[Federal Register Volume 71, Number 43 (Monday, March 6, 2006)]
[Notices]
[Pages 11209-11212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0079]


Draft Guidance for Industry: Guide to Minimize Food Safety 
Hazards of Fresh-Cut Fruits and Vegetables; Availability

AGENCY: Food and Drug Administration.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Guidance for 
Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut 
Fruits and Vegetables'' (the draft fresh-cut guidance). This document 
complements FDA's current good manufacturing practices (CGMP) 
regulations by providing specific guidance on the processing of fresh-
cut produce. The draft fresh-cut guidance and the CGMP regulations are 
intended to assist processors in minimizing microbial food safety 
hazards common to the processing of most fresh-cut fruits and 
vegetables sold to consumers in a ready-to-eat form.

DATES: Submit written or electronic comments on the draft guidance and 
the collection of information provisions by May 5, 2006. General 
comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' to the Office 
of Plant and Dairy Foods (HFS-306), Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-
1400, FAX: 301-436-2651. Send one self-addressed adhesive label to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance. A copy 
of the draft guidance is available for public examination in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Submit written comments on the draft guidance and the proposed 
collection of information provisions to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

[[Page 11210]]

Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amy Green, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy. (HFS-306), College Park, MD 20740, 301-436-2025, FAX: 301-436-
2651, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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.
    With this notice, FDA is announcing the availability of the draft 
fresh-cut guidance. This draft guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent the agency's current thinking 
on the microbiological hazards presented by most fresh-cut fruits and 
vegetables and the recommended control measures for such hazards in the 
processing of such produce. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information listed in the following 
paragraphs.
    With respect to the following collection of information, FDA 
invites comments on the following topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut 
Fruits and Vegetables.
    Description: 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). The methods by which produce is grown, 
harvested, and processed may contribute to its contamination with 
pathogens and, consequently, the role of the food in transmitting 
foodborne illness. The potential for pathogens to survive or grow may 
be enhanced in fresh-cut produce due to the release of plant cellular 
fluids during cutting or chopping, the high moisture content of many of 
the products, the absence of a process lethal to pathogens, and the 
potential for temperature abuse during processing, storage, transport, 
and retail display. In response to the increased consumption of fresh-
cut fruits and vegetables and the potential for foodborne illness 
associated with these products, FDA recognizes the need for guidance 
specific to the processing of fresh-cut fruits and vegetables. 
Accordingly, FDA encourages fresh-cut produce processors to adopt the 
general recommendations in the guidance and to tailor practices to 
their individual operations.
    FDA's fresh-cut draft guidance represents the agency's 
recommendations to industry based on the current state of science. 
Following the recommendations set forth in the fresh-cut guidance is 
the choice of each individual fresh-cut operation, plant, or processor. 
FDA estimates the burden of this draft guidance on industry by assuming 
that those in the fresh-cut industry who do not currently follow the 
recommendations put forth in the guidance will find it of value to do 
so. Therefore, the estimates of the burden associated with the issuance 
of this guidance represent the upper bound estimate of burden, the 
burden if every fresh-cut plant, processor, or operation that does not 
follow the recommendations of the guidance should choose to do so.

A. Industry Profile

    Estimates of the paperwork burden to the fresh-cut industry that 
may result from the publication of FDA's draft guidance are based on 
information from FDA's relationship with a fresh-cut processor who has 
developed and maintained these programs and information from a fresh-
cut produce industry trade association. Because of the small number of 
fresh-cut processors, the agency is able to extrapolate data from 
industry programs to calculate the total estimated upper bound burdens 
that may result from the issuance of this draft guidance (see table 1 
of this document).
    The burden to industry of developing and maintaining the activities 
recommended in FDA's fresh-cut draft guidance will vary considerably 
among fresh-cut processors, depending on the type and number of 
products involved, the sophistication of the equipment or instruments 
(e.g., those that automatically monitor and record food safety 
controls), and the type of controls monitored under any individual 
preventive control program, such as critical control points (CCPs) 
monitored under a hazard analysis and critical control point (HACCP) 
program.
    Currently, the fresh-cut trade association estimates that there are 
250 fresh-cut plants in operation in the United States. 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. FDA estimates that the burden of 
this draft guidance will fall on both existing and new firms entering 
the industry who may follow the recommendations in this draft guidance.

