Federal Development Update for August 2020


In Memoriam – Timothy D. Backstrom: We write to share the sad news that our friend and colleague Timothy D. Backstrom died on Friday, July 24, 2020. For those clients and colleagues who were fortunate to have known or worked with Tim, you will appreciate the enormous void his untimely demise has left. Tim’s prodigious intellect, his encyclopedic understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), his contributions to the law and regulation of fuel and fuel additives under the Clean Air Act (CAA), and his passion for the law and the rule of law were very much a part of Tim’s many contributions to the legal profession. Tim was an incredibly gifted lawyer, respected by his peers, loved by his fellow colleagues here at Bergeson & Campbell, P.C., and a wonderful man, husband, and father. He is survived by his wife Lydia Cox Backstrom, his (step) son Christopher Blancato, his brother Paul Backstrom (Kathy), and his cousins Dan and Don Backstrom.

Tim grew up in Illinois and later Wisconsin, but his strong academic and analytic skills took him East where he received an undergraduate degree from the Massachusetts Institute of Technology (MIT) in 1973. From there he went on to Yale Law School, graduating in 1979. Tim loved the outdoors and developed a particular fondness for rock climbing, which he pursued for most of his adult life. Perhaps combining his love of nature and the law, Tim worked for 25 years in the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel (OGC) on pesticide, toxic substances, and air quality issues. Given Tim’s training as a scientist at MIT and his law degree, working for EPA gave full expression to his strong science and legal skills and love of nature. It was while at EPA that Tim developed an expansive understanding of FIFRA, the highly nuanced federal law that regulates agricultural and biocidal chemicals. Tim knew more about FIFRA law and lore than any person on Earth. For those of us who worked with Tim, we appreciated that Tim was prepared to discuss, at any time, the most obscure aspect of FIFRA law or regulation, and loved every second of it. Tim’s passion, intellect, and extraordinary ability to process large amounts of information and prepare beautifully written memoranda, legal briefs, and related documents made him a lawyer’s lawyer and his judgment and legal ability were greatly respected.

After leaving EPA’s OGC, Tim joined Bergeson & Campbell, P.C. early in 2007 and practiced extensively under FIFRA, the CAA, and related domestic chemical laws. Tim was also an experienced litigator, and litigated extensively in federal appellate and multiple district courts.

Tim’s many friends and colleagues in the Washington, D.C., area and more recently in the Lake Tahoe, California, area will miss Tim greatly. The legal community has lost a truly special lawyer who had a uniquely sophisticated understanding of FIFRA. We will miss Tim’s uncompromising commitment to legal excellence, his passion for the law, his exuberance for any work composed by Gustav Mahler, and his unrelenting belief that the rule of law will ultimately prevail over the societal challenges we are now experiencing.

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B&C To Present At PSX Virtual Conference September 15-17, 2020: PSX 2020, presented by the Product Stewardship Society (PSS), is designed to support professional growth by providing education relevant to current, emerging, and future issues in product stewardship. This year’s virtual event will feature comments from Lynn L. Bergeson, President, PSS, and Chair, Board of Directors, and Managing Partner, Bergeson & Campbell, P.C. (B&C®). B&C professionals Karin F. Baron, MSPH, Senior Regulatory Consultant, and Richard E. Engler, Ph.D., Director of Chemistry, will present “Evaluating New Chemicals and Disconnects in Hazard Communication.” Register now!

CDR Cross-CheckTM: As you gather your company’s information for Chemical Data Reporting (CDR), let The Acta Group (Acta®) assist with the search of the Toxic Substances Control Act (TSCA) Inventory and particular TSCA actions. CDR Cross-Check is a low-cost, straightforward way to have Acta search Chemical Abstracts Service (CAS) Registry Numbers (RN) and TSCA Accession Numbers and provide the output that you need to know whether a particular TSCA action changes a reporting exemption or the reporting threshold.

You do not have to be a current Acta client, simply go to https://cdr-cross-check.actagroup.com/, follow the instructions to upload your list of CAS RNs, and pay the search fee.

You have enough to worry about in CDR reporting, let Acta help with the database searching!

TSCA/FIFRA/TRI

EPA’s Spring 2020 Unified Agenda Includes TSCA Rulemakings: On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for EPA. According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under TSCA. Rulemakings at the proposed stage are summarized in our memorandum.

EPA Releases New Guidance To Reduce Testing On Fish: On July 15, 2020, EPA announced that it took another step toward implementing the directive in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to reduce animal testing by releasing new guidance that reduces unnecessary testing on fish. The guidance clarifies the number of treatment concentrations needed for acceptable fish bioconcentration factor (BCF) studies in the pesticide registration process. EPA routinely requires BCF studies to determine whether pesticide active ingredients can accumulate in fish, enter the food chain, and cause adverse effects in fish-eating predators. Under the new guidance, registrants can forego animal testing when there is enough additional information available to support a registration decision on outdoor pesticides. EPA states that it expects the guidance to save an estimated 240 test animals per year, as well as EPA, industry, and laboratory resources.

NGOs Challenge EPA’s Methylene Chloride Risk Evaluation: On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging EPA’s final risk evaluation for methylene chloride. The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.” The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council (NRDC). According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chlorid[]e from their air and water.”

EPA Proposes SNURs For Certain Chemicals: On July 21, 2020, EPA proposed significant new use rules (SNUR) under TSCA for certain chemical substances that are the subject of premanufacture notices (PMN). 85 Fed. Reg. 44032. The SNURs action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The SNURs would further require that persons not commence manufacture or processing for the significant new use until they have submitted a significant new use notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice under TSCA, and has taken any risk management actions as are required as a result of that determination. Comments are due August 20, 2020.

EPA Accepting Public Comments On SACC Candidates Under Consideration: EPA is accepting public comments on the experts under consideration for membership on the TSCA Science Advisory Committee on Chemicals (SACC). Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135. Comments are due September 1, 2020. EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year. EPA expects to appoint approximately 15 members to SACC by March 2021.

