By Lynn L. Bergeson and Carla N. Hutton
On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal of an existing ICR that is currently approved through October 31, 2022. Before submitting the ICR to OMB for review and approval under the Paperwork Reduction Act (PRA), EPA is soliciting comments on specific aspects of the information collection activities and burden estimates. Comments are due April 11, 2022.
Under TSCA Section 8(e), any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment is required to inform EPA immediately of such information unless they have actual knowledge that EPA has been adequately informed of such information. There is also an option for those who wish to submit voluntarily “For Your Information” (FYI) notices. More information on TSCA Section 8(e) requirements is available in our TSCA frequently asked questions (FAQ).
EPA estimates that the total estimated number of potential respondents is 51 and that the total estimated average number of responses for each respondent is 343. There is a decrease of 3,847 hours from the last approval (from 21,412 to 17,565 hours). According to EPA, this reflects an overall decrease in the number of Section 8(e) and FYI submissions, which decreased from 408 to 343 Section 8(e) submissions and 13 to six FYI submissions, respectively. EPA has also increased the total annual costs due to an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead).
EPA notes that in addition, OMB has requested that it move toward using the 18-question format for ICR Supporting Statements used by other federal agencies and departments that is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA states that it does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs.
Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording, slides, and written Question and Answer (Q&A) document from our “PFAS Reporting Rules -- What Every Company Needs to Know” webinar, focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS), presented by B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D.
Do you wonder if the PFAS reporting rules extend to domestically-produced articles? Or if businesses that incorporate PFAS into their products are required to notify the end users? Do you know whether you need to report your Low Volume Exemption (LVE) substance? We encourage you to view the webinar and read the additional materials to learn answers to these and other questions related to EPA’s recent PFAS actions.
We also encourage you to consider the following issues discussed in the webinar and to submit comments to EPA regarding how these will affect your operations:
- Identifying chemicals subject to reporting (i.e., specific PFAS and whether to include imported articles);
- Considerations for economic analysis;
- Submission period;
- Potential duplicative reporting concerns;
- Scope of “existing environmental and health information” collected;
- Additional data elements or information collected;
- EPA’s use and publication of non-confidential business information (CBI);
- Availability of joint submissions; and
- Small manufacturer considerations (i.e., regulatory and non-regulatory assistance and outreach).
Comments on EPA’s proposed PFAS rules are due on September 27, 2021.
By Lynn L. Bergeson and Carla N. Hutton
On June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA proposes to require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:
- Identifying the chemical substances that would be subject to reporting;
- Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
- Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
- Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
- Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
- Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
- EPA’s use and publication of certain non-confidential business information (CBI) data;
- Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
- Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.
Comments are due August 27, 2021. EPA states that “[u]nder the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.” More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”
By Lynn L. Bergeson and Carla N. Hutton
On March 2, 2021, the U.S. Environmental Protection Agency (EPA) announced that it reached a settlement agreement with Brenntag Pacific, Inc. for violations of the Toxic Substances Control Act (TSCA). According to EPA, Brenntag Pacific, Inc. has corrected the violations and will pay a $128,265 fine. EPA states that it discovered the violations following inspections at Brenntag Pacific, Inc. facilities in Fairbanks, Alaska, and in Santa Fe Springs, California. EPA inspectors “found the company failed to submit accurate and timely reports and notification associated with the import and export of nine chemicals.” According to EPA, between 2012 and 2015, Brenntag Pacific, Inc. failed to report properly the import production volumes and uses of five chemicals as required by the 2016 Chemical Data Reporting (CDR) Rule. In addition, the company failed to produce first-time export notices for four chemicals between 2016 and 2017. EPA notes that under TSCA, chemical importers and manufacturers are required to submit CDR information to EPA every four years. EPA uses these data to track the chemicals being imported into the United States and to assess the potential human health and environmental effects of these chemicals. In addition, EPA makes the non-confidential business information it receives available to the public.
