EPA Issues Two Direct Final Rules Promulgating SNURs For 29 Chemicals: On August 27, 2018, EPA issued two direct final rules promulgating significant new use rules (SNUR) under TSCA. The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Both direct final rules will be effective on October 26, 2018. Written adverse comments on one or more of the SNURs must be received by September 26, 2018. If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date. In addition to the direct final rules, EPA published proposed rules for both the direct final rules. 83 Fed. Reg. 43606, 83 Fed. Reg. 43607. Comments on the proposed rules are due September 26, 2018.

NRDC Moves To Dismiss Petition For Review Of New Chemicals Decision-Making Framework: On August 27, 2018, the Natural Resources Defense Council (NRDC) filed a motion in the U.S. Court of Appeals for the Second Circuit asking to dismiss voluntarily its petition for review of EPA’s “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” NRDC v. EPA, No. 18-25. In its petition for review, NRDC described the Framework Document as a final rule, and argued in its May 1, 2018, opening brief that, based on the Framework Document, EPA “limits its review of a new chemical substance to the manufacturer’s intended conditions of use and disregards Congress’s instruction to address risk concerns through enforceable orders and regulations.” On July 31, 2018, EPA filed its opening brief, which included a declaration from Dr. Jeffery Morris, Director of EPA’s Office of Pollution Prevention and Toxics (OPPT). According to Morris, EPA considers the “conditions of use” of the PMN when making determinations under TSCA Section 5(a)(3). Morris notes that under TSCA Section 3(4), the term “conditions of use” means “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” Since EPA issued the Framework Document for comment, it has made 150 determinations on PMNs under TSCA Section 5(a)(3), but “has not yet followed the SNUR approach described in the Framework.” For 19 PMNs, EPA determined that the new chemical substance was not likely to present an unreasonable risk. According to EPA, “[f]or none of these determinations did EPA consider whether a significant new use rule had been issued in concluding that unreasonable risk was unlikely.” Additionally, for 131 determinations, EPA made a determination under TSCA Section 5(a)(3)(B) related to the sufficiency of information regarding the substance, and then issued orders under TSCA Section 5(e). The basis for a significant number of these determinations was related to the reasonably foreseen conditions of use of the new chemical substance at issue. Notwithstanding EPA’s pronouncement in the Framework Document that it anticipated using SNURs in similar cases, “none of these determinations followed that approach.” NRDC states that, in light of these representations, it “has elected to move for voluntary dismissal of this petition for review.”

EPA Posts New FAQs On Honeybee Toxicity Testing For Registrants And Contract Laboratories: On August 21, 2018, EPA announced it was posting new frequently asked questions (FAQ) for registrants and contract laboratories conducting honeybee toxicity testing. EPA states that these FAQs are “made up of responses to inquiries EPA commonly receives about protocols used to generate honeybee toxicity data for submission in support of pesticide registration,” and are “meant to complement the Agency’s existing Pollinator Risk Assessment Guidance and increase the transparency and clarity of the risk assessment process.” The FAQs include general study questions and questions related to specific kinds of contact toxicity, oral toxicity, chronic toxicity, toxicity of residues on foliage, and field and tunnel colony toxicity levels. Questions not included in the FAQs or risk assessment guidance can be submitted to opppollinatortesting@epa.gov.

President Nominates EPA Region 1 Administrator To Lead OCSPP: On August 31, 2018, President Trump nominated Alexandra Dapolito Dunn to serve as the EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). Ms. Dunn currently serves as the Regional Administrator for EPA Region 1 (Boston). Ms. Dunn previously served as Executive Director and General Counsel for the Environmental Council of the States (ECOS). Prior to joining ECOS, Ms. Dunn was Executive Director and General Counsel for the Association of Clean Water Administrators. Ms. Dunn also served as Dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University. In addition, she has taught at the Columbus School of Law, Catholic University of America, and, most recently, as an Adjunct Associate Professor of Law at the American University’s Washington College of Law. Ms. Dunn received a B.A. in political science from James Madison University and a J.D. from the Columbus School of Law.

OMB Reviewing Final Rule Regarding TSCA User Fees: On August 31, 2018, EPA submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for administration of TSCA. As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by Lautenberg, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs. In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 PMNs, exemption applications and notices, and significant new use notices (SNUN). Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA.

EPA Requests Nominations Of Experts To Consider For Ad Hoc Participation In SACC: On September 13, 2018, EPA requested public nomination of scientific experts to be considered for ad hoc participation and possible membership on the TSCA Science Advisory Committee on Chemicals (SACC). 83 Fed. Reg. 46487. All nominees will be considered for ad hoc participation in the TSCA SACC’s peer reviews of EPA’s risk evaluations for the first ten chemical substances addressed under TSCA. In addition, all nominees may be considered for TSCA SACC membership to fulfill short-term needs when a vacancy occurs on the chartered Committee. As part of a broader process for developing a pool of candidates, EPA staff solicits from the public and stakeholder communities nominations of prospective candidates for service as ad hoc reviewers and possibly members of TSCA SACC. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates. Individuals may self-nominate. Individuals nominated should have expertise in one or more of the following areas: women’s health; children’s health; genetic variability; disproportionately exposed populations; aging; other susceptible populations; biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetics (PBPK) modeling; pharmacology; ecological risk assessment; environmental fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; biostatistics; computational toxicology; fiber science; inhalation toxicology; volatile organics; and systematic review. Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for a TSCA SACC meeting. Nominees should be identified by name, occupation, position, address, e-mail address, and telephone number. Nominations are due by October 29, 2018.

