TSCA-Reform in den USA: Safe Chemicals Act of 2010

One bill, the Safe Chemicals Act of 2010, was introduced by Senator Lautenberg in the U.S. Senate. Another bill was presented by Congressmen Rush and Waxman called the Toxic Chemicals Safety Act of 2010. Both Acts are similar while the latter is more in the form of a discussion draft, rather than a bill.

The Safe Chemicals Act would amend the federal Toxic Substances Control Act of 1976 (TSCA). In the 34 years since TSCA was enacted, the EPA has been able to require testing on just 200 of the more than 80,000 chemicals produced and used in the U.S., and just five chemicals have been regulated under this law.

One prominent example of the failure of the TSCA regulation was in 1989, when EPA issued a regulation to ban most uses of asbestos. However, the regulation was challenged an ultimately tossed out by the courts, which ruled that EPA nad not met its burden of proof to substantiate that asbestos poses an "unreasonable risk" as requireed under TSCA.

According to Richard Denison from EDF, "relative to the status quo, the legislation and discussion draft would represent a major sea change in the way we manage chemical safety in the U.S." The following table from EDF gives a good overview on the proposed changes:

 

Currently under TSCA		Under the Safe Chemicals Act of 2010
Few chemicals are required to be tested and no minimum data set is required even for new chemicals.		A minimum data set (MDS) on all new and existing chemicals sufficient to determine safety would be required to be developed and made public.
EPA is required to prove harm before it can regulate a chemical.		Industry bears the burden of proving their chemicals are safe.
No mandate exists to assess the safety of existing chemicals.  New chemicals undergo a severely time-limited and highly data-constrained review.		All chemicals, new and existing, would be subject to a full safety determination.
The “unreasonable risk” standard under TSCA is not health-based but rather requires extensive cost-benefit considerations.		The safety standard would be a strictly health-based standard, “Reasonable certainty of no harm,” adapted from our pesticide safety laws.
Where the rare chemical assessment is undertaken, there is no requirement to assess exposure to all sources of exposure to a chemical, or to assess risk to vulnerable subpopulations.		The safety standard requires the assessment of a chemical to account for aggregate exposure to all sources of exposure to the chemical, and to ensure protection of vulnerable subpopulations that may be especially susceptible to chemical effects (e.g., children, the developing fetus) or subject to disproportionately high exposure (e.g., low-income communities living near contaminated site or chemical production facilities).
Even chemicals of highest concern, such as asbestos, have not been able to be regulated under TSCA’s unreasonable risk standard. Instead, assessments often drag on indefinitely without conclusion or decision.		Chemicals of highest concern would be subject to expedited safety determinations and/or actions to reduce their use or exposure to them.
Companies are free to claim, often without providing any justification, most information they submit to EPA to be confidential business information (CBI), denying access to the public and even to state and local government.  EPA is not required to review such claims, and the claims never expire.		All CBI claims would have to be justified up front.  EPA would be required to review them, and only approved claims would stand. Approved claims would expire after a period of time.  Other levels of government would have access to CBI.
To require testing or take other actions, EPA must promulgate regulations that take many years and resources to develop.		In addition to the MDS requirement, EPA would have authority to issue an order rather than a regulation to require existing data to be reported or additional testing to be done.

The proposed bill does not explicitly mention nanomaterials. However, the above proposed changes would also affect the way how nanomaterials are handled, whether data must be produced and whether this data needs to be exchanged with the authorities.

Overall, the proposed amendments to TSCA would represent a significant step towards a chemicals regulation close to the REACH approach.

Sources: EDF, Safer Chemicals, Health Families Coalition