| (27) Harvesting--Applies to farms and farm mixed-type
facilities and means activities that are traditionally performed on
farms for the purpose of removing raw agricultural commodities from
the place they were grown or raised and preparing them for use as
food. Harvesting is limited to activities performed on raw agricultural
commodities, or on processed foods created by drying/dehydrating a
raw agricultural commodity without additional manufacturing/processing,
on a farm. Harvesting does not include activities that transform a
raw agricultural commodity into a processed food. Examples of harvesting
include cutting (or otherwise separating) the edible portion of the
raw agricultural commodity from the crop plant and removing or trimming
part of the raw agricultural commodity (e.g., foliage, husks, roots
or stems). Examples of harvesting also include cooling, field coring,
filtering, gathering, hulling, removing stems and husks from, shelling,
sifting, threshing, trimming of outer leaves of, and washing raw agricultural
commodities grown on a farm.
(28) Hazard--Any biological, chemical (including radiological),
or physical agent that has the potential to cause illness or injury.
(29) Hazard requiring a preventive control--A known
or reasonably foreseeable hazard for which a person knowledgeable
about the safe manufacturing, processing, packing, or holding of food
would, based on the outcome of a hazard analysis (which includes an
assessment of the severity of the illness or injury if the hazard
were to occur and the probability that the hazard will occur in the
absence of preventive controls), establish one or more preventive
controls to significantly minimize or prevent the hazard in a food
and components to manage those controls (such as monitoring, corrections
or corrective actions, verification, and records) as appropriate to
the food, the facility, and the nature of the preventive control and
its role in the facility's food safety system.
(30) Holding--Storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating
food during storage, and drying/dehydrating raw agricultural commodities
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). Holding also includes activities
performed as a practical necessity for the distribution of that food
(such as blending of the same raw agricultural commodity and breaking
down pallet loads), but does not include activities that transform
a raw agricultural commodity into a processed food. Holding facilities
could include warehouses, cold storage facilities, storage silos,
grain elevators, and liquid storage tanks.
(31) Known or reasonably foreseeable hazard--A biological,
chemical (including radiological), or physical hazard that is known
to be, or has the potential to be, associated with the facility or
the food.
(32) Lot--Food produced during a period of time and
identified by an establishment's specific code.
(33) Manufacturing/processing--Making food from one
or more ingredients, or synthesizing, preparing, treating, modifying
or manipulating food, including food crops or ingredients. Examples
of manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating
raw agricultural commodities to create a distinct commodity (such
as drying/dehydrating grapes to produce raisins), evaporating, eviscerating,
extracting juice, formulating, freezing, grinding, homogenizing, irradiating,
labeling, milling, mixing, packaging (including modified atmosphere
packaging), pasteurizing, peeling, rendering, treating to manipulate
ripening, trimming, washing, or waxing. For farms and farm mixed-type
facilities, manufacturing/processing does not include activities that
are part of harvesting, packing, or holding.
(34) Microorganisms--Yeasts, molds, bacteria, viruses,
protozoa, and microscopic parasites and includes species that are
pathogens.
(35) Mixed-type facility--An establishment that engages
in both activities that are exempt from registration under Federal
Food, Drug, and Cosmetic Act, §415 and activities that require
the establishment to be registered. An example of such a facility
is a "farm mixed-type facility," which is an establishment that is
a farm, but also conducts activities outside the farm definition that
require the establishment to be registered.
(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.
Cont'd... |