EPA Issues Final SNUR For LCPFAC And Perfluoroalkyl Sulfonate Chemical Substances: On July 27, 2020, EPA promulgated a final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 85 Fed. Reg. 45109. The final SNUR requires persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemical substances for the significant new uses described in the notice. The required significant new use notification initiates EPA’s evaluation of the conditions of use associated with the significant new use. Manufacturing (including import) or processing for the significant new use are prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA notes that as with any SNUR, the final rule excludes ongoing uses as ongoing uses cannot be subject to a SNUR. The final rule will be effective September 25, 2020. More information on the final SNUR is available in our July 27, 2020, memorandum.

Suit Regarding Failure To Disclose Information About New Chemicals Could Be Resolved Without A Trial: As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of NGOs filed suit in the U.S. District Court for the District of Columbia against EPA, claiming that EPA fails to disclose information about new chemical substances under TSCA. Environmental Defense Fund v. Wheeler, No. 1:20-cv-762. On July 27, 2020, the parties submitted a joint case management statement. According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial. The parties propose to submit an updated case management statement no later than August 31, 2020. More information is available in our July 30, 2020, blog item.

EPA Issues Final SNURs For Certain Chemical Substances: Since July 15, 2020, EPA has published two batches of final SNURs for certain chemical substances that are the subject of PMNs: 85 Fed. Reg. 45321 (July 28, 2020) and 85 Fed. Reg. 46550 (Aug. 3, 2020). The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The required notification initiates EPA’s evaluation of the chemical under the conditions of 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 as a result of that determination.

EPA Releases 2019 Preliminary TRI Data Set: On July 30, 2020, EPA published preliminary Toxics Release Inventory (TRI) data about chemical releases, waste management, and pollution prevention activities that took place during 2019 at more than 20,000 federal and industrial facilities across the country. EPA states that it plans to publish a revised snapshot of the TRI data set in October 2020, which will be used to develop the 2019 TRI National Analysis. EPA expects to publish the 2019 TRI National Analysis in early 2021.

Judge Suggests New TSCA Section 21 Petition Be Filed Regarding Fluoride In Drinking Water: On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under TSCA Section 6 to prohibit the addition of fluoridation chemicals to drinking water supplies. Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC. According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.” On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition. Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.” EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.” The court held a status conference on August 6, 2020, via Zoom. The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so. More information is available in our August 11, 2020, blog item.

EPA Awards $4 Million To Develop New Approaches For Evaluating Chemical Toxicokinetics: On August 3, 2020, EPA announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics. According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing. EPA is providing a grant of up to $800,000 to each research team through its Science to Achieve Results (STAR) Program.

EPA Develops New TSCA Section 5(e) Order Boilerplate And SOP For OECA Input In Developing Consent Orders: On August 5, 2020, the EPA Office of Inspector General (OIG) announced that EPA has provided an update to its response to the OIG’s May 2020 report, EPA Toxic Substances Control Act Consent Orders Need Better Coordination. EPA states that the Office of Civil Enforcement/Waste and Chemical Enforcement Division (OECA/WCED) and the Office of Pollution Prevention and Toxics/Chemical Control Division (OCSPP/CCD) have developed a TSCA Section 5(e) Order Boilerplate that “clarifies and strengthens the provisions of the Order for New Chemical Substances.” According to EPA, OCSPP/CCD and OECA/WCED have established and implemented a Standard Operating Procedure (SOP) to ensure that WCED reviews and approves the terms and conditions of TSCA Section 5(e) Orders developed by CCD. EPA states that the Review and Approval Protocol “provides sufficient assurance that compliance and enforcement requirements in TSCA 5(e) orders will be reviewed and approved by OCSPP and OECA.” OIG commented on EPA’s updated response, stating that it now considers this recommendation complete.

EPA Publishes Updated Data On TSCA CBI Reviews: EPA published on August 11, 2020, its quarterly update of the TSCA confidential business information (CBI) review statistics. These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020. In August 2020, EPA published an updated list of cases with completed CBI reviews under TSCA Section 14. The list includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned.

EPA Finds 16 Conditions Of Use Of 1-BP Pose An Unreasonable Risk To Workers, ONUs, Consumers, And Bystanders: On August 12, 2020, EPA announced the availability of the final risk evaluation for 1-bromopropane (1-BP). 85 Fed. Reg. 48687. After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders. For those conditions of use for which EPA has found an unreasonable risk, EPA states that it must take regulatory action to address that unreasonable risk through risk management measures enumerated in TSCA. EPA has also determined that specific conditions of use do not present unreasonable risk of injury to health or the environment. EPA notes that for those conditions of use for which EPA has found no unreasonable risk to health or the environment, its determination is a final agency action and is issued via order in the risk evaluation. A detailed analysis and commentary is available in our August 11, 2020, memorandum, “EPA Publishes Final Risk Evaluation for 1-BP.”

COVID-19

EPA Announces Release Of Guidance To Expedite Review Of Requests To Add Electrostatic Sprayer Application Directions To Disinfectant Product Labels: On July 7, 2020, EPA announced the release of new guidance for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. The guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels. The guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels. EPA’s guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2 (see our May 14, 2020, blog). This guidance is important for many disinfectant products. Affected registrants or potential registrants should review it carefully. More information is available in our July 16, 2020, Pesticide Law and Policy Blog®.

EPA Announces The Approval Of 13 Additional Products Effective Against SARS-CoV-2: On July 30, 2020, EPA announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. Additional information is available here and in our July 30, 2020, blog.

