[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:

[[Page 48694]]



                               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
----------------------------------------------------------------------------------------------------------------
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