An ad hoc committee will study the state of the science of the development of food animals with heritable genetic modifications and our understanding of their potential health risks. The committee will identify knowledge gaps in the ability to assess health risks and recommend approaches to address them.

In the course of its study, the committee will examine:

• Methods for generating heritable genetic modifications in food animals;
• Information on hazards to human health related to food animals developed using heritable genetic modification techniques;
• Information on hazards to the health of the target food animal species developed using heritable genetic modification techniques;
• Information on any other potential hazards that might reasonably be anticipated to occur;
• Methods for the identification and analysis of intended and unintended genetic alterations (e.g., off-target genome editing effects, insertional mutagenesis, introduction of antibiotic resistance) in the process of developing food animals with heritable genetic modifications;
  
• Methods for the identification and analysis of potentially hazardous compositional changes in food animals;
• Challenges to the study of risks of food animals with heritable genetic modifications and approaches to addressing challenges in study design (e.g., appropriate animal models, long-term follow-up, etc.); and
• Approaches to risk assessment in the face of uncertainty of the likelihood and magnitude of health hazards.

The committee will prepare a report summarizing its findings about the topics listed above and describing the committee's conclusions about the state of knowledge of heritable genome modification techniques and the identification of potential hazards to human and animal health. The committee's report will identify key knowledge gaps and recommend areas of research for the near and medium term (3-10 years) that should be pursued by NIH, HHS, and other funders to fill gaps and strengthen regulatory science.