IP Grams
Today, the Centers for Disease Control and Prevention (CDC)’s Division of Select Agents and Toxins published an Interim Final Rule adding SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. In addition, the work to create this chimeric virus is a ‘restricted experiment’ and requires prior approval from CDC before performing the experiment.
The regulation, available at https://www.federalregister.gov/d/2021-25204external icon, was published in the Federal Register and CDC will be accepting public comments on the addition of the agent for the next 60 days.
HHS/CDC believes that immediate regulatory oversight of these experiments and the resulting chimeric viruses is essential to protect the public from the potential consequences of a release of these viruses.
We are sharing this information with all current U.S. permittees working with infectious biological agents or substances so that all are aware of the new requirement. Please note that this Interim Final Rule has implications for anyone currently holding or working with these materials and will require action on their part in order to comply with the select agent regulations.
If you have any questions, please contact CDC’s Division of Select Agents and Toxins at lrsat@cdc.gov or 404-718-2000. Comments on the Interim Final Rule should be submitted via the regulations.gov website; a direct link is available hereexternal icon.
The Centers for Disease Control and Prevention’s Import Permit Program (IPP) may inspect an entity to verify the importer has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance and/or vector to be imported, and the level of risk given its intended use.
IPP inspectors have the authority to perform these inspections in accordance with the Import Permit Regulations (42 CFR Part 71.54).
All IPP inspectors have undergone appropriate Federal background investigations and obtained the necessary medical clearance to conduct IPP inspections. Each inspector also maintains a copy of his/her immunization records and his/her respirator fit testing card.
An IPP inspector may show an entity his/her official government badge to identify themselves prior to performing an inspection. The official government badge consists of the employee’s name, picture of the employee, the individual’s personal identifier number, and the government agency with which the employee is affiliated. In addition, the facility may request IPP to provide the entity with an “Inspector Verification” letter prior to the arrival of the inspectors that includes information on the individual’s current health status.
The IPP inspector is not allowed to:
- Give the entity his/her official government badge in exchange for the entity’s identification badge. In addition, the entity is not allowed to copy the badge.
- Sign a confidentiality agreement.
- Sign any type of document releasing the entity from liability.
Therefore, doing so may not be required as a condition for entry to conduct an IPP inspection.
In addition, the entity to be inspected may not require the inspector to do any of the following as a condition of entry:
- Provide the entity with any personal identification such as driver’s license, social security card, etc.
- Participate in any entity medical surveillance program.
Failure to grant an IPP inspector access to the locations necessary to conduct an inspection may result in denial or revocation of an IPP import permit.
As someone who has received an import permit from the Centers for Disease Control and Prevention (CDC)’s Import Permit Program (IPP), we wanted to let you know that the program is hosting a public webinarexternal icon on December 2, 2021 from 11 a.m. to 4 p.m. EST to address import permit regulations for bringing infectious biological agents, infectious substances, and vectors of human disease into the U.S. While the agenda is still being finalized, additional presenters for this webinar will include representatives from the Department of Transportation, Animal and Plant Health Inspection Service, U.S. National Authority for Containment of Poliovirus, Customs and Border Protection, and the Department of Commerce.
Registration instructions are available on the CDC Import Permit Program website. The webinar agenda will also be posted to this page once finalized. All registration requests should be submitted by Friday, November 26, 2021. The webinar link and supporting information will be sent to registered participants prior to the workshop.
The CDC Import Permit Program (IPP) inspects entities using standardized checklists to verify that facilities have implemented the appropriate biosafety measures for the infectious biological agent, infectious substance, or vector to be imported.
IPP has updated its inspection checklists to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). The updated inspection checklists are available for reference on the IPP website.
The Centers for Disease Control and Prevention, Import Permit Program (IPP) has posted the webcast presentations held on December 3, 2020, on the IPP website.
The Centers for Disease Control and Prevention (CDC) has published a Federal Register Notice seeking public comment on the request for continued approval by the Office of Budget and Management to collect information through use of the CDC’s Import Permit Program’s key reporting forms, including:
- Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States
- Application for Permit to Import or Transport Live Bats
- Application for Permit to Import Infectious Human Remains into the United States
The Federal Register notice and information on how to submit public comments can be found hereexternal icon. The public comment period ends on December 21, 2020.
The CDC Import Permit Program (IPP) wishes to make its stakeholders aware of a new resource that has been posted to its webpage, the Department of Transportation’s Guidance for Completing the Shipper’s Declaration for Dangerous Goods.
This Department of Transportation (DOT) guidance document provides step-by-step instructions for correctly filling out the DOT Shipper’s Declaration for Dangerous Goods to avoid delay in the importation into the U.S. and subsequent transfers within the U.S. of infectious biological materials that could cause disease in humans.
The DOT guidance and additional resources are available here.
