| care kitchens, and nursing home
kitchens are restaurants.
(60) Retail food establishment--An establishment that
sells food products directly to consumers as its primary function.
The term "retail food establishment" includes facilities that manufacture,
process, pack, or hold food if the establishment's primary function
is to sell from that establishment food, including food that it manufactures,
processes, packs, or holds, directly to consumers. A retail food establishment's
primary function is to sell food directly to consumers if the annual
monetary value of sales of food products directly to consumers exceeds
the annual monetary value of sales of food products to all other buyers.
The term "consumers" does not include businesses. A "retail food establishment"
includes grocery stores, convenience stores, and vending machine locations.
A "retail food establishment" also includes certain farm-operated
businesses selling food directly to consumers as their primary function.
(A) Sale of food directly to consumers from an establishment
located on a farm includes sales by that establishment directly to
consumers:
(i) At a roadside stand (a stand situated on the side
of or near a road or thoroughfare at which a farmer sells food from
his or her farm directly to consumers) or farmers' market (a location
where one or more local farmers assemble to sell food from their farms
directly to consumers);
(ii) Through a community supported agriculture program.
Community supported agriculture (CSA) program means a program under
which a farmer or group of farmers grows food for a group of shareholders
(or subscribers) who pledge to buy a portion of the farmer's crop(s)
for that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms,
including door-to-door sales; mail, catalog and Internet order, including
online farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(B) Sale of food directly to consumers by a farm-operated
business includes the sale of food by that farm-operated business
directly to consumers:
(i) At a roadside stand (a stand situated on the side
of or near a road or thoroughfare at which a farmer sells food from
his or her farm directly to consumers) or farmers' market (a location
where one or more local farmers assemble to sell food from their farms
directly to consumers);
(ii) Through a community supported agriculture program.
Community supported agriculture (CSA) program means a program under
which a farmer or group of farmers grows food for a group of shareholders
(or subscribers) who pledge to buy a portion of the farmer's crop(s)
for that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms,
including door-to-door sales; mail, catalog and Internet order, including
online farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(C) For the purposes of this definition, "farm-operated
business" means a business that is managed by one or more farms and
conducts manufacturing/processing not on the farm(s).
(61) Rework--Clean, unadulterated food that has been
removed from processing for reasons other than insanitary conditions
or that has been successfully reconditioned by reprocessing and that
is suitable for use as food.
(62) Safe-moisture level--A level of moisture low enough
to prevent the growth of undesirable microorganisms in the finished
product under the intended conditions of manufacturing, processing,
packing, 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 that demonstrate that the food at or below the
given (aw ) will not support the growth
of undesirable microorganisms.
(63) Sanitize--Following cleaning, a process to treat
a clean surface that is effective in destroying vegetative cells of
pathogens, and in substantially reducing numbers of other undesirable
microorganisms, but without adversely affecting the product or its
safety for the consumer.
(64) Significantly minimize--To reduce to an acceptable
level, including to eliminate.
(65) Small business--For purposes of this subchapter,
a business employing fewer than 500 full-time equivalent employees.
(66) Subsidiary--Any company which is owned or controlled
directly or indirectly by another company.
(67) Supplier--The establishment that manufactures/processes
the food, raises the animal, or grows the food that is provided to
a receiving facility without further manufacturing/processing by another
establishment, except for further manufacturing/processing that consists
solely of the addition of labeling or similar activity of a de minimis
nature.
(68) Supply-chain-applied control--A preventive control
for a hazard in a raw material or other ingredient when the hazard
in the raw material or other ingredient is controlled before its receipt.
(69) Time/Temperature Control for Safety (TCS) food--(formerly
Potentially Hazardous Food (PHF)), A food that requires time/temperature
control for safety to limit pathogenic microorganism growth or toxin
formation. An animal based food that is raw or heat-treated. A plant
based food that is heat-treated or consists of raw seed sprouts, cut
melons, cut leafy greens, cut tomatoes or mixture of cut tomatoes
that are not modified in a way so that they are unable to support
pathogenic microorganism growth or toxin formation, or garlic-in-oil
mixtures that are not modified in a way so that they are unable to
support pathogenic microorganism growth or toxin formation. Except
as specified in Tables A and B of this paragraph, a food that because
of the interaction of aw and pH values
is designated as requiring scientific and technical evidence that
a control measure or combination of control measures, when properly
implemented, effectively controls the identified hazards:
(A) Table A.
Attached Graphic
(B) Table B.
Attached Graphic
(70) Undesirable microorganisms--Includes those microorganisms
that are pathogens, that subject food to decomposition, that indicate
that food is contaminated with filth, or that otherwise may cause
food to be adulterated.
(71) Unexposed packaged food--Packaged food that is
not exposed to the environment.
(72) Validation--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.
(73) Verification--The application of methods, procedures,
tests and other evaluations, in addition to monitoring, to determine
whether a control measure or combination of control measures is or
has been operating as intended and to establish the validity of the
food safety plan.
(74) Very small business--For purposes of this subchapter,
a business (including any 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 market value of human food manufactured, processed, packed,
or held without sale (e.g., held for a fee).
(75) Water activity (aw )--A
measure of the free moisture in a food. The quotient of the water
vapor pressure of the substance divided by the vapor pressure of pure
water at the same temperature.
(76) Written procedures for receiving raw materials
and other ingredients--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, on a temporary
basis from unapproved suppliers whose raw materials or other ingredients
are subjected to adequate verification activities before acceptance
for use).
(77) You--For purposes of this subchapter, the owner,
operator, or agent in charge of a facility.
|
