Current through Register Vol. 49, No. 18, September 16, 2024
(1) The following
definitions shall apply in the interpretation and the enforcement of this rule:
(A) Bottling means filling, capping,
packaging and enclosing in bottles or other containers, including metal cans
and premixed tanks;
(B) Flavor
manufacturing plant means a building in which soft drink flavors are prepared,
manufactured and packaged, including any separate room used for the
accommodation of workers;
(C)
Franchisee means a person authorized or given contractual permission to bottle,
offer for sale or distribute a soft drink in a specified territory for a
company or franchiser who owns the trademark or name and formula for the soft
drink;
(D) Governing jurisdiction
means standards, codes or ordinances as administered by local, state or federal
agencies;
(E) Nonintoxicating
beverage plant means a building in which soft drinks are produced including any
separate room used in the preparation or storage of soft drink flavors and
including any separate room used for the accommodation of production
employees;
(F) Nonnutritive
sweeteners means saccharin salt, aspartame and other such nonsugar sweetening
ingredients as may be approved by the federal Food and Drug Administration
(FDA) and recognized by of the Department of Health;
(G) Person means any individual, firm,
corporation or other legal entity;
(H) Sodium means the amount of this element
expressed in terms of milligrams (mg) per eight (8) fluid ounces.
1. Sodium-free means less than five
milligrams (5 mg) of sodium per eight (8) fluid ounces.
2. Very low sodium means thirty-five
milligrams (35 mg) or less of sodium per eight (8) fluid ounces.
3. Low sodium means one hundred forty
milligrams (140 mg) or less of sodium per eight (8) fluid ounces;
(I) Soft drink shall be held to
mean and include all beverages of every kind manufactured or sold in the state
which shall be understood to include those containing less than one-half (1/2)
of one percent (1%) of or no alcohol, including carbonated beverages, still
drinks, seltzer water, artificial or natural mineral waters and all other
waters used and sold for beverage purposes. Among other products, this rule
shall be interpreted to include carbonated beverages, soda, soda water,
fruitade, any nonalcoholic flavored still beverages, artificial or natural
mineral waters, bottled table waters, artificial waters whether carbonated or
not, seltzer and club soda, and beverages that are manufactured or created by
the use of parts of or natural fruit juices and the use of artificial flavoring
and water such as orange juice, lemon drink, reconstituted orange juice or
other similar names. These rules do not apply to whole or concentrated
beverages such as concentrated grape juice, unfermented grape juice, orange
juice, lemon juice, grapefruit juice, pineapple juice and apple juice or cider,
provided that the same is the juice extracted from the natural fruit and that
it is in its natural state and properly labeled. This rule does, however, cover
all reconstituted products which are bottled from the concentrates referred to
in this subsection;
(J) Soft drink
flavors mean any type of soda water flavor or beverage base, syrup extracts,
concentrate, powder or other compound prepared for use as a flavoring for soft
drinks; and
(K) Sweetening
ingredient means cane sugar or beet sugar, in liquid or crystal form, dextrose,
corn sugar syrup in liquid or direct form, honey or any syrup from any sugar or
any combination of these sugars;
(2) Beverage Labeling. Beverages shall be
labeled in compliance with sections
196.010,
196.015,
196.075,
196.120 and 196.415, RSMo (1986).
(A) Labels
or advertising pertaining to sodium content shall have the serving size and
sodium content declared on the label and shall be in conformance with section
(1) of this rule.
(B) Supplemental
printed information and graphics may appear on the label but shall not imply
properties of the product or preparation methods which are not
factual.
