TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
PART 117 CURRENT GOOD MANUFACTURING PRACTICES, HAZARD
ANALYSIS AND PREVENTIVE CONTROLS BASED ON THE
RISK FOR HUMAN FOOD

Subpart A - General provisions

Second. 117.1 Applicability and status.

(A) The criteria and definitions in this part apply to determine whether a food
is:
(1) Adulterated in the sense of:
(I) section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in which the
food has been manufactured under conditions such that it is unfit for food;
either
(ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act where the
food has been prepared, packaged, or maintained under unsanitary conditions, so
that it may have been contaminated with dirt or has been impaired for health;
and
(2) In violation of section 361 of the Public Health Service Act (42 USC 264).
(B) The operation of a facility that manufactures, processes, packages, or
stores food for sale in the United States if the owner, operator, or agent in
charge of such facility is required to comply, and does not comply with, Section
418 of the Federal Food, Drug, and Cosmetic Act or subpart C, D, E, F, or G of
this part is a prohibited act under section 301 (uu) of the Federal Food, Drug,
and Cosmetic Act.
(C) Foods covered by current specific good manufacturing practice regulations
are also subject to the requirements of those regulations.
[80 FR 56145, September 17, 2015, amended at 81 FR 3715, January 22, 2016]

Second. 117.3 Definitions.

The definitions and interpretations of terms in section 201 of the Federal Food,
Drug, and Cosmetic Act apply to such terms when used in this part. The following
definitions also apply:
Acidic foods or acidified foods means foods that have a balance pH of 4.6 or
less.
Adequate means what is needed to achieve the intended purpose, in accordance
with good public health practice.
Affiliate means any facility that controls, is controlled by, or is under common
control with another facility.
Allergen cross-contact means the unintentional incorporation of a food allergen
into a food.
Audit means the systematic, independent and documented examination (through
observation, investigation, record review, discussions with employees of the
audited entity and, as appropriate, sampling and laboratory analysis) to
evaluate the food safety processes and procedures of the audited entity. an
audited entity.
Batter means a semi-fluid substance, usually composed of flour and other
ingredients, in which the main components of foods are dipped or coated, or
which may be used directly to form bakery foods.
Blanching, except for tree nuts and peanuts, means pre-packaged heat treatment
of food for a time and temperature suitable to partially or completely
inactivate natural enzymes and to effect other physical or biochemical changes
in the food.
Calendar day means each day shown on the calendar.
Correction means an action to identify and correct a problem that occurred
during food production, without other actions associated with a corrective
action procedure (such as actions to reduce the likelihood of the problem
recurring, evaluating all affected foods for safety and prevent affected people
from entering the trade).
Critical control point means a point, step or procedure in a food process at
which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce such risk to an acceptable level.
Defect Action Level means a level of a non-hazardous, natural, unavoidable
defect at which FDA may consider a food product "adulterated" and subject to
enforcement actions under section 402(a)(3) of the Federal Food and Drug
Administration. and Drug Law Cosmetics.
Environmental pathogen means a pathogen capable of surviving and persisting
within the environment of manufacturing, processing, packaging or holding, such
that food may be contaminated and foodborne illness may result if that food is
consumed without treatment to significantly minimize the environmental pathogen.
Examples of environmental pathogens for the purposes of this part include
Listeria monocytogenes and Salmonella spp. But they do not include the spores of
pathogenic sporogenic bacteria.
Facility means a domestic or foreign facility that is required to register under
section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the
requirements of part 1, subpart H of this chapter.
Farm means farm as defined in 1.227 of this chapter.
FDA means the Food and Drug Administration.
Food means food as defined in section 201(f) of the Federal Food, Drug, and
Cosmetic Act and includes raw materials and ingredients.
Food allergen means a significant food allergen as defined in section 201(qq) of
the Federal Food, Drug, and Cosmetic Act.
Food contact surfaces are those surfaces that come into contact with human food
and those surfaces from which drainage or other transfer normally occurs on the
food or food contact surfaces during processing. normal course of operations.
"Food contact surfaces" includes utensils and food contact surfaces of
equipment.
Full-time equivalent employee is a term used to represent the number of
employees of a business entity for the purpose of determining whether the
business qualifies for the small business exemption. The number of full-time
equivalent employees is determined by dividing the total number of hours of
salary or wages paid directly to employees of the business entity and all of its
subsidiaries and affiliates by the number of work hours in 1 year, 2,080 hours (
That is, 40 hours * 52 weeks). If the result is not a whole number, round to the
next lowest whole number.
Harvesting applies to farms and mixed farming facilities and means activities
traditionally carried out on farms for the purpose of removing raw agricultural
products from the place where they were grown or raised and preparing them for
use as food. Harvesting is limited to activities performed on raw produce or
processed foods created by drying/dehydrating a raw produce without additional
manufacturing/processing on a farm. Harvesting does not include activities that
transform a raw agricultural product into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting
include cutting (or otherwise separating) the edible portion of the raw produce
from the crop plant and removing or trimming part of the raw produce ( e.g.,
foliage, peels, roots, or stems). Examples of harvesting also include chilling,
field removal, filtration, harvesting, hulling, hulling, sieving, threshing,
trimming of outer leaves, and washing of raw agricultural products grown on a
farm.
Hazard means any biological, chemical (including radiological), or physical
agent that has the potential to cause illness or injury.
Hazard requiring preventive control means a known or reasonably foreseeable
hazard for which a person with knowledge of the safe manufacture, processing,
packaging or holding of food, based on the result of a hazard analysis
(including an evaluation of the severity of the illness or injury if the hazard
were to occur and the likelihood of the hazard occurring in the absence of
preventive controls), establish one or more preventive controls to significantly
minimize or prevent the hazard in a food and components to manage those controls
Surveillance, corrections or corrective actions, verification and records) as
appropriate for the food, the facility and the nature of the preventive control
and its role in the facility's food safety system.
For example, activities performed for the safe or effective storage of that
food, such as fumigation of food during storage, and drying/dehydrating raw
agricultural products when the drying/dehydrating process does not create a
distinct product (such as drying/dehydrating dehydrate hay or alfalfa)). The
farm also includes activities carried out as a practical necessity for the
distribution of that food (such as mixing the same agricultural raw material and
breaking up pallets), but does not include activities that transform a raw
agricultural product into a processed food such as is defined in section 201(gg)
of the Federal Food, Drug, and Cosmetic Act. Maintenance facilities could
include warehouses, cold storage facilities, storage silos, grain elevators, and
liquid storage tanks.
Known or reasonably foreseeable hazard means a biological, chemical (including
radiological), or physical hazard that is known to be or has the potential to be
associated with the facility or food.
Lot means the food produced during a period of time and identified by the
specific code of an establishment.
Manufacturing/processing means making food from one or more ingredients, or
synthesizing, preparing, treating, modifying or manipulating food, including
crops or food ingredients. Examples of manufacturing/processing activities
include: Baking, boiling, bottling, canning, cooking, cooling, cutting,
distilling, drying/dehydrating raw agricultural products to create a distinct
commodity (such as drying/dehydrating grapes to produce raisins), evaporating,
gutting , Juice extraction, formulation, freezing, grinding, homogenization,
irradiation, labeling, milling, blending, packaging (including modified
atmosphere packaging), pasteurization, peeling, processing and treatment to
manipulate ripening, trimming, washing or hair removal. For farms and mixed
agricultural facilities, manufacturing/processing does not include activities
that are part of harvesting, packaging or holding.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa and microscopic
parasites and includes pathogenic species. The term "undesirable microorganisms"
includes those microorganisms that are pathogenic, that subject the food to
spoilage, that indicate that the food is contaminated with dirt, or that may
otherwise cause the food to become adulterated.
Mixed-type facility means an establishment that is engaged in both activities
that are exempt from registration under section 415 of the Federal Food, Drug,
and Cosmetic Act and activities that require the establishment to be registered.
An example of such a facility is a "mixed agricultural facility", which is an
establishment that is a farm, but also carries out activities outside the
definition of a holding that require the establishment to be registered.
Monitor means carrying out a planned sequence of observations or measurements to
evaluate whether control measures are working as intended.
Packaging means placing food in a container other than the food packaging and
also includes repackaging and activities carried out incidentally to the
packaging or repackaging of a food ( for example, activities carried out for the
safe or effective packing or reshipping of said food), but does not include
activities that transform a raw agricultural product into a processed food as
defined in section 201 (gg) of the Federal Food, Drug and Drug Act, and the
Cosmetic Act.
Pathogen means a microorganism of public health importance.
Pest refers to any objectionable animal or insect including birds, rodents,
flies and larvae.
Plant means the building or structure or parts thereof, used for or in
connection with the manufacture, processing, packaging or holding of human food.
Preventive controls means those reasonably appropriate risk - based procedures,
practices and processes that a person knowledgeable about the safe
manufacturing, processing, packaging or storage of food would employ to
significantly minimize or prevent the hazards identified in the hazard analysis.
that are consistent with current scientific understanding of safe food
manufacturing, processing, packaging, or storage at the time of analysis.
Preventive Controls Qualified individual means a qualified individual who has
successfully completed training in the development and application of risk
preventive controls at least equivalent to that received under a standardized
curriculum recognized as appropriate by the FDA or qualified by experience.
labor to develop and implement a food safety system.
Qualified auditor : A person who is a qualified person as defined in this part
and has technical expertise obtained through education, training, or experience
(or a combination thereof) necessary to perform the audit function required by
117.180(c) (2). Examples of possible qualified auditors include:
(1) A government employee, including a foreign government employee; and
(2) An audit agent of a certification body accredited in accordance with the
regulations of part 1, subpart M of this chapter.
Qualified end user, with respect to a food, means the consumer of the food
(where the term consumer does not include a business); Or a restaurant or retail
food establishment (as defined in 1.227 of this chapter) that:
(1) Located:
(I) In the same State or the same Indian reservation as the qualified facility
that sold the food to such restaurant or establishment; either
Ii) No more than 275 miles from said facility; and
(2) Is purchasing the food for sale directly to consumers in such restaurant or
retail food establishment.
Qualified facility means (in including sales of any subsidiary, affiliate, or
subsidiaries or affiliates, collectively, of any entity of which the facility is
a subsidiary or affiliate) a facility that is a very small business as defined
in this part, or a Facility to which both of the following conditions apply:
(1) During the 3-year period preceding the applicable calendar year, the average
annual monetary value of food manufactured, processed, packaged , or held in such
facility that is sold directly to qualified end users (as defined in this part)
during said period exceeded the average annual monetary value of the food sold
by said facility to all other buyers; and
(2) The average annual monetary value of all food sold during the 3-year period
preceding the applicable calendar year was less than $500,000, adjusted for
inflation.
Qualified facility exemption means an exemption applicable to a qualified
facility under 117.5(a).
Qualified person means a person who has the education, training or experience
(or a combination thereof) necessary to manufacture, process, package or
maintain clean and safe food appropriate to the tasks assigned by the
individual. A qualified individual may be, but is not required to be, an
employee of the establishment.
Quality control operation means a planned and systematic procedure to take all
necessary actions to prevent food from being adulterated.
Gross agricultural product has the meaning given in section 201(r) of the
Federal Food, Drug, and Cosmetic Act.
Ready-to-eat food (RTE food) means any food that is normally consumed in its raw
state or any other food, including a processed food, for which it is reasonably
foreseeable that the food will be consumed without additional processing that
would significantly reduce biological risks.
Receiving facility means a facility that is subject to subparts C and G of this
part and that manufactures/processes a raw material or other ingredient that it
receives from a supplier.
Rework means clean, unadulterated foods that have been removed from processing
for reasons other than unhealthiness or that have been successfully
reconditioned by reprocessing and are suitable for use as food.
The safe humidity level is a level of humidity low enough to prevent the growth
of undesirable microorganisms in the final product under the intended conditions
of manufacturing, processing, packaging and holding. The safe moisture level for
a food is related to its water activity (aw). An aw will be considered safe for
a food if adequate data are available demonstrating that the food at or below
the given aw will not support the growth of undesirable microorganisms.
Disinfecting means properly treating cleaned surfaces by a process that is
effective in destroying vegetative cells of pathogens and substantially reducing
the number of other undesirable microorganisms, but without negatively affecting
the product or its safety for the consumer.
Significantly minimize means to reduce to an acceptable level, including to
eliminate.
Small business means, for purposes of this part, a business (including any
subsidiaries and affiliates) that employs fewer than 500 full-time equivalent
employees.
Subsidiary : any company that is owned or controlled directly or indirectly by
another company.
Supplier means the establishment that manufactures or processes food, raises
animal or grows food that is supplied to a receiving facility without further
manufacturing or processing by another establishment, except for additional
manufacturing or processing consisting solely of the addition of labeling. o
Similar de minimis activity.
Supply chain controlled control means a preventive control of a hazard in a raw
material or other ingredient when the hazard in the raw material or other
ingredient is controlled before receipt.
Unexposed packaged foods mean packaged foods that are not exposed to the
environment.
Validation means obtaining and evaluating scientific and technical evidence that
a control measure, combination of control measures, or the food safety plan as a
whole, when properly implemented, is capable of effectively controlling the
identified hazards.
Verification means the application of methods, procedures, tests and other
evaluations, in addition to monitoring, to determine whether a control measure
or combination of control measures has worked or performed as intended and to
establish the validity of the plan. of food safety.
A very small business means, for purposes of this part, a business (including
subsidiaries and affiliates) averaging less than $1,000,000, adjusted for
inflation, per year, during the 3-year period preceding the applicable calendar
year in sales. of human food plus the The market value of human food
manufactured, processed, packaged or held without sale ( for example, held for a
fee).
Water activity (aw) is a measure of the free moisture in a food and is the ratio
of the water vapor pressure of the substance divided by the vapor pressure of
pure water at the same temperature.
Written procedures for receiving raw materials and other ingredients means
written procedures to ensure that raw materials and other ingredients are
received only from suppliers approved by the receiving facility (or, when
necessary and appropriate, temporarily from unapproved suppliers whose materials
raw materials or other Ingredients undergo appropriate verification activities
prior to acceptance for use).
You mean, for the purposes of this part, the owner, operator or agent in charge
of a facility.
[80 FR 56145, September 17, 2015, amended at 81 FR 3715, January 22, 2016]

Second. 117.4 Qualifications of persons who manufacture, process, package or

store food.

