(e) Sanitation of non-food-contact surfaces. Non-food-contact
surfaces of equipment used in the operation of a food plant must be
cleaned in a manner and as frequently as necessary to protect against
allergen cross-contact and against contamination of food, food-contact
surfaces, and food-packaging materials.
    (f) Storage and handling of cleaned portable equipment and
utensils. Cleaned and sanitized portable equipment with food-contact
surfaces and utensils must be stored in a location and manner that
protects food-contact surfaces from allergen cross-contact and from
contamination.

Sec.  117.37  Sanitary facilities and controls.

    Each plant must be equipped with adequate sanitary facilities and
accommodations including:
    (a) Water supply. The water supply must be adequate for the
operations intended and must be derived from an adequate source. Any
water that contacts food, food-contact surfaces, or food-packaging
materials must be safe and of adequate sanitary quality. Running water
at a suitable temperature, and under pressure as needed, must be
provided in all areas where required for the processing of food, for
the cleaning of equipment, utensils, and food-packaging materials, or
for employee sanitary facilities.
    (b) Plumbing. Plumbing must be of adequate size and design and
adequately installed and maintained to:
    (1) Carry adequate quantities of water to required locations
throughout the plant.
    (2) Properly convey sewage and liquid disposable waste from the
plant.
    (3) Avoid constituting a source of contamination to food, water
supplies, equipment, or utensils or creating an unsanitary condition.
    (4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor.
    (5) Provide that there is not backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for food or food manufacturing.
    (c) Sewage disposal. Sewage must be disposed of into an adequate
sewerage system or disposed of through other adequate means.
    (d) Toilet facilities. Each plant must provide employees with
adequate, readily accessible toilet facilities. Toilet facilities must
be kept clean and must not be a potential source of contamination of
food, food-contact surfaces, or food-packaging materials.
    (e) Hand-washing facilities. Each plant must provide hand-washing
facilities designed to ensure that an employee's hands are not a source
of contamination of food, food-contact surfaces, or food-packaging
materials, by providing facilities that are adequate, convenient, and
furnish running water at a suitable temperature.
    (f) Rubbish and offal disposal. Rubbish and any offal must be so
conveyed, stored, and disposed of as to minimize the development of
odor, minimize the potential for the waste becoming an attractant and
harborage or breeding place for pests, and protect against
contamination of food, food-contact surfaces, food-packaging materials,
water supplies, and ground surfaces.

Sec.  117.40  Equipment and utensils.

    (a)(1) All plant equipment and utensils used in manufacturing,
processing, packing, or holding food must be so designed and of such
material and workmanship as to be adequately cleanable, and must be
adequately maintained to protect against allergen cross-contact and
contamination.
    (2) Equipment and utensils must be designed, constructed, and used
appropriately to avoid the adulteration of food with lubricants, fuel,
metal fragments, contaminated water, or any other contaminants.
    (3) Equipment must be installed so as to facilitate the cleaning
and maintenance of the equipment and of adjacent spaces.
    (4) Food-contact surfaces must be corrosion-resistant when in
contact with food.
    (5) Food-contact surfaces must be made of nontoxic materials and
designed to withstand the environment of their intended use and the
action of food, and, if applicable, cleaning compounds, sanitizing
agents, and cleaning procedures.
    (6) Food-contact surfaces must be maintained to protect food from
allergen cross-contact and from being contaminated by any source,
including unlawful indirect food additives.
    (b) Seams on food-contact surfaces must be smoothly bonded or
maintained so as to minimize accumulation of food particles, dirt, and
organic matter and thus minimize the opportunity for growth of
microorganisms and allergen cross-contact.
    (c) Equipment that is in areas where food is manufactured,
processed, packed, or held and that does not come into contact with
food must be so constructed that it can be kept in a clean and sanitary
condition.
    (d) Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, must be of a
design and construction that enables them to be maintained in an
appropriate clean and sanitary condition.
    (e) Each freezer and cold storage compartment used to store and
hold food capable of supporting growth of microorganisms must be fitted
with an indicating thermometer, temperature-measuring device, or
temperature-recording device so installed as to show

the temperature accurately within the compartment.
    (f) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, acidity, water activity, or other
conditions that control or prevent the growth of undesirable
microorganisms in food must be accurate and precise and adequately
maintained, and adequate in number for their designated uses.
    (g) Compressed air or other gases mechanically introduced into food
or used to clean food-contact surfaces or equipment must be treated in
such a way that food is not contaminated with unlawful indirect food
additives.

Sec.  117.80  Processes and controls.

    (a) General. (1) All operations in the manufacturing, processing,
packing, and holding of food (including operations directed to
receiving, inspecting, transporting, and segregating) must be conducted
in accordance with adequate sanitation principles.
    (2) Appropriate quality control operations must be employed to
ensure that food is suitable for human consumption and that food-
packaging materials are safe and suitable.
    (3) Overall sanitation of the plant must be under the supervision
of one or more competent individuals assigned responsibility for this
function.
    (4) Adequate precautions must be taken to ensure that production
procedures do not contribute to allergen cross-contact and to
contamination from any source.
    (5) Chemical, microbial, or extraneous-material testing procedures
must be used where necessary to identify sanitation failures or
possible allergen cross-contact and food contamination.
    (6) All food that has become contaminated to the extent that it is
adulterated must be rejected, or if appropriate, treated or processed
to eliminate the contamination.
    (b) Raw materials and other ingredients. (1) Raw materials and
other ingredients must be inspected and segregated or otherwise handled
as necessary to ascertain that they are clean and suitable for
processing into food and must be stored under conditions that will
protect against allergen cross-contact and against contamination and
minimize deterioration. Raw materials must be washed or cleaned as
necessary to remove soil or other contamination. Water used for
washing, rinsing, or conveying food must be safe and of adequate
sanitary quality. Water may be reused for washing, rinsing, or
conveying food if it does not cause allergen cross-contact or increase
the level of contamination of the food.
    (2) Raw materials and other ingredients must either not contain
levels of microorganisms that may render the food injurious to the
health of humans, or they must be pasteurized or otherwise treated
during manufacturing operations so that they no longer contain levels
that would cause the product to be adulterated.
    (3) Raw materials and other ingredients susceptible to
contamination with aflatoxin or other natural toxins must comply with
FDA regulations for poisonous or deleterious substances before these
raw materials or other ingredients are incorporated into finished food.
    (4) Raw materials, other ingredients, and rework susceptible to
contamination with pests, undesirable microorganisms, or extraneous
material must comply with applicable FDA regulations for natural or
unavoidable defects if a manufacturer wishes to use the materials in
manufacturing food.
    (5) Raw materials, other ingredients, and rework must be held in
bulk, or in containers designed and constructed so as to protect
against allergen cross-contact and against contamination and must be
held at such temperature and relative humidity and in such a manner as
to prevent the food from becoming adulterated. Material scheduled for
rework must be identified as such.
    (6) Frozen raw materials and other ingredients must be kept frozen.
If thawing is required prior to use, it must be done in a manner that
prevents the raw materials and other ingredients from becoming
adulterated.
    (7) Liquid or dry raw materials and other ingredients received and
stored in bulk form must be held in a manner that protects against
allergen cross-contact and against contamination.
    (8) Raw materials and other ingredients that are food allergens,
and rework that contains food allergens, must be identified and held in
a manner that prevents allergen cross-contact.
    (c) Manufacturing operations. (1) Equipment and utensils and food
containers must be maintained in an adequate condition through
appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment must be taken apart for thorough cleaning.
    (2) All food manufacturing, processing, packing, and holding must
be conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, allergen
cross-contact, contamination of food, and deterioration of food.
    (3) Food that can support the rapid growth of undesirable
microorganisms must be held at temperatures that will prevent the food
from becoming adulterated during manufacturing, processing, packing,
and holding.
    (4) Measures such as sterilizing, irradiating, pasteurizing,
cooking, freezing, refrigerating, controlling pH, or controlling
aw that are taken to destroy or prevent the growth of
undesirable microorganisms must be adequate under the conditions of
manufacture, handling, and distribution to prevent food from being
adulterated.
    (5) Work-in-process and rework must be handled in a manner that
protects against allergen cross-contact, contamination, and growth of
undesirable microorganisms.
    (6) Effective measures must be taken to protect finished food from
allergen cross-contact and from contamination by raw materials, other
ingredients, or refuse. When raw materials, other ingredients, or
refuse are unprotected, they must not be handled simultaneously in a
receiving, loading, or shipping area if that handling could result in
allergen cross-contact or contaminated food. Food transported by
conveyor must be protected against allergen cross-contact and against
contamination as necessary.
    (7) Equipment, containers, and utensils used to convey, hold, or
store raw materials and other ingredients, work-in-process, rework, or
other food must be constructed, handled, and maintained during
manufacturing, processing, packing, and holding in a manner that
protects against allergen cross-contact and against contamination.
    (8) Adequate measures must be taken to protect against the
inclusion of metal or other extraneous material in food.
    (9) Food, raw materials, and other ingredients that are
adulterated:
    (i) Must be disposed of in a manner that protects against the
contamination of other food; or
    (ii) If the adulterated food is capable of being reconditioned, it
must be:
    (A) Reconditioned (if appropriate) using a method that has been
proven to be effective; or
    (B) Reconditioned (if appropriate) and reexamined and subsequently
found not to be adulterated within the meaning of the Federal Food,
Drug, and Cosmetic Act before being incorporated into other food.
    (10) Steps such as washing, peeling, trimming, cutting, sorting and
inspecting, mashing, dewatering, cooling, shredding, extruding, drying,
whipping, defatting, and forming must be performed so as to protect
food

