If your question isn't answered below, please send us a message.
1. Am I covered by the Preventive Controls for Human Food (PCHF) Rule?
Most food businesses are covered at least partially by the Preventive Controls for Human Food (PCHF rule). Coverage depends on the size of your business, what types of foods you process, where you process foods, and whether or not you sell foods directly to consumers.
Not all businesses covered by the PCHF rule are subject to every part of the rule (21 CFR Sec. 117.5). To understand more about whether or not your food business is covered and what parts of the rule apply, please see this resource and visit the Complying with the PCHF Rule section to learn more.
2. What parts of the PCHF rule are required?
If you are covered under the PCHF rule, you may not have to comply with every part of the rule. Facilities that are considered qualified exempt must file an attestation and follow some PCHF requirements, such as Good Manufacturing Practices. You will likely be exempt from Hazard Analysis and Critical Control Point and Supply Chain Protocol requirements.
Other types of facilities, such as those that process juice or seafood, or those who process on farm will be subject rules besides the PCHF rule, including Juice HACCP, Seafood HACCP, the Produce Safety Rule (PSR), Low Acid Canned Foods (LACF), baby formula, or dairy.
3. How do I get started creating a food safety plan?
Creating a food safety plan starts with understanding the PCHF rule and receiving the appropriate trainings. Generally, a food processor will want to take the following courses in the following order:
Good Manufacturing Practices (GMPs) → Hazard Analysis and Critical Control Points (HACCP)→
Food Safety Preventive Controls Alliance Preventive Controls Qualified Individual (FSPCA PCQI)
To learn more about these courses and find opportunities near you, check out the Extension and Consulting Services and Resources category.
According to the FDA, “a PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.” This individual should have the resources and skills to create a food safety plan. Taking the FSPCA PCQI course will allow an individual to be a Preventive Controls Qualified Individual (PCQI), a necessary role to write a food safety plan.
A food safety plan requires the following components: Hazard Analysis, Preventive Controls (including process, food allergen, and sanitation preventive controls), a Supply Chain Program, a Recall Plan, Implementation, Corrective Action, and Verification Procedures. Background information is also recommended.
4. Where can I find forms that I need to fill out?
The most common forms that processors need to fill out include FDA Facility Registration, Attestation Form for Qualified Facilities, and State Specific Forms.
FDA Facility Registration
All facilities, regardless of size, must register with the FDA and renew their registration every other year. Registration can be completed on the FDA’s website, and more information can be found in the FDA’s Registration of Food Facilities: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide.
Attestation Form for Qualified Facility
If you are a qualified facility, you will need to fill out an attestation with the FDA. This is an annual attestation that qualified exempt facilities must complete to demonstrate that they are exempt from certain parts of the PCHF Rule (Hazard Analysis and Critical Control Point and Supply Chain Protocol requirements) and are instead subject to the modified requirements. For more information on filing an attestation, check out the Complying with the PCHF Rule: Exemptions section or visit the FDA’s website.
State Specific Documentation
Many states will have their own requirements for forms and documentation. Look at your state’s individual category in the State and Local Regulations section or check your state’s online resources to see what their requirements may be.
Other documentation related to the PCHF Rule
Key Resources:Different food processors have different requirements for documentation and facility registration. Documents like a food safety plan or standard operating procedure (SOP) need to be customized to fit a facility’s unique design and needs. For information on documentation and food safety plans, check out the Food Safety Plan section as well as the Templates, Examples, and Forms section and Sanitation SOPs section.
5. Where do I find sample plans?
Sample food safety plans can be a great tool to understand what you may need in your own plan. Each food safety plan must be unique and tailored to your facility, written by a Preventive Controls Qualified Individual (PCQI) who understands how your manufacture, process, pack, or hold your products. While a sample food plan can be a good place to start, it is one of several components needed when creating your own food safety plan.
6. Who can help me review a plan or answer my questions?
Complying with the PCHF rule can come with many questions (including the ones listed here). Many university extension programs will have food safety educators who can answer questions and offer supporting guidance/information. These individuals cannot do things like give you legal advice or write your plan, but they can offer guidance and help you find the information that you are looking for. Check out our Connect to a Professional page to learn more.
Food Safety consultants can also help you write or review your plans and can offer guidance. These are paid professionals with experience and training in the field. You can find contact information for some consultants on the Connect to a Professional page, but this information should not be considered an endorsement.
7. What is the difference between an third-party audit and an inspection?
A third-party audit is a voluntary review of a facility and its documentation to show that it conforms to a specific set of standards, which are often required by buyers to ensure a safe and quality food. Third-party audits are not conducted by regulatory agencies and are not required by federal or state law. The type of voluntary audit that you choose to undergo will depend on the standards you want to meet.
An inspection is a required review that assesses compliance with the PCHF rule, and will focus on the full rule or part of the rule. It could be a routine investigation, a survey, or in response to a reported problem. Inspections are conducted by FDA inspectors or State inspectors contracted by the FDA. There are several types of inspections that may be conducted depending on several factors. Inspections may include: food CGMP, limited scope PCHF, full scope PCHF, modified requirements inspections at qualified facilities, and so on. To reference the full list of inspections and details about each type of inspection, view the FDA’s Preventive Controls and Sanitary Human Food Operations Compliance Program. To learn more about inspections and what to expect during an inspection look at the key resources below.