A) Applicability. (1) The management of an establishment must ensure that all

persons who manufacture, process, package, or store food subject to subparts B
and F of this part are trained to perform their assigned duties.
(2) The owner, operator, or agent in charge of a facility must ensure that all
persons who manufacture, process, package, or store food subject to subparts C,
D, E, F or G of this part are qualified to perform Their assigned duties.
(B) Qualifications of all persons involved in the manufacturing, processing,
packaging, or holding of food. Each person engaged in the manufacturing,
processing, packaging or holding of food (including temporary and seasonal
personnel) or supervising the same must:
(1) Be a qualified individual as the term is defined in 117.3 - that is,
the education, training or experience (or a combination thereof) necessary to
manufacture, process, package or maintain clean and safe food appropriate for
the tasks assigned by the individual; and
(2) Receive training on the principles of food hygiene and food safety,
including the importance of employee health and personal hygiene, as appropriate
for the food, the facility, and the individual's assigned tasks.
C) Additional qualifications of supervisory personnel. Responsibility for
ensuring compliance by individuals with the requirements of this part shall be
clearly assigned to supervisory personnel who have the education, training, or
experience (or a combination thereof) necessary to supervise the production of
clean and safe foods. .
D) Records. Records of the document training required by paragraph (b)(2) of
this section must be established and maintained.

Second. 117.5 Exemptions.

(A) Except as provided in subpart E of this part, subparts C and G of this part
do not apply to a qualified facility. Qualified facilities are subject to the
modified requirements in 117.201.
(B) Subparts C and G of this part do not apply with respect to activities that
are subject to part 123 of this chapter (Fish and Fishery Products) at a
facility if it is required to comply with and comply with part 123 of this
chapter. this chapter regarding such activities.
(C) Subparts C and G of this part do not apply with respect to activities that
are subject to part 120 of this chapter (Hazard Analysis and Critical Control
Point (HACCP) Systems) at a facility if required that complies with, Comply with
part 120 of this chapter with respect to such activities.
(1) Subparts C and G of this part do not apply with respect to activities that
are subject to part 113 of this chapter (Low-acid, thermally processed foods
packaged in hermetically sealed containers) in a facility if You are required to
comply with and comply with part 113 of this chapter with respect to such
activities.
(2) The exemption in paragraph (d)(1) of this section is applicable only with
respect to microbiological hazards that are regulated under part 113 of this
chapter.
(E) Subparts C and G shall not apply to any facility with respect to the
manufacturing, processing, packaging, or holding of a dietary supplement that
meets the requirements of part 111 of this chapter (Good Manufacturing Practices
in Manufacturing, Packaging, Labeling, or Holding Operations of Dietary
Supplements) and section 761 of the Federal Food, Drug, and Cosmetic Act
(Notification of Serious Adverse Events for Dietary Supplements).
(F) Subparts C and G of this part do not apply to activities of a facility that
are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Product
Safety Standards).
(G)(1) The exemption in paragraph (g)(3) of this section applies to the
packaging or holding of processed foods in a mixed agricultural facility, except
for processed foods produced by drying/dehydrating products. raw agricultural
products to create a (such as drying/dehydrating grapes to produce raisins and
drying/dehydrating fresh herbs to produce dried herbs), and packaging and
labeling such products, without additional processing ) Which fall within the
definition of "farm" in 1.227 of this chapter. Activities that fall within the
definition of "farm," when conducted in a mixed farming facility, are not
subject to the requirements of subparts C and G of this part and therefore do
not need to be specified in the exemption.
(2) For purposes of paragraphs (g)(3) and (h)(3) of this section, the following
terms describe foods associated with the activity/food combination. Various
foods that are fruits or vegetables are considered separately for the purposes
of these activity/meal combinations ( i.e., coffee beans, cocoa beans, fresh
herbs, peanuts, sugar cane, sugar beets, nuts, seeds for direct consumption)
Hazards associated with these foods and/or processing activities carried out
with these foods.
I) Dried or dehydrated fruit and vegetable products include only processed food
products, such as raisins and dried legumes, produced without additional
processing or processing beyond drying/dehydration, packaging and/or labeling.
Ii) Other fruit and vegetable products, including processed food products that
have undergone one or more of the following processes: acidification, boiling,
canning, coating with products other than wax/oil/resin, cooking, cutting ,
chopped, , Crushing, cutting or trimming. Examples include flours made from
legumes (such as chickpea flour), pickles, and snacks made from potatoes or
bananas. Examples also include dried fruits and vegetable products made with
additional processing (such as dried apple slices, dried plums, dried plums,
cherries and apricots, and sulfite raisins). This category does not include
dried/dehydrated fruit and vegetable products manufactured without additional
processing/processing as described in subsection (g)(2)(i) of this section. This
category also does not include products that require time/temperature control
for safety (such as fresh fruits and vegetables).
III) Peanut and nut products include processed food products such as roasted
peanuts and tree nuts, peanuts and tree nuts, and peanuts and tree nuts.
(iv) Processed seeds for direct consumption include processed food products
as roasted pumpkin seeds, roasted sunflower seeds, and roasted flax seeds.
V) Dried or dehydrated herb and spice products only include processed food
products , such as dried, intact herbs processed without additional processing
or processing beyond drying/dehydration, packaging and/or labeling.
(Vi) Other herb and spice products include processed food products such as fresh
chopped herbs, dried chopped or dried herbs (including tea), herbal extracts (
for example, essential oils, extracts containing more than 20 percent of
ethanol, extracts containing more than 35 percent glycerin), dried honey with
herbs or spices, and oils and/or vinegars infused with herbs or spices. This
category does not include dried/dehydrated herb and spice products made without
additional processing/processing beyond drying/dehydrating, packaging and/or
labeling as described in subsection (g)(2)(v) of this section. This category
also does not include products that require time/temperature control for safety,
such as oils infused with fresh herbs.
vii) Cereals include barley, flint, sorghum, oats, rice, rye, wheat, amaranth,
quinoa, buckwheat and oilseeds for oil extraction (such as cottonseed, flaxseed,
rapeseed, soybeans and seeds). sunflower).
(Viii) Ground grain products include processed food products such as flour, bran,
and cornmeal.
(ix) Baked goods include processed food products such as breads, brownies, cakes,
cookies, and cookies. This category does not include products that require
time/temperature control for safety, such as cream-filled pastries.
(X) Other grain products include processed food products such as dry cereals, dry
pastas, rolled oats, and popcorn. This category does not include ground grain
products described in paragraph (g)(2)(viii) of this section or baked products
as described in paragraph (g)(2)(ix) of this section.
(3) Subparts C and G of this part do not apply to on-farm packing or holding of
food by a small or very small business, and 117.201 does not apply to on-farm
packing or holding of food by a very small business, If the only packaging and
holding activities subject to section 418 of the Federal Food, Drug, and
Cosmetic Act that the business performs are the following low-risk packaging or
holding activities or food combinations - i.e. packing (or reshipping) including
weighing or transportation incidental to packing or reshipping); Classification,
slaughter or sizing incidental to packaging or storage; And storage (room, cold
and controlled atmosphere) of:
(I) Baked products ( for example, bread and cookies);
(ii) Candies ( e.g., hard candies , candies, maple caramels, maple cream, nuts,
butterscotch and butterscotch);
Iii) Cocoa beans (roasted);
Iv) Cocoa products;
V) Coffee beans (roasted);
Vi) dried game meat;
(vii) Gums, latex and resins that are processed foods;
(Viii) Honey (pasteurized);
(Ix) Jams, jellies and preserves;
(X) Ground grain products ( for example, flour, bran, and cornmeal);
(xi) Molasses and molasses;
(xii) Oils ( for example, olive oil and sunflower oil);
Xiii) Other fruit and vegetable products ( for example, legume flours, pitted,
dried fruits, sliced, dried apples, snack pieces);
Xiv) Other grain products ( for example, dried pasta, rolled oats and popcorn);
Xv) Other herbal and spice products ( for example, chopped or ground-dried
herbs, herbal extracts);
xvi) Peanut and tree nut products ( e.g. roasted peanuts and tree nut flour);
Xvii) Seeds processed for direct consumption ( for example, roasted pumpkin
seeds);
Xviii) Carbonated drinks and carbonated water;
(Xix) Sugar;
Xx) Syrups ( for example, maple syrup and agave syrup);
(Xxi) trace and granola mix;
(xxii) Vinegar; and
(Xxiii) Any other processed food that does not require time/temperature control
for safety (e.g., vitamins, minerals, and dietary ingredients (in powder,
granule, or other solid form).
(H)(1) The exemption in paragraph (h)(3) of this section applies to food
manufacturing/processing in a mixed agricultural facility, except for
manufacturing/processing that is within the definition of "farm " in 1,227 of
this chapter. Drying/dehydrating raw agricultural products to create a distinct
commodity (such as drying/dehydrating grapes to produce raisins and
drying/dehydrating fresh herbs to produce dried herbs) and packaging and
labeling such products, without the need for processing/and slicing), are within
the definition of "farm" in 1.227 of this chapter. Additionally, treatment to
manipulate the ripening of raw agricultural products (such as treating products
with ethylene gas), and packaging and labeling of treated raw agricultural
products, without additional manufacturing/processing, falls within the
definition of "farm ". Additionally, the coating of intact fruits and vegetables
with wax, oil, or resin used for storage or transportation purposes falls within
the definition of "farm." Activities that fall within the definition of "farm,"
when conducted in a mixed farming facility, are not subject to the requirements
of subparts C and G of this part and therefore do not need to be specified in
the exemption.
(2) The terms in paragraph (g)(2) of this section describe certain foods
associated with the activity/food combinations in paragraph (h)(3) of this
section.
(3) Subparts C and G of this part do not apply to on-farm
manufacturing/processing activities performed by a small or very small business
for distribution in commerce, and 117.201 does not apply to manufacturing
activities / If the only manufacturing/processing activities subject to section
418 of the Federal Food, Drug and Cosmetic Act that the company carries out are
the following low-risk manufacturing/processing activities/food combinations:
(I) Boiling rubbers, latex and resins;
(ii) Cutting, slicing, slicing, peeling, chopping, mashing, and slicing acidic
fruits and vegetables that have a pH less than 4.2 ( e.g., cutting lemons and
limes), baked goods ( e.g., slicing bread), fruit dried/dehydrated Dried herbs
and other spices ( e.g., chopped intact, dried basil), jerky game meat,
gums/latex/resins, other grain products ( e.g., crushed dried cereals), peanuts
and tree nuts and peanut and tree nut products ( e.g., cut roasted peanuts);
Iii) Coating of dried/dehydrated fruits and vegetables ( e.g. coating of raisins
with chocolate), other fruit and vegetable products, except for non-dried, non-
intact fruits and vegetables ( e.g. coating of dried plums, apricots without
dried pits with chocolate are low-risk food/activity combinations but coating
apples on a stick with caramel is not a low-risk food/activity combination),
other grain products ( for example, adding caramel to popcorn or adding
seasonings to popcorn whenever Seasonings have been treated to significantly
minimize pathogens, peanuts and nuts ( for example, add seasonings whenever
seasonings have been treated to significantly minimize pathogens) and popcorn
products. peanuts and nuts ( for example, add seasonings as long as the
seasonings have been treated to significantly reduce pathogens));
Iv) drying/dehydration (including additional manufacturing or carried out on
processed foods) other fruit and vegetable products with pH less than 4.2 (
example, dried fruits and vegetables with pH less than 4.2) and other fruit and
vegetable products herbs and spices (e.g., drying fresh chopped herbs, including
tea);
( e.g., fresh mint), fruits and vegetables ( e.g., olives, avocados) , fresh
greens, greens, grains ( e.g., oilseeds), and other herb and spice products (
e.g., fresh chopped mint , chopped dried mint);
Vi) Freezing of acidic fruits and vegetables with pH less than 4.2 and other
fruit and vegetable products with pH less than 4.2 ( for example, cut fruits and
vegetables);
( e.g., crackers), cocoa beans (roasted), roasted coffee beans, dehydrated fruit
and vegetable products ( e.g., raisins and dried legumes), dried/dehydrated
herbs ( e.g., intact dried basil) , grains ( e.g., oats, rice, rye, wheat),
other fruit and vegetable products AND spice products ( e.g., chopped dried
herbs), peanuts and tree nuts, and peanut and tree nut products ( e.g., roasted
peanuts );
viii) Labeling of baked goods that do not contain food allergens, candies that
do not contain food allergens, cocoa beans (roasted), cocoa products that do not
contain food allergens), roasted coffee beans, jerky game meat, gums / latex /
Resins that are processed foods, honey (pasteurized), jams/jellies/preserves,
ground grain products that do not contain food allergens ( e.g. corn flour) or
that are single ingredient foods ( e.g. wheat flour, wheat bran) Molasses and
molasses, oils and other fruit and vegetable products that do not contain food
allergens ( for example, potato or banana snacks), other grain products that do
not contain food allergens ( for example, popcorn), other herb and spice
products For example, dried or chopped herbs), peanuts or nuts (provided they
are single ingredient or in forms in which the consumer can reasonably be
expected to recognize the food allergen without declaration of label or both
(For example, roasted whole nuts or whole-seeds processed for direct
consumption, carbonated beverages and carbonated water, sugar, syrups, mushroom
mix and granola (other than those containing milk chocolate and provided that
peanuts and / or tree nuts are in the form of Vinegar and any other processed
food that does not require time/temperature control for safety and does not
contain food allergens ( e.g., vitamins, minerals, and dietary ingredients (
e.g., flour bone) in powdered, granular or other solid form);
(Ix) Manufacture of baked goods from ground grain products ( for example,
and cookies);
(X) Manufacture of candy from peanuts and tree nuts ( e.g., dried fruit),
sugar/syrups ( e.g., caramel, caramel), and soaps ( e.g., maple caramels, maple
cream);
Xi) Manufacture of cocoa products from roasted cocoa beans;
(Xii) Manufacture of dry pasta from grains;
(Xiii) Preparation of jams, jellies and preserves of acidic fruits and
vegetables with a pH of 4.6 or less;
(Xiv) Manufacture of molasses and molasses from sugar beet and sugar cane;
(Xv) Manufacture of oat flakes from grains;
(Xvi) Manufacture of popcorn from grains;
(Xvii) Manufacture of fruit and vegetable jam chips ( for example, making banana
and potato chips);
(Xviii) Manufacture of soft drinks and carbonated water from sugar, syrups and
water;
(Xix) Manufacture of sugars and syrups from fruits and vegetables ( e.g.
grains ( e.g. rice, sorghum), other grain products ( e.g. malt grains such as
barley), soaps ( e.g. agave , birch, maple, palm), Sugar beet and sugar cane;
( e.g., raisins), other fruit and vegetable products ( e.g., chopped dried
fruits), other grain products ( e.g., oats) Peanut and nut products and seeds
processed for direct consumption, provided that processed peanuts, tree nuts and
seeds are treated in a way that significantly reduces pathogens;
Xxi) Manufacture of fruit and vegetable vinegar, other fruit and vegetable
products ( for example, fruit wines, apple cider) and other grain products (
example, malt);
(xxii) Mixture of baked goods ( e.g. types of cookies), candies ( e.g. varieties
of caramels), coffee beans (roasted), roasted coffee beans, dried fruits and
vegetables ( e.g. dried cranberries, raisins dried), and raisins),
dried/dehydrated herb products and spice products ( e.g. , dried and intact
basil, intact oregano), pasteurized honey, ground grain products ( e.g. flour,
bran, and cornmeal) (For example, dried, sliced apples and dried, sliced
peaches), other grain products ( for example, different types of dried pasta),
other herb and spice products ( for example, chopped or chopped dried herbs,
Oils and/or dried vinegars with herbs or spices), peanut and tree nut products,
sugar, syrups, vinegar, and any other processed foods that do not require
time/temperature control for safety ( e.g., vitamins, minerals, E ingredients
dietary ( for example, bone meal) in powdered, granular or other solid form);
(Xxiii) Packaging of baked goods ( e.g., bread and cookies), candy, cocoa beans
(roasted), cocoa products, roasted coffee beans, game meat jerky,
gums/latex/resins that are processed foods, honey pasteurized, ( e.g., flour,
bran, cornmeal), molasses and molasses, oils and other fruits and vegetables (
e.g. , chopped, dried fruits, dried apples, ( e.g., popcorn), other products of
herbs and spices ( e.g., dried or chopped herbs), peanut and tree nut products,
processed seeds for direct consumption, soft drinks and soda water, sugar,
syrups, trail mix and granola, vinegar, and any other processed foods that does
not require time/temperature control for safety ( e.g., vitamins, minerals and
dietary ingredients ( e.g., bone meal) in pulverized, granular or other solid
form);
(xxiv) Pasteurization of honey;
(Xxv) Broiling and toasting baked goods ( for example, toasting bread for
croutons);
(Xxvi) Salting other grain products ( for example, soy nuts), peanuts and
processed nuts and seeds for direct consumption; and
( e.g., flour, bran, corn flour), other fruit and vegetable products ( e.g.,
chickpea flour), and peanut and tree nut products ( e.g., peanut flour, almond
flour).
(1) Subparts C and G of this part do not apply with respect to alcoholic
beverages in a facility that meets both of the following conditions:
(I) Pursuant to the Federal Alcohol Administration Act (27 USC 201 et seq
chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 USC 5001
seq. ), the facility must obtain a permit , Or obtain the approval of a notice
or application of the Secretary of the Treasury as a condition of doing business
in the United States, or is a foreign facility of a type that would require such
permit, registration or approval if it were a domestic business facility; and
(ii) Pursuant to Section 415 of the Federal Food, Drug, and Cosmetic Act, the
facility must register as a facility because it is engaged in the manufacturing,
processing, packaging, or possession of one or more alcoholic beverages.
(2) Subparts C and G of this part do not apply with respect to food other than
alcoholic beverages in a facility described in paragraph (i)(1) of this section,
provided that such food:
(I) is in a packaged form that avoids any direct human contact with said food;
and
(II) Constitutes no more than 5 percent of the facility's total sales, as
determined by the Secretary of the Treasury.
(J) Subparts C and G of this part do not apply to facilities dedicated
exclusively to the storage of raw agricultural products (except fruits and
vegetables) intended for further distribution or processing.
(K) (1) Except as provided in paragraph (k) (2) of this section, subpart B of
this part does not apply to any of the following:
(I) "Farms" (as defined in 1.227 of this chapter);
Ii) Fishing vessels that are not subject to the registration requirements of
part 1, subpart H of this chapter, in accordance with section 1.226 (f) of this
chapter;
Iii) Establishments dedicated exclusively to the exploitation and/or
transportation of one or more raw agricultural products;
Iv) The activities of "mixed agricultural facilities" (as defined in 1,227 of
this chapter) that correspond to the definition of "exploitation"; either
(V) Establishments dedicated exclusively to the shelling, shelling, drying,
packaging and/or retention of nuts (without additional manufacturing/processing,
such as roasted nuts).
(2) If a "farm" or "mixed-type agricultural facility" dries/dehydrates the raw
agricultural products that are produced as defined in part 112 of this chapter
to create a distinct product, subpart B of this part applies to packaging, and
the possession of dry products. Compliance with this requirement may be achieved
by complying with subpart B of this part or the applicable requirements for
packaging and holding in part 112 of this chapter.
[80 FR 56145, September 17, 2015, amended at 81 FR 3716, January 22, 2016]

