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From: Food Quality & Safety magazine, June/July 2005

Transparency, Part Deux

This is the second in a series of articles that discusses the inherent due diligence and transparency while using HACCP and ISO standards

by Lydia Guillot

In the last article, "Transparency Needed When Combining HACCP with ISO" [April/May, p. 20], the importance of transparency and openness were discussed in regards to industry and government. The intentions of all concerned are, of course, to produce a safe and wholesome product; but sometimes testing is not as reliable or consistent as it should be in establishments that are interested in maintaining quality and food safety at the same time.

Using HACCP and/or ISO truly emphasizes the need for transparency, as well as due diligence, which is where the next section of this article begins. Without transparency, the records that are kept and the entry and exit conferences held would not be effective, efficient, or useful. Without due diligence, transparency could not itself be nearly as effective.

What is Due Diligence?

Due diligence has become rather important in a banking industry that has seen its share of ups and downs over the last 10 years, for it has also enabled companies to weather the recession.

Does due diligence have application in the food industry? By examining the definition of due diligence, this question can be answered.

According to one Web site, due diligence means "taking care." It means ensuring that every reasonable precaution has been taken for every circumstance such that all concerned parties, regulators, industrial workers and consumers, are protected, particularly referring to health and safety, both with regard to food safety and occupational safety.

It also means that if a business has tried to meet its obligations and has done what is reasonable and still fails, but has not broken the law, then the business would not be found guilty of wrongdoing in court. That poses two issues: (1) the company cannot break the law, and (2) the prosecutors must prove that a law was broken in its failure to meet its obligations.

In fact, due diligence by its nature sounds like the principles of HACCP; that a plan is in place, employees are trained and supervised , records are up-to-date and corrective actions and future planned actions are given to reduce or prevent the possibility of recurrence.

On the food industry side, these actions indicate that the establishment is operating to the best of its ability in a safe environment. On the regulators side, there are assurances that though something may go dreadfully wrong, the establishment will demonstrate care to maintain safe and sanitary conditions. Transparency is built by the development of these principles and their implementation.

The principles of due diligence are also the principles in the rules of practice, stated in 9 CFR 500, such that fair warning and discussion occurs prior to enforcement actions that might entail cessation of operations for a while. These rules protect both regulators and establishments alike, for it ensures that the establishment had full knowledge that it in fact was failing to meet its obligations and was on the verge of breaking the law and either chose to correct itself or ignored the warnings.

At the same time, due diligence gives regulators the right to ensure that the establishment was given every chance and chose to heed the warnings or chose not to correct their problems. How long should the establishment be under the auspices of due diligence? There is no time frame; that is, if they can prove that they didn't break the HACCP or SSOPs regulations, and there is still a problem but they are attempting to handle the situation in good faith, then due diligence persists.

If there is contamination or adulteration of product, or if there are food safety issues and those are not being addressed then due diligence cannot function, as the law is broken, according to either CFR 416 (regulations addressing sanitation) or CFR 417 (regulations addressing food safety). In short, due diligence helps the regulator and the establishment determine compliance.


Due diligence works based on only one condition: Transparency must be present and practiced on all parts. The biggest barrier to this is the wall between the inspectors and the establishment, particularly in examining establishment's records of pathogen performance standards.

Should inspectors be allowed to examine the establishment's results of salmonella or Listeria testing? According to regulations continuous failures can lead to a suspension in operations. Do inspectors go too far in enforcing the suspension of operation on the basis of results from a salmonella performance test, as was ruled in the Supreme Beef case, or based on various sanitation issues as was under debate in the Nebraska Beef case?

In the case of Supreme Beef, the courts ruled that failed salmonella and E. coli testing should not have been enough to stop operations, and in a statement by Dr. Elsa Murano, the USDA's under secretary of food safety, the agency changed its policy to agree with this.

Dr. Garry McKee, administrator of the Food Safety and Inspection Service, also said that while Nebraska Beef demonstrated poor sanitation issues, the inspection service would follow the Rules of Practice. Regardless of this decision, the question still remains. Do inspectors have the authority to search an establishment's records? Can an establishment prove trustworthy and still prevent this?

