Posted on February 17, 2023 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.
EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.
Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”
Posted on March 30, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
As reported in our February 28, 2022, blog item, on February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. On March 25, 2022, the TSCA New Chemicals Coalition (NCC) sent a letter to Michal Ilana Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), regarding its concerns with the “phasing out” of the TSCA Inventory correction process. The NCC states that it believes EPA’s decision-making process “would benefit greatly from stakeholder input and urges EPA to suspend the phaseout set to occur on April 26, 2022, and to reconsider the revocation of the 1980 corrections guidelines set to occur May 31, 2022.” According to the NCC, “[b]oth decisions invite significant unintended consequences, and stakeholder comment may well provide information that could persuade EPA to go in a different direction.” The NCC urges EPA to address the issues outlined in its letter by suspending its decisions to revoke the guidelines and “phaseout” of the Inventory correction process and seeking comment on its plans.
Posted on March 07, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for summer 2022. According to EPA, the Inventory contains 86,631 chemicals, of which 42,039 are active in U.S commerce. Other updates include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). EPA notes that on October 15, 2021, it announced a list of 377 specific chemical identities that were expected to lose their confidential status and move to the public portion of the Inventory. According to EPA, these 377 are listed in this public Inventory posting by their specific chemical identities.
Posted on February 28, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of Inventory listings to address errors with the chemical identities submitted in the original reporting forms. The regulated community will have until April 26, 2022, to submit any final Inventory corrections. EPA also announced the discontinuation of the related form and associated approval of the collection activities under the Paperwork Reduction Act (PRA). The revocation will be effective May 31, 2022. All final Inventory corrections must be received on or before April 26, 2022.
After April 26, 2022, EPA does not intend to accept requests to correct original Inventory reporting forms. If, after April 26, 2022, a person discovers for any reason an error in the specific chemical identity of a chemical substance submitted on an original Inventory reporting form, a premanufacture notice (PMN) or exemption notice may need to be filed if the chemical substance is not already listed on the TSCA Inventory.
EPA notes that this action does not impact its authority for initiating, at its discretion, corrections to the Inventory should EPA determine on its own that, for example, a chemical substance listed on the Inventory has been unintentionally misidentified. EPA states that only in this situation will it, at its discretion, request and accept documentation from a company to support an Inventory correction in lieu of requiring a PMN or exemption notice. This action also does not impact EPA’s regular maintenance of the Inventory that can include nomenclature updates and correcting minor errors to listings.
EPA’s unilateral decision seems ill-considered and unwise. At the least, EPA should seek comment from the TSCA stakeholder community to inform its judgment.
Posted on February 11, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a January 2022 enforcement alert entitled “Violations May Put Ski Wax Users at Risk from Illegal Perfluoroalkyl Substances.” According to the enforcement alert, EPA has identified several high-performance ski wax consumer products that contain perfluorinated chemicals that were not reviewed by EPA for health risks under the Toxic Substances Control Act (TSCA). EPA notes that these wax products are intended for use on sports equipment to enhance the performance of the equipment’s slick surfaces that are in contact with snow. The alert states that:
- EPA is concerned that recently identified TSCA violations may be putting skiers and wax applicators at risk for exposure to certain persistent and bioaccumulative chemicals; and
- EPA advises sellers of ski wax to ensure that the products they sell do not contain certain perfluorinated chemicals that are not on the TSCA Inventory or have prohibitions on their use in sporting goods.
The enforcement alert states that EPA identified several manufacturers, importers, and sellers that produced or sold ski wax products that included certain perfluorinated chemicals in violation of TSCA, which prohibits the manufacture, processing, or importation of a chemical that is not on the TSCA Inventory or otherwise exempt. TSCA requires anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to submit a premanufacture notice (PMN) at least 90 days prior to the manufacture, import, or processing of the chemical. According to the alert, review of the risks from per- and polyfluoroalkyl substances (PFAS) in ski waxes “is particularly important in light of the potential for ski wax technicians and recreational skiers who apply waxes to the skis to be exposed to PFAS from handling the waxes and from vapors released when the waxes are melted and applied to skis.” The alert notes that PFAS may enter the environment from the use of waxed skis and from the ski wax shavings scraped off during application.
The enforcement alert describes the following best practices for assessing whether a wax product contains a new chemical substance: (1) reviewing the product’s safety data sheet (SDS) and comparing the chemical substances against the TSCA Inventory; (2) contacting manufacturers and suppliers for additional chemical identity information where there is uncertainty regarding whether a chemical is on the TSCA Inventory; and (3) contacting EPA via the TSCA Hotline if it remains unclear whether a chemical substance is on the TSCA Inventory.
