EPA Releases Supplemental Proposed Rulemaking to Modify TSCA Fees Rule

On November 16, 2022, EPA published a supplemental notice of proposed rulemaking (SNPRM) (87 FR 68647) addressing fees for the administration of TSCA. The SNPRM modifies and supplements the Agency’s proposed TSCA fees rule issued on January 11, 2021. The 2021 proposed rule was released pursuant to TSCA section 26(b)(4)(F), which requires EPA to review and, if necessary, adjust fees every three years. EPA determined this SNPRM was necessary based on comments on the proposed rule, adjustments to EPA’s cost estimates, and additional experience in implementing the 2018 Fee Rule. Modifications include:

  • Increasing fee amounts and the estimates of EPA’s costs for TSCA administration.
  • Expansion of the fee requirements to companies required to submit information for test orders.
  • Narrowing the proposed exemptions for the test rule fee activities to only: (1) importers of articles containing a chemical substance; (2) producers of a chemical substance as a byproduct; (3) manufacturers (including importers) of a chemical substance as an impurity; (4) producers of a chemical as a non-isolated intermediate; (5) manufacturers (including importers) of small quantities of a chemical substance solely for research and development and; (6) manufacturers (including importers) of chemical substances with production volume less than 1,100 lbs of a chemical subject to a TSCA section 4 test rule.
  • Adjustments to the self-identification and reporting requirements of EPA-initiated risk evaluation and test rule fees to reduce the burden of calculating and reporting production volumes to comply with the 2021 proposed recordkeeping requirements. EPA is considering using ranking methodologies and reporting production volume ranges instead of averages.
  • The proposal of a partial refund of fees for PMNs withdrawn any time after the first 10 business days during the assessment period for the chemical.
  • Adjustment of the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements.
  • Extending the time frame for test orders and test rule payments.

The proposed fee increases are as follows:

Fee Category 2018 Fee Rule Current Fees* 2022 Supplemental Proposed Rule
Test order $9,800 $11,650 $25,000
Test rule $29,500 $35,080 $50,000
Enforceable consent agreement $22,800 $27,110 $50,000
PMN and consolidated PMN, SNUN, MCAN, and consolidated MCAN $16,000 $19,020 $45,000
LoRex, LVE, TME, Tier II exemption, TERA, Film Articles $4,700 $5,590 $13,200
EPA-initiated risk evaluation $1,350,000 Two payments totaling $2,560,000 Two payments totaling $5,081,000
Manufacturer-requested risk evaluation on a chemical included in the TSCA Work Plan Initial payment of $1.25M with final invoice to recover 50% of actual costs Two payments of $945,000, with final invoice to recover 50% of actual costs Two payments of $1,497,000, with final invoice to recover 50% of actual costs
Manufacturer-requested risk evaluation on a chemical not included in the TSCA Work Plan Initial payment of $2.5M, with final invoice to recover 100% of actual costs Two payments of $1.89M, with final invoice to recover 100% of actual costs Two payments of $2,993,000, with final invoice to recover 100% of actual costs

*The current fees reflect an adjustment for inflation required by TSCA and went into effect on January 1, 2022.

EPA states that increased fees will ensure recovery of 25% of implementation costs, consistent with the direction of the Fiscal Year 2022 appropriations bill. The Agency also states that the fee increases will strengthen its ability to successfully implement TSCA in a manner that is both protective and sustainable.  Furthermore, EPA asserts that the fee increases will improve on-time performance and quality significantly.

EPA officials have repeatedly argued that the 2016 Lautenberg Amendments tasked the Agency with many new responsibilities but did not increase the TSCA budget accordingly. According to the Agency, while there was a fee increase in 2018, EPA was only able to collect about half of the 25% target fees since the 2018 rule’s finalization. Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff commented, “[f]or the last six years, we’ve lacked the needed resources to build a sustainable chemical safety program that’s grounded in science, protects communities from dangerous chemicals, and supports innovation; with today’s action, we’re continuing to adjust TSCA fees to account for the full costs of running the program the way that Congress intended.”

EPA will hold a webinar on December 6, 2022, from 1:00 PM to 2:30 PM to provide stakeholders with an overview of the SNPRM and accept public comments. Registration closes on December 1, 2022; you can register for the webinar here.

EPA Publishes TSCA User Fee Proposed Rule

Under the proposed TSCA User Fee Rule, submitters would pay $16,000 for each PMN. This was announced on February 8, 2018, when the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). The current fee for a PMN submission is $2,500. EPA estimates the average cost of a PMN for processing, reviewing, making determinations, and taking any regulatory action such as with a SNUR or an order is approximately $55,000. Fees would also apply to submissions related to risk evaluation and EPA mandated testing of chemical substances and mixtures.

