[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]


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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.

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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\
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                                                               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
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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 \1/1,000\.


[[Page 26880]]


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         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...........................................................
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\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