Fresh-cut fruits and vegetables are fruits and vegetables that have been processed by peeling, slicing, chopping, shredding, coring, trimming, or mashing, with or without washing or other treatment, prior to being packaged for consumption. The methods by which produce is grown, harvested, and processed may contribute to its contamination with pathogens and, consequently, the role of the produce in transmitting foodborne illness. Factors such as the high degree of handling and mixing of the product, the release of cellular fluids during cutting or mashing, the high moisture content of the product, the absence of a step lethal to pathogens, and the potential for temperature abuse in the processing, storage, transport, and retail display all enhance the potential for pathogens to survive and grow in fresh-cut produce.
FDA recognizes the need for guidance specific to the processing of fresh -cut fruits and vegetables. The guidance document entitled " Guide to Minimize Microbial Food Safety hazards of Fresh cut Fruits and Vegetables", provides FDAs recommendations to fresh -cut processors about how to avoid contamination of their product with pathogens. Two general recommendations in the guidance are for operators to develop and implement both a written Standard Operating Procedures (SOPs) plan and a Sanitary Standard Operation Procedures (SSOPs) plan. SOPs and SSOPs are important components to properly implemented and monitored Good Manufacturing Practices (GMPs) that are required for processed food operations under part 110. Other recommended programs that require documentation and record keeping are recall and traceback programs. In the event of a food safety concern, processors who adopt these recommended programs will be prepared to recall products from the market place or be able to trace back fresh produce, which might be implicated in a foodborne illness outbreak, to its source. The recommended procedures contained in the guidance are voluntary.
US Code:
21 USC 342
Name of Law: Adulterated Food
US Code:
21 USC 331
Name of Law: Prohibited Acts
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
0609 Supporting Statement Part A 2014.docx
Recordkeeping: System Implementation Review- Preventative Control Program Comparable to HACCP System