September 26, 2022

Volume XII, Number 269

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September 26, 2022

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Recent Federal Developments - August 2022

Recording Available For “TSCA New Approach Methodologies” Webinar: Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995. During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), Richard E. Engler, Ph.D., Director of Chemistry, B&C, and James W. Cox, M.S., Senior Scientist, B&C, discussed examples of EPA’s use and development of non-vertebrate testing strategies, successful collaborations between EPA and external partners to advance understanding and use of NAMs, and the need for EPA and stakeholders to approach implementation of NAMs with an “innovation mindset” that fulfills the requirements under TSCA. Lynn L. Bergeson, Managing Partner, B&C, moderated.

The National Tribal Toxics Council — A Conversation With Dianne Barton, Ph.D.: On this episode of All Things Chemical®, Lynn L. Bergeson and Dianne Barton, Ph.D., Water Quality Coordinator at the Columbia River Inter-Tribal Fish Commission in Portland, Oregon, and Chair of the National Tribal Toxics Council (NTTC), discuss toxics issues and how the NTTC is engaged with EPA on a wide variety of Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) implementation issues, particularly those affecting tribal communities. Listen now.

Tips For Working With Foreign Regulators In China — A Conversation With David Cragin, Ph.D.: Lynn L. Bergeson was joined by David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director with a large multinational pharmaceutical company, for this episode of All Things Chemical. Dr. Cragin shares his experience living and working in China and provides advice for working with foreign regulators with the additional challenge of language barriers, cultural differences, and differing regulatory standards. Listen now.

TSCA/FIFRA/TRI

How Does A Recent Supreme Court Ruling Apply To EPA’s Implementation Of TSCA?: Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit EPA authority in implementing Congress’s 2016 amendments to TSCA, the Lautenberg Act.

The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, Managing Partner, B&C, for Chemical Watch is available here.

EPA Amends Significant New Use Rule (SNUR) Regulations To Protect Workers’ Health: As stated in B&C’s July monthly update, B&C has posted to its website a more detailed memorandum on EPA’s final rule amending the regulations governing significant new uses of chemical substances under TSCA to align with revisions that were made to the Occupational Safety and Health Administration (OSHA) Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements for the respiratory protection of workers from exposure to chemicals. 87 Fed. Reg. 39756. The final rule will be effective on September 6, 2022. For more information and a detailed commentary, please read the full memorandum.

United States Court Of Appeals For The Eleventh Circuit Reverses U.S. District Court’s Ruling On Failure To Warn Claim In Glyphosate Case: On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup®, which contains the active ingredient glyphosate, did not have adequate warning of the “harmful nature of glyphosate under Georgia law.” The District Court ruled that FIFRA preempts Georgia law and Plaintiff’s failure to warn claim because EPA classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. Plaintiff appealed. The Court found that the District Court erred in concluding that the Plaintiff’s failure to warn claim was preempted under FIFRA. In its Opinion, the Court stated that a common-law cause of action, such as the failure to warn claim under Georgia law, would be preempted “if two conditions are met: 1) the state requirement must be for ‘labeling or packaging’ under the language of the statute; and 2) the state requirement is ‘in addition to or different from’ requirements derived from FIFRA.” The Court found that EPA’s registration process “is not sufficiently formal to carry with it the force of law” and instead “at most creates a rebuttable presumption of compliance with FIFRA’s registration process and nothing more.” In addition, with regard to FIFRA’s labeling provisions, the Court found that the Georgia law failure to warn claim is not in addition to or different from FFIRA requirements. Instead, the Court states that the Georgia failure to warn claim “simply enforces the FIFRA cause of action, so it is not expressly preempted.” This case potentially places glyphosate registrants in the position of defending themselves for not warning about the potential carcinogenicity of glyphosate despite past EPA statements that any such warning would be considered a violation of FIFRA. Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information is available in our July 20, 2022, blog.

