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Senate Approves Chemical Reform Legislation

The Senate approved on 18 December 2015 its version of legislation (S. 697) effecting the first significant overhaul of the Toxic Substances Control Act since its enactment nearly 40 years ago. The House of Representatives passed its TSCA reform bill (H.R. 2576) by a 398-1 vote in June 2015, and it appears that a conference will be necessary to craft a final measure.

Originally introduced on 10 March 2015 by Sens. Tom Udall (Democrat-New Mexico) and David Vitter (Republican-Louisiana), the Frank R. Lautenberg Chemical Safety for the 21st Century Act would require for the first time that the Environmental Protection Agency review new and existing chemicals and regulate them based on the impact they would have on the most vulnerable populations, defined in the law as infants, pregnant women, the elderly and chemical industry workers. According to a press release by Sen. Udall, the bill would ensure chemical companies can no longer hide information on their products from public view and would require chemical companies to contribute significantly to the cost of regulation and ensure the EPA has the funds to do its job. States would be able to restrict a chemical until and unless the EPA takes up that same chemical and addresses the same uses. Once the EPA acts on a chemical substance, a uniform federal standard would be applied across the nation.

Among other things, the Senate version of TSCA reform would do the following.

  • ensure that only human and environmental health are considered in assessing the safety of chemicals, replacing TSCA’s current standard requiring a cost-benefit balancing during safety review
  • ensure that costs and other non-risk factors are considered only in deciding how to regulate a chemical found not to meet the health-based safety standard
  • require the EPA to identify relevant groups of individuals in assessing the safety of a chemical, to assess risks to any relevant populations and ensure their protection
  • eliminate TSCA’s requirement that the EPA first have evidence of risk to require testing
  • provide for the EPA to issue an order requiring testing, rather than having to promulgate a rule, which can be a multi-year process (testing authority applies to both new and existing chemicals and in limited instances for purposes of prioritisation)
  • upgrade the EPA’s review of new chemicals while retaining a balance with the need not to unduly impede innovation and speed to market
  • require for the first time that the EPA make an affirmative safety finding –  that a new chemical is likely to meet the safety standard –  as a condition for market entry
  • maintain the current 90-day review period for new chemicals and shorten that period when the EPA makes a positive safety determination
  • strike TSCA’s unworkable mandate that the EPA demonstrate that its regulations impose the “least burdensome” possible requirements
  • require the EPA to consider, based on existing information, costs and the availability of alternatives in selecting among regulatory options while ensuring that the EPA’s regulations are sufficient to address identified risks
  • require the EPA to review past confidential business information claims for active chemicals on the TSCA Inventory, the identities of which are not publicly available
  • require that certain CBI claims be substantiated when made and expire after 10 years unless re-substantiated
  • identify specific types of proprietary information for which claims do not require substantiation or re-substantiation
  • specify types of information, including health and safety data, that are not eligible for CBI protection
  • require the EPA to review all new CBI claims, require substantiation for chemicals found not to meet the safety standard, and create a rebuttable presumption of disclosure for a chemical that the EPA bans or phases out
  • require the EPA to collect fees for the review of new and existing chemicals to defray a portion of the costs of implementing the programme
  • specify that fees are capped at 25 percent of relevant EPA programme costs and that companies are to pay 100 percent of the costs of safety assessments they request (50 percent for those already on the EPA’s Work Plan)
  • provide for pre-emption of state authority that is chemical-specific, applies only when the EPA takes up a chemical, and is confined to the hazards, exposures, risks, uses and conditions of use of a chemical that are included in the EPA’s safety assessment and safety determination (and, where required, risk management rule)
  • pre-emption would apply only to state statutes or administrative actions restricting a chemical, not to requirements for reporting, monitoring or disclosure
  • states would be able to impose restrictions that are identical to a federal requirement, adopted under the authority of a federal law, or adopted under a state air or water quality or waste treatment or disposal law, unless they conflict with federal requirements

The legislation would also establish for the first time a mandate for the EPA to review the safety of all chemicals in active commerce, in contrast to TSCA’s grandfathering-in of chemicals then in use without any safety review. The key steps in the review process are as follows:

  • companies would have to identify all chemicals they are currently manufacturing or processing;
  • the EPA would establish the priority (high or low) of all active chemicals at a pace commensurate with agency resources and capacity;
  • high-priority chemicals would undergo full safety assessments and safety determinations against the updated safety standard;
  • for any chemical found not to meet the safety standard, the EPA would be required to impose restrictions sufficient for the chemical to meet the safety standard, and where restrictions cannot be imposed to ensure the chemical can meet the safety standard, the EPA would be required to either ban or phase it out;
  • low-priority chemicals are those the EPA concludes have sufficient information to establish that the chemical is likely to meet the safety standard;
  • in identifying high-priority chemicals, the EPA is to give preference to chemicals on its Work Plan that are persistent and bio-accumulative and those that are known human carcinogens and have high acute and chronic toxicity (the EPA’s criteria would also be required to account for recommendations of the governor of a state, hazard and exposure potential of a chemical substance, and storage near significant sources of drinking water);
  • companies could request and provide funds for the EPA to assess their chemicals (the EPA would be required to conduct a minimum number of such reviews and the maximum number would be capped to ensure EPA-identified chemicals remain the primary focus); and
  • all steps in the review and regulatory process would be subject to full notice and comment rulemaking and judicially enforceable deadlines, and minimum numbers of chemicals to be reviewed would be specified.
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