Authors: Mark Duvall and Margo Ludmer
Beveridge & Diamond, P.C. , March 25, 2015
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On March 10, 2015, Senators Tom Udall (D-N.M.) and David Vitter (R-La.) introduced the Frank R. Lautenberg Chemical Safety for the 21 st Century Act (S. 697),  to modernize the Toxic Substances Control Act (TSCA). This bipartisan “Udall-Vitter” bill, which as introduced had eight Democratic and nine Republican sponsors and co-sponsors, likely marks a turning point in the long history of efforts to amend TSCA. It is off to a quick start, with a hearing held on March 18 before the Senate Environment and Public Works Committee.  However, it already faces a challenge in the form of a competing bill, the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act (S. 725), introduced by Senators Barbara Boxer (D-Calif.) and Ed Markey (D-Mass.), although with no Republican co-sponsors.  The “Boxer-Markey” bill features provisions from earlier Democratic bills that had attracted no Republican support. As explained in this alert, the Boxer-Markey bill and the Udall-Vitter bill overlap substantially. But the two bills diverge on several hot button issues, including preemption of state restrictions on chemicals, the safety standard, and regulation of legacy chemicals such as asbestos.
TSCA is the primary federal law for regulating chemicals. It authorizes EPA to regulate chemicals in a variety of ways, including by requiring manufacturers and/or processors to test chemicals; to report information about chemicals; to notify EPA before manufacturing chemicals not on the TSCA Inventory or before manufacturing or processing them for a significant new use; and to comply with chemical restrictions. Adopted in 1976 and not substantively revised since then, TSCA is widely considered to be outdated and ineffective. Critics charge that EPA has not accomplished much under TSCA during the nearly 40 years since its enactment. EPA has found the testing requirement cumbersome; the risk management provision unworkable; and the lack of a driver for it to review chemicals systematically an impediment. TSCA reform legislation was introduced in 2005, 2008, 2010, 2012, 2013, and 2014.  Although none of these bills was passed by either House of Congress, substantial progress has been made on agreements about the nature of the solutions needed to make TSCA more effective while protecting innovation and a national economy.
The Udall-Vitter and Boxer-Markey bills build on this progress. Most notably, both are based on a bipartisan bill originally introduced in 2013 by Senator Frank Lautenberg and Senator Vitter, the Chemical Safety Improvement Act (CSIA). Senator Lautenberg died 12 days after its introduction, and thereafter Senator Udall joined Senator Vitter in revising the CSIA to address objections to particular provisions. Their draft revision was leaked in September 2014.  These two new bills make changes to that draft revision, although the changes go in different directions, as explained below. Both bills would streamline the process by which EPA could require testing. Both would direct EPA to prioritize chemicals found to be in active commerce for detailed review in a safety assessment (essentially a risk assessment). Both would then require EPA to determine in a safety determination whether reviewed chemicals meet or do not meet a safety standard under the conditions of use. Those found not to meet the safety standard would become the subject of risk management measures intended to make the chemical meet the safety standard under the conditions of use. Both would protect confidential information, while requiring health and safety studies to be made available to the public.
Key Provisions of the 2015 Udall-Vitter Bill
1. Safety Standard
The Udall-Vitter bill’s safety standard would guide EPA in determining whether to take further action to regulate a particular chemical. The heavily negotiated provision would define the safety standard as one where “no unreasonable risk of harm to health or the environment will result from exposure to a chemical substance” under the “conditions of use.” The phrase “conditions of use” would be defined to mean “the intended, known, or reasonably foreseeable circumstances the Administrator determines a chemical substance is manufactured, processed, distributed in commerce, used, or disposed of.” A key change from current TSCA would be that the determination of whether a chemical meets the safety standard under the conditions of use would be made “without taking into consideration cost or other non-risk factors.”
2. State Preemption
The 2014 Udall-Vitter draft bill did not revise the CSIA’s preemption provision, but both Senators Udall and Vitter acknowledged last fall that such a change was needed. The 2015 Udall-Vitter bill makes a number of modifications to the CSIA’s preemption provision. The March 18 hearing indicated that disputes about preemption are likely to be the biggest obstacle to passage.
Like the CSIA, S. 697 would provide for limited preemption of state restrictions prior to EPA adopting risk management measures. The scope of that preemption would be narrower in the new bill, however. Unlike the CSIA, it would not provide for preemption of new state restrictions upon designation of a chemical as a low priority for a safety assessment or determination. The CSIA provision basing preemption on a low-priority designation had attracted more criticism than any other aspect of that bill.
For high-priority substances, the bill would tie preemption of new state prohibitions or restrictions to the scope of EPA’s safety assessment and safety determination. Under the new language, EPA would be required to define the scope of its safety assessment and determination within six months of a high-priority designation.
If EPA were to determine that a chemical met the safety standard, new and existing state laws that impose prohibitions or restrictions within the scope of the safety assessment and determination would be preempted as of the date of the safety determination. If instead EPA were to determine that the chemical did not meet the safety standard, new and existing state prohibitions or restrictions within the scope of the safety assessment and determination would be preempted as of the effective date of the subsequent risk management rule.
