of a listed agent or toxin. (IV) Any nucleic acid that encodes for components contributing to pathogenicity, transmissibility, or toxicity of a listed agent or toxin. (ii) Exemptions The Secretary may exempt from inclusion on the list under this paragraph any biological agent, toxin, or nucleic acid described in clause (i), if such agent, toxin, or nucleic acid does not meet the criteria under subparagraph (B). . 402. Establishment of no-fault reporting system Title III of the Public Health Service Act is amended by inserting after section 351A ( 42 U.S.C. 262a ) the following: 351B. No-fault reporting system (a) Definitions In this section: (1) The term listed agents and toxins has the meaning given the term in section 351A(l). (2) The term reporting system means the reporting system established under subsection (b)(1). (b) Establishment (1) In general Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act , the Secretary shall establish a confidential, anonymous, voluntary, no-fault reporting system related to accidents, near-accidents, or other safety incidents involving biological agents and toxins, in order to support continuous improvement and sharing of lessons learned related to such incidents. (2) Availability The ability to submit reports on a voluntary basis to the reporting system shall be made available to individuals affiliated with laboratories located in the United States, or at federally-funded entities outside the United States, that conduct research involving biological agents and toxins. (3) Data Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act , the Secretary shall publish a notice in the Federal Register on plans for the reporting system, including— (A) data elements that will be included in the submission of reports