The following words and terms, when used in this subchapter,
have the following meanings, unless the context clearly indicates
otherwise. Those definitions and interpretations of terms of the Texas
Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter
431, are also applicable when used in this subchapter.
(1) Acid foods or acidified foods--Foods that have
an equilibrium pH of 4.6 or below.
(2) Act--Texas Food, Drug, and Cosmetic Act, Texas
Health and Safety Code, Chapter 431.
(3) Adequate--That which is needed to accomplish the
intended purpose in keeping with good public health practice.
(4) Adulterated --Has the meaning as defined in the
Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code,
(5) Affiliate--Any facility that controls, is controlled
by, or is under common control with another facility.
(6) Allergen cross-contact--The unintentional incorporation
of a food allergen into a food.
(7) Approved source--A supplier of food that complies
with applicable state and federal laws and is licensed, if required,
and inspected by the regulatory authority having jurisdiction over
the processing and distribution of food.
(8) Audit--The systematic, independent, and documented
examination (through observation, investigation, records review, discussions
with employees of the audited entity, and, as appropriate, sampling
and laboratory analysis) to assess a supplier's food safety processes
(9) Batter--A semifluid substance, usually composed
of flour and other ingredients, into which principal components of
food are dipped or with which they are coated, or which may be used
directly to form bakery foods.
(10) Blanching (except for tree nuts and peanuts)--A
prepackaging heat treatment of foodstuffs for an adequate time and
at a sufficient temperature to partially or completely inactivate
the naturally occurring enzymes and to effect other physical or biochemical
changes in the food.
(11) Calendar day--Every day shown on the calendar.
(12) Cleaning--Physical removal of dirt (soil) from
surfaces which includes the use of clean water and detergent.
(13) Conventional handwashing--The washing of hands
that relies on hot running water of at least 100 degrees Fahrenheit
and a hand cleaning agent to cleanse the hands.
(14) Conventional handwashing sink--A lavatory, trough
basin, or vessel for washing, a wash basin, or plumbing fixture especially
placed for use in personal hygiene and designed only for washing hands
that relies on hot running water of at least 100 degrees Fahrenheit
and a hand cleaning agent to cleanse the hands.
(15) Correction--An action to identify and correct
a problem that occurred during the production of food, without other
actions associated with a corrective action procedure (such as actions
to reduce the likelihood that the problem will recur, evaluate all
affected food for safety, and prevent affected food from entering
(16) Corrosion Resistant Material--A material that
maintains acceptable surface cleanability characteristics under prolonged
influence of a food to be contacted, the normal use of cleaning compounds
and sanitizing solutions, and other conditions of the use environment.
(17) Critical control point--A point, step, or procedure
in a food process at which control can be applied and is essential
to prevent or eliminate a food safety hazard or reduce such hazard
to an acceptable level.
(18) Defect action level--A level of a non-hazardous,
naturally occurring, unavoidable defect at which a food product may
be regarded as "adulterated" and subject to enforcement action under
Texas Health and Safety Code, §431.081(a)(3).
(19) Environmental pathogen--A pathogen capable of
surviving and persisting within the manufacturing, processing, packing,
or holding environment such that food may be contaminated and may
result in foodborne illness if that food is consumed without treatment
to significantly minimize the environmental pathogen. Examples of
environmental pathogens for the purposes of this subchapter include Listeria monocytogenes and Salmonella spp. But
do not include the spores of pathogenic sporeforming bacteria.
(A) A person who manufactures, wholesales, or otherwise
holds food and is subject to the requirements of Texas Health and
Safety Code, Chapter 431.
(B) A domestic facility or a foreign facility that
is required to register under the Federal Food, Drug, and Cosmetic
Act, §415 in accordance with the requirements of 21 Code of Federal
Regulations Part 1, Subpart H.
(A) Primary production farm. A primary production farm
is an operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or
any combination of these activities. The term "farm" includes operations
that, in addition to these activities:
(i) Pack or hold raw agricultural commodities;
(ii) Pack or hold processed food, provided that all
processed food used in such activities is either consumed on that
farm or another farm under the same management, or is processed food
identified in clause (iii)(II)(-a-) of this subparagraph; and
(iii) Manufacture/process food, provided that:
(I) All food used in such activities is consumed on
that farm or another farm under the same management; or
(II) Any manufacturing/processing of food that is not
consumed on that farm or another farm under the same management consists
(-a-) Drying/dehydrating raw agricultural commodities
to create a distinct commodity (such as drying/dehydrating grapes
to produce raisins), and packaging and labeling such commodities,
without additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
(-b-) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and packaging
and labeling treated raw agricultural commodities, without additional
(-c-) Packaging and labeling raw agricultural commodities,
when these activities do not involve additional manufacturing/processing
(an example of additional manufacturing/processing is irradiation);
(B) Secondary activities farm. A secondary activities
farm is an operation, not located on a primary production farm, devoted
to harvesting (such as hulling or shelling), packing, and/or holding
of raw agricultural commodities, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the raw
agricultural commodities harvested, packed, and/or held by the secondary
activities farm owns, or jointly owns, a majority interest in the
secondary activities farm. A secondary activities farm may also conduct
those additional activities allowed on a primary production farm as
described in subparagraph (A)(ii) and (iii) of this paragraph.
(22) FDA--The Food and Drug Administration.
(23) Food--A raw, cooked, or processed edible substance,
ice, beverage, chewing gum or ingredient used or intended for use
or for sale in whole or in part for human consumption, including raw
(24) Food allergen--A major food allergen is:
(A) Milk, egg, fish (e.g., bass, flounder, or cod),
Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(B) A food ingredient that contains protein derived
from a food specified in subparagraph (A) of this paragraph, except
(i) Any highly refined oil derived from a food specified
in subparagraph (A) of this paragraph, and any ingredient derived
from such highly refined oil.
(ii) A food ingredient that is exempt under United
States Code Title 21 Chapter 9, Subchapter IV, §343(w)(6) and
(25) Food-contact surfaces--Those surfaces that contact
human food and those surfaces from which drainage onto the food or
onto surfaces that contact the food ordinarily occurs during the normal
course of operations. "Food-contact surfaces" includes utensils and
food-contact surfaces of equipment.
(26) Full-time equivalent employee--Is a term used
to represent the number of employees of a business entity for the
purpose of determining whether the business qualifies for the small
business exemption. The number of full-time equivalent employees is
determined by dividing the total number of hours of salary or wages
paid directly to employees of the business entity and of all of its
affiliates and subsidiaries by the number of hours of work in 1 year,
2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole
number, round down to the next lowest whole number.
(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
(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
(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.