The Food Safety Modernization Act will affect the entire supply chain, are you prepared for the safety, traceability, and record keeping challenges ahead?
FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA willcontinue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.
The five elements of FSMA encompass preventative controls, inspection and compliance, imported food safety, response to occurrences of contamination, and enhanced partnerships with producers. The biggest change FSMA brings is the FDAs ability to enforce the law. Prior to FSMA, the FDA was not allowed to shut down producer facilities, even those with multiple health violations. The new regulation allows an FDA inspector to shut down a facility for a minimum of 30 days with only a suspicion of the possibility of a violation. If evidence of a violation is found, the FDA is able to shut down a facility for a longer period or even indefinitely.
Under FSMA, every handler taking possession of a product or produces an item touching that product, such as packaging, must have a record keeping system. When a food safety issue is identified, the record keeping system allows an auditor to evaluate the chain of tracking records to determine where the contamination took place. If the auditor finds a break in the chain of records during their audit, the last person with records is liable for the food safety issue, even if contamination occurred prior to them taking possession of the product. Since the U.S. does not have jurisdiction over foreign producers, the broker who brings foreign product into the country is liable for any issue that took place before a product reached the border.
Producers and handlers may choose to keep paper records, however, this is not cost effective. A FSMA audit for a domestic operation is $224 per hour and $300 per hour plus travel for a foreign auditor per auditor. Each audit will include a minimum of one local, two state, and two federal auditors. The FDA is currently in the process of hiring 6,000 newemployees as FSMA auditors for this purpose.
There are many software and digital reporting systems available for FSMA compliance. The main requirement for digital systems is that information is held off-site by a third party. Usually, the third party is the FDA. Full-chain traceability that is compliant with FSMA, the 2002 Bio-Terrorism Law / Food Defense, Country of Origin, BMP, GAP’s, SSOP, HACCP, USDA-FSIS, and EU traceback laws for all food handlers can be achieved in as little as 15 minutes per day with a digital reporting system.
With digital reporting systems, a consultant works with a business to set up its entire operation and provide training, ongoing education, and support. In the case of nut producers, each orchard is coded. Ideally, operations, such as any applications, water tests, and pest control measures, are entered into the system on the day that they happen. During harvest, a label is printed for the product that includes all information on that orchard and the product. These labels provide immediate scanning and retrieval of site-specific records in real time. There is also an option to provide workers with coded name badges to track product using GPS that is accurate within 10 feet. In the case of shippers and haulers or processing facilities, a record of vehicle or facility maintenance operations, such as sanitization of equipment and times of those operations, is recorded. The label will need to be scanned when possession of the product changes hands so that information may be entered into the records of each consecutive handler. This information follows a product throughout the process, from seed to consumer, and even enables this information to be linked to a QR code printed on the packaging of a final product for consumer benefit. In compliance with the law, it is impossible to change or edit a previous recorded entry, however, notes may be added to correct information in entries that are incomplete or contain errors.
While complete compliance is not mandatory until 2016, there is a cost benefit to producers, processors, and handlers who currently have a traceback and traceability record keeping system in place. In anticipation of the possibility of loan default and higher instance of insurance claims resulting from a shut-down due to violations, insurance companies and banks are more likely to respond favorably toward customers who are currently in compliance with FSMA. Using an electronic system which holds information off-site allows producers to avoid the costs of an on-site audit that could result from the use of paper records. Some companies are willing to pay a premium because they believe products with a complete recorded history have a built-in, value-added element. This is allowing these producers to gain reputations as forward-thinking and establish new relationships with buyers before the rest of the industry follows.
Furthermore, in this new age of easily-accessed information and the ultra-concerned consumer, processors who are taking advantage of the option to link information to final packaging are finding they are gaining an edge in the marketplace. Consumers who value certain production practices or local products appreciate having information at their fingertips at the point of sale. For those consumers who are not as concerned about the specifics of production, it simply provides the reassurance that their food was produced as safely as possible. Increased information on packaging also provides the consumer with the confidence of a safe reliable food supply.
About The Author
P. Sweeten consulting was founded by owner Pamela Sweeten to help growers and consumers track their food from farm to table.
Through the use of tracking and data storage technology, we are insuring the safety and integrity of your food. Everyone should know exactly where their food came from, where it ends up and where it has been along the way. With our products you can rest assured knowing that you can track your crop every step of the way.
Pamela focuses on helping growers, transporters, and manufacturers reduce and improve operating efficiency. Got a question, comment, or column idea? She can be reached at firstname.lastname@example.org.