42 U.S.C. § 262a — Enhanced control of dangerous biological agents and toxins

(a) Regulatory control; list of biological agents and toxins. The Secretary must set up, by regulation, a list of biological agents and toxins that could severely threaten public health and safety. In deciding what goes on the list, the Secretary must weigh: how exposure affects human health; how contagious the agent is and how it spreads to people; whether good treatments or vaccines already exist; and any other relevant factor, including the needs of children and other vulnerable people. The Secretary must also consult with other federal agencies and with scientific experts, including experts in pediatric medicine. This list must be reviewed and republished at least every two years, more often if needed, and revised as necessary. (b) Regulating transfers. The Secretary must write regulations covering: safety procedures for transferring listed agents and toxins (including training for people who handle them, who work near labs that transfer them, or who oversee facilities that do, plus proper lab facilities to contain and dispose of them); security measures to stop these agents and toxins from being used in terrorism or other crimes; procedures to protect public safety if a transfer happens, or almost happens, in violation of those safety or security rules; and rules making sure these agents and toxins stay available for legitimate research, education, and other purposes. (c) Possession and use. The Secretary must also write regulations covering the standards and procedures for possessing and using (not just transferring) listed agents and toxins, including the same kinds of safety and security protections described in subsection (b). (d) Registration; national database. The regulations must require anyone who wants to possess, use, or transfer listed agents or toxins to register with the Secretary, and must make sure registrants have a lawful purpose. Registration must include identifying information about the agents or toxins involved, when available. The Secretary must keep a national database listing registered people, what agents and toxins they have, and identifying details about those agents and toxins. (e) Safeguards and security for registered people. The regulations must set security requirements sized to the danger each agent or toxin poses, created together with the Department of Homeland Security and the Attorney General. These requirements must make sure registered people: only let individuals access the agents or toxins if they have a real need; report those individuals' names to the Secretary and Attorney General promptly, and again at least every five years; deny access to anyone the Attorney General has flagged as a "restricted person"; and limit or deny access to anyone flagged as reasonably suspected of terrorism, violent crime, or acting as a foreign agent, if the Secretary decides that's appropriate. When names are submitted, the Attorney General checks them against criminal, immigration, national-security, and other databases, solely to see if the person falls into a restricted or suspect category, and reports back to the Secretary. The Secretary then tells the registered employer — and the individual, if denied — the result. There's an expedited review process available for good-cause requests. The same background-check process applies to people applying to register themselves, and to non-individual applicants such as companies, whose owners or controllers can also be checked, though the Secretary can exempt government agencies from this. People denied access, or denied or revoked registration, can ask the Secretary for a review; that review can consider sensitive information privately (ex parte) if disclosing it would hurt national security or an investigation, and the Secretary's decision counts as final agency action. If that decision is challenged in court, the court can also review sensitive government material privately under special procedures, and neither the Secretary nor the Attorney General has to publicly disclose information that's protected from disclosure under subsection (h). Registered people must promptly report any theft or loss of these agents or toxins. The Secretary, working with the Attorney General, may also give registered people technical help to improve their security. (f) Inspections. The Secretary can inspect anyone covered by the regulations in (b) or (c) to check they're following the rules, including the restricted-persons rules in (e). (g) Exemptions. Regulations must exempt clinical or diagnostic labs (and similar people) that have listed agents or toxins only because they're in specimens being tested or verified, as long as they report the agent's identity to the Secretary (and other authorities, if state or local law requires) and destroy or transfer the specimen the way the Secretary's rules say. Regulations must also exempt products containing listed agents or toxins that are already cleared, approved, licensed, or registered under other named laws — the Food, Drug, and Cosmetic Act, the biologics-licensing law (section 262 of this title), the Virus-Serum-Toxin Act, or the federal pesticide law — unless the Secretary formally decides extra regulation of a specific product is needed for public health and safety. The Secretary may also exempt an investigational product being used in an authorized study, if extra regulation isn't needed for safety; the regulations must spell out how to apply for that exemption, and for products in trials authorized under one of the four named laws, the Secretary must decide on the exemption request within 14 days of getting a complete application plus proof the study is authorized. Beyond that, the Secretary can temporarily exempt someone — for up to 30 days, with one possible 30-day extension — if it's necessary so they can respond to a domestic or foreign public health emergency involving a listed agent or toxin. A similar temporary exemption, also up to 30 days and extendable once by 30 more days, is available at the Secretary of Agriculture's request, to help someone respond to an agricultural emergency. (h) Disclosure of information. Certain federal agencies — HHS, Justice, Agriculture, and Transportation, plus any agency that later receives this information, is itself a registrant, or awards grants or contracts involving these agents — generally can't release under the Freedom of Information Act: registration or transfer records that would identify what agent a specific registrant has or who or where that registrant is; the national database or similar compilations revealing site-specific registration details; parts of records revealing a registrant's specific security measures; reports of releases, thefts, or losses; or parts of inspection reports that would identify a specific registrant's agents or location, if disclosure could endanger public health or safety. This confidentiality rule doesn't change any other Freedom of Information Act exemption that already applies (except one specific one), and it doesn't stop agencies from disclosing or withholding other related information — like general policies, summary statistics, or information about agents and toxins in general — under their normal authority. None of this can be used to withhold information from Congress, or to block disclosures required under some other federal law or treaty. (i) Civil money penalty. Anyone who violates the regulations under (b) or (c) can face a civil money penalty — up to $250,000 for an individual, or up to $500,000 for anyone else, such as a company — on top of any other penalty that applies. Most of the procedural rules that govern civil penalties under a related Social Security Act provision apply here too, and the Secretary can delegate this authority the same way as under that provision. (j) Notification of a release. The regulations must require registrants to promptly notify the Secretary whenever a listed agent or toxin is released outside a facility's biocontainment area, under criteria the Secretary sets. If the Secretary finds the release threatens public health or safety, the Secretary must notify relevant state, local, and other federal health authorities, and the public if necessary. If the released agent is also regulated by the Department of Agriculture as an "overlap agent," the Secretary of Agriculture must be notified too. (k) Reports. If an agent or toxin is released, lost, or stolen from an HHS-owned lab, or another federal lab covered by this section, the Secretary must, without compromising national security, tell two named congressional committees within 72 hours which facility was involved and what happened, then give them an update within 14 days on what's being done to address the threat and prevent it from happening again. The Secretary must also send those same committees an annual report on how many release, loss, and theft notifications came in that year, what actions were taken in response, and what gaps or challenges remain in keeping safety and security practices consistent. Within a year of June 24, 2019, and then every year until it's done, the Secretary must also report to Congress on progress implementing recommendations from a specific federal security advisory panel about the select-agent program. (l) Definitions. "Biological agent" and "toxin" mean whatever they mean under 18 U.S.C. § 178. "Listed agents and toxins" (or "listed agents or toxins") means whatever's on the list from subsection (a)(1). "Overlap agents and toxins" are agents or toxins listed both by this Secretary and by the Secretary of Agriculture under a parallel law. "Person" includes federal, state, and local government bodies. A "registered person" is anyone registered under the (b) or (c) regulations. "Restricted person" means whatever that term means under 18 U.S.C. § 175b. (m) Authorization of appropriations. Congress may appropriate whatever money is needed to carry out this section for fiscal years 2023 through 2027.