[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Notices]
[Pages 6793-6795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3631]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Standards for the Growing, Harvesting, Packing, and 
Holding of Produce for Human Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection associated with the 
standards for the growing, harvesting, packing, and holding of produce 
for human consumption.

DATES: Submit either electronic or written comments on the collection 
of information by April 29, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 29, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3631 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and

[[Page 6794]]

follow the prompts and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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, 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.

Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption; 21 CFR Part 112

OMB Control Number 0910-0816--Revision

    To minimize the risk of serious adverse health consequences or 
death from consumption of contaminated produce, we have established 
science-based minimum standards for the safe growing, harvesting, 
packing, and holding of produce, meaning fruits and vegetables grown 
for human consumption. The standards are codified in part 112 (21 CFR 
part 112) and set forth procedures and processes that include 
information collection activities such as establishing monitoring and 
sampling plans, documenting data and training, and ensuring disclosure 
that produce for human consumption meets these requirements. The 
regulations also provide for certain exemptions and variances to 
qualified respondents. We use the information to verify that the 
standards established by the regulation are followed such that produce 
entering the marketplace is reasonably assured to be safe.
    In addition to the referenced regulations, we have developed a 
draft guidance entitled ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption for Sprout Operations'' 
(``Sprouts draft guidance'') available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. 
Sprouts represent a special food safety concern because the conditions 
under which they are produced (time, temperature, water activity, pH, 
and available nutrients) are ideal for the growth of pathogens, if 
present. The draft guidance, when finalized, will assist sprout 
operations subject to the regulations in part 112 to comply with the 
sprout-specific requirements in subpart M.
    Description of Respondents: Respondents to this information 
collection include farms that grow, harvest, pack, or hold produce for 
human consumption, meaning fruits and vegetables such as berries, tree 
nuts, herbs, and sprouts. Respondents are from the private sector (for-
profit businesses).
    We estimate the burden of the information collection as follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
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                                                   Number of                     Average burden
                                   Number of      records per    Total annual          per
  Activity in 21 CFR Part 112    recordkeepers  recordkeeper 1      records       recordkeeping     Total hours
                                                                                  (in hours) 2
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Exemptions under Sec.   112.7.           3,285               1           3,285  0.5 (30 minutes)           1,643
Training under Sec.   112.30..          24,420               1          24,420  7.25............         177,045
Testing requirements for                48,361           2.990         144,599  0.825 (~50               119,294
 agricultural water under Sec.                                                   minutes).
  Sec.   112.44 and 112.45.
Records related to                     160,605           2.242         360,076  2.160...........         777,765
 agricultural water.
Testing requirements for                   256         245.660          62,889  0.403 (~24                25,344
 sprouts under Sec.  Sec.                                                        minutes).
 112.144, 112.145, and 112.147.
Records related to sprouts....           1,023          62.061          63,488  0.174 (~11                11,047
                                                                                 minutes).
Following Recommendations for            1,023               1           1,023  1...............           1,023
 Implementation of the
 Standards for the Growing,
 Harvesting, Packing, and
 Holding of Produce for Human
 Consumption for Sprout
 Operations.
Documentation supporting                 4,568               1           4,568  0.079...........             361
 compliance with Sec.   112.2.
                               ---------------------------------------------------------------------------------
    Total.....................         243,541  ..............         664,348  ................       1,113,522
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers rounded to nearest 1/1000.


[[Page 6795]]


                            Table 2--Estimated Annual Third-Party Disclosure Burden 1
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                                                     Number of                    Average burden
         21 CFR Part 112             Number of      disclosures        Total      per disclosure    Total hours
                                    respondents   per respondent    disclosures     (in hours)
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Disclosure under Sec.  Sec.               77,165           3.459         266,914           1.422         379,551
 112.2, 112.6, 112.31, 112.33,
 and 112.142....................
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1 There are no capital costs or operating or maintenance costs associated with annual disclosure.