EPA Implements Statutory Addition Of Certain PFAS To Toxics Release Inventory (TRI) Beginning With Reporting Years 2021 And 2022: On July 18, 2022, EPA updated the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 42651. Specifically, this action updates the regulations to identify five per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2020 enacted on December 20, 2019. EPA states that “[a]s this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary.” On August 2, 2022, EPA published a final rule correcting inadvertent errors in the preamble and the amendatory instructions that appeared in the regulatory text portion of the final rule. 87 Fed. Reg. 47102. The final rule is effective August 17, 2022. More information is available in our July 19, 2022, memorandum.

EPA Publishes Receipt And Status Information For Certain New Chemicals For June 2022 And July 2022: On July 19, 2022, EPA published the receipt and status reports for the period from June 1, 2022, to June 30, 2022. 87 Fed. Reg. 43030. EPA states that it is providing notice of receipt of a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. Comments identified by the specific case number provided by EPA are due August 18, 2022. EPA published the receipt and status reports on August 15, 2022, for the period from July 1, 2022, to July 31, 2022. 87 Fed. Reg. 50079. Comments identified by the specific case number are due September 14, 2022.

Draft Revision To Risk Determination For 1-BP Finds 1-BP, As A Whole Chemical Substance, Presents An Unreasonable Risk: On July 20, 2022, EPA announced the availability of and requested public comment on a draft revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation issued under TSCA. 87 Fed. Reg. 43265. EPA states that the draft revision to the 1-BP risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. In the draft revision, EPA finds that 1-BP, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use (COU). Comments are due August 19, 2022. More information is available in our July 21, 2022, memorandum.

EPA Publishes Meeting Minutes And Final Report For April 2022 SACC Meeting On Draft TSCA Systematic Review Protocol: On July 21, 2022, EPA announced that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). EPA intends to issue its response to the SACC’s recommendations along with any revisions to the approach in 2023. More information is available in our July 26, 2022, blog item.

EPA Proposes To Adopt 2022 NAICS Codes For TRI Reporting: On July 22, 2022, EPA proposed to update the list of North American Industry Classification System (NAICS) codes subject to reporting under TRI to reflect the Office of Management and Budget (OMB) 2022 NAICS code revision. 87 Fed. Reg. 43772. EPA currently uses 2017 NAICS codes and is proposing to implement the 2022 codes for TRI Reporting Year 2022 (i.e., facilities reporting to TRI would be required to use 2022 NAICS codes on reports that are due by July 1, 2023). EPA states that the actual data required by a TRI form will not change as a result of this rulemaking, nor will the rule affect the universe of TRI reporting facilities that are required to submit reports to EPA under EPCRA. Comments are due September 20, 2022.

EPA Holds Kick-Off Meeting For TSCA New Chemical Engineering Outreach Initiative: EPA’s New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under TSCA and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online. For a summary of the webinar, see our July 28, 2022, memorandum.

EPA Publishes Additional Resources For Recipients Of TSCA Section 4 Test Orders: EPA has posted two new resource documents for recipients of test orders under Section 4 of TSCA. The August 5, 2022, policy document entitled “Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing” provides two policies:

  • Policy 1: Companies engaged in manufacturing activities for a chemical substance during the five years prior to the projected signature date or effective date of a Section 4(a) action (i.e., a rule, consent agreement, or order) will generally be included in the scope of the action. EPA may apply a longer or shorter period of time when appropriate in specific cases, however.

  • Policy 2: Section 4 actions will not include an option to cease manufacturing as a means to satisfy the requirements of the action. Test orders issued in January 2021 included this option.

The August 5, 2022, policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022” states that although EPA’s policy is that it will no longer provide a “cease manufacture” response option for a company to cease its manufacture of a chemical substance to satisfy the requirements of an order, EPA recognizes that a company that ceased its manufacture of a chemical substance in response to a 2021 order “forewent a business opportunity in reliance upon EPA’s representation that testing on the chemical substance would not be required by the company.” EPA will remove from a 2022 order any company that made successful use of the cease manufacture response option for a 2021 order on that same chemical substance, “provided the company has not, and does not, recommence its manufacture of the chemical substance while testing obligations remain in effect for that chemical substance under the applicable 2021 Order and/or 2022 Order.”

