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From: Food Quality & Safety magazine, December/January 2006

A Perfect Blend, Part 2

Three salient issues with the combination of HACCP and ISO in regards to regulations

by Lydia Guillot

In the last issue, the subject of whether or not it would be possible and feasible to put ISO and HACCP in establishments was discussed. Continuing that discussion, there are three salient issues with the combination of HACCP and ISO in regards to regulations:

  1. Would the establishment consider the combination of both of these systems worth whatever the cost may be incurred?
  2. Will the combination increase food safety more than the current system that is used? It is interesting to note that FSIS reports a decline in pathogens and that CDC reports a decline in the number of people ill from key pathogens, even though this decline may not be present every year.
  3. How feasible is it to put ISO into the regulations concerning food, food sanitation, or food safety? That is, how will ISO improve the mission of FSIS, which is to ensure establishments are producing safe, wholesome, unadulterated products?

In an article “Is Michigan Food Supply Safe?” by Robin Usborne Milsap, of the Michigan Agricultural Experimental Station, the responsibility of making food safe falls on processors, regulatory agencies and consumers.

As well, bringing all foods under HACCP is recommended. But the article brings into question whether or not consumers care about this second point. In a study cited by Drs. Leslie Bourquin and Toby Ten Eck, it is uncertain whether people even understand HACCP. Educating people is important to assure that principles of HACCP are completely applied from farm to table.

But involvement of consumers is only one of the issues that will affect the success of HACCP in food industries. Again, education of food industries in HACCP is vital, because there is often a lack of understanding on the workings of HACCP. Industry in general does not like HACCP, and this is the stumbling block to its success.

Neal Fortin, a food law attorney, gives several reasons why industry doesn’t like HACCP in his article, “The Hang-up with HACCP:”

  • First, HACCP is too time-consuming. In fact far too much time is spent completing both tasks and records to satisfy the regulatory requirements of 417. The personnel in the plant cannot perform other tasks that industry deems important because of the HACCP requirements.
  • Second, HACCP is costly to maintain, especially in terms of training and turnover, both of which affect the effectiveness of an establishment’s HACCP plan. Inadequacy in training exists from hourly employees all the way to supervisors, superintendents, and upper level management.
  • Third, in order to ensure that food is safe, it becomes the chore of the regulators (literally) to impress upon industry that HACCP is the law, and it must take care of its process. There are legal ramifications for not implementing and maintaining its own HACCP plan, and there are legal ramifications for not being able to demonstrate through recordkeeping and other regulatory requirements that the establishment is indeed functioning as it says it is. While HACCP is costly, especially to smaller operations, the establishment is accountable to run its process with food safety in mind. This in fact leads to less lost product ultimately. Not just implementation, but continuous updating is important, and the best and most effective HACCP plans demonstrate accountability with this updating, not just at the reassessment time but whenever there are changes in the system.
  • Lack of accountability can lead to withdrawal of the mark of inspection until problems are amended and the plant can demonstrate that it can run its process adequate to maintain food safety.
  • The message here is that HACCP must constantly improve from both a regulatory standpoint and from a consumer standpoint. All parts in the chain will link together or the system will fall apart. One way to prevent this and to strengthen the chain is to increase accountability not just in HACCP tasks, but also in the Other Consumer Protection tasks, of which Finished Product Standards play a major role. (See Food Quality Magazine, April/May issue) This can be accomplished with ISO, as ISO is used by many processing establishments other than meat and poultry to increase quality standards.

Looking at HACCP as it functions now, there are seven major steps:

  • Identifying hazard and risk assessment and compiling this information into a Hazard Analysis;
  • Determining critical control points;
  • Establishing critical limits;
  • Establishing monitoring procedures for each CCP in the establishment;
  • Establishing effective corrective action in compliance with 417.3(a) or (b), when there is a deviation from the critical limit at the CCP;
  • Establishing accurate and current recordkeeping procedures at each CCP, which include if the establishment met its critical control limit, and what the establishment met its critical control limit and what the establishment did to bring the CCP back into compliance when it exceeded its limit and what is the establishment going to do to prevent the likelihood of the recurrence of the deficiency;
  • Establishing effective verification procedures in order to ensure HACCP is being properly monitored and that corrective actions and preventative measures meet the regulation.

Since its implementation by FSIS, HACCP has undergone many changes. The Sanitation Performance Standards were implemented to replace the FSIS Directive 11000.1 amendment .1. Risk analysis, assessment and management has become important, especially considering ready-to-eat products and Listeria, E. coli in ground beef products and the presence of Salmonella in eggs.

