an interpretation of TSCA Section 14 concerning confidential business information (CBI) claims for information submitted to EPA. 82 Fed. Reg. 6522. Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA. EPA notes that the action is effective March 20, 2017.
Regulatory Freeze Impacts Pesticide Applicator Rule: On January 20, 2017, the White House issued a memorandum titled “Regulatory Freeze Pending Review,” delaying the effective date of certain regulations until March 21, 2017. EPA identified 30 regulations impacted by the memorandum, and published them on January 26, 2017. 82 Fed. Reg. 8499. Among the regulations are the rules certifying pesticide applicators and the accidental release prevention requirements under the Clean Air Act (CAA). Each rule is now effective March 21, 2017. For more information on the Regulatory Freeze, see “White House Issues Regulatory Freeze; EPA Responds By Delaying Effective Date For 30 Rules” under the Miscellaneous section of this update.
CBP Issues Notice Of Delay Of Effective Date For Amendment To CBP Regulations Regarding TSCA Import Certifications: On January 27, 2017, the U.S. Customs and Border Protection (CBP) issued in the Federal Register a notice of delay of an effective date of a final rule issued on December 27, 2016. 82 Fed. Reg. 8590. The final rule (81 Fed. Reg. 94980) announced amendments to CBP regulations regarding the requirement to file a TSCA certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture. Specifically, the final rule amends CBP’s regulations under 19 C.F.R. Parts 12 and 127 to establish an electronic option for importers to file the required EPA TSCA certifications, to clarify and add certain definitions, and to eliminate the paper-based blanket certification process. The effective date of the final rule was initially January 26, 2017, but is now delayed until March 21, 2017, in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017, directing heads of executive departments and agencies temporarily to postpone the effective date for 60 days from the date of the memorandum, of all regulations that had been published in the Federal Register, but had not taken effect. In the notice, CBP states that this additional time is welcome, as it will allow affected entities more time to “become familiar with the increased flexibilities and new processes of the final regulations.”
EPA Forms Science Advisory Committee On Chemicals: As required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has established the Science Advisory Committee on Chemicals (SACC). On January 17, 2017, the EPA Administrator appointed 18 expert members to serve as Special Government Employees (SGE) or Regular Government Employees (RGE) to the SACC. EPA published the names and biographical information for the SACC panel members on the TSCA Scientific Peer Review Committees’ website at https://www.epa.gov/tsca-peer-review. The SACC’s purpose is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches. Members of the SACC possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically-based pharmacokinetics (PBPK) modeling, toxicology, pathology, and chemical exposure to susceptible life stages and subpopulations (including women, children, and others). In addition to scientific expertise, members also have background and experience that will contribute to the diversity of scientific viewpoints on the committee, including professional experience in government, labor, public health, public interest, animal protection, industry, and other groups.
GAO Adds Three Programs, Removes One On “High Risk List”: On February 15, 2017, the U.S. Government Accountability Office (GAO) issued the 2017 High Risk List, which includes three new high risk areas: the management of programs serving Indian tribes; the U.S. government’s environmental liabilities; and the 2020 decennial census. GAO removed sharing and managing of information related to terrorism. GAO updates the list every two years. The 2017 list includes 34 government activities vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation. GAO states that it expanded two areas because of emerging concerns about offshore oil and gas oversight and the Department of Defense’s (DOD) role in mitigating gaps in weather satellite data. The list includes “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals.” GAO added this issue to the High Risk List in 2009 as a government program in need of broad-based transformation because EPA had not developed sufficient chemical assessment information under the Integrated Risk Information System (IRIS) and TSCA programs to limit exposure to many chemicals that may pose substantial health risks. According to GAO, both the IRIS and TSCA programs “need to continue to implement corrective actions to resolve this complex high-risk area.” GAO notes that passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act “may facilitate EPA’s effort to improve its processes for assessing and controlling toxic chemicals in the years ahead.” GAO states that the Lautenberg Act provides EPA with greater authority and the ability to take actions that could help EPA implement its mission of protecting human health and the environment. According to GAO, continued leadership commitment from EPA officials and Congress will be needed to implement reforms fully. Additional work will also be needed to issue a workload analysis to demonstrate capacity, complete a corrective action plan, and demonstrate progress implementing the new legislation.
Lynn L. Bergeson, “Enlisting Modern Technologies to Ensure a Safe Food Supply,”Natural Resources & Environment, Volume 31, Issue 3, Winter 2017: Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the 21st century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.
These emerging technologies do not come without potential risks, however. How to regulate them is a subject upon which stakeholders disagree.
Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed in this article, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures to educate policy makers and regulators on these technologies, and greater involvement by the private sector in facilitating a predictable flow of information on these technologies to all stakeholders.
