estimated to include collecting and preparing the sample. We estimate
that 33 very small sprout farms produce 3,710 batches, 27 small sprout
farms produce 2,976 batches, and 68 large sprout farms produce 33,623
batches. Each farm will have one recordkeeper for each test. Small and
very small farms will average 125 (50 x 2.5 one each for E. coli and
Salmonella and 0.5 to reflect the uncertainty associated with
applicability of testing requirements for additional pathogens) tests
per farm; large farms will average 558 (223 x 2.5) tests.
    It is estimated that a total of 4,163 batches of sprouts will be
tested annually for E. coli and Salmonella and, if certain criteria are
met, emerging pathogens across 33 very small farms. Therefore, 4,163
tests x 0.5 hour per test = 2,081 annual hours for very small farms to
comply with Sec. Sec.  112.144(b) and (c) and 112.147. It is estimated
that a total of 3,375 batches of sprouts will be tested annually across
27 small farms. Therefore 3,375 tests x 0.5 hour per test = 1,688
annual hours for small farms to comply with Sec. Sec.  112.144(b) and
(c) and 112.147. It is estimated that 37,882 batches of sprouts will be
tested annually across 68 large farms. Therefore, 37,882 test x 0.5
hour per = 18,941 annual hours for large farms to comply with
Sec. Sec.  112.144(b) and (c) and 112.147.
    Sections 112.144(a) and 112.145 require testing the sprout growing,
harvesting, packing, and holding environment for Listeria spp. or L.
monocytogenes, and Sec.  112.150(b)(4) requires recordkeeping related
to those tests. This burden is estimated to vary across farm size. It
is estimated that the burden associated with testing is 0.15 hour to
collect and prepare each sample. We expect that all firms will sample
on a monthly basis; it is also expected that the number of samples will
vary with the size of the farm. We expect very small farms to average
five samples for each test; small farms to average ten samples per
test; and large farms to average 15 samples. More samples are expected
as the size of the farm increases because we estimate that the number
and location of sampling sites, including appropriate food-contact
surfaces and non-food-contact surfaces of equipment and other surfaces
would increase as the farm size increases. It is estimated that one
recordkeeper from each of the farms will be responsible for collecting
samples. Therefore, to comply with the requirements of Sec. Sec.
112.144(a) and 112.145, 33 very small farms will incur a total of 300
hours of burden annually (33 farms x 5 samples x 12 annual tests x 0.15
hour per sample); 27 small farms will incur a total of 486 hours
annually, (27 farms x 10 samples x 12 annual tests x 0.15 hour per
sample); and 68 large farms will incur a total of 1,835 hours (68 farms
x 15 samples x 12 annual tests x 0.15 hour per sample).
Recordkeeping Requirements Related to Sprouts
    Section 112.150(b)(1) requires documentation of treatment of seeds
or beans or documentation of previous seed treatment by a third party.
This burden is expected to vary across farms; however, this
documentation burden is estimated to be 0.2 hour per activity,
estimated to consist of the time needed to record the treatment of
seeds or beans. It is estimated that one recordkeeper per very small
farm will document this activity 50 times annually. Therefore, 33 very
small farms x 50 records = 1,665 records x 0.2 hours per record = 333
hours for very small farms to comply with Sec.  112.150(b)(1). It is
estimated that one recordkeeper per small farm will document this
activity 50 times annually. Therefore, 27 small farms x 50 records =
1,350 records x 0.2 hours per record = 270 hours for small farms to
comply with Sec.  112.150(b)(1). It is estimated that one recordkeeper
per large farm will document this activity about 223 times annually.
Therefore, 68 large farms x 223 records = 15,153 records x 0.2 hours
per record = 3,031 hours for large farms to comply with Sec.
112.150(b)(1).
    Section 112.150(b)(2) requires sprout operations to establish and
keep a written environmental monitoring plan

