FSVP Update:

VERY SMALL BUSINESSES MUST COMPLY BY 2019

By Bobbi Greenwell, PCQI, FSVP Compliance Director

The final rule on the U.S. Food Safety Modernization Act (FSMA) was issued three years ago. With that act, the Foreign Supplier Verification Programs (FSVP) for Humans and Animals was created to provide the U.S. with assurances that foreign suppliers of food meet the same health protection standards as domestic suppliers. These programs require that importers ensure the safety of their food, assess risks and conduct hazard audits, take corrective action if needed, and verify that food is not adulterated or misbranded with respect to allergen labeling. Provisions that were at one time non-binding, such as the education and training of employees to safely process, pack and hold food, are now mandatory.

The FDA considers an importer to be the U.S. owner or consignee of a food being offered for import into this country. If there isn’t an U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry. Many foreign food suppliers must now appoint a U.S.- based FSVP Importer to serve in this role if they wish to import food for trade shows and for sale through the retail supply chain.

While there are some FSVP exemptions, a considerable amount of imported food must now comply with these verification requirements. The first compliance date was last year – May 30, 2017 – with the last compliance date scheduled for 2020. The compliance dates differ based on the size of the supplier, the nature of the imports, and whether the foreign supplier is subject to other regulations such as the supply-chain PC rules (a collective set of rules for food for animals). The FDA is now auditing importers and the agency’s efforts will become more stringent with the March 2019 enforcement date.

Foreign suppliers that are considered small businesses were required to comply this past March. By March 2019, more suppliers will be required to comply such as very small businesses and businesses subject to the pasteurized milk ordinance. A very small importer is defined as a company with annual sales of $1 million in human food and $2.5 million of animal food (averaged over a 3-year period). There are some modified FSVP requirements for very small businesses, largely related to hazard analysis and preventive controls, that are in effect for certain categories of food, designation as a qualified facility, or type of usage. There are also modified requirements for certain foods if the foreign supplier is operating in a country with food safety programs recognized as comparable to the equivalent of the U.S. system.

Very small businesses must appoint a U.S. based FSVP Importer with the necessary training and experience to conduct verification activities and must have a written food safety plan in place. This plan is required to include:

• A hazard analysis that identifies and evaluates the known and reasonably foreseeable biological, chemical and physical risks for the food production
• Preventative controls must be identified and implemented in response to any risks identified in the hazard analysis, to prevent or significantly minimize the risks. These include process, food allergen and sanitation controls as well as other types of controls.
• The plan must include monitoring procedures to verify that controls are consistently exercised and to ensure the preventive controls are effective.
• Corrective actions must include a written recall plan that outlines specific procedures to perform a recall.
• The maintaining of records for FDA inspection

At The Radius Group, Inc. we specialize in serving as a FSVP Importer for foreign food suppliers seeking to exhibit at trade shows in the United States. With verification processes that require months of planning, and with key specialty food shows in the U.S., such as the Winter Fancy Food Show, occurring in January 2019, we advise exhibitors, country food pavilion managers and others to begin their efforts to secure an FSVP Importer as soon as possible to meet the necessary FDA regulations and trade show deadlines.

The Radius Group, Inc. (TRGI) is a U.S- based FSVP Importer located in Elizabeth, New Jersey – in the same building as the Port Newark offices of the U.S. Customs and Border Patrol. TRGI is the preferred FSVP Importer regulatory partner for food and beverage trade show exhibitions in North America. In addition to food safety and FDA food and beverage facility registration, TRGI also acts as a basic importer of alcoholic beverages. The TRGI team also serves as a drug and medical device information agent on behalf of foreign manufacturers importing into the U.S. for trade show exhibition, distribution or sale, or for import processing and then export. In the United States + (201) 400-6616 and on the web at TheRadiusGroupInc.com