11/30/2010--Passed Senate amended. (This summary will be expanded.) FDA Food Safety Modernization Act -
Title I - Improving Capacity to Prevent Food Safety Problems
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) … see full wiki
Everyone is for food safety. Who could be opposed? Yet for all the efforts, I think the government is going about things entirely the wrong way.
The first thing that folks need to understand is how outbreaks occur and how they spread. Food outbreaks are of two types: those involving germs that are in the deep food tissues at time of harvest (some salmonella in eggs, some parasites in various meats, TB in raw milk, etc), and those involving germs which contaminate the food during harvest, preparation, packaging, etc. The second includes most E coli, Salmonella, and other bugs. Most outbreaks are of the second type in part because risky foods (like pork) are typically cooked longer. The first type usually causes a few isolated cases, and not a widespread outbreak but of course these cases can be quite serious.
Contamination can occur at time of harvest, and for some vegetables even before harvest. They can also occur in packing plants, supermarkets, manufacturing plants, and the like. If a bug like salmonella or E coli gets into peanut butter, then this has to happen during the manufacturing phase. In contrast, tomatoes can be contaminated at any phase. Thus one has to see the dangers of cross-contamination as the primary vectors to control in terms of food safety.
Economy of scale works directly against controlling cross-contamination. Larger factories and warehouses provide greater opportunities for contamination, and they allow the contamination to reach a larger group of people. Conversely smaller factories and warehouses provide fewer opportunities for contamination, and the outbreaks will be more limited. This means that at a given level of care to control cross contamination, small businesses provide far greater safety than large businesses. Basically, the larger the business, the more frequent and widespread the outbreaks that would arise from it, given a constant level of safety precautions. This also means that anything that unduly burdens small businesses and favors larger businesses will undermine rather than improve food safety, as does anything that favors a substantial economy of scale. Many food safety advocates aren't very aware of this dynamic, however. They fear (unreasonably) that smaller businesses being exempt from full requirements will leave consumers vulnerable, when the best safety is obtained by increasing the standards steeply as scale increases.
(My quick back-of-the-envelope calculations suggest that where only a small portion of food is contaminated, the number of finished, contaminated products will approach proportionality to the square of the volume, so if you double the volume, you will nearly quadruple the contaminated products output.)
Now, with the Tester Amendment, the Food Safety Act at first looks like it conforms to this basic rule, and in some ways it does. However, the fact is that the standards of safety do not actually increase with scale in the act. This means that small businesses must still maintain the same documentation etc. that large businesses must, but that the FDA just doesn't have jurisdiction on them until there is an outbreak. So what is saved on bureaucracy and paperwork up front is still a sword hanging overhead.
Many people reasonably fear that this will drive many smaller businesses out of business. A much better approach would be to create a multi-tiered system with different requirements at different levels, and where the substantive requirements increase drastically as scale increases. For the small business, local regulations should be sufficient (a small, local meat shop really should be no more heavily regulated than a small, local restaurant). For large businesses, frequent inspections, frequent reviews of risk analysis, etc. should be required. Large businesses should be required to stay on the leading edge in terms of food safety procedures. Medium-sized businesses might be somewhere in between, and the goal should be to encourage smaller businesses to prosper and larger businesses to be careful about the unique risks they bring to the situation.
Before the Tester Amendment, this bill was looking extremely bad. Now it's just looking sorta bad.