against allergen cross-contact and against contamination. Food must be
protected from contaminants that may drip, drain, or be drawn into the
food.
    (11) Heat blanching, when required in the preparation of food
capable of supporting microbial growth, must be effected by heating the
food to the required temperature, holding it at this temperature for
the required time, and then either rapidly cooling the food or passing
it to subsequent manufacturing without delay. Growth and contamination
by thermophilic microorganisms in blanchers must be minimized by the
use of adequate operating temperatures and by periodic cleaning and
sanitizing as necessary.
    (12) Batters, breading, sauces, gravies, dressings, dipping
solutions, and other similar preparations that are held and used
repeatedly over time must be treated or maintained in such a manner
that they are protected against allergen cross-contact and against
contamination, and minimizing the potential for the growth of
undesirable microorganisms.
    (13) Filling, assembling, packaging, and other operations must be
performed in such a way that the food is protected against allergen
cross-contact, contamination and growth of undesirable microorganisms.
    (14) Food, such as dry mixes, nuts, intermediate moisture food, and
dehydrated food, that relies principally on the control of
aw for preventing the growth of undesirable microorganisms
must be processed to and maintained at a safe moisture level.
    (15) Food, such as acid and acidified food, that relies principally
on the control of pH for preventing the growth of undesirable
microorganisms must be monitored and maintained at a pH of 4.6 or
below.
    (16) When ice is used in contact with food, it must be made from
water that is safe and of adequate sanitary quality in accordance with
Sec.  117.37(a), and must be used only if it has been manufactured in
accordance with current good manufacturing practice as outlined in this
part.

Sec.  117.93  Warehousing and distribution.

    Storage and transportation of food must be under conditions that
will protect against allergen cross-contact and against biological,
chemical (including radiological), and physical contamination of food,
as well as against deterioration of the food and the container.

Sec.  117.110  Defect action levels.

    (a) The manufacturer, processor, packer, and holder of food must at
all times utilize quality control operations that reduce natural or
unavoidable defects to the lowest level currently feasible.
    (b) The mixing of a food containing defects at levels that render
that food adulterated with another lot of food is not permitted and
renders the final food adulterated, regardless of the defect level of
the final food. For examples of defect action levels that may render
food adulterated, see the Defect Levels Handbook, which is accessible
at http://www.fda.gov/pchfrule and at http://www.fda.gov.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec.  117.126  Food safety plan.

    (a) Requirement for a food safety plan. (1) You must prepare, or
have prepared, and implement a written food safety plan.
    (2) The food safety plan must be prepared, or its preparation
overseen, by one or more preventive controls qualified individuals.
    (b) Contents of a food safety plan. The written food safety plan
must include:
    (1) The written hazard analysis as required by Sec.  117.130(a)(2);
    (2) The written preventive controls as required by Sec.
117.135(b);
    (3) The written supply-chain program as required by subpart G of
this part;
    (4) The written recall plan as required by Sec.  117.139(a); and
    (5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec.  117.145(a)(1);
    (6) The written corrective action procedures as required by Sec.
117.150(a)(1); and
    (7) The written verification procedures as required by Sec.
117.165(b).
    (c) Records. The food safety plan required by this section is a
record that is subject to the requirements of subpart F of this part.

Sec.  117.130  Hazard analysis.

    (a) Requirement for a hazard analysis. (1) You must conduct a
hazard analysis to identify and evaluate, based on experience, illness
data, scientific reports, and other information, known or reasonably
foreseeable hazards for each type of food manufactured, processed,
packed, or held at your facility to determine whether there are any
hazards requiring a preventive control.
    (2) The hazard analysis must be written regardless of its outcome.
    (b) Hazard identification. The hazard identification must consider:
    (1) Known or reasonably foreseeable hazards that include:
    (i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances
such as pesticide and drug residues, natural toxins, decomposition,
unapproved food or color additives, and food allergens; and
    (iii) Physical hazards (such as stones, glass, and metal
fragments); and
    (2) Known or reasonably foreseeable hazards that may be present in
the food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of
economic gain.
    (c) Hazard evaluation. (1)(i) The hazard analysis must include an
evaluation of the hazards identified in paragraph (b) of this section
to assess the severity of the illness or injury if the hazard were to
occur and the probability that the hazard will occur in the absence of
preventive controls.
    (ii) The hazard evaluation required by paragraph (c)(1)(i) of this
section must include an evaluation of environmental pathogens whenever
a ready-to-eat food is exposed to the environment prior to packaging
and the packaged food does not receive a treatment or otherwise include
a control measure (such as a formulation lethal to the pathogen) that
would significantly minimize the pathogen.
    (2) The hazard evaluation must consider the effect of the following
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the facility and
equipment;
    (iii) Raw materials and other ingredients;
    (iv) Transportation practices;
    (v) Manufacturing/processing procedures;
    (vi) Packaging activities and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors, such as the temporal (e.g.,
weather-related) nature of some hazards (e.g., levels of some natural
toxins).

Sec.  117.135  Preventive controls.