Court Invalidates New Applicability Date For 2015 “Waters Of The U.S.” Rule: On August 16, 2018, a federal district court judge in South Carolina issued a decision in litigation over EPA’s and the U.S. Army Corps of Engineers’ (Corps) addition of a future applicability date for the 2015 “Waters of the U.S.” (WOTUS) rule, referred to in the court’s decision as the “Suspension Rule.” Earlier this year, EPA issued a final rule that added a February 6, 2020, effective date to the 2015 WOTUS rule. The 2015 rule is currently the subject of ongoing litigation and is under a judicial stay in 24 states. EPA and the Corps are also in the process of rescinding and replacing the 2015 WOTUS rule. The addition of the applicability date, or “Suspension Rule,” was intended to provide additional time for EPA and the Corps to finalize their rescission and replacement. Several environmental groups and some states challenged the Suspension Rule, alleging EPA and the Corps violated the Administrative Procedure Act (APA) in promulgating the rule. South Carolina District Court Judge David C. Norton, relying on Fourth Circuit precedent, held that EPA and the Corps violated the APA by failing to solicit and consider “meaningful” public comments on the Suspension Rule. Judge Norton issued a nationwide injunction that lifts the Suspension Rule. EPA and the Corps are expected to appeal the ruling. Industry groups that intervened in the lawsuit are also expected to appeal the decision. There are also active petitions in other district courts seeking a nationwide stay of the 2015 WOTUS rule. The lifting of the Suspension Rule does not impact the judicial stays of the 2015 WOTUS rule that cover almost half the states, preventing implementation in those jurisdictions. In the remaining states, the 2015 rule may now take effect. Those states are as follows (in alphabetical order): California, Connecticut, Delaware, Hawaii, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Washington. EPA and the Corps anticipate finalizing its rescission of the 2015 rule by the end of 2018. It is expected that the final rescission will be challenged and could ultimately be stayed preventing the rescission from being implemented. At the same time, EPA and the Corps are working to propose a replacement WOTUS rule sometime this fall. The South Carolina district court ruling creates a jurisdictional patchwork with two different definitions of WOTUS at play. This could in particular create complications for projects that cross state boundaries, such as energy transmission, pipeline projects, and any other land development projects that cross state-lines. This also creates complications for companies operating in multiple jurisdictions as the scope of WOTUS may be different in one site versus another depending on the state where it is located.

Court Vacates Portions Of Coal Combustion Residue Resource Conservation and Recovery Act (RCRA) Rule: On August 21, 2018, in the latest setback in the courts for the Trump Administration, the U.S. Court of Appeals for the D.C. Circuit ordered EPA to reconsider several components of its final rule establishing disposal standards for coal combustion residuals (CCR). United Solid Waste Activities Group, et al., v. EPA, Case No. 15-1219; decided August 21, 2018. EPA promulgated the final rule on April 17, 2015. 80 Fed. Reg. 21302. In it, EPA set standards for facilities where CCRs are disposed. Several industry and environmental groups challenged the final rule. Shortly before oral argument on the rule, EPA also announced its intent to reconsider the final rule and moved to hold all of the court proceedings in abeyance. In the August 21, 2018, decision, the court denied EPA’s abeyance motion. Environmental groups challenged the final rule’s provision that unlined surface impoundments may continue to operate as CCR disposal units until they cause groundwater contamination. Finding numerous flaws in EPA’s rationale for this provision, the court vacated and remanded it to EPA. The environmental petitioners also challenged the rule’s provisions for clay-lined surface impoundments, which essentially treats such impoundments as if they were lined with a synthetic liner. The court similarly vacated this provision of the final rule. The third punch from the court vacated the rule’s provision that legacy ponds -- inactive units -- are exempt from the rule’s scope. Industry groups challenged the rule on several fronts. The court granted the request for voluntary remands on two standards, but it rebuffed the other issues challenged by industry groups.

Court Revives Litigation On MATS SSM Provisions: On August 27, 2018, the U.S. Court of Appeals for the District of Columbia Circuit issued an order, reviving a case that challenged the startup, shutdown and malfunction (SSM) provisions of the mercury and air toxics standards (MATS). The court granted a joint request from EPA and the other parties in the case, Chesapeake Climate Action Network, et al. v. EPA, to restart the litigation. The court also ordered the parties to file motions for briefing format and schedules by September 10, 2018.

