By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 27, 2021, that it will provide $3.8 million in funding to create two EPA Science to Achieve Results (STAR) Centers for Early Lifestage Vulnerabilities to Environmental Stressors. The centers will focus on early lifestage exposures to chemicals and non-chemical environmental stressors and how these exposures may impact early childhood developmental health. EPA states that scientific research suggests that exposures to pollutants and non-chemical stressors during early lifestages may be crucial determinants of lifetime health. Exposures to cumulative mixtures of chemicals, along with other stressors, such as poverty, limited access to services, and changing environmental conditions, may pose developmental and lifelong health risks. According to EPA, accurate and comprehensive assessments of cumulative impacts are needed to make sound decisions regarding risk reduction, mitigation, and prevention measures. Each center will focus on two individual research projects:

• Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina:
  • Evaluating the Causal Impacts of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will identify the occurrences and types of chemicals found in toddlers’ caregiving environments and evaluate how these cumulative chemical exposures are associated with neurodevelopmental functioning in early childhood; and
  • Investigating Whether the Caregiving Environment Moderates the Impact of Early Life Chemical Exposures on Neurodevelopmental Functioning in Early Childhood -- Researchers will investigate whether home caregiving environments alter the impacts of early life chemical exposures on neurodevelopmental outcomes in early childhood.
• University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina:
  • Early Life Exposure and Neurobehavioral Development -- Researchers will leverage an ongoing, longitudinal study of normative brain development, the UNC Baby Connectome Study, to examine the role that early life exposure to phthalates and other chemicals plays in early childhood behavior, memory, language and motor development, and social cognition; and
  • Neural Substrates of Prenatal and Early Life Neurotoxicity Using Non-Invasive Imaging Methods -- Researchers will work to improve the understanding of the relationships between prenatal and early life exposures and structural and functional brain development, particularly in the third trimester of pregnancy, an important time for brain development.

By Lynn L. Bergeson and Carla N. Hutton
 
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 29, 2021, the availability of the preliminary Toxics Release Inventory (TRI) data on chemical releases, chemical waste management, and pollution prevention activities that took place during 2020 at almost 21,000 federal and industrial facilities in the United States. EPA notes that the preliminary data include the first-ever reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA). The dataset is raw data and does not contain any summary or trend analysis. EPA plans to publish the updated TRI dataset in Fall 2021, and EPA will use it to develop the 2020 TRI National Analysis. EPA expects to publish the 2020 TRI National Analysis in early 2022. According to EPA, the public can use the preliminary data to identify facilities that report to TRI (for example, to locate facilities in a given ZIP code) and learn which chemicals facilities manage and in what quantities.

PFAS-Related Information from the 2020 Preliminary Data

EPA states that at this time, the data related to the PFAS added by the NDAA and received by EPA include 89 TRI reporting forms for 44 discrete PFAS filed by 38 individual facilities. The preliminary data indicate facilities managed more than 700,000 pounds of production-related waste of PFAS during 2020. As EPA reviews the data, it will examine the types of facilities that reported and that did not report, the specific PFAS that were reported and not reported, the information reported, by whom, and the communities in which PFAS are being released or otherwise managed as waste. According to EPA, it will seek to learn to what extent the current TRI reporting requirements regarding PFAS were followed and are adequate in providing the public with important information on the waste management practices of PFAS.

In analyzing the PFAS reporting, EPA states that it will also include a “focused and more rapid effort” intended to provide insights regarding the “seemingly limited” scope of the reporting, including the types and number of facilities reporting and PFAS reported. Depending upon its findings, EPA will take action “as appropriate,” including providing compliance assistance, taking enforcement actions, or proposing modifications to the TRI reporting requirements for PFAS.

The 2020 TRI National Analysis will include a section providing more detailed information on PFAS, including discussion on the quantities of PFAS that were released to the environment, recycled, burned for energy recovery or treated; source reduction activities implemented on PFAS; the facilities and sectors that disclosed this information; and the communities in which these activities took place.

