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RAW MILK UPDATES By Pete Kennedy, Esq.
RAW MILK & FSMA
Even though the United States Food and Drug Administration (FDA) hasn’t carried out or threatened an enforce-
ment 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 in-
tentional 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.
FEDERAL; OPDC PETITION
On November 25, the FDA rejected a second citizen’s petition from Organic Pastures Dairy Company (OPDC)
to modify the interstate ban on raw milk for human consumption (for more background on OPDC’s original citizen’s
petition see the Spring 2013 issue of Wise Traditions). OPDC had requested that FDA amend the federal regulation
banning raw milk to contain an exception reading:
“Raw milk that is tested, state-inspected, state-regulated, carries a 'government warning statement' and labeled
for retail sale in one state, may be transported to another state if that state allows the sale of unpasteurized milk and
or dairy products.”
In denying the latest OPDC petition, FDA continued its long history of disrespecting consumer freedom of choice.
The agency also held to its double standard on raw milk requiring that there must be a guarantee of safety for it to be
legal, something it doesn’t demand for any other food. In his letter rejecting the petition, Michael Landa, director of
FDA’s Center for Food Safety and Applied Nutrition, stated “…there is no reliable method available to determine that
raw milk, even from a state-regulated farm or raw milk manufacturer is or will be free of pathogens, or that raw milk
from any such farm or manufacturer will not cause disease.”
The second OPDC petition contained many more documented sources on raw milk safety and benefits than the
original including studies finding raw milk reduces allergies and prevents asthma. In a rare admission, the FDA letter
acknowledged: “In some studies, the association between raw milk consumption and reduced incidence of allergic
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