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AN ACT relating to adulterated food. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 217.015 is amended to read as follows: 3
For the purposes of KRS 217.005 to 217.215: 4
(1) "Advertisement" means all representations, disseminated in any manner or by any 5
means, other than by labeling, for the purpose of inducing, or which are likely to 6
induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; 7
(2) "Bread" and "enriched bread" mean only the foods commonly known and described 8
as white bread, white rolls, white buns, enriched white bread, enriched rolls, and 9
enriched white buns, as defined under the federal act. For the purposes of KRS 10
217.136 and 217.137, "bread" or "enriched bread" also means breads that may 11
include vegetables or fruit as an ingredient; 12
(3) "Cabinet" means the Cabinet for Health and Family Services or its designee; 13
(4) "Color" means but is not limited to black, white, and intermediate grays; 14
(5) "Color additive" means a material that: 15
(a) Is a dye, pigment, or other substance made by a process of synthesis or similar 16
artifice, or extracted, isolated, or otherwise derived, with or without 17
intermediate or final change of identity, from a vegetable, animal, mineral, or 18
other source. Nothing in this paragraph shall be construed to apply to any 19
pesticide chemical, soil or plant nutrient, or other agricultural chemical solely 20
because of its effect in aiding, retarding, or otherwise affecting, directly or 21
indirectly, the growth or other natural physiological process of produce of the 22
soil and thereby affecting its color, whether before or after harvest; or 23
(b) When added or applied to a food, drug, or cosmetic, or to the human body or 24
any part thereof, is capable, alone or through reaction with another substance, 25
of imparting color. "Color additive" does not include any material that has 26
been or may in the future be exempted under the federal act; 27 UNOFFICIAL COPY 25 RS BR 119
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(6) "Contaminated with filth" means any food, drug, device, or cosmetic that is not 1
securely protected from dust, dirt, and as far as may be necessary by all reasonable 2
means, from all foreign or injurious contaminants; 3
(7) "Cosmetic" means: 4
(a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, 5
or otherwise applied to the human body or any part thereof for cleansing, 6
beautifying, promoting attractiveness, or altering the appearance; and 7
(b) Articles intended for use as a component of those articles, except that the term 8
shall not include soap; 9
(8) "Device," except when used in subsection (48) of this section, KRS 217.035(6), 10
KRS 217.065(3), KRS 217.095(3), and KRS 217.175(10), means instruments, 11
apparatus, and contrivances, including their components, parts, and accessories, 12
intended: 13
(a) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease 14
in man or other animals; or 15
(b) To affect the structure or any function of the body of man or other animals; 16
(9) "Dispense" means to deliver a drug or device to an ultimate user or research subject 17
by or pursuant to the lawful order of a practitioner, including the packaging, 18
labeling, or compounding necessary to prepare the substance for that delivery; 19
(10) "Dispenser" means a person who lawfully dispenses a drug or device to or for the 20
use of an ultimate user; 21
(11) "Drug" means: 22
(a) Articles recognized in the official United States pharmacopoeia, official 23
homeopathic pharmacopoeia of the United States, or official national 24
formulary, or any supplement to any of them; 25
(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or 26
prevention of disease in man or other animals; 27 UNOFFICIAL COPY 25 RS BR 119
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(c) Articles, other than food, intended to affect the structure or any function of the 1
body of man or other animals; and 2
(d) Articles intended for use as a component of any article specified in this 3
subsection but does not include devices or their components, parts, or 4
accessories; 5
(12) "Enriched," as applied to flour, means the addition to flour of vitamins and other 6
nutritional ingredients necessary to make it conform to the definition and standard 7
of enriched flour as defined under the federal act; 8
(13) "Environmental Pesticide Control Act of 1972" means the Federal Environmental 9
Pesticide Control Act of 1972, Pub. L. 92-516, and all amendments thereto; 10
(14) "Fair Packaging and Labeling Act" means the Fair Packaging and Labeling Act as it 11
relates to foods and cosmetics, 15 U.S.C. secs. 1451 et seq., and all amendments 12
thereto; 13
(15) "Federal act" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301 14
et seq., 52 Stat. 1040 et seq., or amendments thereto; 15
(16) "Filled milk" means any milk, cream, or skimmed milk, whether or not condensed, 16
evaporated, concentrated, frozen, powdered, dried, or desiccated, to which has been 17