(C) In addition, the
following shall also be required when labeling bottled water:
1. If a public water system is used as the
source of water for the bottled water, the container shall be labeled to
clearly inform the consumer of the source of the water. If the bottler further
processes, conditions or treats the water from the public water system, the
additional treatments may also be included on the label;
2. A bottled water with or without natural or
added carbonation may be prepared with added flavors, extracts, essences or
fruit juice concentrates derived from a spice or fruit and comprising less than
one percent (1%) by weight of the final product. The final product shall
contain no sweeteners or additives-including nonnutritive sweeteners other than
any of the following flavors, extracts, essences or fruit juice concentrates
and carbon dioxide and shall be designated on labels and in advertising as
follows:
A. The common or usual name of the
characterizing flavor shall accompany the designation of the bottled
water-product type;
B. The product
may be designated as natural only if it meets the requirements of the
designation as defined in subparagraph (2)(C)3.E. of this rule and naturally
derived flavors, extracts or essences are used;
C. Products labeled as one (1) type or one
(1) source of bottled water shall not be blended with water that is not bottled
water or that is of another bottled water type; and
D. Water which meets the definition of more
than one (1) type of water as defined in paragraph (2)(C)3. of this rule may be
labeled with either the applicable description or a combination of applicable
descriptions; and
3. If
a manufacturer or distributor provides information on the label or in
advertising stating or implying it is the product of a specific water type-for
example, spring water-or treated in a specific manner-for example, purified
water-the type or treatment shall be on the label in an easily readable format.
A label or advertising implying a specific water type or specific treatment
shall conform to the following criteria:
A.
Artesian well water means water from a well tapping an aquifer in which the
water level will stand above the bottom of the confining bed of the aquifer,
and in which the hydraulic pressure of the water in the aquifer is greater than
the force of gravity. Artesian well water shall not be altered by the addition
or deletion of minerals or by blending it with water from a nonartesian well
water source, except that artesian well water shall be treated with a
disinfection process and may be filtered to reduce the concentration of any
naturally occurring substance which exceeds the bottled water standards set
forth in sections (6)-(8) of this rule;
B. Fluoridated water means water containing
naturally occurring or added fluoride. The label shall specify whether fluoride
is naturally occurring or is added. Any water which meets the designation of
fluoridated water shall contain at least eight-tenths of a milligram per liter
(0.8 mg/l) fluoride and shall otherwise comply with standards established by
the United States FDA in 21 CFR 103.35(d)(2)(1991);
C. Mineral water means water containing more
than five hundred milligrams per liter (500 mg/l) of total dissolved solids and
originating entirely from an underground source, which may be a well, artesian
well or spring. Mineral water may be derived from a natural orifice or from a
bore hole adjacent to the natural orifice. If it is derived from a bore hole
adjacent to the natural orifice, the water shall be from the same underground
stratum and be of the same quality and composition as the water derived from
the natural orifice without external force. Mineral water may not be altered by
the addition or deletion of minerals or by blending it with water from a
nonmineral water source, except that mineral water may be filtered and shall be
treated with a disinfection process approved by the Department of Health and
shall be treated to reduce the concentration of any naturally occurring
substance which exceeds the bottled water standards set forth in sections
(6)-(8) of this rule. Exemption from the requirement for a disinfection process
of the mineral water may be granted on an individual basis and only if the
bottler can demonstrate continuing compliance with the standards of the
European Economic Community Directive 80/777/EEC for Natural Mineral Water,
July 15, 1980. Mineral water may be collected and transported by pipes,
tunnels, trucks or similar devices. Any water which meets the criteria of this
paragraph may also be labeled natural mineral water.
(I) Mineral water which contains carbon
dioxide as it emerges from the source and is bottled directly with its
entrapped gas, or from which the gas is mechanically separated and later
reintroduced into the water at the time of bottling shall be labeled naturally
carbonated or naturally sparkling.
(II) Mineral water which contains carbon
dioxide other than that naturally occurring in the source product shall be
labeled with the words carbonation added or carbon dioxide added, whether the
carbonation is obtained from a natural or manufactured source;
D. Mineralized water means water
which meets the requirements of mineral water in subparagraph (2)(C)3.C. of
this rule, except that the water also contains added minerals;
E. Natural water means spring, artesian well
or well water which is unmodified by mineral addition or deletion, except
natural water may be filtered and shall be treated with a disinfection process
and treated to reduce the concentration of any substance which exceeds
standards set forth in sections (6)-(8) of this rule;
F. Purified water means water produced by
distillation, deionization, ion exchange treatment or reverse osmosis and that
meets the definition of purified water in the United States
Pharmacopeia: Purified water is water obtained by distillation,
exchange, reverse osmosis or other suitable exchange. It is prepared from water
complying with the regulations of the United States Environmental Protection
Agency (U.S. EPA) with respect to drinking water. It contains no added
substance. Purified water which is vaporized and then condensed may be labeled
distilled water;
G. Sparkling,
carbonated or carbonation added means water which contains carbon dioxide.