EPA Issues SSURO Against EcoShield LLC For Selling An Unregistered Product Claiming Effectiveness Against SARS-CoV-2: On August 5, 2020, EPA issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens. EPA states that the product was being sold and distributed in violation of FIFRA because it is an unregistered pesticide making false disinfectant claims. The SSURO against EcoShield is another in a series of enforcement actions EPA has taken against products that EPA believes are making claims in violation of FIFRA during the COVID-19 public health emergency. Some of these actions include the Amazon and eBay SSURO and the prevention of importation of the unregistered “Virus Shut Out” pesticide product. (See our blogs here and here for more information on these two actions.) Additional information on EPA enforcement actions on unregistered products is available here. For more information on the EcoShield action, please read our full blog.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Adds New PFAS Treatment Options And Scientific References To Drinking Water Treatability Database: On July 15, 2020, EPA announced that it updated its Drinking Water Treatability Database with new treatment options and scientific references for per- and polyfluoroalkyl substances (PFAS). According to EPA, the database update will further help states, tribes, and local governments, as well as water utilities, make better decisions to manage PFAS in their communities. In the update, EPA added treatment and contaminant information about four new PFAS compounds, bringing the total number of PFAS compounds in the database to 26, including perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Researchers have also added 20 new scientific references to the existing PFAS entries. The four new PFAS compounds are: difuoro(perfluoromethoxy) acetic acid, also known as perfluoro-2-methoxyacetic acid; perfluoro-3,5-dioxahexanoic acid; perfluoro-3,5,7-trioxaoctanoic acid; and perfluoropropane sulfonate.

EPA Extends Comment Period On Draft Ambient Water Quality Criteria Recommendations For Lakes And Reservoirs Of The Conterminous United States: EPA has extended the comment period on the Draft Ambient Water Quality Criteria Recommendations for Lakes and Reservoirs of the Conterminous United States: Information Supporting the Development of Numeric Nutrient Criteria. 85 Fed. Reg. 44071. According to EPA, these draft national criteria recommendations are models for total nitrogen and total phosphorus concentrations in lakes and reservoirs to protect three different designated uses -- aquatic life, recreation, and drinking water source protection -- from the adverse effects of nutrient pollution. Comments are due August 20, 2020.

EPA Withdraws Determination To Regulate Perchlorate Under SDWA: On July 21, 2020, EPA announced its withdrawal of the 2011 determination to regulate perchlorate in accordance with the Safe Drinking Water Act (SDWA). 85 Fed. Reg. 43990. On February 11, 2011, EPA published a Federal Register document in which it determined that perchlorate met the SDWA’s criteria for regulating a contaminant. On June 26, 2019, EPA published a proposed national primary drinking water regulation (NPDWR) for perchlorate and requested public comments on multiple alternative actions, including the alternative of withdrawing the 2011 regulatory determination for perchlorate. EPA states that it has considered the public comments and based on the best available information, it is withdrawing the 2011 regulatory determination and making a final determination not to regulate perchlorate. According to the notice, EPA has determined that perchlorate does not occur “with a frequency and at levels of public health concern” within the meaning of the SDWA. In addition, in the judgment of the EPA Administrator, regulation of perchlorate does not present a “meaningful opportunity for health risk reduction for persons served by public water systems.” Accordingly, EPA is withdrawing its 2011 determination and is making a final determination not to regulate perchlorate, and therefore will not issue a NPDWR for perchlorate at this time.

EPA Proposes First GHG Emissions Standards For Aircraft: On July 22, 2020, EPA announced proposed emissions standards for airplanes used in commercial aviation and large business jets. According to EPA, this action will align U.S. standards with the international carbon dioxide (CO2) emissions standards set by the International Civil Aviation Organization (ICAO), making domestically manufactured aircraft competitive in the global marketplace. EPA notes that the proposal also sets a precedent with the Trump Administration being the first to propose regulating greenhouse gas (GHG) emissions from aircraft. The implementation process provides significant lead-time to designers and manufacturers of aircraft covered by the standards. The proposed GHG standards would apply to new type design airplanes on or after January 1, 2020, and to in-production airplanes on or after January 1, 2028. The proposed standards would not apply to already manufactured airplanes that are currently in-use. After EPA promulgates a final rule with the standards, the Federal Aviation Administration (FAA) will complete a subsequent rulemaking to enforce the standards. At that point, FAA could begin to certify airplanes of U.S. manufacturers. EPA notes that “[t]his process will take some time, and it is critical that EPA complete this part of the process so that the U.S. standards are in place well in advance of 2028, when the ICAO standards go into effect for in-production airplanes.”

EPA Announces First Update On National Water Reuse Action Plan Implementation: On July 23, 2020, EPA announced that it issued the first update on the collaborative implementation of the National Water Reuse Action Plan (WRAP) that was launched on February 27, 2020. The update highlights “expeditious and meaningful progress” that EPA and its partners have made to advance consideration of water reuse and ensure the security, sustainability, and resilience of America’s water resources.

EPA Publishes Final RTRs For Several NESHAP Sectors: Since July 15, 2020, EPA has published final rules regarding the final residual risk and technology reviews (RTR) conducted for the following National Emission Standards for Hazardous Air Pollutants (NESHAP) source categories:

  • Rubber Tire Manufacturing (85 Fed. Reg. 44752 (July 24, 2020)): EPA is adding electronic reporting of performance test results and reports, compliance reports, and Notification of Compliance Status (NOCS) reports and is removing the provision that exempts emissions from compliance with the standards during startup, shutdown, and malfunction (SSM) periods. EPA states that the amendments are “environmentally neutral”;
     
  • Lime Manufacturing (85 Fed. Reg. 44960 (July 24, 2020)): EPA is addressing SSM periods. The final amendments include new provisions requiring electronic reporting. EPA is making a final determination that the risks are acceptable and that the current NESHAP provides an ample margin of safety to protect public health. EPA states that it determined that there are no developments in practices, processes, or control technologies that necessitate revisions to the standards;
     
  • Taconite Iron Ore Processing (85 Fed. Reg. 45476 (July 28, 2020)): EPA is addressing the exemptions previously allowed for SSM periods and clarifying that the emissions standards apply at all times. The final amendments include no revisions to the numerical emission limits of the rule based on the RTR. The amendments add electronic reporting of performance test results and compliance reports and make minor technical corrections and amendments to monitoring and testing requirements that are intended to reduce the compliance burden on industry while continuing to be protective of the environment;
     
