Food Safety and Related Issues

TASA ID: 1005

Food safety is very much in the news nowadays.  Headlines such as "Food Companies Work to Ensure Safety from Salmonella (1)" and "FDA: Plant Knew Peanuts Laced with Salmonella (2)" are just a few recent examples.  The associated articles describe events that allege that a company knowingly allowed an adulterated product, in this case Salmonella-contaminated peanut butter, to be distributed commercially, and eventually enter the consumer market.  Is Salmonella a serious problem?  Think typhoid fever, think Typhoid Mary, and you will get an idea of the health hazard potential.  Salmonella typhimurium, the species in question, is a well-known food-poisoning bacterium that is frequently lethal. 

And, perhaps more seriously, another article titled, "China Sentences Two to Death over Tainted Milk (3)"depicts the legal outcome of actions taken by companies to purposefully adulterate milk products with the chemical melamine. 

The peanut butter/Salmonella situation is based partially on the reluctance of a company to dispose of food products knowingly unfit for human consumption.  The product, possibly inadvertently, became unfit for human consumption due to a breakdown in the processes and procedures that should have insured its safe use, although deferred maintenance is always a possible contributing factor that must be considered in attempting to get to the root cause of the problem. 

In contrast to the Salmonella contamination, the tainted milk adulteration involves the purposeful addition of a known toxic organic compound, melamine, to a food product.  Melamine, a synthetic industrial compound used in the production of plastic, contains a high proportion of nitrogen.  It was added to milk as a cheap means to fool food processors' quality control into thinking there was the proper amount of protein nitrogen present in carefully, and again purposefully, watered-down milk.  Although it may simply have been conceived of as a sly trade off of nutrition for profit, it ended up trading dollars for death...  initially the death of beloved pets, and then, more frighteningly, children.  The impact was felt throughout the world, but especially in China, the source of the adulteration process. 

Other stories relating to food safety, contamination and adulteration come and go (recall Upton Sinclair's The Jungle), but are rarely out of the news.  The question that immediately comes to mind is "What steps are being taken to prevent a repeat?"  

The proper procedures to maintain food safety are well documented. 

For companies that want to produce an unadulterated product, the starting point is the process-flow plan of the plant combined with the plant design.   That is, even before the first piece of equipment is specified, and therefore, even before the first gram of product (or jar of peanut butter) is produced, a well-thought-out food-production process, and a robust food plant design, must be developed.  This must be done with prevention of contamination as one of the prime design considerations, realizing that contamination may come from one or more sources, such as from unprocessed or incorrectly processed starting material(s), unsanitary working conditions, inappropriate packaging or storage conditions, or any of a number of other sources specific to the industry in question.  

If you are a food processor, you must also know your suppliers and set up a program to accept or reject shipments arriving at your plant, as well as perform regular inspections of your supplier's facilities. 

And the principles of "HACCP" must be included. 

The methodical approach taken to assure an appropriate level of consumer safety of a process for food production has been clearly outlined.  It is known as HACCP, which means "Hazard Analysis and Critical Control Point."  A HACCP system is a guidance method that is logical and scientific.  It is used to make sure that the key steps in a process are carefully spelled out and that those steps that are essential for the safety of the final product (steps to prevent the production of an adulterated product) are clearly defined AND adequately controlled.  Also, by instituting strict controls and monitoring for what are termed the "Critical Control Points" and following the proper production and analysis procedures, application of the HACCP system insures that steps are actively taken to make certain that unhealthful product does not reach the hands of the consumer.  The Critical Control Points, the "CCP" in a HACCP system, are points in the process where the variables must be controlled and measured.  A typical CCP would be the step in a food manufacturing process where the unfinished food is heated to a particular temperature for a particular period of time such that the number and type of microorganisms is reduced to an acceptable (i.e. safe) level.  Since the number of microorganisms might not be zero if procedures are not properly instituted or followed, residual contamination (or re-contamination) of the product after this point (for example, with certain microorganisms such as the bacterial species Listeria monocytogenies or Salmonella typhimurium) could result in an unacceptably high chance that the consumer could get sick upon consuming the final product.   The controls, if properly developed and implemented, will prevent this from happening. 

Deciding what controls are most important is where development and implementation of a proper HACCP system is most useful.  One tool to achieve this end is a HACCP decision tree.

There are a number of variations on a HACCP decision tree (See, for example, diagram 2 from the Codex Alimentarious Commission (4)---Food and Agriculture Organization of the United Nations at the end of this article), but they all involve instituting controls that act to prevent adulterated products from entering commerce.  And, without management buy-in, they are all but worthless. 

I suggest that one of the initial steps in a HACCP decision tree be revised as follows:

In the case of the peanut butter crisis, one may ask if the company properly and methodically developed and/or effectively implemented effective steps to insure that the hazard (in this case, contamination with Salmonella microorganisms) was sufficiently controlled.  These steps involve understanding and developing solutions to Critical Control Points.  SSOPs (Sanitation Standard Operating Procedures), cGMPs (Current Good Manufacturing Practices), and preventive maintenance of equipment also come into play.  Decisions by upper management that are not necessarily in the best interests of the consumer will also have a major impact. 

And, did the adulterated milk producer care to address these steps at all? 

Did either or both producers simply place profit above the costs of implementing these required and crucial steps? 