Naturally sparkling water means water with a carbon dioxide content from the
same source as the water;
H. Spring
water means water which issues by natural forces out of the earth at a
particular place. Spring water may be derived from the natural orifice or from
a bore hole adjacent to the natural orifice. If it is derived from the natural
orifice by external force or from a bore hole adjacent to the natural orifice,
the water shall be from the same underground stratum and be of the same quality
and composition as the water derived from the natural orifice without external
force. Spring water may not be altered by the addition or deletion of minerals
or by blending it with water from a nonspring source. Spring water shall be
treated with a disinfection process and may be filtered. Spring water may be
collected and transported by pipes, tunnels, trucks or similar devices;
and
I. Well water means water from
a hole bored or drilled into the ground which taps the water of an aquifer.
Well water shall be treated with a disinfection process and may be filtered.
Well water may not be altered by the addition or deletion of minerals or by
blending it with water from a nonwell water source.
(3) License Application
and Expiration. Any person desiring to manufacture or distribute soft drinks or
beverages as defined by the statute shall apply to the Department of Health for
a license for each production facility and each warehouse operated by the
applicant. The application shall be made on a form prescribed by the department
for that purpose. Each license shall expire on the last day of June following
the day of issuance. A license is not transferable and no refunds will be made.
If the business is sold, the new owner shall obtain a new license.
(4) Sanitary Requirements. Every building,
room, basement or cellar occupied or used for the preparation for sale, holding
for sale, manufacturing, packing, storage, sale or distribution of soft drinks
or beverages shall be properly lighted, drained, plumbed and ventilated and
conducted with due regard for the purity and wholesomeness of the products
produced there and the strict regard to the influence of the conditions upon
the health of the operatives, employees, clerks or other persons employed
there.
(A) The following rules regarding the
building and premises used within Missouri for the manufacture and distribution
of soft drinks and beverages shall be observed:
1. Location and use of building. The building
or portion of the building shall be used for no other purpose and shall be so
located as to be protected from objectionable surroundings;
2. Plant layout. Bottling plants shall be
located in buildings so constructed that the bottling operation and syrup
preparation are located in a separate room. This relates specifically to
operations such as bottle washing and filling, compounding and mixing of
syrups, warehousing and loading. This requirement, except for the syrup room,
does not apply to existing bottling plants which have been located continuously
in the same building prior to the promulgation of this rule. In all cases of
major structural changes to existing production facility or construction of a
new production facility all separation requirements are to be achieved. The
Department of Health will assist and recommend suggestions prior to the start
of construction;
3. Floors. The
floors of all rooms used for manufacturing operations shall be of a
construction as to be impervious, easily cleaned, smooth and shall be kept
sanitary and in good repair;
4.
Walls and ceilings. Walls and ceilings in the syrup and bottling room shall be
of hard, sound materials with smooth, easily cleaned surfaces and maintained
clean. Surfaces that require painting shall be frequently painted with light
colored paint;
5. Light. All
processing areas shall have shielded fixtures with adequate footcandle
lighting. All other areas shall be adequately lighted;
6. Ventilation. All room areas utilized for
manufacture, bottling and container cleaning shall be provided with the
necessary air movement to prevent excessive condensation on the ceiling and on
filling equipment, which could contaminate the beverage or its ingredients.
When overhead drip due to condensation is exposing cleaned containers on
conveyor lines to possible contamination, shields shall be provided over the
conveyor lines;
7. Screening and
vermin control. Screens or other suitable equipment must be provided and used
for the purpose of excluding insects from the processing area. All necessary
vermin and rodent control measures must be taken;
8. Syrup room. All nonintoxicating beverage
plants shall be equipped with a room known as a syrup room in which syrup,
flavors, extracts and other liquid beverage ingredients or concentrates are
measured, mixed or prepared. This room shall be separately enclosed and
substantially constructed of easily cleanable material. It shall be
well-ventilated and lighted, shall be provided with adequate facilities for
washing and sanitizing equipment and shall have hot and cold running water
easily accessible to all parts. It shall be protected against rodents, vermin,
insects and dust and so constructed as to be easily cleaned;
9. Water and sewer connections. Water supply
(if private) must meet construction requirements as found in
19 CSR
20-3.010 of the rules of the Department of Health and
be of a sanitary quality. Running water under pressure from an approved source
shall be easily accessible to all parts of the plant and adequate provisions
for quickly carrying off and disposing of waste water shall be provided. If
more than one (1) source of water is available in a plant, no cross connections
shall be permitted between the two (2) sources. Sewage and other wastes must be
disposed of in a manner approved by the Department of Natural
Resources;
10. Toilet and
washrooms. Every nonintoxicating beverage plant shall be provided with toilet
facilities complying with plumbing codes of the governing jurisdiction. Toilet
rooms should not open directly into any room used as a processing area. The
doors of all toilet rooms shall be self-closing. Toilet rooms shall be kept in
a clean condition, in good repair and well-ventilated. A sign directing
employees to wash their hands before returning to work shall be posted in all
toilet rooms used by employees;
11.
