Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables, 65491-65494 [2010-26829]
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65491
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATE OF ONE-TIME REPORTING BURDEN1
Annual
frequency
per response
Number of
respondents
Activity
Total
average
annual
responses
Hours per response
Total hours
Providing negative response to request for dissolvable
tobacco product documents ...........................................
Submission of dissolvable tobacco products .....................
110
10
1
1
110
10
0.50
230
55
2,300
Total ............................................................................
120
........................
120
..........................
2,355
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These burden estimates were derived
by taking into consideration FDA’s
experience with document production,
experience with submissions pertaining
to other tobacco product-related
information collections, and comments
received in response to other tobacco
product-related information collections.
FDA is limiting the burden on
respondents by only requesting
documents on specific topics that will
have utility for FDA. FDA is requesting
the final version of documents or the
most recent draft in the absence of a
final document. Also, publically
available published abstracts, editorials,
letters, and manuscripts are not being
requested, although FDA would
appreciate a list of such publications.
Information responsive to this section
904(b) information request that has been
previously provided to FDA under the
FD&C Act or other letter requests does
not have to be resubmitted as long as the
document is fully referenced. FDA
believes that the number of documents
being requested in this information
collection will be limited due to the
estimated small number of respondents
and the relatively shorter amount of
time these tobacco products have been
in existence compared to other tobacco
products.
FDA estimates that there are
approximately 120 tobacco product
manufacturers who may be affected by
this collection of information. Of the
total number of manufacturers, FDA
estimates that most manufacturers (110)
will not have documents which will be
responsive to this section 904(b) request
and that they will only need to send a
letter notifying the FDA’s Center for
Tobacco Products that they have no
documents to report. FDA anticipates it
should take no longer than 30 minutes
to draft such a response and send to
FDA. The total one-time hourly burden
to submit this letter to FDA is estimated
to be 55 hours (30 minutes × 110
manufacturers).
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FDA estimates that there are
approximately 10 tobacco product
manufacturers who may have
documents meeting the criteria of this
information collection request. Because
the volume of responsive documents
each of these respondents may have will
likely vary, the corresponding time
burden for each respondent to satisfy
this information collection request will
also vary. Therefore, FDA estimates that
these 10 respondents will average
approximately 230 hours each to satisfy
the requirements of this section 904(b)
request. The total one-time hourly
burden to locate and send documents
meeting the requirements of this request
is estimated to be 2,300 hours (230
hours × 10 manufacturers). The total
one-time hourly burden for this
collection of information is 2,355 hours
(55 hours + 2,300 hours).
Dated: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26830 Filed 10–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0411]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guide To Minimize
Microbial Food Safety Hazards of
Fresh-Cut Fruits and Vegetables
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
24, 2010.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0609. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guide To Minimize Microbial Food
Safety Hazards of Fresh-Cut Fruits and
Vegetables—(OMB Control Number
0910–0609)—Extension
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
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to pathogens, and the potential for
temperature abuse in the processing,
storage, transport, and retail display all
enhance the potential for pathogens to
survive and grow in fresh-cut produce.
The Federal Food, Drug, and Cosmetic
Act (FD&C 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. The
guidance document entitled ‘‘Guide to
Minimize Microbial Food Safety
Hazards of Fresh-cut Fruits and
Vegetables,’’ which is available at:
https://www.fda.gov/FoodGuidances,
provides FDA’s recommendations to
fresh-cut produce processors about how
to avoid contamination of their product
with pathogens. The guidance is in
addition to the current good
manufacturing practices (cGMPs)
provided in part 110 of FDA’s
regulations (21 CFR part 110). The
guidance is intended to assist fresh-cut
produce 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. Accordingly, FDA encourages
fresh-cut produce processors to adopt
the general recommendations in the
guidance and to tailor practices to their
individual operations.
The guidance provides information
and recommended procedures designed
to help fresh-cut produce processors
minimize microbial food safety hazards.
The recommended procedures
contained in the guidance are voluntary.
Both FDA and fresh-cut produce
processors will use and benefit from the
information collected.
Two general recommendations in the
guidance are for operators to develop
and implement both a written Standard
Operating Procedures (SOPs) plan and a
Sanitary Standard Operation Procedures
(SSOPs) plan. SOPs and SSOPs are
important components to properly
implemented and monitored cGMPs
that are required for processed food
operations under part 110. Other
recommended programs that require
documentation and recordkeeping are
recall and traceback programs. In the
event of a food safety concern,
processors who adopt these
recommended programs will be
prepared to recall products from the
market place or be able to trace back
fresh produce, which might be
implicated in a foodborne illness
outbreak, to its source. Fresh-cut
produce processors are also asked to
consider the application of Hazards
Analysis and Critical Control Point
(HACCP) principles or comparable
preventive control programs to the
processing of fruits and vegetables.
