Wrap-Up of Federal and State Chemical Regulatory Developments, January 2021

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TSCA/FIFRA/TRI

EPA Seeks Comments On Draft Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. 85 Fed. Reg. 81466. The draft guide provides additional clarity on what is meant by a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR. More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.” Comments on the draft guide are due January 15, 2021.

Final Risk Evaluation For Perchloroethylene Finds 59 Conditions Of Use Pose Unreasonable Risks To Workers, ONUs, Consumers, And Bystanders: On December 18, 2020, EPA announced the availability of the final risk evaluation for perchloroethylene. 85 Fed. Reg. 82474. Of the 61 conditions of use that EPA reviewed, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders. The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants. EPA found no unreasonable risks to the environment. More information is available in our December 17, 2020, memorandum.

EPA Releases Report Compiling Letter Peer Review Comments On Revised Draft Risk Evaluation Of PV29: On December 21, 2020, EPA announced that a report compiling the letter peer reviewers’ comments on the revised draft TSCA risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604. EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk evaluation. More information is available in our December 30, 2020, blog item.

EPA Releases Final Chemical Risk Evaluation For NMP: On December 30, 2020, EPA released the final risk evaluation for N-methylpyrrolidone (NMP). 85 Fed. Reg. 86558. Of the 37 conditions of use that EPA reviewed, EPA found that 26 present unreasonable risks to workers and consumers. These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use. These uses also include an unreasonable risk to consumers from one consumer use. EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial, commercial, and consumer applications. EPA also determined that NMP does not present an unreasonable risk to the environment and the general population. For more information, please read our December 29, 2020, memorandum.

EPA Publishes Final Risk Evaluation For Asbestos, Part 1: Chrysotile Asbestos: On January 4, 2021, EPA announced the availability of the final risk evaluation for asbestos, part 1: chrysotile asbestos. 86 Fed. Reg. 89. Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, ONUs, consumers, and/or bystanders within each of the six chrysotile asbestos use categories. EPA found no unreasonable risk to the environment. For more information, please see our January 4, 2021, memorandum.

EPA Provides Companies Opportunity To Submit, Amend, Or Withdraw Filings Under TSCA Active-Inactive Rule: On January 5, 2021, EPA announced that it is reopening the reporting period under the TSCA Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. In its January 5, 2021, announcement, EPA states that it has become aware of “submitter confusion and issues regarding [confidential business information (CBI)] claims” during the initial reporting period. EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity. The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date. A prepublication version of the Federal Register notice is available here.

EPA Seeks Participants For Small Business Review Panels On Perchloroethylene And NMP Risk Management Rulemakings: EPA announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels. One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed TSCA risk evaluation for perchloroethylene. The second Panel will focus on a risk management rulemaking for NMP. EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rules’ requirements. EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted online and must be received by January 19, 2021.

EPA Issues Final TSCA Section 6(h) Rules For Five PBT Chemicals: On January 6, 2021, EPA issued final rules under TSCA Section 6(h) for five persistent, bioaccumulative, and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894). TSCA required EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable. EPA identified these five PBT chemicals for expedited action, following criteria outlined in TSCA. The final rules will be effective February 5, 2021. More information on the final rules is available in our December 23, 2020, memorandum, “EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals.”

EPA Lowers Dust-Lead Clearance Levels: On January 7, 2021, EPA published a final rule lowering the 2001 dust-lead clearance levels (DLCL) from 40 micrograms of lead in dust per square foot (μg/ft2) to 10 μg/ft2 for floors, and from 250 μg/ft2 to 100 μg/ft2 for window sills. 86 Fed. Reg. 983. Clearance levels indicate the amount of lead in dust on a surface following the completion of an abatement activity. The post-abatement dust-lead levels are evaluated against, and must be below, the applicable clearance levels. The final rule will be effective March 8, 2021.

EPA Updates Modeling Tool That Evaluates Chemical’s Potential To Cause Cancer: EPA announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer. EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.” According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool. More information is available in our January 11, 2021, blog item.

Final Risk Evaluation For 1,4-Dioxane Finds Unreasonable Risk To Workers For Certain Uses: On January 8, 2021, EPA released the final risk evaluation for 1,4-dioxane. 86 Fed. Reg. 1495. The final risk evaluation identifies unreasonable risk to workers for 13 out of 24 conditions of use. EPA states that it found no unreasonable risk to the general population and the environment. EPA notes that it also published a supplemental analysis to the draft risk evaluation that evaluated eight additional conditions of use for 1,4-dioxane present as a byproduct in consumer products. According to EPA, after “carefully considering” public comments on the supplemental analysis, it found no unreasonable risk for these consumer uses. More information is available in our memorandum.

EPA Proposes Amendments To TSCA Fees Rule: On January 11, 2021, EPA published a proposed rule that would amend the 2018 TSCA Fees Rule. 86 Fed. Reg. 1890. The proposed updates include:

  • Narrowing the scope of the TSCA Fees Rule by exempting importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that produce a chemical in de minimis amounts, companies that use chemicals solely for research and development (R&D) purposes, and companies that manufacture a chemical that is produced as a non-isolated intermediate from fees;
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations; and
  • Adding new fee categories associated with new chemicals activities.

Comments are due February 25, 2021. More information is available in our December 30, 2020, memorandum.

