Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 241 - SHELLFISH SANITATION
Subchapter B - MOLLUSCAN SHELLFISH
Section 241.63 - General HACCP Requirements
Universal Citation: 25 TX Admin Code ยง 241.63
Current through Reg. 49, No. 38; September 20, 2024
(a) Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of molluscan 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 the hazard will occur in the particular type of molluscan shellfish product being processed in the absence of those controls.
(b) Every dealer shall have, implement, and comply with a written HACCP plan that is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:
(1) each location where
molluscan shellfish products are processed by that dealer; and
(2) each kind of molluscan shellfish product
processed by the dealer. The plan may group kinds of molluscan shellfish
products together, or group kinds of production methods together, if the food
safety hazards, critical control points, critical limits, and procedures
required to be identified and performed in this section are identical for all
molluscan shellfish products so grouped or for all production methods so
grouped.
(c) The HACCP plan shall, at a minimum:
(1) list the food
safety hazards that are reasonably likely to occur, as identified in accordance
with subsection (a) of this section and that must be controlled for each
molluscan 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. If the dealer can demonstrate to the
department through a hazard analysis that the food safety hazard is not
reasonably likely to occur or is otherwise controlled, the critical control
point is not required; and
(B)
critical control points designed to control food safety hazards that could be
introduced in the processing plant environment. If the dealer can demonstrate
to the department through a hazard analysis that the food safety hazard is not
reasonably likely to occur, the critical control point is not
required;
(3) list the
critical limits that must be met at each of the critical control
points;
(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 written corrective action
plans that have been developed in accordance with this section to be followed
in response to deviations from critical limits at critical control
points;
(6) list the verification
procedures, and frequency thereof, that the dealer will use in accordance with
this section. The records shall contain the actual values and observations
obtained during monitoring; and
(7)
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.
(d) The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:
(1) upon
initial acceptance;
(2) upon any
modification; and
(3) upon
verification of the plan in accordance with subsection (g)(1)(A) of this
section.
(e) Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 241.64 of this title (relating to General Sanitation Requirements), they need not be included in the HACCP plan.
(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 paragraph (2)
of this subsection.
(2)
Dealers may develop written corrective action plans, which become part of their
HACCP plans in accordance with subsection (c)(5) of this section, 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 subparagraphs (B) and (C) of this
paragraph 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;
(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; and
(E) perform or obtain timely reassessment by
an individual or individuals who have been trained in accordance with this
section 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
subsection (g) of this section and the record keeping requirements of
subsection (h) of this section.
(g) Verification.
(1) Every dealer 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 at least annually or whenever any changes occur
that could affect the hazard analysis or alter the HACCP plan in any way. The
reassessment shall be performed by an individual or individuals who have been
trained in accordance with subsection (i) of this section. The HACCP plan shall
be modified immediately whenever a reassessment reveals that the plan is no
longer adequate to fully meet the requirements of subsection (c) of this
section. These changes may include:
(i) raw
materials or source of raw materials;
(ii) product formulation;
(iii) processing methods or
systems;
(iv) finished product
distribution systems; or
(v) the
intended use or consumers of the finished product.
(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 subsection (i) of this section, 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 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 subsection (f) of this
section. This review shall occur within one 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 dealer's written procedures as specified in the
HACCP plan. These reviews shall occur within one week of the day the records
are made.
(2)
Dealers shall immediately follow the procedures in subsection (f) of this
section 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 paragraph (1)(B)(ii) and (iii) of this subsection,
shall be documented in records that are subject to the record keeping
requirements of subsection (h) of this section.
(h) Records.
(1) All records required 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 shall be retained at the processing facility for at least one
year after the date they were prepared in the case of refrigerated products and
for at least two 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 years from the date that product is
first produced using the applicable equipment or processes.
(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 producible for official review
upon request by the department.
(5)
All records required by subsection (h) of this section, and HACCP plans
required by subsections (b) and (c) of this section shall be available for
official review and copying upon request by the department.
(6) Tags on containers of molluscan shell
stock are not subject to the requirements of this section unless they are used
to fulfill the requirements of record keeping.
(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 molluscan shellfish processing at least
equivalent to that received under standardized curriculum recognized as
adequate by the FDA 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 subsection (c) of this section;
(B) reassessing and modifying the HACCP plan
in accordance with the corrective action procedures specified in subsection
(f)(3)(E) of this section, and the HACCP plan in accordance with the
verification activities specified in subsection (g)(1)(B) of this section;
and
(C) performing the record
review required by subsection (g)(1)(C) of this section.
(2) Job experience will qualify an individual
to perform these functions if he/she has provided knowledge at least equivalent
to that provided through the standardized curriculum as determined by the
SSD.
(3) The trained individual
need not be an employee of the dealer.
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