19 CSR 20-1.040 - Good Manufacturing Practices

PURPOSE: This amendment updates state food manufacturing standards to be consistent with the U.S. Food and Drug Administration's (FDA) current good manufacturing practices regulation.

(1) Applicability. The requirements of this rule apply to buildings or facilities, or parts thereof, used for, or in connection with, the manufacturing, packaging, processing, or holding of human food.
(2) Standards. Manufacturers, distributors, and warehouses shall operate in accordance with 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, revised as of September 17, 2015, hereby incorporated by reference and made a part of this rule as published by the U.S. Government Publishing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512-1800, http://bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions.
(3) In the case of the giving of a guaranty or undertaking referred to in section 196.015(7), RSMo (1986), each person signing a guaranty, or undertaking shall be considered to have given it.
(A) A guaranty or undertaking referred to in section 196.015(7), RSMo (1986) may be-
1. Limited to a specific shipment or other delivery of an article which may be a part of or attached to the invoice or bill of sale covering the shipment or delivery; or
2. General and continuing, applying to any shipment or other delivery or an article and shall be considered to have been given at the date the article was shipped or delivered by the person who gives the guaranty or undertaking.
(B) The following are suggested forms of guaranty or undertaking under section 196.015(7), RSMo (1986):
1. Limited form for use on invoice or bill of sale (name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or mis-branded within the meaning of this rule or is an article which may not be introduced into commerce under the provisions of section 196.080 or 196.105, RSMo (1986) (signature and post-office address of person giving the guaranty or undertaking); and
2. General and continuing form. The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to or on the order (name and post office address of person to whom the guaranty or undertaking is given) is guaranteed as of the date of the shipment or delivery not to be adulterated or misbranded within the meaning of this rule and not an article, which under the provisions of section 196.080 or 196.105, RSMo (1986), may not be introduced into commerce (signature and post office address of person giving the guaranty or undertaking).
(C) The application of a guaranty or undertaking referred to in section 196.015, RSMo (1986) to any shipment or other delivery of an article shall expire when the article after shipment or delivery by the person who gave the guaranty or undertaking, becomes adulterated or misbranded within the meaning of this rule or becomes an article which may not be introduced into commerce under the provisions of section 196.080 or 196.105, RSMo (1986).
(D) A guaranty or undertaking, if signed by two (2) or more persons, shall state that each of the persons separately guarantees the article to which it applies.
(E) No statement or suggestion that an article is guaranteed under this rule shall be used on labels.
(4) In collection of samples for examination-
(A) The term examination as applied to samples collected includes analyses, tests or other examinations;
(B) When a sample of a food is collected, the owner is the person who owns the shipment or other lot of the article from which the sample is collected;
(C) When an officer or employee of the department collects a sample of a food for examination under this rule, s/he shall collect at least twice the quantity estimated by him/her to be sufficient for examination, unless-
1. The amount of the food available and reasonably accessible for sampling is less than twice the quantity so estimated;
2. The cost of twice the quantity so estimated exceeds ten dollars ($10);
3. The article is perishable;
4. The sample is collected from a person named on the label of the article or his/her agent and the person is also owner of the article;
5. The sample is collected from the owner of the article or his/her agent and the article bears no label or if it bears a label, no person is named on the label; or
6. The examination consists principally of rapid analytical procedures, taste examination or other field examinations or tests made at the place where the sample is collected or in a mobile or temporary laboratory;
(D) In addition to the quantity of sample needed in subsection (4)(C) of this rule, the officer or employee, if practicable, shall collect an additional amount of the article needed for use as exhibits in the trial of any case that may arise under this rule;
(E) After the Department of Health has completed an adequate examination of a sample of food and finds the article is adulterated or misbranded within the meaning of this rule or is otherwise subject to the prohibitions of this rule; and after reserving an amount of the article the department estimates to be adequate for use as exhibits in the trial of any case that may arise under this rule based on the sample, a part of the sample-if any remains available-shall be provided for analysis upon written request by any person on the label of the article, its owner, or the attorney or agent of the person or owner, except when-
1. After collection, the sample or remaining part has become decomposed or otherwise unfit for examination; or
2. The request is not made within a reasonable time before the trial of any case under the rule, based on the sample, to which the person or owner is a party; and
(F) The Department of Health is authorized to destroy-
1. Any sample when it determines that no examination of the sample will be made;
2. Any sample or part of it when the department determines that no notice under section 196.040, RSMo (1986) is or will be based on the sample;
3. Any sample or part of it when the sample was the basis of a notice under section 196.040, RSMo (1986) and when, after opportunity for presentation of views following the notice, the department determines that no other notice and no case under the RSMo (1986) is or will be based on the samples;
4. Any sample or part of it, when the sample was the basis of a case under section 196.070 or 196.075, RSMo (1986) which has gone to final judgment and when the department determines that no other case is or will be based on the sample;
5. Any sample or part of it if the article is perishable; or
6. Any sample or part of it when, after collection, the sample or part of it has become decomposed or otherwise unfit for examination.
