Lautenberg Act: EPA releases Implementation Plan and other resources.

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Following President Obama’s signing, last week, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has begun to roll out a variety of resources to help stakeholders understand this update to the Toxic Substances Control Act (TSCA). Today, EPA posted its Implementation Plan for the Lautenberg Act, a “roadmap of major activities EPA will focus on during the initial year implementation.” The requirements and goals outlined in the Plan are based on deadlines set in the statute. The agency noted that the Plan is a “living document” that will be updated over time.

Notably, the Plan states that the Lautenberg Act’s passage “effectively resets the 90-day review period” for submitted Premanufacture Notices (PMNs). As an “Immediate Action” under the Plan, EPA’s goal is to meet the “applicable” deadlines for reviewing and making affirmative determinations on all PMNs and Significant New Use Notifications (SNUNs). The agency says it “will make every effort to complete its review and make a determination within the remaining time under the original deadline.”

Another “Immediate Action” under the Plan is the routine review and making of determinations on new confidentiality claims for the identities of chemicals offered for commercial distribution. These Confidential Business Information (CBI) claims must receive a determination within 90 days and upheld claims will result in the chemical receiving a unique identifier and associated information. EPA also set a goal of creating a plan to link such associated information in 30 days, by mid-July. For CBI claims not related to chemical identity, EPA is required to review and make determinations for at least 25% of new claims, with a goal of developing an approach for routine review by mid-July. EPA plans to provide additional information on required statements and certifications for asserted CBI claims by mid-July as well.

The new law allows EPA to publish proposed and final rules, under Section 6, for chemicals with risk assessments completed prior to the enactment of the Lautenberg Act. These rules must be consistent with the scope of the risk assessments, “even if they do not cover all conditions of use.” EPA has set “Immediate Action” goals to address the identified risks associated with trichloroethylene (TCE), methylene chloride (MC), and N-methylpyrrolidone (NMP), with various proposed and final rules anticipated to be released from October through December 2017.

Other mandatory actions to be completed within the first year of implementation include:

  • Scope of Initial Risk Evaluations: The scope of the first ten Work Plan chemicals’ risk evaluations will be published in mid-June 2017.
  • Annual Plan for Risk Evaluations: The first annual plan, providing updates on evaluations to be started or completed each calendar year, among other things, will be due January 2017.
  • Additions to Mercury Export Ban: The initial list of mercury compounds prohibited from export is slated for publication mid-September 2016.
  • Mercury Inventory: EPA must publish an inventory of mercury supply, use, and trade in the U.S. by April 1, 2017, and update it every three years thereafter.
  • Small Business Definitions: By mid-December 2016, EPA must review the standards for identifying small manufacturers and processors and determine whether revisions are warranted.
  • Report to Congress: EPA’s first report to Congress must be submitted by mid-December 2016. The report must address the agency’s capacity and resources needed to conduct risk evaluations and issue rules addressing unreasonable risks, as well as EPA’s capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and anticipated schedule for meeting that demand.

Beyond the first year of implementation, the Plan outlines “Framework Actions” that will guide the program on a longer-term basis. These are all on the same timeframe and include:

  • Initial Risk Evaluations: The list of ten Work Plan chemicals will be published in December 2016, with scope of assessments published in June 2017, as mentioned above.
  • Prioritization Process Rule: The Proposed Rule establishing EPA’s process and criteria for prioritizing chemicals for risk evaluations is expected by mid-December 2016; the Final Rule in June 2017.
  • Risk Evaluation Process Rule: The Proposed Rule establishing EPA’s process for evaluating the risk of high priority chemicals is expected in mid-December 2016; the Final Rule in June 2017.
  • Fees Rule: EPA plans to meet and consult with industry in developing the rules for collecting newly-authorized fees, including those for industry-requested risk evaluations, which must be fully funded by fees. The Proposed Rule is expected mid-December 2016 and the Final Rule in June 2017.
  • Inventory Rule: This rule will collect information via required industry reporting on chemicals manufactured or processed in the last ten years to determine which chemicals on the TSCA Inventory are “active” or “inactive.” Publication of the Proposed Rule is slated for mid-December 2016 and the Final Rule in June 2017.
  • Science Advisory Committee on Chemicals: This committee will be established to provide independent advice and scientific and technical expertise on the law’s implementation. EPA aims to establish the Committee by mid-December 2016, six months before the statutory deadline. The agency plans to publish the applicable Federal Register notice in early September 2016, with public comment accepted through early November 2016.

“Later Mandatory Actions” designated in the Plan include the publication of an Alternative Testing Methods Strategy by June 2018 and negotiated rulemaking on byproducts reporting for Chemical Data Reporting (CDR), with a Proposed Rule (by negotiating process) anticipated in June 2019.

