nullum crimea, nulla poena sine praevia lege poenali
"no crime, no punishment without a previous penal law"
The translation of this legal precept is that one cannot be penalized for doing something that is not prohibited by law. This precept is also the one that prevents penal law from being enacted and/or applied retroactively. This sentiment may also be expressed in a positive and more naturally understandable way by simply saying that the law allows what it does not expressly forbid. That is a very good thing, because without this concept there could be no progress in potentially regulated arenas like pasteurization. However, there has been considerable technical progress in this area of late.
There seems little doubt that food manufacturers are obliged to obey the laws concerning the safety of the product they produce. It is also clear that the Food Safety Modernization Act (FSMA) delegates rule-making authority to FDA. Does that mean that every FDA rule or recommendation carries with it the force of law? Yes, except that there are rules about making rules (Executive Order 12866). The "Force of Law" referred to must successfully telegraph through all the rules so as to link current Agency enforcement activities to specific enabling legislation.
Every food manufacturer wants to make a safe and nutritious food product. They also want a product having an exceptional taste (a marketing advantage) and as long a shelf life as possible (an advantage in distribution efficiency). Conventional pasteurization offers a five-log reduction in microbial load and so would seem to fill the need of making a safe food and also of one having a long shelf life. In the case of milk, however, pasteurization is said to significantly destroy both the taste of the natural (raw) product and significantly reduce its nutritional quality. Some consumers feel strongly enough on this point that they will purchase raw milk, ingest it themselves and feed it to their children despite the clear risk of infection that comes from doing so. The legal point at issue is how the definition of pasteurization as a five-log reduction in microbial load may be accepted. The assumption usually made in food manufacturing plants is that the product must be exposed to some variant of high temperature short time (HTST) pasteurization. Following this assumption often leads to packaging issues, degradation of flavor and dramatically increased costs since the bottling of the pasteurized product must now be done aseptically.
Furthermore, each food is different. HTST pasteurization is not going to give you pasteurized cantaloupe, lettuce, celery or bean sprouts. It will only give you safe but unpalatable and therefore unsaleable (i.e., useless) vega-mush.
On the other hand, packaging a food before subjecting it to a sequence of custom-designed pasteurization schema may well provide you with a saleable product that has been exposed to a TOTAL of a five-log (or greater) microbial load reduction. Neither the law nor FDA specifically state that the 5-log microbial load reduction which defines a "pasteurized" product must be reached in one step. A product that may be shown to have undergone, say, three sequential thousand-fold reductions of microbial load (i.e., 6-log reduction) should be legitimately labeled as pasteurized. It may even be possible to, in this way, produce milk that may be labeled (and sold) as pasteurized and yet have both the flavor and the nutritional content of raw milk.
To gain such a competitive advantage, a company doing this must quantify and demonstrate the science behind its sequence of steps. It is very likely that the details of the technical process that satisfies the definition of "pasteurized" in one product will differ from that of another product. The expectation is that optimal pasteurization processes will be product specific.
It also seems likely that the company to first develop a pasteurization sequence for a particular product will be able to either patent the process (for an strictly limited time) or preserve it as a trade secret (for a potentially unlimited period of time). Either way leads to a very significant and long-term competitive advantage for the company involved as well as the positive public relations that comes from such a clear and public commitment to public safety.
An unambiguous example of this is a World Intellectual Property Organization patent [J. Cox et al., "The Hyperpasteurization of Food, PCT/US92/06822 WO93/03622]. This patent claims to describe a method whereby eggs and even whole chickens may be rendered safe from Salmonella enteritidis and other pathogens commonly found in such foods, without cooking either the eggs or the chickens. Despite its aggressively optimistic title, however, some of the evidence presented in support of this process shows that certain applications of this process are able to effect only as low as a 3.62 log reduction in pathogen numbers. It would seem, therefore, that this patent's title may be a misnomer. Not only does this process not really "hyperpasteurize" foods, it does not seem to even meet the definition of what the FDA chooses to define as pasteurization (a 5 log reduction in microbial load). Nevertheless, this lengthy (114 pages, 74 claims) document makes for an interesting read as it points to a direction some of the newer pasteurization technologies may already be going. Also noteworthy is the fact that the international filing date of this patent was 19 August 1992 and its publication date was 4 March 1993. These dates imply that the teachings disclosed by this patent, if not already in the public domain, may soon become so.
Lastly, in addition to making food safer, the prolongation of shelf life from such pasteurization efforts will greatly simplify the distribution to existing customers and also permit expansion of a company's market to areas of the country not previously serviced and even allow exports overseas and especially to the EU where concerns about food safety seem to be taken more seriously than they are in the United States.
Copyright © 2012 by M. Mychajlonka, Ph. D.