The RNRF Washington Round Table on Public Policy met with Dr. Richard Denison, a lead senior scientist with Environmental Defense Fund (EDF), in Washington, D.C. on December 9, 2015. Denison discussed the history of TSCA and recent activity surrounding legislative reform.
Chemicals are now ubiquitous, used to make 96% of all materials and products. Ten trillion pounds of chemicals are produced per year in the United States alone, or about 90 pounds per person per day. There are 85,000 chemicals on the TSCA Inventory, although not all are in use today. Chemical production has increased by 25 times globally since 1976, and is expected to continue to increase. However, our understanding of the human and environmental health risks of these chemicals has not kept pace with their production and use. We are routinely exposed to hundreds of chemicals, many of which are linked to chronic diseases that are on the rise.
Congress enacted the Toxic Substances Control Act (TSCA) in 1976 to address the production, importation, use, and disposal of specific chemicals. TSCA is the United States’ main chemical safety legislation, covering most chemicals used in industry and in commercial and consumer products. It is meant to provide the Environmental Protection Agency (EPA) with the authority to review most new chemicals under development, as well as the power to regulate chemicals already in or entering commerce if they present an “unreasonable risk” to human health or the environment.
However, TSCA is ineffective, hindering both EPA’s ability to generate information and its ability to act on that information when it indicates significant risk. EPA has required testing for less than 300 chemicals in 39 years, while tens of thousands of industrial chemicals already in commerce were grandfathered in and granted a strong “presumption of innocence.” Of the 300 chemicals tested, only 5 have been regulated because of the extraordinarily high hurdles EPA faces for testing and regulation. Recent legislation (S. 697 and H.R. 2576) has been introduced to reform TSCA.
Drivers of legislative reform
In addition to the increased understanding of the link between chemicals and health consequences, other drivers of recent TSCA reform include state legislation, market demand, EPA priorities, and effective reforms of other countries’ policies.
The most significant current driver of TSCA reform has been state action to regulate chemicals at the state level. State actions have removed some of the worst chemicals from commerce, such as phthalates in children’s products. However, state regulation has been limited by the high cost and expertise required to evaluate and regulate chemicals. Only 12 classes of chemicals have been regulated by states. Nevertheless, state action has created uncertainty in markets for the chemical industry. Additionally, there is increasing market demand for chemical regulation, especially from downstream users. This market uncertainty, in addition to falling public confidence in the dysfunctional federal chemical management system, has led to industry interest in “modernizing” the regulation.
Politically, the previous two EPA administrations under Gina McCarthy and Lisa Jackson have made TSCA reform a top priority. Additionally, other countries have taken the lead in chemical regulation reform, leading to more effective regulations than TSCA. The European Union enacted REACH in 2006, while Canada implemented its Canadian Environmental Protection Act in 1999.
Problems with current TSCA and how S. 697 addresses them
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) was introduced on March 10, 2015, with Senators Udall and Vitter as its main sponsors. This bill followed years of unsuccessful attempts at legislative reform, championed by the late Senator Lautenberg.
The most contentious aspect of TSCA reform is federal preemption of state authority over chemical regulation. Favored by industry, preemption in S. 697 is much more extensive than under current TSCA. Organizations such as the Environmental Working Group (EWG) and the Center for Environmental Health – which are opposed to S. 697 – cite the preemption of state action as a flaw in the bill. Under S. 697, states are preempted from taking new actions to regulate any chemical for which EPA has initiated a safety review, and final actions by EPA generally preempt states. According to EWG, EPA’s safety review and regulation process could take more than seven years, blocking state action in the meantime. In addition, states would be prevented from adopting and co-enforcing EPA’s chemical regulations. Finally, review by EPA would be dependent upon receipt of independently appropriated funds by Congress, which are not guaranteed.
EPA testing authority
Under current TSCA, EPA faces a Catch-22 in testing chemicals. In order to require the development of information sufficient to determine whether a chemical poses a risk, EPA must already have information sufficient to document potential risk or extensive exposure. S. 697 eliminates the requirement that EPA show potential risk or high release/exposure in order to require testing. Although the reform still limits what testing EPA can require, it does provide a major expansion in authority.
EPA review of new chemicals
Current TSCA categorizes chemicals into two groups – existing chemicals (on the market at the time the first TSCA Inventory was established) and new chemicals (those that entered commerce at some point since 1979). Existing chemicals were grandfathered in, while EPA has the authority to review new chemicals prior to market entry. However, EPA faces several constraints: no affirmative safety decisions are required, and the burden of proof is on the EPA. S. 697 mandates that EPA make an affirmative finding of safety for each new chemical before it enters the market. If EPA does not have enough information to make a safety determination, it can suspend review, pending receipt of more information.
How chemicals are selected for safety evaluations
Under current TSCA, EPA is not required to review the safety of existing chemicals, nor is it expected to examine a minimum number of chemicals. In fact, only about 2% of chemicals that were already on the market when TSCA was enacted have undergone any safety review. S. 697 would mandate EPA to prioritize all chemicals in active commerce, identifying low- and high-priority chemicals. EPA would be required to conduct safety assessments and determinations for all high-priority chemicals. Under this reform, EPA would be subject to a timeline of prioritization.
Confidential business information
Under current TSCA, companies can claim the identities of any of their chemicals to be confidential business information (CBI), hiding their inventory from public view. This makes it impossible for consumers, researchers, and health professionals to determine whether a chemical is present, or link it to other information about potential health effects or exposures. Under S. 697, upfront justification would be required for most claims; the EPA would review most claims, both existing and future; and states and health providers must be given access to information.
Consideration of costs and other non-risk factors
Current TSCA effectually precludes EPA from identifying a chemical that poses a significant risk without taking into consideration the economic and social costs of imposing controls on the chemical. However, an effective TSCA would separate scientific decisions as to whether a chemical poses a risk from policy decisions to address that risk. S. 697 explicitly prevents EPA from considering costs and other non-risk factors in making safety determinations. EPA’s safety assessment is based solely on risks to human health and the environment.
An amended version of S. 697 passed the Senate Environment and Public Works Committee in April on a 15-5 bi-partisan vote. The next action of S. 697 would be a move to the Senate floor. H.R. 2576, which passed through the full House on a 398-1 vote, is a far more skeletal reform of TSCA, generally avoiding any highly controversial changes to the existing TSCA.
Update: The Senate passed S. 697 on December 17, 2015.
Dr. Denison’s PowerPoint presentation can be downloaded here.
For more information on what a comprehensive TSCA would include, read Dr. Denison’s “Ten Essential Elements in TSCA Reform.”
 In the absence of clear evidence of harm, companies have largely been free to produce and use these chemicals.
 For more details on how S. 697 and H.R. 2576 address key flaws in TSCA, see Dr. Denison’s series of blog posts at http://blogs.edf.org/health/files/2015/09/Update-of-TSCA-reform-legislation-5-part-series-final.pdf.
 For a more detailed discussion of preemption under S. 697, see http://blogs.edf.org/health/2015/05/08/updated-understanding-preemption-in-the-lautenberg-act/.
 See http://www.ewg.org/enviroblog/2015/03/industry-chemical-bill-worse-current-law and http://www.ceh.org/opposition-letter-to-s697-frank-r-lautenberg-chemical-safety-act-for-the-21st-century-act/ for criticisms of S. 697.