Preparing for Domestic FSMA Inspections

Features - Industry & Regulatory Issues

Although FSMA compliance is not expected to roll out until 2016, preparation prior to that time is essential to prevent any unnecessary risk to your organization.

March 26, 2014

The four parts of the Food Safety Modernization Act (FSMA) are in various stages of commentary and rulemaking. Final rules are expected to be issued sometime in early 2015. Although the Act is enforceable by the FDA at any time, it is expected that the compliance rollout will occur sometime in 2016.

Food plants can plan, prepare, and train now for enhanced FDA inspections that will be impacted by Section 101—Inspection of Records and Section 103—Hazard Analysis and Risk-Based Preventive Controls (HARPC). Preparation prior to the compliance rollout is essential to prevent any unnecessary risk to your organization.

Section 101 - Inspection of Records

Regulators have always had access to interstate shipment, proof of FDA registration, and any records seen in plain sight. The threshold in the Bioterrorism Act in of 2002 established the authority to inspect records if there was “credible evidence” that the product would cause serious adverse health consequence or death in humans or animals (SAHCODHA) which equates to a Class 1 recall.

Under FSMA, the threshold for record inspection has been lowered from “credible evidence” to “reasonable belief,” allowing FDA inspectors to review records related to production, traceability, receiving, product testing, sanitation, etc., if suspect products are identified during a FDA inspection. The extent to which “reasonable belief” will be used in relation to the FDA review of risk-based preventive controls and the enforcement actions combined with the new FSMA provisions for violative product is not yet fully understood.

Section 103 – Hazard Analysis nd Risk Based Controls (HARPC)

Hazard Analysis and Risk-Based Controls (HARPC) are somewhat similar to HACCP, but not quite the same. Plants will be required to have a food safety plan for each different process or product produced. These plans will have to include all FDA hazards that are likely to occur and the preventive controls that are in place to control contamination and monitor effectiveness. FDA wants specific hazards to be considered in each hazard analysis, such as natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved colors/additives, and radiological and intentionally added hazards.

Preventive controls will include documented monitoring procedures, acceptable operating parameters, and documented corrective action when preventive food safety requirements are not met. Every food safety plan will need to demonstrate measurable verification activities (e.g., analytical testing, environmental testing, visual inspection, process control limits, key performance indicators, etc.) to prove that hazard controls are effective and that corrective actions were appropriate to prevent adulterated or misbranded products from entering the food chain. If HACCP/food safety corrective action principles are in place, the non-conforming product disposition will have to clearly show that all products were accounted for, acceptably reworked, sent to an alternate use, or destroyed.

FSMA’s preventive controls include sanitation of contact surfaces, management and employee hygiene training, environmental monitoring, allergen control programs, supplier verification, and recall plans. It also is likely that additional GMP programs could be subject to FDA review if objectionable conditions are observed during an inspection or record review.

Although HARPC record access and inspection authority is modeled after existing regulated HACCP programs for seafood, juice, and thermal processing (low acid canning) the expectation for having documented risk-based preventive controls for preventive programs is not exactly the same as traditional HACCP, which emphasizes CCP compliance for science-based critical limits. Companies currently operating using a documented HACCP plan should be able to effectively offer documented raw material and process hazard analysis that identifies raw material and process-related hazards to be controlled by preventive programs. It is expected that regulators will identify any missing or inadequately defined hazards for raw materials and process during their physical inspections.

One potential area of concern is that the content in a plant’s monitoring of preventive programs matches up with the regulator’s findings during a physical inspection. If plant or management personnel cannot adequately explain preventive controls or show objective evidence in monitoring records that identified hazards have been effectively controlled, it will be of great concern. It is anticipated that HARPC inspections will be more assertive, comprehensive, and inspection-oriented with enhanced enforcement. These regulatory requirements require an in-depth review of existing preventive controls and additional employee training to prepare for coming changes in FDA inspections.

Preparation is Key.

It is critical to have a defined and updated policy for regulatory inspections and a gap analysis to ensure that the policy is understood at all levels of the organization. At a minimum, this policy must define access to records, including test results (raw material, environmental, finished product, etc.); recording devices (photographs); collection of samples; labels; packaging; employee interviews; etc. All objectionable findings will be recorded on a Form 483 and explained to the plant.

It is very important to respond to the FDA in 15 working days with the corrections made and any future plans for corrections. It also is recommended to request comment from the FDA on the acceptability of the corrective actions submitted. If corrective actions are not sufficient, the plant will be subject to a re-inspection at your own cost. If the re-inspection is not successful, the plant runs the risk of an injunction usually resulting in closure until corrections are acceptable.

It is strongly recommended that gap analysis and corrective actions be performed for regulatory policies and HARPC food safety plans so that all required programs are effective. Additional consideration should be given to having mock FDA-type inspections and unannounced inspections to further confirm that the preparations made are fully implemented and in alignment with FSMA requirements.


The author is Global Manager, Food Safety Services Innovation, AIB International.