Lavatory facilities. Adequate and convenient handwashing facilities shall be
provided, including hot and cold running water, soap and approved sanitary
towels. The use of a common towel is prohibited. No employee shall resume work
after using the toilet room without first washing his/her hands; and
12. Clothing storage. Suitable places for
changes of garments and proper care of same are required.
(B) The following rules regarding the
machinery and equipment used within Missouri for the manufacture and
distribution of soft drinks and beverages shall be observed:
1. Equipment. Every plant manufacturing soft
drinks, soft drink flavors and beverages shall be equipped with easily cleaned,
suitable mechanical-washing apparatus and with approved machines for
carbonating, filling and closing so that they may be readily accessible for
cleaning and sanitizing;
2.
Conveyors, palletizers and cases. These items shall be maintained free from
accumulating dust, dirt, mud and other foreign materials;
3. Syrup making equipment. All vats, covers,
jars, mixing and storage tanks, pipe lines, filters and other apparatus
employed in the preparation of syrups shall be of sanitary construction and
lined when necessary with materials resistant to the action of syrup
ingredients;
4. Water clarification
equipment. Electrical or chemical coagulation devices and filters employed for
clarification of water shall be of types acceptable to the Department of
Health, shall not be operated beyond their rated capacity and shall be
maintained in a clean, wholesome and sanitary condition at all times;
and
5. Miscellaneous equipment.
Every plant shall be adequately provided with thermometers and methods for
ascertaining the strength of the washer solution employed in bottle washing.
All piping, vats, covers, tanks and other equipment or utensils shall be of
easily cleanable construction and shall be kept in good repair. No containers
shall be used for mixing or storing syrup or soft drink flavors unless they are
of glass, stainless steel, good grade plastic, porcelain lined or block-tin
lined; or made of or lined with, or both, some other suitable impervious,
non-corrosive material. Utensils or equipment which are cadmium plated or zinc
plated or in which cadmium, zinc or lead is a part of the metal are prohibited
for the delivery of finished syrup or beverage. Only solder of a low lead
content should be used for jointing.
(C) The following rules regarding the
manufacturing methods and operations of soft drink and beverage plants which
manufacture beverage products in Missouri shall be observed:
1. Cleaning facilities. Adequate facilities
must be provided for the proper cleaning of all containers, utensils and
equipment used in the manufacturing and processing of soft drinks;
2. Cleaning. All pipe lines, apparatus and
containers employed in the manufacturing process shall be cleaned and washed
after each day's use. Sanitization shall be done as necessary to maintain at
all times a sanitary system. Steam, hot water, chlorine or other equally
efficient agents approved by the Department of Health are permissible for
sanitization;
3. Sanitation of
bottles. All closable containers in which soft drink flavors and beverages are
sold or dispensed shall be washed or rinsed immediately before filling and
shall be free of pathogenic bacteria. No containers intended by the
manufacturer to be nonreturnable shall be refilled with beverages. Hand bottle
washing, except as a preliminary before mechanical washing, shall be
prohibited.
A. All reusable glass containers
used in the manufacture or bottling of soft drinks and beverages, before being
filled, shall be sanitized during the washing cycle in a hot caustic solution
of a temperature of not less than one hundred forty degrees Fahrenheit
(140oF) that shall contain not less than four
percent (4%) caustic or alkali, sodium hydrate or other residual materials
acquired from the sanitizing procedure. Noncaustic cleansers may be used for
reusable glass containers as described in subparagraph (4)(C)3.C. of this rule
if the bottler can demonstrate to the Department of Health that the process is
sufficient to clean and sanitize the glass.
