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. Environmental Protection Agency (EPA) announced on November 20, 2020, the availability of a supplemental analysis to the draft risk evaluation of 1,4-dioxane under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 74341.  EPA states that it developed the supplemental analysis in response to public and peer review comments on the draft risk evaluation.  The supplemental analysis includes eight consumer uses, including surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer, where 1,4-dioxane is present as a byproduct.  The supplemental analysis also assesses exposure to the general population from 1,4-dioxane in surface water.  In the supplemental analysis, EPA preliminarily found no unreasonable risk to consumers from the eight conditions of use assessed.  EPA also preliminarily found no unreasonable risks under any of the conditions of use to the general population from exposure to 1,4-dioxane.  Comments are due December 10, 2020.  More information on the draft risk evaluation of 1,4-dioxane is available in our July 2, 2019, memorandum.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has extended the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 (PV29).  85 Fed. Reg. 74718.  As reported in our October 29, 2020, blog item, EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Comments are due December 19, 2020.
 
EPA will use feedback from the public comment period to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will soon announce that the Chemical Data Reporting (CDR) submission period has been extended from November 30, 2020, to January 29, 2021.  A Federal Register notice has been signed, and EPA expects to post a pre-publication version of the notice on its website.  To assist chemical manufacturers and processors with submitting CDR data, Bergeson & Campbell, P.C.’s (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR and, if so, at what reporting threshold.
 
CDR Cross-Check will identify:

  • Whether the chemical is listed as active or inactive;
  • Whether the chemical was subject to specific Toxic Substances Control Act (TSCA) regulatory actions in 2016;
  • Whether the chemical is exempt; and
  • What the reporting thresholds are based on the updated data released by EPA on May 29, 2020.

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 9, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for the cyclic aliphatic bromide cluster (HBCD).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for HBCD.  As reported in our September 28, 2020, memorandum, EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the processing, use, and disposal of HBCD, largely from building and construction materials.  EPA’s website states “EPA did not find unreasonable risks to the general population or consumers.” Nevertheless, in the risk evaluation document, EPA did find unreasonable risk from fish ingestion at the high-end exposure in one scenario.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by November 23, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulation.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns.  In addition to being open to the public, EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.  EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.”  EPA notes that there will also be an open public comment period on proposed risk management regulations.


 
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By Lynn L. Bergeson and Carla N. Hutton

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.”  The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA, these new data led EPA to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  EPA states that because the new data had a significant impact on its risk evaluation and ultimately the risk determinations, it is providing an opportunity for the public and independent scientific experts to give input before the risk evaluation is prepared in final.
 
EPA will publish a Federal Register notice on October 30, 2020, beginning a 30-day comment period.  During the public comment period, EPA states that it will also conduct a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review will focus on charge questions supplied by EPA, and EPA states that “the public is encouraged to focus their comments on those issues as well.”
 
EPA will use feedback received from the letter peer review and public comment process to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists.  EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case).  If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding.  If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register.  The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC.  More information will be available in a forthcoming memorandum that will be posted on our website.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations.  Companies that amend, update, or file new CBI substantiations must do so electronically via EPA’s Central Data Exchange.

Background

On March 6, 2020, EPA promulgated a final rule on procedures for review of CBI claims made under TSCA.  The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities.  The substantiation requirements describe the applicable procedures and provide instructions for regulated entities.  EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year timeframe set in TSCA.  More information is available in our February 28, 2020, memorandum, “EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”

Tags: CBI, NOA, Inventory

 
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By Lynn L. Bergeson and Carla N. Hutton

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it.  We appreciate having the opportunity to share his analysis with our audience.

TSCA as a Gap-Filling Statute:  Potentially Exposed and Susceptible Subpopulations

By Jeffery Morris, PhD

In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA), the US Environmental Protection Agency (EPA) has asserted that TSCA is a “gap-filling statute” for the regulation of chemical substances in the United States (US EPA, Summary of Public Comments Received on the Draft Scopes of the Risk Evaluations for Twenty Chemical Substances Under the Toxic Substances Control Act (TSCA), August 2020, p. 13).  This assertion relates to the regulatory nexus between TSCA and other federal statutes.  At issue regarding regulatory nexus is whether TSCA’s role is to:  (1) fill gaps where issues are not addressed by other laws that regulate chemicals1, (2) serve as the nation’s primary and preeminent statute for chemicals, or (3) operate somewhere between these two positions.  Inherent in the TSCA-as-gap-filler position is the view that federal laws should work together to advance the public welfare, and that different environmental statutes have their own strengths in how they govern the impact of chemicals on people and the environment.

TSCA requires the consideration of potentially exposed or susceptible subpopulations in the EPA’s evaluation of chemicals.  While TSCA is not the only environmental law with provisions for susceptible or vulnerable subpopulations, the direct, repeated emphasis across multiple sections of the law that the EPA consider potentially exposed or susceptible subpopulations may be unique in US environmental law.  Therefore, how the EPA meets this requirement with respect to other laws’ treatment of such populations is an important consideration for regulatory nexus.  Key questions regarding regulatory nexus and TSCA’s role are how to go about identifying whether other statutes leave gaps in this area for TSCA to fill and if they do, how those gaps should be filled in the EPA’s chemical evaluations.

