Wrap-Up of Federal and State Chemical Regulatory Developments, October 2019

EDF Reports That EPA Has “Muzzled” SACC: The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.” EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).” According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community. EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns. According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.” EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”

EPA Calls For Nominations For 2020 Green Chemistry Challenge Awards: EPA announced on September 18, 2019, that it is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment. Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019. EPA states that it anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2020 nominations and make recommendations to EPA for the 2020 winners.

EPA Includes Unique Identifier Information On Updated TSCA Inventory: On September 19, 2019, EPA announced that it posted the first public TSCA Inventory to include unique identifier (UID) information. EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity. When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID to other information or submissions concerning the same substance; and ensures that any non-confidential information received by EPA identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure. EPA notes that this is the first time that the public version of the TSCA Inventory includes both a field containing a UID for those chemical substances with approved confidentiality claims for specific chemical identity and a field containing the ten-year expiration date from the assertion of such approved claims. EPA states that the UIDs provide the public with a way to connect the specific chemical identity previously listed on the confidential portion of the TSCA Inventory with other relevant information in EPA’s holdings. A more detailed commentary is available in our September 20, 2019, memorandum, “EPA Includes Unique Identifier Information on Updated TSCA Inventory.”

EPA Releases Final Test Guidelines For Premises Treatments: On September 30, 2019, EPA announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines. 84 Fed. Reg. 51557. The guideline, 810.3500 Premises Treatments, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies, and wasps in connection with registration of pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use against public health pests. This guideline does not, however, apply to efficacy testing for treatment of livestock or pets, wide-area mosquito control, structural protection from termites, or bed bug products. Revisions to 810.3500 include: clarifying bait product testing; offering more flexibility in testing design; updating the replication recommendations based on statistical modeling and ease of obtaining pests; and refining the statistical analyses recommendations. Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the Agency’s response to comments are available at www.regulations.gov in Docket Number EPA-HQ-OPP-2017-0693. More information on test guidelines is available on our blog. Comments are due on or before November 29, 2019.

EPA Extends Comment Period For Proposed TSCA PBT Rule: On September 26, 2019, EPA announced that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 50809. EPA identified five chemicals pursuant to TSCA Section 6(h): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action. For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1). Comments are now due October 28, 2019. EPA is required to issue a final rule by December 2020. Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

EPA OIG Will Evaluate Implementation Of 2009 TSCA PMN Consent Order With DuPont [Chemours]: EPA’s Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 TSCA premanufacture notice (PMN) consent order with DuPont [Chemours]. According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear River basin. OIG states that it plans to conduct work in headquarters within the Office of Enforcement and Compliance Assurance (OECA) and the Office of Chemical Safety and Pollution Prevention (OCSPP), as well as Region 4. The anticipated benefits of the project are to improve controls over TSCA PMN consent orders.

EPA OIG Will Audit EPA’s Safer Choice Program: On September 23, 2019, EPA’s OIG announced that it plans to begin fieldwork on EPA’s Safer Choice program. According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process. OIG states that Safer Choice “is a voluntary labeling program that helps consumers and commercial buyers find chemical-based products that are safer for human health and the environment.” OIG plans to conduct work at headquarters and at various third-party assessor and auditor locations. It will use applicable generally accepted government auditing standards in conducting its audit. The anticipated benefits of the audit “are reducing the use of chemicals of concern and empowering consumers to protect their health.”

EPA Recognizes 2019 Safer Choice Partner Of The Year Award Winners: On September 25, 2019, EPA recognized 14 Safer Choice Partner of the Year award winners for outstanding achievement in 2018 for the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide. The Safer Choice program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or performance. According to EPA’s press release, the 2019 Partner of the Year award winners represent businesses -- including woman-owned and small- and medium-sized -- local government, and associations.

EPA Submits Proposed SNUR On LCPFAC And PFAS Chemical Substances To OMB For Review: On September 25, 2019, EPA submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review. EPA states that it is developing a supplemental proposal for the LCPFAC SNUR amendments to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles. According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in TSCA Section 5(a)(5) that was added with the 2016 amendments to TSCA. Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification. Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.

EPA Publishes TSCA SACC Meeting Minutes And Final Report On Draft Risk Evaluation For PV29: On September 30, 2019, EPA announced the availability of the meeting minutes and final report for the June 18-21, 2019, SACC meeting on the draft risk evaluation for Pigment Violet 29 (PV29). SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation. The report notes that this first SACC peer review is the first time the TSCA program is making non-TSCA CBI available to peer reviewers. According to the report, EPA requested comment on the process, integration, and clarity related to the use of the CBI that was provided. More information is available in our October 3, 2019, blog item.

EPA Launches Examination Of Inorganic Mercury: On October 8, 2019, EPA announced an examination of inorganic mercury salts to aid in the management of waste. 84 Fed. Reg. 53720. EPA’s Research and Development Office will assess mercury salts to identify health hazards that may be caused by inorganic salts to workers and exposure others. Comments are due by November 7, 2019.EPA intends to host a webinar on December 5, 2019, to discuss its evaluation.

EPA Updates Aquatic Life Benchmarks For Several Pesticides: On September 30, 2019, EPA released an updated Aquatic Life Benchmarks Table for registered pesticides. The update includes four newly registered pesticides and their degradants as well as new values for around 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation. EPA derived the latest updates from toxicity values from the most recent ecological risk assessments for the registered pesticides as part of regular registration review. EPA aims to update the table on an annual basis. The full table and links to source documents for each of the benchmarks are accessible on EPA’s website here.

Earthjustice Notifies EPA Of Intent To Sue For Failure To Disclose Information About New Chemical Substances: On September 3, 2019, Earthjustice filed with EPA a notice of intent (NOI) to sue EPA under Section 20(a)(2) of TSCA for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.” According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of new chemical applications under the PMN and test marketing exemption (TME) provisions. Earthjustice states that these violations impede the ability of the listed parties -- EDF, Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, Sierra Club, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO/CLC -- “to be meaningfully informed of and able to participate in EPA’s review of new chemicals.” Earthjustice asks that EPA immediately cease further violations of TSCA’s disclosure requirements for new chemicals and disclose the information to which the listed parties are legally entitled in the mandated time frames. Please see our blog for more information here.

EPA Announces Revised Service Fees For Pesticide Registration Applications Under PRIA 4: On October 1, 2019, EPA issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019. 84 Fed. Reg. 52085. The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019. The revised fees will remain in effect until September 30, 2021. The fee schedule provided in PRIA 4 identifies the registration service fees and decision times organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. EPA presents the schedules as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee, and lists the registration service fee for actions received in fiscal years (FY) 2020 and 2021. Applicants must submit fee payments at the time of application. EPA will reject any application that does not contain evidence that the PRIA 4 fee has been paid. The revised fee schedule for PRIA 4 FYs 2020 and 2021 is available on EPA’s website. More information on the PRIA 4 legislation is available on our blog under key word PRIA.