B. All premix and postmix containers, before
being filled, shall be sanitized in a hot caustic solution at a temperature of
not less than one hundred eighty degrees Fahrenheit
(180oF) that shall contain not less than three
percent (3%) caustic or alkali expressed in terms of sodium hydrate for a
washing cycle of not less than one (1) minute and then thoroughly rinsed in
clean water until free of alkali, sodium hydrate or other residual materials
acquired from the sanitizing procedure.
C. Polycarbonate and other plastic containers
designed and intended for reuse shall be sanitized with noncaustic cleansers in
the following manner:
(I) Only noncaustic
cleansers labeled for use for polycarbonate or plastic returnable containers
shall be used. Specific washing conditions directed by the manufacturer shall
be followed;
(II) Washing shall be
performed for at least one (1) minute if using high-velocity jets or for three
(3) minutes if using soaker-type wash;
(III) A sanitizing rinse shall follow the
washing of the container. The sanitizing rinse shall use either water at an
inside bottle temperature not less than one hundred seventy degrees Fahrenheit
(170o F) for not less than fifteen (15) seconds; or
shall use a sanitizing solution. The sanitizing solution shall contain not less
than one hundred parts per million (100 ppm) nor more than two hundred parts
per million (200 ppm) chlorine water solution at seventy-five degrees
Fahrenheit (75oF) for not less than thirty (30)
seconds. Other sanitizing agents may be allowed upon approval of the Department
of Health;
(IV) A final rinse with
product water or operations water shall be used to remove all traces of
sanitizer; and
(V) Manufacturers
currently using caustics for sanitizing plastic containers as of July 1, 1992,
the effective date of this rule may continue to use this method of sanitizing
bottles as described for glass containers in subparagraph (4)(C)3.A. New
installations of bottle washing equipment shall use the non-caustic cleanser
method as described in this section.
D. A record of key operating parameters of
the container washer shall be maintained. The record shall include wash
temperature, concentration of caustic or cleanser, concentration of sanitizer
when using non-caustic cleansers, lack of carry-over of caustic or cleanser in
containers, and maintenance on washers. Records shall be kept on file at least
two (2) years for regulatory inspection.
4. Preparation of syrup. Syrups shall be
prepared in a clean manner and every precaution shall be taken against
contamination or absorption of deleterious substances during the process,
preparation and subsequent storage. All vats, tanks and other equipment must be
provided with suitable covers so as to protect the syrup and other ingredients
used in the manufacturing of soft drinks from contamination. Covers shall be in
place on all vats which contain ingredients;
5. Filling and closing. Manual filling
crowning, closing or both shall be prohibited. Containers shall be filled and
closed with automatic machinery and neither the operator nor his/her clothes
shall come in contact with any portion of the bottle, can or machinery which
might result in contamination of the product. This shall not apply to premix or
postmix tanks for which mechanical closing equipment is not available. If and
when mechanical closing apparatus becomes available, manual closing shall be
prohibited after a period of five (5) years;
6. Storage of closures. Crowns, can covers or
any other closures shall be stored in dustproof containers;
7. Storage of sweetening ingredient.
Sweetening ingredients shall be stored in a clean sanitary manner and protected
from insects, rodents, dust and other contamination;
8. Storage of finished goods. The finished
product shall be stored in a manner as not to interfere with the sanitation of
the processing area;
9. Refuse and
rubbish. All waste, broken bottles and other such refuse shall be promptly and
properly disposed of and all garbage and trash shall be kept in suitable clean,
covered receptacles in a manner as not to become a nuisance;
10. Storage and handling of utensils and
equipment. After bactericidal treatment, utensils shall be stored in a clean,
dry place protected from insects, dust or other contamination and utensils
shall be handled in a manner as to prevent contamination; and
11. Miscellaneous. The surroundings of all
plants shall be kept clean and free from litter or rubbish. None of the
operations shall be conducted in any room used for domestic purposes. Clothing
and hands shall be kept clean. Soiled linens, aprons and coats shall be kept in
covered containers for this purpose. Animals such as dogs, cats or birds, etc.
are not permitted in the plant.
