by Harry Hamil, Guest Blogger, Black Mountain Farmers Market
The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.
– 10th Amendment to the U.S. Constitution
Right now, the United States has a three tiered approach to food safety–local, state and national. However, slowly but surely, the FDA is expanding its power. More and more, states are being told what to do by the FDA and given financial incentives for carrying out its directives.
The FDA Food Safety Modernization Act (S 510) further nationalizes food safety regulation.
Currently, regulation of raw milk clearly respects a diversity of state policies. That will surely change if S 510 passes.
The FDA permits only Grade A milk (i.e, pasteurized milk) to be shipped interstate; whereas, regulation of raw milk (i.e., Grade B) is left up to the individual states and that regulation varies widely. Only available for pet use in NC, raw milk is available through regulated and state inspected dairies in SC. The FDA and some states are pushing hard to abolish raw milk sales. As a result, Farm-to-Consumer Legal Defense Fund and a group of individual plaintiffs are currently suing Kathleen Sebelius, Secretary of HHS over the extent of the FDA’s authority in this area. For more info, see: FDA Interstate Raw Milk Shipment Ban.
In the meantime, along came Sec. 103 Hazard Analysis and Risk-based Preventive Controls (HARPC) in the proposed FDA Food Safety Modernization Act (S 510). If S 510 passes, it will require these HARPC plans of all “food facilities” not exempted by the Tester-Hagan amendment. Grade B dairies, which include raw milk and most cheesemakers, are food facilities so they will have to develop and implement HARPC plans in addition to fulfilling the existing requirements of their home state.
Here is how the FDA can easily use the new HARPC plan requirement to wipe out fresh raw milk and raw milk cheese:
1. Section 415 of the Federal Food, Drug and Cosmetic Act (21USC350d) requires all dairies, whether in interstate commerce or not, to register as a “food facility” (21CFR1.225). This registration is a requirement of the National Preparedness for Bioterrorism and Other Public Health Emergencies (aka 2002 Bioterrorism Act).
2. The current version of Sec. 103 of the FDA Food Safety Modernization Act (S 510) requires all such registered food facilities to have Hazard Analysis & Risk-based Preventive Control (HARPC) plans. HARPC plans are a legislated version of the Hazard Analysis Critical Control Point (HACCP) plans which grew out of the space program.
3. Thus, all dairies would be required to have a HARPC plan(s) in addition to meeting its existing Grade A or Grade B requirements. Pascal Destandau of Pug’s Leap Farm near Healdsburg, CA realized this would make the current requirements of the Pasteurized Milk Ordinance (PMO) and Grade B regulations redundant and, almost certainly, lead to their elimination. This would mean that all dairy regulation would follow the pattern of meat and be via HARPC plans.
4. Appendix K of the current Pasteurized Milk Ordinance (PMO) offers a voluntary National Conference on Interstate Milk Shipments (NCIMS) HACCP Program alternative to the traditional inspection system. This option started in 2002 PMO based upon a pilot program begun by NCIMS in 1999. As a result, it seems clear that it will be the model for the new HARPC plan requirement.
5. All dairies would be required to have a separate HARPC plan approved by the FDA for each individual process before the dairy can sell products created via that process.
6. Just as it with yogurt and cheese, the FDA would be able to view raw milk production as a distinct process.
7. The hazard analysis for raw or pasteurized milk processing would be the same.
8. Thus, the FDA could simply turn down the raw milk portion of the HARPC plan because it doesn’t “identify and implement preventive controls, including at critical control points, if any, to provide assurances that [the] hazards identified in the hazard analysis conducted under subsection (b) will be significantly minimized or prevented.” [See new Section 418(c) Preventive Controls]
9. As shown by the Federal Court ruling in Montana Quality Meats’ lawsuit against the FSIS under similar circumstances, the FDA would be able to turn down a dairy’s proposed HARPC plans without any limitation on the number of times it did so, thereby, denying the dairy recourse to the courts. This is because there will be no way for the dairy to exhaust its administrative remedies.
What You Can Do to Protect Raw Milk Producers
If you favor raw milk or just the freedom of people to obtain raw milk from state regulated dairies, I urge you to call both of your Senators today, every Republican Senator and both Independent Senators (Lieberman of CT and Sanders of VT) and tell them the following:
1. Your name and whether or not you are a constituent. If you are not a constituent, please say where you live.
2. You are a local, healthy food supporter who is concerned about S 510.
3. If you are a North Carolinian calling Hagan or Burr, please thank them for their work and add, “…and I must ask her/him to do more.”
4. You ask the Senator to vote:
“No” on cloture,
“Yes” on the Coburn substitute,
“Yes” on the Managers’ substitute bill, if Coburn fails
“No” on the overall bill.
If you get a busy signal, please call a local office. If you get a voice mail, leave a message covering all of the points quickly.
Please call now or as soon as you can even if it is during the holiday or weekend. I have attached detailed contact info for NC & SC and Washington Office info on the rest.
I recognize that my suggestions are involved and the votes may be a bit confusing. I’ll be happy to answer any questions anyone has about this.
The FDA Food Safety Modernization Act (S 510) is a fundamentally flawed approach to food safety. The Tester-Hagan amendment helps, but nothing can fix S 510 because it is wrongheaded. For more info and talking points, write to firstname.lastname@example.org.
S 510 will have a cataclysmic effect on all of agriculture not just local, healthy food. Please help defeat S 510. Doing so is a gift to our children and grandchildren.
Harry Hamil (with his wife Elaine) is the owner of Black Mountain Farmers Market, a year round store for local food in Black Mountain, North Carolina. They coordinated the local Black Mountain Saturday morning tailgate farmers’ market from 1995 through 2009, and decided in 2003 to create a store as a sort-of full time tailgate market. He is so concerned about the pending Food Safety Modernization Act, he has worked full time for 16 months to sound the alarm about the real impact of S510.