FDA released two useful tools last month to advise and assist companies in complying with new FSMA rules.
The agency issued a Small Entity Compliance Guide(SECG) to help small food businesses comply with the FSMA final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration.
“We encourage you to comply with the [intentional adulteration] rule as soon as possible,” the agency said. The mandatory compliance dates depend on the size of the business. Businesses that do not qualify for exemptions must comply by July 26, 2019. Small businesses – with fewer than 500 full time equivalent employees — have until July 27, 2020 to comply. Very small businesses are exempt from the rule, except for a documentation requirement which has a compliance date of July 26, 2021. A very small business is defined as a business (including any subsidiaries and affiliates) averaging less than $10 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food, plus the market value of human food manufactured, processed, packed, or held without sales.
The intentional adulteration rule requires a written food defense plan that must include:
- A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations;
- Mitigation strategies and associated explanations;
- Procedures for food defense monitoring;
- Procedures for food defense corrective actions; and
- Procedures for food defense verification.
The rule applies to all food facilities, foreign or domestic, that are required to register because they manufacture, process, pack, or hold human food for consumption in the U.S.
Although this new FDA guidance is for small entities, it includes useful advice for any size of business thinking about ways to minimize the risk of intentional adulteration — such as how to prepare a food defense plan, the required contents, who must sign the document, what ongoing records are required, who is qualified to create the plan, where and for how long records must be held, and so on. Perhaps equally useful is the guide reflects current FDA thinking, and offers some reason for confidence that following the guidance will probably be acceptable to FDA.
As a FSMA consultant, I should note that the qualified individual who creates the food defense plan may be, but is not required to be, an employee of the facility.
The agency also unveiled a new software program called the Food Safety Plan Builderto help owners and operators develop food safety plans. The program was modeled after the Food Defense Plan Builder, created to help food facilities create food defense plans.
The new tool asks a series of questions to help identify potential hazards and the preventive controls needed to address the hazards. The FSP Builder, much like the SECG for Mitigation Strategies, is current agency thinking. Using the tool correctly to design a facility specific FSP should satisfy FDA, at least initially, that a good faith effort is being made by a regulated firm to follow food good manufacturing practices, and identify hazards in need of controls(s). It may also help firms distinguish between safety hazards that FDA will review, and quality characteristics unrelated to food safety that are present in many operating SOPs.
The agency won’t have access to any documents developed using the software, Jenny Scott, senior advisor in FDA’s Office of Food Safety, emphasized in an agency blog. However, during an inspection, FDA will review the FSP.