House Passes TSCA Reform H.R. 2576; Senate Vote Slated for Later this Week

The U.S. House of Representatives passed the pending TSCA Reform bill, The “Frank R. Lautenberg -  Chemical Safety for the 21st Century Act,” H.R. 2576, yesterday, May 24, 2016, by a final vote of 403-12.    The legislative agreement negotiated by the House and Senate keeps the framework of the Senate-passed legislation (S. 697) largely intact. Highlights of the new requirements, if the bill becomes law, are described below.H.R. 2576 was the subject of extensive negotiations intended to address several competing policy priorities and stakeholder concerns. The Senate is expected to vote on the legislation without amendment. Key supporters of the legislation in the House, including Representatives Shimkus (R-IL), Pallone (D-NJ), Upton (R-MI), and Hoyer (D-MD), characterized the legislation as striking the right balance to protect people, jobs, and the environment.  

• Testing: EPA has new authority to order chemical testing, and is called upon to use tiered testing, screening approaches, test categories, and encourage alternatives to animal testing.  EPA will charge fees to evaluate submitted test results.    
• New Chemical Reviews: EPA must take sensitive subpopulations and intended conditions of use into account.  Within 90-days of a finding that the safety standard is not met or that testing is required, EPA must publish a decision on whether to issue a significant new use rule.  EPA is required to publish a finding that a new chemical meets the law’s safety standard.     
• Inventory Reset: Within one year of enactment, EPA will require manufacturers and importers to submit reports within six months on those chemicals listed on the TSCA Chemical Substance Inventory (Inventory) they have manufactured or imported for a non-exempt purpose in the previous 10 years (“active” chemicals).  EPA must publish a list of these active substances, and publish a rule within one year after that to require substantiation for chemical identities claimed as confidential business information (CBI).  Inactive substances will remain on the TSCA Inventory, but EPA must be notified before manufacture, import, or processing can commence.   
• Existing Chemicals: The number of chemicals previously proposed for EPA to designate and review in the first three and a half years of the existing chemical review program is doubled to 20 high-priority and 20 low-priority substances. Furthermore, EPA will prioritize and evaluate existing chemicals that present an unreasonable risk of injury to health or the environment without considering costs or other nonrisk factors.  
• Regulatory Controls: To restrict, phase-out, or ban an existing chemical, EPA must consider the effects on health and the magnitude of the exposure, the benefits of the chemical substance or mixture for various uses, the reasonably ascertainable economic consequences of the rule, the costs and benefits of the regulatory action, and alternatives. However, EPA will no longer be required to select the least burdensome regulatory alternative.  Exemptions may be granted for critical or essential uses, disruption of national economy, security, or critical infrastructure, and beneficial uses.  
• Preemption: New and existing state laws are preempted when EPA finds that a high priority chemical meets its safety standard and when EPA has promulgated a rule to regulate a chemical that does not meet the safety standard. There is no preemption of common law tort claim actions.  Once EPA announces the commencement of a chemical risk assessment, states may not enact new laws and regulations regulating the chemical for a period of up to three and a half years while the assessment is being conducted. States may submit waiver requests to EPA to regulate a chemical during this period.  Exemptions from federal preemption include state law adopted pursuant to federal law; reporting, monitoring, or information obligations not otherwise adopted by EPA; and air, water quality, and hazardous waste laws absent a direct conflict with a TSCA regulation.
• Confidential Business Information (CBI): Written support will be required to claim protection for chemical identity and other information.  Only specific manufacturing and processing descriptions, specific volumes, the composition of a mixture, a chemical’s use and function, and sales and marketing information will not require substantiation.  Confidentiality claims carry a ten year time limit, and are renewable for an additional ten year term.  
• Fees and Penalties: EPA is tasked to update fees for PMN submissions and impose new fees for reviews of test data and risk assessments for existing chemicals. Small businesses will pay lower fees.  The maximum civil penalty for TSCA violations is increased to $37,500, and maximum criminal penalties are increased to $50,000.  Individuals may be fined $250,000 as well as be sentenced to up to 15 years imprisonment for willful, imminent endangerment. Organizations may be fined up to $1 million.
• Articles: EPA may require a premanufacture notification (PMN) for a chemical substance imported as part of an “article” after issuing a rule finding that there is reasonable potential for exposure that justifies notification. EPA can impose prohibitions or restrictions on articles containing chemicals that do not meet the safety standard to the extent necessary to address the identified risks from exposure.
• Advisory Committee: EPA is instructed to have an advisory committee with representation from government, industry, nongovernmental organizations, and academia to advise the agency on new and existing chemical reviews.  
• Judicial Review: A determination that a safety standard is met is defined as a final agency action subject to judicial review.  A determination that a safety standard is not met is not subject to judicial review until EPA issues a final rule regulating the substance.  

The measure received broad support from industry, labor, and environmental/consumer action groups.  H.R. 2576 is expected to be fast-tracked for Senate consideration. The White House has announced the President’s intention to sign the legislation into law once passed. For more detailed information, see KHlaw.com.