196.010.  Definitions. — 1.  For the purpose of sections 196.010 to 196.120:

  (1)  The term "contaminated with filth" applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations;

  (2)  The term "cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles, except that such term shall not include soap;

  (3)  The term "device" except when used in subsection 2 of this section and in sections 196.015(10), 196.075(6), 196.100(3) and 196.115(3), means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or to affect the structure or any function of the body of man or other animals;

  (4)  The term "department" shall be construed to mean the department of health and senior services;

  (5)  The term "drug" means (a) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (c) articles, other than food, intended to affect the structure or any function of the body of man or other animals; and (d) articles intended for use as a component of any articles specified in clause (a), (b), or (c); but does not include devices or their components, parts or accessories;

  (6)  The term "federal act" means the Federal Food, Drug and Cosmetic Act (Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.);

  (7)  The term "food" means articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article;

  (8)  The term "immediate container" does not include package liners;

  (9)  The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of sections 196.010 to 196.120 that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper;

  (10)  The term "labeling" means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article;

  (11)  The term "new drug" means any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended or suggested in the labeling thereof; or any drug the composition of which is such that such drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions;

  (12)  The term "official compendium" means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them;

  (13)  The term "person" includes individual, partnership, corporation, and association.

  2.  If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.

  3.  The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.

  4.  The provisions of sections 196.010 to 196.120 regarding the selling of food, drugs, devices, or cosmetics, shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale and the sale, dispensing, and giving of any such article, and the supplying of any such articles in the conduct of any food, drug, or cosmetic establishment.

  196.015.  Certain acts prohibited. — The following acts and the causing thereof within the state of Missouri are hereby prohibited:

  (1)  The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded;

  (2)  The adulteration or misbranding of any food, drug, device, or cosmetic;

  (3)  The receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

  (4)  The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of section 196.080 or 196.105;

  (5)  The dissemination of any false advertisement;

  (6)  The refusal to permit entry or inspection, or to permit the taking of a sample, as authorized by section 196.055;

  (7)  The giving of a guaranty or undertaking referred to in section 196.025(2), which guaranty or undertaking is false; except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the state of Missouri or in the United States, from whom he received in good faith the food, drug, device, or cosmetic;

  (8)  The removal or disposal of a detained or embargoed article in violation of section 196.030;

  (9)  The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being misbranded;

  (10)  Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of sections 196.010 to 196.120;

  (11)  The using, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under section 196.105, or that such drug complies with the provisions of such section;

  (12)  The using by any person to his own advantage, or revealing, other than to the department, or to the courts when relevant in any judicial proceeding under sections 196.010 to 196.120, any information acquired under authority of sections 196.055, 196.080, 196.105 concerning any method or process which as a trade secret is entitled to protection.

  196.020.  Injunction will lie to restrain violations of section 196.015. — In addition to the remedies herein provided the department of health and senior services is hereby authorized to apply to the circuit court for, and such court shall have jurisdiction upon hearing and for cause shown, to grant a temporary or permanent injunction restraining any person from violating any provision of section 196.015; irrespective of whether or not there exists an adequate remedy at law.

  196.025.  Punishment for violations, exceptions. — 1.  Any person who violates any of the provisions of section 196.015 shall, on conviction, be adjudged guilty of a misdemeanor, and punished by a fine of not more than one thousand dollars, or imprisonment for not more than one year or by both such fine and imprisonment.

  2.  No person shall be subject to the penalties of subsection 1 of this section for having violated section 196.015(1) or 196.015(3), if he establishes a guaranty or undertaking signed by the person from whom he purchased the food, drug, device, or cosmetic; if a resident of this state, that the food, drug, device, or cosmetic is not adulterated or misbranded within the meaning of sections 196.010 to 196.120, designating it, or, if a nonresident of this state residing in the United States, or a resident of this state engaged in interstate commerce with reference to the product involved, that the food, drug, device, or cosmetic is not adulterated or misbranded within the meaning of an act of congress entitled "An act to prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes" approved June 25, 1938, and the supplements and amendments thereto.

  3.  No publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates shall be liable under this section by reason of the dissemination by him of such false advertisement, unless he has refused, on the request of the department of health and senior services to furnish the said department the name and post-office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the state of Missouri, or in the United States, who caused him to disseminate such advertisement.

  196.030.  Agent of department of health and senior services shall tag, detain and embargo adulterated, tainted, or misbranded articles. — 1.  Whenever a duly authorized agent of the department of health and senior services finds or has probable cause to believe, that any food, drug, device, or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of sections 196.010 to 196.120, he shall affix to such article a tag or other appropriate marking, giving notice that such article is, or is suspected of being, adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by such agent or the court.  It shall be unlawful for any person to remove or dispose of such detained or embargoed article by sale or otherwise without such permission.

  2.  When an article detained or embargoed under subsection 1 has been found by such agent to be adulterated, or misbranded, he shall petition any circuit or associate circuit judge, in whose jurisdiction the article is detained or embargoed for an order for condemnation of such article.  When such agent has found that an article so detained or embargoed is not adulterated or misbranded, he shall remove the tag or other marking.

  3.  If the court finds that a detained or embargoed article is adulterated or misbranded within the meaning of sections 196.010 to 196.120, such article shall, after entry of the decree, be destroyed or sold under the supervision of such agent, as the court may direct, but no such article shall be sold contrary to any provisions of said sections, and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the general fund of the state of Missouri; provided, that when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the decree and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that such article shall be so labeled or processed, has been executed, may by order direct that such article be delivered to the claimant thereof for such labeling or processing under the supervision of an agent of the department of health and senior services.  The expense of such supervision shall be paid by the claimant.  When the article is no longer in violation of sections 196.010 to 196.120, and the expenses of such supervision have been paid, the department of health and senior services shall present these facts to the court, and such bond shall be then returned to the claimant of the article.

  4.  Whenever the department of health and senior services or any of its authorized agents shall find in any room, building, vehicle of transportation or other structure, any meat, seafood, poultry, vegetable, fruit or other perishable articles which are unsound, or contain any filthy, decomposed, or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, the department of health and senior services, or its authorized agent, shall forthwith condemn or destroy the same or in any other manner render the same unsalable as human food if the person found in possession of same or claiming possession or ownership of same shall agree to such action; provided that if any such person refuse to permit such action by the department of health and senior services or its agent, such agent may serve such person with a written notice directing him to hold or store any such articles for a period not longer than three days from the date of service of such notice.  Such notice shall also prohibit any such person from selling or in any manner disposing of such articles of food during the prescribed period.  The department of health and senior services or its agent after issuing any such notice shall immediately apply to the circuit court in whose jurisdiction such articles of food may be found or held for an order to condemn or destroy same.  Upon the application for such order the court shall immediately hold a summary hearing and at the conclusion thereof shall either grant the order requested or shall order the articles of food in question released to the person claiming ownership or possession thereof.  Upon the application for any such order, the court may make such orders for the custody, storage, or temporary preservation of any of such articles of food as may under the circumstances be deemed proper.  After the hearing prescribed for herein, if the court find the complaint to be sustained, the court may direct the articles of food to be disposed of as provided for by subsection 3 of this section.

  196.035.  Duty of prosecuting attorney. — It shall be the duty of the prosecuting attorney in any county or city in the state, when called upon by the department of health and senior services, or any of its assistants, to render any legal assistance in his power to execute the laws and to prosecute cases rising under the provisions of sections 196.010 to 196.120.  Before any violation of sections 196.010 to 196.120 is reported to any such attorney for the institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views before the department of health and senior services or its designated agent, either orally or in writing, in person, or by attorney, with regard to such contemplated proceeding.  The court at any time after seizure up to a reasonable time before trial, shall, by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized, and as regards fresh fruit or vegetables, a true copy of the analysis on which the proceeding is based and the identifying marks or numbers, if any, of the packages  from which the samples analyses were obtained.

  196.040.  Department of health and senior services not required to report minor violations, when. — Nothing in sections 196.010 to 196.120 shall be construed as requiring the department of health and senior services to report for the institution of proceedings under sections 196.010 to 196.120, minor violations of said sections, whenever the department of health and senior services believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.

  196.045.  Authority for enforcement vested in department of health and senior services — rulemaking, procedure. — 1.  The authority to promulgate regulations for the efficient enforcement of sections 196.010 to 196.120 is hereby vested in the department of health and senior services.  The department shall make the regulations promulgated under said sections conform, insofar as practicable, with those promulgated under the federal act.

  2.  Hearings authorized or required by sections 196.010 to 196.120 shall be conducted by the department of health and senior services or such officer, agent, or employee as the department may designate for the purpose.

  3.  Regulations shall be promulgated pursuant to the requirements of this section and chapter 536.  No rule or portion of a rule promulgated under the authority of this chapter shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  196.050.  Not to prescribe more stringent regulations than prescribed by federal act. — In no event shall the said department of health and senior services prescribe or promulgate any regulation fixing or establishing any definitions or standards which are more rigid or more stringent than those prescribed by the federal act applying to any commodity covered by sections 196.010 to 196.120 and if any product or commodity covered by said sections shall comply with the definitions and standards prescribed by the federal act for such product or commodity, such product or commodity shall be deemed in all respects to comply with sections 196.010 to 196.120.

  196.055.  Access to places in which food, drugs, devices or cosmetics are manufactured. — The department of health and senior services or its duly authorized agent shall have free access at all reasonable hours to any factory, warehouse, or establishment in which foods, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold such foods, drugs, devices, or cosmetics in commerce, for the purposes:

  (1)  Of inspecting such factory, warehouse, establishment, or vehicle to determine if any of the provisions of sections 196.010 to 196.120 are being violated; and

  (2)  To secure samples or specimens of any food, drug, device, or cosmetic after paying or offering to pay for such sample.  It shall be the duty of the department of health and senior services to make or cause to be made examinations or analyses of samples secured under the provisions of this section to determine whether or not any provision of sections 196.010 to 196.120 is being violated.

  196.056.  Charitable fund-raising events, nonprofit organization may prepare food in private home — notification to consumer — exceptions. — 1.  A nonprofit organization may prepare food in a private home or other area for distribution to the end consumer at a charitable fund-raising event.

  2.  The nonprofit organization may inform the consumer by placing a clearly visible placard at the serving location that the food was prepared in a kitchen that is not subject to regulation and inspection by the regulatory authority.

  3.  The nonprofit organization may notify the regulatory authority in writing or via electronic mail prior to the beginning of the event.  If made, such notification shall include the following:  name of the nonprofit organization; date, time, and location of the event; and name and contact information of the person responsible for the event.

  4.  This section does not apply to a food establishment regulated by the department of health and senior services providing food for the event.

  5.  This section shall not apply to any county with a charter form of government and with more than nine hundred fifty thousand inhabitants, any city not within a county, any county with a charter form of government and with more than two hundred thousand but fewer than three hundred fifty thousand inhabitants, any county with a charter form of government and with more than six hundred thousand but fewer than seven hundred thousand inhabitants, any home rule city with more than four hundred thousand inhabitants and located in more than one county, any county with a charter form of government and with more than three hundred thousand but fewer than four hundred fifty thousand inhabitants, any county of the first classification with more than two hundred thousand but fewer than two hundred sixty thousand inhabitants, and any county of the first classification with more than one hundred fifty thousand but fewer than two hundred thousand inhabitants.

  6.  Nothing in this section shall be construed to prohibit the authority of the department of health and senior services or local health departments to conduct an investigation of a food-borne disease or outbreak.

  196.060.  Carriers in interstate commerce shall permit access to records of shipments. — For the purpose of enforcing the provisions of sections 196.010 to 196.120, carriers engaged in interstate commerce, and persons receiving foods, drugs, devices, or cosmetics in interstate commerce, shall upon the request of an officer or employee duly designated by the department of health and senior services, permit such officer or employee to have access to and copy all records showing the movement in interstate commerce of any food, drug, device, or cosmetic, and the quantity, shipper and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a definite statement in writing specifying the nature or kind of food, drug, device, or cosmetic to which such request relates; provided, that evidence obtained under this section shall not be used in a criminal prosecution of the person from whom obtained; provided further, that carriers shall not be subject to the other provisions of sections 196.010 to 196.120 by reason of their receipt, carriage, or delivery of foods, drugs, devices, cosmetics, or advertising matter in the usual course of business as carriers.

  196.065.  Publication of reports of judgments, decrees and court orders. — 1.  The department of health and senior services may cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under sections 196.010 to 196.120, including the nature of the charge and the disposition thereof.

  2.  The department may also cause to be disseminated such information regarding foods, drugs, devices, and cosmetics as the department deems necessary in the interest of public health and the protection of the consumer against fraud.  Nothing in this section shall be construed to prohibit the department from collecting, reporting, and illustrating the results of the investigations of the said department.

  196.070.  Food, when deemed adulterated — industrial hemp content, effect of. — 1.  A food shall be deemed to be adulterated:

  (1)  If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this subdivision if the quantity of such substance in such food does not ordinarily render it injurious to health; or

  (2)  If it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of section 196.085; or

  (3)  If it consists, in whole or in part, of any diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or

  (4)  If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered diseased, unwholesome, or injurious to health; or

  (5)  If it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or

  (6)  If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

  (7)  If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or

  (8)  If any substance has been substituted wholly or in part therefor; or

  (9)  If damage or inferiority has been concealed in any manner; or

  (10)  If any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is; or

  (11)  If it is confectionery and it bears or contains any alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent, harmless natural wax not in excess of four-tenths of one percent, harmless natural gum, and pectin; provided, that this subdivision shall not apply to any confectionery, by reason of its containing less than five percent by weight of alcohol, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances; or

  (12)  If it bears or contains a coal tar color other than one from a batch which has been certified under authority of the federal act.

  2.  A food shall not be considered adulterated solely for containing industrial hemp, or an industrial hemp commodity or product.

  196.075.  Food, when deemed misbranded. — A food shall be deemed to be misbranded:

  (1)  If its labeling is false or misleading in any particular;

  (2)  If it is offered for sale under the name of another food;

  (3)  If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word, "imitation", and, immediately thereafter, the name of the food imitated;

  (4)  If its container is so made, formed or filled as to be misleading;

  (5)  If in package form, unless it bears a label containing:

  (a)  The name and place of business of the manufacturer, packer or distributor;

  (b)  An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under clause (b) of this subdivision reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the department of health and senior services;

  (6)  If any word, statement, or other information required by or under authority of sections 196.010 to 196.120 to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

  (7)  If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 196.050, unless it conforms to such definition and standard, and its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring, and coloring, present in such food;

  (8)  If it purports to be or is represented as:

  (a)  A food for which a standard of quality has been prescribed by regulations as provided by section 196.050 and its quality falls below such standard unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

  (b)  A food for which a standard or standards of fill of container have been prescribed by regulation as provided by section 196.050, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

  (9)  If it is not subject to the provisions of subdivision (7) of this section, unless it bears labeling clearly giving:

  (a)  The common or usual name of the food, if any there be; and

  (b)  In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings, without naming each; provided, that, to the extent that compliance with the requirements of paragraph (b) of this subdivision is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the department of health and senior services; provided further, that the requirements of paragraph (b) of this subdivision shall not apply to any carbonated beverage the ingredients of which have been fully and correctly disclosed, to the extent prescribed by said paragraph (b) to the department of health and senior services in an affidavit;

  (10)  If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the department of health and senior services determines to be, and by regulations prescribed, as necessary in order to fully inform purchasers as to its value for such uses;

  (11)  If it bears or contains any artificial flavoring, coloring, or chemical preservative, unless it bears labeling stating that fact; provided, that to the extent that compliance with the requirements of this subdivision is impracticable, exemptions shall be established by regulations promulgated by the department of health and senior services; and provided further, that subdivision (11) shall not apply to artificial coloring in butter, cheese or ice cream;

  (12)  The department is hereby directed to promulgate regulations exempting from any labeling requirement of sections 196.010 to 196.120 small open containers of fresh fruits and vegetables and food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of said sections upon removal from such processing, labeling or repackaging establishment.

  196.080.  Permits governing manufacture, processing or packing of certain foods — suspension and reinstatement. — 1.  Whenever the department of health and senior services finds after investigation that the distribution in Missouri of any class of food may, by reason of contamination with microorganisms during manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered commerce, it then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into commerce any such food manufactured, processed, or packed by any such food manufacturer, processor, or packer unless such manufacturer, processor or packer holds a permit issued by the department of health and senior services as provided by such regulations.

  2.  The department of health and senior services is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated.  The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the department of health and senior services shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued, or as amended.

  3.  Any officer or employee duly designated by the department of health and senior services shall have access to any factory or establishment, the operator of which holds a permit from the department of health and senior services for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

  196.085.  Use of poisonous or deleterious substances. — Any poisonous or deleterious substance added to any food except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe for purposes of the application of subdivision (2) of section 196.070; but when such substance is so required or cannot be so avoided, the department of health and senior services shall promulgate regulations limiting the quantity therein or thereon to such extent as the department finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of subdivision (2) of section 196.070.  While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of subdivision (1) of section 196.070.  In determining the quantity of such added substance to be tolerated in or on different articles of food, the department shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

  196.090.  Sections 196.010 to 196.120 not applicable to animal food or garbage. — Nothing in sections 196.010 to 196.120 shall apply to any ordinary animal food grown on a farm; nor to any prepared food for animals the contents of which are stated on a label attached to the package or container in which such prepared food is contained; nor garbage fed to hogs.

  196.095.  When drug or device adulterated. — A drug or device shall be deemed to be adulterated:

  (1)  If it consists in whole or in part of any filthy, putrid, or decomposed substance; or

  (2)  If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

  (3)  If it is a drug and its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

  (4)  If it is a drug and it bears or contains, for purposes of coloring only, a coal tar color other than one from a batch certified under the authority of the federal act;

  (5)  If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium.  Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act.  No drug defined in an official compendium shall be deemed to be adulterated under this subdivision because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label.  Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;

  (6)  If it is not subject to the provisions of subdivision (5) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

  (7)  If it is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength, or substituted wholly or in part therefor.

  196.100.  When drug or device misbranded. — 1.  Any manufacturer, packer, distributor or seller of drugs or devices in this state shall comply with the current federal labeling requirements contained in the Federal Food, Drug and Cosmetic Act, as amended, and any federal regulations promulgated thereunder.  Any drug or device which contains labeling that is not in compliance with the provisions of this section shall be deemed misbranded.

  2.  A drug dispensed on an electronic prescription or a written prescription signed by a licensed physician, dentist, or veterinarian, except a drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to a diagnosis by mail, shall be exempt from the requirements of this section if such physician, dentist, or veterinarian is licensed by law to administer such drug, and such drug bears a label containing the name and place of business of the dispenser, the serial number and date of such prescription, and the name of such physician, dentist, or veterinarian.

  3.  The department is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of sections 196.010 to 196.120, drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of said sections upon removal from such processing, labeling, or repacking establishment.

  196.105.  Provisions governing selling or delivering new drug. — 1.  No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless:

  (1)  An application with respect thereto has become effective under 21 U.S.C.A. § 355; or

  (2)  When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the department an application setting forth full reports of investigations which have been made to show whether or not such drug is safe for use; a full list of the articles used as components of such drug; a full statement of the composition of such drug; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; such samples of such drug and of the articles used as components thereof as the department may require; and specimens of the labeling proposed to be used for such drug.

  2.  An application provided for in subdivision (2) of subsection 1 shall become effective on the sixtieth day after the filing thereof, except that if the department finds after due notice to the applicant and giving him an opportunity for a hearing, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the department shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

  3.  This section shall not apply:

  (1)  To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs provided the drug is plainly labeled "For investigational use only"; or

  (2)  To a drug sold in this state at any time prior to the enactment of sections 196.010 to 196.120 or introduced into interstate commerce at any time prior to the enactment of the federal act; or

  (3)  To any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902 (U.S.C. 1934 cd. title 42. Chapter 4).

