| (36) Modified atmosphere packaging--A method of packaging
food in which the atmosphere of a package of food is modified so that
its composition is different from air, which contains 21% oxygen,
but the atmosphere may change over time due to the permeability of
the packaging material or the respiration of the food. Modified atmosphere
packaging includes: reduction in the proportion of oxygen, total replacement
of oxygen, removal of air, or an increase in the proportion of other
gases such as carbon dioxide or nitrogen.
(37) Monitor--To conduct a planned sequence of observations
or measurements to assess whether control measures are operating as
intended.
(38) Non-Time/Temperature Control for Safety (TCS)
food (NTCS)--(formerly non-Potentially Hazardous Food (non-PHF)) An
air-cooled hard-boiled egg with shell intact, or an egg with shell
intact that is not hard-boiled, but has been pasteurized to destroy
all viable salmonella. A food in an
unopened hermetically sealed container that is commercially processed
to achieve and maintain commercial sterility under conditions of non-refrigerated
storage and distribution. A food that because of its pH or aw value, or interaction of a
w and pH values, is designated as a NTCS food in Tables A and
B in §229.211(69). A food that is not designated as a NTCS food
in Tables A and B in §229.211(69) and for which there is scientific
and technical evidence that a control measure or combination of control
measures, when properly implemented, effectively controls the identified
hazards in such a manner that growth or toxin formation of pathogenic
microorganisms that are reasonably likely to occur in that food, is
precluded due to either:
(A) intrinsic factors including added or natural characteristics
of the food such as preservatives, antimicrobials, humectants, acidulants,
or nutrients;
(B) extrinsic factors including environmental or operational
factors that affect the food such as packaging, modified atmosphere
such as reduced oxygen packaging, shelf life and use, or temperature
range of storage and use;
(C) a combination of intrinsic and extrinsic factors;
or
(D) a food that does not support the growth of or toxin
formation of pathogenic microorganisms in accordance with one or more
of the conditions above in this definition even though the food may
contain a pathogenic microorganism or chemical or physical contaminant
at a level sufficient to cause illness or injury.
(39) Nonprofit food establishment--A charitable entity
that prepares or serves food directly to the consumer or otherwise
provides food or meals for consumption by humans in the United States.
The term includes central food banks, soup kitchens, and nonprofit
food delivery services. To be considered a nonprofit food establishment,
the establishment must meet the terms of the U.S. Internal Revenue
Code (26 United States Code §501(c)(3)).
(40) Packaging--(when used as a verb) Placing food
into a container that directly contacts the food and that the consumer
receives.
(41) Packing--Placing food into a container other than
packaging the food and also includes re-packing and activities performed
incidental to packing or re-packing a food (e.g., activities performed
for the safe or effective packing or re-packing of that food such
as sorting, culling, grading, and weighing or conveying incidental
to packing or re-packing), but does not include activities that transform
a raw agricultural commodity into a processed food.
(42) Pathogen--A microorganism of public health significance.
(43) Pests--Any objectionable animal or insect including,
but not limited to, birds, rodents, flies, and larvae.
(44) Plant--The building or structure, or parts thereof,
used for or in connection with the manufacturing, processing, packaging,
labeling, or holding of human food.
(45) pH--(Potential of Hydrogen) A measure of the degree
of the acidity or the alkalinity of a solution.
(46) Preventive controls--Those risk-based, procedures,
practices, and processes that a person knowledgeable about the safe
manufacturing, processing, packing, or holding of food would employ
to significantly minimize or prevent the hazards identified under
the hazard analysis that are consistent with the current scientific
understanding of safe food manufacturing, processing, packing, or
holding at the time of the analysis.
(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 Cont'd... |