The proposed rule was published on February 27, 2018. Comments on the rule must be received on or before April 27, 2018 (Docket Number EPA-HQ-OPPT-2016-0401).

Amended TSCA provides EPA the authority to charge fees to chemical manufacturers, including importers, and processors to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” These fees are to be used for “developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and, making determinations in a timely and transparent manner with respect to the safety of new chemicals before they enter the marketplace.” However, EPA is not proposing to assess greater fees for submissions containing CBI claims.

Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) under section 4;
  • Submit a PMN, SNUR, LVE or other notification under section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation under section 6, including a risk evaluation conducted at the request of a manufacturer.

Beginning in fiscal year (FY) 2019 , EPA will be required to adjust fees every three years to reflect inflation and ensure that fees are sufficient to collect 25 percent of the costs to EPA in administering TSCA sections 4, 5, 6, and 14, up to $25 million. The proposed rule provides a description of proposed TSCA fees and fee categories for FYs 2019, 2020, and 2021, and explains the basis for its proposal.

TSCA Inventory Reset Deadline Is Approaching

The TSCA Inventory Reset process is designed to identify which listed chemical substances are and which are not actively used in commerce. Substances identified as “in commerce” will be placed on the “Active Inventory.” Substances not currently in commerce will be placed on the “Inactive Inventory.” Companies will not be able to lawfully manufacture, import, or process any chemical substance on the “Inactive Inventory” without first notifying the substance to EPA.

The rule establishes “retrospective” (as well as “forward-looking”) reporting requirements. During the initial retrospective reporting period, companies must report on each Inventory-listed substance that they manufactured or imported for a non-exempt purpose during the ten-year look back period (June 21, 2006 and June 21, 2016). The deadline for this reporting period is February 7, 2018.

A subsequent reporting period, beginning April 9, 2018, is designated for reporting by processors. Companies may report substances that they processed during the ten-year look back period if the substances are not already on EPA’s Active Inventory or Interim Active Inventory.

EPA Releases the 2018 Plan for Chemical Risk Evaluations under TSCA

As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has released its annual plan for chemical risk evaluations. The annual plan identifies the next steps for the first 10 chemical reviews currently underway, and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA was required to initiate ten risk evaluations in 2016, and is required to initiate at least 20 more within 3 years after enactment of the Lautenberg Act, or by December 2019. EPA designated the first ten chemical substances on December 19, 2016. By the end of 2018, the EPA will initiate prioritization for 40 chemicals – at least 20 Low-Priority and 20 High-Priority candidates. By December 22, 2019, EPA will designate 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.

In order to support these risk evaluations and other key aspects of TSCA implementation, EPA stated that it will be proposing a draft TSCA Fees Rule in early 2018, which will provide estimates of the resources required to undertake risk evaluations.

EPA Semiannual Regulatory Agenda Postpones Regulation of Methylene Chloride, NMP, and TCE

The EPA Fall 2017 Regulatory Agenda defers Agency action on three chemicals for which the proposed rules had indicated bans would be forthcoming:

  • Methylene chloride in paint strippers,
  • N-methylpyrrolidone (NMP) in paint strippers, and
  • Trichloroethylene (TCE) as a spot cleaner in dry-cleaning and as a degreasing agent.

The rulemakings are listed as “long-term actions” and will be issued “to be determined” in the Semiannual Regulatory Agenda.   EPA has not explained the reason for the deferrals.   Proposed regulations for methylene chloride and NMP were issued in January 2017.  Further information on EPA’s past actions regarding methylene chloride can be found here. Further information on EPA’s past actions regarding NMP can be found here.  Proposed regulations for TCE were issued in December 2016 and January 2017.  Further information on EPA’s past actions regarding the substance can be found here.

The rulemakings were developed under section 6(a) of the Toxic Substances Control Act (TSCA).  They address uses of the chemicals identified to be of concern in risk assessments published prior to the Lautenberg amendments to the statute.  In addition to the proposed rules on these uses of concern, all three chemicals are also are among the first substances selected for risk evaluation under the Lautenberg amendments.  EPA is required to complete each of those risk evaluation within 3 years of its initiation.  (The amendments also allow the Agency two years after each risk evaluation is published to issue final rules restricting the uses of chemicals that present an unreasonable risk of injury to health or the environment.)  A larger set of uses than those identified above will be considered in the forthcoming risk evaluations.  However, EPA has been sued over the final rule for the risk evaluation process.  One issue challenged in that litigation is the scope of uses that will be addressed by the process.  That litigation is ongoing.

