University of Maryland Law Fellow
US EPA Office of Civil Enforcement
Waste and Chemical Enforcement Division
On April 14, 2011, Senator Lautenberg of New Jersey introduced the 2011 Safe Chemicals Act (2011 SCA), almost a year after he introduced a similar bill (S. 3209) that failed to garner sufficient Congressional support. Senator Barbara Boxer of California, Senators Amy Klobuchar and Al Franken of Minnesota, and Senator Charles Schumer of New York co-sponsored the bill. The 2011SCA is intended “to modernize the ‘Toxic Substances Control Act of 1976’ (TSCA) and protect Americans from exposure to dangerous toxins.” Readers familiar with the bill introduced in 2010, S. 3209, will find many of the same concepts and requirements in the 2011 SCA. Whether this latest bill will progress further than its predecessor is unknown, but there are many reasons to believe that it will not, despite support from the high-ranking Democratic Senators Boxer and Schumer.
According to Senator Lautenberg, the 2011 SCA addresses many of TSCA’s weaknesses identified by the US Government Accountability Office in its 2005 Report to Congress, Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program. It also adopts many of the recommendations for US Chemicals Management Policy advocated by the American Academy of Pediatrics, former EPA Associate Administrators for the Office of Prevention, Pesticides, and Toxic Substances, and National Institutes of Health officials. Readers unfamiliar with those recommendations should know that they stressed that efforts to modernize TSCA must: (1) ensure that chemicals in commerce demonstrate reasonable certainty of no harm, at all stages of human development, and through all possible exposure routes; (2) provide EPA practical tools to assess the safety of chemicals currently in use; and (3) establish public access to chemical safety information. Senator Lautenberg also emphasized that the 2011 SCA would require safety testing of all industrial chemicals, and put the burden on industry to prove that chemicals are safe in order to get on, or remain on, the market. In contrast, current TSCA parameters generally do not require chemical companies to test new chemicals for toxicity or to gauge exposure levels before they are submitted for EPA’s review.
Again, the 2011 SCA has many conceptual similarities to legislation the Senator sponsored in 2010 (S. 3209), but there are differences in some of the details of implementation. The 2011 SCA would:
- require manufacturers to submit minimum data sets to allow the EPA to conduct screening-level risk assessments for new and existing chemical substances (see amended §4(a));
- facilitate data sharing across federal agencies (see amended §4(f));
- require manufacturers and processors to submit new chemical notifications for chemical substances (and mixtures upon certain EPA findings) that EPA could approve upon a finding that the substance meets the Section 6 safety standard or that the substance does not meet other criteria concerning production volume, release, toxicity, etc. (see amended §5);
- require manufacturers to submit reports describing current manufacturing or processing (see amended §8(a)), including
- chemical identity,
- manufacturing and processing facility location,
- known uses of, exposure to, and fate information, and
- health and safety studies not previously filed with the Administrator;
- allow the Administrator to order manufacturers to make supplemental information submissions (see amended §8(b)) to assist
- in making safety determinations, and
- any aspect of administering TSCA; and
- establish an Internet-accessible database to provide public access to significant chemical safety information (see amended §§5(b)(2), 8(d)), including
- premanufacture notices (PMNs),
- safety testing, and
- Agency decisions.
In addition to maintaining a number of the conceptual changes to TSCA proposed in 2010, the 2011SCA includes new authorities regarding safety standard determinations and confidential information. For example, the amended Section 6 would establish a risk classification scheme for chemical substances currently in use.
- Priority Class 1 would comprise chemical substances that are assessed by the Administrator as requiring immediate risk management. Substances in Class 1 would be those that are degraded and metabolized into persistent, bioaccumulative, and toxic substances with the potential for widespread exposure to humans or other organisms. Within 18 months of assignment to this priority class, the Administrator would be required to impose conditions on the manufacturing, processing, use, distribution in commerce, and disposal of the substance to achieve the greatest practicable reductions in human and environmental exposure.
- Priority Class 2 would include chemical substances, presently in commerce, for which the Administrator found a more-than-theoretical concern of uncertainty that they could meet the safety standard required for new chemicals. Assignment to Class 2 would be conducted in order of risk presented to human health and the environment.
- Priority Class 3 would include only those chemical substances for which the Administrator determined no immediate action was required because the substance did not and would not, at any stage of the lifecycle, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.
No judicial review would be available for assignment to any priority class.
The 2011 SCA also specifies minimum considerations for safety standard determinations of both new and existing chemicals (see amended §6(b)). The legislation would require the Administrator’s risk assessment to include consideration of scientific literature relating to the effect of cumulative exposure to chemical substances. The Administrator would be permitted to find that a substance meets the safety standard only when there is a reasonable certainty that neither human health nor the environment would be harmed from aggregate exposure. Judicial review would not available for determinations that manufacturers have not established that chemical substances meet applicable safety standards.
The 2011 SCA would limit protections for confidential business information. Section 14 would also allow the Administrator to determine that particular information previously considered eligible for confidential treatment is no longer entitled to such treatment.
Lastly, 2011 SCA would have limited preemptive effect. States and their subdivisions would remain free to adopt or enforce any regulation, requirement, or standard of performance that was different from, or in addition to, a regulation, requirement, liability, or standard of performance established under TSCA, unless it was impossible to comply with both, in which case the TSCA requirement would control. Although the preemption provision was revised from the 2010 bill, Senator Lautenberg continues to prefer robust state involvement in chemicals management.
The website for Senator Lautenberg’s office provides summaries of and the text of the Safe Chemicals Act of 2010 and 2011 (2010 bill, 2010 summary, 2011 bill, 2011 summary).
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DISCLAIMER: This work is not a product of the United States Government or the United States Environmental Protection Agency, and the author is not doing this work in any governmental capacity. The views expressed are those of the author only and do not necessarily represent those of the United States or the US EPA.