Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 1 - General Regulations, Definitions, Permits, Registration, Machinery, Equipment and Utensils, Premises and Buildings, Temperature Control › Section VI-101 - Definitions [formerly paragraph 6:001]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless otherwise specifically provided
				herein, the following words and terms used in this Chapter of the
Sanitary Code
, and all other Chapters which are adopted or may
				be adopted, are defined for the purposes thereof as follows.
Adulterated Foods, Filth,
and
Contamination
-are defined in
				  R.S.
				  40:607.
Advertisement
-includes all representations
				  of fact or opinion disseminated to the public in any manner or by any means
				  other than by the labeling.
Bakery
-any establishment operating to
				  manufacture any bread or bread products, pies, cakes, cookies, crackers,
				  doughnuts, or other similar products.
CCP
-see
Critical Control
				  Point
.
Confirmed Positive Test Result
-any result
				  obtained from a laboratory test of an ingredient, equipment, container, or
				  finished product that indicates the presence of an adulterant, as defined by
				  R.S.
				  40:607 et seq., in excess of any tolerance
				  specified in state or federal law or regulations.
Control
-to manage the conditions of an
				  operation to maintain compliance with established criteria,
control
also means that correct procedures are being followed
				  and criteria are being met.
Control Measure
-any action or activity that
				  can be used to prevent, eliminate, or reduce a significant
hazard
that is managed as a
critical control
				  point
.
Control Point
-any step at which biological,
				  chemical or physical factors can be controlled.
Corrective Action
-procedures followed when a
deviation
occurs.
Cosmetic
-includes all substances and
				  preparations intended for cleansing, altering the appearance of, or promoting
				  the attractiveness of a person. The term includes soaps only when medicinal or
				  curative qualities are claimed by the use thereof.
Critical Control Point (CCP)
-a step at which
control
can be applied and is essential to prevent or
				  eliminate a
food
,
drug
, or
cosmetic
safety
hazard
or reduce it to an
				  acceptable level.
Critical Limit
-the value(s) to which a
				  biological, chemical or physical parameter must be controlled at a
CCP
to prevent, eliminate or reduce to an acceptable level the
				  occurrence of a
food
,
drug
, or
cosmetic
safety
hazard
.
Dba
-the actual or juridical person whose
				  name and address appear on the label of a product as the responsible party for
				  said product.
Deviation
-a failure to meet a
critical limit
.
Device
-includes all substances and
				  preparations intended for use in diagnosis, treatment or prevention of disease
				  in man or beast, or intended to affect the structure of any function of the
				  body.
Drug
-includes all substances and
				  preparations recognized in the official compendium, as herein defined. It
				  includes all substances and preparations intended for use in the diagnosis,
				  treatment or prevention of disease in man or beast, and all substances and
				  preparations, other than food and cosmetics, intended to affect the structure
				  or any function of the body.
Factory
-any establishment operating to
				  manufacture, process, can, bottle, pack, or hold any food, drug or cosmetic
				  unless covered by other specific provisions of this state sanitary code.
Food
-includes all substances and
				  preparations used for, or entering into the composition of food, drink,
				  confectionery, chewing gum, condiment, for consumption by humans or other
				  animals and includes water and alcoholic beverages.
Food Processing Plant
-a commercial operation
				  that manufactures
food
for human consumption and does not
				  provide
food
directly to a consumer from that location. Such
				  term shall not include a commercial operation that produces raw agricultural
				  commodities and whose end product remains a raw agricultural product.
GMP
-see
good manufacturing
				  practices
.
Good Manufacturing Practices
-practices,
				  methods, and controls used in the manufacturing, processing, packing or holding
				  of
foods
,
drugs
or
cosmetics
that comply with the requirements in this Part and for
foods
,
				  with 21 CFR 110.10,
				  110.19,
				  110.20,
				  110.35,
				  110.37,
				  110.40,
				  110.80,
				  and
				  110.93,
				  to assure that
foods
,
drugs
or
cosmetics
for human consumption or use are safe and have been
				  prepared, packed and held under sanitary conditions.
HAACP
-see
hazard analysis critical
				  control point
.
HAACP Plan
-the written document which is
				  based upon the principles of
HACCP
and which delineates the
				  procedures to be followed.