(5) A food is considered misbranded when-
(A) A statement is false or misleading with respect to another food; or
(B) The label of the food states a name which includes or suggests the name of one (1) or more but not all of the ingredients, even though the names of all the ingredients are stated elsewhere on the label.
(6) Packaged Food Label Requirements.
(A) If a food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase which reveals the connection the person has with the food, such as "Manufactured for and packed by. . .", "Distributed by. . ." or a similar phrase which expresses the facts.
(B) The statement of the place of business shall include the street address, if any, unless the street address is shown in a current city directory or telephone directory.
(C) When a person manufactures, packs or distributes a food at a place other than his/her principal place of business, the label may state the principal place of business instead of the actual place where each package of the food was manufactured or packed or is to be distributed, if the statement is not misleading in any particular.
(D) The requirement that the label shall contain the name and place of business of the manufacturer, packer or distributor shall not be considered to relieve any food from the requirement that its label shall not be misleading in any particular.
(E) The statement of the quantity of the content on a label shall-
1. Reveal the quantity of the food in the package, exclusive of wrappers and other material packed with the food; and
2. Be expressed in terms of weight, measure, numerical count or a combination of numerical count and weight or measure generally used by consumers to express quantity of the food and which give accurate information as to the quantity. If no general consumer usage exists to express accurate information as to the quantity of the food, the statement shall be in terms of liquid measure if the food is liquid or in terms of weight if the food is solid, semisolid, viscous or a mixture of solid and liquid.
(F) Statements of weights and measures on labels shall-
1. Be in terms of the avoirdupois pound and ounce for solids. Liquid measure shall be stated in terms of the United States gallon of two hundred thirty-one (231) cubic inches and quart, pint and fluid ounce subdivisions and except in case of frozen food which is so consumed shall state the volume at sixty-eight degrees Fahrenheit (68° F) or twenty degrees Celsius (20° C). A statement of dry measure shall be in terms of the United States bushel of two thousand one hundred fifty and forty-two hundredths (2150.42) cubic inches and peck, dry quart and dry pint subdivisions; or in terms of the United States standard barrel and its subdivisions of one-third (1/3), one-half (1/2) and three-fourths (3/4) barrel. In an export shipment, the statement may be in terms of a system of weight or measure in common use in the country to which the shipment is exported;
2. Be in terms specified in paragraph (6)(F)1. of this rule and may be supplemented by a statement in terms of the metric system;
3. Be supplemented by a statement of weight, measure or size of the individual units of the food unless an unqualified statement of numerical count gives accurate information on the quantity of food in the package;
4. Use only fractions as are generally used in expressing the quantity of the food. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two (2) places; and
5. Express the number of the largest unit contained in the package except as provided in paragraph (6)(F)1. of this rule. (For example, the statement on the label of a package which contains one (1) quart of food shall be "1 quart" and not "2 pints" or "32 fluid ounces".) When the statement is a whole number and a fraction, there may be substituted for the fraction its equivalent in smaller units, if any smaller unit is specified in paragraphs (6)(F)1.-4. of this rule. (For example, 1 3/4 quarts may be expressed as "1 quart 1 1/2 pints" or "1 quart 1 pint 8 fluid ounces".) The stated number of any unit which is smaller than the largest unit contained in the package shall not equal or exceed the number of the smaller units in the next larger unit. (For example, instead of "1 quart 16 fluid ounces" the statement shall be "1 1/2 quarts" or "1 quart 1 pint"; instead of "24 ounces" the statement shall be "1 1/2 pounds" or "1 pound 8 ounces".)
