established. If animals are determined to be no-takes, there is no scientifically based rationale to exclude them from entering the food chain.

A challenge to regulatory oversight of cloned and transgenic animals is development and implementation of effective programs to monitor the presence of these animals. The challenges this poses for transgenic animals have been reviewed by Howard and colleagues (2001), and an important issue to be resolved is whether cloned animals should be differentiated from noncloned animals at the point of entry of animals into the food system. Currently, there is no analytical method available to differentiate cloned from noncloned animals. However, should subsequent scientific review establish an increased risk to human health associated with the consumption of food products from cloned animals, it will be necessary to distinguish cloned animals from noncloned animals prior to entry into the food chain.

It is envisioned that the greatest likelihood of increased risk may arise from cloned, transgenic animals in which the genetic modification, as the result of transgenesis, has been made for the production of biomaterials or pharmaceuticals. In this case, methodological approaches are available to identify the transgene. This will be important in order to differentiate cloned, transgenic animals developed for food production purposes from cloned, transgenic animals developed for the production of biomaterials, pharmaceuticals, and other non-food purposes.

Due to the possible need to differentiate cloned, transgenic animals, a national system for animal identity and identity preservation is required. This system must be implemented at the point of slaughter or processing to rapidly and inexpensively identify the presence of cloned, transgenic animals or products derived from these animals. While the question of animal identification is beyond the scope of this report, it will likely be an important component of future oversight processes developed to monitor the entry of cloned, transgenic animals into the food system.

1. Profiling techniques are appropriate for establishing compositional differences between cloned and noncloned animals.

2. Profiling methods and their interpretation are not sufficiently developed to allow direct assessment of potential health effects associated with most unintended compositional changes.

3. There is no scientific basis to exclude animals deemed to be “no-takes” from entering the food chain.

4. There is a need to improve our ability to detect and assess the health

Front Matter (R1-R18)

Executive Summary (1-16)

1 Introduction (17-22)

2 Methods and Mechanisms for Genetic Manipulation of Plants (23-38)

3 Unintended Effects from Breeding (39-72)

4 New Approaches for Identifying Unintened Changes in Food Composition (73-102)

5 Adverse Impacts of Food on Human Health (103-126)

6 Methods for Predicting and Assessing Unintended Effects on Human Health (127-174)

7 Framework, Findings, and Recommendations (175-188)

Appendix A: Glossary (189-206)

Appendix B: Open Session and Workshop Agendas (207-210)

Appendix C: Committee Member Biographical Sketches (211-216)

Subreport: Methods and Mechanisms of Genetic Manipulation and Cloning of Animals (217-236)