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New FSMA Guidelines

To maintain a high level of food both grown and imported into the United States, the Food and Drug Administration continually changes and improves requirements to ensure the safety of consumers. Seven new guideline requirements have reached the FDA with three in the final stages of approval. Once signed off on, farmers, manufacturers and producers in other nations exporting to the U.S. have a set deadline to reach these requirements, or else receive excessive fines. The three new guidelines in the final approval stage are Produce Safety, Foreign Supplier Verification Programs and Accredited Supplier Verification

Produce Safety

Produce safety covers how produce is grown starting with water quality. The changes set in place regarding water include new microbial testing for bacteria, namely E. coli. Set standards for direct and indirect contact are included in the new guidelines. Biological soil amendments, including raw manure and stabilizing compost have new requirements and specialized requirements on sprouts are highlighted in the Produce Safety changes. A high level of outbreaks and illness have been linked to sprout consumption, which has led to the specific sprout changes. The handling of domesticated and wild animals in the production process, as well as worker training and equipment, tools and building upkeep are final aspects covered by the new FSMA guidelines.

The compliance dates for these procedures varies slightly. For very small businesses ranging $25,000 to $250,000 is four years, small businesses from $250,000 to $500,000 in sales is three years and all other farms is two years. Compliance for labeling is set at January 1, 2020. Compliance for retention records for small small business is four years after the effective date while small businesses is three years after the date. Lastly, there is compliance dates for anything affected with sprouts. Small businesses have three years to comply with three years, small businesses have two and all other farms need to comply within one year.

Foreign Supplier Verification Programs

The ability to ensure produce comes from an authenticated location is the focal point of the Foreign Supplier Verification Programs. All foreign producers of food imported into the United States must receive a Foreign Supplier Verification Program (FSVP) certificate. This states the company produces food in a manner that is at the same level of the food produced within the United States and it meets all U.S. requirements. The new guidelines cover importers as well, ensuring the companies properly handle imported food, are evaluated  and receive supplier verification for all activities. The importers must check and verify the FSVP of the foreign producer or will be held accountable. The new guidelines also cover hazard analysis (such as formulation of the food, raw material and ingredients, the transportation practices and proper packaging). Corrective actions, testing of supplier goods and supplier verification all fall under these new updates.

All farms and companies must comply to these rules within 18 months after the final rules are publicized.

Accredited Supplier Verification

The supplier of goods used in connection with the food production must also receive proper accreditation through the FSMA guidelines. Third party accreditation requirements are designed to promote consistency regardless of the nation of origin. Companies looking to audit and offer certification to food suppliers must undergo additional monitoring from the FDA. These companies and organizations seeking audit authority must perform unannounced inspections and submit monitoring and self assessment reports to the FDA on all findings, both internally and with the food suppliers. The FDA intends for companies to implement these changes as soon as possible as the accreditation is straight forward and does not require drastic changes in protocol.

While these three changes are currently in the final stages of approval, four other potential changes are being investigated for potential final approval by the FDA.

If you would like see how your organization compares to the newest guidelines or complete your certification, Quality Systems Enhancement can help. They provide consulting, auditing and training for numerous food safety standards and for the FSMA guidelines that will equip your company with the necessary knowledge and skills to achieve and maintain certification. You can reach them through this number 770-518-9967 or by filling out a proposal request here.

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Bhaskar Kotte

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