EPA Final Rule Triggers Federal Plans In States Failing To Meet Ozone NAAQS Requirements: On February 3, 2017, EPA issued a final rule taking action against 15 states and the District of Columbia for their failure to submit timely State Implementation Plan (SIP) revisions to implement provisions of the 2008 National Ambient Air Quality Standard (NAAQS) for ozone. 82 Fed. Reg. 9158. The air districts affected by the rule are located in California, Connecticut, Delaware, Illinois, Indiana, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin, and D.C. The finding requires EPA to develop Federal Implementation Plans (FIP) in these states within two years. The rule is effective on March 6, 2017.
EPA Updates RCRA Public Participation Manual: For the first time in 20 years, EPA has revised its Resource Conservation and Recovery Act (RCRA) Public Participation Manual. The revised document, issued by EPA in January 2017, replaces the 1996 version. EPA has updated the document to reflect current regulations, policies, and practices. It also presents new information about technical assistance, environmental justice, social media, and other topics. In addition, the revised document focuses more attention on public involvement during permit modifications, as permit maintenance and modifications currently account for most RCRA permitting activities.
FDA Releases Guidance On Products Of Genetic Modification: On January 19, 2017, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine released three documents setting forth its revised approach to regulating certain new products, including: revised draft guidance titled “Regulation of Intentionally Altered Genomic DNA in Animals,” 82 Fed. Reg. 6561; draft guidance titled “Regulation of Mosquito-Related Products,” 82 Fed. Reg. 6574, and a Federal Register notice requesting comment on the use of genome editing techniques to produce new plant varieties used for human and animal food. 82 Fed. Reg. 6564. With the exception of the mosquito notice, the documents reflect FDA’s response, in part, to the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, issued by the Office of Science and Technology Policy (OSTP) in January 2017. Comments are due as follows: on the draft industry guidance comments must be submitted by April 19, 2017; comments on the mosquito-related products guidance by February 21, 2017; and comments on the genome editing notice are due by April 19, 2017.
FDA Announces Availability Of Draft Guidance On Sprout Operations: On January 23, 2017, FDA announced the availability of a draft guidance for industry, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations. 82 Fed. Reg. 7751. FDA states that when final, the draft guidance will help sprout operations subject to FDA’s final rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the Produce Safety Rule), and primarily focuses on assisting such operations in complying with the sprout-specific requirements in Subpart M (Sprouts) of the Produce Safety Rule. Topics discussed in the draft guidance include: General Sprout Production; Buildings, Tools, and Equipment; Cleaning and Sanitizing; Agricultural Water in Sprouting Operations; Seeds for Sprouting; Sampling and Testing of Spent Sprout Irrigation Water or Sprouts; Environmental Monitoring; and Recordkeeping.
FDA is welcoming comment on any aspect of this draft guidance, but it is particularly interested in receiving information about the types of seed or bean treatments that have been used by sprout operations and/or seed suppliers, as well as their feasibility of use, cost, and impact on germination; scientific information related to the effectiveness in reducing or eliminating microorganisms of public health significance; and any variability in treatment effectiveness based on seed type. FDA is requesting comment by July 24, 2017.
FDA Announces Public Hearing And Requests Comments On Safety Of Imported Food: On January 17, 2017, FDA issued a notice of public hearing and a request for comments regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. 82 Fed. Reg. 4896. The hearing, scheduled for February 14-15, 2017, focused on the following: partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk-based decision making; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation’s entire food safety system.
FDA states it is also seeking information from a variety of viewpoints, including from competent authorities in other countries and from private entities, to help inform itself regarding risk-based decision making, commodity-specific export control programs in other countries, and systems recognition. Comments are requested by May 16, 2017.
KEMI Consulting On Draft Nano Register Regulation: The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019. According to KEMI, the proposal is the same as presented in its 2015 report. The report states that KEMI does not propose any reporting requirements for nanomaterials in articles. Comments are due March 24, 2017. KEMI will review the responses and consider whether any revisions are necessary. Once KEMI prepares a final draft, it will notify the European Commission (EC) of the regulation. More information is available in our January 25, 2017, blog item, “KEMI Consulting on Draft Nano Register Regulation.”
NIOSH Accepting Input On How Best To Protect Workers, Including In Nanotechnology: John Howard, M.D., Director of the National Institute for Occupational Safety and Health (NIOSH), authored a January 10, 2017, NIOSH blog item entitled “Occupational Health Issues in the USA.” Howard shares a recent editorial he wrote in Occupational Medicine, “Occupational health issues in the USA,” that highlights some of the occupational safety and health (OSH) issues identified as needing attention by the industry sector groups of the National Occupational Research Agenda (NORA). The identified issues include nanotechnology. According to the blog item, NIOSH “welcome[s] input on how to best protect workers in these areas in the comment section below.”
