Food Protection Trends - January/February 2022 - 31

therefore not subject to this rule under 112.2 (a)(1). " The FDA
also states the following:
" We consider beans to fit within the definition of produce.
Beans are typically sold in both a fresh and a dried form
and the drying creates a distinct commodity. The fresh
beans are produce RACs [raw agricultural commodities]
and are subject to this rule except where an exemption
applies. Some types of fresh beans are not subject to
this rule because they fit the criteria for produce that is
rarely consumed raw, and are therefore exempt under
112.2 (a)(1) ...We understand that many beans receive
commercial processing that adequately reduces the
presence of microorganisms of public health significance,
such that in many cases, beans that are not exempt from
this rule as rarely consumed raw may be eligible for the
exemption in 112.2 (b). In addition, dried beans are
distinct commodities from fresh beans and are therefore
processed foods. Processed foods are not subject to this
rule, such that once beans subject to this rule are dried/
dehydrated, they are no longer subject to this rule. We also
consider that lentils fit within the definition of produce
... However, lentils are rarely consumed raw and are
therefore not subject to this rule under 112.2 (a)(1). "
In the preamble to the PCAF rule (22) FDA states that " We
classify peanuts and beans (such as kidney beans, lima beans,
and pinto beans) within the category of " fruits and vegetables; "
we classify soybeans as grain (see the discussion of grains at
78 FR 64736 at 64764 and 79 FR 58476 at 5848, and fruits
and vegetables at 78 FR 3646 at 3690 and proposed §§ 112.1
and 112.2 in the Produce Safety rule). " The FDA states in
the " Policy regarding certain entities subject to the current
GMP and preventive controls, produce safety, and/or foreign
supplier verifications programs: Guidance for industry " (31)
(4.a.; p.13) that although they classify dried beans as " produce
RACs " in 1998 (FR54532@54542; 9 October 1998), dried
beans were characterized by both FDA and EPA in a group of
commodities that included legumes and grains that remain
RACs even though they were dried (FR54532@54542).
The Produce Safety rule has exemptions for produce that is
" rarely consumed raw " (RCR); in 21 CFR 112.2(a)(1), the
FDA lists black beans, great northern beans, kidney and lima
beans, navy and pinto beans, chickpeas, and lentils. Dry field
peas are not included in this rarely consumed raw list, despite
being inedible in their dry state. Raw agricultural commodities
that are covered under the rule include broad beans, cowpea
beans, peas, peas-pigeon, and snow peas (21 CFR112.1(b)
(1)). The " covered produce " under the rule is therefore
subject to all the good agriculture practices components
mandated in the regulation, such as " Worker Training and
Health and Hygiene, " " Agricultural Water, " " Domesticated
and Wild Animals, " " Biological Soil Amendments, " " Growing,
Harvesting, Packing, and Holding Activities; and " Equipment
Tools and Building. " The FDA does not differentiate between
a dry field pea and a succulent pea and therefore has included
dry peas as a produce raw agricultural commodity that falls
under the produce safety regulation requirements (Table 1).
Dry field peas, whether whole or split, in contrast to
succulent peas, are not consumed raw; they are typically
further processed into foods such as soup through cooking,
retorting, and other forms of thermal processing. As defined
by the FDA, large farms (>US$500,000 revenue per year) that
grow covered produce such as dry field peas were required to
comply with this rule by 26 January 2018 (except for the rule's
customer assurance provisions).
In March 2019, the FDA issued a guidance for industry,
" Produce Safety Rule: Enforcement Policy for Entities
Growing, Harvesting, Packing, or Holding Hops, Wine
Grapes, Pulse Crops, and Almonds; Guidance for industry
(32). In section C of this guidance, the FDA indicated
an understanding that succulent peas and dry peas " are
recognized as distinct commodities " and that dry field peas
are a pulse crop. Consequently, the FDA decided to " exercise
enforcement-discretion for entities growing, harvesting,
packing or holding pulse crops that are not currently classified
as rarely consumed raw, while we explore this topic further
and consider pursuing rulemaking to address the unique
circumstances of these commodities. " Enforcement discretion
as explained in the introduction to this guidance means that
FDA will not enforce the requirements of the Produce Safety
rule as they apply to entities growing, harvesting, packing, and
holding certain commodities, which includes dry field peas.
Pulse storage and handling
Storage and holding of pulses on farms defined by the FDA
as " primary production " or " secondary activities " farms are
exempt from food facility registration (21 CFR Part 1, Subpart
H) (Table 2). Registration is required for off-farm food holding
and processing facilities under section 415 of the Federal
Food, Drug and Cosmetic Act. Primary production farms may
pack or package or hold RACs. A secondary activities farm is
one that is not located where crops are grown and harvested
(e.g., the primary production farm) and that is devoted to
harvesting, packing, and/or holding of RACs, provided that
the primary production farm owns or jointly owns a majority
interest in the secondary activities farm (21 CFR 1.227) (25).
Because primary production and secondary activities farms are
exempted from FDA registration, they are generally not subject
to the PCHF and PCAF rules (25). Farms may be regulated
under the Produce Safety rule, however, if they work with
covered produce.
The FDA defines holding as storage of food and includes
activities performed incidental to storage of food, such as
activities performed for the safe or effective storage, including
fumigating food, and drying or dehydrating raw agricultural
commodities. However, " holding " does not include drying or
dehydrating that creates a distinct commodity, such as drying
or dehydrating alfalfa or drying grapes to produce raisins.
Holding also includes activities performed as a practical
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Food Protection Trends - January/February 2022

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