The Udall-Vitter bill’s preemption provision also differs from that of the CSIA in that it would grandfather all state restrictions in effect on January 1, 2015. Several state attorneys general had argued that their state restrictions should be preserved. The 2014 Udall-Vitter draft bill would have created an exception for California’s Proposition 65 only; the 2015 bill would substantially broaden that exception.
Two aspects of the Udall-Vitter preemption provision came under particular attack during the March 18 hearing. One was preemption of new state restrictions before EPA either enacted federal restrictions or decided that no federal restrictions were necessary. The other was that the bill has no exclusion from preemption for state restrictions that are identical to federal restrictions. Such an exclusion is a common feature of many federal product regulatory statutes so as to “put more cops on the beat,” as was repeatedly stated at the hearing.
The Udall-Vitter bill would authorize EPA to assess fees for certain activities and require that the fees be set so as to cover approximately 25 percent of the costs of administering the covered activities. Collectively, the fees would be capped at $18 million and would “reflect an appropriate balance” between manufacturers and processors. The following activities would be subject to potential fees:
The fees would go to a special fund in the Treasury, rather than to general revenues as under the current TSCA fee provision. No fees could be assessed if Congressional appropriations for TSCA administration fell below those approved for fiscal year 2015, providing a disincentive for Congress to reduce appropriations. EPA’s handling of fees would be audited annually by the EPA Inspector General’s office. In addition, EPA would have to consult with persons potentially subject to fees every three years to consider readjusting the fee amounts. This is similar to the procedure for setting fees for pesticides, prescription drugs, and medical devices, except new fees would be set through EPA rulemaking rather than through legislation.
The bill would limit EPA in applying any requirement for chemicals in articles. If EPA intended “to prohibit or otherwise restrict an article on the basis of a chemical substance contained in that article,” it would need to have “evidence of significant exposure to the chemical substance from such article.” At the hearing, EPA Assistant Administrator Jim Jones expressed concern about this provision.
The Udall-Vitter bill would set new requirements and deadlines for prioritization of chemicals. Within 180 days of the enactment of the bill, EPA would need to consider and publish an initial list of 10 high-priority substances and 10 low-priority substances. At least 5 of the initial high-priority substances would have to be drawn from the October 2014 TSCA Work Plan and subsequent updates. At least 50% of future high-priority substances would be drawn from the TSCA Work Plan until all such chemicals are prioritized. These new provisions come in response to requests for more immediate action on persistent bioaccumulative and toxic (PBT) chemicals, which are included in the TSCA Work Plan.
Following the initial prioritization of chemicals, EPA would be required to continue to designate high- and low-priority substances. After three years, EPA would need to add additional substances to ensure 20 high-priority substances had undergone or were undergoing safety assessments and determinations and to ensure that 20 low-priority substances had been designated. Within five years, EPA would need to ensure that 25 high- and 25-low priority substances had been addressed.
6. New Chemicals and SNURs
The TSCA regulatory scheme for new chemicals and significant new uses has been largely preserved under the Udall-Vitter bill. The bill would make one significant change, however. It would require EPA to make an affirmative determination that a chemical or significant new use is likely to meet the safety standard, rather than merely allow the applicable review period to expire, in order for production of the chemical or manufacture or processing for the significant new use to begin. If EPA were to determine instead that the chemical or significant new use would not be likely to meet the safety standard, risk management would be required.
Comparison of the Udall-Vitter Bill and the Boxer-Markey Bill
1. Common Requirements
Because the Udall-Vitter bill and the Boxer-Markey bill both work off of the 2014 Udall-Vitter draft bill, most of their provisions are substantially similar. Some of the more notable commonalities include:
2. Major Differences
Distinctions between the bills include:
Beveridge & Diamond’s Chemicals, Products & Nanotechnology Practice Group provides strategic, business-focused advice to the global chemicals industry. We work with large and small chemical companies from industries including basic and specialty chemicals, pharmaceuticals, electronics, crop protection, food contact materials and additives, and consumer products, and have substantial experience representing clients whose products and activities are subject to EPA's broad chemical regulatory authority under the Toxic Substances Control Act . For more information on the TSCA reform bills, please contact Mark Duvall . This alert was prepared with the assistance of Margo Ludmer.
 The Frank R. Lautenberg Chemical Safety for the 21st Century Act , S. 697, 114th Cong. (2015).
 Senator Markey, Press Release, Senators Boxer and Markey Introduce TSCA Reform Bill to Protect Health of Children and Communities (Mar. 12, 2015).
 See recent B&D client alerts on TSCA reform legislation: House Republicans Release Draft TSCA Modernization Legislation (March 6, 2014); Senate TSCA Hearing Highlights Perils of Path Forward for Updated Chemicals Management Framework (August 15, 2013); Bipartisan TSCA Modernization Bill, Chemical Safety Improvement Act, Introduced in Senate (May 24, 2013); “Safe Chemicals Act,” First TSCA Reform Bill of 113th Congress, Reintroduced (April 16, 2013).
 The Chemical Safety Improvement Act , S. 1009, 113th Cong. (as revised by Senators Udall and Vitter, September 2014).