Preventive Controls
The
Food Safety Modernization Act (FSMA),
a federal law enacted in 2011, requires firms that manufacture, process, pack
or hold human food, and that must register with FDA, follow the Preventive
Controls for Human Food (PCHF)
rule’s new food safety requirements found in 21 CFR Part 117. The PCHF rule is
final, and compliance dates for some businesses began as early as September
2016.
The
Pennsylvania Department of Agriculture (PDA) adopts the new federal regulations
as dictated by the Food Safety Act (3 Pa. C.S.A. §5733(f)) and will enforce all
applicable provisions. As Pennsylvania regulation, all PDA registered firms
will be expected to comply with the applicable portions of the PC rule
regardless of FDA registration status, unless specifically exempted in the
rule. During inspection of food establishments, PDA will evaluate the required
food safety plans and make sure the plans are being implemented properly.
PCHF
requires eligible food establishments to follow updated good manufacturing practices (Modernized
GMPs), and to establish and implement a comprehensive PCHF food safety
plan.
PCHF
Food Safety Plan Requirements:
Firms that are subject to the full requirements of PCHF must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. This Food saftey system includes a written food safety plan that covers:
Hazard analysis: What are the known or reasonably foreseeable biological, chemical, and physical hazards that occur naturally, are unintentionally introduced, or are intentionally introduced, that could affect the safety of the food.
Preventive controls: Measures that are required to minimize or prevent the identified
hazards, including:
Process controls: procedures, practices, and processes to control parameters during operations. Examples of process controls are cooking and refrigeration, and product formulation.
Food allergen controls: procedures, practices, and processes to control allergen cross-contact within a facility and procedures to ensure all food allergens are correctly labeled.
Sanitation controls: procedures, practices, and processes to make sure the facility is maintained in a sanitary manner to control hazards such as environmental pathogens. Environmental monitoring is required if contamination of a ready-to-eat food with an environmental pathogen such as Listeria monocytogenes is a hazard requiring a preventive control.
Supplier-chain controls: a risk-based approach to ensure suppliers are not providing food
establishments with raw materials or ingredients that pose a significant risk
to the final product made by the firm.
Other appropriate controls: preventive control procedures that are not process, food allergen, or sanitation controls, but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.
Oversight and management of preventive controls:
Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.
Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.
Corrective Actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.
Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.
Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.
Record-keeping: Documentation of compliance with the written food safety plan to include
but not limited to monitoring, corrective actions, corrections and verification
activities. Required records shall be made available to the regulatory
authority (which will include PDA and FDA).
Recall Plan: If the hazard analysis identifies a hazard that requires a preventive control, you must have a written recall plan that includes the procedures that describe the steps to perform the recall and at minimum assigns responsibility for:
Notifying the direct consignees of the food being recalled, including how to return or dispose of the affected food;
Notifiying the public about hazards in the food;
Conducting effectiveness checks; and
Appropriately disposing of the recalled product.
Exemptions
(from Subparts C, G and
D)
Food establishments covered by separate
regulations including juice, seafood, dietary supplements,
alcoholic beverages, or Low-acid canned
foods (for C. botulinum control ONLY as regulated by Part 113).
Establishments
such as grain elevators and warehouses that are solely engaged in storing
agricultural commodities (other than fruits and vegetables) intended
for further processing.
Establishments,
such as warehouses, that only store packaged foods that are not exposed to the environment and for which
refrigeration is not required for safety (Dry Warehouses).
Establishments
that are Small or Very Small On-Farm businesses
that conduct certain low-risk manufacturing and processing, packing, or
holding activities (e.g., making
jams/jellies, honey, maple syrup, candy, soft drinks, etc.); see more
information in 117.5(g)(3) and 117.5(h)(3).
NOTE: A Farm is not
covered by the new requirements, unless it is a mixed-type facility which is an
establishment that is a Farm, but also conducts activities outside the farm
definition that require the establishment to be registered as required under
section 415 of the Federal FD&C Act.
