Avoiding Paralysis by Analysis - EDF's Analysis of the EPA TSCA Chemical Prioritization Proposal

Last week the USEPA held a webinar to introduce their proposal for how they will attempt to prioritize TSCA chemicals for closer assessment.  One day prior to the webinar the ACC announced its own competing prioritization scheme. Earlier this week, Environmental Defense Fund Senior Scientist Richard Denison offered his views on the EPA scheme, which he called "a sensible approach to identifying chemicals of concern." [Note: Denison will be addressing the ACC proposal in a following post on the EDF web site.]

The "paralysis by analysis" noted to in the title refers to the futility of asking EPA to evaluate the entire TSCA Inventory akin to the Canadian approach.  The Canadian approach was actually "mandated by statute" (via the 1999 amendments to the CEPA) and both Environment Canada and Health Canada were given "seven years and a major infusion of new resources" just to complete the first phase of the process.  According to Denison, with nearly four times as many chemicals on the Inventory, and "without the authority and the resources, well, that's just a recipe for paralysis by analysis" to ask EPA to do the same. 

Which is why the EPA proposal is so reasonable, according to Denison.  He indicates that EDF and the Safer Chemicals Healthy Families coalition "generally support EPA's approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis."  Denison does, however, offer a series of 10 additional suggestions for improving the EPA proposal.  The full list can be seen on the EDF blog page, but include broadening the sources of data specified in Step 1 (perhaps by including some of the source from Step 2), consideration of the published literature, adding specific criteria for children's health and exposure, expanding the range of "vulnerable subpopulations" beyond just children's health, and providing additional clarity on how EPA plans to move from Step 1 to Step 2.

Overall, Denison finds that the attempts by EPA to reintroduce "action" into their proposed prioritization and action plan process are much needed.  He welcomes EPA looking at chemicals in commerce to identify those for which it would be prudent to take a closer look at their potential risk.  And with the additional actions suggested, he believes that it is a good step in the right direction.

To read EDF's analysis and the full list of suggestions, see Richard Denison's blog entry for September 13, 2011.

Congressional Briefing Says Animal Testing Should be Replaced with Alternative Methods

Yesterday there was a briefing held on Capitol Hill to update lawmakers on the status of non-animal test methods for assessing the toxicity of chemicals.  Led by Dr. Paul Locke of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), the briefing discussed the "3Rs" in US chemical law and policy.  Speaking at the briefing was Representative James Moran, who is ranking member of the House Appropriation Committee's subcommittee on Interior, Environment and Related Agencies.

Moran is also co-chair of the Congressional Animal Protection Caucus (CAPC), a group staffed by both parties that seeks to raise awareness of animal welfare issues in Congress.  CAPC replaced the "Friends of Animals Caucus" that had existed in previous Congresses.  The briefing was in conjunction with CAPC.

Dr. Locke outlined the 3Rs, i.e., finding alternative testing methods that refine existing tests by minimizing animal distress, reduce animal usage, or replace whole animal tests.  Ultimately, CAAT and other organizations would like to see a shift to all non-animal testing such as those being developed as part of Tox21, the testing program that came out of the National Academy of Sciences report "Toxicity Testing for the 21st Century: A Vision and a Strategy."

Representative Moran concurred.  During the meeting he said that "virtually all animal tests are outdated in terms of efficiency and effectiveness."  He strongly suggested that the robotic tests being advanced by Tox21 could help rapidly screen the thousands of existing chemicals that so far have received no technical review, and do so more effectively than the standard animal tests.

More information on CAAT and the briefing can be found here.

Inspector General Seeks More Answers as EPA Nears Key Deadline for Endocrine Disruptor Chemicals

The Inspector General (IG) has issued a further response to EPA's continuing attempts to address issues raised by the IG regarding how EPA will assess potential endocrine disrupting chemicals.  The IG also seeks clarification that the EPA will indeed provide additional feedback by September 30, 2011.  The deadline is supposed to be when EPA will complete its prioritization approach for selecting chemicals for testing.

The crux of the concerns raised by the IG relate to an oft-repeated industry question about how EPA will use the Tier 1 screening data already underway for List 1 Test Orders.  Industry filed a petition asking EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment."  Last month EPA issued a Federal Register notice seeking public comment on the industry petition.

The IG's memorandum indicates that they are satisfied with EPA's response to recommendations 4 and 5 pending agreed upon Agency action.  The IG also was satisfied with responses to recommendations 3(a) and 6.  However, while the IG indicates that EPA is showing progress in developing a "mutually satisfactory solution" for recommendations 1, 2 and 3(b), the IG was "seeking additional information regarding OCSPP's planned corrective actions for these recommendations." They also wanted to have clarification of what would be completed by September 30, 2011 and what would not be completed until a Management Plan is published on June 30, 2012.

The IG memorandum can be read here and downloaded as a PDF.