Dear Mr. Hochstetler:
A joint investigation by the U.S. Food and Drug Administration, the Indiana Board of Animal Health, and the Michigan Department of Agriculture, has documented violations of the Public Health Service Act (PHS Act) and a Federal regulation promulgated under the PHS Act.
Our investigation determined that your firm distributes unpasteurized raw milk and cream in interstate commerce, in finished form for human consumption. Such distribution is a violation of the PHS Act, 42 U.S.C. § 271(a), and the regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a) The regulation prohibits the delivery into interstate commerce of milk and milk products in final package form for direct human consumption unless they have been pasteurized. The milk and cream you produce in Indiana and distribute to Cooperatives in Michigan and Illinois for further distribution to their Co-op members is in final package form for direct human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29,509 (Aug 10, 1987).
The above observation is not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act and implementing regulations. You should take prompt action to correct this deviation and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice.
In addition to the violation above, we have several comments concerning the lack of labeling of your raw milk and cream products. First, we note that your raw milk and cream products do not contain labeling that specifies the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). We also note that your raw milk and cream products do not contain a principal display panel bearing a declaration of the net quantity of contents (21 CFR 101.105). Lastly, we note that your raw milk and cream products fail to have labels that declare their ingredients (21 CFR 101.4).
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to Judith A. Jankowski, Compliance Officer, at the above letterhead address. If you have any questions regarding any issues in this letter,please contact Ms. Jankowski at 313-393-8125.
Last Friday (March 26, 2010), FDA announced the following:
The FDA is collaborating with the Michigan Department of Community Health (MDCH), the Illinois Department of Public Health, the Indiana State Board of Animal Health and the Indiana State Health Department, to investigate the outbreak. MDCH reports that, as of March 24, 2010, it received reports of 12 confirmed cases of illness from Campylobacter infections in consumers who drank raw milk. The raw milk originated from Forest Grove Dairy in Middlebury, Ind.
In addition to the 12 confirmed cases in Michigan, three Indiana residents also have been infected with this Campylobacter strain.
Several readers have commented on my earlier posts regarding the risks inherent in drinking raw milk in general, and the implications of this current Campylobacter outbreak in particular.
One reader said, "Phyllis Entis' suggestions that the cowshare milk wasn't fresh because it traveled through several states is typical of the hyperbole and misstatements of the public health establishment. She ought to look at a map, and see how close northeast IL, northwest IN, and southern MI are to each other."
I ran a Google mapping of the distances between Middlebury, Iowa (where the milk originated), Vandalia, Michigan (the location of the distributor) and Wayne County, Michigan (where some of the Campylobacter cases were reported. From Middlebury to Vandalia is just 29 miles; from Vandalia to Wayne County is an additional 190 miles. From Middlebury to Chicago (where some of the milk was shipped, according to the Illinois Department of Public Health) is 118 miles. That's a long way to go for a glass of milk!
A reader commented, "It is legal for anyone to possess, consume, and cross state lines with the milk. The federal law against interstate shipment only applies to milk that is in commerce, which means it has to be sold or given away. This milk was always owned by the shareholders, and it was never sold or given away."
The last time I checked, boarding an animal in exchange for money is providing a service. Milking somebody's cow for him in exchange for money is providing a service. This is commerce. When the customer is in Michigan and the supplier of the service is in Indiana, this is interstate commerce. And it comes under FDA's jurisdiction.
I have no quarrel with anyone who prefers to consume raw milk. But let's keep the discussion grounded in fact – not flimflam.
If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link. Please include "subscribe eFoodAlert" in the subject line.
The service is animal boarding and is perfectly legal. A lactating cow has to be milked as part of its standard care. The milk that is extracted is the private property of the cow owners, and anyone may legally return it to the owner. Detractors of raw milk may characterize this as "circumventing the law," but there is a clear line that determines whether the federal interstate commerce law has jurisdiction. There has to be a change in ownership of the milk--not just a change in possession.
ReplyDeleteIt is not reasonable to ask raw milk advocates to keep their discussions grounded in facts. Take a look at the sources that websites such as Realmilk.com cite and you will find wikipedia, random blogs, basic biochemistry textbooks. Comical.
ReplyDeleteRegulations on raw milk consumption have to be restrictive. If regulations on the sale of raw milk were relaxed one would see the quality of production plummet and the frequency of outbreaks increase. Thankfully demand is relatively low and farmers can focus on producing a higher quality product, limiting the risk. But as we see time and time again outbreaks still occur, and they are frequent and unnecessary.
I am directly affected by what is happening with this milk, so let me tell you what is really happening. There were reports of the outbreak, and FFC has gone above and beyond what my expectations were. They have kept everyone in the loop since the very beginning, and continue to update us as time goes on (sending an email today even). They have tested and re-tested their milk, as well as other things on the farm, and it all comes back free from the bacteria. The Michigan Department of Food Safety (I think that was the name) also stated that there was no infection. As more tests keep showing... THERE IS NO PROBLEM FROM THE RAW MILK.
ReplyDeleteThe FDA has a history of shutting down small raw dairies, blaming them for infections from their products when there was no link to begin with. If you don't believe me then do your own extensive research and you should start to see what I am talking about. The information is out there, it is up to you to find it. I hope the same doesn't end up happening with this, but my guess is that it won't.
As far as people and their raw milk beliefs, if you don't believe that it can be safe then I really feel sorry for you. That is all I am going to say because I don't want to make anyone feel threatened by what I want to say on the matter. Some of us know the truth and we have made changes in our life based on those truths. Are we better than you are? Not really. Do we take personal responsibility for our lives more than you do? Maybe so.