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.