By Lynn L. Bergeson and Carla N. Hutton
On January 22, 2021, the U.S. Environmental Protection Agency (EPA) published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS). 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) to fund and carry out this testing under the direction of a panel of independent scientists. EPA states that it finds the petitioners have not provided the facts necessary for it to determine for each of the 54 PFAS that “existing information and experience are insufficient and testing of such substance or mixture with respect to such effects is necessary to develop such information.” After “careful consideration,” EPA denied the TSCA petition for the following reasons:
- Insufficient Information and Experience: According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” for each of the 54 PFAS. The petitioners state, in part, “[f]or the 54 PFAS, the sufficiency of available information should be determined by comparing available data with the known adverse effects of other PFAS. The goal should be to conduct a scientifically sound assessment of each of the 54 chemicals for the critical toxic endpoints that have been identified in studies on [perfluorooctane sulfonate (PFOS)], [perfluorooctanoic acid (PFOA)] and other well-characterized studies.” EPA states that the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience, however;
- Testing of Such Substance or Mixture with Respect to Such Effects Is Necessary to Develop Such Information: According to EPA, the petitioners do not demonstrate “testing of such substance or mixture with respect to such effects is necessary to develop such information.” EPA finds that the petitioners failed to address ongoing testing and data collections for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish there is a need for the testing sought in the petition. According to EPA, this research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA Section 4(a)(1)(A)(i)(III);
- Class-Based Approach to Testing: TSCA Section 4(h)(1)(B)(ii) “encourage[s]” EPA to consider “the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category.” EPA states that it “is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities.” EPA notes that it collaborated with the National Toxicology Program (NTP) “to construct a PFAS screening library subset composed of 75 PFAS on a structural category basis and considerations such as structural diversity within a category, data availability, and read-across category-level weight (e.g., value of substance for anchoring read-across trends within a category, serving as an analog); four of the 54 PFAS the petitioners identify are included in this subset.” While the petitioners mention this effort, they “incorrectly state that just two of the 54 PFAS the petitioners cover are included in the EPA testing.”
- Practicability of National Academy of Sciences Oversight: The petitioners also request that the National Academy of Sciences (NAS) oversee all aspects of the proposed testing program. EPA states that it “finds such an oversight arrangement is not within the scope of what a TSCA section 21 petitioner can request when seeking the initiation of a rule or the issuance of an order under TSCA section 4.” Furthermore, according to EPA, projects and studies must meet certain conditions for the NAS to accept private funding. EPA concludes that it is not in a position to require NAS to oversee the testing requested by the petitioners, and the petitioners provide no administrative or organizational procedures for implementation.
- Selection of PFAS for Health and Environmental Effects Testing: The petitioners divide the 54 PFAS at issue into Tier 1 substances “for which there is known human exposure based on detection in blood, food or drinking water,” and Tier 2 substances “for which human exposure is probable based on detection in environmental media.” According to EPA, the petitioners do not set forth facts showing that for all 40 PFAS it ranks as Tier 2 substances “human exposure is probable based on detection in environmental media” or that “a strong inference of exposure can be drawn from their presence in surface water, stormwater, wastewater, sediment, groundwater, soil, private wells, and/or air emissions,” however.
- Scientific Standards: EPA states that it “finds the petitioners have not evaluated the quality of the data they have provided or indicated how they conducted their searches, evaluated the quality of the sources, or indicated what gaps were located and then explained why the specific tests requested, as compared to others, would provide the data being sought.” According to EPA, such an evaluation is necessary for EPA to conduct the considerations under TSCA Section 26(h).
- Vertebrate Testing: TSCA Section 4(h) requires that EPA reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA Section 4. EPA states that it must consider “as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including (i) Toxicity information; (ii) Computational toxicology and bioinformatics; and (iii) High-throughput screening methods and the prediction models of those methods.”
More information on the TSCA Section 21 petition is available in our October 29, 2020, memorandum, “TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS.”
By Lynn L. Bergeson and Carla N. Hutton
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS). According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes. EPA states that Swix violated the TSCA Premanufacturing Notice requirements and Import Certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes. Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States.
