Food Protection Trends - January/February 2022 - 32

necessity for the distribution of that food (such as blending
of the same raw agricultural commodity and breaking down
pallets), but does not include activities that transform a raw
agricultural commodity into processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic
Act. The farm definition therefore allows holding, packing,
packaging, and labeling of RACs, but not processed foods.
Holding facilities could include warehouses, cold storage
facilities, storage silos, grain elevators, and liquid storage tanks.
In the guidance document, " Classification of Activities as
Harvesting, Packing, Holding, or Manufacturing/Processing
for Farms and Facilities: Guidance for Industry " (25), FDA
provides further clarification as to what type activities can
be considered part of 'holding' and 'packing'. " Holding can
include " activities performed incidental to storage of a food, "
and includes fumigation during storage, aeration for safe and
effective storage, coating grains with diatomaceous earth to
control insects during storage, cooling, heat treatment for
purposes of pest control, and turning for safe or effective
storage, such as turning grain to manage temperature and
moisture, and to monitor condition and quality. It can also
include " activities performed as a practical necessity for the
distribution of a food. " These activities are limited to " only
those activities that are truly necessary, as a practical matter,
to any holding and distribution of the food in question,
rather than value-adding activities. " These allowed activities
include placing grain in a silo, blending RACs such as grain
to meet a customer's quality specification, loading food
into a vehicle, sampling food for grading or quality control
purposes, screening grain with scalpers and shakers to
remove rocks and other extraneous material, sorting-cullinggrading,
and weighing or conveying. Alternately, the FDA
does not consider " sifting " to be a holding activity. Sifting,
as in sifting of flour to make baked goods, is categorized by
the FDA as a manufacturing or processing activity. A facility
that " manufactures " must register with the FDA and loses the
farm exemption.
Nonfarm facilities for storage and holding of pulses
(elevators or silos not located on primary production or
secondary activities farms) that do not fall within the FDA
" farm " definition are not exempt from facility registration
under section 415 (Table 2). The FDA definitions do not
fully clarify the categories of primary production farms and
secondary activities farms. They do not completely explain
which types of farm businesses and ownership qualify for
primary production and secondary activities farm status.
The farm definition includes both entities that are primary
production farms and secondary activities farms that are
cooperatives (21) and notes that a farm must be under one
management, defined as persons or person controlling and
directing the affairs of a business or institution (see response
23 in the PCHF final rule's preamble, FR55926) (20). After
specifying farm definitions in the final PCHF rule, the FDA
further addressed farm definitions in the " Extension and
Clarification of Compliance Dates " rule (26). It is still not
fully resolved as to what business structures and ownership
arrangements (corporations, partnerships, cooperatives or
other business enterprises) constitute a farm under the rules.
Under the PCAF and PCHF rules, establishments (nonfarm
facilities) that are " solely engaged " in the holding and/or
transportation of one or more RACs are exempt from human
food GMPs requirements (21 CFR 117.5(k)(1)(iii)) or
animal food GMPs requirements (21 CFR 507.5(h)(1)).
The GMPs exemption applies to FDA-defined RACs and not
dried pulses that have been categorized as " processed food. "
If the exemption no longer applies, Subpart B of PCHF or
PCAF rules must be implemented, including documented
Qualified Individual training in food hygiene and food safety
(21 CFR 117.4(d) or 21 CFR 507.4(d)) and compliance to all
applicable GMP rules (Table 2).
Human food GMP exemptions also do not apply to
nonfarm facilities that are not solely engaged in storage and
that also pack, package, and store pulses (21 CFR 117.8).
These facilities must either comply with the GMPs in 21 CFR
Subpart B, or implement applicable GMPs in the Produce
Safety rule. In addition, farms or farm mixed-type facilities
that dry or dehydrate RACs that are produce (i.e., pulses)
must comply with GMPs in either 21 CFR 117 Subpart B
or applicable GMP requirements for packing and holding
specified in 21 CFR 112 (21 CFR 117.5(k)(2)) (Table 2).
There are also exemptions that apply to human food
preventive control and supply-chain requirements (21 CFR
117.5(j)) or animal food preventive control and supply-chain
program requirements (21CFR 507.5(g)) for facilities solely
engaged in storage of RACs other than fruits or vegetables that
are intended for further distribution or processing (28). The
allowable exemptions to the rules imposing preventive controls
and supply-chain requirements apply only apply to facilities
solely engaged in storage of nonproduce RACs intended for
further distribution or processing. These nonproduce RACs
include items such as wheat, corn, and soybean ( " grains " ).
The FDA classifies pulses as produce in the Produce Safety
rule. Dried beans (i.e., garbanzo beans) are also called out as
" processed food. " The PCHF rule also defines dried legumes as
processed food (21 CFR 117.5(g)(2)(i)).
Nonfarm pulse storage elevators are therefore not exempt
from preventive control requirements because they are not
solely engaged in storing nonfruit and vegetable RACs (21
CFR 117.5(j))(23). These facilities would be required to
employ or contract a trained or experienced preventive
controls qualified individual (21 CFR 117.180 or 21 CFR
507.53) (Table 2). This person, while creating a required
written food safety plan, would conduct hazard analyses for
these facilities, and maintain the written plan on-site. If food
hazards are identified during the hazard analysis that require
preventive controls (due to severity and likelihood), there
must be ongoing documented monitoring, corrective action,
and verification, along with a written recall plan. The food
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Food Protection Trends January/February
Food Protection Trends - January/February 2022

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