EPA Proposes Replacement For Clean Power Plan: On August 31, 2018, EPA issued the Affordable Clean Energy (ACE) rule. 83 Fed. Reg. 44746. The proposal seeks to replace the 2015 Clean Power Plan (CPP), the centerpiece of President Obama’s environmental legacy. Unlike the CPP, however, the ACE rule does not set limits for greenhouse gas (GHG) emissions from fossil fuel-fired power plants. Instead, it vests the states with broad discretion to set -- or not set -- GHG limits at individual power plants based on what emissions reductions are achievable at each facility. This devolvement of authority to the states is the cornerstone of the proposed rule: states now have the primary authority to determine what emission controls, if any, are warranted at individual facilities. EPA’s role under the rule is to create a regulatory framework and make recommendations for improving efficiencies at power plants and reducing GHG emissions. EPA will do so by identifying the best system of emission reduction (BSER) as heat-rate efficiency improvements at an existing power plant, and then provide states with a list of “candidate technologies” to consider as they make plant-by-plant determinations. The ACE rule is comprised of three components. First, EPA is proposing to replace the CPP with revised emissions guidelines that inform the development, submittal, and implementation of state plans to reduce GHG emissions from certain electric utility generating units (EGU). In the proposed emissions guidelines, EPA is proposing to determine that Heat Rate Improvement (HRI) measures are BSER for existing coal-fired EGUs. (HRIs are efficiency upgrades that reduce the amount of carbon dioxide emitted per unit of electricity generated.) Second, EPA is proposing new regulations that provide direction to EPA and the states on the implementation of emission guidelines. Third, EPA is proposing revisions in the form of reduced regulations to the New Source Review (NSR) program that EPA believes will help prevent NSR from being a barrier to the implementation of efficiency projects at EGUs. The rule also provides states with a list of “candidate technologies” that can be used to establish standards of performance and incorporated into their state plans. EPA is also proposing a new applicability test for determining whether a physical or operational change made to an EGU may be a “major modification” triggering NSR. And EPA is proposing revisions to the NSR permitting program to give states the option to adopt an hourly emissions increase test for such projects. Under this approach, only projects that increase a plant’s hourly rate of pollutant emissions would trigger NSR analysis. With respect to NSR, EPA specifically is proposing to amend the NSR regulations to include an hourly emissions increase test for modifications at EGUs. EPA is proposing two alternatives for an hourly emissions test based on maximum achieved emissions (i.e., what the unit has actually emitted in the past) and one alternative based on maximum achievableemissions (i.e., what the unit could have emitted when operating at its maximum capacity). Under each of the proposed alternatives, NSR applicability for projects undertaken at an EGU would be determined using a four-step applicability process:

• Will the project constitute a physical change or change in the method of operation (applying the current major NSR regulations)?;
• If so, will the change result in an increase in the hourly emissions rate of the EGU (based either on the maximum achieved hourly emissions rate (Alternatives 1 and 2 in the proposal) or maximum achievable hourly emissions rate (Alternative 3 in the proposal))?;
• If there is an increase in the unit’s hourly emissions rate, is the project also predicted to result in a significant increase in annual emissions (applying the current major NSR regulations)?; and
• If the project is predicted to result in a significant increase in annual emissions, will there also be a significant netincrease in annual emissions at the major stationary source?

The comment period closes on October 30, 2018.

Court Issues Mandate In RMP Decision: On August 31, 2018, the U.S. Court of Appeals for the District of Columbia Circuit granted a motion from environmental groups to strike down quickly the Trump EPA’s delay on implementing the Risk Management Program (RMP) rule. The court issued two filings that put in final its ruling even before EPA has exhausted its appeal options. In the case, Air Alliance Houston, et al., v. EPA and Andrew Wheeler, on August 17, 2018, the court vacated a rule promulgated by EPA that delayed until February 19, 2019, implementation of the RMP rule. Although the court vacated the rule, it did not immediately issue its mandate in the case. On August 24, 2018, environmental groups filed a motion urging the court to expedite issuance of the mandate. Industry groups and EPA intervened, but the court swept aside their arguments and issued the mandate on August 31, 2018. On September 4, 2018, however, the court allowed EPA and industry intervernors additional time to address the mandate.

EPA Seeks Comments On ICR Petition To CAA Section 112(r): On September 11, 2018, EPA announced it plans to submit an information collection request (ICR), “Risk Management Program Requirements and Petitions to Modify the List of Regulated Substances under Section 112(r) of the Clean Air Act (CAA),” EPA ICR No. 1656.16, OMB Control No. 2050-0144 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. 83 Fed. Reg. 45928. The notice is a proposed extension of the ICR, which is currently approved through January 31, 2019. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Comments must be submitted on or before November 13, 2018.

EPA Proposes To Ease Methane Release Requirements For Oil And Natural Gas Industry: On September 11, 2018, EPA proposed “targeted improvements” to the 2016 New Source Performance Standards (NSPS) for the Oil and Natural Gas Industry. The proposal would, among other things, ease the fugitive emissions monitoring requirements in the rule. EPA claims that the proposed changes would significantly reduce regulatory burden, saving the industry tens of millions of dollars in compliance costs each year. The changes also would streamline requirements and improve alignment between EPA’s rule and existing state programs, EPA states. The proposed amendments address a range of technical issues in response to administrative petitions and would clarify certain requirements in the rule. They include proposed changes to the frequency for monitoring fugitive emissions at well sites and compressor stations, requirements for pneumatic pumps at well sites, and requirements that a professional engineer certify when meeting those requirements is technically infeasible. EPA is also proposing amendments to requirements that a professional engineer certify the design of closed vent systems, and requirements for requesting alternative means of emissions limitations. The proposal addresses implementation issues that industry brought to EPA’s attention in the two years since the final standards were issued, including clarifying the acceptable location of separators used during well completions, clarifying the definition of “well site” to avoid unintended burdens on third parties, and correcting the definition of “capital expenditure” for onshore natural gas processing plant requirements. According to the pre-publication of the proposed rule, comments will be due 60 days after the proposed rule is published in the Federal Register.

For First Time, EPA Lists NPL Sites Due To Vapor Intrusion: For the first time, EPA has added sites to the National Priorities List (NPL) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) due to risks posed by the vapor intrusion (VI) pathway. EPA on September 13, 2018, added theRockwell International Wheel & Trim site in Grenada, MS, and the Delfasco Forge site in Grand Prairie, TX, to the NPL, marking the first time EPA has added sites to the NPL due to subsurface intrusion (SsI), often referred to as VI. 83 Fed. Reg. 46408. EPA proposed to add the sites on January 18, 2018 (83 Fed. Reg. 2576). EPA listed the Rockwell site due to VI, noting that over 200 people work in the main building on the Rockwell site in an area where the indoor air has elevated levels of volatile organic compounds (VOC). EPA concluded that trichloroethylene vapors beneath the operating manufacturing building are passing into the building through cracks, joints, and other openings in the concrete floor, contaminating the building’s indoor air. EPA decided to list the Delfasco Forge site due to VI of VOCs into residential properties adjacent to the facility.