added, or which has been blended or compounded with, any fat or oil other than 18
milk fat, except the fat or oil of contained eggs and nuts and the fat or oil of 19
substances used for flavoring purposes only, so that the resulting product is an 20
imitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or 21
frozen desserts, whether or not condensed, evaporated, concentrated, frozen, 22
powdered, dried, or desiccated, whether in bulk or in containers, hermetically 23
sealed or unsealed. This definition does not mean or include any milk or cream 24
from which no part of the milk or butter fat has been extracted, whether or not 25
condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has 26
been added any substance rich in vitamins, nor any distinctive proprietary food 27 UNOFFICIAL COPY 25 RS BR 119
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compound not readily mistaken for milk or cream or for condensed, evaporated, 1
concentrated, powdered, dried, or desiccated milk or cream, if the compound is 2
prepared and designed for the feeding of infants or young children, sick or infirm 3
persons, and customarily used on the order of a physician, and is packed in 4
individual containers bearing a label in bold type that the contents are to be used for 5
those purposes; nor shall this definition prevent the use, blending, or compounding 6
of chocolate as a flavor with milk, cream, or skimmed milk, desiccated, whether in 7
bulk or in containers, hermetically sealed or unsealed, to or with which has been 8
added, blended or compounded no other fat or oil other than milk or butter fat; 9
(17) "Flour" means only the foods commonly known as flour, white flour, wheat flour, 10
plain flour, bromated flour, self-rising flour, self-rising white flour, self-rising 11
wheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour, 12
defined under the federal act; 13
(18) "Food" means: 14
(a) Articles used for food or drink for man or other animals; 15
(b) Chewing gum; and 16
(c) Articles used for components of any such article; 17
(19) "Food additive" means any substance the intended use of which results or may be 18
reasonably expected to result, directly or indirectly, in its becoming a component or 19
otherwise affecting the characteristics of any food, including any substance 20
intended for use in producing, manufacturing, packing, processing, preparing, 21
treating, packaging, transporting, or holding food; and including any source of 22
radiation intended for any of these uses, if the substance is not generally 23
recognized, among experts qualified by scientific training and experience to 24
evaluate its safety, as having been adequately shown through scientific procedures 25
or, in the case of a substance used in a food prior to January 1, 1958, through either 26
scientific procedures or experience based on common use in food to be safe under 27 UNOFFICIAL COPY 25 RS BR 119
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the conditions of its intended use; except that the term does not include: 1
(a) A pesticide chemical in or on a raw agricultural commodity; 2
(b) A pesticide chemical to the extent that it is intended for use or is used in the 3
production, storage, or transportation of any raw agricultural commodity; 4
(c) A color additive; or 5
(d) Any substance used in accordance with a sanction or approval granted prior to 6
the enactment of the Food Additives Amendment of 1958, pursuant to the 7
federal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.; 8
or the Meat Inspection Act of 1907; and amendments thereto; 9
(20) "Food processing establishment" means any commercial establishment in which 10
food is manufactured, processed, or packaged for human consumption, but does not 11
include retail food establishments, home-based processors, or home-based 12
microprocessors; 13
(21) "Food service establishment" means any fixed or mobile commercial establishment 14
that engages in the preparation and serving of ready-to-eat foods in portions to the 15
consumer, including but not limited to: restaurants; coffee shops; cafeterias; short 16
order cafes; luncheonettes; grills; tea rooms; sandwich shops; soda fountains; 17
taverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding 18
establishments; private, public or nonprofit organizations or institutions routinely 19
serving food; catering kitchens; commissaries; charitable food kitchens; or similar 20
places in which food is prepared for sale or service on the premises or elsewhere 21
with or without charge. It does not include food vending machines, establishments 22
serving beverages only in single service or original containers, or retail food stores 23
which only cut, slice, and prepare cold-cut sandwiches for individual consumption; 24
(22) "Food storage warehouse" means any establishment in which food is stored for 25
subsequent distribution; 26
(23) "Immediate container" does not include package liners; 27 UNOFFICIAL COPY 25 RS BR 119
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(24) "Imminent health hazard" means a significant threat or danger to health that is 1
