Thursday, April 29, 2010

Safe Chemicals Act - What is "Expedited Action?"

Yesterday I presented a set of chemicals listed in the House version of the recently introduced TSCA reform bill. These are chemicals for which significant risk has already been documented, and thus the bill provides for "expedited action."

What is "expedited action?"

Oddly enough, it means that manufacturers of the chemical substances listed shall not be required to submit a minimum data set for such chemicals unless and until EPA makes a determination. But it does mean manufacturers must, within 6 months, submit a declaration of safety.

Meanwhile, EPA has 1 year to determine if the manufacturers of the listed substances have established that the substance meets the safety standard. If not, EPA must "take appropriate action" to ensure that the "manufacturing, processing, distribution in commerce, use, and disposal of the chemical meets the safety standard. In other words, if the chemical cannot be determined to meet the safety standard within that time frame, EPA has the authority to severely restrict its use or even ban it.

The idea is to deal with these "low hanging fruit" that have been studied for years and that have been found to be problematic. The Act essentially says "enough is enough" and facilitates their removal, or in some cases, a decision that they aren't as bad as their press.

Wednesday, April 28, 2010

House version of Safe Chemicals bill has a list of chemicals!

For those who have been following this page you will have noticed that I have used the Senate version of the TSCA Reform bill as my reference point. The Senate bill was introduced by Senator Lautenberg, the sponsor of the previous two Kid Safe Chemical Acts (that never even made it to committee discussion). But there is also a House version of the bill. It is largely the same on the key features, but not completely the same. One point of departure is that the House bill, which Representatives Waxman and Rush issued as a "discussion draft" under the moniker Toxic Substances Safety Act of 2010, has a SEC. 33. EXPEDITED ACTION FOR CHEMICAL SUBSTANCES WITH DOCUMENTED RISKS.

The section states that "In the case of a chemical substance identified in subsection (b) for which risk to health and the environment have been well documented yet sufficient risk management actions have not been taken, expedited action under this title is warranted."

And guess what? Unlike the Senate bill, the House bill names names! Well, chemical names. They pick much of the low hanging fruit, that is, chemicals that have already been identified some place or another to be substances of very high concern. The idea is to deal with these quickly, like while EPA is waiting for companies to notify the chemicals for the new inventory. So the chemicals listed are:

(1) Anthracene, pure
(2) Asbestos
(3) Bisphenol A
(4) Cadmium and cadmium compounds
(5) Chloroalkanes, C10–13 (short-chain chlorinated paraffins)
(6) Decabromodiphenyl ether and congeners in the commercial DecaBDE mixture
(7) p-Dichlorobenzene
(8) Formaldehyde
(9) n-Hexane
(10) Hexabromocyclododecane, including all major diastereomers
(11) Hexachlorobutadiene
(12) Hexavalent chromium
(13) Lead and lead compounds
(14) Methylene chloride
(15) Mercury and mercury compounds
(16) Musk xylene
(17) The following perfluorinated compounds:
(A) Fluorinated telomers
(B) Perfluoroalkyl sulfonates
(C) Perfluorooctane sulfonic acid, its salts, and perfluorooctane sulfonyl fluoride
(D) Perfluorooctanoic acid and related salts
(E) Polyfluoroalkyl phosphoric acid diesters
(18) Phenanthrene
(19) The following phthalates:
(A) Benzylbutyl phthalate
(B) Dibutyl phthalate
(C) Diethylhexyl phthalate
(D) Di-isodecyl phthalate
(E) Di-n-hexyl phthalate
(20) Polybrominated biphenyls
(21) Polychlorinated terphenyls
(22) Tetrabromobisphenol A
(23) 1,2,3–Trichlorobenzene
(24) 1,2,4–Trichlorobenzene
(25) 1,2,3,4–Tetrachlorobenzene
(26) 1,2,4,5–Tetrachlorobenzene
(27) Trichloroethylene
(28) Tris (1,3-dichloro-2-propyl) phosphate
(29) Tris (2-chloroethyl) phosphate
(30) Tris (2,3-dibromopropyl) phosphate
(31) Vinyl chloride

I'm sure many of the chemicals will sound familiar to everyone. I'll talk more about what will happen to these chemicals if the bill passes.

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!!

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]