Raw Milk and FSMA

By Pete Kennedy, Esq.

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-ranking in several areas which could make life more difficult for raw milk producers.

Intentional Adulteration of Food

Under “Intentional Adulteration of Food”, FSMA authorizes FDA to work 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 businesses 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 is proposing to give itself broad power to revoke the exemption for those in the latter category. 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.

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