[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65491-65494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26829]
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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.
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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 [email protected]. 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: http://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\
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Annual
Activity No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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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..........
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Annual burden hours......... .............. .............. .............. .............. 47,172
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\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