OVERVIEW OF THE SANITARY TRANSPORTATION ACT

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1 OVERVIEW OF THE SANITARY TRANSPORTATION ACT Kara Baldus Copyright 2016 Covance. All Rights Reserved

2 Background Kara Baldus 20 years food microbiology UW-Madison in Bacteriology and Genetics MBA with Management and Total Quality Certificate Deibel Laboratories, Kraft Foods, TRAC Microbiology Microbiology consultant Lead Trainer FSPCA HACCP

3 Food Safety Modernization Act SEVEN FOUNDATIONAL REGULATIONS 6 Preventive Controls Human Food 7

4 Why FSMA? Biggest food safety regulation change for Food and Drug Administration (FDA) since the 1930 s Create a safer food supply from farm to fork Rather than react to contamination, prevent

5 FSMA FDA has released the regulations and several guidance documents. Food Safety Preventive Controls Alliance (FSPCA) was formed to help harmonize training and technical help

6 Sanitary Transportation of Human Food

7 Twenty Years Ago

8 Or last week..

9 Why does this happen? Lack of knowledge? Lack of communication? Lack of understanding?

10 More Global Economy

11 Photos: US Department of Transportation

12

13 What is the rule trying to prevent?

14 Contamination Biological Microbial growth by temperature abuse Cross-contamination Chemical Non-food chemicals (fertilizers) Cross-contact with allergens Physical Wood Plastic

15 What is the rule meant to do? To establish requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport FSMA Final rule on Sanitary Transportation of Human and Animal Food, April 6, 2016

16 Why? To prevent the food being transported from becoming filthy, putrid, decomposed, or otherwise unfit for food, or rendered injurious to health. FSMA Final rule on Sanitary Transportation of Human and Animal Food, April 6, 2016

17 Definitions Shipper Person who initiates a shipment of food by motor or rail vehicle Loader Person that loads food onto a motor car or rail vehicle used during transportation operations. Carrier Person who owns, leases, or is otherwise ultimately responsible for the use of a motor or rail vehicle to transport food Receiver Person who receives food after transportation, whether of not that person represents the final point of receipt for the

18 Exemptions Transportation of food that is completely enclosed by a container, unless the food requires temperature control for safety. Transportation of compressed food gases Transportation of food contact substances Transportation of live food animal, except molluscan shellfish Transportation activities performed by a farm Transportation of human food byproducts for use as animal food without further processing Transportation of food that is transshipped through the US to another country Transportation of food that is imported for future export and that is neither consumed nor distributed in US Firms that have less than $ in average annual revenue.

19 Shippers Duties Develop and implement written procedures to ensure equipment and vehicles are in appropriate sanitary condition Develop and implement written procedures to ensure that a previous cargo does not make food unsafe, if they are transporting food in bulk Develop and implement written procedures to ensure food is transported under adequate temperature control if food requires temperature control for safety

20 Shippers and Receivers MUST If at any point in the transportation chain, there is a failure of temperature control or other condition that may render a food unsafe, the food cannot be sold/ distributed until deemed safe.

21 The shipper must specify to the carrier, in writing. 1 Sanitary requirements for the carrier s vehicle and equipment 2 Specific design requirements 3 Cleaning procedures 4 Temperature conditions, including the pre-cooling phase 5 Must verify that each freezer and mechanically refrigerated cold storage has been pre-cooled in accordance with information submitted by the shipper 6 Temperature records required of the carrier

22 Carriers Must 1 Demonstrate to the shipper and if requested, to the receiver, that it has maintained temperature conditions during the transportation operation Receive written shipper agreement for shipper responsibility for temperature monitoring Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use Pre-cool in the absence of temperature control and precool each mechanically refrigerated freezer and cold storage compartment as specified by the shipper

23 Carrier must Bulk carriers (unless agreed in writing): Identify 3 previous cargoes (or fewer if agreed in writing) Provide information to the shipper that describes the most recent cleaning Unless contractually agreed to use a specified cleaning procedure at specified intervals or if the shipper cleans the vehicle at his own facility Describe how it will comply with the provisions for the use of bulk

24 Training Training provided by Carriers Provide an awareness of potential food safety Problems that may occur during food transportation Basic sanitary transportation practices

25 What records? Written procedures (including loading) Any agreements between shipper and carrier Training (required of carriers) WAIVERS: Valid permits and inspected under National Conference on Interstate Milk Shipments (NCIMS) Valid permits issued by relevant regulatory authority, food is relinquished to customers (restaurants, supermarkets and home grocery delivery)

26 When Do You Have to Comply? Small business businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million annual receipts would have to comply two years after the publication of the final rule (April 6, 2016 published) Other businesses a business that is not small and is not otherwise excluded from coverage would have to comply one year after publication of the final rule.

27 I need help.. FDA: FSMA Final Rule on Sanitary Transportation of Human and Animal Food and Guidance Documents 3.htm entsregulatoryinformation/sanitationtransportation/ucm htm Training for Carriers covered by the Sanitary Transportation of Human and Animal Food Rule GMA:

28 FDA FSMA Website

29 Start of Training

30 Start of Training

31 Quiz Score

32 Certificate

33 Thank you! Kara Baldus Covance, Inc