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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 safety 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;
    • Food Allergen Controls;
    • Sanitation Controls;
    • 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.
  •   Oversight and management of preventive controls:
    • Monitoring: to provide assurance that preventive controls are consistently performed.
    • Corrective Actions and Corrections: to quickly identify and correct a minor isolated problem that occurs during food production.
    •  Verification: to ensure that preventive controls are consistently implemented and effective.
  • Recordkeeping: 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 reveals that a preventive control is needed, the firm must also have a recall plan as part of their food safety plan. It must include steps and methods to be used to notify the direct recipients of the food about the recall, notify the public about any hazard, verify that the recall is carried out effectively, as well as procedures to appropriately dispose of the recalled food in the food establishment and by all recipients

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)

  •  Very Small businesses as defined in 21 CFR 117.3
  • Qualified facilities as defined in 21 CFR 117.3 to which both of the following apply:

    1. 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
    2. 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)

NOTE: To be eligible for modified requirements, a qualified facility is required to notify FDA about its status and submit an attestation.  Please click HERE for more information. 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.

  • Establishments that are solely engaged in the storage of refrigerated unexposed packaged foods when temperature controls are necessary to prevent pathogen growth. These firms must: (See complete requirements in §117.206)

    1. Establish and implement temperature controls adequate to significantly minimize or prevent pathogen growth, and toxin formation,
    2. Monitor the temperature controls at adequate frequency,
    3. Take appropriate corrective actions when there is loss of temperature control,
    4. Verify temperature controls,
    5. 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:

  • Clarifications on protections against cross-contact of food by allergens,
  • Deletion of certain nonbinding provisions (any language containing “recommendations”),
  • Some previously nonbinding provisions are now modified to be binding provisions.

An example is education and training, in which management is now required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. These employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene).


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)