A.
|
Hazard Analysis. Every dealer
shall conduct a hazard analysis to determine the food safety hazards
that are reasonably likely to occur for each kind of shellfish product
processed by that dealer and to identify the preventive measures that
the dealer can apply to control those hazards. Such food safety hazards
can be introduced both within and outside the processing plant
environment, including food safety hazards that can occur before,
during , and after harvest. A food safety hazard that is reasonably
likely to occur is one for which a prudent dealer would establish
controls because experience, illness data, scientific reports, or other
information provide a basis to conclude that there is a reasonable
possibility that it will occur in the particular type of shellfish
product being processed in the absence of those controls. In the hazard
analysis, the dealer shall consider the critical control points listed
in Chapters XI, XII, XIII, XIV and XV. |
|
|
| B. |
HACCP Plan. Every dealer shall
have and implement a written HACCP plan. A HACCP plan shall be specific
to:
| (1) |
Each location where
shellfish products are processed by that dealer; and |
(2)
|
Each kind of shellfish
product processed by the dealer. The plan may group kinds of shellfish
products together, or group kinds of production methods together, if
the food safety hazard, critical control points, critical limits, and
procedures required to be identified and performed in §.01C. are
identical for all shellfish products so grouped or for all production
methods so grouped. |
|
|
|
C.
|
Contents of the HACCP Plan. The
HACCP plan shall, at a minimum:
| (1) |
List the food safety
hazards that are reasonably likely to occur, as identified in
accordance with §.01A. and that thus must be controlled for each
shellfish product. Consideration should be given to whether any food
safety hazards are reasonably likely to occur as a result of the
following:
| (a) |
Natural toxins; |
| (b) |
Microbiological
contamination; |
| (c) |
Chemical
contamination; |
| (d) |
Pesticides; |
| (e) |
Drug residues; |
(f)
|
Unapproved
use of direct or indirect food or color additives; and |
(g)
|
Physical
hazards;
|
|
(2)
|
List the critical control
points for each of the identified food safety hazards, including as
appropriate:
(a)
|
Critical control
points designed to control food safety hazards introduced outside the
processing plant environment, including food safety hazards that occur
before, during, and after harvest. At a minimum, the critical control
points shall include those identified in Chapter XI.01, Chapter XII.01,
Chapter XIII.01, Chapter XIV.01 and Chapter XV.01, as applicable. As an
alternative, the dealer may establish other critical control points
which the dealer can demonstrate to the Authority provide equivalent
public health protection. If the dealer can demonstrate to the
Authority through a hazard analysis that the food safety hazard is not
reasonably likely to occur, the critical control point is not required
with the exception of receiving which shall always be considered as a
critical control point.
|
(b)
|
Critical control
points designed to control food safety hazards that could be introduced
in the processing plant environment. As an alternative, the dealer may
establish other critical control points which the dealer can
demonstrate to the Authority provide equivalent public health
protection. If the dealer can demonstrate to the Authority through a
hazard analysis that the food safety hazard is not reasonably likely to
occur, the critical control point is not required. At a minimum, the
critical control points shall include those identified in Chapter
XI.01A., Chapter XII.01A., Chapter XIII.01A., Chapter XIV.01A and
Chapter XV.01A., as applicable. |
|
| (3) |
List the critical limits
that must be met at each of the critical control points. At a minimum,
the critical limits shall include those listed in Chapter XI.01,
Chapter XII.01, Chapter XIII.01, Chapter XIV.01 and Chapter XV.01, as
applicable. As an alternative the dealer may establish other critical
limits which the dealer has demonstrated provide equivalent public
health protection with the exception of receiving which shall always be
considered as a critical control point. In any case, the critical
limits identified in Chapter XI.01, Chapter XII.01, Chapter XIII.01,
Chapter XIV.01, and Chapter XV.01 shall be met as components of good
manufacturing practices.
|
| (4) |
List the procedures, and
frequency thereof, that will be used to monitor each of the critical
control points to ensure compliance with the critical limits.
|
(5)
|
Include any corrective
action plans that have been developed in accordance with
§.01F.(2), to be followed in response to deviations from critical
limits at critical control points.
|
(6)
|
Provide for a record
keeping system that documents the monitoring of the critical control
points. The records shall contain the actual values and observations
obtained during monitoring.
|
(7)
|
List the verification
procedures, and frequency thereof, that the dealer will use in
accordance with §.01G.(1).
|
|
| D. |
Signing and Dating the HACCP
Plan.