    (a)(1) You must identify and implement preventive controls to
provide assurances that any hazards requiring a preventive control will
be

significantly minimized or prevented and the food manufactured,
processed, packed, or held by your facility will not be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic
Act.
    (2) Preventive controls required by paragraph (a)(1) of this
section include:
    (i) Controls at critical control points (CCPs), if there are any
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate
for food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and
the food:
    (1) Process controls. Process controls include procedures,
practices, and processes to ensure the control of parameters during
operations such as heat processing, acidifying, irradiating, and
refrigerating foods. Process controls must include, as appropriate to
the nature of the applicable control and its role in the facility's
food safety system:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to
which any biological, chemical, or physical parameter must be
controlled to significantly minimize or prevent a hazard requiring a
process control.
    (2) Food allergen controls. Food allergen controls include
procedures, practices, and processes to control food allergens. Food
allergen controls must include those procedures, practices, and
processes employed for:
    (i) Ensuring protection of food from allergen cross-contact,
including during storage, handling, and use; and
    (ii) Labeling the finished food, including ensuring that the
finished food is not misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act.
    (3) Sanitation controls. Sanitation controls include procedures,
practices, and processes to ensure that the facility is maintained in a
sanitary condition adequate to significantly minimize or prevent
hazards such as environmental pathogens, biological hazards due to
employee handling, and food allergen hazards. Sanitation controls must
include, as appropriate to the facility and the food, procedures,
practices, and processes for the:
    (i) Cleanliness of food-contact surfaces, including food-contact
surfaces of utensils and equipment;
    (ii) Prevention of allergen cross-contact and cross-contamination
from insanitary objects and from personnel to food, food packaging
material, and other food-contact surfaces and from raw product to
processed product.
    (4) Supply-chain controls. Supply-chain controls include the
supply-chain program as required by subpart G of this part.
    (5) Recall plan. Recall plan as required by Sec.  117.139.
    (6) Other controls. Preventive controls include any other
procedures, practices, and processes necessary to satisfy the
requirements of paragraph (a) of this section. Examples of other
controls include hygiene training and other current good manufacturing
practices.

Sec.  117.136  Circumstances in which the owner, operator, or agent in
charge of a manufacturing/processing facility is not required to
implement a preventive control.

    (a) Circumstances. If you are a manufacturer/processor, you are not
required to implement a preventive control when you identify a hazard
requiring a preventive control (identified hazard) and any of the
following circumstances apply:
    (1) You determine and document that the type of food (e.g., raw
agricultural commodities such as cocoa beans, coffee beans, and grains)
could not be consumed without application of an appropriate control.
    (2) You rely on your customer who is subject to the requirements
for hazard analysis and risk-based preventive controls in this subpart
C to ensure that the identified hazard will be significantly minimized
or prevented and you:
    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject
to the requirements of Sec.  117.137, that the customer has established
and is following procedures (identified in the written assurance) that
will significantly minimize or prevent the identified hazard.
    (3) You rely on your customer who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
this subpart to provide assurance it is manufacturing, processing, or
preparing the food in accordance with applicable food safety
requirements and you:
    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it
is manufacturing, processing, or preparing the food in accordance with
applicable food safety requirements.
    (4) You rely on your customer to provide assurance that the food
will be processed to control the identified hazard by an entity in the
distribution chain subsequent to the customer and you:
    (i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject
to the requirements of Sec.  117.137, that your customer:
    (A) Will disclose in documents accompanying the food, in accordance
with the practice of the trade, that the food is ``not processed to
control [identified hazard]''; and
    (B) Will only sell to another entity that agrees, in writing, it
will:
    (1) Follow procedures (identified in a written assurance) that will
significantly minimize or prevent the identified hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in this subpart) or manufacture, process, or
prepare the food in accordance with applicable food safety requirements
(if the entity is not subject to the requirements for hazard analysis
and risk-based preventive controls in this subpart); or
    (2) Obtain a similar written assurance from the entity's customer,
subject to the requirements of Sec.  117.137, as in paragraphs
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the food product you distribute and you document the implementation of
that system.
    (b) Records. You must document any circumstance, specified in
paragraph (a) of this section, that applies to you, including:
    (1) A determination, in accordance with paragraph (a) of this
section, that the type of food could not be consumed without
application of an appropriate control;
    (2) The annual written assurance from your customer in accordance
with paragraph (a)(2) of this section;
    (3) The annual written assurance from your customer in accordance
with paragraph (a)(3) of this section;
    (4) The annual written assurance from your customer in accordance
with paragraph (a)(4) of this section; and
    (5) Your system, in accordance with paragraph (a)(5) of this
section, that

ensures control, at a subsequent distribution step, of the hazards in
the food product you distribute.

Sec.  117.137  Provision of assurances required under Sec.
117.136(a)(2), (3), and (4).

    A facility that provides a written assurance under Sec.
117.136(a)(2), (3), or (4) must act consistently with the assurance and
document its actions taken to satisfy the written assurance.

Sec.  117.139  Recall plan.

    For food with a hazard requiring a preventive control:
    (a) You must establish a written recall plan for the food.
    (b) The written recall plan must include procedures that describe
the steps to be taken, and assign responsibility for taking those
steps, to perform the following actions as appropriate to the facility:
    (1) Directly notify the direct consignees of the food being
recalled, including how to return or dispose of the affected food;
    (2) Notify the public about any hazard presented by the food when
appropriate to protect public health;
    (3) Conduct effectiveness checks to verify that the recall is
carried out; and
    (4) Appropriately dispose of recalled food--e.g., through
reprocessing, reworking, diverting to a use that does not present a
safety concern, or destroying the food.

Sec.  117.140  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec.  117.135 are subject to the
following preventive control management components as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control and its role in the
facility's food safety system:
    (1) Monitoring in accordance with Sec.  117.145;
    (2) Corrective actions and corrections in accordance with Sec.
117.150; and
    (3) Verification in accordance with Sec.  117.155.
    (b) The supply-chain program established in subpart G of this part
is subject to the following preventive control management components as
appropriate to ensure the effectiveness of the supply-chain program,
taking into account the nature of the hazard controlled before receipt
of the raw material or other ingredient:
    (1) Corrective actions and corrections in accordance with Sec.
117.150, taking into account the nature of any supplier non-
conformance;
    (2) Review of records in accordance with Sec.  117.165(a)(4); and
    (3) Reanalysis in accordance with Sec.  117.170.
    (c) The recall plan established in Sec.  117.139 is not subject to
the requirements of paragraph (a) of this section.

Sec.  117.145  Monitoring.

    As appropriate to the nature of the preventive control and its role
in the facility's food safety system:
    (a) Written procedures. You must establish and implement written
procedures, including the frequency with which they are to be
performed, for monitoring the preventive control; and.
    (b) Monitoring. You must monitor the preventive controls with
adequate frequency to provide assurance that they are consistently
performed.
    (c) Records. (1) Requirement to document monitoring. You must
document the monitoring of preventive controls in accordance with this
section in records that are subject to verification in accordance with
Sec.  117.155(a)(2) and records review in accordance with Sec.
117.165(a)(4)(i).
    (2) Exception records. (i) Records of refrigeration temperature
during storage of food that requires time/temperature control to
significantly minimize or prevent the growth of, or toxin production
by, pathogens may be affirmative records demonstrating temperature is
controlled or exception records demonstrating loss of temperature
control.
    (ii) Exception records may be adequate in circumstances other than
monitoring of refrigeration temperature.

Sec.  117.150  Corrective actions and corrections.

