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FSMA has sent food suppliers into a frenzy, but what does it really entail? While there is much information on the topic, a simplified, initial outline is close to nonexistent. We decided to fix this problem by providing this resource for those attempting to wrap their minds around what this new act really means.
There are two main things that suppliers should note about registration with FSMA. First, what registration allows. Without proper registration, intrastate or interstate distribution is prohibited. For foreign facilities, registration is required for importations into the United States. The second aspect to account for is the the timing of registration. It must take place biennially to stay valid.
Preventative controls are a major focus under FSMA, so it is important to understand each part.
A hazard analysis is the initial step of preventative controls, defining the hazards that exist within the facility or as a result of risks that are inherent to each food type. Hazards include biological, chemical (including radiological), physical, or intentional implementation of hazards for economic gain (often adulteration). Along the chain, the manufacturing, processing, and packing of the food must be analysed. The probability of each hazard and the impact it would have on the consumer serve as guidance in the development of a preventative controls program. In this program, each hazard must be addressed with an appropriate control.
Preventative controls that emerge from the identified hazards are compiled into a HACCP (Hazard Analysis and Critical Control Points). This is comprised of controls for process, environment, supply chains, and allergens. Testing to ensure that the controls are effective must accompany the plans produced. Additionally, environmental monitoring should be integrated into the processes of each company.
Parameters set for Critical Limits in HACCP and continual monitoring come after controls are determined, but are no less vital. There is no specified frequency for monitoring, as it is left up to the discretion of the individual facilities.
If any problems are seen as a possibility, then procedures must counteract them. When preventative controls fall short, corrections should be enacted without hesitation to keep food safety intact.
Verification (including validation) must confirm methods of control as effective. An individual that is qualified through training, experience, or a combination of the two carries out the verification to deem the preventive controls program adequate. Controls should be assessed weekly, but complete reassessment of plans is only required every 3 years.
All records must be kept on-site for 2 years. Documentation requires signed and dated approval from a ‘preventive control qualified individual.’ Records should be easily accessible to be provided to the FDA upon request.
Recall and Calibration
A recall program is necessary for quick removal of contamination at any stage along the supply chain. Calibration of instruments used for measurements are to be checked, validated, and documented.
Both domestic and imported produce is subject to new regulations, with an emphasis on hygiene. The sanitation of the establishments the food pass through whether in the growing, packing, harvesting, or holding stages must be controlled with suitable measures. Other aspects that methods should be in place for include worker training, safety of soil amendments, water, and equipment. Overall, health and hygiene remain the two characteristics FSMA desires to be present at every level of production.
When it comes to adulteration, the bottom line is that it is not worth it. Especially with FSMA in the picture. Anyone that processes, packs, or holds food should be prepared to provide hard evidence that adulteration of any kind isn’t a part of their processes. Although adulteration can enter at many points along the chain before making it to the consumer, there are 4 particular areas that must be heavily guarded against this illegal practice:
- Bulk liquid receiving and loading
- Liquid storage and handling
- Handling of a secondary ingredients
- Mixing and similar activities
To prevent adulteration in each one of these sections, a food defense plan must be drawn up. This will serve as proof of handling the possibility of adulteration with due significance.
Foreign suppliers have more demands with the foreign supplier verification programs (FSVP) that are introduced with FSMA. Tiering based on risk can be a helpful tool with a company like FDAzilla that helps in navigating compliance status reviews to designate verification activities and corrective actions. A periodic reassessment of the FSVP must follow. Finally, importer identification with a DUNS number has to be established for importation, and extensive record-keeping is to record the entire program.
All equipment involved in transportation of food items must ensure no contamination. As with the areas of food production, controls for temperature and food separation are mandatory.
Information must be transferred with each step in the transport system with specific methods for communicating prior conditions and controls.
There is also particular training that all carrier personnel in sanitary transportation practices must participate in for qualification (records of training are essential to have on hand). Records mean all documentation relating to the above points in the form of written procedures and records by carriers and shippers. Maintaining these records is crucial.
(NOTE: Want to know what your supply chain is up to? Get your FREE SUPPLIER ASSESSMENT.)
This information has been compiled and condensed from information presented by the FDA. Since it is simply a general summary, additional research is the next step for those that truly desire to know the inner workings of this fresh legislation.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
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