Second. 117.7 Applicability of subparts C, D, and G of this part to a facility

dedicated exclusively to the storage of undisplayed packaged foods.

(A) Applicability of subparts C and G. Subparts C and G of this part do not

apply to a facility dedicated exclusively to the storage of undisplayed packaged
foods.
B) Applicability of Subpart D. A facility dedicated exclusively to the storage
of unexposed packaged foods, including unexposed packaged foods that requires
time/temperature control to significantly minimize or prevent the growth or
production of toxins by pathogens, is subject to modification in En 117.206 for
any unexposed packaged food that requires time/temperature control to
significantly minimize or prevent the growth or production of toxins by
pathogens.

Second. 117.8 Applicability of subpart B of this part to packaging and off-farm

handling of raw agricultural products.

Except as provided in subparagraph 1 of section 117.5(k)(1), subpart B of this

part applies to the off-farm packing, packaging, and holding of raw agricultural
products. Compliance with this requirement for raw agricultural products
produced as defined in part 112 of this chapter may be achieved by complying
with subpart B of this part or with the applicable packaging and retention
requirements in part 112 of this chapter. This chapter.
[81 FR 3956, January 25, 2016]

Second. 117.9 Records required for this subpart.

(A) Records of the document training required by 117.4(b)(2) shall be

established and maintained.
(B) Records that must be established and maintained are subject to the
requirements of subpart F of this part.

Subpart B - Current Good Manufacturing Practices

Second. 117.10 Personnel.

The management of the establishment must take reasonable measures and

precautions to ensure the following:
A) Control of the disease. Any person who, by medical examination or supervisory
observation, is shown to have, or appears to have, an illness, open injury,
including boils, infected sores or wounds, or any other abnormal source of
microbial contamination for which there is a reasonable risk. If food, food
contact surfaces, or food packaging materials become contaminated, they should
be excluded from any operation that could be expected to produce such
contamination until the condition is corrected, unless conditions exist such as
open injuries, (for example, from a waterproof cover). Staff should be
instructed to report such health conditions to their supervisors.
(B) Cleanliness. All persons working in direct contact with food, food contact
surfaces and food packaging materials must comply with hygiene practices during
service to the extent necessary to protect against cross-contact of allergens
and against food contamination. Methods to maintain cleanliness include:
(1) The use of outer garments appropriate for the operation so as to protect
against cross-contact with allergens and against contamination of food, food
contact surfaces, or food packaging materials.
(2) Maintain proper personal cleanliness.
(3) Thoroughly wash your hands (and disinfect them if necessary to protect them
against contamination with undesirable microorganisms) in appropriate
handwashing before starting work, after each absence from the workplace, and at
any other time when hands have become dirty or contaminated.
(4) Remove all unsecured jewelry and other objects that may fall into food,
equipment or containers, and remove hand-held jewelry that cannot be adequately
disinfected during periods when food is handled by hand. If such hand jewelry
cannot be removed, it may be covered by material that can be maintained in an
intact, clean and hygienic condition and that effectively protects against
contamination by these objects of food, food contact surfaces or packaging. of
food Materials.
(5) Keep gloves, if used in food handling, in an intact, clean and sanitary
condition.
(6) Use, where appropriate, effective hair nets, hair bands, caps, beard covers
or other effective hair devices.
(7) Storing clothing or other personal belongings in areas other than where food
is displayed or where equipment or utensils are washed.
(8) Confine the following to areas other than where food may be exposed or where
equipment or utensils are washed: eating food, chewing gum, drinking beverages,
or using tobacco.
(9) Take any other precautions necessary to protect against cross-contact with
allergens and against contamination of food, food contact surfaces, or food
packaging materials with microorganisms or foreign substances (including sweat,
hair, cosmetics, tobacco, products chemicals and medications Applied to the
skin).

Second. 117.20 Facilities and land.