EPA Determines to Update to Standards for “Small Manufacturers and Processors” for TSCA Reporting

On November 30, 2017, EPA published a final determination, as required under the amended TSCA, that an update is warranted to the size standards for small manufacturers and processors currently used to determine which small businesses are exempt from reporting regulations under TSCA Section 8(a).  EPA’s determination was made after reviewing public comments and consulting with the Small Business Administration (SBA).  The determination today does not include changing the standards themselves. The future revisions to the standards will occur by subsequent rulemaking, which allows for further opportunities for consultation with the SBA and public notice and comment.

EPA to Hold Public Meeting on Identifying Potential Candidates for Prioritization for Risk Evaluation

EPA is holding two meetings in December to discuss ongoing implementation activities under the Frank R. Lautenberg Chemical Safety Act, which amended Toxic Substances Control Act (TSCA). On December 11, 2017 EPA is holding the second public meeting on possible approaches for identifying potential candidate chemicals for EPA’s prioritization process under TSCA. The meeting will be held December 11, 2017, 8:30 a.m. to 5:00 p.m. at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, DC 20004.

As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemicals. EPA will describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemicals for prioritization.

EPA will accept questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows. To register to attend, submit questions, and learn more follow this link.

EPA to Hold Public Meeting on New Chemicals Review program

EPA is holding two meetings in December to discuss ongoing implementation activities under the Frank R. Lautenberg Chemical Safety Act, which amended Toxic Substances Control Act (TSCA). On December 6, 2017, EPA is holding the first public meeting on new chemicals. The first meeting is to update and engage with the public on the Agency’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, including discussion of EPA’s New Chemicals Decision-Making Framework.

The meeting will be held December 6, 2017, 9:00 a.m. to 5:00 p.m. at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, DC 20004. EPA will describe its review process for new chemicals under the amended statute, and interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program since the statute was amended and to ask questions.

EPA will accept questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows. To register to attend, submit questions, and learn more follow this link.

EPA Issues Three Final Rules under New TSCA

On June 22, 2017, the U.S. Environmental Protection Agency (EPA) released pre-publication Federal Register notices of the final framework actions under the new Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The final rules include:

  • The Inventory Reset Rule (AKA the Active-Inactive Rule), which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years;
  • The Prioritization Process Rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; and
  • The Risk Evaluation Process Rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment.

EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA, and a guidance document to assist interested persons in developing and submitting draft risk evaluations.

EPA Grants First ‘Conditional’ Approval Under TSCA Reform

EPA recently approved a new chemical additive subject to the conditions of the polymer exemption criteria.  The Agency found that the chemical substance is “not likely to present an unreasonable risk” under TSCA (5(a)(3)(C)), so long as it meets the requirements of the polymer exemption as described under 40 CFR §723.250(e)(1).  Specifically the Agency found that the substance presents both a low human hazards and a low environmental hazard.  The requirement that “the chemical must be manufactured such that it meets the polymer exemption criteria” gives little insight into restrictions that EPA might impose on future conditional approvals.

EPA’s Determination for Premanufacture Notice explains that although the agency estimates that the new chemical substance will be very persistent, it is unlikely that the chemical substance would present an unreasonable risk, given that it has low potential for bioaccumulation, low human health hazard, and low environmental hazard.  The Determination’s discussion of potential exposures is particularly interesting.  The Agency explained that, although the exposure to a new chemical substance is potentially relevant to whether a new chemical substance is likely to present unreasonable risks, EPA did not estimate the exposure.  The Agency elected not to estimate exposure because the substance present low health and environmental hazard.  The Determination concludes that, “Due to low hazard, EPA believes that this chemical substance would be unlikely to present an unreasonable risk even if exposures were high.”

The name of the substance was claimed confidential business information, as was the manufacturers name. The generic substance name is 2–alkenoic acid, 2–alkyl–, alkyl ester, polymer with 2–alkyl 2–propenoate and a-(2–alkyl-1-oxo-2-alken-1-yl-[iquest]-alkoxypoly(oxy-1,2-alkanediyl), ester with a–2–alken–1–yl–[iquest]–hydroxypoly(oxy–1,2–alkanediyl).

The approval, announced online on May 12, 2017, was the first time EPA has approved a new chemical with a condition since the Toxic Substances Control Act was amended in June 2016.