EPA Announces Antimicrobial Performance Evaluation Program (APEP): Draft Risk-Based Strategy To Ensure The Effectiveness Of Hospital-Level Disinfectants: On October 2, 2019, EPA announced the availability of, and requested comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP): A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy). 84 Fed. Reg. 52502. EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants and tuberculocide products continue to meet Agency efficacy standards once they are in the marketplace.” The draft Strategy was developed in response to the EPA OIG report titled “EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants,” which recommends that EPA’s OPP develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace. EPA developed the draft Strategy based on OIG’s recommendations. More information on the APEP is available on our blog. Comments on the draft Strategy are due on or before December 2, 2019.

Clean Air Scientific Advisory Committee To Hold Teleconference On PM_2.5 NAAQS: On October 22, 2019, EPA’s Clean Air Scientific Advisory Committee (CASAC) will hold a public teleconference to receive comments for the CASAC to consider in its peer review of EPA’s Policy Assessment for Particulate Matter (PM). EPA is currently evaluating whether to revise the National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM_2.5). Additional information is available online.

Court Remands Portions Of Cross State Air Pollution Rule: On September 13, 2019, the U.S. Court of Appeals for the District of Columbia Circuit issued a ruling remanding to EPA part of its Cross State Air Pollution Rule. State of Wisconsin, et al., v. EPA, Case No. 16-1406. In the 2016 rule, EPA promulgated a regulation addressing the interstate transport of ozone. That rule generally required upwind states to limit emissions of ozone that could negatively impact downwind states. A number of parties brought challenges to the rule, some contending that it is too strict and others contending it is too lenient. Environmental groups ended up prevailing on their argument that the rule allows upwind states “to continue their significant contributions to downwind air quality problems beyond the statutory deadlines by which downwind States must demonstrate their attainment of air quality standards.” The court remanded that portion of the rule to EPA without vacating it. The court upheld, however, all other portions of the rule.

Court Dismisses Clean Power Plan Litigation: On September 17, 2019, the U.S. Court of Appeals for the District of Columbia Circuit dismissed cases that had been pending since 2015 targeting EPA’s Clean Power Plan (CPP). Consolidated into West Virginia v. EPA, D.C. Cir., Case No. 15-1363, the cases were brought in challenge to or support of EPA’s CPP rule. Because the Trump Administration has issued a rule replacing the CPP -- the Affordable Clean Energy (ACE) rule -- those cases are now moot, the court ruled.

Rotterdam Convention Requirements On HBCD Take Effect September 16, 2019: Effective September 16, 2019, the Rotterdam Convention’s restrictions on shipments of the flame retardant hexabromocyclododecane (HBCD) took effect. This means that HBCD is now subject to prior informed consent (PIC) procedures. Any party wishing to ship HBCD to one of the nations that have ratified the Rotterdam Convention must receive consent from the receiving country prior to shipping the chemical. The United States has not ratified the convention. HBCD was added to Annex III of the Rotterdam Convention. Any Annex III export must receive permission in advance from a receiving country that is party to the Convention, and must give permission for any import. Under the Rotterdam Convention, countries make informed decisions to accept the chemicals they are prepared to receive, and exclude those they decide they cannot manage safely. Article 13 of the Rotterdam Convention outlines information that is to accompany any import and export of certain hazardous chemicals. These include:

• The specific Harmonized System customs code (assigned by the World Customs Organization) for a chemical listed in Annex III of the Rotterdam Convention; and
• Globally Harmonized System of Classification and Labeling of Chemicals (GHS) labeling and a current safety data sheet (SDS) in the official language of the importing country.

The chemicals listed in Annex III of the Rotterdam Convention include pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons by two or more Parties and which the Conference of the Parties has decided to subject to the PIC procedure. There are a total of 50 chemicals listed in Annex III, 34 pesticides, 16 industrial chemicals, and 1 chemical in both the pesticide and the industrial chemical categories.

Trump Administration Revokes California CAA Waiver: On September 19, 2019, igniting a firestorm of protest, the Trump Administration announced that it “would address and correct the current fuel economy and greenhouse gas emissions standards.” It plans on doing so by having EPA and the Department of Transportation’s (DOT) National Highway Traffic Safety Administration (NHTSA) revoke a Clean Air Act (CAA) waiver that allows California and other states to set their own emission standards for automobiles. The Administration stated that it will issue a final action entitled the “One National Program Rule.” This rule “will enable the federal government to provide nationwide uniform fuel economy and greenhouse gas emission standards for automobiles and light duty trucks.” According to the Administration, “This action brings much-needed certainty to consumers and industry by making it clear that federal law preempts state and local tailpipe greenhouse gas (GHG) emissions standards as well as zero emission vehicle (ZEV) mandates.” Specifically, in this action, NHTSA is affirming that its statutory authority to set nationally applicable fuel economy standards under the express preemption provisions of the Energy Policy and Conservation Act dictates that such state and local programs are preempted. For its part, EPA is withdrawing the CAA preemption waiver it granted to the State of California in January 2013 as it relates to California’s GHG and ZEV programs. The Administration’s decision is certain to be challenged in court by California and others.

EPA Requests Comment On Water Quality Trading Under The NPDES Program: On September 19, 2019, EPA issued a notice requesting comment on water quality trading under the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) program. 84 Fed. Reg. 49293. EPA specifically is requesting comment on policy approaches for addressing issues in watersheds with EPA-approved Total Maximum Daily Loads (TMDL) where policy makers would like to pursue water quality trading as a regulatory option for NPDES permit compliance. The comment period closes on November 18, 2019.

EPA Completes Risk And Technology Review For Paper Source Category: On September 19, 2019, EPA announced that it has completed its residual risk and technology review (RTR) of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Paper and Other Web Coating (POWC) source category that is required under the CAA. 84 Fed. Reg. 49382. As a result of its review, EPA concludes that the risks due to emissions of air toxics to be acceptable from this source category and that the current NESHAP provides an ample margin of safety to protect public health. EPA also stated that it identified no new cost-effective controls under the technology review that would achieve significant further emissions reductions. EPA thus is proposing “no revisions are necessary based on developments in practices, processes, or control technologies.” EPA is, however, proposing certain amendments to the POWC NESHAP. Specifically, EPA is proposing to add a compliance demonstration equation that accounts for retained volatiles in the web coating; to amend provisions addressing periods of startup, shutdown, and malfunction (SSM); to add repeat testing and electronic reporting requirements; and to make technical and editorial changes. EPA is proposing these amendments to improve the effectiveness of the NESHAP. EPA is taking comments on this decision until November 4, 2019.

PHMSA To Host Public Meeting Of Research And Development Roundtable: On September 23, 2019, DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that PHMSA’s Office of Hazardous Materials Safety (OHMS) will hold a public Research and Development (R&D) Roundtable on October 24, 2019, in Washington, DC. 84 Fed. Reg. 49785. OHMS will host the meeting to provide an overview of its next Broad Agency Announcement (BAA), which will help PHMSA meet its goals of promoting safety and fostering innovation. The meeting will provide an overview of OHMS’ R&D program; internal and external processes behind the BAA; limits of the BAA; and the results of the 2017 BAA. OHMS is particularly interested in research gaps associated with: development of new standards for bulk and non-bulk packaging; proved materials and designs for hazardous materials packaging; self (default) classification of hazardous materials and/or articles; improvements to the North American emergency response guidebook; charge storage device transportation safety; and innovative technologies to improve hazmat transportation safety. Those interested in attending the meeting (either in person or remotely) must register online.

RCRA Improvements Rule: An Update And Discussion: On November 28, 2016, EPA issued the final “Generator Improvements Rule” under the Resource Conservation and Recovery Act (RCRA). 81 Fed. Reg. 85732. The potential scope of the revised regulatory program is immense -- the changes will affect almost 700,000 facilities. The rule is the most comprehensive overhaul of the RCRA generator requirements in 30 years. Although the rule took effect on May 30, 2017, it is not effective in RCRA-authorized states until the states adopt the provisions. Many states are doing so; an update on the rule thus is timely. The rule is a hodgepodge of over 60 sweeping changes to the existing regulations and the inclusion of new requirements for generators of hazardous waste. The changes include a reorganization of the hazardous waste generator requirements to make them more user-friendly and thus easier for the regulated community to be in compliance. The changes also provide a better understanding of how the hazardous waste generator regulatory program works and address gaps in existing regulations that will bolster environmental protection. Additional flexibility for generators is also built into the changes.

Oil And Gas Methane Rule Published In Federal Register: On September 24, 2019, EPA issued a proposed rule that would relieve segments of the oil and gas industry sector from complying with standards intended to cut emissions of methane. 84 Fed. Reg. 50244. The proposed rule would revise the 2012 and 2016 New Source Performance Standards (NSPS) for the oil and natural gas industry that, according to EPA, “would remove regulatory duplication and save the industry millions of dollars in compliance costs each year, while maintaining health and environmental protection from oil and gas sources that the Agency considers appropriate to regulate.” The proposal even posits whether EPA has the authority to regulate methane emissions. EPA stated that it is proposing the rule in response to President Trump’s Executive Order (EO) on Promoting Energy Independence and Economic Growth. That order directs agencies to review existing regulations that potentially “burden the development or use of domestically produced energy resources,” including oil and natural gas, and to rescind or suspend regulatory requirements if appropriate. The proposed rule would remove all sources in the transmission and storage segment of the oil and natural gas industry from regulation under the NSPS, both for ozone-forming volatile organic compounds (VOC) and for GHGs. The existing NSPS regulates GHGs through limitations on emissions of methane. EPA also proposed to rescind the methane requirements in the 2016 NSPS that apply to sources in the production and processing segments of the industry. As an alternative, EPA also is proposing to rescind the methane requirements that apply to all sources in the oil and natural gas industry, without removing any sources from the current source category. EPA also is seeking comment on alternative interpretations of EPA’s legal authority to regulate pollutants under Section 111(b) of the CAA. The comment period on the rule closes on November 25, 2019.

EPA Completes CAA Risk And Technology Review For Taconite Ore Processing Operations: On September 25, 2019, EPA issued a proposed rule presenting the results of EPA RTRs for the NESHAP for Taconite Iron Ore Processing. 84 Fed. Reg. 50660. EPA found that risks from emissions of air toxics from this source category are acceptable and that the existing standards provide an ample margin of safety. Furthermore, EPA identified no cost-effective developments in controls, practices, or processes to achieve further emissions reductions. Therefore, EPA is proposing no revisions to the existing standards based on the RTRs. The comment period closes on November 12, 2019.

EPA Extends Comment Period On Proposal Rescinding “Once-In-Always-In” CAA Policy: On October 2, 2019, EPA extended until November 1, 2019, the comment period on its July 26, 2019, proposal to rescind EPA’s “once-in always-in” policy under the CAA. 84 Fed. Reg. 52419. The CAA defines a “major source” as one that emits, or has the potential to emit (PTE), 10 tons per year of any hazardous air pollutant (HAP), or 25 tons per year or more of any combination of HAPs. Sources with emissions below this threshold are “area sources.” All major sources are subject to Maximum Achievable Control Technology (MACT) standards, while area sources generally are subject to less stringent standards. In a 1995 memorandum, EPA established a “once-in always-in” policy stating that any facility subject to major source standards would always remain subject to those standards, even if the owner or operator of the facility implemented production process changes or controls that eliminated or permanently reduced the facility’s potential to emit HAPs. EPA first articulated the policy in a May 1995 memorandum. In that memorandum, EPA stated that “facilities that are major sources for HAP … are required to comply permanently with the MACT standard.” See “Potential to Emit for MACT Standards -- Guidance on Timing Issues.” John Seitz, Director, Office of Air Quality Planning and Standards, EPA (May 16, 1995). EPA, however, revisited the policy on January 25, 2018, and issued a memorandum rescinding it. The withdrawal was published in the Federal Register on February 8, 2018. 83 Fed. Reg. 5543. In the January 25, 2018, memorandum, EPA argues that the 1995 policy “is contrary to the plain language of the CAA, and, therefore, must be withdrawn.” EPA further explained that Congress defined the terms “major source” and “area source” in CAA Section 112(a) in unambiguous language. The 1995 policy violated those definitions by regulating area sources as major sources, EPA concluded. Accordingly, EPA has now determined that a major source that limits its PTE and takes measures to bring its HAP emissions below the applicable threshold becomes an area source, no matter when the source may choose to take measures to limit its PTE. “That source, now having area source status, will not be subject thereafter to those requirements applicable to the source as a major source under CAA section 112, including, in particular, major source MACT standards -- so long as the source’s PTE remains below the applicable HAP emission thresholds,” EPA states. To codify this new approach, EPA proposes to amend the applicability section found in 40 Code of Federal Regulations (C.F.R.) Section 63.1 by adding a new paragraph (c)(6). This paragraph will specify that a major source can become an area source at any time by limiting its HAP PTE to below the major source thresholds established in 40 C.F.R. Section 63.2. In another major shift from past policy, EPA is proposing to amend the definition of PTE in 40 C.F.R. Section 63.2 to remove the requirement that limits on emissions be federally enforceable. Instead, EPA is proposing that it will consider any physical or operational limitation on the capacity of the stationary source to emit a pollutant as part of its design if the limitation or the effect it would have on emissions is legally and practicably enforceable. This includes air pollution control equipment; restrictions on hours of operation; or limits on the type or amount of material combusted, stored, or processed. By proposing this amendment, EPA is allowing for the use of non-federally enforceable limits to be recognized as limiting a source’s PTE, provided those limits are legally and practicably enforceable. EPA also is allowing facilities to switch back and forth between major and area source status. EPA proposes regulatory text at 40 C.F.R. Section 63.1(c)(6)(i) under which major sources that reclassify to area source status become subject to applicable area source requirements immediately upon becoming an area source. For sources that reclassify from major to area source status and then revert back to their previous major source status, EPA is proposing that upon reverting back to major source status, a source must meet the major source requirements at the time that those requirements again become applicable to the source. Switching from a major source to an area source will not, however, allow facilities to escape enforcement actions initiated against them while they were major sources. To prohibit this, EPA proposes that reclassification from major source to area source does not affect a source’s liability, enforcement investigations, or enforcement actions for a source’s past violations of major source requirements that occurred prior to the source’s reclassification.

