Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 26878-26880 [2019-12108]
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khammond on DSKBBV9HB2PROD with NOTICES
26878
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved information collection
request; Title of Information Collection:
Reassignment of Medicare Benefits; Use:
The reassignment application is
submitted at the time the provider/
supplier first reassigns of his/her
Medicare benefits to a group practice, as
well as any subsequent reassignments,
changes to current reassignment
information or terminations of
established reassignments as requested
by the provider/supplier or group. The
application is used by the Medicare
Administrative Contractor (MAC) to
collect data to assure the applicant has
the necessary information that allows
the MAC to correctly establish, change,
or terminate the reassignment.
The collection and verification of
reassignment information defends and
protects our beneficiaries from
illegitimate providers/suppliers. These
procedures also protect the Medicare
Trust Fund against fraud. It gathers
information that allow Medicare
contractors to ensure that the provider/
supplier is not sanctioned from the
Medicare and/or Medicaid program(s),
or debarred, or excluded from any other
Federal agency or program. The data
(e.g., Social Security Numbers,
Employer Identification Numbers)
collected also ensures that the applicant
has the necessary credentials to provide
the health care services for which they
intend to bill Medicare through the
reassignment. This is sole instrument
implemented for this purpose. Form
Number: CMS–855R (OMB control
number: 0938–1179); Frequency:
Occasionally; Affected Public: Private
Sector; Businesses or other for-profits,
Not-for-profit institutions; Number of
Respondents: 357,628; Number of
Responses: 357,628; Total Annual
Hours: 89,407. For policy questions
regarding this collection, contact
Kimberly McPhillips at 410–786–5374.
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Dated: June 5, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
delegation is effective upon date of
signature.
[FR Doc. 2019–12118 Filed 6–7–19; 8:45 am]
Dated: June 3, 2019.
Alex M. Azar II,
Secretary.
BILLING CODE 4120–01–P
[FR Doc. 2019–12141 Filed 6–7–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator of the
Administration for Community Living
the following authorities vested in the
Secretary:
• The authority to oversee and
administer the implementation of the
Recognize, Assist, Include, Support, and
Engage Family Caregivers Act of 2017
(Pub. L. 115–119), commonly referred to
as the ‘‘RAISE Family Caregivers Act’’.
This authority may be redelegated, but
only to an officer or inferior officer as
those terms are used in Art. II, § 2, cl.
2 of the U.S. Constitution.
This delegation excludes the authority
to issue regulations and appoint nonfederal council members, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidance.
Dated: June 3, 2019.
Alex M. Azar II,
Secretary.
[Docket No. FDA–2018–D–3631]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
SUMMARY:
Fax written comments on the
collection of information by July 10,
2019.
DATES:
[FR Doc. 2019–12140 Filed 6–7–19; 8:45 am]
BILLING CODE 4154–01–P
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0816. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator of the
Administration for Community Living
the following authorities vested in the
Secretary:
• The authority to oversee and
administer the implementation of the
Supporting Grandparents Raising
Grandchildren Act (Pub. L. 115–196).
This authority may be redelegated, but
only to an officer or inferior officer as
those terms are used in Art. II, § 2, cl.
2 of the U.S. Constitution.
This delegation excludes the authority
to issue regulations and appoint nonfederal council members, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidance. This
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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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
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 sciencebased 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 unlikely
to be associated with foodborne illness.
In addition to the referenced
regulations, we developed two draft
guidance documents: ‘‘Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption’’ and ‘‘Compliance with
and Recommendations for
Implementation of the Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption for Sprout Operations;’’
both are available at https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/default.htm. The
former was developed to help covered
farms comply with the requirements of
the Produce Safety regulation. This draft
guidance, when finalized, will not
create any additional burden not already
considered as part of the Produce Safety
regulation.