  • Miscellaneous Organic Chemical Manufacturing (85 Fed. Reg. 49084 (Aug. 12, 2020)): The final rule includes amendments pursuant to the technology review for equipment leaks and heat exchange systems, and also amendments pursuant to the risk review to address specifically ethylene oxide emissions from storage tanks, process vents, and equipment leaks. The final rule corrects and clarifies regulatory provisions related to emissions during SSM periods. EPA is also adding monitoring and operational requirements for flares that control ethylene oxide emissions and flares used to control emissions from processes that produce olefins and polyolefins; adding provisions for electronic reporting of performance test results and other reports; and making other technical corrections to improve consistency and clarity. EPA estimates that the final amendments will reduce hazardous air pollutant (HAP) emissions from this source category by approximately 107 tons per year (tpy) and reduce ethylene oxide emissions from this source category by approximately 0.76 tpy. EPA also estimates that the final amendments will reduce excess emissions of HAP from flares that control ethylene oxide emissions and flares used to control emissions from processes that produce olefins and polyolefins by an additional 263 tpy;
     
  • Plywood and Composite Wood Products (PCWP) (85 Fed. Reg. 49434 (Aug. 13, 2020)): The final rule addresses SSM periods; adds electronic reporting; adds repeat emissions testing; and makes technical and editorial changes. The final amendments include no revisions to the numerical emission limits in the rule based on the RTR. EPA states that while the amendments do not result in reductions of HAP emissions, this action results in improved monitoring, compliance, and implementation of the rule; and
     
  • Miscellaneous Coating Manufacturing (85 Fed. Reg. 49724 (Aug. 14, 2020)): The final rule addresses emissions during SSM periods, including clarifying regulatory provisions for certain vent control bypasses; provisions for electronic reporting of performance test results, performance evaluation reports, compliance reports, and NOCS reports; and provisions to conduct periodic performance testing of oxidizers used to reduce emissions of organic HAPs.
     

EPA Submits Two New PFAS Proposals To OMB For Interagency Review: On July 27, 2020, EPA transmitted two new PFAS proposals to the Office of Management and Budget (OMB) for interagency review.

  • Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS: The guidance would provide information on technologies that may be feasible and appropriate for the destruction or disposal of PFAS and PFAS-containing materials. It would also identify ongoing research and development (R&D) activities related to destruction and disposal technologies, which may inform future guidance; and
     
  • The Unregulated Contaminant Monitoring Rule 5 (UCMR 5): EPA anticipates proposing nationwide drinking water monitoring for PFAS under UCMR 5 using new methods that can detect PFAS that could not be detected before as the new methods detect more PFAS chemicals at lower concentrations than previously possible.
     

EPA Announces Final Rule Intended To Reduce Lead In Drinking Water: On July 29, 2020, EPA announced a final rule to reduce lead in plumbing materials used in public water systems, homes, schools and other facilities. EPA states that “[t]he Lead-Free final rule significantly limits the lead content allowed in plumbing materials (e.g., pipes, fittings, and fixtures) used in new construction and replacement of existing plumbing.” Specifically, the new rule reduces the percentage of lead content allowed from eight percent to 0.25 percent. The final rule also requires that manufacturers or importers certify that their products meet the requirements using a consistent verification process. EPA also announced that it sent the final Lead and Copper Rule to OMB for review. The Lead-Free final rule will be effective 30 days after publication in the Federal Register, and the certification requirement must be implemented within three years.

Final Rule Revises CCR Closure Regulations: On July 29, 2020, EPA announced a final rule that revises the regulations for coal combustion residuals (CCR) to implement the court’s vacatur of certain closure requirements, as well as adding provisions that enhance the public’s access to information about the management of coal ash at electric utilities. The final rule specifies that all unlined surface impoundments are required to retrofit or close, not just those that have detected groundwater contamination above regulatory levels. The rule also changes the classification of compacted-soil lined or “clay-lined” surface impoundments from “lined” to “unlined,” which means that formerly defined clay-lined surface impoundments are no longer considered lined surface impoundments and need to be retrofitted or closed. Under the final rule, unlined surface impoundments and units that failed the aquifer location restriction must cease receiving waste and initiate closure or retrofit by April 11, 2021.

Final Rules Are Intended To Make It “Simpler And Less Burdensome” For Oil And Natural Gas Industry To Comply With The NSPS For Oil And Natural Gas Industry: EPA released on August 13, 2020, two final rules that intended to make it “simpler and less burdensome” for the oil and natural gas industry to comply with the New Source Performance Standards (NSPS) for the Oil and Natural Gas Industry. According to a fact sheet, the two rules combined are estimated to yield net benefits of $750 to $850 million dollars from 2021 to 2030, the annualized equivalent of about $100 million a year. The fact sheet states that the final rules, combined with other deregulatory actions, “have saved Americans an estimated $94 billion in unnecessary regulatory costs.” The rules are:

  • Final policy amendments to the 2012 and 2016 NSPS, which remove the transmission and storage segment from the rule, rescind volatile organic compounds (VOC) and methane emissions standards for that segment, and rescind methane emissions standards for the production and processing segments; and
     
  • Final technical amendments to the 2016 NSPS, which make a number of changes to the rule to simplify compliance, including changes to the leaks monitoring and repair schedules for gathering and boosting compressor stations and low-production wells, changes to recordkeeping and reporting requirements (leaks are called “fugitive emissions” in the rule), and changes to incorporate several states’ requirements, among others.
     

EPA Proposes To Retain Current Ozone NAAQS, Will Hold Virtual Public Hearings: Based on EPA’s review of the air quality criteria and the National Ambient Air Quality Standards (NAAQS) for photochemical oxidants including ozone (O3), EPA proposed on August 14, 2020, to retain the current standards, without revision. 85 Fed. Reg. 49830. The existing primary and secondary standards, established in 2015, are 0.070 parts per million (ppm), as the fourth-highest daily maximum eight-hour concentration, averaged across three consecutive years. EPA proposes to conclude that the current primary standard is requisite to protect public health, with an adequate margin of safety, from effects of O3 in ambient air and should be retained, without revision. EPA also proposes to conclude that the current secondary standard is requisite to protect the public welfare from known or anticipated adverse effects of O3 in ambient air, and should be retained, without revision. EPA solicits comment on the proposed conclusions, and on the proposed decisions to retain the standards, without revision. EPA also solicits comment on the array of issues associated with review of these standards, including public health and science policy judgments inherent in the proposed decision. EPA will hold two virtual public hearings on August 31, 2020, and September 1, 2020. Comments are due October 1, 2020.

