The new Food Safety Modernization Act (FSMA) dramatically changes how food manufacturers must deal with the ingredients that go into their products. Heretofore, they could simply rely upon a vendor's invoice to identify any particular ingredient. They could also reply upon their vendor's certificate of analysis to document the quality status of the ingredients they use. FSMA now requires that food manufacturers validate their ingredient vendor's performance regarding both the identity of the ingredients being provided and their quality. Of course, such validations will require testing efforts (and attendant expenses) for the manufacturer. How much (if any) of a chargeback ingredient vendors will be willing to extend to their customers may be the subject of considerable negotiation. The law does not seem to prohibit vendors and their customers from working together in order to save on possibly redundant analyses. On the other hand, potential conflict of interest issues seem real enough that any such negotiation might well best be attempted by a third (and disinterested) party, such as Food Safety Analysis, LLC.
Furthermore, while identity testing for simple ingredients may well be straightforward, such identity testing for complex ingredients (as most natural products are) may pose a considerable technical challenge. Analytic techniques such as gas liquid chromatography (GLC) and high performance liquid chromatography (HPLC) both rely upon a large variety of rather expensive columns. Any laboratory is going to think twice before introducing a complex ingredient onto a column that may be destroyed thereby. A complex ingredient that is extracted before being loaded onto an analytic column, may save the column, but may also be of little value since now only a subset of a complex ingredient's components can possibly be tested. Those components eliminated by the extraction procedure can therefore no longer contribute to the results. It is, of course, possible to run different, complimentary extraction procedures so that a larger subset of all possible components of an ingredient are there to contribute to an identity determination. However, doing so will obviously greatly increase the cost of an analysis and exposes additional columns to risk. Merely throwing money at regulatory compliance is never a good idea. Better to tailor an analysis that is both affordable and effective, even if that means employing more analytic creativity (i.e., HPTLC, FTIR, Raman, CD, ORD, etc.) than has been necessary in the past, even if these methods seem esoteric and not commonly employed in the general food industry.
Microbial quality is another matter as well. Of course, using ingredients having a low overall microbial load and which are also free of pathogens would be the preference of any manufacturer. However, cost always matters in manufacturing. FDA has long allowed manufacturers to irradiate their ingredients (up to a certain dosage limit) to control the microbial load introduced from the ingredient into the final product. What is often not appreciated is that such irradiation of ingredients does not impose a labeling requirement upon the final product using those irradiated ingredients, assuming certain regulatory requirements are met. Use of such a radiation-mediated intervention may bring down both the cost of production and lessen, down the road, subsequent costs of testing of intermediate and/or final product. If such a strategy is adopted, then it becomes a Critical Control Point (CCP) and should become part of the HACCP plan.
It is important for food manufacturers to realize that the FDA has publicly expressed its lack of faith in product testing because it feels that, in order to be a valid indication of product quality, such a large number of product samples would have to be tested as to make product testing economically untenable. What testing needs to establish is that all potential hazards have been identified and that the critical control points used in the manufacture of this product are sufficient to eliminate the hazards found to exist. HACCP, however, is not the answer to everything. Difficulties arise, for example, in the application of HACCP principles to situations where HACCP really does not apply, such as food products that are delivered raw to market. One can take precautions, of course, but when did any precaution become a critical control point? How can one pasteurize a steak or a stalk of celery or a fresh tomato, especially when research has shown that vegetative cells of pathogenic Salmonella spp. applied only to the leaf of a tomato vine are nevertheless able to turn up in the fruit? If irradiation is out of the question because of consumer acceptance issues, then answers to these questions must be found, otherwise we will be left with wondering about such matters as why California cantaloupe appear to be "safer" than Colorado grown cantaloupe.
Likewise, any sanitation efforts made need to have their efficacy tested, since sanitary effectiveness is certainly a critical control point that should also be in the HACCP plan. A common way to get this done these days is to swab a standard sized sanitized area and then measure the adenosine triphosphate (ATP) content of the swabbed area. There should be none. Presence of ATP is an indication that live bacteria were present in the swabbed area. This is a perfectly good method even if it is somewhat expensive. There are recognized alternatives to ATP surface sampling, however, that any food manufacturer should explore, even if only to limit the expensive technique to where it is actually required.
Copyright © 2012 by M. Mychajlonka, Ph. D.