Okay, saddle up, safety nerds. This section is a doozy, which is why it's the only one I'm covering today. I've talked about this legislative improvement to TSCA here and here.

Before I get started though, some sad news related to CSIA:

Senator Frank Lautenberg, one of the main co-sponsors of this bill, passed away yesterday at the age of 89. I'm no Washington insider, so I can't tell you whether or not this will have an impact on how CSIA goes through committee. But still, it's sad, and my condolences to his friends and family.

Section 4

Section 4 of this proposed bill is revolutionary. It proposes an entirely new framework for chemical assessments, creates a system for prioritizing chemicals for assessment, and lays out guidelines for testing. The goal of this section is to treat new and existing chemicals in the same manner, which is one of the major flaws in TSCA.


This section also authorizes the EPA to use rules, testing consent agreements, and tie this testing directly to safety assessments. The EPA will be given a deadline to develop a new system to accomplish these goals - the first is to establish a "Prioritization Screening Process", which is basically a means by which the EPA can triage chemicals for evaluation, focusing on the ones of most concern first. The actual deadline for this new system is not specified in the legislation's present form - I imagine that this is being discussed in committee.

Section 4 also requires the EPA to establish criteria by which to evaluate the data from the chemical testing. This criteria must be "scientifically sound" and requires that any entity that submits testing results or studies to the EPA must also disclose the source of the funding for those tests and studies. I really, really like that part. Transparency!

The EPA will encourage the use of good laboratory practices, scientifically reliable test methods, standardized protocols, and other methods to ensure the scientific quality of the data.


Now, the U.S. has obligations as a member of the Organization for Economic Cooperation and Development to abide by the Mutual Acceptance of Data. One of the challenges that the EPA faces is to make sure that this new system produces data that fits the criteria laid out by the OECD.

Using the data gathered by this as-yet non-existant system, the EPA needs to determine whether a chemical substance exceeds a threshold of toxicity. This distinction is crucial, because some chemical substances may contain similar components but have different levels of toxicity, and some may not exceed a particular threshold at all.

Section 4 also allows the EPA to consider data from multiple sources, which might include information from companies, public studies, state governments, or other governmental bodies. The reference to "other" there probably means information submitted by the European Union through their REACH program. Right after this part, the legislation states that the EPA will make information, guidance, procedures, tools and data available to the public - this will be an item of some debate in order to balance the interests of intellectual property.


The next part of Section 4 addresses establishing definitions of "high priority" and "low priority" chemical substances, and makes a distinction between substances that are currently "active" in commerce, or "inactive." This is all about getting the EPA to make safety determinations in a timely manner - hence the characterizations. Safety assessments will not be conducted for "low priority" chemical substances.

Companies that submit their chemical substances for assessment must also shoulder a part of the testing, and the EPA's standard requires the data to be obtained from non-animal testing whenever possible. The EPA may prescribe guidelines for the development of test methods that keep the U.S. in compliance with the OECD.

Whew! That was a long one. See you next time, and so long, Senator Lautenberg.