EPA Awards $6 Million To Research Potential Environmental Impacts Of PFAS Substances In Waste Streams: EPA on September 17, 2019,announced approximately $6 million to fund research by eight organizations to expand the understanding of the environmental risks posed by PFAS in waste streams. The funding -- issued under EPA’s Science To Achieve Results (STAR) Program -- also is intended to identify practical approaches to manage the potential impacts as PFAS enters the environment. The eight recipients receiving this funding include:

• New York State Department of Health -- Health Research Inc., Menands, NY – to build a data set by analyzing samples from approximately 150 landfills in New York. These data will be used to understand the types and concentrations of PFAS that are found in and around landfills, as well as the key landfill attributes that contribute to the release of PFAS.
• North Carolina State University, Raleigh, NC -- to collect landfill gas (LFG) samples from over 400 landfills across the U.S. to determine if PFAS from LFG is a significant source of PFAS released into the atmosphere.
• University of Florida, Gainesville, FL -- to study the role of waste type, management strategies, and treatment methods on the occurrence, source, and fate of PFAS in landfills. The study will identify the sources of PFAS compounds in the domestic waste stream using laboratory-scale batch leaching and landfill simulation studies.
• Clemson University, Clemson, SC -- to examine the chemical process for the destruction of PFAS in leachate and groundwater. This project will assess degradation kinetics, test hypothesized process modifications, and conduct trials of leachate treatment.
• Purdue University, West Lafayette, IN -- to develop methods to decrease PFAS concentrations in both municipal wastewater treatment plant effluent and sludge. The study will determine the technical and economic feasibility of using a treatment approach consisting of nanofiltration followed by electrochemical oxidation.
• Texas A&M AgriLife Research, College Station, TX -- to investigate the feasibility of electron beam technology for the destruction of PFAS compounds during the remediation of groundwater, wastewater, sewage sludges, and soils.
• Texas Tech University, Lubbock, TX -- to identify and quantify the occurrence of PFAS in landfill leachate, investigate the fate of PFAS passing through typical landfill liner systems, and test the ability to break down PFAS in landfill leachate using soundwaves.
• University of North Dakota, Grand Forks, ND -- to develop practical strategies for removing legacy and emerging PFAS from leachate and groundwater by studying the adsorption, desorption, and biodegradation of PFAS and precursor compounds in landfills.

EPA Proposes Updates To Lead And Copper Rule: For the first time in nearly 30 years, EPA is proposing to update regulations around drinking water service lines known as the Lead and Copper Rule (LCR). EPA’s LCR proposal maintains the existing action level of 15 parts per billion (ppb) and creates a new trigger level of 10 ppb that will require communities to take a more proactive approach in addressing lead service lines.

In addition to changes to sampling methods and procedures, key updates in the LCR proposal include:

• Requiring a public service lead line inventory;
• Compelling communities to “find-and-fix” localized sources of elevated lead levels;
• Replacing a minimum of three percent of lead service lines annually where lead levels exceed 15 ppb;
• Prohibiting “test outs” previously allowed to avoid replacing lead lines;
• Requiring drinking water utilities to notify customers within 24 hours of lead exceedance;
• Requiring systems to conduct regular outreach to homeowners with lead service lines; and
• Requiring drinking water testing at schools and childcare facilities.

Once published in the Federal Register, there will be a 60-day public comment period on the LCR proposal. More information including fact sheets are available on EPA’s website here.

FDA Announces Smarter Food Safety Meeting: On September 18, 2019, the U.S. Food and Drug Administration (FDA) announced additional details for the upcoming public meeting titled “A New Era of Smarter Food Safety.” 84 Fed. Reg. 49111. The purpose of the meeting is to foster dialogue between the FDA and other stakeholders in the food safety industry and input received in the meeting will be used to inform and shape FDA’s Blueprint for a New Era of Smarter Food Safety. Focus areas announced for the meeting include traceability, smarter tools and approaches for prevention, the challenges of new business models and retail food safety, and support for the development of food safety cultures. The public meeting will be held on October 21, 2019. Comments on the public meeting are due by November 20, 2019. Please consult the Federal Register notice for more details.

FDA Launches Food Safety Initiative For Leafy Greens: On September 23, 2019, FDA launched an initiative with support from the Arizona Department of Agriculture to study the ecology of human pathogens in the Yuma agricultural region. The multi-year study, which will probe how pathogens survive, move, and possibly contaminate produce prior to harvest, follows the multi-state E.coli O157:H7 outbreak that ended on June 28, 2018. FDA expects that results from the study will lead to improved practices to prevent or mitigate food safety risks, and enhance the safety of produce grown in Yuma County in Arizona and the Imperial Valley in California.

Food Additive Petition Filed For Silicon Dioxide: On October 1, 2019, FDA announced that Evonik Corp. filed a food additive petition (FAP) for the use of silicon dioxide as an additive in animal feed components. 84 Fed. Reg. 52055. The petition, filed on July 24, 2019, proposes to amend Title 21 of the C.F.R. Part 573 (21 C.F.R. Part 573) titled Food Additives Permitted in Feed and Drinking Water of Animals, which would, if approved, provide for the safe use of the additive as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed ingredients, intermediate premixes, premixes, supplements, or concentrates.

FDA Releases FSMA Recall Plan Guidance: On October 7, 2019, FDA announced the availability of “Chapter 14: Recall Plan,” which is part of the agency’s draft guidance for industry titled “Hazard Analysis and Risk-Based Preventative Controls for Human Food.” The guidance is intended to help establish and implement a written recall plan as required by 21 C.F.R. Section 117.139. Actions to be taken in the event of a recall, such as notification of consignees and the public, and resources for complying with the rule are detailed in the guidance.

Lynn L. Bergeson And Carla N. Hutton Co-Author Article On Nanotechnology And Regulatory Certainty: We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.” The article provides an overview of how EPA and FDA are using their existing authorities to ensure that nanomaterials do not pose a risk to human health and the environment. The complete article is available only to Section members.

EPA Researches Carbon Nanotubes In 3D Printing Filament: The September 10, 2019, issue of EPA’s Science Matters newsletter includes an article entitled “Keeping up with 3D Printing: EPA Researchers Build on New Plastic Emissions Study.” According to the article, EPA scientists, through an agreement with the Consumer Products Safety Commission (CPSC), are investigating whether increased use of 3D printers can lead to unintended adverse impacts to human health. The scientists studied a commonly available filament that is sold both with and without carbon nanotube inclusions to determine whether VOCs emissions changed between the two types of product. The scientists concluded that: (1) the filaments with carbon nanotubes emitted two new VOC gases that could potentially pose an inhalation hazard to users printing several kilograms of material; (2) increased print temperature had the most significant effect on increasing VOC emissions, followed by increased length of time heating the material; and (3) carbon nanotube filament may “trap” certain VOC gases in particulates of the printed plastic.

