[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