EPA states that it will continue to add PFAS to the TRI per the requirements of the NDAA. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a significant new use rule under the Toxic Substances Control Act (TSCA). According to EPA, the TRI data collected will help inform its efforts under EPA Administrator Regan’s EPA Council on PFAS to understand better and ultimately reduce the potential risks caused by PFAS.

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our June 28, 2021, blog item, on June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA announced on July 29, 2021, that it is extending the comment deadline to September 27, 2021. EPA will announce the extension of the comment deadline in the Federal Register.
 
The proposed rule would require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:

• Identifying the chemical substances that would be subject to reporting;
• Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
• Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
• Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
• Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
• Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
• EPA’s use and publication of certain non-confidential business information (CBI) data;
• Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
• Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.

More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”

By Lynn L. Bergeson, Lisa M. Campbell, and Carla N. Hutton

The U.S. Consumer Product Safety Commission (CPSC) announced on July 14, 2021, that it filed an administrative complaint against Amazon.com, “the world’s largest retailer, to force Amazon to accept responsibility for recalling potentially hazardous products sold on Amazon.com.” CPSC claims that the specified products sold through Amazon’s “fulfilled by Amazon” (FBA) program are defective and pose a risk of serious injury or death to consumers and that Amazon is legally responsible to recall them. According to the complaint, the products include “24,000 faulty carbon monoxide detectors that fail to alarm, numerous children’s sleepwear garments that are in violation of the flammable fabric safety standard risking burn injuries to children, and nearly 400,000 hair dryers sold without the required immersion protection devices that protect consumers against shock and electrocution.”

CPSC filed the complaint under the Consumer Product Safety Act (CPSA). According to the complaint, Amazon acts as a “distributor,” as defined by CPSA, of its FBA products by: (a) receiving delivery of FBA consumer products from a merchant with the intent to distribute the product further; (b) holding, storing, sorting, and preparing for shipment FBA products in its warehouses and fulfillment centers; and (c) distributing FBA consumer products into commerce by delivering FBA products directly to consumers or to common carriers for delivery to consumers.

The complaint states that after CPSC notified Amazon about the hazards presented by the specified products, Amazon took “several unilateral actions,” including:

• Removing the Amazon Standard Identification Numbers (ASIN) for certain of the specified products; and
• Notifying consumers who purchased certain of the specified products that they could present a hazard. Amazon also offered a refund to these consumers in the form of an Amazon gift card credited to their account.

According to the complaint, these actions “are insufficient to remediate the hazards posed by the Subject Products and do not constitute a fully effectuated Section 15 mandatory corrective action ordered by” CPSC. The complaint states that “[a] Section 15 order requiring Amazon to take additional actions in conjunction with the CPSC as a distributor is necessary for public safety.” The complaint asks CPSC to:

1. Determine that Amazon is a distributor of consumer products in commerce, as those terms are defined in the CPSA;
2. Determine that the specified products are substantial product hazards under CPSA Sections 15(a)(1), 15(a)(2), and 15(j);
3. Determine that public notification in consultation with CPSC is required to protect the public adequately from substantial products hazards created by the specified products, and order Amazon to take actions set out in CPSA Section 15(c)(1), including but not limited to:
   1. Cease distribution of the specified products, including removal of the ASINs and any other listings of the specified products and functionally identical products, from Amazon’s online marketplace and identifying such ASINs to CPSC;
   2. Issue a CPSC-approved direct notice to all consumers who purchased the specified products that includes a particularized description of the hazard presented by each specified product and encourage the return of the specified product;
   3. Issue a CPSC-approved press release, as well as any other public notice documents or postings required by CPSC staff, that inform consumers of the hazard posed by the specified products and encourage the return or destruction of the specified products;
4. Order that Amazon facilitate the return and destruction of the specified products, at no cost to consumers, to protect the public adequately from the substantial product hazard posed by the specified products, and order Amazon to take actions set out in CPSA Section 15(d)(1), including but not limited to:
   1. Refund the full the purchase price to all consumers who purchased the specified products and, to the extent not already completed, conditioning such refunds on consumers returning the specified products or providing proof of destruction;
   2. Destroy the specified products that are returned to Amazon by consumers or that remain in Amazon’s inventory, with proof of such destruction via a certificate of destruction or other acceptable documentation provided to CPSC staff;
   3. Provide monthly progress reports to reflect, among other things, the number of specified products located in Amazon’s inventory, returned by consumers, and destroyed;
   4. Provide monthly progress reports identifying all functionally equivalent products removed by Amazon from amazon.com pursuant to the CPSC Order, including the ASIN, the number distributed prior to removal, and the platform through which the products were sold;
5. Provide monthly reports summarizing the incident data submitted to CPSC through the Retailer Reporting Program;
6. Order that Amazon is prohibited from distributing in commerce the specified products, including any functionally identical products; and
7. Order that Amazon take other and further actions as CPSC deems necessary to protect the public health and safety and to comply with CPSA and the Flammable Fabrics Act (FFA).

