New Laws, Enforcement, Reconditioning and Food Recalls

If your company transports food products, either forward or reverse for reconditioning or recall purposes, you need to be aware of changes to food transportation laws. These new laws allow the Food and Drug Administration (FDA) to work with homeland security, customs and border protection, the Center for Disease Control (CDC), the EPA, USDA, DOD, DOT and the Federal Trade Commission to cause significant tightening of logistics procedures in the food transportation end of things.

This combination of federal, state and local enforcement capabilities is being established because the FDA will not have the budget to enforce food transportation laws without enlisting the help of other agencies. Put simply, what money the FDA has in its coffers is shared in order to greatly broaden enforcement powers.

Food recalls and controlling food involved in recalls for reconditioning or shipment inventory control purposes have long been subjects of consumer and legal concern. Many food recalls result in the collection and disposal of the rejected or “adulterated” foods at the end site which is usually a distribution center, market or restaurant. In such cases, collection and disposal might not require returns or the need to provide reverse logistics. The food is simply dumped in a trash bin for disposal. Other recalls may cover the need to return food products in order to change or update labels that might have been incorrectly applied during some process.

But rejected foods may also be “reconditioned” and returned to distribution channels. Reconditioning is a salvage and rework process that is similar to most industries. Food is returned to an operation, and relabeled, repackaged, strained, cleaned, recooked or otherwise reprocessed to make it consumable.

Foods requiring the shipment or return to some processing or distribution point fall under food new food safety transportation laws and rules. In general, foods transported under sanitary and temperature controlled conditions are usually perishable and often packaged in a manner that exposes the food to environmental conditions during transportation processes. Boxes of tomatoes open or partially open is a good example of perishables exposed to environmental conditions. Another example is a plastic bag of carrots if the plastic bag is slotted to allow moisture evaporation. In both cases the food is exposed to adulterants.

What is adulteration? Here is a partial list: • Pests (Bug parts, bird droppings, etc.) • Bacteria • Food Residues (testing reveals the container contains old food particles) • Intentional Adulteration (Lapses in security that allow someone to contaminate the food) • Economically Motivated Adulteration (EMA) – e.g. reefers are turned off to save fuel • Foreign Matter/Objects (Dirt, glass, wood, etc.) • Radiation • Paint chips, mold, any other residues (from the trailer or container, etc.) • Spoilage (food is rotten, defrosted, etc.)

The FDA’s “Proposed Rules on the Sanitary Transportation of Human and Animal Foods”

Don’t let the name fool you. There are a couple of big issues involved that focus on the prevention of food adulteration through sanitation and temperature control practices.

If your company is involved in moving food, especially perishables, there are some new and critical issues you need to become aware of. The Food and Drug Administration (FDA) is involved in the translation of the Food Safety Modernization Act (FSMA) into rules to be used to support federal, state and local food safety enforcement efforts.

While the FDA and the USDA have previously issued “guidance” for the transportation of foods, the passage of the FSMA in 2011 requires the FDA to develop and publish rules focused on food transportation. The publication of “Proposed” rules in January this year has added significantly to the previous guidance documents. The new rules will become law and have legal impact which guidance documents do not. While the proposed rules are currently in the comment period, their publication requires food transporters to pay some attention to what is likely to impact future logistics and reverse logistics operations.

The rules focus on food shippers, carriers and receivers. That pretty much covers all logistics and every food supply chain link. If your company moves or causes food to move internationally, interstate or intrastate by truck or rail you are covered. The FDA estimates some 84,000 companies are involved. The FDA does not distinguish between forward or reverse food movements but they do distinguish between food intended for human consumption in the US and food that is not intended for human consumption. If there is any chance the recalled or returned food could end up on someone’s table, it is covered by the rules.

There are a couple of big issues involved. First, protection of food from adulteration through sanitation of the loading, unloading and transportation tools and equipment and people is required. Sanitation implies that a company not only protect perishable foods from contaminants, but that trucks, trailers, containers and other devices used to transport food be adequately cleaned prior per sanitation procedures and that records of the cleaning must be maintained for at least one year. Sanitation also implies that some type of testing such as ATP (adenosine triphosphate) testing is conducted to validate and verify sanitation process integrity is also performed and results recorded.

The purpose of the rules is 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.”

The rules cover all practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to ensure that food is transported under the conditions and controls necessary to prevent contamination and other safety hazards. Of equal importance, shippers, carriers and receivers must have records that can verify implementation of preventive practices.

Specifically, the proposed rule establishes requirements for: • Vehicles and transportation equipment; • Transportation operations (includes movement, loading and unloading); • Training (driver temperature monitoring, as well as food safety and food handling); • Records; and • Waivers.

