Module 4 (v1.0) - Oregon State University · MODULE 4 Preventive Controls for Human Food (PCHF)...
Transcript of Module 4 (v1.0) - Oregon State University · MODULE 4 Preventive Controls for Human Food (PCHF)...
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.