  4.  An order refusing to permit an application under this section to become effective may be revoked by the department of health and senior services.

  196.110.  When a cosmetic deemed adulterated. — A cosmetic shall be deemed to be adulterated:

  (1)  If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual; provided, that this provision shall not apply to coal tar hair dye, the label of which bears the following legend conspicuously displayed thereon:

"Caution — This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made.  This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness."

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and the labeling of which bears adequate directions for such preliminary testing.  For the purposes of this subdivision and subdivision (5), the term "hair dye" shall not include eyelash dyes or eyebrow dyes;

  (2)  If it consists in whole or in part of any filthy, putrid, or decomposed substance;

  (3)  If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

  (4)  If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

  (5)  If it is not a hair dye and it bears or contains a coal tar color other than one from a batch which has been certified under authority of the federal act.

  196.115.  When a cosmetic deemed misbranded. — A cosmetic shall be deemed to be misbranded:

  (1)  If its labeling is false or misleading in any particular;

  (2)  If in package form unless it bears a label containing:

  (a)  The name and place of business of the manufacturer, packer, or distributor; and

  (b)  An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under (b) of this subdivision reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the department of health and senior services;

  (3)  If any word, statement, or other information required by or under authority of sections 196.010 to 196.120 to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

  (4)  If its container is so made, formed, or filled as to be misleading;

  (5)  The department is hereby directed to promulgate regulations exempting from any labeling requirement of sections 196.010 to 196.120 cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of said sections upon removal from such processing, labeling or repackaging establishment.

  196.120.  Advertisement, when deemed false. — An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any material respect.

  196.150.  Sale of horse and mule meat prohibited except when labeled as such meat. — It shall hereafter be unlawful for any person, firm, association, or corporation to sell or offer for sale, either in wholesale or retail lots, any horse or mule meat under the guise or name of beef or any other animal flesh under the guise or name of any meat or meat product except that which in fact and truth it may be, without having attached thereto, a tag or other mark for identification plainly and legibly setting forth the true name of the animal from which such meat or flesh was taken or without having prominently displayed over or in conjunction with such meat or flesh, a legible sign or placard containing the true name of the animal from which the same was taken and without also advising the purchaser thereof by verbal, written or printed notice of the true name of the animal from which such meat or flesh was taken.

  196.155.  Penalty. — Any person violating the provisions of section 196.150 shall be deemed guilty of a misdemeanor.

  196.160.  Lawful to sell goat meat, when. — It shall hereafter be lawful for any person, firm, association, or corporation to sell or offer for sale either in wholesale or retail lots, goat meat; provided, the same is branded goat meat or chevon.

  196.165.  Falsely representing food to be kosher prohibited, penalty — kosher defined. — Any hotel, inn, delicatessen, grocery or butcher shop, or restaurant keeper, or any individual, firm or corporation, carrying on and conducting a boardinghouse, eating house, lunchroom business, or engaged in the catering business (all hereinafter referred to as "person" ), who shall with intent to defraud, sell, prepare or expose for sale, any meat or meat preparation, articles of food or food products, either raw or prepared for human consumption, whether the same is to be consumed on the premises where prepared and sold, or whether same is taken or carried elsewhere for consumption, falsely represents such food or food preparation to be kosher, that is, that same is prepared under and of products sanctioned by the orthodox Hebrew religious rules and requirements; or who shall falsely represent that such meat or meat preparation, food or food product is, or will be prepared and served in accordance with such orthodox Hebrew religious rules and requirements, by displaying a sign or signs, in, on, or about said person's place of business or establishment, or by advertisement in any newspaper, magazine, or periodical, or by publication in any other manner whatsoever, the intent and purpose whereof shall be to represent to the public by such advertisement, or any other manner whatsoever, that kosher meat or meat preparations, or food or food products are prepared and sold in such place of business or establishment, or served therein, or prepared or sold to be taken for consumption elsewhere than on said premises; or who prepares, sells, serves, or prepares for sale, either to be consumed on the premises, or elsewhere, both kosher and nonkosher meat or meat preparations, or food or food products in the same place of business, who fails to keep separate kitchens and dining rooms, wherein meat or meat preparations, or food or food products are prepared and served; or who fails to keep and use separate and distinctly labeled or marked dishes and utensils wherein such meat or meat preparation of food or food product is prepared and served; or who shall fail to indicate on all signs and display advertising, in, on, or about said person's premises, in block letters, at least four inches in height, "kosher and nonkosher food prepared and sold here", as the case may be, or persons dealing in kosher meat or meat preparations, kosher food or food products only and persons dealing in both kosher and nonkosher meat or meat preparations, kosher and nonkosher food or food products who fail^* to adhere to and abide by orthodox Hebrew religious rules and requirements, shall be guilty of a misdemeanor, punishable by a fine of not less than twenty-five dollars, nor more than five hundred dollars, or by imprisonment of not less than thirty days nor more than one year, or both.  Possession of nonkosher meat or meat preparation, or food or food product in any place of business advertising the sale of kosher meat and food only, is prima facie evidence that the person in possession exposes the same for sale with intent to defraud in violation of the provisions of this section.

  196.170.  Mixed flour to be branded. — No person shall sell or offer for sale any flour, meal, grits or hominy, made from the admixture or adulteration of grains, unless there shall have been first branded upon each of the barrels or packages containing the same, the kind of grains composing said admixture, the quality and weight thereof, and the name and place of business of the person manufacturing the same; provided, always, that the admixture of the several grades or kinds of wheat shall not be construed to be mixed or adulterated grains.

  196.175.  Penalty. — Any person doing any of the acts prohibited in section 196.170, or omitting to do any of the acts therein commanded, shall be guilty of a misdemeanor, and for each and every offense shall be punished by a fine of not less than twenty nor more than two hundred dollars, one-half of which shall be paid to the person who shall be named as prosecuting witness.

  196.190.  To what places law applies. — Every building, room, basement, or cellar occupied or used as a bakery, confectionery, cannery, packinghouse, slaughterhouse, restaurant, hotel, dining car, grocery, meat market, dairy, creamery, butter factory, cheese factory, or other place or apartment used for the preparation for sale, manufacture, packing, storage, sale or distribution of any food, shall be properly lighted, drained, plumbed and ventilated and conducted with strict regard to the influence of such condition upon the health of the operatives, employees, clerks or other persons therein employed, and the purity and wholesomeness of the food therein produced; and for the purpose of sections 196.190 to 196.265, the term "food", as used herein, shall include all articles used for food, drink, confectionery condiment, whether simple, mixed or compound, and all substances or ingredients used in the preparation thereof.

  196.195.  Contents of places and utensils used must be protected. — 1.  The floors, sidewalks, ceilings, lockers, closets, furniture, receptacles, implements and machinery of every establishment or place where food is manufactured, packed, stored, sold or distributed, and all cars, trucks and vehicles used in the transportation of food products, shall at no time be kept in an unclean, unhealthy or insanitary condition, and for the purpose of sections 196.190 to 196.265, unclean, unhealthful and insanitary conditions shall be deemed to exist:

  (1)  If food in the process of manufacture, preparation, packing, storing, sale, distribution or transportation is not securely protected from flies, dust, dirt and, as far as may be necessary, by all reasonable means from all other foreign or injurious contamination; and

  (2)  If the refuse, dirt and waste products, subject to decomposition and fermentation, incident to the manufacture, preparation, packing, storing, selling, distributing and transporting of food, are not removed daily; and

  (3)  If all trucks, trays, boxes, baskets, buckets and other receptacles, chutes, platforms, racks, tables, troughs, shelves and all knives, saws, cleavers and other utensils, and machinery used in moving, handling, cutting, chopping, mixing, canning and all other processes are not fairly cleaned daily; and

  (4)  If the clothing of operatives, employees, clerks or other persons therein employed is unclean.

  2.  The placing of vinegar or other liquid, used as food or drink, in open vessels without covering the same is forbidden.  The use of secondhand bottles for vinegar or other liquids, used as food or drink, is forbidden unless the same are first sterilized with live steam.

  3.  The sidewalk display of food products is prohibited unless such products are enclosed in a showcase or similar device, which will protect the same from flies, dust or other contamination; provided, that food products that necessarily have to be peeled, pared or cooked before they are fit for consumption may be displayed on the sidewalk; but the sidewalk display of meat or meat products is prohibited.

  196.210.  Toilet rooms provided. — 1.  Every building, room, basement or cellar, occupied or used for the preparation, manufacture, packing, canning, sale or distribution of food, shall have convenient toilet or toilet rooms, separate and apart from the room or rooms where the process of production, manufacture, packing, canning, selling or distributing is conducted.

  2.  The floors of such toilet rooms shall be of cement, tile, wood, brick or other nonabsorbent material and shall be furnished with separate ventilating flush or pipes, discharging into soil pipes, or on outside of the building in which they are situated.

  3.  Lavatories and washrooms shall be adjacent to toilet rooms, and shall be supplied with soap, running water and towels, and shall be maintained in a sanitary condition.

  4.  Operatives, employees, clerks and all other persons who handle the material from which food is prepared, or the finished product, before beginning work or after visiting toilets, shall wash their hands and arms thoroughly with soap and clean water.

  196.220.  Not used for sleeping purposes. — No person or persons shall be allowed to live or sleep in any room of a bakeshop, kitchen, dining room, confectionary or place where food is prepared, served or sold.

  196.225.  Employees with communicable disease prohibited, where. — No employer shall require or permit a person, nor shall a person work, affected with any disease in a communicable form or while a carrier of such disease, to work in any building or vehicle occupied or used for the production, preparation, manufacture, packing, storage, sale, distribution, and transportation of food in any capacity which brings the person into contact with the food.

  196.230.  Abatement of violations by director. — The director of the department of health and senior services and his assistants or agents by him appointed, the state, county, city and town health officers shall have full power at any time to enter and inspect every building, room, basement or cellar, occupied or used, or suspected of being used, for the production for sale, manufacture for sale, storage, sale, distribution or transportation of food and all utensils, fixtures, furniture and machinery used as aforesaid, and if upon inspection any food producing or distributing establishment, conveyance, employer, operative, employee, clerk, driver or other person is found to be violating any of the provisions of sections 196.190 to 196.265, or if the production, cooking, preparation, manufacture, packing, storing, sale, distribution or transportation of food is being conducted in a manner detrimental to the health of the employees and operatives and the character or quality of the food therein being produced, manufactured, packed, stored, sold, distributed or conveyed, the officer or inspector, making the examination or inspection, shall furnish evidence of said violation to the prosecuting attorney of the county in which the violation occurs, and it shall be the duty of all prosecuting attorneys to represent and prosecute, in behalf of the people, when called upon by the director of the department of health and senior services to do so, all such cases of offenses arising under the provisions of sections 196.190 to 196.265.  When complaint is made by the said director of the department of health and senior services, security for costs shall not be required of the complainant in any case at any time of the prosecution or trial.

  196.235.  Penalty. — Any person who violates any of the provisions of sections 196.190 to 196.230, shall be guilty of a misdemeanor, and, on conviction, shall be punished for the first offense by a fine of not less than ten dollars nor more than one hundred dollars, or be imprisoned in the county jail not exceeding thirty days, or both, in the discretion of the court.

  196.240.  Authorization by director to close health menace. — It shall be the duty of the director of the department of health and senior services, and he is hereby authorized and empowered, to close any market place, grocery store, general store, bakery, confectionery, butcher shop, slaughterhouse, dining car, refrigerator car, cold storage plant or warehouse, hotel dining room or kitchen, cafe, restaurant, lunch counter, drug store, or any other place, or places, where articles or commodities intended for human food, or for human consumption as medicine, are manufactured, sold, stored or prepared for sale, or wherever food and drink is served, where such places shall, in the judgment of said director, constitute a menace to the public health, by reason of dirt, filth, or other insanitary cause.

  196.245.  Order to specify what — revocation — reopening. — Any order issued by the director of the department of health and senior services for the closing of any place or places mentioned in section 196.240, shall specify the cause or causes for which such order was issued, and the time during which same shall be in effect.  The director shall revoke such order before the time specified therein for its expiration; provided, that the cause for which such order was issued is removed, and if the director is satisfied that such place or places may be reopened without endangering the public health.

  196.250.  Construction of the word close. — The word "close", as used in sections 196.190 to 196.265, shall be construed to mean a suspension of business, and it shall be unlawful for the proprietor, manager, or person having charge of any place mentioned in section 196.240 to transact any business in violation of any order of the director of the department of health and senior services closing same.

  196.265.  Penalty for violation. — Any person who shall fail, or refuse, to obey any order of the director of the department of health and senior services to close any place, or places, mentioned in section 196.240, or who shall exhibit or expose for sale in any show window upon any sidewalk, any vegetables or other articles or commodities whatsoever intended for human food, in violation of any order of the director, or who shall, in any way, resist or interfere with the director in the enforcement of sections 196.190 to 196.265, or any order of the director made pursuant to the authority of this law, shall be deemed guilty of a misdemeanor.

  196.271.  Food manufacturers or distributors may register. — All establishments engaged in the manufacture of food or distribution of foods to wholesale accounts may register with the department of health and senior services as a food manufacturer or food distributor.

  196.276.  Food delivery platform — definitions — certification or registration — limitations — agreements, requirements — violation, penalties. — 1.  As used in this section, the following terms mean:

  (1)  "Consent", a mutual acknowledgment by both a restaurant and a food delivery platform, which may be obtained electronically;

  (2)  "Food delivery platform", a business that acts as a third-party intermediary by taking and arranging for the delivery or pickup of orders from multiple restaurants for ultimate consumers.  The term does not include delivery or pickup orders placed directly with, and fulfilled by, a restaurant.  The term does not include websites, mobile applications, or other electronic services that do not post restaurant menus, logos, or pricing information on their platforms;

  (3)  "Likeness", a mark or trade name;

  (4)  "Mark", a trademark or service mark, regardless of whether the trademark or service mark is actually registered;

  (5)  "Restaurant", a business in this state that:

  (a)  Operates its own permanent food service facilities with commercial cooking equipment on its premises; and

  (b)  Prepares and offers to sell multiple entrees for consumption on or off the premises;

  (6)  "Trade name", a name used by a person or entity to identify the person's or entity's business or vocation.

  2.  (1)  A food delivery platform shall not take and arrange for the delivery or pickup of an order from a restaurant in this state unless such food delivery platform has filed a certificate of formation or registration with the secretary of state.

  (2)  A food delivery platform shall:

  (a)  Not use a restaurant's likeness in a manner that could reasonably be interpreted to falsely suggest sponsorship or endorsement by the restaurant;

  (b)  Not, without the restaurant's consent, take and arrange for the delivery or pickup of an order from a restaurant;

  (c)  Not, without an agreement with the restaurant, intentionally inflate or alter a restaurant's pricing, although other charges may be assessed to the ultimate consumer if they are noted separately to the consumer;

  (d)  Not, without an agreement with the restaurant, attempt to charge a restaurant or expect the restaurant to pay or absorb any fee, commission, or charge;

  (e)  Remove a restaurant from the food delivery platform's services within ten days of receiving the restaurant's request for removal unless an agreement between the food delivery platform and the restaurant states otherwise; and

  (f)  Clearly provide to the ultimate consumer a mechanism to express order concerns directly to the food delivery platform.

  (3)  Any agreement between a food delivery platform and a restaurant to take and arrange for the delivery or pickup of orders shall:

  (a)  Be in writing and expressly authorize the food delivery platform to take and arrange for the delivery or pickup of orders from the restaurant;

  (b)  Clearly identify any fee, commission, or charge that the restaurant will be required to pay or absorb; and

  (c)  Not include a provision, clause, or covenant that requires a restaurant to indemnify a food delivery platform, or any employee, independent contractor, or agent of the food delivery platform, for any damages or harm caused by the actions or omissions of the food delivery platform or any employee, independent contractor, or agent of the food delivery platform.

  (4)  Any provision in an agreement between a food delivery platform and a restaurant, or in a written consent, that is contrary to subdivision (3) of this subsection is void and unenforceable.

  3.  (1)  A restaurant may bring an action to enjoin a violation of this section.  If the court finds a violation, the court shall issue an injunction and may:

  (a)  Subject to subdivision (2) of this subsection, require the violator to pay to the injured party all profits derived from or damages resulting from the wrongful acts; and

  (b)  Order that the wrongful act be terminated.

  (2)  If the court finds that the food delivery platform committed a wrongful act in bad faith, in violation of this section by not having an agreement or written consent, or otherwise, as according to the circumstances of the case, the court, in the court's discretion, may:

  (a)  Enter judgment in an amount not to exceed three times the amount of profits and damages; and

  (b)  Award reasonable attorney's fees to the restaurant.

  196.291.  Food sold at religious events or charitable functions exempt from food inspection laws and regulations, when. — All sales of foods which are not potentially hazardous foods, as defined by regulation, sold by religious, charitable, or nonprofit organizations at their religious events or at charitable functions and activities shall be exempt from all state laws and regulations relating to food inspection, pursuant to sections 196.190 to 196.271.

  196.298.  Definitions — operation not deemed food service establishment, when — no state or local regulation. — 1.  As used in this section, the following terms shall mean:

  (1)  "Baked good", includes cookies, cakes, breads, danish, donuts, pastries, pies, and other items that are prepared by baking the item in an oven.  A baked good does not include a potentially hazardous food item as defined by department rule;

  (2)  "Cottage food production operation", an individual operation out of the individual's home who:

  (a)  Produces a baked good, a canned jam or jelly, or a dried herb or herb mix for sale at the individual's home; and

  (b)  Sells the food produced under paragraph (a) of this subdivision only directly to consumers;

  (3)  "Department", the department of health and senior services;

  (4)  "Home", a primary residence that contains a kitchen and appliances designed for common residential usage.

  2.  A cottage food production operation is not a food service establishment and shall not be subject to any health or food code laws or regulations of the state or department other than this section and rules promulgated thereunder for a cottage food production operation.

  3.  (1)  A local health department shall not regulate the production of food at a cottage food production operation.

  (2)  Each local health department and the department shall maintain a record of a complaint made by a person against a cottage food production operation.

  4.  The department shall promulgate rules requiring a cottage food production operation to label all of the foods described in this section which the operation intends to sell to consumers.  The label shall include the name and address of the cottage food production operation and a statement that the food is not inspected by the department or local health department.

  5.  A cottage food production operation shall not sell any foods described in this section through the internet unless both the cottage food production operation and the purchaser are located in this state.

  6.  Nothing in this section shall be construed to prohibit the authority of the department of health and senior services or local health departments to conduct an investigation of a food-borne disease or outbreak.

  196.311.  Definitions. — Unless otherwise indicated by the context, when used in sections 196.311 to 196.361:

  (1)  "Consumer" means any person who purchases eggs for such person's own family use or consumption; or any restaurant, hotel, boardinghouse, bakery, or other institution or concern which purchases eggs for serving to guests or patrons thereof, or for its own use in cooking, baking, or manufacturing their products;

  (2)  "Container" means any box, case, basket, carton, sack, bag, or other receptacle.  "Subcontainer" means any container when being used within another container;

  (3)  "Dealer" means any person who purchases eggs from the producers thereof, or another dealer, for the purpose of selling such eggs to another dealer, a processor, or retailer;

  (4)  "Denatured" means eggs (a) made unfit for human food by treatment or the addition of a foreign substance, or (b) with one-half or more of the shell's surface covered by a permanent black, dark purple or dark blue dye;

  (5)  "Director" means the director of the department of agriculture;

  (6)  "Eggs" means the shell eggs of a domesticated chicken, turkey, duck, quail, goose, or guinea that are intended for human consumption;

  (7)  "Inedible eggs" means eggs which are defined as such in the rules and regulations of the director adopted under sections 196.311 to 196.361, which definition shall conform to the specifications adopted therefor by the United States Department of Agriculture;

  (8)  "Person" means and includes any individual, firm, partnership, exchange, association, trustee, receiver, corporation or any other business organization, and any member, officer or employee thereof;

  (9)  "Processor" means any person engaged in breaking eggs or manufacturing or processing egg liquids, whole egg meats, yolks, whites, or any mixture of yolks and whites, with or without the addition of other ingredients, whether chilled, frozen, condensed, concentrated, dried, powdered or desiccated;

  (10)  "Retailer" means any person who sells eggs to a consumer;

  (11)  "Sell" means offer for sale, expose for sale, have in possession for sale, exchange, barter, or trade.