EPA Publishes 2019 TRI National Analysis: On January 12, 2021, EPA announced the release of the 2019 Toxics Release Inventory (TRI) National Analysis, which shows that EPA and companies that manage chemicals continue to make progress in preventing pollution. The report shows that between 2018 and 2019 total releases of TRI chemicals decreased by nine percent. EPA lists the following highlights:

  • Air releases decreased by 23 million pounds from 2018 to 2019, continuing a long-term trend;
  • Facilities reported initiating 3,285 new source reduction activities to prevent or reduce the creation of TRI chemical waste. This is the first year since 2014 that more new source reduction activities were implemented than in the prior year;
  • Regional profiles illustrate the geographic diversity of U.S. industrial operations;
  • For the first time, data on nonylphenol ethoxylates, which are surfactants used in adhesives, dispersants, cleaners, paints, coatings, and other products, are reported; and
  • The percentage of chemical waste generated that facilities recycled in 2019 increased, continuing this trend in facilities opting to use EPA’s most preferred waste management method.

EPA And OSHA Sign MOU For Implementing TSCA Section 5 And Sharing CBI: On January 12, 2021, EPA and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under TSCA. EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks. As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals. More information will be available in a forthcoming memorandum that will be posted on our website.

EPA Determines That HDPE Containers Contain PFAS Compounds Leaching Into Pesticide Product: EPA announced on January 14, 2021, that as part of its extensive efforts to address PFAS, it is making new information available about EPA testing that shows PFAS contamination from fluorinated containers. Through a coordinated effort with both the Commonwealth of Massachusetts and a pesticide manufacturer, it has determined that fluorinated high-density polyethylene (HDPE) containers that are used to store and transport a mosquito control pesticide product contain PFAS compounds that are leaching into the pesticide product. According to EPA, the affected pesticide manufacturer has voluntarily stopped shipment of any products in fluorinated HDPE containers and is conducting its own testing to confirm EPA results and product stability in un-fluorinated containers. EPA states that in addition, it has issued a request for information under TSCA to the company that fluorinates the containers used by certain pesticide manufacturers. The TSCA subpoena requests information about the fluorination process used to treat the containers. EPA asks that pesticide and other companies using fluorinated containers, and entities that provide container fluorination services, engage in good product stewardship and examine their distribution chains to identify potential sources of contamination. EPA states that it will also continue to work closely with the entities involved and their supply and distribution chains, mosquito control districts, the pesticide and packaging industry, federal partners, states, and tribes that may be affected to provide information and guidance on next steps. EPA created a web page that it will update with information as it becomes available.

EPA Releases Final Risk Evaluation For PV29: EPA released the final risk evaluation for PV29 on January 14, 2021. EPA states that the final risk evaluation determined that there are unreasonable risks to workers and ONUs from ten out of 14 conditions of use. EPA found no unreasonable risks to the environment, consumers, or the general public. The next step in the process required by TSCA is developing a plan to address the unreasonable risks identified in the final risk evaluation. Potential actions EPA could take to address these risks include regulating how PV29 is used, and limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of PV29, as applicable. More information will be available in a forthcoming memorandum that will be posted on our website.

EPA Discontinues Three TSCA Section 6(a) Rulemaking Efforts Listed In The Regulatory Agenda: On January 15, 2021, EPA announced that is withdrawing the proposed regulatory requirements described in three proposed rules and that it no longer intends to issue final rules. 86 Fed. Reg. 3932. EPA officially terminated the ongoing rulemaking activities, allowing it to close out the following individual rulemaking entries for these actions that appear in EPA’s Regulatory Agenda:

  • Trichloroethylene (TCE); Regulation of Certain Uses Under TSCA Section 6(a); Proposed Rule; RIN 2070-AK03: On December 16, 2016, EPA issued a proposed rule under TSCA Section 6(a) to address unreasonable risks that EPA had preliminarily determined exist with certain uses of TCE: aerosol degreasing and spot cleaning in dry cleaning. EPA proposed to prohibit the manufacture, processing, and distribution in commerce of TCE for use in aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.
  • TCE; Regulation of Use in Vapor Degreasing Under TSCA Section 6(a); Proposed Rule; RIN 2070-AK11: On January 19, 2017, EPA issued a proposed rule under TSCA Section 6(a) to address unreasonable risks that EPA had preliminarily determined exist with use of TCE in vapor degreasing. EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.
  • NMP; Regulation of Certain Uses Under TSCA Section 6(a); Proposed Rule; RIN 2070-AK07: On January 19, 2017, EPA issued a proposed rule under TSCA Section 6(a) to address risks that EPA had preliminarily identified with certain uses of NMP, which is a solvent used in a variety of applications, including paint and coating removal. EPA preliminarily identified significant health risks associated with NMP use in commercial and consumer paint and coating removal and EPA proposed a determination that these are unreasonable risks. EPA co-proposed two different options: one co-proposal was to prohibit the manufacture (including import), processing, and distribution in commerce of NMP for all consumer and commercial paint and coating removal; to prohibit the use of NMP for all commercial paint and coating removal; to require downstream notification of these prohibitions throughout the supply chain; to require recordkeeping; and to provide a time-limited exemption from these proposed regulations on NMP for coating removal uses critical for national security. As an alternate proposal, EPA proposed that: (1) commercial users of NMP for paint and coating removal establish a worker protection program for dermal and respiratory protection and not use paint and coating removal products that contain greater than 35 percent NMP by weight (except for product formulations destined to be used by the Department of Defense (DOD) or its contractors performing work only for DOD projects); and (2) processors of products containing NMP for paint and coating removal reformulate products such that these products do not exceed a maximum of 35 percent NMP by weight, identify gloves that provide effective protection for the formulation, and provide warning and instruction labels on the products.
  • Methylene chloride; Regulation of Certain Uses under TSCA Section 6(a); Proposed Rule; RIN 2070-AK07: The January 19, 2017, proposed rule for NMP also proposed requirements for methylene chloride. Requirements addressing the use of methylene chloride for consumer paint and coating removal were subsequently grouped under RIN 2070-AK07. EPA also announced an advance notice of proposed rulemaking (ANPRM) on March 27, 2019, to solicit public input on training, certification, and limited access requirements that could address any unreasonable risks that EPA could potentially find to be presented by methylene chloride when used for commercial paint and coating removal. EPA states that this withdrawal applies only to provisions of the January 19, 2017, proposed rule related to commercial paint and coating removal of methylene chloride.

