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.

By Lynn L. Bergeson and Carla N. Hutton
 

On May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina.  OIG notes that GenX chemicals are a type of per- and polyfluoroalkyl substances (PFAS) found in surface water, groundwater, drinking water, rain water, and air emissions.  OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the consent order requirements designed to reduce risks in the manufacture of GenX chemicals.  Under the 2009 Consent Order, EPA required DuPont to determine how to recover and capture 99 percent of GenX’s manufacturing discharges and air emissions.  The Consent Order was not reviewed or approved by the Office of Enforcement and Compliance Assurance (OECA), which is responsible for conducting inspections to verify compliance, however.  Until June 2017, EPA’s actions to verify compliance with the 2009 Consent Order and new chemicals testing requirements consisted of tracking and reviewing information provided by the manufacturer.  According to OIG, following the local media coverage of the presence of GenX chemicals in the Cape Fear River in 2017, Region 4 and EPA contractors conducted EPA’s first on-site compliance monitoring inspection at the Fayetteville Works facility, which manufactures GenX.  OIG found that the Region 4 inspectors were unaware of the 2009 Consent Order and its requirements until the inspection was requested by EPA headquarters.
 
OIG recommends that EPA establish and implement processes:

  1. For OECA to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and
     
  2. To provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final consent orders.

OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.”  For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable.  OIG considers Recommendation 2 resolved with corrective action pending.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 32036.  The new due date is June 15, 2020.  EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations.  EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.

EPA held a conference call on TSCA fees on April 16, 2020, and posted the slides and transcript for the call.  EPA’s web page on TSCA fees for EPA-initiated risk evaluations includes frequently asked questions.  Our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia,” provides information on forming a consortium.  More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS).  According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes.  EPA states that Swix violated the TSCA Premanufacturing Notice requirements and Import Certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes.  Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States.
 
Under the terms of the settlement, Swix has agreed to spend approximately $1 million to develop and implement an outreach and training program referred to as a Responsible Waxing Project (RWP) and pay a $375,625 civil penalty.  The RWP is aimed at:  (1) educating the ski racing community about PFAS chemicals in racing waxes and their impact on the environment; and (2) promoting the use of wax alternatives with lower environmental impact, including but not limited to racing waxes that are PFAS-free.  Another objective of the RWP is to educate and motivate the ski racing community to phase out (and ultimately eliminate) the use of PFAS-containing waxes in ski racing beginning with the 2020 ski season.
 
EPA notes that the RWP has several elements, including an education and training component for ski wax technicians on the proper disposal of racing wax shavings and the use of appropriate personal protective equipment (PPE) during the waxing process.  Other RWP elements include:

  • PFAS ski wax education program, including two on-site presentations at a major ski event that attracts more than 10,000 participants;
     
  • Training for wax technicians on the proper use of PPE, proper ventilation, and proper disposal of wax shavings;
     
  • Program for ski wax coaches available online and used at on-site presentations at a minimum of ten events designed for coach certifications;
     
  • Additional outreach to college racing teams and clubs that educates high school and college level skiers about the RWP content;
     
  • A dedicated Swix project manager who oversees the project to completion;
     
  • Website development for all videos created as part of the settlement for technicians, coaches, and teams; and
     
  • Distribution of PFAS alternative wax information materials at a minimum of 50 ski sites.