A) Reasons. The grounds above a food plant under the control of the operator
must be maintained in a condition that protects against contamination of food.
Methods for proper maintenance of motifs should include:
(1) Properly store equipment, remove trash and debris, and cut weeds or weeds
within the immediate vicinity of the plant that may constitute an attractant,
breeding site, or harborage for pests.
(2) Maintain roads, yards, and parking lots so that they do not constitute a
source of contamination in areas where food is displayed.
(3) Adequately drain areas that may contribute to food contamination by seepage,
foot soiling, or providing a breeding ground for pests.
(4) Operational systems for the treatment and disposal of waste appropriately so
that it does not constitute a source of contamination in areas where food is
displayed.
(5) If plant grounds are bordered for reasons not under the control of the
operator and are not maintained in the manner described in paragraphs (a)(1)
through (4) of this section, care must be taken on the plant by inspection,
extermination, or other means to exclude pests, dirt and grime that may be a
source of food contamination.
(B) Plant construction and design. The plant must be suitable in size,
construction and design to facilitate maintenance and sanitary operations for
the purposes of food production ( i.e. manufacturing, processing, packaging and
storage). The plant must:
(1) Provide adequate space for the placement of equipment and the storage of
materials necessary for maintenance, sanitary operations, and the production of
safe food.
(2) Allow appropriate precautions to be taken to reduce the potential for
allergen cross-contact and contamination of food, food contact surfaces, or food
packaging materials with microorganisms, chemicals, dirt, and other foreign
materials. The potential for allergen cross-contact and contamination can be
reduced by appropriate food safety controls and operational practices or
effective design, including separation of operations where allergen cross-
contact and contamination by one or more of the following means: location, time,
partition, air flow systems, dust control systems, closed systems or other
effective means.
(3) Allow adequate precautions to be taken to protect food in bulk containers
installed outdoors by any effective means, including:
(I) Use of protective coatings.
(ii) Control areas on and around vessels to eliminate pest flooding.
Iii) Periodic checking for pests and pest infestation.
(iv) Skimming fermentation vessels, as necessary.
(4) Be constructed in such a manner that the floors, walls and ceilings are
adequately cleaned and kept clean and in good repair; That dripping or
condensation from fittings, conduits and pipes does not contaminate food, food
contact surfaces or food packaging materials; And that corridors or work spaces
are arranged between the equipment and walls and are adequately clear and of
adequate width to allow employees to perform their duties and to protect against
contamination of food, food contact surfaces or work materials. packaging food
with clothing or personal contact.
(5) Provide adequate lighting in handwashing areas, locker rooms and locker
rooms, and restrooms and in all areas where food is examined, manufactured,
processed, packaged, or held and where equipment or utensils are cleaned; And
provide light bulbs, fixtures, skylights, or any other glass suspended over
exposed food at any preparation step or otherwise protect against food
contamination in the event of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize dust, odors,
and vapors (including noxious vapor and fumes) in areas where they may cause
cross-contact with allergens or contaminate food; And locate and operate fans
and other air blowing equipment in a manner that minimizes the potential for
cross-contact with allergens and for contaminating food, food packaging
materials, and food contact surfaces.
(7) Provide, when necessary, adequate screening or other protection against
pests.

Second. 117.35 Sanitary operations.

A) General maintenance. Plant buildings, fixtures and other physical facilities

must be maintained in a clean and sanitary condition and must be kept in
adequate repair to prevent food from becoming adulterated. Cleaning and
disinfection of utensils and equipment should be performed in a manner that
protects against cross-contact with allergens and against contamination of food,
food contact surfaces, or food packaging materials.
B) Substances used in cleaning and disinfection; Storage of toxic materials.
Cleaning compounds and disinfectants used in cleaning and disinfection
procedures must be free of undesirable microorganisms and must be safe and
appropriate under the conditions of use. Compliance with this requirement must
be verified by any effective means, including the purchase of these substances
under a letter of guarantee or certification or the examination of these
substances for contamination. The following toxic materials may only be used or
stored in a plant where Foods are processed or exposed:
(I) Those required to maintain clean and sanitary conditions;
Ii) those necessary for use in laboratory testing procedures;
(III) Those necessary for the maintenance and operation of plants and equipment;
and
(Iv) Those necessary for use in plant operations.
(2) Toxic cleaning compounds, disinfectants, and pesticide chemicals must be
identified, maintained, and stored in a manner that protects against
contamination of food, food contact surfaces, or food packaging materials.
C) Pest control. Pests should not be allowed in any area of a food plant. Guard,
guide or pest detection dogs may be permitted in some areas of a plant if the
presence of dogs is unlikely to result in contamination of food, food contact
surfaces or food packaging materials. Effective measures should be taken to
exclude to pests in manufacturing, processing, packaging and storage areas, and
protect against contamination of food in the facilities by pests. The use of
pesticides to control plant pests is permitted only under precautions and
restrictions that protect against contamination of food, food contact surfaces,
and food packaging materials.
D) Sanitation of surfaces in contact with food. All food contact surfaces,
including utensils and food contact surfaces, should be cleaned as frequently as
necessary to protect against allergen cross-contact and food contamination.
(1) Food contact surfaces used for manufacturing/processing, packaging, or
holding low-moisture foods must be in a clean, dry, and sanitary condition
before use. When surfaces are wet cleaned, they should be disinfected and dried
thoroughly before further use.
(2) In the wet process, when cleaning is necessary to protect against cross-
contact with allergens or the introduction of microorganisms into food, all food
contact surfaces must be cleaned and disinfected before use and after any
interruption during which surfaces have been contaminated. When equipment and
utensils are used in a continuous production operation, utensils and food
contact surfaces of the equipment should be cleaned and disinfected as
necessary.
(3) Single-service items (such as utensils intended for single use, paper cups,
and paper towels) must be stored, handled, and disposed of in a manner that
protects against cross-contact with allergens and against contamination of food.
Surfaces in contact with food or food packaging materials.
E) Sanitation of surfaces that do not come into contact with food. Non-food
contact surfaces of equipment used in the operation of a food plant should be
cleaned as frequently as necessary to protect against cross-contact with
allergens and against contamination of food, food contact surfaces. and food
packaging materials.
F) Storage and handling of clean portable equipment and utensils. Cleaned and
sanitized portable equipment with food contact surfaces and utensils should be
stored in a location and manner that protects food contact surfaces from cross-
contact with allergens and contamination.

Second. 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 intended operations
and must be derived from a suitable source. Any water that comes into contact
with food, food contact surfaces, or food packaging materials must be safe and
of adequate sanitary quality. Running water at an appropriate temperature and
under pressure, as necessary, must be provided in all areas required for food
processing, for cleaning equipment, utensils and food packaging materials, or
for employee sanitary facilities.
B) Plumbing. Plumbing must be of adequate size and design and properly installed
and maintained to:
(1) Bring adequate amounts of water to required locations throughout the plant.
(2) Properly transfer wastewater and disposable liquid waste from the plant.
(3) Avoid constituting a source of contamination to food, water supply,
equipment or utensils or creating an unsanitary condition.
(4) Provide adequate floor drainage in all areas where floors are subject to
flood-type cleanup or where normal operations release or discharge water or
other liquid waste onto the floor.
(5) Provide that there is no backflow or cross-connection between piping systems
that discharge wastewater or piping and sewer systems that convey water for food
or feed manufacturing.
C) Disposal of wastewater. Wastewater must be disposed of in a suitable sewer
system or disposed of by other suitable means.
D) Sanitary facilities. Each plant must provide employees with adequate and
easily accessible sanitary facilities. Sanitary facilities should be kept clean
and should not be a potential source of contamination of food, food contact
surfaces, or food packaging materials.
E) Hand washing facilities. Each plant must provide handwashing 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 adequate,
convenient facilities, and by supplying running water to a Proper temperature.
F) Elimination of waste and debris. Waste and offal should be transported,
stored and disposed of in a manner that minimizes the development of odors,
minimizes the potential for the waste to become an attractant and breeding site
for pests, and protects against contamination of food, surfaces. food contact,
food packaging materials, water supplies and ground surfaces.

Second. 117.40 Equipment and

utensils.

(A) (1) All plant equipment and utensils used in the manufacturing, processing,
packaging, or holding of food must be designed so that they are adequately
cleanable and must be adequately maintained to protect against cross-contact
with allergens and contamination. .
(2) Equipment and utensils must be properly designed, constructed, and used to
prevent adulteration of food with lubricants, fuel, metal fragments,
contaminated water, or any other contaminant.
(3) Equipment must be installed to facilitate cleaning and maintenance of the
equipment and 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 intended use and the action of food and, where
applicable, cleaning compounds, disinfectants, and cleaning procedures.
(6) Food contact surfaces must be maintained to protect food from cross-contact
of allergens and contamination from any source, including illegal indirect food
additives.
(B) Joints on food contact surfaces should be loosely bonded or held to minimize
the accumulation of food particles, dirt, and organic matter and thus minimize
the opportunity for microorganism growth and cross-contact with allergens.
(C) Equipment located in areas where food is manufactured, processed, packaged
or held and that does not come into contact with food must be constructed in such
a manner that it can be maintained in a clean and sanitary condition.
D) Fastening, transportation and manufacturing systems, including gravimetric,
pneumatic, closed and automated systems, must be of a design and construction
that allows them to be maintained in appropriate clean and sanitary conditions.
E) Each freezer and cold storage compartment used to store and maintain foods
capable of supporting the growth of microorganisms shall be equipped with an
indicating thermometer, temperature measuring device, or temperature recording
device installed to display the temperature accurately inside the compartment.
F) Instruments and controls used to measure, regulate or record temperatures,
pH, acidity, water activity or other conditions that control or prevent the
growth of undesirable microorganisms in foods must be precise and accurate and
properly maintained, For its 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 the
food is not contaminated with illegal indirect food additives.
Second. 117.80 Processes and controls.

(A) General. (1) All food manufacturing, processing, packaging, and storage
operations (including operations aimed at receiving, inspecting, transporting,
and segregating) must be conducted in accordance with proper 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) General plant sanitation must be under the supervision of one or more
competent persons responsible for this function.
(4) Appropriate precautions must be taken to ensure that production procedures
do not contribute to cross-contact of allergens and contamination from any
source.
(5) When necessary, chemical, microbial, or foreign material procedures should
be used to identify sanitation failures or possible cross-contact with allergens
and food contamination.
(6) Any food that has been 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 handled as necessary to ensure that they are
clean and suitable for processing into foods and must be stored under conditions
that protect against cross-contact of allergens and against contamination and
minimize deterioration. Raw materials should be washed or cleaned as necessary
to remove soil or other contamination. Water used to wash, rinse or transport
food must be safe and of adequate sanitary quality. Water can be reused to wash,
rinse or transport food if it does not cause cross-contact with allergens or
increase the level of contamination of the food.
(2) Raw materials and other ingredients must not contain levels of
microorganisms that could make the food harmful to human health or must be
pasteurized or otherwise treated during manufacturing operations so that they no
longer contain levels that cause the product to be adulterated.
(3) Raw materials and other ingredients susceptible to contamination with
aflatoxin or other naturally occurring toxins must comply with FDA regulations
for poisonous or harmful substances before these raw materials or other
ingredients are incorporated into the finished food.
(4) Raw materials, other ingredients, and rework susceptible to contamination
with pests, undesirable microorganisms, or foreign material must comply with FDA
regulations applicable to natural or unavoidable defects if a manufacturer
wishes to use the materials in food manufacturing.
(5) Raw materials, other ingredients and reprocessing must be kept in bulk or in
containers designed and manufactured to protect against cross-contact of
allergens and contamination and must be maintained at such temperature and
relative humidity and of such way To prevent food from being adulterated.
Material scheduled for rework must be identified as such.
(6) Frozen raw materials and other ingredients must be kept frozen. If thawing
is necessary before use, it should be done in a way that prevents raw materials
and other ingredients from becoming adulterated.
(7) Liquid or dry raw materials and other ingredients received and stored in
bulk must be maintained in a manner that protects against cross-contact of
allergens and against contamination.
(8) Raw materials and other ingredients that are food allergens, and
reprocessing that contains food allergens, must be identified and maintained in
a manner that prevents cross-contact with allergens.
C) Manufacturing operations. (1) Equipment and food utensils and containers must
be maintained in proper condition by appropriate cleaning and disinfection, as
necessary. To the extent necessary, the equipment should be disassembled for
thorough cleaning.
(2) All food preparation, processing, packaging and holding must be carried out
under conditions and controls necessary to minimize the potential for growth of
microorganisms, cross-contact with allergens, contamination of food and food
spoilage.
(3) Foods that can support the rapid growth of undesirable microorganisms must
be maintained at temperatures that prevent the food from becoming adulterated
during manufacturing, processing, packaging, and holding.
(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing,
refrigerating, pH control, or particle control that are taken to destroy or
prevent the growth of undesirable microorganisms must be appropriate under the
conditions of manufacturing, handling, and distribution. a Prevent food from
being adulterated.
(5) Work in process and rework should be handled in a manner that protects
against cross-contact with allergens, contamination, and the growth of
undesirable microorganisms.
(6) Effective measures must be taken to protect finished foods from cross-
contact of allergens and from contamination by raw materials, other ingredients
or waste. When raw materials, other ingredients or waste are not protected, they
should not be handled simultaneously in a receiving, loading or shipping area if
such handling could lead to contact with allergens or contaminated food. Food
transported by conveyor must be protected against cross-contact of allergens and
against contamination as necessary.
(7) Equipment, containers and utensils used to transport, store or store raw
materials and other ingredients, works in process, reprocessing or other foods
must be constructed, handled and maintained during manufacturing, processing,
packaging and maintaining it in a manner that protects against cross contact
with allergens and against contamination.
(8) Appropriate measures must be taken to protect against the inclusion of metal
or other foreign material in food.
(9) Adulterated foods, raw materials and other ingredients:
(I) It must be disposed of in a manner that protects against contamination of
other foods; either
(ii) If the adulterated food is capable of being reconditioned, it must be:
(A) Reconditioned (if applicable) using a method proven to be effective; either
B) Reconditioned (if applicable) and reexamined and subsequently not adulterated
within the meaning of the Federal Food, Drug and Cosmetic Act before being
incorporated into other foods.
(10) Measures such as washing, peeling, trimming, cutting, sorting and
inspection, grinding, dehydration, cooling, grinding, extrusion, drying,
beating, degreasing and forming should be carried out to protect foods from
cross-contact of allergens and Against pollution. Food must be protected from
contaminants that can drip, drain or be attracted to the food.
(11) Heat blanching, when necessary in the preparation of foods capable of
supporting microbial growth, should be carried out by heating the food to the
required temperature, holding it at this temperature for the required time and
then rapidly cooling the food or passing to its subsequent manufacturing without
delay. Growth and contamination by thermophilic microorganisms in bleaches
should be minimized by the use of proper operating temperatures and by periodic
cleaning and disinfection as necessary.
(12) Confections, breading, sauces, sauces, dressings, dipping solutions and
other similar preparations that are kept and used repeatedly over time must be
treated or maintained in such a way that they are protected against cross-
contact with allergens and against contamination, AND minimizing the potential
for the growth of undesirable microorganisms.
(13) Filling, assembly, packaging, and other operations must be performed in
such a manner that the food is protected from cross-contact with allergens,
contamination, and the growth of undesirable microorganisms.
(14) Foods, such as dry mixes, nuts, intermediate moisture foods, and dehydrated
foods, which rely primarily on aw control to prevent the growth of undesirable
microorganisms, should be processed and maintained at a moisture level sure.
(15) Foods, such as acid and acidified foods, which rely primarily on pH control
to prevent the growth of undesirable microorganisms, should be controlled and
maintained at a pH of 4.6 or lower.
(16) When ice is used in contact with food, it must be made from safe water of
adequate sanitary quality in accordance with 117.37(a), and must be used only if
it has been manufactured in accordance with current good manufacturing practice
described in this part.