The proposed rules were withdrawn on January 15, 2021.

EPA Issues TSCA Section 4 Test Orders For Nine Chemicals Undergoing Risk Evaluation: EPA announced on January 15, 2021, that it has issued test orders under TSCA Section 4 to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. According to EPA, companies subject to the test orders may provide EPA with existing data or conduct new tests. Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing. The nine chemicals subject to the Section 4 test orders are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,1-Dichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

More information will be available in a forthcoming memorandum that will be posted on our website.

EPA Announces Environmental Justice Consultations On Risk Management Rulemakings For HBCD And Carbon Tetrachloride: EPA will hold webinars on February 2, 2021, and February 18, 2021, to consult with environmental justice communities on risk management for the cyclic aliphatic bromide cluster (HBCD) and carbon tetrachloride. The webinars will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals. EPA states that both sessions will address HBCD and carbon tetrachloride. According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from HBCD and carbon tetrachloride, and discussion of environmental justice concerns.

EPA Compliance Advisory Addresses Applicability Of TSCA To Chemicals Made From Petroleum And Renewable Sources Used As Fuels, Fuel Additives, And Distillates: EPA has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.” The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to TSCA. Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5. EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.” More information is available in our December 24, 2020, blog item.

COVID-19

Drug Facility Fees Will Not Apply To Distilleries Producing Hand Sanitizer: In late December 2020, press reported that FDA would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees.” FDA announced the fee rates on December 29, 2020. 85 Fed. Reg. 85646. According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 -- an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pandemic. According to the complete HHS statement, posted by the Distilled Spirits Council, FDA’s March 2020 guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), “contains no discussion regarding user fees or any indication such fees would be due by these entities, many of which would be entering the drug manufacturing business for the first time.” HHS states that FDA’s action “was not cleared by HHS leadership, who only learned of it through media reports.” The HHS Office of the General Counsel (OGC) reviewed the matter and “determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule. Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19.” Because HHS OGC has determined FDA’s notice is a legislative rule and that no one at FDA has been delegated authority to issue such a rule, HHS states that the notice is void. HHS leadership, based on the legal opinion, has ordered FDA’s Federal Register notice to be withdrawn, “meaning these surprise user fees will not need to be paid.”

On January 6, 2021, HHS issued a notice of withdrawal. 86 Fed. Reg. 550. The notice states that “…FDA lacked the delegated authority to issue the Notice.” It further clarifies that the Notice was issued without approval of the Secretary. If FDA intends to revisit, a public notice with an opportunity for public comment must be included. On January 12, 2021, HHS issued a notice “to clarify that persons that entered into the OTC drug industry for the first time to supply hand sanitizers during the COVID-19 Public Health Emergency are not persons subject to the facility fee the Secretary is authorized to collect under section 744M of the Food, Drug, and Cosmetic Act.” 86 Fed. Reg. 2420.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Announces Final Decision To Retain Existing NAAQS For Primary And Secondary PM: On December 18, 2020, EPA published its final decision to retain the current National Ambient Air Quality Standards (NAAQS) for particulate matter (PM), without revision. 85 Fed. Reg. 82684. The Federal Register notice states that EPA has established primary (health-based) and secondary (welfare-based) NAAQS for PM2.5 (particles with diameters generally less than or equal to 2.5 micrometers (µm)) and PM10 (particles with diameters generally less than or equal to 10 µm). This includes two primary PM2.5 standards, an annual average standard with a level of 12.0 micrograms per cubic meter (µg/m3) and a 24-hour standard with a 98th percentile form and a level of 35 µg/m3. It also includes a primary PM10 standard with a 24-hour averaging time, a 1-expected exceedance form, and a level of 150 µg/m3. Secondary PM standards are set equal to the primary standards, except that the level of the secondary annual PM2.5 standard is 15.0 µg/m3. According to EPA, in reaching decisions on these PM standards in the current review, the Administrator considered the available scientific evidence assessed in the Integrated Science Assessment (ISA), analyses in the Policy Assessment (PA), advice from the Clean Air Scientific Advisory Committee (CASAC), and public comments on the proposal. The final action was effective December 18, 2020.

EPA Seeks Information On Beneficial Use And Piles Of Coal Ash: On December 22, 2020, EPA announced that it is seeking information and data related to the beneficial use and piles of coal combustion residuals (CCR, commonly known as coal ash). 85 Fed. Reg. 83478. According to EPA, it received new information and data pertaining to its August 14, 2019, proposed rule. EPA seeks public comment on whether this additional information may inform its reconsideration of the beneficial use definition and provisions for CCR accumulations. EPA also is accepting additional information and data from the public that may further help inform its reconsideration of the beneficial use definition and provisions for CCR accumulations, such as information on how coal ash is beneficially used that can help EPA distinguish among the different types of beneficial use applications; information on the management of coal ash at each point in its distribution system; and information on federal, state, and local program provisions and regulations related to beneficial use and CCR accumulations. EPA is requesting comment only on those two issues. Comments are due February 22, 2021.

EPA Will Amend Lead And Copper Rule: On January 15, 2021, EPA amended the National Primary Drinking Water Regulation (NPDWR) for lead and copper under the authority of the Safe Drinking Water Act (SDWA). 86 Fed. Reg. 4198. According to EPA’s December 22, 2020, press release, the amendments include the following improvements:

  • Using science-based testing protocols to find more sources of lead in drinking water;
  • Establishing a trigger level to jumpstart mitigation earlier and in more communities;
  • Driving more and complete lead service line replacements;
  • For the first time, requiring testing in schools and child care facilities; and
  • Requiring water systems to identify and make public the locations of lead service lines.