HACCP System
-the implemented
HACCP
				  plan
and
pre-requisite programs
including any other
				  applicable requirements.
Hazard
-a biological, chemical, radiological
				  or physical agent that is reasonably likely to cause illness or injury in the
				  absence of its
control
.
Hazard Analysis Critical Control Point
				  (HAACP)
-a systematic approach to the identification, evaluation and
				  control of significant
food
,
drug
, or
cosmetic
safety
hazards
.
Label
-the principal display or displays of
				  written, printed or graphic matter upon any food, drug device, or cosmetic, or
				  the immediate container, thereof, or upon the outside container or wrapper, if
				  any, of the retail package of any food, drug, device or cosmetic.
Labeling
-includes all labels and other
				  written, printed and graphic matter in any form whatsoever, accompanying any
				  food, drug, device or cosmetic.
LSPC
-Louisiana State Plumbing Code, i.e.,
				  Part XIV (Plumbing) of this Code (LAC 51:XIV).
Manufacturing Confectionary
-any
				  establishment operating to manufacture any candy, either plain, chocolate or
				  chocolate coated, mixed with nuts, fruits, or other fillers, covered with
				  chocolate or other coatings and shaped, molded or formed in various
				  shapes.
Medical Opinion
-the opinion, within their
				  respective fields, of the practitioners of any branch of the medical
				  profession, the practice of which is licensed by law in this state.
Monitor
-to conduct a planned sequence of
				  observations or measurements to assess whether a
CCP
is under
				  control or to assess the conditions and practices of all required
Pre-Requisite Programs (PPs)
and to produce an accurate record
				  for future use in
verification
.
Offal
-waste parts, especially of a butchered
				  animal, including but not limited to bones, cartilage, fatty tissue and
				  gristle.
Out-of-State Soft Drink
-those items meeting
				  the definition of
soft drink
in §1101. A of this Part and
				  bearing a dba statement whose address is outside of the state of
				  Louisiana.
Patent
or
Proprietary
				  Medicine
-trademarks, registered or unregistered, consisting of word or
				  words, device, symbol, brand or logo which serves to designate the source or
				  origin of the drug or drug product.
Plant
-the building or buildings or plants
				  thereof, used for or in connection with the manufacturing, processing,
				  packaging, labeling, or holding of food products.
PP
-see
Pre-Requisite
				  Program
.
Pre-Requisite Program (PP)
-procedures,
				  including
good manufacturing practices
, that address
				  operational conditions providing the foundation for the
HACCP
				  system
.
Product Category
-classification of products
				  subject to registration into one of five groups: milk and dairy products (M),
				  seafood products (S), other foods and beverages (F), drugs (D), cosmetics (C),
				  or prophylactics (P). These categories are exclusive of items defined as
out-of-state soft drinks
.
Sanitize
-adequate treatment of surfaces by a
				  process that will destroy vegetative cells of pathogenic bacteria and will
				  substantially reduce other microorganisms. Such treatment shall not adversely
				  affect products and shall be safe and non-toxic.
Scientific Opinion
-the opinion, within their
				  respective fields, of competent pharmacologists, physiologists or
				  toxicologists. [R.S.
				  40:602 (12)]
State Health Officer
-the legally appointed
				  or acting State Health Officer of the Department of Health and Hospitals having
				  jurisdiction over the entire state of Louisiana, and includes his/her duly
				  authorized representative in accordance with
				  R.S.
				  40:4 and
				  40:5.
Validation
-the element of
verification
focused on collecting and evaluating scientific
				  and technical information to determine whether the
HACCP plan
,
				  when properly implemented, will effectively control the
hazards
.
Verification
-those activities, other than
monitoring
, that determine the validity of the
HACCP
				  plan
and that the system is operating according to the
				  plan.
AUTHORITY NOTE: The
				  first source of authority for promulgation of the sanitary code is in
				  R.S.
				  36:258(B), with more
				  particular provisions found in Chapters 1 and 4 of Title 40 of the Louisiana
				  Revised Statutes. This Part is promulgated in accordance with
				  R.S.
				  40:4(A)(1)(a) and
				  R.S.
				  40:5(2)(3)(5)(8)(15)(17)(19)(21).
				  Also see
				  R.S. 40:601 et
				  seq.