    (a) Corrective action procedures. As appropriate to the nature of
the hazard and the nature of the preventive control, except as provided
by paragraph (c) of this section:
    (1) You must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented, including procedures to address, as appropriate:
    (i) The presence of a pathogen or appropriate indicator organism in
a ready-to-eat product detected as a result of product testing
conducted in accordance with Sec.  117.165(a)(2); and
    (ii) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec.  117.165(a)(3).
    (2) The corrective action procedures must describe the steps to be
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken, when necessary, to reduce the
likelihood that the problem will recur;
    (iii) All affected food is evaluated for safety; and
    (iv) All affected food is prevented from entering into commerce, if
you cannot ensure that the affected food is not adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
    (b) Corrective action in the event of an unanticipated food safety
problem. (1) Except as provided by paragraph (c) of this section, you
are subject to the requirements of paragraphs (b)(2) of this section if
any of the following circumstances apply:
    (i) A preventive control is not properly implemented and a
corrective action procedure has not been established;
    (ii) A preventive control, combination of preventive controls, or
the food safety plan as a whole is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  117.165(a)(4)
finds that the records are not complete, the activities conducted did
not occur in accordance with the food safety plan, or appropriate
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this
section apply, you must:
    (i) Take corrective action to identify and correct the problem,
reduce the likelihood that the problem will recur, evaluate all
affected food for safety, and, as necessary, prevent affected food from
entering commerce as would be done following a corrective action
procedure under paragraphs (a)(2)(i) through (iv) of this section; and
    (ii) When appropriate, reanalyze the food safety plan in accordance
with Sec.  117.170 to determine whether modification of the food safety
plan is required.
    (c) Corrections. You do not need to comply with the requirements of
paragraphs (a) and (b) of this section if:
    (1) You take action, in a timely manner, to identify and correct
conditions and practices that are not consistent with the food allergen
controls in Sec.  117.135(c)(2)(i) or the sanitation controls in Sec.
117.135(c)(3)(i) or (ii); or
    (2) You take action, in a timely manner, to identify and correct a
minor

and isolated problem that does not directly impact product safety.
    (d) Records. All corrective actions (and, when appropriate,
corrections) taken in accordance with this section must be documented
in records. These records are subject to verification in accordance
with Sec.  117.155(a)(3) and records review in accordance with Sec.
117.165(a)(4)(i).

Sec.  117.155  Verification.

    (a) Verification activities. Verification activities must include,
as appropriate to the nature of the preventive control and its role in
the facility's food safety system:
    (1) Validation in accordance with Sec.  117.160.
    (2) Verification that monitoring is being conducted as required by
Sec.  117.140 (and in accordance with Sec.  117.145).
    (3) Verification that appropriate decisions about corrective
actions are being made as required by Sec.  117.140 (and in accordance
with Sec.  117.150).
    (4) Verification of implementation and effectiveness in accordance
with Sec.  117.165; and
    (5) Reanalysis in accordance with Sec.  117.170.
    (b) Documentation. All verification activities conducted in
accordance with this section must be documented in records.

Sec.  117.160  Validation.

    (a) You must validate that the preventive controls identified and
implemented in accordance with Sec.  117.135 are adequate to control
the hazard as appropriate to the nature of the preventive control and
its role in the facility's food safety system.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a preventive controls
qualified individual:
    (i)(A) Prior to implementation of the food safety plan; or
    (B) When necessary to demonstrate the control measures can be
implemented as designed:
    (1) Within 90 calendar days after production of the applicable food
first begins; or
    (2) Within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 90 calendar days
after production of the applicable food first begins;
    (ii) Whenever a change to a control measure or combination of
control measures could impact whether the control measure or
combination of control measures, when properly implemented, will
effectively control the hazards; and
    (iii) Whenever a reanalysis of the food safety plan reveals the
need to do so;
    (2) Must include obtaining and evaluating scientific and technical
evidence (or, when such evidence is not available or is inadequate,
conducting studies) to determine whether the preventive controls, when
properly implemented, will effectively control the hazards; and
    (c) You do not need to validate:
    (1) The food allergen controls in Sec.  117.135(c)(2);
    (2) The sanitation controls in Sec.  117.135(c)(3);
    (3) The recall plan in Sec.  117.139;
    (4) The supply-chain program in subpart G of this part; and
    (5) Other preventive controls, if the preventive controls qualified
individual prepares (or oversees the preparation of) a written
justification that validation is not applicable based on factors such
as the nature of the hazard, and the nature of the preventive control
and its role in the facility's food safety system.

Sec.  117.165  Verification of implementation and effectiveness.

    (a) Verification activities. You must verify that the preventive
controls are consistently implemented and are effectively and
significantly minimizing or preventing the hazards. To do so you must
conduct activities that include the following, as appropriate to the
facility, the food, and the nature of the preventive control and its
role in the facility's food safety system:
    (1) Calibration of process monitoring instruments and verification
instruments (or checking them for accuracy);
    (2) Product testing, for a pathogen (or appropriate indicator
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of a ready-to-eat
food with an environmental pathogen is a hazard requiring a preventive
control, by collecting and testing environmental samples; and
    (4) Review of the following records within the specified
timeframes, by (or under the oversight of) a preventive controls
qualified individual, to ensure that the records are complete, the
activities reflected in the records occurred in accordance with the
food safety plan, the preventive controls are effective, and
appropriate decisions were made about corrective actions:
    (i) Records of monitoring and corrective action records within 7
working days after the records are created or within a reasonable
timeframe, provided that the preventive controls qualified individual
prepares (or oversees the preparation of) a written justification for a
timeframe that exceeds 7 working days; and
    (ii) Records of calibration, testing (e.g., product testing,
environmental monitoring), supplier and supply-chain verification
activities, and other verification activities within a reasonable time
after the records are created; and
    (5) Other activities appropriate for verification of implementation
and effectiveness.
    (b) Written procedures. As appropriate to the facility, the food,
the nature of the preventive control, and the role of the preventive
control in the facility's food safety system, you must establish and
implement written procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring
instruments and verification instruments (or checking them for
accuracy) as required by paragraph (a)(1) of this section.
    (2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
117.150(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;

    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
117.150(a)(1).

Sec.  117.170  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a
whole at least once every 3 years;
    (b) You must conduct a reanalysis of the food safety plan as a
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at
your facility creates a reasonable potential for a new hazard or
creates a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential
hazards associated with the food;
    (3) Whenever appropriate after an unanticipated food safety problem
in accordance with Sec.  117.150(b); and
    (4) Whenever you find that a preventive control, combination of
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and
(b) of this section and validate, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
any additional preventive controls needed to address the hazard
identified:
    (1) Before any change in activities (including any change in
preventive control) at the facility is operative; or
    (2) When necessary to demonstrate the control measures can be
implemented as designed:
    (i) Within 90 calendar days after production of the applicable food
first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 90-calendar days
after production of the applicable food first begins.
    (d) You must revise the written food safety plan if a significant
change in the activities conducted at your facility creates a
reasonable potential for a new hazard or a significant increase in a
previously identified hazard or document the basis for the conclusion
that no revisions are needed.
    (e) A preventive controls qualified individual must perform (or
oversee) the reanalysis.
    (f) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.

Sec.  117.180  Requirements applicable to a preventive controls
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do
or oversee the following:
    (1) Preparation of the food safety plan (Sec.  117.126(a)(2));
    (2) Validation of the preventive controls (Sec.  117.160(b)(1));
    (3) Written justification for validation to be performed in a
timeframe that exceeds the first 90 calendar days of production of the
applicable food;
    (4) Determination that validation is not required (Sec.
117.160(c)(5));
    (5) Review of records (Sec.  117.165(a)(4));
    (6) Written justification for review of records of monitoring and
corrective actions within a timeframe that exceeds 7 working days;
    (7) Reanalysis of the food safety plan (Sec.  117.170(d)); and
    (8) Determination that reanalysis can be completed, and additional
preventive controls validated, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
in a timeframe that exceeds the first 90 calendar days of production of
the applicable food.
    (b) A qualified auditor must conduct an onsite audit (Sec.
117.435(a)).
    (c)(1) To be a preventive controls qualified individual, the
individual must have successfully completed training in the development
and application of risk-based preventive controls at least equivalent
to that received under a standardized curriculum recognized as adequate
by FDA or be otherwise qualified through job experience to develop and
apply a food safety system. Job experience may qualify an individual to
perform these functions if such experience has provided an individual
with knowledge at least equivalent to that provided through the
standardized curriculum. This individual may be, but is not required to
be, an employee of the facility.
    (2) To be a qualified auditor, a qualified individual must have
technical expertise obtained through education, training, or experience
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of
risk-based preventive controls must be documented in records, including
the date of the training, the type of training, and the person(s)
trained.

