CDC Final Rule Requires Biosafety Plans, Inspections for Import Permits
The Centers for Disease Control issued a final rule clarifying its permit requirements for imports of animals and animal products. Effective April 5, importers of microorganisms, animals and animal products that are or contain infectious biological agents, infectious substances, or disease vectors will need to implement biosafety measures as a condition of the permit, and may be subject to CDC inspections. Importers will also have to verify compliance of their shippers. Certain exceptions for imports already authorized by other agencies and animals and animal products exempted from permit requirements will apply.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
Permits Required for Biological Agents, Infectious Substances, Vectors
The final rule would revise 42 CFR 71.54 to clarify that, prior to entry, permits are required to import an “infectious biological agent, infectious substance, or vector.” Permits will also be required for subsequent transfers. Definitions for these terms included in new Part 71.54 are as follows:
Infectious biological agents: A microorganism or prion or a component of such microorganism or prion that is capable of causing communicable disease in a human.
Infectious substance: Any material that is known or reasonably expected to contain an infectious biological agent.
Vector: Any animals or animal products (including a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws of an animal) that are known to transfer or are capable of transferring an infectious biological agent to a human.
Imports cleared by other agencies, including the Food and Drug Administration, would not be subject to CDC permit requirements. Other exceptions to the permit requirements include: (1) biological agents listed in 42 CFR 73 as “Select Agents”; (2) diagnostic specimens (except bats and primates) that the importer has certified as not containing biological agents; and (3) an animal or animal products imported for educational, exhibition, or scientific purposes that is accompanied by documentation confirming it doesn’t contain infectious biological agents. (See final rule for a full list of exceptions.)
New Biosafety Measures Requirement; CDC May Inspect Facilities
To get a permit, importers will need to have biosafety measures in place that are “commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector.” CDC may conduct inspections to verify importers’ biosafety measures. CDC said it expects to inspect about 25 facilities each year, and will prioritize inspections based on required biosafety levels and whether inspections on a facility have been performed by other agencies.
According to CDC, 98 percent of permit applicants already have biosafety plans in place that would satisfy permit requirements.
Importers Responsible for Verifying Shipper Compliance
The final rule says importers must “take measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious substances.”
Appeals of Permit Denials
Under the final rule, permits may be denied or revoked if importers’ biosafety plans are not adequate, or if the importer isn’t satisfying a permit’s requirements. In the event of denial, suspension, or revocation of a permit, importers may submit a written appeal to the director of CDC within 30 calendar days.
(See ITT’s Online Archives 11101410 for summary of CDC’s October 2011 proposed rule.)