[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11364-11368]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr07-60]
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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: amy.green@fda.hhs.gov.
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
[[Page 11368]]
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