Nanomaterials Inventory For Cosmetics Will Be Published “In The Next Weeks”: ClientEarth published a January 11, 2017, blog item entitled “Three-year wait for nanomaterial risk data promised ‘in the next weeks.’” Under the Cosmetics Directive, the EC was to publish by January 11, 2014, an inventory of nanomaterials used in cosmetic products on the European Union market. The EC has postponed publication of the inventory several times, due to the allegedly poor quality of the information it received from industry. ClientEarth requested access to the information in June 2014, and the EC responded that the inventory would be published “in the next few weeks.” The non-governmental organization sent a second request in December 2016. The EC responded: “The catalogue of nanomaterials used in cosmetics will be published on our website . . . in the next weeks, so we kindly ask for some patience.” ClientEarth requested clarification from the unit responsible for cosmetics. Their answer, according to ClientEarth, was: “There are ongoing discussions at a higher level within the Commission. At this stage no specific date can be indicated for the publication.”
Review Of Draft REACH Guidance Documents On Nanomaterials Continues: On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation. The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the EC’s Recommendation for the definition of nanomaterial. The aim of the draft guidance is to define the term “nanoform,” the minimum criteria for distinguishing between different nanoforms, and the minimum set of elements that should be reported on the characterization of nanoforms. The draft recommendations for nanomaterials applicable to the guidance on quantitative structure-activity relationships (QSAR) and grouping of chemicals was sent to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL) on January 23, 2017. The draft guidance is intended to provide an approach on how to justify the use of hazard data between nanoforms (and the non-nanoform(s)) and within groups of nanoforms of the same substance. On January 31, 2017, the draft appendices on recommendations for nanomaterials for environmental endpoints were sent to CARACAL:
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance;
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7b Endpoint specific guidance; and
- Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance.
Summaries of comments from earlier stages of the consultation process are available on ECHA’s website.
Nano-Portal On Safe Handling Of Nanomaterials Available In English: The Nano-Portal: Safe Handling of Nanomaterials, the result of a project supported by the Deutsche Gesetzliche Unfallversicherung (DGUV) and developed by the Innovation Society, is now available in English. The website is intended to extend knowledge about OSH in the fields of nanomaterials and nanotechnologies. It includes five nanoramas in which the user enters a virtual room and can move and explore work situtations. The nanoramas focus on the use of nanomaterials, as well as on the appropriate workplace safety measures when handling nanomaterials. Users can find situations and answer the questions that appear when clicking on the individual situations. Three different interactions are possible: (1) multiple-choice questions; (2) “traffic light“ questions; and (3) information windows. Nanorama Laboratory and Nanorama Production are available in English, while the others (Nanorama Construction, Nanorama Laboratory, Nanorama Car Workshop, Nanorama Textile, and Nanorama Production) are available only in German at this time. More information is available in our January 31, 2017, blog item, “Nano-Portal on Safe Handling of Nanomaterials Available in English. ”
IRSST Project Measures Nanoparticle Penetration Into Protective Gloves: The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published a news item on January 16, 2017, entitled “Nanoparticles -- to handle with care.” IRSST states that although research is still in development, it appears that nanoparticles can enter the respiratory tract or penetrate through the skin and make their way to the bloodstream, which may carry the nanoparticles to various organs. While studies have been conducted on respiratory protection equipment, IRSST notes that few have been done on skin protection and especially gloves. IRSST is funding a research project to develop a method for measuring nanoparticle penetration into materials used to make protective gloves under conditions representative of the workplace setting. IRSST links to a Prévention au travail article in which Ludwig Vinches, the lead researcher for the project, explains why the gloves are fragile.
New Article Discusses TSCA Reform Provisions Pertinent To Manufacturers And Processors Of Nanoscale Materials: We are pleased to announced that Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton published an article, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” in the January 26, 2017, issue of Bloomberg BNA’s Daily Environment Report. The article reviews and analyzes TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although new TSCA dramatically changes how EPA evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. The article focuses on the key changes in new TSCA that could affect manufacturers and processors of nanoscale materials, and notes opportunities for stakeholders to engage in forthcoming rulemaking processes and other regulatory initiatives to ensure EPA is successful in implementing new TSCA.
