Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Consumer Product Safety Commission (CPSC) announced on April 12, 2021, that it will hold a public webinar on April 28, 2021, to receive information from interested parties about updates CPSC is making to www.SaferProducts.gov/Business for reports filed electronically under Section 15(b) of the Consumer Product Safety Act (CPSA).  86 Fed. Reg. 18966.  The presentation will focus on Section 15(b) reporting for the purposes of entering the Fast Track Recall Program.  Webinar participants will have an opportunity to see the improvements to www.SaferProducts.gov/Business and provide feedback to CPSC through a moderated discussion.  CPSC states that it would like to hear from manufacturers, distributors, and retailers that have participated in the Fast Track Recall Program, including those who use www.SaferProducts.gov/Business to report potentially defective or hazardous products to CPSC.  The goal of the webinar is to receive feedback on these updates and to assess the impact, if any, that the improvements will have on the website’s utility and usability and the Fast Track Recall Program.

CPSA Section 15(b) requires every manufacturer of a consumer product, or other product or substance over which CPSC has jurisdiction, distributed in commerce, and every distributor or retailer of such product, to report immediately when it obtains certain information.  Such reporting is required when manufacturers, distributors, or retailers obtain information that reasonably supports the conclusion that a product:

  • Fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard that CPSC relied on under CPSA Section 9;
  • Fails to comply with any other rule, regulation, standard, or ban under the CPSA or any other act CPSC enforces;
  • Contains a defect that could create a substantial product hazard (i.e., a product defect that (because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise) creates a substantial risk of injury to the public); or
  • Creates an unreasonable risk of serious injury or death.

This reporting is required unless the manufacturer, distributor, or retailer has actual knowledge that CPSC has been adequately informed of such defect, such failure to comply, or such risk.  Manufacturers, distributors, and retailers can submit Section 15(b) reports to CPSC at www.SaferProducts.gov/Business.  When submitting a Section 15(b) report through www.SaferProducts.gov/Business, manufacturers, distributors, and retailers may elect to participate in the Fast Track Recall Program, which is an alternative procedure for recalling products reported under CPSA Section 15(b).


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS).  EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS.  According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.”  EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff -- these were all issues with a version of the assessment that was posted during the previous administration.  The release of today’s PFBS assessment upholds the integrity of EPA’s science, which EPA, states, tribes, and more rely on to make decisions that protect the health of their communities.”
 
According to EPA’s fact sheet on the toxicity assessment, PFBS is a replacement chemical for perfluorooctanesulfonic acid (PFOS), a PFAS that was voluntarily phased out by the primary U.S. manufacturer by 2002.  PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.  The fact sheet states that the PFBS toxicity assessment is comparable to assessments developed under EPA’s Integrated Risk Information System (IRIS) and Provisional Peer-Reviewed Toxicity Value (PPRTV) Programs in that it provides hazard identification, dose-response information, and toxicity values.  EPA will continue to work with state, tribal, and local partners to provide technical assistance as they consider the final PFBS toxicity values in relevant exposure scenarios.  The fact sheet notes that at this time, EPA does not plan to issue a regulation for PFBS.


 
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On March 31, 2021, the Product Stewardship Society (PSS) presented “Product Stewardship and the Pandemic: Surviving and Thriving in Disruptive Times.” Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and PSS President, moderated a lively and informative discussion identifying the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.
 
Presenters included:

  • Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies, Inc.;
  • Louise Proud, Vice President, Global Environment, Health & Safety, Pfizer;
  • Tina Armstrong, Ph.D., Principal Scientist and Vice President, Arcadis; and
  • Jon Hellerstein, CIH, CSP, of Global Product Stewardship Solutions.

A recording of the webinar is now available for PSS members and non-members alike to watch on demand via PSS's e-learning portal. The portal also contains a wealth of resources and tools to equip product stewards and enhance the many roles they play in creating successful, sustainable products and solutions.


 
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SAVE THE DATE
NEW TSCA AT FIVE
Virtual Conference
June 30, 2021
 
This June marks the fifth anniversary of the enactment of the game-changing Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) that amended the Toxic Substances Control Act (TSCA). With a new Administration and the relentless pace of regulatory developments related to Lautenberg implementation, there are many issues to consider and problems to solve.

The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the fifth annual conference providing updates and insights regarding the current state of TSCA implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in new chemical review, existing chemical risk management provisions, and TSCA’s role in achieving environmental justice, among other topics.

As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry, and academia will convene to inform, analyze, discuss, and debate the most pressing issues related to TSCA with regulatory practitioners and other stakeholder attendees.

Detailed program and registration information to come. SAVE THE DATE!


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA), “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  EPA “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of the amended [TSCA] including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

Comments were due April 5, 2021, but EPA is extending the comment period an additional 30 days.  After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).


