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From: Food Quality & Safety magazine, April/May 2005

Transparency Needed When Combining HACCP with ISO

The necessity of transparency cannot and is not subject to debate, particularly from the standpoint of producing a safe, wholesome product. From a regulatory standpoint, transparency is of utmost importance.

by Lydia Guillot

In 1998, the Final Rule was passed concerning HACCP implementation in the meat and poultry industries in order to ensure the nation’s meat and poultry products were produced in a safe manner and that these products were not produced in conditions that would cause adulteration or contamination.

Some organizations that work with food safety, using HACCP in combination with food quality issues, using ISO 9000 and higher, are Stoller’s honey 1, Sealord 2 and Chilton Consulting 3. Theoretically, because of the accountability that is present due to monitoring, verification, corrective actions and recordkeeping of all of the steps required by both HACCP and ISO, food safety and food quality are maintained in a more efficient and effective fashion. But the combination is not likely to occur in American food industry in general. The food industry in particular will offer much resistance as the food industry has just come through HACCP implementation that proved rather expensive 4.

According to Christine Bedillion of NSF, many companies in the U.S. don’t wish to incorporate ISO into their food safety/quality system because they feel that their own quality systems are sufficient to provide good quality. 5 In fact, many industrial and governmental workers, while being well aware of HACCP and the HACCP regulations found in 9 CFR 417, were not aware of ISO, or knew of it but did not use the system 6.

Any combination would mean the expense of retraining. Many poultry and red meat plants, particularly smaller plants, are still recovering from having to comply with HACCP regulations 7. The consensus is, “If it ain’t broke, don’t fix it,” which gives a false sense of security, especially in regards to existing regulations on finished products.

FPS and Accountability

FPS deals with dressing defects, that indicate problems with the mechanization in the establishment, as well as trimming defects, that are related to how well the establishment is preparing its product for further processing or for shipping to various consumers.

FPS has accountability problems in many establishments. Once a particular lot of poultry has passed testing after having initially failed, the testing of that lot is completed although subsequent lots may be in violation. While testing can be done again, the time constraints usually dictate that further testing is not done. When the test is deemed complete by markers exiting the chiller defining the lot of birds that is questionable, the establishment is allowed to return to its usual testing pattern in accordance to FSIS regulations and directives.

Since this is not considered food safety, emphasis is not placed on finished product standards. On the other hand, FPS does indicate a problem that could lead to food safety and/or sanitation issues. The accountability that is lacking can be amended with the use of ISO, particularly from the standpoint of recordkeeping, much as HACCP has done with food safety.

This will call for a more consistent application of transparency that must be present in HACCP and SSOP in order to be effective. Regulators will have to be consistent in their observations and establishments will have to be more transparent in demonstrating the effectiveness and efficiency of their process. This will further call for the consistent application of transparency between the various segments involved with the production and processes of the poultry and red meat industries, i.e., production itself, the maintenance department, quality assurance and any other department that has an involvement in the production of food, including governmental regulators 8. So state the HACCP regulations 9.

From the governmental standpoint, the important directive to keep in mind with HACCP, SSOP and Sanitation Performance Standards is Directive 5000.1, Verifying an Establishment’s Food Safety System.

Also of considerable importance regarding transparency are tests results showing the presence and quantity of E. coli, Salmonella and Listeria in the establishment, from testing that is done by the government and by the establishment. Levels obtained from regular testing by governmental officials are available to field governmental officials through LEARN 10 and correlations can then be made between the results of performance standards and zero tolerance testing and what is seen on various in-plant testing in order to improve food safety, sanitation and quality.

Establishments are often reluctant, if not unwilling, to share their data obtained by their own labs with inspection personnel. This was never more apparent than in the recall of poultry products in Franconia, Pa. 11 For transparency to be effective, these test results should be available and both regulators and establishment should be open so that compliance with regulations regarding pathogen levels can be determined.

Establishments need more consistency in their application of HACCP regulations in the performance of various tasks, as there is more emphasis on those tasks that are strictly for food safety issues, i.e., 03J01 tasks, than those that are commonly known as OCP (other consumer protection) tasks, even though those tasks may point to sanitation and/or food safety issues. A revamping of the task system would put some tasks under the 03 tasks, some under pathogen reduction performance testing (the 05 tasks), some under sanitation task codes 01 and 06 and the rest could be categorized under ISO.

While there are things that are company business, when it comes to food safety and sanitary handling issues, because government officials are public servants and because records are part and parcel of food safety, performance standards, sanitation and other tasks, establishments must comply with the oversight of pertinent records.

The Need for Transparency

The necessity of transparency cannot and is not subject to debate, particularly from the standpoint of producing a safe, wholesome product. From a regulatory standpoint, transparency of both the regulatory agencies with regard to expectations from and establishments of their processes and the safety of their products is of utmost importance.

From the standpoint of international trade, transparency is necessary to comply with the standards set by the sanitary and phytosanitary standards and technical barriers to trade. Transparency is also necessary in discussions in the World Trade Organization and in the formation of trade agreements. Barriers often arise because of lack of transparency and lack of accurate use of science 12. Trade agreements seek not to have barriers, and ISO will reduce these barriers even more so, since ISO standards provide an accounting for the quality of products that enter the country from other countries, much as HACCP provides that products entering other countries are safe food products 13.

Many barriers have arisen due to confusion about how far USDA’s authority in the field extends. In terms of ensuring the safety of the national food supply, authority of the USDA has come into question in both the Supreme Beef case and the Nebraska Beef case 14-16 in which inspectors were charged with harassment for their part in trying to enforce regulations governing sanitation, as found in 9 CFR 416, as well as food safety regulations, as found in 9 CFR 417.

In both of these landmark cases, it appeared that even with the rules of practice, industry was nevertheless convinced that USDA had overstepped its bounds in not allowing the establishment to work its HACCP plan. How far regulators go in working with the establishment has a lot to do with trust and transparency between all parties. On the other hand, how far should inspectors allow an establishment to produce a product that is suspect as long as the establishment is trying to bring their process under control and some point in their system? That is a question that is still under considerable debate, even within the USDA.


  1. http://Stoller’s Honey recognized by NSF International for exceptional food safety and quality systems (Winter 2000).htm
  3., Q Pro Con System description
  4. meat.htm, Data- Food Safety Technologies and HACCP Compliance Survey of Meat and Poultry Slaughter and Processing Plants, Ollinger, Michael, Nov. 2003.
  5. Christine Bedillion, NSF
  6. Tweaking HACCP, Lydia M. Guillot, DVM, Paper presented in completion of special projects class, VM 815, Appendix: Team Building.
  7. Meat and Poultry Plant’s Food Safety Investments: Survey Findings/ TB-1911. pg.13-36.
  8. International Openness, Science. Vol. 272. May 24, 1996. pg. 1086-1087
  9. HACCP regulatory process for HACCP-based inspection, USDA/FSIS Human Resource Development Staff, Jan. 1998.
  10., LEARN: Laboratory Electronic Application for Results Notification. Found in FSIS Directive 10200.1.
  11. Pennsylvania firm recalls turkey and chicken product for Listeria contamination, Oct., 2002.
  12. International Openness, Science, Vol. 272. May 24, 1996. pg.1086-1087.
  14. 0267.htm, USDA to continue testing for Salmonella in Meat.
  15. FSIS News and Notes, , Congressional and Public Affairs Office, Nebraska Beef, Inc. sues USDA, 9 inspectors. Pg. 2. May, 2003.
  16., inaccuracies in news articles concerning the decision by US Court of appeals for the Fifth Circuit in Supreme Beef Processing, Inc.

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



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