In 1976, Congress enacted the Toxics Substances Control Act (TSCA) to control hazards posed by chemical substances. 5 U.S.C. §§ 2601–2692 (1976). TSCA authorizes the U.S. Environmental Protection Agency (EPA) to obtain chemical data; require testing of chemical substances; and regulate the manufacture, use, labeling, and disposal of chemical substances posing unreasonable risks of injury to health or the environment.
Despite TSCA’s considerable ambitions to address chemical hazards, few dispute that it has failed to achieve its goals. “Virtually every expert panel that has examined the U.S. system of chemical regulation has concluded that it inadequately protects public health and the environment.” Noah Sachs, Jumping the Pond: Transnational Law and the Future of Chemical Regulation, 62 Vand. L. Rev. 1817, 1818 (2009) [hereinafter Jumping the Pond]. Notably, “[t]he great majority of chemicals [subject to TSCA] remain largely unstudied for any but the most obvious effects, and EPA would have tremendous difficulties in restricting dangerous uses, even if these effects were known.” John, S. Applegate, Synthesizing TSCA and REACH: Practical Principles for Chemical Regulation Reform, 35 ELQ 721, 750 (2008) [hereinafter Synthesizing].
In 2007, the European Union (EU) put into effect the Registration, Evaluation, and Authorization of Chemicals (REACH) regulation. Regulation No 1907/2006 of the European Parliament and of the Council (EC) (Dec. 2006). Like TSCA, REACH aims to protect human health and the environment from chemical risks. However, the drafters of REACH, cognizant of TSCA’s deficiencies and failures, designed REACH with TSCA’s shortcomings in mind, and thereby crafted REACH, in many respects, as the “Anti-TSCA.” See Synthesizing at 743, Jumping the Pond at 1832.
This article recaps a number of commonly acknowledged flaws of TSCA, considers the regulatory approach taken by REACH and the EU’s attempt to counter TCSA’s flaws, and compares two recent congressional efforts to amend TSCA.
Critical shortcomings most often associated with TSCA include data deficiencies, limited public access to information, and nearly insurmountable agency burdens for restricting chemical manufacture and use. In contrast, REACH demands far greater data development and information sharing and adopts a precautionary approach that transfers many regulatory burdens from governmental regulators to the regulated chemical industry.
In testimony before members of Congress in November 2013, law professor Wendy Wagner explained TSCA’s data gap: “The literature . . . reveal[s] a central and noncontroversial reason for the failure of TSCA—the lack of basic toxicity information on chemicals and the tendency of this regulatory program to perversely create incentives that perpetuate this ignorance.” Testimony of Wendy E. Wagner to the U.S. House of Rep. Energy & Commerce Committee’s Subcommittee on Env. and the Economy 6 (Nov. 13, 2013) [hereinafter Wagner Testimony]. One reason for TSCA’s data gap is its exemption of “existing” chemicals. “About 64,000 of the 82,000 chemicals (78 percent) that have been introduced in the United States are ‘existing’ chemicals that are grandfathered under the Act. By volume, the grandfathered ‘existing’ chemicals represent 99 percent of chemicals on the U.S. market.” Jumping the Pond at 1826. Due in large part to just such scientific information deficiencies, the U.S. Government Accountability Office (GAO) added EPAs processes for assessing and controlling toxic chemicals to its list of programs at high risk of “waste, fraud, abuse, and mismanagement” in 2009. See U.S. Gov’t Accountability Office, High-Risk Series: An Update, 22–24 (Jan 22, 2009).
In addition, although TSCA requires submission of available human health and environment data for new chemicals, it does not provide for development of data unless and until EPA first determines that a chemical warrants such testing. See U.S. Gov’t Accountability Office, GAO-07-825, Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approached to Protect Against the Risks of Toxic Chemicals 8–9 (2007) [hereinafter GAO Report]. And herein lies a disconcerting hitch: “EPA must have chemical information in order to prove that it needs it, but it needs the information because it does not have it.” Synthesizing at 738. And, to the extent EPA has sufficient information to support a rulemaking, such determinations are resource intensive (costing as much as $234,000 per rule) and time consuming (taking two to ten years for rule promulgation). See GAO Report at 9–10. Not surprisingly, in the first three decades of implementation EPA required testing of “fewer than two hundred out of thousands of existing chemicals.” Synthesizing at 738.
In contrast, REACH demands that the chemical industry provide and develop more information than TSCA, in part by creating “a single system” for the regulation of new and existing chemicals. GAO Report at 15–16. To register any chemical produced or imported at 1 metric ton or more per year, companies must submit information such as “the chemical’s identity; how it will be produced; how it will be used; guidance on its safe use; exposure information; and study summaries of physical/chemical properties and their effects on human health or the environment.” Id. Under REACH, the greater the tonnage of a chemical produced or imported, the more information mandated for registration. Id. at 16. Significantly, “failure to submit the required chemical registration package, including the suite of toxicity data specified in the legislation, results in denial of access to the billion European chemical market.” Jumping the Pond at 1835. Reportedly, this “No Data, No Market” approach is “already making toxicity testing a routine part of doing business in Europe, rather than the exception, as it is in the United States.” Id.
REACH also provides for greater public access to toxics information. Although both TSCA and REACH require that existing information on chemical health and safety be made publically available, TSCA allows chemical companies to assert confidentiality claims on nearly all information provided to EPA. Id. at 25. In contrast, REACH “places substantial restrictions on the types of data that chemical companies may claim as confidential.” Id. at 27. And, unlike TSCA, REACH promotes access to chemical toxicity data by establishing a publically accessible website with all nonconfidential chemical data and by allowing even confidential chemical information to be shared with non-EU governmental authorities and international organizations. Id. at 28. See also Jumping the Pond 1834.