in accordance with Sec.  112.145. It is estimated that there is a one-
time burden to establish this record (that is, determining the
information needed to be included in the sampling plan and developing a
template for the plan) and an annual burden to maintain this record
(such as updating or making needed changes to the plan). For annual
burdens, it is estimated that each record will require one recordkeeper
to work 0.15 hour to maintain the environmental monitoring plan (such
as updating or making needed changes to the plan), across all farm
sizes. For 46 very small farms, it is estimated that one record will be
generated annually. Therefore, 46 records x 0.15 hour per record = 7
total annual hours for very small farms to comply with Sec.
112.150(b)(2). For 37 small farms, it is estimated that 37 total
records will be generated annually. Therefore, 37 records x 0.15 hour
per record = 6 total annual hours for small farms to comply with Sec.
112.150(b)(2). For 94 large farms, it is estimated that 94 total
records will be generated annually. Therefore, 94 records x 0.15 hour
per record = 14 total annual hours for very small farms to comply with
Sec.  112.150(b)(2).
    Section 112.150(b)(3) requires the documentation of the written
sampling plan for each production batch of sprouts in accordance with
Sec.  112.147(a). It is estimated that there is a one-time burden to
establish this record (that is, determining the information needed to
be included in the sampling plan and developing a template for the
plan) and an annual burden to maintain this record (such as updating or
making needed changes to the plan). For each of 177 sprout farms, it is
estimated that there will be an annual burden of 1 hour per farm to
update and make needed changes to the plans. Therefore, 177 sprout
farms x 1 hour = 177 annual hours for sprout farms to comply with Sec.
112.150(b)(3).
    Section 112.150(b)(4) requires records of all testing conducted in
accordance with the requirements of Sec.  112.144 for sprouting
operations. To comply with this, records of testing for E. coli O157:H7
and Salmonella spp. and any pathogen meeting the criteria in Sec.
112.144(c) will be kept, and it is estimated that each such record will
represent a burden of 0.15 hour, estimated as the time needed to record
the results of the tests, but the number of records will vary across
farm sizes. For 33 very small sprouting operations testing for E. coli
O157:H7 and Salmonella and other pathogens as applicable, it is
estimated that 2,498 total records will be generated annually (or an
average of 50.13 per firm x 1.5 to account for the uncertainty
associated with applicability of testing requirements for additional
pathogens). Therefore, 2,498 x 0.15 = 375 annual hours for very small
sprouting operations to comply with Sec.  112.150(b)(4). For 27 small
sprouting operations it is estimated that 2,025 total records will be
generated annually (or an average of about 49.6 per sprouting operation
x 1.5 to account for the uncertainty associated with applicability of
testing requirements for additional pathogens). Therefore, 2,025
records x 0.15 hour per record = 304 annual hours for small sprouting
operations to comply with Sec.  112.150(b)(4) with respect to testing
for E. coli O157:H7 and Salmonella and other pathogens as applicable.
For 68 large sprouting operations it is estimated that 22,689 total
records will be generated annually (or an average of about 222.6 per
sprouting operation x 1.5 to account for the uncertainty associated
with applicability of testing requirements for additional pathogens).
Therefore, 22,689 records x 0.15 hour per record = 3,403 annual hours
for large sprouting operations to comply with Sec.  112.150(b)(4) with
respect to testing for E. coli O157:H7 and Salmonella, and other
pathogens as applicable.
    Section 112.150(b)(4) requires records of all testing conducted in
accordance with the requirements of Sec. Sec.  112.144 and 112.145 for
sprouting operations. To comply with this, records of testing for
Listeria spp. or L. monocytogenes will be kept, and it is estimated
that each such record will represent a burden of 0.17 hour, estimated
as the time needed to record the results of the tests, but the number
of records will vary across sprouting operation sizes. For 33 very
small sprouting operations, it is estimated that a total of 1,998
records will be kept annually (or an average of 60 per sprouting
operation) with respect to testing for Listeria spp. or L.
monocytogenes. Therefore, 1,998 records x 0.17 hour per record = 340
total annual hours for small sprouting operations to comply with Sec.
112.150(b)(4) with respect to testing for Listeria spp. or L.
monocytogenes. For 27 small farms, it is estimated that a total of
3,240 records will be kept annually (or an average of 120 per sprouting
operation). Therefore, 3,240 records x 0.17 hour per record = 551 total
annual hours for small farms to comply with Sec.  112.150(b)(4) with
respect to testing for Listeria spp. or L. monocytogenes. For 68 large
sprouting operations, it is estimated that a total of 12,231 records
will be kept annually (or an average of 180 per sprouting operation).
Therefore, 12,231 records x 0.17 hour per record = 2,079 total annual
hours for large sprouting operations to comply with Sec.  112.150(b)(4)
with respect to testing for Listeria spp. or L. monocytogenes.
    Section 112.150(b)(6) requires records of corrective actions
conducted in accordance with the requirements of Sec. Sec.
112.142(b)(2), 112.146, and 112.148 for sprouting operations. It is
estimated that all sprouting operations may collectively perform
approximately 285 corrective actions annually. For each of 285 sprout
operations, it is estimated that there will be an annual burden of 0.5
hour per operation to make the required record documenting these
corrective actions. Therefore, 285 sprout farms x 0.5 hour = 143 annual
hours for sprout farms to comply with Sec.  112.150(b)(6).

Commercial Processing Exemption Recordkeeping

    Under Sec.  112.2(b)(4), farms relying on the commercial processing
exemption must establish and maintain records of their required
disclosures to customers regarding produce that has not been
commercially processed and the annual written assurances obtained from
customers regarding such commercial processing. It is estimated that
Sec.  112.2(b)(4) represents a recordkeeping requirement for 4,568
entities (4,153 farms that only grow produce exempt from the rule due
to commercial processing, who would otherwise be subject to the rule x
an additional 10 percent to account for covered farms relying on this
exemption for only some of their produce, and other entities that will
be required to make these records). We estimate that it will take
approximately 5 minutes to make these records each year. Therefore,
4,568 entities x 0.08 hour per entity = 365 annual hours to comply with
Sec.  112.2(b)(4).

                                 Table 32--Estimated Annual Recordkeeping Burden
                                            [One-time hourly burden]
----------------------------------------------------------------------------------------------------------------
                                                                                Operating
                                                                                costs in
                                 Number of     Number of      Total       Average                    millions
           21 CFR              recordkeepers    records      records       hourly    Total hours    (related to
                                                                           burden                     testing
                                                                                burdens)
----------------------------------------------------------------------------------------------------------------
Agricultural Water--
 Documentation of Scientific
 Data:
    112.50(b)(3)............           5,547            1        5,547          0.5        2,773  ..............
    112.50(b)(5)............           3,661            2        7,322          0.5        3,661  ..............
    112.50(b)(8); 112.49(a).           8,757            1        8,757          0.5        4,379  ..............
    112.50(b)(8); 112.49(b).           3,661            1        3,661          0.5        1,830  ..............
    112.50(b)(8); 112.49(c).           2,511            1        2,511          0.5        1,255  ..............
    112.50(b)(8); 112.49(d).           2,511            1        2,511          0.5        1,255  ..............
    112.50(b)(9)............               1            1            1          5.0            5  ..............
----------------------------------------------------------------------------------------------------------------
Sprouts--Establishment of
 Environmental Monitoring
 Plan:
    112.150(b)(2), Very                   46            1           46          7.0          321  ..............
     Small Farms............
    112.150(b)(2), Small                  37            1           37         12.0          446  ..............
     farms..................
    112.150(b)(2), Large                  94            1           94         17.0        1,592  ..............
     farms..................
Sprouts--Establishment of
 Sampling Plan:
    112.150(b)(3)...........             177            1          177          8.0        1,414  ..............
----------------------------------------------------------------------------------------------------------------
Sprouts--Documentation of
 Scientific Data:
    112.150(b)(5)...........               1            1            1          5.0            5  ..............
    112.150(b)(5); 112.144(c             177            2          353          2.0          707  ..............
     )......................
Variances:
    112.173.................               7            1            7        120.0          840  ..............
                             -----------------------------------------------------------------------------------
        Total One-Time        ..............  ...........  ...........  ...........       20,484             N/A
         Hourly Burden......
----------------------------------------------------------------------------------------------------------------