FDA, other Federal and State food
agencies, industry, and food
establishments have found such
preventive control programs, when
properly designed and maintained by
the establishment’s personnel, to be
valuable in managing the safety of food
products.
FDA’s fresh-cut guidance represents
the agency’s recommendations to
industry based on the current state of
science. Following the
recommendations set forth in the freshcut guidance is the choice of each
individual fresh-cut operation, plant, or
processor. FDA estimates the burden of
the 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 the
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.
In the Federal Register of August 11,
2010 (75 FR 48692), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received .
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of recordkeepers
Activity
Annual frequency per
recordkeeping
122
10
290
3,315
1
1
404,430
10
290
0.067
20
40
27,097
200
11,600
10
1
10
100
1,000
145
510
73,950
0.067
4,955
145
4
580
4
2,320
........................
........................
........................
........................
47,172
SOP and SSOP: Maintenance ............................................
Traceback development .......................................................
Traceback maintenance .......................................................
Preventive control program comparable to a HACCP system: System development ................................................
Preventive control program comparable to a HACCP system: System implementation ............................................
Preventive control program comparable to a HACCP system: Implementation review .............................................
Annual burden hours ....................................................
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1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Industry Profile
Estimates of the paperwork burden to
the fresh-cut industry are based on
information received from 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
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to calculate the total estimated upper
bound burdens (see table 1 of this
document).
The burden to industry of developing
and maintaining the activities
recommended in FDA’s 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
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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 HACCP program.
In 2007, FDA estimated that there
were 250 fresh-cut plants in operation
in the United States, and that
approximately 10 new firms enter the
fresh-cut industry each year (72 FR
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11364, at 11366, March 13, 2007). Using
these figures, we estimate that in 2010
there are 280 fresh-cut plants in
operation and that approximately 10
new firms will enter the fresh-cut
industry each year, over the next 3
years. 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 the fresh-cut guidance will
fall on both existing and new firms
entering the industry who may follow
the recommendations in the guidance.
SOPs and SSOPs
Two general recommendations in the
guidance are for operators to develop
and implement both a written SOPs
plan and a written 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
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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
280 fresh-cut processors, we estimate
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 112 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 122
firms will choose to implement such a
maintenance strategy as a result of the
recommendations in the fresh-cut
guidance document.
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
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); 1 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 × 13) per year per firm;
122 firms will be performing these
activities to generate a total 404,430
records (3,315 × 122) 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 404,430.
Therefore, the total annual burden in
hours for 122 processors to maintain
their SOP and SSOP records is
approximately 27,097 hours (404,430 ×
0.067). The maintenance burden for
these 122 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.
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65493
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. In 2007, we previously estimated
that firms in the industry would choose
to begin a traceback program after the
guidance was made available and
estimated that the 250 existing fresh-cut
firms and the 10 new businesses
expected to enter the industry annually
from 2007 to 2010 would spend 5,200
hours (250 × 20) on this activity.
Accordingly, we only need to estimate
the burden of this one-time activity on
the 10 new businesses expected to enter
the industry annually in the next 3
years. We estimate that the 10 new firms
will spend 20 hours each preparing a
traceback program, for a total of 200
hours (10 × 20). 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 280
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 11,600 hours yearly (290 ×
40). This burden estimate is shown in
row 3 of table 1 of this document.
The fresh-cut guidance refers to
previously approved collections of
information found in FDA regulations.
The recommendations in this document
regarding establishing and maintaining
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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.
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 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. 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.
In 2007, we previously estimated that,
of the estimated 250 fresh-cut
processors, approximately 50 percent of
the firms already have HACCP plans in
place. We therefore assumed that the
remaining fresh-cut processors (125
existing firms plus the 10 new firms),
would voluntarily develop a HACCP
plan, and estimated that 135 processors
would spend 13,500 hours (135 × 100)
to develop their individual HACCP
plans. Accordingly, we only need to
estimate the burden of this one-time
activity on the 10 new businesses
expected to enter the industry annually
in the next 3 years. We estimate that the
10 new firms will spend 100 hours each
to develop their individual HACCP
plans, for a total of 1,000 hours (10 ×
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100). This burden estimate 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 145 firms (the 135 firms
plus the 10 new businesses expected to
enter the industry) is 73,950 (510 × 145),
and the total hours required are 4,955
(73,950 records × 0.067 hours per record
= 4,954.65, rounded to 4,955). 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 145
firms 4 hours per review each quarter,
the total burden of this activity, for
firms that choose to review their plans
annually, is 2,320 (145 × 4 × 4) hours
per year. This annual burden is shown
in row 6 of table 1 of this document.