FDA Releases Q&As On Next Compliance Dates For FSMA Preventive Controls For Animal Foods Rule: On August 14, 2018, the U.S. Food and Drug Administration (FDA) released a Question and Answer (Q&A) document titled “What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule: A Conversation with Jenny Murphy.” The announcement states that this Q&A document “explains what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” Further, “[t]he third major compliance dates will soon arrive for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). By September 17, 2018, facilities that are small animal food businesses must comply with preventive controls requirements mandated by FSMA.”

FDA Announces Release Of Two Guidance Documents To Help Facilities Meet Their Registration Requirements Under FFDCA: On August 20, 2018, FDA issued two new guidance documents to help facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA), specifically: (1) a guidance for industry titled Questions and Answers Regarding Food Facility Registration (Seventh Edition), to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements (83 Fed. Reg. 42024); and (2) a supplemental draft guidance to the Seventh Edition that includes questions and answers that clarify FDA’s thinking about the registration requirements in situations in which multiple entities are involved in the use of shared physical space, including when manufacturers lease their facility, store food at self-storage warehouses, or use commercial communal kitchens that are also used by other manufacturers to process food (83 Fed. Reg. 42062). Comments on the supplemental draft guidance are due by October 19, 2018.

FDA Provides Updates Regarding The Accredited Third-Party Certification Program: On August 23, 2018, FDA recognized International Accreditation Services, Inc. (IAS) of Brea, California, as an Accreditation Body under the Accredited Third-Party Certification Program for a period of five years. IAS was recognized as having the authority to accredit certification bodies with the ability to conduct food safety audits and issue certifications of foreign food facilities. On August 23, 2018, the American National Standards Institute (ANSI) notified FDA that Perry Johnson Registrars Food Safety, Inc. of Troy, Michigan, has become the first certification body (CB) to be accredited under FDA’s Accredited Third-Party Certification Program for the following program scopes: Produce Safety; Preventive Controls for Human Food; Juice HACCP, and Seafood HACCP, and will therefore be able to conduct food safety audits and issue food and facility certifications. Certifications issued by CBs accredited through FDA’s Accredited Third Party Certification Program can be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP); in certain circumstances, FDA can require that imported products be certified before entering the United States.

FDA Announces New Fees For Issuing Export Certificates: On September 4, 2018, FDA announced the fees it will assess for issuing export certificates for food and human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use; FDA is authorized to assess these fees under FSMA to cover its costs associated with issuing export certificates for food. 83 Fed. Reg. 44890. This is the first time FDA has exercised its FSMA authority to collect fees for export certificates issued for food for human consumption. The Federal Register notice provides the fee schedule for issuing these certificates and the basis for the fees. In FDA’s news release regarding the certification program, FDA’s Commissioner Scott Gottlieb, M.D., states that “[w]e anticipate that this new export certification will facilitate trade by assisting U.S. food exporters in fulfilling importing country requirements for FDA certification of FDA-regulated food products.” The fees will be effective October 1, 2018.

12th International Nano-Authorities Dialogue Held In Germany In June: The 12th International Nano-Authorities Dialogue was held in Germany on June 7-8, 2018. According to the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU), meeting participants evaluated the state of play of nano regulation and focused discussions on recommendations on how to improve the implementation of European and national regulations. BMU states that the results and recommendations that were supported by all stakeholders will be the basis for further discussions on the regulatory action needs and are documented in “Roadmap 2025.” Presentations from the Dialogue are available, in German.

Austrian Academy Of Sciences Publishes English Version Of Dossier On Nanotechnological Applications For Food Contact Materials: In July 2018, the Institute of Technology Assessment of the Austrian Academy of Sciences published an English version of Dossier No. 49, “Nanotechnological Applications for Food Contact Materials.” The Dossier concludes that nanomaterials can significantly improve the properties of plastic materials, making nanocomposites “increasingly interesting for manufacturers, especially for food packaging.” More information is available in our August 30, 2018, blog item, “Austrian Academy of Sciences Publishes English Version of Dossier on Nanotechnological Applications for Food Contact Materials.”

EC JRC Publishes Report On Mapping Nanomedicine Terminology In Regulatory Landscape: The European Commission’s (EC) Joint Research Center (JRC) has published a Technical Report entitled Mapping Nanomedicine Terminology in the Regulatory Landscape. According to the abstract, to support a better understanding of terms used in the regulatory domain, the Nanomedicines Working Group of the International Pharmaceutical Regulators Forum prioritized the need to map, compile, and discuss the currently used terminology of regulatory scientists coming from different geographic areas. JRC compiled, discussed, and analyzed the 31 relevant and most frequently used terms derived from various agencies for their similarities and differences. The descriptions are intended to support the development of harmonized use of terminology in the future. The report “provides necessary background information to advance the discussion among stakeholders. It will strengthen activities aiming to develop harmonised standards in the field of nanomedicine, which is an essential factor to stimulate innovation and industrial competitiveness.”

