title: Select agent regulations.
abstract: In recent years, there has been an increase in research with biological agents, particularly those that pose a potential for use by terrorists. In this environment, laws have been enacted and regulations developed to ensure the appropriate use of specified "select agents and toxins" for legitimate research. Within this regulatory environment, it has been necessary for institutions and investigators to adapt to an entirely new set of requirements to begin or continue to work with these pathogens. Registration and approval for use of select agents and toxins, security and safety requirements, and daunting record-keeping requirements are only some of the regulatory challenges that researchers face in working with these agents. A brief overview of recent regulations is presented, as well as where to obtain additional information on regulations, standards, and guidelines related to work with select agents and toxins.
authors.affiliation: Garber Consulting LLC, Pinehurst, NC, USA.
authors.forename: Janet C
authors.initials: JC
authors.lastname: Gonder
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D002487:Centers for Disease Control and Prevention, U.S.; D003264:Containment of Biohazards / Q000379:methods*; D004189:Disaster Planning; D033161:Government Regulation; D015386:Hazardous Substances; D006801:Humans; D012637:Security Measures / Q000331:legislation & jurisprudence*; D014481:United States; D016885:United States Department of Agriculture / Q000331:legislation & jurisprudence; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence
chemical_list: D015386:Hazardous Substances