EPA Issues Supplemental Proposed Rule To Add DINP Category To TRI List Of Chemicals: EPA published on August 8, 2022, a supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under EPCRA and PPA. 87 Fed. Reg. 48128. On September 5, 2000, EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that this category met the EPCRA toxicity criterion. According to the supplemental proposed rule, EPA has updated its hazard assessment for DINP and proposes to add DINP as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. EPA requests comment on the updated DINP hazard assessment and associated updated economic analysis. Comments are due October 7, 2022.

EPA Updates Safer Chemical Ingredients List, Adding 22 Chemicals And Changing The Status Of One Chemical: EPA announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” More information is available in our August 11, 2022, blog item.

EPA Publishes Statements Of Findings For Certain New Chemicals Or Significant New Uses For March 2022 And April 2022: TSCA requires EPA to publish in the Federal Register a statement of its findings after its review of certain TSCA submissions when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA. EPA published on August 12, 2022, its statements of findings made on such submissions during the period from March 1, 2022, to April 30, 2022. 87 Fed. Reg. 49821.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

PHMSA Posts Recording Of Webinar On FAQs Initiative: The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) held a webinar on June 27, 2022, on an initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ) on its website. A recording of the webinar is available online. According to PHMSA, the first batch of 12 FAQs will be published in final in the Federal Register. PHMSA will review and revise the FAQs in light of future rulemakings. More information on the initiative is available in our March 24, 2022, memorandum. Comments on the FAQs are available online in Docket ID PHMSA-2021-0109.

PHMSA Harmonizes HMR With International Standards: On July 27, 2022, PHMSA amended the HMR to maintain alignment with international regulations and standards by adopting various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. 87 Fed. Reg. 44944. Additionally, PHMSA amended the HMR to allow for better alignment with Transport Canada’s Transportation of Dangerous Goods Regulations. PHMSA also withdrew the unpublished October 1, 2020, Notice of Enforcement Policy Regarding International Standards on use of select updated international standards in complying with the HMR during the pendency of this rulemaking. The rule is effective August 25, 2022. The voluntary compliance date was January 1, 2021. The delayed compliance date is July 26, 2023.

EPA Proposes To List Certain Substances As Substitutes Under SNAP Program In Refrigeration, Air Conditioning, And Fire Suppression: On July 28, 2022, pursuant to the Significant New Alternatives Policy (SNAP) program, EPA proposed to list certain substances as acceptable subject to use conditions in the refrigeration and air conditioning sector for chillers - comfort cooling, residential dehumidifiers, non-residential dehumidifiers, residential and light commercial air conditioning, and heat pumps, and a substance as acceptable subject to use conditions and narrowed use limits in very low temperature refrigeration. 87 Fed. Reg. 45508. Through this action, EPA proposes to incorporate by reference standards that establish requirements for electrical air conditioners, heat pumps, and dehumidifiers, laboratory equipment containing refrigerant, safe use of flammable refrigerants, and safe design, construction, installation, and operation of refrigeration systems. Additionally, EPA proposes to list certain substances as acceptable subject to use conditions in the fire suppression sector for certain streaming and total flooding uses. Finally, EPA requests advance comment on potential approaches to SNAP listing decisions for very short-lived substances that have ozone depletion potentials similar to those of ozone-depleting substances scheduled to be phased out. Comments are due September 12, 2022.