[[Page 11211]]

B. SOPs and SSOPs

    Two general recommendations in this draft guidance are for 
operators to develop and implement both a written standard operating 
procedures (SOPs) plan and a written sanitary standard operation 
procedures (SSOPs) plan. SOPs describe in writing the performance of 
the day-to-day operations of a processing plant. Examples of activities 
that would fall under SOPs would be developing written specifications 
for agricultural inputs, ingredients, and packaging materials; 
production steps for the processing and packaging operations; 
instructions for packaging and storage activities; and procedures for 
equipment maintenance, calibration, and replacement and facility 
maintenance and upkeep; and maintaining SOP records on product 
processing and distribution activities.
    SSOPs provide written instructions or procedures for sanitary 
practices developed for each specific sanitation activity in and around 
the facility. Sanitation activities include procedures for cleaning 
equipment, food-contact surfaces and plant facilities; chemical use and 
storage; cleaning equipment maintenance, use, and storage; pest 
control; and maintaining SSOP records for the activities. From 
communication with the fresh-cut industry, we know that existing fresh-
cut processors already have developed SOPs and SSOPs. We therefore 
consider the development of SOPs and SSOPs to be ``usual and 
customary'' for manufacturers and processors in the fresh-cut industry 
(see 5 CFR 1320.3(b)(2)). Thus, we do not calculate this burden for 
existing firms or new firms entering this industry.
    FDA recommends that facilities not only develop but also maintain 
SOPs and SSOPs. Implementation and maintenance of SOPs and SSOPs 
include maintaining daily records for each of the firm's operational 
days for the following activities: Inspection of incoming ingredients, 
such as the fresh produce and packaging material; facility and 
production sanitation inspections; equipment maintenance, sanitation, 
and visual safety inspections; equipment calibration, e.g., checking pH 
meters; facility and premises pest control audits; temperature controls 
during processing and in storage areas; and audits of ingredients, food 
contact surfaces, and equipment for microbiological contamination.
    Of the 250 fresh-cut processors, the fresh-cut trade association 
estimates that well over half have SOP and SSOP maintenance programs in 
place. Therefore, for purposes of estimating the annual record keeping 
burden for SOP and SSOP maintenance, the agency assumed that 40 percent 
of the existing processors, or 100 firms, and the 10 new firms do not 
have SOP and SSOP maintenance in place. FDA estimates the recordkeeping 
burden for SOP and SSOP maintenance by assuming that these 110 firms 
will choose to implement such a maintenance strategy as a result of the 
recommendations in this draft guidance document, if finalized.
    A typical fresh-cut processing plant operates about 255 days per 
year. For an 8-hour shift, assuming the ingredients are received twice 
during that time, under the recommendations in the draft guidance, 
there would be about 13 records kept (two for inspecting incoming 
ingredients; two for inspecting the facility and production areas once 
every 4 hours; three records for equipment (maintenance, sanitation, 
and visual inspections for defects); one for calibrating equipment; two 
temperature recording audits (one time for each of the two processing 
runs); and three microbiological audits (ingredients, food contact 
surfaces, and equipment)). Therefore, the annual frequency of 
recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x 
13) per year per firm; 110 firms will be performing these activities to 
generate a total 364,650 records (3,315 x 110) annually, assuming all 
firms choose to follow the recommendations on keeping records.
    The total time to record observations for SOP and SSOP maintenance 
is estimated to take 4 minutes or 0.067 hours per record, and the 
number of records maintained is 364,650. Therefore, the total annual 
burden in hours for 110 processors to maintain their SOP and SSOP 
records is approximately 24,432 hours. The maintenance burden for these 
110 firms, along with the annual maintenance burden of audits or 
testing, is estimated in row 1 of table 1 of this document. Again, 
these figures assume that all firms choose to follow the 
recommendations on recording observations.

C. Recall and Traceback

    We recommend that fresh-cut processors establish and maintain 
written traceback procedures to respond to food safety hazard problems 
when they arise and establish and maintain a written contingency plan 
for use in initiating and effecting a recall. In order to facilitate 
tracebacks and recalls, we recommend that processors establish a 
program that documents and tracks fresh-cut products back to the source 
of their raw ingredients, and keep records of product identity and 
specifications, the product in inventory, and where, when, to whom, and 
how much of the product is shipped.
    Traceback programs are used for those times when a food safety 
problem has been identified or a product has been implicated in a 
foodborne illness outbreak. The burden to develop a traceback program 
is a one-time activity estimated to take approximately 20 hours. Firms 
in the industry may choose to begin a traceback program after this 
guidance is made available. The total annual estimated burden for this 
activity for the 250 existing fresh cut firms and the 10 new businesses 
expected to enter the industry annually is 5,200 hours. The burden 
estimate of developing a traceback program is shown in row 2 of table 1 
of this document.
    Traceback program adjustments or revisions may, or may not, be 
needed annually. Firms may test their traceback programs yearly to see 
if adjustments are needed to maintain traceback capabilities. 
Evaluating and updating traceback programs is estimated to take 40 
hours to complete. The annual burden of maintaining a traceback program 
is estimated for the 250 existing firms in the industry plus the 10 
firms new to the industry that may decide to implement this type of 
program. Assuming that each firm completes this exercise once a year, 
the total maintenance burden of traceback programs is 10,400 hours 
yearly. This burden estimate is shown in row 3 of table 1 of this 
document.
    This draft guidance refers to previously approved collections of 
information found in FDA regulations. The recommendations in this draft 
guidance regarding establishing and maintaining a recall plan in Sec.  
7.59 have been approved under OMB control number 0910-0249. Therefore, 
FDA is not calculating a new paperwork burden for recall plans.

