By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton
On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs. The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk. The final rule will become effective on June 4, 2019. Please see our full memorandum for more information on this final rule.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program: Reviewing its Progress and Roadblocks Ahead.” The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act (Chemical Assessments Report) and High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (High-Risk Report). Please see our full memorandum for more information on what transpired at the hearing, including some background and commentary.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA). New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time. The 20 high priority candidate chemicals include:
- Seven chlorinated solvents;
- Six phthalates;
- Four flame retardants;
- Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
- A fragrance additive; and
- A polymer pre-curser.
EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates. The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria.
Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however. EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.” EPA is scheduled to publish the notice regarding this list in the Federal Register on March 21, 2019. The pre-publication notice is available here. Comments will be due 90 days after publication in the Federal Register. EPA is opening a docket for each of the 40 chemicals. EPA is then directed to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority.
Please be on the lookout for our memorandum that will contain more information regarding EPA’s list. It will be posted on our Regulatory Developments webpage.
By Lynn L. Bergeson and Carla N. Hutton
On March 18, 2019, the U.S. Environmental Protection Agency (EPA) released new tools intended to help companies, organizations, and individuals fulfill their reporting requirements under the mercury reporting requirements rule. Those required to report under the mercury rule can now do so online through the Mercury Electronic Reporting (MER) application accessed through EPA’s Central Data Exchange (CDX). EPA states that it designed this reporting tool “to be user-friendly, with drop-down menus and lists of check-box options, to help make reporting easy and efficient.” As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019. Based on the information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use. More information is available in our memorandum.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On March 15, 2019, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler signed a final rule prohibiting the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution to and by retailers; requiring manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions; and requiring recordkeeping. The rule states that EPA has determined that “the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality.” This final rule does not prohibit the use of methylene chloride in commercial paint and coating removal, however. EPA is instead soliciting comment, through an advance notice of proposed rulemaking (ANPRM) also signed by Administrator Wheeler on March 15, 2019, on questions related to a potential training, certification, and limited access program as an option for risk management for all of the commercial uses of methylene chloride in paint and coating removal. More information will be available on these issuances in a forthcoming memorandum to be available on our Regulatory Developments webpage.
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.
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 Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On January 14, 2019, in the U.S. District Court for the District of Vermont, the Vermont Public Interest Group; Safer Chemicals, Health Families; and two individuals (plaintiffs) followed up on their earlier notice of intent to sue and filed a complaint against Andrew Wheeler and the U.S. Environmental Protection Agency (EPA) to compel EPA to perform its “mandatory duty” to “address the serious and imminent threat to human health presented by paint removal products containing methylene chloride.” Plaintiffs bring the action under Toxic Substances Control Act (TSCA) Section 20(a) which states that “any person may commence a civil action … against the Administrator to compel the Administrator to perform any act or duty under this Act which is not discretionary.” Plaintiffs allege that EPA has not performed its mandatory duty under TSCA Sections 6(a) and 7. TSCA Section 6(a) gives EPA the authority to regulate substances that present “an unreasonable risk of injury to health or the environment” and TSCA Section 7 gives EPA the authority to commence civil actions for seizure and/or relief of “imminent hazards.” Plaintiffs’ argument to direct EPA to ban methylene chloride is centered on the issue of risk to human health only, however, stating that it presents “an unreasonable risk to human health” as confirmed by EPA. Under TSCA Section 20(b)(2), plaintiffs are required to submit a notice of intent to sue 60 days prior to filing a complaint which they did on October 31, 2018.
On January 19, 2017, EPA issued a proposed rule under TSCA Section 6 to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal (82 Fed. Reg. 7464). EPA also proposed to prohibit the use of methylene chloride in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. EPA relied on a risk assessment of methylene chloride published in 2014, the scope of which EPA stated included “consumer and commercial paint and coating removal.” The proposed rule stated that in the risk assessment, EPA identified risks from inhalation exposure including “neurological effects such as cognitive impairment, sensory impairment, dizziness, incapacitation, and loss of consciousness (leading to risks of falls, concussion, and other injuries)” and, based on EPA’s analysis of worker and consumer populations' exposures to methylene chloride in paint and coating removal, EPA proposed “a determination that methylene chloride and NMP in paint and coating removal present an unreasonable risk to human health.” The comment period on the proposed rule was extended several times, ending in May 2017, and in September 2017 EPA held a workshop to help inform EPA’s understanding of methylene chloride use in furniture refinishing.
No further action was taken to issue the rule in final, however, until December 21, 2018, when EPA sent the final rule to the Office of Management and Budget (OMB) for review. On the same day, EPA also sent another rule to OMB for review titled “Methylene Chloride; Commercial Paint and Coating Removal Training, Certification and Limited Access Program,” which has not previously been included in EPA’s Regulatory Agenda; very little is known about this rule. Plaintiffs do not refer to it in the complaint but there is speculation, based on its title, that this second rule may allow for some commercial uses of methylene chloride.
We recall the lawsuit filed by the Natural Resources Defense Counsel (NRDC) in 2018 challenging EPA’s draft New Chemicals Decision-Making Framework document as a final rule. The current action further reflects the commitment of detractors of EPA to use the courts and every other means available to oppose the Administration’s TSCA implementation efforts. Whether and when this court will respond is unclear. What is clear is that the case will be closely watched, as the outcome will be an important signal to the TSCA stakeholder community regarding the utility of TSCA Section 20(a)(2) to force non-discretionary EPA actions that the Administration may be disinclined to take.