Matching up 3-A standards and FSMA rules
Food Safety Modernization Act compliance will finally move from the level of abstraction to something more tangible in the coming months. 3-A SSI has a strong interest in the equipment-related provisions of two of the seven major rules to be issued. We submitted comments in both rulemakings. FDA is under a court-ordered deadline to publish the final rules on preventive controls (PC) for both human food and animal food by Aug. 30. The final rules on Sanitary Food Transportation (SFT) must be issued by March 31, 2016.
The SFT rules will establish good transportation practices applicable to all ground transportation operations. All food is covered, unless specifically exempted. Grade A Milk and Milk Products are covered under the Pasteurized Milk Ordinance (PMO). Nonetheless, the general sanitary design criteria of 3-A Sanitary Standards for transport equipment are important for all food, thus, the interest of 3-A SSI.
The rules are process-oriented
Both the PC and SFT proposed rules reflect far more proactive and more process/prevention-oriented approaches to the food safety system than previously required. FSMA will require food facilities to maintain a written preventive controls plan. This involves:
- evaluating the hazards that could affect food safety,
- specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards,
- specifying how the facility will monitor these controls to ensure they are working,
- maintaining routine records of the monitoring, and
- specifying what actions the facility will take to correct problems that arise.
The PC rule will clearly place more focus on “performance-based” elements. While there are a number of schemes designed to help processors show compliance with the new rule, such as Safe Quality Foods (SQF), British Retail Consortium (BRC), ISO/Food Safety System Certification (FSSC) 22000, and other “principles of sanitary design,” these programs share the common trait of being largely aspirational in nature. There is little guidance available when it comes to how to achieve the desired goals or for the auditing of food equipment and hygienic design.
Filling an important gap
Further, the interpretation and scrutiny of detailed information on equipment design may vary with the knowledge and experience of the auditor. There is an important gap to be filled when it comes to effectively documenting numerous equipment-related issues of hygienic design and fabrication in a PC plan.
Let’s consider the documentation of just one hazard – allergens – and some of the challenges of assembling a credible PC plan. Melanie Downs, assistant professor in the Food Allergy Research & Resource Program, Department of Food Science and Technology, at the University of Nebraska-Lincoln, presented “Validation of Cleaning Systems: Allergens” at the yearly education session of 3-A SSI in Milwaukee, Wis. She noted “Between 3.5% to 4% of the U.S. population (or 10 to 14 million Americans) has a food allergy, and the prevalence of food allergies is increasing.”
She explored the essentials of allergen control, where risks occur and the keys to effective allergen control: dedicate (facility, system, line, etc.), segregate, separate and sanitize. Then, an effective sanitation standard operating procedure must be implemented for each line and each allergenic ingredient, and each SSOP must be validated.
Equipment design, along with the appropriate cleaning method, represents just one set of many variables to consider in developing the SSOP. The design criteria for processing equipment — from installation, operation, maintenance, to cleaning and sanitation — are fundamental to an effective SSOP.
This is where the baseline design criteria encompassed by 3-A Sanitary Standards for processing equipment play an indispensable role. The new 3-A SSI standard, “ANSI/3-A 00-00-2014, 3-A Sanitary Standards for General Requirements,” covers the sanitary design, materials of construction and fabrication techniques for food and beverage equipment used to handle, process and package consumable products where a high degree of sanitation is required.
Specifically, the standard provides extensive specific information on the equipment fabrication/properties of product and solution contact surfaces, such as surface texture, joints, coatings, cleaning and inspectability, draining, dead ends, gaskets, gasket retaining grooves, O-rings and seals, radii, threads, perforated surfaces, coil springs, shafts, bearings, openings and covers (other than personnel access ports), and temperature-sensing device connections.
Conformance to hygienic design and construction principles reflected in 3-A Sanitary Standards improves and facilitates cleaning and sanitation programs. It also facilitates validation. Without proper hygienic design and construction, validation of cleaning efficacy is difficult, if not impossible.