ECHA Executive Director Authors First EUON Nanopinion Post: The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market. The first item, posted on September 16, 2019, is “EUON: past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA). EUON invites its stakeholders and partners to use Nanopinion “to share their views on anything and everything to do with nanomaterials, their safety and their benefits.”

EUON Study Finds EU Regulatory Framework Ready For Next Generation Nanomaterials: On September 19, 2019, EUON announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges. According to EUON, the study findings “indicate that although the regulatory framework is well-equipped to handle these materials in the near future, further guidance would benefit companies registering nanomaterials” under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The study recommends further clarifications for some parameters characterizing both nanomaterials and their uses and that the guidelines on how to determine whether an object is an article under REACH could be complemented with specific examples of different nanomaterials, from simple nanoparticles to more complex assembly structures.

NIOSH Nanotechnology Research Center Seeks Input From Manufacturers, Distributors, Fabricators, Formulators, And Users Of Engineered Nanomaterials: According to an item in the September 2019 issue of NIOSH eNews, the National Institute for Occupational Safety and Health (NIOSH) is working with RTI International to distribute a survey to companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials. The item states that the goal of the survey is to assess the impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of engineered nanomaterials in the workplace. Adrienne Eastlake, aeastlake@cdc.gov, is the contact for any questions.

EUON Publishes Nanopinion On Strengthening Societal Engagement With Nanotechnologies: On October 7, 2019, EUON published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.” Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement. Bitsch also explains what societal engagement is by using the Horizon 2020 project GoNano as an example.

ECHA Urges Companies To Get Ready For New REACH Requirements For Nanomaterials: ECHA issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the EU market under REACH. The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH. ECHA states that the purpose is to ensure that companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment. The amendments apply to all the new and existing registrations covering nanoforms. ECHA states that it expects registrants to update their existing dossiers with nanoform-specific information by January 1, 2020. More information is available in our October 9, 2019, blog item.

ECHA Will Hold November Webinar On Updated REACH Information Requirements For Nanoforms: On November 12, 2019, ECHA will hold a webinar on the amended information requirements for nanoforms under REACH. The first part of the November 12, 2019, webinar will explain what a nanoform is and how to build a set of similar nanoforms. It will also explain how to fulfil data requirements for the characterization of nanoforms. The second part will introduce new International Uniform Chemical Information Database (IUCLID) fields for reporting the characterization parameters of nanoforms and give some practical examples on how to use the different fields. Attendees will also have the chance to ask questions from ECHA’s experts.

EPA Proposes SNUR For Multiwalled Carbon Nanotubes (Generic): On October 11, 2019, EPA published proposed SNURs for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of PMNs. 84 Fed. Reg. 54816. According to EPA, the PMN states that multiwalled carbon nanotubes (generic) will be used in heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems, such as electronics, to improve mechanical properties or electrical conductivities of other materials or products and for light absorption properties. The proposed SNUR states that EPA identified concerns for pulmonary toxicity based on carbon nanotube analogues and for aquatic toxicity when the substance is at low concentrations and in the presence of natural organic matter. The proposed SNUR would designate as a “significant new use” the absence of specified protective measures. Comments are due November 12, 2019.

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.

Two House Committees Press EPA Administrator On Scientific Integrity: On September 16, 2019, House Energy and Commerce Chair Frank Pallone (D-NJ) and House Science, Space, and Technology Chair Eddie Bernice Johnson (D-TX) pressed EPA Administrator Andrew Wheeler on scientific integrity issues. In a sharply worded letter, the lawmakers announced that their Committees are investigating efforts by EPA “to systematically undermine key environment and public health protections and discredit the role of science.” They warned that they “are deeply concerned about actions EPA has taken to weaken scientific integrity in reviewing and setting National Ambient Air Quality Standards (NAAQS) under the Clean Air Act (CAA).” In October 2018, Mr. Wheeler disbanded a panel of independent experts supporting the CASAC’s review of the NAAQS for PM. EPA also declined to convene a panel of independent experts to support CASAC’s review of the NAAQS for ozone. The letter argues that “Without sufficient expertise, we are concerned that CASAC will be unable to support setting NAAQS.” Lawmakers expanded their criticism beyond the CASAC, adding that “under your leadership [EPA] appears to fail to recognize the need for robust and independent scientific expertise.” The letter requests that Mr. Wheeler respond to six questions related to the issues lawmakers raised by September 30, 2019. The letter is available online.

House Passes Senate Bill Aimed At Reducing Lead In Drinking Water: On September 17, 2019, under a suspension of the rules, the House of Representatives passed a bill intended to assist states in reducing lead contamination in drinking water. Senator Cory Booker (D-NJ) introduced the bill (S. 1689) in May. It would give states one year to transfer funds from their Clean Water Act State Revolving Funds (CWASRF) to their Drinking Water State Revolving Funds (DWSRF) to reduce lead contamination in drinking water. States may transfer up to five percent of the cumulative CWASRF to the DWSRF. The Senate passed the bill on September 9, 2019, by unanimous consent. The bill now heads to the White House; President Trump is expected to sign the bill.

House Subcommittee Holds Hearing On Sustainability Within The Transportation Sector: On September 18, 2019, the House Science, Space, and Technology Subcommittee on Energy held a hearing to examine ways to accelerate sustainability within the transportation sector. The hearing focused on “technology pathways” that would be relied upon to improve and accelerate sustainability. Entitled “The Next Mile: Pathways to Accelerate Sustainability within the Transportation Sector,” the hearing comes after the transportation sector surpassed the power sector as the country’s largest source of GHG emissions. Testifying before the Subcommittee were:

• Ms. Ann M. Schlenker, Director, Center for Transportation Research, Argonne National Laboratory;
• Mr. James Chen, Vice President of Public Policy, Rivian Automotive LLC;
• Mr. Brooke Coleman, Executive Director, Advanced Biofuels Business Council;
• Dr. Claus Daniel, Director, Sustainable Transportation Program, Oak Ridge National Laboratory; and
• Mr. Tim Cortes, Vice President of Hydrogen Energy Systems, Plug Power Inc.

Witness testimony and an archived webcast of the hearing are available online.

House Subcommittee Holds Hearing On Trump Administration’s Water Priorities: On September 18, 2019, responding to the Trump Administration’s decision to repeal the Waters of the United States (WOTUS) rule, the House Transportation and Infrastructure Subcommittee on Water Resources and the Environment held a hearing to examine this and other decisions by the Administration. Entitled “The Administration’s Priorities and Policy Initiatives Under the Clean Water Act,” the hearing provided lawmakers with an opportunity to hear from EPA and stakeholders regarding the Trump Administration’s clean water initiatives. The hearing came on the heels of a report released by Subcommittee Chair Grace Napolitano (D-CA) outlining “how the actions of the Trump EPA hasten the return of polluted rivers, lakes and streams.” The principal witness at the hearing was Dave Ross, Assistant Administrator for the Office of Water at EPA. Other witnesses were:

• Ms. Maia Bellon, Director, Department of Ecology, State of Washington;
• Ms. Becky Keogh, Secretary, Department of Arkansas Energy and Environment, State of Arkansas;
• Mr. Ken Kopocis, Associate Professor, College of Law, American University;
• Mr. Michael Hickey, Hoosick Falls, NY;
• Ms. Pam Nixon, President, People Concerned About Chemical Safety; and
• Mr. Geoffrey R. Gisler, Senior Attorney, Southern Environmental Law Center.

