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RuleSignificant02-313702002-12-13

Possession, Use, and Transfer of Select Agents and Toxins

Health and Human Services Department,

Abstract

This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. This document also contains delegations of authority to the Office of Inspector General concerning civil money penalties. The interim final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts. In addition and in accordance with the Agricultural Bioterrorism Protection Act of 2002, the Department of Agriculture is establishing, by separate regulation, standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. This action is necessary to protect animal and plant health, and animal and plant products.

Action & Dates

Action
Interim final rule.
Dates
The interim final rule is effective as of February 7, 2003. However, for dates of specific applicability see Sec. 73.0. Written comments must be submitted on or before February 11, 2003. The final rule will be published after consideration of the comments.
Effective Date
2003-02-07

CFR References

Topics

Administrative practice and procedureBiologicsFraudGrant programs-healthHealth facilitiesHealth professionsMaternal and child healthMedicaidMedicarePackaging and containersPenaltiesReporting and recordkeeping requirementsSocial securityTransportation

Public Comment

Comments Close
2003-02-11

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services 42 CFR Part 73 Office of Inspector General 42 CFR Part 1003 RIN 0920-AA08 AGENCY: Centers for Disease Control and Prevention, Office of Inspector General, HHS. ACTION: Interim final rule. SUMMARY: This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. This document also contains delegations of authority to the Office of Inspector General concerning civil money penalties. The interim final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts. In addition and in accordance with the Agricultural Bioterrorism Protection Act of 2002, the Department of Agriculture is establishing, by separate regulation, standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal healt

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Full Document

Citation: 67 FR 76886