  196.313.  License to sell eggs required — exceptions. — No person shall buy, sell, trade or traffic in eggs in this state without a license with the following exceptions:

  (1)  Those who sell only eggs produced by their own flocks, provided such eggs are not sold at an established place of business away from the premises of such producer;

  (2)  Hatcheries which purchase eggs used exclusively for hatching purposes;

  (3)  Hotels, restaurants, and other public eating places where all eggs purchased are served in the establishment;

  (4)  Bakeries, confectioneries, and ice cream manufacturers purchasing eggs for use and used only in the manufacture of their products.

  196.316.  License requirements — applications — kinds of licenses — fees — posting. — 1.  All persons engaged in buying, selling, trading or trafficking in, or processing eggs, except those listed in section 196.313, shall be required to be licensed under sections 196.311 to 196.361.  Such persons shall file an annual application for such license on forms to be prescribed by the director, and shall obtain an annual license for each separate place of business from the director.  The following types of licenses shall be issued:

  (1)  A "retailer's license" shall be required of any person defined as a retailer in section 196.311.  A holder of a retailer's license shall not, by virtue of such license, be permitted or authorized to buy eggs from any person other than a licensed dealer, and any retailer desiring to buy eggs from persons other than licensed dealers shall obtain a dealer's license in addition to a retailer's license.  Fees for such license shall not exceed one hundred dollars annually per license;

  (2)  A "dealer's license" shall be required of any person defined as a dealer in section 196.311.  A holder of a dealer's license shall not, by virtue of such license, be authorized or permitted to sell eggs to consumers, and any dealer desiring to sell eggs to consumers shall obtain a retailer's license in addition to a dealer's license.  Fees for such license shall not exceed one hundred seventy-five dollars annually per license;

  (3)  A "processor's license" shall be required of any person defined as a processor in section 196.311.  A holder of a processor's license shall not, by virtue of such license, be authorized or permitted to sell eggs in the shell to other persons, and any person desiring to sell eggs in the shell to other persons shall obtain a dealer's license in addition to a processor's license.  Fees for such license shall not exceed two hundred fifty dollars annually per license.

  2.  The director of agriculture shall have the authority to assess egg licensing fees to assist in defraying operating expenses.  A schedule of licensing fees shall be fixed by rule or regulation promulgated under chapter 536 by the director of the department of agriculture.

  3.  All licenses shall be conspicuously posted in the place of business to which it applies.  The license year shall be twelve months, or any fraction thereof, beginning July first and ending June thirtieth.

  4.  No license shall be transferable, but it may be moved from one place to another by the consent of the director.

  5.  All moneys received from license fees collected hereunder shall be deposited in the state treasury to the credit of the agriculture protection fund created in section 261.200.

  196.318.  Licensees to keep records. — All persons licensed under the provisions of sections 196.311 to 196.361 shall keep records of purchases and sales of eggs, of the grades of eggs bought and sold, and other related information necessary for the proper enforcement of sections 196.311 to 196.361, in the manner and form, and for such reasonable period of time, as may be prescribed by the rules and regulations of the director.

  196.321.  Standards and grades to be fixed. — The quality standards for grades of eggs, the size designation and standards therefor by weight, and tolerances within grades, shall be established by the director through the promulgation and issuance of regulations; provided, the quality standards and designations, size standards and designations, and tolerances within grades shall not be lower than those established by the United States Department of Agriculture.

  196.323.  Kinds of eggs which may be sold. — 1.  Only eggs of the quality standard designated Grade "AA", Grade "A", Grade "B", or Grade "C", shall be sold to any consumer by any person.

  2.  Inedible eggs shall not be bought, sold or trafficked in and any inedible eggs found in the hands of any person are declared to be contraband and shall be destroyed as contraband.  The director, by regulation, may permit the sale and use of denatured inedible eggs for purposes other than human food.

  196.326.  Egg containers to be marked or labeled. — Eggs, which have been graded as to quality and size for sale to consumers, shall not be prepared, packed, placed, delivered for shipment or sale, loaded, shipped, transported, or sold in bulk or in containers or subcontainers:

  (1)  Unless each container and subcontainer of eggs is marked with the full, correct and unabbreviated designation of size and quality of the eggs therein, according to the standards established by the director, together with the name and address of the producer, dealer, retailer, or agent by or for whom the eggs were graded or marked;

  (2)  Unless all markings on any container which do not properly and accurately apply to the eggs placed or packed therein have been removed, erased or obliterated;

  (3)  Which are mislabeled by the placing or presence of any false, deceptive or misleading mark, term, statement, design, device, inscription, or any other designation, upon any eggs or upon any container or subcontainer of eggs, or upon the label or lining or wrapper thereof, or upon any placard or sign used in connection therewith, or in connection with any bulk lot or display having reference to eggs;

  (4)  Which are deceptive by any arrangement of the contents of any container, or subcontainer, or of any lot, load, or display, in which the eggs in the outer layer or in any portion exposed to view are in quality, size, condition, or in any other respect so superior to those in the interior or unexposed portion as to materially misrepresent the contents or any part thereof as to size, quality, condition, or any other respects;

  (5)  Unless designations of size and quality upon containers and subcontainers of eggs shall be plainly and conspicuously marked in boldface type letters on a contrasting background of (a) not less than three-eighths of an inch in height on the outside top face of each container holding less than fifteen dozen eggs, and (b) not less than two inches in height on one outside end of any oblong container holding fifteen dozen or more eggs, and on one outside side of any other container holding fifteen dozen or more eggs.

  196.328.  Containers not required to be marked, when. — No markings are required on containers or subcontainers of eggs:

  (1)  When sold at retail from a properly marked bulk display and packaged in the presence of the purchaser for the immediate purpose of the sale;

  (2)  When sales are made without advertising, by the producer, from eggs produced on his own premises and are not sold at an established place of business away from premises of such producer;

  (3)  On containers of fifteen dozen or more eggs which contain properly marked subcontainers.

  196.331.  Sign required on sale from bulk lots. — Eggs shall not be sold to consumers, from bulk lots without displaying a plainly legible sign or placard conspicuously placed and posted in such a position as to clearly and accurately identify the eggs designated thereby, marked with the full, correct and unabbreviated designation of quality and size of such eggs in boldface type letters not less than one inch in height, according to the standards established by the director.

  196.333.  Markings in case of eggs from different species of fowl. — No person shall sell or represent eggs from any other species of fowl as chicken eggs, or sell mixed eggs from more than one species of fowl, or eggs from ducks, turkeys, geese, or any species of fowl other than chickens, without marking the containers and subcontainers of such eggs or otherwise indicating fully by sign, placard or other inscription the species of fowl from which such eggs were produced.

  196.336.  Advertisements of price to give size and quality. — No person shall advertise by sign, placard, or otherwise, the price at which eggs are offered for sale without marking the full, correct, and unabbreviated designation of size and quality of such eggs on such advertisement, in conjunction with the price.  Such designations of size and quality shall be in boldface type or other conspicuous letters, and at least one-half the size of the letters or figures used to designate the price of such eggs.

  196.338.  Dealer to furnish retailer with invoice showing size and quality. — Every dealer selling eggs to a retailer shall furnish an invoice showing the size and quality of such eggs according to the standards prescribed by sections 196.311 to 196.361 and by the rules and regulations of the director.

  196.341.  Processing plants kept clean — standards — inspection — rulemaking, procedure. — The premises, plants and facilities operated and maintained by egg processors shall be operated and maintained in a clean and sanitary condition.  The director shall adopt and promulgate rules and regulations pursuant to this section and chapter 536 establishing standards of cleanliness and sanitation for such premises, plants and facilities, and the director, or his authorized agents or representatives, are authorized and empowered to inspect such premises, plants and facilities in order to enforce such cleanliness and sanitation requirements.  No rule or portion of a rule promulgated under the authority of sections 196.311 to 196.361 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  196.343.  Inspection of business premises and records. — The director, or his authorized agents or representatives, may enter, during the regular business hours, any establishment where eggs are bought, stored, sold, offered for sale, or processed, in order to inspect and examine eggs, the products of eggs, egg containers, and the premises, and to examine the records of such establishments relating thereto.

  196.346.  Stop-sale orders, effect — appeals. — The director, or his authorized agents or representatives, are authorized and empowered to issue and enforce a written or printed "Stop-Sale" order to the owner or custodian of any eggs which are found to be in violation of any of the provisions of sections 196.311 to 196.361, or the rules or regulations adopted under the authority of sections 196.311 to 196.361, which order shall prohibit the further sale of such eggs until sections 196.311 to 196.361 have been complied with and the owner or custodian shall have the right to take such steps as may be possible to bring the eggs into compliance, such as regrading or relabeling, and, provided that in respect to eggs that have been denied sale as provided in sections 196.311 to 196.361, the owner or custodian of such eggs shall have the right to appeal from such order to the circuit court of the county or city in which the eggs are located, praying for a judgment as to the justification of such order and for the discharge of such eggs from the order prohibiting the sale in accordance with the findings of the court.

  196.348.  Court may order seizure of eggs, when — condemnation. — Any eggs found in the possession of an owner or custodian and not in compliance with the provisions of sections 196.311 to 196.361, or the rules or regulations adopted hereunder, shall be subject to seizure upon complaint of the director to the circuit court of the county or city in which such eggs are located.  Such seizure shall not be made until the owner or custodian of the eggs has been given forty-eight hours from the time of a "Stop-Sale" order to bring the eggs into compliance with sections 196.311 to 196.361, or the rules and regulations adopted hereunder. In the event the court finds that the eggs do not comply with sections 196.311 to 196.361, or the rules and regulations adopted hereunder, it shall order the condemnation thereof, and the eggs shall be denatured, processed, destroyed, regraded, relabeled, or otherwise disposed of by the court.

  196.351.  License suspended or revoked, when, procedure — appeal. — The director is hereby authorized and empowered to suspend or revoke the license of any dealer, processor, or retailer, or to refuse to issue a license to any applicant therefor if the director, after a public hearing, has found that such dealer, processor, retailer, or applicant for a license, has violated any of the provisions of sections 196.311 to 196.361, or the rules and regulations adopted hereunder.  Any such dealer, processor, retailer, or applicant shall have full rights to have counsel, to produce witnesses in his behalf at such hearing, and to have ten days' notice in writing of the date, time and place of such hearing, and the charges and grounds upon which his license is sought to be revoked or suspended, or to be refused a license.  The order of suspension, revocation, or refusal to issue a license, shall not become final until ten days after the date thereof, and after the party to the proceeding has been notified in writing of the action of the director.  Any party to the proceedings that is aggrieved by any final decision or order of the director, may appeal such order in the manner provided for such appeals in the Administrative Procedure Act of Missouri (Chapter 536).

  196.352.  Civil penalty authorized, when. — In addition to the penalties and remedies provided in sections 196.311 to 196.361, if the director determines, after inquiry and opportunity for a hearing, that any individual is in violation of any provision of sections 196.311 to 196.361 or any regulation promulgated thereunder, the director shall have the authority to assess a civil penalty of not more than five hundred dollars for each violation and not more than five hundred dollars for each day such violation continues.  Any individual aggrieved by any act of the director under this section may appeal according to the provisions of chapter 621.

  196.354.  Duties of director of agriculture — rules and regulations. — The duty of enforcing sections 196.311 to 196.361 is vested in the director who shall adopt and promulgate such rules and regulations as are necessary to secure the enforcement of and carry out the provisions of sections 196.311 to 196.361.  No rule or portion of a rule promulgated under the authority of this section shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  196.357.  Violations may be enjoined. — In addition to the remedies provided for in sections 196.311 to 196.361 or by law, the prosecuting attorney of any county in which a violation of any provision of sections 196.311 to 196.361 occurs or the attorney general of the state, is hereby authorized to apply to any court of competent jurisdiction for, and such court shall have jurisdiction upon hearing and for cause shown to grant, a temporary or permanent injunction to restrain any person from violating any provision of sections 196.311 to 196.361.

  196.361.  Violation a misdemeanor. — Any person who violates any of the provisions of sections 196.311 to 196.361 shall, upon conviction, be deemed guilty of a misdemeanor.

  196.450.  Definitions. — When used in sections 196.450 to 196.515, unless the context otherwise requires:

  (1)  "Chill room" means a room or space in a locker plant, artificially cooled, provided for the temporary holding or storage of food prior to its processing or freezing for storage;

  (2)  "Cutting or processing room" means a separate room or space in a locker plant in which food products are prepared for quick or sharp freezing;

  (3)  "Department" means department of agriculture of the state of Missouri;

  (4)  "Director" means the director of the department of agriculture of the state of Missouri;

  (5)  "Food" means all articles used for food, drink, confectionery or condiment by man, whether simple, mixed or compound, and any substance used as a constituent in the manufacture thereof;

  (6)  "Locker" means the individual sections or compartments of a capacity of not to exceed fifty cubic feet, in the locker room of a locker plant;

  (7)  "Locker plant" means a location or establishment in which space in individual lockers is rented for the storage of food;

  (8)  "Locker room" means that space or room in a locker plant which contains individual lockers or compartments which are for rent for the storage of frozen food;

  (9)  "Operator" means any person, copartnership, firm or corporation operating or maintaining a locker plant;

  (10)  "Quick or sharp freeze" means the freezing of food in a room in which the temperature is zero or lower;

  (11)  "Quick or sharp freezing room" means that space in a locker plant in which food is quick or sharp frozen prior to storage in lockers;

  (12)  "Quick or sharp frozen" means the condition of food which has been thoroughly frozen in a quick or sharp freezing room;

  (13)  "Temperature" means degrees shown on Fahrenheit thermometer.

  196.455.  Annual license required. — It shall be unlawful for any person, firm, copartnership or corporation to operate a locker plant in this state unless such person, firm, copartnership or corporation has secured an annual license therefor from the department.  A separate license shall be secured for each locker plant.  The application for such license shall be in writing on forms prescribed and furnished by the department.  A license issued for a locker shall be transferable upon written permission of the director.

  196.465.  Semiannual inspection of plants. — Upon receipt of the application for a license accompanied by the required fee, the department shall inspect the plant to be licensed and if it finds that such plant complies with the provisions of law, the department shall issue such license.  The persons designated by the department to make such inspection shall be persons having practical knowledge of the operation of cold storage plants and the storage of food therein, and shall be thoroughly familiar with the provisions of the law applicable to locker plants and the applicable rules and regulations of the department.  The department shall inspect all locker plants licensed under sections 196.450 to 196.515 at least once each six months, and may make such additional inspections as the department deems necessary.  The department and its representatives shall have access to locker plants at all reasonable times for the purpose of making inspections.

  196.470.  Form and expiration of license. — The license issued under sections 196.450 to 196.515 shall be in such form as the department may prescribe.  Licenses shall expire December thirty-first following date of issue.  All licenses must be conspicuously displayed by the licensee in locker plants.

  196.475.  Gas masks, alarm bell, and illumination required. — 1.  Any plant using a toxic gas refrigerant shall have at least one gas mask of a type approved by the department and shall keep the same where it will be readily accessible.

  2.  An alarm bell or buzzer provided with a suitable button shall be placed just inside the door of each locker room in a conspicuous place.  Illumination shall be provided in the locker room at all times while open to the public, the switch operating same shall be accessible only to the operator.

  196.480.  Requirements before issuance of license. — No locker plant shall be licensed if located in insanitary, unclean or contaminating surroundings which might endanger public health, and all rooms and equipment of a locker plant shall at all times be maintained in a clean and sanitary condition consistent with the purpose for which such rooms and equipment are used.  Locker plants shall have ample and sanitary water and toilet facilities.  All employees handling food shall have an approved health certificate.

  196.485.  Temperature requirements and record. — 1.  The refrigeration system for a locker plant shall be equipped with accurate and reliable controls for the automatic maintenance of uniform temperatures, provided this shall not apply to locker plants having constant temperature supervision.

  2.  Temperatures shall be maintained in the respective rooms as follows:

  (1)  Chill room, temperatures within two degrees plus or minus of thirty-seven degrees or lower with a tolerance of ten degrees for a reasonable time after fresh food is placed in the chill room;

  (2)  Quick or sharp freeze room   quick or sharp freeze compartments: Temperatures of ten degrees below zero or lower in rooms where still air cooling is employed and temperatures of zero degrees or lower in rooms where forced air circulation is employed, with a tolerance of ten degrees for either type of installation for a reasonable time after putting fresh food into the freezer;

  (3)  Locker room, temperatures of zero degrees or lower, with a tolerance of five degrees above zero degrees.

  3.  The locker room shall be equipped with a self-registering, accurate recording thermometer.  Chill room and sharp freeze room shall be equipped with an accurate, direct reading thermometer.

  4.  Thermometer charts shall be available for inspection at the locker plant by agents of the commission and shall be preserved for at least a period of one year from date of recording.

  196.490.  Food to be quick frozen before placed in locker. — All food, before being placed in a locker shall be quick or sharp frozen in a quick or sharp freeze room, unless the locker room temperature is maintained at not more than the maximum temperature required by sections 196.450 to 196.515 for a quick or sharp freeze room.  No food shall be placed in a locker unless previously inspected by the operator and each portion shall be wrapped and be marked or stamped showing contents, correct locker number and date of wrapping.  All fruits and vegetables shall be prepared by an approved method before being quick or sharp frozen.

  196.495.  Record of name and address of user. — Every operator of a locker plant shall keep an accurate record of the name and address of the user of each locker.

  196.500.  Accurate and complete report of weight of food. — If requested by the user, the locker plant operator shall supply the person delivering the carcass or parts of carcasses an accurate and complete report showing the carcass weight at time of delivery, and disposition of carcass, including the quantity used for sausage or other meat products.  Likewise, the operator shall supply a complete and accurate record showing the weights and quantity of any fruits or vegetables received and the size and number of containers of finished products packed.

  196.505.  Designation of food not for human consumption. — Any food not intended for human consumption, if acceptable by the operator for storage, may be stored in the chill room, sharp freeze room or locker room of any locker plant only when such items of animal or vegetable matter have been inspected and approved by the representatives of the Bureau of Animal Industry of the United States Department of Agriculture or a representative of the department of agriculture of this state.  Such food not intended for human consumption also shall bear a label or tag showing plainly and conspicuously in letters not less than three-eighths of an inch in height the words:

"NOT FOR HUMAN CONSUMPTION."

  196.510.  Operator to have lien on property for rentals — furnish content insurance. — 1.  Every operator shall have a lien upon all property of every kind stored in the locker plant for all locker rentals, processing, handling, and other charges due from owner of such property; and the locker plant operator may enforce the lien by suit and shall have authority to prevent removal of food stored pending the outcome of suit to enforce said lien.  Operators of locker plants shall not be construed to be warehousemen, nor shall receipts or other instruments issued by such persons in the operation contracts of their business be construed to be warehouse receipts or subject to the laws applicable thereto, nor shall the provisions of sections 196.450 to 196.515 apply to any warehouseman licensed under the provisions of chapter 415.

  2.  The operators of all locker plants shall furnish satisfactory locker content insurance to indemnify users against loss, issued by companies duly authorized and licensed to do and transact business in the state of Missouri, in a minimum amount for each locker or locker plant to be determined by the director; provided, however, that such operator may, and is hereby authorized to, collect the pro rata amount of the premium for such insurance from the user in addition to the locker rental as an additional service.