Because HACCP is a growing continuum, when problems arise in verification or enforcement, adjustments can be made, such as the use of CFR 500, Rules of Practice, in order to pursue the documentation, notification and actions necessary for proper enforcement and ensuring food safety.

In the past few years, new enforcement training has come about in food safety regulation enforcement. The Consumer Safety Inspectors and Veterinarians group within FSIS are trained such that HACCP enforcement is more clearly defined and so that the nation is uniform in its HACCP decision-making.

This uniformity is important to further ensure food safety and at the same time to provide equitability in carrying out HACCP’s main function, that is, to afford the plants to demonstrate that they can control their system even when deviations occur. This involves understanding and application of the principles of HACCP by the establishment and verification of establishment’s performance by regulators. These have resulted in reassessments of HACCP plans in terms of E. coli in livestock operations; an update of FSIS Directive 10010.1, Microbiological Testing Program for E. coli 0157:H7 in Raw Ground Beef and an update on the Reassessment of HACCP plans dealing with E. coli 0157:H7; updates to the sampling programs for detection of Listeria monocytogenes; and modifications and updates to enforcement procedures in establishments, listed and discussed in FSIS Directive 5000.1.

In this directive, sanitation SOPs and performance standards and HACCP are presented together and enforcement discussed, as well as the rules of practice which are also found in CFR 500. In 2003, Garry McKee--then administrator of USDA--affirmed that those in the field must continue to enforce HACCP using a science-based approach and to remember the goal of pathogen reduction. He then charged both regulators and industry with the responsibility for food safety.

ISO is a little more complicated than HACCP, in that each establishment uses international standards and customizes its programs accordingly. It designs its own steps to assure quality and meeting the standard. As such, ISO gives the establishment flexibility. From the quality standpoint, ISO provides for development and implementation of a program that is able to audited, accredited and measured. Now with ISO 22000, HACCP, along with supporting measures is being incorporated into companies around the world. The standards are auditable and useful for building confidence. The British Retail Consortium (BRC) has a Web page devoted to the use of ISO 22000. In ISO 22000, all points of the food chain are considered, as well as the regulations regarding food safety. (9 CFR 417) It is the purest incorporation of HACCP into ISO and the combination of both sets of standards.

But can both be used successfully, at least theoretically? One way to determine both the drawbacks and benefits of just such an arrangement is by risk management, assessment and communication which ultimately formulate risk analysis.


  • Futures. Michigan Agricultural Experimental Station. Is Michigan Food Supply Safe? PP. 18 -21. Robin Usbourne Milsap. Winter, 2003.
  • The Hang-up with HACCP: The Resistance to Translating Science into Food Safety Law. Food and Drug Law Journal. Vol 58:4 (2003) pp 565 – 594
  • Meat and Poultry Food Safety Investments: Survey Findings/ TB-1911.
  • FSIS Notice 54-03 Review of Establishment’s Data by Inspection Program Personnel. 12/6/04.
  • “HACCP Technology and Services” Jeff Chilton Feb/Mar 2004
  • “Tweaking HACCP”, Chapter VIII, Lydia M. Guillot, DVM, MS, presented as the final project paper for Master’s Degree in Food Safety from Michigan State University, May 2004 7. FSIS Directive 5000.1 Revision 1. Verifying an Establishment’s Food Safety System. 5/21/2003.
  • Practical application of risk.
  • FSIS Directive 10240.3 Microbial Samples of Ready-to-Eat (RTE) products for the FSIS Verification Testing Program. 12/9/2002
  • FSIS Directive 10240.4 Verification Procedures for the Listeria monocytogenes Regulation and Microbial Sampling of Ready-to-Eat (RTE) Products for the FSIS Verification Testing Program. 10/2/2003
  • Draft FSIS Listeria Risk Assessment. May 26, 2003.
  • Draft Risk Assessment of the Public Health Impact of Escherichia coli 0157:H7 in Ground Beef. September 7, 2001.
  • Prevalence of E. coli during processing
  • Federal Register: Salmonella enteriditis in eggs.
  • FSIS Notice 11-03. An update of FSIS Directive 10010. Microbiological Testing Program for Escherichia coli 0157: H7 in Raw Ground Beef (4/18/2003).
  • FSIS Notice 44-02. Instructions for Verifying E. coli 0157:H7 Reassessment. 11/4/02.
  • CFR 500. Rules of Practice
  • Field Operations: Heart and Soul of FSIS. Dr. Garry McKee, Administrator. Office of Field Operations Supervisory Committee. 10/27/03.
  • Development of ISO and the BRC.

Lydia Guillot is a veterinary medical officer/public health veterinarian for USDA. Reach her at



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