considered to exist when there is evidence sufficient to show that a product, 2
practice, circumstance, or event creates a situation that requires immediate 3
correction or cessation of operation to prevent illness or injury based on: 4
(a) The number of potential illnesses or injuries; or 5
(b) The nature, severity, and duration of the anticipated illness or injury; 6
(25) "Interference" means threatening or otherwise preventing the performance of lawful 7
inspections or duties by agents of the cabinet during all reasonable times of 8
operation; 9
(26) "Label" means a display of written, printed, or graphic matter upon the immediate 10
container of any article; and a requirement made by or under authority of KRS 11
217.005 to 217.215 that any word, statement, or other information appearing on the 12
label shall not be considered to be complied with unless the word, statement, or 13
other information also appears on the outside container or wrapper, if any there be, 14
of the retail package of the article, or is easily legible through the outside container 15
or wrapper; 16
(27) "Labeling" means all labels and other written, printed, or graphic matter: 17
(a) Upon an article or any of its containers or wrappers; or 18
(b) Accompanying the article; 19
(28) "Legend drug" means a drug defined by the Federal Food, Drug and Cosmetic Act, 20
as amended, and under which definition its label is required to bear the statement 21
"Caution: Federal law prohibits dispensing without prescription."; 22
(29) "Meat Inspection Act" means the Federal Meat Inspection Act, 21 U.S.C. secs. 71 23
et seq., 34 Stat. 1260 et seq., including any amendments thereto; 24
(30) "New drug" means: 25
(a) Any drug the composition of which is such that the drug is not generally 26
recognized among experts qualified by scientific training and experience to 27 UNOFFICIAL COPY 25 RS BR 119
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evaluate the safety of drugs as safe for use under the conditions prescribed, 1
recommended, or suggested in the labeling thereof; or 2
(b) Any drug the composition of which is such that the drug, as a result of 3
investigations to determine its safety for use under prescribed conditions, has 4
become so recognized, but which has not, otherwise than in the investigations, 5
been used to a material extent or for a material time under the conditions; 6
(31) "Official compendium" means the official United States pharmacopoeia, official 7
homeopathic pharmacopoeia of the United States, official national formulary, or 8
any supplement to any of them; 9
(32) "Person" means an individual, firm, partnership, company, corporation, trustee, 10
association, or any public or private entity; 11
(33) "Pesticide chemical" means any substance that alone in chemical combination, or in 12
formulation with one or more other substances, is an "economic poison" within the 13
meaning of the Federal Insecticide, Fungicide and Rodenticide Act and 14
amendments thereto, and that is used in the production, storage, or transportation of 15
raw agricultural commodities; 16
(34) "Poultry Products Inspection Act" means the Federal Poultry and Poultry Products 17
Inspection Act, 21 U.S.C. secs. 451 et seq., Pub. L. 85-172, 71 Stat. 441, and any 18
amendments thereto; 19
(35) "Practitioner" means medical or osteopathic physicians, dentists, chiropodists, and 20
veterinarians who are licensed under the professional licensing laws of Kentucky to 21
prescribe and administer drugs and devices. "Practitioner" includes optometrists 22
when administering or prescribing pharmaceutical agents authorized in KRS 23
320.240(12) to (14), advanced practice registered nurses as authorized in KRS 24
314.011 and 314.042, physician assistants when administering or prescribing 25
pharmaceutical agents as authorized in KRS 311.858, and health care professionals 26
who are residents of and actively practicing in a state other than Kentucky and who 27 UNOFFICIAL COPY 25 RS BR 119
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are licensed and have prescriptive authority under the professional licensing laws of 1
another state, unless the person's Kentucky license has been revoked, suspended, 2
restricted, or probated, in which case the terms of the Kentucky license shall 3
prevail; 4
(36) "Prescription" means a written or oral order for a drug or medicine, or combination 5
or mixture of drugs or medicines, or proprietary preparation, that is signed, given, 6
or authorized by a medical, advanced practice registered nurse, dental, chiropody, 7
veterinarian, or optometric practitioner, and intended for use in the diagnosis, cure, 8
mitigation, treatment, or prevention of disease in man or other animals; 9
(37) "Prescription blank" means a document that conforms with KRS 217.216 and is 10
intended for prescribing a drug to an ultimate user; 11
(38) "Raw agricultural commodity" means any food in its raw or natural state, including 12