A. When there exists an established custom of stating the quantity of the contents of a food as a fraction of a unit which is larger than the quantity contained in the package or as units smaller than the largest unit in it, the statement may be made in accordance with the custom if it is informative to the consumer.
B. The statement shall express the minimum quantity or the average quantity of the contents of the package. If the statement is not so qualified as to show definitely that the quantity expressed is the minimum quantity, the statement shall be considered to mean the average quantity.
(G) In a statement that expresses the minimum quantity, no variation below the stated minimum shall be permitted except variations below the stated weight or measure caused by ordinary and customary exposure after the food is received from commerce or introduced into commerce to conditions which normally occur in good distribution practice and which unavoidably result in decreased weight or measure. Variations above the stated minimum shall not be unreasonably large.
(H) When the statement does not express minimum quantity-
1. Variations from the stated weight or measure shall be permitted when caused by ordinary and customary exposure after the food is introduced into commerce to conditions which normally occur in good distribution practice and which unavoidably result in change of weight or measure;
2. Variations from the stated weight, measure or numerical count shall be permitted when caused by unavoidable deviations in weighing, measuring or counting individual packages which occur in good packing practice; or
3. Under paragraph (6)(H)2. of this rule, variations shall not be permitted to the extent that the average of the quantities in the packages comprising a shipment or other delivery of the food is below the quantity stated and no unreasonable shortage in any package shall be permitted even though overages in other packages in the same shipment or delivery compensate for the shortage.
(I) The extent of variations from the stated quantity of the contents permissible under subsections (6)(G) and (H) of this rule shall be determined by the facts in the case of each shipment or other delivery.
(J) A food shall be exempt from compliance with the requirements of section 196.075(5)(b), RSMo (1986) if-
1. The quantity of the contents as expressed in terms applicable to the food under the provisions of paragraph (6)(E)2. of this rule, is less than one-half (1/2) ounce avoirdupois; or less than one-half (1/2) fluid ounce; or in packages where the units of the food can be easily counted without opening the package, less than six (6) units; or
2. The statement on the label of the quantity of the contents of the package, together with all other words, statements and information required by or under authority of this rule, because of insufficient label space, cannot be so placed on the label as to comply with the requirements of section 196.075(6), RSMo (1986) and the corresponding rules.
(7) Prominence and Conspicuousness of Labels.
(A) A word, statement or other information to appear on the label may lack that prominence and conspicuousness required by section 196.075(6), RSMo (1986) because of-
1. The failure of a word, statement or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;
2. The failure of a word, statement or information to appear on two (2) or more parts or panels of the label, each of which has sufficient space and is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;
3. The failure of the label to extend over the area of the container of package available for the extension, so as to provide sufficient label space for the prominent placing of the word, statement or information;
4. Insufficient label space for the prominent placing of the word, statement or information resulting from the use of label space for any word, statement, design or device which is not required to appear on the label;
5. Insufficient label space for the prominent placing of a word, statement or information resulting from the use of label space to give greater conspicuousness to any other word, statement or information or to any design or device; or
6. Smallness or style of type in which a word, statement or information appears; insufficient background contrast; obscuring designs or vignettes; or crowding with other written, printed or graphic matter.
(B) No exemption depending on insufficiency of label space as prescribed in rules promulgated under section 196.075(5) or (9), RSMo (1986) shall apply if the insufficiency is caused by the use of label space-
1. For any word, statement, design or device which is not required to appear on the label;
2. To give greater conspicuousness to any word, statement or other information that is required by section 196.075(6), RSMo (1986); or
3. For any representation in a foreign language.
(C) All words, statements and other information required to appear on the label shall appear in the English language. If the label(ing) contains any information in a foreign language, all words, statements and other information required to appear on the label shall appear in the foreign language.
(8) Possible Misleading Ingredient Designations on Labels.
(A) No ingredient shall be designated on the label as a spice, flavoring or coloring unless it is a spice, flavoring or coloring within the meaning of the term as commonly understood by consumers. The term coloring shall not include any bleaching substance.
(B) An ingredient which is both a spice and a coloring or both a flavoring and a coloring shall be designated as spice and coloring or flavoring and coloring, unless the ingredient is designated by its specific name.
