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From: Food Quality & Safety magazine, August/September 2005

How much information about HACCP and ISO is Enough?

by Lydia Guillot

If one considers the public well-being as the raison d’etre for regulating food establishments, the use of HACCP and ISO combined to encompass all food safety and food quality issues should enhance consumer confidence that the establishments and regulators are in fact working in their best interest. But is this always the case?

With consumer confidence, establishments should be more at ease and be more open in their dealings. This, in fact, is necessary. In order for any food system to function with precautionary policies, as well as for due diligence to be effective, transparency is a must. Transparency is the only way to build good faith, and without good faith and trust it is impossible to work HACCP and ISO successfully.

Consumers interact with industry and regulatory agencies in many ways:

Establishments are willing to share some, but not all information regarding the safety of their food with consumers. Regulatory agencies as well sometimes don’t make all information with regard to food safety in establishments available to the public.

USDA and establishments often are not transparent with each other with regard to information. That is the purpose for the presence of 9CFR 500, Rules of Practice.

USDA personnel in two separate but nearby plants or even between two shifts in the same plant are not open with each other. For meaningful enforcement, there must be consistency and uniformity, and for this to happen; there must be communication.

Finally, there must be openness between the USDA field personnel and the upper supervisory levels, in order to accomplish the mission of the agency, and that doesn’t always happen. Again, good communication must take place.

The weakest link in any regulatory situation is transparency and openness, and this is demonstrated most prominently during the BSE situation in England in the late 1980s and early 1990s. In order to keep the public informed, all interested parties must be given a chance to respond to problems.

During the BSE crisis in England, this didn’t occur. The main complaint in England was that consumers were not kept in the loop of information when the situation with BSE certainly concerned them. The ensuing furor was so strong that The Food Safety Act and its enforcing agency, the Food Safety Agency, were born. The FSA has since developed into an independent agency, with various committees. Its purpose is to keep the public informed of food safety and sanitation issues, as well as provide regulators with authority for enforcing the given regulations. In the US, while there are links that consumers can log onto on the USDA and FSIS websites, and while there are programs such as Fight-Bac and Thermy which provide public education, the consumer still is not fully aware of what goes on in the world of both industry and regulatory agencies.

Keeping Consumers in the Loop vs. Food Security

The reason given by both industry and the regulatory agencies concerning consumers is this. Not all information need to or get to consumers. Why? After all, isn’t it in the best interest of consumers to know methods for reducing pathogens and how these work on pathogens? Perhaps not, for some information that regulators, academians and those in industry may be aware of may not be within the best interest of the general public to be made aware of and may in fact be dangerous to the security of local, state or even national security.

Who decides what information is important? Should that be the government? Or should an independent body, similar to FSA, decide what is in the best interest of the public? That is a dilemma that will be hard to solve. On one hand, one deals with public trust of the government, regulators, academians and industry. On the other hand, there are certain members of society that would want to do harm to the public for the promotion of a cause. It becomes the task of those in public service to use best judgment in relating to the public what it needs to know to be in the best of health, while exercising care that no one is able to use such public knowledge and get access to research from universities and industry that he/she would use for his/her own means to everyone’s detriment. Securing the food supply is a hard road for government and industry alike.

The Role of Transparency in Recalls

Keeping the public safe is the goal of regulatory inspection. This includes keeping the public informed to make good educated decisions regarding its own health. Since the Sept. 11th attacks, this has included food security as well.

Neither food safety nor food security will be effective without more of a commitment to transparency on the part of establishments. Two questions should be answered: 1) has the establishment supplied regulators with information regarding a possible pathogen threat? 2) Is the process under control in the face of an imminent threat due to a pathogen? For the answers to these questions to be “yes” transparency is a must. If the answer is “no”, sooner or later the end result of a process out of control and the existence of the imminent threat to the public is a recall.

Recalls are carried out when all other inspection enforcement activities have failed. It is the last step that inspectors, both in the field and administratively, can take to fully protect the consumer. With a more solid commitment, adulterated food may never leave an establishment and that last step may not be necessary. In that vein, HACCP and ISO (if it is being used) will be working to the fullest extent possible. At this point in time a recall also may be the only thing that protects the majority of the consumers in the event of a foodborne attack from terrorists. With the use of transparency, that tainted substance might not even leave the establishment where it was produced. Further, if a terrorist did not attack at an establishment, transparency can allow a successful investigation of what step in the chain terrorists did taint the food supply.

The time for “us vs. them” is over. Industry has as much responsibility to the public as regulators do. Under HACCP, establishments have an excellent opportunity to prove they are living up to their responsibilities. For example, according to Thomas Billy, in “Inaccuracies in News Articles Concerning the Decision by US Court of Appeals for the Fifth Circuit in Supreme Beef Processing, Inc., vs. USDA,” pathogen reduction monitoring and sampling will continue, establishments are given the opportunity to correct any sanitation and food safety deficiencies that they have. Under the Rules of Practice, 9 CFR 500, the only reason that an establishment’s operations will cease would be under the drastic measures. Most of the time, under the Rules of Practice, regulators allow establishments time to get their processes back under control. Establishments must realize that part of the regulators’ job is to ensure establishments are following their HACCP and SSOP plans and performing the pathogen reduction standards.

Establishments must not view what regulators do as harassment but should understand their responsibility to the public. It is disturbing that even our court system doesn’t realize this responsibility of industry and that they allowed operation in the face of repeated failures of the Pathogen Performance Standards in the Supreme Beef case, and that there would have been a court decision to keep a plant in operation after repeated failures, as in the case Nebraska Beef, Inc., where nine inspectors and the USDA were sued for “harassment”, had Dr. McKee, then Administrator of the USDA, not stepped in to negotiate with all parties.

What this means is that while the USDA is committed to ensuring industry produces safe, wholesome, unadulterated product and in some cases, industry doesn’t seem to make that same commitment, nor do they have the same level of transparency. The two lawsuits certainly have demonstrated that, but also in the case of the statement of the American Meat Institute that USDA shouldn’t punish plants making efforts. Sometimes what the establishment calls “making efforts” and how the regulations say that an establishment should make those efforts are two different things. It is not enough, for example, to grab a mop to wipe down condensation that is there. How is that going to be prevented from occurring in the future? What steps are being taken to ensure that pipes are better insulated or that sweating doesn’t occur or that the ceiling is impervious to moisture, as the regulations say in 416.2 (d)?

A person with a mop will not always be able to be present when water is forming. The establishment is accountable to ensure the prevention of food safety and sanitary deficiencies as well as correcting them when deficiencies occur. Establishments are also responsible for demonstrating control once these measures are in place and that requires transparency. The results of the lack of transparency can be demonstrated with the Franconia recall due to detection of Listeria monocytogenes. In the Houston Chronicle, the USDA and Pilgrim’s Pride came to the agreement that more testing was going to be done and that the establishment would be open about its testing. In the Morning Call, it was reported that was one of the major problems in the Pilgrim’s Pride plant, that it was not open with its information.

Openness is so important in maintaining the safety and sanitation of the food supply, as for example with genetically modified organisms. Because of their usefulness, GMOs are becoming more and more important globally. Clearly without transparency on either side then it could be disastrous to pursue use of GMOs in terms of potential public health difficulties that may not have been made apparent, and those very real public heath problems that exist in allergies. Recordkeeping, research, regulatory factors will all be important in considering the future course not only of GMOs but other food products and processes. As well, how well HACCP works in ensuring safe food, along with quality that is sought after by using ISO, is dependent on transparency. Without transparency, none of the goals of the USDA or of industry can be fully met. With transparency, public safety can be secured.

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



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