In addition, EPA will hold an informational overview of the Lautenberg Act by webinar tomorrow, June 30, at 2:00 p.m. EST. The webinar will be accessible here: http://epawebconferencing.acms.com/overviewreform/. Audio will be available by phone by dialing 866-299-3188 and entering the code 2025648098#.

Other resources from EPA’s website about the Lautenberg Act include a summary of key provisions, a Frequently Asked Questions document, and the full text of the Act itself.

President Obama to sign Lautenberg Act tomorrow.

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The White House has announced that on Wednesday, June 22, President Obama will sign into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the long-awaited update to the 40-year-old Toxic Substances Control Act (TSCA). The Senate passed the Lautenberg Act by voice vote on June 6, two weeks after the House approved the negotiated legislation. Both houses of Congress approved different versions of the bill in 2015, but were unable to reach a deal to reconcile the legislation until last month.

The bipartisan bill gives EPA new authority to regulate chemicals based on impacts to health and the environment, not cost, and order testing via order rather than rulemaking. Existing chemicals in commerce will be screened and prioritized for risk assessment, and industry will be allowed to apply for fee-funded expedited assessments. Fees for new and existing chemicals will be collected into a “TSCA Implementation Fund” to defray about 25% (initially $25 million annually) of the program cost. For new chemicals, EPA will be required to make an affirmative safety finding that the substance is not likely to present an unreasonable risk. The Lautenberg Act also provides for an “Inventory reset” under Section 8 of TSCA, requiring industry to report to EPA which Inventory chemicals they have manufactured or imported in the previous ten years. Most claims of Confidential Business Information (CBI), which allow companies to avoid disclosing certain information to EPA, will now have to be substantiated when made and will expire after ten years unless re-substantiated. EPA will be required to review and approve or deny past CBI claims for chemical identities on the Inventory.

The preemption of state and local laws was a major sticking point throughout TSCA reform negotiations, resulting in a complicated system of limited preemption. Generally, restrictions by states will not be preempted until EPA takes action on a particular substance, while reporting, monitoring, and disclosure requirements will not be affected. State actions in effect by April 22, 2016, or actions taken under a law in effect on August 31, 2003, will not be preempted. The Act also provides for a process under which states can seek waivers from preemption.

After the Lautenberg Act is signed into law, EPA will soon face a variety of tough implementation challenges. Within the first six months, EPA must designate ten chemicals from the Work Plan for risk assessment. Within the first year, EPA must develop guidance for industry-initiated risk evaluations and rules for Inventory reset reporting, prioritization of chemicals, and risk evaluation process.

Whether EPA will receive adequate funding from Congress to achieve all these goals remains to be seen; the Lautenberg Act does not permit EPA to assess fees unless Congress has appropriated at least the amount appropriated for the “Chemical Risk Review and Reduction” program project in FY 2014. Last week, the Senate Appropriations Committee reported out its appropriations bill for FY 2017, which included language to meet that requirement.

CPSC: No mandatory recall for Lumber Liquidators.

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Last week, the U.S. Consumer Product Safety Committee (CPSC) declined to issue a mandatory recall but announced that Lumber Liquidators has agreed to not sell its inventory of laminate wood flooring imported from China. The announcement marked the end of the CPSC’s investigation of Lumber Liquidators, which was prompted by a March 2015 segment on 60 Minutes alleging that the company sold Chinese-made flooring with unsafe formaldehyde levels.

Lumber Liquidators has agreed to continue operating its “recall to test” program, offering free test kits to the over 600,000 consumers who purchased the flooring before the company stopped selling it in May 2015. If the test kit reveals elevated formaldehyde levels, Lumber Liquidator has agreed to cover the costs of helping homeowners conduct additional tests and any necessary remediation. So far, the testing program has analyzed indoor air quality in 17,000 homes and found elevated formaldehyde levels in about 1,300 of them; however, CPSC reports that “none of the floors tested above the remediation guideline.”

Based on its examination of the product and test data, CPSC concluded that the flooring does not contain unsafe levels of formaldehyde. According to a report from the Centers for Disease Control and Prevention’s National Center for Environmental Health/Agency for Toxic Substances and Disease Registry,

eye, nose, and throat irritation could occur with the higher formaldehyde emitting flooring samples in certain home environments. Irritation can happen in anyone, but is more likely among children, older adults, and people with respiratory issues, such as asthma or other breathing problems. Very high levels of formaldehyde in homes may also be associated with a small increase in cancer risk.

CPSC will continue to monitor test results and consider new information as it becomes available. Lumber Liquidators has also agreed that future flooring products will be subject to “enhanced supplier controls designed to achieve compliance with California formaldehyde requirements and any future federal requirements for laminate flooring.” In March, the company paid $2.5 million to settle the California Air Resources Board’s claims that the flooring exceeded state formaldehyde limits and reported in May that it will pay $26 million to settle related shareholder suits.