The latter (the Sprouts draft guidance)
was developed to assist sprout
operations also subject to the Produce
Safety regulation. 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 Sprouts draft guidance,
when finalized, will assist sprout
operations subject to the regulations in
part 112 in complying with the sproutspecific requirements in subpart M.
In the Federal Register of February
28, 2019 (84 FR 6793), we published a
60-day notice requesting public
comment on the proposed collection of
information. A number of comments
were received; however, only those
responsive to the information collection
topics solicited are discussed here.
(Comment 1) One comment suggested
that some entities such as tree nut
hullers and shellers may be overly
burdened by the definition of a
secondary activities farm, which may
cause it to be covered by regulations
promulgated under the Preventive
Controls rule as well as the Produce
Safety rule. The comment argues that an
entity of this sort should be covered
only by the Produce Safety regulation.
26879
(Response) In the Federal Register of
January 5, 2018 (83 FR 598), we
announced the availability of the
guidance for industry ‘‘Policy Regarding
Certain Entities Subject to the Current
Good Manufacturing Practice and
Preventive Controls, Produce Safety,
and/or Foreign Supplier Verification
Programs’’ in which we indicated our
intent to exercise enforcement
discretion for the Preventive Controls
for Human Food requirements for
facilities that would be secondary
activities farms except for ownership of
the facility.
Our intent is to exercise enforcement
discretion for any operation not located
on a primary production farm that is
dedicated to harvesting, packing, and/or
holding raw agricultural commodities
while we pursue future rulemaking/
solutions to relevant issues. The
guidance provides examples of the types
of facilities likely to fit within this
category as facilities engaged in nut
hulling and shelling operations.
(Comment 2) One comment suggested
that there should be documentation for
the source of all products used for
processing produce as well as for daily
testing of the water used for produce.
(Response) We assume that the phrase
‘‘products used for processing produce’’
refers to herbicides, pesticides, or
fertilizers used when growing produce.
Under various regulations of FDA and
the Environmental Protection Agency,
these substances are regulated for
proper usage to not endanger human
health.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
khammond on DSKBBV9HB2PROD with NOTICES
Activity in 21 CFR part 112
Number of
records per
recordkeeper 2
3,285
24,420
48,361
1
1
2.990
3,285
24,420
144,599
0.5 (30 minutes) .............
7.25 ................................
0.825 (∼50 minutes) .......
1,643
177,045
119,294
160,605
126
2.242
245.660
360,076
30,953.16
2.160 ..............................
0.825 (∼50 minutes) .......
777,765
25,536
126
126
62.061
233
7,819.686
29,358
1.412 (∼85 minutes) .......
1 .....................................
11,041
29,358
4,568
1
4,568
0.079 ..............................
361
241,617
........................
605,079
........................................
1,142,043
Exemptions under § 112.7 ...................................
Training under § 112.30 ......................................
Testing requirements for agricultural water
under §§ 112.44 and 112.45.
Records related to agricultural water ..................
Testing requirements for sprouts under
§§ 112.144, 112.145, and 112.147.
Records related to sprouts ..................................
‘‘Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout
Operations’’.
Documentation supporting compliance with
§ 112.2.
Total .............................................................
1 There
Average
burden per
recordkeeping 2
Number of
recordkeepers
Total annual
records
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to nearest 1⁄1,000.
2 Numbers
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Total hours
26880
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 112
Number of
respondents
Number of
disclosures
per
respondent
Total
disclosures
Average
burden per
disclosure
Total hours
Disclosure under §§ 112.2, 112.6, 112.31, 112.33, and
112.142 .............................................................................
77,165
3.459
266,914
1.422
379,551
khammond on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating or maintenance costs associated with this collection of information.
Section 112.7 (21 CFR 112.7) requires
farms eligible for the qualified
exemption in accordance with § 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 × 0.5
average hours per recordkeeping =
1,642.5 hours (rounded to 1,643) to meet
the recordkeeping requirements of
§ 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 maintain one
record of required training and spend an
average of 7.25 hours per year on
recordkeeping. Therefore, 24,420
recordkeepers × 7.25 average hours per
recordkeeping = 177,045 hours to meet
the recordkeeping requirements of
§ 112.30.
