On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011. The bill is intended to amend and modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. The bill is co-sponsored by Senators Amy Klobuchar (D-MN), Charles Schumer (D-NY), and Barbara Boxer (D-CA).
Lautenberg previously introduced TSCA reform legislation last April in the 111th Congress, the Safe Chemicals Act of 2010 (S. 3209). In response to considerable comment from the chemical industry, public health officials, scientists, doctors, academics, and non-profit organizations, Lautenberg states that he has made several changes to improve the bill. For example, according to Lautenberg, the updated bill establishes risk-based prioritization categories so that EPA is able to focus its resources on chemicals believed to pose the highest risk. The bill also requires chemical manufacturers to submit initially basic hazard and exposure data to determine quickly any risk, and to assess the need for further testing requirements or restrictions.
Below is a summary of key differences and similarities between Lautenberg's current bill and S. 3209 as they relate to the narrow topic of manufactured nanoscale materials. A detailed analysis of the draft bill, a copy of which is available at this link and on another website. A detailed analysis of S. 3209 is available in Bergeson & Campbell, P.C.'s April 27, 2010 (and July 28, 2010 ) memoranda.
TSCA Reform Nano Provisions
For nano stakeholders, the most important provisions in the draft bill are found in Section 4 (Definitions).
- Section 4: Definitions -- Section 3 of TSCA has been revised as follows (numbers in parentheses identify the placement of the definitions discussed):
- The definition for 'chemical substance' (5) deletes the reference to 'articles' that appeared in S. 3209, but retains the provision allowing the EPA Administrator to determine, notwithstanding molecular identity, that a variant of a chemical substance is a 'new' chemical substance.
- Consistent with S. 3209, a 'new chemical substance' (15) would be defined as one 'for which the manufacturer or processor of the chemical substance has not submitted a declaration.' The use of 'the' in this context has the effect of extending this requirement to each manufacturer or processor of the new chemical, an important subtlety.
- The definition for 'special substance characteristic' has been retained from S. 3209, including considerations for size or size distribution; shape and surface structure; reactivity; and any other properties that may significantly affect the risks posed.
In short, the new bill is largely unchanged from last year's version. If these definitions were included in enacted legislation, EPA would have significantly more latitude in determining whether a chemical substance is 'new' and thus subject to additional EPA review and scrutiny as that determination would be based on a review of factors other than the substance's molecular identity, which is now the case under current EPA policy.
Specifically, under EPA's current interpretation of its TSCA authority, if a manufactured nanoscale material is listed on the TSCA Inventory, presumably as a conventionally sized substance, it is considered existing and thus not subject to chemical notification requirements as a 'new' chemical. If a manufactured nanoscale material is not listed on the TSCA Inventory (and determined not to be present on the confidential portion of the TSCA Inventory), EPA considers the substance 'new' and, unless a Pre-Manufacture Notification (PMN) exemption otherwise applies, the manufacturer/importer is required to submit a TSCA notification of one form or another (PMN, Low Volume Exemption, etc.) to EPA before commercial manufacture or import. EPA outlined this approach in a January 23, 2008, document entitled TSCA Inventory Status of Nanoscale Substances -- General Approach.
The newly circulated draft language evidences the sponsors' intent to ensure EPA is authorized to assess more than molecular identity in determining whether a chemical substance may pose a risk. Many in the nano community would agree that chemical substance characteristics, including size, size distribution, shape, surface structure, and reactivity, are among the properties that could influence the risk profile of a substance and are relevant features in characterizing a chemical substance risk profile. These 'special substance characteristics' are directly relevant to manufactured nanoscale materials, and consideration of them is important in fully characterizing risk potential and thus critically important in making informed risk management decisions.
In the context of the draft bill, authorizing EPA to acknowledge the potential for special substance characteristics to influence the risk profile of a chemical substance is neither startling nor inappropriate. As is often noted, however, 'the devil is in the details,' and exactly how this explicit grant of authority may be implemented in the context of a regulatory/governance program that will seek to quantify and manage potential risks is what may be cause for discomfort or at the least uncertainty. Plainly, a reasonable application of this statutory language would studiously avoid any inclination reflexively to apply regulatory controls in inverse proportion to size considerations (meaning nanoscale substances necessarily warrant more regulatory controls).
The inclusion of these provisions at the least telegraphs a clear understanding of the controversy that exists under current TSCA implementing regulations and EPA policy and should incentivize nano stakeholders to be actively engaged in ongoing TSCA reform legislative efforts. As the legislative process unfolds, the nano community must stay engaged and seek to ensure that any new legislation both nurtures the development of the technology, while at the same time ensuring that potential risks are identified and appropriately controlled.