Regulatory DevelopmentsNovember 14, 2013
On November 13, 2013, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on the Chemical Safety Improvement Act (S. 1009) (CSIA), which was introduced in May 2013 by the late Senator Frank R. Lautenberg (D-NJ) and Senator David Vitter (R-LA). Earlier this year, the House Subcommittee held hearings to provide an overview of Title I of the Toxic Substances Control Act (TSCA); examine TSCA Sections 5 and 14, which address the regulation of new chemicals, new uses of existing chemicals, and the protection of confidential business information (CBI); and consider the regulation of existing chemicals and the role of preemption under TSCA Sections 6 and 18. The goal of the Subcommittee's November 13 hearing was to provide the Subcommittee an opportunity to examine the CSIA. The Subcommittee's background memorandum provides a summary of the following changes proposed by the CSIA to TSCA Title I and how they compare to existing law: definitions; data development requirements; notice requirements for new chemicals and uses; safety assessments, determinations, and regulatory restrictions; information gathering and the TSCA Inventory; imports; CBI; and preemption. An archived webcast of the hearing and the background memorandum are available online.
The Subcommittee heard from the following witnesses, whose statements are available online:
- Senator David Vitter (R-LA);
- Senator Tom Udall (D-NM);
- Jim Jones, Assistant Administrator, Office of Chemical
Safety and Pollution Prevention, U.S. Environmental
Protection Agency (EPA);
- Calvin M. Dooley, President and Chief Executive Officer
(CEO), American Chemistry Council;
- Ernie Rosenberg, President and CEO, American Cleaning
- Richard Denison, Ph.D., Senior Scientist, Environmental
Defense Fund (EDF);
- Dean C. Garfield, President and CEO, Information
Technology Industry Council;
- Andy Igrejas, National Campaign Director, Safer
Chemicals, Healthy Families; and
- Wendy Wagner, Joe A. Worsham Centennial Professor, The University of Texas School of Law.
In his opening statement, Representative John Shimkus (R-IL), Chair of the Subcommittee, expressed his hope that the Subcommittee would hear about the best attributes of the CSIA, as well as what provisions need improvement. Representative Paul Tonko (D-NY), Ranking Member, noted that, while the bipartisan bill offers an opportunity for broad participation to reform TSCA, the CSIA does not yet address the flaws in TSCA and, in some cases, moves backwards. According to Tonko, there is no need for the CSIA to preempt state regulation of chemicals if the bill will do what it claims.
In his testimony, Vitter repeatedly stressed his willingness to work with anyone interested in achieving a meaningful, bipartisan compromise. Vitter acknowledged that since the bill's introduction, some legitimate issues have been raised, and anyone committed to resolving those issues is welcome to work with him to do so. Vitter concluded his testimony by stating that the CSIA is the "core and foundation" of TSCA reform legislation.
Udall also acknowledged that the CSIA, as introduced, is not a perfect bill and that some provisions need to be addressed. According to Udall, TSCA reform legislation must address three significant issues: (1) ensuring EPA will have the tools it needs to protect citizens and review the existing chemicals in commerce; (2) making sure to protect private rights of action for citizens to hold companies accountable; and (3) protecting the rights of states to safeguard their citizens.
In his testimony, Jones noted that EPA has not developed a formal position on the CSIA, but offered several observations in light of the EPA's September 2009 "Essential Principles for Reform of Chemicals Management Legislation." According to Jones, TSCA reform legislation should provide EPA the authority to establish risk-based safety standards that are protective of human health and the environment. EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard. Clear, enforceable, and practible deadlines should be set for EPA to review and make decisions on chemicals. A sustained source of funding should be provided for implementation, and unwarranted CBI claims should be discouraged. Jones testified that the proposed changes to TSCA Section 5 that would include requiring EPA to make an affirmative finding of safety are important ones. Jones expressed concern that the CSIA continued to use the phrase "unreasonable risk," and that, in conjunction with other language in the bill, this would lead to "paralysis by analysis" by requiring EPA to conduct endless analysis of alternatives before it can take action. According to Jones, while the CSIA would require EPA to set deadlines, it would also allow EPA an "unlimited ability" to change those deadlines.