CPSC “urges consumers to visit SaferProducts.gov to check for recalls prior to purchasing products and to report any incidents or injuries to the CPSC.” CPSC published the complaint in the July 21, 2021, Federal Register. 86 Fed. Reg. 38450.

Commentary

In CPSC’s July 14, 2021, press release, Acting Chair Robert Adler states that the decision to file an administrative complaint is “a huge step across a vast desert -- we must grapple with how to deal with these massive third-party platforms more efficiently, and how best to protect the American consumers who rely on them.” According to The Washington Post, CPSC issued the administrative complaint “after months of behind-the-scenes negotiations between regulators and Amazon as the agency tried to persuade the company to follow the CPSC’s rules for getting dangerous products off the market, according to a senior agency official who spoke on the condition of anonymity to comment on internal discussions.” This same official stated that “Amazon officials refused to acknowledge that the CPSC has the authority to compel the company to remove unsafe products.”

As reported in our February 16, 2018, blog item, “EPA Settles with Amazon on Distribution of Unregistered Pesticides,” the U.S. Environmental Protection Agency (EPA) and Amazon entered into a Consent Agreement and Final Order (CAFO) whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately 4,000 alleged violations under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the distribution of unregistered pesticide products. EPA later issued stop sale, use, or removal orders (SSURO) to Amazon and eBay for selling certain pesticide products that EPA claims are unregistered, misbranded, or restricted-use pesticides, and pesticide devices that EPA asserts make false or misleading claims. More information on the SSURO is available in our June 17, 2020, blog item, “EPA Issues Stop Sale, Use, or Removal Orders to Amazon and eBay for Unregistered and Misbranded Pesticides and Devices, Including Products with Claims Related to COVID-19.”

As reported in our October 8, 2020, blog item, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, requested that Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold.

CPSC’s administrative complaint is just the latest indication of the pressure on Amazon to ensure the safety of the products the platform hosts. These federal agency and Congressional efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant with the relevant regulations.

By Lynn L. Bergeson and Carla N. Hutton
 
The White House Office of Science and Technology Policy (OSTP) announced on July 20, 2021, that it is organizing a series of three virtual listening sessions to hear about issues and concerns related to scientific integrity from members of the public who produce, communicate, and use scientific and technical information. 86 Fed. Reg. 38363. According to OSTP, it will use perspectives gathered during the virtual listening sessions to inform the assessment of federal agencies’ scientific-integrity policies and identification of best practices and lessons learned that the National Science and Technology Council’s Task Force on Scientific Integrity is preparing, pursuant to the January 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking.

Each of three listening sessions will be organized around a particular theme and audience:

• Session 1 (Wednesday, July 28, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Communications, including using effective policies and practices to improve the communication of scientific and technological information, including for engagement of federal scientists and contractors with news media and on social media. The target audience includes individuals from news media, science writers, and science communicators;
   
• Session 2 (Thursday, July 29, 2021, 11:00 a.m. to 1:00 p.m. (EDT)): Science and Education, including using effective policies and practices to support professional development of scientists and researchers of all genders, races, ethnicities, and backgrounds; to address scientific-integrity issues related to emerging technologies, such as artificial intelligence and machine learning, and evolving scientific practices, such as citizen science and community-engaged research; to improve training of scientific staff about scientific integrity; and to handle disagreements about scientific methods and conclusions. The target audience includes scientists, engineers, and educators from the federal and non-federal sectors; and
   
• Session 3 (Friday, July 30, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Use of Scientific and Technical Information, including using the effectiveness of federal scientific integrity policies to promote trust in federal science and address concerns about a lack of scientific integrity impeding the equitable delivery of the federal government’s programs. The target audience includes individuals who use federal scientific and technical information for decision-making or provision of services; individuals from disadvantaged communities; and other consumers of science.

