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Even though the United States Food and Drug Administration (FDA) hasn’t carried out or threatened an enforcement action against raw milk producers for several years, FDA remains the most anti-raw milk government agency in the country. In 2010 Congress, greatly expanded FDA’s power with the passage of the FDA Food Safety Modernization Act (FSMA).
FSMA authorizes FDA to issue regulations to implement its provisions; the agency is currently conducting rule-making in several areas which could make life more difficult for raw milk producers.
Of particular concern are the following:
Intentional Adulteration of Food
Under “Intentional Adulteration of Food”, FSMA authorizes FDA to coordinate with the Department of Homeland Security to “promulgate regulations to protect against the intentional adulteration of food.” Congress and FDA have determined that activities occurring on farms producing milk pose a high risk for intentional adulteration caused by acts of terrorism.
FDA has not yet indicated whether farms producing raw milk for human consumption will be subject to this regulation but, if they are, FDA could require them to have a written food defense plan outlining ways the farm can reduce the possibility of a terrorist attack and what steps it will take to do so. The National Milk Producers Federation is lobbying FDA to have those producing raw milk for direct consumption be subject to the regulation. FDA also has the power to seek criminal penalties for non-compliance with the regulation.
Hazard Analysis and Risk-Based Preventative Controls (HARPC)
FDA has proposed rules requiring producers to develop food safety plans addressing “Hazard Analysis and Risk-Based Preventative Controls” (HARPC). HARPC is similar to HACCP [Hazard Analysis Critical Control Points] food safety plans–a requirement that is good in theory but shuts down scores of food business when interpreted by an arbitrary regulator. Any raw milk dairy whose sales of all foods direct to consumers account for over half its revenue will be exempt from the HARPC requirement as will most raw milk producers with annual sales of less than $500,000.
FDA, however, is proposing to give itself broad power to revoke the exemption which was originally provided under the Tester-Hagen Amendment. Once the producer receives notification that the exemption has been revoked, the producer has only 120 days to comply with HARPC requirements; by contrast, those businesses not under the exemption are allowed a much longer period to comply once the rule takes effect. “Very small businesses” (i.e., less than $1 million in annual sales) as defined by the proposed HARPC regulations have three years to comply; “small businesses” (i.e., less than 500 employees) have two years to comply and all other businesses would have one year. It’s easy to see where the 120-day requirement would discourage potential start-ups from getting into the food business at all. Again, FDA has the power to seek criminal penalties for non-compliance with this regulation.
Current Good Manufacturing Practice (CGMP)
The federal regulations on Current Good Manufacturing Practice (CGMP) establish standards for, among other things, plant construction and design, sanitary facilities, equipment, warehousing and distribution. CGMP has long been a part of the Code of Federal Regulations but FDA has made the CGMPs, with just minor changes, a part of the proposed regulation on HARPC. The significance of this could be that it indicates FDA’s intent to start enforcing the CGMP requirements on a more regular basis. CGMP which contains broad requirements, like HACCP, can be subject to any number of interpretations by an inspector.
FDA is claiming that the CGMP regulations like HARPC and the rules on intentional adulteration apply even to those engaging only in intrastate commerce; unlike HARPC, there is no exemption from CGMP for anyone producing raw milk for human consumption. CGMP was not a part of FSMA but FDA is adding it to the package of FSMA regulations that threaten to bury raw milk dairies and other small-scale food producers in paperwork.
Through FSMA and its implementing regulations, FDA can place itself in a position to reduce access to raw milk. If the market share for locally produced food is to grow to its potential, Congress needs to cut back the agency’s power.
A shorter version of this article was originally submitted for the November 2014 edition of Graze Magazine. Those interested in learning more about Graze may go to www.grazeonline.com or call 608-455-3311.
TESTER-HAGAN EXEMPTION
The extensive new requirements for food producers under the Food Safety Modernization Act (FSMA) favor large-scale industrial producers over small-scale sustainable producers. Senator Tester of Montana fought for an amendment, co-sponsored by Senator Hagan of North Carolina, to exempt small-scale local food producers from the most burdensome portions of the bill [HR 2751 passed in 2010], namely the regulations governing on-farm growing of produce and the hazard analysis plans for “facilities,” which would include anyone doing any processing. Among others, FDA is refining its proposed regulations on preventive controls for human food [Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC)]. The Tester-Hagen exemption offers some respite but FDA is working hard to undermine it.
Instead of reining in FDA and making it accountable for its failure to exercise the powers it already possessed, FSMA surrendered even more power to FDA, putting food security at risk by further centralizing the food system. Increasing local food sources and reversing the tide of food imports is exactly what FSMA fails to do.
Under the Tester-Hagan Amendment, producers who gross under half a million dollars (adjusted for inflation) and who sell more than half their products directly to individual consumers or to local retailers and restaurants are to be exempt from these new federal regulations.
The amendment also required FDA to conduct a study [within 18 months] to look at the incidence of foodborne illness in relation to food producers’ scale and type of operation; this study is to be used by FDA to define “very small businesses” that will also be exempt from the HARPC requirements.
The FSMA Tester-Hagan exemption is vital for protecting vulnerable, small-scale businesses that are providing safe, healthy food for their local communities. The exemption will help some, but not all, raw milk producers. Many raw milk producers generate much more income from sales of raw milk to a cooperative for pasteurization than they do from the sale of retail raw milk to consumers. Those producers would not benefit from the exemption.
FMSA also provides that the exemption is withdrawn if an active investigation links the “qualified facility” to an outbreak of foodborne illness or “if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed or held at such facility.”
Instead of focusing on the real sources of food safety problems in the industrialized, interstate and international food system, FDA has been given power to micro-manage small operations and even to usurp states’ powers to regulate food.
Most Recent FDA Submissions for Comment:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food – Comments due 12/15/14
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption – Comments due 12/15/14