  196.515.  Revocation of license — enforcement. — 1.  Failure on the part of any locker plant operator to properly comply with the provisions of sections 196.450 to 196.515 shall authorize and empower the director to refuse to license or to revoke or suspend any license of the offending operator.

  2.  Injunction may issue by any court of competent jurisdiction to enforce the provisions hereof.

  196.520.  Short title. — Sections 196.520 to 196.610 shall be known as "The Missouri Manufacturing Milk and Dairy Market Testing Law".

  196.525.  Definitions. — Definitions, terminology, and standards of identity provided in Title 7, Code of Federal Regulations, Agriculture, Part 2858, subpart A-V and Title 21, Code of Federal Regulations, Food and Drugs, Parts 131 and 133, shall have precedence unless further defined herein.  Additions and exceptions to the definitions contained therein shall include:

  (1)  "Agent" means any duly authorized representative of the Missouri department of agriculture under the authority of the director;

  (2)  "Bulk milk truck operator" means any qualified individual who, as operator of a bulk milk transportation vehicle, is licensed by the department to make organoleptic inspection, and to sample and test milk as it is collected from dairy farm bulk milk cooling tanks;

  (3)  "Dairy farm" means any place or premises where one or more cows or goats are kept, and from which a part or all of the milk or milk products are provided, sold or offered for sale to a milk plant, transfer station or receiving station for manufacturing purposes;

  (4)  "Dairy manufacturing plant" means any processing or manufacturing plant utilizing milk, or a major ingredient thereof, in the production of products for human consumption.  The items pertaining to ice cream and frozen dessert products manufacturing plants regulated by the department of health and senior services contained in sections 196.851 to 196.918, and pertaining to grade "A" fluid milk plants regulated by the state milk board contained in sections 196.931 to 196.959 are exempt from this definition;

  (5)  "Dairy product" means any product or by-product which has as its precursor milk or an ingredient exclusive to milk, with the exception of products or by-products which are subject to the provisions of sections 196.851 to 196.918, relating to ice cream and frozen food products, and sections 196.931 to 196.959, as regulated by the state milk board;

  (6)  "Department" or "department of agriculture" means the department of agriculture of the state of Missouri;

  (7)  "Director" means the ranking authority or administrator of the department of agriculture, or the representative or agent of the director;

  (8)  "Department of health and senior services" means the department of health and senior services of the state of Missouri;

  (9)  "Fieldman" means any qualified person who is duly authorized as a field representative of a processing or manufacturing plant or producer cooperative, whose responsibilities include procurement and quality control, and who is duly licensed by the department;

  (10)  "Grader" means any qualified individual licensed by the department to sample, test and grade milk or cream;

  (11)  "Manufacturing milk" is all milk and cream produced and made available for market that is not under the inspection supervision of the Missouri state milk board as it administers sections 196.931 to 196.959;

  (12)  "Person" shall mean any individual, plant operator, partnership, corporation, company, firm, trustee, association or institution;

  (13)  "Producer" means one who milks or supervises the milking of one or more cows or goats, and is legally entitled to market the production therefrom;

  (14)  "Receiving plant or station" means the delivery point for milk and cream collected from, or delivered by, one or more producers;

  (15)  "Regulations" means the rules and official orders authorized and promulgated by the director of agriculture according to the provisions of chapter 536 in accordance with the provisions of sections 196.520 to 196.610, along with other regulations of state and federal agencies;

  (16)  "State milk board" means the board created by section 196.941, and authorized to administer the provisions of sections 196.931 to 196.959;

  (17)  "Test or analysis" means the inclusion of prescribed sampling, sample preservation and preparation with appropriate analytical procedure to reach the desired objective; such procedures shall be used as are set forth in the latest editions of the "Official Methods of Analysis of the Association of Official Analytical Chemists" and the "Standard Methods for the Examination of Dairy Products".

  196.527.  Purposes. — It shall be the responsibility of the state milk board^* to encourage orderly and sanitary production, transportation, processing and grading of manufactured milk and its products, to assure wholesome, stable, and high-quality dairy products; and to provide the basis for measuring, weighing and testing all milk, including grade "A" fluid milk and manufacturing milk, to determine its value at first point of sale.

  196.530.  Standards to be maintained. — The standards of quality and purity associated with healthful and wholesome milk and dairy products shall be maintained for manufactured dairy products.  All regulations adopted shall be equal or superior to those of the United States Department of Agriculture, "Milk for Manufacturing Purposes and Its Production and Processing Recommended Requirements", as published in the Federal Register of April 7, 1972, Volume 37, Number 68, Part II, or the latest revision thereof.

  196.540.  Administration by state milk board — rules, promulgation — exempt products. — 1.  The state milk board^* shall administer the provisions of sections 196.520 to 196.610, and is hereby authorized to:

  (1)  Promulgate those regulations necessary to fulfill the intent of sections 196.520 to 196.610 as related to the production, transportation, grading, use and processing of manufacturing milk; to the packaging, labeling and storage of dairy products made therefrom; and to the measuring, weighing, sampling and testing of all milk, grade "A" fluid milk and manufacturing milk, at first point of sale; provided, such regulations are promulgated according to the provisions of this section and chapter 536;

  (2)  Inspect manufacturing dairy farms and dairy manufacturing plants;

  (3)  Certify dairy farms for the production and sale of manufacturing milk;

  (4)  License dairy manufacturing plants to handle and process manufacturing milk in conformity with basic requirements and specifications prescribed by such regulations as may be issued hereunder in effectuation of the intent hereof;

  (5)  Inspect and license laboratories involved in market testing of milk at first point of sale;

  (6)  Require the keeping of appropriate books and records by plants, farms, and laboratories licensed hereunder; and

  (7)  License qualified milk graders, fieldmen, and bulk milk truck operators.

  2.  No rule or portion of a rule promulgated under the authority of sections 196.520 to 196.614 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  3.  Exempt from the provisions of sections 196.520 to 196.610 shall be ice cream and frozen desserts which are under the authority of the department of health and senior services, which administers sections 196.851 to 196.918^**; and grade "A" fluid milk products, which are under the authority of the state milk board pursuant to sections 196.931 to 196.959.

  196.542.  Fees for licenses. — The state milk board^* shall establish the fees for all licenses by regulation promulgated in accordance with chapter 536.

  196.545.  Unlawful sale of dairy products. — It shall be unlawful to sell, offer or expose for sale, or deliver manufacturing milk or any dairy products made from manufacturing milk which:

  (1)  Are produced by animals afflicted with a contagious or infectious disease deleterious to man or detrimental to milk quality;

  (2)  Are not colostrum free or which have been taken from a cow fed or in contact with any substance that is unhealthful or that may produce unhealthful, impure or unwholesome milk;

  (3)  Are adulterated by the addition of any unauthorized substance including water or other material foreign to milk;

  (4)  Have been handled by any person afflicted with an infectious or contagious disease; or

  (5)  Are produced in unhealthy or unsanitary surroundings or held in unclean or unsanitary containers.

  196.550.  Grading of products — right to protest accuracy, procedure. — Whenever milk or cream, whether it be grade "A" fluid or of manufacturing grade, is bought or sold, market tests conforming to sampling and testing procedures as prescribed by the most recent edition of the "Official Methods of Analysis of the Association of Official Analytical Chemists" and the "Standard Method for the Examination of Dairy Products" shall be used to determine the desired component content.  It shall be unlawful for any person to manipulate, underread, or overread the test, or any other contrivance for determining the quality or value of milk or cream, or to falsify or fail to keep the record thereof, or to pay for such milk or cream on other than the true measurement, grade, weight and test; provided that, any person selling milk or cream who is dissatisfied with the grade or test designated for his milk or cream shall be entitled to receive pay for such milk or cream on the grade or test as made and reported to him without waiving his right to protest the accuracy thereof.  Such seller shall have the right to have his milk or cream officially graded or tested under a procedure whereby he and the buyer thereof jointly take a sample of such milk or cream and submit such sample to an appropriate laboratory chosen by the director.  The results of the test conducted shall be final and either the buyer or the seller shall be entitled to receive any financial adjustment due him on the basis of the test made as provided in this section.

  196.555.  The state milk board's right of access. — The state milk board^* shall have access to all dairy farms producing manufacturing milk, dairy manufacturing plants and dairy receiving stations; to all equipment; and to all vehicular conveyances used in the production, transportation and manufacture of milk and its products when offered, exposed for sale or sold; and to locations where market sampling, measuring, weighing, or testing is done for the first point of sale.

  196.560.  Records of purchases and sales. — Persons engaged in the purchase and sale of milk for manufacturing and processing shall keep receipts of sale and records of all such purchases of milk and cream for a period of at least one year.  Records of such purchases shall include date received, weight, results of all tests to determine value or grade, and price paid.  The state milk board^* shall have access to these records all of which shall be kept confidential as to individual items or totals of an individual person or plant.

  196.565.  The state milk board may take samples. — The state milk board^* may, for the purpose of examination or testing for the enforcement of this law, procure at any time samples of milk or its products whether produced within this state or shipped into and offered, exposed for sale or sold in the state.  Any samples taken shall be carefully sealed and labeled with the name, or brand name; the name and address of the owner from whose stock it was taken; the date and place where the sample was obtained; and bear the signature of the person taking the sample.  Upon request a duplicate sample sealed and labeled in the same manner shall be delivered to the owner or owner's representative.

  196.570.  Condemnation of illegal dairy products. — The state milk board^* or its agent is authorized to condemn any illegal manufactured dairy product as defined in section 196.545, which is offered, exposed for sale, or sold for human food purposes, and shall identify same as an unlawful product.  It shall be unlawful to remove or deface any identification placed upon the container of a condemned milk supply or upon a condemned product.  A harmless food coloring may be used to identify a supply of illegal milk.

  196.575.  Unidentified products subject to seizure. — Any articles found in the possession of any person which are not identified as to the name and address of the manufacturer, the name of the product, and the list of ingredients, as required for specific product identity, may be seized and held until properly graded and labeled.

  196.580.  Confiscated products released to owner, when. — Any condemned or seized milk or dairy products shall be released to the owner upon determination of satisfactory grade and identification, upon assurance that such products will not be used for human food, or upon their destruction by the owner under the supervision of the director.

  196.585.  Inspection, interference prohibited. — It is unlawful for any person to hinder, obstruct or in  any manner interfere with the state milk board^* in the performance of inspection or any other duty under sections 196.520 to 196.610.

  196.590.  Suspension or revocation of licenses. — The state milk board^* may for good cause, after notice and opportunity for hearing in accordance with the provisions of chapter 536, suspend or revoke certifications and licenses issued hereunder; provided, that nothing in sections 196.520 to 196.610 shall be construed to prevent the temporary suspension of the operation of any production or manufacturing facility prior to a hearing when such action is necessary to stop the production, distribution, purchase or sale of illegal milk or illegal dairy products.

  196.595.  Substandard products, sale or production prohibited. — Beginning September 28, 1981, no person shall produce, sell, offer for sale or process milk or cream for the manufacture of human food except in accordance with the provisions of sections 196.520 to 196.610 and the regulations promulgated hereunder.

  196.610.  Penalty for violation. — 1.  Any person who violates any provision of sections 196.520 to 196.610 shall, upon conviction, be guilty of an infraction.

  2. Any person who knowingly violates any provision of sections 196.520 to 196.610 shall, upon conviction, be guilty of a class A misdemeanor.

  3.  Nothing in sections 196.520 to 196.610 shall be so construed as to prohibit any dairy farmer who holds a valid permit at the inception of sections 196.520 to 196.610 to produce and sell manufactured grade milk.

  196.612.  Contract with the United States Department of Agriculture to inspect plants and grade products. — The state milk board may contract with the United States Department of Agriculture regarding the inspection of manufacturing milk plants, the grading of product, or both.  Fees paid to the board from the department for inspection or grading services are to be set forth by contractual agreement and paid according to the board's performance of the required inspections as stipulated by the Federal Register guidelines.

  196.614.  State contracted manufacturing dairy plant inspection and grading fee fund — purpose — interest — unexpended balance, transfer to general revenue prohibited. — 1.  All moneys received by the state milk board from the United States Department of Agriculture for contracted manufacturing dairy plant inspection or grading shall be deposited in the state treasury and credited to the "State Contracted Manufacturing Dairy Plant Inspection and Grading Fee Fund", which is hereby established, subject to appropriations by the general assembly.  Amounts appropriated to the fund shall be paid to the state milk board and used exclusively for the purpose of defraying the cost of the contracted manufacturing milk inspection and grading program.  All interest generated by the fund shall be credited to the fund.

  2.  Notwithstanding the provisions of section 33.080 to the contrary, any unexpended balance remaining in the fund shall not be transferred or placed to the credit of the ordinary revenue fund of the state by the state treasurer at the end of each biennium.

  196.695.  Filled milk defined. — The term "filled milk" means any milk, cream or skim milk, whether or not condensed, evaporated, concentrated, powdered, dried or desiccated, to which has been added, or which has been blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream or skim milk, whether or not condensed, evaporated, concentrated, powdered, dried or desiccated, which has been melted or refined by heating, boiling or mixing; provided, that the above definition shall not include any distinctive proprietary food compound, not readily mistaken in tests for milk or cream, or for evaporated, condensed or powdered milk or cream; provided, however, that such compound is prepared and designed for feeding infants and young children and customarily used on the order of a physician; is packed in individual cans containing not more than sixteen and one-half ounces and bearing the label in bold type, that the contents are to be used only for said purposes; is shipped in interstate or foreign commerce exclusively to physicians, wholesale or retail druggists, orphan asylums, child welfare associations, hospitals and similar institutions and generally distributed by them.

  196.700.  Emulsified cream defined. — The term "emulsified cream" means any milk, cream or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried or desiccated, to which has been added that which is commonly known as process butter, or butter which has been clarified or refined by heating, boiling or by mixing under pressure, or otherwise, so that the resulting product is in imitation or semblance of pure cream arising from pure fresh milk.

  196.705.  Fat or oil other than milk fat prohibited. — It shall be unlawful for any person, firm or corporation, by himself or itself, his or its agent or servant, or as the servant or as agent of another to manufacture, sell or exchange, or have in possession with the intent to sell or exchange, any milk, cream, emulsified cream, skim milk, buttermilk, condensed or evaporated milk, powdered milk, condensed skim milk, or any of the fluid derivatives thereof, or any of them, to which has been added any fat or oil other than milk fat, either under the name of said product or articles or the derivatives thereof, or under any fictitious or trade name whatsoever.

  196.710.  Emulsified cream and filled milk prohibited. — It shall be unlawful to use the article known as emulsified cream in milk, or in any milk product, or any purpose whatsoever.  It is hereby declared that filled milk, and emulsified cream as herein defined, are adulterated articles of food injurious to the public health and its sale constitutes a fraud upon the public.  It shall be unlawful for any person, firm or corporation to manufacture or ship or deliver to any person within this state any filled milk or emulsified cream.

  196.715.  Penalty for violation. — Any person violating any provision of sections 196.695 to 196.710 shall be deemed guilty of a misdemeanor.  When construing and enforcing the provisions of sections 196.695 to 196.710, the act, omission, or failure of any person acting for or employed by any individual, partnership or corporation, or association, within the scope of his employment or office, shall in every case be deemed the violation of sections 196.695 to 196.710, by such individual, partnership, corporation, or association, as well as the act of such person.

  196.735.  Labeling of cheese. — No person or persons, corporation, company or other association or congregation of individuals shall manufacture, sell or offer for sale, directly or indirectly, at retail or at wholesale in this state any article to be known or denominated cheese, not made from pure cream or unskimmed milk or cream of the milk, unless such person, or persons, corporation, company or association of individuals manufacturing the same, or offering the same for sale, or selling the same, shall brand or label such cheese or articles so offered for sale denominated a cheese, with black letters not less than one inch in length in a conspicuous place and of large size in the English language as follows: "Skimmed milk cheese", or with the words "not full cream cheese", giving the true name of such article called cheese so manufactured or offered for sale, clearly and indelibly branded, marked or labeled thereon, so that the same can be distinctly read and fully comprehended, at all stores or places or factories where the same may be offered for sale.

  196.740.  Labeling for shipments of skimmed milk. — No person by himself or another shall ship, consign or forward by any common carrier, whether public or private, any substance designed to be used as cheese, not made from pure, unskimmed milk or cream of the same, testing at least three percent butterfat, unless such cheese is marked or labeled "skimmed milk cheese", or with the words "not full cream cheese", labeled thereon, or labeled as prescribed in sections 196.695 to 196.845.

  196.815.  Receptacles defined. — As used in sections 196.820 to 196.830, the term "receptacle" shall include not only bottles, siphons, tins, kegs, barrels of all sizes, boxes, ice cream cabinets, cans and tubs, but all other receptacles used for holding any of the commodities named in said sections.

  196.820.  Receptacles kept clean. — Every person delivering milk, cream or ice cream to creameries, cheese factories, common carriers, or any person, persons, copartnership, association or corporation, in cans, bottles or other vessels, shall have such cans, bottles or other vessels free from deleterious substance, filth or rust, and in a wholesome condition for containing such milk, cream or ice cream.

  196.825.  Return of shipping containers. — Every person receiving milk, cream or ice cream from a common carrier in cans, bottles or other vessels which are to be returned to the shipper shall cause such vessels to be promptly emptied, cleansed and delivered to the common carrier to be returned to the shipper, and it shall be the duty of such common carrier receiving the same to have said cans, bottles or other vessels in transit within not to exceed twenty-four hours after receiving the same.

  196.830.  Receptacle cleaned and returned to distributor. — Every person receiving milk, cream or ice cream from a manufacturer or distributor of the same in cans, bottles or other vessels which are to be returned to the manufacturer or distributor, shall cause such vessels, after being emptied, to be promptly cleansed and returned.

  196.835.  Penalty. — Any person offending against any provision of sections 196.820 to 196.830 shall be deemed guilty of a misdemeanor, and upon conviction thereof by a court of competent jurisdiction shall be punished by a fine of not less than five dollars nor more than twenty-five dollars, and each receptacle unlawfully dealt with as herein provided shall be deemed and held to constitute a separate offense.

  196.840.  Examination and tuberculin test of cattle, when. — No person, firm or corporation owning, or in charge of, any herd of cattle containing five head of cows or more, after January 1, 1922, shall sell, offer for sale, give away, or deliver any milk, cream, butter, or buttermilk from any of the cows of such herd, unless all the herd of cattle containing such five head of cows or more, owned by, or in possession of, such person, firm or corporation have been duly inspected and tested and found free from tuberculosis and other communicable diseases, as determined by a physical examination and the tuberculin test by an official, duly authorized by this state or by the federal government; provided, that said examination and tuberculin test shall incur no expense whatever to the owner of said herd.

  196.845.  Violation a misdemeanor. — Any person, firm or corporation, who violates any of the provisions of section 196.840 shall be deemed guilty of a misdemeanor.

  196.851.  Applicability — purpose of law. — The provisions of sections 196.851 to 196.895 shall apply to all ice cream and related frozen food products defined in section 196.856; and the purpose of sections 196.851 to 196.895 is declared to be to secure the wholesomeness and purity of such products, and to prevent confusion, fraud and deception in connection with their manufacture and sale and to make unlawful the misbranding and adulteration of such products.