OECD Publishes Report On Alternative Testing Strategies In Risk Assessment Of Manufactured Nanomaterials: The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use. Experts from academia, industry, public interest groups, and government researched, analyzed, and discussed how alternative models could be used to advance the risk analysis of manufactured nanomaterials. The objectives were to identify how alternative testing strategies could be used in a risk analysis context to inform human health, ecosystem health, and exposure data needs for manufactured nanomaterials in the near term and longer term, and identify research needs to support the development of these strategies in the near future. OECD expects that the conclusions from the report can contribute to the development and implementation of relevant alternative testing strategies for manufactured nanomaterial testing that will expedite the ability to identify high-risk manufactured nanomaterials, and lead to more rapid, cost-effective, and reliable safety testing for specific risk management decision contexts. More information is available in our February 1, 2017, blog item, “OECD Publishes Report on Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials.”
NIOSH Publishes Blog Item On Art And Science Of OELs For Nanomaterials: On February 1, 2017, NIOSH posted a blog item entitled “The Art and Science of OELs for Nanomaterials.” According to the item, NIOSH searched for proposals for occupational exposure limits (OEL) for new nanomaterials as part of the development of a World Health Organization (WHO) guideline for working safely with nanomaterials. The blog item cites the article “Occupational exposure limits for manufactured nanomaterials, a systematic review,” which Nanotoxicology published last month. The blog item notes that the time to develop test data and the rapid increase in the number of nanomaterials can make the traditional method of quantitative risk assessment for OEL derivation difficult. When searching for proposed OELs, only about half were published in peer-reviewed journals, while the rest were “scattered across project reports published on the Internet only, conference abstracts or government reports.” The OELs found varied in many cases, ranging from a factor of 50 for OELs for carbon nanotubes to even more for OELs for metallic nanomaterials. The blog item concludes that “[t]he challenge is to find consensus on how to derive the OELs for nanomaterials and next to underpin the proposed values with more empirical research.” According to NIOSH, at this time, “the OELs for nanomaterials are bench mark levels to which the exposure levels measured in a specific workplace can be compared. Compared to the concentrations that have been measured in workplaces, these OEL benchmark levels are often still substantially lower and should be an incentive to reduce exposure.” More information is available in our February 2, 2017, blog item, “NIOSH Publishes Blog Item on Art and Science of OELs for Nanomaterials.”
NIOSH Seeks Comment On Proposed Survey Of Engineered Nanomaterial OSH Practices: NIOSH published a Federal Register notice on February 10, 2017, inviting comment on a proposed information collection plan, “Survey of Engineered Nanomaterial OSH Practices.” 82 Fed. Reg. 10360. The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The intended use of the data is to inform NIOSH’s research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials. NIOSH states that it will survey companies who manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials. After analysis, NIOSH will use the information to develop a final report. This project will also help evaluate the influence of NIOSH products, services, and outputs on industry OSH practices. Under this project, NIOSH will conduct the following activities and data collections:
- Company pre-calls. Sampled companies will be contacted to identify the person who will complete the survey and to ascertain whether or not the company handles engineered nanomaterials; and
- Survey. A web-based questionnaire, with a mail option, will be administered to companies. The purpose of the survey is to learn directly from companies about their use of NIOSH materials and their OSH practices concerning engineered nanomaterials.
NIOSH would compile a sample of 600 companies from lists of industry associations, research reports, marketing databases, and web-based searches. Of the 600 selected companies, NIOSH states that it anticipates that 500 will complete the survey. NIOSH expects the company pre-call to require five minutes to complete, and the survey to require 20 minutes to complete, including the time it may take respondents to look-up and retrieve needed information. NIOSH invites comment on:
- Whether the proposed collection of information is necessary for the proper performance of the functions of NIOSH, including whether the information shall have practical utility;
- The accuracy of NIOSH’s estimate of the burden of the proposed collection of information;
- Ways to enhance the quality, utility, and clarity of the information to be collected;
- Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and
- Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Comments are due April 11, 2017.
BRAG Biobased Products News And Policy Report: B&C’s 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 http://www.braginfo.org.
Senate Committee Suspends Rules, Approves Scott Pruitt As EPA Administrator: Republicans on the Senate Environment and Public Works Committee on February 2, 2017, suspended the Committee’s rules on quorums and approved Scott Pruitt as the next EPA Administrator. Committee Democrats, for the second consecutive day, boycotted the meeting to demonstrate displeasure with Pruitt’s responses to their questions. The Committee’s rules require at least two minority members to be present during a vote, but Committee Chair John Barrasso (R-WY) suspended the rules, allowing Pruitt’s nomination to head for the full Senate for consideration.
