[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69684-69686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1432]


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 invites 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 January 21, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written

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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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our 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 increase the potential for pathogens to survive and grow in 
fresh-cut produce.
    Sections 301 and 402 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 331 and 342) prohibits the distribution of adulterated food 
in interstate commerce. In response to the increased consumption of 
fresh-cut fruits and vegetables and the potential for foodborne illness 
associated with these products, we recognize 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 our recommendations to 
fresh-cut produce processors about how to avoid contamination of their 
product with pathogens. The guidance is in addition to the good 
manufacturing practice (GMP) regulations found in part 110 (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, we encourage 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 
(SOP) plan and a Sanitary Standard Operation Procedures (SSOP) plan. 
SOPs and SSOPs are important components to properly implement and 
monitor GMP, which 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 marketplace or be able to 
traceback fresh produce 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. An 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. FDA, along with other Federal 
and State food Agencies and 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.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                  No. of records                  Average burden
            Activity                  No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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 an HACCP system:
 System development.............
Preventive control program                   145             510          73,950           0.067           4,955
 comparable to an HACCP system:
 System implementation..........

[[Page 69686]]

 
Preventive control program                   145               4             580               4           2,320
 comparable to an HACCP system:
 Implementation review..........
    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.

A. 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. We estimate that there are 280 
fresh-cut plants in operation and that approximately 10 new firms will 
enter the fresh cut industry over the next 3 years.

B. SOPs and SSOPs

    We consider the guidance's recommendation to develop SOPs and SSOPs 
to be ``usual and customary'' for manufacturers and processors in the 
fresh-cut industry (see 5 CFR 1320.3(b)(2)). Therefore, we do not 
calculate this burden.
    We recommend that facilities not only develop but also maintain 
SOPs and SSOPs. Of the 280 fresh-cut processors, we estimate that 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, we assume 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. We estimate 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 guidance.
    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 22) annually.
    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 is estimated in row 1 of Table 
1.

C. Recall and Traceback

    The burden to develop a traceback program is a one-time activity 
estimated to take approximately 20 hours. Accordingly, we only need to 
estimate the burden of this one-time activity on the 10 new businesses 
expected to enter the industry 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.
    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. 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.
    The guidance refers to previously approved collections of 
information found in our regulations. The recommendations regarding 
establishing and maintaining a recall plan, as provided in 21 CFR 7.59, 
have been approved under OMB control number 0910-0249. Therefore, we 
are not calculating a paperwork burden for recall plans.

D. Preventative Control Program

    Developing an HACCP plan is a one-time activity during the first 
year that is estimated to take 100 hours based on a trained HACCP team 
working on the plan full time. Accordingly, we only need to estimate 
the burden on the 10 new businesses expected to enter the industry 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.
    After the HACCP plan is developed, the frequency for recordkeeping 
for implementing or maintaining daily records is estimated to be 510 
records per year. The total time to record observations is estimated to 
take 4 minutes or 0.067 hours per record. Of the 280 existing firms, we 
estimate that approximately 135 firms have not implemented HACCP plans. 
We assume that these fresh-cut processors (135 existing firms plus 10 
new firms) would voluntarily implement an HACCP plan. Therefore, the 
total annual records kept by 145 firms 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.
    Fresh-cut processors are presumed to review their HACCP plans four 
times per year (once per quarter). Estimating that it takes each of the 
145 firms 4 hours per review each quarter, the total burden of this 
activity is 2,320 (145 x 4 x 4) hours per year. This annual burden is 
shown in row 6 of Table 1.

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27782 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P