Second. 117.93 Storage and distribution.

The storage and transportation of food must be under conditions that protect
against cross-contact with allergens and against biological, chemical (including
radiological) and physical contamination of food, as well as against
deterioration of food and packaging.

Second. 117.95 Conservation and distribution of human food by-products intended

for animal feed.

A) Human food byproducts intended to be distributed as animal feed without

additional processing or transformation by the human food processor, identified
in Article 507.12 of this chapter, must be maintained in conditions that protect
against contamination, including the following: :
(1) Containers and equipment used to transport or hold human food byproducts for
use as animal feed prior to distribution must be designed, manufactured from
appropriate materials, cleaned as necessary, and maintained to protect against
contamination by human food byproducts. Use as animal feed;
(2) Human food byproducts intended for use as feed for animals intended for
distribution must be maintained in a manner that protects them from
contamination from sources such as garbage; and
(3) During exploitation, human food by-products for use as animal feed must be
accurately identified.
B) Labeling that identifies the by-product with the common or usual name must be
placed on human food by-products or accompany them for use as animal feed when
distributed.
(C) Shipping containers ( e.g., totes, drums, and tubs) and bulk vehicles used
to distribute human food byproducts for use as animal feed must be examined
before use to protect against contamination of the food byproducts. for use as
animal feed from the container or vehicle when the facility is responsible for
transporting human food byproducts for use as animal feed itself or is
responsible for transporting human food byproducts for use as feed for animals.
[80 FR 56337, September 17, 2015]

Second. 117.110 Defect Action Levels.

(A) The food manufacturer, processor, packager, and holder must at all times use
quality control operations that reduce natural or unavoidable defects to the
lowest level currently practicable.
B) Mixing a food containing defects at levels that render the adulterated food
with another batch of food impermissible and causes the final food to be
adulterated, regardless of the defect level of the final food. For examples of
defect action levels that can cause foods to be adulterated, see the Defect
Levels Manual, which is available at http://www.fda.gov/pchfrule and at
http://www.fda.gov/pchfrule. fda.gov .

Subpart C - Hazard Analysis and Risk- Based Preventive Controls

Second. 117.126 Food security plan.

A) Requirement of 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 supervised, by one
or more preventive controls of qualified individuals.
(B) Content of a food safety plan. The written food safety plan must include:
(1) The written hazard analysis as required by 117.130(a)(2);
(2) The written preventive controls required by 117.135(b);
(3) The written supply chain program as required in subpart G of this part;
(4) The written retirement plan required by 117.139(a); and
(5) Written procedures to monitor the implementation of preventive controls
required by 117.145(a)(1);
(6) The written corrective action procedures required by 117.150(a)(1); and
(7) The written verification procedures required by 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.
Second. 117.130 Hazard analysis.

A) Requirement of a risk analysis. (1) You must conduct a risk analysis to

identify and evaluate, on the basis of experience, disease data, scientific
reports, and other information, known or reasonably foreseeable hazards for each
type of food manufactured, processed, packaged, or held in your facility.
installation to Determine if there are hazards that require preventive control.
(2) The risk analysis must be written regardless of its result.
B) Hazard identification. Hazard identification must consider:
(1) Known or reasonably foreseeable hazards including:
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 foods 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 danger occurs naturally;
(ii) The danger may be introduced inadvertently; either
(iii) Risk may be intentionally introduced for purposes of economic benefit.
C) Hazard assessment. (1) (i) The risk analysis must include an evaluation of
the hazards identified in paragraph (b) of this section to evaluate the severity
of the illness or injury if the risk were to occur and the likelihood of the
hazard occurring in the Absence of preventive controls.
Ii) The risk assessment required in paragraph 1(c)(i) of this section shall
include an assessment of environmental pathogens whenever ready-to-eat foods are
exposed to the environment prior to packaging and packaged foods not Receive a
treatment or otherwise include a control measure (such as a formulation lethal
to the pathogen) that would significantly reduce the pathogen.
(2) The risk assessment 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 facilities 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 temporary nature ( for example,
climate-related) of some hazards ( for example, levels of some natural toxins).
Second. 117.135 Preventive controls.

(A) (1) You must identify and implement preventive controls to provide assurance
that any hazard requiring a preventive control will be significantly minimized
or prevented and the food manufactured, processed, packaged or held by your
facility will not be adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act or false labeling 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 (CCP), if there are CCPs; and
(ii) Controls, other than those of CCPs, that are also appropriate for food
safety.
(B) Preventive controls must be written.
(C) Preventive controls include, as appropriate for the facility and food:
(1) Process controls. Process controls include procedures, practices and
processes to ensure control of parameters during operations such as heat
processing, acidification, irradiation and refrigeration of foods. Process
controls shall include, as appropriate to the nature of the applicable control
and its role in the facility's food safety system:
(I) Parameters associated with hazard control; and
(ii) The maximum or minimum value, or combination of values, at which any
biological, chemical or physical parameter must be controlled to significantly
minimize or prevent a hazard requiring process control.
(2) Control of food allergens. Food allergen controls include procedures,
practices and processes for controlling food allergens. Food allergen controls
must include the procedures, practices and processes used to:
I) Ensure the protection of food from cross-contact with allergens, including
during storage, handling and use; and
(ii) Label 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 adequate sanitary
condition to minimize or prevent hazards such as environmental pathogens,
biological hazards due to employee handling, and allergenic hazards. Sanitation
controls shall include, as appropriate for the facility and food, procedures,
practices and processes for:
I) cleaning of food contact surfaces, including food contact surfaces of
utensils and equipment;
Ii) Prevention of cross-contact of allergens and cross-contamination from
unhealthy objects and personnel to food, food packaging material and other
surfaces in contact with food and from raw product to processed product.
(4) Supply chain controls. Supply chain controls include the supply chain
program as required in subpart G of this part.
(5) Retirement plan. Retirement plan as required by 117.139.
(6) Other controls. Preventive controls include 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 good
manufacturing practices.

Second. 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 risk that requires a
preventive control (identified hazard) and any of the following circumstances
apply:
(1) You determine and document that the type of food ( for example, raw
agricultural products such as cocoa beans, coffee beans, and grains) could not
be consumed without the application of appropriate control.
(2) You rely on your client to be subject to the requirements for risk analysis
and risk -based preventive controls in this subpart to ensure that the identified
risk will be significantly minimized or prevented and you:
(I) Disclose in documents accompanying the food, in accordance with trade
practice, that the food "is not processed to control [identified hazard]"; and
(ii) Annually obtain from your client written assurance, subject to the
requirements of 117.137, that the client has established and follows procedures
(identified in the written assurance) that will significantly minimize or avoid
the identified risk.
(3) You rely on your customer not to be subject to the requirements for risk
analysis and risk - based preventive controls in this subpart to ensure that food
is manufactured, processed, or prepared in accordance with food safety
requirements. applicable and you:
(I) Disclose in documents accompanying the food, in accordance with trade
practice, that the food "is not processed to control [identified hazard]"; and
(ii) Annually obtain from your customer a written assurance that the food is
manufactured, processed or prepared 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 risk identified by an entity in the downstream
distribution chain to the customer, and you:
(I) Disclose in documents accompanying the food, in accordance with trade
practice, that the food "is not processed to control [identified hazard]"; and
(ii) Annually obtain from your client a written guarantee, subject to the
requirements of 117.137, that your client:
(A) disclose in the documents accompanying the food, consistent with trade
practice, that the food "is not processed to control [identified hazard]"; and
(B) You will only sell to another entity that agrees, in writing, that:
(If the entity is subject to the requirements for risk analysis and risk
preventive controls in this subpart) or manufacture, process or prepare the food
in accordance with applicable food safety requirements (if the entity is not is
subject to the requirements for risk analysis and risk - based preventive
controls in this subpart); either
( 2 ) Obtain a similar written assurance from the entity's customer, subject to
the requirements of 117.137, as set forth in paragraphs (a)(4)(ii)(A) and (B) of
this section, as applicable. ; either
(5) You have established, documented, and implemented a system that ensures
control, at a later distribution stage, of hazards in the food you distribute
and document the implementation of that system.
B) Records. You must document any circumstances, specified in paragraph (a) of
this section, that apply to you, including:
(1) A determination, in accordance with paragraph (a) of this section, that the
type of food could not be consumed without the application of appropriate
control;
(2) Your customer's annual written warranty in accordance with paragraph (a)(2)
of this section;
(3) Your customer's annual written warranty in accordance with paragraph (a)(3)
of this section;
(4) Your customer's annual written warranty 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 later distribution stage, of hazards in the food you
distribute.
[80 FR 56145, September 17, 2015, amended at 81 FR 3716, January 22, 2016]

Second. 117.137 Provision of collateral required under 117.136(a)(2), (3), and

(4).

A facility that provides a written warranty under 117.136(a)(2), (3), or (4)

must act consistently with the warranty and document its actions taken to
satisfy the written warranty.

Second. 117,139 Retirement plan.

For hazardous foods that require preventive control:

(A) You must establish a written withdrawal plan for the food.
(B) The written retirement plan must include procedures that describe the steps
to be taken and assign responsibility for taking those actions, to carry out the
following actions as appropriate for the facility:
(1) Notify direct consignees of the food being recalled, including how to return
or dispose of the affected food;
(2) Notify the public of any hazards posed by food when appropriate to protect
public health;
(3) Carry out effectiveness checks to verify that the withdrawal is carried out;
and
(4) Appropriately dispose of recalled food , for example, by reprocessing,
reprocessing, diversion to a use that does not present a safety concern, or
destruction of the food.
Second. 117,140 Preventive control components.

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

Second. 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 will be performed, to monitor preventive
control; and
B) Surveillance. You must monitor preventive controls at appropriate frequency
to ensure they are performed consistently.
C) Records. (1) Requirement to document monitoring. You must document monitoring
of preventive controls in accordance with this section in records that are
subject to verification in accordance with 117.155(a)(2) and record review in
accordance with 117.165(a)(4)(i).
(2) Exception records. I) Refrigeration temperature records during food storage
that require time/temperature control to minimize or significantly prevent
growth or toxin production by pathogens may be affirmative records demonstrating
that the temperature is controlled or exception records demonstrating loss of
temperature control.
ii) Exception logs may be appropriate in circumstances other than refrigeration
temperature monitoring.
[80 FR 56145, September 17, 2015, amended at 81 FR 3716, January 22, 2016]

Second. 117,150 Corrective actions and corrections.

(A) Corrective procedures. As appropriate to the nature of the hazard and the
nature of the preventive control, except as provided in paragraph (c) of this
section:
(1) You must establish and implement written corrective action procedures to be
taken if preventive controls are not properly implemented, including procedures
to address, as appropriate:
I) the presence of a pathogen or an appropriate indicator organism in a ready-
to-eat product detected as a result of product testing conducted in accordance
with paragraph 117.165(a)(2); and
Ii) The presence of an environmental pathogen or an appropriate indicator
organism detected through environmental monitoring conducted in accordance with
section 117.165(a)(3).
(2) Corrective action procedures must describe the steps to be taken to ensure
that:
I) Appropriate measures are adopted to identify and correct a problem that has
occurred with the application of a preventive control;
Ii) Appropriate measures are taken, where necessary, to reduce the likelihood of
the problem recurring;
(iii) The safety of all affected foods is evaluated; and
(iv) All affected foods are prevented from entering 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). Drugs
and Cosmetics.
B) Corrective measures in case of an unforeseen food safety problem. (1) Except
as provided in 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 has not been correctly applied and a corrective
procedure has not been established;
Ii) The preventive control, the combination of preventive controls or the food
safety plan as a whole is considered ineffective; either
Iii) A review of the records in accordance with paragraph 117.165(a)(4) finds
that the records are not complete, the activities performed were not carried out
in accordance with the food safety plan, or appropriate decisions were not made
regarding 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 reoccur, evaluate all affected foods for
safety, and, when necessary, prevent affected foods from entering commerce as
they would later do. of a corrective procedure Paragraphs (a) (2) (i) to (iv) of
this section; and
Ii) Where appropriate, re-analyze the food safety plan in accordance with
section 117.170 to determine if modifications to the food safety plan are
necessary.
C) Corrections. It is not necessary 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 117.135(c)
(2)(i) or the sanitation controls in 117.135(c) (3) (I) or (ii); either
(2) You take action, in a timely manner, to identify and correct a minor,
isolated problem that does not directly affect the safety of the product.
D) Records. All corrective actions (and, if applicable, corrections) taken in
accordance with this section must be documented in records. These records are
subject to verification in accordance with 117.155(a)(3) and record review in
accordance with 117.165(a)(4)(i).

