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