The agency has responded to comments from ANH-USA activists and other stakeholders. Here’s what they’re proposing now. Action Alert!
In May we reported that the FDA is currently drafting rules that implement the 2011 Food Safety Modernization Act (FSMA). As we noted then, some of the rules that have been proposed so far have brought a deafening outcry from small farmers, prominent members of Congress, consumers, and even big business. This response presumably caused the FDA to backtrack considerably, and the agency addressed many of the concerns you raised. On September 19, the FDA released several revised rules. The public has an additional seventy-five days to comment.
Soil: The FDA initially said farmers had to wait nine months to harvest whenever they apply biological soil enhancements (e.g., manure, agricultural tea, and yard refuse rather than synthetic chemicals). This runs contrary to organic regulations, and puts many organic fields out of production for an entire growing season. We reported about this last February when Jim Crawford, a celebrated organic farmer in Maryland, was warned of the huge fines that awaited him if he continued applying manure as he had for decades (and as organic regulations require).
Facing a backlash of “strong concerns expressed by stakeholders,” FDA decided to defer its decision on an appropriate interval between manure application and harvest, pending further study. While we’ve bought time and further study, will have to keep an eye on FDA for what they ultimately decide. The agency noted, however, that they will work with the USDA to encourage (read: pressure) growers to use compost instead of raw manure.
Water: The FDA’s water quality standards mandated that farmers test and chemically treat their irrigation water on a weekly basis. If the water exceeds the FDA’s standards for generic E. coli, farmers would either have to cease to use it or chemically treat it. In the revised rule, the FDA is now providing more options for water sources that don’t immediately meet quality standards, including allowing enough days either from the last irrigation to the harvest or from the harvest to the end of storage to allow pathogens to die off naturally, as well as a tiered approach to water testing, in which the frequency of testing would depend on the level of risk from the water source and on the results of prior tests. These changes make it even more complicated for small or family farmers, and even with them some farmers will have to chemically to treat their water.
In May we discussed how for centuries, small breweries and bakeries have been giving their spent grains—free of charge—to local farmers, who then feed it to their cattle. Under FSMA, the FDA placed spent grain under the same regulations as pet food. We were concerned that brewers would be forced to spend thousands of dollars a year on grain disposal (which will still be cheaper than implementing the FDA’s “safety” regulations), while farmers would be forced to pay an additional $300 to $400 per day for feed.
Under the revised rule, food manufacturers like brewers or bakers will not be subject to additional controls under the animal feed rule except for upholding current Good Manufacturing Practices to prevent physical or chemical contamination. As we said a few months ago, it is apparent that cGMPs like these are already being followed, since there hasn’t been a single reported case of an animal or human being harmed by spent grain.
We were also concerned that the FDA, using vague criteria in the food safety regulations, could revoke the exemptions that some small farms enjoy. The legislation, clearly influenced by big company lobbyists, provided that small farmers have only sixty days to come into compliance, whereas regular facilities have anywhere from one to six years. In the revised rule, the FDA has agreed to provide greater specificity on the conditions that could result in a revoked exemption. Farmers would have an extended compliance period—120 days instead of sixty—so while it’s a little better, it’s still a far cry from one to six years!
The food safety legislation for the first time gave the FDA authority over farming. We warned at the time that the agency knew nothing about farming. In addition it would be, as usual, influenced by major corporations, not by organic or small family farmers.
The agency’s evident bias against manure and natural water sources makes it clear how little it knows about farming. How could it know about farming, a complicated subject that requires years of hands on experience to master? How can drug or food analysts in Washington know what makes sense for actual on-the-ground farmers? Even the US Department of Agriculture, which has had decades to develop agricultural expertise, has never been given the power over farmers that Congress just gave the FDA.
We all know what FDA control of drugs has done to drug prices, quite apart to the damage to natural health methods. Imagine what food prices we may eventually see if we keep going this way, again quite apart from the damage to organic agriculture.
We should note that these new rule revisions were just released. They are dense and complicated (each of the four new rules has hundreds of pages of technical, regulatory language), and we are continuing to study them carefully. We will, of course, alert you if we find anything else here that is cause for concern!
Action Alert! Please send your comments to the FDA about the agency’s newly revised rules. Explain how their revisions are heading in the right direction, but don’t go nearly far enough.