Description
Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2004D-0311.
Scope & Applicability
Product Classes
2The letter reminds processors of actions to enhance the safety of cider.
The primary product category addressed by the guidance.; The specific food product category subject to the action level guidance
Stakeholders
3Businesses exempt from juice HACCP if selling directly to consumers.
expert with knowledge about process parameters and values; Expert who develops alternate processes or establishes parameters.; Salsa Processor A's PCQI/ process authority determined process parameters
An establishment that performs processing steps on ACTPs.
Regulatory Context
Attributes
1Required statement for juice not achieving 5-log reduction
Identified Hazards
Hazards
3Adulteration link that triggers DWPE.
Pasteurization typically is applied to foods to kill pathogenic strains of E. coli.
Effect of low temperatures and pasteurization on viability
Related CFR Sections (7)
- 21CFR120.24§ 120.24 Process controls.
(a) In order to meet the requirements of subpart A of this part , processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( i.e., 10 5 ) reduction, for a period at least as lonRead full regulation →
- 21CFR120.11§ 120.11 Verification and validation.
(a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to design.Read full regulation →
- 21CFR120.20§ 120.20 General.
This subpart augments subpart A of this part by setting forth specific requirements for process controls.Read full regulation →
- 21CFR120.3§ 120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, § 101.9(j)(18)(vi) of this chapter , and parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms wheRead full regulation →
- 21CFR110.80§ 110.80 Processes and controls.
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human coRead full regulation →
- 21CFR173.368§ 173.368 Ozone.
Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 ), in accordance with the following prescribed conditions:Read full regulation →
- 21CFR101.17§ 101.17 Food labeling warning, notice, and safe handling statements.
(a) Self-pressurized containers.Read full regulation →
Related Warning Letters (10)
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Tamara Fruit CJSC
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Raya Green Coconut Co.
- 2024-05-14
Juice/HACCP/Adulterated
G.N.R. Group Co., LTD.
- 2024-04-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Thuan Thien Producing Trading Limited Company
- 2024-03-05
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Barsotti Juice Company, Inc.
- 2023-08-22
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Sol-ti Inc.
- 2023-05-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Juicer Connections, Inc.
- 2023-03-28
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Liberty Fruit Co. Inc. DBA Carol’s Cuts
- 2022-12-27
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Bainbridge Beverage West, LLC
- 2022-05-31
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Russ Davis Wholesale Inc
See Also (8)
- Small Entity Compliance Guide: Juice HACCP (Status: Final)
- Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (Status: Final)
- Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Exemptions from the Warning Label Requirement for Juice (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)