  196.856.  Definitions of products subject to law. — Only ingredients or products recognized by the department of health and senior services in properly adopted rules may be used in addition to those ingredients or products defined in this section.  For the purpose of sections 196.851 to 196.895 the products within their purview are defined as follows, and in each instance it is implied that the product is clean and sound:

  (1)  "Ice cream" is the food prepared by freezing, while stirring, a pasteurized mix composed of one or more of the optional dairy ingredients specified in subdivision (2) of this section, sweetened with one or more of the optional sweetening ingredients specified in subdivision (3) of this section, flavored with one or more of the optional flavoring ingredients specified in subdivision (4) of this section; one or more of the optional egg ingredients specified in subdivision (5) may be used; one or more of the optional stabilizing ingredients specified in subdivision (6) may be used; one or more of the optional acidity standardizing ingredients specified in subdivision (7) may be used subject to the conditions set forth in subdivisions (5), (6) and (7), as the case may be.  U.S.  certified food color may be added.  The mix may be seasoned with salt and may be homogenized.  Water may be added. The kind and quantity of optional dairy ingredients used, and the content of milk fat and total milk solids are such that the weight of milk fat and total milk solids are not less than ten percent and twenty percent, respectively, of the weight of the finished ice cream.  If one or more of the optional flavoring ingredients specified in paragraphs (d), (e), (f), (g), (h) and (i) of subdivision (4) of this section are used, the weight of milk fat and total milk solids are not to be less than ten percent and twenty percent, respectively, except for such reduction in milk fat and in total milk solids as is due to the addition of one or more of the optional ingredients specified in paragraphs (d), (e), (f), (g), (h) and (i) of subdivision (4) of this section but in no case shall it contain less than eight percent of milk fat nor less than sixteen percent of total milk solids.  Ice cream shall contain not less than one and six-tenths pounds of total food solids per gallon and shall weigh not less than four and one-half pounds per gallon.

  (2)  The optional dairy ingredients are sweet cream, dried cream, butter, butter oil, concentrated milk fat, milk, concentrated milk, evaporated milk, sweetened condensed milk, superheated condensed milk, dried milk, skim milk, concentrated (evaporated or condensed) skim milk, superheated condensed skim milk, sweetened condensed skim milk, sweetened condensed partly skimmed milk, nonfat dry milk solids, edible dry whey, cheese whey, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, and any of the foregoing products from which all or a portion of the lactose has been removed after crystallization or the lactose has been converted to simple sugars by hydrolysis.  Harmless optional ingredients may be used to prevent fat oxidation in any of the foregoing optional dairy ingredients in an amount not exceeding five-thousandths of one percent of the weight of the milk fat present in any of such dairy ingredients.  Sour cream shall never be used as an ingredient.

  (3)  The optional sweetening ingredients are sugar, liquid sugar, dextrose, invert sugar (paste or sirup), lactose, fructose, corn sugar, dried or liquid corn sirup, maple sirup, maple sugar, honey, brown sugar, malt sirup, dried malt extract, molasses (other than blackstrap) and any other nutritive sweetening ingredient approved by the federal Food and Drug Administration.

  (4)  The optional flavoring ingredients are:

  (a)  Natural food flavoring;

  (b)  Artificial food flavoring;

  (c)  Fruit juices, which may be fresh, frozen, canned, concentrated or dried and which may be sweetened and thickened with one or more of the optional stabilizing ingredients specified in subdivision (6);

  (d)  Chocolate;

  (e)  Cocoa;

  (f)  Fruit which may be fresh, frozen, canned, concentrated, shredded, pureed, comminuted or dried and which may be sweetened, thickened with stabilizer, and acidulated with citric, tartaric, malic, lactic or ascorbic acid;

  (g)  Nut meats;

  (h)  Confectionery; and

  (i)  Vanilla flavoring may be fortified with vanillin only.

  (5)  Optional egg ingredients are liquid eggs, frozen eggs, dried eggs, egg yolks, frozen yolks, dried yolks; however, the total weight of egg yolk solids used singly, or in combination of two or more, must be less than the minimum prescribed in subdivision (8) for French ice cream.

  (6)  The optional stabilizing ingredients are gelatin, algin, extractive of Irish moss, psyllium seed husk, agar-agar, gum acacia, gum karaya, locust bean gum, gum tragacanth, cellulose gum, guar seed gum, monoglycerides or diglycerides or both of fat forming fatty acids or other harmless stabilizers or emulsifiers; but the total weight of the active material contained in the solids of any such ingredient used singly, or of any combination of two or more such ingredients used, is not more than one-half of one percent of the weight of the finished ice cream.

  (7)  The following harmless optional ingredients or combination of such ingredients may be added to control viscosity, adjust protein stability and adjust pH of the combined mix ingredients:

  (a)  Sodium bicarbonate;

  (b)  Magnesium oxide as such or as carbonate or hydroxide;

  (c)  Calcium oxide as such or as hydroxide or sucrate;

  (d)  Sodium citrate;

  (e)  Sodium phosphates.  

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The total ingredients (a) through (c) shall not exceed one-tenth of one percent by weight of the finished mix; nor shall the weight of ingredients (d) and (e) exceed two-tenths of one percent by weight of the finished mix.  It is further provided that the percentage of developed lactic acid in the mix prior to the addition of the above listed optional ingredients shall not exceed three one-thousandths of one percent by weight for each one percent of milk-solids-not-fat present in the mix.

  (8)  "French ice cream", "frozen custard", "French custard ice cream" conforms to the definition and standard of identity prescribed for ice cream by subdivision (1) that one or more of the optional egg ingredients permitted by subdivision (5) are used in such quantity that the total weight of egg yolk solids therein is not less than one and four-tenths percent of the weight of the finished French ice cream, except when any of the optional flavoring ingredients specified in paragraphs (d), (e), (f), (g), (h) and (i) of subdivision (4) of this section are used, in which case the weight of the egg yolk solids is not less than one and twelve-hundredths percent of the weight of the finished French ice cream.

  (9)  "Ice milk" conforms in all respects to the definition and standard of identity for ice cream prescribed in subdivision (1), except that it contains not less than two percent but not more than seven percent of milk fat and not less than fourteen percent total milk solids and except that it contains not less than one and three-tenths pounds of food solids per gallon.

  (10)  "Sherbet" is the food prepared by freezing, while stirring, a mix composed of one or a combination of the optional pasteurized dairy ingredients specified in subdivision (2), one or more of the optional sweetening ingredients specified in subdivision (3), fruit, fruit juice, or flavoring as hereinafter provided.  It may contain one or more of the optional stabilizing ingredients specified in subdivision (6) or pectin provided the weight of such stabilizer is not more than one-half of one percent of the weight of the finished sherbet.  The kind and quantity of optional dairy ingredients used is such that the total milk solids content is not more than five percent by weight of the finished sherbet and the milk fat content is not more than two percent and not less than one percent by weight of the finished sherbet.  It contains fruit or fruit juice as prescribed in subdivisions (1), (2), (3) and (6) of subsection 4 of this section.  It may contain citric, tartaric, malic, phosphoric, or lactic acid.  The acidity of the finished sherbet shall be not less than thirty-five hundredths of one percent of acid as determined by titrating with standard alkali and expressed as lactic acid.  It weighs not less than six pounds per gallon.

  (11)  "Water ice" conforms in all respects to the definition and standard of identity for sherbet prescribed in subdivision (10) except that it does not contain any of the optional dairy ingredients and consequently does not meet the provision respecting total milk solids and milk fat.

  (12)  "Mellorine" is a vegetable fat frozen dessert product which is a clean, frozen or semifrozen food prepared by freezing, while stirring, a pasteurized mix composed of edible vegetable fats, milk solids not fat, sugar or optional sweetening ingredients and optional flavoring ingredients as defined in section 196.856.  It may contain one or more optional stabilizing ingredients and emulsifiers as specified in subdivision (6) of this section, in an amount not exceeding one percent of active ingredients, whether used singly or in combination, of the weight of the finished product.

  (13)  "Edible fats", the edible natural fats derived from vegetable or milk sources including only such milk fat as is normally contained in the products enumerated in subdivision (2) of this section; the food fats may be hydrogenated or nonhydrogenated.  Harmless optional ingredients may be used to prevent fat oxidation in an amount not exceeding five-thousandths percent of the weight of the fat used.

  (14)  "Milk solids not fat", skim milk, concentrated (evaporated or condensed) skim milk, superheated condensed skim milk, sweetened condensed skim milk, nonfat dry milk solids, edible dry whey, cheese whey, sweet cream buttermilk (whether fluid, condensed or dried), and any of the foregoing products from which all or a portion of the lactose has been removed after crystallization or the lactose has been converted to simple sugar by hydrolysis.

  (15)  "Mix" or "mixes", the liquid which contains the ingredients of a vegetable or milk fat frozen dessert product and which, after freezing, becomes the vegetable or milk fat frozen dessert product.

  (16)  "Frozen dietary dairy dessert" and "frozen dietary desserts" is a food for any special dietary use, prepared by freezing, with or without agitation, composed of a pasteurized mix which may contain edible fat, protein, carbohydrates, natural or artificial sweeteners, flavoring stabilizers, emulsifiers, vitamins and minerals.

  196.872.  Rules and regulations for minimum sanitation to be established, procedure. — The department of health and senior services shall promulgate rules, pursuant to the provisions of this section and chapter 536, setting forth the minimum sanitation requirements of manufacturing ice cream or other related frozen food products.  No person, firm, association or corporation shall manufacture ice cream or other related frozen food products defined in sections 196.851 to 196.895 in any room or other place that is not maintained in compliance with these rules as determined by the director of the department of health and senior services or his agents.  No rule or portion of a rule promulgated under the authority of sections 196.851 to 196.895 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  196.881.  Samples for analysis to be furnished the department of health and senior services, when. — It shall be the duty of every person, firm, company, copartnership, or corporation to whom sections 196.851 to 196.895 apply, at the request of the director of the department of health and senior services or his agents, to furnish such samples of manufactured products defined in section 196.856, as said director may require for purpose of analysis.

  196.886.  Sale regulations — labeling. — No person, firm, association or corporation shall:

  (1)  Manufacture and sell ice cream, and related frozen food products defined in sections 196.851 to 196.895 in containers unless each container shall bear the name of the manufacturer or packer or distributor on the body or lid of such container.  When the name of the distributor is used, the national assigned plant number identifying location of the manufacturer shall appear on the container or^* consumer purchasing unit; or

  (2)  Sell or offer for sale or have in his or its possession with intent to sell, any product defined in sections 196.851 to 196.895 in or from a container which is falsely labeled or branded as to the manufacturer of such product; or

  (3)  Sell any product defined in sections 196.851 to 196.895 from a container or compartment of a fountain or cabinet which contains any article of food other than such products; or

  (4)  Use any container furnished or used for containing products defined in sections 196.851 to 196.895 for any other purposes.

  196.895.  Violation of law a misdemeanor. — Any person who violates any provision of sections 196.851 to 196.895 shall, upon conviction, be deemed guilty of a misdemeanor.

  196.931.  Definitions. — As used in sections 196.931 to 196.953 unless the context clearly indicates otherwise, the following words and terms shall have the meaning indicated:

  (1)  "Grade A pasteurized milk", grade A raw milk for pasteurization which has been pasteurized, cooled, and placed in the final container in a milk plant and conforming with the sanitation and bacteriological standards authorized by sections 196.931 to 196.953 and regulations promulgated thereunder;

  (2)  "Grade A raw milk for pasteurization", raw milk for pasteurization from producer dairies and conforming with all of the sanitation and bacteriological standards authorized by sections 196.931 to 196.953 and regulations which are promulgated thereunder;

  (3)  "Graded fluid milk and fluid milk products", milk products include cream, light cream, coffee cream, table cream, whipping cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, whipped coffee cream, whipped table cream, sour cream, cultured sour cream, half-and-half, sour half-and-half, cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, skimmed milk, lowfat milk, fortified milk and milk products, vitamin D milk and milk products, homogenized milk, flavored milk or milk products, eggnog, eggnog flavored milk, eggnog flavored lowfat milk, buttermilk, cultured buttermilk, cultured milk, cultured whole milk buttermilk, and acidified milk and milk products, and other fluid milk and fluid milk products so declared by the board which are sold, offered for sale, exposed for sale, delivered or advertised as graded milk and milk products;

  (4)  "Manufacturing raw milk", milk that does not meet the requirements of grade A raw milk for pasteurization as defined in sections 196.931 to 196.959;

  (5)  "Milk plant", any place, premises or establishment where graded fluid milk or fluid milk products are collected, handled, processed, stored, bottled, pasteurized and prepared for distribution, except an establishment where graded fluid milk products are sold at retail as purchased from a milk plant;

  (6)  "Milk plant operator", any person, firm, corporation or association operating any milk plant;

  (7)  "Milk producer", any person who operates a dairy farm and provides, sells, or offers milk for sale to a milk plant, receiving station, or transfer station;

  (8)  "Official rating agency", the state milk board;

  (9)  "Official rating survey", the survey conducted by the official state rating agency, as required by sections 196.931 to 196.953;

  (10)  "Person" shall mean an individual or individuals, or a firm, partnership, company, corporation, trustee, or association;

  (11)  "Political subdivision", any municipality, city, incorporated town, village, county, township, district or authority, or any portion or combination of two or more thereof;

  (12)  "State department of agriculture", the department of agriculture of Missouri;

  (13)  "State department of health and senior services", the department of health and senior services of Missouri;

  (14)  "State milk board", an appointed state agency functioning as administrator of state milk inspection; and

  (15)  "State milk inspection", the services of inspection, regulation, grading, and program evaluation of fluid milk and fluid milk products by agents, representatives or employees of the state milk board under the terms and provisions of sections 196.931 to 196.959 and regulations adopted to regulate the production, transportation, processing, manufacture, distribution and sale of graded fluid milk and fluid milk products.

  196.933.  Certain products exempted. — The provisions of sections 196.931 through 196.953 and regulations promulgated thereunder do not apply to manufacturing raw milk and manufactured dairy products, including, but not limited to, butter, condensed milk, evaporated milk, sterilized milk or milk products in hermetically sealed containers and not requiring refrigeration, all types of cheese, nonfat dry milk, dry whole milk and part fat dry milk unless used in the preparation of graded fluid milk or fluid milk products.

  196.935.  State milk inspection required on all graded fluid milk or milk products — pasteurization required, exception. — No person shall sell, offer for sale, expose for sale, transport, or deliver any graded fluid milk or graded fluid milk products in this state unless the milk or milk products are graded and produced, transported, processed, manufactured, distributed, labeled and sold under state milk inspection and the same has also been produced or pasteurized as required by a regulation authorized by section 196.939 and under proper permits issued thereunder.  Only pasteurized graded fluid milk and fluid milk products as defined in subdivision (3) of section 196.931 shall be sold to the final consumer, or to restaurants, soda fountains, grocery stores, or similar establishments; except an individual may purchase and have delivered to him for his own use raw milk or cream from a farm.

  196.937.  Penalty — violation by employee is violation by employer. — Any person violating any provision of section 196.935 is guilty of a misdemeanor.  When construing and enforcing the provisions of sections 196.931 through 196.953, the act, omission or failure of any person acting for or employed by an individual, partnership, corporation, or association within the scope of his employment or office shall, in every case, be deemed a violation of sections 196.931 through 196.953, by the individual, partnership, corporation or association, as well as the violations of sections 196.931 through 196.953, by the person.

  196.939.  Rules and regulations — inspection by political subdivisions prohibited, exceptions — hearings, notice — rules, procedure. — 1.  The state milk board shall promulgate, adopt, and file with the secretary of state as prescribed by law such regulations as deemed necessary for the purpose of sections 196.931 to 196.953.  Such regulations shall be enforced by the state milk board through either contractual agreements with political subdivisions of the state or employees of the state milk board.  The adoption of regulations for the purpose of establishing a milk inspection program other than one under contractual agreement with the state milk board by any political subdivision is prohibited.  Milk inspection by any political subdivision of the state except under contractual arrangements with the board is prohibited; provided the duly authorized official of any political subdivision of this state may take samples of such products which have been moved into, distributed within, or sold within the boundaries of such political subdivisions of this state for the sole purpose of determining that such milk and milk products comply with the standards developed by the state milk board.  Nothing in sections 196.931 to 196.959 shall be construed as prohibiting any epidemiological investigations by the proper authorities of any political subdivision.  A public hearing shall be held prior to the adoption of any regulation or modification thereof, upon notice published at least thirty days prior to the public hearings.  At the public hearing, any person shall be permitted to appear and to be heard on the proposed regulations or modifications thereof.  The standards of a regulation may exceed but shall not be less than those contained in the current edition of the Grade A Pasteurized Milk Ordinance of the United States Public Health Service as it exists or as it may be amended.  The board may employ an executive secretary and adequate staff for administering sections 196.931 to 196.959, the cost of which shall be paid from the milk inspection fee fund.

  2.  No rule or portion of a rule promulgated under the authority of sections 196.931 to 196.959 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

  196.941.  State milk board, membership, qualifications, appointment. — There is hereby created a board to be known as the "State Milk Board" to consist of twelve members to be nominated by the director of the department of agriculture and shall be appointed by the governor, with the advice and consent of the senate, four of whom shall be representatives and active members of the staff of each of four local health jurisdictions including St. Louis County, Missouri, health department; St. Louis City, Missouri, health division; Kansas City, Missouri, health department; Springfield, Missouri, health department.  Four grade A milk producers shall represent dairy producers through a registered milk producer organization or farm organization with no more than one representing any one organization; one member shall represent dairy processors through a recognized processor organization; and one member shall be a consumer at large.  Not more than six of the twelve board members shall be members of the same political party.  The consumer at large or his spouse shall not be affiliated with any of the above-mentioned groups.  The director of the state department of health and senior services or his designated representative and the state director of the department of agriculture or his designated representative shall serve as members.  The term of service of each board member shall expire September twenty-eight of the fourth year after appointment.  However, the term of the first members appointed shall expire September twenty-eight of the first to fourth year after appointment as specified by the governor and as equally as possible.  Provisions of sections 196.931 to 196.959 shall be implemented within one year of August 13, 1972.  Board members shall serve without financial compensation.

  196.943.  Appointments, when made — authority to act, when — failure of senate to consent, effect of. — Within thirty days after August 13, 1972, the governor shall appoint ten persons as members of the state milk board as set forth in section 196.941 and their authority to act shall commence upon receiving the advice and consent of the senate, if the senate shall be in session, but if the senate not be in session, the authority to act as an acting board member shall commence immediately upon appointment by the governor, but shall terminate if advice and consent is not received within thirty days after the senate convenes.  If advice and consent is not given, such person shall not be reappointed by the governor to the board.  To be eligible for appointment by the governor, the board member must be a citizen of the United States and a resident of the state.  Advice and consent may be withdrawn with regard to the appointment of a member of the state milk board by a majority vote of the elected members of the senate.

  196.945.  Inspection fee, payable when — hearing and notice before fee established. — An inspection fee shall be annually established by the board not to exceed five cents on each one hundred pounds of grade A raw milk for pasteurization produced under state milk inspection and^* shall be paid by the milk plant to the state milk board.  Milk dealers, processors, or distributors selling graded fluid milk and fluid milk products in the state as provided for by section 196.949 shall pay a fee, to be established annually by the board, not to exceed five cents on each one hundred pounds of milk or milk products to the state milk board; provided that no milk producer, person, milk dealer, milk processor or milk distributor shall be liable for inspection fees on fluid milk and fluid milk products for which fees have previously been paid to the state milk board.  Such fees shall be paid to the state milk board on or before the twentieth day of each month for the preceding calendar month.  The annual inspection fees shall be set by the board after holding a public hearing giving thirty days' public notice.

  196.947.  State milk inspection fee fund created — funds, how expended, not to revert to general revenue. — All moneys received for state milk inspection shall be deposited in the state treasury and credited to the "State Milk Inspection Fee Fund", which is hereby created, subject to appropriation by the general assembly and to be appropriated to the state milk board and used exclusively for the purpose of defraying the cost of state milk inspection and to other state agencies for such services in addition thereto that are provided by the state government.  The state milk board shall remit to the treasury of the local jurisdictions for which it may contract to provide services for administering milk inspection if other than by its own employees, moneys not exceeding five cents per one hundred pounds of milk or milk products.  The unexpended balance in the state milk inspection fee fund at the end of the biennium shall not be transferred to the general revenue fund of the state treasury and, accordingly, shall be exempt from the provisions of section 33.080 relating to the transfer of funds to the general revenue fund of the state by the state treasurer.  The financial proceedings of the board shall be subject to an annual audit by a certified public accountant and the audit report shall be a public record, subject to the inspection by the general public.