FDA

Technical Amendment For Chromium Propionate Food Additive Listing: The U.S. Food and Drug Administration (FDA), on August 11, 2020, amended 21 Code of Federal Regulations (C.F.R.) Section 573.304, which provides for the safe use of chromium propionate in feed and drinking water for animals. 85 Fed. Reg. 48650. FDA removed the word “complete” in paragraphs (d)(1) and (e)(1) to correct an inaccurate statement. The rule became effective on August 12, 2020.

FDA Updates Temporary Policies For Alcohol-Based Hand Sanitizers: On August 7, 2020, FDA issued updated guidance on testing alcohol used in hand sanitizers manufactured under FDA’s temporary policies. The updated guidance is meant to address ongoing issues with methanol contamination and to ensure “widespread access to alcohol-based hand sanitizers that are free of contamination.” FDA, on July 27, 2020, and July 31, 2020, provided updates to several warnings related to dangerous alcohol-based hand sanitizers. FDA notes in the August 7, 2020, update that “any alcohol (ethanol) or [isopropyl alcohol (IPA)] found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination.” “FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).” For more details, see FDA’s website.

NANOTECHNOLOGY

NIEHS Grantees Construct New Database To Facilitate Nanomaterial Research: The July 2020 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an item on a new database that facilitates nanomaterial research. According to the article, NIEHS grantees constructed PubVINAS, “a large database of structure, chemical property, and activity information on 705 nanomaterials, covering 11 material types.” The NIEHS article cites a Nature Communications article, “Construction of a web-based nanomaterial database by big data curation and modeling friendly nanostructure annotations.”

EUON Nanopinion Highlights Benefits Of Bio-Based Nanomaterials: On July 23, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Material manufacturing from nano-scaled particles: moving forward using plants” by Dr. Blaise Tardy, Research Fellow, Bio-Based Colloids and Materials Research Group -- Aalto University in Finland. As the field of nanotechnology moves forward, integrating the use of green, bio-based nanoparticles will become increasingly beneficial, particularly for materials with a short service lifetime, such as packaging, single-use personal protective equipment, and disposable filters. More information is available in our July 23, 2020, blog item.

OECD Publishes Guidance Documents For The Testing And Assessment Of Nanomaterials: The Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment:

More information is available in our July 27, 2020, blog item.

Germany Publishes Overview Of Field Of Advanced Materials: In July 2020, the German Environment Agency (UBA) published a report entitled Advanced materials: Overview of the field and screening criteria for relevance assessment. The report describes activities within the project “Advanced materials -- Thematic conferences: Assessment of needs to act on chemical safety” to provide discussion input on approaches to describe, cluster, and prioritize advanced materials. The aim of the report is to identify relevant advanced materials in regard to chemical safety.

ACGIH® Will Not Proceed With TLV® For Carbon Nanotubes In 2021: As reported in our February 5, 2020, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2020 list of chemical substances and other issues under study. Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®). ACGIH® has now released its two-tier under study list. Tier 1 lists the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process. Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on or be removed from the under study list for the next year. Carbon nanotubes are included in Tier 2. If carbon nanotubes are included on the 2021 under study list, stakeholders will have an opportunity to submit substantive data and comments.

Australia Releases Extra Guidance On Categorizing Chemicals At The Nanoscale Under AICIS: The Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020. Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical is listed on the Inventory. If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically categorized as a “listed” introduction. If the chemical is not listed, it must be categorized into one of five categories. On August 3, 2020, Australia published additional guidance for the introduction of industrial chemicals (and products that release industrial chemicals) with at least one external dimension in the nanoscale. More information is available in our August 7, 2020, blog item.

FDA Publishes Report On Nanotechnology -- Over A Decade Of Progress And Innovation, Holds Webinar: FDA published a report entitled Nanotechnology -- Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007. The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology. On August 13, 2020, FDA held a webinar to present the report. More information is available in our August 10, 2020, blog item.

NanoExplore Recruiting Companies In Certain EU Member States To Participate In Study Of Occupational Exposure To Nanomaterials: The NanoExplore project, which is supported by the EU’s LIFE program, aims at an integrated approach for exposure and health effects monitoring of engineered and incidental nanomaterials in occupational settings. The project is currently in its pilot phase. NanoExplore seeks employees of companies and organizations manufacturing and/or handling nanomaterials in their occupational settings or concerned with ultrafine particle exposure. Companies must be based in Spain, Italy, Switzerland, France, or Germany. More information is available in our August 12, 2020, blog item.

EC Will Hold Virtual Workshop On Safe And Sustainable Smart Nanomaterials: The European Commission’s (EC) Joint Research Center (JRC) and the Directorate-General for Research and Innovation (RTD) will jointly organize a virtual “Workshop on Safe and Sustainable Smart Nanomaterials” on September 9-10, 2020. The workshop is focused on smart (responsive, multi-functional) nanomaterials, as such or embedded in products, that are developed for application in industrial sectors such as agriculture, food, packaging, and cosmetics. The conference is open to experts from authorities, research organizations, and industry. Registration is required.

BIOBASED/RENEWABLE PRODUCTS

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 summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.

LEGISLATIVE

President Signs Bill Reauthorizing CFATS Program: On July 22, 2020, President Trump (R) signed legislation (S. 4148) that extends the Chemical Facility Anti-Terrorism Standards (CFATS) Program. The Program, which was set to expire on July 23, 2020, will now expire July 27, 2023.

National Defense Authorization Acts Would Promote Sustainable Chemistry: Both the House and Senate recently passed defense bills that include sustainable chemistry provisions. The House passed the National Defense Authorization Act (H.R. 6395) by a vote of 295 to 125 on July 21, 2020. The Senate passed its own version (S. 4049) on July 23, 2020, by a vote of 86 to 14. Both bills include the bipartisan Sustainable Chemistry Research and Development Act of 2019 (H.R. 2051, S. 999), which is intended to improve coordination of federal activities, including R&D of more sustainable chemicals, processes, and systems. The Act also supports improved education and training in sustainable chemistry and expands opportunities for the federal government to partner with industry to bring innovations to market. The House and Senate defense bills must be reconciled before a single bill is sent to President Trump for signature. The White House issued a Statement of Administration Policy on July 21, 2020, stating that it would recommend that Trump veto H.R. 6395 in its current form.