NNCO Will Focus On Public Outreach And Promoting Commercialization Of Nanotechnology: According to the Summer 2018 edition of the National Nanotechnology Coordination Office’s (NNCO) quarterly newsletter, in 2018, NNCO will focus on two of its primary responsibilities -- providing public outreach and promoting commercialization of nanotechnology. According to NNCO, these efforts focus on sharing information intended to assist the commercialization of nanotechnologies, aimed in particular at small- and medium-sized enterprises. NNCO states that additional efforts “will also concentrate on nanotechnology-focused entrepreneurship and the burgeoning community of interest in this area.”

NNI Publishes Supplement To President’s 2019 Budget Request: The National Nanotechnology Initiative (NNI) has published The National Nanotechnology Initiative Supplement to the President’s 2019 Budget. The August 2018 document not only supplements the President’s budget request for FY 2019, but also serves as NNI’s annual report and addresses the requirement for Department of Defense reporting on its nanotechnology investments. President Trump requests nearly $1.4 billion for NNI, “a continued investment in basic research, early-stage applied research, and technology transfer efforts that will lead to the breakthroughs of the future.” The document provides highlights illustrating progress toward each of the four NNI goals:

• Goal 1. Advance a World-Class Nanotechnology Research and Development (R&D) Program;
• Goal 2. Foster the Transfer of New Technologies into Products for Commercial and Public Benefit;
• Goal 3. Develop and Sustain Educational Resources, a Skilled Workforce, and a Dynamic Infrastructure and Toolset to Advance Nanotechnology; and
• Goal 4. Support Responsible Development of Nanotechnology.

More information is available in our August 22, 2018, blog item, “NNI Publishes Supplement to President’s 2019 Budget Request.”

IRSST Publishes Assessment Of Methods Of Sampling And Characterizing Engineered Nanomaterials In The Workplace In English: The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) recently published a report, in English, entitled An Assessment of Methods of Sampling and Characterizing Engineered Nanomaterials in the Air and on Surfaces in the Workplace. As reported in our March 29, 2017, blog item, IRSST first published the report in French. Based on IRSST’s investigations, it proposes a strategy for more accurate assessment of exposure to engineered nanomaterials using methods that require a minimum of preanalytical handling. The recommended strategy is a systematic two-step assessment of workplaces that produce and use engineered nanomaterials. More information is available in our September 7, 2018, blog item, “IRSST Publishes Assessment of Methods of Sampling and Characterizing Engineered Nanomaterials in the Workplace in English.”

EUON Study Finds Knowledge Gaps Exist In Risk Assessment Of Nano-Sized Pigments: The European Union (EU) Observatory for Nanomaterials (EUON) announced on September 7, 2018, that a new study found gaps in the current knowledge on the hazard and risk assessment of nano-sized pigments. The study was done to collect publicly available information on the identified nano-sized pigments that are on the EU market. EUON states that the study found that the available toxicological data are often inconsistent, and that the reported results are often contradictory -- “with the exception of a limited number of well-tested substances where general conclusions can still be drawn.” The study established an inventory of 81 currently known nano-sized pigments used in consumer and professional products on the EU market. The study provides recommendations for further work, including an increased emphasis on exposure assessment and control, as well as “generating well-designed and realistic exposure scenarios on particular nanomaterials for easy access and for benchmarking different safety measures.”

ECHA Article Addresses New REACH Information Requirements For Nanomaterials: The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA). As reported in our April 26, 2018, blog item, the EC Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. Holmqvist’s article provides answers to what the revised Annexes change, who the changes impact, when the new Annexes come into force, what ECHA is doing to help companies prepare, whether there are test methods already available to comply with the amended requirements, and if the new information requirements imply that nanomaterials on the EU market are unsafe. The article also lists guidance that is already available to help companies prepare for the revised information requirements.

Registration Open For NNI Webinar On Technology Pathways Toward Commercializing Nanotechnology: Registration is available for NNI’s September 19, 2018, webinar on “Technology Pathways Toward Commercializing Nanotechnology.” Webinar panelists will engage in a dialogue about the criticality of and issues surrounding quality control in the production of nanomaterials. The panelists will include:

• Katherine Barton, Director of Production and Laboratory Operations, Nano-C; and
• Doug Singer, Executive Vice President of Manufacturing, Cerion Advanced Materials.

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

PFAS Bills Introduced In Senate: On August 24, 2018, Senators introduced two bipartisan bills aimed at addressing contamination from chemicals containing per- and polyfluoroalkyl substances (PFAS). The PFAS Detection Act (S. 3382) was introduced by Senators Debbie Stabenow (D-MI), Mike Rounds (R-SD), and Gary Peters (D-MI). It provides the U.S. Geological Survey (USGS) with $45 million to develop new technologies to detect PFAS and then requires USGS to conduct nationwide sampling for PFAS in the environment. There are more than 3,000 chemicals containing PFAS, but less than 30 of these substances can be detected using current technology, according to a statement released by the Senators. The data collected by the USGS could be used to assess better the likely health and environmental impacts of exposure to PFAS chemicals and determine how to address contamination. The PFAS Accountability Act (S. 3381), introduced by Stabenow, Marco Rubio (R-FL), and Gary Peters (D-MI), seeks to hold federal agencies accountable for addressing contamination from PFAS at military bases. The bill sets deadlines and reporting requirements for cleaning up PFAS contamination at all federal facilities, including active and decommissioned military bases, and mandates greater transparency. Earlier this year, the Senators secured funding to investigate and clean up contamination at active and decommissioned military bases. For much of the federal money to be used to address PFAS contamination, however, federal agencies must enter into cooperative agreements with states. The PFAS Accountability Act calls for federal facilities to expedite cooperative agreements with states to address PFAS contamination. These agreements commit the federal government to take specific actions and enable states and local communities to be reimbursed for costs incurred to address PFAS contamination. If a cooperative agreement is not reached within a year after a state requests one, the Department of Defense must send a report to Congress explaining the reason for the delay and a projected timeline for completing the agreement.