 
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This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Karin Baron, Senior Regulatory Consultant to B&C and our affiliated consultancy, The Acta Group, to discuss the European Union’s (EU) Commission Regulation issued last June relating to the completion of safety data sheets (SDS).  As listeners know, SDSs are critically important commercial documents that describe the hazards identified with a particular chemical product or mixture as it makes  its way in commerce.  While this is an EU rule, Karin explains why the new regulation has important consequences for U.S. businesses.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2021 Bergeson & Campbell, P.C.  All Rights Reserved


 
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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives.  EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures.  EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.  According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.”  Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future.  EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means.  According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS).  Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable.  This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5.  In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order.  EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk.  It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain.  EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise.  The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process.  A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.”  Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision.  If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data.  In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development.  B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting.  A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector.  The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so.  Today’s unexplained reversal is difficult to reconcile with these facts.  If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016.  As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.


 
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March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
Register here

The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.

This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.

SPEAKERS:

 

Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis

 

 Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)

 

Jon Hellerstein, CIH, CSP, a career environmental health professional 

 

Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies

 

Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.

 

In addition to receiving 1.5 contact hours, participants will learn:

  • How product stewards can integrate product stewardship into business continuity and crisis management.
     
  • What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
     
  • How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.

Make sure to register now for what promises to be a timely, resourceful, and interesting event!


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 23, 2021, that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards.  According to a Federal Register notice scheduled for publication on March 24, 2021, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.  EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality.  All Safer Choice stakeholders and program participants in good standing are eligible for recognition.  Interested parties should submit to EPA information about their accomplishments and contributions during 2020.  Submissions are due May 31, 2021.  EPA will recognize award winners at a ceremony in fall 2021.
 
Safer Choice is an EPA Pollution Prevention (P2) program, which includes practices that reduce, eliminate, or prevent pollution at its source, such as using safer ingredients in products.  The Safer Choice program certifies products containing ingredients that have met its “specific and rigorous” human health and environmental toxicological criteria.  EPA notes that the Safer Choice program allows companies to use its label “on certified products that contain safer ingredients and perform, as determined by expert evaluation.”  EPA states that the Safer Choice program certification “represents a high level of achievement in formulating products that are safer for people and the environment.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on March 17, 2021, on “Brain Drain:  Rebuilding the Federal Scientific Workforce.”  The Subcommittee heard from the following witnesses:

  • Ms. Candice Wright, Acting Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
     
  • Mr. Max Stier, President and Chief Executive Officer (CEO), Partnership for Public Service;
     
  • Dr. Andrew Rosenberg, Director of the Center for Science and Democracy, Union of Concerned Scientists; and
     
  • Dr. Betsy Southerland, Former Director of Science and Technology, Office of Water, U.S. Environmental Protection Agency (EPA).

During the hearing, Subcommittee Chair Bill Foster (D-IL) submitted a Majority staff report into the record on “trends in the Science, Technology, Engineering and Mathematics (STEM) workforce within federal science agencies following the sequestration in the early 2010s that impacted staffing within federal agencies and workforce-related actions taken by the Trump Administration that contributed to destabilizing the federal STEM workforce over the last four years.”  The staff report, “Scientific Brain Drain:  Quantifying the Decline of the Federal Scientific Workforce,” evaluates how STEM civil service employment has expanded or contracted over the past decade at several federal agencies, including EPA.  According to the Committee’s press release, the report finds significant declines in the STEM workforce at EPA, particularly within the Office of Research and Development, the Department of Energy (DOE), and the National Oceanic and Atmospheric Administration (NOAA), as well as that racial and ethnic employment gaps are significant in STEM fields compared to the total federal workforce.  The press release states that “[t]hese trends suggest the United States may need to recommit to promoting U.S. competitiveness in science and innovation, especially as China redoubles its investments in advanced technology and commitment to a pipeline of highly educated STEM workers.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings.  EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.”  EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
 
Information about chemical reporting is available on the TSCA Chemical Data Reporting web page.  EPA notes that the chemical data reports for 2016 to 2019 were due from industry manufacturers by January 29, 2021.  The Substance Registry Services web page offers a search function to find out if a specific chemical is on the TSCA Inventory.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 
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By Lynn L. Bergeson, Scott J. Burya, Ph.D., and Carla N. Hutton
 
Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name application).  As of April 1, 2019, Environment and Climate Change Canada (ECCC) modifies NSN fees annually based on the country’s Consumer Price Index (CPI).  Based on a decrease in Canada’s CPI over the past 12 months, fees for NSN submissions will decrease by 0.2% starting April 1, 2021.  ECCC has posted a revised fee table, effective April 1, 2021, to March 31, 2022.

Tags: Canada, NSN, Fees

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our February 17, 2021, blog item, on February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  In its final report, the Committee to Review EPA’s TSCA Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the Integrated Risk Information System (IRIS) Program.  In their March 4, 2021, press release, the Republicans state that the IRIS Program “has come under fire from Congress and independent reviewers like the National Academies for its inconsistent process, lack of transparency, and failure to complete assessments in a timely fashion.”  The Republicans ask for EPA’s commitment that, “in accordance with congressional intent to operate with flexibility and speed, TSCA does not fully or consistently adopt program processes or procedures implemented by IRIS.”  If EPA incorporates elements developed by the IRIS Program into TSCA, the Republicans “expect the Agency to assess their benefits and impacts thoroughly, while also adhering to the statutorily prescribed deadlines and scientific standards mandated.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”


 
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