Witness testimony and an archived webcast of the hearing are available online.

House Subcommittee Holds Hearing On Net Zero Industrial Emissions: On September 18, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing entitled “Building a 100 Percent Clean Economy: Pathways to Net Zero Industrial Emissions.” The hearing examined the challenges and opportunities associated with reducing GHG emissions from the U.S. industrial sector. The industrial sector is the third largest source of GHG emissions in the U.S., accounting for 22.2 percent of emissions in 2017. That number increases to 29.7 percent of U.S. emissions when indirect emissions are counted.In contrast to emissions from other sectors, industrial emissions come from a diverse mix of heat production, power generation, and chemical reactions -- and that mix varies widely across individual subsectors and facilities. Many industrial processes -- such as steel, cement, copper, and aluminum production -- require high-temperature heat sustained over long periods to convert raw materials into useful end-products. In most cases, renewables are unable to provide the required high-temperature, long-duration heat. Certain renewable energy technologies, such as concentrating solar power, can generate both electricity and heat at high enough temperatures to support various industrial activities, but these technologies have not yet been deployed in industrial settings. The Subcommittee heard from witnesses to help guide solutions to curbing GHG emissions from this sector. Testifying before the Subcommittee were:

• Julio Friedmann, Ph.D., Senior Research Scholar, Columbia University Center on Global Energy Policy;
• Jason Walsh, Executive Director, BlueGreen Alliance;
• Gaurav Sant, Ph.D., Professor and Henry Samueli Fellow, UCLA Samueli School of Engineering;
• Bob Perciasepe, President, Center for Climate and Energy Solutions (C2ES);
• Jeremy Gregory, Ph.D., Executive Director, MIT Concrete Sustainability Hub, On behalf of Portland Cement Association; and
• Ross E. Eisenberg, Vice President, Energy and Resources Policy, National Association of Manufacturers.

Witness testimony and an archived webcast of the hearing are available online.

EPA Administrator Testifies Before House Science Committee: On September 19, 2019, EPA Administrator Andrew Wheeler testified before the House Science, Space and Technology Committee on the importance of science in EPA’s actions. Democratic members pressed Mr. Wheeler on EPA’s recent actions. He responded to questions on a broad variety of topics, including chlorpyrifos, climate change, transparency in scientific deliberations, ethylene oxide emissions, recycling of solid waste, methane emissions from oil and gas operations, the ozone NAAQS, the Great Lakes, formaldehyde, and other issues. The theme of questioning, however, was EPA’s use of science and scientific integrity in its deliberations. Mr. Wheeler staunchly supported EPA’s actions, stating that his agency has imposed a more rigorous scientific standard under the Trump Administration than it has in years. He explained that his reorganization of the Office of Research and Development (ORD) will not result in any diminishment of EPA’s dedication to science. Questioned several times on transparency in its use of science and review of data, Mr. Wheeler repeatedly said that he “cut his teeth” at EPA in the Emergency Planning and Community Right-to-Know program, and as such has for decades been dedicated to the principle that transparency is of paramount importance to EPA’s mission and the public safety. The hearing was pointed at times. Perhaps the most heated comments came from Subcommittee member Steve Cohen (D-TN), who stated that he was disturbed and alarmed that EPA would favor profit over lives. Mr. Wheeler pledged to continue to work with the Committee and that he considered this hearing the start of an open dialogue between EPA and lawmakers on the Committee.

House Resolution Condemns Trump Administration’s Cancellation Of California’s CAA Waiver: On September 19, 2019, joined by almost 60 of his Democratic House colleagues, Representative Mark DeSaulnier (D-CA) introduced a resolution condemning the Trump Administration’s September 19, 2019, announcement that it will cancel California’s longstanding CAA waiver to set state-specific automobile standards. The resolution (H. Con. Res. 65) also blasts the Administration’s impending rollback of Obama-era fuel economy standards. The resolution, supported by a coalition of 57 Democrats, demonstrates multi-state support for the existing federal clean car standards and states’ right to adopt California’s more stringent standards. Senator Kamala Harris (D-CA) has authored a similar resolution in the Senate. The CAA waiver was first enacted in 1970 and allows California to adopt its own emissions standards so long as they are at least as stringent as the federal standard. In 1977, other states were allowed to adopt California’s emissions standards. In revoking California’s waiver, the Administration prevents California and 13 other states from creating their own standards to help reduce harmful pollutants and slow the progression of climate change. Under the Obama Administration, federal fuel economy standards were made comparable to those set by the California Air Resources Board (CARB), thereby creating the current One National Program. The CARB standards have since been adopted by 13 other states, accounting for over 35 percent of the U.S. auto market, and are on track to reduce America’s oil dependence by more than two million barrels a day -- effectively eliminating the impact of 59 million vehicles from the road by 2030. The Administration’s impending rollback of these fuel standards could undo the success of this program. Congressman DeSaulnier also urged California’s public retirement funds to divest from companies that participate in the rollback. He also called on automobile manufacturers to clarify how they will respond to the Administration’s actions.

House Subcommittee Hears Testimony On Building A 100 Percent Clean Economy: On September 19, 2019, the House Energy and Commerce Subcommittee on Energy held a hearing entitled “Building a 100 Percent Clean Economy: Solutions for the U.S. Building Sector.” The building sector in the U.S. consumes a significant amount of energy for a variety of purposes, including heating, cooling, and lighting. Lawmakers state that the sector’s energy use has grown exponentially since the 1950s and is currently responsible for approximately 40 percent of energy consumed and GHGs produced. The majority of the sector’s emissions, including emissions from residential and commercial buildings, are largely attributed to electricity produced remotely to meet energy demands. The hearing focused on ways in which the sector can reduce its environmental footprint. Testifying before the Subcommittee were:

• Carl Elefante, President, American Institute of Architects;
• Elizabeth Beardsley, Senior Policy Counsel, U.S. Green Building Council;
• Steven Nadel, Executive Director, American Council for an Energy-Efficient Economy;
• Timothy Keane, International Vice President at Large, International Association of Heat and Frost Insulators and Allied Workers;
• Dr. Curtis J. Zimmermann, Ph.D., Manager, Government Liaison, BASF Corporation; and
• Arn McIntyre, President, McIntyre Builders Inc., on behalf of National Association of Home Builders.

Witness testimony and an archive webcast of the hearing are available online.