Under the terms of the settlement, Swix has agreed to spend approximately $1 million to develop and implement an outreach and training program referred to as a Responsible Waxing Project (RWP) and pay a $375,625 civil penalty. The RWP is aimed at: (1) educating the ski racing community about PFAS chemicals in racing waxes and their impact on the environment; and (2) promoting the use of wax alternatives with lower environmental impact, including but not limited to racing waxes that are PFAS-free. Another objective of the RWP is to educate and motivate the ski racing community to phase out (and ultimately eliminate) the use of PFAS-containing waxes in ski racing beginning with the 2020 ski season.
EPA notes that the RWP has several elements, including an education and training component for ski wax technicians on the proper disposal of racing wax shavings and the use of appropriate personal protective equipment (PPE) during the waxing process. Other RWP elements include:
- PFAS ski wax education program, including two on-site presentations at a major ski event that attracts more than 10,000 participants;
- Training for wax technicians on the proper use of PPE, proper ventilation, and proper disposal of wax shavings;
- Program for ski wax coaches available online and used at on-site presentations at a minimum of ten events designed for coach certifications;
- Additional outreach to college racing teams and clubs that educates high school and college level skiers about the RWP content;
- A dedicated Swix project manager who oversees the project to completion;
- Website development for all videos created as part of the settlement for technicians, coaches, and teams; and
- Distribution of PFAS alternative wax information materials at a minimum of 50 ski sites.
EPA’s Environmental Appeals Board approved the consent agreement and final order on May 13, 2020.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (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.
TSCA Tutor™ online training courses include:
- Video lessons.
- Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
- Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
Online courses are offered at $100 for one-hour modules and $200 for 2-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com
, or read our full course descriptions here
TSCA Tutor -- Curriculum
- An Overview of TSCA (Course number T101)
- New TSCA at a Glance (Course number T102)
- Import Requirements, TSCA Section 13 (Course number T103)
- Export Requirements, TSCA Section 12 (Course number T104)
- Confidential Business Information (CBI) (Course number T105)
- Reporting and Retention of Information, TSCA Section 8 (Course number T106)
- Inspections and Audits (Course number T201)
- Preparing for a TSCA Audit
- TSCA Penalties/Overview of Self-Confession Policy
- TSCA Section 5, Part 1: TSCA Chemical Inventory, Exemptions (Course number T202)
- TSCA Inventory
- TSCA Section 5, Part 2: New Chemicals/New Use (Course number T203)
- New Chemicals/New Use
- Chemical Data Reporting (CDR) (Course number T204)
- CDR Overview
- Byproduct Reporting under CDR
- Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
- Chemical Testing
- How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
- Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
- Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
- How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs. The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada. According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements. The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
On February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of chemical substances on the TSCA Inventory.
If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking. Our TSCA experts would be pleased to assist you with the reporting process!
More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage. Specific information on the upcoming reporting deadline and changes in the CDX system is available in our blog items EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline and EPA Updates eNOA Template in CDX System.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
On January 27, 2017, the U.S. Customs and Border Protection (CBP) issued in the Federal Register a notice of delay of an effective date of a final rule issued on December 27, 2016 (81 Fed. Reg. 94980). The final rule announced amendments to CBP regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture. 82 Fed. Reg. 8590. Specifically, the final rule amends CBP’s regulations under 19 C.F.R. Parts 12 and 127 to establish an electronic option for importers to file the required U.S. Environmental Protection Agency (EPA) TSCA certifications, to clarify and add certain definitions, and to eliminate the paper-based blanket certification process.
The effective date of the final rule was initially set at January 26, 2017, but is now delayed until March 21, 2017, in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017, directing heads of executive departments and agencies temporarily to postpone the effective date for 60 days from the date of the memorandum, of all regulations that had been published in the Federal Register, but had not taken effect. In the notice, CBP states that this additional time is not unwelcome, as it will allow affected entities more time to “become familiar with the increased flexibilities and new processes of the final regulations.”