  196.949.  State inspection of milk or milk products not required, when. — Graded fluid milk or fluid milk products not inspected under state milk inspection may be sold, offered for sale, exposed for sale, and delivered in the state of Missouri, or any municipality thereof, if approved by the state milk board as provided for by regulations adopted by the state milk board; provided that, the graded fluid milk or fluid milk products from other states shall be produced and processed under the supervision of a duly authorized governmental agency operating under the provisions of an ordinance, statute, or regulation substantially equivalent to the regulations promulgated and adopted by the state milk board and enforced with equal effectiveness as determined by an official rating survey, and products meet applicable temperature, bacteriological and composition standards when sampled on arrival at point of retail sale.  Nothing in this section shall prohibit the state or local health officer from satisfying himself or herself that the governmental agency having jurisdiction over the production and processing is properly enforcing such provisions.

  196.951.  State milk board official rating agency — survey made, when, how. — The state milk board is hereby designated as the official rating agency.  At least biannually, or as often as necessary, the state milk board shall make an official rating survey to determine if there is appropriate and effective enforcement of the standards and provisions of sections 196.931 through 196.953 and such other surveys as may be necessary to assure enforcement of sections 196.931 through 196.953 throughout the state.  Unsatisfactory conditions shall be deemed to exist when a rating below the minimum acceptable rating established by the state milk board is found by the official rating survey.  Violation of sections 196.931 through 196.953 shall be deemed to exist when the unsatisfactory conditions causing the rating to fall below the minimum acceptable rating are not corrected within ninety days.  The minimum acceptable rating shall be ninety percent for the pasteurized milk supply as determined by rating methods recognized by the United States Public Health Service Food and Drug Administration.  The state milk board shall promulgate and adopt a single method of making official rating surveys of all milksheds.  Official surveys shall be made by a method substantially equivalent to procedures outlined in United States Governmental Printing Office Publication Number 678, titled "Methods of Making Sanitation Ratings of Milksheds".

  196.953.  Injunctive relief authorized. — In addition to the remedies provided in sections 196.931 through 196.953, or by law, the attorney general of the state or the prosecuting attorney of any county in which a violation of any provisions of sections 196.931 through 196.953 occurs is authorized to apply to any court of competent jurisdiction for, and the court shall have jurisdiction upon hearing and for cause shown to grant, a temporary or permanent injunction to restrain any person, partnership, corporation, or association from violating any provisions of sections 196.931 through 196.953.

  196.955.  Valid grade A milk permit holder may continue to sell grade A milk. — Nothing in sections 196.931 to 196.959 shall be so construed as to prohibit any grade A dairyman, who holds a valid grade A milk permit at the inception of sections 196.931 to 196.959, to continue to sell grade A milk.

  196.957.  Only one inspection required. — It is expressly provided that any milk or milk products once inspected and approved under sections 196.931 to 196.959 shall be freely marketable anywhere in the state of Missouri without any further inspection.

  196.959.  Appeal from order or regulation of board, how taken. — Any person aggrieved by an order or regulation of the milk board may appeal directly to the circuit court having jurisdiction over his principal place of business.  The case shall be placed at the head of the docket for a de novo hearing.

  196.970.  Citation of law. — Sections 196.970 to 196.984 shall be known and may be cited as the "Prescription Drug Repository Program Act".

  196.973.  Definitions. — As used in sections 196.970 to 196.984, the following terms shall mean:

  (1)  "Health care professional", any of the following persons licensed and authorized to prescribe and dispense drugs and to provide medical, dental, or other health-related diagnoses, care, or treatment:

  (a)  A licensed physician or surgeon;

  (b)  A registered nurse or licensed practical nurse;

  (c)  A physician assistant;

  (d)  A dentist;

  (e)  A dental hygienist;

  (f)  An optometrist;

  (g)  A pharmacist; and

  (h)  A podiatrist;

  (2)  "Hospital", the same meaning as such term is defined in section 197.020;

  (3)  "Nonprofit clinic", a facility organized as not for profit in which advice, counseling, diagnosis, treatment, surgery, care, or services relating to the preservation or maintenance of health are provided on an outpatient basis for a period of less than twenty-four consecutive hours to persons not residing or confined at such facility;

  (4)  "Out-of-state charitable repository", any of the following:

  (a)  A bona fide charitable, religious, or nonprofit organization, licensed or registered in this state as an out-of-state wholesale drug distributor under sections 338.210 to 338.370 and that otherwise qualifies as an exempt organization under Section 501(c)(3) of Title 26, United States Code, as amended; or

  (b)  A foreign medical aid mission group that distributes pharmaceuticals and health care supplies to needy persons abroad;

  (5)  "Prescription drug", a drug which may be dispensed only upon prescription by an authorized prescriber and which is approved for safety and effectiveness as a prescription drug under Section 505 of the Federal Food, Drug, and Cosmetic Act.

  196.976.  Prescription drug repository program established, criteria. — 1.  By January 1, 2005, the department of health and senior services shall establish the "Prescription Drug Repository Program" to accept and dispense prescription drugs donated for the purpose of being dispensed to persons who are residents of Missouri and who meet eligibility requirements established by rules promulgated pursuant to section 196.984.

  2.  The following criteria shall be used in accepting drugs for use in the program:

  (1)  Only prescription drugs in their original sealed and tamper-evident unit dose packaging shall be accepted and dispensed pursuant to the program;

  (2)  The packaging must be unopened; except that prescription drugs packaged in single-unit doses may be accepted and dispensed when the outside packaging is opened if the single-unit-dose packaging is undisturbed;

  (3)  Prescription drugs donated by individuals shall bear the manufacturer's lot number and an expiration date that is less than six months from the date the prescription drug is donated shall not be accepted or dispensed; and

  (4)  A prescription drug shall not be accepted or dispensed if there is reason to believe that the drug is adulterated as described in section 196.095;

  (5)  Subject to the limitations specified in this section, unused prescription drugs dispensed for purposes of a medical assistance program may be accepted and dispensed under the prescription drug repository program.

  196.979.  Donation of prescription drugs to the program, procedure — distribution to out-of-state charitable repositories, when. — 1.  Any person, including but not limited to a prescription drug manufacturer or health care facility, may donate prescription drugs to the prescription drug repository program.  The drugs shall be donated at a pharmacy, hospital, or nonprofit clinic that elects to participate in the prescription drug repository program and meets the criteria for participation established by rule of the department pursuant to section 196.984.  Participation in the program by pharmacies, hospitals, and nonprofit clinics shall be voluntary.  Nothing in sections 196.970 to 196.984 shall require any pharmacy, hospital, or nonprofit clinic to participate in the program.

  2.  A pharmacy, hospital, or nonprofit clinic which meets the eligibility requirements established in section 196.984 may dispense prescription drugs donated under the program to persons who are residents of Missouri and who meet the eligibility requirements of the program, or to other governmental entities and nonprofit private entities to be dispensed to persons who meet the eligibility requirements of the program.  A prescription drug shall be dispensed only pursuant to a prescription issued by a health care professional who is authorized by statute to prescribe drugs.  A pharmacy, hospital, or nonprofit clinic which accepts donated prescription drugs shall comply with all applicable federal and state laws dealing with the storage and distribution of dangerous drugs and shall inspect all prescription drugs prior to dispensing the prescription drugs to determine that they are not adulterated as described in section 196.095.  The pharmacy, hospital, or nonprofit clinic may charge persons receiving donated prescription drugs a handling fee, not to exceed a maximum of two hundred percent of the Medicaid dispensing fee, established by rule of the department promulgated pursuant to section 196.984. Prescription drugs donated to the program shall not be resold.  Any individual who knowingly resells any donated prescription drugs pursuant to sections 196.970 to 196.984 shall be guilty of a class E felony.

  3.  Drugs donated under this section that are not used or accepted by any pharmacy, hospital, or nonprofit clinic in this state may be distributed to out-of-state charitable repositories for use outside of this state.  Such donated drugs may be repackaged in a manner appropriate for distribution by participating pharmacies, hospitals, and nonprofit clinics.

  196.981.  Immunity from civil or criminal liability, when. — 1.  The following persons and entities when acting in good faith shall not be subject to criminal or civil liability for injury, death, or loss to person or property, or professional disciplinary action for matters related to donating, accepting, or dispensing prescription drugs under the prescription drug repository program:

  (1)  The department of health and senior services;

  (2)  The director of the department of health and senior services;

  (3)  Any prescription drug manufacturer, governmental entity, or person donating prescription drugs to the program;

  (4)  Any pharmacy, hospital, nonprofit clinic, out-of-state charitable repository, or health care professional that prescribes, accepts or dispenses prescription drugs under the program; and

  (5)  Any pharmacy, hospital, nonprofit clinic, or out-of-state charitable repository that employs or has a hospital medical staff affiliation with a health care professional who accepts or dispenses prescription drugs under the program.

  2.  A prescription drug manufacturer shall not, in the absence of bad faith, be subject to criminal or civil liability for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a prescription drug manufactured by the prescription drug manufacturer that is donated by any person under the program, including but not limited to liability for failure to transfer or communicate product or consumer information or the expiration date of the donated prescription drug.

  196.984.  Administrative rules, authority to promulgate. — 1.  In consultation with the board of pharmacy, the director of the department of health and senior services shall adopt and promulgate rules to implement the prescription drug repository program.  Such rules shall include:

  (1)  Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to receive and dispense donated prescription drugs under the program;

  (2)  Standards and procedures for accepting, safely storing, and dispensing donated prescription drugs;

  (3)  Standards and procedures for inspecting donated prescription drugs to determine that the original single-unit-dose packaging is sealed and tamper-evident and that the prescription drugs are unadulterated, safe, and suitable for dispensing;

  (4)  Eligibility requirements for recipients in the program shall be based on economic need for persons to receive prescription drugs under the program.  For purposes of this subdivision, "economic need" means a net family income below three hundred percent of the federal poverty level;

  (5)  An identification card by which a person who is eligible to receive donated prescription drugs under the program may demonstrate eligibility to the pharmacy, hospital, or nonprofit clinic;

  (6)  A form that a person receiving a prescription drug from the program must sign before receiving the drug to confirm that such person understands the criminal and civil immunity from liability provisions of the program;

  (7)  Establishing^* a maximum handling fee that pharmacies, hospitals, and nonprofit clinics may charge to drug recipients to cover restocking and dispensing costs;

  (8)  For prescription drugs donated to the program by individuals:

  (a)  A list of prescription drugs, arranged by category or by individual drug, that the program will and will not accept from individuals.  If a drug is ineligible for donation, the list must include a statement as to the reason the drug is ineligible for donation; and

  (b)  A form each donor must sign stating that the donor is the owner of the prescription drugs and intends to voluntarily donate such drugs to the program;

  (9)  For prescription drugs donated to the program by health care facilities, a list of prescription drugs, arranged by category or by individual drug, that the program will and will not accept from health care facilities.  If a drug is ineligible for donation, the list must include a statement as to the reason the drug is ineligible for donation; and

  (10)  Any other standards and procedures the department deems appropriate or necessary to implement the provisions of sections 196.970 to 196.984.

  2.  Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in sections 196.970 to 196.984 shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028.  Sections 196.970 to 196.984 and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2004, shall be invalid and void.

  196.990.  Epinephrine auto-injectors, authorized entities may stock supply — definitions — procedure — immunity from liability — applicability. — 1.  As used in this section, the following terms shall mean:

  (1)  "Administer", the direct application of an epinephrine auto-injector to the body of an individual;

  (2)  "Authorized entity", any entity or organization at or in connection with which allergens capable of causing anaphylaxis may be present including, but not limited to, qualified first responders, as such term is defined in section 321.621, restaurants, recreation camps, youth sports leagues, amusement parks, and sports arenas.  "Authorized entity" shall not include any public school or public charter school;

  (3)  "Epinephrine auto-injector", a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body;

  (4)  "Physician", a physician licensed in this state under chapter 334;

  (5)  "Provide", the supply of one or more epinephrine auto-injectors to an individual;

  (6)  "Self-administration", a person's discretionary use of an epinephrine auto-injector.

  2.  A physician may prescribe epinephrine auto-injectors in the name of an authorized entity for use in accordance with this section, and pharmacists, physicians, and other persons authorized to dispense prescription medications may dispense epinephrine auto-injectors under a prescription issued in the name of an authorized entity.

  3.  An authorized entity may acquire and stock a supply of epinephrine auto-injectors under a prescription issued in accordance with this section.  Such epinephrine auto-injectors shall be stored in a location readily accessible in an emergency and in accordance with the epinephrine auto-injector's instructions for use and any additional requirements established by the department of health and senior services by rule.  An authorized entity shall designate employees or agents who have completed the training required under this section to be responsible for the storage, maintenance, and general oversight of epinephrine auto-injectors acquired by the authorized entity.

  4.  An authorized entity that acquires a supply of epinephrine auto-injectors under a prescription issued in accordance with this section shall ensure that:

  (1)  Expected epinephrine auto-injector users receive training in recognizing symptoms of severe allergic reactions including anaphylaxis and the use of epinephrine auto-injectors from a nationally recognized organization experienced in training laypersons in emergency health treatment or another entity or person approved by the department of health and senior services;

  (2)  All epinephrine auto-injectors are maintained and stored according to the epinephrine auto-injector's instructions for use;

  (3)  Any person who provides or administers an epinephrine auto-injector to an individual who the person believes in good faith is experiencing anaphylaxis activates the emergency medical services system as soon as possible; and

  (4)  A proper review of all situations in which an epinephrine auto-injector is used to render emergency care is conducted.

  5.  Any authorized entity that acquires a supply of epinephrine auto-injectors under a prescription issued in accordance with this section shall notify the emergency communications district or the ambulance dispatch center of the primary provider of emergency medical services where the epinephrine auto-injectors are to be located within the entity's facility.

  6.  No person shall provide or administer an epinephrine auto-injector to any individual who is under eighteen years of age without the verbal consent of a parent or guardian who is present at the time when provision or administration of the epinephrine auto-injector is needed.  Provided, however, that a person may provide or administer an epinephrine auto-injector to such an individual without the consent of a parent or guardian if the parent or guardian is not physically present and the person reasonably believes the individual shall be in imminent danger without the provision or administration of the epinephrine auto-injector.

  7.  The following persons and entities shall not be liable for any injuries or related damages that result from the administration or self-administration of an epinephrine auto-injector in accordance with this section that may constitute ordinary negligence:

  (1)  An authorized entity that possesses and makes available epinephrine auto-injectors and its employees, agents, and other trained persons;

  (2)  Any person who uses an epinephrine auto-injector made available under this section;

  (3)  A physician that prescribes epinephrine auto-injectors to an authorized entity; or

  (4)  Any person or entity that conducts the training described in this section.

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Such immunity does not apply to acts or omissions constituting a reckless disregard for the safety of others or willful or wanton conduct.  The administration of an epinephrine auto-injector in accordance with this section shall not be considered the practice of medicine.  The immunity from liability provided under this subsection is in addition to and not in lieu of that provided under section 537.037.  An authorized entity located in this state shall not be liable for any injuries or related damages that result from the provision or administration of an epinephrine auto-injector by its employees or agents outside of this state if the entity or its employee or agent is not liable for such injuries or related damages under the laws of the state in which such provision or administration occurred.  No trained person who is in compliance with this section and who in good faith and exercising reasonable care fails to administer an epinephrine auto-injector shall be liable for such failure.

  8.  All basic life support ambulances and stretcher vans operated in the state shall be equipped with epinephrine auto-injectors and be staffed by at least one individual trained in the use of epinephrine auto-injectors.

  9.  The provisions of this section shall apply in all counties within the state and any city not within a county.

  10.  Nothing in this section shall be construed as superseding the provisions of section 167.630.

  196.1000.  Definitions. — Definitions.

  (a)  "Adjusted for inflation" means increased in accordance with the formula for inflation adjustment set forth in Exhibit C to the Master Settlement Agreement.

  (b)  "Affiliate" means a person who directly or indirectly owns or controls, is owned or controlled by, or is under common ownership or control with, another person.  Solely for purposes of this definition, the terms "owns,""is owned" and "ownership" mean ownership of an equity interest, or the equivalent thereof, of ten percent or more, and the term "person" means an individual, partnership, committee, association, corporation or any other organization or group of persons.

  (c)  "Allocable share" means Allocable Share as that term is defined in the Master Settlement Agreement.

  (d)  "Cigarette" means any product that contains nicotine, is intended to be burned or heated under ordinary conditions of use, and consists of or contains (1) any roll of tobacco wrapped in paper or in any substance not containing tobacco; or (2) tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette; or (3) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in clause (1) of this definition.  The term "cigarette" includes "roll-your-own" (i.e., any tobacco which, because of its appearance, type, packaging, or labeling is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes).  For purposes of this definition of "cigarette," 0.09 ounces of "roll-your-own" tobacco shall constitute one individual "cigarette."

  (e)  "Master Settlement Agreement" means the settlement agreement (and related documents) entered into on November 23, 1998 by the State and leading United States tobacco product manufacturers.

  (f)  "Qualified escrow fund" means an escrow arrangement with a federally or State chartered financial institution having no affiliation with any tobacco product manufacturer and having assets of at least $1,000,000,000 where such arrangement requires that such financial institution hold the escrowed funds' principal for the benefit of releasing parties and prohibits the tobacco product manufacturer placing the funds into escrow from using, accessing or directing the use of the funds' principal except as consistent with section 2(b)(2) of this Act.

  (g)  "Released claims" means Released Claims as that term is defined in the Master Settlement Agreement.

  (h)  "Releasing parties" means Releasing Parties as that term is defined in the Master Settlement Agreement.

  (i)  "Tobacco Product Manufacturer" means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  (1)  manufactures cigarettes anywhere that such manufacturer intends to be sold in the United States, including cigarettes intended to be sold in the United States through an importer (except where such importer is an original participating manufacturer (as that term is defined in the Master Settlement Agreement) that will be responsible for the payments under the Master Settlement Agreement with respect to such cigarettes as a result of the provisions of subsection II(mm) of the Master Settlement Agreement and that pays the taxes specified in subsection II(z) of the Master Settlement Agreement, and provided that the manufacturer of such cigarettes does not market or advertise such cigarettes in the United States);

  (2)  is the first purchaser anywhere for resale in the United States of cigarettes manufactured anywhere that the manufacturer does not intend to be sold in the United States; or

  (3)  becomes a successor of an entity described in paragraph (1) or (2).

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The term "Tobacco Product Manufacturer" shall not include an affiliate of a tobacco product manufacturer unless such affiliate itself falls within any of (1)-(3) above.

  (j)  "Units sold" means the number of individual cigarettes sold in the State by the applicable tobacco product manufacturer (whether directly or through a distributor, retailer or similar intermediary or intermediaries) during the year in question, as measured by excise taxes collected by the State on packs (or "roll-your-own" tobacco containers) bearing the excise tax stamp of the State.  The department of revenue shall promulgate such regulations as are necessary to ascertain the amount of State excise tax paid on the cigarettes of such tobacco product manufacturer for each year.

