Specialty Food Magazine

Winter 2017

Specialty Food Magazine is the leading publication for retailers, manufacturers and foodservice professionals in the specialty food trade. It provides news, trends and business-building insights that help readers keep their businesses competitive.

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food safety update Ron Tanner is vice president, philanthropy, government, and industry relations for the Specialty Food Association. Registered Facilities in the US The most significant FSMA ruling for the specialty food industry, Preventive Controls for Human Food, states that the organization responsible for complying with FSMA is the registered facility; i.e. the manufacturing plant where the food is produced. In other words, it is the co-packer who has the ultimate responsibility for complying with FSMA, not the brand owner. Nevertheless, nobody wants to market unsafe food. Although not legally responsible, specialty food producers and suppliers should be monitoring their co-packers to make sure the co-packer is satisfying the regulations of the Preventive Controls for Human Food final rule. Producers who use a co-packer, should do the following: • determine that the co-packer has a Preventive Controls Qualified Individual on staff; • require that the PCQI write a Food Safety Plan for the product; • inspect the Food Safety Plan written by the PCQI, making sure that she or he identifies where there could be a safety hazard; • make sure that there are preventive controls in place that eliminate the safety hazard; • if a food safety issue occurs, require the co-packer to take corrective action, record that action, and update the Food Safety Plan; • make sure the facility has a Recall Plan for the product; • determine that the facility is treating allergens as food safety hazards and monitoring them as hazards; • make sure the facility keeps records of its production and safety activity for at least two years, because FDA can demand two years of records when it inspects. In addition, producers and their co-packer need to determine if any hazards can be controlled through the supply chain. If a hazard is taken care of before the ingredient arrives at the co-packer, there must be records that support that. This would ultimately be the responsibility of the co-packer, even if the producer specified where and from whom the ingredients are purchased. A spice that could be controlled for a hazard through irradiation before it is delivered to the co-packer would be an example. Registered Facilities Outside the US If the product is being produced by a co-packer outside of the U.S., the rules are more stringent. It is still the facility registered with the FDA that is responsible for creating and implementing a food safety plan. However, the Foreign Supplier Verification Program requires producers to verify that the regulations are being followed. The rules for a manufacturer having a product co-packed outside the U.S. are the same as for importers bringing in branded products. FSMA puts new obligations on importers and requires them to exercise more oversight over their food chain. Producers who import foods produced by a foreign co-packer, are responsible for verifying that they are safe. Specifically, they must: • perform risk-based foreign supplier verification activities; • verify that the imported food is produced according to FDA rules; • verify that the food is not mislabeled or adulterated; • have a written Foreign Supplier Verification Program. Verification may include monitoring records for shipments, lot- by-lot certification of compliance, annual on-site inspections, check- ing the hazard analysis and risk-based preventive controls of the foreign supplier, and periodically testing and sampling shipments. All records must be kept for at least two years and are included within the records access authority of FDA. Takeaway Although FSMA specifically requires the registered facility (i.e. co- packer) to comply, all producers and suppliers within the specialty food industry should be aware of the requirements and be diligent about following the law and selling safe food to the consumer. It is the co-packer who has the ultimate responsibility for complying with FSMA, not the brand owner. The rules for a manufacturer having a product co-packed outside the US are the same as for importers bringing in branded products. FSMA puts new obligations on importers and requires them to exercise more oversight over their food chain. 100 ❘ SPECIALTY FOOD MAGAZINE specialtyfood.com

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