| (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);
(G) grinding/cracking/crushing/milling baked goods
(e.g., crackers), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated
fruit and vegetable products (e.g., raisins and dried legumes), dried/dehydrated
herb and spice products (e.g., intact dried basil), grains (e.g.,
oats, rice, rye, wheat), other fruit and vegetable products (e.g.,
dried, pitted dates), other grain products (e.g., dried cereal), other
herb and spice products (e.g., chopped dried herbs), peanuts and tree
nuts, and peanut and tree nut products (e.g., roasted peanuts);
(H) labeling baked goods that do not contain food allergens,
candy that does not contain food allergens, cocoa beans (roasted),
cocoa products that do not contain food allergens), coffee beans (roasted),
game meat jerky, gums/latexes/resins that are processed foods, honey
(pasteurized), jams/jellies/preserves, milled grain products that
do not contain food allergens (e.g., corn meal) or that are single-ingredient
foods (e.g., wheat flour, wheat bran), molasses and treacle, oils,
other fruit and vegetable products that do not contain food allergens
(e.g., snack chips made from potatoes or plantains), other grain products
that do not contain food allergens (e.g., popcorn), other herb and
spice products (e.g., chopped or ground dried herbs), peanut or tree
nut products, (provided that they are single-ingredient, or are in
forms in which the consumer can reasonably be expected to recognize
the food allergen(s) without label declaration, or both (e.g., roasted
or seasoned whole nuts, single-ingredient peanut or tree nut flours)),
processed seeds for direct consumption, soft drinks and carbonated
water, sugar, syrups, trail mix and granola (other than those containing
milk chocolate and provided that peanuts and/or tree nuts are in forms
in which the consumer can reasonably be expected to recognize the
food allergen(s) without label declaration), vinegar, and any other
processed food that does not require time/temperature control for
safety and that does not contain food allergens (e.g., vitamins, minerals,
and dietary ingredients (e.g., bone meal) in powdered, granular, or
other solid form);
(I) making baked goods from milled grain products (e.g.,
breads and cookies);
(J) making candy from peanuts and tree nuts (e.g.,
nut brittles), sugar/syrups (e.g., taffy, toffee), and saps (e.g.,
maple candy, maple cream);
(K) making cocoa products from roasted cocoa beans;
(L) making dried pasta from grains;
(M) making jams, jellies, and preserves from acid fruits
and vegetables with a pH of 4.6 or below;
(N) making molasses and treacle from sugar beets and
sugarcane;
(O) making oat flakes from grains;
(P) making popcorn from grains;
(Q) making snack chips from fruits and vegetables (e.g.,
making plantain and potato chips);
(R) making soft drinks and carbonated water from sugar,
syrups, and water;
(S) making sugars and syrups from fruits and vegetables
(e.g., dates), grains (e.g., rice, sorghum), other grain products
(e.g., malted grains such as barley), saps (e.g., agave, birch, maple,
palm), sugar beets, and sugarcane;
(T) making trail mix and granola from cocoa products
(e.g., chocolate), dried/dehydrated fruit and vegetable products (e.g.,
raisins), other fruit and vegetable products (e.g., chopped dried
fruits), other grain products (e.g., oat flakes), peanut and tree
nut products, and processed seeds for direct consumption, provided
that peanuts, tree nuts, and processed seeds are treated to significantly
minimize pathogens;
(U) making vinegar from fruits and vegetables, other
fruit and vegetable products (e.g., fruit wines, apple cider), and
other grain products (e.g., malt);
(V) mixing baked goods (e.g., types of cookies), candy
(e.g., varieties of taffy), cocoa beans (roasted), coffee beans (roasted),
dried/dehydrated fruit and vegetable products (e.g., dried blueberries,
dried currants, and raisins), dried/dehydrated herb and spice products
(e.g., dried, intact basil and dried, intact oregano), honey (pasteurized),
milled grain products (e.g., flour, bran, and corn meal), other fruit
and vegetable products (e.g., dried, sliced apples and dried, sliced
peaches), other grain products (e.g., different types of dried pasta),
other herb and spice products (e.g., chopped or ground dried herbs,
dried herb- or spice-infused honey, and dried herb- or spice-infused
oils and/or vinegars), peanut and tree nut products, sugar, syrups,
vinegar, and any other processed food that does not require time/temperature
control for safety (e.g., vitamins, minerals, and dietary ingredients
(e.g., Cont'd... |
