MODULE 4Preventive Controls for Human Food (PCHF)

Exemptions and Modified Requirements

Learning objectives

■ Who is and who is not covered by the Preventive Control Human Food (PCHF) regulation.■ Exemption from Hazard Analysis and Preventive

Controls.■ Modified Requirements.

Who is covered by Preventive

Controls for Human Foods

(PCHF) Regulation?

Facilities that manufacture, process, pack or hold human food.

In general, facilities required to register with FDA under sec. 415 of the FD&C Act.

Applies to domestic and imported food.

Who is not covered by PCHF?

Farms Retail food establishments Restaurants

21 CFR Part 117

Subpart A – General Provisions■ § 117.5 Exemptions■ § 117.7 Applicability of subparts

C, D and G to a facility solely engaged in the storage of unexposed packaged food

■ § 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities

Exemptions and Modified

Requirements

■ The following are exempt from preventive controls requirements because they are being regulated by mandatory HACCP (hazard analysis critical control points) programs or other safety requirements.– Seafood– Juice– Low-acid canned food

regulations (microbiological hazards only)

– Dietary supplements – Alcoholic beverages

Exemptions and Modified

Requirements

– Facilities, such as warehouses, that only store unexposed packaged food are exempt from preventive controls requirements.

Ø Note: Packaged food for which refrigeration is required for safety must have temperature controls, monitoring, verification, and records.

Ø GMPs apply

Exemptions and Modified

Requirements

– Certain storage facilities such as grain elevators and warehouses that only store raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing are exempt.

Ø Note: Facilities such as warehouses that store raw agricultural commodities that are fruits and vegetables are NOTexempt from hazard analysis and risk-based preventive controls

“RAC” Exemptions

and Modified Requirements

GMPs do not apply to holding or transportation of raw agricultural commodities (RACs) Note: This exemption is not new.

GMPs apply to packaging, packing and holding of certain dried raw agricultural commodities. Compliance can be achieve by complying with subpart B or requirements for packing and holding in 21 CFR 112 (Product Safety Rule)

A similar approach can be used for off-farm packaging, packing and holding of produce RACs.

Farm-Related Exemptions ■ Activities within the definition of “farm,”

including farm activities that are covered by the Produce Rule.

■ Certain low-risk manufacturing/processing, packing and holding activities conducted by small/very small businesses on farms for specific foods.

Ø Note: There is a lengthy list of items stated in the regulation. See the codified regulation for details. Some examples: baked goods, candy, jam pH less than 4.2, vinegar, trail mixes, granola, popping popcorn, etc.

Preventive Control – Not Required

When an identified hazard requiring a preventive control is controlled by another entity later in the distribution chain… Obtain written assurances that the hazard

will be controlled later in the food chain.

Disclose that food has not been processed to control an identified hazard.

Preventive control is not required IF you:

Modified Requirements

Subpart D – Modified Requirements

■ § 117.201 Modified requirements that apply to a qualified facility.

■ § 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.

Qualified Facility Exemptions

Definition for a Qualified Facility:

■ Very small business - Less than $1 million in total annual sales of human food plus the value of food held without sale annually averaged over a three-year period.OR

■ Food sales averaging less than $500,000 per year during the last three years And sales to qualified end-users must exceed sales to others.

q A Qualified Facility is exempt from the requirements for Hazard Analysis, Risk-based Preventive Controls and the Supply Chain Program.

Qualified Facility

Modifications

Attestation:A qualified facility

submits an attestations to

FDA.

Attestation that you have identified the potential

hazards associated with the food being produced, are implementing preventive

controls OR the facility is in compliance with State, local,

county, tribal, or other applicable non-Federal food

safety law.

The form to be submitted is

3942a.

Exemptions and Modified Requirements Summary ■ Very small businesses have exemptions for preventive controls

and the supply chain program. An attestation applies.■ A facility solely engaged in the storage of unexposed packaged

food that require refrigeration has modified requirements.■ There are exemptions for some low risk processing and

packaging on a farm. ■ Retail and restaurants are exempted from the Preventive

Controls Human Food rule.■ Primary Production farm and Secondary Activities farm are

exempted from Preventive Controls Human Food rule.