FSMA – Critical Control Points

The Food Safety Modernization Act (FSMA) mandates that any entity engaged in Manufacture, Storage or Distribution of Food should have a validated HACCP Plan.

HACCP stands for Hazard Analysis Critical Control Point.

Hazard is Defined as a Biological or Chemical or Physical or Radiological Agent that is:

  • Reasonably Likely to Cause Illness or Injury in the Absence of its Control
  • Thus, the word Hazard as used is limited to  `Food Safety’
  • Critical Control Point (CCP) is Defined as a Step at which Control Can be Applied
  • It is  a Step Essential to Prevent or Eliminate a Food Safety Hazard or Reduce it to an Acceptable Level

Within the food chain, if series of Critical Points are identified, analyzed for all possibilities of preventing such contaminations and initiating actions for the same is what is meant by HACCP Plan.

Food Safety Inspection Services (FSIS) inspectors do not validate or approve any HACCP plans in advance. It is the discretion of the facility to draw up a plan, follow the Plan and ensure that contaminants are avoided. All prevention activities are to be recorded and the Data retained for review and approval of FSIS.

The Seven Principles that are associated with HACCP are

(1)  Conduct Hazard Analysis

(2) Determine the Critical Control Point

(3) Establish Critical Limits

(4) Establish a System to Monitor Control of CCP

(5) Establish Corrective Actions to be Taken When Monitoring Indicates a Particular CCP is not Under Control

(6) Establish a Procedure for Verification to Confirm that HACCP is Working Effectively

(7) Establish Documentation Concerning the procedures and Records Appropriate to These Principles and Their Application

On November 23, 2013, FSMA has issued an amendment as a final rule which mandates that an element of Risk is also to be considered when determining the Critical Control Points. Food Safety Risk is defined as:

“The Scientific Evaluation of Known or Potential Adverse Health Effects Resulting from Human Exposure to Foodborne Hazards”

The Plan which covers the elements of Risk is called Hazard Action Risk-Based Preventive Control or HARPC.

HARPC Systems must be based on following Seven Requirements:

 (1) Identify Hazards

(2) Risk-Based Preventive Controls

(3) Monitoring of Effectiveness

(4) Corrective Actions

(5) Verification

(6) Record Keeping and Documentation

(7) Requirement to Reanalyze

These requirements are in addition to good manufacturing practices and prerequisite programs required for the entity. These requirements vary as per the nature of business and be compliant with ISO/TS 22000 -1 through 4

FDA has clarified that Compliance dates for covered activities, except for those involving sprouts, after the effective date (11/23/2013) of the final rule are:

  • Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period: four years
  • Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years
  • All other farms: two years
  • The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule*

*Note: On September 12, 2017, FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023, and January 26, 2024, respectively.(Source:https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm)

FSIS expects that all HACCP and HARPC plans are verified by experts before putting into action and validation records are retained by the facility.

QSE an enterprise in the business of consulting for Standardization can offer expert services in Training, Document Simplification, Expert advice on preparation of HACCP and HARPC Plans and can help Organization obtain certifications in Food safety, be it FSSC 22000, SQF or BRC. Contact info@enhancequality.com or call 770-518-9967