(1)
|
The HACCP plan shall be
signed and dated, either by the most responsible individual on site at
the processing facility or by a higher-level official of the dealer.
This signature shall signify that the HACCP plan has been accepted for
implementation by the dealer.
|
(2)
|
The HACCP plan shall be
signed and dated:
(a) Upon initial acceptance;
(b) Upon any modification; and
(c) Upon verification of the plan in accordance with §.01G.(1)(a).
|
|
E.
|
Sanitation. Sanitation controls
may be included in the HACCP plan. However, to the extent that they are
monitored in accordance with §.02 they need not be included in the
HACCP plan, and vice versa.
|
|
F.
|
Corrective Actions.
(1)
|
Whenever a deviation from
a critical limit occurs, a dealer shall take corrective action either
by:
(a) Following a corrective action plan that is appropriate for the
particular deviation, or
(b) Following the procedures in §.01F.(3).
|
(2)
|
Dealers may develop
written corrective action plans, which become part of their HACCP plans
in accordance with §.01C.(5), by which they predetermine the
corrective actions that they will take whenever there is a deviation
from a critical limit. A corrective action plan that is appropriate for
a particular deviation is one that describes the steps to be taken and
assigns responsibility for taking those steps, to ensure that:
| (a) |
No product enters
commerce that is either injurious to health or is otherwise adulterated
as a result of the deviation; and |
| (b) |
The cause of the
deviation is corrected. |
|
(3)
|
When a deviation from a
critical limit occurs and the dealer does not have a corrective action
plan that is appropriate for that deviation, the dealer shall:
(a)
|
Segregate and hold
the affected product, at least until the requirements of
§.01F.(3)(b) and (c) are met; |
(b)
|
Perform or obtain a
review to determine the acceptability of the affected product for
distribution. The review shall be performed by an individual or
individuals who have adequate training or experience to perform such a
review. Adequate training may or may not include training in accordance
with §.01I.; |
(c)
|
Take corrective
action, when necessary, with respect to the affected product to ensure
that no product enters commerce that is either injurious to health or
is otherwise adulterated as a result of the deviation; |
(d)
|
Take corrective
action, when necessary, to correct the cause of the deviation; |
(e)
|
Perform or obtain
timely reassessment by an individual or individuals who have been
trained in accordance with §.01I., to determine whether the HACCP
plan needs to be modified to reduce the risk of recurrence of the
deviation, and modify the HACCP plan as necessary. |
|
(4)
|
All corrective actions
taken in accordance with this section shall be fully documented in
records that are subject to verification in accordance with §.01G.
and the record keeping requirements of §.01H. |
|
|
| G. |
Verification.
| (1) |
Every processor shall
verify that the HACCP plan is adequate to control food safety hazards
that are reasonably likely to occur, and that the plan is being
effectively implemented. Verification shall include, at a minimum:
| (a) |
A reassessment of
the adequacy of the HACCP plan whenever any changes occur that could
affect the hazard analysis or alter the HACCP plan in any way or at
least annually. These changes may include: Raw materials or source of
raw materials, product formulation, processing methods or systems,
finished product distribution systems, or the intended use or consumers
of the finished product. The reassessment shall be performed by an
individual or individuals who have been trained in accordance with
§.01I. The HACCP plan shall be modified immediately whenever a
reassessment reveals that the plan is no longer adequate to fully meet
the requirements of §.01C.
|
| (b) |
Ongoing verification
activities including:
| (i)
|
A review of
any consumer complaints that have been received by the
dealer to determine whether they relate to the performance of critical
control points or reveal the existence of unidentified critical control
points;
|
| (ii) |
The
calibration of process-monitoring instruments; and
|
| (iii) |
At the option
of the dealer, the performing of periodic end product or
in-process testing. |
|
(c)
|
A review, including
signing and dating, by an individual who has been trained in accordance
with § .01I., of the records that document:
| (i)
|
The monitoring
of critical control points. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that they document values that are within the critical limits.