    Section 112.7 (21 CFR 112.7) requires farms eligible for the 
qualified exemption in accordance with Sec.  112.5 (21 CFR 112.5) to 
maintain the records necessary to demonstrate that the farm satisfies 
the criteria for the qualified exemption, including a written record 
reflecting that the owner, operator, or agent in charge of the farm has 
performed an annual review and verification of the farm's continued 
eligibility for the qualified exemption. We estimate that 3,285 farms 
are eligible for the qualified exemption and that each farm will spend 
an average of 0.5 hours per year to maintain one record. Therefore, 
3,285 recordkeepers x 0.5 average hours per recordkeeping = 1,642.5 
hours (rounded to 1,643) to meet the recordkeeping requirements of 
Sec.  112.7.
    Section 112.30 (21 CFR 112.30) requires the maintenance of records 
of required training of personnel, including the date of training, 
topics covered, and persons trained. We estimate that 24,420 farms will 
maintain one record of required training and spend an average of 7.25 
hours per year on recordkeeping. Therefore, 24,420 recordkeepers x 7.25 
average hours per recordkeeping = 177,045 hours to meet the 
recordkeeping requirements of Sec.  112.30.
    Section 112.46 (21 CFR 112.46) requires testing agricultural water 
subject to the requirements of Sec. Sec.  112.44 and 112.45 (21 CFR 
112.44 and 112.45). We estimate that 48,361 farms that will conduct 
these tests. Thus, it is estimated that about three (2.990) records for 
each farm will spend an average of 0.825 hours per record on testing 
water. Therefore, 48,361 farms x 2.990 records x 0.825 average hours 
per recordkeeping = 119,294.175 hours (rounded to 119,294) to meet the 
recordkeeping requirements of Sec. Sec.  112.44 and 112.45.
    For records related to agricultural water, FDA estimates that there 
are 160,605 recordkeepers each maintaining just over 2 records (2.242), 
with each recordkeeping taking just over 2 hours (2.160). Therefore, 
160,605 recordkeepers x 2.242 records x 2.160 hours = 777,765.046 hours 
(rounded to 777,765) for the recordkeeping burden related to 
agricultural water.
    Sections 112.144, 112.145, and 112.147 (21 CFR 112.144, 112.145, 
and 112. 147) require testing for sprouts. We estimate that 256 
recordkeepers will conduct these tests. Thus, it is estimated that 
about 245 (245.660) records for each recordkeeper will spend an average 
of 0.403 hour per record on testing sprouts. Therefore, 256 
recordkeepers x 245.660 records x 0.403 average hours per recordkeeping 
= 25,344.251 hours (rounded to 25,344) to meet the recordkeeping 
requirements of Sec. Sec.  112.144, 112.145, and 112.147.
    We estimate that there are 1,023 recordkeepers for other records 
related to sprouts. Thus, it is estimated that about 62 (62.061) 
records for each recordkeepers will spend an average of 0.174 hour per 
record. Therefore, 1,023 recordkeepers x 62.061 records x 0.174 average 
hour per recordkeeping = 11,046.982 (rounded to 11,047) hours for the 
burden to maintain records related to sprouts.
    We estimate 1,023 recordkeepers will utilize the recommendations in 
the Sprouts draft guidance, once finalized, to maintain additional 
records related to sprouts. We estimate each recordkeeping will take 
about an hour for a recordkeeping burden of 1,023 hours.
    Section 112.2 relates to documentation supporting compliance. We 
estimate that there are 4,568 recordkeepers each maintaining a record 
of compliance. We estimate that each recordkeeper will spend 0.079 hour 
maintaining their record. Therefore, 4,568 recordkeepers x 0.079 hour = 
360.872 (rounded to 361) hours for the burden to maintain documentation 
supporting compliance.
    Sections 112.2, 112.6, 112.31, 112.33, and 112.142 (21 CFR 112.2, 
112.6, 112.31, 112.33, and 112.142) require third-party disclosures. We 
estimate that 77,165 respondents are making these disclosures. Thus, it 
is estimated that each respondent has around three (3.459) disclosures 
and will spend an average of 1.422 hours per disclosure. Therefore, 
77,165 respondents x 3.459 disclosures x 1.422 average hours per 
disclosure = 379,551.331 hours (rounded to 379,551) for the third-party 
disclosure burden to meet the requirements of Sec. Sec.  112.2, 112.6, 
112.31, 112.33, and 112.142.
    The burden estimate reflects adjustments resulting in an overall 
decrease of 19,847 hours. We have removed one-time burden that has been 
realized since establishing the regulations; however, we have added 
burden we attribute to our estimate of recordkeepers following the 
recommendations in the Sprouts draft guidance.

    Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03507 Filed 2-27-19; 8:45 am]
 BILLING CODE 4164-01-P