| (a) Except as provided by 21 Code of Federal Regulations
Part 117 Subparts E, C and G does not apply to a qualified facility.
Qualified facilities are subject to the modified requirements in 21
Code of Federal Regulations, §117.201.
(b) 21 Code of Federal Regulations Part 117 Subparts
C and G do not apply with respect to activities that are subject to
21 Code of Federal Regulations Part 123, Fish and Fishery Products,
at a facility if you are required to comply with, and are in compliance
with, Part 123 with respect to such activities.
(c) 21 Code of Federal Regulations Part 117 Subparts
C and G of this part do not apply with respect to activities that
are subject to 21 Code of Federal Regulations Part 120, Hazard Analysis
and Critical Control Point (HACCP) Systems, at a facility if you are
required to comply with, and are in compliance with, Part 120 with
respect to such activities.
(d) Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers.
(1) 21 Code of Federal Regulations Part 117 Subparts
C and G do not apply with respect to activities that are subject to
21 Code of Federal Regulations Part 113, Thermally Processed Low-Acid
Foods Packaged in Hermetically Sealed Containers, at a facility if
you are required to comply with, and are in compliance with 21 Code
of Federal Regulations Part 113 with respect to such activities.
(2) The exemption in paragraph (1) of this subsection
is applicable only with respect to the microbiological hazards that
are regulated under 21 Code of Federal Regulations Part 113.
(e) 21 Code of Federal Regulations Part 117 Subparts
C and G do not apply to any facility with regard to the manufacturing,
processing, packaging, or holding of a dietary supplement that is
in compliance with the requirements of 21 Code of Federal Regulations
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements, and the Federal
Food, Drug, and Cosmetic Act, §761, Serious Adverse Event Reporting
for Dietary Supplements.
(f) 21 Code of Federal Regulations Part 117 Subparts
C and G of do not apply to activities of a facility that are subject
to the Federal Food, Drug, and Cosmetic Act, §419, Standards
for Produce Safety.
(g) Low Risk packing or holding activity/food combinations.
(1) The exemption in paragraph (3) of this subsection
applies to packing or holding of processed foods on a farm mixed-type
facility, except for processed foods produced by drying/dehydrating
raw agricultural commodities 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
commodities, without additional manufacturing/processing (such as
chopping and slicing), the packing and holding of which are within
the "farm" definition in §229.211 of this title (relating to
Definitions). Activities that are within the "farm" definition, when
conducted on a farm mixed-type facility, are not subject to the requirements
of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore,
do not need to be specified in the exemption.
(2) For the purposes of paragraph (3) of this subsection
and subsection (h)(3) of this section, the following terms describe
the foods associated with the activity/food combinations. Several
foods that are fruits or vegetables are separately considered for
the purposes of these activity/food combinations (i.e., coffee beans,
cocoa beans, fresh herbs, peanuts, sugarcane, sugar beets, tree nuts,
seeds for direct consumption) to appropriately address specific hazards
associated with these foods and/or processing activities conducted
on these foods.
(A) Dried/dehydrated fruit and vegetable products includes
only those processed food products such as raisins and dried legumes
made without additional manufacturing/processing beyond drying/dehydrating,
packaging, and/or labeling.
(B) Other fruit and vegetable products includes those
processed food products that have undergone one or more of the following
processes: acidification, boiling, canning, coating with things other
than wax/oil/resin, cooking, cutting, chopping, grinding, peeling,
shredding, slicing, or trimming. Examples include flours made from
legumes (such as chickpea flour), pickles, and snack chips made from
potatoes or plantains. Examples also include dried fruit and vegetable
products made with additional manufacturing/processing (such as dried
apple slices; pitted, dried plums, cherries, and apricots; and sulfited
raisins). This category does not include dried/dehydrated fruit and
vegetable products made without additional manufacturing/processing
as described in subparagraph (A) of this paragraph. This category
also does not include products that require time/temperature control
for safety (such as fresh-cut fruits and vegetables).
(C) Peanut and tree nut products includes processed
food products such as roasted peanuts and tree nuts, seasoned peanuts
and tree nuts, and peanut and tree nut flours.
(D) Processed seeds for direct consumption include
processed food products such as roasted pumpkin seeds, roasted sunflower
seeds, and roasted flax seeds.
(E) Dried/dehydrated herb and spice products includes
only processed food products such as dried intact herbs made without
additional manufacturing/processing beyond drying/dehydrating, packaging,
and/or labeling.
(F) Other herb and spice products includes those processed
food products such as chopped fresh herbs, chopped or ground dried
herbs (including tea), herbal extracts (e.g., essential oils, extracts
containing more than 20 percent ethanol, extracts containing more
than 35 percent glycerin), dried herb- or spice-infused honey, and
dried herb or spice-infused oils and/or vinegars. This category does
not include dried/dehydrated herb and spice products made without
additional manufacturing/processing beyond drying/dehydrating, packaging,
and/or labeling as described in subparagraph (E) of this paragraph.
This category also does not include products that require time/temperature
control for safety, such as fresh herb-infused oils.
(G) Grains include barley, dent or flint-corn, sorghum,
oats, rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for
oil extraction (such as cotton seed, flax seed, rapeseed, soybeans,
and sunflower seed).
(H) Milled grain products include processed food products
such as flour, bran, and corn meal.
(I) Baked goods include processed food products such
as breads, brownies, cakes, cookies, and crackers. This category does
not include products that require time/temperature control for safety,
such as cream-filled pastries.
(J) Other grain products include processed food products
such as dried cereal, dried pasta, oat flakes, and popcorn. This category
does not include milled grain products as described in subparagraph
(H) of this paragraph or baked goods as described in subparagraph
(I) of this paragraph.