Dated: October 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26829 Filed 10–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Award of Three Single-Source
Expansion Supplements to The
University of Colorado Health Sciences
Center in Aurora, CO, The University of
Massachusetts (Institute for
Community Inclusion) in Boston, MA,
and The University of Minnesota (The
Research and Training Center) in
Minneapolis, MN
Administration on
Developmental Disabilities, ACF, HHS.
ACTION: Notice.
AGENCY:
CFDA Number: 93.631.
Statutory Authority: This award will
be made pursuant to Section 161 of the
Developmental Disabilities Assistance
and Bill of Rights Act of 2000 (42 U.S.C.
15081–15083).
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Amount of Award: $200,000 per
award.
Project Period: 9/30/2010–9/29/2012.
SUMMARY: This notice announces that
the Administration for Children and
Families (ACF), Administration on
Developmental Disabilities (ADD) has
awarded three single-source expansion
supplements for data collection,
analyses, and reporting.
The following projects will be funded:
The University of Colorado Health
Sciences Center, Aurora, CO. This
cooperative agreement will allow for
data collection, analysis and reporting
on spending and services for
individuals with intellectual and
developmental disabilities, including
disaggregation of data related to specific
demographic groups. The project will
analyze and report on trends in
utilization of and spending for
institutional services and home and
community-based services. Project staff
will also participate in collaborative
efforts with ADD and other data
collection projects to review and report
on unmet needs in data collection,
analyses, and reporting activities that
would promote the self-determination,
independence, productivity, and
integration and inclusion of people with
intellectual and developmental
disabilities in all facets of community
life.
The University of Massachusetts
(Institute for Community Inclusion),
Boston, MA. This cooperative agreement
will provide for data collection and
analyses related to the effectiveness of
State agencies in promoting community
integrated employment for individuals
with intellectual and developmental
disabilities. The project will collect
data, analyze, and report on the
employment and economic status of
individuals with intellectual and
developmental disabilities including
disaggregation of data related to specific
demographic groups. The project will
also make recommendations related to
the standardization of data and
reporting of employment outcomes.
Project staff will also participate in
collaborative efforts with ADD and other
data collection projects to review and
report on unmet needs in data
collection, analyses, and reporting
activities that would promote the selfdetermination, independence,
productivity, and integration and
inclusion of people with intellectual
and developmental disabilities in all
facets of community life.
The University of Minnesota (The
Research and Training Center),
Minneapolis, MN. This cooperative
agreement will provide for data
collection, analyses, and reporting of
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]]>Agencies
[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65491-65494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0411]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guide To Minimize
Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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.
DATES: Fax written comments on the collection of information by
November 24, 2010.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0609.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and
Vegetables--(OMB Control Number 0910-0609)--Extension
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
[[Page 65492]]
to pathogens, and the potential for temperature abuse in the
processing, storage, transport, and retail display all enhance the
potential for pathogens to survive and grow in fresh-cut produce.
The Federal Food, Drug, and Cosmetic Act (FD&C 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. The guidance document
entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut
Fruits and Vegetables,'' which is available at: https://www.fda.gov/FoodGuidances, provides FDA's recommendations to fresh-cut produce
processors about how to avoid contamination of their product with
pathogens. The guidance is in addition to the current good
manufacturing practices (cGMPs) provided in part 110 of FDA's
regulations (21 CFR part 110). The guidance is intended to assist
fresh-cut produce 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. Accordingly, FDA encourages fresh-cut produce processors to
adopt the general recommendations in the guidance and to tailor
practices to their individual operations.
The guidance provides information and recommended procedures
designed to help fresh-cut produce processors minimize microbial food
safety hazards. The recommended procedures contained in the guidance
are voluntary. Both FDA and fresh-cut produce processors will use and
benefit from the information collected.
Two general recommendations in the guidance are for operators to
develop and implement both a written Standard Operating Procedures
(SOPs) plan and a Sanitary Standard Operation Procedures (SSOPs) plan.
