The Tester-Hagan Amendment was supposed to be the savior of S510, giving smaller producers an exemption from the worst requirements of the so-called food safety legislation. Now, it turns out, the amendment may be the great black hole of the entire food safety steamroller.
While the lawyers are trying to figure out ways to finagle around the U.S. Senate’s error in venturing into the U.S. House’s territory by initiating revenue-generating legislation, another hole has opened in the crumbling dike that is S510. (Even The Wall Street Journal, normally a supporter of the FDA, has come out against it, stealing some of my lines, it seems.)
On close reading, the Tester-Hagan Amendment looks to be doing a lot of the things that the discredited National Animal Identification System (NAIS) tried to do and failed when it was pulled by the U.S. Department of Agriculture in the face of vehement farmer opposition last year. In other words, Tester-Hagan might well be seen as a wolf in sheep’s clothing, as it were.
As Blair sees it, the big problem with the amendment is that it doesn’t exempt small producers as easily, or completely, as suggested in the media reports. The small producers need to make the case to the U.S. Food and Drug Administration that they qualify. One path to qualify would be for a food producer to show it has “identified potential hazards associated with the food being produced” and is “implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective.” These are similar to what larger food producers must do.
Now, I’d go further and say that those are just the beginning of the problems. For years, the USDA tried to implement NAIS to force farmers to register their farms and each and every animal–known as the National Animal Identification System.
Well, Tester-Hagan may wind up accomplishing the NAIS goals. I had assumed, in offering advice to farmers in my previous post, that to qualify for the Tester-Hagan protections, a small food producer would simply stay away from FDA offices, or tell an inspector they didn’t qualify. Presumably, if the FDA felt differently from information it might have, it could audit a small producer to make sure it qualified. Absolutely not so. Under Tester-Hagan, small producers that don’t have documentation that they have “identified hazards” and are “monitoring preventive controls,” (presumably equivalent to a HACCP plan, which very few small producers have) need to produce for the FDA “documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight)…”
That’s not all. They will be required to show additional as yet unspecified “documentation” specified in a “guidance document” to be produced by the FDA within a year of passage of S510.
You don’t have to have a very fertile imagination to conjure up what might be in that “guidance document.” How many cows, chickens, pigs, and goats do you have? How is your land being apportioned to different crops, by exact acreage or square footage?
Still skeptical about where I’m going? Then consider this requirement under the Tester-Hagen Amendment: That within 18 months of implementation of the new law, the FDA and U.S. Department of Agriculture “shall conduct a study of the food processing sector regulated by the Secretary to determine—(i) the distribution of food production by type and size of operation, including monetary value of food sold; (ii) the proportion of food produced by each type and size of operation; (iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; (iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and (v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.”
As I read this, the FDA and USDA will need to send out an army of inspectors to each food production facility and farm that qualifies as a food production facility (once you package food, you’re generally considered to be in the food production business) in the country and conduct a detailed analysis of the business of each. Not to mention a detailed assessment of the “incidence of foodborne illness” and “the effect of foodborne illness”–whatever that means.
And this is all on top of the requirement that all farms, including those that might be exempted under Tester-Hagan, need to conform with “Good Agricultural Practices”. This is the program originated by the United Nations that involves the government in farm operations.
Tester-Hagan isn’t just bad news. It’s awful news. If it passes, I suspect Violet Willis is going to have a lot of company for any march on Washington she helps organize.