House And Senate Use Congressional Review Act To Halt Stream Protection Rule: The House on February 1, 2017, dusted off the Congressional Review Act (CRA) and passed a resolution (H.J. Res. 38) that repeals the Department of Interior’s (DOI) Stream Protection Rule. Issued on December 20, 2016 (81 Fed. Reg. 93066), the so-called Stream Buffer Rule, issued by DOI’s Office of Surface Mining Reclamation and Enforcement, set forth new standards for the protection of waterbodies potentially impacted by coal mining operations. The resolution, passed by a vote of 228-194, nullifies the rule. The Senate did not waste time approving the measure: on February 2, 2017, it passed the resolution by a 54-45 vote. The CRA has been used only once before to kill a regulation, and that was in 2001 when lawmakers removed a Clinton regulation on ergonomics. The White House has stated that President Trump will sign the measure, providing him with the first opportunity of his term to remove an Obama era regulation.
House Bill Would Ban Climate Change Regulation: Representative Gary Palmer (R-AL) on January 30, 2017, introduced the “Stopping EPA Overreach Act of 2017” (H.R. 637). The bill would prohibit federal regulation of climate change or global warming under the CAA, the Clean Water Act (CWA), the National Environmental Policy Act (NEPA), the Endangered Species Act (ESA), and the Solid Waste Disposal Act (SWDA). The bill also would amend the CAA to revise the definition of “air pollutant” to exclude carbon dioxide, water vapor, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, or sulfur hexafluoride. The bill goes even further: it would void EPA’s final rules setting greenhouse gas emission standards for the oil and gas sector (81 Fed. Reg. 35823 (June 3, 2016)) and for existing power plants (80 Fed. Reg. 64661 (Oct. 23, 2015)).
House Bill Would Place Moratorium On Mountaintop Removal Mining: On February 1, 2017, Representatives John Yarmuth (D-KY) and Louise Slaughter (D-NY) reintroduced the “Appalachian Community Health Emergency Act,” legislation that would place a moratorium on all new mountaintop coal removal mining permits while federal officials examine health consequences to surrounding communities. The bill would authorize the first comprehensive federal study of the health dangers of the practice. The bill (H.R. 786) specifically would require the Department of Health and Human Services (DHHS) to conduct a comprehensive study to determine the health effects of mountaintop removal mining. The bill would halt mountaintop mining operations until the DHHS study is complete.
Ozone Standards Implementation Act Reintroduced: On February 1, 2017, Senators Shelley Moore Capito (R-WV), Jeff Flake (R-AZ), and Joe Manchin (D-WV) joined Representatives Pete Olson (R-TX), Bill Flores (R-TX), and Bob Latta (R-OH) to reintroduce the Ozone Standards Implementation Act. This legislation would update how EPA addresses ozone requirements in the CAA. Currently, EPA must review NAAQS every five years. The bill would increase the review period to ten years. The bill also addresses the overlap between ozone NAAQS EPA issued in 2008 and 2015. States did not receive implementation guidelines for the 2008 ozone standards until March 2015. Seven months later, in October 2015, EPA issued new standards to replace the existing 2008 standards, which states are still working to comply with. This bill extends the compliance date for the 2015 standards to 2025. It also directs EPA to submit a report to Congress within two years regarding the impact of foreign pollutions sources on compliance. The bill also requires EPA to consider technological feasibility when revising standards.
Resolution Would Nullify RMP Final Rule: Representative Markwayne Mullin (R-OK) on February 1, 2017, introduced a resolution (H.J. Res. 59) under the CRA to repeal EPA’s final rule revising its Risk Management Plan (RMP) program. EPA promulgated the final RMP rule on January 13, 2017, in response to Executive Order 13650, which required EPA and other federal agencies to improve chemical facility safety and security. 82 Fed. Reg. 4594. The CRA allows Congress to pass disapproval resolutions on simple majority votes in the House and Senate to reverse discretionary rules promulgated within 60 legislative days of their actions. In a statement, Mullin stated: “Predictably, the Obama Administration continued to issue harmful and overreaching regulations until the bitter end . . . EPA’s RMP rule is no exception. It trades safety for paperwork and delivers far more burden than benefit for businesses that have to abide by it. The RMP rule wraps our businesses up in more bureaucratic red tape and makes it more difficult for them to keep their doors open, risking not only safety but also valuable jobs. This joint resolution provides much needed relief.” The resolution has broad support from industry trade groups; it has been endorsed by the Agricultural Retailers Association, American Chemistry Council, American Coatings Association, American Forest & Paper Association, American Fuel & Petrochemical Manufacturers, American Petroleum Institute, Corn Refiners Association, Environmental Technology Council, The Fertilizer Institute, Global Cold Chain Alliance, International Association of Refrigerated Warehouses, International Institute of Ammonia Refrigeration, International Liquid Terminals Association, Institute of Makers of Explosives, International Warehouse Logistics Association, Louisiana Chemical Association, National Association of Chemical Distributors, National Association of Manufacturers, Society of Chemical Manufacturers and Affiliates, U.S. Chamber of Commerce, and The Vinyl Institute. Despite the support, it is unclear whether H.J. Res. 59 will be provided any floor time in the House for a vote.
