Specialty Food Magazine

FALL 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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Whereas FDA does conduct some foreign inspections, it does not have the resources to make sure that all foreign manufacturers are meeting U.S. food safety regulations. This is especially true for smaller foreign manufacturers and the facilities that produce specialty food. The law now puts the responsibility on the importer. A New Role for Importers FDA is relying on the importer to make sure all food entering the U.S. is safe. Importers have never before been required to verify that their suppliers are following good manufacturing practices, control- ling hazards, and producing food that is as safe as that which is produced in the U.S. FSVP is a revolutionary food safety approach and it will be a massive undertaking for U.S. importers to comply with the law. Importers need not personally inspect their suppliers. Their responsibility is to make sure the facilities are following food safety protocol. FDA has given importers a great deal of f lexibility in implementing the FSVP rule, in that there is such a variance in food production across the globe. Importers can figure out the best way to meet the FSVP requirements. This f lexibility, though sound in theory, has led to confusion in the importing community, especially in specialty foods. Here's a basic synopsis of how the rules work: • Importers must make sure the foreign facility is producing safe food. • Importers should compile records showing that the facility is safe, including a food safety plan prepared by a Qualified Individual, safety audits such as SQF or BRC, and/or inspec- tion reports from a national, regional, or local authority. • FDA will inspect the importer's records to determine that the production facility has met the FSVP requirements. FDA defines the foreign supplier as "the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the U.S. without further manufacturing or processing that consists solely of the addition of labeling or any similar activity of a de minimis nature." In simple terms, the foreign supplier is the person or business outside the U.S. that has the most to do with the safety of the product. (While the FSVP regulation is a challenge for importers of processed foods, it is even more difficult for importers of produce and meat, who are often purchasing from hundreds or even thousands of farms.) The importer is defined as "the person in the U.S. who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food." The FSVP importer must be identified for each line entry of food coming into the U.S. More than one company may fall under the definition of FSVP importer; for instance, a specialty food being brought into the East Coast and West Coast by two different firms could have two FSVP importers. A company needs to be identified as the FSVP importer at entry or the product will be rejected by U.S. Customs and Border Protection. However, this is not a customs law. The food safety records will not be looked at by CBP and nothing will be delayed at the border if an FSVP importer is listed on the form. (CBP is currently also accepting the code UNK, or Unknown, while it is educating the import community.) All FSVP inspections will take place at the importer's place of business. The verification of the safety of the food must be done by a Qualified Individual. The creation of a food safety plan by a Qualified Individual is the backbone of the Preventive Controls for Human Food regulations. For FSVP, FDA defines a Qualified Individual as "a person who has the education, training or experi- ence (or a combination thereof ) necessary to perform an activ- ity required" by the FSVP rule and "can read and understand the language of any records that the person must review in performing this activity." This Qualified Individual can be an employee of the importer, but does not have to be on staff. Allergen labeling and adulteration are part of the verification process, just as in the FSMA requirements for U.S. manufacturers. The rules are even more complicated for companies that import ingredients. An ingredient importer can comply in two ways: • Through the supply chain provision of the Preventive Controls rules. • Through the FSVP requirements. The FSVP importer(s) must still be identified upon the ingre- dient's entry into the U.S. If you, as an importer of finished products or ingredients, are not proving that your foreign supplier is producing food in a facility that meets the FSMA regulations for a U.S. manufacturer, you are breaking the law. A company needs to be identified as the FSVP importer at entry or the product will be rejected by U.S. Customs and Border Protection. FALL 2017 89

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