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By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA).  According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective public communication in developing risk mitigation requirements for companies following EPA completion of a Risk Evaluation under TSCA.”  ACA states that a procedural rule “is needed to establish a central point of reference for all requirements and considerations involved in crafting a risk management rule regulating a specific chemical.”  The petitioners ask EPA to implement an updated risk management procedural rule addressing considerations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).  According to the press release, the petition lists and describes various risk mitigation considerations under the Lautenberg Act’s framework that should be addressed in a procedural rule, including considerations related to transparency, deadlines for compliance, notice, effective dates, exemptions for critical or essential use, coordination with and/or delegation to other agencies, and processes to amend a risk mitigation rule.  ACA states that EPA has 90 days from filing to grant or deny the petition.  If EPA grants the petition, EPA can enter into a public rulemaking process, as requested by petitioners, though it is not required to do so.  ACA notes that while the Administrative Procedure Act (APA) provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements, “petitioners believe that EPA should publish the requested section 6 risk management procedural rule for notice and comment because the information and opinions supplied by the public will inform the Agency’s views.”


 

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
 
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.”


 

By Lynn L. Bergeson and Christopher R. Blunck
 
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, the U.S. Environmental Protection Agency (EPA) has changed the way that toll manufacturing must be reported.  In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals.  As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs.  Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer.  In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR Rule and instead relied on the contracting company to do so.

EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company.  EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies.  The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:

(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
 

In both cases, the producing company (toll manufacturer) must provide the manufacturing details.  There is no mechanism for the contracting company to submit the entire Form U.
 
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, Reporting

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos.  The public meeting will be virtual, with participation by phone and webcast only.  There will be no in-person gathering for this meeting.  EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting.  Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting.  Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The risk to consumers from perchloroethylene’s use in dry cleaning is from skin exposure to items cleaned with perchloroethylene.  EPA notes that it also found environmental risks to aquatic organisms.
 
EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation and will provide “frequent updates” on its progress throughout the process.  EPA notes that if its final risk evaluation finds there are unreasonable risks associated with perchloroethylene under the specific conditions of use, EPA will propose actions to address those risks within the time frame required by TSCA.  EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation, beginning a 60-day comment period.  EPA will also hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation May 26-29, 2020.  The virtual peer review meeting is open to the public to attend and provide comments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for that chemical substance.  EPA is also opening a 45-day comment period on these draft scope documents to allow for the public to provide additional data or information that could be useful to EPA in preparing the final scope documents.  Comments are due June 8, 2020.  More information on the draft scope documents is available in our April 21, 2020, memorandum, “EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review.  EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust review of the evaluation.”  As a result, EPA will reschedule the SACC meeting “as soon as practicable.”  EPA notes that while it does not anticipate extending the written public comment period on the draft risk evaluation past June 2, 2020, “as needs arise EPA will review and respond appropriately.”  EPA will provide all written comments received by June 2, 2020, to SACC for their review prior to the meeting.  Once EPA has selected a new date for the SACC meeting, EPA will provide an update on public commenting, including registering to provide oral public comments during the SACC meeting.  EPA states that it “remains committed to completing this process as expeditiously as possible.”  More information on EPA’s draft risk evaluation is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  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 “[‌i]t 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 the following chemicals:

 
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 second batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.  Our April 7, 2020, memorandum, “EPA Seeks Public Comment on First Batch of Draft Scope Documents,” offers an overview of the draft scope documents on the other 13 of the 20 chemicals undergoing risk evaluation, as well as an insightful commentary.


 
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