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The most The main exemption to the HARPC rule 2. Either provide documentation that they

general comes from the Tester-Hagan amendment. As comply with state and/or local food safety
with the Produce Rule, producers who gross less
laws or create a simplified HARPC plan;
concern than five hundred thousand dollars annually and 3. Have a label on the food or a sign at the point
comes from sell more than half directly to consumers or to of sale with your name and the complete ad-
the risk of local retailers or restaurants, have a “qualified dress of the farm. As with the Tester-Hagan
exemption for the Produce Rule, the FDA
exemption.” The Tester-Hagan amendment also
arbitrary directed FDA to define “very small businesses” can revoke the exemption on a qualified
and unfair that would have this same qualified exemption. facility on a case-by-case basis.
enforcement. To be honest, little attention was paid to this
provision because many of us assumed that FDA THE SUBSTANTIVE ISSUES
would set the bar so low that this additional ex- WITH THE PROPOSED RULES
emption would be of little use. However, when For those farmers and food producers who
the FDA issued its first set of proposed rules, it will be subject to new requirements under one
specifically requested comments as to what the or both of these rules, what are the concerns?
cutoff should be. WAPF urged a one million The most general concern comes from the
dollars gross annual sales test, and the FDA has risk of arbitrary and unfair enforcement. It is
accepted that recommendation! Thus, anyone almost certain that FDA will not receive enough
who sells less than one millon dollars annually funding to fully implement all the inspections
of human food—whether or not those are through and actions called for under FSMA. While a
direct sales—will have a qualified exemption to rational assessment of the risk would dictate
the HARPC rule if the FDA stays with its current that the agency focus its limited resources on
proposal. the large, high-risk operations that dominate the
Facilities with qualified exemptions must: conventional food market, FDA’s track record
indicates that the agency is all too likely to target
1. Provide documentation showing that they operations that are raising or processing food
fall within the exemption; using non-conventional methods. The exten-

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