Food Protection Trends - January/February 2022 - 33

safety plan must be reanalyzed at least once every 3 years, and
the facility must comply with record keeping requirements
in PCHF Subpart F. The pulse storage facility would also
be subject to FSMA inspections. If the same elevator was
used for grains, rather than pulses, these preventive controls
requirements would be exempted.
The FDA was contacted via their TAN by the author to
gain clarification on the question (FDA TAN #00104672)
whether pulse storage elevators enjoy the same exemptions
as elevators that store food grains, such as wheat (27). The
FDA TAN response was that dry beans are not RACs; rather,
they are a processed food according to 21 CFR 112 and 80
Federal Register, 74354 at 74385. Furthermore, " although the
dry beans that you store/hold cannot be consumed without
further processing, they are a vegetable and therefore are not
subject to the exemption in 21 CFR 117.5(j). Dry beans are
not a raw agricultural commodity (RAC), but rather have
been transformed into a distinct commodity by drying and are
therefore a processed food (see Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human
Consumption rule (Produce Safety rule) (21 CFR part
112; 80 Fed. Reg. 74354 at 74385)). " Storage elevators are
therefore not eligible for the exemption in 21 CFR 117.5(j).
Under this rationale, these facilities would be subject to both
the GMPs (Subpart B) and Preventive Controls (Subpart
C) requirements of the PCHF rule. Interestingly, in a later
guidance document, the FDA acknowledges inconsistencies
between its definitions of dry beans as a processed food, and
the EPA's categorization of beans as RACs, " even though they
may have undergone some drying " (31).
Pulse cleaning and packing
On-farm cleaning facilities are also exempt from FDA
registration, because the holding and packing or packaging
operations in the cleaning of pulses are allowed farm activities.
They are not considered " processing " activities by the FDA
(Table 3).
Packaging is defined by the FDA to mean " placing food
into a container that directly contacts the food and that the
consumer [a consumer is not a business by FDA definition]
receives (25). " Packing, however, is when food is placed into
containers that are not consumer containers. Although the
FDA considers packaging RACs to be a manufacturing activity,
the farm definition rulemaking allows this activity to take place
within the " farm " definition (25). This status holds true as long
as there is no further " manufacturing/processing " performed
on the RAC. Therefore, farms may package or pack RACs,
and because of the registration exemption, do not have to
implement PCAF or PCHF regulations.
In addition, the FDA has stated that activities performed for
the safe or effective packing of food, such as sorting, culling,
grading, and weighing/conveying all can be considered part of
" packing " under the rule. Other activities categorized as part
of packing include blending different lots; cooling; mixing
RACs in a packing container; hulling; shelling; sifting for safe
or effective packing (such as sifting grains to remove plant
debris); and washing RACs to remove dirt, where pesticides
can be used in the wash water. If the on-farm packing or
packaging facility also performs at least one activity that falls
outside the " farm " definition, the food facility registration
requirement also may be triggered, requiring compliance
with the PCHF and/or PCAF regulations. An example of
this activity includes manufacturing or processing certain
types of foods (see Table 6, Examples of manufacturing/processing
activities, in Classification of activities as harvesting,
packing, holding, or manufacturing/processing for farms and
facilities: guidance for industry) such as milling chickpea or
wheat flour (25).
Facilities that store, clean, package, and pack RACs that
are not considered part of primary production or secondary
activities farms must register with the FDA because they do
not qualify for the farm registration exemption and therefore
fall under the processing or manufacturing definition; they
are subject to the PCHF or PCAF rules (Table 3). Extensive
feedback was received by the FDA during rulemaking from
the food industry regarding this requirement for RACs,
and a guidance document was issued in January 2018,
" Policy Regarding Certain Entities Subject to Current Good
Manufacturing Practice and Preventive Controls, Produce
Safety, and/or Foreign Supplier Verification Programs:
Guidance for Industry " (31). The guidance also addresses
facilities that store " produce RACs, " which under the current
definitions includes all pulses.
Specifically, relative to pulse storage, cleaning, packing,
and packaging operations, the guidance states that the FDA
will exercise enforcement discretion for two types of facilities
(Table 2). Below is a summary of the enforcement policy with
regard to human food (31):
1) Facilities that would qualify as secondary activities farms
except for the ownership of the facility; these fall under
either the PCHF or the PCAF rule. The FDA has provided
examples of such facilities, those engaged in farm-related
activities on produce RACs (produce packinghouses
and warehouses), and facilities engaged in farm-related
activities on non-produce RACs (grain elevators).
2) Facilities that would qualify as secondary activities
farms except that they pack, package, label, and/or hold
processed foods that consists only of RACs that have been
dried/dehydrated to create a distinct commodity and
therefore fall under either the PCHF or the PCAF rule.
The FDA, in the preamble to the final rule of the Produce
Safety regulation (24), has stated " that dried beans are a
processed food (i.e., a distinct commodity). " This stance
regarding dried beans is also echoed in the " Policy Regarding
Guidance. " Food processing activities do not meet FDA
farm definitions. However, due to feedback received by the
FDA through the TAN from industry regarding dried beans
and their categorization as " produce RACs, " the FDA is
January/February Food Protection Trends
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Food Protection Trends - January/February 2022

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