Food Protection Trends - January/February 2022 - 34

reconsidering their status. They will not be enforcing the
PCHF preventive controls requirements for facilities that
pack, package, label, and/or hold processed food that consists
only of dried or dehydrated RACs that have become a distinct
commodity (Table 3), until further rulemaking regarding farm
activities is completed (31).
In addition, the FDA will not enforce the human food
GMP requirements for the same type of facilities that are
packing, labeling, and/or holding nonproduce RACs; this
notably would not include pulses. The same rules apply to
facilities handling animal foods that consist only of dried
or dehydrated RACs that are subject to the PCAF rule,
except that enforcement discretion will be applied for both
preventive controls and CGMP requirements for these dried
or dehydrated nonproduce and produce RACs.
DISCUSSION
Food safety track record of pulses
As a raw agricultural commodity, pulses in the United
States have an extensive history of product safety. Dry,
packed, or packaged field peas, chickpeas, and lentils are food
commodities more closely aligned with farm production
activities than with processed, ready-to-eat foods. Their normal
expected or intended use is further processing or preparation
by an end user or consumer. As such, they present no
significant biological, chemical, or physical hazards in their
dry commodity state.
During further processing of pulses into products such as
hummus or sprouts, health-threatening hazards may be introduced.
These potential hazards include microbial pathogens
and physical contaminants. Likely sources include the facility
environment, employees, and food processing equipment.
Processors use prerequisite food safety programs, hazard
analysis (and) critical control point critical control points, and
preventive controls to manage such hazards. Further processing
of pulses falls under FDA and state regulations, especially
the pertinent rules of FSMA.
This article presents potential food safety hazards to pulses
during farming, storage, cleaning, and packing of raw product.
Biological hazards evaluated include vegetative pathogens,
spore-forming pathogens, viruses, and parasites. For chemical
hazards, the risk of mycotoxins, natural toxins such as lectins
and phytic acid, heavy metals, and pesticides was reviewed.
Physical hazards such as rocks, metal, glass, plastic, and extraneous
vegetable matter were considered. For all of these potential
hazards, there have been no foodborne illness outbreaks
reported by the Centers for Disease Control and Prevention
that can be attributed to raw, dry, packed, or packaged pulses.
During the cultivation of pulses, there is controlled and
regulated application of agricultural chemicals. Raw manure is
not used during planting and growing of these products, and
farm harvesting equipment is routinely cleaned. Dry field peas,
chickpeas, and lentils are naturally dried in the field before
harvest and not through the use of processing equipment.
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Food Protection Trends January/February
Facilities implementing best food safety practices incorporate
controls during storage to prevent product contamination. These
controls include pest control; proper ventilation; and moisture
control, sanitation, and preventive maintenance.
Finally, during cleaning and packing of raw pulses, many
food safety controls are applied to eliminate physical and
chemical hazards. These controls may include preventive
maintenance, extensive metal and foreign material control or
removal equipment, GMPs, and dry cleaning practices. During
cleaning, incidental grains that may create allergen hazards
(i.e., wheat) are removed by vibratory screens, gravity tables,
and other equipment. A health risk from biological hazards
has a very low likelihood of occurring, as cleaning facilities
are operated under dry conditions. Many of the cleaning
facilities voluntarily participate in GFSI certification through
recognized audit schemes. Although these operations are more
related to farming and product storage than to food processing,
most comply with FDA and state regulations and third-party
audits to ensure a safe product is provided to the end customer
or consumer.
FSMA regulatory challenges
The FDA regulates pulses through the Produce Safety
rule, the PCHF and PCAF rules, and facility registration
requirements and exemptions (1.227 of section 415 of the
Federal Food, Drug, and Cosmetic Act). Other FSMA
regulations may apply, such as the Mitigation Strategies
to Protect Food Against Intentional Adulteration (Food
Defense) rule (21 CFR 121) and the Sanitary Transportation
of Human and Animal Food (Sanitary Transport) rule (21
CFR 1), depending on types of facilities, products, and means
of transportation. These rules come into play during farming,
on-farm storage, on-farm cleaning of pulses, off-farm storage,
off-farm cleaning of pulses, and transport of final product.
Classifying dry field peas as " vegetables " initiates the full
requirements of the Produce Safety rule for growers of this
commodity. Dried field peas are a crop that is handled in
similar manner to wheat, which is not classified as a vegetable.
There would be many challenges to implementing the rule for
field peas. For example, there would be a significant economic
impact to inspect all crop land before harvest for wild animal
excreta (see 21 CFR 112.83(b)(1)), over thousands of acres
of dry pea farming ground in the Palouse region. The FDA's
announcement of enforcement discretion in a March 2019
guidance document (32) for growing dry peas addresses these
challenges, although further rulemaking to address the status
of dry field peas in the Produce Safety rule has yet to occur.
All storage and processing facilities that are not part of
farms must register with the FDA. Registrations triggers many
requirements under the PCHF and the PCAF rules. The
FDA has not clearly defined all allowable business structures
for primary production and secondary activities farms, and
this has an adverse impact on the pulse industry by requiring
regulatory compliance for businesses which may be otherwise
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