quod gratis asseritur, gratis negatur
"What is asserted without reason, may be denied without reason."
If the Food Safety Modernization Act (FSMA) can be boiled down to just one phrase, this one would be a good bet. Food manufacturers must now be able to show that they have a good reason for everything they do. The place where all these good reasons are to be kept are the HACCP plans on file, designed by the manufacturer and arranged by product. These plans comprise a manufacturer's food safety strategy. The strategies behind such plans must be periodically reviewed. Depending upon the outcome of such reviews, they must be adjusted as needed. Of course, HACCP also applies to foods regulated by USDA. After all, the HACCP concept's first widespread adoption occurred in response to an outbreak of hemolytic uremic syndrome (HUS) epidemiologically traced back to the presence of Escherichia coli O157:H7 in hamburgers sold in Jack in the Box restaurants. This outbreak ultimately involved 73 locations of this restaurant chain. Before the outbreak was over, over 700 people in four different states had gotten sick, 161 people had been hospitalized and 4 had died. The restaurant chain itself came close to being driven out of business, saved by its new and much improved HACCP plan.
No longer can a manufacturer merely trust the certificate of analysis presented by her supplier before accepting an ingredient. Instead, the manufacturer must herself validate the certificates of analysis and show that there exist good reasons why she is accepting them. No longer can a manufacturer "prove" the safety of a product by simply testing a handful of product packages out of the thousands or tens of thousands produced in a given production lot and, finding no untoward results, declare the entire lot as "safe." Now the statistical sequelae of sampling error must be taken into account.
A HACCP plan, once written and accepted, cannot just be kept in force from one year to the next without documenting that this particularly strategy has successfully achieved its purpose. No HACCP plan may be kept around without a documented reason for doing so.
Many food manufacturers, faced with with what they perceive of as a whole host of new requirements, wring their hands over all the new costs they will have to bear to satisfy FSMA. They may not see the entire picture. Under FSMA the HACCP plan becomes the guarantor of food safety. There is therefore no longer any need to withhold shipping out a lot of product until all the testing results for a particular lot are completed, the results received and a "release this lot to shipping" order sent. The testing that is done may now be done more efficiently, grouping like tests across many lots in order to achieve costing economies from the laboratories involved, whether in-house or independent. Trusting food safety to HACCP rather than attempting (usually unsuccessfully) to demonstrate food safety by testing each lot may actually save money in the long run.
Nevertheless, FSMA's emphasis on HACCP is likely to complicate the internal workings of any food manufacturer who seeks to develop and maintain HACCP plans in-house. The person designated with this task may, of course, be seen, by her fellow employees, as a kind of "pesky philosopher" at odds with the needs of her more production-oriented colleagues and interfering with the profit goals, bottom line and overall business plan of the company. An outside consultant would have a much easier time with this uncomfortable role than any salaried employee if only because a consultant need only analyze conclusions and/or recommend courses of action. An outsider, free from the constraints of past traditions and charged only with the presentation of facts and development of strategy will have an easier time with the task at hand. Having no history with and/or standing within the company, she can concentrate on assembling and facing any uncomfortable facts that may be lurking about and then laying out a series of alternative strategies without the attendant concerns of politics or personalities. In the same vein, unlike the situation with employees, a company is free to "test-drive" any number of consultants on a troublesome task just to compare their performance and then choose the best solution from among those proposed by several minds.
A government regulation is not necessarily carved in stone. It may, indeed, be something of a moving target. In all this talk of HACCP, one must stay nimble, consider jurisdictional differences and be aware of how regulatory interpretations may evolve over time. Take, for example, a recent noteworthy change promulgated in the way USDA's Food Safety and Inspection Service (FSIS) now plans to issue its inspection determinations. This change has been described on page 19952 of the Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices. Heretofore, FSIS has allowed meat products to bear the mark of inspection and to enter commerce even though all test results had not yet been received. This new ruling [Docket No. FSIS-2005-0044] specifies that the determination that a given product is not adulterated and thus is ready to enter commerce will not be given unless and until all pending test results for that lot of product have been received and found satisfactory.
Granted, this ruling seems quite reasonable even though it will require a good deal of freezer storage of product pending the results of testing and is certain to delay sale of a product. Nevertheless, it is interesting because it may be taken as a indication that regulators in at least some jurisdictions (i.e., USDA, not FDA) are not entirely comfortable with HACCP since they clearly want each product lot tested. This position should be closely evaluated since, historically, careful and thorough implementation of HACCP proved to be the path whereby the Jack in the Box episode of contaminated meat making customers ill was finally put to rest. There are those who argue that a timely and effective HACCP plan is the very reason why that restaurant chain was able to weather the crisis at all and stay in business.
Copyright © 2012 by M. Mychajlonka, Ph. D.