                                              Annual Hourly Burden
----------------------------------------------------------------------------------------------------------------
                                                              Total       Average                    Operating
           21 CFR                Number of     Number of      annual       hourly    Total hours    costs  (in
                               recordkeepers    records      records       burden                    millions)
----------------------------------------------------------------------------------------------------------------
                          Qualified Exempt Farms--Documenting Eligibility for Exemption
----------------------------------------------------------------------------------------------------------------
112.7(b)....................           3,285            1        3,285          0.5        1,643  ..............
----------------------------------------------------------------------------------------------------------------
                                                    Training
----------------------------------------------------------------------------------------------------------------
112.30(b)(1)................          24,420            1       24,420         7.25      177,045  ..............
----------------------------------------------------------------------------------------------------------------
                                   Testing Requirements for Agricultural Water
----------------------------------------------------------------------------------------------------------------
Records of Testing for 0
 Detectable Generic E. coli:
    112.44(a), 112.46(c)....          26,038            2       52,077          0.7       34,371           $2.48
Testing for GM of 126 CFU/
 100 mL and STV of 410 CFU/
 100 mL Generic E. coli--
 Untreated Surface Water
 Used For Direct Application
 Irrigation of Non-Sprout
 Covered Produce:
    112.44(b), 112.46(b)....          12,554         6.29       78,965         0.92       72,647            5.24
Testing for GM of 126 CFU/
 100 mL and STV of 410 CFU/
 100 mL Generic E. coli--
 Untreated Ground Water Used
 For Direct Application
 Irrigation of Non-Sprout
 Covered Produce:
    112.44(b), 112.46(b)....           9,471            1       13,259          0.9       12,198            0.88
Records of Analytical Test
 Results as Part of
 Corrective Steps:
    112.45..................             298            1          298         0.33           98  ..............
----------------------------------------------------------------------------------------------------------------
Recordkeeping Related to Agricultural Water
----------------------------------------------------------------------------------------------------------------
Findings of Water System
 Inspection:
    112.50(b)(1)............          34,396            4      137,583          0.8      110,066  ..............
Records of Testing for 0
 Detectable Generic E. coli:
    112.50(b)(2)............          26,038            2       52,077         0.33       17,185  ..............

Records of Testing for GM of
 126 CFU/100 mL and STV of
 410 CFU/100 mL Generic E.
 coli--Untreated Surface
 Water Used For Direct
 Application Irrigation of
 Non-Sprout Covered Produce:
    112.50(b)(2)............          12,554         6.29       78,965         0.08        6,317  ..............
Records of Testing for GM of
 126 CFU/100 mL and STV of
 410 CFU/100 mL Generic E.
 coli--Untreated Ground
 Water Used For Direct
 Application Irrigation of
 Non-Sprout Covered Produce:
    112.50(b)(2)............           9,471            1       13,259         0.08        1,061  ..............
Documentation of Monitoring
 Water Treatment
    112.50(b)(4)............           5,547            1        5,547         0.98        5,436  ..............
Documentation of corrective
 actions applied:
112.50(b)(6)................          14,643            1       14,643          0.5        7,322  ..............
Documentation from Public
 Water Systems:
    112.50(b)(7)............           9,108            1        9,108         0.33        3,005  ..............
Recordkeeping Related to
 Soil Amendments:
    112.60(b)(1)............           3,503            1        3,503         0.25          876  ..............
    112.60(b)(2)............             420            1          420         0.50          210  ..............
Recordkeeping Related to
 Cleaning and Sanitation:
    112.140(b)(1) Cleaning            16,061            1       16,061          8.0      128,485  ..............
     worker tools, very
     small farms............
    112.140(b)(1) Cleaning             8,635            1        8,635         25.0      215,871  ..............
     worker tools, small and
     large farms............
    112.140(b)(1) Cleaning            13,156            1       13,156          8.0      105,248  ..............
     machinery, very small
     farms..................
    112.140(b)(1) Cleaning             7,073            1        7,073         25.0      176,831  ..............
     machinery, small and
     large farms............
----------------------------------------------------------------------------------------------------------------
Testing Requirements for Sprouts
----------------------------------------------------------------------------------------------------------------
Testing for E. coli and
 Salmonella and additional
 pathogens as applicable
    112.144(b) and (c),                   33          125        4,163         0.50        2,081            0.15
     112.147, very small
     farms..................
112.144(b) and (c), 112.147,              27          125        3,375         0.50        1,688           $0.12
 small farms................
    112.144(b) and (c),                   68          558       37,882         0.50       18,941            1.37
     112.147, large farms...
Testing for Listeria spp. or
 L. monocytogenes:
    112.144(a), 112.145,                  33           60        1,998         0.15          300            0.02
     very small farms.......
    112.144(a), 112.145,                  27          120        3,240         0.15          486            0.04
     small farms............
    112.144(a), 112.145,                  68          180       12,231         0.15        1,835            0.13
     large farms............
----------------------------------------------------------------------------------------------------------------
Recordkeeping Related to Sprouts
----------------------------------------------------------------------------------------------------------------
Documentation of Treatment
 of Seeds or Beans:
    112.150(b)(1), very                   33           50        1,665         0.20          333  ..............
     small farms............
    112.150(b)(1), small                  27           50        1,350         0.20          270  ..............
     farms..................
    112.150(b)(1), large                  68          223       15,153         0.20        3,031  ..............
     farms..................
Environmental Monitoring
 Plan--Updating:
    112.150(b)(2), very                   46            1           46         0.15            7  ..............
     small farms............
    112.150(b)(2), small                  37            1           37         0.15            6  ..............
     farms..................
    112.150(b)(2), large                  94            1           94         0.15           14  ..............
     farms..................
Sampling Plan--Updating:
    112.150(b)(3)...........             177            1          177         1.00          177  ..............
Records of Testing for
 E.coli and Salmonella and
 additional pathogens as
 applicable:
    112.150(b)(4), very                   33           75        2,498         0.15          375  ..............
     small farms............
    112.150(b)(4), small                  27           75        2,025         0.15          304  ..............
     farms..................
    112.150(b)(4), large                  68          334       22,689         0.15        3,403  ..............
     farms..................
Records of Testing for
 Listeria spp. or L.
 monocytogenes:
    112.150(b)(4), very                   33           60        1,998         0.17          340  ..............
     small farms............
    112.150(b)(4), small                  27          120        3,240         0.17          551  ..............
     farms..................
    112.150(b)(4), large                  68          180       12,231         0.17        2,079  ..............
     farms..................
Records of corrective
 actions:
    112.150(b)(6)...........             285            1          285         0.50          143  ..............
----------------------------------------------------------------------------------------------------------------
Commercial processing exemption recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of disclosures to customers and annual written assurances obtained from customers:......................
----------------------------------------------------------------------------------------------------------------

