Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-Cut Fruits and Vegetables; Availability, 11209-11212 [E6-3084]
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Federal Register / Vol. 71, No. 43 / Monday, March 6, 2006 / Notices
Medicare Part D Low-Income Subsidy
(LIS) or Medicaid. This will allow BDT
to create the ‘‘cleanest’’ list possible of
potential LIS-eligibles. BDT reported
that use of similarly refined lists for
outreach efforts to low income
populations has increased the
enrollment success rate, and decreased
the cost of enrollment.
Secondly, NCOA is seeking CMS
funding to evaluate alternative, listbased outreach strategies. NCOA
intends to partner with L&M Policy
Research for the evaluation of
intervention approaches. In addition,
NCOA will rely on Bridgespan to be an
advisor for cost-effectiveness studies.
Evaluation of these approaches could
supplement existing market research
knowledge, and be useful for quality
improvement of ongoing and future
beneficiary outreach efforts for LIS.
FOR FURTHER INFORMATION CONTACT:
Susie Butler, Project Officer, Center for
Beneficiary Choices, Centers for
Medicare & Medicaid Services, 7500
Security Blvd., Stop S2–22–05,
Baltimore, MD 21244, (410) 786–7211 or
Judy Norris, Grants Officer, Department
of Health and Human Services, OAGM/
CMS, 7500 Security Blvd., Stop C2–21–
15, Baltimore, MD 21244, (410) 786–
5130.
Authority: Catalog of Federal Domestic
Assistance Program No. 93–779, Center for
Medicare and Medicaid Services, Research,
Demonstrations and Evaluations; Section
1110 of the Social Security Act.
Dated: February 28, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and
Medicaid Services.
[FR Doc. 06–2092 Filed 3–1–06; 1:52 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
hsrobinson on PROD1PC70 with NOTICES
(a) Authority Delegated
Authority to make placement
determinations for all unaccompanied
alien children who are in Federal
Jkt 208001
(b) Limitations and Conditions
Draft Guidance for Industry: Guide to
Minimize Food Safety Hazards of
Fresh-Cut Fruits and Vegetables;
Availability
This delegation shall be exercised
under financial and administrative
requirements applicable to all
Administration for Children and
Families authorities. In making
placement determinations, the DUCS
Director and DUCS Program Specialists
shall consult with the Department of
Homeland Security to ensure that such
determinations ensure that
unaccompanied alien children: Are
likely to appear for all hearings or
proceedings in which they are involved;
are protected from smugglers,
traffickers, or others who might seek to
victimize or otherwise engage them in
criminal, harmful, or exploitive activity;
and are placed in a setting in which
they are not likely to pose a danger to
themselves or others. In making
placement determinations, the DUCS
Director and DUCS Program Specialists
shall not release unaccompanied alien
children upon their own recognizance.
The DUCS Director and DUCS Program
Specialists will follow the policies and
procedures on placement
determinations set forth in DUCS
placement guidelines. In appropriate
cases, as set forth in DUCS placement
guidelines, DUCS Program Specialists
will obtain approval from the DUCS
Director prior to making and
implementing placement
determinations. This authority may not
be further redelegated.
(d) Effective Date
Notice is hereby given that I have
delegated to the Director of the Division
of Unaccompanied Children’s Services
(DUCS) and to the DUCS Program
Specialists, the following authority
vested in the Director of the Office of
Refugee Resettlement under the
Homeland Security Act of 2002, Public
Law No. 107–296, 462, 6 U.S.C. 279.
14:30 Mar 03, 2006
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
None.
Statement of Organization, Functions
and Delegations of Authority
VerDate Aug<31>2005
custody by reason of their immigration
status and to implement such placement
determinations under the Homeland
Security Act of 2002, Public Law 107–
296, 462(b)(1)(C) and (D), 6 U.S.C.
279(b)(1)(C) and (D).
(c) Effect on Existing Delegations
Administration for Children and
Families
11209
This delegation of authority is
effective upon date of signature. In
addition, I hereby affirm and ratify any
actions taken by the DUCS Director or
the DUCS Program Specialists, which,
in effect, involved the exercise of this
authority prior to the effective date of
this delegation.
Dated: December 14, 2005.
Nguyen Van Hanh,
Director, Office of Refugee Resettlement.
[FR Doc. E6–3087 Filed 3–3–06; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. 2006D–0079]
Food and Drug Administration.
Notice.
AGENCY:
ACTION:
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 readyto-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
https://www.fda.gov/dockets/ecomments.
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Federal Register / Vol. 71, No. 43 / Monday, March 6, 2006 / Notices
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: amy.green@fda.hhs.gov.
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.
hsrobinson on PROD1PC70 with NOTICES
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
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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
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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.
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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.
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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
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11211
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 § 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
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Federal Register / Vol. 71, No. 43 / Monday, March 6, 2006 / Notices
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 onetime 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 onetime 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 BURDEN1
No. of
Recordkeepers
Activity
Annual
Frequency per
Recordkeeping
Total Annual
Records
Hours per
Record
0.067
Total
Hours
SOP and SSOP: Maintenance
110
3,315
364,650
24,432
Traceback Development2
260
1
260
20
5,200
Traceback Maintenance
260
1
260
40
10,400
Preventive control program comparable to a HACCP system: System development2
135
1
135
100
13,500
Preventive control program comparable to a HACCP system: System implementation
135
510
68,850
Preventive control program comparable to a HACCP system: Implementation review
135
4
540
0.067
4,613
4
2,160
One-time burden hours
18,700
Annual burden hours
41,605
1There
2First
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
hsrobinson on PROD1PC70 with NOTICES
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
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14:30 Mar 03, 2006
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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.
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
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.cfsan.fda.gov/guidance.html.
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]]>Agencies
[Federal Register Volume 71, Number 43 (Monday, March 6, 2006)]
[Notices]
[Pages 11209-11212]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3084]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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: amy.green@fda.hhs.gov.
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.
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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
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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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total
Activity Recordkeepers per Recordkeeping Records Record Hours
----------------------------------------------------------------------------------------------------------------
SOP and SSOP: Maintenance 110 3,315 364,650 0.067 24,432
----------------------------------------------------------------------------------------------------------------
Traceback Development\2\ 260 1 260 20 5,200
----------------------------------------------------------------------------------------------------------------
Traceback Maintenance 260 1 260 40 10,400
----------------------------------------------------------------------------------------------------------------
Preventive control program 135 1 135 100 13,500
comparable to a HACCP system:
System development\2\
----------------------------------------------------------------------------------------------------------------
Preventive control program 135 510 68,850 0.067 4,613
comparable to a HACCP system:
System implementation
----------------------------------------------------------------------------------------------------------------
Preventive control program 135 4 540 4 2,160
comparable to a HACCP system:
Implementation review
----------------------------------------------------------------------------------------------------------------
One-time burden hours 18,700
----------------------------------------------------------------------------------------------------------------
Annual burden hours 41,605
----------------------------------------------------------------------------------------------------------------
\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
https://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
