On September 17, 2015, the Food and Drug Administration published the long-awaited final rules to establish requirements for current good manufacturing practices, hazard analysis and risk-based preventive controls for human and animal food as required by the Food Safety and Modernization Act ("FSMA"). These final rules apply to domestic and foreign facilities that manufacture, process, pack, or hold human food, animal feed, or the ingredients used therein and are required to register with the FDA under the agency's existing regulations implements by the Bioterrorism Act.
FSMA Preventive Controls for Human Food
The main thrust of the final rule for Preventive Controls for
Human Food is unchanged from prior versions; that is, a shift to
Hazard Analysis and Risk-Based Preventive Controls. Food
manufacturers and processors required to register with the FDA are
tasked with identifying their significant hazards with the
potential to cause illness in humans and animals and developing a
Food Safety Plan to control those hazards. Ongoing monitoring and
record keeping related to the Food Safety Plan is also mandated.
While the main thrust of the rule has not changed, the final rule
does have some important clarifications and additions discussed
below.
Flexibility for Oversight & Management of Preventive
Controls – Rather than take a "one size fits
all" approach to monitoring hazards, the final rule will
permit monitoring to be tailored to fit each particular preventive
control. An example provided by the FDA is that the monitoring of
the actual temperature values used in a heat process designed to
kill pathogens would be more frequent and extensive than the simple
record keeping of preventive maintenance activities used to
minimize metal hazards.
Clarification of the Definition of a "Farm"
– The FSMA definition of a "farm" was
clarified and expanded to include a "secondary activities
farm," which is defined as an operation not located on a
"primary production farm" that "is devoted to
harvesting packing and/or holding raw agricultural
commodities." The "secondary activities farm" must
be majority owned by the "primary production farm" that
supplies the majority of the raw agricultural commodities
harvested, packed, or held by the "secondary activities
farm."
Supply Chain Program Flexibility – The rule
requires that a covered manufacturing/processing facility
("Facility") have a risk-based supply chain program for
those raw materials or ingredients for which the Facility has
identified a hazard requiring a supply-chain applied control.
However, those Facilities that control the hazard using preventive
controls or who appropriately rely on a customer to control the
hazard do not need to have a supply chain
program for that hazard. Furthermore, a Facility will not be
required to implement a preventive control when an identified
hazard will be controlled by a subsequent entity in the supply
chain, such as a customer or processor, so long as the food is
identified as one "not processed to control (identified
hazard)." Additionally, the Facility must have obtained
written assurance from the subsequent entity regarding the actions
to be taken to control the hazard down the line. A Facility may
also shift the responsibility for conducting supplier verification
activities to another entity in the supply chain, such as a broker
or distributor, so long as the Facility reviews and assesses that
entity's documentation of the supplier verification.
Additional Binding Provisions Added to Current Good
Manufacturing Processes ("CGMP") –
Formerly non-binding provisions, such as those related to employee
education and training, are now binding. Management is now required
to ensure that all employees involved in manufacturing, processing,
packing or holding food are qualified to perform their assigned
duties. These employees must also receive training in the
principles of good hygiene and food safety, including employee
health and hygiene.
FSMA Preventive Controls for Animal Food
Establish CGMPs for Animal Food Production
– The final rule establishes baseline CGMPs for animal food
production that arguably provide greater flexibility than those
related to human food. With that said, animal food processors
already implementing human food safety requirements do not need to
implement additional preventive controls or CGMP regulations when
supplying a by-product for animal food, except to the extent needed
to prevent physical or chemical contamination of the by-product.
Further processing of a by-product for use as animal food, however,
does require Facilities to process the by-product in compliance
with CGMPs. In such a scenario, the Facility can elect to follow
either the animal food or human food CGMP.
Covered Facilities Must Adopt a Written Food Safety Plan
– The written Food Safety Plan must include the
identification of all known or reasonably foreseeable biological,
chemical, and physical hazards; the adopting of preventive controls
designed to minimize or prevent the identified hazards; a plan for
ensuring the efficacy of the preventive controls through monitoring
and verification; and, finally, a recall plan in the event the
Facility fails to prevent a hazard to its animal food.
Supply Chain Flexibility – The animal food
rule adopts substantially the same flexible supply chain program
described above in the Human Food section.
Exempts Vertically Integrated Feed Mills –
Feed mills associated with farming operations in which the feed
mill, animals, land and establishment are all owned by the same
entity satisfy the definition of a "farm" and are
generally not subject to the preventive controls for animal food
final rule. The FDA, however, has expressed an intent to publish a
future proposed rule that would require some vertically integrated
feed mills to adopt the CGMPs established by the preventive
controls for animal food final rule.
Exempts Bulk Grain Storing Facilities – Bulk
grain storage facilities that do not process raw commodities into
animal food, e.g. grain elevators, are not subject to the Final
Rule. Grain elevators with integrated feed mill operations,
however, remain subject to CGMP requirements.
Compliance Dates
The final rules for preventive controls for both human food and
animal food become effective sixty (60) days after publication
– on November 17, 2015. Businesses are required to be in
compliance with the final rule one year after publication –
September 17, 2016. However, "small businesses" (those
with fewer than 500 full-time employees) are given two years to
comply with the preventive controls for human food final rule
– until September 17, 2017. "Very small
businesses," defined as those businesses averaging less than
$1 million per year in both annual sales of human food plus the
market value of human food manufactured, processed, packed or held
without sale are given three years – until September 17, 2018
– to comply, although they must have records to support their
status as very small businesses by January 1, 2016.
Compliance dates for animal food are similar, although slightly
more complex. The general date of CGMP compliance is one year for
"businesses," two years for "small businesses,"
and three years for "very small businesses." For the
purposes of the preventive controls for animal food final rule, a
"very small business" is defined as one averaging less
than $2,500,000 per year during the three year period preceding the
applicable calendar year in sales of animal food plus the market
value of animal food manufactured, processed, packed or held
without sale. For each of those three business categories, however,
the compliance date for preventive controls is pushed out one year
beyond the date of CGMP compliance (e.g. a "small
business" has three years to comply with establishing
preventive controls).
Finally, the supply chain requirements will phase in over a period
starting as early as 18 months after the effective date (for a
receiving business other than a small or very small business whose
supplier will not be subject to human food preventive controls
rule) to as late as three years after the rule's publication
date or six months after the supplier is required to comply with
the rule, whichever is later, for a small business with a supplier
that is subject to the preventive controls for animal food final
rule.
Conclusion
While the final rules are not substantially different than the earlier published proposed and supplemental rules, the final rules do start the clock running on Facilities to shift from a more reactive food safety regime to a more preventive, and arguably more onerous, outlook. Facilities are encouraged to familiarize themselves with the rules and begin preparing to implement the rules' requirements as soon as practicable
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