  196.1003.  Requirements. — Requirements.

Any tobacco product manufacturer selling cigarettes to consumers within the State (whether directly or through a distributor, retailer or similar intermediary or intermediaries) after the date of enactment of this Act shall do one of the following:

(a)  become a participating manufacturer (as that term is defined in section II(jj) of the Master Settlement Agreement) and generally perform its financial obligations under the Master Settlement Agreement; or

(b)  (1)  place into a qualified escrow fund by April 15 of the year following the year in question the following amounts (as such amounts are adjusted for inflation) —

(2)  A tobacco product manufacturer that places funds into escrow pursuant to paragraph (1) shall receive the interest or other appreciation on such funds as earned.  Such funds themselves shall be released from escrow only under the following circumstances —

(A)  to pay a judgment or settlement on any released claim brought against such tobacco product manufacturer by the State or any releasing party located or residing in the State.  Funds shall be released from escrow under this subparagraph (i) in the order in which they were placed into escrow and (ii) only to the extent and at the time necessary to make payments required under such judgment or settlement;

(B)  to the extent that a tobacco product manufacturer establishes that the amount it was required to place into escrow in a particular year was greater than the State's allocable share of the total payments that such manufacturer would have been required to make in that year under the Master Settlement Agreement (as determined pursuant to section IX(i)(2) of the Master Settlement Agreement, and before any of the adjustments or offsets described in section IX(i)(3) of that Agreement other than the Inflation Adjustment) had it been a participating manufacturer, the excess shall be released from escrow and revert back to such tobacco product manufacturer; or

(C)  to the extent not released from escrow under subparagraphs (A) or (B), funds shall be released from escrow and revert back to such tobacco product manufacturer twenty-five years after the date on which they were placed into escrow.

(3)  Each tobacco product manufacturer that elects to place funds into escrow pursuant to this subsection shall annually certify to the Attorney General that it is in compliance with this subsection.  The Attorney General may bring a civil action on behalf of the State against any tobacco product manufacturer that fails to place into escrow the funds required under this section.  Any tobacco product manufacturer that fails in any year to place into escrow the funds required under this section shall —

(A)  be required within 15 days to place such funds into escrow as shall bring it into compliance with this section.  The court, upon a finding of a violation of this subsection, may impose a civil penalty to be paid to the State's general revenue fund in an amount not to exceed 5 percent of the amount improperly withheld from escrow per day of the violation and in a total amount not to exceed 100 percent of the original amount improperly withheld from escrow;

(B)  in the case of a knowing violation, be required within 15 days to place such funds into escrow as shall bring it into compliance with this section.  The court, upon a finding of a knowing violation of this subsection, may impose a civil penalty to be paid to the State's general revenue fund in an amount not to exceed 15 percent of the amount improperly withheld from escrow per day of the violation and in a total amount not to exceed 300 percent of the original amount improperly withheld from escrow; and

(C)  in the case of a second knowing violation, be prohibited from selling cigarettes to consumers within the State (whether directly or through a distributor, retailer or similar intermediary) for a period not to exceed 2 years.

Each failure to make an annual deposit required under this section shall constitute a separate violation.  Any tobacco product manufacturer that violates the provisions of this section shall pay the State's cost and attorney's fees incurred during a successful prosecution under this section.

  196.1020.  Definitions. — As used in sections 196.1020 to 196.1035, the following terms mean:

  (1)  "Brand family", all styles of cigarettes sold under the same trademark and differentiated from one another by means of additional modifiers or descriptors, including but not limited to "menthol", "lights", "kings", and "100s", and includes any brand name alone or in conjunction with any other word trademark, logo, symbol, motto, selling message, recognizable pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, a previously known brand of cigarettes;

  (2)  "Cigarette", the same meaning as such term is defined in section 196.1000;

  (3)  "Director", the director of the Missouri department of revenue;

  (4)  "Master settlement agreement", the same meaning as such term is defined in section 196.1000;

  (5)  "Nonparticipating manufacturer", any tobacco product manufacturer that is not a participating manufacturer;

  (6)  "Participating manufacturer", the same meaning as such term is defined in section II(jj) of the master settlement agreement and all amendments thereto;

  (7)  "Qualified escrow fund", the same meaning as such term is defined in section 196.1000;

  (8)  "Stamping agent", a person who is authorized to affix tax stamps to packages or other containers or cigarettes under chapter 149 or any person who is required to pay the tax imposed under section 149.160 on other tobacco products;

  (9)  "Tobacco product manufacturer", the same meaning as such term is defined in section 196.1000;

  (10)  "Units sold", the same meaning as such term is defined in section 196.1000.

  196.1023.  Certification, compliance with tobacco master settlement agreement required — directory listing. — 1.  Every tobacco product manufacturer whose cigarettes are sold in this state, whether directly or through a distributor, retailer, or similar intermediary or intermediaries, shall execute and deliver on a form prescribed by the director a certification to the director no later than the thirtieth day of April each year certifying, under penalty of perjury, that as of the date of such certification such tobacco product manufacturer is a participating manufacturer or is in full compliance with section 196.1003.

  (1)  A participating manufacturer shall include in its certification a list of its brand families.  The participating manufacturer shall update such list thirty calendar days prior to any addition to or modification of its brand families by executing and delivering a supplemental certification to the director.

  (2)  A nonparticipating manufacturer shall include in its certification:

  (a)  A list of all of its brand families and the number of units sold for each brand family that were sold in the state during the preceding calendar year;

  (b)  A list of all of its brand families that have been sold in the state at any time during the current calendar year, which shall indicate, by an asterisk, any brand family sold in the state during the preceding calendar year that is no longer being sold in the state as of the date of such certification; and

  (c)  The name and address of any other manufacturer of such brand families in the preceding or current calendar year.  

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The nonparticipating manufacturer shall update such list thirty calendar days prior to any addition to or modification of its brand families by executing and delivering a supplemental certification to the director.

  (3)  For a nonparticipating manufacturer, such certification shall further certify:

  (a)  That such nonparticipating manufacturer is registered to do business in the state or has appointed a resident agent for service of process and provided notice thereof as required in this subsection;

  (b)  That such nonparticipating manufacturer has established, and continues to maintain, a qualified escrow fund and has executed a qualified escrow agreement, governing the qualified escrow fund, which has been reviewed and approved by the director;

  (c)  That such nonparticipating manufacturer is in full compliance with sections 196.1003 and 196.1020 to 196.1035 and any rules promulgated thereunder;

  (d)  The name, address, and telephone number of the financial institution where the nonparticipating manufacturer has established such qualified escrow fund required under section 196.1003 and all rules promulgated thereunder;

  (e)  The account number of such qualified escrow fund and any subaccount number for the state;

  (f)  The amount such nonparticipating manufacturer placed in such fund for cigarettes sold in the state during the preceding calendar year;

  (g)  The date and amount of each such deposit, and such evidence or verification as may be deemed necessary by the director to confirm the foregoing; and

  (h)  The amount and date of any withdrawal or transfer of funds the nonparticipating manufacturer made, at any time, from such fund or from any other qualified escrow fund into which it ever made escrow payments under section 196.1003 and all rules promulgated thereunder.

  (4)  A tobacco product manufacturer shall not include a brand family in its certification unless:

  (a)  In the case of a participating manufacturer, such participating manufacturer affirms that the brand family is deemed to be its cigarettes for purposes of calculating its payments under the master settlement agreement for the relevant year, in the volume and shares determined under the master settlement agreement; and

  (b)  In the case of a nonparticipating manufacturer, such nonparticipating manufacturer affirms that the brand family is deemed to be its cigarettes for purposes of section 196.1003.  

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Nothing in this section shall be construed as limiting, or otherwise affecting, the state's right to maintain that a brand family constitutes cigarettes of a different tobacco product manufacturer for purposes of calculating payments under the master settlement agreement or for purposes of section 196.1003.

  (5)  Tobacco product manufacturers shall maintain all invoices and documentation of sales and other such information relied upon for such certification for a period of five years, unless otherwise required by law to maintain them for a greater period of time.

  2.  On or after January 1, 2011, the director shall issue, maintain, update when necessary but only on the first calendar day of each month, make available for public inspection and publish on its website a directory listing of all tobacco product manufacturers that have provided current and accurate certifications in compliance with the requirements of subsection 1 of this section and all brand families listed in such certifications, except:

  (1)  The director shall not include, or retain, in such directory the name or brand families of any nonparticipating manufacturer that fails to provide the required certification, or whose certification the director determines is not in compliance with subdivisions (2) and (3) of subsection 1 of this section, unless the director has determined that such violation has been cured to the satisfaction of the director;

  (2)  Neither a tobacco product manufacturer nor brand family shall be included, or retained, in the directory if the director concludes, in the case of a nonparticipating manufacturer that:

  (a)  Any escrow payment required under section 196.1003 for any period, for any brand family, whether or not listed by such nonparticipating manufacturer has not been fully paid into a qualified escrow fund governed by a qualified escrow agreement approved by the director; or

  (b)  Any outstanding final judgment, including interest thereon, for violations of section 196.1003 has not been fully satisfied for such brand family and such manufacturer;

  (3)  Every stamping agent shall provide, and update as necessary, an electronic mail address to the director for the purpose of receiving any notifications that may be required by sections 196.1020 to 196.1035.

  3.  (1)  The directory issued and updated in subsection 2 of this section shall become effective immediately but only as it applies to tobacco product manufacturers, and it shall be unlawful for any tobacco wholesaler or retailer to purchase from any tobacco product manufacturer any cigarette or brand family not listed in the directory.

  (2)  The directory issued in subsection 2 of this section shall become effective on the first day of the month following the month in which said directory is published or updated as it applies to tobacco wholesalers, and on the fifteenth day of the month following the month in which said directory is published or updated as it applies to tobacco retailers in order to allow wholesalers and retailers sufficient time to sell their inventory.

  (3)  Unless otherwise permitted herein, it shall be unlawful for any person to:

  (a)  Affix a stamp to a package or other container of cigarettes of a tobacco product manufacturer or brand family not included in the directory; or

  (b)  Sell, offer, or possess for sale in this state, or import for personal consumption in this state, cigarettes of a tobacco product manufacturer or brand family not included in the directory.

  196.1026.  Nonresident or foreign nonparticipating manufacturers, requirements. — 1.  Any nonresident or foreign nonparticipating manufacturer not registered to do business in this state as a foreign corporation or business entity shall, as a condition precedent to having its brand families listed or retained in the directory, appoint, and continually engage without interruption the services of an agent in this state to act as agent for the service of process on whom all process shall be served, and any action or proceeding against it concerning, or arising out of, the enforcement of sections 196.1003 and 196.1020 to 196.1035 may be served in any manner authorized by law.  Such service shall constitute legal and valid service of process on the nonparticipating manufacturer.  The nonparticipating manufacturer shall provide the name, address, phone number, and proof of the appointment and availability of such agent to the satisfaction of the director.

  2.  The nonparticipating manufacturer shall provide notice to the director thirty calendar days prior to termination of the authority of an agent and shall further provide proof, to the satisfaction of the director, of the appointment of a new agent no less than five calendar days prior to the termination of an existing agent appointment.  In the event an agent terminates an agency appointment, the nonparticipating manufacturer shall notify the director of the termination within five calendar days and shall include proof, to the satisfaction of the director, of the appointment of a new agent.

  3.  Any nonparticipating manufacturer whose cigarettes are sold in this state and who has not appointed and engaged an agent as herein required shall be deemed to have appointed the secretary of state as such agent and may be proceeded against in courts of this state by service of process upon the secretary of state.  However, the appointment of the secretary of state as such agent shall not satisfy the condition precedent for having the brand families of the nonparticipating manufacturer included, or retained, in the directory.

  196.1029.  Quarterly reports required, contents — disclosure to attorney general, when — escrow fund required, when — additional information may be required, when. — 1.  Not later than twenty days after the end of each calendar quarter and more frequently if so directed by the director, each stamping agent shall submit such information as the director requires to facilitate compliance with sections 196.1020 to 196.1035 including but not limited to:

  (1)  A list by brand family of the total number of cigarettes; or

  (2)  In the case of roll-your-own, the equivalent stick count for which the stamping agent affixed stamps during the previous calendar quarter or otherwise paid the tax due for such cigarettes.  

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The stamping agent shall maintain and make available to the director all invoices and documentation of sales of all nonparticipating manufacturer cigarettes and any other information relied upon in reporting to the director for a period of five years.

  2.  The director shall disclose to the attorney general any information received under sections 196.1020 to 196.1035 which is requested by the attorney general for purposes of determining compliance with and enforcing the provisions of sections 196.1020 to 196.1035.  The director and attorney general shall share with each other information received under sections 196.1003 and 196.1020 to 196.1035, or corresponding laws of other states.

  3.  The director may, at any time, require from the nonparticipating manufacturer proof from the financial institution, in which such manufacturer has established a qualified escrow fund for the purpose of compliance with section 196.1003, of the amount of money in such fund exclusive of interest, and the amount and date of each deposit to such fund, and the amount and date of each withdrawal from such fund.

  4.  In addition to any other information required to be submitted under sections 196.1020 to 196.1035, the director may require a stamping agent or tobacco product manufacturer to submit any additional information, including but not limited to samples of the packaging or labeling of each brand family, as is necessary to enable the director to determine whether a tobacco product manufacturer is in compliance with sections 196.1020 to 196.1035.

  196.1032.  Remedies for violations — distribution of cigarettes prohibited, when — violations, penalty. — 1.  In addition to, or in lieu of, any other civil or criminal remedy provided by law, upon a determination that a stamping agent or any person has violated subsection 3 of section 196.1023 or any regulation adopted under subsection 3 of section 196.1023, the director may revoke or suspend the license of any stamping agent in the manner provided in subsection 3 of section 149.035.  Each stamp affixed and each sale, or offer to sell, cigarettes in violation of subsection 3 of section 196.1023 shall constitute a separate violation.  Upon a determination of a violation of subsection 3 of section 196.1023 or any regulations adopted thereunder, the director may impose a civil penalty in an amount not to exceed the greater of five hundred percent of the retail value of the cigarettes or five thousand dollars for each such violation.

  2.  Any cigarettes deemed by a court of competent jurisdiction to have been sold, offered for sale, or possessed for sale in this state in violation of subsection 3 of section 196.1023 shall be contraband and such cigarettes shall be subject to seizure and forfeiture as provided in chapter 149 and all such cigarettes so seized and forfeited shall be destroyed and not resold.

  3.  The attorney general, on behalf of the director, may seek an injunction to restrain a threatened or actual violation of subsection 3 of section 196.1023, or subsection 1 or 4 of section 196.1029 by a stamping agent and to compel a stamping agent to comply with such provisions.  In any successful action brought under this section, the state may be entitled to recover the costs of investigation and action including reasonable attorney fees.

  4.  It shall be unlawful for a person to sell or distribute cigarettes, or acquire, hold, own, possess, transport, import, or cause to be imported, cigarettes that the person knows or should know are intended for distribution or sale in the state in violation of subsection 3 of section 196.1023.  A violation of this subsection shall be a class A misdemeanor.

  5.  A person who violates subsection 3 of section 196.1023 shall be deemed to have engaged in an unfair practice in violation of section 407.020.

  196.1035.  Judicial review of director's decision not to list — compliance agreement required — rulemaking authority — funds created. — 1.  A determination of the director not to list, or to remove from the directory, a brand family or tobacco product manufacturer shall be subject to review by a court of competent jurisdiction.

  2.  No person shall be issued, or granted a renewal of, a license under chapter 149 unless such person has certified, in writing and under the penalty of perjury, that such person will comply fully with sections 196.1020 to 196.1035.

  3.  The director may promulgate rules necessary to effect the purpose of sections 196.1020 to 196.1035.  Any rule or portion of a rule, as that term is defined in section 536.010 that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028.  This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2010, shall be invalid and void.

  4.  There is hereby created in the state treasury the "Tobacco Control Special Fund", which shall consist of money collected under this section.  The state treasurer shall be custodian of the fund and may approve disbursements from the fund in accordance with sections 30.170 and 30.180.  Upon appropriation, money in the fund shall be used solely for the administration of this section.  Any moneys remaining in the fund at the end of the biennium shall revert to the credit of the general revenue fund.  The state treasurer shall invest moneys in the fund in the same manner as other funds are invested.  Any interest and moneys earned on such investments shall be credited to the fund.

  5.  If a court of competent jurisdiction determines that a person has violated sections 196.1020 to 196.1035, such court shall order any profits, gains, gross receipts, or other benefits from such violation be disgorged and paid to the state treasurer for deposit in the "Tobacco Control Special Fund" which is hereby created.  Unless otherwise expressly provided, the remedies or penalties provided by sections 196.1020 to 196.1035 are cumulative to each other and to the remedies or penalties available under all other laws of this state.

  6.  If a court of competent jurisdiction finds that the provisions of sections 196.1003 and 196.1020 to 196.1035 conflict and cannot be harmonized, the provisions of section 196.1003 shall control.  If any section or portion of a section in sections 196.1020 to 196.1035 causes section 196.1003 to no longer constitute a qualifying or model statute, as those terms are defined in the master settlement agreement, that portion of sections 196.1020 to 196.1035 shall be invalid.

  196.1050.  Opioid addiction treatment, any opioid-related settlement moneys to be used for — fund established. — 1.  The proceeds of any monetary settlement or portion of a global settlement between the attorney general of the state and any drug manufacturers, distributors, pharmacies, or combination thereof to resolve an opioid-related cause of action against such drug manufacturers, distributors, pharmacies, or combination thereof in a state or federal court shall only be utilized to pay for opioid addiction treatment and prevention services and health care and law enforcement costs related to opioid addiction treatment and prevention.  Under no circumstances shall such settlement moneys be utilized to fund other services, programs, or expenses not reasonably related to opioid addiction treatment and prevention.

  2.  (1)  There is hereby established in the state treasury the "Opioid Addiction Treatment and Recovery Fund", which shall consist of the proceeds of any settlement described in subsection 1 of this section, as well as any funds appropriated by the general assembly, or gifts, grants, donations, or bequests.  The state treasurer shall be custodian of the fund.  In accordance with sections 30.170 and 30.180, the state treasurer may approve disbursements.  The fund shall be a dedicated fund and money in the fund shall be used by the department of mental health, the department of health and senior services, the department of social services, the department of public safety, the department of corrections, and the judiciary for the purposes set forth in subsection 1 of this section.

  (2)  Notwithstanding the provisions of section 33.080 to the contrary, any moneys remaining in the fund at the end of the biennium shall not revert to the credit of the general revenue fund.

  (3)  The state treasurer shall invest moneys in the fund in the same manner as other funds are invested.  Any interest and moneys earned on such investments shall be credited to the fund.

  196.1100.  Trust fund established, purpose — reversion to general revenue prohibited. — 1.  There is hereby established in the state treasury the "Life Sciences Research Trust Fund" to be held separate and apart from all other public moneys and funds of the state, including but not limited to the tobacco securitization settlement trust fund established in section 8.550.  The state treasurer shall deposit into the fund twenty-five percent of all moneys received from the master settlement agreement, as defined in section 196.1000, beginning in fiscal year 2007 and in perpetuity thereafter.  Moneys in the fund shall not be subject to appropriation for purposes other than those provided in sections 196.1100 to 196.1130 without a majority vote in each house of the general assembly.  All moneys in the fund shall be used for the purposes of sections 196.1100 to 196.1130 only. Notwithstanding the provisions of section 33.080 to the contrary, the moneys in the fund shall not revert to the credit of general revenue at the end of the biennium.

  2.  Moneys in the life sciences research trust fund shall be used strategically, in cooperation with other governmental and not-for-profit private entities, to enhance the capacity of the state of Missouri's ability to perform research to better serve the health and welfare of the residents of the state of Missouri as a center of life sciences research and development by building on the success of research institutions located in Missouri, creating in and attracting to Missouri new research and development institutions, commercializing the life sciences technologies developed by such institutions, and enhancing their capacity to carry out their respective missions.