The enforcement alert provides information on EPA’s Audit Policy, under which regulated entities that voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. The alert states that most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system. According to the alert, many states also offer incentives for self-policing, and EPA suggests checking with the appropriate state agency for more information.
Posted on November 10, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On November 8, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule revising the regulations associated with persons who must report data to the mercury inventory established under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 61708. The revisions implement an order issued by the U.S. Court of Appeals for the Second Circuit on June 5, 2020, that vacated the exemption at 40 C.F.R. Section 713.7(b)(2) for persons who import pre-assembled products that contain a mercury-added component. As a result, such persons are now required to report pursuant to 40 C.F.R. Section 713.7(b). EPA states that the rule is effectuating the vacatur ordered by the Second Circuit by making necessary amendments to the corresponding text in 40 C.F.R. Section 713.7(b). The final rule will be effective on December 8, 2021. EPA states in its November 2, 2021, press release that the final rule “offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is July 1, 2022.” EPA will update the mercury inventory reporting rule compliance guide and other supporting materials to reflect these new reporting requirements.
As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule and its reporting requirements apply 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 TSCA, such as for the manufacture of pharmaceuticals and pesticides).
Posted on October 15, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on October 15, 2021, that it is updating the confidential status of 377 chemical identities and will include these chemical identities on the next update of the Toxic Substances Control Act (TSCA) Inventory, planned for winter 2022. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, the Inventory contains 86,607 chemicals, of which 41,953 are active in U.S commerce.
As reported in our April 30, 2021, blog item, in April 2021, EPA announced its review of 390 specific chemical identities that were expected to lose their confidential status on the TSCA Inventory. Of the 390 chemicals under review, EPA states that it found that 13 accession numbers corresponded to substances that are already on the public portion of the Inventory or to substances reported using an invalid accession number (which was later corrected and/or the confidentiality claim was withdrawn). The remaining 377 chemical identities were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) periods -- “meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce. Therefore, these substances are no longer eligible for continued confidential Inventory status.”
Posted on September 21, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 24, 2021, for stakeholders to learn how to access and use the pollution prevention (P2) information collected by the Toxics Release Inventory (TRI) Program about projects implemented by companies to eliminate or reduce the creation of chemical waste. According to EPA, community members, local government representatives, facility personnel, and others can access this information through multiple online resources and use it to further the identification and advancement of P2 opportunities. The webinar will include a live demonstration of how to find P2 data for specific facilities, chemicals, and industry sectors, as well as:
- Details on what data facilities are required to report;
- Examples of P2 projects implemented at manufacturing facilities; and
- Resources for and benefits of implementing P2 projects at facilities.
The webinar is also part of a series of webinars to mark the 35th anniversary of the TRI Program. Registration is now open.
Posted on September 01, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 31, 2021, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). In April 2021, EPA released a list of 390 chemicals expected to lose their confidential status and move to the public portion of the Inventory. EPA states that it continues to work on final declassifications for these chemicals and plans to include them in the next public posting of the TSCA Inventory.
Posted on May 14, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
As reported in our April 30, 2021, blog item, on April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.” EPA announced on May 14, 2021, that it is extending the notification deadline to June 30, 2021. According to EPA, the American Chemistry Council and BASF requested additional time to review the list of 390 chemicals. EPA states that concerns were expressed over the potential that some of the chemicals overlap with those reported under the Active-Inactive rule and the perception that EPA relied only on 2020 Chemical Data Reporting (CDR) rule submissions to identify these chemicals.
According to EPA, in regard to the industry concerns that it relied solely on 2020 CDR submissions, it plans to declassify the specific identities of these chemicals because one or more manufacturers reported the chemicals as non-confidential during the 2012, 2016, and/or 2020 CDR reporting periods -- “meaning that at least one manufacturer did not request that each of the chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce.” EPA states that additionally, it did an “extensive review” of each individual instance in which confidential status was not requested for these chemical identities to confirm the accuracy of the list.
EPA acknowledges that some of the chemicals may also have been reported or subject to reporting under the Active-Inactive rule, which required companies to identify chemicals manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. Although EPA is aware that there may have been submitter confusion and questions regarding confidentiality claims during the initial reporting period, it states that for each of the 390 chemicals, “there is also one or more independent CDR-based (and EPA-validated) reasons to consider the chemical identities to be no longer eligible for inclusion on the confidential portion of the Inventory.” EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory during summer 2021.
EPA states that stakeholders with interest, questions, or concerns about this change in confidential status may contact the EPA staff listed on its webpage no later than June 30, 2021. Stakeholders should review the list of substances and ensure that none of those substances is of critical importance to maintain confidential status.
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