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.
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
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