By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
GAO released on March 6, 2019, a report entitled High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas. GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges. GAO’s report describes the status of high-risk areas and outlines actions necessary to assure further progress. GAO states that in the two years since its last high-risk report, three areas, including “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals,” have regressed in their ratings against GAO’s criteria for removal from the High-Risk List. GAO notes that since adding this area to its High-Risk List in 2009, it has made 12 recommendations to EPA related to the IRIS Program and TSCA. According to GAO, while EPA has taken steps to manage chemicals that pose risks to human health and the environment, leadership and implementation challenges remain. More information is available in B&C’s March 8, 2019, memorandum, “EPA’s Process for Assessing and Controlling Toxic Chemicals Remains on GAO’s High-Risk List.”
By Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, Ph.D., Richard E. Engler, Ph.D., and Carla N. Hutton
On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act. The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA). GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations. GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities. GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain. Read the full memorandum for more information on the report including why GAO did the study, GAO’s findings, and an insightful commentary.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham, M.S.
On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar: Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See in 2019.
In attendance were: The Honorable Alexandra Dapolito Dunn, the newly appointed Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP); Jeffery T. Morris, Ph.D., Director, Office of Pollution Prevention and Toxics (OPPT); Rick P. Keigwin, Jr., Director of the Office of Pesticide Programs (OPP); Beau Greenwood, Executive Vice President, Government Affairs, CropLife America; Lynn L. Bergeson, Managing Partner of B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C. Ms. Dunn, Dr. Morris, and Mr. Keigwin described their priorities in the webinar. Ms. Dunn stated 2019 “is going to be one of those buckle-your-seat-belt kind of years” in relation to getting everything done as required under TSCA. Some of the takeaways from that webinar are listed below.
TSCA Milestones: 2019 and Beyond
- EPA must complete the first ten risk evaluations by December 2019, with a possible extension up to June 2020; EPA may need to take advantage of the extension;
- By April 2019, EPA will need to release the “20 high- and 20 low-” priority candidate chemicals;
- EPA released its first draft chemical risk evaluation -- Colour Index (C.I.) Pigment Violet 29 -- on which many comments were submitted. EPA realized that this selection was challenging given certain data ownership issues and restrictions on those data occasioned by European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation issues; therefore, this initial evaluation was not the best representation of how the other evaluations will be conducted (more information on the risk evaluation is available in our memo EPA Publishes First Draft TSCA Chemical Risk Evaluation);
- EPA is using a new risk assessment program process called “Systematic Review” that has been used in non-risk assessment fields; EPA is the first agency to use this process. EPA welcomes input on the process and stated that the National Academy of Sciences (NAS) will be reviewing this process as well;
- In March 2019, EPA will release a proposed rule outlining how it will review and substantiate all Confidential Business Information (CBI) claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory; and
- EPA will be proposing its rule to regulate five persistent, bioaccumulative, and toxic chemicals by June 2019; EPA will be using a different approach than what is typically used for risk assessments.
Approving New Chemicals:
- EPA intends to explore its process for new chemical review to be more predictable and to make reviews final within 90 days;
- EPA will post “frequently asked questions” documents to help chemical manufacturers submit clearer applications online;
- EPA is urging pre-submission meetings between premanufacture notice (PMN) submitters and EPA staff prior to submitting a PMN for a new product to reduce agency time spent clarifying omissions; and
- EPA has pledged to make all PMNs, all health and safety studies, attachments, amendments and other associated information available in public dockets.
B&C’s other upcoming seminars and webinars are available here. Some other resources of interest are B&C’s newly minted TSCA Tutor™ Modular Training Program which provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training; as well as B&C’s All Things Chemical™ Podcasts, which provide intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.
By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham
On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA. Some of the highlights from EPA’s announcement are:
- A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce; EPA states that this information will help it focus risk evaluation efforts on chemicals that are still on the market.
- As recently as 2018, the TSCA Inventory showed over 86,000 chemicals available for commercial production and use in the U.S. Until this update, EPA states that it was not known which of these chemicals on the TSCA Inventory were actually in commerce.
