FSMA Regulations and the Human Food Audit Checklist

FSMA (Food Safety Modernization Act) regulations place more of an emphasis on prevention of food contamination rather than response when contamination does occur, prompting many in bulk agriculture to implement formalized processes that may or may not comply with FSMA requirements.

This checklist for manufacturers of human food focuses on two parts, and should be done sequentially while collecting documentation along the way.

Hazard Analysis and Risk-Based Preventive Controls
Hazard Analysis is the practice of identifying and evaluating all known or reasonably foreseeable food processing hazards that could present risks, then comparing their likelihood and severity in order to identify any which require preventive controls plans for mitigation.

Procedures must then be put in place that ensure these controls are consistently executed and monitored, and documented to demonstrate compliance with a food safety plan.

Under the Food Safety Modernization Act (FSMA), these procedures may be known as HACCP, HARPC or risk-based preventive control programs. They all basically serve the same function.

FSMA requires food facilities producing human foods to implement food safety plans and develop tracking mechanisms should any product need recalling. At the 2014 American Coalition for Ethanol Conference, experts presented insights on what impact the new food safety law would have on ethanol plants and their operations.

Current Good Manufacturing Practices
cGMPs (current Good Manufacturing Practices) are the essential requirements to ensure food is produced under safe and hygienic conditions, similarly to USDA Good Agricultural Practices certification and form the cornerstone of any food safety system.

The Food Safety Modernization Act’s Preventive Controls Rule mandates that all food manufacturers create and implement an appropriate Hazard Analysis and Risk-Based Preventive Controls plan (HARBPC). Each product manufactured or processed on site must include its own HARBPC plan; inspection and documentation processes must also be documented and observed throughout.

ISU Extension will soon release an ISU Extension is currently creating a generic food safety plan template to take into account FDA rules and guidance once available. In the meantime, this checklist for manufacturers of human food focuses on organization materials as well as assessment current food safety preparedness levels; additionally it includes some limited information pertaining to Sanitary Transportation Rule (21 CFR Part 1 Subpart O). FSMA human food checklist should only be used by individual manufacturers.

Sanitary Transportation
Sanitary transportation regulations mandate food producers, loaders, carriers and receivers to develop robust procedures that guarantee sanitary conditions during shipment. These processes include temperature control, separating foods by type to avoid cross-contamination and adequate cleaning between loads as well as safe container/equipment storage when not needed. Carriers must also train their personnel as well as document these activities.

Some commenters assert that the sanitary transportation rule should exclude shell egg transport operations because they are already subject to USDA oversight under requirements established under the Egg Product Inspection Act (EPIA), or participate in voluntary quality assurance programs like SQF and United Egg Producer’s 5-Star program. Furthermore, such operations tend to operate intra-corporately according to internal Standard Operating Procedures and practices for transportation outlined within SOPs or agreements for quality assurance programs like United Egg Producers 5-Star program.

Other comments point out that the sanitary transportation rule could conflict with State laws requiring trucking facilities to follow certain sanitation practices, citing preemption as justification for this position. According to this doctrine, any federal law preempts State laws to the extent they frustrate or impede its goals and objectives.

Registration of Food Facilities
All facilities involved in manufacturing, repacking, relabeling and holding food items for use within the US must register with the Food and Drug Administration (FDA). These activities encompass human food as well as animal feed, seed and veterinary medications that will be stored and distributed within this region.

Registered facilities must implement and regularly assess an effective food safety preventive control plan for their operation, outlining how they will manage potential risks that can threaten safety in order to achieve safety levels that comply with industry requirements. The plan acts as an internal evaluation of risks involved with operations as well as how those risks will be reduced safely.

Owners, operatorss or agents in charge of facilities must register them themselves or authorize someone else to do it on their behalf. Foreign facilities must appoint a US agent as liaison with the FDA on their behalf. Once registered with FDA, each establishment will receive its own unique 11-digit food facility registration number that does not indicate approval or certification by FDA.