How to Get FSMA/PCHF Compliant: for Manufacturers
What exactly is the regulation? FSMA stands for Food Safety Modernization Act which is the name of the paw that was passed by Congress and signed into law by President Obama in 2011.
PCHF: FSMA has 7 final rules, one of which is the “Good Manufacturing Practices, Hazard Analysis and Risk Based Preventive Controls for Human Food Rule” (21 CFR 117) often abbreviated as the PCHF (Preventive Controls for Human Food) Rule
Who needs to comply with this regulation? any company that “manufactures, processes, packs, or holds human food”. That means every food company from produce packers, pre-processors of ingredients, manufacturers of consumer products, and even warehouses that only store food all must comply. Basically everyone in the food supply chain except for:
· Farmers/Growers – they come under the FSMA Produce Safety Rule
· Transporters – they come under the FSMA Sanitary Transport Rule
· Retail Stores/Restaurants/Caterers – they are regulated by local health departments
· Processors of meat, poultry, eggs – regulated by the USDA
· Processors of seafood, juice, and other items which have existing FDA regulations
What is required to comply?
Good Manufacturing Practices relating to the building, equipment, operations, and personnel as defined in 21 CFR 117 Subpart B. This does not require documentation just that the facility and practices be in line with the regulations.
Documented Food Safety Plan including:
Hazard Analysis identifying known and reasonably foreseeable hazards including all significant biological, chemical, and process related hazards and to identify which require preventive controls
Preventive Control Procedures for each of the 4 types of Preventive Controls identified in the Hazard Analysis: Process Preventive Controls, Sanitation Preventive Controls, Allergen Preventive Controls, and Supply Chain Preventive Controls including procedures for monitoring, corrective actions, verifications, and record for each
Environmental Monitoring Program (only for operations that have RTE foods that are exposed to the environment)
Records for monitoring, corrective actions, and verifications for all preventive controls fully implemented and maintained
PCQI: it’s required by the PCHF for every company to have a Preventive Control Qualified Individual (PCQI), and the preferred way to qualify to be a PCQI is to take the Preventive Controls for Human Food class through a licensed FSCPA trainer.
How do I get compliant?
Have at least one person in the company take the “Preventive Control for Human Food” course– both to qualify as a PCQI and to learn how to write a Food Safety Plan
Write your Food Safety Plan – the course provide templates, and the FDA has other materials online including a “Food Safety Plan Builder”. If you prefer not to do it yourself, contact your friendly neighborhood consultant to assist you.
Implement your program and train your employees in the new practices and records
Maintain your program, keeping all records for at least 2 years, and updating as changes occur
Wait for the FDA to come to review your program, and make any changes that they identify
When does compliance need to happen by? Compliance was phased in over a few years starting with larger companies on down, but we are now more than 3 years past the point when even very small companies are required to comply so anyone that doesn’t have a program in place already is in violation of the law and needs to correct that ASAP.
Does the FDA need to approve the Food Safety Plan? No: food companies are just required to have one and the FDA will review it whenever they decide to conduct an inspection which may not be for several years. In the meantime the company can continue operations without FDA approval, just making sure that the food safety plan is being followed and records kept so that they’re ready when the FDA does come.
Does FSMA require a certification or paid audit? No! FSMA is enforced by the FDA which is paid for by tax dollars and the regulation does not require any paid services to comply. Anyone trying to sell you a FSMA Inspection or any other paid services is a private company; such services may be helpful but they are not required by law and if they claim or imply otherwise they are not being honest.
Does a HACCP Plan cover FSMA compliance as well? Yes and no. While PCHF is based on HACCP Principles it is not identical so a HACCP Plan is not automatically compliant with the PCHF rule, however it can be modified into a FSMA Food Safety Plan as well. One of the main difference is that the PCHF concept if Preventive Controls is more expansive than the HACCP concept of CCPs so there will be more PC’s than CCP’s. In addition the hazards requiring controls are more rigidly defined in PCHF so if the Hazard Analysis was not written specifically with FSMA in mind it will likely be lacking those. A company can choose to have both a HACCP Plan and a FSMA Food Safety Plan, or one plan which service both purposes.
Note: “HARPC” (short for Hazard Analysis and Risk Based Preventive Controls) is a term that some people use to refer to the plan required by the PCHF “HARPC Plan” (in contrast to “HACCP Plan”) though the correct term is “Food Safety Plan”
Are there any other regulations to know about and comply with? Yes, several more. FSMA did not supersede all other regulations so there could be several more that you need to comply with such as:
If the manufacturer/packer/warehouse is also a Farmer, Transporters, Retailer, or processor of meat, poultry, eggs, seafood, juice they will come under other regulations as listed above
State food safety regulations and licensing requirements
Other FSMA rules such as FSVP or Intentional Adulteration
Other FDA regulations such as the Bioterrorism Act or FALCPA
This article discusses the PCHF only, continue to learn about additional federal rules and regulations that may impact your company.