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 April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment.  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “it is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation:

EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the first batch of draft scope documents 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 March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule.  EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.”  The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
     
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
     
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
     
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020.  85 Fed. Reg. 15396.  EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.”  On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020.  EPA anticipates promulgating a final rule later in 2020.  More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on April 2, 2020, that it sent a letter to all members of Congress to correct the record on its temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic.  EPA states that “[a]s should be apparent to anyone who reads the policy, allegations that EPA ‘will cease all enforcement actions during the coronavirus pandemic’ and that the temporary policy ‘absolves polluters of all responsibility’ are simply not true.”  According to EPA, it expects regulated entities to comply with all obligations, and if they do not, EPA emphasizes that the policy says EPA will consider the pandemic, on a case-by-case basis, when determining an appropriate response.  Furthermore, in cases that may involve acute risks, or imminent threats, or failure of pollution control or other equipment that may result in exceedances, “EPA’s willingness to provide even that consideration is conditioned on the facility contacting the appropriate EPA region, or authorized state or tribe, to allow regulators to work with that facility to mitigate or eliminate such risks or threats.”

EPA states that it is “not unusual for EPA to exercise enforcement discretion to address emergency situations that disrupt normal operations, such as hurricanes.  What is unusual is that the current crisis caused by the COVID-19 pandemic affects the entire nation,” rather that a discrete geographic area.”  According to EPA, it developed the temporary policy to allow it to prioritize its resources to respond to acute risks and imminent threats, rather than making case-by-case determinations regarding routine monitoring and reporting.  EPA notes that the development of the policy was a group effort, involving “multiple calls” and with “drafts shared among EPA staff and managers, both career and political, at both headquarters and in the regions.”  Once the COVID-19 threat has ended, “EPA expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible.”  Additionally, according to EPA, “the policy makes clear that EPA expects operators of public water systems to continue normal operations and maintenance during this time, as well as required sampling, to ensure the safety of vital drinking water supplies.”

More information on EPA’s temporary policy is available in our March 27, 2020, blog item, “EPA Announces Temporary Enforcement Discretion Policy.”


 
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The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020.  EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk:

  • EPA did not find risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment under any of the conditions of use.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders.  EPA found that workers, occupational non-users, consumers, and bystanders could be adversely affected by asbestos under certain conditions of use.

EPA states that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not final determinations on whether asbestos presents unreasonable risks under the conditions of use.  EPA will use feedback received from the public comment and peer review processes to inform the final risk determinations.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 30, 2020, the U.S. Environmental Protection Agency (EPA) published the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States.  The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes.  The inventory report also provides a broad view of U.S. mercury stored, sold, and exported, as well as industry sectors and countries involved in the supply, use, and trade of mercury.  According to EPA, highlights of the report include:

  • No indication of imports or exports of elemental mercury into or out of the United States during the reporting year;
     
  • Continuation of the overall steady decline in the use of mercury in products, indicative of the growing presence and use of effective alternatives;
     
  • A decrease in the amount of mercury used in switches and relays manufactured in or imported into the United States -- data submitted also fill a significant information gap;
     
  • Only a single mercury-based manufacturing process identified as ongoing in the United States; and
     
  • Information relevant for U.S. implementation of the Minamata Convention on Mercury.

EPA notes that the 2020 Mercury Inventory Report is the first inventory published under the 2018 rule requiring reporting from persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process.  According to EPA, this means that the data presented in the 2020 report come directly from the companies that are using, manufacturing, or importing mercury, providing EPA and the public with more reliable and complete information on the supply, use, and trade of mercury in the United States.  EPA states that the initial 2017 inventory, on the other hand, was limited to publicly available data.  In addition, the 2020 report incorporates data from contextual reporting requirements, resulting “in more extensive information on the industries that purchase mercury-added products, countries of origin and destination for imports and exports, and the specific ways that mercury is used in certain manufacturing processes.”  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

The U.S. Environmental Protection Agency (EPA) announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic.  EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak.  The policy addresses different categories of noncompliance differently.  For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.”  The policy describes the steps that regulated facilities should take to qualify for enforcement discretion.  To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic. 

EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments.  EPA states that it will address these matters in separate communications.  The policy states that it does not apply to imports.  According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.”  EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”

The policy will apply retroactively beginning on March 13, 2020.  EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary.  To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges.  EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment.  According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years.  EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.”  EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time.  More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations.  EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website.  More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
Effective March 29, 2020, Yvette T. Collazo will be the new Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT).  Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility.  Ms. Collazo also served as Senior Advisor and Director for the Office of Technology Innovation and Development at DOE’s Office of Environmental Management.  In this capacity, she led the identification and advancement of technologies, processes, and technical practices that improved the performance of waste processing, groundwater and soil, facility decontamination and decommissioning, and nuclear materials projects over their life cycles, from planning to disposal.  Starting in 2013, Ms. Collazo served as District Director of the U.S. Small Business Administration (SBA) Puerto Rico and Virgin Islands District Office.  As District Director, she was responsible for the delivery of the SBA’s financial assistance, business counseling, entrepreneurial training, and federal contracting programs throughout the District.  Ms. Collazo has a Master of Science in Environmental Management from the Illinois Institute of Technology and a Bachelor of Science in Mechanical Engineering from the University of Puerto Rico, Mayagüez Campus.

Tags: OPPT, Collazo

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards.  85 Fed. Reg. 16334.   EPA states that it developed the Partner of the Year Awards to 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, furthering outstanding or innovative source reduction.  All Safer Choice stakeholders and program participants in good standing are eligible for recognition.  Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2019.  EPA notes that there is no form associated with this year’s application.  EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony that is being planned for fall 2020.  Submissions are due May 31, 2020.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  85 Fed. Reg. 16094.  EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to:  human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.  In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations).  Any interested person or organization may nominate qualified persons to be considered for appointment to SACC.  Individuals also may self-nominate.  The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)).  Nominations are due no later than April 20, 2020.

Background
 
SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention 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.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
In a Federal Register notice published on March 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that the March 24-26, 2020, Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meeting to review the draft risk evaluation for trichloroethylene (TCE) is being changed to a virtual public meeting.  85 Fed. Reg. 16096.  Participation will be by telephone and webcast only.  EPA states the meeting times and dates have been adjusted, and that the meeting will be held on March 24-27, 2020, from 10:00 a.m. to approximately 5:00 p.m. (EDT).  EPA asks that stakeholders who want to make oral comments register by noon on March 20, 2020.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation.


 
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Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle.  As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical space.

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.

©2020 Bergeson & Campbell, P.C.  All Rights Reserved


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule.  According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA).  EPA states that some of the key revisions include:

  • Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
     
  • Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
     
  • Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.

Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool.  The reporting period will still begin on June 1, 2020.  EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool.  EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period.  More information will be available in a forthcoming memorandum that will be posted on our website.

Tags: CDR, Reporting

 
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By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals of which 41,484 are active in U.S commerce.  Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
  • Additional unique identifiers.

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA.  More information on the TSCA Inventory is available on EPA’s website.

 

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