Although compliance dates for the
agricultural water provisions (subpart E)
for covered produce other than sprouts
are delayed to January 26, 2024, for very
small businesses, January 26, 2023, for
small businesses, and January 26, 2022,
for all other businesses, we have
estimated the burden. Section 112.46
(21 CFR 112.46) requires testing
agricultural water subject to the
requirements of §§ 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 × 2.990 records
× 0.825 average hours per recordkeeping
= 119,294.175 hours (rounded to
119,294) to meet the recordkeeping
requirements of §§ 112.44 and 112.45.
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Jkt 247001
For records related to agricultural
water, we estimate 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 × 2.242 records × 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 126 recordkeepers will
maintain records for these tests. Thus, it
is estimated that for about 246 (245.660)
records each recordkeeper will spend an
average of 0.825 hour per record on
testing sprouts. Therefore, 126
recordkeepers × 245.660 records × 0.825
average hours per recordkeeping =
25,536.357 hours (rounded to 25,536) to
meet the recordkeeping requirements of
§§ 112.144, 112.145, and 112.147.
We estimate that there are 126
recordkeepers for other records related
to sprouts. Thus, it is estimated that for
about 62 (62.061) records each
recordkeeper will spend an average of
1.412 hours per record. Therefore, 126
recordkeepers × 62.061 records × 1.412
average hours per recordkeeping =
11,041.397 (rounded to 11,041) hours
for the burden to maintain records
related to sprouts.
We estimate 126 recordkeepers will
utilize the recommendations in the draft
guidance document 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,’’ once finalized, to
maintain additional records related to
sprouts. We estimate each recordkeeper
will keep 233 records and
recordkeeping will take about an hour
per record for a recordkeeping burden of
29,358 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,
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4,568 recordkeepers × 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 × 3.459
disclosures × 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 §§ 112.2, 112.6, 112.31,
112.33, and 112.142.
The burden estimate reflects
adjustments resulting in an overall
increase of 8,515 hours. Although we
removed the one-time burden that has
been realized since establishing the
regulations, we have added burden
attributed to recommendations found in
the Sprouts draft guidance.
Dated: June 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12108 Filed 6–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4735]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug,
and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26878-26880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3631]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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.
DATES: Fax written comments on the collection of information by July
10, 2019.
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 0910-0816.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 26879]]
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 unlikely to be associated with
foodborne illness.
In addition to the referenced regulations, we developed two draft
guidance documents: ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption'' and ``Compliance with
and Recommendations for Implementation of the Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption for Sprout Operations;'' both are available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. The former was
developed to help covered farms comply with the requirements of the
Produce Safety regulation. This draft guidance, when finalized, will
not create any additional burden not already considered as part of the
Produce Safety regulation.
The latter (the Sprouts draft guidance) was developed to assist
sprout operations also subject to the Produce Safety regulation.
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 Sprouts draft guidance, when finalized, will assist sprout
operations subject to the regulations in part 112 in complying with the
sprout-specific requirements in subpart M.
In the Federal Register of February 28, 2019 (84 FR 6793), we
published a 60-day notice requesting public comment on the proposed
collection of information. A number of comments were received; however,
only those responsive to the information collection topics solicited
are discussed here.
(Comment 1) One comment suggested that some entities such as tree
nut hullers and shellers may be overly burdened by the definition of a
secondary activities farm, which may cause it to be covered by
regulations promulgated under the Preventive Controls rule as well as
the Produce Safety rule. The comment argues that an entity of this sort
should be covered only by the Produce Safety regulation.