Dooley stressed the broad support that the CSIA has received from Republicans and Democrats, as well as industry and environmental groups such as EDF. Dooley stated his understanding that the non-governmental organization (NGO) believes certain provisions of the CSIA need to be revised, including attention to sensitive subpopulations; preserving state authority to regulate chemicals; EPA's ability to restrict chemicals; data requirements; and deadlines. According to Dooly, these issues can be resolved.
Rosenberg testified that TSCA reform is necessary to provide a robust and credible federal program, which is crucial to the national uniformity required by the cleaning products industry. TSCA reform would allow scientific developments and advances to be incorporated into safety assessments and determinations.
Denison stated that the CSIA would address several flaws that currently exist, such as by establishing safety requirements for all chemicals in use; requiring that new chemicals be found likely to meet the safety standard before entering the market, providing greater access to CBI; and striking the "least burdensome" requirement, which has paralyzed EPA. Denison testified that several provisions under the CSIA need to be addressed, however, such as including a safety standard that would ensure protection of vulnerable populations, addressing the lack of deadlines and imposition of numerous procedural requirements, and significantly narrowing the bill's broad preemption of state authority. Denison chose to end on a positive note, describing the CSIA as offering a major political opportunity. Although there are deficiencies in the current bill, they are fixable, and Senate negotiations appear to be moving in the right direction.
Garfield suggested that Congress use the CSIA to provide guidance to EPA on regulating chemicals in articles. While TSCA currently allows EPA to apply its import and export provisions to chemicals in articles, the U.S. government has historically exempted articles from the import/export provisions, while reserving its ability to regulate articles on a case-by-case basis. Garfield testified that the CSIA contains a problematic definition in its import provision that conflates articles with chemical substances and mixtures, and recommended that the definition either be deleted or rewritten to ensure consistency.
Igrejas urged Congress to revise the CSIA to redefine the safety standard to clarify that it is a risk-only standard and end the "least burdensome" requirement. Safety determinations should clearly incorporate protection for vulnerable populations such as children and pregnant women. According to Igrejas, the CSIA requires new frameworks and guidance that would substantially delay implementation. The CBI provisions should be revised to strike a balance on the issue of chemical identity. Igrejas stated that one of the only benefits of TSCA was that it did not limit states in regulating chemicals, and stated that the preemption provisions of the CSIA must be revised.
Wagner focused on the good science provisions of the CSIA and how they would impact EPA's use of science. According to Wagner, the CSIA is just as likely to undermine the scientific rigor of EPA's decision making as support it. Wagner testified that Congress should not restrict the scientific evidence that EPA can consider. To date, the issue has been that EPA does not have enough information available to make decisions, and legislation that restricts the information available to EPA seems to move backwards. Wagner also questioned the CSIA's use of the phrase "best available science."
During the questioning period, the Subcommittee members expressed a keen interest in having an EPA witness available and spent over two hours with Jones during which they explored a wide array of issues through numerous rounds of questioning. Over the course of the questioning, Jones identified areas for which he thought S. 1009 represented an improvement relative to TSCA, as well as areas needing more work. Among the examples he cited were the following:
- "Improvements" in S. 1009:
- The requirement under Section 5 for an affirmative
finding by EPA on new chemical notifications.
- The ability to use order authority under Section 4 to
- The ability to share CBI with states.
- Areas needing more work/discussion:
- Section 6 -- While an improvement over current TSCA,
requires extensive analysis of alternatives that could
lead to "paralysis by analysis."
- Funding and resources -- EPA will need some source of
sustained funding and Jones seemed to reference fee
approaches such as those under the Food Quality Protection
- Deadlines should be strengthened -- Here Jones recalled
the experience under FQPA in dealing with food use
pesticides in a ten-year period.
- Preemption -- Jones agreed that preemption needed to be
better balanced, e.g., it might make sense for preemption
to be more limited for final risk management actions
whereas perhaps not for prioritization decisions that could
require years before EPA was positioned to identify and
implement risk management actions.