    112.2(b)(4).............            4568            1        4,568         0.08          365  ..............
                             -----------------------------------------------------------------------------------
        Annual Hourly Burden  ..............  ...........  ...........  ...........    1,112,641  ..............
                             -----------------------------------------------------------------------------------
        Operating Costs.....  ..............  ...........  ...........  ...........  ...........           10.42
----------------------------------------------------------------------------------------------------------------

Third-Party Disclosure Burden
    Under Sec.  112.6(b) certain qualified exempt farms (those that
would otherwise be covered by the rule but that meet the criteria in
Sec.  112.5) must comply with certain food labeling or disclosure
requirements. A total of 21,666 non-sprout farms are estimated to be
eligible for the qualified exemption in Sec.  112.5. After subtracting
the number of farms that are not covered by the rule because they have
annual monetary value of produce sold of $25,000 or less, 3,285 farms
remain that must comply with Sec.  112.6(b). It is estimated that it
will take the farm operator approximately 5 minutes to buy and prepare
one poster board. It is also estimated that the operator will buy
posters bi-weekly. The total annual time required to buy and prepare a
poster board is 24 hours [(60 minutes x 24)/60]. Therefore, 3,285 farms
x 24 annual hours = 78,840 annual hours for these farms to comply with
the requirement of Sec.  112.6(b).
    It is estimated that farms with other marketing channels will
provide their name and complete business address on an invoice or
receipt that accompanies their product. We estimate that a total of
3,083 farms will incur a cost to comply with this provision. It is
estimated that it will take a farm operator 5 minutes (0.08 hour) to
change this template for new invoices, and that this is a one-time
burden. Therefore, 3,083 x 0.08 hour = about 247 hours to comply with
Sec.  112.6(b).
    Under Sec.  112.31(b)(2), covered farms are required to instruct
personnel to notify their supervisor(s) if they are have, or if there
is a reasonable possibility that they have an applicable health
condition (such as communicable illnesses that present a public health
risk in the context of normal work duties, infection, open lesion,
vomiting, or diarrhea). The number of farms that will need to implement
this disclosure is based on the estimated number of farms that are not
currently implementing the requirements imposed by the rule in the RIA.
It is estimated that one worker from each of 29,175 farms will spend 5
minutes annually to comply with Sec.  112.31(b)(2), which will consist
of the employer giving verbal instructions to employees. Therefore,
29,175 x 5 minutes = 2,334 hours to comply with Sec.  112.31(b)(2).
    Under Sec.  112.33(a), covered farms must make visitors aware of
policies and procedures to protect covered produce and food-contact
surfaces from contamination by people and take all steps reasonably
necessary to ensure that visitors comply with such policies and
procedures. It is estimated that farms with voluntary food safety
programs in place will already have practices aligned with this
provision; therefore no burden is estimated for those farms. After
subtracting these farms, it is estimated that Sec.  112.33(a)
represents a third-party disclosure requirement for 35,556 farms. We
estimate that it will take 8 hours annually for the operator to inform
visitors of the farm policies, including showing them where the
restrooms are, and to take reasonable steps to ensure their compliance,
such as monitoring visitors to ensure they are following the policies
and procedures. Therefore, 35,556 farms x 8 hours per farm = 284,448
annual hours to comply with Sec.  112.33(a).
    Under Sec.  112.2(b)(2), farms must disclose in documents
accompanying produce that is eligible for the commercial processing
exemption that the food is ``not processed to adequately reduce the
presence of microorganisms of public health significance.'' It is
estimated that Sec.  112.2(b)(2) represents a third-party disclosure
requirement for 4,568 entities (4,153 farms that only grow produce
exempt from the rule due to commercial processing, who would otherwise
be subject to the rule x an additional 10 percent to account for
covered farms relying on this exemption for only some of their produce,
and other entities that will be required to make these disclosures). We
estimate that it will take 0.08 hours to provide this statement, and
the statement will occur on average about 26 times per year (or once a
week for half of the year). Therefore, 4,568 entities x 0.08 hours per
entity x 26 shipments = 9,502 annual hours to comply with Sec.
112.2(b)(2).
    Under Sec.  112.2(b)(3), farms relying on the commercial processing
exemption must receive certain annual documentation from their buyers
ensuring that the relevant produce will receive the required
processing. It is estimated that Sec.  112.2(b)(3) represents a third-
party disclosure requirement for 4,568 entities (the same entities
described previously regarding Sec.  112.2(b)(2)). We estimate that it
will take 1 hour to provide this documentation each year. Therefore,
4,568 entities x 1 hour per entity = 4,568 annual hours to comply with
Sec.  112.2(b)(3).
    Under Sec.  112.142(b)(2), with certain limited exceptions, if a
sprouting operation knows or has reason to believe that a lot of seeds
or beans may be contaminated with a pathogen, the sprouting operation
must report that information to the seed grower, distributor, supplier,
or other entity from whom the sprouting operation received the seeds or
beans. We estimate that this requirement will apply to only a small
percentage of sprouting operations; therefore this requirement
represents a burden to 13 sprouting operations (128 x 10 percent). We
estimate that it will take 1 hour to provide this documentation each
year. Therefore, 13 sprouting operations x 1 hour per sprouting
operations = 13 annual hours to comply with Sec.  112.2(b)(3).

                                Table 33--Estimated Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of         Total        burden per
 21 CFR Section  (or FDA Form #)    respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
----------------------------------------------------------------------------------------------------------------
                                     One Time Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
112.6(b) Documentation..........           3,083               1           3,083            0.08             247
                                 -------------------------------------------------------------------------------
    Total One-Time Burden.......  ..............  ..............  ..............  ..............             247
----------------------------------------------------------------------------------------------------------------
                                      Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
112.6(b) Posting signage........           3,285              24          78,840               1          78,840
112.31(b)(2)....................          29,175               1          29,175            0.08           2,334
112.33(a).......................          35,556               1          35,556               8         284,448
112.2(b)(2).....................           4,568              26         118,776            0.08           9,502
112.2(b)(3).....................           4,568               1           4,568               1           4,568
112.142(b)(2 )..................              13               1              13               1              13
                                 -------------------------------------------------------------------------------
    Total annual burden hours...  ..............  ..............  ..............  ..............         379,705
----------------------------------------------------------------------------------------------------------------

XXIX. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, FDA has concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.

XXX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
These references are also available electronically at http://www.regulations.gov. We have verified the Web site addresses, but we
are not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.

1. Food and Drug Administration. ``FDA Actions to Date.'' last
modified August 17, 2015. accessed October 19, 2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359450.htm.
2. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls for Human Food Facilities.
Public Meeting, Day One. February 28, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket
No. FDA-2011-N-0920, 2013.
3. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls For Human Food Facilities.
Public Meeting, Day Two. March 1, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket
No. FDA-2011-N-0920, 2013.
4. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls For Human Food Facilities.
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and Holding of Produce for Human Consumption, October 2015.
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(E. coli) in Water by Membrane Filtration Using Modified membrane-
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species or L. monocytogenes in Environmental Samples, Version 1,
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Sprouts), Version 1, October 2015.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 112

    Foods, Fruits and vegetables, Incorporation by reference, Packaging
and containers, Recordkeeping requirements, Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
11, 16, and 112 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

0
2. In Sec.  11.1, add paragraph (k) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (k) This part does not apply to records required to be established
or maintained by part 112 of this chapter. Records that satisfy the
requirements of part 112 of this chapter, but that also are required
under other applicable statutory provisions or regulations, remain
subject to this part.
* * * * *

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
3. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
4. Amend Sec.  16.1 by:
0
a. In paragraph (b)(1), adding an entry in numerical order.
0
b. In paragraph (b)(2), adding an entry in numerical order.
    The additions read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) * * *
    Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act
relating to the modification or revocation of a variance from the
requirements of section 419 (see part 112, subpart P of this chapter).
* * * * *
    (2) * * *
    Sec. Sec.  112.201 through 112.213, (see part 112, subpart R of
this chapter), relating to withdrawal of a qualified exemption.
* * * * *

0
5. Add part 112 to read as follows:

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

Subpart A--General Provisions
Sec.
112.1 What food is covered by this part?
112.2 What produce is not covered by this part?
112.3 What definitions apply to this part?
112.4 Which farms are subject to the requirements of this part?
112.5 Which farms are eligible for a qualified exemption and
associated modified requirements based on average monetary value of
all food sold and direct farm marketing?
112.6 What modified requirements apply to me if my farm is eligible
for a qualified exemption in accordance with Sec.  112.5?
112.7 What records must I establish and keep if my farm is eligible
for a qualified exemption in accordance with Sec.  112.5?
Subpart B--General Requirements
112.11 What general requirements apply to persons who are subject to
this part?
112.12 Are there any alternatives to the requirements established in
this part?
Subpart C--Personnel Qualifications and Training
112.21 What requirements apply regarding qualifications and training
for personnel who handle (contact) covered produce or food contact
surfaces?
112.22 What minimum requirements apply for training personnel who
conduct a covered activity?
112.23 What requirements apply regarding supervisors?
112.30 Under this subpart, what requirements apply regarding
records?
Subpart D--Health and Hygiene
112.31 What measures must I take to prevent ill or infected persons
from contaminating covered produce with microorganisms of public
health significance?
112.32 What hygienic practices must personnel use?
112.33 What measures must I take to prevent visitors from
contaminating covered produce and food contact surfaces with
microorganisms of public health significance?
Subpart E--Agricultural Water
112.41 What requirements apply to the quality of agricultural water?
112.42 What requirements apply to my agricultural water sources,
water distribution system, and pooling of water?
112.43 What requirements apply to treating agricultural water?
112.44 What specific microbial quality criteria apply to
agricultural water used for certain intended uses?
112.45 What measures must I take if my agricultural water does not
meet the requirements of Sec.  112.41 or Sec.  112.44?
112.46 How often must I test agricultural water that is subject to
the requirements of Sec.  112.44?
112.47 Who must perform the tests required under Sec.  112.46 and
what methods must be used?
112.48 What measures must I take for water that I use during
harvest, packing, and holding activities for covered produce?
112.49 What alternatives may I establish and use in lieu of the
requirements of this subpart?
112.50 Under this subpart, what requirements apply regarding
records?
Subpart F--Biological Soil Amendments of Animal Origin and Human Waste
112.51 What requirements apply for determining the status of a
biological soil amendment of animal origin?
112.52 How must I handle, convey, and store biological soil
amendments of animal origin?
112.53 What prohibitions apply regarding use of human waste?
112.54 What treatment processes are acceptable for a biological soil
amendment of animal origin that I apply in the growing of covered
produce?
112.55 What microbial standards apply to the treatment processes in
Sec.  112.54?
112.56 What application requirements and minimum application
intervals apply to biological soil amendments of animal origin?
112.60 Under this subpart, what requirements apply regarding
records?
Subpart G-H--[Reserved]
Subpart I--Domesticated and Wild Animals
112.81 How do the requirements of this subpart apply to areas where
covered activities take place?
112.83 What requirements apply regarding grazing animals, working
animals, and animal intrusion?
112.84 Does this regulation require covered farms to take actions
that would constitute a ``taking'' of threatened or endangered
species; to take measures to exclude animals from outdoor growing
areas; or to destroy animal habitat or otherwise clear farm borders
around outdoor growing areas or drainages?
Subpart J--[Reserved]
Subpart K--Growing, Harvesting, Packing, and Holding Activities
112.111 What measures must I take if I grow, harvest, pack or hold
both covered and excluded produce?
112.112 What measures must I take immediately prior to and during
harvest activities?
112.113 How must I handle harvested covered produce during covered
activities?
112.114 What requirements apply to dropped covered produce?
112.115 What measures must I take when packaging covered produce?
112.116 What measures must I take when using food-packing (including
food packaging) material?

Subpart L--Equipment, Tools, Buildings, and Sanitation
112.121 What equipment and tools are subject to the requirements of
this subpart?
112.122 What buildings are subject to the requirements of this
subpart?
112.123 What requirements apply regarding equipment and tools
subject to this subpart?
112.124 What requirements apply to instruments and controls used to
measure, regulate, or record?
112.125 What requirements apply to equipment that is subject to this
subpart used in the transport of covered produce?
112.126 What requirements apply to my buildings?
112.127 What requirements apply regarding domesticated animals in
and around a fully-enclosed building?
112.128 What requirements apply regarding pest control in buildings?
112.129 What requirements apply to toilet facilities?
112.130 What requirements apply for hand-washing facilities?
112.131 What must I do to control and dispose of sewage?
112.132 What must I do to control and dispose of trash, litter, and
waste in areas used for covered activities?
112.133 What requirements apply to plumbing?
112.134 What must I do to control animal excreta and litter from
domesticated animals that are under my control?
112.140 Under this subpart, what requirements apply regarding
records?
Subpart M--Sprouts
112.141 What commodities are subject to this subpart?
112.142 What requirements apply to seeds or beans used to grow
sprouts?
112.143 What measures must I take for growing, harvesting, packing,
and holding sprouts?
112.144 What testing must I do during growing, harvesting, packing,
and holding sprouts?
112.145 What requirements apply to testing the environment for
Listeria species or L. monocytogenes?
112.146 What actions must I take if the growing, harvesting,
packing, or holding environment tests positive for Listeria species
or L. monocytogenes?
112.147 What must I do to collect and test samples of spent sprout
irrigation water or sprouts for pathogens?
112.148 What actions must I take if the samples of spent sprout
irrigation water or sprouts test positive for a pathogen?
112.150 Under this subpart, what requirements apply regarding
records?
Subpart N--Analytical Methods
112.151 What methods must I use to test the quality of water to
satisfy the requirements of Sec.  112.46?
112.152 What methods must I use to test the growing, harvesting,
packing, and holding environment for Listeria species or L.
monocytogenes to satisfy the requirements of Sec.  112.144(a)?
112.153 What methods must I use to test spent sprout irrigation
water (or sprouts) from each production batch of sprouts for
pathogens to satisfy the requirements of Sec.  112.144(b) and (c)?
Subpart O--Records
112.161 What general requirements apply to records required under
this part?
112.162 Where must I store records?
112.163 May I use existing records to satisfy the requirements of
this part?
112.164 How long must I keep records?
112.165 What formats are acceptable for the records I keep?
112.166 What requirements apply for making records available and
accessible to FDA?
112.167 Can records that I provide to FDA be disclosed to persons
outside of FDA?
Subpart P--Variances
112.171 Who may request a variance from the requirements of this
part?
112.172 How may a State, tribe, or foreign country request a
variance from one or more requirements of this part?
112.173 What must be included in the Statement of Grounds in a
petition requesting a variance?
112.174 What information submitted in a petition requesting a
variance or submitted in comments on such a petition are publicly
available?
112.175 Who responds to a petition requesting a variance?
112.176 What process applies to a petition requesting a variance?
112.177 Can an approved variance apply to any person other than
those identified in the petition requesting that variance?
112.178 Under what circumstances may FDA deny a petition requesting
a variance?
112.179 When does a variance approved by FDA become effective?
112.180 Under what circumstances may FDA modify or revoke an
approved variance?
112.181 What procedures apply if FDA determines that an approved
variance should be modified or revoked?
112.182 What are the permissible types of variances that may be
granted?
Subpart Q--Compliance and Enforcement
112.192 What is the applicability and status of this part?
112.193 What are the provisions for coordination of education and
enforcement?
Subpart R--Withdrawal of Qualified Exemption
112.201 Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec.  112.5?
112.202 What procedure will FDA use to withdraw an exemption?
112.203 What information must FDA include in an order to withdraw a
qualified exemption?
112.204 What must I do if I receive an order to withdraw a qualified
exemption applicable to my farm?
112.205 Can I appeal or request a hearing on an order to withdraw a
qualified exemption applicable to my farm?
112.206 What is the procedure for submitting an appeal?
112.207 What is the procedure for requesting an informal hearing?
112.208 What requirements are applicable to an informal hearing?
112.209 Who is the presiding officer for an appeal and for an
informal hearing?
112.210 What is the timeframe for issuing a decision on an appeal?
112.211 When is an order to withdraw a qualified exemption
applicable to a farm revoked?
112.213 If my qualified exemption is withdrawn, under what
circumstances would FDA reinstate my qualified exemption?

    Authority:  21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

Subpart A--General Provisions

Sec.  112.1  What food is covered by this part?

    (a) Unless it is excluded from this part under Sec.  112.2, food
that is produce within the meaning of this part and that is a raw
agricultural commodity (RAC) is covered by this part. This includes a
produce RAC that is grown domestically and a produce RAC that will be
imported or offered for import in any State or territory of the United
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (b) For the purpose of this part and subject to the exemptions and
qualified exemptions therein, covered produce includes all of the
following:
    (1) Fruits and vegetables such as almonds, apples, apricots,
apriums, Artichokes-globe-type, Asian pears, avocados, babacos,
bananas, Belgian endive, blackberries, blueberries, boysenberries,
brazil nuts, broad beans, broccoli, Brussels sprouts, burdock,
cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes,
carambolas, carrots, cauliflower, celeriac, celery, chayote fruit,
cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as
clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines,
tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly
endive, currants, dandelion leaves, fennel-Florence, garlic, genip,
gooseberries, grapes, green beans, guavas, herbs (such as basil,
chives, cilantro, oregano, and parsley), honeydew, huckleberries,
Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek,
lettuce, lychees, macadamia nuts, mangos, other melons (such as Canary,
Crenshaw and Persian), mulberries, mushrooms, mustard greens,
nectarines, onions, papayas, parsnips, passion fruit, peaches, pears,
peas, peas-pigeon, peppers (such as bell

and hot), pine nuts, pineapples, plantains, plums, plumcots, quince,
radishes, raspberries, rhubarb, rutabagas, scallions, shallots, snow
peas, soursop, spinach, sprouts (such as alfalfa and mung bean),
strawberries, summer squash (such as patty pan, yellow and zucchini),
sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips (roots and
tops), walnuts, watercress, watermelons, and yams; and
    (2) Mixes of intact fruits and vegetables (such as fruit baskets).

Sec.  112.2  What produce is not covered by this part?

    (a) The following produce is not covered by this part:
    (1) Produce that is rarely consumed raw, specifically the produce
on the following exhaustive list: Asparagus; beans, black; beans, great
Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets,
garden (roots and tops); beets, sugar; cashews; cherries, sour;
chickpeas; cocoa beans; coffee beans; collards; corn, sweet;
cranberries; dates; dill (seeds and weed); eggplants; figs; ginger;
hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint;
potatoes; pumpkins; squash, winter; sweet potatoes; and water
chestnuts.
    (2) Produce that is produced by an individual for personal
consumption or produced for consumption on the farm or another farm
under the same management; and
    (3) Produce that is not a raw agricultural commodity.
    (b) Produce is eligible for exemption from the requirements of this
part (except as noted in paragraphs (b)(1), (2), and (3) of this
section) under the following conditions:
    (1) The produce receives commercial processing that adequately
reduces the presence of microorganisms of public health significance.
Examples of commercial processing that adequately reduces the presence
of microorganisms of public health significance are processing in
accordance with the requirements of part 113, 114, or 120 of this
chapter, treating with a validated process to eliminate spore-forming
microorganisms (such as processing to produce tomato paste or shelf-
stable tomatoes), and processing such as refining, distilling, or
otherwise manufacturing/processing produce into products such as sugar,
oil, spirits, wine, beer or similar products; and
    (2) You must disclose in documents accompanying the produce, in
accordance with the practice of the trade, that the food is ``not
processed to adequately reduce the presence of microorganisms of public
health significance;'' and
    (3) You must either:
    (i) Annually obtain written assurance, subject to the requirements
of paragraph (b)(6) of this section, from the customer that performs
the commercial processing described in paragraph (b)(1) of this section
that the customer has established and is following procedures
(identified in the written assurance) that adequately reduce the
presence of microorganisms of public health significance; or
    (ii) Annually obtain written assurance, subject to the requirements
of paragraph (b)(6) of this section, from your customer that an entity
in the distribution chain subsequent to the customer will perform
commercial processing described in paragraph (b)(1) of this section and
that the customer:
    (A) Will disclose in documents accompanying the food, in accordance
with the practice of the trade, that the food is ``not processed to
adequately reduce the presence of microorganisms of public health
significance''; and
    (B) Will only sell to another entity that agrees, in writing, it
will either:
    (1) Follow procedures (identified in a written assurance) that
adequately reduce the presence of microorganisms of public health
significance; or
    (2) Obtain a similar written assurance from its customer that the
produce will receive commercial processing described in paragraph
(b)(1) of this section, and that there will be disclosure in documents
accompanying the food, in accordance with the practice of the trade,
that the food is ``not processed to adequately reduce the presence of
microorganisms of public health significance''; and
    (4) You must establish and maintain documentation of your
compliance with applicable requirements in paragraphs (b)(2) and (3) in
accordance with the requirements of subpart O of this part, including:
    (i) Documents containing disclosures required under paragraph
(b)(2) of this section; and
    (ii) Annual written assurances obtained from customers required
under paragraph (b)(3) of this section; and
    (5) The requirements of this subpart and subpart Q of this part
apply to such produce; and
    (6) An entity that provides a written assurance under Sec.
112.2(b)(3)(i) or (ii) must act consistently with the assurance and
document its actions taken to satisfy the written assurance.

Sec.  112.3  What definitions apply to this part?

    (a) The definitions and interpretations of terms in section 201 of
the Federal Food, Drug, and Cosmetic Act apply to such terms when used
in this part.
    (b) For the purpose of this part, the following definitions of very
small business and small business also apply:
    (1) Very small business. For the purpose of this part, your farm is
a very small business if it is subject to any of the requirements of
this part and, on a rolling basis, the average annual monetary value of
produce (as defined in paragraph (c) of this section) you sold during
the previous 3-year period is no more than $250,000.
    (2) Small business. For the purpose of this part, your farm is a
small business if it is subject to any of the requirements of this part
and, on a rolling basis, the average annual monetary value of produce
(as defined in paragraph (c) of this section) you sold during the
previous 3-year period is no more than $500,000; and your farm is not a
very small business as provided in paragraph (b)(1) of this section.
    (c) For the purpose of this part, the following definitions also
apply:
    Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
    Adequately reduce microorganisms of public health significance
means reduce the presence of such microorganisms to an extent
sufficient to prevent illness.
    Agricultural tea means a water extract of biological materials
(such as stabilized compost, manure, non-fecal animal byproducts, peat
moss, pre-consumer vegetative waste, table waste, or yard trimmings),
excluding any form of human waste, produced to transfer microbial
biomass, fine particulate organic matter, and soluble chemical
components into an aqueous phase. Agricultural teas are held for longer
than one hour before application. Agricultural teas are soil amendments
for the purposes of this rule.
    Agricultural tea additive means a nutrient source (such as
molasses, yeast extract, or algal powder) added to agricultural tea to
increase microbial biomass.
    Agricultural water means water used in covered activities on
covered produce where water is intended to, or is likely to, contact
covered produce or food contact surfaces, including water used in
growing activities (including irrigation water applied using direct
water application methods, water used for preparing crop sprays, and
water used for growing sprouts) and in harvesting, packing, and holding
activities (including water used for washing or cooling harvested
produce and water used for preventing dehydration of covered produce).