The final rule will be effective March 16, 2021.

EPA Publishes Final Rule Intended To Increase Consistency And Transparency In Considering Benefits And Costs In CAA Rulemaking Process: On December 23, 2020, EPA published a final rule establishing processes that EPA will be required to undertake in promulgating regulations under the Clean Air Act (CAA) to ensure that information regarding the benefits and costs of regulatory decisions is provided and considered in a consistent and transparent manner. 85 Fed. Reg. 84130. EPA states that it is establishing procedural requirements governing the preparation, development, presentation, and consideration of benefit-cost analyses (BCA), including risk assessments used in the BCA, for significant rulemakings conducted under the CAA. Together, these requirements are intended to help ensure that EPA implements its statutory obligations under the CAA, and describes its work in implementing those obligations, in a way that is consistent and transparent. According to EPA’s fact sheet, the final rule consists of three main requirements:

  • EPA will prepare a BCA for all future significant proposed and final regulations under the CAA. EPA anticipates significant regulations will include those with the largest annual impact on the economy; those that would disproportionately affect an industry, group, or area; or those that are novel or relevant for other policy reasons;
  • The BCAs are developed in accordance with best practices from the economic, engineering, physical, and biological sciences. The rule outlines required elements of BCAs, following established protocols for conducting best cost analyses published by the Office of Management and Budget (OMB) and further elaborated in EPA’s “Guidelines for Preparing Economic Analyses.” These include addressing all key elements of a BCA and -- to the extent permitted by law -- making underlying data available to the public; and
  • EPA must increase transparency in the presentation of the benefits and costs resulting from significant CAA regulations. In addition to a clear reporting of the overall results of the BCA, EPA will require separate reporting of the public health and welfare benefits that are specific to the objective of the CAA provision under which the rule is promulgated.

This final rule was effective December 23, 2020, but does not apply to final rules for which a proposal was published prior to the effective date.

EPA Will Amend Heavy-Duty Vehicle Regulations, Propose Further Improvements: On December 28, 2020, EPA announced that it is issuing two actions regarding technical adjustments to improve testing procedures for vehicle and engine emissions programs. EPA states that the first action is a final rule that will reduce testing burden and improve accuracy of required emissions testing procedures for heavy-duty vehicles and engines. The final rule will also amend test procedures for exhaust emissions standards for light-duty vehicles, heavy-duty vehicles, highway motorcycles, locomotives, marine engines, other nonroad engines and vehicles, and stationary engines. According to EPA, many of these updates will take effect for model year (MY) 2021. EPA is also issuing a supplemental notice of proposed rulemaking (SNPRM) that would issue corrections, clarifications, flexibilities, and adjustment factors to improve the Greenhouse gas Emissions Model (GEM) compliance tool for heavy-duty vehicles. The proposed amendments would be required for MY 2022 and later vehicles and optional for MY 2021. Publication of the SNPRM in the Federal Register will begin a 60-day comment period.

EPA Will Retain Current Ozone NAAQS: On December 31, 2020, EPA issued a final notice stating that it will retain, without changes, the 2015 ozone NAAQS. 85 Fed. Reg. 87256. The existing primary (health-based) and secondary (welfare-based) standards are 0.070 parts per million (ppm), as the fourth-highest daily maximum eight-hour concentration, averaged across three consecutive years. According to EPA, the decision to retain the existing ozone standards “comes after careful review and consideration of the most recent available scientific evidence and technical information, consultation with the agency’s independent science advisors, and consideration of more than 50,000 public comments on the proposal.” In the prior review of the ozone standards, the Obama Administration increased the stringency of the levels of the ozone standards to 70 parts per billion (ppb) from the 2008 standard of 75 ppb. EPA’s action was effective December 31, 2020.

EPA Publishes Rivers And Streams Assessment, Seeks Comment On Modernizing Survey Methods: On December 31, 2020, EPA announced the availability of a report entitled National Rivers and Streams Assessment (NRSA) 2013-2014: A Collaborative Survey that provides a historical snapshot of water quality in U.S. rivers and streams. EPA states that it is seeking input on all aspects of the design and implementation of the National Aquatic Resource Survey (NARS) program to improve future assessments. EPA states that the report includes a comparison between water quality metrics in 2013-2014 and 2008-2009, “which generally show that water quality in rivers and streams across the country remained relatively unchanged between 2008 and 2014.” Publication of the notice in the Federal Register will begin a 60-day comment period.

EPA Publishes Briefing Paper On Renewable Energy Waste Management: On January 6, 2021, EPA posted a briefing paper outlining difficulties the United States will face recycling and safely disposing of the materials used for green energy technologies. According to EPA’s January 6, 2021, press release, Renewable Energy Waste Streams: Preparing for the Future examines the waste produced when solar panels, lithium-ion batteries, and windmills reach the end of their useful life. EPA states that the briefing paper “identifies key challenges that America faces in the near future as the growing use of renewable energy technologies creates a new generation of materials that need to be recycled or properly disposed of in order to protect human health and the environment.”

EPA Releases MOVES3 Motor Vehicle Emissions Model For SIPs And Transportation Conformity: On January 7, 2021, EPA announced the availability of the MOtor Vehicle Emission Simulator model (MOVES3) for official purposes outside of California. 86 Fed. Reg. 1106. According to EPA, MOVES3 is the latest state-of-the art upgrade to its modeling tools for estimating emissions from cars, trucks, buses, and motorcycles based on the latest data and regulations. MOVES3 is available for use in state implementation plans (SIP) and transportation conformity analyses outside of California. The January 7, 2021, Federal Register notice starts a two-year grace period before MOVES3 will need to be used as the latest EPA emissions model in new regional emissions analyses and a two-year grace period before MOVES3 will need to be used in new hot-spot analyses for transportation conformity determinations outside of California.

