What is the Preventive Controls Rule?

FDA released re-proposed sections of this rule on September 19, 2014. This text has been updated to reflect changes to the proposed rule, but is NOT updated. For more information about the final rule to understand current requirements see NSAC’s report on Understanding FDA’s FSMA Rule for Food Facilities.

The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to write new regulations for entities that are required to register with FDA as food facilities. According to FDA, a food facility manufactures, processes, packs, or holds human food.

Certain on-farm activities may classify a farm as a “facility.” In that case, the farm would have to register, and be subject to the requirements of the Preventive Controls rule (see “Do These Requirements Apply to Me?” below).

The proposed Preventive Controls rule has two main parts:

New requirements for hazard analysis and risk-based preventive controls, and
Revisions to existing Current Good Manufacturing Practice (GMP) requirements.

These requirements are not yet final. FDA has revised some of the proposed requirements under this rule, and is currently requesting additional comments from the public on these revised or “re-proposed” sections. Before finalizing the standards for food facilities, FDA must consider all of the public comments received on both the initial draft of the proposed Preventive Controls rule and the re-proposed sections.

Proposed Preventive Controls Rule Basics

The proposed Preventive Controls Rule sets forth new requirements and updates existing requirements for facilities that manufacture, process, pack, or hold human food. We have indicated below where FDA has revised the proposed requirements.

New Requirements

The proposed new requirements include maintaining and implementing a written food safety plan that includes:

Hazard Analysis: The plan must identify and evaluate hazards for each type of food manufactured, processed, packed, or held at the facility.
Preventive Controls: The plan must identify preventive controls that significantly minimize or prevent hazards. Preventive controls include process controls, food allergen controls, sanitation controls, and a recall plan.
**Supplier Program (NEW): The plan must establish and implement a risk-based supplier program for raw materials and ingredients for which the receiving facility identifies a significant hazard and the hazard is controlled by the supplier.
Monitoring Procedures: The plan must document procedures to ascertain that preventive controls are consistently performed.
Corrective Actions: The plan must identify steps to take if preventive controls are not adequately implemented, to minimize the likelihood of problems reoccurring, to evaluate the food for safety, and to block problem food from entering commerce.
Verification: The plan must spell out verification activities and document that preventive controls are effective and consistently implemented.
**Verification of Implementation and Effectiveness (NEW): Verification measures must include product testing and environmental monitoring, as appropriate to the facility, the food, and the nature of the preventive control.

A facility is required to maintain a written food safety plan and to keep records of each element of the plan. The revised rule adds a supplier approval and verification program, as well as environmental monitoring and product testing, to the requirements of the food safety plan.

Only an individual qualified either through training or experience could write the plan. Food safety plans would be reassessed every three years, or more frequently if there are problems.

Updated Requirements

The proposed Preventive Control Rule also updates Current Good Manufacturing Practice (GMP) requirements. Updates include clarifications on protections against cross-contact of food by allergens, stylistic language changes, and deletion of certain provisions containing recommendations. Facilities that are exempt or subject to modified requirements in the new requirements for hazard analysis and preventive controls would generally be subject to GMP requirements.

Do These Requirements Apply to Me?

Check out our Who Is Affected? guidance to help you determine if you may be affected by these proposed rules. At the heart of trying to understand whether farms will be subject to the Preventive Controls rule is the definition of a “facility.” At this point there is still a lot of confusion about the activities conducted by a farm that might trigger the FDA’s definition of a facility. This is a large gray area in the proposed rules. We strongly recommend you read our Who Is Affected? guidance to start asking questions about whether your own operation may be affected.

Learn More about the Issues with the Proposed Preventive Controls Rule

In the revised or “re-proposed” Preventive Controls rule, FDA has modified its approach on the following key issues:

Definition of a Facility: Do I Operate a Farm or a Facility?
Definition of a “Very Small Business”
Food Safety Plan and Recordkeeping (including new requirements for a Supplier Program, Environmental Monitoring, and Product Testing)
Modified Requirements for Qualified Facilities
Costs to Producers, Facilities, and Consumers
Facility Registration
Direct-to-Consumer Marketing Clarification
Supplier Approval and Verification Program
Environmental Monitoring and Product Testing

Get more information on these issues and how they might impact farmers and processors, among others, on the Learn About the Issues page. Further guidance that goes into greater detail on all of these issues will be available soon.

Read the Rules

They aren’t exactly beach vacation reading, but if you think you may be affected it is in your best interest to read and analyze the proposed rules yourself! Farmers and processors who have a direct stake in these rules need to read them and start asking questions about what they might mean for their businesses.

See our old comment on the Re-Proposed Preventive Controls Rule.

The following link is to our outdated comments on the proposed rule available here.