FAA Warning Letter

Bio Safety Update web

The Federal Aviation Administration (FAA) has audited UCSF several times this year for compliance with Federal Shipping Regulations. In July 2010, the FAA issued a warning letter to UCSF because an employee had improperly shipped hazardous biologic materials via FedEx without completing required training. 

The warning letter stated:

“This is a violation of Title 49, code of Federal Regulations. Each violation of the regulations may result in a civil penalty of up to $50,000. Persons who willfully violate these regulations may be subject to criminal prosecution with penalties of up to $500,000 and/or five years imprisonment.”

Currently, the FAA is not pursuing a civil penalty in this matter. However, the FAA stated:

“any further violation of this type would be an extremely serious issue and could possibly necessitate the assessment of a civil penalty and/or criminal referral.”  

Several issues were identified during these recent inspections including:

 

1. Biological materials were shipped using the incorrect hazard classification.

 

2. Failure to comply with training requirements.

 

3. Use of cell phone as 24/7 emergency contact number.

 

4. Failure to keep all shipping related documents for 2 years.

To maintain compliance with Federal Shipping Regulations, please ensure the following:

1. Classification of biomaterials for shipping must be accurate. Only biological agents listed on the Category A Infectious Substances list (attached) should be shipped as a Category A Infectious Substance and require a Dangerous Goods Declaration Form.  Most shipments from UCSF are Category B and must be shipped with a completed “Air Waybill.” If you do ship Category A Infectious Substances, please call the UCSF Biosafety Officer (BSO, 514-2824) in order to confirm the correct categorization. Contact the BSO for assistance if you are unsure about the classification of your material.

2. Individuals that sign shipping documentation must be trained and this training must be refreshed every two years. The UCSF “Safe Shipping” training is available at the UC Learning Center.

3. For Category A shipments requiring a Dangerous Goods Declaration Form, a 24/7 emergency contact number is required. This number cannot be a cell phone since there are dead zones for cell phone service. University of California has contracted with an outside company (CHEMTREC) that will respond to shipping emergencies on a 24/7 basis. For all future shipments, the shipper must be indicated as “University of California but not by UCSF”. The emergency telephone number should be entered as “CHEMTREC 1-800-424-9300, Customer Number: ccn23320”.

4. All shipping documentation must be kept on file for a minimum of 2 years and available for FAA inspection.

Please also remember if you are exporting and/or importing hazardous materials (chemical, biological, radioactive, etc.) and/or technology items (i.e. scientific equipment, computers, etc.), you may be subject to Import/Export Control regulations. For questions regarding exports/imports, contact ExportControl@ucsf.edu or call the BSO at 514-2824.

Please do not hesitate to contact the UCSF Biosafety Officer (514-2824) if you have additional questions or need further assistance.

Posted: September 24, 2010