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

  • Mercury Cell Chlor-Alkali Plants (86 Fed. Reg. 1362 (Jan. 8, 2021)): EPA is proposing to find risks due to emissions of hazardous air pollutants (HAP) to be acceptable from the Mercury Cell Chlor-Alkali Plants source category, and to determine that the current NESHAP provides an ample margin of safety to protect public health and that no more stringent standards are necessary to prevent an adverse environmental effect. EPA proposes to amend the requirements for cell room fugitive mercury emissions to require work practice standards for the cell rooms and to require instrumental monitoring of cell room fugitive mercury emissions under the technology review. EPA proposes not to require conversion to non-mercury production technology and invites comments and data and information regarding this proposed determination. In addition, EPA is proposing standards for fugitive chlorine emissions from mercury cell chlor-alkali plants, which are not currently regulated under the NESHAP. EPA proposes to address applicability for thermal mercury recovery units when chlorine and caustic are no longer produced in mercury cells. EPA is also proposing revisions related to emissions during periods of startup, shutdown, and malfunction (SSM); provisions for electronic submission of performance test results, performance evaluation reports, and Notification of Compliance Status (NOCS) reports; and correction of various compliance errors in the current rule. Comments are due February 22, 2021.
  • Primary Magnesium Refining (86 Fed. Reg. 1390 (Jan. 8, 2021)): EPA proposes that risks from emissions of air toxics from this source category are acceptable and that after removing the SSM exemptions, the NESHAP provides an ample margin of safety. Under the technology review, EPA is proposing one development in technology and practices that will require continuous pH monitoring for all control devices used to meet the acid gas emission limits of this subpart. In addition, as part of the technology review, EPA is addressing a previously unregulated source of chlorine emissions by proposing a maximum achievable control technology (MACT) emissions standard for chlorine emissions. EPA also proposes amendments to the regulatory provisions related to emissions during periods of SSM, including removing exemptions for periods of SSM and adding a work practice standard for malfunction events associated with the chlorine reduction burner; all emission limits will apply at all other times. In addition, EPA is proposing electronic reporting of performance test results and performance evaluation reports. Comments are due February 22, 2021.
  • Flexible Polyurethane Foam Fabrication Operations and Flexible Polyurethane Foam Production and Fabrication (86 Fed. Reg. 1868 (Jan. 11, 2021)): EPA proposes to establish a numeric emission limit for one major source subcategory; remove exemptions for SSM periods and specify that the emissions standards apply at all times; require periodic performance tests; and require electronic reporting of performance test results and compliance reports. EPA states that implementation of these proposed rules is not expected to result in significant changes to the HAP emissions from affected facilities in these source categories or to human health impacts or environmental impacts associated with those emissions. According to EPA, the proposed rule would result in improved monitoring, compliance, and implementation of the existing standards and codify existing industry practices to prevent backsliding. Comments are due February 25, 2021.
  • Carbon Black Production (86 Fed. Reg. 3054 (Jan. 14, 2021)): The proposed amendments address HAP emissions that occur after the main unit filter of a carbon black production unit, as well as emissions from boilers and process heaters. The proposed amendments also address SSM provisions of the existing standards, and would require electronic reporting of certain notifications, performance test results, and semiannual reports. Additionally, the proposal addresses the results of the technology review for the Carbon Black Production Area Source NESHAP. Comments are due March 1, 2021.
  • Refractory Products Manufacturing (86 Fed. Reg. 3079 (Jan. 14, 2021)): EPA proposes to find the risks due to emissions of air toxics from this source category under the current standards to be acceptable and that the standards provide an ample margin of safety to protect public health. EPA proposes no revisions to the existing numerical emission limits based on these analyses; EPA is proposing new provisions for certain HAPs, however. EPA also proposes to amend provisions addressing emissions during SSM periods and provisions addressing emissions during periods of scheduled maintenance; to amend provisions regarding electronic reporting of performance test results; and to make miscellaneous clarifying and technical corrections. Comments are due March 1, 2021.
  • Cyanide Chemicals Manufacturing (86 Fed. Reg. 3906 (Jan. 15, 2021)): EPA proposes to find that risk from emissions of air toxics from this source category is acceptable, and that the current standards provide an ample margin of safety to protect public health. EPA also proposes to find that there are no developments in practices, processes, and control technologies, and, as such, is not proposing any development-based changes to the current standards pursuant to the technology review. EPA proposes new emissions standards to address emissions from process wastewater at existing sources, however. EPA proposes to amend SSM provisions, to add electronic reporting, and to update the reporting and recordkeeping requirements. EPA states that it does not expect these proposed amendments to result in changes in emissions from the source category but anticipates improved monitoring, compliance, and implementation of the existing standards. Comments are due March 1, 2021.

Final Rule Intended To Reduce Regulatory Burden And Emissions From Large Storage Tanks By Allowing Alternative Inspection Method: EPA announced on January 11, 2021, a final rule that “offers regulatory flexibility to more than 3,500 petroleum, chemical, and coal products manufacturing facilities and petroleum bulk stations and terminals by allowing an alternate, less cumbersome mode of inspection of liquid storage tanks to show compliance” with CAA regulations. The amendments to the Standards of Performance for Volatile Organic Liquid Storage Vessels (Including Petroleum Liquid Storage Vessels) for Which Construction, Reconstruction, or Modification Commenced After July 23, 1984, will allow owners/operators of Volatile Organic Liquid Storage Vessels to conduct less cumbersome “in-service” inspections of the tanks, without emptying and degassing the storage tank. EPA states that since 2018, it has received more than 300 requests from facilities seeking permission to conduct in-service inspections and that these requests “are time consuming and burdensome for both tank owners and operators and for EPA.”