Bill Would Abolish EPA: A freshman Republican Congressman from Florida (Matt Gaetz) on February 3, 2017, introduced a bill that would eliminate EPA. The bill, H.R. 861, would transfer EPA’s responsibilities to other agencies and departments and to the states.
House Bill Would Exempt Nutrient Management Practices From RCRA: Representative Dan Newhouse (R-WA) on February 3, 2017, introduced legislation that would exempt certain nutrient management activities from RCRA regulation. The Farm Regulatory Certainty Act (H.R. 848) “reaffirms and clarifies Congress’ intent regarding the inappropriateness of subjecting agricultural operation nutrient management activities under . . . RCRA.” The bill would also codify EPA’s regulations regarding the treatment of agricultural operation nutrients under RCRA. Newhouse introduced the legislation in response to a 2015 ruling by a federal judge in Washington deciding that nitrates found in groundwater -- commonly a byproduct of manure and fertilizers -- were a “solid waste” under RCRA and that high water nitrate levels constituted “open dumping.”
House Science Committee Holds Hearing On EPA’s Use Of Science: The House Science, Space and Technology Committee on February 7, 2017, held a hearing entitled “Making EPA Great Again.” According to the Committee’s charter for the hearing, its intended purpose was to examine EPA’s process for evaluating and using science during its regulatory decision making activities. Testifying at the hearing were Jeffrey Holmstead, Bracewell LLP; Dr. Kimberly White, Senior Director, Chemical Products and Technology, American Chemistry Council; Rush Holt, CEO, American Association for the Advancement of Science, and Dr. Richard Belzer, Independent Consultant. Committee Chair Lamar Smith (R-TX) opened the hearing by stating that sound science should be at the core of EPA’s mission, but “unfortunately, over the last eight years, the EPA has pursued a political agenda, not a scientific one.” He criticized many of the Obama EPA’s major rules for not being based in science, including the Clean Power Plan (CPP). With respect to the CPP, he stated “even EPA data shows that this regulation would only eliminate a miniscule amount of global carbon emissions and would reduce sea level rise by only 1/100th of an inch.” He also called EPA to task for routinely relying upon “questionable science based on nonpublic information that could not be reproduced, a basic requirement of the scientific method.” He promised to propose legislative remedies and hold EPA accountable regarding the science upon which its regulations are based. The hearing witnesses generally echoed the refrain that EPA must do a better job in basing its regulations on sound science. Committee member and witness testimonies and an archived webcast of the hearing are available.
Representative Gibbs Renews Push For Legislative Exemption From CWA Pesticide Permitting: On February 7, 2017, Representative Bob Gibbs (R-OH) introduced H.R. 953, the Reducing Regulatory Burdens Act, which would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the CWA to eliminate federal CWA discharge permits for application of FIFRA-approved pesticides applied in accordance with FIFRA label requirements. Representative Gibbs has introduced three similar bills over the past six years in response to the 2009 U.S. Sixth Circuit Court of Appeals decision in National Cotton Council of America v. EPA. Cotton Council mandated EPA regulation of pesticide applications into, over, or near “Waters of the United States” (WOTUS) under the CWA National Pollutant Discharge Elimination System (NPDES) permitting scheme.
As Representative Gibbs stated in a February 7 related press release, and opponents of NPDES pesticide permitting assert, “[r]equiring an NPDES permit is unnecessary. It only adds compliance costs, and no new environmental protections.” In 2011, EPA issued the first NPDES Pesticide General Permit (PGP), which was recently reissued in November 2016 for another five-year cycle. Many of the PGP requirements are rooted in FIFRA compliance (e.g., calibration and maintenance of spray equipment), which gives credence to the opposition argument that permitting under the CWA is redundant and duplicative. Unlike FIFRA, the CWA attaches a powerful citizen suit provision, which gives standing for environmental advocacy groups to file suits for perceived CWA violations, including violations of PGP permits. Although no lawsuits have been filed since EPA first issued the PGP in 2011, opponents assert that these increased liabilities have had a chilling effect on the pesticide application industry and the ability to combat effectively public health crises like the Zika virus and other mosquito-borne illnesses. In comments filed on EPA’s 2016 PGP reissuance, the Benton County Mosquito Control District in Washington State stated that it sets aside 20 percent of its annual budget for potential legal costs related to CWA citizen suits. EPA has stated that grace periods for meeting PGP reporting and filing deadlines during Declared Pest Emergencies ensure timely pesticide applications when crises like the Zika virus epidemic arise.
