[Federal Register Volume 72, Number 48 (Tuesday, March 13, 2007)]
[Notices]
[Pages 11364-11368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0079]


Draft Final Guidance for Industry: Guide to Minimize Food Safety 
Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency 
Information Collection Activities; Submission for Office of Management 
and Budget Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft final guidance document entitled ``Guidance for 
Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut 
Fruits and Vegetables'' (the draft final fresh-cut guidance). This 
document complements FDA's Current Good Manufacturing Practice (CGMP) 
requirements for foods by providing specific guidance on the processing 
of fresh-cut produce. The draft final 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 and retail establishments in a ready-
to-eat form. FDA also is announcing that a proposed collection of 
information has been submitted to the Office of Management and Budget 
(OMB) for review and clearance under the Paperwork Reduction Act of 
1995 (the PRA).

DATES: Submit written or electronic comments on the guidance at any 
time. Fax written comments on the collection of information by April 
12, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974. Submit written requests for single copies of the 
draft final guidance entitled: ``Guidance for Industry: Guide to 
Minimize Microbial Food Safety Hazards for Fresh-Cut Fruits and 
Vegetables'' to the Center for Food Safety and Applied Nutrition, 
Office of Plant and Dairy Foods (HFS-306), 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-1400 or FAX: 301-436-2651. Include a 
self-addressed adhesive label to assist that office in processing your 
request.
    Submit written comments on the draft final guidance, identified 
with Docket

[[Page 11365]]

No. 2006D-0079, 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance. A copy of the draft final 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. Persons with access to the Internet may obtain 
the draft final guidance at http://www.cfsan.fda.gov/~dms/
guidance.html.

FOR FURTHER INFORMATION CONTACT:
    With regard to the information collection: Jonna Capezzuto, Office 
of the Chief Information Officer (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
    With regard to the draft final guidance document: Amy Green, Center 
for Food Safety and Applied Nutrition (HFS-306), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2025 or FAX: 301-436-2651, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Fresh-cut fruits and vegetables are minimally processed fruits and 
vegetables that have been altered in form by peeling, slicing, 
chopping, shredding, coring, or trimming, with or without washing or 
other treatment, prior to being packaged for use by the consumer or a 
retail establishment. 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 chopping, 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 
final fresh-cut guidance. The draft final fresh-cut guidance is 
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. The draft final 
guidance was revised based on public comments. This draft final 
guidance represents FDA'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. You may use an 
alternative approach if such approach satisfies the requirements of the 
applicable statutes and regulations. If you want to discuss an 
alternative approach, contact the FDA staff responsible for 
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

II. Paperwork Reduction Act of 1995

    This draft final guidance contains information collection 
provisions that are subject to review by the OMB under the PRA (44 
U.S.C 3501-3520). Under the PRA, Federal agencies must obtain approval 
from 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 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, in the Federal Register of March 6, 2006 (71 FR 11209), 
FDA gave interested persons 60 days to comment on the information 
collection provisions in the draft guidance. FDA received a number of 
comments on the draft guidance but received no comments regarding the 
information collection provisions.
    After publishing the 60-day notice requesting public comment, 
section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to 
submit the proposed collection to OMB for review and clearance. In 
compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information to OMB for review and clearance. FDA 
will not finalize this guidance unless and until OMB approves the 
collection of information. If the collection is approved, FDA will 
publish a notice in the Federal Register announcing that the guidance 
is final and providing an OMB control number.

Draft Final Guidance for Industry: Guide to Minimize Food Safety 
Hazards for 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). 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 draft final fresh-cut 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 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 final fresh-cut 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 final fresh-cut guidance (see table 1 of this document).
    The burden to industry of developing and maintaining the activities 
recommended in FDA's draft final fresh-cut 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

[[Page 11366]]

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 final fresh-cut guidance will fall on both existing and new 
firms entering the industry who may follow the recommendations in the 
guidance.

B. SOPs and SSOPs

    Two general recommendations in this draft final 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 recordkeeping 
burden for SOP and SSOP maintenance programs, 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 programs in place. FDA 
estimates the recordkeeping burden for SOP and SSOP maintenance 
programs by assuming that these 110 firms will choose to implement such 
a maintenance strategy as a result of the recommendations in this draft 
final fresh-cut guidance document, when 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 final 
guidance, there would be about 13 records kept (2 for inspecting 
incoming ingredients; 2 for inspecting the facility and production 
areas once every 4 hours; 3 records for equipment (maintenance, 
sanitation, and visual inspections for defects); one for calibrating 
equipment; 2 temperature recording audits (1 time for each of the 2 
processing runs); and 3 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.

[[Page 11367]]

    This draft final fresh-cut guidance refers to previously approved 
collections of information found in FDA regulations. The 
recommendations in this document regarding establishing and maintaining 
a recall plan, as provided in 21 CFR 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 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 
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 final 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 2 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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                                       Annual Frequency
     Activity            No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
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SOP and SSOP:                    110              3,315            364,650              0.067             24,432
 Maintenance
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Traceback                        260                  1                260                 20              5,200
 Development\2\
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Traceback                        260                  1                260                 40             10,400
 Maintenance
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Preventive                       135                  1                135                100             13,500
 control program
 comparable to a
 HACCP system:
System
 development\2\
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Preventive                       135                510             68,850              0.067              4,613
 control program
 comparable to a
 HACCP system:
System
 implementation
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Preventive                       135                  4                540                  4              2,160
 control program
 comparable to a
 HACCP system:
Implementation
 review
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One-time burden    .................  .................  .................  .................             18,700
 hours
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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 submit written or electronic comments to the 
Division

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of Dockets Management (see ADDRESSES) regarding this guidance document 
at any time. 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 final guidance 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

IV. Electronic Access

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

    Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4446 Filed 3-12-07; 8:45 am]
BILLING CODE 4160-01-S