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Evaluate the consequences should the identiﬁed effects be realized (the risk) a means for dealing with uncertainties and incom- 4. Consider appropriate risk-management strategies plete data in order that decisions may be made in 5. Estimate the overall potential environmental full consideration of potential consequences. It is impact, including a consideration of potential inﬂuenced by policy choices, individual experience, impacts that may be beneﬁcial to human health and public reaction. or the environment At any point, more data may be needed to arrive at a ﬁnal recommendation about whether the Risk Assessment 23 Deﬁnitions of Risk Assessment “.
Investigations consider: humans and animals. In other words, could use of these genes increase the problem of drug-resistant • Toxicity to humans, other animals, birds, ﬁsh, 6 insects, and soil microbes “super bugs”? Antibiotic resistance is a serious public health issue. However, scientists widely • Pathogenicity agree that the root cause of the problem is the • Allergenicity overuse or misuse of antibiotics in clinical treat- • Nutritional and compositional changes ments and animal production.
Preliminary food- 36 Once individual lines (“events”) have been Biosafety in Principle and in Practice chosen for commercialization, collection of rele- interest to make it easier to determine whether the vant food-safety data begins in earnest. Material treated cells or tissues are in fact genetically from ﬁeld trials is gathered and used in compara- modiﬁed. There is some concern that the use of tive assessments against the non-GM variety. Food- antibiotic-resistance genes as markers in trans- and feed-safety reviews generally focus on the genic crops might cause or increase resistance to products of the foreign genes and the characteris- antibiotics in microorganisms that cause disease in tics of the whole food.