The Trump Administration has not issued any official statements on H.R. 953, however, the legislation’s goal fits with the Administration’s policies aimed at reducing regulations. The 22 co-sponsors of the House bill include two Democrats, Representatives Collin Peterson (D-MN) and Kurt Schrader (D-OR). On the Senate side, on February 13, Senators Claire McCaskill (D-MO) and Mike Crapo (R-ID) introduced a companion bill, S.340. Without the threat of a Presidential veto, the renewed push to enact a legislative “fix” for the PGP has a greater likelihood of success than previous attempts. Ultimately, if enacted, the legislation would eliminate the federal PGP that applies in four states (Massachusetts, New Hampshire, New Mexico, and Idaho), the District of Columbia, most U.S. territories, and federal and tribal lands. The remaining 46 states administer state versions of the PGP, and many states could choose to retain these state requirements. More information on the 2016 PGP requirements is available here. Susan Kirsch’s article provides further commentary on the merits of the PGP.
Energy And Commerce Subcommittee Schedules February 16 Hearing On Amending CAA And Superfund: The House Energy and Commerce’s Environment Subcommittee has scheduled a hearing on February 16, 2017, entitled “Modernizing Environmental Laws: Challenges and Opportunities for Expanding Infrastructure and Promoting Development and Manufacturing.” In a statement announcing the hearing, Subcommittee Chair John Shimkus (R-IL) stated the hearing will “consider practical reforms to promote the expansion of domestic infrastructure and manufacturing.” The hearing will examine potential amendments to the CAA and to the Brownfields Program administered by EPA under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The witnesses for the hearing have not yet been released by the Subcommittee.
Senate Bill Seeks To Protect Scientific Integrity: Senator Bill Nelson (D-FL) on February 7, 2017, introduced legislation intended to safeguard scientific integrity within the federal government. The bill quickly garnered 27 cosponsors, all Democrats. Senator Nelson introduced the bill in response to concerns by some regarding the Trump Administration’s actions towards the use of science by the federal government. The bill seeks to protect the scientific method and the ability for scientists freely to publish their findings. Given the Republican majority in the Senate, the bill is unlikely to advance.
Federal Agencies Announce Revision To Modernize Federal Policy For The Protection Of Human Subjects: On January 19, 2017, EPA, together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. 82 Fed. Reg. 7149. The notice states that the final rule is intended to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators," and “[t]hese revisions are an effort to modernize, simplify, and enhance the current system of oversight.” The rule will become effective on January 19, 2018. The compliance date is also January 19, 2018, with some exceptions. The final rule differs in important ways from the proposed rule issued on September 8, 2015; most significantly, several proposals are not being adopted. Other minor changes have been to improve the rule for purposes of clarity and accuracy. Some of the changes include:
- The final rule does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
- To the extent some of the proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
- The final rule does not expand the policy to cover clinical trials that are not federally funded.
- The final rule does not adopt the proposed new concept of ‘‘excluded’’ activities. Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
- The proposed revisions to the exemption categories have been modified to better align with the longstanding ordering in the final rule. The final rule does not include the proposed requirement that exemption determinations need to be made in specified ways.
- The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.
- The final rule does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.
The final rule makes the following significant changes to the Common Rule:
- Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
- Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
- Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
- Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective three years after publication of the final rule.
- Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.
More information on the Federal Policy for the Protection of Human Subjects is available on the DHHS’ website.
USDA Proposes New GE Organism Regulations: On January 19, 2017, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) proposed sweeping plant pest rules that would effectively overhaul USDA’s genetically engineered (GE) organism regulations. 82 Fed. Reg. 7008. APHIS proposed to revise its regulations regarding the importation, interstate movement, and environmental release of certain GEs to update its regulations in light of technological developments. According to APHIS, the revisions are needed to reduce the burden for regulated entities “whose organisms pose no pest or noxious weed risks.” APHIS notes the revisions reflect the first significant revisions to the regulations since 1987. Comments are due by May 19, 2017.
White House Issues Regulatory Freeze; EPA Responds By Delaying Effective Date For 30 Rules: On January 20, 2017, the White House issued a directive freezing the issuance and effective dates of pending federal regulations. 82 Fed. Reg. 8346 (Jan. 24, 2017). Issued by White House Chief of Staff Reince Priebus “to ensure that the President’s appointees or designees have the opportunity to review any new or pending regulations,” the memorandum orders the following:
- No agencies may send a regulation to the Office of the Federal Register (OFR) until a department or agency head appointed or designated by the President after noon on January 20, 2017, reviews and approves the regulation.
