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.

Seventh Circuit Adopts Carcinogen Exposure Test

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

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.

Overview of TSCA Inventory Reset

The Environmental Protection Agency (EPA) published the final rule establishing the process for TSCA “Inventory Reset” under the Toxic Substances Control Act (TSCA) on August 11, 2017. The final rule was effective as of the same day. The TSCA Inventory Reset process concerns chemical substances that are listed on the TSCA Inventory; it does not apply to every chemical substance in commerce, as many such substances are exempt from Inventory listing requirements. The Reset process is designed to identify which of the listed chemical substances are and are not actively in commerce. Inventory Reset is required by the Lautenberg amendments to TSCA.

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 Active and Inactive Inventories will be created through “retrospective” reporting. Retrospective reporting requires companies to notify EPA regarding the non-exempt chemicals they manufactured or imported during the ten years prior to Lautenberg’s enactment (June 21, 2006 and June 21, 2016). Manufacturer/importer reporting began the day the final rule was published. Companies have 180 days to submit notifications. In addition, a subsequent 180-day 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.

After retrospective reporting closes, EPA will formally establish the Active and Inactive Inventories. Once these Inventories are published, forward-looking reporting will be required before a company can lawfully manufacture, import, or process any chemical substance on the “Inactive Inventory.” In addition, EPA has designated the period between retrospective and forward-looking reporting as the “Transition Period.” The forward-looking reporting requirements are optional, but recommended, during this period.

Considerable effort to coordinate with the companies that manufacture and supply one’s raw materials will be required to ensure that these products remain available for use in the company’s commercial activities.

TSCA Negotiated Rulemaking Committee Meetings — Inorganic Byproducts and CDR

On August 18, 2017, EPA announced two upcoming meetings of the TSCA Chemical Data Reporting Negotiated Rulemaking Committee.  These meetings will be held on September 13 – 14 and October 25 – 26, 2017 in Washington, DC.  The public is invited to attend.

EPA issued a Federal Register Notice of its intent to form the committee December 16, 2016.  That notice explained that the objective of the Negotiated Rulemaking Committee will be to negotiate a proposed rule that would limit chemical data reporting requirements under section 8(a) of the amended TSCA for manufacturers of any inorganic byproduct chemical substances, when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.  It also explained that the Negotiated Rulemaking Committee will attempt to reach consensus on proposed regulatory language. The negotiation process is required by section 8(a)(6) of TSCA.

EPA believes the Chemical Data Reporting (CDR) rule is the only current reporting obligation under TSCA section 8(a) that is likely to affect the manufacturers of inorganic byproduct chemical substances.

The December 16, 2016 Federal Register Notice also explained that the Agency intends to conduct the negotiated rulemaking proceedings with particular attention to ensuring full and adequate representation of those interests that may be significantly affected by a rule providing for limiting CDR requirements for inorganic byproduct chemical substances.  EPA initially identified the following groups as representing interests likely to be significantly affected by a rule:

  • Aluminum Association
  • American Chemistry Council
  • American Coal Ash Association
  • Environmental Defense Fund
  • Institute of Scrap Recycling Industries
  • IPC—Association Connecting Electronics Industries
  • North American Metals Council
  • National Mining Association
  • S. Environmental Protection Agency
  • Utility Solid Waste Activities Group

Additional information about the Committee, including information about attending Committee meetings and meeting agendas, can be found on the Committee webpage.


EPA Releases Working Guidance for the Nanoscale Material Reporting Rule

On August 14, 2017, EPA released the Working Guidance for the Nanoscale Material Reporting Rule.  The Working Guidance considerably narrowed the scope of “reportable chemical substance” from the draft Guidance.  EPA considers the Guidance a “working” document because it intends to update the Guidance based on questions the Agency receives.

The Working Guidance also discusses other aspects of what makes a chemical a “reportable chemical substance” and a number of other issues.  It is divided into the following sections:

  • What Chemicals are Reportable?
  • Who is Required to Report?
  • What Information is to be Reported?
  • When is Reporting Required?
  • General Questions.

The most helpful information is found under “What Chemicals are Reportable?” and “Who is Required to Report?”

What Chemicals are Reportable.  A reportable chemical substance is one that it solid at 25º C, 1 – 100 nanometers in size in at least one dimension, and intentionally manufactured or processed to exhibit unique or novel properties because of its size.  The draft Guidance had raised a number of unanswered questions regarding what comprised unique and novel properties.

In the Working Guidance, EPA explicitly states that “size is not considered to be a unique and novel property.”  The Working Guidance differentiates between unique and novel properties and enhanced or continuously scaling properties.  The later are those which do not intrinsically change on the nanoscale and instead scale proportionately with size.  Chemicals that have different functionality at the nanoscale than the form greater than 100 nanometers would be considered substances demonstrating unique and novel properties.

Additional points about “reportable chemical substances” include discussion of discrete chemical substances and coatings.  The Working Guidance notes that some nanoscale materials are engineered to give all the particles a certain morphology or shape.  The change in shape needs to be a specifically engineered change in the shape of particles to be a discrete form of a reportable chemical substances.  EPA explains that coating a nanoscale material results in a nanoscale material with different properties; in other words, by coating a nanoscale material, one has created a reportable chemical substance.

Who is Required to Report.  According to the Working Guidance, each manufacturer and processor in the supply chain must report on the reportable chemical substance.  EPA notes that processors should document the steps they took to determine whether reporting is required.  If processors do not know about specific properties that would allow them to know if they are processing a chemical substance subject to the rule, EPA believes that it would be within the reasonably ascertainable standard to ask their suppliers.