On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and Critical Control Points (HACCP) food safety management system, which according to FDA must be followed under federal law.

Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the business. Then, in 2010 and 2014, FDA inspectors documented what the Agency alleged to be the company’s failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. According to the FDA, the Company failed to heed the Agency’s prior warning and was still not in compliance with HACCP regulations.

There have been no reported complaints from the public or reports of illnesses from the sandwiches from Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products.

FDA HACCP Regulations

HACCP is a food safety system which encompasses all facets of food production, from manufacturing, to distribution, to consumption of the finished product. HACCP plans analyze food safety issues resulting from biological, chemical, and physical hazards. The HACCP management system relies on the following seven principles:

1) Conducting a hazard analysis;

2) Determining the critical control points (CCPs);

3) Establishing critical limits;

4) Establishing monitoring procedures;

5) Establishing corrective actions;

6) Establishing verification procedures, and

7) Establishing record-keeping and documentation procedures.

Appendix C describes the questions that a typical HACCP team will need to consider when creating a plan. A typical plan includes hazard analysis, decision-making trees, and verification processes as well as procedures for record keeping.

Currently, there are generic HACCPs for the dairy, juice, seafood, and retail and foodservice industries. However, the FDA encourages each food producer to assemble an HACCP team to devise a strategy to make an HACCP plan. Each HACCP plan will vary, depending on the industry, product, and specific process utilized by each individual company.

In addition, it is important to note that there are various exemptions to the HACCP requirements. For example, under the juice HACCP regulations, a person who makes and sells apple cider or other fresh juices directly to consumers may not be required to have a HACCP plan or otherwise comply with HACCP requirements. However, a person who sells their juices to a store which will then sell to customers is required to have an HACCP plan.

Determining whether an exemption to HACCP requirements exists is a complex task. Due to the number of different requirements, such as the retail juice exception, voluntary HACCP rules for food service industries, and requirements for pasteurized milk, it is important to ensure that you are complying with all applicable regulations prior to beginning operations. For questions regarding HACCP plans and compliance with FDA regulations, please contact us at contact@sglawfl.com.