all fruits that are washed, colored, or otherwise treated in their unpeeled natural 13
form prior to marketing; 14
(39) "Retail food establishment" means any food service establishment, retail food store, 15
or a combination of both within the same establishment; 16
(40) "Retail food store" means any fixed or mobile establishment where food or food 17
products, including prepackaged, labeled sandwiches or other foods to be heated in 18
a microwave or infrared oven at the time of purchase, are offered for sale to the 19
consumer, and intended for off-premises consumption, but does not include 20
establishments which handle only prepackaged, snack-type, nonpotentially 21
hazardous foods, markets that offer only fresh fruits and vegetables for sale, food 22
service establishments, food and beverage vending machines, vending machine 23
commissaries, food processing establishments, or home-based processors; 24
(41) "Salvage distributor" means a person who engages in the business of distributing, 25
peddling, or otherwise trafficking in any salvaged merchandise; 26
(42) "Salvage processing plant" means an establishment operated by a person engaged in 27 UNOFFICIAL COPY 25 RS BR 119
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the business of reconditioning, labeling, relabeling, repackaging, recoopering, 1
sorting, cleaning, culling or who by other means salvages, sells, offers for sale, or 2
distributes for human or animal consumption or use any salvaged food, beverage, 3
including beer, wine and distilled spirits, vitamins, food supplements, dentifices, 4
cosmetics, single-service food containers or utensils, containers and packaging 5
materials used for foods and cosmetics, soda straws, paper napkins, or any other 6
product of a similar nature that has been damaged or contaminated by fire, water, 7
smoke, chemicals, transit, or by any other means; 8
(43) "Second or subsequent offense" has the same meaning as it does in KRS 218A.010; 9
(44) "Secretary" means the secretary of the Cabinet for Health and Family Services; 10
(45) "Temporary food service establishment" means any food service establishment 11
which operates at a fixed location for a period of time, not to exceed fourteen (14) 12
consecutive days; 13
(46) "Traffic" has the same meaning as it does in KRS 218A.010; 14
(47) "Ultimate user" has the same meaning as it does in KRS 218A.010; 15
(48) If an article is alleged to be misbranded because the labeling is misleading, or if an 16
advertisement is alleged to be false because it is misleading, in determining whether 17
the labeling or advertisement is misleading, there shall be taken into account, 18
among other things, not only representations made or suggested by statement, word, 19
design, device, sound, or in any combination thereof, but also the extent to which 20
the labeling or advertisement fails to reveal facts that are material in the light of the 21
representations or material with respect to consequences which may result from the 22
use of the article to which the labeling or advertisement relates under the conditions 23
of use prescribed in the labeling or advertisement thereof or under the conditions of 24
use as are customary or usual; 25
(49) The representation of a drug in its labeling or advertisement as an antiseptic shall be 26
considered to be a representation that it is a germicide, except in the case of a drug 27 UNOFFICIAL COPY 25 RS BR 119
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purporting to be, or represented as, an antiseptic for inhibitory use as a wet 1
dressing, ointment, dusting powder, or other use involving prolonged contact with 2
the body; 3
(50) The provisions of KRS 217.005 to 217.215 regarding the selling of food, drugs, 4
devices, or cosmetics shall be considered to include the manufacture, production, 5
processing, packing, exposure, offer, possession, and holding of those articles for 6
sale, the sale, dispensing, and giving of those articles, and the supplying or applying 7
of those articles in the conduct of any food, drug, or cosmetic establishment; 8
(51) "Home" means a primary residence occupied by the processor, that contains only 9
two (2) ranges, ovens, or double-ovens, and no more than three (3) refrigerators 10
used for cold storage. This equipment shall have been designed for home use and 11
not for commercial use, and shall be operated in the kitchen within the residence; 12
(52) "Formulated acid food product" means an acid food in which the addition of a small 13
amount of low-acid food results in a finished equilibrium pH of 4.6 or below that 14
does not significantly differ from that of the predominant acid or acid food; 15
(53) "Acidified food product" means a low-acid food to which acid or acidic food is 16
added and which has a water activity value greater than 0.85, and a finished 17
equilibrium pH of 4.6 or below; 18
(54) "Low-acid food" means foods, other than alcoholic beverages, with a finished 19
equilibrium pH greater than 4.6, and a water activity value greater than 0.85; 20
(55) "Acid food" means foods that have a natural pH of 4.6 or below; 21
