Page 93 - Winter2014

Under the Tester-Hagan exemption, you food products directly to consumers exceeds the Under the
must place a label on the food or a sign at the annual monetary value of sales of food products
point of sale with your name and the complete to all other buyers.” The term “consumers” did Tester-Hagan
address of the farm. Moreover, FDA is able not include businesses, just individuals. exemption,
to revoke the qualified exemption if there is a Logically, most people would read the defi- you must
foodborne illness investigation that is “directly nition of “retail food establishments” to include
linked” to the exempt farm or if there are “condi- farms or food businesses that sell the majority of place a label
tions or conduct” that are “material” to the safety their food directly to consumers at places such on the food
of the food produced at the exempt farm. The as farmers’ markets or roadside farm stands. But or a sign at
process for revoking the exemption is one of the thanks to the structure of the Bioterrorism Act,
major issues in the proposed rules, as discussed that wasn’t the case. the point of
more in the final section of this article. The Bioterrorism Act was focused on physi- sale with your
For produce that will be processed in a way cal locations of “facilities.” For example, Kraft name and
that kills potential pathogens, such as through foods would not simply do a single registration,
canning, you are subject to a few requirements but would register each individual location of the complete
such as recordkeeping, but not the substantive each manufacturing plant. So if a business pro- address of
requirements on how the produce is raised for cesses food at one location and sells at another— the farm.
that produce. If you raise a mix of produce, some such as someone who makes jams in their kitchen
of which will be processed and some of which and then sells it at the local farmers market—the
will be eaten fresh, then the full rule applies to pre-FSMA law was unclear as to whether or
the produce that you raise for fresh eating. not they would be a retail food establishment,
and FDA had made conflicting statements over
WHO IS SUBJECT TO THE HARPC RULE? whether such operations were instead “facilities”
While the applicability of the Produce Rule that had to register.
is confusing, the situation with the HARPC Rule One of the less-publicized aspects of the
is even more convoluted because it is the result Tester-Hagan amendment was a provision di-
of FSMA layered on top of pre-existing law. The recting FDA to clarify that farmers’ markets,
HARPC rule applies to “facilities,” a term that community-supported agriculture (CSA) pro-
was initially defined in the Bioterrorism Act of grams, and other direct-to-consumer sales plat-
2002. In the Bioterrorism Act, Congress required forms came under the definition of a retail food
any “facility engaged in manufacturing, process- establishment and, therefore, were not facilities
ing, packing, or holding food for consumption in and did not have to register with FDA. While
the United States” to register with FDA. the Congressional directive was very clear, FDA
The Bioterrorism Act specified that farms still has failed to amend this definition, which is
were excluded from coverage, but the FDA’s confusing and cause for worry.
implementing regulations very narrowly defined The FDA has made some minor changes to
“farms.” Farms could grow, harvest and pack the definition of a “farm” in the HARPC rule,
their own crops, but packing another farm’s expanding it to allow for packing produce from
produce (such as with a multi-farm CSA), was other farms and dehydrating uncut produce (such
considered a facility’s activity. And any type of as raisins or herbs).
processing, even as slight as cutting up greens What does this mean? If you meet the defini-
for a salad mix, would also turn a “farm” into a tion of a farm or a retail food establishment, then
“facility” that had to register. you are not a facility, you do not have to register
In addition to excluding farms (narrowly with the FDA under the 2002 Bioterrorism Act,
defined) from the definition of facilities, the and the HARPC rule doesn’t affect you. If you
Bioterrorism Act also excluded “retail food are a “facility,” however, you not only have to
establishments.” FDA defined the term as “an register with the FDA under the 2002 Bioterror-
establishment that sells food products directly ism Act, but you will also have to undergo the
to consumers as its primary function,” specifi- extensive HARPC requirements under FSMA,
cally if “the annual monetary value of sales of unless one of the exemptions applies.
Wise Traditions WINTER 2014 Wise Traditions 89

145881_text.indd 89 12/23/14 12:17 AM