EPA Announces Community Engagement Efforts On New Ethylene Oxide Risk Information: On August 3, 2022, EPA announced its plans to engage and inform communities, states, Tribes, Territories, and stakeholders about up-to-date information on the risks posed by air emissions of ethylene oxide from commercial sterilizers, as well as EPA’s efforts to address these risks. EPA states that its analysis indicates that the air near facilities does not exceed short-term health benchmarks. The concern is that a lifetime of exposure to ethylene oxide emissions could lead to long-term health impacts if some of these facilities continue to emit at the current levels, however. According to EPA, it is working with these facilities to take appropriate steps to reduce emissions. In addition to community outreach, EPA continues to take significant action to address ethylene oxide and advance critical ethylene oxide research, including:

Later this year, EPA expects to propose an air pollution regulation to protect public health by addressing ethylene oxide emissions at commercial sterilizers.

White House OSTP Releases Plan To Advance Research On Emerging Contaminants In Drinking Water: On August 5, 2022, the White House Office of Science and Technology Policy (OSTP) released a new report on the National Emerging Contaminants Research Initiative (NECRI). The report outlines a federal strategy to address critical research gaps related to detecting and assessing emerging contaminants in drinking water, as well as identifying and mitigating the adverse health effects those contaminants cause. The report also outlines strategic steps needed to track, identify, and mitigate more effectively contaminants of emerging concern (CEC), which have been traditionally difficult to detect in drinking water.

EPA Amends NESHAP For RICE And NSPS For ICE: On August 10, 2022, EPA published a final rule amending the C.F.R to reflect a 2015 court decision regarding the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Stationary Reciprocating Internal Combustion Engines (RICE) and the New Source Performance Standards (NSPS) for Stationary Internal Combustion Engines (ICE). 87 Fed. Reg. 48603. The court vacated provisions in the regulations specifying that emergency engines could operate for emergency demand response or during periods where there is a deviation of voltage or frequency. This ministerial rule revises the RICE NESHAP and ICE NSPS to conform to the court’s decision. The final rule was effective on August 10, 2022.

Hazardous Waste Electronic Manifest (e-Manifest) Advisory Board Will Meet In October 2022: EPA announced on August 12, 2022, that it will convene the Hazardous Waste Electronic System (e-Manifest) Advisory Board for a three-day virtual public meeting on October 4-6, 202287 Fed. Reg 49830. EPA hosted two virtual public meetings on October 27, 2021, and November 3, 2021, to discuss how to increase electronic adoption and solicit feedback from stakeholders. The meetings described existing electronic manifest functionality and the feasibility of several options to increase use of electronic manifests. The October 4-6, 2022, meeting will include discussion of the comments EPA received from the public meetings, as well as related policy and technical changes EPA is considering for the e-Manifest system to increase adoption of electronic manifests. The general purpose of this meeting is for the Board to advise EPA on these potential changes. Registration is required. Written comments and requests to make oral comments are due September 27, 2022.

FDA

FDA Marks Anniversary Of New Era Of Smarter Food Safety Blueprint: July 13, 2022, marked the second anniversary of the release of the U.S. Food and Drug Administration’s (FDA) New Era of Smarter Food Safety Blueprint that lays out goals to enhance food traceability, respond more rapidly and thoroughly to outbreaks, reduce contamination of food, and foster stronger food safety culture. On the anniversary, FDA highlighted the progress made to date, which includes exploring the use of artificial intelligence to predict risk of violation, launching the Low- or No-Cost Tech-Enabled Traceability Challenge, and releasing the New Era of Smarter Food Safety Foodborne Outbreak Response Improvement Plan. Additional information is available at the link here.

FDA Proposes To Revoke Methods Of Analysis Regulation: On July 15, 2022, FDA proposed revocation of the “Methods of analysis,” which would remove 21 C.F.R. Section 2.1987 Fed. Reg. 42398. It is FDA’s view that “the regulation is unnecessary as a general matter” and that it is “more appropriate, flexible, and efficient to identify the Agency's preferred methods of analysis in documents such as the Office of Regulatory Affairs Laboratory Procedures Manual, FDA compliance programs, and other resources.” Comments must be received by September 28, 2022.