(D) The following rules regarding personnel
employed in the manufacture and distribution of soft drinks and beverages must
be observed:
1. Appearance and sanitary
habits. All employees engaged in the mixing of syrups, filling of containers or
in any other capacity which brings them in contact with the ingredients or
containers of soft drinks, soft drink flavors or beverages shall be clean, have
a neat appearance and wear clean clothes as determined by the licensee.
Spitting or the use of tobacco in any form in the syrup room or bottling rooms
is prohibited; and
2. Health. It is
the employer's responsibility to assure him/herself that no employee has a
contagious or infectious disease while engaged in handling, production,
preparation, manufacture, packing, storage, sale or distribution of soft
drinks, soft drink flavors or beverages.
(E) All bulk water sources and facilities
shall be approved and maintained for sanitary quality at all times.
1. Bulk water shall be from approved sources.
A. All sources of water within the state
intended for bulk water that is obtained from community public water supplies,
non-community public water supplies or both shall comply with the laws and
rules administered by the Public Drinking Water Program, Department of Natural
Resources, governing public water supplies.
B. All sources of water within the state
intended for bulk water that is obtained from springs or private wells shall be
approved by the Department of Health. The Department of Health shall request a
preliminary review by the Division of Geology and Land Survey, Department of
Natural Resources of the geology and potential sources of contamination of
springs and their recharge areas, such as sinkholes or chemical pipelines. The
review, at the option of the Division of Geology and Land Survey, may include
site evaluation, dye tracing, flow movement or other criteria to assist in
determining characteristics of the spring. The spring orifice shall be
protected from avoidable contamination, such as keeping livestock out. Because
each spring and surrounding area may be unique, plans for protection from
avoidable contamination shall be presented for review and approval by the
Department of Health.
C. All
privately owned wells within the state intended for bulk water shall be in
compliance with the laws and rules administered by the Division of Geology and
Land Survey, Department of Natural Resources, governing wells.
D. Sources of water which may be classified
as surface or ground water under the influence of surface water shall be
provided with filtration or disinfection methods capable of controlling
pathogenic organisms or both.
E.
All sources of water outside the state intended for bulk water, after treatment
if needed, shall be in compliance with the appropriate regulatory authority for
that jurisdiction and shall meet the requirements for microbiological, chemical
and radiological standards set forth in sections (6)-(8) of this rule.
Documentation of compliance with the appropriate regulatory authority shall be
provided to the Department of Health.
2. Bulk water sources shall meet requirements
for microbiological, chemical and radiological standards set forth in sections
(6)-(8) of this rule.
3. All water
storage facilities shall be maintained clean and sanitary at all times and
shall meet the requirements set forth in section (4) of this rule.
4. Tank trucks, loading and unloading
facilities, and other equipment used to transport bulk water shall be
constructed of materials that do not import toxic substances, tastes, odor or
color to the water, and shall be maintained clean and sanitary at all times.
Tanks previously used to transport toxic materials, petroleum products or other
deleterious substance shall not be used to haul drinking water.
5. Bulk transport and transfer procedures, at
a minimum, shall meet the following requirements:
A. The tank shall be sanitized monthly and at
any time contamination is suspected or any substance other than water has been
introduced or transported in the tank. The tank interior shall be cleaned,
flushed with potable water, sanitized with a chemical sanitizer equivalent in
bactericidal action of either a two (2)-minute exposure of fifty parts per
million (50 ppm) of available chlorine at fifty-seven degrees Fahrenheit
(57o F) when used as a circulating solution or an
exposure of one hundred parts per million (100 ppm) available chlorine at
fifty-seven degrees Fahrenheit (57o F) when used as
a spray or fog. The tank cover shall not be opened after sanitizing;
B. Tanks also used for the transport of dairy
products must have the interior of the tank inspected with an ultraviolet lamp
by the hauler each time water is to be transported. Tanks shall be rejected for
use when odors or contaminants are found. The dome cover shall be closed
immediately after inspection;
C.