Sec.  117.190  Implementation records required for this subpart.

    (a) You must establish and maintain the following records
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec.  117.136(b), of the basis
for not establishing a preventive control in accordance with Sec.
117.136(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable,
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification
instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.

Subpart D--Modified Requirements

Sec.  117.201  Modified requirements that apply to a qualified
facility.

    (a) Attestations to be submitted. A qualified facility must submit
the following attestations to FDA:
    (1) An attestation that the facility is a qualified facility as
defined in Sec.  117.3. For the purpose of determining whether a
facility satisfies the definition of qualified facility, the baseline
year for calculating the adjustment for inflation is 2011; and
    (2)(i) An attestation that you have identified the potential
hazards associated with the food being produced, are implementing
preventive controls to address the hazards, and are monitoring the
performance of the preventive controls to ensure that such controls are
effective; or
    (ii) An attestation that the facility is in compliance with State,
local, county, tribal, or other applicable non-Federal food safety law,
including relevant laws and regulations of foreign countries, including
an attestation based on licenses, inspection reports, certificates,
permits, credentials, certification by an appropriate agency (such as a
State department of agriculture), or other evidence of oversight.
    (b) Procedure for submission. The attestations required by
paragraph (a) of this section must be submitted to FDA by one of the
following means:
    (1) Electronic submission. To submit electronically, go to http://
www.fda.gov/

furls and follow the instructions. This Web site is available from
wherever the Internet is accessible, including libraries, copy centers,
schools, and Internet cafes. FDA encourages electronic submission.
    (2) Submission by mail. (i) You must use Form FDA 3942a. You may
obtain a copy of this form by any of the following mechanisms:
    (A) Download it from http://www.fda.gov/pchfrule;
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5100
Paint Branch Parkway, College Park, MD 20550; or
    (C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
    (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug
Administration (HFS-681), 5100 Paint Branch Parkway, College Park, MD
20550. We recommend that you submit a paper copy only if your facility
does not have reasonable access to the Internet.
    (c) Frequency of determination of status and submission. (1) A
facility must determine and document its status as a qualified facility
on an annual basis no later than July 1 of each calendar year.
    (2) The attestations required by paragraph (a) of this section must
be:
    (i) Submitted to FDA initially:
    (A) By December 17, 2018, for a facility that begins manufacturing,
processing, packing, or holding food before September 17, 2018;
    (B) Before beginning operations, for a facility that begins
manufacturing, processing, packing, or holding food after September 17,
2018; or
    (C) By July 31 of the applicable calendar year, when the status of
a facility changes from ``not a qualified facility'' to ``qualified
facility'' based on the annual determination required by paragraph
(c)(1) of this section; and
    (ii) Beginning in 2020, submitted to FDA every 2 years during the
period beginning on October 1 and ending on December 31.
    (3) When the status of a facility changes from ``qualified
facility'' to ``not a qualified facility'' based on the annual
determination required by paragraph (c)(1) of this section, the
facility must notify FDA of that change in status using Form 3942a by
July 31 of the applicable calendar year.
    (d) Timeframe for compliance with subparts C and G of this part
when the facility status changes to ``not a qualified facility.'' When
the status of a facility changes from ``qualified facility'' to ``not a
qualified facility,'' the facility must comply with subparts C and G of
this part no later than December 31 of the applicable calendar year
unless otherwise agreed to by FDA and the facility.
    (e) Notification to consumers. A qualified facility that does not
submit attestations under paragraph (a)(2)(i) of this section must
provide notification to consumers as to the name and complete business
address of the facility where the food was manufactured or processed
(including the street address or P.O. box, city, state, and zip code
for domestic facilities, and comparable full address information for
foreign facilities), as follows:
    (1) If a food packaging label is required, the notification
required by paragraph (e) of this section must appear prominently and
conspicuously on the label of the food.
    (2) If a food packaging label is not required, the notification
required by paragraph (e) of this section must appear prominently and
conspicuously, at the point of purchase, on a label, poster, sign,
placard, or documents delivered contemporaneously with the food in the
normal course of business, or in an electronic notice, in the case of
Internet sales.
    (f) Records. (1) A qualified facility must maintain those records
relied upon to support the attestations that are required by paragraph
(a) of this section.
    (2) The records that a qualified facility must maintain are subject
to the requirements of subpart F of this part.

Sec.  117.206  Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged food.

    (a) If a facility that is solely engaged in the storage of
unexposed packaged food stores any such refrigerated packaged food that
requires time/temperature control to significantly minimize or prevent
the growth of, or toxin production by pathogens, the facility must
conduct the following activities as appropriate to ensure the
effectiveness of the temperature controls:
    (1) Establish and implement temperature controls adequate to
significantly minimize or prevent the growth of, or toxin production
by, pathogens;
    (2) Monitor the temperature controls with adequate frequency to
provide assurance that the temperature controls are consistently
performed;
    (3) If there is a loss of temperature control that may impact the
safety of such refrigerated packaged food, take appropriate corrective
actions to:
    (i) Correct the problem and reduce the likelihood that the problem
will recur;
    (ii) Evaluate all affected food for safety; and
    (iii) Prevent the food from entering commerce, if you cannot ensure
the affected food is not adulterated under section 402 of the Federal
Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented
by:
    (i) Calibrating temperature monitoring and recording devices (or
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time
after the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken
to correct a problem with the control of temperature within 7 working
days after the records are created or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7 working days;
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature
is controlled or exception records demonstrating loss of temperature
control) documenting the monitoring of temperature controls for any
such refrigerated packaged food;
    (ii) Records of corrective actions taken when there is a loss of
temperature control that may impact the safety of any such refrigerated
packaged food; and
    (iii) Records documenting verification activities.
    (b) The records that a facility must establish and maintain under
paragraph (a)(5) of this section are subject to the requirements of
subpart F of this part.

Subpart E--Withdrawal of a Qualified Facility Exemption

Sec.  117.251  Circumstances that may lead FDA to withdraw a qualified
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec.
117.5(a):
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conditions or conduct associated with the qualified facility that are
material to the safety of the food manufactured, processed, packed, or
held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility
exemption, FDA:
    (1) May consider one or more other actions to protect the public
health or

mitigate a foodborne illness outbreak, including a warning letter,
recall, administrative detention, suspension of registration, refusal
of food offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
facility, 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 facility 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 facility to address the
circumstances that may lead FDA to withdraw the exemption.

Sec.  117.254  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, 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 facility.
    (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.  117.257  Contents of an order to withdraw a qualified facility
exemption.

    An order to withdraw a qualified facility exemption under Sec.
117.5(a) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (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 facility; or
    (2) Conditions or conduct associated with a qualified facility that
are material to the safety of the food manufactured, processed, packed,
or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and G of this part on the date that is
120 calendar days after 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.  117.264.
    (e) A statement that a facility may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
117.287.
    (f) The text of section 418(l) 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.  117.270;
    (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 facility is located (or, in the
case of a foreign facility, 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.  117.260  Compliance with, or appeal of, an order to withdraw a
qualified facility exemption.