Proof that the process to make the food product is properly designed and working correctly, both from a product quality standpoint and a safety standpoint, must be confirmed through the process of validation.  This would occur in a functioning plant, or its predecessor, a properly designed pilot plant.  The latter is useful since no product should be placed into commerce until all the bugs (pun intended) are worked out of the system.  Product quality, of course, may have many facets, many interacting variables, and involve many tests, often routine.  To stay in business, one must produce a product that sells, that gives you a profit, hopefully gives benefit to the customer (you may read this as "nutritious", a property sometimes absent...  have another sip of your cola while you read this) and at the same time when it is consumed is not detrimental to the health of the consumer.  The lack of detriment as a driving criterion seems to have been absent, or ignored, in the training manual of the companies (but hopefully not the industries) involved above. 

So what does validation mean? 

As discussed by the National Center for Food Safety and Technology (5), validation, as it relates to the presence of microorganisms, may be considered to be a proof that a particular food process delivers the level of treatment necessary to "eliminate the threat of a public health hazard from a food product's organism of concern."  In the recent case of the adulterated peanut butter, this organism is Salmonella.  For the validation process to be beneficial, quality control must be strictly adhered to, the proper tests run, and as often as required, and the quality control personnel given the power to immediately stop the shipment of product that is outside of specifications.  If this is not the case, the quality control function is simply advisory, and quality and safety may take a back seat to expediency and profit. 

The above events relating to the adulterated peanuts have prompted the FDA to perform the relatively uncommon task of issuing a "Letter to International Colleagues on Salmonella Outbreak (6)."  In effect, the letter stated that a number of hundreds of products were "involved" and that the number continued to expand rather than be contained.  Needless to say, this situation is impacting many other food producers, even those that have no products associated in any fashion with the original producer of contaminated peanuts. 

In a situation where there has been purposeful adulteration with a chemical agent known beforehand to be harmful (the melamine in milk or pet food), or at the least, not demonstrated to be benign, this appears to me, a non-legal expert, to be criminal fraud.  The quality control department of the producer may simply be involved in making sure that the adulterating agent passes the quality control tests performed when the product arrives at the quality control department of the next laboratory in the chain of production, and has no bearing upon the safety or efficacy of the product.  Legal experts may define this as conspiracy to commit fraud. 

So where has this brought the food industry?  At least in the case of the peanut industry, this fiasco, in the apparent failure of the mechanism to prevent at least one manufacturer from releasing contaminated product into commerce, has had a tremendous negative impact on the entire peanut industry.  And echoes are reverberating throughout the food industry in general.  It was estimated that "the effects of the widespread peanut butter recall..." would cost producers "$1 billion in lost production and sales." (7). This impact is being most acutely felt by rural farmers. 

In closing, I initially thought that the following words from Henry Dreyfus (8), the noted industrial designer, if modified to apply to food process safety, would be appropriate:

However, under the recent circumstances, a phrase variously attributed to the ancient Roman Physician Galen, English physician Thomas Sydenham, or other authors, and usually applied to the medical profession, is apparently now becoming just as applicable to the food industry:  

Click on above chart for larger image.

References 

1.  Ricks, Delthia.  January 26, 2009.  Food companies work to ensure safety from salmonella. Newsday,  http://www.newsday.com/services/newspaper/printedition/monday/longisland/ny-lisalm256013112jan26,0,5137934.story (accessed January 26, 2009).  

2.  Blackledge, Brett J. and Alonso-Zaldivar, Ricardo.  February 07, 2009.  FDA: Plant knew peanuts laced with Salmonella. Associated Press, http://cbs5.com/health/peanut.butter.insecticides.2.928964.html  (accessed February 07, 2009). 

3.  Hornby, Lucy.  January 22, 2009.  China sentences two to death over tainted milk. Reuters, http://www.reuters.com/article/worldNews/idUSTRE50L0ZG20090122 (accessed January 22, 2009). 

4. Food and Agriculture Organization of the United Nations, Joint FAO/WHO Food Standards Programme. CAC/RCP 1-1969, Rev. 3 (1997), Amended 1999.  Codex alimentarious recommended international code of practice general principles of food hygiene, "hazard analysis and critical control point (HACCP) system and guidelines for its application" http://jckspaqj.aqsiq.gov.cn/dwyxspjyjy/gwxgbz/200610/P020061027684134152467.pdf  (accessed February 07, 2009). 

5.  National Center for Food Safety and Technology.  Science Platforms - food processing http://www.ncfst.iit.edu/platforms/food_processing.html  (accessed March 19, 2009).

6.  Lumpkin, Murray M., Department of Health and Human Services. February 11, 2009.  Letter to international colleagues on salmonella outbreak.  http://www.fda.gov/oc/opacom/hottopics/salmonellatyph/lumpkin_letter021109.html  (Accessed February 28, 2009). 

7.  Fredrix, Emily.  March 11, 2009.   Salmonella recall could cost peanut producers $1B.  Associated Press, http://news.yahoo.com/s/ap/20090311/ap_on_bi_ge/salmonella_impact/print (Accessed March 11, 2009). 

8.  Dreyfus, Henry. 1955.  Designing for people.  New York: Allworth Communications, Inc. http://www.goodreads.com/author/show/743875.Henry_Dreyfuss  (Accessed March 20, 2009). 

This article discusses issues of general interest and does not give any specific legal, medical, or business advice pertaining to any specific circumstances.  Before acting upon any of its information, you should obtain appropriate advice from a lawyer or other qualified professional.

This article may not be duplicated, altered, distributed, saved, incorporated into another document or website, or otherwise modified without the permission of the author, who will be contacted by TASA.