EPA Announces Final GHG Emissions Standards For Aircraft: On January 11, 2021, EPA published final greenhouse gas (GHG) emissions standards for airplanes used in commercial aviation and large business jets. 86 Fed. Reg. 2136. 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), ensuring domestically manufactured aircraft remain competitive in the global marketplace. EPA states in its December 28, 2020, press release that the ICAO standards were developed with significant input from EPA, the Federal Aviation Administration (FAA), and U.S. and international aviation industries. Typically, three out of four aircraft manufactured in the U.S. are sold overseas. The standards “will help ensure consistent standards across the world, and most importantly allow U.S. manufactured planes, such as commercial and large passenger jets, to continue to compete in the global marketplace.” The final rule was effective January 11, 2021.

EPA Publishes Final Effluent Guidelines Program Plan 14: EPA announced on January 11, 2021, the availability of its Effluent Guidelines Program Plan 14 (Plan 14). 86 Fed. Reg. 1960. Plan 14 presents early results from new analyses and provides updates on EPA’s reviews of industrial wastewater discharges and treatment technologies discussed in the October 2019 Preliminary Plan 14, including analyses of industrial sources and discharges of nutrients, proposed treatment technology reviews, and the effluent limitations guidelines database. Plan 14 provides updates on ongoing point source category studies, including studies on the Petroleum Refining Category and the Electrical and Electronic Components Category, as well as the PFAS Multi-Industry study. EPA is developing:

  • Revisions to the Centralized Waste Treatment category to increase flexibility for facilities that treat produced water from oil and gas extraction wells;
  • An upcoming proposed rule to consider best available technology (BAT) limitations for two wastestreams (landfill leachate and legacy wastewater) for the Steam Electric Power Generating category; and
  • An upcoming ANPRM for the Organic Chemicals, Plastics, and Synthetic Fibers category to solicit additional information or data about PFAS manufacturers and formulators.

EPA Makes Significant Contribution Finding For GHG Emissions For Electric Generating Units: EPA published a final rule on January 13, 2021, announcing a final significant contribution finding (SCF) for purposes of regulating source categories for GHG emissions for electric generating units (EGU), and in doing so, reaffirming that EGUs remain a listed source category. 86 Fed. Reg. 2542. EPA states that it reached that conclusion by articulating a framework under which source categories are considered to contribute significantly to dangerous air pollution due to their GHG emissions if the amount of those emissions exceeds three percent of total U.S. GHG emissions. According to the notice, EPA is applying the three-percent threshold to the EGU source category to demonstrate that GHG emissions from the EGU source category would contribute significantly to dangerous air pollution. EPA notes that while EGU GHG emissions exceed this threshold by a sufficient magnitude to warrant an SCF without more ado, “EPA has also, for completeness, analyzed EGU emissions under a secondary criteria framework, which also demonstrates the propriety of the SCF.” The final rule will be effective March 15, 2021.

FDA

Happy Anniversary FSMA!: FDA’s Food Safety Modernization Act (FMSA) was signed into law ten years ago on January 4, 2011, with the intent of preventing outbreaks of foodborne illness. In a recent statement, FDA discusses the progress made under FSMA and what it hopes to achieve in the coming years.

FDA’s 2020 Achievements: FDA, in a recent statement, covered a variety of topics, including the COVID-19 response, the New Era of Smarter Food Safety Blueprint, employing artificial intelligence, and a proposed food traceability rule.

FDA Extends Comment Period For The Food Traceability Proposed Rule And Provides Clarifications: FDA announced on December 18, 2020, that it is extending the comment period for the FSMA proposed “Requirements for Additional Traceability Records for Certain Foods” rule. 85 Fed. Reg. 82393. The original notice, issued on September 23, 2020, included a 120-day comment period and a 60-day period for information collection. FDA, with this announcement, extends both comment deadlines until February 22, 2021. In addition, FDA announced on January 12, 2021, that it made clarifying edits, and is providing frequently asked questions (FAQ) that address questions that have been received to date regarding the proposed rule.

FDA Issues Guidance On Consumer Antiseptic Rub Final Rule: FDA issued on December 31, 2020, additional guidance for industry in the form of a Questions and Answers document. 85 Fed. Reg. 86937. FDA notes that the guidance is provided “…to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR).” The guidance provides an overview on the complex regulatory background surrounding these types of products, and discusses the active ingredients that are eligible for evaluation.

NANOTECHNOLOGY

OECD Publishes Reports On Outcome Of Project On Advancing Adverse Outcome Pathway Development For Nanomaterial Risk Assessment And Categorization: In 2016, OECD’s Working Party on Manufactured Nanomaterials (WPMN) included the Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization (NanoAOP) project in its program of work. OECD has published three reports presenting the outcomes of the project:

More information is available in our December 22, 2020, blog item.

OECD Publishes Report On Ability Of Biopersistent/Biodurable Manufactured Nanomaterials To Induce LMP As A Prediction Of Their Long-Term Toxic Effects: OECD has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects. The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable manufactured nanomaterials.” OECD intends the compilation of available information in the report to contribute to the development of test systems to predict the long-term toxicity and hence the safety of manufactured nanomaterials.

OECD Publishes Report On Moving Toward A Safe(r) Innovation Approach For More Sustainable Nanomaterials And Nano-Enabled Products: OECD published a report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products. According to the Executive Summary, the report “presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness.” The report compiles existing risk assessment tools, frameworks, and initiatives developed for Safe(r)-by-Design. OECD states that the inventory of risk assessment tools and frameworks should help industry implement a “Safe(r) Innovation Approach” for nanomaterials and nano-enabled products. More information is available in our December 29, 2020, blog item.

ACGIH® TLV®-CS Committee Seeks Information On Carbon Nanotubes: The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2021 list of chemical substances and other issues under study. The TLV®-CS Committee seeks substantive data and comments and will consider only those addressing issues of health and exposure, not economic or technical feasibility. More information is available in our January 4, 2021, blog item.

