Tuesday, April 27, 2010

Safe Chemicals and Minimum Data Sets - What Does it Mean? (Part 2)

So the new Safe Chemicals Act institutes what is called a "minimum data set rule." Which states:

"Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish, by rule, the data that constitute the minimum data set for chemical substances and mixtures. The rule shall require submission of a minimum data set including information on substance characteristics and on hazard, exposure, and use of chemical substances and mixtures that the Administrator anticipates will be useful in conducting safety standard determinations pursuant to section 6(b) or carrying out any provision of this chapter."

The manufacturers and processors of a chemical must then submit this "minimum data set" to the EPA within "18 months after the date on which the Administrator places the chemical substance on the priority list" or for new chemicals, "the date on which the notice required in section 5(b)(1) is filed [i.e., to notify a new chemical]."

A bit later on the bill specifies "the types of health and environmental information" that EPA could request, including:

- information pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may be considered in a safety determination;

- information pertaining to exposure to the chemical substance or mixture, including information regarding the presence of the chemical or mixture in human blood, fluids, or tissue; and

- information pertaining to bioaccumulation, persistence, acute toxicity, subacute toxicity, chronic toxicity, and "any other characteristic which may present an adverse effect."

When you think about it, that is a pretty comprehensive and open-ended list. The REACH program in Europe has very specific data requirements tied to tonnage band. Chemicals produced in smaller quantities have fewer data requirements. Those produced in very large quantities have very extensive requirements. These more extensive data requirements are also necessary if the chemical is considered a "substance of very high concern." But the data requirements under the Safe Chemicals Act bill seems to add the idea of biomonitoring, that is, if a chemical shows up in analyses of people's blood or other bodily fluids it might trigger additional data.

The SCA also seems to add the rather undefined "behavioral disorders," and "cumulative or synergistic effects." It's unclear just exactly how these things might be measured.

And don't forget nanomaterials!!

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