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From: Monona Rossol <0000030664c37427-dmarc-request**At_Symbol_Here**LISTS.PRINCETON.EDU>
Subject: Re: [DCHAS-L] EPA Releases Draft Strategy to Reduce Animal Testing
Date: Fri, 9 Mar 2018 07:23:38 -0500
Reply-To: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU>
Message-ID: 1620ab773bf-c8c-1c30**At_Symbol_Here**webjas-vab090.srv.aolmail.net
In-Reply-To <00e701d3b753$6389a510$2a9cef30$**At_Symbol_Here**twc.com>
Wow, Bruce, you hit all of the points I make in lectures except for your central issue of liability. I just assume no one's going to be liable for making these wrong-headed decisions. We recover big punitive damage settlements from the tobacco and asbestos manufacturers only because we have the documents to show they distributed after they knew. But if the EPA supports this in silico crap, and if industry relies on this faulty data to OK their toxic products, and if those products wipe out a whopping bunch of consumers and workers, both EPA and industry will be off the hook.
"Ooops, who knew?" appears to be the perfect defense in the US legal system.
They will be immune to liability and we little guys will still be ponying up that $3000 + per/year for our professional liability policies and sweating out every possible grammatical misinterpretation in our reports.
And, as consumers and workers, we and our families will still be the lab rats for the in silico-vetted chemicals in our products while we take comfort in having protected our wee rodent brethren. Just how humane is that?
Monona Rossol, M.S., M.F.A., Industrial Hygienist
President: Arts, Crafts & Theater Safety, Inc.
Safety Officer: Local USA829, IATSE
181 Thompson St., #23
New York, NY 10012 212-777-0062
-----Original Message-----
From: Bruce Van Scoy <bvanscoy**At_Symbol_Here**TWC.COM>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**PRINCETON.EDU>
Sent: Thu, Mar 8, 2018 10:26 pm
Subject: Re: [DCHAS-L] EPA Releases Draft Strategy to Reduce Animal Testing
Monona,
We agree, in silico testing is not ready to replace in-vivo testing, but it must be politically correct if you read today's announcement.
We're replacing lab mice/rats with either unverified computing processes without statistical analysis v. consumers, including children. My questions are: why should we trust a computer program that has not been vetted? Who and how is it determined that the computer models "adequately" replace in-vivo? Once those scientific studies are published, will those making the claims be held accountable scientifically, professionally and liability?
Who will be performing the toxicological testing on those exposed consumers? How relevant will it be? Who will be looking for metabolites of a compound, potential additive or synergistic effects in the consuming population from a compound exposed to when/how? I don't know about you, but I can't remember what I had for lunch/supper two days ago. Now the most important, will we recognize AND correct the mistake in the years to come as a society? When will we return to focus on science, as compared to political correctness?
My observation is that the late =E2=80=9870's started an awareness, the =E2=80=9880's to =E2=80=9890's built on the science, impact and repercussions. Look at significantly the regulations have changed. How successful has OSHA been at updating PEL's or adding new chemicals regulated by OSHA? It's a farce, the original OSHA Act adopted the 1969 list of the ACGIH TLVs and we know significantly more now. How many chemicals have TLVs now compared to the initial '69 list compared to the ACGIH TLVs (the new update was just released)?
We're talking orders of magnitude here, but my question holds, will those who are proven wrong be held accountable? I don't think the process FDA follows would ever enable an FDA official to be held accountable for negligence. I think legally, government officials, e.g., EPA, OSHA, FDA, USDA, etc. "cannot be held liable". Do we have the same luxury? What ethical standards do we need to impose - upon ourselves? I'm thinking of which to apply, PEL, TLV, MAK, etc.? At what level do you enforce - can you justify your choice to management, courts, etc.? We are professional practitioner=E2=80™s and unlike gov't officials, we can be held accountable.
I know I=E2=80™m asking a lot of questions. I'm only asking for due consideration, research and reflection of the questions for consideration.
Sincerely,
BruceV
How kind. I'm especially feisty because our kitchen ceiling fell last Friday and the workmen are here every day tearing up our lives and creating dust. Hopefully tomorrow they will paint and leave forever! A couple more days of this and I'd go to some straight bar (hard to find in the Village), walk up to a trucker, and pick a fight.