SOPs and SSOPs are important components to properly implemented and
monitored cGMPs that are required for processed food operations under
part 110. Other recommended programs that require documentation and
recordkeeping are recall and traceback programs. In the event of a food
safety concern, processors who adopt these recommended programs will be
prepared to recall products from the market place or be able to trace
back fresh produce, which might be implicated in a foodborne illness
outbreak, to its source. Fresh-cut produce processors are also asked to
consider the application of Hazards Analysis and Critical Control Point
(HACCP) principles or comparable preventive control programs to the
processing of fruits and vegetables. FDA, other Federal and State food
agencies, industry, and food establishments have found such preventive
control programs, when properly designed and maintained by the
establishment's personnel, to be valuable in managing the safety of
food products.
FDA's 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 the 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 the 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.
In the Federal Register of August 11, 2010 (75 FR 48692), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received .
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Activity No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
SOP and SSOP: Maintenance....... 122 3,315 404,430 0.067 27,097
Traceback development........... 10 1 10 20 200
Traceback maintenance........... 290 1 290 40 11,600
Preventive control program 10 1 10 100 1,000
comparable to a HACCP system:
System development.............
Preventive control program 145 510 73,950 0.067 4,955
comparable to a HACCP system:
System implementation..........
Preventive control program 145 4 580 4 2,320
comparable to a HACCP system:
Implementation review..........
-------------------------------------------------------------------------------
Annual burden hours......... .............. .............. .............. .............. 47,172
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Industry Profile
Estimates of the paperwork burden to the fresh-cut industry are
based on information received from 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
(see table 1 of this document).
The burden to industry of developing and maintaining the activities
recommended in FDA's 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 controls monitored under any individual preventive control
program, such as critical control points (CCPs) monitored under a HACCP
program.
In 2007, FDA estimated that there were 250 fresh-cut plants in
operation in the United States, and that approximately 10 new firms
enter the fresh-cut industry each year (72 FR
[[Page 65493]]
11364, at 11366, March 13, 2007). Using these figures, we estimate that
in 2010 there are 280 fresh-cut plants in operation and that
approximately 10 new firms will enter the fresh-cut industry each year,
over the next 3 years. 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 the fresh-cut guidance
will fall on both existing and new firms entering the industry who may
follow the recommendations in the guidance.
SOPs and SSOPs
Two general recommendations in the guidance are for operators to
develop and implement both a written SOPs plan and a written 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 280 fresh-cut processors, we estimate 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 112 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 122 firms
will choose to implement such a maintenance strategy as a result of the
recommendations in the fresh-cut guidance document.
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 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); 1 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;
122 firms will be performing these activities to generate a total
404,430 records (3,315 x 122) 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 404,430. Therefore, the total annual
burden in hours for 122 processors to maintain their SOP and SSOP
records is approximately 27,097 hours (404,430 x 0.067). The
maintenance burden for these 122 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.
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. In
2007, we previously estimated that firms in the industry would choose
to begin a traceback program after the guidance was made available and
estimated that the 250 existing fresh-cut firms and the 10 new
businesses expected to enter the industry annually from 2007 to 2010
would spend 5,200 hours (250 x 20) on this activity. Accordingly, we
only need to estimate the burden of this one-time activity on the 10
new businesses expected to enter the industry annually in the next 3
years. We estimate that the 10 new firms will spend 20 hours each
preparing a traceback program, for a total of 200 hours (10 x 20). 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 280 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 11,600 hours
yearly (290 x 40). This burden estimate is shown in row 3 of table 1 of
this document.
The fresh-cut guidance refers to previously approved collections of
information found in FDA regulations. The recommendations in this
document regarding establishing and maintaining
[[Page 65494]]
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.
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 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. 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.
In 2007, we previously estimated that, of the estimated 250 fresh-
cut processors, approximately 50 percent of the firms already have
HACCP plans in place. We therefore assumed that the remaining fresh-cut
processors (125 existing firms plus the 10 new firms), would
voluntarily develop a HACCP plan, and estimated that 135 processors
would spend 13,500 hours (135 x 100) to develop their individual HACCP
plans. Accordingly, we only need to estimate the burden of this one-
time activity on the 10 new businesses expected to enter the industry
annually in the next 3 years. We estimate that the 10 new firms will
spend 100 hours each to develop their individual HACCP plans, for a
total of 1,000 hours (10 x 100). This burden estimate 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 145 firms
(the 135 firms plus the 10 new businesses expected to enter the
industry) is 73,950 (510 x 145), and the total hours required are 4,955
(73,950 records x 0.067 hours per record = 4,954.65, rounded to 4,955).
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 145 firms 4 hours per review each quarter, the total
burden of this activity, for firms that choose to review their plans
annually, is 2,320 (145 x 4 x 4) hours per year. This annual burden is
shown in row 6 of table 1 of this document.
Dated: October 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26829 Filed 10-22-10; 8:45 am]
BILLING CODE 4160-01-P