House Passes Four-Bill Appropriations Minibus: On July 24, 2020, the House passed a $259.5 billion package (H.R. 7608) consisting of the fiscal year (FY) 2021 State-Foreign Operations, Agriculture-Rural Development-FDA, Interior-Environment, and Military Construction and Veterans Affairs appropriations bills. The bill includes $9.38 billion for EPA, $2.67 billion more than the President’s budget request. Amendments to the bill would prevent the Trump Administration from implementing changes to the National Environmental Policy Act (NEPA) and block drilling in the Arctic National Wildlife Refuge and the National Petroleum Reserve-Alaska. The bill includes $12.9 million for the study and regulation of PFAS while prohibiting EPA’s use of funds to implement the Strengthening Transparency in Regulatory Science rule. The House passed the bill by a vote of 224 to 189, but it could have a difficult path in the Senate.

House Subcommittee Holds Hearing To Reform EPA’s Safe Drinking Water Standards: On July 28, 2020, the House Energy and Commerce Subcommittee on Environment and Climate Change held an oversight hearing entitled “There’s Something in the Water: Reforming Our Nation's Drinking Water Standards.” The hearing concentrated on the SDWA and the provisions of its standard-setting process as administered by EPA and whether legislative reform is necessary to ensure safe drinking water nation-wide. Witnesses represented the Association of State Drinking Water Administrators (ASDWA), the Association of Metropolitan Water Agencies (AMWA), and NRDC. For more information provided during the hearing, please read the full memorandum.

Senator Carper Requests EPA IG Investigate SNUR For LCPFAC And Perfluoroalkyl Sulfonate Chemical Substances: On July 28, 2020, Senator Tom Carper (D-DE), Ranking Member of the Senate Environment and Public Works Committee, requested that the EPA Inspector General (IG) commence an investigation into potential irregularities associated with the July 27, 2020, final SNUR for LCPFAC and perfluoroalkyl sulfonate chemical substances. The letter published in Carper’s July 28, 2020, press release claims that “significant changes” were made to the final SNUR that were directed to be included by Dr. Nancy Beck, a White House official and nominee to chair the Consumer Product Safety Commission (CPSC). The final rule “deleted EPA’s accurate description of Congress’s intent that a time-consuming analytic barrier to the regulation of toxic chemicals in consumer products was not required under TSCA,” and “deleted EPA’s statement that any portion of a product that was coated with PFAS would be subject to the rule, even if the coated portion was on an interior-facing surface of the product (because of the potential for exposure to the PFAS during disposal of the product).” The letter notes that the final rule “also added a statement indicating that EPA would be issuing guidance on which coatings would be covered by the rule later, raising questions about whether that guidance would ultimately make fewer products coated with PFAS subject to the rule.”

House Passes WRDA: On July 29, 2020, the House passed the bipartisan Water Resources Development Act of 2020 (WRDA) (H.R. 7575). The legislation provides authority for the U.S. Army Corps of Engineers (Corps) to carry out water resources development projects and studies, as well as policy direction to the Corps for implementation of its Civil Works missions. More information on the WRDA is available online. The White House issued a Statement of Administration Policy on July 29, 2020, describing ways that the WRDA could be improved.

Public Health Air Quality Act Of 2020 Intended To Improve Air Quality Monitoring, Protect Front-Line Communities: On July 29, 2020, Representative Lisa Blunt Rochester (D-DE) and Senator Tammy Duckworth (D-IL) introduced the Public Health Air Quality Act of 2020. Blunt Rochester’s press release states that the bill would require EPA to implement immediate fenceline monitoring for toxic air pollutants at facilities contributing to “high local cancer and other health threats from dangerous pollutants like ethylene oxide, chloroprene, and formaldehyde within 4 months for at least a two-year period.” The legislation would also ensure that fenceline monitoring and continuous emission monitoring are core components of national emission standards for chemical, petrochemical, and other sources of fugitive toxic air pollution; require a rapid expansion of the NAAQS or national ambient air monitoring network through the addition of at least 80 new multipollutant monitoring stations in communities where this is most needed to protect people with asthma and other health conditions and from COVID-19; and deploy at least 1,000 new air quality sensors in communities affected by air pollution and COVID-19 to boost and complement the NAAQS monitoring network and increase communities’ access to information about air quality.

Environmental Justice Legislation Introduced In The Senate: On July 30, 2020, Senators Kamala D. Harris (D-CA), Cory Booker (D-NJ), and Tammy Duckworth (D-IL) introduced the Environmental Justice for All Act, comprehensive environmental justice legislation intended to achieve health equity and climate justice for all, particularly underserved communities and communities of color. Harris’s July 30, 2020, press release states that the legislation:

  • Amends and strengthens the Civil Rights Act of 1964: Prohibits discrimination based on disparate impacts and overturns Alexander v. Sandoval;
     
  • Requires the consideration of cumulative impacts: Explicitly adds cumulative impacts in permitting decisions under the Clean Water Act (CWA) and CAA;
     
  • Codifies the Clinton Administration’s environmental justice Executive Order: Creates a working group to ensure compliance and enforcement and develop government-wide strategies;
     
  • Reinforces NEPA: Requires early and meaningful involvement in actions impacting communities, including Tribes;
     
  • Asserts health equity: Funds programs to study potentially harmful products marketed towards women and girls of color;
     
  • Provides outdoor access for all: Establishes programs to ensure more equitable access to parks and the outdoors;
     
  • Establishes environmental justice grant programs: Funds grants for research, education, and projects to address environmental and public health issues; and
     
  • Ensures a fair and just transition: Establishes a Federal Energy Transition Economic Development Assistance Fund to support communities and workers as they transition away from fossil fuel-dependent economies.
     

Representative Raúl M. Grijalva (D-AZ), Chair of the House Natural Resources Committee, introduced the Environmental Justice for All Act (H.R. 5986) in the House on February 27, 2020.

