[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4350-4353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01423]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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

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 (the PRA).

DATES: Fax written comments on the collection of information by 
February 26, 2014.

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

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 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 
(the FD&C 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.

[[Page 4351]]

    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 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. 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. 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.
    In the Federal Register of November 20, 2013 (78 FR 69684), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two letters in response to the 
notice, with one containing multiple comments. Those comments outside 
the scope of the four collection of information topics on which the 
notice solicits comments are not discussed in this document.
    One comment suggested that, to ensure the safety of consumers, FDA 
should mandate by law the recommendations in the guidance. The comment 
stated that the Food Safety Modernization Act (FSMA) gave FDA authority 
``to require producers to implement prevention based food safety 
standards.'' In response, we note that Agency guidance documents are 
issued consistent with our good guidance practices regulations (GGPs) 
found at 21 CFR 10.115. Guidance documents represent our current 
thinking on a particular subject, but do not create or confer any 
rights for or on any person and do not operate to bind FDA or the 
public. The guidance document entitled ``Guide to Minimize Microbial 
Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' discusses 
microbiological hazards presented by most fresh-cut fruits and 
vegetables and recommends control measures for such hazards in the 
processing of such produce. Firms are free to adopt as many or as few 
of the guidance's recommendations as they choose.
    At the same time, we continue our rulemaking efforts under FSMA to 
build a food safety system for the future that makes modern, science-, 
and risk-based preventive controls the norm across all sectors of the 
food system. In the Federal Register of January 16, 2013 (78 FR 3504), 
we published a proposed rule proposing to establish science-based 
standards for growing, harvesting, packing, and holding produce on 
domestic and foreign farms. In the same issue of the Federal Register, 
we published another proposed rule proposing to amend our regulation 
for current good manufacturing practice in manufacturing, packing, or 
holding human food to modernize it and to add requirements for domestic 
and foreign facilities that are required to register under the FD&C to 
establish and implement hazard analysis and risk-based preventive 
controls for human food (78 FR 3646).
    One comment agreed, generally, that the information collection 
provisions of the guidance are necessary. Another comment agreed, 
generally, that our burden hour estimates are accurate, but suggested 
they did not take into account the financial cost of training required 
for the HACCP team. With regard to the latter comment, FDA notes that, 
although only an estimate of reporting and recordkeeping burden is 
included in Federal Register notices announcing agency information 
collection activities (5 CFR 1320.5(a)(1)(iv)), we have provided an 
estimate of the cost burden to industry in our supporting statement for 
this collection, which is available at www.reginfo.gov.
    One comment suggested that we should require all processors in the 
fresh-cut industry to electronically upload their SOPs and SSOPs to an 
FDA Web site for review and audit. The comment maintained that such a 
system ``would reduce the amount of man hours spend [sic] collecting, 
reviewing, filing, auditing, and analyzing the written SOPs SSOPS 
[sic]. It would also make communication, education, and support readily 
available to the fresh-cut industry.'' Finally, one comment suggested 
that we should require the fresh-cut industry to use an automated 
system and standardized templates to scan and submit data to us for 
review. As an example, the comment referenced the system used by 
hospitals to submit information to a ``national healthcare regulator.'' 
The comment also noted the periodic scheduling of audits and 
inspections of hospitals by the regulator.
    As previously discussed, the guidance document entitled ``Guide to 
Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and 
Vegetables'' represents our current thinking on the microbiological 
hazards presented by most fresh-cut fruits and vegetables and provides 
recommended control measures to protect against these hazards. We may 
not impose requirements through Agency guidance.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 4352]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 comparable to a HACCP system: System                   10                1               10              100            1,000
 development.......................................................
Preventive control program comparable to a HACCP system: System                  145              510           73,950            0.067            4,955
 implementation....................................................
Preventive control program comparable to a HACCP system:                         145                4              580                4            2,320
 Implementation review.............................................
                                                                    ------------------------------------------------------------------------------------
    Annual burden hours............................................  ...............  ...............  ...............  ...............           47,172
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 122) 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 a 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 a 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.

[[Page 4353]]

    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: January 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01423 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P