1.1                          A bill for an act
  1.2             relating to health; requiring the commissioner of 
  1.3             health to establish and maintain a biological agents 
  1.4             registry; directing the commissioner to establish 
  1.5             biological agent safety standards; authorizing 
  1.6             rulemaking; providing a civil penalty; appropriating 
  1.7             money; amending Minnesota Statutes 2001 Supplement, 
  1.8             section 13.3806, by adding a subdivision; proposing 
  1.9             coding for new law in Minnesota Statutes, chapter 144. 
  1.10  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.11     Section 1.  Minnesota Statutes 2001 Supplement, section 
  1.12  13.3806, is amended by adding a subdivision to read: 
  1.13     Subd. 11a.  [BIOLOGICAL AGENTS REGISTRY.] Data collected by 
  1.14  the commissioner of health for the biological agents registry 
  1.15  are classified in section 144.482, subdivision 6.  Sharing of 
  1.16  data from the biological agents registry is governed by section 
  1.17  144.482, subdivision 6. 
  1.18     Sec. 2.  [144.482] [BIOLOGICAL AGENTS REGISTRY AND SAFETY 
  1.19  STANDARDS.] 
  1.20     Subdivision 1.  [DEFINITIONS.] (a) For purposes of this 
  1.21  section, the following terms have the meanings given to them. 
  1.22     (b) "Biological agent" means: 
  1.23     (1) any select agent that is a microorganism, virus, 
  1.24  bacterium, fungus, rickettsia, or toxin listed in Code of 
  1.25  Federal Regulations, title 42, part 72, appendix A; 
  1.26     (2) any genetically modified microorganism or genetic 
  1.27  element from an agent listed in Code of Federal Regulations, 
  2.1   title 42, part 72, appendix A, shown to produce or encode for a 
  2.2   factor associated with a disease; or 
  2.3      (3) any genetically modified microorganism or genetic 
  2.4   element that contains nucleic acid sequences coding for a toxin 
  2.5   listed in Code of Federal Regulations, title 42, part 72, 
  2.6   appendix A, or a toxic subunit of such a toxin. 
  2.7      (c) "Person" means a public or private entity of any kind 
  2.8   and includes an individual, post-secondary educational 
  2.9   institution, or state agency. 
  2.10     Subd. 2.  [REGISTRY ESTABLISHED.] The commissioner of 
  2.11  health shall establish and maintain a registry of biological 
  2.12  agents.  The biological agents registry must identify the 
  2.13  biological agents possessed and maintained by any person in this 
  2.14  state and must contain other information as required by the 
  2.15  commissioner in rule. 
  2.16     Subd. 3.  [REPORTING REQUIRED FOR REGISTRY.] Any person who 
  2.17  possesses or maintains a biological agent for which a report is 
  2.18  required under this section must report to the commissioner of 
  2.19  health and must provide information required by the commissioner 
  2.20  for the biological agents registry. 
  2.21     Subd. 4.  [RULEMAKING FOR REGISTRY.] The commissioner of 
  2.22  health shall adopt rules to administer the biological agents 
  2.23  registry, collect information, and distribute data.  In adopting 
  2.24  rules, the commissioner may use the expedited process in section 
  2.25  14.389.  The rules adopted must include but are not limited to: 
  2.26     (1) listing the biological agents that must be reported to 
  2.27  the commissioner; 
  2.28     (2) designating persons required to report; 
  2.29     (3) specifying information that must be included in a 
  2.30  report, the form of a report, timelines for reporting, and to 
  2.31  whom reports must be submitted; and 
  2.32     (4) establishing procedures to cooperate with and release 
  2.33  information contained in the registry to state and federal law 
  2.34  enforcement agencies and the federal Centers for Disease Control 
  2.35  and Prevention in the following circumstances: 
  2.36     (i) as part of an epidemiologic investigation initiated by 
  3.1   the commissioner, the Centers for Disease Control and 
  3.2   Prevention, or a state or federal law enforcement agency; or 
  3.3      (ii) in connection with any investigation involving the 
  3.4   release, theft, or loss of a biological agent. 
  3.5      Subd. 5.  [RULEMAKING FOR SAFE HANDLING AND USE, 
  3.6   UNAUTHORIZED POSSESSION.] (a) The commissioner of health shall 
  3.7   adopt rules to: 
  3.8      (1) establish a system of safeguards to ensure that persons 
  3.9   possessing and maintaining a biological agent satisfy federal 
  3.10  standards regarding the safe handling and use of biological 
  3.11  agents; and 
  3.12     (2) establish a process for a person possessing and 
  3.13  maintaining a biological agent to alert the commissioner or 
  3.14  other appropriate authorities if an unauthorized person obtains 
  3.15  or attempts to obtain such a biological agent.  The rules must 
  3.16  designate what authority a person must alert in these 
  3.17  circumstances. 
  3.18     (b) In adopting rules, the commissioner may use the 
  3.19  expedited process in section 14.389. 
  3.20     Subd. 6.  [DATA CLASSIFICATION, ACCESS.] (a) Data prepared 
  3.21  for or maintained by the biological agents registry are private 
  3.22  data on individuals or nonpublic data. 
  3.23     (b) Notwithstanding paragraph (a), the commissioner of 
  3.24  health may, in accordance with rules adopted by the 
  3.25  commissioner, release information contained in the biological 
  3.26  agents registry to the Centers for Disease Control and 
  3.27  Prevention or a state or federal law enforcement agency as 
  3.28  necessary to conduct or aid in an epidemiologic investigation or 
  3.29  to facilitate an investigation involving the release, theft, or 
  3.30  loss of a biological agent. 
  3.31     Subd. 7.  [CIVIL PENALTY.] If the commissioner of health 
  3.32  finds that a person has committed a knowing or willful violation 
  3.33  of this section, the commissioner may impose a civil penalty of 
  3.34  up to $1,000 for each separate violation.  Each day in which a 
  3.35  person does not comply with this section constitutes a separate 
  3.36  violation.  The administrative hearing procedures in chapter 14 
  4.1   apply to any person wishing to contest a civil penalty levied 
  4.2   under this subdivision. 
  4.3      Subd. 8.  [FEE.] The commissioner of health shall charge an 
  4.4   annual fee of $....... to any person who possesses or maintains 
  4.5   a biological agent and reports to the commissioner as required 
  4.6   under this section.  The total fees collected must support the 
  4.7   costs of administering this program.  Fees collected under this 
  4.8   subdivision must be deposited in the state government special 
  4.9   revenue fund. 
  4.10     Sec. 3.  [APPROPRIATION.] 
  4.11     $....... is appropriated for the fiscal year ending June 
  4.12  30, 2003, from the state government special revenue fund to the 
  4.13  commissioner of health to fund the biological agents registry 
  4.14  and the development of safety standards under Minnesota 
  4.15  Statutes, section 144.482.