Monona Rossol, M.S., M.F.A., Industrial Hygienist
President: Arts, Crafts & Theater Safety, Inc.
Safety Officer: Local USA829, IATSE
New York, NY 10012 212-777-0062
Oh, Monona, how I love your feistiness!
How sad. We have so little data on chemical toxicity and we are still finding new metabolic pathways. It's way too early to set up in silico testing. It will just be a garbage in/garbage out, cheaper process to help industry avoid the gold standard testing that so sorely needs to be done. And the consumer and worker will still be the real lab rat.
Want to save vertebrate animals? Stop eating meat and fish and wearing leather. It's easy and good for you. How do you think I got so old and yet am still capable of annoying people every day?
Monona Rossol, M.S., M.F.A., Industrial Hygienist
President: Arts, Crafts & Theater Safety, Inc.
Safety Officer: Local USA829, IATSE
New York, NY 10012 212-777-0062
-----Original Message-----
From: DCHAS Membership Chair <membership**At_Symbol_Here**DCHAS.ORG>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**PRINCETON.EDU>
Sent: Wed, Mar 7, 2018 2:26 pm
Subject: [DCHAS-L] EPA Releases Draft Strategy to Reduce Animal Testing
EPA Releases Draft Strategy to Reduce Animal Testing
WASHINGTON (March 7, 2018) - Today, U.S. Environmental Protection Agency (EPA) is releasing a draft strategy to reduce the use of vertebrate animals in chemical testing for public comment. This fulfills another milestone the Agency has met under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act (TSCA).
"This draft strategy is a first step toward reducing the use of animals and increasing the use of cutting-edge science to ensure chemicals are reviewed for safety with the highest scientific standards," said EPA Administrator Scott Pruitt. "EPA is committed to working with animal welfare groups and other groups to produce a sound, effective plan in line with the law."
"We welcome the draft strategy as a progressive step to reduce and ultimately replace the use of animals to regulate chemicals in the U.S. through the implementation of TSCA reform," said Catherine Willett, director of science policy at The Humane Society of the United States. "We have every indication that EPA intends to make good on this unprecedented opportunity to not only reduce animal use, but improve the science used to evaluate chemical safety."
Under the Lautenberg Chemical Safety Act, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing by June 22, 2018. The draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods.
The draft strategy follows the progress EPA has made finalizing three important rules and proposing a fees rule as outlined by the Lautenberg Chemical Safety Act. EPA is working diligently to implement the new law, the first major update to an environmental statute in 20 years, and get the most modern and safe chemicals to market quickly in order to provide regulatory certainty for manufacturers and confidence for American consumers.
This draft strategy will be available for comment for 45 days in docket EPA-HQ-OPPT-2017-0559. Comments received will be considered in the Agency's development of the final strategy.
A public meeting will be held on the draft strategy in Washington, DC on April 10, 2018.
Read the draft strategy and learn more about the April 10 public meeting: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce
Background
On June 22, 2017 - the one-year anniversary of the Lautenberg Chemical Safety Act - EPA met milestones for three framework TSCA rules: the Prioritization Process Rule, the Risk Evaluation Process Rule, and the Inventory Rule.
The Prioritization Process Rule establishes a framework and criteria for identifying high-priority chemicals for EPA risk evaluations.
The Risk Evaluation Process Rule establishes a framework for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health and/or the environment. The rule ensures transparency and confidence in the risk evaluation process while retaining flexibility to allow for new scientific approaches as they are developed.
The Inventory Rule requires industry reporting of chemicals manufactured, imported, or processed in the U.S. over the past 10 years to identify which chemical substances on the TSCA Inventory are active in U.S. commerce. This will inform the chemicals EPA prioritizes for risk evaluations.
In addition to finalizing framework TSCA rules so the Agency can properly implement the law within the timeframes set by Congress, EPA has effectively addressed and eliminated the backlog of new chemicals awaiting EPA review. The current caseload is back at the baseline level.
EPA also proposed a fees rule on certain chemical manufacturers - including importers and processors - to provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.
For more information on TSCA implementation, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act-5
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