By Lynn L. Bergeson and Margaret R. Graham, M.S.
On March 11, 2019, the U.S. Environmental Protection Agency (EPA) released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates for the Committee on Appropriations. EPA’s budget request reduces the overall budget by $2.76 billion (31 percent), to $6.068 billion, but requests $66.418 million to support its Chemical Risk Review and Reduction (CRRR) program, an increase of $5.313 million.
EPA zeros out the other programs under Toxics Risk Review and Prevention, however, including the Endocrine Disruptor Screening Program (EDSP), the Pollution Prevention (P2) program, and the Lead Risk Reduction Program. EPA states that it will “absorb the remaining functions [of the EDSP] within the Pesticides Program using the currently available tiered testing battery,” “continue to meet core statutory requirements under the Pollution Prevention Act of 1990 in other programs,” and that “lead paint certifications will continue under the [CRRR] Program.”
In its budget, EPA states that “the resources requested by EPA will support continued implementation of the amendments to [the Toxic Substances Control Act (TSCA)], with emphasis on the critical mandates and timelines applicable to pre-market review of new chemicals, chemical risk evaluation and management, review and determinations on incoming [confidential business information (CBI)] claims, and other statutory priorities.” EPA anticipates an increased workload to support these efforts in FY 2020 as the Agency reaches statutory deadlines to conclude the first ten risk evaluations for existing chemicals, and initiate risk management regulatory actions as necessary. As part of this work load, EPA lists its primary TSCA implementation activities under Sections 4, 5, 6, 14; its other TSCA mandates and activities under Section 8; and the information technology systems being developed in support of TSCA implementation, all of which are extensive.
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, 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 and Carla N. Hutton
The House Energy and Commerce Subcommittee on Environment and Climate Change announced on March 6, 2019, that it will hold a hearing on March 13, 2019, on “Mismanaging Chemical Risks: EPA’s Failure to Protect Workers.” The Subcommittee will address how the U.S. Environmental Protection Agency (EPA) “is systemically ignoring worker risks in its implementation of the Frank R. Lautenberg Chemical Safety Act and other worker protections.” Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Environment and Climate Change Subcommittee Chairman Paul Tonko (D-NY) stated that protecting vulnerable populations is an essential part of EPA’s mission, but under the Trump Administration, EPA “has systematically undervalued or completely overlooked the risks workers face from exposure to chemicals on the job. Workers should not have to choose between their health and their jobs.” Information for the hearing, including the Majority Memorandum, witness list and testimony, and a live webcast, will be posted on the hearing web page as they become available.
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, 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 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
On February 5, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced the launch of its Twitter account, @EPAChemSafety. EPA states that this account will post the latest news on chemicals and pesticides including updates on its chemical review initiatives under the Toxic Substances Control Act (TSCA) and information on upcoming webinars and public meetings.