Second. 117.155 Verification.

A) Verification activities. Verification activities shall 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 117.160.
(2) Verification that monitoring is being carried out as required by 117.140
(and in accordance with 117.145).
(3) Verification that appropriate decisions on corrective actions are being made
as required by 117.140 (and in accordance with 117.150).
(4) Verification of implementation and effectiveness in accordance with 117.165;
and
(5) Reanalysis in accordance with 117.170.
B) Documentation. All verification activities performed in accordance with this
section must be documented in records.

Second. 117.160 Validation.

(A) You must validate that the preventive controls identified and implemented in
accordance with 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) Validation of preventive controls:
(1) Must be performed (or supervised) by a qualified preventive controls
individual:
(I) (A) Before implementation of the food safety plan; either
(B) When necessary to demonstrate that control measures can be implemented as
designed:
( 1 ) Within 90 calendar days after production of the applicable food begins;
either
( 2 ) Within a reasonable time, provided that the qualified preventive controls
individual prepares (or supervises the preparation of) a written justification
for a period of time that exceeds 90 calendar days after production of the
applicable food begins;
Ii) Whenever a change in a control measure or combination of control measures
could affect whether the control measure or combination of control measures,
when properly applied, will effectively control the hazards; and
Iii) Whenever a new analysis 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 inadequate, conducting studies) to
determine whether preventive controls, when properly implemented, will
effectively control hazards; and
(C) It is not necessary to validate:
(1) Food allergen controls in 117.135(c)(2);
(2) The sanitation controls in 117.135(c)(3);
(3) The recovery plan at 117.139;
(4) The supply chain program of subpart G of this part; and
(5) Other preventive controls, if the qualified individual preventive controls
prepare (or supervise the preparation of) a written justification that the
validation is not applicable based on factors such as the nature of the risk and
the nature of the preventive control and its function In the facility's food
safety system.

Second. 117.165 Verification of implementation and effectiveness.

A) Verification activities. You must verify that preventive controls are

consistently implemented and that they effectively and significantly minimize or
prevent hazards. To do this, you must carry out activities that include the
following, as appropriate for 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 control instruments and verification instruments (or
verification of their 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 that requires preventive control, by
collecting and testing environmental samples; and
(4) Review of the following records within specified time frames by (or under
the supervision of) a qualified preventive controls individual, to ensure that
the records are complete, the activities reflected in the records occurred in
accordance with the security plan Food, Preventive controls are effective and
appropriate decisions were made on corrective actions:
I) Records of surveillance and corrective action records within 7 business days
of creating the records or within a reasonable period of time, provided that
preventive controls prepare (or supervise the preparation of) a written
justification of a period greater than 7 days; and
(ii) calibration records, testing ( e.g., product testing, environmental
monitoring), supplier and supply chain verification activities, and other
verification activities within a reasonable time after the records have been
created; and
(5) Other activities appropriate for verification of implementation and
effectiveness.
B) Written procedures. As appropriate for 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 control instruments and
verification instruments (or verifying their accuracy) as required in paragraph
(a)(1) of this section.
(2) Product testing as required in paragraph (a)(2) of this section. The
procedures for testing the product must:
(I) Be scientifically valid;
(ii) Identify the test microorganism(s) or other analyte(s);
(Iii) Specify procedures for identifying samples, including their relationship
to specific lots of product;
Iv) Include sampling procedures, including the number of samples and sampling
frequency;
(V) Identify the tests performed, including the analytical method(s) used;
(Vi) Identify the laboratory that carries out the tests; and
(vii) Include corrective action procedures required by 117.150(a)(1).
(3) Environmental monitoring as required by paragraph (a)(3) of this section.
The procedures for environmental monitoring must:
(I) Be scientifically valid;
(ii) Identify the test microorganism(s);
(iii) Identify the locations where 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 time and frequency for collecting and testing samples. The
timing and frequency of collecting and testing samples must be appropriate to
determine whether preventive controls are effective;
(V) Identify the tests performed, including the analytical method(s) used;
(Vi) Identify the laboratory that carries out the tests; and
(vii) Include corrective action procedures required by 117.150(a)(1).

Second. 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 perform 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 carried out at your facility
creates a reasonable potential for a new risk 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 following an unforeseen food safety issue in accordance
with 117.150(b); and
(4) Whenever you find that a preventive control, a 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 necessary to address the identified hazard:
(1) Before any change in activities (including any change in preventive control)
at the facility is operational; either
(2) When necessary to demonstrate that control measures can be implemented as
designed:
(I) Within 90 calendar days following the start date of production of the
applicable food; either
(ii) Within a reasonable time, provided that the preventive controls prepared by
the person prepare (or supervise the preparation of) a written justification for
a period of time exceeding 90 calendar days after production of the applicable
food begins .
(D) You must review the written food safety plan if a significant change in
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 of There are no revisions necessary.
(E) A qualified preventive controls individual must perform (or supervise) the
reanalysis.
(F) You must conduct a reanalysis of the food safety plan when FDA determines
that it is necessary to respond to new hazards and developments in scientific
understanding.

Second. 117.180 Requirements applicable to a qualified preventive controls

individual and a qualified auditor.

(A) One or more preventive controls qualified individuals must do or supervise

the following:
(1) Preparation of food safety plan (117.126(a)(2));
(2) Validation of preventive controls (117.160(b)(1));
(3) Written justification for the validation to be carried out within a period
that exceeds the first 90 calendar days of production of the applicable food;
(4) Determination that validation is not necessary (117.160(c)(5));
(5) Review of records (117.165(a)(4));
(6) Written justification for the review of monitoring records and corrective
actions within a period exceeding 7 business days;
(7) Food safety plan reanalysis (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, within a time frame that exceeds
the first 90 days natural food production.
(B) A qualified auditor must conduct an on-site audit (117.435(a)).
(C) (1) To be a qualified preventive control individual, the individual must
have successfully completed training in the development and application of risk
based preventive controls at least equivalent to those received under a
standardized curriculum recognized as adequate. by the FDA or be otherwise
qualified through work experience to develop and implement a food safety system.
Work experience may qualify an individual to perform these functions if such
experience has provided an individual with knowledge at least equivalent to that
provided by 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 person must have technical expertise
obtained through education, training or experience (or a combination thereof)
necessary to perform the audit 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 ( s).

Second. 117.190 Implementation records required for this subpart.

(A) You must establish and maintain the following records documenting the
implementation of the food safety plan:
(1) Documentation, as required by 117.136(b), of the basis for not establishing
a preventive control in accordance with 117.136(a);
(2) Records documenting monitoring of preventive controls;
(3) Records documenting corrective actions;
(4) Records document verification, including, as applicable, those related to:
I) Validation;
II) Verification of follow-up;
(III) Verification of corrective actions;
(Iv) Calibration of process monitoring and verification instruments;
V) Product testing;
Vi) Environmental monitoring;
Vii) Examination of documents; and
viii) Reanalysis;
(5) Records documenting the supply chain program; and
(6) Records documenting 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

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

A) Attestations that must be presented. A qualified facility must submit the

Second. 117.206 Modified requirements that apply to a facility dedicated
exclusively to the storage of undisplayed packaged foods.

(A) If a facility that is engaged exclusively in the storage of undisplayed

packaged foods stores such refrigerated packaged foods that require time/temperature
control to minimize or significantly prevent the growth or production of toxins
by pathogens, the facility You must carry out the following appropriate
activities to ensure the effectiveness of temperature controls:
(1) Establish and implement adequate temperature controls to significantly
minimize or prevent the growth of, or production of toxins by, pathogens;
(2) Monitor temperature checks with appropriate frequency to ensure that
temperature checks are performed consistently;
(3) If there is a temperature loss control that may affect the safety of such
refrigerated packaged foods, take appropriate corrective measures to:
(I) Correct the problem and reduce the likelihood of the problem recurring;
(ii) Evaluate all affected foods for safety; and
(iii) Prevent food from entering commerce if you cannot ensure that 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) calibrate temperature monitoring and recording devices (or verify their
accuracy);
ii) examine the calibration records within a reasonable time after the records
have been created; and
(iii) Review monitoring records and corrective actions taken to correct a
problem with temperature control within 7 business days of creating the records
or within a reasonable time frame, provided preventive controls prepare (or
supervise) A written justification for a period that exceeds 7 business days;
(5) Establish and maintain the following records:
I) records (whether affirmative records demonstrating temperature control or
exception records demonstrate loss of temperature control) documenting oversight
of temperature controls of such refrigerated packaged foods;
(ii) Records of corrective actions taken when there is a loss of temperature
control that may affect the safety of any refrigerated packaged food; and
Iii) Records that document verification activities.
(B) The records that a facility must establish and maintain pursuant to
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

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

(A) FDA may withdraw a qualified facility exemption under 117.5(a):

(1) In the case of an active investigation of a foodborne illness outbreak that
is directly related to the qualified facility; either
(2) If the FDA determines that it is necessary to protect public health and
prevent or mitigate an outbreak of foodborne illness based on conditions or
conduct associated with the qualified facility that are materials for the safety
of manufactured, processed, packaged foods or maintained in said facility.
(B) Before FDA issues an order to withdraw a qualified facility exemption, FDA:
(1) May consider one or more actions to protect public health or mitigate a
foodborne illness outbreak, including a warning letter, recall, administrative
detention, suspension of registration, rejection of food offered for
importation, seizure, and injunction;
(2) You must notify the owner, operator, or agent in charge of the facility in
writing of the 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 to the FDA notification, within 15 calendar days
of the date of receipt of the notification; and
(3) You must consider actions taken by the facility to address circumstances
that may lead FDA to withdraw the exemption.

Second. 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). Such Director must approve
an order to withdraw the exemption before the order is issued.
(B) Any qualified officer or 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 withdrawing the exemption to the owner, operator, or
agent in charge of the facility.
(D) The FDA must issue an order to withdraw the exemption in writing, signed and
dated by the official or qualified employee of the FDA who is issuing the order.

Second. 117.257 Contents of an order to withdraw a qualified facility exemption.

An order to withdraw a qualified facility exemption under 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 leading FDA
to issue the order:
(1) An active investigation of a foodborne illness outbreak that is directly
linked to the facility; either
(2) Conditions or conduct associated with a qualified facility that is important
to the safety of food manufactured, processed, packaged , or held at such
facility.
(D) A statement that the facility must:
(1) Comply with subparts C and G of this part by the date that is 120 calendar
days after the date of receipt of the order, or within a reasonable time agreed
upon by FDA, based on written justification, For a period that exceeds 120
calendar days from the date of receipt of the order; either
(2) Appeal the order within 15 calendar days of the date of receipt of the order
in accordance with the requirements of 117.264.
(E) A statement that a facility may request that FDA reinstate an exemption that
was withdrawn following the procedures in 117.287;
(F) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and
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 117.270;
(H) The postal 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 from a foreign facility, the
same information For the Director of the Compliance Office of the Center for
Food Safety and Applied Nutrition); and
(I) The name and title of the FDA representative who approved the order.
[80 FR 56145, September 17, 2015, amended at 81 FR 3716, January 22, 2016]

Second. 117.260 Compliance with or appeal of an order to withdraw a qualified

facility exemption.

(A) If you receive an order under 117.254 to withdraw a qualified facility

exemption, you must:
(1) Comply with the applicable requirements of this part within 120 calendar
days of the date of receipt of the order, or within a reasonable time agreed
upon by FDA, based on written justification submitted to FDA, for a period
exceeding 120 calendar days from the date of receipt of the order; either
(2) Appeal the order within 15 calendar days of the date of receipt of the order
in accordance with the requirements of 117.264.
B) The filing of an appeal, including the filing of a request for an informal
hearing, will not operate to delay or suspend any administrative action,
including enforcement by the FDA, unless the Commissioner of Food and Drugs
determines in his discretion that the delay or stay is in the public interest.
(C) If you request the order, and FDA confirms the order:
(1) You must comply with the applicable requirements of this part within 120
calendar days of the date of receipt of the order, or within a reasonable time
agreed upon by FDA, based on written justification. Exceeds 120 calendar days
from the date of receipt of the order; and
(2) You are no longer subject to the modified requirements in 117.201.