Senate EPW Committee Approves Nomination Of New CSB Head: On September 25, 2019, the Senate Environment and Public Works (EPW) Committee approved the nomination of Katherine Andrea Lemos, Ph.D., to chair the Chemical Safety and Hazard Identification Board (CSB). The vote was along party lines. Dr. Lemos previously served in the Federal Aviation Administration and on the National Transportation Safety Board. She is currently the Director of Programs for Northrop Grumman Corporation’s Aerospace Sector. According to the White House, which nominated her on June 19, 2019, Dr. Lemos has a distinguished background in system safety, accident investigation, human factors, and advanced technology research and integration. She also has broad experience across the product life cycle in analyzing and promoting product, process, and operational performance.

House Subcommittee Passes Package Of PFAS Legislation, Marks Up Asbestos Bill: On Septemer 26, 2019, the House Energy and Commerce Subcommittee on the Environment and Climate Change passed more than a dozen bills addressing PFAS contamination. The Subcommittee forwarded the following bills to the full Committee without amendment:

• H.R. 535 -- to require EPA to designate PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) within one year of enactment. (A similar provision is included in the House’s Department of Defense appropriations bill (H.R. 2500).)
• H.R. 2377 -- to require EPA to establish a Maximum Contaminant Level Goal (MCLG) and a Maximum Contaminant Level (MCL) under the Safe Drinking Water Act (SDWA) for PFAS.
• H.R. 2533 -- to amend the SDWA to require EPA to implement a grant program to fund the remediation of water systems contaminated with PFAS.
• H.R. 2566 -- to revise the EPA Safer Choice Standard to prohibit the labeling of kitchenware that contains PFAS from a Safer Choice product.
• H.R. 2570 -- to require PFAS manufacturers to pay fees of at least $2 billion every year to cover the costs of remediating water contaminated with PFAS.
• H.R. 2577 -- to amend the Emergency Planning and Community Right-to-Know Act (EPCRA) to add PFAS to the Toxics Release Inventory (TRI).
• H.R. 2591 -- to prohibit the disposal by incineration of firefighting foam containing PFAS.
• H.R. 2596 -- to amend Section 5 of TSCA to ban the manufacture of PFAS unless the manufacturer can demonstrate the chemical poses no reasonable risk to human health or the environment.
• H.R. 2600 -- to amend Section 6 of TSCA to ban the manufacture of any new PFAS.
• H.R. 2605 -- to require EPA to issue a final rule adding all PFAS compounds to the list of HAPs under Section 112 of the CAA.
• H.R. 2608 -- to require EPA to promulgate a test rule under Section 4 of TSCA for PFAS compounds.
• H.R. 2626 -- to encourage federal agencies to enter into cooperative agreements with states for removal and remedial actions to address PFAS contamination in drinking, surface, and ground water and land surface and subsurface strata.
• H.R. 2638 -- to require EPA to issue guidance on minimizing the use of firefighting foam containing PFAS.

The Subcommittee also marked up a bill addressing asbestos: H.R. 1603, the Alan Reinstein Ban Asbestos Now Act of 2019. That bill and the PFAS bills now proceed to the full Energy and Commerce Committee for consideration.

Senate Appropriations Committee Passes EPA Funding Bill: On September 26, 2019, the Senate Appropriations Committee passed the EPA FY 2020 funding bill. The Committee approved $9.011 billion for EPA, an increase of $161 million above the FY 2019 enacted level, but about half a billion below what the House has approved for EPA.

EFSA Opens Consultation Period On Two Pilot Assessments On The Risks Caused By Multiple Pesticide Residues In Foods: On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food. The first assessment considers the chronic effects of multiple pesticides on the thyroid system. The second looks at acute effects on the nervous system. In the two pilot assessments, EFSA classified pesticides into “cumulative assessment groups” (CAG) based upon whether they produce similar toxic effects in a specific organ or system. EFSA states that “[t]he overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.” EFSA will present the assessments at a special stakeholder event in Brussels, Belgium, on October 22, 2019. All comments must be submitted by November 15, 2019. More information is available in our October 8, 2019, blog item.

EPA Reestablishing Children’s Health Protection Advisory Committee: On September 19, 2019, despite rumors that EPA had marked it for dissolution, EPA announced that it is reestablishing the Children’s Health Protection Advisory Committee (CHPAC). 84 Fed. Reg. 49292. CHPAC will continue to provide policy advice, information, and recommendations to assist EPA in the development of regulations, guidance, and policies to address children’s environmental health. CHPAC will be composed of approximately 18 to 24 members who will generally serve as representatives of non-federal interests. EPA will solicit nominations for membership through the Federal Register and other sources.

U.S. Chamber Launches Task Force On Climate Actions: On September 24, 2019, the U.S. Chamber of Commerce launched a Task Force on Climate Actions. According to a fact sheet, the task force is open to all U.S. Chamber members. The goals of the task force are to:

• Understand how and for what purposes businesses across industries are internally pricing carbon;
• Gain an understanding of the implications and issues associated with carbon pricing and other potential climate actions;
• Learn how carbon pricing policies outside of the United States are impacting companies and issues;
• Recognize the extent to which and how businesses are calculating the risks and costs to the business of climate change;
• Ascertain the issues associated with explicit (e.g., carbon tax or cap and trade) and implicit (e.g., regulation) carbon price mechanisms; and
• Promote a dialogue among companies and sectors.

OSHA Issues Final Rule Revising Respirator Fit Testing Protocols: On September 26, 2019, the Occupational Safety and Health Administration (OSHA) issued a final rule authorizing two new fit testing protocols for ensuring that respirators fit properly. 84 Fed. Reg. 50739. The new protocols are the modified ambient aerosol condensation nuclei counter (CNC) quantitative fit testing protocol for full-facepiece and half-mask elastomeric respirators, and the modified ambient aerosol CNC quantitative fit testing protocol for filtering facepiece respirators. Both protocols are variations of the original OSHA-approved ambient aerosol CNC protocol but have fewer test exercises, shorter exercise duration, and a more streamlined sampling sequence. These two quantitative methods add to the four existing in Appendix A of OSHA’s Respiratory Protection Standard. The rule does not require employers in general industries, shipyard employment, and construction to update or replace their current fit testing methods and does not impose additional costs, OSHA states. The rule became effective on September 26, 2019.

OSHA Issues Final Rule Revising Beryllium Standards: OSHA on September 30, 2019, issued a final rule revising the construction and shipyard standards for beryllium. 84 Fed. Reg. 51377. In the final rule, OSHA did not implement the proposal to revoke all of the standards’ ancillary provisions. OSHA did, however, extend the compliance dates for the ancillary provisions to September 2020 to account for OSHA’s new proposal to revise or remove specific provisions. OSHA also maintains enforcement of the permissible exposure limit. OSHA stated that in a forthcoming rulemaking, it will propose to amend the beryllium standards for construction and shipyards by more appropriately tailoring the requirements of the standards to the exposures in these industries.