(56) "Home-based processor" means a person who in his or her home, produces or 22
processes non-potentially hazardous foods, including but not limited to dried herbs, 23
spices, nuts, candy, dried grains, whole fruit and vegetables, mixed-greens, jams, 24
jellies, sweet sorghum syrup, preserves, fruit butter, bread, fruit pies, cakes, or 25
cookies, and who has a gross income of no more than sixty thousand dollars 26
($60,000) annually from the sale of the products; 27 UNOFFICIAL COPY 25 RS BR 119
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(57) "Home-based microprocessor" means a farmer who, in the farmer's home or 1
certified or permitted kitchen, produces or processes foods, including but not 2
limited to acid foods, formulated acid food products, acidified food products, or 3
low-acid canned foods, and who has a gross income of no more than sixty thousand 4
dollars ($60,000) annually from the sale of the product; 5
(58) "Certified" means any person or home-based microprocessor who: 6
(a) Has attended the Kentucky Cooperative Extension Service's microprocessing 7
program or pilot microprocessing program and has been identified by the 8
Kentucky Cooperative Extension Service as having satisfactorily completed 9
the prescribed course of instruction; or 10
(b) Has attended some other school pursuant to 21 C.F.R. sec. 114.10; 11
(59) "Farmer" means a person who is a resident of Kentucky and owns or rents 12
agricultural land pursuant to subsection (9) of KRS 132.010 or horticultural land 13
pursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to 14
217.139, "farmer" also means any person who is a resident of Kentucky and has 15
grown the primary horticultural and agronomic ingredients used in the home-based 16
microprocessed products which they have produced;[ and] 17
(60) "Farmers market temporary food service establishment" means any temporary food 18
service establishment operated by a farmer who is a member of the market which 19
operates within the confines of a farmers market registered with the Kentucky 20
Department of Agriculture for the direct-to-consumer marketing of Kentucky-21
grown farm products from approved sources for a period of time not to exceed two 22
(2) days per week for any consecutive six (6) months period in a calendar year; and 23
(61) "Red dye 3" means a synthetic dye that gives food or drink a red color and has a 24
Chemical Abstracts Service registry number of 16423-68-0. 25
Section 2. KRS 217.025 is amended to read as follows: 26
A food shall be deemed to be adulterated: 27 UNOFFICIAL COPY 25 RS BR 119
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(1) (a) If it bears or contains any poisonous or deleterious substance which may 1
render it injurious to health; but in case the substance is not an added 2
substance such food shall not be considered adulterated under this subsection 3
if the quantity of such substance in such food does not ordinarily render it 4
injurious to health; or 5
(b) If it bears or contains any added poisonous or added deleterious substance 6
which is unsafe within the meaning of KRS 217.045; or 7
(c) If it consists in whole or in part of a diseased, contaminated, filthy, putrid, or 8
decomposed substance, or if it is otherwise unfit for food; or 9
(d) If it has been produced, prepared, packed, or held under insanitary conditions 10
whereby it may have become contaminated with filth, or whereby it may have 11
been rendered diseased, unwholesome, or injurious to health; or 12
(e) If it is the product of a diseased animal or an animal which has died otherwise 13
than by slaughter, or that has been fed upon the uncooked offal from a 14
slaughterhouse; or 15
(f) If its container is composed, in whole or in part, of any poisonous or 16
deleterious substance which may render the contents injurious to health; 17
(2) (a) If any valuable constituent has been in whole or in part omitted or abstracted 18
therefrom; or 19
(b) If any substance has been substituted wholly or in part therefor; or 20
(c) If damage or inferiority has been concealed in any manner; or 21
(d) If any substance has been added thereto or mixed or packed therewith so as to 22
increase its bulk or weight, or reduce its quality or strength or make it appear 23
better or of greater value than it is; 24
(3) If it is confectionery and it bears or contains any nonnutritive article or substance 25
except harmless coloring, harmless flavoring, harmless resinous glaze not in excess 26
of four-tenths of one percent (0.4%), harmless natural wax not in excess of four-27 UNOFFICIAL COPY 25 RS BR 119
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tenths of one percent (0.4%), harmless natural gum, and pectin; provided that this 1
subsection shall not apply to any chewing gum by reason of its containing harmless 2
nonnutritive masticatory substances; 3
(4) If it bears or contains a coal-tar color other than one from a batch which has been 4
certified under authority of the federal act; 5
(5) If it is filled milk; or 6
(6) If it contains red dye 3. 7