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Big Changes in Store for TSCA

By James A. Vroman  

Congress enacted the Toxic Substances Control Act ("TSCA") in 1976 amid much fanfare.  Ostensibly, the Act gave the U.S. EPA authority to regulate chemicals manufactured in, or imported into, the United States with the goal of banning or restricting the use of chemicals that could pose an unacceptable risk to human health or the environment.  However, from the date of its enactment, the "authority" the Agency had to regulate the manufacture or importation of chemicals under TSCA was severely limited and restricted.  See, High Risk Series: An Update. GAO-09-271. Washington, D.C.: Jan. 22, 2009, at pp. 22-23.


For example, the Act initially exempted thousands of chemicals from the notification requirements of the Act.  Chemicals that existed at the time TSCA was enacted were “grandfathered” onto the TSCA Inventory of chemicals. See, 44 Fed. Reg. 28558 (May 15, 1979). The Act’s requirement that manufacturers or importers of chemicals submit a Pre-Manufacture Notice, or PMN, with the U.S. EPA, for the Agency’s review, before producing or importing a new chemical only applied to chemicals created after TSCA became a law. See, 15 U.S.C. §§ 2602(9), 2607 (B)(1). As a result, the Agency has no authority to regulate the manufacture or importation of thousands of chemicals unless the manufacturer or importer will be using the “grandfathered” chemical in a “significantly new” manner from the way the chemical was used before TSCA was enacted.  See, 15 U.S.C. §2604(a)(1)(B).

In addition, the information that TSCA requires to be included in a PMN for a new chemical is limited.  See, 15 U.S.C. § 2604(a).  Although the PMN form requests information on a submitter’s identity, the new chemical’s identity, the anticipated production volume, the intended uses of the chemical, the risk of exposure to, and the environmental fate of, the chemical and other information, TSCA does not require the submitter to test the chemical and requires the submitter to provide health and safety data only to the extent the submitter knows of, or can reasonably ascertain, such data.  40 C.F.R. §§720.50, 720.40(d).   Moreover, under TSCA, the PMN automatically becomes effective after 90 days unless the Agency extends the review period an additional 90 days. 40 C.F.R. §720.75(d).  Nevertheless, the onus is on the Agency to assess, within the review period for a PMN, the new chemical’s risks to human health and the environment and to determine whether to ban or restrict the manufacture or importation of a chemical.  As a result of these provisions, in the 34 years since TSCA was enacted, the Agency has acted to ban or restrict the manufacture or distribution of only five chemicals, one of which was asbestos.  However, the asbestos restriction was overturned by the Fifth Circuit Court of Appeals when it found that the U.S. EPA’s TSCA regulation restricting the use of asbestos was not based on “substantial evidence.” Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).

Finally, TSCA prohibits the disclosure of confidential business information and the Act grants PMN submitters broad authority to assert that information contained in their PMNs is confidential and cannot be disclosed to the public.  As a result, even the limited information submitters provide in their PMNs relating to a new chemical may be unavailable to the public if it has been designated “business confidential” by the submitter of the PMN.  See, 40 C.F.R. §720.25(b)(1).

Although environmental activists have complained for a number of years that TSCA has proved ineffectual in protecting the environment and the public from the risks inherent in many new and existing chemicals, TSCA remains as the only federal environmental law enacted in the late 1970’s or early 1980’s, when the major federal environmental programs were implemented, that has never been significantly amended or revised.  However, this may be about to change.  In the last few years, a series of recent events and developments have highlighted TCSA’s shortcomings.  These developments include: (1) the dramatic advancements the private and academic sectors are making in nanotechnology and the creation of new types of nanomaterials, which TSCA is ill-equipped to address (see, “Nanomaterials and U.S. EPA’s “General Approach”[1]; (2) the recent discoveries that chemicals used in a wide variety of consumer products may pose substantial risks to human health and the environment, which risks were previously unknown, but, perhaps, should have been known (such chemicals include polybrominated diphenyl ethers, used as flame retardants in clothing, perflourooctanoic acid, used in the manufacture of non-stick Teflon cookware, and phthalates that are used as ingredients in children’s toys and products); and (3) the European Union’s recent implementation of REACH (the “Registration, Evaluation, Authorisation, and Restriction of Chemicals”), which, according to the European Union’s website, is to “to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals…”[2]  Under the European Union’s REACH program, manufacturers and importers will be responsible “for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users.” Id.

As a result of these developments and events, as well as the long-standing frustration that many in industry and the environmental community have experienced with TSCA, an overhaul of TSCA may be forthcoming, if not this year, may be in the next congressional session.  On April 15, 2010, Senator Lautenberg, (D. N.J.), introduced in the Senate the “Safe Chemicals Act.”   He was joined by representatives Bobby Rush, (D. Ill.) and Henry Waxman, (D. Calif.), in introducing this legislation in Congress, which, according to the New York Times, would, if enacted, amend TSCA and:

require manufacturers to provide a minimum data set for each chemical they produce, and EPA would have the authority to request any additional data it deems necessary to make a safety determination…. The bill would instruct EPA to take quick action on those chemicals that clearly demonstrate high risk, and manufacturers would have to prove that a chemical is safe to keep it on the market.

Sen. Lautenberg Introduces Chemicals Reform Bill, Saying Current Regulation 'Is Broken', by Sara Goodman, New York Times, April 15, 2010.

We are now reviewing this proposed legislation and will summarize its salient provisions in future blogs.  We also will monitor the legislation’s progress, or lack of progress, through Congress and report on that as well.

[1] See, http://www.jenner.com/files/tbl_s20Publications/RelatedDocumentsPDFs1252/1759/Nanomaterials_and_the_U_S_EPAs_General_Approach_07_07.pdf

[2] See, http://ec.europa.eu/enterprise/sectors/chemicals/reach/index_en.htm