Four useful elements of the draft guidance for FSMA’s preventive controls for human food rule

November 03, 2016

In its entirety, the Food Safety Modernization Act (FSMA) may seem a little overwhelming. Through a variety of resources, however, you can better understand what is expected of your food facility and learn how FSMA directly applies to you.

For example, a draft guidance covering FSMA’s preventative controls for human food regulation was recently released and Neogen would like to bring your attention to a variety of useful points, which can help you formulate an effective food safety plan.

  1. The FDA has a succinct table comparing HACCP to a food safety plan.

One of the critical questions with FSMA and preventive controls is the logistics of moving from a HACCP plan to a food safety plan (FSP). Table 1-1 in the draft guidance shows specific elements of HACCP and food safety plans, and outlines the differences.

One example relates to the monitoring that is required in a HACCP plan. Monitoring in a HACCP plan requires surveillance of critical control points (CCPs). Under a food safety plan, monitoring is required as appropriate for preventive controls (21 CFR 117.145). While this allows for more flexibility, and ultimately allows for innovation in food safety, it is somewhat ambiguous and could cause confusion as a company transitions from a HACCP plan to a food safety plan.

Table 1

2. The draft guidance document contains example questions for identifying potential hazards

The draft guidance document provides a fairly expansive list (beginning on page 22 of the PDF document) that contains several topics to consider when conducting a hazard analysis.  This includes questions to ask yourself based on food ingredients, intrinsic factors, processing procedures, microbial content, facility design, equipment design and use, packaging, employee health, hygiene and education, storage conditions between packaging and the end user, and the intended use and user of the product. This discussion continues into Chapter 2, which addresses the seriousness and severity of potential illness or injury resulting from exposure to the hazard, and the likelihood of occurrence in the absence of a preventive control. These sets of questions should help a facility determine the type of controls and verification of such controls based on risk.

On page 33, the document then helps categorize the basic types of controls a facility can implement. These include:

  • Supply-chain controls

  • Food allergen controls

  • Sanitation controls

  • Process controls

Neogen’s test kits fall under food allergen controls and sanitation controls. For information on how to implement an allergen control plan (including validation and verification), download Neogen’s handbooks on allergens.

3. The monitoring section resides in chapter 5, section 5: preventive control management components

Chapter 5 includes several tables outlining the preventive control, common procedures, practices and processes, and related examples (often a “how” field) depending on the type of hazard being addressed. Section 5 of chapter 5 specifically addresses monitoring and although specific examples are not given of monitoring activities based on hazards, the section does identify some key questions. These include:  What will be monitored? How will monitoring be done? How often will monitoring occur? And, who will do the monitoring? Section 5 also addresses food safety plans with infrequent calibration or accuracy checks — often an overlooked issue that results in higher risks for your facility.

4. Worksheets are available for preventive controls

Beginning on page 145, the draft guidance document also provides worksheets to assist you in your food safety plan. The documents are presented in a progressive fashion, starting with the product description, and working through the elements that a food safety plan will need to address.

table 2

Navigating the aspects of FSMA can be challenging but by using Neogen as a resource, we can help provide diagnostic solutions to address the monitoring, verification, and documentation elements that are required by FSMA. For example, Neogen’s recently AOAC approved AccuPoint® Advanced ATP Sanitation Verification System addresses sanitation effectiveness, provides documentation, and helps manage sanitation issues through the Data Manager software.

21 CFR 117:
Draft Guidance:

Category: Food Safety