| (47) Preventive controls individual--An individual
who has successfully completed training in the development and application
of risk-based preventive controls at least equivalent to that received
under a standardized curriculum recognized as adequate by FDA or is
otherwise qualified through job experience to develop and apply a
food safety system.
(48) Processed food--Any food other than a raw agricultural
commodity and includes any raw agricultural commodity that has been
subject to processing, such as but not limited to, canning, cooking,
freezing, dehydration, or milling.
(49) Processing--Including, but not limited, to the
preparing, blending, filtering, preserving, treating, changing into
different market forms, manufacturing, packing, repacking, or labeling
of food ingredients and or products.
(50) Qualified auditor--A person who is an individual
as defined in this part and has technical expertise obtained through
education, training, or experience (or a combination thereof) necessary
to perform the auditing function as required by 21 Code of Federal
Regulations §117.180(c)(2). Examples of potential qualified auditors
include:
(A) a government employee, including a foreign government
employee; and
(B) an audit agent of a certification body that is
accredited in accordance with regulations in 21 CFR, Part 1, Subpart
M.
(51) Qualified end-user--With respect to a food, the
consumer of the food (where the term consumer does not include a business);
or a restaurant or retail food establishment (as those terms are defined
in this) section that:
(A) is located:
(i) in the same State or the same Indian reservation
as the qualified facility that sold the food to such restaurant or
establishment; or
(ii) not more than 275 miles from such facility; and
(B) is purchasing the food for sale directly to consumers
at such restaurant or retail food establishment.
(52) Qualified facility--(When including the sales
by 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 apply:
(A) during the 3-year period preceding the applicable
calendar year, the average annual monetary value of the food manufactured,
processed, packed or held at such facility that is sold directly to
qualified end-users (as defined in this section) during such period
exceeded the average annual monetary value of the food sold by such
facility to all other purchasers; and
(B) 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.
(53) Qualified facility exemption--An exemption applicable
to a qualified facility under 21 Code of Federal Regulations §117.5(a).
(54) Qualified individual--A person who has the education,
training, or experience (or a combination thereof) necessary to manufacture,
process, pack, or hold clean and safe food as appropriate to the individual's
assigned duties. A qualified individual may be, but is not required
to be, an employee of the establishment.
(55) Quality control operation--A planned and systematic
procedure for taking all actions necessary to prevent food from being
adulterated.
(56) Raw agricultural commodity--Any food in its raw
or natural state, including all fruits that are washed, colored, or
otherwise treated in their unpeeled natural form prior to marketing.
(57) Ready-to-eat food (RTE food)--Any food that is
normally eaten in its raw state or any other food, including a processed
food, for which it is reasonably foreseeable that the food will be
eaten without further processing that would significantly minimize
biological hazards.
(58) Receiving facility--A facility that is subject
to 21 Code of Federal Regulations Part 117 Subparts C and G and that
manufactures/processes a raw material or other ingredient that it
receives from a supplier.
(59) Restaurant--A facility that prepares and sells
food directly to consumers for immediate consumption. "Restaurant"
does not include facilities that provide food to interstate conveyances,
central kitchens, and other similar facilities that do not prepare
and serve food directly to consumers. Entities in which food is provided
to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food
establishments, food stands, saloons, taverns, bars, lounges, catering
facilities, hospital kitchens, day 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.
Cont'd... |
