Adoption Of Alt Testing Methods Should Pick Up Under Cooperation Memo

Agencies from the U.S., EU, Canada and Japan have signed a memorandum of cooperation to accelerate the process by which non-animal testing methods are validated and implemented across the globe.

The agreement "will yield globally coordinated scientific recommendations on alternative toxicity testing methods that should speed their adoption in each of these countries, thus reducing the number of animals needed for product safety testing," according to the National Institutes of Health.

While an animal testing ban has gone into effect in Europe, its feasibility has been questioned - and deadlines pushed back - due to a lack of alternative methods for certain testing endpoints.

The memorandum was signed by high-level reps from the U.S. National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - which oversees the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) - and the European Center for the Validation of Alternative Methods (ECVAM), along with validation bodies from Japan and Canada.

NICEATM notes that collaborations between the participating agencies have increased over the past 10 years; however, "coordination of interactions has been on an ad hoc informal basis," it says. While not legally binding, the International Cooperation on Alternative Test Methods (ICATM) is expected to streamline activities and smooth out wrinkles that have arisen due to a lack of consistent coordination, NICEATM says.

Inefficiencies to date have included "validation studies, peer reviews and development of formal recommendations by one organization without adequate consultation and input from others" and "test method recommendations by one organization that often cannot be considered by another organization without extensive additional review efforts."

NICEATM also cites "wide variations in transparency and outcomes of peer review processes" and "differences in recommendations on the usefulness of alternative methods."

A globally harmonized approach to replacing, reducing or refining animal use in product safety testing was identified as a priority at the first meeting of the four-country International Cooperation on Cosmetics Regulation in October 2007 (¹ (Also see "ICCR Addresses Cosmetic Labeling, Nanotechnology At First Meeting" - HBW Insight, 15 Oct, 2007.), p. 4).

At that time, FDA, Health Canada, the European Commission and Japanese Ministry of Health also cited uniformity in labeling requirements and a harmonized stance on nanotechnology as key objectives. ICCR's mission is to lower hurdles to international trade while maintaining "the highest level of global consumer protection" (² (Also see "CTFA Supports International Harmonization Project In Comments To CFSAN" - HBW Insight, 24 Sep, 2007.), p. 3).

To ensure greater acceptance worldwide of alternative testing strategies that provide equivalent or improved protection for people and the environment, ICATM aims to foster international coordination on studies conducted to validate alternative tests, the independent peer review of validation research, and the development of recommendations for regulatory consideration.

For every test method proposed, one center will take the lead and follow standardized procedures to ensure that input is obtained from the others. NICEATM Director Dr. William Stokes offered some idea of past frustrations: Previously, one validation organization "could get done with a study and another could say, 'Well, you didn't use the chemical that I would've wanted used ... so go back and test those and then come back and talk to me.'"

By sharing information and developing consensus prior to the launch of validation studies, the participating agencies are optimistic that optimal study designs can be implemented. Similarly, close contact throughout the peer review process should ensure that reports meet the needs of all ICATM member organizations, which in turn will increase the likelihood of harmonized recommendations to regulatory authorities and, ultimately, likelihood of the test method's adoption.

Generally, "if the toxicity methods are shown to be reproducible based on strong scientific information, and able to accurately identify product-related health hazards, the tests are more readily accepted by regulatory agencies," NIH says.

Stokes acknowledged April 29 that "it is going to take a lot of staff time to be involved in this, it's going to take travel, it's going to take a lot of work, but we think that it's very much worth it."

- Ryan Nelson ([email protected])