This information collection request is approved consistent with information provided by FDA indicating that information collection provisions are largely consistent with current industry practice and based on the voluntary nature of the guidelines. OMB notes that FDA will include the PRA burden disclosure statement on the final version of the guidance.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
10/31/2010
36 Months From Approved
434,431
0
0
47,838
0
0
0
0
0
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.
The Federal Food, Drug, and Cosmetic Act (the act) prohibits the distribution of adulterated food in interstate commerce (21 U.S.C. 331 and 342). In response to the increased consumption of fresh-cut fruits and vegetables and the potential for foodborne illness associated with these products, the Food and Drug Administration (FDA) recognizes the need for guidance specific to the processing of fresh-cut fruits and vegetables. The guidance document entitled, "Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables," provides FDA's recommendations to fresh-cut produce processors about how to avoid contamination of their product with pathogens. This guidance is in addition to the good manufacturing practices (GMPs) provided in part 110 of FDA's regulations (21 CFR part 110). The guidance is designed to help fresh-cut produce processors minimize microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form. Accordingly, FDA encourages fresh-cut produce processors to adopt the general recommendations in the guidance and to tailor practices to their individual operations.
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
This is a new guidance document. FDA estimates that the burden of the guidance will fall on both existing and new firms entering the fresh-cut industry who may follow the recommendations in the guidance. Currently, the fresh-cut trade association estimates that there are 250 fresh-cut plants in operation in the U.S. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year. Many of the existing firms in the fresh-cut industry already make use of CGMP-related, recall, HACCP, and other activities.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
Reginfo record details
No
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.
Response to OMB Comments on Fresh Cut Guidance PRA 3.doc
Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables