Integral Consulting Inc.

Integral consulting on forefront of emerging guidance for biotech crops


Source: Integral Consulting Inc.

Dr. Peter Jensen of Integral Consulting Inc. participated in an industry-initiated workshop titled “Problem Formulation for Biotechnology Derived Crops and Aquatic Ecosystems” on October 13–15, 2009 at the International Life Sciences Institute (ILSI) Center for Environmental Risk Assessment in Washington, DC.

The workshop gathered prominent North American and European experts from industry, academia, and government to discuss the current state of knowledge and data gaps regarding risk from genetically engineered (GE) crops expressing pesticidal proteins to non-target aquatic organisms.

Because no regulations or standard test protocols exist to guide the testing of terrestrial or aquatic non-target organisms for GE crops, one of the goals of workshop was to produce guidance for the development of Tier 1 tests for surrogate terrestrial and aquatic organisms. Standardized Tier 1 tests would provide both predictable data requirements for industry and some of the toxicological information that agencies worldwide require for the registration of new biotech crops.

Progress was made on two fronts: 1) the refinement of a white paper outlining requirements for a good Tier 1 test for terrestrial non-target organisms, and 2) problem formulation and an outline for Tier 1 testing guidance in a white paper for aquatic non-target organisms.

Integral will continue to participate in the guidance development at the next workshop to be held in conjunction with the national meeting of the Entomological Society of America, on December 13–16 in Indianapolis, Indiana.

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