[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48692-48696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19747]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0411]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions in the guidance document entitled ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and
Vegetables.''
DATES: Submit either electronic or written comments on the collection
of information by October 12, 2010.
[[Page 48693]]
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under 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, including
each proposed extension of an existing 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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these 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.
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 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 (the act) prohibits the
distribution of adulterated food in interstate commerce (21 U.S.C. 331
and 342). In response to the increased consumption of fresh-cut fruits
and vegetables and the potential for foodborne illness associated with
these products, FDA recognizes the need for guidance specific to the
processing of fresh-cut fruits and vegetables. 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. This guidance is in addition to the good manufacturing
practices (GMPs) 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 GMPs 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 this guidance on industry by assuming that those in the
fresh-cut industry who do not currently follow the recommendations put
forth in the guidance will find it of value to do so. Therefore, the
estimates of the burden associated with the issuance of this guidance
represent the upper bound estimate of burden, the burden if every
fresh-cut plant, processor, or operation that does not follow the
recommendations of the guidance should choose to do so.
FDA estimates the burden of this collection of information as
follows:
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Table 1.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency per Total Annual
Activity Recordkeepers Recordkeeping Records Hours per Record Total Hours
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SOP and 122 3,315 404,430 0.067 27,097
SSOP:
Maintenance
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Traceback 10 1 10 20 200
Development
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Traceback 290 1 290 40 11,600
Maintenance
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Preventive 10 1 10 100 1,000
Control
Program
Comparable
to a HACCP
System:
System
Development
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Preventive 145 510 73,950 0.067 4,955
Control
Program
Comparable
to a HACCP
System:
System
Implementat
ion
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Preventive 145 4 580 4 2,320
Control
Program
Comparable
to a HACCP
System:
Implementat
ion 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 11364 at 11366). 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 current good
manufacturing practices-related, recall, HACCP, and other activities.
FDA estimates that the burden of this 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 this guidance are for operators to
develop and implement both a 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
[[Page 48695]]
guidance, there would be about 13 records kept (2 for inspecting
incoming ingredients; 2 for inspecting the facility and production
areas once every 4 hours; 3 records for equipment (maintenance,
sanitation, and visual inspections for defects); one for calibrating
equipment; 2 temperature recording audits (1 time for each of the 2
processing runs); and 3 microbiological audits (ingredients, food
contact surfaces, and equipment)). Therefore, the annual frequency of
recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x
13) per year per firm; 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 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
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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: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19747 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S