The recently released final scope documents and the accompanying response-to-comments document do not fully answer these questions, including regarding comments that have been raised about how the EPA will apply exposure and susceptibility considerations to people living in communities located near high concentrations of chemicals-related activity.  My hope is that exploring these questions now can help inform a path forward for further addressing comments the EPA has received on potentially exposed or susceptible subpopulations as the twenty draft risk evaluations are developed, as well as in scope documents for future chemicals brought into the TSCA prioritization process.

In its response to scope document comments, the EPA makes two important statements regarding the regulatory nexus issue as applied to potentially exposed or susceptible subpopulations.  The first, on page 13, is that “EPA believes that coordinated action on exposure pathways and risks addressed by other EPA-administered statutes and regulatory programs is consistent with statutory text and legislative history, particularly as they pertain to TSCA’s function as a ‘gap-filling’ statute ….”  In the second statement, also on page 13, the EPA adds that “[t]o the extent that specific exposure pathways are not under the jurisdiction of other EPA-administered statutes and associated regulatory programs, EPA plans to evaluate those exposures in the risk evaluations for the individual substances.”

The first statement’s focus on “coordinated action” between laws and regulations with respect to chemical evaluation and management is a crucial consideration for regulatory nexus.  Coordination by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which administers TSCA, with other EPA offices that manage statutes that address chemicals, as well as with other federal agencies that implement laws impacting chemicals, is good government practice.  What is missing from the final scope documents, and therefore would be a valuable addition to the chemical-specific dockets, is a detailed description of the type of coordination cited in the response to comments.  Ideally, this description would appear in the scope documents, but for these twenty chemicals an addition to the dockets would be helpful.  For example, the EPA could strengthen its explanation of whether potential exposures or susceptibilities are based on geography (e.g., exposures are higher in a particular location), biology (e.g., a particular population has a genetic or otherwise biologically based predisposition to suffer adverse effects from exposure to a chemical), or cultural/societal factors (e.g., a cultural or community practice results in exposure potential greater than in the general population, or an attribute of the subpopulation’s location in society, such as having low income or poor access to health care, creates susceptibilities to adverse effects from chemical exposure).

Because some comments on community exposures refer specifically to 1,3-butadiene, it is a useful example to illustrate the challenges and opportunities presented by the coordination the EPA is conducting within the regulatory nexus construct; it also can illustrate what I mean by a detailed description of cross-office coordination on potentially exposed or susceptible subpopulations.  This example looks at just one of 1,3-butadiene’s uses:  in the production of tires.  Under its Clean Air Act (CAA) authority, the EPA’s Office of Air and Radiation (OAR) conducted a Residual Risk Assessment for the Rubber Tire Manufacturing Source Category in Support of the 2020 Risk and Technology Review Final Rule (EPA-HQ-OAR-2019-0392-0047, February 2020) that includes 1,3-butadiene within this source category, among numerous other chemical substances designated as hazardous air pollutants (HAP).  This assessment supports a July 24, 2020, final rule, National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review (EPA-HQ-OAR-2019-0392; FRL 10008-48-OAR, 85 FR 44752, July 24, 2020).

The coordination challenge, therefore, is to crosswalk the CAA review, which covers numerous HAPs within one sector, with a TSCA risk evaluation covering the conditions of use of a single HAP chemical across multiple sectors.  On page 49 of the 1,3-butadiene TSCA scope document, the EPA states that air emission pathways are covered under the CAA (Final Scope of the Risk Evaluation for 1,3-Butadiene, EPA Document # EPA-740-R-20-011, August 2020).  It would be useful for the 1,3-butadiene record to include a table and/or narrative that describes how, for its TSCA coordination on the consideration of potentially exposed or susceptible subpopulations, OCSPP evaluated the 1,3-butadiene conditions of use against the respective source category-based and any other analyses conducted by OAR that included 1,3-butadiene.  Such a crosswalk could serve as a best practice for application of regulatory nexus analysis in the implementation of TSCA.  It would also aid in transparency to the public around a very complex but important concept:  that although different environmental statutes may use different approaches (e.g., sector or source category versus individual chemical analysis), it is possible to coordinate their respective contributions to chemical evaluation and management so that, if gaps exist, TSCA can play its appropriate role in health and environmental protection.

For instance, OAR’s 2020 final rule states that “the percentage of the population potentially impacted by Rubber Tire Manufacturing emissions is greater than its corresponding nationwide percentage for: African Americans (25 percent for the source category compared to 12 percent nationwide) and below the poverty level (21 percent for the source category compared to 14 percent nationwide)” (page 44759).  Strong coordination between TSCA and the CAA would suggest that such information obtained through CAA activities would be helpful to OCSPP in determining how to address the “potentially exposed or susceptible subpopulations” considerations required under TSCA section 6, including as they may apply to TSCA’s gap-filler role in addressing comments to the 1,3-butadiene scope document concerning disproportionate exposure to communities located near high concentrations of chemicals-related activity.