FDA Releases New Total Diet Study Report: On July 15, 2022, FDA released the Total Diet Study (TDS) Report: Fiscal Years 2018-2020 rhat analyzes 307 foods (including foods, beverages, and water) for 25 elements (nutrients and toxic elements). Nutrients such as calcium, iron, and potassium were analyzed because inadequate intakes of these nutrients can lead to poor health outcomes. Testing of toxic elements such as arsenic, cadmium, lead, and mercury have been prioritized by FDA as detailed in the Closer to Zero Action Plan.

FDA Extends Comment Period For Phthalate Plasticizers: On July 19, 2022, FDA announced that it will extend the comment period for a Request for Information for Ortho-phthalates for Food Contact Use issued on May 20, 2022, with comments due originally on July 19, 2022. FDA is extending the comment period “to provide stakeholders with more time to fully consider the request for information [RFI] and submit comments.” The new deadline will be published in an upcoming Federal Register notice.

FDA Publishes RFI On Fluorinated Polyethylene Containers For Food Contact Use: On July 20, 2022, FDA published an RFI to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain PFAS that may migrate from fluorinated polyethylene food containers. The purpose of the request is to ensure that FDA has current information to support its review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe. According to the RFI, FDA may use submitted information to update dietary exposure estimates and safety assessments for the authorized food contact use of fluorinated polyethylene. Either electronic or written comments and scientific data and information are due October 18, 2022. More information is available in our July 21, 2022, blog item.

NANOTECHNOLOGY

EC Requests Scientific Opinion On Titanium Dioxide In Cosmetic Products: On June 22, 2022, the Scientific Committee on Consumer Safety (SCCS) announced that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles. More information is available in our July 18, 2022, blog item.

OECD Publishes Project Report On Chemical Accidents Involving Nanomaterials: The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures -- Project Report. The report intends to introduce briefly issues related to chemical accidents involving nanomaterials and to serve as a gateway to guide readers into more detailed information sources.

NIOSH Publishes Program Performance One-Pager for Nanotechnology Research Center: On July 18, 2022, NIOSH published a program performance one-pager for the Nanotechnology Research Center (NTRC). More information on accomplishments and future actions is available in our July 22, 2022, blog item.

DaNa Publishes Research Spotlight On Three-Stage Model For The Formation Of Micro- And Nanoplastic Particles: The German Federal Ministry of Education and Research (BMBF) project (DaNa4.0) is addressing the question of whether new advanced materials, including nanomaterials, can be harmful to humans and the environment and how humans and the environment come into contact with these materials. DaNa has published an August 2022 research spotlight on a “Three-stage model for the formation of micro- and nanoplastic particles.” The paper, “Degradation of low-density polyethylene to nanoplastic particles by accelerated weathering,” investigates how the process of decomposition due to weathering occurs and what happens to nanoplastic particles. More information is available in our August 4, 2022, blog item.

NIOSH Publishes Technical Report On Occupational Exposure Sampling For Engineered Nanomaterials: On July 29, 2022, NIOSH published a Technical Report: Occupational Exposure Sampling for Engineered Nanomaterials. According to NIOSH, occupational health and safety professionals “have expressed a need for one document that explains all of the available nanomaterial sampling techniques, and this document provides a summary of the different sampling techniques.” The document includes recommendations for an exposure monitoring program, carbon nanotubes and carbon nanofibers, silver, titanium dioxide, use of the nanomaterial exposure assessment technique for other engineered nanomaterials, and optional sampling methods. More information is available in our August 1, 2022, blog item.

NNI And EPA Will Hold Webinar On SBIR/STTR Funding Opportunities For Water Nanotechnologies: The National Nanotechnology Initiative (NNI) and EPA will co-host a webinar on August 25, 2022, on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities for water nanotechnologies. Small businesses and academic researchers will have an opportunity to hear from some of the federal agencies that fund water technologies, with a special focus on investments in nanotechnology-enabled solutions. Registration is now open.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C® Biobased And Sustainable Chemicals BlogFor access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.

