Environmental Protection under Resource Constraints: Prioritizing Chemical Risk Assessments
August 26, 2017
American consumers routinely come into contact with harmful chemicals, including those hiding within products they might have assumed safe. The Federal Government historically had very little oversight of chemicals in the marketplace, and now an estimated 85,000 chemicals are available for common use.  On June 22nd, 2016, Congress took action to address this issue through amending the Toxic Substances Control Act (TSCA). New TSCA was passed with overwhelming bipartisan support, and grants the Environmental Protection Agency (EPA) the authority to require health-based safety findings for new chemicals before they can enter the marketplace.
But what about regulating the thousands of chemicals already in commerce?
Federal Regulatory Authority
The EPA has had the authority to regulate chemicals under the Toxic Substances Control Act since 1976, however; this control was significantly limited. EPA was required to go through a rulemaking to request a test on a single chemical if that chemical was already on the market. Further, in order to initiate a chemical review the Agency first had to receive evidence that a chemical substance posed a risk to human health or the environment.  Risk-related information was often in the hands of the Industry, that is, the manufacturers and processors of chemicals, and their supply chains. Ultimately, TSCA created a chemical regulation program in the United States that was self-regulated by the Chemical Industry and its beneficiaries. In recent decades the science of bio-monitoring, and improvements in international chemical laws, have led to growing pressures on the U.S. Federal Government to improve its control over chemicals.  Last year, the government finally took action to address these concerns.
June 22nd, 2017 marked the one-year anniversary since the Frank R. Lautenberg Chemical Safety for the 21st Act, which significantly amended TSCA, was signed into law.  This Act, commonly referred to as New TSCA, received bipartisan support in both the U.S. Senate and the House of Representatives before being signed by President Barak Obama. New TSCA gained the support of many regulators, environmental non-profits, NGO’s, and doctors, due to much needed reforms that significantly strengthened EPA’s authority to ensure the safety of chemicals.
The amendment includes the following improvements among others :
- New risk-based safety standard in which risk evaluations exclude cost considerations and other non-risk factors.
- Need to evaluate risks to susceptible subpopulations
- Increased public transparency on chemical information findings.
- Requirement for EPA to evaluate existing chemicals with clear deadlines.
Prioritizing Risk Assessments
A Final New TSCA Framework Rule, Procedures for Prioritization of Chemicals for Risk Evaluation Under TSCA, was released onto the Federal Register for public comment on July 20th, 2017, and will be effective on September 18, 2017. 
As required by New TSCA, the final Prioritization Rule establishes the process by which the EPA will systematically designate thousands of existing chemicals as “High Priority Substances” for risk evaluation, or “Low-Priority Substances” for which no risk evaluations are immediately prompted.  The rule states that the “prioritization of chemical substances for further evaluation will ensure that the Agency’s limited resources are conserved for those chemical substances most likely to present risks, thereby furthering EPA’s overall mission to protect health and the environment.”  Although the high priority substances will be a relatively small subset of the universe of chemicals in the marketplace, such characterization is necessary to focus on the most pressing threats to human health and the environment.
The California Environmental Protection Agency urges EPA to “move forward quickly to finalize the rule and implement the prioritization process.”  CalEPA fears that if EPA were to delay the issuance of this final prioritization rule, then a cascading effect could result in which later assessment and management stages could experience delay as well.
Other stakeholders, such as The American Coatings Association℠, have concerns that the EPA is overreaching their resource capabilities with this prioritization proposal. ACA, a trade association representing the paint and coatings industry (including downstream users, processors, and manufacturers of chemical products), submitted a comment on the Federal Register in response to EPA’s Prioritization Rule:
ACA is concerned that all uses of a chemical substance will be included when making a designation of High Priority or Low Priority… The bar for a High Priority designation is extremely low, where only one condition of use can result in a designation of High Priority… ACA urges EPA to consider specific uses when making prioritization decisions. 
The debate surrounding EPA’s proposed prioritization process involves the question as to whether or not it is sensible to prioritize chemical risk evaluations before having assessed risk.
Safer Chemical Future?
Ultimately, New TSCA is an example of legislative reform in which the Federal Government is given more power to regulate Industry practices. As the EPA moves forth with prioritizing their review of both new and existing chemicals, undergoing health and environmental fate assessments, and developing risk management solutions, businesses are given an opportunity to get ahead of future regulations. Dr. Frank Wigen, Professor of Strategic Management and Entrepreneurship at the Rotterdam School of Management, has demonstrated in his research that stricter environment laws, or the anticipation of such standards, tends to increase green innovation and technology.  With the possibility of new chemical regulations in sight, businesses focused on long-term sustainability are likely to seek safer alternatives to harmful chemicals. Initiatives to assess, improve, and take responsibility for a company’s own impact on human and environmental wellbeing is known as Corporate Social Responsibility, or, CSR.  An increased demand for healthier substitutes could lead to environmentally-focused R&D, and to strategies for importing, designing, manufacturing, and using safer chemicals in the United States.
With limited EPA funding and personnel, and a U.S. history of chemicals freely entering the marketplace in industrial and consumer products, prioritization of risk evaluations will focus the Agency’s attention on chemical substances that have demonstrated the greatest concerns to human health and the environment. Ultimately, the chemical substances selected as “High Priority” during the EPA prioritization process will determine which of the hundreds of thousands of chemicals in commerce will be evaluated straight away, for the protection of future generations to come.
Student Blog Disclaimer
The views expressed on the Student Blog are the author’s opinions and don’t necessarily represent the Penn Wharton Public Policy Initiative’s strategies, recommendations, or opinions.
Additional Blog Posts
 Urbina, Ian. “Think Those Chemicals Have Been Tested?” The New York Times, The New York Times, 13 Apr. 2013, www.nytimes.com/2013/04/14/sunday-review/think-those-chemicals-have-been-tested.html?_r=1.
 Kerr, Bob. “Chemicals in Consumer Products: New Progress in Transparency.” Sustainablebrands.com, Sustainable Life Media Inc. , 30 Jan. 2014, www.sustainablebrands.com/news_and_views/chemistry_materials/bob_kerr/chemicals_consumer_products_new_progress_transparency.
 “The Frank R. Lautenberg Chemical Safety for the 21st Century Act.” EPA, Environmental Protection Agency, 2 Aug. 2017, www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.
 “Highlights of Key Provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act.” EPA, Environmental Protection Agency, 23 June 2016, www.epa.gov/assessing-and-managing-chemicals-under-tsca/highlights-key-provisions-frank-r-lautenberg-chemical.
 “Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act.” Federal Register, EPA-HQ-OPPT-2016-0636 FRL-9964-24, 20 July 2017, www.federalregister.gov/documents/2017/07/20/2017-14325/procedures-for-prioritization-of-chemicals-for-risk-evaluation-under-the-toxic-substances-control.
 Solomon , Gina M. “Comments from the California Environmental Protection Agency [Docket: EPA‐HQ‐OPPT‐2016‐0636].” Regulations.gov, Federal Register, 20 Mar. 2017, www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0636-0029.
 Davis, Raleigh. “Comment Submitted by Raleigh Davis, Assistant Director, Environmental Health and Safety, American Coatings Association (ACA).” Federal Register, American Coatings Association, 20 Mar. 2017, www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0636-0053.