Senators Collins, Carper Introduce Legislation To Track Mercury Pollution: On August 28, 2018, Senators Susan Collins (R-ME) and Tom Carper (D-DE) introduced legislation seeking to establish a national mercury monitoring network. Senator Collins stated that “Mercury is a potent neurotoxin of significant ecological and public health concern, especially for children and pregnant women. An estimated 200,000 children born in the United States each year are exposed to levels of mercury in the womb that are high enough to impair neurological development.” She added that “scientists must rely on limited information to understand the critical linkages between mercury emissions and environmental response and human health.” To design, implement, and assess solutions to the problem of mercury pollution, scientists need comprehensive long-term data, she stated, and her legislation -- the Comprehensive National Mercury Monitoring Act (S. 3394) -- seeks to provide that data. The bill directs EPA and other federal agencies to establish a national mercury monitoring program to measure and monitor mercury levels in the air and watersheds; water and soil chemistry; and marine, freshwater, and terrestrial organisms across the nation. EPA also would be required to establish a scientific committee to advise on the establishment, site selection, measurement, recording protocols, and operations of the monitoring program. The bill calls for a centralized database for existing and newly collected environmental mercury data that can be freely accessed on the Internet and that is comprised of data compatible with international efforts. And the bill authorizes $95 million over three years to carry out the program. The bill has been endorsed by the American Lung Association, the Biodiversity Research Institute, the Environmental Health Strategy Center, the League of Conservation Voters, NRDC, and the Science Policy Exchange.

House Democrats Renew Request For Hearing On TSCA Implementation: On August 29, 2018, the Democrats on the House Committee on Energy and Commerce issued a press release announcing that they have renewed their request for a hearing on EPA’s implementation of the amendments made by Lautenberg to TSCA. The Democrats note this is the fourth request they have made for hearings to be held on EPA’s management of toxic chemicals. According to the press release, the Democrats “remain concerned that EPA’s implementation of the reformed TSCA program contradicts the new law’s language and intent and undermines public confidence in the program.” The press release states that the Democrats “are concerned that EPA is ignoring its own scientific evidence and the recommendations of its experienced career staff regarding TSCA implementation at the expense of public health. They point to a recent report from the New York Times that found EPA officials proposed a rulemaking to review applications for use of asbestos in consumer products over the objections of EPA attorneys and scientists.” The Democrats “also charge that EPA has abandoned its statutory mandate to review all new and existing chemicals known or foreseeable uses and exposure putting human health and the environment at risk,” possibly resulting in an incomplete evaluation of the health and environmental risk of a number of “extremely toxic chemicals, including asbestos, perchloroethylene (PERC), methylene chloride, and trichloroethylene (TCE).” The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Environment Subcommittee Ranking Member Paul Tonko (D-NY), Raul Ruiz (D-CA), Scott Peters (D-CA), Gene Green (D-TX), Diana DeGette (D-CO), Jerry McNerney (D-CA), Tony Cardenas (D-CA), Debbie Dingell (D-MI), and Doris Matsui (D-CA).

Senate Bill Seeks To Reauthorize CFATS Program: On September 4, 2018, Senator Ron Johnson (R-WI) introduced legislation seeking to reauthorize the Chemical Facility Anti-Terrorism Standards (CFATS) program. Senator Johnson chairs the Senate Homeland Security and Governmental Affairs Committee. The CFATS program is set to expire in January 2019. The bill, the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2018 (S. 3405) reauthorizes the program, which is managed by the Department of Homeland Security (DHS) for another five years. In addition, the bill introduces several management reforms to the CFATS program “to bring much-needed regulatory relief to the U.S. chemical industry without compromising the safety and security of these facilities,” Senator Johnson stated. These revisions address risk-based performance standards, expedited approvals, audits and inspections, personnel surety, security risk assessment approach and corresponding tiering methodology, and requirements for small covered chemical facilities. Senator Johnson sponsored a roundtable on the CFATS program in June 2018.

Senate Committee Approves Nominee For White House Science Office: On September 5, 2018, the Senate Commerce, Science, and Transportation Committee approved the nomination of Kelvin Droegemeier to lead the White House’s Office of Science and Technology Policy (OSTP). The post has been vacant for some 19 months. Mr. Droegemeier is an extreme weather expert and professor of meteorology at the University of Oklahoma. He currently serves as the Oklahoma Secretary of Science and Technology. Previously he was the Vice Chair of the National Science Board. His nomination has generally been praised by the scientific community. John Holdren, who held the OSTP post in the Obama Administration, stated the nomination is “a very solid choice.” OSTP is a vital, yet often overlooked office. Established by Congress in 1976, it provides the White House with the most current scientific advances so that White House policies are shaped by sound science and provide the maximum benefit to society. This includes weighing matters of the economy, national and homeland security, foreign relations, public health, and the environment from a science, engineering, and technology perspective.

House Bill Introduced On Perchlorate In Drinking Water: On September 5, 2018, Representative Tony Cárdenas (D-CA) introduced legislation on perchlorate. The bill (H.R. 6705) would require EPA to establish a maximum contaminant level goal (MCLG) and promulgate a national primary drinking water standard under the Safe Drinking Water Act (SDWA) for perchlorate.

