FDA Food Safety Modernization Act (FSMA)
Compiled from the www.fda.gov/fsma website by AgMatters LLC June 4, 2012
Guidance for Industry (not laws) and some illustrations of what FDA is thinking.
Why is FSMA needed?
1 in 6 Americans get sick each year from foodborne illness. 128,000 are hospitalized and 3000
15% of our food is imported, there are new hazards in food never seen before, and there are
more foods on the marketplace. Our food supply is complex and more high-tech than ever
The focus of the law is on Prevention rather than reaction. A breakdown at any point on the farm-to-
table course can cause catastrophe and harm. “So we need to look at the food system as a whole, be
clear about the food safety responsibility of all of its participants, and strengthen accountability for
prevention throughout the entire food system, domestically and internationally”—Margaret A.
Hamburg M.D. Commissioner of Food and Drugs.
Comprehensive preventive controls for human and animal food facilities
All facilities that manufacture/process, pack or hold food for consumption in the US are
subject to the registration requirement. (Note—dehydration is not included in this)
Facilities will be classified as high-risk (HR) or non-high-risk (NHR).
A HR facility may have known safety risks of the food manufactured, processed, packed
or held at it and/or it may have a compliance history (food recalls; outbreaks of food
borne illness; violations of standards).
HR facilities will be inspected minimally within 5 years of enactment (enacted January,
2011) and no less than every 3 years thereafter. NHR facilities must be inspected a least
once in the first 7 years following enactment and once every 5 years thereafter.
Facilities will have to evaluate hazards that could affect safety; they must identify and
implement preventive controls to prevent hazards; monitor them and maintain
monitoring records, and conduct verification activities.
Facilities are exempt if they are defined as very small business or have a limited annual
monetary value of sales. (During last 3 years, sales were less than $500,000. and the
majority of sales must have been made directly to consumers or farmers’ markets and
restaurants either intrastate or within a 275 mile radius)
If you have a business in your home that involves manufacturing/processing, packing or
holding food you do not have to register as a food facility. A private residence is not a
If there is a separate manufacturing/processing facility that is located on the private
residence site, it would be considered a mixed-type establishment and that site would
have to be registered (unless it qualifies under another exemption). For instance an
orchard that made juice would have to be registered as a facility because the process of
making the cider is not covered by the “farm” definition. The same would be true if you
made maple syrup from sap. You don’t have to be registered to gather sap, but if you
cook it and change it into syrup, you are processing and must be registered, unless all
the sap is consumed on the farm or another farm under the same ownership.
The farm definition would exempt a farm with a separate packing house if all the food
used in the manufacturing/processing is consumed on that farm or another farm under
the same ownership.
If you grow and sell produce directly to consumers you are exempted as a “retail food
establishment”. This also exempts stores, restaurants, and bakeries (unless more than
50% of sales are to wholesalers).
If you apply chemicals pre-harvest, it is farming. If you apply chemicals post-harvest, it
is considered manufacturing/processing. (This does not include things used to wash
produce, unless, for example, the concentration is greater than 200ppm of chlorine, that
would be called “treating.”)
The legislation provides FDA authority to suspend a facility’s registration under certain
circumstances, which would prevent that facility from introducing any food into
commerce in the U.S., including importing or exporting food into the U.S. It also
provides more flexibility for FDA in using its administrative detention authority to keep
potentially adulterated or misbranded products from entering the marketplace.
Produce Safety Standards
The Produce Safety Regulation is not out yet. However it will establish mandatory, science-
based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of
fresh fruits and vegetables and will apply to raw agricultural commodities for which FDA
determines that such standards minimize the risk of serious adverse health consequences or
Since 1998, “Good Agricultural Practices” issued by FDA and USDA have been available, but
they are not an enforceable regulation like the Produce Safety one will be. It will include
sanitation, training for supervisors and employees; environmental controls and monitoring,
food allergen controls, recall contingency plan, Good Management Practices; and supplier
The theme of input from growers has been that the produce safety standards should be
appropriate and flexible, science-based and risk based; practical, apply to both imported and
domestic produce, and have a strong education and outreach program.
Fresh fruits and vegetables, mushrooms, sprouts, peanuts and tree nuts will be regulated.
Exempt will be items usually consumed cooked such as potatoes, sweet potatoes, artichokes,
or those produced by small growers (Tester amendment). Produce destined for a kill step (to
be canned or glass processed) and items not used for food or feed will also be exempt.
There will be collaboration amongst all food safety agencies (Federal, state, local, territorial, tribal,
and foreign). FSMA authorizes grants for training, conducting inspections, building capacity of labs,
and food safety programs and activities. Items are being prioritized based on public health
protection. The EPA groups are engaging with stakeholders to determine reasonable and practical
ways to implement preventive control provisions.