Participants in all sessions may also comment on the predominant challenges they perceive to scientific integrity in federal agencies and effective practices for minimizing political or other inappropriate interference in the conduct, communication, or use of federal science. Speakers will have up to two minutes each to make a comment. As many speakers will be accommodated as the scheduled time allows. Individuals unable to attend the listening sessions or who would like to provide more detailed information may respond to the Request for Information (RFI) to Improve Federal Scientific Integrity Policies. Comments on the RFI are due July 28, 2021. The registration deadline for the virtual listening sessions is July 23, 2021, at 5:00 p.m. (EDT).

By Lynn L. Bergeson and Carla N. Hutton
 
On July 14, 2021, the U.S. Environmental Protection Agency (EPA) announced a stewardship program to encourage the voluntary withdrawal of previously granted low volume exemptions (LVE) for per- and polyfluoroalkyl substances (PFAS). According to EPA, the goal of the PFAS LVE Stewardship Program is to stop the ongoing manufacture of PFAS under previously approved LVEs that have not gone through the full pre-manufacture review process under the Toxic Substances Control Act (TSCA). EPA will hold a webinar on July 29, 2021, to provide an overview of the program.
 
EPA states that there are approximately 600 PFAS with currently granted LVEs. Through the program, EPA intends to work with trade associations, non-governmental organizations (NGO), and companies to encourage voluntary withdrawal of the LVEs. According to EPA, it based the new program on a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that were targeted for voluntary withdrawal at the time.
 
To participate in the program, companies with previously granted PFAS LVEs may choose to withdraw voluntarily their LVEs and certify that they will no longer manufacture or import those PFAS. Alternatively, companies may choose to withdraw voluntarily their LVEs following submission and review of a pre-manufacture notice (PMN), “which will provide for a robust safety review and the imposition of appropriate and enforceable protections for human health and the environment.” EPA states that it will provide recognition of program participants on its website.

By Lynn L. Bergeson and Carla N. Hutton
 
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention, including human health and ecological risk assessment and chemical exposure to susceptible life stages and subpopulations. EPA states that in addition to scientific expertise, members also have backgrounds and experiences that will contribute to the diversity of scientific viewpoints, including professional experiences in government, public health, industry, and other groups. According to EPA, TSCA SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 13, 2021, that Amazon’s Climate Pledge Friendly initiative now includes cleaning and other products certified by EPA’s Safer Choice program. According to EPA, Safer Choice is now one of 30 sustainability certifications highlighted under Amazon’s Climate Pledge Friendly initiative that helps customers shop for more than 75,000 products through the company’s online store. EPA notes that highlighting Safer Choice-certified products makes it easier for consumers to locate products that contain safer chemical ingredients without sacrificing quality or performance. Products identified as Climate Pledge Friendly are distinguished on Amazon’s website by an hourglass-with-wings symbol. The company also provides its customers with detailed web pages that include information on how and why products are certified as sustainable.

By Lynn L. Bergeson and Carla N. Hutton
 
On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.