LEGISLATIVE

House Bill Would Amend CAA To Overturn Decision In West Virginia v. EPA: On July 15, 2022, Representative Alexandria Ocasio-Cortez (D-NY) introduced the EPA Regulatory Authority Act of 2022 (H.R. 8395). The bill would amend CAA Section 111 to allow the EPA Administrator, in identifying the best system of emission reduction for purposes of a standard of performance, to include measures that apply beyond an individual stationary source or category of stationary sources. On June 30, 2022, the Supreme Court issued its decision in West Virginia v. EPA, finding that the “best system of emission reduction” identified in the Obama Administration’s Clean Power Plan was not within the authority granted to EPA by CAA Section 111(d).

Senate Bill Would Amend FIFRA To “Maintain Availability Of Vital Crop Protection Tools”: On July 21, 2022, Senator Roger Marshall, M.D. (R-KS) introduced the EPA Transparency for Agriculture Products Act (S. 4585) to prevent EPA “from overregulating essential pesticides that the ag industry heavily depends upon.” According to the one-pager on the bill, it would require EPA, with the concurrence of the U.S. Department of Agriculture (USDA), to consider if there are any viable and affordable alternatives to a product if they are planning a non-voluntary cancelation or revocation of a label. Any non-voluntarily proposed decision that adjusts a label to become more restrictive for the user would go through OMB for interagency review. Under the bill, the effective date of any non-voluntary final decision that makes a label more restrictive would be delayed for one year “to allow users more time to adjust.” EPA would be required to base its decision on “USDA, commercially available, and industry agronomic use data.”

House Passes Amended Federal PFAS Research Evaluation Act: On July 26, 2022, the House passed the Federal PFAS Research Evaluation Act (H.R. 7289) as amended by the House Committee on Science, Space, and Technology. Under the amended bill, EPA would enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study and report on human exposure estimation that:

  • Considers life-cycle information on the manufacture, use, and disposal of PFAS-containing products to identify potential human exposure sources, including occupational exposures, and potential exposure pathways for the public;

  • Evaluates the fate and transport of PFAS and their breakdown products;

  • If feasible, estimates human exposure to individual or total PFAS to determine relative source contributions for various exposure pathways (such as air, water, soil, or food);

  • Determines the range of solubility, stability, and volatility of PFAS most likely to be found in the environment and the resulting prevalence in animals and humans;

  • Gives consideration as to whether chemical category-based approaches would be appropriate for evaluating PFAS toxicity and exposure;

  • Identifies research needed to advance exposure estimation to individual or total PFAS; and

  • Identifies research needed to advance toxicity and hazard assessment of individual or total PFAS.

Under the bill, NASEM will conduct a second study and prepare a report to understand better the research and development needed to advance the understanding of the extent and implications of human and environmental contamination by PFAS, how to manage and treat such contamination, and the development of safe alternatives.

Senate Appropriations Bill Would Provide $10.6 Billion For EPA: On July 28, 2022, the Senate Appropriations Committee announced the release of the FY 2023 Senate appropriations bill, including the bill for the Department of the Interior, environment, and related agencies. According to the bill summary, EPA would receive $10.6 billion, an increase of $1.1 billion to the FY 2022 enacted level. The bill would increase EPA’s climate and clean air programs by $231 million (54 percent). The bill would include a $70 million (26 percent) increase for EPA’s enforcement and compliance programs and “an historic $180 million investment in environmental justice” at EPA. The bill would fully fund EPA’s toxic chemicals program by providing an increase of $65 million (66 percent), “providing significantly increased resources to meet the agency’s expanded responsibilities under the bipartisan 2016 Lautenberg amendments.” The bill would also help clean up contaminated lands and pollution through $1.29 billion for EPA’s Superfund program, $96 million for brownfields grants, and $96 million for diesel engine clean up grants.

