The use of consumption data to assess exposure to biotechnology-derived foods and the feasibility of identifying effects on human health through post-market monitoring

The pre-market safety assessment of foods derived through biotechnology provides a scientific basis for concluding reasonable certainty of no harm and ensuring safety. At a minimum, the outcome of such an assessment provides sufficient information to estimate the likelihood of adverse effects on consumers, generally precluding the need for post-market monitoring. Post-market monitoring (PMM) may be appropriate under certain conditions where a better estimate of dietary exposure and/or nutritional consequence of a biotechnology-derived food is required, when a potential safety issue, such as allergenicity, cannot be adequately addressed through pre-market studies, or to corroborate dietary intakes of a nutritionally improved food with beneficial effects on human health. Monitoring programs must be hypothesis-driven, and are dependent upon the availability of accurate consumption data. Exposure assessment methods include both deterministic and probabilistic estimates of intakes using food supply data, individual dietary surveys, household surveys, or total diet studies. In the development of a monitoring approach, resource allocation should be dependent upon both the desired level of conservatism and the endpoint of interest. However, the cost of monitoring varies substantially, and the potential to determine causation may be limited.