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.

EPA Reopens Consultation on TSCA Small Manufacturer and Small Processor Definition

The EPA reopened its consultation with the public regarding the definition of “small manufacturer” and “small processor” under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA).

TSCA, as amended, requires EPA to review the size standards for small manufacturers and processors, which are currently used in connection with reporting regulations under TSCA Section 8(a). EPA preliminary decided that a revision in the size standards was warranted, but it wanted the public’s input as well. As such, EPA requested public comment on whether a revision of the current size standard definitions is necessary. It also requested a consultation with the Small Business Association to review the definition.

The comment period ended in January, but EPA is now accepting further comment on this issue until May 24, 2017.