Legislation Would Protect Polar Bear Cubs From Oil Development In Arctic Refuge: On July 30, 2020, Representative Jared Huffman (D-CA), Chair of the Natural Resources Subcommittee on Water, Oceans, and Wildlife, introduced the Polar Bear Cub Survival Act. According to Huffman’s July 30, 2020, press release, the bill will “fight back against the recent actions of the Trump administration to open the Arctic National Wildlife Refuge coastal plain to oil and gas drilling.” The bill would safeguard polar bears by prohibiting oil and gas activities from impacting maternal denning habitat on the coastal plain of Arctic Refuge.

Bipartisan Bill Would Update FIFRA: On August 4, 2020, Senator Tom Udall (D-NM), Ranking Member of the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies, and Representative Joe Neguse (D-CO) introduced pesticide reform legislation intended to prevent the use of toxic pesticides that harm children, farmworkers, and consumers in the United States. Udall’s press release states that the Protect America’s Children from Toxic Pesticides Act of 2020 “represents the first comprehensive update since 1996 to the law governing pesticide use in the United States,” FIFRA. According to Udall’s press release, the bill would:

  • Ban some of the most damaging pesticides: organophosphate insecticides; neonicotinoid insecticides; and paraquat;
     
  • Restore balance to protect ordinary citizens by:
     
    • Creating a petition process to enable individual citizens to petition EPA to identify dangerous pesticides so that EPA “would no longer be able to indefinitely allow dangerous pesticides to remain on the market”;
       
    • Closing “dangerous loopholes” that have allowed EPA to issue emergency exemptions and conditional registrations to use pesticides before they have gone through full health and safety review by the Agency;
       
    • Enabling local communities to enact protective legislation and other policies without being vetoed or preempted by state law; and
       
    • Suspending the use of pesticides deemed unsafe by the EU or Canada until they are thoroughly reviewed by EPA;
       
  • Provide protections for “frontline communities that bear the burden of pesticide exposure” by:
     
    • Requiring employers of farmworkers to report all pesticide-caused injuries to EPA, with strong penalties for failure to report injuries or retaliating against workers;
       
    • Directing EPA to review pesticide injury reports and work with the pesticide manufacturers to develop better labeling to prevent future injury; and
       
    • Requiring that all pesticide label instructions be written in Spanish and in any language spoken by more than 500 pesticide applicators.
       

President Trump Signs Great American Outdoors Act: On August 4, 2020, President Trump signed the Great American Outdoors Act (H.R. 1957), dedicating up to $1.9 billion per year for five years to fund deferred maintenance projects identified by the National Park Service, the U.S. Forest Service, the U.S. Fish and Wildlife Service, the Bureau of Land Management (BLM), and the Bureau of Indian Education. The August 4, 2020, White House press release states that the Act also provides permanent funding for the Land and Water Conservation Fund (LWCF), which supports recreational access, protection, and preservation of natural and cultural resources. LWCF grants enable state and local governments to develop and improve parks in their communities, as well as permanently conserve outdoor recreation areas for public use and enjoyment.

Senate Democrats Oppose Nominee To Lead BLM: On August 11, 2020, Senator Martin Heinrich (D-NM), a member of the Senate Energy and Natural Resources Committee, led the Democratic Caucus in a letter to President Trump opposing the nomination of William Perry Pendley for Director of BLM. According to a press release issued by Heinrich, the letter states that Pendley’s public record, including his advocacy for reducing public lands and access to them, routine attempts to undermine tribes, and climate change denial, makes him unfit for the position. The letter notes that BLM “is responsible for stewarding vast expanses of public lands” and that it “needs a leader who reflects the values of the American people and their support for access to public lands.”

Carper, Blunt Rochester Call For EPA Briefing For Delaware Residents On Dangers Of Ethylene Oxide: Senator Tom Carper (D-DE) and Representative Lisa Blunt Rochester (D-DE) sent a letter on August 11, 2020, to EPA Administrator Andrew Wheeler expressing “grave concern over the apparent failure of the EPA to communicate the health risks of ethylene oxide to Delaware residents, despite a report from the Office of the Inspector General [(OIG)] directing the agency to do so.” The August 11, 2020, Senate Committee on Environment and Public Works minority press release states that Carper and Blunt Rochester request a meeting between senior EPA officials and the community residents living near the Croda plant be held within the next 30 days, virtually or in person; whether EPA has held a public meeting or meetings with residents living near the Croda plant to communicate the health risks associated with ethylene oxide; and whether EPA has conducted or has future plans to conduct outreach efforts to inform residents living near the Croda plant of the health risks associated with ethylene oxide.

MISCELLANEOUS

CEQ Updates Regulations Implementing NEPA Procedural Provisions: On July 16, 2020, the Council on Environmental Quality (CEQ) issued a final rule to update its regulations for federal agencies to implement NEPA. 85 Fed. Reg. 43304. According to CEQ, the final rule “comprehensively updates, modernizes, and clarifies the regulations to facilitate more efficient, effective, and timely NEPA reviews by Federal agencies in connection with proposals for agency action.” CEQ states that the rule will improve interagency coordination in the environmental review process, promote earlier public involvement, increase transparency, and enhance the participation of States, Tribes, and localities. The final rule is a major rule subject to Congressional review. The effective date is September 14, 2020. If Congressional review changes the effective date, CEQ will publish a Federal Register notice to establish the actual effective date or to terminate the rule. A July 15, 2020, White House fact sheet states that the final rule “improves management by incorporating President Trump’s One Federal Decision policy, establishing time limits of two years for completion of environmental impact statements, when required, and one year for completion of environmental assessments.” As reported above, H.R. 7608 would prevent the Trump Administration from implementing these changes.

EPA Issues Final Rule Intended To Streamline And Modernize EPA Permit Process: On July 22, 2020, EPA announced a final rule intended to streamline and modernize the review of permits by EPA’s Environmental Appeals Board (EAB). Additionally, the final rule provides more flexibility to regulated parties, states and tribes, and the public. EPA states that the final rule “streamlines the often-lengthy permitting review process before EAB by expediting certain timelines of the prior process and imposing new, targeted deadlines.” The final rule clarifies EAB’s scope of review and makes permits effective more quickly by expediting administrative appeals through the following measures. It establishes a 60-day deadline for EAB to issue final decisions once an appeal has been fully briefed and argued, with a one-time 60-day extension; limits the availability of filing extensions to one request per party, with a maximum extension of 30 days; and streamlines the amicus process.