EPA’s Environmental Appeals Board approved the consent agreement and final order on May 13, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan).  Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has been initiated but not yet completed, and includes an updated schedule for completion of risk evaluations, if appropriate.  The Annual Plan states that in fiscal year (FY) 2020, EPA intends to complete final risk evaluations for the first ten chemicals.  As reported in our April 7 and April 20, 2020, blog items, EPA has published the draft scope documents for the risk evaluations to be conducted for the 20 high-priority substances designated in December 2019.  According to the Annual Plan, EPA expects to issue final draft scope documents in June 2020.  In accordance with statutory timelines, EPA states that it will publish final risk evaluations within three years of initiation, with a possible six-month extension.  In May 2019, EPA received manufacturer requests to conduct risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  EPA expects to release draft scope documents in the third quarter of FY 2020, complying with statutory timelines.  In March 2020, EPA received a facially complete manufacturer request to conduct a risk evaluation on octamethylcyclotetrasiloxane (D4).  EPA expects to ask for public comment on this request and make a final determination as to whether to grant this request within FY 2020.  EPA notes that it may receive additional requests in FY 2020 and will conduct the process to review these requests as directed in the Risk Evaluation Process Rule.  TSCA requires EPA to review fees and consider updating the fees rule every three years to ensure fees are adequate to defray 25 percent of the costs for implementing TSCA Sections 4, 5, 6, and 14, and to consult with stakeholders again if fees change.  In 2020, EPA expects to begin this process to review fees and propose certain 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, and produce or import the chemical substance as an impurity.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on the U.S. Environmental Protection Agency (EPA).  EPA Administrator Andrew Wheeler was the only witness.  During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under the amended Toxic Substances Control Act (TSCA), particularly the risk evaluation of asbestos.  Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for issuing final risk evaluations for the first ten chemicals.  According to Wheeler, EPA is spending more time on these first risk evaluations to make sure they get them right.  Wheeler noted that the peer reviews are taking longer than expected and that the interagency review process has taken longer than anticipated.  Wheeler stated that he thinks EPA is on track to have at least two of the first ten risk evaluations done by June 2020 and the remainder by the end of summer 2020.  Regarding the asbestos risk evaluation, EPA will do a separate supplemental risk evaluation on the legacy uses since EPA can likely complete the final risk evaluation of asbestos this summer.  Merkley asked Wheeler whether he would commit to examining all significant pathways of exposure to asbestos, including air, waste, and drinking water.  Wheeler responded that when a chemical under the TSCA review process is already being regulated under a different program, EPA decided early on that in setting out the parameters for the TSCA risk evaluations, it would not double regulate to focus its time on the areas of the chemicals that are unregulated at this point.  Wheeler states that the way to meet the strict deadlines required by TSCA is to allow the other programs that are already regulating aspects of those chemicals to continue to regulate them, whether it is a hazardous air pollutant under the air program or a regulation under the water program.


 
 
A virtual day-long symposium presented by the Environmental Law Institute (ELI), Bergeson & Campbell, P.C. (B&C®), and the George Washington University Milken Institute School of Public Health
 

Free and Open to the Public
Wednesday, June 24, 2020
9:30 a.m. - 4:30 p.m. (EDT)
 
 
B&C, ELI, and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform -- Four Years Later."  This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists will cover "TSCA Implementation: Where Are We Now?," "Science Policy Issues," and "Regulatory and Policy Issues" while offering unique insights into the decision making process of top U.S. Environmental Protection Agency (EPA) officials.  
 
Speakers include:
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Mark your calendar to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA.

More information about "TSCA Reform -- Four Years Later" is available at the ELI website. A recording of last year's TSCA Reform seminar can be accessed online with a free ELI account, providing a clear example of how this seminar translates to a virtual space. 

 

By Christopher R. Blunck
 
As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  In the comments, linked to in EDF’s May 14, 2020, blog item on the subject (the comments are not yet posted to the EPA dockets), the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require to be included, and then make the revised draft scopes available for public comment.  In their comments, the NGOs note that TSCA Section 6(b)(4)(D) requires that EPA, “not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” (emphasis added) and that under EPA’s risk evaluation rule at 40 C.F.R. Section702.41(c), the scope of a risk evaluation must, among other things, identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate;
     
  • The hazards to health and the environment that EPA plans to evaluate; and
     
  • The “reasonably available information” on which EPA relies to identify these required scope elements.
The NGOs state that EPA regulations at 40 C.F.R. Section 702.41(c)(7) make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  According to the NGOs, despite the regulatory requirements, EPA has not addressed the specific obligations and “Instead, EPA has only generally described some broad categories of hazards, exposures, and potentially exposed or susceptible subpopulations, and has suggested it will identify the specific hazards, exposures, and subpopulations -- and the reasonably available information it relies on to identify them -- only later, well after the current comment periods have closed and possibly even after the scopes are finalized.”  This, the NGOs state, is not allowed under TSCA and the TSCA risk evaluation rule.
 
