Friday, May 7, 2010
The Congressionally-mandated clock is ticking and EPA is hard at work trying to put together a list list of 100 chemicals to test for possible endocrine disrupting effects. The deadline is October, which seems far off until you figure that EPA has agreed (well, sort of agreed) to allow public review of the list. The public review will be informal, that is, it won't be the official kind of proposed comment, respond, final comment process usually required. The idea is to give this informal shot at the list by industry and other interested stakeholders before EPA has to get the list to Congress.
There will, of course, be a formal commenting process when the chemical test orders are prepared. But right now EPA is under the gun. And with the fall elections likely to result in substantial seat-changing, there really isn't any way to delay it further. Why? Because the Congressman Jim Moran inserted language into EPA’s fiscal year 2010 appropriations law requiring the release of a new list of no less than 100 chemicals, including drinking water contaminants, and to issue testing orders for the chemicals under the agency’s existing Endocrine Disruptor Screening Program (EDSP). And just this week Congressman Markey introduced a bill to update the EDSP to mandate the screening of the drinking water contaminants.
All of this means that EPA is going to have to get up to speed on the Endocrine Disruptor Screening Program that has been languishing since it was originally mandated way back in 1996.
More to come.
Wednesday, May 5, 2010
As various stakeholders hold their stakes, i.e., hold out as long as they can for their positions on either end of the political and regulatory spectrum, the discussions go on as to whether the new Safe Chemicals Act (SCA) bill is "just like REACH." One aspect that we can look at is how each of these regulations, the one already in force in Europe and the one proposed and possibly not even passing in the US, handles the problem of tens of thousands of existing chemicals grandfathered onto an Inventory.
First it was TSCA, and not having the faintest idea how to handle about 63,000 chemicals already in commerce, the law simply put them on a list and said "we'll get to them in time." Then came the Dangerous Substances Directive in Europe, and faced with the same dilemma, they created the EINECS Inventory.
And now there is REACH. To deal with the existing chemicals (and the "new" ones added since then), REACH created the "pre-registration" of chemicals. Only chemicals that companies pre-registered could be considered "existing" for purposes of gaining some phase-in time to produce the required data sets. Anything not pre-registered becomes a "new" chemical and must have the data set provided before being placed on the market (and if you were on the market already and didn't pre-register, then you're in violation and must stop production until you provide the data). When all is said and done only those chemicals with complete data sets will gain the status of "existing."
So what does the SCA do about those existing chemicals? Well, they make you provide a "declaration" that you are manufacturing or processing specific chemicals. And you have one year to do so (with updates every three years or immediately when obtaining new toxicity information). Sounds a lot like the REACH pre-registration, doesn't it? Well, almost. Under REACH you only have to provide some basic information like name and ID of the chemical, where and who you are, and how much you manufacture or import. But the SCA would go much further. Besides that information you would also have to provide all the available health and safety data on the chemical and use patterns. And you have to certify that the information is not only true, but reliable. That's a lot of work up front.
But it actually is good in a way. The data to be provided isn't going to be a full data set (as defined by EPA). It's going to be whatever you have in your file drawer and/or have readily available. There is an incentive to do this up front because then you can show that your chemical is one that shouldn't be of much concern, which means EPA won't be likely to put it on their priority list of 300 chemicals. At least not the first version. Of course, if your chemical has some special concerns then the data may cause the chemical to rise to the top of the priority list. Which is exactly what the priority list should be all about.
Tuesday, May 4, 2010
The new Safe Chemicals Act of 2010 (SCA), introduced recently by Senator Frank Lautenberg with a companion bill in the House, includes several concepts that are not currently part of the Toxic Substances Chemical Act (TSCA) that it seeks to reform. One of those differences is the inclusion of a mandate to reduce animal testing.
Section 31 of the SCA states that EPA "shall take action to minimize the use of animals in testing of chemical substances and mixtures." This includes:
1) Encouraging and facilitating a) use of existing data of sufficient scientific quality, b) use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality, c) grouping of two or more chemicals into scientifically appropriate categories where data on one substance will provide reliable and useful data on others, d) formation of industry consortia to jointly conduct testing to avoid unnecessary duplication, and e) parallel submission of testing from animal based studies and from emerging methods and models.
Those familiar with REACH might recognize a similar approach. The idea is to provide scientifically defensible data in the most efficient manner, so that modeling, read-across, alternative testing, and other methods can be used to meet the data requirements. The bottom line means less animal testing. The consortium idea also comes from the HPV Challenge days.
In addition, the section also authorizes:
2) the funding of research and validation of studies to reduce, refine, and replace (i.e., the "3 Rs") the use of animal tests.
The section also goes into some detail about an "Interagency Science Advisory Board on Alternative Testing Methods" that EPA shall establish within 90 days after enactment. The Board would consist of representatives from several key programs such as the NIEHS, CDC, NTP, NCI, NTSC and others. [Sorry for the acronyms, but I can define them if anyone doesn't already know what they mean.] The EPA, with input from the Board, would have one year to publish a list of testing methods that reduce the use of animals in testing. EPA and the Board would also promote the development of new testing methods that are not animal based. Finally, the section gives EPA some flexibility to waive testing requirements if there is sufficient weight-of-evidence from other sources.
So all in all there is an effort to reduce animal testing. That said, it is highly likely that animal testing will remain a key tool in the evaluation of hazard and risk. At least until sufficient non-animal methods have been developed and validated, a process that will likely take a long, long time.
Monday, May 3, 2010
The USEPA has just opened up to public access a database on chemical hazard, exposure and toxicity data. The database, called ToxRefDB (i.e., Toxicity Reference Database), provides detailed chemical toxicity data that is easy for anyone to access.
Find it here: ToxRefDB
The database is part of an online data warehouse called ACToR (Aggregated Computational Toxicology Resource), that collects data from about 500 public sources on tens of thousands of environmentally relevant chemicals, including several hundred in ToxRefDB.
It also connects to another EPA chemical screening tool called ToxCast, a "multi-year, multi-million dollar effort that uses advanced science tools to help efficiently (~$20K per chemical) understand biological processes impacted by chemicals that may lead to adverse health effects."