What is the Preventive Controls Rule?
The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to write new regulations for facilities that manufacture, process, pack, or hold human food. Certain on-farm activities may classify a farm as a “facility” subject to the Preventive Controls rule (see “Do These Requirements Apply to Me?” below). Facilities must also register with FDA.
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 final and FDA is requesting comments from the public before finalizing the proposed Preventive Controls rule.
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.
The 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.
- 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.
A facility is required to maintain a written food safety plan, and to keep records of preventive controls, monitoring, corrective actions, and verification. 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.
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
Some key issues with the proposed rule center around:
- Definition of a Facility: Do I Operate a Facility?
- Definition of a “Very Small Business”
- Food Safety Plan and Recordkeeping
- Modified Requirements for Qualified Facilities
- Costs to Producers, Facilities, and Consumers
- Facility Registration
- Direct-to-Consumer Marketing Clarification
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.
Comment on the Proposed Preventive Controls Rule!
We need your help! Everyone – farmers, processors, and consumers – can and should comment on this rule! Learn more about how to comment and speak out today!