Hello Dr. McLellan,
Thank you for your comments, insights and advice to the listserv.
Unfortunately, Wednesday's webinar left no time for questions and answers.
MIT has begun moving forward to identify how the new provisions may impact
our university R&D activities.
I submitted the following questions to EPA (with the exception of question 5),
and am wondering if anyone else on this listserv has either already asked or clarified the following:
1. How do the provisions of the Lautenberg Chemical Safety Act impact
compliance requirements for existing chemical-specific rules, namely 40 CFR 761, Polychlorinated Biphenyls?
The unofficial copy of the amended TSCA retains the language prohibiting PCB uses.
2. Will a cross-walk be published identifying how regulated entities can continue to ensure compliance?
3. Can someone verify whether EPA has completed a risk assessment for PCBs? If so, where can
I access a copy? As an FYI, IARC published a monograph on PCBs in 2015.
4. Will PCBs be included under the PBT workplan or excluded due to the existing PCB rule?
5. In 2010, EPA initiated an Advanced Notice of Proposed Rulemaking (ANPRM) that focused entirely on 40 CFR 761. Many of the comments raised both in EPA's background information on the ANPRM and stakeholder submittals referenced concerns with the basis on which the rule was promulgated - 50 ppm threshold, etc. At the time, stakeholder comments referenced the work being done to craft the Lautenberg Act. Are the follow up milestones
to the 2010 ANPRM now void?
Thank you and wishing all a Happy 4th of July,
From: DCHAS-L Discussion List [dchas-l**At_Symbol_Here**med.cornell.edu] on behalf of Roger McClellan [roger.o.mcclellan**At_Symbol_Here**ATT.NET]
Sent: Friday, July 01, 2016 12:08 AM
Subject: Re: [DCHAS-L] Today?s Overview Webinar on New TSCA
This bill has been moving through the system for years and with passage by the Congress and signature by the President it is the law of the line. I would be shocked if any substantive amendments will be made to the legislation in the next decade. Yes, there may be some minor clean up of legislative language next year as is customary for major legislation. However, I doubt the Congress will have any "stomach" for re-opening the legislation for major changes. The opportunity for addressing perceived short comings is now history.
This legislation as always has some latitude as to how it is implemented. Thus, I urge interested parties to closely follow the actions of EPA, especially over the next 1 to 2 years, as it implements the legislation. This is always challenging and time consuming. However, occasionally specific targeted efforts by interested persons and parties can influence EPA's actions on the first chemicals addressed which in turn can set the precedent for actions on future reviews on other chemicals.
It is my personal opinion that the legislation contains a lot of language, for example, frequent use of the phrase-- "unreasonable risk", that gives the EPA broad policy discretion in taking or not taking certain actions on specific chemicals. Finally, I would note my own personal view from following EPAs actions since its origins --- "Science needs to inform policy judgements and regulatory actions, however, science alone is not sufficient for dictating specific policy outcomes." It is important for scientists to make certain EPA gets the science right. If a scientist or group of scientists have difficulty with a particular agency decision it is important to critically examine the matter and determine whether the problem is with the science or the policy decisions leading to a particular regulatory outcome..
It is going to be interesting to follow the EPAs actions over the next several years. One thing the legislation does do is set some specific goals and time lines for the Agency to attempt to meet in the future. This is a clear response to the slow progress made by the EPA in moving chemicals through IRIS review over the last several decades.
Over past decades much time and energy has been expended in debating the relevance and role of data from laboratory animal studies in assessing human hazards and risks. Increasingly, attention will shift to interpreting the results of studies with experimental systems that do not use animals. The debate over emphasis on hazard characterization versus quantitative risk assessment will also continue. The recent debate over actions of IARC is a preview of what to expect. As an aside, did you note that IARC changed its classification of coffee consumption -its cancer hazard is no longer established. However, be careful what you drink, hot water is now on the IARC list of possible human carcinogens.
It is a wild, wild world at the interface between science and policy. I urge everyone to become engaged in the process, but, try to distinguish between whether your arguments are with how the science was used or with your own preference for a different policy outcome.
Regards to all.
Roger O. McClellan, DVM, MMS, DSc(Honorary)
Diplomate - ABVT and ABT; Fellow -ATS, SRA ,HPS, AAAR and AAAS
Member - National Academy of Medicine
Advisor, Toxicology and Human Health Risk Assessment
Albuquerque, NM 87111
-------------------------------------------- Subject: Re: [DCHAS-L] Today?s Overview Webinar on New TSCA Ralph, In view of the Sent > On Jun 30, 2016, at > Previous post | Top of Page | Next post
On Thu, 6/30/16, Alvaldenio**At_Symbol_Here**verizon.net
Date: Thursday, June 30, 2016, 5:19 PM
many shortcomings of the new law, should our Division start
proposing a series of amendments for the next session of
Congress? Al Denio
from my iPad
6:23 PM, Secretary, ACS Division of Chemical Health and
> Note that
the slides from today's webinar are available at:
> - Ralph
> From: "U.S. EPA
Office of Chemical Safety and Pollution Prevention"
> Regarding today?s
webinar on the new TSCA, our sincere regrets that some
people were not able hear the audio or were not able to join
at the beginning of the presentation. Our conference lines
were overwhelmed by the large number of participants. We
plan to host another overview webinar in the near future.
Information for this future webinar will be sent out through
this Listserv and available at the new TSCA webpage. Please
accept our regrets.
Subject: Re: [DCHAS-L] Today?s Overview Webinar on New TSCA
Ralph, In view of the
> On Jun 30, 2016, at > Previous post | Top of Page | Next post
> Previous post | Top of Page | Next post
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