This review shall occur within one (1) week of the day that the records
are made; |
| (ii) |
The taking of
corrective actions. The purpose of this review shall
be,
at a minimum, to ensure that the records are complete and to verify
that appropriate corrective actions were taken in accordance with
§.01F. This review shall occur within one (1) week of the day that
the
records are made; and |
| (iii) |
The
calibrating of any process monitoring instruments used at critical
control points and the performing of any periodic end product or in
process testing that is part of the dealer's verification activities.
The purpose of these reviews shall be, at a minimum, to ensure that the
records are complete, and that these activities occurred in accordance
with the processor's written procedures. These reviews shall occur
within a reasonable time after the records are made. |
|
|
| (2) |
Dealers shall immediately
follow the procedures in §.01F. whenever any verification
procedure, including the review of a consumer complaint, reveals the
need to take a corrective action.
|
| (3) |
The calibration of
process-monitoring instruments, and the performing of any periodic
end-product and in-process testing, in accordance with
§.01G(1)(b)(ii) and (iii) shall be documented in records that are
subject to the record keeping requirements of §.01H. |
|
|
| H. |
Records.
| (1) |
All records required by
§.01 and §.02 shall include:
| (a) |
The name and
location of the dealer;
|
| (b) |
The date and time of
the activity that the record reflects; |
| (c) |
The signature or
initials of the person performing the operation; and |
| (d) |
Where appropriate,
the identity of the product and the production code, if any. Processing
and other information shall be entered on records at the time that it
is observed.
|
|
| (2) |
All records required by
§.01 and §.02 shall be retained at the processing facility
for at least one (1) year after the date they were prepared in the case
of refrigerated products and for at least two (2) years after the date
they were prepared in the case of frozen products.
|
| (3) |
Records that relate to the
general adequacy of equipment or processes being used by a processor,
including the results of scientific studies and evaluations, shall be
retained at the processing facility for at least two (2) years after
their applicability to the product being produced at the facility.
|
| (4) |
If the processing facility
is closed for a prolonged period between seasonal operations, or if
record storage capacity is limited on a processing vessel or at a
remote processing site, the records may be transferred to some other
reasonably accessible location at the end of the seasonal operations
but shall be immediately returned for official review upon request.
|
(5)
|
All records required by
§.01 and §.02 and HACCP plans required by §.01B. and
§.01C. shall be available for official review and copying at
reasonable times.
|
(6)
|
Tags on containers of
shellstock are not subject to the requirements of this section unless
they are used to fulfill the requirements of Chapter X.05.
|
(7)
|
The maintenance of records
on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
electronic signatures.
|
|
|
I.
|
Training.
(1)
|
At a minimum, the
following functions shall be performed by an individual who has
successfully completed training in the application of HACCP principles
to shellfish processing at least equivalent to that received under
standardized curriculum recognized as adequate by the SSCA or who is
otherwise qualified through job experience to perform these functions:
| (a) |
Developing a HACCP
plan, which could include adapting a model or generic-type HACCP plan
that is appropriate for a specific processor, in order to meet the
requirements of §.01C.; |
| (b) |
Reassessing and
modifying the HACCP plan in accordance within the corrective action
procedures specified in §.01F.(3)(e), and the HACCP plan in
accordance with the verification activities specified in §
.01G.(1)(a); and |
| (c) |
Performing the
record review required by §.01G.(1)(c).
|
|
(2)
|
Job experience will
qualify an individual to perform these functions if it has provided
knowledge at least equivalent to that provided through the standardized
curriculum as determined by the Authority.
|
(3)
|
The trained individual
need not be an employee of the dealer.
|
|
|