Second. 117.264 Procedure for filing 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 of the Center for Food Safety and Applied Nutrition).
postal address, email address or fax number identified in the order within 15
calendar days following the date of receipt of the order confirmation; and
(2) Respond with particularity to the facts and matters contained in the order,
including any supporting documentation upon which you rely.
(B) In a written appeal of the order to withdraw a waiver provided under
117.5(a), you may include a written request for an informal hearing as provided
in 117.267.
[80 FR 56145, September 17, 2015, amended at 81 FR 3716, January 22, 2016]

Second. 117.267 Procedure for requesting an informal hearing.

(A) If you request the order, you:

(1) You may request an informal hearing; and
(2) You must submit any request for an informal hearing along with your written
appeal filed in accordance with 117.264 within 15 calendar days of the date you
receive the order.
B) A request for an informal hearing may be denied, in whole or in part, if the
president of the chamber determines that no real and substantial issue of
material fact has been raised by the material presented. If the presiding
officer determines that a hearing is not warranted, you will be given written
notice of the determination explaining the reason for the denial.

Second. 117.270 Requirements applicable to an informal hearing.

If you request an informal hearing, and the FDA grants the request:
(A) The hearing will be held within 15 calendar days from the date the appeal is
filed or, if applicable, within a time period agreed upon in writing by you and
the FDA.
(B) The President may require that a hearing conducted under this subpart be
completed within one 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 117.254 and 117.257, in lieu of
notice under 16.22(a) of this chapter, provides notice of opportunity for a
hearing under this section and forms part of the administrative record of the
regulatory hearing under 16.80. (A) of this chapter.
(2) The request for a hearing under this subpart must be directed to the
District Director of the FDA (or, in the case of a foreign facility, to the
Director of the Office of Compliance of the Center for Food Safety and Applied
Nutrition) The order to withdraw an exemption.
(3) Section 117.274, instead of 16.42(a) of this chapter, describes FDA
employees who preside over hearings under this subpart.
(4) Section 16.60(e) and (f) of this chapter do 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 chairperson must include as part of the hearing report a finding on
the credibility of witnesses (other than expert witnesses) when credibility is
an important issue and must include a proposed decision, accompanied by a
statement of reasons. The hearing participant The audience may review and
comment on the presiding officer's report within two calendar days of the
issuance of the report. The president 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 hearing officer's report and any comments on the hearing
participant's report under 117.270(c)(4) are part of the administrative record.
(6) No party shall have the right, under 16.119 of this chapter, to request the
Commissioner of Food and Drugs for reconsideration or a stay of the president'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
16.95(b) 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 16.80 (a) (1) through (3) and (a) (5) of this chapter
and 117.270 (c) (5) Record for the final decision of the president. For purposes
of judicial review under 10.45 of this chapter, the record of the administrative
proceeding consists of the hearing record and the final decision of the
presiding officer.

Second. 117.274 President of an appeal and for an informal hearing.

The presiding officer for an appeal, and for an informal hearing, must be a
program director from the Office of Regulatory Affairs or another senior FDA
official to an FDA District Director.
[82 FR 14146, March 17, 2017]

Second. 117.277 Deadline to issue 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
reversing the removal no later than 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 hearing
participants to review and submit comments on the hearing report under
117.270(c) ), and must issue a final decision within 10 calendar days after the
hearing is held; either
(2) If the FDA denies the hearing request, the presiding officer must issue a
final decision on the appeal confirming or reversing the recall within 10
calendar days of the date the appeal is filed.
Second. 117.280 Revocation of an order to withdraw a qualified facility
exemption.

An order to withdraw a qualified facility exemption is revoked if:

(A) appeal the order and request an informal hearing, the FDA grants the request
for an informal hearing, and the president does not confirm the order within 10
calendar days after the hearing or issues a decision revoking the order within
that date hour; either
(B) You will appeal the order and request an informal hearing, the FDA denies
the request for an informal hearing, and the FDA does not confirm the order
within 10 calendar days after the appeal is filed, or issues a decision revoking
the order. order within that time; either
(C) You will appeal the order without requesting an informal hearing, and the
FDA will not confirm the order within 10 calendar days after the appeal is
filed, or issue a decision revoking the order within that time.

Second. 117.284 Final agency action.

Confirmation of a removal order by the presiding officer is considered final

agency action for purposes of 5 USC 702.

Second. 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 at
the Center for Food Safety and Applied Nutrition) determines that a facility has
adequately resolved any problems with conditions and conduct that are material
to the safety of food manufactured, processed, packaged 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 at the Center for
Food Safety and Applied Nutrition) , on its own initiative or at the request of
a facility, restore the exemption.
(B) You may ask FDA to reinstate an exemption that has been withdrawn under the
procedures of this subpart as follows:
(1) Send a request, in writing, to the FDA District Director in whose district
your facility is located (or, in the case of a foreign facility, to the Director
of the Office of Compliance at the Center for Food Safety and Applied
Nutrition ) ; and
(2) Submit data and information to demonstrate that you have adequately resolved
problems related to conditions and conduct that are important to the safety of
foods manufactured, processed, packaged or held in your facilities, so that the
continued recall of the exemption is Not necessary to protect public health and
prevent or mitigate an outbreak of foodborne illness.
(C) If your exemption was withdrawn under 117.251(a)(1) and FDA later
determines, after completing the active investigation of a foodborne illness
outbreak, that the outbreak is not directly related to your facility, the FDA
will reinstate your exemption under 117.5(A), and FDA will notify you in writing
that your exempt status has been reinstated.
(D) If your exemption was withdrawn under terms 117.251(a)(1) and (2) and FDA
subsequently determines, after completing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to your
facility, AND you may ask FDA to reinstate your exemption under 117.5(a) in
accordance with the requirements of paragraph (b) of this section.

Subpart F - Requirements applicable to records that must be established and

maintained

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

(A) Except as provided in 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 117.310 apply only to the written food safety plan.
(C) The requirements of 117.305(b), (d), (e), and (f) do not apply to records
required by 117.201.

Second. 117.305 General requirements applicable to records.

Records must:
(A) True copies (such as photocopies, photographs, scanned copies, microfilm,
microfiche or other accurate reproductions of the original records) or
electronic records shall be maintained as original records;
B) It will contain the actual values and observations obtained during monitoring
and, where appropriate, during verification activities;
(C) Be accurate, indelible and legible;
(D) Be created simultaneously with the performance of the documented activity;
(E) Be as detailed as necessary to provide the history of the work performed;
and
(F) Include:
(1) Information adequate to identify the plant or facility ( for example,
name and, where necessary, the location of the plant or facility);
(2) The date and, where applicable, the timing of the documented activity;
(3) The signature or initials of the person carrying out the activity; and
(4) If applicable, the identity of the product and the batch code, if
applicable.
(G) Records that are established or maintained to satisfy the requirements of
this part and that meet the definition of electronic records in 11.3(b)(6) of
this chapter are exempt from the requirements of part 11 of this chapter.
Records that meet the requirements of this part, but are also required under
other applicable laws or regulations, remain subject to part 11 of this chapter.

Second. 117.310 Additional requirements applicable to the food safety plan.

The owner, operator or agent in charge of the facility must sign and date the
food safety plan:
A) Once the process is finished; and
(B) After any modification.

Second. 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) The records on which a facility relies during the 3-year period preceding
the applicable calendar year to support its status as a qualified facility must
be maintained at the facility as long as necessary to support a facility's
status as a qualified facility. qualified during the applicable calendar year.
B) Records relating to the general suitability of equipment or processes used by
a facility, including the results of scientific studies and evaluations, shall
be retained by the facility for at least 2 years after discontinuation (
the facility has updated the written food safety plan (117.126) or records
documenting validation of the written food safety plan (117.155(b)));
C) Except in the case of the food safety plan, off-record storage is permitted
if it can be retrieved and supplied on site within 24 hours of the official
review request. The food safety plan must remain in place. Electronic records
are considered on-site if they are accessible from a location on the site.
D) If the plant or facility is closed for an extended period, the food safety
plan may be transferred to another reasonably accessible location, but must be
returned to the plant or facility within 24 hours for official review upon
request. .

Second. 117.320 Requirements for official review.

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

Second. 117.325 Public disclosure.

Records obtained by FDA pursuant to this part are subject to the disclosure
requirements of part 20 of this chapter.

Second. 117.330 Use of existing records.

(A) Existing records ( for example, records maintained to comply with other
federal, state, or local regulations, or for any other reason) do not need to be
duplicated if they contain all required information and meet the requirements of
this Subpart. Existing records may be supplemented as necessary to include all
required information and satisfy the requirements of this subpart.
(B) The information required by this part need not be kept in a record set. If
existing records contain part of the required information, any new information
required by this part may be maintained separately or combined with existing
records.

Second. 117.335 Special requirements applicable to a written warranty.

(A) Any written warranty required by this part must contain the following
elements:
(1) Effective date;
(2) Printed names and signatures of authorized officials;
(3) The warranty applicable 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); either
(Vi) Section 117.430(e)(2);
(B) A written guarantee required under 117.136(a)(2), (3), or (4) must include:
(1) Acknowledgment that the facility providing the written warranty assumes
legal responsibility to act consistently with the warranty and document its
actions taken to satisfy the written warranty; and
(2) Provide that if the warranty is terminated in writing by either entity,
responsibility for compliance with the applicable provisions of this part
returns to the manufacturer/processor on the date of termination.

Subpart G - Supply Chain Program

Second. 117.405 Requirement to establish and implement a supply chain program.

(A)(1) Except as provided in 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 Receiver has
identified a hazard that requires control applied to the supply chain.
(2) A receiving facility that is an importer meets the foreign supplier
verification program requirements of part 1, subpart L of this chapter, and has
documentation of verification activities conducted under 1.506(e) of this
chapter. That the hazards requiring control applied to the supply chain for the
raw material or other ingredient have been significantly minimized or prevented)
do not need to perform supplier verification activities for that raw material or
other ingredient.
(3) The requirements of this subpart do not apply to foods that are supplied for
use in research or evaluation, provided that such foods:
(I) It is not intended for retail sale and is not sold or distributed to the
public;
(ii) Be labeled with the statement "Food for research or evaluation use";
(iii) It is supplied in a small quantity that is consistent with a research,
analysis or quality assurance purpose, the feed is used only for this purpose,
and any unused quantity is disposed of appropriately; and
(Iv) Be accompanied by documents, in accordance with commercial practice,
indicating 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 control not applied by the supply chain is applied by an entity other
than the supplier to the receiving facility ( for example, when a non-supplier
applies controls to certain products ( i.e., products covered by part 112 of
this chapter), Harvesting and packaging activities are under other direction),
the receiving facility must:
(1) Verify the control applied to the supply chain; either
(2) Obtain documentation of an appropriate verification activity from another
entity, review and evaluate the entity's applicable documentation, and document
that review and evaluation.
[80 FR 56145, September 17, 2015; 81 FR 3956, January 25, 2016]
Effective date Note:
To 80 FR 56145, September 17, 2015, 117.405 was added, effective November 16,
2015, except for paragraph (a)(2). FDA will publish a document in the Federal
Register announcing the effective date for this paragraph.

Second. 117.410 General requirements applicable to a supply chain program.

(A) The supply chain program must include:

(1) Use approved providers as required by 117.420;
(2) Determine appropriate supplier verification activities (including
determining the frequency of performance of the activity) as required in
117.425;
(3) Conduct supplier verification activities as required by 117.430 and 117.435;
(4) Document supplier verification activities as required by 117.475; and
(5) Where applicable, verifying a supply chain control applied by an entity
other than the receiving facility supplier and documenting such verification as
required in 117.475, or obtaining documentation of an appropriate verification
activity from another entity, reviewing and evaluating that documentation, AND
documenting the review and evaluation required by 117.475.
(B) The following are appropriate verification activities for suppliers of raw
materials and other ingredients:
(1) On-site audits;
(2) Sampling and testing of raw material or other ingredient;
(3) Review of relevant supplier food safety records; and
(4) Other appropriate supplier verification activities based on the supplier's
performance and the risk associated with the raw material or other ingredient.
C) The supply chain program must ensure that a hazard requiring control applied
to the supply chain has been significantly reduced or prevented.
(D)(1) Except as provided in paragraph (d)(2) of this section, in approving
suppliers and determining appropriate supplier verification activities and the
frequency with which they are conducted, consideration shall be given to the
following:
I) Food risk analysis, including the nature of the hazard controlled prior to
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 that
require a control applied to the supply chain;
(iii) Supplier performance, including:
(A) The supplier's procedures, processes and practices related to the safety of
raw materials 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 related to food safety and other FDA compliance measures. FDA
related to food safety (or, AND regulations of a country whose food safety
system has been officially recognized by the FDA as comparable or determined to
be equivalent to that of the United States and information relevant to
compliance with such laws and regulations by the supplier); and
(C) The supplier's food safety history related to the raw materials or other
ingredients that the receiving facility receives from the supplier, including
available information on the testing results of raw materials or other
ingredients for hazards, AND the supplier's responsiveness to correct problems;
and
Iv) Any other factors, as appropriate and necessary, such as storage and
transportation practices.
(2) Whereas the provider's performance may be limited to the provider's
compliance history as required in paragraph (d)(1)(iii)(B) of this section, if
the provider:
(I) A qualified facility as defined in 117.3;
(ii) A farm that grows produces and is not a farm covered under part 112 of this
chapter in accordance with 112.4(a), or in accordance with 112.4(b) and 112.5;
either
(iii) A producer of shell eggs that is not subject to the requirements of part
118 of this chapter because it has fewer than 3,000 laying hens.
(E) If the owner, operator, or agent in charge of a receiving facility
determines through audits, verification testing, document review, relevant
consumer, customer, or other complaints, or otherwise that the provider is not
controlling hazards that the receiving facility has identified As requiring
control applied to the supply chain, the receiving facility must take and
document immediate action in accordance with 117.150 to ensure that the
supplier's raw materials or other ingredients do not cause adulteration of the
food manufactured or processed by the receiving facility under section 402 of the
Federal Food, Drug, and Cosmetic Act or counterfeit brand under section 403(w)
of the Federal Food, Drug, and Cosmetic Act.

