President Obama signed the FDA Food Safety Modernization Act into law on January 4, 2011.
Upcoming final rules and dates:
•Preventive Controls for Human and Animal Food August 30, 2015
•Sanitary Transportation of Food March 31, 2016
•Intentional Adulteration / Food Defense Plan May 31, 2016
•Product Tracing / Record Keeping for high-risk foods June 30, 2015
As a food distributor and or any company hauling food, are you up-to-date on the six major Sanitary Transportation of Food sections of FSMA and the “proposed rules”?
1.Vehicle and transportation equipment
6.Product tracing for high-risk foods
VEHICLE AND TRANSPORTATION EQUIPMENT
Proposed rule will require equipment be designed of such material, and workmanship:
•To be adequately cleanable for their intended use to prevent food from becoming filthy, putrid, decomposed, or otherwise unfit
•Being rendered injurious to health from any source during transportation.
•When applicable, records will be required to prove that the separation of foods with different temperature requirements was taken to prove adequate temperature control was achieved.
•Prove and ensure no cross-contamination took place. As an example, a bulkhead in poor condition could cause temperature swings in trailer and or product cross-contamination.
•Another example for potential for cross-contamination could come from incorrect use of packing materials such as reusing wood pallets and containers for produce that once held raw meat.
•Proposed rule regarding vehicle and transportation equipment design requirements and cleaning procedures must be in writing.
TRANSPORTATION AND OPERATIONS
•Transportation operations of food haulers and receivers involved with any movement of food in commerce by motor or rail vehicle. Includes food being imported and will be consumed in the United States.
•All activities associated with food transportation that may affect the sanitary condition of the food including cleaning, inspection, maintenance, loading/unloading, and operation of vehicles and transportation equipment.
•Food distributors, carriers, shippers, and receivers may be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls.
•A history of food hauled must be kept. FDA will not restrict what can be hauled. Rather, they may regulate the cleaning between loads. Wash tickets may be required to be kept on file.
•Food distributors must complete training in sanitary transportation practices and must have documentation of the training.
•Includes personal hygiene for drivers and loading/unloading workers, training in security, accessibility to hand washing, and avoiding cross-contamination in handling mixed loads.
•Food haulers must retain required training records for a period of 12 months beyond when such person identified in records continues to perform the duties for which the training was provided.
Who must establish and maintain records?
•Domestic persons in the U.S. that manufacture, process, pack, transport, distribute, receive, hold or import food for consumption in the U.S.
•For these regulations, the term “persons” include individuals, partnerships, corporations, and associations.
•Any company handling food throughout the “farm to fork” cold chain, must have written Food Safety Plans and Standard Operating Practices in place and on file and retain records as dictated by FDA accordingly.
Length of record retention for food products:
•Record retention for both the handler and carrier depends on the perishability and shelf life of the product.
•If the shelf life is less than 60 days, length is 6 months.
•If the shelf life is between 60 days and 6 months, or if the product is animal food, length is 12 months.
•If the shelf life is greater than 6 months, length is 2 years
•Records must be available within 24 hours of a request by FDA. Records are also subject to audit and verification by FDA and Civil Action could taken if not complied with.
Will the FDA require electronic record-keeping?
•NO! The agency does not have the statutory authority to require companies to use electronic record-keeping.
•BUT! The FDA is very cognizant of the fact that electronic record- keeping and telematics systems are the way of the future and “prefers” them for companies to meet FSMA compliance.
•As proposed rule is presently written, they will allow companies to keep their records however they want as long as they can be produced to the FDA within 24 hours.
PRODUCT TRACING FOR HIGH RISK FOOD
At the time FDA issues a final rule on product tracing, the agency will publish a list of high-risk foods:
•They will also issue regulations containing new record-keeping requirements applicable to all food haulers and facilities that manufacture, process, pack, or hold high-risk foods.
•FDA has the authority through FSMA to require additional records be kept for high risk foods.
•FDA also has an appetite for traceability requirements to be more “robust”, but they are limited to what is economically feasible and practical.
•Looking towards the future, food industry experts are predicting FDA to strengthen traceability requirements.
•Whole-chain traceability involves linking internal proprietary traceability systems with external systems.
•By partners communicating the same "language“ to identify and capture data about products, specific product information can be shared more efficiently and accurately. Which ultimately benefits all companies in the food supply chain.
•Ultimately, the FDA will establish a product tracing system that focuses heavily on receiving information quickly to improve the response side of a recall plan.
•Will allow for rapid tracking and tracing of food that and or was imported and will be consumed into the United States.
•Recommendations have been made to the FDA that all foods should be designated as “traceable” and not just those that will be designated as high risk foods. Be prepared!
Technology and Telematics Solutions for FSMA compliance
•“Passive” Temperature Recorders
•Strip Chart Temperature Recorders
•“Real-Time” Temperature Sensors
•Reefer OEM Microprocessor Integrated Data Recorders
•Basic GPS Systems with Temperature Probes
•1-Way Telematic Solutions that connects to the Reefer micro
•2-Way Telematic Solutions that connects to the Reefer micro
Benefits of Technology and Telematics solutions for FSMA compliance
•Real time, comprehensive temperature monitoring, equipment location, and full visibility to TRU to provide traceability through your chain of custody.
•Document pre-cooling and monitor equipment door activity.
•Instant and full TRU data retention and reporting for you and any other entity that requests and or requires information.
•For TRU equipment maintenance due reporting and record-keeping, real time reefer health status, alarms, and alerts.
•To ensure product is not taken into custody “hot”, remote temperature probes to “pulp” product(s) as necessary.
•To ensure correct temperature is set on TRU, 2-Way remote control of reefer allows changing of temperature set points
•In the case where you have third party maintenance providers and telematics a way to ensure TRU is maintained and working properly.
•By monitoring equipment in real time, you can reduce administrative and human resource labor, along with improving your operations and lowering your maintenance costs!
If you would like information about the Telematics solution, please contact:
Executive Director of Business Development, North America
Phone: (315) 453-9064
Cell: (315) 569-7777
Questions About the Law
Given the importance of this legislation, it is not surprising that people have many questions, especially the question of "when will the changes happen?" Some of the changes from the law went into effect immediately, such as the new mandatory recall authority. Other changes will require more time. And some of this simply comes down to budgeting.
For more information about the new law, check out these resources: