Produce means any fruit or vegetable (including mixes of intact
fruits and vegetables) and includes mushrooms, sprouts (irrespective of
seed source), peanuts, tree nuts, and herbs. A fruit is the edible
reproductive body of a seed plant or tree nut (such as apple, orange,
and almond) such that fruit means the harvestable or harvested part of
a plant developed from a flower. A vegetable is the edible part of an
herbaceous plant (such as cabbage or potato) or fleshy fruiting body of
a fungus (such as white button or shiitake) grown for an edible part
such that vegetable means the harvestable or harvested part of any
plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots,
tubers, bulbs, stems, leaves, or flower parts are used as food and
includes mushrooms, sprouts, and herbs (such as basil or cilantro).
Produce does not include food grains meaning the small, hard fruits or
seeds of arable crops, or the crops bearing these fruits or seeds, that
are primarily grown and processed for use as meal, flour, baked goods,
cereals and oils rather than for direct consumption as small, hard
fruits or seeds (including cereal grains, pseudo cereals, oilseeds and
other plants used in the same fashion). Examples of food grains include
barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth,
quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed,
rapeseed, soybean, and sunflower seed).
    Production batch of sprouts means all sprouts that are started at
the same time in a single growing unit (e.g., a single drum or bin, or
a single rack of trays that are connected to each other), whether or
not the sprouts are grown from a single lot of seed (including, for
example, when multiple types of seeds are grown in a single growing
unit).
    Qualified end-user, with respect to a food, means the consumer of
the food (where the term consumer does not include a business); or a
restaurant or retail food establishment (as those terms are defined in
Sec.  1.227) that is located:
    (i) In the same State or the same Indian reservation as the farm
that produced the food; or
    (ii) Not more than 275 miles from such farm.
    Raw agricultural commodity (RAC) means ``raw agricultural
commodity'' as defined in section 201(r) of the Federal Food, Drug, and
Cosmetic Act.
    Sanitize means to adequately treat cleaned surfaces by a process
that is

effective in destroying vegetative cells of microorganisms of public
health significance, and in substantially reducing numbers of other
undesirable microorganisms, but without adversely affecting the product
or its safety for the consumer.
    Sewage sludge biosolids means the solid or semi-solid residue
generated during the treatment of domestic sewage in a treatment works
within the meaning of the definition of ``sewage sludge'' in 40 CFR
503.9(w).
    Soil amendment means any chemical, biological, or physical material
(such as elemental fertilizers, stabilized compost, manure, non-fecal
animal byproducts, peat moss, perlite, pre-consumer vegetative waste,
sewage sludge biosolids, table waste, agricultural tea and yard
trimmings) intentionally added to the soil to improve the chemical or
physical condition of soil in relation to plant growth or to improve
the capacity of the soil to hold water. The term soil amendment also
includes growth media that serve as the entire substrate during the
growth of covered produce (such as mushrooms and some sprouts).
    Spent sprout irrigation water means water that has been used in the
growing of sprouts.
    Stabilized compost means a stabilized (i.e., finished) biological
soil amendment produced through a controlled composting process.
    Static composting means a process to produce stabilized compost in
which air is introduced into biological material (in a pile (or row)
that may or may not be covered with insulating material, or in an
enclosed vessel) by a mechanism that does not include turning. Examples
of structural features for introducing air include embedded perforated
pipes and a constructed permanent base that includes aeration slots.
Examples of mechanisms for introducing air include passive diffusion
and mechanical means (such as blowers that suction air from the
composting material or blow air into the composting material using
positive pressure).
    Surface water means all water open to the atmosphere (rivers,
lakes, reservoirs, streams, impoundments, seas, estuaries, etc.) and
all springs, wells, or other collectors that are directly influenced by
surface water.
    Table waste means any post-consumer food waste, irrespective of
whether the source material is animal or vegetative in origin, derived
from individuals, institutions, restaurants, retail operations, or
other sources where the food has been served to a consumer.
    Turned composting means a process to produce stabilized compost in
which air is introduced into biological material (in a pile, row, or
enclosed vessel) by turning on a regular basis. Turning is the process
of mechanically mixing biological material that is undergoing a
composting process with the specific intention of moving the outer,
cooler sections of the material being composted to the inner, hotter
sections.
    Visitor means any person (other than personnel) who enters your
covered farm with your permission.
    Water distribution system means a system to carry water from its
primary source to its point of use, including pipes, sprinklers,
irrigation canals, pumps, valves, storage tanks, reservoirs, meters,
and fittings.
    We means the U.S. Food and Drug Administration (FDA).
    Yard trimmings means purely vegetative matter resulting from
landscaping maintenance or land clearing operations, including
materials such as tree and shrub trimmings, grass clippings, palm
fronds, trees, tree stumps, untreated lumber, untreated wooden pallets,
and associated rocks and soils.
    You, for purposes of this part, means the owner, operator, or agent
in charge of a covered farm that is subject to some or all of the
requirements of this part.

Sec.  112.4  Which farms are subject to the requirements of this part?

    (a) Except as provided in paragraph (b) of this section, a farm or
farm mixed-type facility with an average annual monetary value of
produce (as ``produce'' is defined in Sec.  112.3(c)) sold during the
previous 3-year period of more than $25,000 (on a rolling basis),
adjusted for inflation using 2011 as the baseline year for calculating
the adjustment, is a ``covered farm'' subject to this part. Covered
farms subject to this part must comply with all applicable requirements
of this part when conducting a covered activity on covered produce.
    (b) A farm is not a covered farm if it satisfies the requirements
in Sec.  112.5 and we have not withdrawn the farm's exemption in
accordance with the requirements of subpart R of this part.

Sec.  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?

    (a) A farm is eligible for a qualified exemption and associated
modified requirements in a calendar year if:
    (1) During the previous 3-year period preceding the applicable
calendar year, the average annual monetary value of the food (as
defined in Sec.  112.3(c)) the farm sold directly to qualified end-
users (as defined in Sec.  112.3(c)) during such period exceeded the
average annual monetary value of the food the farm sold to all other
buyers during that period; and
    (2) The average annual monetary value of all food (as defined in
Sec.  112.3(c)) the farm sold during the 3-year period preceding the
applicable calendar year was less than $500,000, adjusted for
inflation.
    (b) For the purpose of determining whether the average annual
monetary value of all food sold during the 3-year period preceding the
applicable calendar year was less than $500,000, adjusted for
inflation, the baseline year for calculating the adjustment for
inflation is 2011.

Sec.  112.6  What modified requirements apply to me if my farm is
eligible for a qualified exemption in accordance with Sec.  112.5?

    (a) If your farm is eligible for a qualified exemption in
accordance with Sec.  112.5, you are subject to the requirements of:
    (1) This subpart (General Provisions);
    (2) Subpart O of this part (Records);
    (3) Subpart Q of this part (Compliance and Enforcement); and
    (4) Subpart R of this part (Withdrawal of Qualified Exemption).
    (b) In addition, you are subject to the following modified
requirements:
    (1) When a food packaging label is required on food that would
otherwise be covered produce under the Federal Food, Drug, and Cosmetic
Act or its implementing regulations, you must include prominently and
conspicuously on the food packaging label the name and the complete
business address of the farm where the produce was grown.
    (2) When a food packaging label is not required on food that would
otherwise be covered produce under the Federal Food, Drug, and Cosmetic
Act, you must prominently and conspicuously display, at the point of
purchase, the name and complete business address of the farm where the
produce was grown, on a label, poster, sign, placard, or documents
delivered contemporaneously with the produce in the normal course of
business, or, in the case of Internet sales, in an electronic notice.
    (3) The complete business address that you must include in
accordance with the requirements of paragraph (b)(1) or (2) of this
section must include the street address or post office box, city,
state, and zip code for domestic farms, and comparable full address
information for foreign farms.

Sec.  112.7  What records must I establish and keep if my farm is
eligible for a qualified exemption in accordance with Sec.  112.5?

    If your farm is eligible for a qualified exemption in accordance
with Sec.  112.5:
    (a) You must establish and keep records required under this
provision in accordance with the requirements of subpart O of this
part, except that the requirement in Sec.  112.161(a)(4) for a
signature or initial of the person performing the activity is not
required for sales receipts kept in the normal course of business. Such
receipts must be dated as required under Sec.  112.161(a)(4).
    (b) You must establish and keep adequate records necessary to
demonstrate that your farm satisfies the criteria for a qualified
exemption that are described in Sec.  112.5, including a written record
reflecting that you have performed an annual review and verification of
your farm's continued eligibility for the qualified exemption.

Subpart B--General Requirements

Sec.  112.11  What general requirements apply to persons who are
subject to this part?

    You must take appropriate measures to minimize the risk of serious
adverse health consequences or death from the use of, or exposure to,
covered produce, including those measures reasonably necessary to
prevent the introduction of known or reasonably foreseeable hazards
into covered produce, and to provide reasonable assurances that the
produce is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act on account of such hazards.

Sec.  112.12  Are there any alternatives to the requirements
established in this part?

    (a) You may establish alternatives to certain specific requirements
of subpart E of this part, as specified in Sec.  112.49, provided that
you satisfy the requirements of paragraphs (b) and (c) of this section.
    (b) You may establish and use an alternative to any of the
requirements specified in paragraph (a) of this section, provided you
have adequate scientific data or information to support a conclusion
that the alternative would provide the same level of public health
protection as the applicable requirement established in this part, and
would not increase the likelihood that your covered produce will be
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act, in light of your covered produce, practices, and conditions.
    (c) Scientific data and information used to support an alternative
to a requirement specified in paragraph (a) of this section may be
developed by you, available in the scientific literature, or available
to you through a third party. You must establish and maintain
documentation of the scientific data and information on which you rely
in accordance with the requirements of subpart O of this part. You are
not required to notify or seek prior approval from FDA regarding your
decision to establish or use an alternative under this section.

Subpart C--Personnel Qualifications and Training

Sec.  112.21  What requirements apply regarding qualifications and
training for personnel who handle (contact) covered produce or food
contact surfaces?

    All of the following requirements apply regarding qualifications
and training for personnel who handle (contact) covered produce or food
contact surfaces:
    (a) All personnel (including temporary, part time, seasonal, and
contracted personnel) who handle covered produce or food contact
surfaces, or who are engaged in the supervision thereof, must receive
adequate training, as appropriate to the person's duties, upon hiring,
and periodically thereafter, at least once annually.
    (b) All personnel (including temporary, part time, seasonal, and
contracted personnel) who handle covered produce or food contact
surfaces, or who are engaged in the supervision thereof, must have a
combination of education, training, and experience necessary to perform
the person's assigned duties in a manner that ensures compliance with
this part.
    (c) Training must be conducted in a manner that is easily
understood by personnel being trained.
    (d) Training must be repeated as necessary and appropriate in light
of observations or information indicating that personnel are not
meeting standards established by FDA in subparts C through O of this
part.

Sec.  112.22  What minimum requirements apply for training personnel
who conduct a covered activity?

    (a) At a minimum, all personnel who handle (contact) covered
produce during covered activities or supervise the conduct of such
activities must receive training that includes all of the following:
    (1) Principles of food hygiene and food safety;
    (2) The importance of health and personal hygiene for all personnel
and visitors, including recognizing symptoms of a health condition that
is reasonably likely to result in contamination of covered produce or
food contact surfaces with microorganisms of public health
significance; and
    (3) The standards established by FDA in subparts C through O of
this part that are applicable to the employee's job responsibilities.
    (b) Persons who conduct harvest activities for covered produce must
also receive training that includes all of the following:
    (1) Recognizing covered produce that must not be harvested,
including covered produce that may be contaminated with known or
reasonably foreseeable hazards;
    (2) Inspecting harvest containers and equipment to ensure that they
are functioning properly, clean, and maintained so as not to become a
source of contamination of covered produce with known or reasonably
foreseeable hazards; and
    (3) Correcting problems with harvest containers or equipment, or
reporting such problems to the supervisor (or other responsible party),
as appropriate to the person's job responsibilities.
    (c) At least one supervisor or responsible party for your farm must
have successfully completed food safety training at least equivalent to
that received under standardized curriculum recognized as adequate by
the Food and Drug Administration.

Sec.  112.23  What requirements apply regarding supervisors?

    You must assign or identify personnel to supervise (or otherwise be
responsible for) your operations to ensure compliance with the
requirements of this part.

Sec.  112.30  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep records of training that document
required training of personnel, including the date of training, topics
covered, and the persons(s) trained.

Subpart D--Health and Hygiene

Sec.  112.31  What measures must I take to prevent ill or infected
persons from contaminating covered produce with microorganisms of
public health significance?

    (a) You must take measures to prevent contamination of covered
produce and food contact surfaces with microorganisms of public health
significance from any person with 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).
    (b) The measures you must take to satisfy the requirements of
paragraph (a) of this section must include all of the following
measures:
    (1) Excluding any person from working in any operations that may
result in contamination of covered produce or food contact surfaces
with microorganisms of public health significance when the person (by
medical examination, the person's acknowledgement, or observation) is
shown to have, or appears to have, an applicable health condition,
until the person's health condition no longer presents a risk to public
health; and
    (2) Instructing personnel to notify their supervisor(s) (or a
responsible party) if they have, or if there is a reasonable
possibility that they have an applicable health condition.

Sec.  112.32  What hygienic practices must personnel use?

    (a) Personnel who work in an operation in which covered produce or
food contact surfaces are at risk of contamination with known or
reasonably foreseeable hazards must use hygienic practices while on
duty to the extent necessary to protect against such contamination.
    (b) The hygienic practices that personnel use to satisfy the
requirements of paragraph (a) of this section when handling
(contacting) covered produce or food contact surfaces during a covered
activity must include all of the following practices:
    (1) Maintaining adequate personal cleanliness to protect against
contamination of covered produce and food contact surfaces;
    (2) Avoiding contact with animals other than working animals, and
taking appropriate steps to minimize the likelihood of contamination of
covered produce when in direct contact with working animals;
    (3) Washing hands thoroughly, including scrubbing with soap (or
other effective surfactant) and running water that satisfies the
requirements of Sec.  112.44(a) (as applicable) for water used to wash
hands, and drying hands thoroughly using single-service towels,
sanitary towel service, electric hand dryers, or other adequate hand
drying devices:
    (i) Before starting work;
    (ii) Before putting on gloves;
    (iii) After using the toilet;
    (iv) Upon return to the work station after any break or other
absence from the work station;
    (v) As soon as practical after touching animals (including
livestock and working animals), or any waste of animal origin; and
    (vi) At any other time when the hands may have become contaminated
in a manner that is reasonably likely to lead to contamination of
covered produce with known or reasonably foreseeable hazards;
    (4) If you choose to use gloves in handling covered produce or food
contact surfaces, maintaining gloves in an intact and sanitary
condition and replacing such gloves when no longer able to do so;
    (5) Removing or covering hand jewelry that cannot be adequately
cleaned and sanitized during periods in which covered produce is
manipulated by hand; and
    (6) Not eating, chewing gum, or using tobacco products in an area
used for a covered activity (however, drinking beverages is permitted
in designated areas).

Sec.  112.33  What measures must I take to prevent visitors from
contaminating covered produce and food contact surfaces with
microorganisms of public health significance?

    (a) You 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.
    (b) You must make toilet and hand-washing facilities accessible to
visitors.

Subpart E--Agricultural Water

Sec.  112.41  What requirements apply to the quality of agricultural
water?

    All agricultural water must be safe and of adequate sanitary
quality for its intended use.

Sec.  112.42  What requirements apply to my agricultural water sources,
water distribution system, and pooling of water?

    (a) At the beginning of a growing season, as appropriate, but at
least once annually, you must inspect all of your agricultural water
systems, to the extent they are under your control (including water
sources, water distribution systems, facilities, and equipment), to
identify conditions that are reasonably likely to introduce known or
reasonably foreseeable hazards into or onto covered produce or food
contact surfaces in light of your covered produce, practices, and
conditions, including consideration of the following:
    (1) The nature of each agricultural water source (for example,
ground water or surface water);
    (2) The extent of your control over each agricultural water source;
    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent and nearby land; and
    (5) The likelihood of introduction of known or reasonably
foreseeable hazards to agricultural water by another user of
agricultural water before the water reaches your covered farm.
    (b) You must adequately maintain all agricultural water
distribution systems to the extent they are under your control as
necessary and appropriate to prevent the water distribution system from
being a source of contamination to covered produce, food contact
surfaces, areas used for a covered activity, or water sources,
including by regularly inspecting and adequately storing all equipment
used in the system.
    (c) You must adequately maintain all agricultural water sources to
the extent they are under your control (such as wells). Such
maintenance includes regularly inspecting each source to identify any
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food contact
surfaces; correcting any significant deficiencies (e.g., repairs to
well cap, well casing, sanitary seals, piping tanks and treatment
equipment, and control of cross-connections); and keeping the source
free of debris, trash, domesticated animals, and other possible sources
of contamination of covered produce to the extent practicable and
appropriate under the circumstances.
    (d) As necessary and appropriate, you must implement measures
reasonably necessary to reduce the potential for contamination of
covered produce with known or reasonably foreseeable hazards as a
result of contact of covered produce with pooled water. For example,
such measures may include using protective barriers or staking to keep
covered produce from touching the ground or using an alternative
irrigation method.

Sec.  112.43  What requirements apply to treating agricultural water?

    (a) When agricultural water is treated in accordance with Sec.
112.45:
    (1) Any method you use to treat agricultural water (such as with
physical treatment, including using a pesticide device as defined by
the U.S. Environmental Protection Agency (EPA); EPA-registered
antimicrobial pesticide product; or other suitable method) must be
effective to make the water safe and of adequate sanitary quality for
its intended use and/or meet

the relevant microbial quality criteria in Sec.  112.44, as applicable.
    (2) You must deliver any treatment of agricultural water in a
manner to ensure that the treated water is consistently safe and of
adequate sanitary quality for its intended use and/or consistently
meets the relevant microbial quality criteria in Sec.  112.44, as
applicable.
    (b) You must monitor any treatment of agricultural water at a
frequency adequate to ensure that the treated water is consistently
safe and of adequate sanitary quality for its intended use and/or
consistently meets the relevant microbial quality criteria in Sec.
112.44, as applicable.

Sec.  112.44  What specific microbial quality criteria apply to
agricultural water used for certain intended uses?

    (a) When you use agricultural water for any one or more of these
following purposes, you must ensure there is no detectable generic
Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural
water, and you must not use untreated surface water for any of these
purposes:
    (1) Used as sprout irrigation water;
    (2) Applied in any manner that directly contacts covered produce
during or after harvest activities (for example, water that is applied
to covered produce for washing or cooling activities, and water that is
applied to harvested crops to prevent dehydration before cooling),
including when used to make ice that directly contacts covered produce
during or after harvest activities;
    (3) Used to contact food contact surfaces, or to make ice that will
contact food contact surfaces; and
    (4) Used for washing hands during and after harvest activities.
    (b) When you use agricultural water during growing activities for
covered produce (other than sprouts) using a direct water application
method, the following criteria apply (unless you establish and use
alternative criteria in accordance with Sec.  112.49):
    (1) A geometric mean (GM) of your agricultural water samples of 126
or less colony forming units (CFU) of generic E. coli per 100 mL of
water (GM is a measure of the central tendency of your water quality
distribution); and
    (2) A statistical threshold value (STV) of your agricultural water
samples of 410 or less CFU of generic E. coli per 100 mL of water (STV
is a measure of variability of your water quality distribution, derived
as a model-based calculation approximating the 90th percentile using
the lognormal distribution).

Sec.  112.45  What measures must I take if my agricultural water does
not meet the requirements of Sec.  112.41 or Sec.  112.44?

    (a) If you have determined or have reason to believe that your
agricultural water is not safe or of adequate sanitary quality for its
intended use as required under Sec.  112.41 and/or if your agricultural
water does not meet the microbial quality criterion for the specified
purposes as required under Sec.  112.44(a), you must immediately
discontinue that use(s), and before you may use the water source and/or
distribution system again for the intended use(s), you must either:
    (1) Re-inspect the entire affected agricultural water system to the
extent it is under your control, identify any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce or food contact surfaces, make necessary
changes, and take adequate measures to determine if your changes were
effective and, as applicable, adequately ensure that your agricultural
water meets the microbial quality criterion in Sec.  112.44(a); or
    (2) Treat the water in accordance with the requirements of Sec.
112.43.
    (b) If you have determined that your agricultural water does not
meet the microbial quality criteria (or any alternative microbial
quality criteria, if applicable) required under Sec.  112.44(b), as
soon as practicable and no later than the following year, you must
discontinue that use, unless you either:
    (1) Apply a time interval(s) (in days) and/or a (calculated) log
reduction by:
    (i) Applying a time interval between last irrigation and harvest
using either:
    (A) A microbial die-off rate of 0.5 log per day to achieve a
(calculated) log reduction of your geometric mean (GM) and statistical
threshold value (STV) to meet the microbial quality criteria in Sec.
112.44(b) (or any alternative microbial criteria, if applicable), but
no greater than a maximum time interval of 4 consecutive days; or
    (B) An alternative microbial die-off rate and any accompanying
maximum time interval, in accordance with Sec.  112.49; and/or
    (ii) Applying a time interval between harvest and end of storage
using an appropriate microbial die-off rate between harvest and end of
storage, and/or applying a (calculated) log reduction using appropriate
microbial removal rates during activities such as commercial washing,
to meet the microbial quality criteria in Sec.  112.44(b) (or any
alternative microbial criteria, if applicable), and any accompanying
maximum time interval or log reduction, provided you have adequate
supporting scientific data and information;
    (2) Re-inspect the entire affected agricultural water system to the
extent it is under your control, identify any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce or food contact surfaces, make necessary
changes, and take adequate measures to determine if your changes were
effective and adequately ensure that your agricultural water meets the
microbial quality criteria in Sec.  112.44(b) (or any alternative
microbial criteria, if applicable); or
    (3) Treat the water in accordance with the requirements of Sec.
112.43.

Sec.  112.46  How often must I test agricultural water that is subject
to the requirements of Sec.  112.44?

    (a) There is no requirement to test any agricultural water that is
subject to the requirements of Sec.  112.44 when:
    (1) You receive water from a Public Water System, as defined under
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that
furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State (as defined in 40 CFR
141.2) approved to administer the SDWA public water supply program, and
you have Public Water System results or certificates of compliance that
demonstrate that the water meets that requirement;
    (2) You receive water from a public water supply that furnishes
water that meets the microbial quality requirement described in Sec.
112.44(a), and you have public water system results or certificates of
compliance that demonstrate that the water meets that requirement; or
    (3) You treat water in accordance with the requirements of Sec.
112.43.
    (b) Except as provided in paragraph (a) of this section, you must
take the following steps for each source of water used for purposes
that are subject to the requirements of Sec.  112.44(b):
    (1) Conduct an initial survey to develop a microbial water quality
profile of the agricultural water source.
    (i) The initial survey must be conducted:
    (A) For an untreated surface water source, by taking a minimum
total of 20 samples of agricultural water (or an alternative testing
frequency that you establish and use, in accordance with Sec.  112.49)
over a minimum period of 2 years, but not greater than 4 years.
    (B) For an untreated ground water source, by taking a minimum total
of four samples of agricultural water during the growing season or over
a period of 1 year.

    (ii) The samples of agricultural water must be representative of
your use of the water and must be collected as close in time as
practicable to, but prior to, harvest. The microbial water quality
profile initially consists of the geometric mean (GM) and the
statistical threshold value (STV) of generic Escherichia coli (E. coli)
(colony forming units (CFU) per 100 milliliter (mL)) calculated using
this data set. You must determine the appropriate way(s) in which the
water may be used based on your microbial water quality profile in
accordance with Sec.  112.45(b).
    (iii) You must update the microbial water quality profile annually
as required under paragraph (b)(2) of this section, and otherwise
required under paragraph (b)(3) of this section.
    (2) Conduct an annual survey to update the microbial water quality
profile of your agricultural water.
    (i) After the initial survey described in paragraph (b)(1)(i) of
this section, you must test the water annually to update your existing
microbial water quality profile to confirm that the way(s) in which the
water is used continues to be appropriate. You must analyze:
    (A) For an untreated surface water source, a minimum number of five
samples per year (or an alternative testing frequency that you
establish and use, in accordance with Sec.  112.49).
    (B) For an untreated ground water source, a minimum of one sample
per year.
    (ii) The samples of agricultural water must be representative of
your use of the water and must be collected as close in time as
practicable to, but prior to, harvest.
    (iii) To update the microbial water quality profile, you must
calculate revised GM and STV values using your current annual survey
data, combined with your most recent initial or annual survey data from
within the previous 4 years, to make up a rolling data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (iv) You must modify your water use, as appropriate, based on the
revised GM and STV values in your updated microbial water quality
profile in accordance with Sec.  112.45(b).
    (3) If you have determined or have reason to believe that your
microbial water quality profile no longer represents the quality of
your water (for example, if there are significant changes in adjacent
land use that are reasonably likely to adversely affect the quality of
your water source), you must develop a new microbial water quality
profile reflective of the time period at which you believe your
microbial water quality profile changed.
    (i) To develop a new microbial water quality profile, you must
calculate new GM and STV values using your current annual survey data
(if taken after the time of the change), combined with new data, to
make up a data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (ii) You must modify your water use based on the new GM and STV
values in your new microbial water quality profile in accordance with
Sec.  112.45(b).
    (c) If you use untreated ground water for the purposes that are
subject to the requirements of Sec.  112.44(a), you must initially test
the microbial quality of each source of the untreated ground water at
least four times during the growing season or over a period of 1 year,
using a minimum total of four samples collected to be representative of
the intended use(s). Based on these results, you must determine whether
the water can be used for that purpose, in accordance with Sec.
112.45(a). If your four initial sample results meet the microbial
quality criteria of Sec.  112.44(a), you may test once annually
thereafter, using a minimum of one sample collected to be
representative of the intended use(s). You must resume testing at least
four times per growing season or year if any annual test fails to meet
the microbial quality criteria in Sec.  112.44(a).

Sec.  112.47  Who must perform the tests required under Sec.  112.46
and what methods must be used?

    (a) You may meet the requirements related to agricultural water
testing required under Sec.  112.46 using:
    (1) Test results from your agricultural water source(s) performed
by you, or by a person or entity acting on your behalf; or
    (2) Data collected by a third party or parties, provided the water
source(s) sampled by the third party or parties adequately represent
your agricultural water source(s) and all other applicable requirements
of this part are met.
    (b) Agricultural water samples must be aseptically collected and
tested using a method as set forth in Sec.  112.151.

Sec.  112.48  What measures must I take for water that I use during
harvest, packing, and holding activities for covered produce?

    (a) You must manage the water as necessary, including by
establishing and following water-change schedules for re-circulated
water, to maintain its safety and adequate sanitary quality and
minimize the potential for contamination of covered produce and food
contact surfaces with known or reasonably foreseeable hazards (for
example, hazards that may be introduced into the water from soil
adhering to the covered produce).
    (b) You must visually monitor the quality of water that you use
during harvest, packing, and holding activities for covered produce
(for example, water used for washing covered produce in dump tanks,
flumes, or wash tanks, and water used for cooling covered produce in
hydrocoolers) for buildup of organic material (such as soil and plant
debris).
    (c) You must maintain and monitor the temperature of water at a
temperature that is appropriate for the commodity and operation
(considering the time and depth of submersion) and is adequate to
minimize the potential for infiltration of microorganisms of public
health significance into covered produce.

Sec.  112.49  What alternatives may I establish and use in lieu of the
requirements of this subpart?

    Provided you satisfy the requirements of Sec.  112.12, you may
establish and use one or more of the following alternatives:
    (a) An alternative microbial quality criterion (or criteria) using
an appropriate indicator of fecal contamination, in lieu of the
microbial quality criteria in Sec.  112.44(b);
    (b) An alternative microbial die-off rate and an accompanying
maximum time interval, in lieu of the microbial die-off rate and
maximum time interval in Sec.  112.45(b)(1)(i);
    (c) An alternative minimum number of samples used in the initial
survey for an untreated surface water source, in lieu of the minimum
number of samples required under Sec.  112.46(b)(1)(i)(A); and
    (d) An alternative minimum number of samples used in the annual
survey for an untreated surface water source, in lieu of the minimum
number of samples required under Sec.  112.46(b)(2)(i)(A).

Sec.  112.50  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) The findings of the inspection of your agricultural water
system in accordance with the requirements of Sec.  112.42(a);
    (2) Documentation of the results of all analytical tests conducted
on agricultural water for purposes of compliance with this subpart;
    (3) Scientific data or information you rely on to support the
adequacy of a

method used to satisfy the requirements of Sec.  112.43(a)(1) and (2);
    (4) Documentation of the results of water treatment monitoring
under Sec.  112.43(b);
    (5) Scientific data or information you rely on to support the
microbial die-off or removal rate(s) that you used to determine the
time interval (in days) between harvest and end of storage, including
other activities such as commercial washing, as applicable, used to
achieve the calculated log reduction of generic Escherichia coli (E.
coli), in accordance with Sec.  112.45(b)(1)(ii);
    (6) Documentation of actions you take in accordance with Sec.
112.45. With respect to any time interval or (calculated) log reduction
applied in accordance with Sec.  112.45(b)(1)(i) and/or (ii), such
documentation must include the specific time interval or log reduction
applied, how the time interval or log reduction was determined, and the
dates of corresponding activities such as the dates of last irrigation
and harvest, the dates of harvest and end of storage, and/or the dates
of activities such as commercial washing);
    (7) Annual documentation of the results or certificates of
compliance from a public water system required under Sec.  112.46(a)(1)
or (2), if applicable;
    (8) Scientific data or information you rely on to support any
alternative that you establish and use in accordance with Sec.  112.49;
and
    (9) Any analytical methods you use in lieu of the method that is
incorporated by reference in Sec.  112.151(a).

Subpart F--Biological Soil Amendments of Animal Origin and Human
Waste

Sec.  112.51  What requirements apply for determining the status of a
biological soil amendment of animal origin?

    (a) A biological soil amendment of animal origin is treated if it
has been processed to completion to adequately reduce microorganisms of
public health significance in accordance with the requirements of Sec.
112.54, or, in the case of an agricultural tea, the biological
materials of animal origin used to make the tea have been so processed,
the water used to make the tea is not untreated surface water, and the
water used to make the tea has no detectable generic Escherichia coli
(E. coli) in 100 milliliters (mL) of water.
    (b) A biological soil amendment of animal origin is untreated if
it:
    (1) Has not been processed to completion in accordance with the
requirements of Sec.  112.54, or in the case of an agricultural tea,
the biological materials of animal origin used to make the tea have not
been so processed, or the water used to make the tea is untreated
surface water, or the water used to make the tea has detectable generic
E. coli in 100 mL of water;
    (2) Has become contaminated after treatment;
    (3) Has been recombined with an untreated biological soil amendment
of animal origin;
    (4) Is or contains a component that is untreated waste that you
know or have reason to believe is contaminated with a hazard or has
been associated with foodborne illness; or
    (5) Is an agricultural tea made with biological materials of animal
origin that contains an agricultural tea additive.

Sec.  112.52  How must I handle, convey, and store biological soil
amendments of animal origin?

    (a) You must handle, convey and store any biological soil amendment
of animal origin in a manner and location such that it does not become
a potential source of contamination to covered produce, food contact
surfaces, areas used for a covered activity, water sources, water
distribution systems, and other soil amendments. Agricultural teas that
are biological soil amendments of animal origin may be used in water
distribution systems provided that all other requirements of this rule
are met.
    (b) You must handle, convey and store any treated biological soil
amendment of animal origin in a manner and location that minimizes the
risk of it becoming contaminated by an untreated or in-process
biological soil amendment of animal origin.
    (c) You must handle, convey, and store any biological soil
amendment of animal origin that you know or have reason to believe may
have become contaminated as if it was untreated.

Sec.  112.53  What prohibitions apply regarding use of human waste?

    You may not use human waste for growing covered produce, except
sewage sludge biosolids used in accordance with the requirements of 40
CFR part 503, subpart D, or equivalent regulatory requirements.

Sec.  112.54  What treatment processes are acceptable for a biological
soil amendment of animal origin that I apply in the growing of covered
produce?

    Each of the following treatment processes are acceptable for a
biological soil amendment of animal origin that you apply in the
growing of covered produce, provided that the resulting biological soil
amendments are applied in accordance with the applicable requirements
of Sec.  112.56:
    (a) A scientifically valid controlled physical process (e.g.,
thermal), chemical process (e.g., high alkaline pH), biological process
(e.g., composting), or a combination of scientifically valid controlled
physical, chemical and/or biological processes that has been validated
to satisfy the microbial standard in Sec.  112.55(a) for Listeria
monocytogenes (L. monocytogenes), Salmonella species, and E. coli
O157:H7; or
    (b) A scientifically valid controlled physical, chemical, or
biological process, or a combination of scientifically valid controlled
physical, chemical, and/or biological processes, that has been
validated to satisfy the microbial standard in Sec.  112.55(b) for
Salmonella species and fecal coliforms. Examples of scientifically
valid controlled biological (e.g., composting) processes that meet the
microbial standard in Sec.  112.55(b) include:
    (1) Static composting that maintains aerobic (i.e., oxygenated)
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 3
consecutive days and is followed by adequate curing; and
    (2) Turned composting that maintains aerobic conditions at a
minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days (which do not have
to be consecutive), with a minimum of five turnings, and is followed by
adequate curing.

Sec.  112.55  What microbial standards apply to the treatment processes
in Sec.  112.54?

    The following microbial standards apply to the treatment processes
in Sec.  112.54 as set forth in that section.
    (a) For L. monocytogenes, Salmonella species, and E. coli O157:H7,
the relevant standards in the table in this paragraph (a); or

------------------------------------------------------------------------
        For the microorganism--            The microbial standard is--
------------------------------------------------------------------------
(1) L. monocytogenes...................  Not detected using a method
                                          that can detect one colony
                                          forming unit (CFU) per 5 gram
                                          (or milliliter, if liquid is
                                          being sampled) analytical
                                          portion.

(2) Salmonella species.................  Not detected using a method
                                          that can detect three most
                                          probable numbers (MPN) per 4
                                          grams (or milliliter, if
                                          liquid is being sampled) of
                                          total solids.
(3) E. coli O157:H7....................  Not detected using a method
                                          that can detect 0.3 MPN per 1
                                          gram (or milliliter, if liquid
                                          is being sampled) analytical
                                          portion.
------------------------------------------------------------------------

    (b) Salmonella species are not detected using a method that can
detect three MPN Salmonella species per 4 grams of total solids (dry
weight basis); and less than 1,000 MPN fecal coliforms per gram of
total solids (dry weight basis).

Sec.  112.56  What application requirements and minimum application
intervals apply to biological soil amendments of animal origin?

    (a) You must apply the biological soil amendments of animal origin
specified in the first column of the table in this paragraph (a) in
accordance with the application requirements specified in the second
column of the table in this paragraph (a) and the minimum application
intervals specified in the third column of the table in this paragraph
(a).

------------------------------------------------------------------------
                                  Then the biological     And then the
    If the biological soil         soil amendment of         minimum
amendment of animal origin is--  animal origin must be     application
                                       applied--          interval is--
------------------------------------------------------------------------
(1)(i) Untreated..............  In a manner that does   [Reserved].
                                 not contact covered
                                 produce during
                                 application and
                                 minimizes the
                                 potential for contact
                                 with covered produce
                                 after application.
(ii) Untreated................  In a manner that does   0 days.
                                 not contact covered
                                 produce during or
                                 after application.
(2) Treated by a                In a manner that        0 days.
 scientifically valid            minimizes the
 controlled physical,            potential for contact
 chemical, or biological         with covered produce
 process, or combination of      during and after
 scientifically valid            application.
 controlled physical,
 chemical, and/or biological
 processes, in accordance with
 the requirements of Sec.
 112.54(b) to meet the
 microbial standard in Sec.
 112.55(b).
(3) Treated by a                In any manner (i.e.,    0 days.
 scientifically valid            no restrictions).
 controlled physical,
 chemical, or biological
 process, or combination of
 scientifically valid
 controlled physical,
 chemical, or biological
 processes, in accordance with
 the requirements of Sec.
 112.54(a) to meet the
 microbial standard in Sec.
 112.55(a).
------------------------------------------------------------------------

    (b) [Reserved]

Sec.  112.60  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart
in accordance with the requirements of subpart O of this part.
    (b) For any biological soil amendment of animal origin you use, you
must establish and keep the following records:
    (1) For a treated biological soil amendment of animal origin you
receive from a third party, documentation (such as a Certificate of
Conformance) at least annually that:
    (i) The process used to treat the biological soil amendment of
animal origin is a scientifically valid process that has been carried
out with appropriate process monitoring; and
    (ii) The biological soil amendment of animal origin has been
handled, conveyed and stored in a manner and location to minimize the
risk of contamination by an untreated or in process biological soil
amendment of animal origin; and
    (2) For a treated biological soil amendment of animal origin you
produce for your own covered farm(s), documentation that process
controls (for example, time, temperature, and turnings) were achieved.

Subpart G-H [Reserved]

Subpart I--Domesticated and Wild Animals

Sec.  112.81  How do the requirements of this subpart apply to areas
where covered activities take place?

    (a) The requirements of this subpart apply when a covered activity
takes place in an outdoor area or a partially-enclosed building and
when, under the circumstances, there is a reasonable probability that
animals will contaminate covered produce.
    (b) The requirements of this subpart do not apply:
    (1) When a covered activity takes place in a fully-enclosed
building; or
    (2) To fish used in aquaculture operations.

Sec.  112.83  What requirements apply regarding grazing animals,
working animals, and animal intrusion?

    (a) You must take the steps set forth in paragraph (b) of this
section if under the circumstances there is a reasonable probability
that grazing animals, working animals, or animal intrusion will
contaminate covered produce.
    (b) You must:
    (1) Assess the relevant areas used for a covered activity for
evidence of potential contamination of covered produce as needed during
the growing season (based on your covered produce; your practices and
conditions; and your observations and experience); and
    (2) If significant evidence of potential contamination is found
(such as observation of animals, animal excreta or crop destruction),
you must evaluate whether the covered produce can be harvested in
accordance with the requirements of Sec.  112.112 and take measures
reasonably necessary during growing to assist you later during harvest
when you must identify, and not harvest, covered produce that is
reasonably likely to be contaminated with a known or reasonably
foreseeable hazard.

Sec.  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?

    No. Nothing in this regulation authorizes the ``taking'' of
threatened or endangered species as that term is defined by the
Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm,
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to
attempt to engage in any such conduct), in violation of the Endangered
Species Act. This regulation does not require covered farms 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

Sec.  112.111  What measures must I take if I grow, harvest, pack or
hold both covered and excluded produce?

    If you grow, harvest, pack or hold produce that is not covered in
this part (i.e., excluded produce in accordance with Sec.  112.2) and
also conduct such activities on covered produce, and the excluded
produce is not grown, harvested, packed or held in accordance with this
part, you must take measures during these covered activities, as
applicable, to:
    (a) Keep covered produce separate from excluded produce (except
when covered produce and excluded produce are placed in the same
container for distribution); and
    (b) Adequately clean and sanitize, as necessary, any food contact
surfaces that contact excluded produce before using such food contact
surfaces for covered activities on covered produce.

Sec.  112.112  What measures must I take immediately prior to and
during harvest activities?

    You must take all measures reasonably necessary to identify, and
not harvest, covered produce that is reasonably likely to be
contaminated with a known or reasonably foreseeable hazard, including
steps to identify and not harvest covered produce that is visibly
contaminated with animal excreta. At a minimum, identifying and not
harvesting covered produce that is reasonably likely to be contaminated
with animal excreta or that is visibly contaminated with animal excreta
requires a visual assessment of the growing area and all covered
produce to be harvested, regardless of the harvest method used.

Sec.  112.113  How must I handle harvested covered produce during
covered activities?

    You must handle harvested covered produce during covered activities
in a manner that protects against contamination with known or
reasonably foreseeable hazards--for example, by avoiding, to the degree
practicable, contact of cut surfaces of harvested produce with soil.

Sec.  112.114  What requirements apply to dropped covered produce?

    You must not distribute dropped covered produce. Dropped covered
produce is covered produce that drops to the ground before harvest.
Dropped covered produce does not include root crops that grow
underground (such as carrots), crops that grow on the ground (such as
cantaloupe), or produce that is intentionally dropped to the ground as
part of harvesting (such as almonds).

Sec.  112.115  What measures must I take when packaging covered
produce?

    You must package covered produce in a manner that prevents the
formation of Clostridium botulinum toxin if such toxin is a known or
reasonably foreseeable hazard (such as for mushrooms).

Sec.  112.116  What measures must I take when using food-packing
(including food packaging) material?

    (a) You must use food-packing material that is adequate for its
intended use, which includes being:
    (1) Cleanable or designed for single use; and
    (2) Unlikely to support growth or transfer of bacteria.
    (b) If you reuse food-packing material, you must take adequate
steps to ensure that food contact surfaces are clean, such as by
cleaning food-packing containers or using a clean liner.

Subpart L--Equipment, Tools, Buildings, and Sanitation

Sec.  112.121  What equipment and tools are subject to the requirements
of this subpart?

    Equipment and tools subject to the requirements of this subpart are
those that are intended to, or likely to, contact covered produce; and
those instruments or controls used to measure, regulate, or record
conditions to control or prevent the growth of microorganisms of public
health significance. Examples include knives, implements, mechanical
harvesters, waxing machinery, cooling equipment (including
hydrocoolers), grading belts, sizing equipment, palletizing equipment,
and equipment used to store or convey harvested covered produce (such
as containers, bins, food-packing material, dump tanks, flumes, and
vehicles or other equipment used for transport that are intended to, or
likely to, contact covered produce).

Sec.  112.122  What buildings are subject to the requirements of this
subpart?

    Buildings subject to the requirements of this subpart include:
    (a) Any fully- or partially-enclosed building used for covered
activities, including minimal structures that have a roof but do not
have any walls; and
    (b) Storage sheds, buildings, or other structures used to store
food contact surfaces (such as harvest containers and food-packing
materials).

Sec.  112.123  What general requirements apply regarding equipment and
tools subject to this subpart?

    All of the following requirements apply regarding equipment and
tools subject to this subpart:
    (a) You must use equipment and tools that are of adequate design,
construction, and workmanship to enable them to be adequately cleaned
and properly maintained; and
    (b) Equipment and tools must be:
    (1) Installed and maintained as to facilitate cleaning of the
equipment and of all adjacent spaces; and
    (2) Stored and maintained to protect covered produce from being
contaminated with known or reasonably foreseeable hazards and to
prevent the equipment and tools from attracting and harboring pests.
    (c) Seams on food contact surfaces of equipment and tools that you
use must be either smoothly bonded, or maintained to minimize
accumulation of dirt, filth, food particles, and organic material and
thus minimize the opportunity for harborage or growth of
microorganisms.
    (d)(1) You must inspect, maintain, and clean and, when necessary
and appropriate, sanitize all food contact surfaces of equipment and
tools used in covered activities as frequently as reasonably necessary
to protect against contamination of covered produce.
    (2) You must maintain and clean all non-food-contact surfaces of
equipment and tools subject to this subpart used during harvesting,
packing, and holding as frequently as reasonably necessary to protect
against contamination of covered produce.
    (e) If you use equipment such as pallets, forklifts, tractors, and
vehicles such that they are intended to, or likely to, contact covered
produce, you must

do so in a manner that minimizes the potential for contamination of
covered produce or food contact surfaces with known or reasonably
foreseeable hazards.

Sec.  112.124  What requirements apply to instruments and controls used
to measure, regulate, or record?

    Instruments or controls you use to measure, regulate, or record
temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or
other conditions, in order to control or prevent the growth of
microorganisms of public health significance, must be:
    (a) Accurate and precise as necessary and appropriate in keeping
with their purpose;
    (b) Adequately maintained; and
    (c) Adequate in number for their designated uses.

Sec.  112.125  What requirements apply to equipment that is subject to
this subpart used in the transport of covered produce?

    Equipment that is subject to this subpart that you use to transport
covered produce must be:
    (a) Adequately clean before use in transporting covered produce;
and
    (b) Adequate for use in transporting covered produce.

Sec.  112.126  What requirements apply to my buildings?

    (a) All of the following requirements apply regarding buildings:
    (1) Buildings must be suitable in size, construction, and design to
facilitate maintenance and sanitary operations for covered activities
to reduce the potential for contamination of covered produce or food
contact surfaces with known or reasonably foreseeable hazards.
Buildings must:
    (i) Provide sufficient space for placement of equipment and storage
of materials;
    (ii) Permit proper precautions to be taken to reduce the potential
for contamination of covered produce, food contact surfaces, or packing
materials with known or reasonably foreseeable hazards. The potential
for contamination must be reduced by effective design including the
separation of operations in which contamination is likely to occur, by
one or more of the following means: Location, time, partition, enclosed
systems, or other effective means; and
    (2) You must provide adequate drainage in all areas where normal
operations release or discharge water or other liquid waste on the
ground or floor of the building.
    (b) You must implement measures to prevent contamination of your
covered produce and food contact surfaces in your buildings, as
appropriate, considering the potential for such contamination through:
    (1) Floors, walls, ceilings, fixtures, ducts, or pipes; and
    (2) Drip or condensate.

Sec.  112.127  What requirements apply regarding domesticated animals
in and around a fully-enclosed building?

    (a) You must take reasonable precautions to prevent contamination
of covered produce, food contact surfaces, and food-packing materials
in fully-enclosed buildings with known or reasonably foreseeable
hazards from domesticated animals by:
    (1) Excluding domesticated animals from fully-enclosed buildings
where covered produce, food contact surfaces, or food-packing material
is exposed; or
    (2) Separating domesticated animals in a fully enclosed building
from an area where a covered activity is conducted on covered produce
by location, time, or partition.
    (b) Guard or guide dogs may be allowed in some areas of a fully
enclosed building if the presence of the dogs is unlikely to result in
contamination of produce, food contact surfaces, or food-packing
materials.

Sec.  112.128  What requirements apply regarding pest control in
buildings?

    (a) You must take those measures reasonably necessary to protect
covered produce, food contact surfaces, and food-packing materials from
contamination by pests in buildings, including routine monitoring for
pests as necessary and appropriate.
    (b) For fully-enclosed buildings, you must take measures to exclude
pests from your buildings.
    (c) For partially-enclosed buildings, you must take measures to
prevent pests from becoming established in your buildings (such as by
use of screens or by monitoring for the presence of pests and removing
them when present).

Sec.  112.129  What requirements apply to toilet facilities?

    All of the following requirements apply to toilet facilities:
    (a) You must provide personnel with adequate, readily accessible
toilet facilities, including toilet facilities readily accessible to
growing areas during harvesting activities.
    (b) Your toilet facilities must be designed, located, and
maintained to:
    (1) Prevent contamination of covered produce, food contact
surfaces, areas used for a covered activity, water sources, and water
distribution systems with human waste;
    (2) Be directly accessible for servicing, be serviced and cleaned
at a frequency sufficient to ensure suitability of use, and be kept
supplied with toilet paper; and
    (3) Provide for the sanitary disposal of waste and toilet paper.
    (c) During growing activities that take place in a fully-enclosed
building, and during covered harvesting, packing, or holding
activities, you must provide a hand-washing station in sufficiently
close proximity to toilet facilities to make it practical for persons
who use the toilet facility to wash their hands.

Sec.  112.130  What requirements apply for hand-washing facilities?

    All of the following requirements apply to hand-washing facilities:
    (a) You must provide personnel with adequate, readily accessible
hand-washing facilities during growing activities that take place in a
fully-enclosed building, and during covered harvest, packing, or
holding activities.
    (b) Your hand-washing facilities must be furnished with:
    (1) Soap (or other effective surfactant);
    (2) Running water that satisfies the requirements of Sec.
112.44(a) for water used to wash hands; and
    (3) Adequate drying devices (such as single service towels,
sanitary towel service, or electric hand dryers).
    (c) You must provide for appropriate disposal of waste (for
example, waste water and used single-service towels) associated with a
hand-washing facility and take appropriate measures to prevent waste
water from a hand-washing facility from contaminating covered produce,
food contact surfaces, areas used for a covered activity, agricultural
water sources, and agricultural water distribution systems with known
or reasonably foreseeable hazards.
    (d) You may not use antiseptic hand rubs as a substitute for soap
(or other effective surfactant) and water.

Sec.  112.131  What must I do to control and dispose of sewage?

    All of the following requirements apply for the control and
disposal of sewage:
    (a) You must dispose of sewage into an adequate sewage or septic
system or through other adequate means.
    (b) You must maintain sewage and septic systems in a manner that
prevents contamination of covered produce, food contact surfaces, areas
used for a covered activity, agricultural water sources, and
agricultural water distribution systems with known or reasonably
foreseeable hazards.
    (c) You must manage and dispose of leakages or spills of human
waste in a manner that prevents contamination of

covered produce, and prevents or minimizes contamination of food
contact surfaces, areas used for a covered activity, agricultural water
sources, or agricultural water distribution systems.
    (d) After a significant event (such as flooding or an earthquake)
that could negatively impact a sewage or septic system, you must take
appropriate steps to ensure that sewage and septic systems continue to
operate in a manner that does not contaminate covered produce, food
contact surfaces, areas used for a covered activity, agricultural water
sources, or agricultural water distribution systems.

Sec.  112.132  What must I do to control and dispose of trash, litter,
and waste in areas used for covered activities?

    All of the following requirements apply to the control and disposal
of trash, litter, and waste in areas used for covered activities:
    (a) You must convey, store, and dispose of trash, litter and waste
to:
    (1) Minimize the potential for trash, litter, or waste to attract
or harbor pests; and
    (2) Protect against contamination of covered produce, food contact
surfaces, areas used for a covered activity, agricultural water
sources, and agricultural water distribution systems with known or
reasonably foreseeable hazards.
    (b) You must adequately operate systems for waste treatment and
disposal so that they do not constitute a potential source of
contamination in areas used for a covered activity.

Sec.  112.133  What requirements apply to plumbing?

    The plumbing must be of an adequate size and design and be
adequately installed and maintained to:
    (a) Distribute water under pressure as needed, in sufficient
quantities, in all areas where used for covered activities, for
sanitary operations, or for hand-washing and toilet facilities;
    (b) Properly convey sewage and liquid disposable waste;
    (c) Avoid being a source of contamination to covered produce, food
contact surfaces, areas used for a covered activity, or agricultural
water sources; and
    (d) Not allow backflow from, or cross connection between, piping
systems that discharge waste water or sewage and piping systems that
carry water used for a covered activity, for sanitary operations, or
for use in hand-washing facilities.

Sec.  112.134  What must I do to control animal excreta and litter from
domesticated animals that are under my control?

    (a) If you have domesticated animals, to prevent contamination of
covered produce, food contact surfaces, areas used for a covered
activity, agricultural water sources, or agricultural water
distribution systems with animal waste, you must:
    (1) Adequately control their excreta and litter; and
    (2) Maintain a system for control of animal excreta and litter.
    (b) [Reserved]

Sec.  112.140  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep documentation of the date and
method of cleaning and sanitizing of equipment subject to this subpart
used in:
    (1) Growing operations for sprouts; and
    (2) Covered harvesting, packing, or holding activities.

Subpart M--Sprouts

Sec.  112.141  What commodities are subject to this subpart?

    The requirements of this subpart apply to growing, harvesting,
packing, and holding of all sprouts, except soil- or substrate-grown
sprouts harvested without their roots.

Sec.  112.142  What requirements apply to seeds or beans used to grow
sprouts?

    In addition to the requirements of this part, all of the following
requirements apply to seeds or beans used to grow sprouts.
    (a) You must take measures reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into or onto
seeds or beans that you will use for sprouting.
    (b) Except as provided in paragraph (c) of this section, if you
know or have reason to believe that a lot of seeds or beans may be
contaminated with a pathogen (either because it has been associated
with foodborne illness; or based on microbial test results, including a
positive finding of a pathogen in tests required under Sec.
112.144(b)), you must:
    (1) Discontinue use of all seeds or beans from that lot for sprout
production and ensure that sprouts grown from that lot of seeds or
beans do not enter commerce; and
    (2) Report the information (association with illness and/or
findings of microbial testing) to the seed grower, distributor,
supplier, or other entity from whom you received the seeds or beans.
    (c) If your reason to believe that a lot of seeds or beans may be
contaminated was based only on microbial test results:
    (1) You are not required to take the steps set forth in paragraph
(b)(1) of this section if you treat your lot of seeds or beans with a
process that is reasonably certain to achieve destruction or
elimination in the seeds or beans of the most resistant microorganisms
of public health significance that are likely to occur in the seeds or
beans; or
    (2) You are not required to take the steps set forth in paragraphs
(b)(1) and (2) of this section if you later reasonably determine,
through appropriate followup actions, that the lot of seeds or beans is
not the source of contamination (e.g., the lot of seeds or beans is not
the source of a pathogen found in spent sprout irrigation water or
sprouts).
    (d) You must visually examine seeds and beans, and packaging used
to ship seeds or beans, for signs of potential contamination with known
or reasonably foreseeable hazards.
    (e) You must either:
    (1) Treat seeds or beans that will be used to grow sprouts using a
scientifically valid method to reduce microorganisms of public health
significance; or
    (2) Rely on prior treatment of seeds or beans conducted by a
grower, distributor, or supplier of the seeds or beans (whether to
fulfill this requirement completely or for the purpose of considering
such prior treatment when applying appropriate additional treatment of
the seeds or beans at the covered farm immediately before sprouting),
provided that you obtain documentation (such as a Certificate of
Conformance) from the grower, distributor, or supplier that:
    (i) The prior treatment was conducted using a scientifically valid
method to reduce microorganisms of public health significance; and
    (ii) The treated seeds or beans were handled and packaged following
the treatment in a manner that minimizes the potential for
contamination.

Sec.  112.143  What measures must I take for growing, harvesting,
packing, and holding sprouts?

    You must take all of the following measures for growing,
harvesting, packing, and holding sprouts:
    (a) You must grow, harvest, pack, and hold sprouts in a fully-
enclosed building.
    (b) Any food contact surfaces you use to grow, harvest, pack, or
hold sprouts must be cleaned and sanitized before

contact with sprouts or seeds or beans used to grow sprouts.
    (c) You must conduct testing during growing, harvesting, packing,
and holding sprouts, as specified in Sec.  112.144.
    (d) You must establish and implement a written environmental
monitoring plan as specified in Sec.  112.145.
    (e) You must take certain actions if you detect Listeria species or
L. monocytogenes in the growing, harvesting, packing, or holding
environment, as specified in Sec.  112.146.
    (f) You must establish and implement a written sampling plan to
test spent sprout irrigation water or sprouts for pathogens as
specified in Sec.  112.147.
    (g) You must take certain actions if the samples of spent sprout
irrigation water or sprouts test positive for a pathogen as specified
in Sec.  112.148.

Sec.  112.144  What testing must I do during growing, harvesting,
packing, and holding sprouts?

    All of the following testing must be done during growing,
harvesting, packing, and holding sprouts:
    (a) You must test the growing, harvesting, packing, and holding
environment for Listeria species or L. monocytogenes in accordance with
the requirements of Sec.  112.145.
    (b) You must either:
    (1) Test spent sprout irrigation water from each production batch
of sprouts for E. coli O157:H7, Salmonella species, and any pathogens
meeting the criteria in paragraph (c) of this section, in accordance
with the requirements of Sec.  112.147; or
    (2) If testing spent sprout irrigation water is not practicable
(for example, soil-grown sprouts harvested with roots or for
hydroponically grown sprouts that use very little water), test each
production batch of sprouts at the in-process stage (i.e., while
sprouts are still growing) for E. coli O157:H7, Salmonella species, and
any pathogens meeting the criteria in paragraph (c) of this section, in
accordance with the requirements of Sec.  112.147.
    (c) In addition to E. coli O157:H7 and Salmonella species, you must
conduct tests as provided in paragraph (b) of this section for
additional pathogens when the following conditions are met:
    (1) Testing for the pathogen is reasonably necessary to minimize
the risk of serious adverse health consequences or death from use of,
or exposure to, sprouts; and
    (2) A scientifically valid test method for the pathogen is
available to detect the pathogen in spent sprout irrigation water (or
sprouts).

Sec.  112.145  What requirements apply to testing the environment for
Listeria species or L. monocytogenes?

    All of the following testing requirements apply for the growing,
harvesting, packing, and holding environment for Listeria species or L.
monocytogenes.
    (a) You must establish and implement a written environmental
monitoring plan that is designed to identify L. monocytogenes if it is
present in the growing, harvesting, packing, or holding environment.
    (b) Your written environmental monitoring plan must be directed to
sampling and testing for either Listeria species or L. monocytogenes.
    (c) Your written environmental monitoring plan must include a
sampling plan that specifies:
    (1) What you will test collected samples for (i.e., Listeria
species or L. monocytogenes);
    (2) How often you will collect environmental samples, which must be
no less than monthly, and at what point during production you will
collect the samples; and
    (3) Sample collection sites; the number and location of sampling
sites must be sufficient to determine whether measures are effective
and must include appropriate food contact surfaces and non-food-contact
surfaces of equipment, and other surfaces within the growing,
harvesting, packing, and holding environment.
    (d) You must aseptically collect environmental samples and test
them for Listeria species or L. monocytogenes using a method as set
forth in Sec.  112.152.
    (e) Your written environmental monitoring plan must include a
corrective action plan that, at a minimum, requires you to take the
actions in Sec.  112.146, and details when and how you will accomplish
those actions, if the growing, harvesting, packing, or holding
environment tests positive for Listeria species or L. monocytogenes.

Sec.  112.146  What actions must I take if the growing, harvesting,
packing, or holding environment tests positive for Listeria species or
L. monocytogenes?

    You must, at a minimum, take the following actions if you detect
Listeria species or L. monocytogenes in the growing, harvesting,
packing, or holding environment:
    (a) Conduct additional testing of surfaces and areas surrounding
the area where Listeria species or L. monocytogenes was detected to
evaluate the extent of the problem, including the potential for
Listeria species or L. monocytogenes to have become established in a
niche;
    (b) Clean and sanitize the affected surfaces and surrounding areas;
    (c) Conduct additional sampling and testing to determine whether
the Listeria species or L. monocytogenes has been eliminated;
    (d) Conduct finished product testing when appropriate;
    (e) Perform any other actions necessary to prevent recurrence of
the contamination; and
    (f) Take appropriate action to prevent any food that is adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act from
entering into commerce.

Sec.  112.147  What must I do to collect and test samples of spent
sprout irrigation water or sprouts for pathogens?

    All of the following requirements apply for collecting and testing
samples of spent sprout irrigation water or sprouts for pathogens as
required in Sec.  112.144(b):
    (a) You must establish and implement a written sampling plan that
identifies the number and location of samples (of spent sprout
irrigation water or sprouts) to be collected for each production batch
of sprouts to ensure that the collected samples are representative of
the production batch when testing for contamination.
    (b) In accordance with the written sampling plan required under
paragraph (a) of this section, you must aseptically collect samples of
spent sprout irrigation water or sprouts, and test the collected
samples for pathogens using a method as set forth in Sec.  112.153. You
must not allow the production batch of sprouts to enter into commerce
unless the results of the testing of spent sprout irrigation water or
sprouts are negative for E. coli O157:H7, Salmonella species, and, if
applicable, a pathogen meeting the criteria in Sec.  112.144(c).
    (c) Your written sampling plan must include a corrective action
plan that at a minimum, requires you to take the actions in Sec.
112.148, and details when and how you will accomplish those actions, if
the samples of spent sprout irrigation water or sprouts test positive
for E. coli O157:H7, Salmonella species, or a pathogen meeting the
criteria in Sec.  112.144(c).

Sec.  112.148  What actions must I take if the samples of spent sprout
irrigation water or sprouts test positive for a pathogen?

    You must, at a minimum, take the following actions if the samples
of spent sprout irrigation water or sprouts test positive for E. coli
O157:H7, Salmonella species, or a pathogen meeting the criteria in
Sec.  112.144(c):
    (a) Take appropriate action to prevent any food that is adulterated
under

section 402 of the Federal Food, Drug, and Cosmetic Act from entering
into commerce;
    (b) Take the steps required in Sec.  112.142(b) with respect to the
lot of seeds or beans used to grow the affected production batch of
sprouts (except as allowed under Sec.  112.142(c));
    (c) Clean and sanitize the affected surfaces and surrounding areas;
and
    (d) Perform any other actions necessary to prevent reoccurrence of
the contamination.

Sec.  112.150  Under this subpart, what requirements apply regarding
records?

    (a) You must establish and keep records required under this subpart
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) Documentation of your treatment of seeds or beans to reduce
microorganisms of public health significance in the seeds or beans, at
your farm; or alternatively, documentation (such as a Certificate of
Conformance) from your seed supplier that seeds or beans are treated to
reduce microorganisms of public health significance and are
appropriately handled and packaged following the treatment, in
accordance with the requirements of Sec.  112.142(e);
    (2) Your written environmental monitoring plan in accordance with
the requirements of Sec.  112.145;
    (3) Your written sampling plan for each production batch of sprouts
in accordance with the requirements of Sec.  112.147(a) and (c);
    (4) Documentation of the results of all analytical tests conducted
for purposes of compliance with this subpart;
    (5) Any analytical methods you use in lieu of the methods that are
incorporated by reference in Sec. Sec.  112.152 and 112.153; and
    (6) Documentation of actions you take in accordance with Sec. Sec.
112.142(b) and (c), 112.146, and 112.148.

Subpart N--Analytical Methods

Sec.  112.151  What methods must I use to test the quality of water to
satisfy the requirements of Sec.  112.46?

    You must test the quality of water using:
    (a) The method of analysis published by the U.S. Environmental
Protection Agency (EPA), ``Method 1603: Escherichia coli (E. coli) in
Water by Membrane Filtration Using Modified membrane-Thermotolerant
Escherichia coli Agar (Modified mTEC), EPA-821-R-09-007),'' December,
2009. The Director of the Federal Register approves this incorporation
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You
may obtain a copy from EPA, Office of Water (4303T), 1200 Pennsylvania
Avenue NW., Washington, DC 20460. You may inspect a copy at FDA's Main
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993,<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; or
    (b)(1) A scientifically valid method that is at least equivalent to
the method of analysis in Sec.  112.151(a) in accuracy, precision, and
sensitivity; or
    (2) For any other indicator of fecal contamination you may test for
pursuant to Sec.  112.49(a), a scientifically valid method.

Sec.  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)?

    You must test the growing, harvesting, packing, and holding
environment for Listeria species or L. monocytogenes using:
    (a) The method of analysis described in ``Testing Methodology for
Listeria species or L. monocytogenes in Environmental Samples,''
Version 1, October 2015, U.S. Food and Drug Administration. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may
obtain a copy from, and/or inspect a copy at, the Division of Produce
Safety, Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740,<PHONE_NUMBER>; FDA's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993,<PHONE_NUMBER>; http://www.fda.gov/fsma; or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; or
    (b) A scientifically valid method that is at least equivalent to
the method of analysis in Sec.  112.152(a) in accuracy, precision, and
sensitivity.

Sec.  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)?

    You must test spent sprout irrigation water (or sprouts) from each
production batch for pathogens using:
    (a) For E. coli O157:H7, Salmonella species:
    (1) The method of analysis described in ``Testing Methodologies for
E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water
(or Sprouts),'' Version 1, October 2015, U.S. Food and Drug
Administration. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 5. You may obtain a copy from, and/or inspect a copy at, the
Division of Produce Safety, Center for Food Safety and Applied
Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,<PHONE_NUMBER>; FDA's Main Library, 10903
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039; http://www.fda.gov/fsma; or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; or
    (2) A scientifically valid method that is at least equivalent to
the method of analysis in Sec.  112.153(a)(1) in accuracy, precision,
and sensitivity; and
    (b) For any other pathogen(s) meeting the criteria in Sec.
112.144(c), a scientifically valid method.

Subpart O--Records

Sec.  112.161  What general requirements apply to records required
under this part?

    (a) Except as otherwise specified, all records required under this
part must:
    (1) Include, as applicable:
    (i) The name and location of your farm;
    (ii) Actual values and observations obtained during monitoring;
    (iii) An adequate description (such as the commodity name, or the
specific variety or brand name of a commodity, and, when available, any
lot number or other identifier) of covered produce applicable to the
record;
    (iv) The location of a growing area (for example, a specific field)
or other area (for example, a specific packing shed) applicable to the
record; and
    (v) The date and time of the activity documented;
    (2) Be created at the time an activity is performed or observed;

    (3) Be accurate, legible, and indelible; and
    (4) Be dated, and signed or initialed by the person who performed
the activity documented.
    (b) Records required under Sec. Sec.  112.7(b), 112.30(b)(2),
112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and
112.150(b)(1), (4), and (6), must be reviewed, dated, and signed,
within a reasonable time after the records are made, by a supervisor or
responsible party.

Sec.  112.162  Where must I store records?

    (a) Offsite storage of records is permitted if such records can be
retrieved and provided onsite within 24 hours of request for official
review.
    (b) Electronic records are considered to be onsite at your farm if
they are accessible from an onsite location at your farm.

Sec.  112.163  May I use existing records to satisfy the requirements
of this part?

    (a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be duplicated if they contain all of the required
information and satisfy the requirements of this part. Existing records
may be supplemented as necessary to include all of the required
information and satisfy the requirements of this part.
    (b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.

Sec.  112.164  How long must I keep records?

    (a)(1) You must keep records required by this part for at least 2
years past the date the record was created.
    (2) Records that a farm relies on during the 3-year period
preceding the applicable calendar year to satisfy the criteria for a
qualified exemption, in accordance with Sec. Sec.  112.5 and 112.7,
must be retained as long as necessary to support the farm's status
during the applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or
processes or records that relate to analyses, sampling, or action plans
being used by a farm, including the results of scientific studies,
tests, and evaluations, must be retained at the farm for at least 2
years after the use of such equipment or processes, or records related
to analyses, sampling, or action plans, is discontinued.

Sec.  112.165  What formats are acceptable for the records I keep?

    You must keep records as:
    (a) Original records;
    (b) True copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records); or
    (c) Electronic records. Records that are established or maintained
to satisfy the requirements of this part and that meet the definition
of electronic records in Sec.  11.3(b)(6) of this chapter are exempt
from the requirements of part 11 of this chapter. Records that satisfy
the requirements of this part, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.

Sec.  112.166  What requirements apply for making records available and
accessible to FDA?

    (a) You must have all records required under this part readily
available and accessible during the retention period for inspection and
copying by FDA upon oral or written request, except that you have 24
hours to obtain records you keep offsite and make them available and
accessible to FDA for inspection and copying.
    (b) If you use electronic techniques to keep records, or to keep
true copies of records, or if you use reduction techniques such as
microfilm to keep true copies of records, you must provide the records
to FDA in a format in which they are accessible and legible.
    (c) If your farm is closed for a prolonged period, the records may
be transferred to some other reasonably accessible location but must be
returned to your farm within 24 hours for official review upon request.

Sec.  112.167  Can records that I provide to FDA be disclosed to
persons outside of FDA?

    Records obtained by FDA in accordance with this part are subject to
the disclosure requirements under part 20 of this chapter.

Subpart P--Variances

Sec.  112.171  Who may request a variance from the requirements of this
part?

    A State, Federally-recognized tribe (or ``tribe''), or a foreign
country from which food is imported into the United States may request
a variance from one or more requirements of this part, where the State,
tribe, or foreign country determines that:
    (a) The variance is necessary in light of local growing conditions;
and
    (b) The procedures, processes, and practices to be followed under
the variance are reasonably likely to ensure that the produce is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act and to provide the same level of public health protection as the
requirements of this part.

Sec.  112.172  How may a State, tribe, or foreign country request a
variance from one or more requirements of this part?

    To request a variance from one or more requirements of this part,
the competent authority (i.e., the regulatory authority for food
safety) for a State, tribe, or a foreign country must submit a petition
under Sec.  10.30 of this chapter.

Sec.  112.173  What must be included in the Statement of Grounds in a
petition requesting a variance?

    In addition to the requirements set forth in Sec.  10.30 of this
chapter, the Statement of Grounds in a petition requesting a variance
must:
    (a) Provide a statement that the applicable State, tribe, or
foreign country has determined that the variance is necessary in light
of local growing conditions and that the procedures, processes, and
practices to be followed under the variance are reasonably likely to
ensure that the produce is not adulterated under section 402 of the
Federal Food, Drug and Cosmetic Act and to provide the same level of
public health protection as the requirements of this part;
    (b) Describe with particularity the variance requested, including
the persons to whom the variance would apply and the provision(s) of
this part to which the variance would apply;
    (c) Present information demonstrating that the procedures,
processes, and practices to be followed under the variance are
reasonably likely to ensure that the produce is not adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342)
and to provide the same level of public health protection as the
requirements of this part.

Sec.  112.174  What information submitted in a petition requesting a
variance or submitted in comments on such a petition are publicly
available?

    We will presume that information submitted in a petition requesting
a variance and comments submitted on such a petition, including a
request that a variance be applied to its similarly situated persons,
does not contain information exempt from public disclosure under part
20 of this chapter and will be made public as part of the docket
associated with this request.

Sec.  112.175  Who responds to a petition requesting a variance?

    The Director or Deputy Directors of the Center for Food Safety and
Applied Nutrition (CFSAN), or the Director, Office of Compliance,
CFSAN, responds to a request for a variance.

Sec.  112.176  What process applies to a petition requesting a
variance?

    (a) In general, the procedures set forth in Sec.  10.30 of this
chapter govern our response to a petition requesting a variance.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a
notice in the Federal Register, requesting information and views on a
filed petition, including information and views from persons who could
be affected by the variance if the petition were to be granted (e.g.,
because their farm is covered by the petition or as a person similarly
situated to persons covered by the petition).
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the
petitioner in writing and will also make public a notice on FDA's Web
site announcing our decision to either grant or deny the petition.
    (1) If we grant the petition, either in whole or in part, we will
specify the persons to whom the variance applies and the provision(s)
of this part to which the variance applies.
    (2) If we deny the petition (including partial denials), our
written response to the petitioner and our public notice announcing our
decision to deny the petition will explain the reason(s) for the
denial.
    (d) We will make readily accessible to the public, and periodically
update, a list of filed petitions requesting variances, including the
status of each petition (for example, pending, granted, or denied).

Sec.  112.177  Can an approved variance apply to any person other than
those identified in the petition requesting that variance?

    (a) A State, tribe, or a foreign country that believes that a
variance requested by a petition submitted by another State, tribe, or
foreign country should also apply to similarly situated persons in its
jurisdiction may request that the variance be applied to its similarly
situated persons by submitting comments in accordance with Sec.  10.30
of this chapter. These comments must include the information required
in Sec.  112.173. If FDA determines that these comments should instead
be treated as a separate request for a variance, FDA will notify the
State, tribe, or foreign country that submitted these comments that a
separate request must be submitted in accordance with Sec. Sec.
112.172 and 112.173.
    (b) If we grant a petition requesting a variance, in whole or in
part, we may specify that the variance also applies to persons in a
specific location who are similarly situated to those identified in the
petition.
    (c) If we specify that the variance also applies to persons in a
specific location who are similarly situated to those identified in the
petition, we will inform the applicable State, tribe, or foreign
country where the similarly situated persons are located of our
decision in writing and will publish a notice on our Web site
announcing our decision to apply the variance to similarly situated
persons in that particular location.

Sec.  112.178  Under what circumstances may FDA deny a petition
requesting a variance?

    We may deny a variance request if it does not provide the
information required under Sec.  112.173 (including the requirements of
Sec.  10.30 of this chapter), or if we determine that the variance is
not reasonably likely to ensure that the produce is not adulterated
under section 402 of the Federal Food, Drug and Cosmetic Act and to
provide the same level of public health protection as the requirements
of this part.

Sec.  112.179  When does a variance approved by FDA become effective?

    A variance approved by FDA becomes effective on the date of our
written decision on the petition.

Sec.  112.180  Under what circumstances may FDA modify or revoke an
approved variance?

    We may modify or revoke a variance if we determine that such
variance is not reasonably likely to ensure that the produce is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act and to provide the same level of public health protection as the
requirements of this part.

Sec.  112.181  What procedures apply if FDA determines that an approved
variance should be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify a State, tribe, or a foreign country directly,
in writing at the address identified in its petition, if we determine
that a variance granted in response to its petition should be modified
or revoked. Our direct, written notification will provide the State,
tribe, or foreign country with an opportunity to request an informal
hearing under part 16 of this chapter.
    (2) We will publish a notice of our determination that a variance
should be modified or revoked in the Federal Register. This notice will
establish a public docket so that interested parties may submit written
comments on our determination.
    (3) When applicable, we will:
    (i) Notify in writing any States, tribes, or foreign countries
where a variance applies to similarly situated persons of our
determination that the variance should be modified or revoked;
    (ii) Provide those States, tribes, or foreign countries with an
opportunity to request an informal hearing under part 16 of this
chapter; and
    (iii) Include in the Federal Register notice described in paragraph
(a)(2) of this section public notification of our decision to modify or
revoke the variance granted to States, tribes, or foreign countries in
which similarly situated persons are located.
    (b) We will consider submissions from affected States, tribes, or
foreign countries and from other interested parties as follows:
    (1) We will consider requests for hearings by affected States,
tribes, or foreign countries under part 16 of this chapter.
    (i) If FDA grants a hearing, we will provide the State, tribe, or
foreign country with an opportunity to make an oral submission. We will
provide notice on our Web site of the hearing, including the time,
date, and place of the hearing.
    (ii) If more than one State, tribe, or foreign country requests an
informal hearing under part 16 of this chapter about our determination
that a particular variance should be modified or revoked, we may
consolidate such requests (for example, into a single hearing).
    (2) We will consider written submissions submitted to the public
docket from interested parties.
    (c) We will provide notice of our final decision as follows:
    (1) On the basis of the administrative record, FDA will issue a
written decision, as provided for under part 16 of this chapter.
    (2) We will publish a notice of our decision in the Federal
Register. The effective date of the decision will be the date of
publication of the notice.

Sec.  112.182  What are the permissible types of variances that may be
granted?

    A variance(s) may be requested for one or more requirements in
subparts A through O of this part. Examples of permissible types of
variances include:
    (a) Variance from the microbial quality criteria when agricultural
water is used during growing activities for covered produce (other than
sprouts) using a direct water application method, established in Sec.
112.44(b);

    (b) Variance from the microbial die-off rate that is used to
determine the time interval between last irrigation and harvest, and/or
the accompanying maximum time interval, established in Sec.
112.45(b)(1)(i); and
    (c) Variance from the approach or frequency for testing water used
for purposes that are subject to the requirements of Sec.  112.44(b),
established in Sec.  112.46(b).

Subpart Q--Compliance and Enforcement

Sec.  112.192  What is the applicability and status of this part?

    (a) The failure to comply with the requirements of this part,
issued under section 419 of the Federal Food, Drug, and Cosmetic Act,
is a prohibited act under section 301(vv) of the Federal Food, Drug,
and Cosmetic Act.
    (b) The criteria and definitions in this part apply in determining
whether a food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act
in that the food has been grown, harvested, packed, or held under such
conditions that it is unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act
in that the food has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
    or
    (2) In violation of section 361 of the Public Health Service Act
(42 U.S.C. 264).

Sec.  112.193  What are the provisions for coordination of education
and enforcement?

    Under section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic
Act, FDA coordinates education and enforcement activities by State,
territorial, tribal, and local officials by helping develop education,
training, and enforcement approaches.

Subpart R--Withdrawal of Qualified Exemption

Sec.  112.201  Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec.  112.5?

    (a) We may withdraw your qualified exemption under Sec.  112.5:
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm; or
    (2) If we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm.
    (b) Before FDA issues an order to withdraw your qualified
exemption, FDA:
    (1) May consider one or more other actions to protect the public
health and prevent or mitigate a foodborne illness outbreak, including
a warning letter, recall, administrative detention, refusal of food
offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
farm, in writing, of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the farm to respond in writing, within 15 calendar days of
the date of receipt of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the farm to address the
circumstances that may lead FDA to withdraw the exemption.

Sec.  112.202  What procedure will FDA use to withdraw an exemption?

    (a) An FDA District Director in whose district the farm is located
(or, in the case of a foreign farm, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition), or an
FDA official senior to either such Director, must approve an order to
withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the farm.
    (d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.

Sec.  112.203  What information must FDA include in an order to
withdraw a qualified exemption?

    An order to withdraw a qualified exemption applicable to a farm
under Sec.  112.5 must include the following information:
    (a) The date of the order;
    (b) The name, address and location of the farm;
    (c) A brief, general statement of the reasons for the order,
including information relevant to one or both of the following
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is
directly linked to the farm; or
    (2) Conduct or conditions associated with a farm that are material
to the safety of the food that would otherwise be covered produce
grown, harvested, packed and held at such farm.
    (d) A statement that the farm must either:
    (1) Comply with subparts B through O of this part on the date that
is 120 calendar days from the date of receipt of the order, or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  112.206.
    (e) A statement that a farm may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
112.213;
    (f) The text of section 419(f) of the Federal Food, Drug, and
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 of this
chapter, with certain exceptions described in Sec.  112.208;
    (h) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and the name of the FDA
District Director in whose district the farm is located (or for foreign
farms, the same information for the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition); and
    (i) The name and the title of the FDA representative who approved
the order.

Sec.  112.204  What must I do if I receive an order to withdraw a
qualified exemption applicable to my farm?

    The owner, operator, or agent in charge of a farm that receives an
order to withdraw a qualified exemption applicable to that farm under
Sec.  112.5 must either:
    (a) Comply with applicable requirements of this part within 120
calendar days of the date from receipt of the order or, if operations
have ceased and will not resume within 120 calendar days, before the
beginning of operations in the next growing season, or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a

timeframe that exceeds 120 calendar days from the date of receipt of
the order; or
    (b) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  112.206.

Sec.  112.205  Can I appeal or request a hearing on an order to
withdraw a qualified exemption applicable to my farm?

    (a) Submission of an appeal, including submission of a request for
an informal hearing, will not operate to delay or stay any
administrative action, including enforcement action by FDA, unless the
Commissioner of Food and Drugs, as a matter of discretion, determines
that delay or a stay is in the public interest.
    (b) If the owner, operator, or agent in charge of the farm appeals
the order, and FDA confirms the order:
    (1) The owner, operator, or agent in charge of the farm must comply
with applicable requirements of this part within 120 calendar days from
the date of receipt of the order, or, if operations have ceased and
will not resume within 120 calendar days, before the beginning of
operations in the next growing season, or within a reasonable
timeframe, agreed to by FDA, based on a written justification,
submitted to FDA, for a timeframe that exceeds 120 calendar days from
the date of receipt of the order; and
    (2) The owner, operator, or agent in charge of the farm is no
longer subject to the modified requirements in Sec. Sec.  112.6 and
112.7.

Sec.  112.206  What is the procedure for submitting an appeal?

    (a) To appeal an order to withdraw a qualified exemption applicable
to a farm under Sec.  112.5, the owner, operator, or agent in charge of
the farm must:
    (1) Submit the appeal in writing to the FDA District Director in
whose district the farm is located (or in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition), at the mailing address, email address, or
facsimile number identified in the order within 15 calendar days of the
date of receipt of the order; and
    (2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which the owner,
operator or agent in charge of the farm relies.
    (b) In a written appeal of the order withdrawing an exemption
provided under Sec.  112.5, the owner, operator, or agent in charge of
the farm may include a written request for an informal hearing as
provided in Sec.  112.207.

Sec.  112.207  What is the procedure for requesting an informal
hearing?

    (a) If the owner, operator, or agent in charge of the farm appeals
the order, the owner, operator, or agent in charge of the farm:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
its written appeal submitted in accordance with Sec.  112.206 within 15
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in
part, if the presiding officer determines that no genuine and
substantial issue of material fact has been raised by the material
submitted. If the presiding officer determines that a hearing is not
justified, a written notice of the determination will be given to the
owner, operator, or agent in charge of the farm explaining the reason
for the denial.

Sec.  112.208  What requirements are applicable to an informal hearing?

    If the owner, operator, or agent in charge of the farm requests an
informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date
the appeal is filed or, if applicable, within a timeframe agreed upon
in writing by the owner, operator, or agent in charge of the farm and
FDA.
    (b) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this
chapter, except that:
    (1) The order withdrawing an exemption under Sec.  112.5, rather
than the notice under Sec.  16.22(a) of this chapter, provides notice
of the opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec.  16.80(a) of
this chapter.
    (2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign farm, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 112.209, rather than Sec.  16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under Sec.  112.208(c)(4) are part of the administrative
record.
    (6) No party shall have the right, under Sec.  16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing under a regulation in accordance with part 16 of
this chapter, except that Sec.  16.95(b) does not apply to a hearing
under this subpart. With respect to a regulatory hearing under this
subpart, the administrative record of the hearing specified in
Sec. Sec.  16.80(a)(1), (2), (3), and (5) of this chapter and
112.208(c)(5) constitutes the exclusive record for the presiding
officer's final decision. For purposes of judicial review under Sec.
10.45 of this chapter, the record of the administrative proceeding
consists of the record of the hearing and the presiding officer's final
decision.

Sec.  112.209  Who is the presiding officer for an appeal and for an
informal hearing?

    The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.

Sec.  112.210  What is the timeframe for issuing a decision on an
appeal?

    (a) If the owner, operator, or agent in charge of a farm appeals
the order without requesting a hearing, the presiding officer must
issue a written report that includes a final decision confirming or
revoking the withdrawal by the 10th calendar day after the appeal is
filed.
    (b) If the owner, operator, or agent in charge of a farm appeals
the order and requests an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is
held, the

presiding officer must provide a 2 calendar day opportunity for the
hearing participants to review and submit comments on the report of the
hearing under Sec.  112.208(c)(4), and must issue a final decision
within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer
must issue a final decision on the appeal confirming or revoking the
withdrawal within 10 calendar days after the date the appeal is filed.

Sec.  112.211  When is an order to withdraw a qualified exemption
applicable to a farm revoked?

    An order to withdraw a qualified exemption applicable to a farm
under Sec.  112.5 is revoked if:
    (a) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA grants the request for an
informal hearing, and the presiding officer does not confirm the order
within the 10 calendar days after the hearing, or issues a decision
revoking the order within that time; or
    (b) The owner, operator, or agent in charge of the farm appeals the
order and requests an informal hearing, FDA denies the request for an
informal hearing, and FDA does not confirm the order within the 10
calendar days after the appeal is filed, or issues a decision revoking
the order within that time; or
    (c) The owner, operator, or agent in charge of the farm appeals the
order without requesting an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time.
    (d) Confirmation of a withdrawal order by the presiding officer is
considered a final Agency action for purposes of 5 U.S.C. 702.

Sec.  112.213  If my qualified exemption is withdrawn, under what
circumstances would FDA reinstate my qualified exemption?

    (a) If the FDA District Director in whose district your farm is
located (or, in the case of a foreign farm, the Director of the Office
of Compliance in the Center for Food Safety and Applied Nutrition)
determines that the farm has adequately resolved any problems with the
conduct and conditions that are material to the safety of the food
produced or harvested at such farm, and that continued withdrawal of
the exemption is not necessary to protect the public health or prevent
or mitigate a foodborne illness outbreak, the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition) will, on his own initiative or at the request of
a farm, reinstate the qualified exemption.
    (b) You may ask FDA to reinstate a qualified exemption that has
been withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in the Center for Food Safety
and Applied Nutrition); and
    (2) Present, in writing, data and information to demonstrate that
you have adequately resolved any problems with the conduct and
conditions that are material to the safety of the food produced and
harvested at your farm, such that continued withdrawal of the exemption
is not necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak.
    (c) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your farm, FDA will reinstate your qualified
exemption under Sec.  112.5, and FDA will notify you in writing that
your exempt status has been reinstated.
    (d) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and (2) and FDA later determines, after finishing the
active investigation of a foodborne illness outbreak, that the outbreak
is not directly linked to your farm, FDA will inform you of this
finding, and you may ask FDA to reinstate your qualified exemption
under Sec.  112.5, in accordance with the requirements of paragraph (b)
of this section.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28159 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P