Ohio Administrative Code|Rule 901:3-23-09 | Process controls and verification.

                                                

(A) In order to meet the requirements of
rules 901:3-23-01 to 901:3-23-09 of the Administrative Code, processors of
juice products shall include in their hazard analysis and critical control
point plans control measures that will consistently produce, at a minimum, a
five-log reduction of the pertinent microorganism, for a period at least as
long as the shelf life of the product when stored under normal and moderate
abuse conditions. For the purposes of this rule, the ``pertinent
microorganism'' is the most resistant microorganism of public health
significance that is likely to occur in the juice. The following juice
processors are exempt from this paragraph:

(1) A juice processor
that is subject to the requirements of Chapter 901:3-3 of the Administrative
Code and Chapter 901:3-5 of the Administrative Code; and

(2) A juice processor
using a single thermal processing step sufficient to achieve shelf-stability of
the juice or a thermal concentration process that includes thermal treatment of
all ingredients, provided that the processor includes a copy of the thermal
process used to achieve shelf-stability or concentration in its written hazard
analysis required by rule 901:3-23-03 of the Administrative Code.

(B) All juice processors shall meet the
requirements of paragraph (A) of this rule through treatments that are applied
directly to the juice, except that citrus juice processors may use treatments
to fruit surfaces, provided that the 5-log reduction process begins after
culling and cleaning as defined in rule 901:3-23-01 (C)(1) and (C)(7) of the
Administrative Code and the reduction is accomplished within a single
production facility.

(C) All juice processors shall meet the
requirements of paragraphs (A) and (B) of this rule and perform final product
packaging within a single production facility operating under the applicable
provisions found in Chapter 901:3-17 of the Administrative Code. Processors
claiming an exemption under paragraph (A)(1) or (A)(2) of this rule shall also
process and perform final product packaging of all juice subject to the claimed
exemption within a single production facility operating under the applicable
provisions found in Chapter 901:3-17 of the Administrative Code.

(D) Each juice processor that relies on
treatments that do not come into direct contact with all parts of the juice to
achieve the requirements of this rule shall analyze the finished product for
biotype I Escherichia coli at an approved laboratory at the following frequency
and sample sizes:

(1) One twenty mL sample
(consisting of two ten mL subsamples) for each one-thousand gallons of juice
produced shall be sampled each production day. If less than one thousand
gallons of juice is produced per day, the sample must be taken for each
one-thousand gallons produced but not less than once every five working days
that the facility is producing that juice. Each subsample shall be taken by
randomly selecting a package of juice ready for distribution to
consumers.

(2) If the facility is
producing more than one type of juice covered by this rule, processors shall
take subsamples according to paragraph (D)(1) of this rule for each of the
covered juice products produced.

(3) Processors shall
analyze each subsample for the presence of E. coli by a method designed to
detect the presence or absence of E. coli in a twenty mL sample of juice
(consisting of two ten mL subsamples).

(4) If either ten mL
subsample is positive for E. coli, the twenty mL sample is recorded as positive
and the processor shall:

(a) Review monitoring records for the control measures to attain
the five-log reduction standard and correct those conditions and practices that
are not met.

(b) If the review of monitoring records or the additional testing
indicates that the five-log reduction standard was not achieved, the processor
shall take corrective action as set forth in rule 901:3-23-05 of the
Administrative Code.

(5) If two samples in a
series of seven tests are positive for E. coli, the control measures to attain
the five-log reduction standard shall be deemed to be inadequate and the
processor shall immediately:

(a) Use an alternative process or processes that achieve the
five-log reduction after the juice has been expressed until corrective actions
are completed;

(b) Perform a review of the monitoring records for control
measures to attain the five-log reduction standard. The review shall be
sufficiently extensive to determine if there are trends towards loss of
control:

(i) If the conditions and
practices are not being met, correct those that do not conform to the HACCP
plan; or

(ii) If the conditions
and practices are being met, the processor shall validate the HACCP plan in
relation to the five-log reduction standard.

(c) Take corrective action as set forth in rule 901:3-23-05 of
the Administrative Code.

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