(Response) In the Federal Register of January 5, 2018 (83 FR 598),
we announced the availability of the guidance for industry ``Policy
Regarding Certain Entities Subject to the Current Good Manufacturing
Practice and Preventive Controls, Produce Safety, and/or Foreign
Supplier Verification Programs'' in which we indicated our intent to
exercise enforcement discretion for the Preventive Controls for Human
Food requirements for facilities that would be secondary activities
farms except for ownership of the facility.
Our intent is to exercise enforcement discretion for any operation
not located on a primary production farm that is dedicated to
harvesting, packing, and/or holding raw agricultural commodities while
we pursue future rulemaking/solutions to relevant issues. The guidance
provides examples of the types of facilities likely to fit within this
category as facilities engaged in nut hulling and shelling operations.
(Comment 2) One comment suggested that there should be
documentation for the source of all products used for processing
produce as well as for daily testing of the water used for produce.
(Response) We assume that the phrase ``products used for processing
produce'' refers to herbicides, pesticides, or fertilizers used when
growing produce. Under various regulations of FDA and the Environmental
Protection Agency, these substances are regulated for proper usage to
not endanger human health.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total annual
Activity in 21 CFR part 112 recordkeepers recordkeeper records Average burden per recordkeeping \2\ Total hours
\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 agricultural 48,361 2.990 144,599 0.825 (~50 minutes)......................... 119,294
water under Sec. Sec. 112.44 and
112.45.
Records related to agricultural water..... 160,605 2.242 360,076 2.160....................................... 777,765
Testing requirements for sprouts under 126 245.660 30,953.16 0.825 (~50 minutes)......................... 25,536
Sec. Sec. 112.144, 112.145, and
112.147.
Records related to sprouts................ 126 62.061 7,819.686 1.412 (~85 minutes)......................... 11,041
``Compliance with and Recommendations for 126 233 29,358 1........................................... 29,358
Implementation of the Standards for the
Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption for
Sprout Operations''.
Documentation supporting compliance with 4,568 1 4,568 0.079....................................... 361
Sec. 112.2.
-------------------------------------------------------------------------------------------------------------
Total................................. 241,617 .............. 605,079 ............................................ 1,142,043
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers rounded to nearest \1/1,000\.
[[Page 26880]]
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 112 Number of disclosures per Total Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosure under Sec. Sec. 112.2, 112.6, 112.31, 112.33, and 77,165 3.459 266,914 1.422 379,551
112.142...........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating or maintenance costs associated with this collection of information.
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
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.
Although compliance dates for the agricultural water provisions
(subpart E) for covered produce other than sprouts are delayed to
January 26, 2024, for very small businesses, January 26, 2023, for
small businesses, and January 26, 2022, for all other businesses, we
have estimated the burden. 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, we estimate 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 126
recordkeepers will maintain records for these tests. Thus, it is
estimated that for about 246 (245.660) records each recordkeeper will
spend an average of 0.825 hour per record on testing sprouts.
Therefore, 126 recordkeepers x 245.660 records x 0.825 average hours
per recordkeeping = 25,536.357 hours (rounded to 25,536) to meet the
recordkeeping requirements of Sec. Sec. 112.144, 112.145, and 112.147.
We estimate that there are 126 recordkeepers for other records
related to sprouts. Thus, it is estimated that for about 62 (62.061)
records each recordkeeper will spend an average of 1.412 hours per
record. Therefore, 126 recordkeepers x 62.061 records x 1.412 average
hours per recordkeeping = 11,041.397 (rounded to 11,041) hours for the
burden to maintain records related to sprouts.
We estimate 126 recordkeepers will utilize the recommendations in
the draft guidance document 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,'' once finalized, to maintain additional records
related to sprouts. We estimate each recordkeeper will keep 233 records
and recordkeeping will take about an hour per record for a
recordkeeping burden of 29,358 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
increase of 8,515 hours. Although we removed the one-time burden that
has been realized since establishing the regulations, we have added
burden attributed to recommendations found in the Sprouts draft
guidance.
Dated: June 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12108 Filed 6-7-19; 8:45 am]
BILLING CODE 4164-01-P