ECOS Demands Meeting With EPA On Cooperative Federalism: On September 26, 2019, the Environmental Council of the States (ECOS) sent a letter to EPA demanding a meeting with Administrator Andrew Wheeler and other senior Agency officials. “ECOS is seriously concerned about a number of unilateral actions by U.S. EPA that run counter to the spirit of cooperative federalism and to the appropriate relationship between the federal government and the states who are delegated the authority to implement federal environmental statutes,” ECOS Executive Director Donald Welsh wrote. The letter further lamented EPA’s recent letters to states and Federal Register notices “that lacked discussion with and notification to states [and that] violate the principles of Cooperative Federalism 2.0.” Mr. Welsh added that “We are concerned about the lack of advance consultation with states and the impact of these and several other actions on the ability of states to protect human health and the environment, and call on U.S. EPA to return to the appropriate relationship with the states as coregulators under our nation’s environmental protection system.” The letter can be viewed online. EPA responded in a statement that it has made it a priority “to restore the appropriate balance between federal and state management of water resources within state borders.” EPA said in the statement that it “will continue to work directly with State Departments of Environmental Quality on issues important to assist them in their missions to protect human health and the environment.”

OSHA Implements New Weighting System For Workplace Safety And Health Inspections: OSHA on September 27, 2019, announced that it has implemented the OSHA Weighting System (OWS) for FY 2020. Under the current enforcement weighting system, OSHA weights certain inspections based on the time taken to complete the inspection or, in some cases, the impact of the inspection on workplace safety and health. OWS recognizes that time is not the only factor to assess when considering the potential impact of an inspection. Other factors -- such as types of hazards inspected and abated, and effective targeting -- also influence the impact on workplace safety and health. The new system adds enforcement initiatives such as the Site-Specific Targeting to the weighting system. The OWS replaces the current enforcement weighting system initiated in FY 2015. The new system is based on an evaluation of the existing criteria and a working group’s recommendations regarding improvements to the existing weighting system. The system will continue to weight inspections, but will do so based on other factors, including agency priorities and the impact of inspections, rather than simply on a time-weighted basis. OWS became effective October 1, 2019.

OSHA To Hold Public Meeting On Leading Indicators: OSHA on October 7, 2019, announced that it will hold a public meeting on leading indicators for occupational safety and health programs. The meeting will be held on November 7, 2019, in Washington, D.C. In the announcement, OSHA states:

A key component of a safety and health program is to monitor performance and progress using leading indicators that track how well various aspects of the program are performing. The November discussion will focus on the use of leading indicators, how they are chosen, what they track, whether they are effective, if there is commonality across an industry, and any challenges encountered using such indicators.

Those interested in participating in the meeting or attending as an observer must register at Leading Indicators Meeting Registration by October 30, 2019. The meeting will not include formal presentations, but instead will be conducted as a group discussion. The comment period closes on February 7, 2020.

OSHA Proposes Revisions To Standards For Beryllium In Construction And Shipyard Sectors: OSHA on October 8, 2019, proposedto revise the standards for occupational exposure to beryllium and beryllium compounds in the construction and shipyards industries. 84 Fed. Reg. 53902. OSHA states that these proposed changes will accomplish three goals:

• Tailor more appropriately the requirements of the construction and shipyards standards to the particular exposures in these industries;
• Aid compliance and enforcement; and
• Clarify requirements with respect to materials containing only trace amounts of beryllium.

OSHA estimates that these proposed changes will result in total annualized cost savings of $2.5 million. The comment period closes on November 7, 2019.

Trump EO Places Limits On Agencies Issuing Guidance: On October 9, 2019, President Trump issued an EO on Promoting the Rule of Law Through Improved Agency Guidance Documents. The EO states that the order ensures that Americans have fair notice and are only subject to “binding rules imposed through duly enacted statutes or through regulations lawfully promulgated under them.” The EO goes on to state that agencies may clarify existing obligations through issuance of non-binding guidance; at times, however, agencies have inappropriately used guidance vehicles to get around Administrative Procedure Act rulemaking procedures. Although guidance is not binding, it “carr[ies] the implicit threat of enforcement action if the regulated public does not comply.” The EO requires that, except where incorporated into a contract, agencies must treat guidance documents as non-binding in law and practice. Agencies must also take public input into account where appropriate in developing guidance documents and must make them readily accessible to the public. Noteworthy requirements set forth in the EO include the following:

• Searchable Online Index: The EO imposes a 120-day deadline from the date OMB issues an implementing memorandum for federal agencies to establish or maintain a searchable index of guidance documents on agency websites.
• Review and Rescission of Existing Guidance: The EO directs agencies to review existing guidance and rescind any guidance it determines to no longer be in effect within 120 days of OMB’s implementation memorandum.
• Procedure for Issuing Guidance: Within 300 days of OMB’s forthcoming implementation memorandum, agencies must finalize or amend existing regulations to set forth procedures for issuing guidance documents. The process must provide for a public procedure to petition for withdrawal or modification of guidance.
• Public Notice and Comment: With the exception of emergency circumstances, if a guidance document is deemed “significant” by OMB’s Office of Information and Regulatory Affairs (OIRA), then the process must include a public comment period of at least 30 days before issuance of a final guidance document.

CalChamber Files Complaint Seeking Declaration That Prop 65 Warnings For Acrylamide Violate First Amendment: On October 7, 2019, the California Chamber of Commerce (CalChamber) filed a complaint for declaratory and injunctive relief (Complaint) asking that the U.S. District Court for the Eastern District Court of California find that Proposition 65 (Prop 65) warnings for acrylamide violate the First Amendment of the U.S. Constitution. Acrylamide has been listed under Prop 65 since 1990 and has been subject to more than 500 private plaintiff cases, most of which relate to the presence of acrylamide in food. Although acrylamide was first listed based on potential industrial exposures, in 2002 it was found that acrylamide also “forms naturally from chemical reactions in certain types of starchy foods when cooked at high temperatures or otherwise processed using heat.”

In its Complaint, CalChamber sets forth the factual and legal basis supporting its argument that a Prop 65 cancer warning requirement as applied to acrylamide in food products “compels speech that is false, misleading, and factually controversial” and as such violates the First Amendment. CalChamber details the epidemiologic studies demonstrating that acrylamide does not increase the risk of cancer in humans, and the fact that “[b‌]ecause of California’s listing of acrylamide and the attendant Proposition 65 warning requirement, Plaintiff’s members must either take action, in conjunction with their distributors and customers, to provide false, misleading, and factually controversial warnings to California consumers about acrylamide in their food products -- conveying the unsubstantiated message that acrylamide in food products increases cancer risk in humans -- or face enforcement actions seeking substantial civil penalties and attorneys’ fees for failing to do so.”

This case is an interesting development following the same court’s February 26, 2018, memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate” under Prop 65 and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case. The February 26, 2018, Order precluded the Office of Health Hazard Assessment (OEHHA) from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018. In granting the request for a preliminary injunction enjoining the application of the warning requirements for glyphosate, the court stated: “On the evidence before the court, the required warning for glyphosate does not appear to be factually accurate and uncontroversial because it conveys the message that glyphosate’s carcinogenicity is an undisputed fact, when almost all other regulators have concluded that there is insufficient evidence that glyphosate causes cancer.

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