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By Joseph A. Levitt, partner at global law firm Hogan Lovells
The U.S. Food and Drug Administration (FDA) has recently issued sweeping regulations designed to dramatically improve food safety in America. These regulations implement the FDA Food Safety Modernization Act (FSMA), which President Obama signed into law in January 2011. Although the primary focus of these regulations is on food manufacturers, here are five key provisions that affect supermarkets:
1. Foreign Supplier Verification Program: If your supermarket imports food for sale in the U.S., then the foreign supplier verification program (FSVP) regulations likely apply to you – either directly or indirectly. This is the single most important provision of FSMA for supermarkets.
Recognizing that FDA is able to inspect only 1 percent of imported food each year, Congress placed the responsibility on all “importers” to oversee the safety of the food they bring into the country. This includes both packaged food and fresh produce – nearly every type of food in the supermarket.
Under FSVP, the “importer” is the “U.S. owner or consignee” of the food when it crosses the border. Typically, the importer could be either the supermarket itself or an intermediary (i.e., broker or distributor). The first step every supermarket needs to take is to determine for which foods it's the importer, and for which foods an intermediary meets this definition.
For all imported food for which your supermarket is the “importer,” you need to establish a written program that outlines the steps you are taking to ensure that your foreign suppliers are effectively controlling any pertinent food safety hazards. This is particularly important for any food products that could become contaminated with foodborne pathogens, such as fresh produce or soft cheeses.
Each supermarket has the flexibility to establish its own program. For verification activities, many supermarkets are likely to rely on independent third-party audits. This allows the supermarket to rely on a qualified auditor to engage in verification and allows the foreign supplier to use the same certification to satisfy multiple U.S. customers. As many third-party audits identify areas for improvement, it's essential that your oversight program captures these and documents that corrective actions were made.
2. Warehouses or Distribution Centers: Although supermarkets themselves are inspected by state or local health departments, any separate warehouses or distribution centers are subject to FDA oversight -- and potentially subject to the “preventive controls” provisions of FSMA. Depending on the kind of food stored, a warehouse can be subject to either full requirements, modified requirements, or exempt from preventive controls. You need to identify which of your warehouses fall into which category, and apply the necessary safeguards.
3. Store-Label Manufacturers: If your supermarket is vertically integrated and has its own manufacturing facility for its store-label products, then those manufacturing facilities are subject to the full range of FSMA requirements – which are beyond the scope of this article. It's essential for you to investigate further if this applies to you.
4. Posting of Recall Notices: This provision has not yet been implemented by the FDA, but at some point grocery stores will be required to post recall notices in a conspicuous manner so consumers can be properly alerted. Stay tuned.
5. Documentation: FSMA contains detailed requirements for documentation so that FDA can verify that the necessary steps have taken place. For FSVP, the FDA can ask you to send your records to them electronically. For warehouses or manufacturers, the FDA is required to view these records during an on-site inspection. Good recordkeeping practices are essential and encompass two adages:
- “If you didn’t document it, it didn’t happen;” and
- “If you did document it, it happened just that way.”
It’s important that you take the time to get your records in order and to train your team on these new requirements.
When does all this take effect? The FDA has established a staggered timeline for implementation, beginning in the fall of 2016 for the largest warehouses and manufacturers, and May of 2017 for foreign supplier verification. Additional time is granted for smaller U.S. companies and for smaller foreign suppliers and growers of fresh produce. But it's time to start getting ready now.
Bottom line: (1) Be aware, these are new legal requirements and you will need to comply; but (2) Don’t be afraid, there are experts who can help you understand what you need to do and how to accomplish this.