- More than 80 percent (32,898) of the chemicals in commerce have identities that are not Confidential Business Information (CBI), increasing public access to additional information about them.
- For the less than 20 percent of the chemicals in commerce that have confidential identities, EPA states that it is developing a rule outlining how it will review and substantiate all CBI claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory.
- From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported or processed in the U.S. over the past ten years, the period ending June 21, 2016. EPA received more than 90,000 responses, a significant reporting effort by manufacturers, importers and processors.
Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments webpage.
On March 13, 2019, EPA will host a webinar to assist manufacturers (including importers) and processors with future reporting requirements. Under the final TSCA Inventory notification (active-inactive) rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive. EPA states that manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days to file a Notice of Activity (NOA) Form B so that they can continue their current activity. Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.
The webinar is scheduled for 1:00 p.m. - 4:00 p.m. (EDT) on Wednesday, March 13, 2019. The webinar will include an overview of filing a NOA Form B, a demonstration of the electronic reporting application, and time for questions and answers. Registration for the webinar is not required.
More information about the TSCA Inventory update and the webinar is available on EPA’s TSCA Chemical Substance Inventory webpage.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce an exciting and important new component to our suite of Toxic Substances Control Act (TSCA) offerings. Our TSCA Tutor™ training platform provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
B&C developed TSCA Tutor in recognition that TSCA awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
B&C is now scheduling its TSCA Tutor sessions. The full TSCA Tutor program includes 18 hours of training. More information on the sessions is available on the B&C website.
By Lynn L. Bergeson and Margaret R. Graham
On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018. 84 Fed. Reg. 2851. The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3). The duration of the extension period is a total of 33 days, but the notice states that because the extension is less than 90 days, EPA reserves the right under TSCA Section 5(c) to issue, for good cause, future additional extensions for individual cases up to a total of 90 days.
More information on why EPA has chosen to do this is in our blog item regarding the pre-publication version of this notice “EPA Extends Review Periods for TSCA Section 5 PMNs, SNUNs, MCANs and Exemption Notices Due to Lack of Authorized Funding and Shutdown.”
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.
Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods. Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018. Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.
EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019). The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).
By Richard E. Engler, Ph.D. and Margaret R. Graham
As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA). Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during the shutdown.
We are unaware of EPA publishing a formal notice that it is suspending the review period of new chemical notices, but EPA will not be making any determinations on such notices during the shutdown. Submitters should continue to submit any required information (e.g., Notices of Commencement) even though EPA will not process or review such submissions.
EPA actions on existing chemicals (including risk evaluations and publication of the updated TSCA Inventory with active/inactive status) will be delayed. As previously reported, the first preparatory meeting on the Colour Index (C.I.) Pigment Violet 29 risk evaluation (scheduled for January 8, 2019) will be cancelled if the shutdown continues through January 4, 2019, at 5:00 p.m., which appears probable.
By Lynn L. Bergeson and Margaret R. Graham
On December 31, 2018, the U.S. Environmental Protection Agency (EPA), even though they had already shut down due to funding issues, announced that if the government shutdown continues through 5:00 p.m. (EST) January 4, 2019, the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals’ (SACC) January 8, 2019, Preparatory Virtual Meeting for the January 29 through February 1, 2019, meeting on Colour Index (C.I.) Pigment Violet 29 will be cancelled, and discussion of charge questions will be folded into the face-to-face meeting scheduled for January 29 through February 1, 2019. Further, if the shutdown continues through 5:00 p.m. (EST) January 11, 2019, the TSCA SACC’s January 29 through February 1, 2019, Peer Review of the draft risk evaluation for C.I. Pigment Violet 29 will be postponed. More information on the draft risk evaluation of C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.
By Lynn L. Bergeson and Margaret R. Graham
On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST). The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST). The official announcement is scheduled to be published in the Federal Register on November 30, 2018. Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.
The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA. EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23). The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).
During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting. Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions.
More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.