[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.
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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