(C) A label may be misleading for the following reasons:
1. The order in which the names of ingredients appear on the label or the relative prominence otherwise given those names; or
2. It fails to reveal the proportion of an ingredient or another fact about it when the proportion or other fact about the ingredient was used in fabricating the food.
(9) Label Exemptions.
(A) A food shall be exempt from the requirements of section 196.075(9)(b), RSMo (1986) if all words, statements and other information required to appear on the label of the food cannot, because of insufficient label space, be so placed on the label as to comply with the requirements of section 196.075(6), RSMo (1986). The exemption shall be on the condition that, if omission from the label of the statement of the quantity of the contents affords sufficient space to state legibly all the information required, the statement of the quantity of the contents shall be omitted as authorized under section 196.075(5)(b), RSMo (1986) and the information required by it shall be stated as prominently as practicable even though the statement is not of the conspicuousness as to render it likely to be read by the ordinary individual under customary conditions of purchase.
(B) In an assortment of different items of food packaged together with variations in the ingredients in different packages, these foods shall be exempt from compliance with the requirements of section 196.075(9)(b), RSMo (1986) with respect to any ingredient which is not common to all packages. The exemption shall be on the condition that the label shall bear, in conjunction with the names of the ingredients common to all packages, a statement in terms as informative as practicable and which is not misleading and which indicates that other ingredients may be present.
(C) An open container of a fresh fruit or fresh vegetable of a quantity not more than one (1) dry quart shall be exempt from the labeling requirements of sections 196.075(5) and (7), RSMo (1986) with respect to the name of the food specified in the definition and standard and section 196.075(9)(a), RSMo (1986); but the exemption shall be on the condition that if two (2) or more containers are enclosed in a crate or other shipping package, the crate or package shall bear labeling showing the number of containers enclosed and the quantity of the contents of each. An open container is a container of rigid or semirigid construction not closed by lid, wrapper or otherwise.
(D) Except as provided by subsections (9)(E) and (G) of this rule, a shipment or other delivery of a food which is to be processed, labeled or repacked in substantial quantity at an establishment other than that where originally processed or packed, during the time of introduction into and movement in commerce and the time of holding in an establishment shall exempt from compliance with the labeling requirements of section 196.075(3), (5), (7), (8)(a) and (b), (10) and (11) RSMo (1986), if-
1. The person who introduced the shipment or delivery into commerce is the operator of the establishment where the food is to be processed, labeled or repacked; or
2. The person is not the operator, the shipment or delivery is made to the establishment under a written agreement, signed by and containing the post office addresses of the person and the operator, and containing the specifications for the processing, labeling or repacking as the case may be of a food in the establishment as will insure, if the specifications are followed that a food will not be adulterated or misbranded within the meaning of the rule, upon completion of the processing, labeling or repacking. The person and the operator shall keep a copy of each agreement until all the shipment or delivery has been removed from the establishment and shall make the copies available for inspection at any reasonable hour to any officer or employee of the department who requests them.
(E) An exemption of a shipment or other delivery of a food under subsection (9)(D) of this rule shall become void ab initio at the beginning of the act of removing from the establishment the shipment or delivery or any part of it if the food comprising the shipment, delivery or part is adulterated or misbranded when removed.
(F) An exemption of a shipment or other delivery of a food under paragraph (9)(D)2. of this rule shall become void ab initio with respect to the person who introduced the shipment or delivery into commerce upon refusal by the person to make available for inspection a copy of the agreement.
(G) An exemption of a shipment or other delivery of a food under paragraph (9)(D)2. of this rule shall expire-
1. At the beginning of the act of removing the shipment or delivery or any part of it from the establishment if the food comprising a shipment, delivery or part is adulterated or misbranded when so removed; or
2. Upon refusal by the operator of the establishment where the food is to be processed, labeled or repacked to make available for inspection a copy of the agreement.

Notes

19 CSR 20-1.040
AUTHORITY: section 196.045, RSMo 1986.* This rule was previously filed as 13 CSR 50-70.010. Original rule entitled Missouri Division of Health E 1.20 was filed Nov. 17, 1949, effective Nov. 27, 1949. Amended by Missouri Register March 15, 2018/Volume 43, Number 6, effective 4/30/2018

*Original authority: 196.045, RSMo 1943.

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