All hoses, connections and fittings shall be sanitized with a chemical solution
equivalent in bactericidal action of a one (1) minute exposure of fifty parts
per million (50 ppm) chlorine water solution by brushing solution on all
exposed parts;
D. A minimum
chlorine residual of one-half parts per million (0.5 ppm) shall be maintained
in the water being hauled;
E. Tank
trucks or tank trailers may be filled through the fitting on the inner-dome
cover when the tailpipe cannot be used;
F. Water quality in the tank, after twenty to
thirty (20-30) gallons have been delivered into the tank, shall be checked as
follows:
(I) Stop filling;
(II) Have discharge valve opened;
(III) Inspect water as it discharges. If
water has unpleasant odor or looks dirty, it shall be rejected for use;
and
(IV) When these checks indicate
satisfactory water quality, proceed to fill the tank; and
G. The dome cover and tank discharge valve
cover shall be closed and sealed after filling to volume desired;
H. When a fill connection is used, it shall
be constructed in a manner to prevent contamination and shall be capped at all
times when not in use; and
I.
Records, at a minimum, shall meet the following requirements:
(I) Records shall be maintained and include
the number of gallons delivered daily and cleansing and sanitizing methods used
for tank truck and tank trailer interiors, riser, connections and
hoses;
(II) Records shall include
date, time and location of delivery, concentration of chlorine residual and
time of contact when applicable; and
(III) The records shall be maintained for two
(2) years and be available upon written or oral request by the Department of
Health.
(5) Approval of License. When the analysis of
samples shows the beverages to be unadulterated and free from ingredients
injurious to health and sanitation conditions are satisfied as described in
subsections (5)(A) and (B) of this rule, the manufacturer, upon payment of
license fee, will be issued a license authorizing the applicant to manufacture
a nonintoxicating beverage or a soft drink. A license will be renewed annually
upon the same terms and conditions as required for the original license.
Licenses are not transferable and no refunds shall be made. If the business is
sold, the new owner shall obtain a new license to operate.
(A) The buildings and equipment to be used by
beverage manufacturers located in Missouri are found by the Department of
Health to be in a sanitary condition as described in section (4) of this
rule.
(B) Out-of-state
manufacturers shall provide a copy of a current license or permit from the
regulatory authority of the state or country of origin to manufacture the
beverage; a copy of a current inspection report indicating the manufacturer is
approved for a license or permit by the regulatory authority of the state or
country of origin and that application for a license or permit has been made
and issuance of a license or permit is pending; or other documentation
acceptable by the Department of Health may be provided when a license or permit
is not yet available. If a license or permit is not required by the regulatory
authority of the state or country of origin, the manufacturer shall provide the
Department of Health a copy of a current inspection report indicating the
manufacturer is in compliance with the standards of the regulatory authority.
If no regulatory authority exists for the inspection of the manufacturer, the
manufacturer shall provide either a copy of the most current inspection report
from an independent third party acceptable to the Department of Health which
indicates the manufacturer complies with the standards of the state or country
of origin or a signed affidavit that the beverages were manufactured under
sanitary conditions, are unadulterated and do not contain ingredients injurious
to health.
(6) Bacteria,
Yeast and Mold Standards. All product-contact surfaces of nonreturnable
containers shall be exposed to an adequate clean water rinse. Each size and
flavor of beverage shall be sampled at least annually. The following bacteria,
yeast and mold standards shall be used to determine the sanitary status of all
containers and their contents:
(A) No
carbonated beverages, including carbonated natural and mineral waters, shall be
sold, offered for sale or held in possession for sale in the state which
contains a total bacterial count above one hundred (100) bacteria per
milliliter as determined by the pour plate method using plate count agar,
incubated at thirty-two degrees Centigrade (32o C)
for seventy-two (72) hours; or a most probable number of coliforms which
exceeds a count of two (2) per one hundred (100) milliliters as determined by
the multiple-tube ferrmentation test method or which indicates the presence of
coliforms as determined by the membrane filter method; or the yeast or mold
count or a combination of yeast and mold count which exceeds ten (10) per
milliliter;
(B) No still beverage
including nondairy fluid products used as a beverage, excluding bottled water,
shall be sold, offered for sale or held in possession for sale in the state
which contains a bacterial count in excess of one thousand (1,000) bacteria per
milliliter; or a most probable number of coliforms which exceeds a count of two
(2) per one hundred (100) milliliters as determined by the multiple-tube
fermentation test method or which indicates the presence of coliforms as
determined by the membrane filter method; or the yeast or mold count or a
combination of yeast or mold count which exceeds ten (10) per
milliliter;
(C) No still, flat or
uncarbonated bottled water shall be sold, offered for sale or held in
possession for sale in the state: which contains a total bacterial count above
twenty thousand (20,000) bacteria per milliliter as determined by the pour
plate method using R2A agar, incubated at twenty-eight degrees Centigrade
(28o C) for five (5) days or which contains a most
probable number of coliforms which exceeds a count of two (2) per one hundred
(100) milliliters as determined by the multiple-tube fermentation test method
or which indicates the presence of coliforms as determined by the membrane
filter method, presence-absence coliform method, minimal medium ONPG-MUG
(MMO-MUG) method or any other analytical method approved by the U.S. E PA for
the determination of coliform in drinking water; or which indicates the
presence of Pseudomonas aeruginosa; or which contains a yeast
or mold count or a combination of yeast or mold count which exceeds ten (10)
per milliliter; and
(D) Total
bacteria counts by the rinse method shall not exceed two hundred fifty (250)
bacteria per bottle for sanitized empty bottles. Sanitized equipment or premix
containers should not exceed an estimated count of one hundred (100) bacteria
per swabbed area of eight (8) square inches.
