Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statute and regulations.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2

Low-Acid Juices

Subject to pathogen reduction provisions of the juice HACCP requirements.

Refrigerated Carrot Juice

Guidance for processors of refrigerated carrot juice and other low-acid juices.

Regulatory Context

Document Types

1

HACCP Plan

hazard analysis and critical control point plan

Technical Details

Substances

3

Salmonella spp.

Pathogen subject to hazard analysis; Known hazard that can become established in dry food production environments.; Pathogen of concern in dried foods; Pathogen discussed in multiple references regarding contamination

E. coli O157:H7

Pathogen that triggers corrective action if detected in sprouts or irrigation water.; primary consideration given to reduction of Salmonella spp. and E. coli O157:H7; Pathogen tested for in spent sprout irrigation water.; Pathogen associated with radish and alfalfa sprouts

Clostridium botulinum

Pathogen that may grow in reduced oxygen packaging.; spore-forming bacterium found in soil

Processes

2

Acidification

In-process control to prevent C. botulinum germination; direct addition of acid to a low-acid food as a process control; Lowering pH to inhibit spore germination and vegetative growth; used to control C. botulinum; Method of controlling pH; Process to attain acceptable equilibrium pH levels; Treatment of ingredients in infused oils to control hazards

Pasteurization

heating procedure used to effectively eliminate L. monocytogenes; historically established process control for milk

Identified Hazards

Hazards

1

Botulism

severe paralytic illness caused by C. botulinum toxin

Standards & References

Specifications

1

pH of 4.6 or below

Control measure to prevent C. botulinum growth.

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to verify and document production in accordance with 21 CFR part 113

8

Failure to develop, maintain, and follow an FSVP

4

Did not develop, maintain, and follow an FSVP

4

Failure to validate HACCP plan

3

Failure to process in conformity with the scheduled process

3

Failure to conduct a hazard analysis

3

Failure to develop an FSVP

3

Failure to establish scheduled processes by a qualified person

3

Failure to maintain processing and production records showing adherence to the scheduled process

2

Lack of approved school training for supervisors

2