Aside from data deficiencies, TSCA’s ability to regulate toxic chemicals has been plagued by nearly insurmountable proof problems. “Not only does EPA not receive adequate data, but the agency’s ability actually to act on those data is both procedurally and legally difficult.” Synthesizing at 737. For EPA to limit an existing chemical’s production or use, the agency must first demonstrate that the chemical “presents or will present an unreasonable risk of injury to health or the environment.” 5 U.S.C. § 2605(a). Although a somewhat relaxed standard applies for new chemicals, TSCA still imposes heavy burdens on EPA to demonstrate that restriction of new chemicals is warranted. GAO Report at 21.
In contrast, REACH places responsibility on the chemical industry to prove chemicals safe before manufacture and use. Whereas the “[d]efault presumption of TSCA . . . is that the vast majority of chemicals can be freely marketed, even absent any toxicity testing, unless and until EPA can prove that they pose unreasonable risks,” REACH adopts the principle that the chemical industry bears the burden of proving chemical are safe and “should ensure that the chemicals they manufacture, place on the market, or use do not adversely affect human health or the environment.” Jumping the Pond at 1827; GAO Report at 18.
There are two TSCA reform bills before the 113th Congress: the Safe Chemicals Act of 2013 (SCA) and the Chemical Safety Improvement Act (CSIA). Both propose to address TSCA’s failings.
In April 2013, the late Senator Frank Lautenberg (D-NJ) along with Senator Barbara Boxer (D-CA) reintroduced the SCA. See S. 696, 113th Cong. (2013). Key amendments provide for (1) categorizing and prioritizing regulation of chemicals by their hazard and exposure potential (level of concern); (2) requiring minimum chemical safety information for existing (previously grandfathered) and new chemicals; (3) authorizing EPA’s use of “orders” to obtain data or require data development (in addition to rulemaking); (4) shifting responsibility to chemical manufacturers and processors to prove chemical substances meet applicable safety standards; (5) limiting confidential business information (CBI) claims; and (6) establishing an Internet-accessible database for storing and sharing chemical toxicity, use, and exposure information. See Congressional Research Service (CRS), S. 696 Bill Summary. In addition, the SCA would add provisions to identify and aid communities subject to disproportionately high toxic chemical exposures, establish programs to promote safer alternatives to existing chemicals and advance understanding of the vulnerability of children to chemical substances, and increase international cooperation. Id.
As drafted, the SCA embraces a number of the anti-TSCA adaptations of REACH. In particular, SCA would narrow the data gap by regulating existing toxic substances, adopt a more precautionary approach by shifting burdens of proof to industry, and enhance transparency and information sharing. The SCA has elicited support from environmental and public health organizations, little enthusiasm from the chemical industry, and, to date, insufficient bipartisan support for passage.
In May 2013, Senator David Vitter (R-LA) and the Senator Lautenberg introduced the more modest CSIA. See S. 1009, 113th Cong. (2013). Key amendments provide for (1) evaluation of new and existing (previously grandfathered) chemicals based on a high/low prioritization system; (2) application of “best available science”; (3) adjustment of the unreasonable risk standard to focus on health and safety factors rather than cost considerations; (4) reduction of the burden on EPA to gather test information from manufacturers; and (5) revision of existing CBI provisions. See Committee on Energy & Commerce: Majority Committee Staff, Memorandum re Hearing on Senate-Introduced Legislation Reforming TSCA, S.1009 (Nov. 2013); Environmental Working Group, Side-By-Side Comparison: Safe Chemicals Act vs. Chemical Safety Improvement Act Chart (June 2013) [hereinafter EWG Comparison].
The CSIA, like SCA and REACH, targets TSCA’s data gap problem by requiring review of previously exempt existing chemicals and by allowing EPA to issue orders (rather than use rulemaking) to mandate safety testing. See Richard Denison, Reality Check on TSCA Reform Legislation, EDF Health (June 2013). The CSIA also moves in the direction of REACH by requiring an affirmative safety decision before market entry for new chemicals. Id. Regarding transparency, CSIA would adjust TSCA’s CBI protections, albeit with a more watered-down version than SCA (CSIA would grandfather protection for most pre-amendment CBI information), but would not provide for international information sharing as authorized by SCA and REACH. See EWG Comparison.
Overall, CSIA retains a more “TSCA-like” flavor than SCA. By tinkering with, but essentially preserving TSCA’s “unreasonable risk” standard (EPA retains the burden of proving chemicals unsafe and cost considerations factor in for imposition of restriction), the CSIA rejects the precautionary approach of REACH. Further, SCIA’s procedural and “good science” requirements may impose even greater constraints on EPA’s ability to demand new test data, consider information received, and regulate commercial chemicals than under TSCA’s existing provisions. See Wagner Testimony 3–9. Not surprisingly, the CSIA evokes significantly less enthusiasm from environmental and public health advocates than SCA and a more favorable response from industry. More interestingly, however, the CSIA has bipartisan congressional backing despite the current notoriously partisan climate in Washington.
Given TSCA’s well-acknowledged flaws, a bipartisan willingness to consider change, and REACH’s growing influence (literally and figuratively “reaching” across the globe), congressional updating of TSCA seems possible, even probable. Just as EU regulators thoughtfully crafted REACH taking into account the successes and failures of TSCA, TSCA reformers should likewise carefully consider REACH in remaking TSCA.