(A) Treatment of product water.
All treatment of product water by distillation, ion-exchanging,
filtration, ultraviolet treatment, reverse osmosis, carbonation, mineral
addition, or any other process shall be done in a manner so as to be effective
in accomplishing its intended purpose and in accordance with section
3715.62 of the Revised Code. All
such processes shall be performed in and by equipment and with substances which
will not adulterate the bottled product. A record of the type and date of
physical inspections of such equipment, conditions found, and the performance
and effectiveness of such equipment shall be maintained by the plant. Product
water samples shall be taken after processing and prior to bottling by the
plant and analyzed as often as is necessary to assure uniformity and
effectiveness of the processes performed by the plant.
(B) Containers.
(1) Multiservice primary containers shall be
adequately cleaned, sanitized, and inspected just prior to being filled,
capped, and sealed. Containers found to be unsanitary or defective by the
inspection shall be reprocessed or discarded. All multiservice primary
containers shall be washed, rinsed, and sanitized by mechanical washers or by
any other method giving adequate sanitary results.
Mechanical washers shall be inspected as often as is necessary
to assure adequate performance. Records of physical maintenance, inspections
and conditions found, and performance of the mechanical washer shall be
maintained by the plant.
(2) Multiservice shipping cases shall be
maintained in such condition as to assure they will not contaminate the primary
container or the product water. Adequate dry or wet cleaning procedures shall
be performed as often as necessary to maintain the cases in satisfactory
condition.
(C) Cleaning
and sanitizing solutions.
Cleaning and sanitizing solutions utilized by the plant shall
be sampled and tested by the plant as often as is necessary to assure adequate
performance in the cleaning and sanitizing operations. Records of these tests
shall be maintained by the plant.
(D) Sanitizing operations.
Sanitizing operations, including those performed by chemical
means or by any other means such as circulation of live steam or hot water,
shall be adequate to effect sanitization of the intended product water-contact
surfaces and any other critical area. The following times and intensities shall
be considered a minimum:
(1) Steam in
enclosed system: At least one-hundred-seventy degrees Fahrenheit for at least
fifteen minutes or at least two-hundred degrees Fahrenheit for at least five
minutes.
(2) Hot water in enclosed
system: At least one-hundred-seventy degrees Fahrenheit for at least fifteen
minutes or at least two-hundred degrees Fahrenheit for at least five
minutes.
(3) Chemical sanitizers
shall be equivalent in bactericidal action to a two-minute exposure of fifty
ppm of available chlorine at fifty-seven degrees Fahrenheit when used as an
immersion or circulating solution. Chemical sanitizers applied as a spray or
fog shall have as a minimum one-hundred ppm of available chlorine at
fifty-seven degrees Fahrenheit or its equivalent in bactericidal
action.
(4) One-tenth ppm ozone
water solution in an enclosed system for at least five minutes.
(5) When containers are sanitized using a
substance other than one provided for in
21 C.F.R. Part
178.1010
(1977), such substance shall be removed from the
surface of the container by a rinsing procedure. The final rinse, prior to
filling the container with product water, shall be performed with a disinfected
water rinse free of pathogenic bacterial or by an additional sanitizing
procedure equivalent in bactericidal action to that required in paragraph
(D)(3) of this rule.
(E)
Unit package production code.
Each unit package from a batch or segment of a continuous
production run of bottled water shall be identified by a production code. The
production code shall identify a particular batch or segment of a continuous
production run and the day produced. The plant shall record and maintain
information as to the kind of product, volume produced, date produced, lot code
used, and the distribution of the finished product to wholesale and retail
outlets.
(F) Filling,
capping, or sealing.
(1) During the process of
filling, capping or sealing either single-service or multiservice containers,
the performance of the filler, capper or sealer shall be monitored and the
filled containers visually or electronically inspected to assure they are
sound, properly capped or sealed, and coded; and labeled.
(2) Containers which are not satisfactory
shall be reprocessed or rejected.
(3) Only nontoxic containers and closures
shall be used.
(4) All containers
and closures shall be sampled and inspected to ascertain that they are free
from contamination.
(5) At least
once each three months, a bacteriological swab or rinse count or both shall be
made from at least four containers and closures selected just prior to filling
and sealing. No more than one of the four samples may exceed more than one
bacteria per milliliter of capacity or one colony per square centimeter of
surface area. All samples shall be free of coliform organisms.
Tests shall be performed either by personnel at the plant or an
approved laboratory.
(G) Compliance procedures.
To assure that the plant's production of bottled water complies
with this chapter, the plant will analyze product samples as follows:
(1) For bacteriological purposes, take and
analyze at least once a week for total coliform a representative sample from a
batch or segment of a continuous production run for each type of bottled water
produced during a day's production. The representative sample shall consist of
primary containers of product or unit packages of product.
(2) For chemical, physical, and radiological
purposes, take and analyze at least annually a representative sample from a
batch or segment of a continuous production run for each type of bottled water
produced during a day's production. The representative sample(s) consists of
primary containers of product of unit packages of product. If any coliform
organisms are detected, follow-up testing must be conducted to determine
whether any of the coliform organisms are E. coli. If the finished product is
positive for E. Coli it is considered adulterated under section
3715.59 of the Revised
Code.
(3) Analyze such samples by
methods prescribed in
21
C.F.R. Part
165.110(b)
(2011). The plant shall maintain records of date of sampling, type of product
sampled, production code, and results of the analysis.
(H) Record retention.
All records required by rules
901:3-62-05
and 901:3-62-07 of the Administrative Code shall be maintained at the plant for
not less than two years. Plants shall also retain, on file at the plant,
current certificates or notifications of approval issued by the E.P.A. or the
local board of health, or an engineer or hydrologist, as applicable, approving
the plant's source and supply of product water and operations water. All
required documents shall be available for official review at reasonable
times.
(I) Quality.
Bottled water shall, meet
the standards of microbiological, physical, chemical, and radiological quality
set forth in
21
C.F.R. Part 165.110
(2011).
(J) Bottled water containing a substance at a
level considered injurious to health shall be considered adulterated under
section 3715.59 of the Revised Code,
regardless of whether or not the bottled water bears a label statement of
substandard quality prescribed in paragraph (I) of this rule.