D. Preventative Control Program

    When properly designed and maintained by the establishment's 
personnel, a preventive control program is a valuable program for 
managing the safety of food products. A common preventive control 
program used by the fresh-cut industry is a Hazards Analysis and 
Critical Control Point (HACCP) system. A HACCP system allows managers 
to assess the inherent risks and identify hazards attributable to a 
product or a process, and then determine the necessary steps to control 
the hazards. Monitoring and verification

[[Page 11212]]

steps, which include recordkeeping, are included in the HACCP system to 
ensure that potential risks are controlled. We use HACCP as an example 
of a preventive control program that a firm may choose based on the 
recommendations in the draft guidance to estimate the burden of 
developing, implementing, and reviewing a preventive control program.
    FDA estimated the paperwork burden of developing and implementing a 
HACCP plan based on a plan with two CCPs. The number of CCPs may vary 
depending on how the processor chooses to identify the CCPs for a 
particular operation. Of the estimated 250 fresh-cut processors, the 
fresh-cut industry estimates that approximately 50 percent of the firms 
already have HACCP plans in place. Therefore, assuming that the 
remaining fresh-cut processors voluntarily decide to develop a HACCP 
plan, 125 existing firms plus the 10 new firms, will develop a HACCP 
plan.
    Developing a HACCP plan is a one-time activity that is estimated to 
take 100 hours based on a trained HACCP team working on the plan full 
time. The HACCP team identifies the CCPs and measures needed to control 
them, and then identifies the approach needed to verify the 
effectiveness of the controls. During this plan development period, the 
firm chooses the records to be kept and information and observations to 
be recorded. This is a one-time process during the first year. 
Therefore, the total time for 135 processors to develop their 
individual HACCP plans is approximately 13,500 hours. This one-time 
burden is shown in row 4 of table 1 of this document.
    After the HACCP plan is developed, the frequency for recordkeeping 
for implementing or maintaining daily records is estimated to be 510 
records per year. (This is based on a firm choosing to maintain daily 
records for two CCPs for one 8-hour shift per day for each of the 
estimated 255 operational days per year.) The total time to record 
observations for the CCPs was estimated to take 4 minutes or 0.067 
hours per record. Therefore, the total annual records kept by the 135 
firms choosing to implement the HACCP plan is 68,850, and the ``Total 
Hours'' required are 4,613. This annual burden is shown in row 5 of 
table 1 of this document.
    After the HACCP plan has been developed and implemented, we 
recommend that the plan is reviewed regularly to ensure that it is 
working properly. Fresh-cut processors are estimated to review their 
HACCP plans four times per year (once per quarter). Assuming that it 
takes each of the 135 firms 4 hours per review each quarter, the total 
burden of this activity, for firms that choose to review their plans 
annually, is 2,160 hours per year. This annual burden is shown in row 6 
of table 1 of this document.
    FDA estimates the burden of the collection of information described 
in the previous paragraphs as follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                           No. of       Annual  Frequency  Total Annual   Hours per      Total
              Activity                 Recordkeepers    per Recordkeeping     Records       Record       Hours
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SOP and SSOP: Maintenance                          110              3,315       364,650        0.067      24,432
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Traceback Development\2\                           260                  1           260       20           5,200
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Traceback Maintenance                              260                  1           260       40          10,400
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Preventive control program                         135                  1           135      100          13,500
 comparable to a HACCP system:
 System development\2\
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Preventive control program                         135                510        68,850        0.067       4,613
 comparable to a HACCP system:
 System implementation
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Preventive control program                         135                  4           540        4           2,160
 comparable to a HACCP system:
 Implementation review
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One-time burden hours                                                                                     18,700
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Annual burden hours                                                                                       41,605
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\First year activity.

    Summing the ``Total Hours'' column, the estimated one-time 
recordkeeping burden for firms that choose to follow the 
recommendations is 18,700 hours; the annual burden for firms, existing 
and new, is estimated to be 41,605 hours.

III. Comments

    Interested persons may sumbit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance document and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: February 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3084 Filed 3-3-06; 8:45 am]
BILLING CODE 4160-01-S