Summary

GAO reviewed the Food and Drug Administration's (FDA) new rule on the establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. GAO found that (1) the final rule would require the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States and would implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to help address credible threats of serious adverse health consequences or death to humans and animals; and (2) FDA complied with applicable requirements in promulgating the rule.