“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, and to qualify, must show they have “identified potential hazards associated with the food being produced” and are “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-Hager, small producers 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 S 510….”