Senate Passes Bipartisan Recycling Legislation: On July 29, 2022, the Senate passed the Recycling and Composting Accountability Act (S. 3743) and the Recycling Infrastructure and Accessibility Act (S. 3742) by unanimous consent. According to the July 29, 2022, press release from the Senate Committee on Environment and Public Works, the Recycling and Composting Accountability Act would improve data collection on recycling systems and explore the potential of a national composting strategy. The legislation would require EPA to collect and distribute data on recycling and composting rates across the country to provide an accurate reflection of performance both nationwide and at the state level. The Recycling Infrastructure and Accessibility Act would establish a pilot recycling program at EPA that would award grants, on a competitive basis, to eligible entities for improving recycling accessibility in a community or communities within the same geographic area. The press release states that the goal of the program is to fund eligible projects that would significantly improve access to recycling systems in underserved communities through the use of a hub-and-spoke model for recycling infrastructure development.

EPN Urges Senate Committee To Amend NDAA Regarding “Critical Actions” On PFAS: On August 5, 2022, the Environmental Protection Network (EPN) sent a letter to the Senate Committee on Armed Services regarding the NDAA for FY 2023 (S. 4543). EPN urged the Committee to adopt two amendments similar to those included in H.R. 7900 regarding critical actions on PFAS: an amendment requiring EPA to use the definition of PFAS developed by OECD for the PFAS reporting rule mandated by the FY 2020 NDAA; and an amendment requiring EPA to promulgate national technology-based PFAS permit limits for the wastewater discharges of ten industries by 2027.

Inflation Reduction Act Includes Energy And Environmental Provisions: On August 12, 2022, the House passed the Inflation Reduction Act of 2022 (H.R. 5376) by a vote of 220 to 207. The Senate passed the bill on August 7, 2022, by a vote of 51 to 50. According to the House Committee on Energy and Commerce’s August 12, 2022, press release, the bill includes the following energy and environmental provisions passed out of the Committee in September 2021:

  • Methane Emissions Reduction Program: The bill establishes a Methane Emissions Reduction Program to control excess methane pollution from the oil and gas industry above specific waste emissions thresholds;

  • Greenhouse Gas (GHG) Reduction Fund: The bill invests $27 billion in nonprofit, state, and local climate finance institutions that support the rapid deployment of low- and zero-emission technologies, including solar and other distributed resources;

  • Clean Heavy-Duty Vehicles: The bill invests $1 billion in replacing certain heavy-duty vehicles, such as refuse trucks and school buses, with zero emission vehicles through a new grant program at EPA;

  • Appliance and Building Efficiency Rebates: The bill invests $9 billion in home energy efficiency and appliance electrification rebates and ensures that low-income and underserved communities have access to these energy-saving upgrades;

  • Industrial Emissions Reductions: The bill invests $5.8 billion for installing and implementing advanced industrial technology at energy intensive industrial and manufacturing facilities; and

  • Environmental and Climate Justice Block Grants: The bill invests $3 billion to community-led projects that address environmental and public health harms related to pollution and climate change.

MISCELLANEOUS

NASEM Publishes Report On The Importance Of Chemical Research To The U.S. Economy: On July 21, 2022, NASEM announced publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. According to NASEM, “a new and evolving chemistry landscape requires changes with regard to funding, training, and a focus on integrating sustainability into manufacturing, product usage, and product disposal.” The report recommends that funding agencies and philanthropic organizations that support the chemical sciences “fund as large a breadth of fundamental research projects as possible.” The chemical industry and their partners at universities, scientific research institutions, and national laboratories “should align the objectives of fundamental research” to assist directly with new practices toward environmental stewardship, sustainability, and clear energy.

GAO Publishes Report On Technologies For PFAS Assessment, Detection, And Treatment: On July 28, 2022, the U.S. Government Accountability Office (GAO) published a report entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on PFAS assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. More information is available in our August 3, 2022, blog item.

