In the same manner of the produce safety rule earlier published on Fresh Talk, here is the executive summary of the Preventive Controls Rule.

Executive Summary of Preventive Controls Rule


Purpose and Coverage of the Proposed Rule

The proposed rule would revise FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways. First, it would add new preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA).

In general, with some exceptions the new preventive controls provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards.

Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule would update, revise, or otherwise clarify certain requirements of our CGMP regulations, which were last updated in 1986.

In addition, this proposed rule would clarify the scope of the exemption for “farms” in FDA’s current food facility registration regulations and make corresponding clarifications to FDA’s current regulations for the establishment, maintenance, and availability of records.

These clarifications would affect who would be subject to the current regulations for registration and recordkeeping as well as the new preventive controls requirements that would be established by this proposed rule. To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, we provide several sections of background.

This background discusses the history of food regulation and current regulatory framework, provides an overview of the provisions of FSMA applicable to this proposed rule, explains the principles and history of the use of Hazard Analysis and Critical Control Point (HACCP) systems, and describes a variety of hazards that have been associated with foods and food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system, and the role of supplier approval and verification programs in a food safety system.

Summary of the Major Provisions of the Proposed Rule

The proposed rule would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based

preventive controls. Specifically, the proposed rule would establish requirements for:

• A written food safety plan;

• Hazard analysis;

• Preventive controls for hazards that are reasonably likely to occur;

• Monitoring;

• Corrective actions;y

• Verification; and

• Associated records.


The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities.

 The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls.

Facilities that manufacture, process, pack or hold food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms.

Importantly, the table in this Executive Summary does not include all the details that you must consider to determine whether an exemption applies to you. We provide those details in the proposed regulation (proposed § 117.5) and explain them in section X.C of this document.

Proposed Exemptions from the New Requirements for Hazard Analysis and Risk-Based Preventive Controls

Who or What Would Be Exempt From the Requirements for Hazard Analysis and Risk- Based Preventive Controls


“Qualified Facility” as defined by FSMA:

• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or

• Very small business

• Option 1: Average annual sales of < $250,000

• Option 2: Average annual sales of < $500,000

• Option 3: Average annual sales of <$1,000,000


FDA is proposing three options for defining “very small business” and requests comment on which to adopt in a final rule.

Modified requirements would apply - i.e., a qualified facility would be required to:

• Notify FDA about its status; and

• Either:

o Notify FDA that it is addressing hazards through preventive controls and monitoring;


o Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed.

• Low risk, on farm activities performed by small business (< 500 employees)


• Low-risk, on-farm activities performed by a very small business

o Option 1: very small = <$250,000

o Option 2: very small =<$500,000

o Option 3: very small = <$1,000,000

Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule’s requirements. We would define the low-risk activities that qualify for the exemption, including the specific foods to which they relate (such as re-packing intact fruits and vegetables, or grinding/milling/cracking/crushing grains)

Activities that are subject to the seafood HACCP requirements of part 123 (21 CFR part 123)

The facility must be in compliance with part 123.

Activities that are subject to the juice HACCP requirements of part 120 (21 CFR part 120)

The facility must be in compliance with part 120. Activities that are subject to the “low-acid canned food” requirements of part 113 (21 CFR part 113)

• The exemption applies only with respect to microbiological hazards.

• The facility must be in compliance with part 113.

The manufacturing, processing, packing, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR part 111)

• The facility must be in compliance with part 111.

• The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements Activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety)

 Elsewhere in this issue of the Federal Register, FDA is proposing standards for produce safety.

 Who or What Would Be Exempt From the Requirements for Hazard Analysis and Risk- Based Preventive Controls


Alcoholic beverages at a facility that is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States The exemption also would apply to food other than alcoholic beverages at such a facility, provided that the food is in prepackaged form and constitutes not more than 5 percent of the overall sales of the facility.

Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing

A facility that stores raw agricultural commodities that are fruits and vegetables would not be exempt.

A facility solely engaged in the storage of packaged food that is not exposed to the environment

Modified requirements would apply for the storage of refrigerated packaged food.

The proposed rule also would establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements. The proposed rule would require that a qualified individual prepare the food safety plan,validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the “qualified individual,” who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities.

FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: a product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate.

 Costs and Benefits

We summarize the domestic annualized costs of the three options for the proposed rule in the table immediately below. We are unable to estimate the benefits of the proposed rule. Instead we show the Breakeven Illness Percentage for each of the three options for the proposed rule. This is calculated by dividing the number of illnesses that would have to be prevented annually under each option by the total estimated number of illnesses attributable to FDAregulated food products under the scope of each option of the proposed rule. This ignores the costs to foreign firms and benefits to foreign consumers.