Furthermore, the NGOs state that EPA also refers in each draft scope to “systematic review documentation” that has not yet been made public.  While EPA states it plans to publish this second document prior to issuing the final scope document, and take comment on it, the comments state that “EPA has wholly divorced any public comment opportunity it will provide on that systematic review document from the current public comment opportunity” and “[g]iven that the systematic review document is not yet available, the public is unable to consider its content in preparing comments on the draft scope document.”
 
The NGOs indicate that given these faults, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  They request EPA simultaneously to publish and take comment on, for a period of no less than 30 days, revised draft scope documents that reflect the planned systematic review, and the systematic review documentation for each scope.
 
We agree that the faults identified by the NGOs on the draft scope documents and the associated process are significant and that if not remedied, any risk evaluations with scopes founded on the drafts would be legally vulnerable as not comporting with TSCA and EPA’s risk evaluation rule.  EPA may wish to consider taking corrective measures along the lines urged.  This change would include adding into revised draft scopes for comment the reasonably available information EPA has indicated it will identify through the yet-to-be-completed systematic review process, and will identify the specific hazards, exposures, and potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations.
 

 

By Lynn L. Bergeson and Carla N. Hutton
 
Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require be included, and then make the revised draft scopes available for public comment.  The NGOs maintain that under both TSCA and EPA regulations codifying the risk evaluation rule, the scope of a risk evaluation must identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate; and
     
  • The hazards to health and the environment that EPA plans to evaluate.

The scope document must also present the “reasonably available information” on which EPA relies to identify these required scope elements.  The NGOs note that EPA regulations make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  Instead, according to the NGOs, “EPA’s draft scopes repeatedly indicate that these required scope elements will be developed and provided later -- thereby denying the public an opportunity to provide comment on the specific hazards, exposures and potentially exposed or susceptible subpopulations EPA expects to consider, as required at this stage in the process.”
 
The NGOs state that EPA also repeatedly refers in each draft scope to “systematic review documentation” that has not yet been made public.  EPA will use this separate document to identify the required scope elements and the reasonably available information on which it relies.  While EPA plans to publish this second document prior to issuing the final scope document, and take public comment on it, “EPA has wholly divorced that process from the public comment process for the draft scopes.”  By doing so, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  The NGOs urge EPA to publish and take comment simultaneously on the systematic review documentation for each scope along with the revised draft scopes themselves.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements.  The 2020 CDR submission period is from June 1, 2020, to November 30, 2020.  The webinar will include information about the revised reporting requirements, including:

  • New requirements for making confidential business information (CBI) claims;
  • Reporting refinements related to byproducts, including exemptions;
  • Phasing in certain processing and use data codes; and
  • Process improvements for reporting co-manufacturing.

The webinar will also introduce the updated e-CDRweb reporting tool.  EPA notes that the presentation will be similar to the webinars EPA hosted on March 31 and April 9, 2020.
 
EPA states that although registration is not required, it is preferred.  Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com.  Participants should follow along with the webinar slides and use the following call-in number to access the audio:  (866) 609-6049; Conference ID:  2499985.  EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.

Tags: CDR, Webinar, CBI

 

By Lynn L. Bergeson and Carla N. Hutton
 

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA).  According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States.  The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition.  When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.”  The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.
 
EPA notes that the updated definitions will apply to the Chemical Data Reporting (CDR) rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules.  EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation.  The final rule will be effective 30 days after publication in the Federal Register.  EPA has posted the pre-publication version of the final rule on its website.
 
More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”


 
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