I’ve written several postings about the dilemma facing Indiana farmer David Hochstetler and the Family Foods Cooperative (FFC) over the federal Food and Drug Administration’s recent warning letter, ordering Hochstetler to discontinue sending raw milk to Michigan and Illinois. The legalities behind that warning letter are both complex and subtle. The Weston A. Price Foundation in a recent email alert explained those issues as well as I’ve seen them explained.
Because of the inconsistency in the FDA’s approach, and the special circumstances surrounding this case, it could become "a litmus test" of federal regulations, the foundation warns. It also points out that going to court to overturn the current FDA regulation could be very costly and time consuming…and while the foundation doesn’t say so, there is no guarantee of success.
If you want to understand the legalities behind the federal government’s fear campaign against consumption of raw milk, I suggest you review this:
The United States Food and Drug Administration has recently sent a "Warning Letter" to Indiana farmer, David Hochstetler of Forest Grove Dairy, informing him that the agency has determined David distributed unpasteurized milk and cream for human consumption in interstate commerce, violating the regulation codified in Title 21 Code of Federal Regulations, section 1240.61(a) [21 CFR 1240.61]. The letter notified David that he has 15 working days to issue a written response to FDA outlining the steps he has taken to correct the violations and prevent their recurrence.
21 CFR 1240.61 reads, in part: "(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized . . . ."
David has entered into herd lease agreements with consumer cooperatives in Michigan and Illinois under the terms of which he provides raw dairy to the cooperatives’ members (Richard Hebron, manager of the Family Farms Cooperative, is currently under investigation by the Prosecutor’s office in Cass County Michigan for the business he has conducted with Forest Grove Dairy). David has indicated that he will contest FDA’s finding of a violation on the grounds that the lease agreements are private contracts not subject to the agency’s jurisdiction.
The FDA issued 21 CFR 1240.61 in 1987 in response to a federal judge’s order that the agency ban the sale of raw milk for human consumption in interstate commerce. The agency expanded the scope of the regulation far beyond what the judge ordered. FDA contends that any raw milk product for human consumption (except cheese aged at least 60 days) crossing state lines constitutes a violation, not just when there is an actual sale involved.
During the 20-year existence of the regulation, the agency has never enforced it beyond sending warning letters to suspected violators. With David set to challenge the agency’s finding of violations, his case could be a litmus test of the validity of the regulation. Much is at stake.
Many consumers are currently able to obtain raw dairy products from out-of-state sources only. FDA enforcement action against David Hochstetler could make suppliers of raw dairy products more reluctant to ship interstate, effectively denying many the freedom to consume foods of their choice. Conversely, an FDA decision not to enforce the regulation against David would make producers more willing to ship raw dairy products interstate and would increase their chances of being able to opt out of the dairy cooperative system and the poverty-level prices paid its members.
21 CFR 1240.61 is an oppressive regulation making no distinction between milk from confinement cows and milk from cows on pasture. It particularly penalizes farmers like David Hochstetler who have an exemplary track record for producing clean, safe milk. For many years David held a Grade A license from the state of Indiana; during that time, tests for bacteria in the milk he produced consistently showed levels well below the limit required for pasteurized milk under the Pasteurized Milk Ordinance (PMO), the governing document for interstate shipments of milk to be sold at retail.
Overturning the regulation in court would be costly and take years to accomplish. A more realistic goal would be to put enough public pressure on FDA so that they don’t enforce the regulation.
The foundation encourages individuals to write the FDA and Sen. Carl Levin of Michigan, to object to the FDA’s warning letter.
Here are addresses:
Joann Givens, Detroit District DirectorFDA, Detroit District Office300 River Place, Suite 5900Detroit, MI 48207Fax: 313-393-8139CAPT Robert Hennes, Chief CFSAN/Milk Safety BranchFood and Drug Administration5100 Paint Branch Parkway College Park, MD 20740Fax: (301) 436-2715Also copy U.S. Senator Carl Levin of Michigan who, on behalf of Family Farms Coop, has made inquiries into the investigation of David Hochstetler (mail to Levin’s Washington office is delayed two weeks for security screening somail to:
Patrick V. McNamara Federal Building477 Michigan Avenue, Suite 1860Detroit, MI 48226-2576Fax: 202-224-1388 (DC office)Go to http://levin.senate.gov to email
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