CDC Proposes Import Permit, Facility Inspections for Infectious Bio Agents, Etc.
The Centers for Disease Control and Prevention has issued a proposed rule to require imports and transfers of infectious biological agents, infectious material, and vectors to be accompanied by a CDC-issued permit. To apply for the permit, importers would need to have certain biosafety measures in place and CDC inspections of importer facilities could be required.
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Comments are due by December 13, 2011.
Imports & Transfers Would Need to Be Accompanied by CDC Permit(s)
CDC states that its proposed changes to the regulations at 46 CFR 71 would improve its ability to prevent the introduction, transmission, or spread of communicable diseases into the U.S. from foreign countries. Under the proposed rule, CDC proposes that infectious biological agents, infectious materials, and vectors1 be required to be accompanied by a permit issued by the CDC Director2 prior to entry into the U.S., or subsequent transfer within the U.S. (for which an additional CDC permit would be required).
Importers Would Need to Have in Place Biosafety Measures to Apply for Permit
CDC proposes to revise the import regulations so they clearly state that to apply for a permit, an importer must have in place biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious material, and/or vector to be imported, and the level of risk given its intended use.
(CDC states that most, if not all, subject importers already have adequate written biosafety plans. Based on permit applications submitted to CDC between March 1 and July 22, 2011, 98% of applications had adequate written biosafety plans. CDC states that if an importer's biosafety measures were found to be inadequate, CDC would offer to work with them to address any issues prior to denying the permit.)
Permit Could also be Contingent on CDC Inspection of Importer's Facility
CDC also proposes that the issuance of a permit could be contingent upon CDC's inspection of the importer’s facility. CDC would evaluate whether the importer’s implementation of its biosafety measures (e.g., physical structure and features of the facility, and operational and procedural safeguards) are effective and commensurate with the hazard posed by the infectious biological agent, infectious material, and/or vector, and the level of risk given its intended use.
Importer Would Need to Comply w/ Applicable Packaging & Shipment Laws
CDC proposes to clarify its policy on the transportation of such agents, materials and vectors by revising regulations to state that during importation, the importer would need to be in compliance with all applicable laws concerning the packaging and shipment of infectious substances. Such laws concern agriculture, the Occupational Health and Safety Administration, Transportation, and the Postal Service. (See proposed rule for full list of applicable laws.)
Proposes Written Appeal Process for Denied, Suspended, or Revoked Permits
CDC also proposes to provide applicants with an opportunity for a written appeal in the event that the CDC Director denies a request for a permit. Under the proposal, an applicant who wishes to make such an appeal would have 30 calendar days after receiving a denial, suspension, or revocation of a permit to submit an appeal in writing to the CDC Director. CDC would issue a written response to the appeal, which would constitute CDC's final action. Since 2003, CDC has denied two applications for permits.
Permit Exemptions Proposed to Allow Imports Approved by Other Agencies, Etc.
To reduce the burden for clinical/diagnostic laboratories or small business selling manufactured goods, CDC is proposing permit exemptions to allow importers to import certain material that is already approved or authorized by another agency or material that has been determined not to be an infectious biological agent. For example, no permit would be required if a material is contained in a product that is cleared, approved, licensed, or authorized under the provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act. (See proposed rule for full list of exemptions.)
1Note that with this proposed rule, the heading for 42 CFR 71.54 would also be changed from “Etiological agents, hosts, and vectors.” to “Import Regulations for Infectious Biological Agents, Infectious Material, and Vectors” to clarify CDC's proposed changes.
Infectious biological agents include microorganisms including, but not limited to, bacteria, viruses, fungi, protozoa, or prion. Infectious material is any material known or suspected to contain a biological agent infectious to humans. Vectors are any animals known or capable of transferring infectious biological agents to humans (e.g. a mosquito.) See proposed rule for full definitions of these terms.
2CDC states that the possession of a permit issued by CDC does not satisfy permitting requirements placed on materials by the U.S. Department of Agriculture that may pose hazards to agriculture or agricultural production in addition to hazards to human health.
CDC Contact -- Robbin Weyant (404) 718-2000
(D/N CDC-2011-0007, FR Pub 10/14/11)