NTP Publishes Revised Technical Reports On The Toxicity Studies Of Perfluoroalkyl Sulfonates And Perfluoroalkyl Carboxylates: On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

  • Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and

  • Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database.

NASEM Publishes Report On Guidance On PFAS Exposure, Testing, And Clinical Follow-Up: On July 28, 2022, NASEM released a report recommending that the Centers for Disease Control and Prevention (CDC) update its guidance to advise clinicians to offer PFAS blood testing to patients who are likely to have a history of elevated exposure, such as those with occupational exposures or those who live in areas known to be contaminated. If testing reveals PFAS levels associated with an increased risk of adverse effects, patients should receive regular screenings and monitoring for those and other health impacts. The report recommends that the CDC, Agency for Toxic Substances and Disease Registry (ATSDR), and public health departments support clinicians in communities where PFAS contamination has been identified by creating educational materials on PFAS exposure, potential health effects, the limitations of testing, and the benefits and harms of testing.

White House CEQ Publishes RFI On Environmental Justice Scorecard: On August 3, 2022, the White House Council on Environmental Quality (CEQ) issued an RFI to solicit feedback on the vision, framework, and outcomes of the Environmental Justice Scorecard. 87 Fed. Reg. 47397. According to the CEQ’s August 3, 2022, press release, the Environmental Justice Scorecard will be updated over time, with the goal of creating a comprehensive platform for assessing the federal government’s efforts to secure environmental justice for all. The first version of the Scorecard will describe the actions that federal agencies have undertaken, including processes that they have started, since 2021. The federal government will then build on and improve the Scorecard. The draft framework for the Environmental Justice Scorecard would assess the efforts that federal agencies are taking toward reducing burdens and harms in communities; delivering benefits to communities; and centering justice in decision-making. Comments are due October 3, 2022.

FTC Intends To Initiate Review Of, And Seek Comment On, Green Guides In 2022: On August 5, 2022, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 87 Fed. Reg. 47947. According to the review schedule, FTC intends to initiate its review of, and seek public comment on, the Guides for the Use of Environmental Marketing Claims (Green Guides) in 2022. As reported in our October 3, 2012, memorandum, FTC last revised the Green Guides in 2012. The 2012 revision included modified sections on general environmental benefit, compostable, degradable, ozone, recyclable, and recycled content. FTC added new sections concerning carbon offsets, certifications and seals of approval, free-of claims, non-toxic claims, made with renewable energy claims, and made with renewable materials claims.

NEJAC Will Meet In September 2022: On August 9, 2022, EPA announced that the National Environmental Justice Advisory Council (NEJAC) will meet on September 28, 202287 Fed. Reg. 48478. The meeting discussions will focus on several topics, including, but not limited to, EPA administration priorities, recommendations on EPA’s 2021 PFAS Strategic Roadmap, and recommendations on community air quality monitoring that provides greater protection and clean and healthy air to environmental justice communities. A public comment period relevant to the specific issues will be considered by the NEJAC during the meeting. Members of the public who wish to register to speak during the public comment period must register by September 21, 2022Registration is required for the virtual public meeting.

EPA Will Hold Webinar On PFAS Strategic Roadmap: Research Tools And Resources: On August 17, 2022, EPA will hold a webinar, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists will highlight two recently released data sources: EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes, and Systematic Evidence Map for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS. Recent updates to other PFAS resources will also be shared. Registration is now open.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 228
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Biobased chemicals and biofuels have taken root thanks to both popular appeal and political support.  The consumer and political goals of reducing America’s dependence on foreign oil, enhancing national security, and greening the economy converge in biobased chemicals and advanced biofuels, the promising technology of producing commercial chemicals and fuels from renewable resources.  With Congress’s commitment to advanced biofuels found in the 2007 Energy Independence and Security Act, compelling incentives to invest in and support growth of biotechnologies has spurred record production...

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