(7) Chemical Quality Standards for Source
Water for Bottled Water. Source water for bottled water shall meet standards of
chemical quality as established by the United States FDA in 21 CFR
103.35(1991)Standards of Quality for Bottled Water, except-
(A) Samples for all chemical parameters shall
be analyzed at least every three (3) years;
(B) The total dissolved solids limitation and
other standards for which the U.S. EPA has not established a primary drinking
water standard shall not apply to mineral water; and
(C) The level of lead shall not exceed
fifteen thousandths milligrams per liter (0.015 mg/l).
(8) Radiological Quality Standards for Source
Water for Bottled Water. Source water for bottled water shall meet the
standards of radiological quality as established by the United States FDA in 21
CFR 103.35(1991)Standards of Quality for Bottled Water.
Samples shall be analyzed at least every four (4) years. Instate sources of
water may be exempted from these standards if they are located in areas
unlikely to yield water excessive of the United States FDA standards. Sources
will be exempted on an individual basis by the Department of Health after
consultation with the Department of Natural Resources.
(9) Routine Sampling of Beverages Including
Bottled Waters. Manufacturers or their distributors shall send samples for
microbiological quality standards either to the Department of Health laboratory
or to an approved laboratory, as described in paragraph (9)(C)3. of this rule,
with results of required analyses recorded and routinely forwarded to the
Department of Health. Samples of source water or finished water for bottled
water for chemical and radiological quality standards shall be sent to an
approved laboratory, as described in paragraph (9)(C)3. of this rule, with
results of required analyses recorded and routinely forwarded to the Department
of Health.
(A) Beverages shall be sampled at
the minimum frequency and analyzed for the parameters described in sections
(6)-(8) of this rule.
(B) Samples
for any parameter not specified in sections (6)-(8) of this rule shall be
collected and analyzed as may be required by the Department of
Health.
(C) Sampling methods and
analyses, at a minimum, shall meet the following requirements:
1. Source water samples for bulk water,
bottled water or both shall be taken from each approved source;
2. Product samples shall be taken from a
batch or segment of a continuous production run for each type of beverage
produced in a day's production. The representative sample shall consist of a
primary container of the beverage;
3. All beverage manufacturers and source
water suppliers for bulk water, water bottled or both within Missouri shall
submit microbiological samples either to the Department of Health laboratory or
to a laboratory meeting one (1) of the following criteria; and all chemical and
radiological samples shall be sent to a laboratory meeting one (1) of the
following criteria:
A. A laboratory certified
by the Department of Health for analyses required for beverages, bulk water or
source water;
B. A laboratory
operated or approved the governmental regulatory agency having authority for
beverage regulation or drinking water regulation or both in that state,
province or country, provided their laboratory tests and procedures are
acceptable to the Department of Health; or
C. A laboratory operated by or approved by
the United States FDA, the U.S. E PA or other appropriate federal agency,
provided the laboratory tests and procedures are acceptable to the Department
of Health; and
4. If a
laboratory other than a Department of Health laboratory is used, each
manufacturer or distributor must submit proof of certification approval or
acceptance by an appropriate governmental agency concerning the ability to
perform the designated analyses.
*Original authority: 192.005, RSMo 1985; 192.020, RSMo
1939, amended 1945, 1951; and 196.440, RSMo
1943.