Monday, April 26, 2010

What goes into a minimum data set for the Safe Chemicals Act? (Part 1)

The new Safe Chemicals Act of 2010 bill introduced by Senator Lautenberg on April 15th (and the companion bill introduced the same day in the House) notes that all chemicals will be required to provide a "minimum data set." But what data are minimum? Will this mean more animal testing?

In this first part I'll introduce some thoughts and then follow up in subsequent posts. It's important to keep in mind that data doesn't mean just hazard data but also use and exposure information. So the minimum data set could include information on the amount of the chemical produced, locations of production, how is it used (e.g., as an intermediate in making other chemicals versus as a component of a consumer product we all use every day), and any specific exposure information.

The minimum data set could also include basic hazard information such as physical-chemical properties (is it soluble in water? high or low pH?), environmental fate (is it persistent in the environment or does it break down quickly? does it end up in the water, the air, sediment, soil?), ecotoxicology (does it kill fish or slow the reproduction of invertebrates or stunt algal growth?), and toxicology (does it kill rats if exposed orally or dermally or via inhalation? does it have more subtle effects on endocrine systems of organisms?), etc., etc., etc.

In short, there is a lot of information that can be needed in a "minimum data set" for EPA to make informed risk assessments and for the appropriate risk management measures to be implemented. So the minimum data set needs to be defined.

It's also important to note that "hazard data" doesn't mean animal testing. In fact, there has been quite a bit of effort put into finding non-animal methods. I'll address that in a subsequent post.

[Please note also the comment and response below for more information]


Kristie said...

I'm curious to know whether you believe, by stating "the minimum data set needs to be defined" whether you mean it should be specified the new TSCA revision legislation itself, or by the EPA as a regulation (as the House draft currently states).

The Dake Page said...

Hi Kristie

I would say that the "minimum data set" has to be defined by EPA, not Congress. The way the bill is written defines the types of information that should be considered. It will be up to EPA to say that endpoints a through s plus x,y and z are required under certain circumstances.

The minimum data set might actually be different for different situations, e.g., less data for small production specialty chemicals than for very high production chemicals. Or more data for chemicals that consumers use all the time (e.g., the chemicals in your shampoo and deoderant) or that are inherently hazardous (e.g., PBTs).

REACH in Europe and the SIDS before that have strictly defined data sets for different tonnage bands of production and different hazard levels. It's likely that EPA will do something similar.

Unknown said...

I agree! Leave it flexible so that the requirements can adapt and be subtracted (or added) as necessary.

I actually think REACH got it wrong because now they have to go change the legislation itself every time they want to, for example, incorporate a new method or test.

The Dake Page said...

That's a good point, Kristie. Though even under REACH there is the ability to waive and/or use alternative testing if it can be justified to provide better results. The regulation requires "data," and while standard testing is usually expected, REACH allows for data to be presented in different ways - testing, read-across from similar chemicals, QSAR models, other non-animal methods, etc.