NASEM Seeks Nominations For Experts For Committee On Anticipatory Research For EPA’s ORD To Inform Future Environmental Protection: The National Academies of Sciences, Engineering, and Medicine (NASEM) are now assembling an ad hoc committee to identify emerging scientific and technological advances from across a broad range of disciplines that EPA’s Office of Research and Development (ORD) should consider in its research planning to support EPA’s mission for protecting human health and the environment. In addition, according to NASEM, the committee will recommend how ORD could best take advantage of those advances to meet current and future challenges during the next 10 - 20 years. Nominations for committee members and reviewers were due August 5, 2020.

New York Legislature Passes Bill That Would Prohibit TCE: On July 22, 2020, the New York Senate passed a bill (A. 8829A/S. 6829B) that would prohibit the use of trichloroethylene (TCE) as a vapor degreaser, an intermediate chemical to produce other chemicals, a refrigerant, or an extraction solvent or in any other manufacturing or industrial cleaning process or use beginning December 1, 2021. The New York Assembly passed the bill on July 23, 2020, and the bill was sent to Governor Andrew Cuomo (D) for his consideration. Cuomo has not indicated whether he will sign it. As reported in our February 26, 2020, memorandum, EPA released its draft risk evaluation of TCE earlier this year. EPA did not find risk to the environment, but did preliminarily find unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA Begins Comment Period On IRIS Assessment Plan For Oral Exposure To Vanadium And Compounds: On July 24, 2020, EPA announced a 30-day public comment period on the IRIS Assessment Plan for Oral Exposure to Vanadium and Compounds (Scoping and Problem Formulation Materials). 85 Fed. Reg. 44887. The document communicates information on the scoping needs identified by EPA program and regional offices and the Integrated Risk Information System (IRIS) Program’s initial problem formulation activities. It outlines the objectives for the IRIS assessment and the type of evidence considered most pertinent to address the scoping needs. EPA will hold a public science webinar on August 19, 2020. EPA requests comment on all aspects of the assessment plan, including key science issues and identification of any new or missing studies. Comments are due August 24, 2020.

EPA Begins Public Comment Period On Technical Documents For External Peer Review For Report On PBPK Modeling For Chloroprene: On July 24, 2020, EPA announced a 30-day public comment period on documents associated with a Report on Physiologically Based Pharmacokinetic (PBPK) Modeling for Chloroprene and a Supplemental Analysis of Metabolite Clearance. 85 Fed. Reg. 44885. EPA states that the documents will undergo independent external scientific peer review. Public comments on the documents associated with the PBPK modeling will be provided to the external peer reviewers. Versar, an EPA contractor, will convene a virtual meeting of the peer reviewers, which will be open to the public and include an opportunity to provide oral comments. In preparation for the external peer review, EPA is also announcing a 30-day public comment period on the pool of candidates to conduct the external peer review of the documents. According to EPA, Versar will consider public comments on these candidates and evaluate any conflicts of interest and/or appearance of lack of impartiality, and will then select nine independent experts from the pool of 19 candidates. Once complete, the final peer review report will be used to inform EPA’s Reconsideration of a 2017 Request for Correction related to the IRIS assessment of chloroprene. Comments are due August 24, 2020.

NASEM Will Hold Public Workshop To Review Federal Research On PFAS: On July 27, 2020, EPA announced that in partnership with the U.S. Department of Defense (DoD), U.S. Department of Agriculture (USDA), and U.S. Department of Health and Human Services (HHS), it has engaged NASEM to coordinate a Workshop on Federal Government Human Health PFAS Research. EPA states that as outlined in its PFAS Action Plan, this collaborative workshop will ensure coordination of PFAS research across the federal government. The National Academies will organize a two-day virtual public workshop to review federal agency research on PFAS and identify research and data gaps. According to EPA, the workshop should take place in fall 2020. Following the workshop, NASEM will assemble a report summarizing the views of participants on how to ensure that the federal research program for PFAS is robust and focused on addressing the highest priority human health concerns. The proceedings will be made available to participating federal agencies and to the public.

NIOSH Publishes IDLH Value Profiles For Bromine Trifluoride, Chlorine Trifluoride, And Ethylene Dibromide: On July 28, 2020, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of Immediately Dangerous to Life or Health (IDLH) Value Profiles for Bromine Trifluoride, Chlorine Trifluoride, and Ethylene Dibromide. 85 Fed. Reg. 45431. These IDLH Value Profiles present a brief summary of technical data associated with acute inhalation exposures and the rationale behind the IDLH value.

CDTSC Announces Workshop And Comment Period On Food Packaging With PFAS As New Priority Product: The California Department of Toxic Substances Control (CDTSC) is holding a public consultation on its proposal to regulate plant fiber-based food packaging containing PFAS as a priority product under the Safer Consumer Products (SCP) regulations. CDTSC will hold a virtual workshop on its proposal on August 31, 2020. Comments on the proposal are due September 13, 2020. CDTSC states that stakeholder comments and input provided during the public comment period and at the related workshop will help it refine its priority product definition.

EPA Extends Nomination Period For Candidates For SAB And SAB Standing Committees: On August 14, 2020, EPA announced that it is extending the nomination period of scientific experts from a diverse range of disciplines to be considered for appointment to the EPA Science Advisory Board (SAB) and four SAB standing committees: the Agricultural Science Committee; the Chemical Assessment Advisory Committee; the Drinking Water Committee; and the Radiation Advisory Committee. 85 Fed. Reg. 49650. EPA states that on April 15, 2020, a federal district court vacated the grants policy articulated in EPA’s 2017 federal advisory committee membership directive. In light of that intervening decision, EPA is extending the nomination period until August 31, 2020. Appointments will be announced by the Administrator and are anticipated to be filled by the start of FY 2021 (October 2020).

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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