Wednesday, April 21, 2010

More on the "reasonable certainty of no harm" standard under the new Safe Chemicals Act of 2010

A couple of days ago I asked the question "What does "reasonable certainty of no harm" mean anyway?" and offered some ideas. I want to follow up on that and talk about a definition of "adverse effect" as stipulated in the Senate bill.

‘‘(14) ADVERSE EFFECT.—The term ‘adverse effect’ means a biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that—
‘‘(A) affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism;
‘‘(B) causes irreversible change in the homeostasis of an organism;
‘‘(C) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; or
‘‘(D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.

Again, that is a lot.

Okay, the first bullet "(A)" sounds pretty normal. Does the chemical kill or otherwise cause observable harm to test organisms? That has been the standard for a long time.

The second bullet "(B)" deals with homeostasis, or roughly, the ability of the body to regulate itself through physiological and biochemical means. This has also been used to some extent in the past, but the use here suggests that EPA will have flexibility to include more subtle effects like biomarkers, endocrine disruption, and even some of the new "Toxicology for the 21st Century" enzyme and gene markers currently being developed.

Bullet "(C)" is a little more difficult to pin down. Presumably a chemical that would decrease the body's ability to react to the heat stress of a very hot summer day could fall under this definition. That isn't the intent, of course, but EPA will need to be a lot clearer in defining what this means before it starts to require "minimum data sets" and identify priority chemicals.

The final bullet point "(D)" is interesting because it gets into not what the chemical does to organisms (humans, plants or animals), but what it might do to the ecosystems in which we and they live. This almost sounds like something from the Endangered Species Act, where protection of habitat can be part of the rationale for listing. It's hard to determine exactly what this might mean with respect to the ability to measure environmental impacts without some form of monitoring.

So it looks like EPA will have some work to do before the Safe Chemicals Act will go into force.

More tomorrow.

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