The Precautionary Principle

Hand-in-hand with this goes the precautionary principle. This principle works when an activity could be harmful to the public. However, no cause and effect of a particular event can be established by scientific means either to prove the harm or the benefits of the event.

In employing this principle and policies based on this principle, establishments are guided to use care in how they employ various methods of slaughter and processing in order that hazards, either unforeseen or those accounted for in the hazard analysis, are noted and corrected, eliminated or reduced, even though scientific evidence may not be overtly present to verify that the cause is due to machinery, personnelor operations. Precautionary principle has been used in developing environmental policy throughout the United States particularly in the past six years, when the concept truly caught fire.

The precautionary principle is also present in biotechnology and food emergencies.10 The policies developed from this err on the side of public health and are based on using scientific uncertainties to demonstrate that until further knowledge can be gained if there is public health significance, i.e. if illness or fatalities can be associated with the particular process or product produced, there should at least be a warning to the public.

The precautionary principle first arose in dealing with pollution issues in the 1970s and it is used in the event there are limits to predicting threats to public health with only the use of science. That is, the availability of product alternatives must not be discounted if the original is not suitable or causes problems whether or not reported by the public. Finally, there is the need for continuing evaluation of economic consideration to all sides.

The precautionary principle allows for seeking out alternatives to methods that appear to be innovative and effective in productivity but which may , over the long term, be injurious or at least not aesthetic or acceptable to the public. The use of ISO along with HACCP may in fact give some of those assurances to the public that using just HACCP cannot, since HACCP is solely concerned with food safety and sanitation and not the whole picture.

An establishment feels more accountable to be up-to-date with their HACCP and SSOP plans because of the food safety and sanitation issues and these are weighted heavier in some regards, but also because records generate more of how the process in a particular establishment is run, whether or not the records themselves are accurate. In other words, records will show whether or not an establishment is transparent and open about its process, much more so than records that are of finished product standards.

While records show compliance with product during time points throughout a shift, HACCP, SSOP and ISO records demonstrate overall compliance during both time points in the process of production. This is a much more accurate record, and one in which transparency is much more necessary in order to have a consistent and effective production.

At present, transparency is inconsistently applied, while due diligence is demanded. Recordkeeping in particular is inconsistent at best. Can the inherent problems with observing records and enforcement based on poor recordkeeping be solved combining HACCP and ISO? The answer to that is no. Just because sophisticated methods of monitoring, verification and recordkeeping have been added to the existing system, this does in no way correct the inherent problems with transparency. If any thing, before ISO is added to a HACCP system in meat and poultry industries, transparency must be insisted upon. In addition, regulators should insist on consistent application of the regulations, including enforcement, from establishment to establishment.


  1. Tweaking HACCP. Lydia M. Guillot, DVM. presented in completion of Special Projects class, VM 815, Appendix: Team Building.
  2., Due Diligence in AEP. Due Diligence in Banking.
  3. Slides on Due Diligence
  4. Module 3 International Food Law in the United Kingdom, Fall 2002.
  5. FSIS Directive 5000.1, Enforcement of Regulatory Requirements in Establishments Subject to HACCP System Regulations. 1998, Attachment 1. (2) and (3) (i), (ii), (iii)
  6. FSIS Directive 5400.5 Inspection System Activities (11/27/97).
  7. 9 CFR 500.2. What circumstances call for regulatory control action; 9 CFR 500.3, When prior notification may not be necessary, even though written notification must be accomplished promptly; 9 CFR 500.4. When is prior notification necessary before taking a withholding action; Rules of Practice.
  8. FSIS News and Notes and , Congressional and Public Affairs Office. Nebraska Beef, Inc. Sues USDA, 9 inspector,. Pg. 2. May 16, 2003.
  9. The precautionary principle.
  10. The precautionary principle.
  11. HACCP Regulatory Process For HACCP-Based Inspection, Reference Guide, Published by USDA/FSIS Human Resource Development Staff,. January 1998.

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



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