Second. 117.415 Responsibilities of the receiving

center.
(A) (1) The receiving facility must approve providers.
(2) Except as provided in 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 evaluates the entity's
applicable documentation and the documents they review and evaluate:
I) Establish written procedures to receive raw materials and other ingredients
by the entity;
(ii) Document that the entity is following written procedures to receive raw
materials and other ingredients; and
(iii) Determine, conduct or determine and conduct appropriate supplier
verification activities, with appropriate documentation.
(4) The supplier may perform 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. receiving facility reviews and
evaluates that documentation and the documents they review and evaluate.
(B) For purposes of this subpart, a receiving facility may not accept any of the
following as a provider verification activity:
(1) A determination by your supplier of the appropriate supplier verification
activities for that supplier;
(2) An audit performed by your supplier;
(3) A review by your supplier of that supplier's relevant food safety records;
either
(4) The conduct by your supplier of other appropriate supplier verification
activities for that supplier within the meaning of 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 supplier's audit was
performed by a qualified third-party auditor in accordance with 117.430(f) and
117.435.

Second. 117.420 Use of approved suppliers.

(A) Supplier approval. The receiving facility must approve suppliers in

accordance with the requirements of 117.410(d), and document that approval,
prior to receiving raw materials and other ingredients received from such
suppliers;
B) Written procedures for receiving raw materials and other ingredients.
Written procedures must be established and followed for receiving raw materials
and other ingredients;
(2) Written procedures for receiving raw materials and other ingredients must
ensure that raw materials and other ingredients are received only from approved
suppliers (or, where necessary and appropriate, temporarily from non-approved
suppliers whose raw materials or other ingredients ingredients are subject to
appropriate verification activities prior to acceptance for use); and
(3) The use of written procedures for receiving raw materials and other
ingredients must be documented.

Second. 117.425 Determination of appropriate supplier verification activities

(including determining the frequency of performance of the activity).

Appropriate supplier verification activities (including the frequency of

performance of the activity) must be determined in accordance with the
requirements of 117.410(d).

Second. 117,430 Carry out verification activities for suppliers of raw materials
and other ingredients.

(A) Except as provided in paragraphs (c), (d), or (e) of this section, one or
more of the supplier verification activities specified in 117.410(b), as set
forth in 117.410(d) For each supplier before using that supplier's raw material
or other ingredient and periodically thereafter.
(B) (1) Except as provided in paragraph (b) (2) of this section, when a hazard
in a raw material or other ingredient is controlled by the supplier and is one
for which there is a reasonable probability that the exposure to The hazard will
have serious consequences for the health or death of human beings:
(I) The appropriate supplier verification activity is an on-site audit of the
supplier; and
(ii) The audit must be carried out before using the raw material or other
ingredient of the supplier and at least once a year.
(2) The requirements of paragraph (b)(1) of this section do not apply if there
is a written determination that other less frequent verification and/or audit
activities at the supplier's site provide sufficient assurance that the hazards
are controlled. .
(C) If a provider is a qualified facility as defined in 117.3, the receiving
facility need not comply with paragraphs (a) and (b) of this section if the
receiving facility:
(1) Obtains written assurances that the provider is a qualified facility as
defined in 117.3:
(I) Before first approving the provider 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 assurances, at least every 2 years, that the supplier is
producing the raw material or other ingredient in accordance with applicable FDA
food safety regulations (or, where applicable, relevant FDA laws and
regulations). a country whose food safety system the FDA has officially
recognized as comparable or has determined to be equivalent to that of the
United States). The written guarantee must include:
(I) A brief description of the preventive controls that the supplier is
implementing to control the applicable hazard in the food; either
(ii) A statement that the facility complies with applicable federal, local,
county, tribal, or other non-federal food safety laws, including relevant laws
and regulations of foreign countries.
(D) If a supplier is a grow-produce farm and is not a farm covered under part
112 of this chapter in accordance with 112.4(a), or in accordance with 112.4(b)
and 112.5, the receiving facility need not comply. with paragraphs (a) and (b)
of this section for products that the receiving facility receives from the farm
as a raw material or other ingredient if the receiving facility:
(1) Obtain written assurances that the raw material or other ingredient provided
by the supplier is not subject to part 112 of this chapter in accordance with
112.4(a), or in accordance with 112.4(b) and 112.5:
(I) Before first approving the provider 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 assurances, 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, where applicable, that its food is subject to the laws and
regulations of a country whose food safety system is officially recognized by
the FDA as comparable or has been 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 fewer than 3,000 laying hens, the
receiving facility need not comply with paragraphs (a) and (b) From this section
if the receiving facility:
(1) Obtains written assurances that shell eggs produced by the supplier are not
subject to part 118 because the shell egg producer has fewer than 3,000 laying
hens:
(I) Before first approving the provider 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 assurances, at least every two years, that the producer of
shell eggs acknowledges that its food is subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, where applicable, Federal Laws). and
regulations of a country whose food safety system has been officially recognized
by the FDA as comparable or determined to be equivalent to that of the United
States).
(F) There must be no financial conflicts of interest that influence the results
of the verification activities listed in section b) of article 117.410 and the
payment must not be related to the results of the activity.

Second. 117,435 On-site audit.

(A) An on-site audit of a supplier must be performed by a qualified auditor.

(B) If the supplier's raw material or other ingredient is subject to one or more
FDA food safety regulations, an on-site audit must consider such regulations and
include a review of the supplier's written plan ( e.g., Hazard Analysis and
HACCP Critical Control Points) or any other food safety plan, and its
implementation, for the controlled risk (or, where applicable, an on-site audit
may consider the relevant laws and regulations of a country whose safety system
officially recognized as comparable OR determined to be equivalent to that of
the United States).
(C) (1) The following may be substituted for an on-site audit, provided that the
inspection was carried out within one year of the date the on-site audit would
have been required:
(I) The written results of an appropriate inspection of the supplier for
compliance with applicable FDA food safety regulations by the FDA, by
representatives of other Federal Agencies (such as the United States Department
of Agriculture), or by representatives of local tribal authorities, tribal, or
territorial agencies; either
(ii) For a foreign supplier, the written results of an inspection by the FDA or
the food safety authority of a country whose food safety system has been
officially recognized by the FDA as comparable or determined to be equivalent to
that of the United States.
(2) In the case of inspections carried out by the food safety authority of a
country whose food safety system is officially recognized by the FDA as
comparable or determined equivalent, the food that is the subject of the on-site
audit must be within the scope of official recognition or Equivalence, and the
foreign supplier must be in, and under the regulatory supervision of, such
country.
(D) If the on-site audit is conducted exclusively to meet the requirements of
this subpart, by an audit agent of a certification body accredited in accordance
with the regulations of part 1, subpart M of this chapter, the audit is not
subject to the requirements in said regulations.
Effective date Note:
To 80 FR 56145, September 17, 2015, 117.435 was added, effective November 16,
2015, except for paragraph (d). FDA will publish a document in the Federal
Register announcing the effective date for this paragraph.

Second. 117,475 Records documenting the supply chain program.

(A) 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 117.165(a)(4).
(C) The receiving facility shall 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 complies with
the foreign supplier verification program requirements of part 1, subpart L of
this chapter, including documentation of verification activities conducted under
1.506(e) ) of this chapter;
(3) Documentation of a provider's approval;
(4) written procedures for receiving raw materials and other ingredients;
(5) Documentation demonstrating the use of written procedures to receive raw
materials and other ingredients;
(6) Documentation of the determination of appropriate supplier verification
activities for raw materials and other ingredients;
(7) Documentation of the completion of an on-site audit. This documentation must
include:
(I) The name of the supplier subject to the on-site audit;
Ii) Documentation of audit procedures;
Iii) The dates on which the audit was carried out;
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 performed by a qualified auditor;
(8) Documentation of sampling and testing performed as a supplier verification
activity. This documentation must include:
I) Identification of the raw material or other ingredient tested (including
batch number, as applicable) and the number of samples tested;
Ii) Identification of the tests carried out, including the analytical method(s)
used;
Iii) the date or dates on which the tests were carried out and the date of the
report;
Iv) the results of the tests;
V) Corrective measures taken in response to the detection of hazards; and
Vi) Information that identifies the laboratory that performs the tests;
(9) Documentation of review of relevant supplier food safety records. This
documentation must include:
(I) The name of the provider whose records were reviewed;
(ii) The review date(s);
Iii) The general nature of the documents examined;
Iv) The conclusions of the review; and
V) Corrective measures taken in response to significant deficiencies identified
during the review;
(10) Documentation of other appropriate supplier verification activities based
on the supplier's performance and the risk associated with the raw material or
other ingredient;
(11) Documentation of any determination that verification activities other than
an on-site audit and/or less frequent on-site audit of a supplier, provide
adequate assurance that hazards are controlled when a hazard in a raw material
or other ingredient will be controlled by Supplier and is one for which there is
a reasonable probability that exposure to the hazard will result in serious
health consequences or death to humans;
(12) The following documentation of an alternative verification activity for a
supplier that is a qualified facility:
(I) Written assurance that the provider is a qualified facility as defined in
117.3, prior to approving the provider and on an annual basis thereafter; and
(ii) Written assurance that the supplier is producing the raw material or other
ingredient in accordance with applicable FDA food safety regulations (or, where
applicable, the relevant laws and regulations of a country whose food safety
system officially recognized as comparable or 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
that is not a farm covered under Part 112 of this chapter:
(I) Written assurance that the provider is not a farm covered under Part 112 of
this chapter in accordance with 112.4(a), or in accordance with 112.4(b) and
112.5, prior to approving the provider and upon a annual basis thereafter; and
(ii) Written assurance that the farm acknowledges that its food is subject to
section 402 of the Federal Food, Drug, and Cosmetic Act (or, where applicable,
that its food is subject to the applicable laws and regulations of a country
whose food safety system the FDA has officially recognized as comparable or
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 producer of shell eggs that is not subject to the
requirements established in part 118 of this chapter because it has fewer than
3,000 laying hens:
I) Written assurance that shell eggs provided by the supplier are not subject to
part 118 of this chapter because the supplier has fewer than 3,000 laying hens,
prior to 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,
where applicable, its food is subject to the laws and relevant regulations of a
country whose Safety System the FDA has officially recognized as comparable or
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 the FDA, by
representatives of other Federal Agencies (such as the United States Department
of Agriculture), or by representatives of the State, , or territorial agencies,
or the food safety authority of another country when the results of such
inspection are replaced by an on-site audit;
(16) Documentation of actions taken regarding supplier nonconformity;
(17) Documentation of verification of a supply chain control applied by an
entity other than the supplier of the receiving facility; and
(18) Where applicable, documentation of the receiving facility's review and
evaluation of:
(I) Applicable documentation from an entity other than the receiving facility
that written procedures are followed to receive raw materials and other
ingredients;
Ii) Applicable documentation, from an entity other than the receiving facility,
of the determination of appropriate verification activities for suppliers of raw
materials and other ingredients;
(iii) Applicable documentation, from an entity other than the receiving
facility, of carrying out appropriate verification activities for suppliers of
raw materials and other ingredients;
(Iv) Applicable documentation, from your supplier, of:
 (A) The results of sampling and testing performed by the supplier; either
(B) The results of an audit performed by a qualified third-party auditor in
accordance with 117.430(f) and 117.435; and
V) Applicable documentation, from an entity other than the receiving facility,
of verification activities when a control applied by the supply chain is applied
by an entity other than the supplier of the receiving facility.
Effective date Note:
To 80 FR 56145 September 17, 2015, 117,475 was added, effective November 16. of
2015, except for paragraph (c) (2). FDA will publish a document in the Federal
Register announcing the effective date of this paragraph.

Authority: 21 USC 331, 342, 343, note 350d, 350g, note 350g, 371, 374; 42 USC 243,
264, 271.
Source: 80 FR 56145, September 17, 2015, unless otherwise noted.
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Last update: 08/14/2017