Terry Levee AERS Manager Deloitte and Touche LLP

Key Elements Segregation of Foods and Non-Foods Temperature Monitoring Distinction Between Packaged Foods v. Bulk Commodities Trailer/Truck Washing Requirements

History During the late 1980s, complaints and press reports indicated trucks were hauling garbage and subsequently used to carry meat, poultry and produce without a sanitation step in between. GAO looked into the matter and upon review concluded it could not find any conclusive evidence that this was a common practice. Although the report stated these findings, Congress enacted the Sanitary Food Transportation Act in 1990.

History This Act directed DOT to address regulations regarding the transportation used to transport nonfood products that could make food unsafe. In 1993 DOT issued a proposed rule. In 1998, DOTs OIG determined the agency did not have the expertise to implement the law while FDA did. In 2005 Congress amended the law and directed FDA to implement it, but without a deadline. FDA takes initial steps in 2010 to develop the regulation. Although FDA has not issued a rule, FSMA-Section 111 Sanitary Transportation of foods will now cover it.

Over the last 35 years FDA has only cited a handful of events that was used to justify the need for the regulation. None of these incidents involve the transportation of food by the major distributors, restaurants or supermarkets but by smaller local independent distributors. The report from the 2007 Interstate Food Transportation Assessment Project that notes there were little or no areas of concern with large semi-trucksthe mode of transportation used by major distributors, restaurants and supermarkets.

The state of current laws, regulations and guidance Why new rules?-The incidents of record used to justify the rule are violations of current laws, regulations and misuse of guidance documents Chapter 3-FDA Food Code, 21 CFR and GMPs 2007 Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance 2006 Notice from FDA to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles 2008 Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables DOT has stated that taken together, the... FDA regulations and implementing guidance documents adequately address the overarching goal of protecting food and food products from contamination during transportation.

So how much food is really shipped?- based on an industry average of a major retail grocer A distribution center facility ships in excess of 2.9 million cases of product every week. Thats more than 150 million cases of food that is shipped out of this distribution center annually. To keep this amount of food safe during transportation, one key is to have a sound logistics program.

In retail, restaurant and end use product distribution, the risk of microbial contamination from the trailer may be minimized by following leading practices that reduce contamination since products are contained in packaging and are not in direct contact with the trailer. Different concerns exist with bulk transportation as most all product is raw and in direct contact with the trailer increasing the risk of contamination. The risk of cross contamination of packaged food and nonfood products may be minimized by current industry best practices.

Its a common industry practice to have quality control processes in place to check and inspect the temperature of products during shipping, unloading and loading activities. One such common practice is that companies check temperatures of fresh, temperature- sensitive products when making backhaul pick- ups and receiving product. Other common practices is for receiving firms to implement policies to have 3 rd party distributors record product temperatures en route to their distribution center.

Trailers are frequently swept throughout the day to remove any debris. Spills and odors are addressed promptly and thoroughly when identified through inspection. Inspection, verification and documentation are integral part of most food safety plans. Retailers, wholesalers and distributors should have effective methods which meet the needs of their individual supply chain systems.

Most non-bulk foods being transported by the industry are enclosed in packaging and do not come into direct contact with trailer surfaces. When following the above leading practices - trailer washing regimens may not be appropriate or necessary. A review of your trailer cleaning program may be needed to determine if your current program meets the act.

Current industry practices indicate foods may be transported simultaneously and sequentially with nonfood products with minimal risk. By using a leading practice that segregates food and non foods on the same trailer the potential risk of cross-contamination from nonfood may be minimized. By implementing a leading practice it may minimize excessive wear and tear on trucks, reduce man-hours and reduce gas emissions and consumption for fuel.

Employee awareness and training Management review of records (sanitation, temperature, shipping manifests) Proper communication between shipper, transporter and receiver Applicable loading procedures for transportation units Applicable unloading procedures for transportation units Suitable documentation accompanying each load (tanker cleaning record, seal numbers on the bill-of-lading, temperature readings, time in-transit and time on docks Appropriate packaging/packing of food products and transportation units

Sanitation Temperature Control Proper Placement (Co-mingling of loads) Pest Control Handling Complete security management (seals) Receiving

Involve stakeholders Focus on internal core competencies Gain access to knowledge and technology Promote real-time organizational awareness of opportunities for innovation Lessen the cycle time for experiment conception and design Tap into the power of grassroots participation to drive acceptance, adoption and expansion of ideas

First and foremost FDA must take a science and risk-based approach in implementing SFTA Reassess your current programs, identify gaps and implement new programs in the most efficient manor to help minimize costs. FDA should implement SFTA allowing the distribution industry the flexibility to develop and maintain current industry best practices.

Terry Levee AERS Manager Deloitte and Touche LLP