From: Ralph Stuart <ras2047**At_Symbol_Here**MED.CORNELL.EDU>
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA
Date: Tue, 5 Jul 2016 13:24:41 -0400
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>

The concatenation of e-mails in this string is creating problems for the LISTSERV program because it is so long. So I have taken the liberty of moving the messages that Roger is replying to from his e-mail. I think his comments stand on their own.

- Ralph

From: Roger McClellan
Sent: Fri, Jul 1, 2016 6:03 am
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

Monona and others:
I am enjoying the continuing exchange. It is unfortunate it did not start about five years ago when it might have influenced the bill. But, as I have noted, that is history. Now the only avenue is to attempt to influence implementation of the legislation . As yet I have not seen a real robust summary of the bill and the likely path forward. It is a complex bill and I suspect many of the ramifications will not be clear for several years.
Using Monona's opening sentence as a jumping off point I would argue that the replacement of in vivo animal studies with in vitro and in silico approaches is a key part of the legislation. Indeed, the primary motivation of some proponents of the legislation was to see animal studies eliminated. Hence, the Animal Welfare movement became a major player influencing the final legislation along with Environmental NGOs and Industry.
To understand some aspects of this crusade one needs to go back a couple of decades to the origins of concern for "endocrine disrupters" and major expenditures by EPA and NIH to development replacements approaches for animal bioassays. This movement is also apparent in the activities of the National Research Council funded largely by EPA and focusing on review of the EPA's Integrated Risk and Information System (IRIS) and the path forward for toxicology and risk assessment , ie Tox-21, Toxicology in the 21st Century. I urge serious students of these issues to carefully read all the NRC reports on these issues over the past two decades.
As an aside, I share Monona's concerns for potential 'over reliance" on in vitro and in silico approaches. I am concerned that these approaches are being over sold by advocates who have limited knowledge of the complexities of disease processes and health. If these approaches are as good as some would advocate the pharmaceutical "pipeline" would be flooded with new prospects. The fact is these approaches are still being advocated. In my opinion, the evaluation process has not included enough well known human toxicants. I am not concerned about the new approaches ability to predict toxicity in rats. My concern is with the ability of the new approaches to predict human disease.
Without question the world is getting more complex. I have been following a particular product for years and was pleased to learn it was going to be evaluated in a 2 year cancer bioassay. A few days later I was told the study could not be conducted in Germany as planned because animal studies are now prohibited unless mandated by law. This animal study was viewed as "discretionary".
Regards to all.
Roger O. McClellan

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