    (a) If you receive an order under Sec.  117.254 to withdraw a
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120
calendar days of 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.  117.264.
    (b) 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.
    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part
within 120 calendar days of 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; and
    (2) You are no longer subject to the modified requirements in Sec.
117.201.

Sec.  117.264  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption,
you must:
    (1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, 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 confirmation of the order;
    (2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption
provided under Sec.  117.5(a), you may include a written request for an
informal hearing as provided in Sec.  117.267.

Sec.  117.267  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec.  117.264 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, written notice of the determination will be given to you
explaining the reason for the denial.

Sec.  117.270  Requirements applicable to an informal hearing.

    If you request 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 you 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. Sec.  117.254 and
117.257, rather than the notice under Sec.  16.22(a) of this chapter,
provides notice of 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 facility, 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 117.274, 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.  117.270(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) of this chapter 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) through (3) and (a)(5) of this chapter and
117.270(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.  117.274  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.  117.277  Timeframe for issuing a decision on an appeal.

    (a) If you appeal 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 you appeal the order and request 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.  117.270(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.  117.280  Revocation of an order to withdraw a qualified facility
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request 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) You appeal the order and request 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) You appeal 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.

Sec.  117.284  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.

Sec.  117.287  Reinstatement of a qualified facility exemption that was
withdrawn.

    (a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Office of Compliance in the Center for Food Safety and Applied
Nutrition) determines that a facility has adequately resolved any
problems with the conditions and conduct that are material to the
safety of the food manufactured, processed, packed, or held at the
facility and that continued withdrawal of the exemption is not
necessary to protect public health and prevent or mitigate a foodborne
illness outbreak, the FDA District Director in whose district your
facility is located (or, in the case of a foreign facility, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition) will, on his own initiative or on the request of a
facility, reinstate the exemption.
    (b) You may ask FDA to reinstate an 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 facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition); and
    (2) Present data and information to demonstrate that you have
adequately resolved any problems with the conditions and conduct that
are material to the safety of the food manufactured, processed, packed,
or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public health and prevent or
mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  117.251(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 facility, FDA will reinstate your exemption under Sec.  117.5(a),
and FDA will notify you in writing that your exempt status has been
reinstated.
    (d) If your exemption was withdrawn under both Sec.  117.251(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 facility, FDA will inform you of this finding,
and you may ask FDA to reinstate your exemption under Sec.  117.5(a) in
accordance with the requirements of paragraph (b) of this section.

Subpart F--Requirements Applying to Records That Must Be
Established and Maintained

Sec.  117.301  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (b) and (c) of this section,
all records required by this part are subject to all requirements of
this subpart.
    (b) The requirements of Sec.  117.310 apply only to the written
food safety plan.
    (c) The requirements of Sec.  117.305(b), (d), (e), and (f) do not
apply to the records required by Sec.  117.201.

Sec.  117.305  General requirements applying to records.

    Records must:
    (a) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records;
    (b) Contain the actual values and observations obtained during
monitoring and, as appropriate, during verification activities;
    (c) Be accurate, indelible, and legible;
    (d) Be created concurrently with performance of the activity
documented;
    (e) Be as detailed as necessary to provide history of work
performed; and
    (f) Include:
    (1) Information adequate to identify the plant or facility (e.g.,
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity
documented;
    (3) The signature or initials of the person performing the
activity; and
    (4) Where appropriate, the identity of the product and the lot
code, if any.
    (g) 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.  117.310  Additional requirements applying to the food safety
plan.

    The owner, operator, or agent in charge of the facility must sign
and date the food safety plan:
    (a) Upon initial completion; and
    (b) Upon any modification.

Sec.  117.315  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the
plant or facility for at least 2 years after the date they were
prepared.
    (2) Records that a facility relies on during the 3-year period
preceding the applicable calendar year to support its status as a
qualified facility must be retained at the facility as long as
necessary to support the status of a facility as a qualified facility
during the applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained by the facility for at least
2 years after their use is discontinued (e.g., because the facility has
updated the written food safety plan (Sec.  117.126) or records that
document validation of the written food safety plan (Sec.
117.155(b)));
    (c) Except for the food safety plan, offsite storage of records is
permitted if such records can be retrieved and provided onsite within
24 hours of request for official review. The food safety plan must
remain onsite. Electronic records are considered to be onsite if they
are accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the
food safety plan may be transferred to some other reasonably accessible
location but must be returned to the plant or facility within 24 hours
for official review upon request.

Sec.  117.320  Requirements for official review.

    All records required by this part must be made promptly available
to a duly authorized representative of the Secretary of Health and
Human Services for official review and copying upon oral or written
request.

Sec.  117.325  Public disclosure.

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

Sec.  117.330  Use of existing records.

    (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 subpart. Existing
records may be supplemented as necessary to include all of the required
information and satisfy the requirements of this subpart.
    (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.  117.335  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Section 117.136(a)(2);
    (ii) Section 117.136(a)(3);
    (iii) Section 117.136(a)(4);
    (iv) Section 117.430(c)(2);
    (v) Section 117.430(d)(2); or
    (vi) Section 117.430(e)(2);
    (b) A written assurance required under Sec.  117.136(a)(2), (3), or
(4) must include:
    (1) Acknowledgement that the facility that provides the written
assurance assumes legal responsibility to act consistently with the
assurance and document its actions taken to satisfy the written
assurance; and
    (2) Provision that if the assurance is terminated in writing by
either entity, responsibility for compliance with the applicable
provisions of this part reverts to the manufacturer/processor as of the
date of termination.

Subpart G--Supply-Chain Program

Sec.  117.405  Requirement to establish and implement a supply-chain
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other
ingredients for which the receiving facility has identified a hazard
requiring a supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with
the foreign supplier verification program requirements under part 1,
subpart L of this chapter, and has documentation of verification
activities conducted under Sec.  1.506(e) of this chapter (which
provides assurance that the hazards requiring a supply-chain-applied
control for the raw material or other ingredient have been
significantly minimized or prevented) need not conduct supplier
verification activities for that raw material or other ingredient.
    (3) The requirements in this subpart do not apply to food that is
supplied for research or evaluation use, provided that such food:
    (i) Is not intended for retail sale and is not sold or distributed
to the public;
    (ii) Is labeled with the statement ``Food for research or
evaluation use'';
    (iii) Is supplied in a small quantity that is consistent with a
research, analysis, or quality assurance purpose,

the food is used only for this purpose, and any unused quantity is
properly disposed of; and
    (iv) Is accompanied with documents, in accordance with the practice
of the trade, stating that the food will be used for research or
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity
other than the receiving facility's supplier (e.g., when a non-supplier
applies controls to certain produce (i.e., produce covered by part 112
of this chapter)), because growing, harvesting, and packing activities
are under different management), the receiving facility must:
    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity
from another entity, review and assess the entity's applicable
documentation, and document that review and assessment.