By Lynn L. Bergeson and Carla N. Hutton

The Center for Environmental Health (CEH) announced on June 29, 2021, that it filed suit against three companies in the U.S. District Court for the District of Columbia for alleged violations of the Chemical Data Reporting (CDR) rule. According to CEH, an investigation found that four companies imported 65 chemicals that are subject to reporting under the CDR rule. CEH states that the chemicals “include several recognized carcinogens, including benzene, butadiene, trichloroethylene, isoprene, di(2-ethylhexyl)phthalate, di-isononyl phthalate, carbon black and arsenic.” In February 2021, CEH notified the importers of the apparent violations in accordance with Section 20(b) of the Toxic Substances Control Act (TSCA). One of the four companies, Tribute Energy, “approached CEH and entered into an agreement to audit its operations and come into compliance. CEH is not taking legal action against Tribute in recognition of its good faith and commitment to following the law.” CEH filed suit against the other three companies under TSCA Section 20(a). The three companies are 3N International, Harwick Standard Distribution Corp., and Braskem Inc. CEH notes that the U.S. Environmental Protection Agency (EPA) has designated some of the chemicals as high-priority substances under TSCA and is conducting risk evaluations to determine whether they present an unreasonable risk to human health or the environment. CEH states that “CDR reporting is critical in determining these risks because, according to EPA, the ‘exposure information [reported] is an essential part of developing risk evaluations and . . . collecting this exposure information is critical to [EPA’s] mission of characterizing exposure [and] identifying potential risks.’” CEH asks that the court order the companies to report their imports in compliance with the CDR rule and restrain the companies from any other ongoing violations of CDR reporting requirements.

By Lynn L. Bergeson and Carla N. Hutton
 
On June 24, 2021, a “unique and broad group” of chemical manufacturers, brand owners, environmental non-governmental organizations (NGO), states, and municipalities sent a letter to the leaders of the House and Senate Appropriations Subcommittees on Interior, Environment, and Related Agencies to express their “strong support” for the U.S. Environmental Protection Agency’s (EPA) Safer Choice Program and to encourage that the program be funded fully. The letter asks that the following language be included in the report:

The Committee supports the Safer Choice program and directs that the program be funded and operated at least at levels consistent with Fiscal Year 2014, adjusted for inflation.

According to the letter, in the last quarter of 2020, EPA reorganized the Office of Chemical Safety and Pollution Prevention (OCSPP), dissolving the Safer Choice branch and reassigning most staff to the areas of OCSPP. The letter states that “[a]s a result, the program is now severely under-resourced with approximately four full-time staff.” The Biden-Harris EPA has taken steps to restore the program, but EPA still faces resource constraints.

The letter describes how companies across the value chain use the Safer Choice brand to advance their individual safer chemical initiatives. Chemical manufacturers invested in developing safer chemicals now listed on the Safer Choice’s Safer Chemicals Ingredients List (SCIL). Brand owners and product manufacturers have reformulated products using the SCIL to obtain Safer Choice certification. Major retailers specify the Safer Choice label as a verifiable way to meet corporate goals laid out in public-facing chemicals policies.

According to the letter, the Safer Choice Program also provides value to entities outside of the supply chain. States and municipalities rely on the Safer Choice Program “because it is the only third-party program that requires all ingredients to be screened for hazards instead of simply using a restricted substances list.” NGOs and consumers “find significant value in an authoritative government program that can be trusted to vet safer chemicals and products.”

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to the rule consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). EPA states that it is taking this action because the TSCA Interagency Testing Committee (ITC) added these chemical substances to the TSCA Section 4(e) Priority Testing List through its 69th and 74th Reports. EPA will use the submitted information to inform the risk evaluations currently underway for 20 high-priority substances and for future prioritization.
 
The table below lists the high-priority substances and organohalogen flame retardants included in the final rule.
 

 
The final rule will be effective July 29, 2021. Requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021. Information specified in the final rule is due to EPA by September 27, 2021. Detailed information about the final rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA proposes to require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:

• Identifying the chemical substances that would be subject to reporting;
• Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
• Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
• Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
• Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
• Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
• EPA’s use and publication of certain non-confidential business information (CBI) data;
• Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
• Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.

Comments are due August 27, 2021. EPA states that “[‌u]nder the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.” More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”

Wednesday, June 30, 2021
9:00 a.m. - 4:30 p.m. (EDT)
Register Now

Bergeson & Campbell, P.C. (B&C^®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Five Years Later.” This complimentary virtual conference marks the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the systems of risk evaluation and risk management, environmental justice, regulating per- and polyfluoroalkyl substances (PFAS), new chemicals, and more. Register online.

Full Agenda:

 
Join ELI, Bergeson & Campbell, P.C., the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA. Full program and registration available online.