Design of vehicles and transportation equipment used in transportation operations must consider and be deemed “adequate” for each of the following inspection items: • Materials • Workmanship • Temperature monitoring where required • Corrosion resistant • No flaking or chipping • Meet industry standards • No surface delamination, blistering, distortion, pitting • Wood containers/pallets used to hold raw meat/poultry are not cleanable • Hoses, pumps cleaned after use • Pallets in good repair (no damage to food) require pallet control measures • Proper maintenance of equipment and utensils used to handle food

What’s not covered by the new requirements? • Shelf stable food (can’t spoil easily – canned goods, pasta, etc.) • Small businesses (under $500,000 in annual income – be careful here if your customer is a big business. • Transportation of raw farm commodities being moved on the farm (harvest to packing) • Compressed food gasses • Live food animals (animals being shipped for slaughter)

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The rules focus a great deal on the “shipper” (a person who initiates a shipment of food by motor vehicle or rail vehicle) and “carrier” (a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food (private truck fleets, private fleet truck drivers, contracted drivers, distributors, leased vehicles). The idea is that the shipper must prevent adulteration by specifying the correct sanitary and temperature controlled conditions. Carriers that are hired by the shipper are then responsible for assuring that the specifications are met.

What You Might Want to Work On

If you aren’t sure of where to start, here is a brief list for you to begin working on:

1. Develop preventive transportation operation sanitation and temperature control requirements, procedures and work instructions that are designed to prevent adulteration.

2. Specify compliance to company procedures and work instructions in a “contract of carriage” between the shipper and carrier

3. Carriers should be qualified and certified with regard to their ability and willingness to comply

4. Carrier and food shipper load and unload employees and drivers should be trained in terms of food safety, safety problems, sanitary transportation practices, driver awareness of temperature controls and abuse, contamination and vehicle sanitation and sanitary food handling.

5. Rank carriers and making sure you have the records/data to prove carriers are in compliance.

These new food transportation rules will be supported by a number of federal, state and local agencies. No segment of the food supply chain will be excluded. Companies that begin to establish practices to meet the new requirements will also be ahead of the competition in terms of meeting their customer’s requirements. Time is not on your side and recall prevention is more important than recall reaction.

Two New FDA Issues for Food Transportation

1. The FDA Food Safety Modernization Act (FSMA) “Proposed Rules on the Sanitary Transportation of Human and Animal Foods”

Don’t let the name fool you. There are a couple of big issues involved that focus on the prevention of food adulteration through sanitation and temperature control practices.

If your company is involved in moving food, especially perishables, there are some new and critical issues you need to become aware of. The rules focus on food shippers, carriers and receivers. That pretty much covers all logistics and every food supply chain link. If your company moves or causes food to move internationally, interstate or intrastate by truck or rail you are covered. The FDA estimates some 84,000 companies are involved.

The rules focus a great deal on the “shipper” (a person who initiates a shipment of food by motor vehicle or rail vehicle) and “carrier” (a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food (private truck fleets, private fleet truck drivers, contracted drivers, distributors, leased vehicles). The idea is that the shipper must prevent adulteration by specifying the correct sanitary and temperature controlled conditions. Carriers that are hired by the shipper are then responsible for assuring that the specifications are met.

2. “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)

Explosive food distribution systems dictate the need to significant changes in the way laws and the FDA address food safety issues. The FDA Operational Strategy lays out how they will proceed as they implement the FSMA.

The FDA will:

1. Focus on whether systems are working effectively to prevent food safety problems
2. Leverage resources of multiple federal, state and local partnerships (increase enforcement)
3. Build robust data integration and information sharing systems
4. Provide education and assistance (be proactive and call the FDA before they call you)
5. Implement changes to FDA resource planning and deployment
6. Conduct in-depth environmental assessments
7. Enable stronger produce safety standards
8. Respond to outbreaks
9. Take action against violators
10. Require documented assurance that food importers take proper steps to prevent problems

More details can be found at: http://www.SanitaryColdChain.com

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John Ryan
Dr. John Ryan is the president of TransCert.com and holds a Ph.D. in research and statistical methods. He has recently retired from his position as the administrator for the Hawaii State Department of Agriculture’s Quality Assurance Division where he headed up Hawaii’s commodity inspection, food safety certification and measurement standards service groups. His latest book published is “Guide to Food Safety and Quality during Transportation: Controls, Standards and Practices” is now offered by Elsevier Press. Dr. Ryan’s Company tests new cold chain technologies and certifies food and drug transporters to TransCert standards. For more than 25 years, he has implemented quality control systems for international corporations in the United States and around the world.