  196.1103.  Board established — appointment, terms, qualifications, expenses, appointment to life sciences committee not to disqualify for membership on board. — The management, governance, and control of moneys appropriated from the life sciences research trust fund shall be vested in the "Life Sciences Research Board" which is hereby created in the department of economic development as a type III agency and which shall consist of seven members.  The following provisions shall apply to the life sciences research board and its members:

  (1)  Each member shall be appointed by the governor with the advice and consent of the senate pursuant to the procedures herein set forth for a term of four years; except that, of the initial members of the board appointed, three shall be appointed for two-year terms and four shall be appointed to four-year terms;

  (2)  The members of the board shall be generally familiar with the life sciences and current research trends and developments with either technical or scientific expertise in life sciences and with an understanding of the application of the results of life sciences research.  The appointment of a person to the life sciences research committee created by Executive Order 01-10 issued by the governor on July 23, 2001, shall not disqualify a person from serving as a member, either contemporaneously or later, on the life sciences research board;

  (3)  No member of the life sciences research board shall serve more than two consecutive full four-year terms;

  (4)  The members of the life sciences research board shall receive no salary or other compensation for their services as a member of the board, but shall receive reimbursement for their actual and necessary expenses incurred in performance of their duties as members of the board.

  196.1106.  Centers to be established — definition — areas in which centers to be established — approval by board — screening committee appointed for each area — rules, powers and duties. — Centers for life sciences research shall be established and shall be subject to the following provisions:

  (1)  A "center for excellence for life sciences research" means a system or regional consortium of public and private not-for-profit academic, research, or health care institutions or organizations engaged in competitive research in targeted fields consistent with the strategic purposes of life sciences research as provided in sections 196.1100 to 196.1130;

  (2)  The life sciences research board shall monitor and adopt such rules as are necessary to assure quality and accountability in the operation of the centers for excellence for life sciences research;

  (3)  One St.  Louis area center for excellence may be established within the geographical area encompassing the city of St. Louis and St.  Louis, St.  Charles, Jefferson, and Franklin counties.  If any part of a municipality is located within any one such county and also encompasses a part of another county in this state, the entire area encompassed within the city limits of such municipality shall be a part of the geographical area of the St. Louis area center for excellence;

  (4)  One Kansas City area center for excellence may be established within the geographical area encompassing Jackson, Clay, Andrew, Buchanan, and Platte counties.  If any part of a municipality is located within any one such county and also encompasses a part of another county in this state, the entire area encompassed within the city limits of such municipality shall be a part of the geographical area of the Kansas City area center for excellence;

  (5)  One Springfield center for excellence may be established within the geographical area encompassing Greene, Christian, and Webster counties;

  (6)  A Missouri statewide center for excellence may be established that shall encompass the institutions, agricultural research centers dedicated to the development of plant-made pharmaceuticals, and campuses within the University of Missouri system and those regions of Missouri not encompassed within another center for excellence; provided that the University of Missouri-Kansas City and the University of Missouri-St. Louis shall participate in the centers for excellence in their respective geographical regions;

  (7)  The life sciences research board shall receive and review suggestions for the formation and composition of the initial centers for excellence.  After receiving and reviewing such suggestions, the life sciences research board shall determine the initial composition, and shall consider and approve the organizational plan and structure of the St. Louis area, Kansas City area, Springfield area, and Missouri statewide centers for excellence;

  (8)  Before any center for excellence is considered to be a center for excellence for life sciences research under sections 196.1100 to 196.1130, its composition and organizational structure shall be approved by the life sciences research board;

  (9)  Any center for excellence for life sciences research that is established within a geographical area specified in sections 196.1100 to 196.1130 shall be comprised of a consortium of public and private not-for-profit academic, research, or health care institutions or organizations that have collectively at least fifteen million dollars in annual research expenditures in the life sciences, including a collective minimum of two million dollars in basic research in life sciences;

  (10)  Each center for excellence for life sciences research shall appoint a screening committee.  The centers, through their screening committees, shall solicit, collect, prioritize, and forward to the life sciences research board proposed research initiatives for consideration for funding by the board.  Members of each screening committee shall generally be familiar with the life sciences and current trends and developments with either technical or scientific expertise in the life sciences with an understanding of life sciences and with an understanding of the application of the results of life sciences research.  No member of a screening committee shall be employed by any public or private entity eligible to receive financial support from the life sciences research trust fund; and

  (11)  The centers for excellence for life sciences research shall have any and all powers attendant to carrying out the operations that are not contrary to the provisions of sections 196.1100 to 196.1130 or any rules, guidelines, or decisions adopted by the life sciences research board.

  *196.1109.  Moneys appropriated from trust fund, purposes. — All moneys that are appropriated by the general assembly from the life sciences research trust fund shall be appropriated to the life sciences research board to increase the capacity for quality of life sciences research at public and private not-for-profit institutions in the state of Missouri and to thereby:

  (1)  Improve the quantity and quality of life sciences research at public and private not-for-profit institutions, including but not limited to basic research (including the discovery of new knowledge), translational research (including translating knowledge into a usable form), and clinical research (including the literal application of a therapy or intervention to determine its efficacy), including but not limited to health research in human development and aging, cancer, endocrine, cardiovascular, neurological, pulmonary, and infectious disease, and plant sciences, including but not limited to nutrition and food safety; and

  (2)  Enhance technology transfer and technology commercialization derived from research at public and private not-for-profit institutions within the centers for excellence.  For purposes of sections 196.1100 to 196.1130, "technology transfer and technology commercialization" includes stages of the regular business cycle occurring after research and development of a life science technology, including but not limited to reduction to practice, proof of concept, and achieving federal Food and Drug Administration, United States Department of Agriculture, or other regulatory requirements in addition to the definition in section 348.251.  

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Funds received by the board may be used for purposes authorized in sections 196.1100 to 196.1130 and shall be subject to the restrictions of sections 196.1100 to 196.1130, including but not limited to the costs of personnel, supplies, equipment, and renovation or construction of physical facilities; provided that in any single fiscal year no more than thirty percent of the moneys appropriated shall be used for the construction of physical facilities and further provided that in any fiscal year up to eighty percent of the moneys shall be appropriated to build research capacity at public and private not-for-profit institutions and at least twenty percent and no more than fifty percent of the moneys shall be appropriated for grants to public or private not-for-profit institutions to promote life science technology transfer and technology commercialization.  Of the moneys appropriated to build research capacity, twenty percent of the moneys shall be appropriated to promote the development of research of tobacco-related illnesses.

  *196.1109.  Moneys appropriated from trust fund, purposes. — All moneys that are appropriated by the general assembly from the life sciences research trust fund shall be appropriated to the life sciences research board to increase the capacity for quality of life sciences research at public and private not-for-profit institutions in the state of Missouri and to thereby:

  (1)  Improve the quantity and quality of life sciences research at public and private not-for-profit institutions, including but not limited to basic research (including the discovery of new knowledge), translational research (including translating knowledge into a usable form), and clinical research (including the literal application of a therapy or intervention to determine its efficacy), including but not limited to health research in human development and aging, cancer, endocrine, cardiovascular, neurological, pulmonary, and infectious disease, and plant sciences, including but not limited to nutrition and food safety; and

  (2)  Enhance technology transfer and technology commercialization derived from research at public and private not-for-profit institutions within the centers for excellence.  For purposes of sections 196.1100 to 196.1130, "technology transfer and technology commercialization" includes stages of the regular business cycle occurring after research and development of a life science technology, including but not limited to reduction to practice, proof of concept, and achieving federal Food and Drug Administration, United States Department of Agriculture, or other regulatory requirements in addition to the definition in section 348.251.  

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Funds received by the board may be used for purposes authorized in sections 196.1100 to 196.1130 and shall be subject to the restrictions of sections 196.1100 to 196.1130, including but not limited to the costs of personnel, supplies, equipment, and renovation or construction of physical facilities; provided that in any single fiscal year no more than ten percent of the moneys appropriated shall be used for the construction of physical facilities and further provided that in any fiscal year eighty percent of the moneys shall be appropriated to build research capacity at public and private not-for-profit institutions and twenty percent of the moneys shall be appropriated for grants to public or private not-for-profit institutions to promote life science technology transfer and technology commercialization.  Of the moneys appropriated to build research capacity, twenty percent of the moneys shall be appropriated to promote the development of research of tobacco-related illnesses.

  196.1112.  Projects for centers to be determined by board, subject to peer review — distribution of funds, amounts authorized. — In determining projects to authorize, the life sciences research board shall consider those proposals endorsed by a center for excellence, subject to a process of peer review conducted under the auspices of the board, and shall also consider the potential of any proposal to bring both health and economic benefits to the people of Missouri.  Specifically, at least eighty percent of the moneys that are appropriated to the board in each fiscal year shall be distributed to public and private not-for-profit institutions or organizations whose programs and proposals have been recommended by a center for excellence that meets the requirements set forth in subdivisions (8) and (9) of section 196.1106.  Collectively, the institutions or organizations within a single center for excellence shall receive in a single fiscal year no more than fifty percent of the moneys appropriated to the board during such fiscal year.  No single institution or organization shall receive in any consecutive three-fiscal-year period more than forty percent of the moneys appropriated to the board during such three-fiscal-year period.

  *196.1115.  Board's powers, duties and limitation on expenditures. — 1.  The moneys appropriated to the life sciences research board that are not distributed by the board in any fiscal year to a center for excellence or a center for excellence endorsed program pursuant to section 196.1112, if any, shall be held in reserve by the board or shall be awarded on the basis of peer review panel recommendations for capacity building initiatives proposed by public and private not-for-profit academic, research, or health care institutions or organizations, or individuals engaged in competitive research in targeted fields consistent with the provisions of sections 196.1100 to 196.1130.

  2.  The life sciences research board may, in view of the limitations expressed in section 196.1130:

  (1)  Award and enter into grants or contracts relating to increasing Missouri's research capacity at public or private not-for-profit institutions;

  (2)  Make provision for peer review panels to recommend and review research projects;

  (3)  Contract for support services;

  (4)  Lease or acquire facilities and equipment;

  (5)  Employ administrative staff; and

  (6)  Receive, retain, hold, invest, disburse or administer any moneys that it receives from appropriations or from any other source.

  3.  The Missouri technology corporation, established under section 348.251, shall serve as the administrative agent for the life sciences research board.

  4.  The life sciences research board shall utilize as much of the moneys as reasonably possible for building capacity at public and private not-for-profit institutions to do research rather than for administrative expenses.  The board shall not in any fiscal year expend more than two percent of the total moneys appropriated to it and of the moneys that it has in reserve or has received from other sources for its own administrative expenses for appropriations equal to or greater than twenty million dollars; three percent for appropriations less than twenty million dollars but equal to or greater than fifteen million dollars; four percent for appropriations less than fifteen million dollars but equal to or greater than ten million dollars; five percent for appropriations less than ten million dollars; provided, however, that the general assembly by appropriation from the life sciences research trust fund may authorize a limited amount of additional moneys to be expended for administrative costs.

  *196.1115.  Board's powers, duties and limitation on expenditures. — 1.  The moneys appropriated to the life sciences research board that are not distributed by the board in any fiscal year to a center for excellence or a center for excellence endorsed program pursuant to section 196.1112, if any, shall be held in reserve by the board or shall be awarded on the basis of peer review panel recommendations for capacity building initiatives proposed by public and private not-for-profit academic, research, or health care institutions or organizations, or individuals engaged in competitive research in targeted fields consistent with the provisions of sections 196.1100 to 196.1130.

  2.  The life sciences research board may, in view of the limitations expressed in section 196.1130:

  (1)  Award and enter into grants or contracts relating to increasing Missouri's research capacity at public or private not-for-profit institutions;

  (2)  Make provision for peer review panels to recommend and review research projects;

  (3)  Contract for administrative and support services;

  (4)  Lease or acquire facilities and equipment;

  (5)  Employ administrative staff; and

  (6)  Receive, retain, hold, invest, disburse or administer any moneys that it receives from appropriations or from any other source.

  3.  The life sciences research board shall utilize as much of the moneys as reasonably possible for building capacity at public and private not-for-profit institutions to do research rather than for administrative expenses.  The board shall not in any fiscal year expend more than two percent of the total moneys appropriated to it and of the moneys that it has in reserve or has received from other sources for its own administrative expenses; provided, however, that the general assembly by appropriation from the life sciences research trust fund may authorize a limited amount of additional moneys to be expended for administrative costs.

  196.1118.  Annual audit by state auditor or private accounting firm — audit available to public — every three years comprehensive report for governor and general assembly, content — audit and report not administrative expense. — The life sciences research board shall make provision for and secure the state auditor or outside public accounting firm an annual audit of its financial affairs and the moneys expended from the life sciences research trust fund.  Such audit shall be performed on a fiscal year basis and the cost of such audit shall not be considered as an administrative expense for purposes of subsection 3 of section 196.1115.  The board shall make copies of each audit available to the public.  Every three years the board, with the assistance of its staff or independent contractors as determined by the board, shall prepare a comprehensive report assessing the work and progress of the life sciences research program.  Such assessment report shall analyze the impact of the board's programs, grants, and contracts performed, shall be provided to the governor and the general assembly, and shall be available to the public.  The cost of such assessment report shall not be considered an administrative expense for purposes of subsection 3 of section 196.1115.

  196.1121.  Reimbursement of costs allowed if four-part test met — institutions or organizations receiving grants or awards to retain title to all inventions, data and discoveries — rulemaking authority. — 1.  Grant or contract awards made with moneys appropriated from the life sciences research trust fund shall provide for the reimbursement of costs.  Whether reimbursement of specific costs is allowed depends on the application of a four-part test balancing which shall include:

  (1)  The reasonableness of the cost;

  (2)  The connection to the grant or contract;

  (3)  The consistency demonstrated in assigning costs to the grant or contract; and

  (4)  Conformance with the specific terms and conditions of the award or contract.  

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The life sciences research board may from time to time issue rules and guidelines consistent with such four-part test and provide grant and contract recipients with a list or other explanation of regularly permitted costs.

  2.  Grant and contract recipients shall preserve research freedom, ensure timely disclosure of their research findings to the scientific community, including through publications and presentations at scientific meetings, and promote utilization, commercialization, and public availability of their inventions and other intellectual property developed as a general institutional policy.  Institutions or organizations receiving grant or contract awards shall retain all right, title, and interest, including all intellectual property rights, in and to any and all inventions, ideas, data, improvements, modifications, know-how, creations, copyrightable material, trade secrets, methods, processes, discoveries, and derivatives, regardless of patentability, that are made in the performance of work under a grant award.  The life sciences research board shall adopt reasonable rules to ensure that any such intellectual property rights are utilized reasonably and in a manner that is in the public interest.

  196.1124.  Board members not to be employed by public or private entity receiving financial support from trust fund — conflict of interest guidelines to be developed. — No member of the life sciences research board shall be employed by any public or private not-for-profit entity entitled to receive financial support from the life sciences research trust fund, or participate in the making of any decision by the board to make any grant to the board member, any person who is related to the board member within the fourth degree of consanguinity or affinity, any public entity for which the board member serves as an officer, director, or other member of the entity's governing body, or any private entity for which the board member or the member's spouse is employed, serves as an officer, director, or other member of the entity's governing body.  The board may from time to time issue conflict of interest guidelines and requirements with respect to the administration of the life sciences research program, to govern the actions of its employees and agents, and to implement the provisions of this section.

  196.1127.  Appropriation to board subject to certain requirements. — 1.  The moneys appropriated to the life sciences research board pursuant to sections 196.1100 to 196.1124 shall be subject to the provisions of this section.

  2.  As used in this section, the following terms shall mean:

  (1)  "Abortion services" include performing, inducing, or assisting with abortions, as defined in section 188.015, or encouraging patients to have abortions, referring patients for abortions not necessary to save the life of the mother, or development of drugs, chemicals, or devices intended to be used to induce an abortion;

  (2)  "Child", a human being recognized as a minor pursuant to the laws of this state, including if in vivo, an unborn child as defined in section 188.015 and if in vitro, a human being at any of the stages of biological development of an unborn child from conception or inception onward;

  (3)  "Conception", the same meaning as such term is defined in section 188.015;

  (4)  "Facilities and administrative costs", those costs that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular research project or any other institutional activity;

  (5)  "Human cloning", the creation of a human being by any means other than by the fertilization of an oocyte of a human female by a sperm of a human male;

  (6)  "Prohibited human research", research in a research project in which there is the taking or utilization of the organs, tissues, or cellular material of:

  (a)  A deceased child, unless consent is given by the parents in a manner provided in sections 194.210 to 194.290 relating to anatomical gifts, and neither parent caused the death of such child or consented to another person causing the death of such child;

  (b)  A living child, when the intended or likely result of such taking or utilization is to kill or cause harm to the health, safety, or welfare of such child, or when the purpose is to target such child for possible destruction in the future;

  (7)  "Public funds", include:

  (a)  Any moneys received or controlled by the state of Missouri or any official, department, division, agency, or political subdivision thereof, including but not limited to moneys derived from federal, state, or local taxes, gifts, or grants from any source, settlements of any claims or causes of action, public or private, bond proceeds, federal grants or payments, or intergovernmental transfers;

  (b)  Any moneys received or controlled by an official, department, division, or agency of state government or any political subdivision thereof, or to any person or entity pursuant to appropriation by the general assembly or governing body of any political subdivision of this state;

  (8)  "Research project", research proposed to be funded by an award of public funds conducted under the auspices of the entity or entities that applied for and received such award, regardless of whether the research is funded in whole or in part by such award.  Such research shall include basic research, including the discovery of new knowledge; translational research, including translational knowledge in a usable form; and clinical research, including but not limited to health research in human development and aging, cancer, endocrine, cardiovascular, neurological, pulmonary, and infectious disease.

  3.  Public funds shall not be expended, paid, or granted to or on behalf of an existing or proposed research project that involves abortion services, human cloning, or prohibited human research.  A research project that receives an award of public funds shall not share costs with another research project, person, or entity not eligible to receive public funds pursuant to this subsection; provided that a research project that receives an award of public funds may pay a pro rata share of facilities and administrative costs determined in the award of public funds according to standards that ensure that public funds do not in any way subsidize facilities and administrative costs of other research projects, persons, or entities not eligible to receive public funds pursuant to this subsection.  The application for an award of public funds shall set forth the proposed rates of pro rata cost reimbursement and shall provide supporting data and rationale for such rates.  All applicants for and recipients of awards of public funds shall comply with the cost accounting principles set forth in Part 9905 of Title 48 of the Code of Federal Regulations, or successor regulations, in connection with the application for and administration of the research project.  All moneys derived from an award of public funds shall be expended only by checks, drafts, or electronic transfers using a separate accounting process maintained for each research project.  No moneys derived from an award of public funds shall be used to cover costs for any other research project or to any other person or entity.  No moneys derived from an award of public funds shall be passed through to any other research project, person, or entity unless included in the original application for the award of public funds or in subsequent amendments or requests to use separate contractors.  A research project that receives an award of public funds shall maintain financial records that demonstrate strict compliance with this subsection.  Any audit conducted pursuant to any grant or contract awarding public funds shall also certify whether there is compliance with this subsection and shall note any noncompliance as a material audit finding.

  4.  The provisions of this section shall inure to the benefit of all residents of this state.  Any taxpayer of this state or any political subdivision of this state shall have standing to bring suit against the state of Missouri or any official, department, division, agency, or political subdivision of this state, and any recipient of public funds who or which is in violation of this subsection in any circuit court with jurisdiction to enforce the provisions of this section.

  5.  This section shall not be construed to permit or make lawful any conduct that is otherwise unlawful pursuant to the laws of this state.

  6.  Any provision of this section is not severable from any appropriation subject to this section or any application declared by any court to be subject to this section.  If any provision of this section is found to be invalid or unconstitutional, any appropriation subject to this section or any appropriation declared by any court to be subject to this section shall be void, invalid, and unenforceable.

  196.1130.  Rules to become effective, when. — No rule or portion of a rule promulgated pursuant to the authority of sections 196.1100 to 196.1130 shall become effective unless it has been promulgated pursuant to chapter 536.