This consideration leads to the EPA’s statement in its response-to-comments document that where there is not overlap with another regulatory jurisdiction, the EPA will evaluate the exposures.  Using the above TSCA-CAA coordination example for 1,3-butadiene, a question for OCSPP could be whether the TSCA requirement that the EPA consider potentially exposed or susceptible subpopulations in its risk evaluations is covered by the work done by OAR on 1,3-butadiene, specifically with respect to commenters’ input on community-based impacts.  One would assume “covered” to mean that this particular aspect of TSCA’s potentially exposed or susceptible subpopulations requirement has been evaluated and addressed in OAR’s CAA activities, and therefore can be excluded from the 1,3-butadiene risk evaluation.  However, if the CAA has not addressed this particular TSCA requirement in a manner or to an extent intended by the best read of TSCA’s language regarding the consideration of those potentially exposed or susceptible subpopulations in a particular chemical risk evaluation, then there exists a gap that TSCA, as a gap-filling statute, should address.

The manner in which a TSCA risk evaluation fills any identified gaps is also important.  This again will require careful and transparent coordination and analysis between statutes.  In its chemical risk evaluations, EPA would presumably want to fill gaps in ways that meet the specific requirements of TSCA for potentially exposed or susceptible subpopulations, without doing so in a manner that is at odds with other statutes’ treatment of a chemical substance under TSCA evaluation.  Not only would this careful gap filling be in general sound government practice, but it also would help avoid difficulties if the risk evaluation identifies unreasonable risks that the EPA determines, under TSCA section 9, should be addressed under a law other than TSCA.

The 1,3-butadiene example shows how greater explanation, preferably in scoping documents, on how the EPA coordinates among its offices and other agencies to make regulatory nexus decisions for TSCA risk evaluations can not only provide greater transparency to the public on individual chemical evaluations, but also can inform broader discussions on regulatory nexus by showing how such coordination can identify gaps that TSCA is best situated to fill.  For some chemicals, it may be the case that other statutes have already adequately assessed the risks to potentially exposed or susceptible subpopulations, obviating the need for additional analysis in a TSCA risk evaluation.  However, the mere existence of another statute with jurisdiction over a particular environmental pathway or human exposure scenario for a chemical substance subject to TSCA review should not lead to an a priori assumption that there is not an evaluation gap for TSCA to fill.  Any assumptions about other statutes’ coverage of TSCA’s chemical evaluation requirements should be explored, tested, and fully described in TSCA chemical scope documents or elsewhere in the risk evaluation record.  This is particularly important with potentially exposed or susceptible subpopulations, given TSCA’s unique approach to requiring their consideration in chemical prioritization, evaluation, and management.  I would argue that a good starting point for articulating TSCA’s gap-filling role is in the application of these requirements to people living near high concentrations of chemicals-related activity.

1  By “chemicals” I refer in this article to chemicals regulated under TSCA, and not to chemicals that are regulated under other federal statutes, such as pesticides, drugs, and food additives.


 
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By Lynn L. Bergeson , Lisa M. Campbell, and Carla N. Hutton
 
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, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he 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.
 
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:

  • What Amazon-owned products are no longer for sale due at least in part to safety concerns?
     
  • What products -- both Amazon-owned and third party -- have been officially recalled?
     
  • What notification does Amazon provide to customers who have purchased products that are later recalled or found to be unsafe?
     
  • In addition to direct notification, what other kinds of consumer or public outreach does Amazon conduct to ensure consumers properly dispose of, repair, or replace an unsafe product?
     
  • How can consumers find information regarding recalled products? If information is not readily available, why not, and what plans exist to make it available?
     
  • How can consumers report product safety issues to Amazon?
     
  • How many staff does Amazon have devoted to ensuring that products sold on its platform follow all applicable laws and regulations, and that Amazon is in compliance with obligations to notify the U.S. Consumer Product Safety Commission (CPSC) when a product is suspected of being unsafe?

The letter requests a response no later than October 21, 2020.
 
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts.  Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same.  These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA).  For manufacturer-requested risk evaluations under TSCA Section 6, the manufacturers requesting the risk evaluation are responsible for payment of the associated fees.  The fee for a manufacturer-requested risk evaluation of a chemical included in the 2014 update to the TSCA Work Plan is 50 percent of total actual costs, with a $1,250,000 initial payment.  D4 is included in the 2014 update to the TSCA Work Plan.  EPA notes that if the request is not withdrawn within 30 days, D4 will enter the TSCA risk evaluation process.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is accepting public comments for all candidates under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute.  Comments are due October 30, 2020.  EPA will use public comments to assist in selecting multiple members of the SACC over the next year. 
 
EPA anticipates appointing approximately 15 members to the SACC by March 2021.  EPA notes that current SACC members are eligible for reappointment during this period.  Therefore, the appointments completed by March 2021 may include a mix of newly appointed and reappointed members.


 
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By Christopher R. Blunck and Lynn L. Bergeson

In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce.  In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21.  EPA goes on to state “[‌u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.”  The acknowledgement letter further states that “EPA will, however,  consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” 

As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.  A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”


 
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