NC Register Volume 16 Issue 15 - Office of Administrative Hearings

TEMPORARY RULESTemporary Adoption Eff. December 21, 2001.A person possessing and maintaining a listed biological agent onthe effective date of these Rules shall make a report within 45* * * * * * * * * * * * * * * * * * * *days of the effective date of these Rules. A person who does notpossess and maintain any listed biological agents on the effectiveRule-making Agency: Commission for Health Servicesdate of these Rules shall make a report within seven days ofreceipt of such agents. A person shall make an amended reportRule Citation: 15A NCAC 19A .0901-.0907within seven days of any change in the information contained inthe report. A person shall make a report within 24 hours of anyEffective Date: January 10, 2002suspected release, loss or theft of any listed biological agent.Findings Reviewed and Approved by: Beecher R. GrayAuthority for the rulemaking: G.S. 130A-149Reason for Proposed Action: Recent bioterrorism in thiscountry necessitiates the creation and active maintenance of aBiological Agent Registry in North Carolina. Such a registrywill make it easier for the Department of Health and HumanServices to track and otherwise account for biological agents inthe state, as well as investigate suspected or confirmed instancesof bioterrorism.Comment Procedures: Written comments concerning this rulemakingaction may be submitted after the date of publication inthis issue of the North Carolina Register. Comments must besubmitted to Chris Hoke, Rule-making Coordinator, Division ofPublic Health, 2001 Mail Service Center, Raleigh, NC 27699-2001.CHAPTER 19 – HEALTH: EPIDEMIOLOGYSUBCHAPTER 19A – COMMUNICABLE DISEASECONTROLSECTION .0900 - BIOLOGICAL AGENT REGISTRY15A NCAC 19A .0901 GENERALThe biological agent registry established by G.S. 130A-149 isadministered by the N.C. Department of Health and HumanServices, Division of Public Health, Epidemiology Section, 225N. McDowell Street, Raleigh, N.C. 27603.History Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0902 BIOLOGICAL AGENTS TO BEREPORTEDThe biological agents that shall be reported to the registry shallbe those agents listed as select agents in 42 C.F.R. Part 72,Appendix A which is adopted herein by reference includingsubsequent amendments and editions. Copies of this federalprovision may be inspected at and copies obtained from the N.C.Department of Health and Human Services, Division of PublicHealth, Epidemiology Section, 225 N. McDowell Street,Raleigh, N.C. 27603, at a cost of ten cents ($.10) per page at thetime of adoption of this Rule.History Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0903WHEN TO REPORTHistory Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0904 WHAT TO REPORTThe report shall be made on a form created by the Departmentand shall identify the listed biological agents possessed andmaintained at the facility; shall specify the use of the agents forvaccine production, research purposes, quality control or otheruse; shall indicate the form of the agents; shall identify thephysical location of the laboratories and the storage areas; andshall identify the person in charge of the agents.History Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0905 EXEMPTION FROMREPORTINGA person who detects a listed biological agent in a clinical orenvironmental sample for the purpose of diagnosing disease,epidemiological surveillance, exposure assessment, reference,verification or proficiency testing, and who discards the agentwithin 14 calendar days of receiving notice of the completion ofconfirmation testing, or discards the agent within 14 calendardays of using the agent for reference, verification or proficiencytesting, is not required to make a report.History Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0906 SECURITYAll persons possessing and maintaining a listed biological agentmust demonstrate compliance with all safeguards contained in42 C.F.R. Part 72 and the rules promulgated thereunder, andmust employ those federal safeguards over the agents theypossess and maintain, regardless of whether the mere possessionof the agent is itself required to be registered under federal law.The safeguards contained in 42 C.F.R. Part 72 and the rulespromulgated thereunder are adopted herein by referenceincluding subsequent amendments and additions. Copies of thisfederal provision may be inspected at and copies obtained fromthe N.C. Department of Health and Human Services, Division ofPublic Health, Epidemiology Section, 225 N. McDowell Street,Raleigh, N.C. 27603, at a cost of ten cents ($.10) per page at thetime of adoption of this Rule.History Note: Authority G.S. 130A-149;Temporary Adoption Eff. January 10, 2002.15A NCAC 19A .0907 RELEASE OF INFORMATIONThe Department shall release information contained in theBiological Agents Registry only by order of the State Health16:15 NORTH CAROLINA REGISTER February 1, 20021724