Sec.  117.410  General requirements applicable to a supply-chain
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec.  117.420;
    (2) Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity) as
required by Sec.  117.425;
    (3) Conducting supplier verification activities as required by
Sec. Sec.  117.430 and 117.435;
    (4) Documenting supplier verification activities as required by
Sec.  117.475; and
    (5) When applicable, verifying a supply-chain-applied control
applied by an entity other than the receiving facility's supplier and
documenting that verification as required by Sec.  117.475, or
obtaining documentation of an appropriate verification activity from
another entity, reviewing and assessing that documentation, and
documenting the review and assessment as required by Sec.  117.475.
    (b) The following are appropriate supplier verification activities
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on
supplier performance and the risk associated with the raw material or
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard
requiring a supply-chain-applied control has been significantly
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in
approving suppliers and determining the appropriate supplier
verification activities and the frequency with which they are
conducted, the following must be considered:
    (i) The hazard analysis of the food, including the nature of the
hazard controlled before receipt of the raw material or other
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of food and other
FDA compliance actions related to food safety (or, when applicable,
relevant laws and regulations of a country whose food safety system FDA
has officially recognized as comparable or has determined to be
equivalent to that of the United States, and information relevant to
the supplier's compliance with those laws and regulations); and
    (C) The supplier's food safety history relevant to the raw
materials or other ingredients that the receiving facility receives
from the supplier, including available information about results from
testing raw materials or other ingredients for hazards, audit results
relating to the safety of the food, and responsiveness of the supplier
in correcting problems; and
    (iv) Any other factors as appropriate and necessary, such as
storage and transportation practices.
    (2) Considering supplier performance can be limited to the
supplier's compliance history as required by paragraph (d)(1)(iii)(B)
of this section, if the supplier is:
    (i) A qualified facility as defined by Sec.  117.3;
    (ii) A farm that grows produce and is not a covered farm under part
112 of this chapter in accordance with Sec.  112.4(a), or in accordance
with Sec. Sec.  112.4(b) and 112.5; or
    (iii) A shell egg producer that is not subject to the requirements
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving
facility determines through auditing, verification testing, document
review, relevant consumer, customer or other complaints, or otherwise
that the supplier is not controlling hazards that the receiving
facility has identified as requiring a supply-chain-applied control,
the receiving facility must take and document prompt action in
accordance with Sec.  117.150 to ensure that raw materials or other
ingredients from the supplier do not cause food that is manufactured or
processed by the receiving facility to be adulterated under section 402
of the Federal Food, Drug, and Cosmetic Act or misbranded under section
403(w) of the Federal Food, Drug, and Cosmetic Act.

Sec.  117.415  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this
section, the receiving facility must determine and conduct appropriate
supplier verification activities, and satisfy all documentation
requirements of this subpart.
    (3) An entity other than the receiving facility may do any of the
following, provided that the receiving facility reviews and assesses
the entity's applicable documentation, and documents that review and
assessment:
    (i) Establish written procedures for receiving raw materials and
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct the
appropriate supplier verification activities, with appropriate
documentation.
    (4) The supplier may conduct and document sampling and testing of
raw materials and other ingredients, for the hazard controlled by the
supplier, as a supplier verification activity for a particular lot of
product and provide such documentation to the receiving facility,
provided that the receiving facility reviews and assesses that
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier
verification activities for that supplier;

    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food
safety records; or
    (4) The conduct by its supplier of other appropriate supplier
verification activities for that supplier within the meaning of Sec.
117.410(b)(4).
    (c) The requirements of this section do not prohibit a receiving
facility from relying on an audit provided by its supplier when the
audit of the supplier was conducted by a third-party qualified auditor
in accordance with Sec. Sec.  117.430(f) and 117.435.

Sec.  117.420  Using approved suppliers.

    (a) Approval of suppliers. The receiving facility must approve
suppliers in accordance with the requirements of Sec.  117.410(d), and
document that approval, before receiving raw materials and other
ingredients received from those suppliers;
    (b) Written procedures for receiving raw materials and other
ingredients. (1) Written procedures for receiving raw materials and
other ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other
ingredients must ensure that raw materials and other ingredients are
received only from approved suppliers (or, when necessary and
appropriate, on a temporary basis from unapproved suppliers whose raw
materials or other ingredients are subjected to adequate verification
activities before acceptance for use); and
    (3) Use of the written procedures for receiving raw materials and
other ingredients must be documented.

Sec.  117.425  Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the
frequency of conducting the activity) must be determined in accordance
with the requirements of Sec.  117.410(d).

Sec.  117.430  Conducting supplier verification activities for raw
materials and other ingredients.

    (a) Except as provided by paragraph (c), (d), or (e) of this
section, one or more of the supplier verification activities specified
in Sec.  117.410(b), as determined under Sec.  117.410(d), must be
conducted for each supplier before using the raw material or other
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when
a hazard in a raw material or other ingredient will be controlled by
the supplier and is one for which there is a reasonable probability
that exposure to the hazard will result in serious adverse health
consequences or death to humans:
    (i) The appropriate supplier verification activity is an onsite
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not
apply if there is a written determination that other verification
activities and/or less frequent onsite auditing of the supplier provide
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec.
117.3, the receiving facility does not need to comply with paragraphs
(a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified
facility as defined by Sec.  117.3:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or other ingredient in
compliance with applicable FDA food safety regulations (or, when
applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States). The written
assurance must include either:
    (i) A brief description of the preventive controls that the
supplier is implementing to control the applicable hazard in the food;
or
    (ii) A statement that the facility is in compliance with State,
local, county, tribal, or other applicable non-Federal food safety law,
including relevant laws and regulations of foreign countries.
    (d) If a supplier is a farm that grows produce and is not a covered
farm under part 112 of this chapter in accordance with Sec.  112.4(a),
or in accordance with Sec. Sec.  112.4(b) and 112.5, the receiving
facility does not need to comply with paragraphs (a) and (b) of this
section for produce that the receiving facility receives from the farm
as a raw material or other ingredient if the receiving facility:
    (1) Obtains written assurance that the raw material or other
ingredient provided by the supplier is not subject to part 112 of this
chapter in accordance with Sec.  112.4(a), or in accordance with
Sec. Sec.  112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
farm acknowledges that its food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its
food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to
the requirements of part 118 of this chapter because it has less than
3,000 laying hens, the receiving facility does not need to comply with
paragraphs (a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the
supplier are not subject to part 118 because the shell egg producer has
less than 3,000 laying hens:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
shell egg producer acknowledges that its food is subject to section 402
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that
its food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interests that
influence the results of the verification activities listed in Sec.
117.410(b) and payment must not be related to the results of the
activity.

Sec.  117.435  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified
auditor.
    (b) If the raw material or other ingredient at the supplier is
subject to one or more FDA food safety regulations, an onsite audit
must consider such regulations and include a review of the supplier's
written plan (e.g., Hazard Analysis and Critical Control Point (HACCP)
plan or other food safety plan), if any, and its implementation, for
the hazard being controlled (or, when applicable, an onsite audit may
consider relevant laws

and regulations of a country whose food safety system FDA has
officially recognized as comparable or has determined to be equivalent
to that of the United States).
    (c)(1) The following may be substituted for an onsite audit,
provided that the inspection was conducted within 1 year of the date
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives of State,
local, tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection
by FDA or the food safety authority of a country whose food safety
system FDA has officially recognized as comparable or has determined to
be equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent, the food that is the subject
of the onsite audit must be within the scope of the official
recognition or equivalence determination, and the foreign supplier must
be in, and under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the
requirements of this subpart by an audit agent of a certification body
that is accredited in accordance with regulations in part 1, subpart M
of this chapter, the audit is not subject to the requirements in those
regulations.