House Committee Holds Hearing On Infrastructure Environmental Permitting: For years there has been debate about whether permitting for infrastructure permits drags on for too long. On September 6, 2018, the House Oversight and Government Reform Committee held a hearing to examine that issue. Specifically, the hearing focused on the economic cost of delays and inefficiencies in the federal environmental review and permitting system for infrastructure projects. On average, it takes eight to ten years to obtain permit approval for large infrastructure construction projects in the U.S., the Committee stated in background documents related to the hearing. These delays “increase the overall project costs and directly harm communities while they wait for vital projects like safe roads and clean drinking water systems,” the Committee stated. Testifying before the panel were Daren Bakst, Senior Research Fellow, The Heritage Foundation; Philip K. Howard, Founder and Chair, Common Good; Frank Rusco, Director, Natural Resources and Environment Issues, U.S. Government Accountability Office (GAO); and Christy Goldfuss, Senior Vice President, Energy and Environment Policy, Center for American Progress. An archived webcast of the hearing and witness testimony are available online.

House Subcommittee Holds Hearing On PFAS Contamination: On September 6, 2018, the House Committee on Energy and Commerce’s Subcommittee on Environment held a hearing entitled “Perfluorinated Chemicals in the Environment: An Update on the Response to Contamination and Challenges Presented.” PFAS, also known as highly fluorinated chemicals, are a large group of man-made chemicals that include perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), and GenX chemicals. A background memorandum prepared by the Subcommittee majority states that the scientific community is rapidly recognizing and evolving its understanding of PFAS in the environment, and there is an increased pace of development of guidance values and regulations. In 2012, EPA required approximately 5,000 public water systems to monitor for six PFAS between January 2013 and December 2015. Completed in 2016, it comprises much of the current data available regarding PFAS in public drinking water and showed the following results among public water systems that conducted testing:

• PFOA was detected in 0.3% (13) of systems at levels exceeding 70 parts per trillion (ppt), which is EPA’s Lifetime Health Advisory (LHA) for PFOA and PFOS, individually or combined.
• PFOS was detected in 0.9% (46) of systems exceeding 70 ppt.
• None of the four other PFAS were detected above the LHA.

Further analysis of these data by academic and other researchers showed:

• Of the six PFAS compounds for which monitoring was required, one or more of them were detected in 194 out of 4,864 PWS tested (~4%), which serve about 16.5 million people in 33 states, three territories, and one Native-American community.
• Drinking water from 13 states accounted for 75% of detections, including, by order of frequency of detection, California, New Jersey, North Carolina, Alabama, Florida, Pennsylvania, Ohio, New York, Georgia, Minnesota, Arizona, Massachusetts, and Illinois.
• Approximately six million residents of the United States served by 66 public water systems had drinking water with concentrations of PFOA or PFOS, separately or combined, above the EPA’s LHA -- many of the public water systems with detections of PFOA or PFOS above the EPA LHA have acted to reduce these levels.

Testifying before the Subcommittee were: Dr. Peter Grevatt,Director, Office of Ground Water and Drinking Water, EPA; Maureen Sullivan, Deputy Assistant Secretary of Defense for Environment, U.S. Department of Defense; Sandeep Burman, Manager, Site Remediation and Redevelopment, Minnesota Pollution Control Agency, on behalf of Association of State and Territorial Solid Waste Management Officials; Lisa Daniels, Director, Bureau of Safe Drinking Water, Pennsylvania Department of Environmental Protection, on behalf of Association of State Drinking Water Administrators; Emily Donovan, Co-Founder, Clean Cape Fear; Ms. Carol Isaacs, Director, Michigan PFAS Action Response Team; and Erik D. Olson, Senior Director, Health and Food, Healthy People and Thriving Communities Program, NRDC. Witness testimony and an archived webcast of the hearing are available online.

House Committee Passes Permitting Streamlining Bill: On September 6, 2018, the House Judiciary Committee passed the Permitting Litigation Efficiency Act of 2018 (H.R. 5468) by a vote of 13-11. This legislation, sponsored by Tom Marino (R-PA) and cosponsored by Bob Goodlatte (R-VA), seeks to eliminate delays and reforms litigation processes to allow infrastructure projects to be completed in a timely manner. According to a release from the Committee, the purpose of the legislation “is to reform America’s outdated, slow-moving permitting system.” The bill seeks to accelerate the decision-making process by establishing an incentive for permitting agencies to issue final decisions within a two-year deadline. The bill sets a statute of limitations for lawsuits challenging those decisions and requires those suits to be based on matters actually presented to the permitting agencies during the administrative process. Furthermore, the bill assures that judges considering preliminary injunction requests in those cases will take into better account the potential economic and environmental harms of delaying project construction by injunctions.

Bill Seeks To Boost Funding For Water Treatment: Representative Gwen Moore (D-WI) on September 7, 2018, introduced the Water Technology Acceleration Act (H.R. 6727). The bill is intended to boost federal funding for state and local governments to implement newly developed technologies for supplying and treating water. Ms. Moore’s bill is in response to unsafe levels of lead found in Milwaukee’s drinking water supply.