(See Definition in 21 CFR 117.3)
Firms Subject to the Modified Requirements
(Subpart D)
During the
3-year period preceding the applicable calendar year, the average annual
monetary value of the food manufactured, processed, packed or held at such
facility that is sold directly to qualified end-users (as defined in this part)
during such period exceeded the average annual monetary value of the food sold
by such facility to all other purchasers; AND
The average annual monetary value of all food sold during the
3-year period preceding the applicable calendar year was less than $500,000,
adjusted for inflation.
(See
modified requirements that apply to qualified facilities in §117.201)
Qualified facilities must submit the following attestations to FDA:
- An attestation that the facility is a qualified facility as defined in § 117.3; AND
- (i) An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; OR
(ii) An attestation that the facility is in compliance with PDA Food Safety Law based on licenses/permits, inspection reports, or other evidence of oversight.
A qualified facility must submit these notifications to FDA during the same two-year timeframe that the facility is required to update its facility registration. An otherwise Qualified Facility that does not notify FDA may be subject to the requirements for Hazard Analysis and Preventive Controls.
Attestations can be submitted to FDA either electronically at
www.fda.gov/furls or by mail using FDA Form 3942a. Click
HERE for more information.
Establish and
implement temperature controls adequate to significantly minimize or prevent
pathogen growth, and toxin formation,
Monitor the
temperature controls at adequate frequency,
Take
appropriate corrective actions when there is loss of temperature control,
Verify
temperature controls,
Establish and
maintain records.
NOTE: Warehouse and
distribution establishments engaged in the storage of any exposed food products
and/or engaged in any processing/ manufacturing activities or “value added
services” (e.g. blast freezing, roasting, tempering, labeling, repacking), may
be subject to the PC rule requirements where they need to conduct a hazard
analysis and may need to implement preventive controls.
Updated Good Manufacturing Practices (modernized GMPs)
The PCHF Rule also updates the current Good Manufacturing Practice requirements. All food establishments (regardless of exemption status) are subject to modernized GMP regulations. The new updates include:
- Training: Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. The employees must be trained in the principles of food hygiene and food safety, including the importance of employee health and hygiene as appropriate to the food, the facility, and the individual’s assigned duties. Records of training must be maintained.
- Allergen cross-contact: Allergen cross-contact is now explicit in the regulatory text. You are required to employ practices and procedures to control allergen cross-contact.
- Human food by-products used for animal foods: The updated CGMPs contain provisions for holding and distributing human food by-products that are used for animal food.
Guidance for Industry - Human Food By-Products for Use as Animal Food
How
does the Preventive Controls Plan compared to a HACCP plan?
The
general concepts are very similar. However, these “preventive controls plans”
also cover monitoring, records, and corrective actions for items that are
generally considered pre-requisite programs in HACCP plans, including food
allergen controls, sanitation controls, and a recall plan. The table below
compares the requirements for both plans
|
Element
|
HACCP Plan
|
PC Rule Food Safety Plan
|
|
Hazard
Analysis
|
Biological,
chemical, physical hazards
|
Biological,
Physical & Chemical. Chemical hazards include radiological hazards. Also,
consideration of economically motivated adulteration (21 CFR
117.130(b)(1)(ii))
|
|
Preventive
Controls
|
CCPs for
processes
|
Process
CCPs + controls at other points that are not CCPs (21 CFR 117.135(a)(2))
|
|
Parameters
and values
|
Critical
limits at CCPs
|
Parameters
and minimum/maximum values (equivalent to critical limits for process
controls) (21 CFR 117.135(c)(1))
|
|
Monitoring
|
Required
for CCPs
|
Required
as appropriate for preventive controls (21 CFR 117.145)
|
|
Corrective
actions and Corrections
|
Corrective
actions
|
Corrective
actions or corrections as appropriate (21 CFR 117.150(a))
|
|
Verification
(including validation)
|
For
process controls
|
Verification
as appropriate for all preventive controls; validation for process controls;
supplier verification required when supplier controls a hazard (21 CFR
117.155, 117.160)
|
|
Records
|
For
process controls
|
As
appropriate for all preventive controls (21 CFR 117.190)
|
|
Recall
plan
|
Not
required in the plan
|
Required
when a hazard requiring a preventive control is identified (21 CFR 117.139) |