NIOSH Science Blog Reports On Recent Article Concerning Carbon Nanotubes And Nanofibers Used Or Produced In U.S. Facilities: On January 5, 2021, the National Institute for Occupational Safety and Health (NIOSH) posted a Science Blog item entitled “Understanding the Broad Class of Carbon Nanotubes and Nanofibers (CNT/F) Used or Produced in U.S. Facilities.” The item summarizes a recently published article in the journal Particle and Fibre Toxicology, “Physicochemical characterization and genotoxicity of the broad class of carbon nanotubes and nanofibers used or produced in U.S. facilities” that addresses whether different-sized CNT/F materials have similar toxicity if inhaled. More information is available in our January 5, 2021, blog item.

SCCS Opinion On The Safety Of Nanomaterials In Cosmetics Includes Prioritized List Of Nanomaterials For Risk Assessment: On January 11, 2021, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted a final opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics. The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg. 1223/2009). The final opinion states that SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products. Annex 1 of the opinion lists the nanomaterials included in the 2019 catalogue of nanomaterials in order of priority according to risk potential. The nanomaterials listed in Annex 1 with the highest scores are colloidal copper, methylene bis benzotriazolyl tetramethylbutylphenol, colloidal silver, and silver. More information is available in our January 12, 2021, blog item.

OECD Will Hold Webinar On Aquatic And Sediment Ecotoxicity Testing Of Nanomaterials: On January 26, 2021, OECD will hold a webinar on Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317). The webinar will discuss the scope and use of the guidance document, which addresses practical aspects of carrying out valid tests on nanomaterials, and modifications or additions to OECD Test Guidelines procedures intended to improve the accuracy of test results. Registration for the webinar is open.

BIOBASED/RENEWABLE PRODUCTS

B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://blog.braginfo.org.

LEGISLATIVE

Omnibus Funding Bill Includes Environmental Innovation, Water Infrastructure, And Energy Legislation: On December 22, 2020, Congress passed the Consolidated Appropriations Act of 2021, omnibus legislation consisting of 12 FY appropriations bills, coronavirus relief, and authorizations. According to the Senate Committee on Environment and Public Works’ December 22, 2020, press release, the omnibus legislation includes:

  • The Utilizing Significant Emissions with Innovative Technologies (USE IT) Act to promote carbon capture technologies;
  • The reauthorization of the Diesel Emissions Reduction Act (DERA) program; and
  • The American Manufacturing and Innovation (AIM) Act, which would implement a 15-year phasedown of hydrofluorocarbons (HFC) at a national level for the first time, administered by EPA.

The omnibus bill also includes the Water Resources Development Act of 2020, which will increase water storage, provide protection from dangerous floodwaters, deepen nationally significant ports, maintain the navigability of inland waterways, and address the threat of invasive species.

Senators Lisa Murkowski (R-AK) and Joe Manchin (D-WV) announced that their bipartisan, bicameral Energy Act of 2020 has been included as Division Z of the Consolidated Appropriations Act of 2021. The Energy Act features consensus provisions from the Senate’s American Energy Innovation Act (S. 2657) and the House’s Clean Economy Innovation and Jobs Act (H.R. 4447). The package focuses on energy storage; advanced nuclear; carbon capture, utilization, and storage; carbon removal; renewable energy; critical minerals and materials; fusion; industrial technologies; smart manufacturing; and grid modernization, among other areas. The package also includes a range of measures intended to boost energy efficiency and to bring administrative reforms to improve the Department of Energy.

President Trump signed the Consolidated Appropriations Act of 2021 on December 28, 2020, but he sent a “redlined version” back to Congress with a formal request for lawmakers to rescind certain spending items. A recissions message puts a 45-day hold on targeted funds. If Congress does not pass legislation approving the request, the funds must be released.

House Bill Intended To Spur Innovation, Reduce Power Sector Emissions: On December 28, 2020, Representatives David B. McKinley, P.E. (R-WV) and Kurt Schrader (D-OR) announced the introduction of the Clean Energy Future through Innovation Act of 2020, a bipartisan proposal intended to accelerate the development and commercialization of clean energy technologies and establish clear and durable standards for their use in the electric power sector. According to Schrader’s December 28, 2020, press release, the bill would make significant investments in energy innovation and infrastructure, including carbon capture, advanced nuclear, renewables, efficiency, and storage. After a decade of innovation, the Act would establish a technology-neutral clean energy standard that would reduce CO2 emissions 80 percent by 2050.

MISCELLANEOUS

EPA Publishes Interim Guidance On Destroying And Disposing Of Certain PFAS And PFAS-Containing Materials: On December 22, 2020, EPA announced the availability of new interim guidance on destroying and disposing of certain PFAS and PFAS-containing materials for public comment. 85 Fed. Reg. 83554. The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products, including aqueous film-forming foam for firefighting. According to EPA’s December 18, 2020, press release, the interim guidance assembles and consolidates information in a single document that generally describes thermal treatment, landfill, and underground injection technologies that may be effective in the destruction or disposal of PFAS and PFAS-containing materials. To help ensure informed decision-making, the technology-specific information describes uncertainties and how those uncertainties should be weighed given situation-specific factors, such as the waste’s physical phase (liquid, solid, gas). Comments are due February 22, 2021. More information is available in our December 23, 2020, blog item.

OSHA Announces New Debt Collection Initiative: On December 22, 2020, OSHA announced a new initiative designed to collect better citation penalties. OSHA states that it is implementing a series of three penalty payment letters to be sent seven, 30, and 60 days after an establishment fails to pay timely a penalty based on a final order. In addition, OSHA will contact establishments by phone 14 days after the payment comes due. Establishments that pay their penalties by their due date will not receive the new letters or phone call. If an establishment fails to make a civil monetary penalty payment from an inspection resulting in a citation, and is not on an affordable payment plan, OSHA states that it will place the establishment on a priority list for further inspection. In addition, OSHA compliance safety and health officers will gather employer identification numbers (EIN) as part of the pre-inspection preparation.

