EPA Releases Draft Guidance on TSCA CBI Disclosures and Requests Comments

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On March 13, 2018, EPA released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose TSCA confidential business information (CBI) with an expanded set of people. Comments will be accepted until April 16, 2018.

Amendments to the Toxic Substances Control Act (TSCA) expanded the categories of people who may now access information claimed as CBI under TSCA. Information that a business claims as CBI under TSCA is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.

The draft guidance documents are:

EPA Publishes TSCA User Fee Proposed Rule

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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

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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

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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

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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

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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

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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

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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.

Seventh Circuit Adopts Carcinogen Exposure Test

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The Federal Court of Appeals for the Seventh Circuit recently joined the 6th and 9th Circuits in holding that a plaintiff seeking recovery for harm from carcinogen exposure must demonstrate that the exposure was a “substantial contributing factor” to the injury. The opinion notes that cancer causation “is dosage dependent—that is, the risk of contracting lung cancer from asbestos depends on the length of time of exposure and the amount of exposure. To determine whether any exposure constitutes a substantial contributing factor, therefore, one would have to understand the timing and amount of exposure.” The court rejected arguments that de minimis exposures are compensable, holding that the “any exposure” theory “ignored fundamental principles of toxicology that illnesses like cancer are dose dependent.” The court also rejected a cumulative exposure theory, under which “every minute of exposure adds to the cumulative exposure and thus becomes a substantial contributing factor,” finding that such an approach is “merely more of the same.”

While these are toxic tort cases, the opinions may be relevant to regulatory consideration of similar issues. For example, EPA must consider exposure in regulating new and existing products under the 2016 TSCA Amendments. Exposure also must be considered in making the “substantial risk” determination under TSCA Section 8(e). These opinions suggest that the courts will take a hard look at exposure data in these and other similar regulatory contexts. The case is Krik v. Exxon Mobile Corp., 7th Cir. No. 15-3112 (decided August 31, 2017).

EPA Announces Changes to the New Chemical Review Program

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In the wake of the 2016 amendment to the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has been focusing on streamlining new chemical review. On August 7, 2017, the Agency announced several related changes to the new chemical review process. Major reforms include:

  • Where a Premanufacture Notice (PMN) raises risk concerns, EPA will allow manufacturers to submit an amended PMN to address those concerns, and will base its judgment on the amended PMN.
  • Where EPA has concerns with product uses that can reasonably be foreseen but are not the intended uses described in the PMN, EPA’s concerns can be addressed through significant new use rules (SNURs).
  • Identification of reasonably foreseen conditions of use that are not addressed in a PMN will be fact-specific. EPA will find that a use is reasonably foreseeable where facts suggest that the use is not only possible but probable.
  • Section 5 testing orders will be confined to cases where they are necessary to reduce uncertainty in “unreasonable risk” findings, and will be structured to reduce or replace animal testing where appropriate.

EPA also announced that it will increase the full-time staff for new chemical review and will streamline related work processes. In addition, to help companies prepare PMNs, EPA will institute a voluntary pre-submission consultation process to provide submitters with a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process. Further support for submitters will be available this fall. EPA announced that it will publish for public comment draft guidance to provide more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations.