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CDR Diane L. Kelsch FDA Florida District

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Presentation on theme: "CDR Diane L. Kelsch FDA Florida District"— Presentation transcript:

1 CDR Diane L. Kelsch FDA Florida District
Planes, Trains, and What? An Introduction to the FDA’s Interstate Travel Program (ITP) CDR Diane L. Kelsch FDA Florida District

2 History 1894: 1st Interstate Quarantine Regulations (IQR) established
Fell under Marine Hospital Service (USPHS) Treasury Department Quarantine and detention only 1917: Vessel Sanitation Program becomes a function of the PHS 1798: Beginning of the PHS (Marine Hospital Service) President John Adams signed into law an act which furnished medical relief to merchant seaman A healthy merchant marine was necessary for economic prosperity and a strong national defense

3 History Continued 1921: IQR revisions
(a) included water for drinking and culinary purposes on any car, vessel, or other conveyance while engaged in interstate travel and approved water sources (b) included general sanitation requirements for conveyance dining and lavatory facilities

4 History Continued 1951: Bus and Railcar service area requirements (related to lavatory waste discharge) 1969: IQR transferred to FDA Vessel Sanitation Program CDC?

5 History Continued 1972: IQR amended and regulations transferred to CFR Title 21 Food & Drugs Part 1240: Control of Communicable Diseases Part 1250: Interstate Conveyance Sanitation 2000: FDA transfers regulatory authority to CDC for Interstate quarantine over persons Animals and products remain under FDA 1972: PHS Regulations recodified transfers IQR from 42 CFR (Public Health) Part 12 to 42 CFR part 72 (Interstate Quarantine) FDA does things and CDC does people.  During the discussions and in the run up to the BT Act and regulations quarantine and detention of people was transferred (transfer of regulations) from FDA to CDC when it involves interstate conveyances.  For food borne illness, it usually begins with the State EIS (CDC) or DOH, then FDA if a specific food is implicated, then the collaboration begins with the DOH and CDC doing the EPI and FDA doing the environmental and food trace back.  I am attaching an example of a Shigella sp. outbreak involving a caterer, airlines, and the State of Hawaii DOH and EIS. It is dual jurisdiction until food and water is ruled out.   CDC is the primary for such things as TB, influenza, SARS. 

6 Program Goal (ITP) To ensure that the personnel, facilities, and equipment are adequate and managed to prevent food borne illness, and the introduction or spread of communicable disease via common carriers operating in interstate commerce

7 ITP Definitions 21 CFR Part 1250 Definitions:
Conveyance: Any land or air carrier, or any vessel (as defined) Interstate traffic: The movement of any conveyance or the transportation of persons or property

8 Jurisdiction Conveyances: Aircraft Vessels Busses Trains
US flagged only CDC inspects foreign flagged Busses Trains

9 Jurisdiction Continued
Support facilities Providing food, water, and/or lavatory service Caterers/commissaries Airports Vessel ports Bus stations Train stations

10 Program Activities Include
Construction/Plan review Certificates of Sanitary Construction Inspections Investigations Sample Collections Administrative and regulatory actions As necessary

11 Inspectional Frequency
Conveyances and Service Areas Every 3 years Caterers Every 6-12 months Passenger vessel and passenger rail with operating galleys Every 6 months

12 Airline Caterer Inspections
Conducted by FDA Standardized Retail Food Safety Training Officers Standardized by FDA Regional Retail Food Specialists Re-standardization every 3 years

13 Questions?

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