- Judicial review -- Jones questioned whether it made
sense to bar review of "low priority" decisions that could
essentially represent a final Agency action.
- Vulnerable populations -- Jones agreed that the concept
is mentioned in S. 1009 (which is an improvement over
TSCA), but thought that limiting it to consideration under
safety assessments (but not under safety determinations
and risk management actions) was too narrow.
- Section 4 -- Jones indicated that he thought testing to inform prioritization decisions was not precluded under the bill, but recognized that others disagreed with this view and thought the point should be clarified.
When questioned about the need for "base set" testing for new chemicals or to inform prioritization decisions, Jones argued that EPA tools to predict toxicity and environmental fate worked pretty well such that the testing needs could be tailored (as is allowed under S. 1009) rather than look to a flat requirement. Jones also expressed support of the view that two prioritization levels (high and low priority) were sufficient and that not much would be gained by additional levels.
Jones' written testimony did not offer much beyond the Administration's "principles." The insights and suggestions offered during questioning, while they did not suggest specific fixes, offered much food for thought as to where and how changes might be considered, a point reflected in the several members who thanked Jones at the end of his time.
The questioning of the witnesses on the third panel (industry, NGO, academia) was more limited (only a single round) and did not produce much new understanding. When asked if they thought S. 1009 was an improvement over TSCA, two of the six said "yes," two said "yes and no," and two said "no"; Shimkus noted, given all the problems with TSCA, that he found this reaction was a bit surprising.
The House hearing on the Senate bill was welcomed by members from both parties and also by the witnesses who agreed that TSCA needed to be changed. Given the complexities involved in revising TSCA, the hearing may indicate that the House would rather work with the Senate to develop TSCA reform legislation than introduce separate legislation. Nonetheless, there has been a tendency in the current Congress to pursue separate bills in each chamber, so time will tell.
Vitter and Udall's willingness to work with anyone committed to meaningful bipartisan reform was welcomed and important to hear. While certain provisions of the CSIA have been criticized in previous hearings, most notably the state preemption provisions in the July 31, 2013, hearing by the Senate Committee on Environment and Public Works on "Strengthening Public Health Protections by Addressing Toxic Chemical Threats," no specific revisions to the CSIA were discussed to address these concerns. Senator Barbara Boxer (D-CA), Chair of the Senate Committee on Environment and Public Works, stated on November 5, 2013, that she is "making every effort" to complete TSCA reform in 2013. She previously pledged to write a bill combining both the CSIA and the Safe Chemicals Act of 2013 (S. 696), which Lautenberg reintroduced on April 10, 2013, before introducing the CSIA with Vitter.
The testimony and questions often came back to the question of preemption, and although the discussion mostly centered on the need to "fix" the language currently in S. 1009, there was no discussion of alternative language. Less prominent and virtually ignored was the testimony of Jones that S. 1009 replaces the current TSCA language of "least burdensome" with new language that EPA assesses to be equally troublesome (language EPA lawyers have judged to be almost equivalent in terms of requiring endless analysis of alternatives). Any successful bill will need a more resounding endorsement from EPA. Committee members, mostly along party lines, expressed some familiar themes throughout the event (e.g., Republicans stressing the need to protect innovation in the chemical industry; Democrats stressing the need to protect sensitive subpopulations and have deadlines for Agency action). There was repeated focus on the safety standard and whether any new legislation should have a cost-benefit standard or a risk-only approach -- an issue likely to receive much more scrutiny if the legislation appears to have a serious chance of success in this session of Congress.
In general, however, the tone was exceedingly cordial and courteous among the Committee members and between the Chair and the witnesses, which is not always the case in the current Congress. Promises of continued attempts to reach consensus abounded among members and witnesses across the ideological spectrum. What remains to be seen is if these good wishes and good intentions will be enough to have the various constituencies persevere in the attempt to achieve a consensus bill.
Memoranda regarding the TSCA reform bills and on the hearings held to date are available online.