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Posts Tagged ‘GLP’

EPA finally finished it’s peer review of results from the infamous Ramazzini Institute labs that test sick animals after pressure from industry that the lab’s practices were inappropriate.  It will no longer rely on findings from this lab when it does IRIS reports.  Immediately affected are dropping cancer findings for methanol, MTBE and ETBE.  http://www.epa.gov/iris/ramazzini.htm

It took awhile, but scientific peer review is necessary and proper.

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As follow on to its Chemical Action Plan on Bisphenol A (BPA), EPA published an Advance Notice of Proposed Rulemaking July 26, 2011, to develop environmental effects and exposure testing.  EPA is not addressing human health effects in this notice as there is ongoing testing work already with other agencies.  (See a pointed Trevor Butterworth blog about that work here.)

Related to my earlier blog on GLP, it’s nice to see the following acknowledgement regarding  effects “data” that has been generated by academia:

It is difficult to interpret this information in a regulatory context, because the scientific methods employed in individual academic settings to test a hypothesis are not necessarily geared toward meeting or establishing generally applicable guidelines for evaluating ecotoxicity and setting corresponding regulatory limits or controls. In terms of environmental toxicity, EPA considers the currently available research as evidence that BPA has the potential to interact with the estrogen hormone system.

In order to be useful to an investigation of potential environmental risks posed by BPA, environmental testing must be representative and of known quality. To accomplish this, data should be collected using approved or recognized sampling, preparation, and analytical techniques. Appropriate quality assurance and quality controls also should be incorporated in the protocols for collection and analyses.

EPA is soliciting comment on “whether and on what basis they believe the current data are sufficient to determine whether BPA does or does not present an unreasonable risk of injury to the environment.”  This is the threshold for a TSCA section 6 control regulation, whereas a section 4 test regulation requires only a “may present” hurdle.  So maybe the point is to skip any additional testing and go straight to a ban.  Sorry, EPA, get some good, reliable data first.

Not that there aren’t challenges to getting environmental monitoring data, especially when it’s off-site.  There should be some creative work done to figure out how to get manufacturers (and processors?) to pitch in to cover monitoring by EPA or some third party.  Yikes – do it through some sort of SIEF process?

Getting some quality, meaningful data to support risk evaluation and potential restrictions is a valid and doable Action Plan under today’s TSCA .

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Kind of ironic:

Industry has submitted a petition to EPA to hold off on getting data on List 2 for the Endocrine Disruptor Screening Program (EDSP) until the Agency reviews and issues final guidance on how they are going to deal with the results they get on the first list of chemicals – especially if the agency is going to change the rules of the game in the middle of testing.  Allegedly, one issue of controversy is around Good Laboratory Practices (GLP) – a careful set of documentation, review and  recordkeeping requirements to ensure data quality every step of the way for any given written protocol.  By following GLP, it should be possible to verify the protocol was followed and any deviations noted so that the test could be replicated (or challenged) by others.  Failure to follow GLP leaves open the possibility of biased short-cuts or modifications (or ignoring uncomfortable data points) that make the results unreliable.

When EPA first started demanding GLP studies in the ’80’s, industry howled because it is expensive and time-consuming to use GLP.  A lot of internal studies had been relied on as showing product safety were challenged by the agency and environmentalists as self-serving and worthless.  Only GLP was acceptable.  (A major hullabaloo around the High Production Volume (HPV) voluntary testing program relying on old studies.)
Ironically, environmentalists are now saying that industry is using GLP as a shield preventing EPA from relying on non-GLP tests done in academic labs.  Gee… I guess only industry has biased testing using slipshod methods.  Academics (aka grad students) – who are looking for juicy publications of the latest headline toxicity (endocrine disruption) and who whip up some nifty in vitro test or use a small number of test animals on a poorly characterized “chemical” dose that isn’t and can’t be replicated – couldn’t possibly be biased or sloppy.

A quote from Toxics Regulation News, July 20,2011, on “EPA Urged To Delay Second Round Of EDSP Pending Review Of First List”:

“This is all part of a big campaign on their part to try to preserve GLP to make it apply to all studies,” the source [with the Endocrine Disruption Exchange] says. “If CropLife can make GLP mandatory that really puts their science in the drivers seat.”

Excuse me, “their science”?  The protocol is EPA’s.  GLP is quality control to show the protocol was followed.  Maybe the ED Exchange needs to focus on nailing down their preferred protocols and requiring GLP on them, assuming those tests are validated as having any real meaning in causing adverse health effects due to endocrine system disruption.

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