USDA Publishes ANPRM Regarding Movement Of Animals Modified Or Developed By Genetic Engineering: On December 28, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published an ANPRM soliciting public comment on establishing regulations for the movement of certain animals modified or developed by genetic engineering. 85 Fed. Reg. 84269. Under the regulatory framework being contemplated, the USDA would promulgate regulations using the authorities granted to it through the Animal Health Protection Act, the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Pursuant to these authorities, APHIS would conduct a safety assessment of animals subject to the FMIA or PPIA that have been modified or developed using genetic engineering that may increase the animal’s susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same. The Food Safety and Inspection Service would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of certain animals modified or developed using genetic engineering would not result in a product that is adulterated or misbranded. Comments are due February 26, 2021.

EPA Issues Final Rule Intended To Strengthen Transparency In Pivotal Science Underlying Significant Regulatory Actions And Influential Scientific Information: On January 6, 2021, EPA issued a final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” 86 Fed. Reg. 469. EPA’s January 5, 2021, press release states the final rule establishes that when promulgating significant regulatory actions or developing influential scientific information, EPA will give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. The final rule requires EPA to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed or draft stage to the extent practicable; reinforces the applicability of peer review requirements for pivotal science; and provides criteria for the Administrator to exempt certain studies from the requirements of the rule. The final rule was effective on January 6, 2021. Its provisions apply to significant regulatory actions for which a proposed rule was published in the Federal Register after January 6, 2021, and influential scientific information submitted for peer review after January 6, 2021. For more information, please read the full memorandum.

EPA Publishes FY 2020 Environmental Justice Progress Report: EPA announced on January 11, 2021, the release of its Fiscal Year 2020 Environmental Justice Progress Report highlighting its progress in advancing environmental justice for minority, low-income, tribal, and indigenous communities across the country. The report describes how EPA is working to promote a cleaner, healthier environment, more effective partnerships, and greater certainty, compliance, and effectiveness to meet the needs of vulnerable communities to address disproportionate environmental impacts, health disparities, and economic distress. Highlights of EPA’s work include:

  • Providing over $160 million in grant funding to support low income and minority communities. These grants will clean up brownfield sites in communities with Opportunity Zones, reduce emissions from diesel vehicles and equipment at ports, provide environmental job training to residents of underserved communities, and address challenges faced by communities related to the pandemic;
  • Deleting all or part of 27 sites from the National Priorities List for a second consecutive year, to reduce exposure to contaminants;
  • Announcing a new $4.3 million grant program, under the Water Infrastructure Improvements of the Nation Act, to help protect children in tribal communities from lead in drinking water by boosting lead testing in schools and childcare centers;
  • Issuing final rules that will make a meaningful difference to communities by ensuring that more people -- particularly lower-income and minority populations -- have greater access to newer, cleaner, more affordable cars, and by reducing lead dust-related risks to children in pre-1978 homes and childcare facilities where lead removal activities take place; and
  • Reclassifying 20 communities that now meet air quality standards.

DOJ Issues Memorandum On Equitable Mitigation In Civil Environmental Enforcement Cases: On January 12, 2021, the Environment and Natural Resources Division (ENRD) of the U.S. Department of Justice (DOJ) issued a memorandum to ENRD Deputy Assistant Attorneys General and Section Chiefs to clarify its March 2020 memorandum explaining why Supplemental Environmental Projects (SEP) “are illegal absent explicit Congressional authorization.” The March 2020 memorandum notes that the prohibition on SEPs “does not apply to payments that ‘directly remedy the harm that is sought to be redressed in a case, including for example, harm to the environment.’” The January 12, 2021, memorandum seeks to explain this point more fully and to provide practical guidance to ENDR attorneys considering whether mitigation relief is appropriate in a specific instance.

CDTSC Grants Petition To List Motor Vehicle Tires Containing Zinc As A Priority Product: The California Department of Toxic Substances Control (CDTSC) announced on January 12, 2021, that it granted the May 2018 petition filed by the California Stormwater Quality Association (CASQA) to list motor vehicle tires with tire-tread containing zinc as a Priority Product. CDTSC states that it will issue a technical document explaining the rationale for its decision to accept the petition and propose motor vehicle tires containing zinc as a Priority Product, anticipated to be released by March 2021. CDTSC will hold a public comment period and workshop on the proposal prior to initiating the formal rulemaking process. It will also use the workshop as an opportunity to begin a discussion about other tire-related chemicals of concern.

USDA Releases Agriculture Innovation Research Strategy Summary And Dashboard: USDA announced on January 12, 2021, the release of its U.S. Agriculture Innovation Strategy: A Directional Vision for Research and dashboard that will help to guide future research decisions within USDA. USDA states that it collected hundreds of responses through its request for information and stakeholder-led workshops. Respondents were asked to identify transformational research goals for the next era of agriculture productivity and environmental conservation. They were also asked to propose approaches to these opportunities around four innovation cluster areas (genome design, digital automation, prescriptive intervention, and systems based farm management), and to identify gaps, barriers, and hurdles to meeting these goals. The report summarizes the extensive stakeholder input and defines discovery goals that will help inform research to best address the Agriculture Innovation Agenda for the next ten to 30 years. USDA developed the public dashboard to help sort the information collected from stakeholders. According to USDA, stakeholders and customers “can use the dashboard to take a deeper dive into the data to gain insights on agricultural innovation opportunities over three time horizons, including near-term solutions, longer-term transformational solutions, and next era concepts.”

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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