Bill Would Reallocate RFS Obligations: On September 7, 2018, Representative David Young (R-IA) introduced the Restoring Our Commitment to Renewable Fuels Act of 2018 (H.R. 6731). The bill would reallocate the renewable fuel obligation of exempted small refineries under Section 211(o) of the CAA to other refineries, blenders, distributors, and importers. The bill also would require EPA to disclose which refineries received “hardship waivers” exempting them from renewable fuel standard (RFS) obligations. EPA recently released its proposed 2019 Renewable Volume Obligations, which did not include a plan to reallocate gallons that might be waived by EPA for small refineries moving forward.

Bipartisan Bill Seeks To Amend Fracking Disclosure Regulations: On September 10, 2018, a bipartisan group of representatives, lead by Darren Soto (R-FL), introduced a bill that would reestablish certain hydraulic fracturing chemical disclosure rules, standards for well construction, and waste management rules. The bill, H.R. 6768, was referred to the Committee on Energy and Commerce, and several other Committees.

Lawmakers Pass Appropriations Bills: Lawmakers have reached a deal to avert a shutdown by passing a large package of spending bills, along with a continuing resolution that would fund the rest of the government through December 7, 2018. The package keeps the federal government funded past October 1, 2018, the deadline for Congress to act, assuming President Trump signs the measures. The Senate acted on September 12, 2018, on the measures; the House did its part on September 13, 2018, sending the appropriations bills to the White House.

EPA Pivots From National Enforcement Initiatives To National Compliance Initiatives: On August 21, 2018, Susan Bodine, Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance (OECA), issued a memorandum to EPA Regional Administrators ordering a shift from enforcement to compliance. “Recognizing the need to focus resources to achieve environmental law compliance . . . EPA intends to evolve National Enforcement Initiatives [NEIs] into a National Compliance Initiatives (NCIs) program by providing states and tribes with additional opportunities for meaningful engagement, by developing and applying a broader set of compliance assurance tools, and by aligning the NCIs with the Agency Strategic Plan measures and priorities,” the memorandum states. OECA’s goal is to increase compliance “and enforcement actions are not the only tool for achieving this goal.” Ms. Bodine states that in the transition to NCIs, EPA will make four adjustments:

• Modify its selection criteria for the FY 2020-2023 NCI cycle to align better with EPA Strategic Plan measures and priorities;
• Engage more fully with states and tribes in the selection and development of the initiatives;
• Enhance EPA’s use of the full range of compliance assurance tools in an NCI; and
• Extend the priorities cycle to four years to align better with EPA’s National Program Guide cycle.

In selecting the NCIs for the FY 2020-2023 cycle, EPA will consider the following factors:

• Alignment with EPA Strategic Plan measures and priorities -- EPA will create NCIs to address: nonattainment areas, impaired waters, public health threats posed by drinking water noncompliance, populations vulnerable to air toxics or chemical accidents, and children’s exposure to lead.
• Need for EPA expertise, authority, or resources -- States or EPA may determine that EPA’s expertise, authority, or resources are needed to improve compliance. Examples may include: remedying violations where states lack authority or the expertise; sharing technologies; providing national compliance assistance tools; or creating data tools to identify serious environmental problems or disproportionate adverse impacts to public health.
• Need to address serious and widespread noncompliance across the country -- While a noncompliance problem may not be present in every EPA region or state, it may be so common that a national focus is necessary to remedy the noncompliance to maintain certainty for regulated entities through a level playing field and a consistent level of environmental and public health protection across our country.

The memorandum commits EPA to using the full range of compliance assurance tools. Although, EPA states that “enforcement actions will continue to be a critical tool for addressing serious violators and deterring violations.”

For FY 2019, EPA will evolve the existing NEIs into NCIs. EPA’s priorities will be to create NCIs that:

• Keep industrial pollutants out of the nation’s waters;
• Prevent animal waste from contaminating surface and ground water;
• Keep raw sewage and contaminated stormwater out of our nation’s waters;
• Reduce air pollution from the largest sources;
• Reduce risks of accidental releases at industrial and chemical facilities;
• Cut hazardous air pollutant emissions;
• Ensure energy extraction activities comply with environmental laws; and
• Reduce toxic air emissions from hazardous waste facilities.

OSHA Posts FAQs And Videos On Silica In Construction Standard: On August 22, 2018, the Occupational Safety and Health Administration (OSHA), posted new FAQs and training videos on its standard for respirable crystalline silica in construction. The FAQs provide employers and workers with guidance on the standard’s requirements. Six new videos instruct users on methods for controlling exposure to silica dust when performing common construction tasks, or using construction equipment.

EPA Realigns Regional Office: On September 6, 2018, EPA Acting Administrator Andrew Wheeler announced that EPA is realigning its Regional Offices to establish a standard organizational structure that more closely aligns with EPA’s Headquarters’ structure. This realignment is intended to: increase coordination between EPA’s National Programs and its Regional counterparts, improve the consistent implementation of EPA regulations and policies, allow for better resource allocation to carry out more effectively EPA’s mission, facilitate EPA’s overall operational excellence, and provide greater transparency for EPA’s customers. Currently, every EPA Regional Office has a different structure. The proposed new standard structure for every Regional Office includes a Regional Administrator, Deputy Regional Administrator, and the following divisions:

• Air and Radiation;
• Administration and Resource Management (to include Office of Administration and Resources Management (OARM), Office of the Chief Financial Officer (OCFO), and Office of Environmental Information (OEI) functions);
• Enforcement and Compliance Assurance;
• Land and Redevelopment (to include OCSPP and Brownfields functions);
• Superfund and Emergency Management;
• Water;
• Laboratory Services and Applied Science; and
• Regional Counsel (to include the Freedom of Information Act (FOIA) program).

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