Sec.  117.475  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in
paragraph (c) of this section in accordance with Sec.  117.165(a)(4).
    (c) The receiving facility must document the following in records
as applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is
in compliance with the foreign supplier verification program
requirements under part 1, subpart L of this chapter, including
documentation of verification activities conducted under Sec.  1.506(e)
of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other
ingredients;
    (5) Documentation demonstrating use of the written procedures for
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant
deficiencies identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified
auditor;
    (8) Documentation of sampling and testing conducted as a supplier
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
    (ii) Identification of the test(s) conducted, including the
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards;
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant
deficiencies identified during the review;
    (10) Documentation of other appropriate supplier verification
activities based on the supplier performance and the risk associated
with the raw material or other ingredient;
    (11) Documentation of any determination that verification
activities other than an onsite audit, and/or less frequent onsite
auditing of a supplier, provide adequate assurance that the hazards are
controlled when a hazard in a raw material or other ingredient will be
controlled by the supplier and is one for which there is a reasonable
probability that exposure to the hazard will result in serious adverse
health consequences or death to humans;
    (12) The following documentation of an alternative verification
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility
as defined by Sec.  117.3, before approving the supplier and on an
annual basis thereafter; and
    (ii) The written assurance that the supplier is producing the raw
material or other ingredient in compliance with applicable FDA food
safety regulations (or, when applicable, relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States);
    (13) The following documentation of an alternative verification
activity for a supplier that is a farm that supplies a raw material or
other ingredient and is not a covered farm under part 112 of this
chapter:
    (i) The written assurance that supplier is not a covered farm under
part 112 of this chapter in accordance with Sec.  112.4(a), or in
accordance with Sec. Sec.  112.4(b) and 112.5, before approving the
supplier and on an annual basis thereafter; and
    (ii) The written assurance that the farm acknowledges that its food
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act
(or, when applicable, that its food is subject to relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States);
    (14) The following documentation of an alternative verification
activity for a supplier that is a shell egg producer that is not
subject to the requirements established in part 118 of this chapter
because it has less than 3,000 laying hens:
    (i) The written assurance that the shell eggs provided by the
supplier are not subject to part 118 of this chapter because the
supplier has less than 3,000 laying hens, before approving the supplier
and on an annual basis thereafter; and
    (ii) The written assurance that the shell egg producer acknowledges
that its food is subject to section 402 of the Federal Food, Drug, and
Cosmetic Act (or, when applicable, that its food is subject to relevant
laws and regulations

of a country whose safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States);
    (15) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives from State,
local, tribal, or territorial agencies, or the food safety authority of
another country when the results of such an inspection is substituted
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied
control applied by an entity other than the receiving facility's
supplier; and
    (18) When applicable, documentation of the receiving facility's
review and assessment of:
    (i) Applicable documentation from an entity other than the
receiving facility that written procedures for receiving raw materials
and other ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the
receiving facility, of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the
receiving facility, of conducting the appropriate supplier verification
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier;
or
    (B) The results of an audit conducted by a third-party qualified
auditor in accordance with Sec. Sec.  117.430(f) and 117.435; and
    (v) Applicable documentation, from an entity other than the
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving
facility's supplier.

PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS

0
17. The authority citation for 21 CFR part 120 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e,
381, 393; 42 U.S.C. 241, 242l, 264.

0
18. In Sec.  120.3, revise the first sentence of the introductory text
to read as follows:

Sec.  120.3  Definitions.

    The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act, Sec.  101.9(j)(18)(vi) of this chapter, and parts 110
and 117 of this chapter are applicable to such terms when used in this
part, except that the definitions and terms in parts 110 and 117 do not
govern such terms where such terms are redefined in this part and
except that the terms facility, hazard, and manufacturing/processing in
parts 110 and 117 do not govern such terms where used in this part. * *
*
* * * * *

0
19. Revise Sec.  120.5 to read as follows:

Sec.  120.5  Current good manufacturing practice.

    Except as provided by Sec.  117.5(c), parts 110 and 117 of this
chapter apply in determining whether the facilities, methods,
practices, and controls used to process juice are safe, and whether the
food has been processed under sanitary conditions.

0
20. In Sec.  120.6, revise the first sentence of paragraph (b) to read
as follows:

Sec.  120.6  Sanitation standard operating procedures.

* * * * *
    (b) Monitoring. The processor shall monitor the conditions and
practices during processing with sufficient frequency to ensure, at a
minimum, conformance with those conditions and practices specified in
part 110 of this chapter and in subpart B of part 117 of this chapter
that are appropriate both to the plant and to the food being processed.
* * *
* * * * *

PART 123--FISH AND FISHERY PRODUCTS

0
21. The authority citation for 21 CFR part 123 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e,
381, 393; 42 U.S.C. 241, 2411, 264.

0
22. In Sec.  123.3, revise the first sentence of the introductory text
to read as follows:

Sec.  123.3  Definitions.

    The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117
of this chapter are applicable to such terms when used in this part,
except that the definitions and terms in parts 110 and 117 do not
govern such terms where such terms are redefined in this part and
except that the terms facility, hazard, and manufacturing/processing in
parts 110 and 117 do not govern such terms where used in this part. * *
*
* * * * *

0
23. In Sec.  123.5, revise paragraph (a) to read as follows:

Sec.  123.5  Current good manufacturing practice.

    (a) Except as provided by Sec.  117.5(b), parts 110 and 117 of this
chapter apply in determining whether the facilities, methods,
practices, and controls used to process fish and fishery products are
safe, and whether these products have been processed under sanitary
conditions.
* * * * *

0
24. In Sec.  123.11, revise the introductory text of paragraph (b) to
read as follows:

Sec.  123.11  Sanitation control procedures.

* * * * *
    (b) Sanitation monitoring. Each processor shall monitor the
conditions and practices during processing with sufficient frequency to
ensure, at a minimum, conformance with those conditions and practices
specified in part 110 of this chapter and in subpart B of part 117 of
this chapter that are both appropriate to the plant and the food being
processed and relate to the following:
* * * * *

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
25. The authority citation for 21 CFR part 129 continues to read as
follows:

    Authority:  21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.

0
26. Revise Sec.  129.1 to read as follows:

Sec.  129.1  Current good manufacturing practice.

    The applicable criteria in parts 110 and 117 of this chapter, as
well as the criteria in Sec. Sec.  129.20, 129.35, 129.37, 129.40, and
129.80 shall apply in determining whether the facilities, methods,
practices, and controls used in the processing, bottling, holding, and
shipping of bottled drinking water are in conformance with or are
operated or administered in conformity with good manufacturing practice
to assure that bottled drinking water is safe and that it has been
processed, bottled, held, and transported under sanitary conditions.

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF
FOOD

0
27. The authority citation for 21 CFR part 179 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 343, 348, 373, 374.

0
28. In Sec.  179.25, revise paragraph (a) to read as follows:

Sec.  179.25  General provisions for food irradiation.

* * * * *
    (a) Any firm that treats foods with ionizing radiation shall comply
with the requirements of parts 110 and 117 of this chapter and other
applicable regulations.
* * * * *

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS

0
29. The authority citation for 21 CFR part 211 continues to read as
follows:

    Authority:  21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42
U.S.C. 216, 262, 263a, 264.

0
30. In Sec.  211.1, revise the last sentence in paragraph (c) to read
as follows:

Sec.  211.1  Scope.

* * * * *
    (c) * * * Therefore, until further notice, regulations under parts
110 and 117 of this chapter, and where applicable, parts 113 through
129 of this chapter, shall be applied in determining whether these OTC
drug products that are also foods are manufactured, processed, packed,
or held under current good manufacturing practice.

    Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21920 Filed 9-10-15; 8:45 am]
 BILLING CODE 4164-01-P