(3) 21 Code of Federal Regulations Part 117 Subparts
C and G do not apply to on-farm packing or holding of food by a small
or very small business, and 21 Code of Federal Regulations §117.201
does not apply to on-farm packing or holding of food by a very small
business, if the only packing and holding activities subject to the
Federal Food, Drug, and Cosmetic Act, §418 that the business
conducts are the following low-risk packing or holding activity/food
combinations-i.e., packing (or re-packing) (including weighing or
conveying incidental to packing or re-packing); sorting, culling,
or grading incidental to packing or storing; and storing (ambient,
cold and controlled atmosphere) of:
(A) baked goods (e.g., bread and cookies);
(B) candy (e.g., hard candy, fudge, maple candy, maple
cream, nut brittles, taffy, and toffee);
(C) cocoa beans (roasted);
(D) cocoa products;
(E) coffee beans (roasted);
(F) game meat jerky;
(G) gums, latexes, and resins that are processed foods;
(H) honey (pasteurized);
(I) jams, jellies, and preserves;
(J) milled grain products (e.g., flour, bran, and corn
meal);
(K) molasses and treacle;
(L) oils (e.g., olive oil and sunflower seed oil);
(M) other fruit and vegetable products (e.g., flours
made from legumes; pitted, dried fruits; sliced, dried apples; snack
chips);
(N) other grain products (e.g., dried pasta, oat flakes,
and popcorn);
(O) other herb and spice products (e.g., chopped or
ground dried herbs, herbal extracts);
(P) peanut and tree nut products (e.g., roasted peanuts
and tree nut flours);
(Q) processed seeds for direct consumption (e.g., roasted
pumpkin seeds);
(R) soft drinks and carbonated water;
(S) sugar;
(T) syrups (e.g., maple syrup and agave syrup);
(U) trail mix and granola;
(V) vinegar; and
(W) any other processed food that does not require
time/temperature control for safety (e.g., vitamins, minerals, and
dietary ingredients (e.g., bone meal) in powdered, granular, or other
solid form).
(h) Low risk manufacturing/processing activity/food
combinations.
(1) The exemption in paragraph (3) of this subsection
applies to manufacturing/processing of foods on a farm mixed-type
facility, except for manufacturing/processing that is within the "farm"
definition. Drying/dehydrating raw agricultural commodities 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 commodities, without additional manufacturing/processing
(such as chopping and slicing), are within the "farm" definition.
In addition, treatment to manipulate ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and packaging
and labeling the treated raw agricultural commodities, without additional
manufacturing/processing, is within the "farm" definition. In addition,
coating intact fruits and vegetables with wax, oil, or resin used
for the purpose of storage or transportation is within the "farm"
definition. Activities that are within the "farm" definition, when
conducted on a farm mixed-type facility, are not subject to the requirements
of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore,
do not need to be specified in the exemption.
(2) The terms in subsection (g)(2) of this section
describe certain foods associated with the activity/food combinations
in paragraph (3) of this subsection.
(3) 21 Code of Federal Regulations Part 117 Subparts
C and G do not apply to on-farm manufacturing/processing activities
conducted by a small or very small business for distribution into
commerce, and 21 Code of Federal Regulations §117.201 does not
apply to on-farm manufacturing/processing activities conducted by
a very small business for distribution into commerce, if the only
manufacturing/processing activities subject to the Federal Food, Drug,
and Cosmetic Act, §418 that the business conducts are the following
low-risk manufacturing/processing activity/food combinations:
(A) boiling gums, latexes, and resins;
(B) chopping, coring, cutting, peeling, pitting, shredding,
and slicing acid fruits and vegetables that have a pH less than 4.2
(e.g., cutting lemons and limes), baked goods (e.g., slicing bread),
dried/dehydrated fruit and vegetable products (e.g., pitting dried
plums), dried herbs and other spices (e.g., chopping intact, dried
basil), game meat jerky, gums/latexes/resins, other grain products
(e.g., shredding dried cereal), peanuts and tree nuts, and peanut
and tree nut products (e.g., chopping roasted peanuts);
(C) coating dried/dehydrated fruit and vegetable products
(e.g., coating raisins with chocolate), other fruit and vegetable
products except for non-dried, non-intact fruits and vegetables (e.g.,
coating dried plum pieces, dried pitted cherries, and dried pitted
apricots with chocolate are low-risk activity/food combinations but
coating apples on a stick with caramel is not a low-risk activity/food
combination), other grain products (e.g., adding caramel to popcorn
or adding seasonings to popcorn provided that the seasonings have
been treated to significantly minimize pathogens, peanuts and tree
nuts (e.g., adding seasonings provided that the seasonings have been
treated to significantly minimize pathogens), and peanut and tree
nut products (e.g., adding seasonings provided that the seasonings
have been treated to significantly minimize pathogens);
(D) drying/dehydrating (that includes additional manufacturing
or is performed on processed foods) other fruit and vegetable products
with pH less than 4.2 (e.g., drying cut fruit and vegetables with
pH less than 4.2), and other herb and spice products (e.g., drying
chopped fresh herbs, including tea);
(E) extracting (including by pressing, by distilling,
and by solvent extraction) from dried/dehydrated herb and spice products
(e.g., dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables
(e.g., olives, avocados), grains (e.g., oilseeds), and other herb
and spice products (e.g., chopped fresh mint, chopped dried mint);
(F) freezing acid fruits and vegetables with pH less
than 4.2 and other fruit and vegetable products with pH less than
4.2 (e.g., cut fruits and vegetables);
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