    Animal excreta means solid or liquid animal waste.
    Application interval means the time interval between application of
an agricultural input (such as a biological soil amendment of animal
origin) to a growing area and harvest of covered produce from the
growing area where the agricultural input was applied.
    Biological soil amendment means any soil amendment containing
biological materials such as stabilized compost, manure, non-fecal
animal byproducts, peat moss, pre-consumer vegetative waste, sewage
sludge biosolids, table waste, agricultural tea, or yard trimmings,
alone or in combination.
    Biological soil amendment of animal origin means a biological soil
amendment which consists, in whole or in part, of materials of animal
origin, such as manure or non-fecal animal byproducts including animal
mortalities, or table waste, alone or in combination. The term
``biological soil amendment of animal origin'' does not include any
form of human waste.
    Composting means a process to produce stabilized compost in which
organic material is decomposed by the actions of microorganisms under
thermophilic conditions for a designated period of time (for example, 3
days) at a designated temperature (for example, 131 [deg]F (55
[deg]C)), followed by a curing stage under cooler conditions.
    Covered activity means growing, harvesting, packing, or holding
covered produce on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that
such activities are performed on raw agricultural commodities and only
to the extent that such activities are within the meaning of ``farm''
as defined in this chapter. Providing, acting consistently with, and
documenting actions taken in compliance with written assurances as
described in Sec.  112.2(b) are also covered activities. This part does
not apply to activities of a facility that are subject to part 110 of
this chapter.
    Covered produce means produce that is subject to the requirements
of this part in accordance with Sec. Sec.  112.1 and 112.2. The term
``covered produce'' refers to the harvestable or harvested part of the
crop.
    Curing means the final stage of composting, which is conducted
after much of the readily metabolized biological material has been
decomposed, at cooler temperatures than those in the thermophilic phase
of composting, to further reduce pathogens, promote further
decomposition of cellulose and lignin, and stabilize composition.
Curing may or may not involve insulation, depending on environmental
conditions.
    Direct water application method means using agricultural water in a
manner whereby the water is intended to, or is likely to, contact
covered produce or food contact surfaces during use of the water.
    Farm means:
    (i) Primary Production Farm. A Primary Production Farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term ``farm'' includes operations
that, in addition to these activities:
    (A) Pack or hold raw agricultural commodities;
    (B) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(i)(C)(2)(i) of this definition; and
    (C) Manufacture/process food, provided that:
    (1) All food used in such activities is consumed on that farm or
another farm under the same management; or
    (2) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
    (i) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
    (ii) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
    (iii) Packaging and labeling raw agricultural commodities, when
these activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
    (ii) Secondary Activities Farm. A Secondary Activities Farm is an
operation, not located on a Primary Production Farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of
raw agricultural commodities, provided that the Primary Production
Farm(s) that grows, harvests, and/or raises the majority of the raw
agricultural commodities harvested, packed, and/or held by the
Secondary Activities Farm owns, or jointly owns, a majority interest in
the Secondary Activities Farm. A Secondary Activities Farm may also
conduct those additional activities allowed on a Primary Production
Farm in paragraphs (i)(B) and (C) of this definition.
    Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes seeds and beans used to grow
sprouts.
    Food contact surfaces means those surfaces that contact human food
and those surfaces from which drainage, or other transfer, onto the
food or onto surfaces that contact the food ordinarily occurs during
the normal course of operations. ``Food contact surfaces'' includes
food contact surfaces of equipment and tools used during harvest,
packing and holding.
    Ground water means the supply of fresh water found beneath the
Earth's surface, usually in aquifers, which supply wells and springs.
Ground water does not include any water that meets the definition of
surface water.
    Growth media means material that acts as a substrate during the
growth of covered produce (such as mushrooms and some sprouts) that
contains, may contain, or consists of components that may include any
animal waste (such as stabilized compost, manure, non-fecal animal
byproducts or table waste).
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, removing stems and husks from,
shelling, sifting, threshing, trimming of outer leaves of, and washing
raw

agricultural commodities grown on a farm.
    Hazard means any biological agent that has the potential to cause
illness or injury in the absence of its control.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). Holding also includes
activities performed as a practical necessity for the distribution of
that food (such as blending of the same raw agricultural commodity and
breaking down pallets), but does not include activities that transform
a raw agricultural commodity into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological hazard
that is known to be, or has the potential to be, associated with the
farm or the food.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding,
homogenizing, labeling, milling, mixing, packaging (including modified
atmosphere packaging), pasteurizing, peeling, rendering, treating to
manipulate ripening, trimming, washing, or waxing. For farms and farm
mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
    Manure means animal excreta, alone or in combination with litter
(such as straw and feathers used for animal bedding) for use as a soil
amendment.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species having public health
significance. The term ``undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject
food to decomposition, that indicate that food is contaminated with
filth, or that otherwise may cause food to be adulterated.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but that also conducts activities outside the farm definition that
require the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point or procedure is under
control and, when required, to produce an accurate record of the
observation or measurement.
    Non-fecal animal byproduct means solid waste (other than manure)
that is animal in origin (such as meat, fat, dairy products, eggs,
carcasses, blood meal, bone meal, fish meal, shellfish waste (such as
crab, shrimp, and lobster waste), fish emulsions, and offal) and is
generated by commercial, institutional, or agricultural operations.
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling, grading, and weighing or conveying
incidental to packing or re-packing)), but does not include activities
that transform a raw agricultural commodity, as defined in section
201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed
food as defined in section 201(gg) of the Federal Food, Drug, and
Cosmetic Act.
    Pest means any objectionable animals or insects, including birds,
rodents, flies, and larvae.
    Pre-consumer vegetative waste means solid waste that is purely
vegetative in origin, not considered yard trash, and derived from
commercial, institutional, or agricultural operations without coming in
contact with animal products, byproducts or manure or with an end user
(consumer). Pre-consumer vegetative waste includes material generated
by farms, packing houses, canning operations, wholesale distribution
centers and grocery stores; products that have been removed from their
packaging (such as out-of-date juice, vegetables, condiments, and
bread); and associated packaging that is vegetative in origin (such as
paper or corn-starch based products). Pre-consumer vegetative waste
does not include table waste, packaging that has come in contact with
materials (such as meat) that are not vegetative in origin, or any
waste generated by restaurants.