- Agencies must withdraw immediately regulations sent to the OFR but that have not yet been published in the Federal Register.
- Regulations that have been published in the Federal Register but that have not yet taken effect will have their effective date suspended for 60 days (from January 20, 2017). The memorandum further states that agencies “should consider proposing for notice and comment a rule to delay the effective date for regulations beyond that 60-day period.” If there are no “substantial questions of law or policy” after the delayed effective date, the rules may take effect. If, however, such questions do arise, “agencies should notify the [Office of Management and Budget (OMB)] Director and take further appropriate action in consultation with the OMB Director.” The memorandum does not define the phrase “substantial questions of law or policy.”
Certain rules are exempted, notably regulations subject to statutory or judicial deadlines. This is neither an unexpected nor unprecedented action. On January 26, 2017, EPA responded by delaying until March 21, 2017, the effective date of 30 regulations. 82 Fed. Reg. 8499. Among the 30 regulations are EPA’s final RMP rule and a final rule revising EPA’s regulations concerning the certification of applicators of restricted use pesticides. The final rule states that EPA “may consider delaying the effective dates … beyond March 21, 2017,” but in that event, “the Agency would propose any later effective date for public comment.”
Trump “Beachhead Team” Arrives At EPA: President Trump’s “beachhead team” arrived at EPA shortly after the inauguration. In an announcement, Senior White House Advisor Don Benton and White House Liaison Charles Munoz stated: “As the leaders for the new Administration on EPA transition, we would like to say thank you for the warm reception that we have received. We are looking forward to working with the career professionals at the EPA to make this transition work as well as possible, and to carry out the Agency’s mission to protect public health and the environment. We know and understand the incredible knowledge level and commitment of the people who work here. We will be asking you for help. We are committed to working with you. While transitions are always hard, straight forward honest communication combined with respect for each other will make the process work much better.” The EPA transition team consists of Benton and Munoz, Layne Bangerter, Patrick Davis, Doug Ericksen, Holly Greaves, David Kreutzer, David Schnare, Justin Schwab, and George Sugiyama.
President Issues “One In, Two Out” Regulatory Reform Order; Groups File Court Challenge: On January 30, 2017, President Trump signed an executive order aimed at reducing regulations. The executive order requires federal agencies to revoke two regulations for every new regulation they issue. The Administration is referring to the order as the “one in, two out” directive. The President met with small business owners at the White House prior to signing the new order and called it “a big one.” The order states that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.” President Trump further directed in the order that for FY 2017, the heads of all agencies ensure that “the total incremental cost of all new regulations, including repealed regulations, to be finalized this year shall be no greater than zero.” The executive order exempts regulations for emergencies and national security. The Director of OMB is to oversee implementation of the directive. The order was published in the Federal Register on February 3, 2017 (82 Fed. Reg. 9339). The White House on February 3, 2017, released interim guidance for implementing the executive order. Issued by Dominic Mancini, Acting Administrator of the Office of Information and Regulatory Affairs in OMB, the guidance clarifies that the order applies only to significant rules (rules with an annual economic impact of $100 or more). The guidance also clarifies the intent of the order: the “one in, two out” directive is intended to spur agencies to conduct retrospective reviews of regulations and identify those that are outdated, ineffective or unnecessary. Also, rules deemed “transfer rules” are not subject to the order. Rules imposing recordkeeping or reporting requirements on the regulated community are subject to the order. Guidance and interpretive documents that pertain to rules and could incur costs, but are not regulations, will be reviewed on a case-by-case basis, the guidance states. On February 8, 2017, three public interest groups challenged the order in court. Public Citizen, the Natural Resources Defense Council, and the Communications Workers of America filed suit against the order in the U.S. District Court for the D.C. Circuit. They contend that the order “exceeds President Trump’s constitutional authority, violates his duty under the Take Care Clause of the Constitution, and directs federal agencies to engage in unlawful actions that will harm countless Americans.” They add that implementing the order “cannot be undertaken without violating the statutes from which the [federal] agencies derive their rulemaking authority and the Administrative Procedure Act.”
Lynn L. Bergeson, “Next Generation Compliance and Its Implications for Industry,” Environmental Quality Management, Volume 26, Issue 1, Fall 2016: “Next Generation Compliance” is EPA’s signature initiative intended to increase compliance with environmental regulations by using advances in pollution monitoring and information technology and by more effectively using and designing regulations and permits to reduce pollution and enhance compliance. This column describes EPA’s initiative, discusses several examples of its applications in rulemakings and civil enforcement settlements, discusses another new compliance-related tool, eDisclosure, and outlines the implications for industry of these novel approaches to incentivizing compliance.