The National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) is finalizing its five-year plan for submission to federal House and Senate appropriations committees by year-end, according to director William S. Stokes, DVM.

Released in draft form in May by NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the plan highlighted four key challenges: identifying priority areas for research, naming research initiatives that will support the development of novel alternative test methods, fostering the acceptance of alternative test methods and strengthening interactions with stakeholders (¹ Also see "ICCVAM Plans Next Steps Toward Reducing Animal Use In Toxicity Testing" - HBW Insight, 14 May, 2007., p. 5).

Comments on the draft were due in June. Public comment was also invited at multiple town meetings following the plan's release.

In a Sept. 12 interview with "The Rose Sheet," Stokes offered NICEATM's perspective on some of the criticism the five-year plan has received.

"Some of the comments that we heard [were to the effect] that ICCVAM needed to be more proactive. Under the law we're required to consider test methods that come in that have evidence of scientific validity and then do a technical evaluation and then forward them to appropriate federal agencies for their consideration."

The final plan places "much emphasis on ICCVAM taking a greater leadership role in helping to facilitate research development, translation and validation activities," rather than merely reacting to proposed alternatives brought before it, Stokes said.

ICCVAM Vs. ECVAM

ICCVAM's "commitment" to reducing, refining and replacing the use of animals in toxicology testing was called into question in a June 7 letter signed by members of the animal protection community including People for the Ethical Treatment of Animals, the Humane Society Legislative Fund and Physicians Committee for Responsible Medicine (² Also see "Federal Commitment To Reducing Animal Testing Called Into Question" - HBW Insight, 18 June, 2007., p. 3).

The groups noted, in particular, that ICCVAM has not considered "the great majority" of alternative testing strategies endorsed by the European Center for the Validation of Alternative Methods (ECVAM), while ECVAM has "promptly" reviewed and endorsed multiple alternative methods based on ICCVAM's precedent.

Thirteen tests endorsed by ECVAM as far back as 1997 have yet to be reviewed by ICCVAM, the groups asserted.

Stokes points out that "ICCVAM - even though it sounds like 'ECVAM' - is an interagency committee. The 'C' stands for 'Committee' rather than 'Center,'" as is the case for ECVAM.

"ECVAM, as a center, has laboratories and a huge staff and a lot more resources than ICCVAM," Stokes said.

The director noted also that ICCVAM's process, by nature, can be lengthier than ECVAM's.

In establishing ICCVAM in 1997, "we solicited public input ... and we heard loud and clear that what people wanted as part of that process were two things - transparency and the opportunity for stakeholder participation," Stokes said.

"So the process we put together incorporates a high level of transparency and extensive opportunity for stakeholder involvement" - which can delay the endorsement of proposed alternative methods.

The animal protection groups also claimed that - when it does undertake a review of an ECVAM-backed method - ICCVAM frequently takes a more conservative stance on the method, effecting "only a modest reduction in animal use."

Stokes maintains that "what you will find - and what we have found in virtually every method we've looked at - is that there are certain limitations associated with the test method [so that] you still have to go back in some situations and use the traditional guinea-pig-based method," for example.

The director also suggested that confusion surrounding the term "replacement," as applied to an alternative method, has contributed to the perception that ICCVAM's recommendations for tests are more guarded in general.

"For ICCVAM to call something a 'replacement,' that would mean that you could always, in every situation, replace the traditional test with the new test. ... When [a test method] is called a replacement in Europe, that isn't necessarily the case. They recognize that there may be exceptions or limitations ... but they still may call it a replacement," Stokes said.

Stakeholders also have criticized the 5-year plan for a perceived lack of prioritization, urging ICCVAM to identify the "top three" testing areas on which it will focus.

Stokes says the committee continues to be most dedicated to evaluating alternatives to test methods that involve significant unrelieved pain and distress for animals - ocular toxicity, acute system toxicity and dermal irritation and corrosion being high on the list.

However, "we recognize that advances in science and technology are going to vary in different areas, so we will shift our priorities to take advantage of advances that occur," Stokes said.

World Congress on Alternatives & Animal Use

The 6 World Congress on Alternatives & Animal Use in the Life Sciences - held in Tokyo, Japan Aug. 21-25 - was "very successful," Stokes said.

He noted that "there was increased emphasis on refinement - kind of the lost art. ... The point was made by many speakers that while we're working toward replacement, it's very important to try to do as much as we can to eliminate pain and distress right now" through the refinement of existing methods.

According to Stokes, it was also evident at the World Congress that recently instituted Registration, Evaluation, Authorization & Restriction of Chemicals (REACH) laws in Europe have spurred interest in safety testing that incorporates in vitro methods in addition to or in place of traditional animal-based approaches.

Generally speaking, "it's very clear that increased coordination, collaboration and communication will enhance the global progress in this area," the director concluded.

- Ryan Nelson (r.nelson@elsevier.com)

NICEATM Readies 5-Year Plan For Congress; Director Stokes Discusses

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