Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part IX - Marine and Fresh Water Animal Food Products › Chapter 3 - Preparation and Handling of Seafood for Market › Section IX-317 - Seafood Plant Operation [formerly paragraph 9:027 and 9:027-1]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The operation of
				plants engaged in shucking, cleaning, picking, peeling or packing marine or
				fresh water animal food products shall meet the requirements listed in §317 B-O.
1. 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.
2. HACCP Plan. Every dealer shall have and
				implement a written HACCP plan. A HACCP plan shall be specific to:
a. each location where shellfish products are
				processed by that dealer; and
b.
				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 Paragraph 3. are
				identical for all shellfish products so grouped or for all production methods
				so grouped.
3. Contents
				of the HACCP Plan. The HACCP plan shall, at a minimum:
a. list the food safety hazards that are
				reasonably likely to occur, as identified in accordance with Paragraph 1 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:
i. natural
				toxins;
ii. microbiological
				contamination;
iii. chemical
				contamination;
iv.
				pesticides;
v. drug
				residues;
vi. unapproved use of
				direct or indirect food or color additives; and
vii. physical hazards;
b. list the critical control points for each
				of the identified food safety hazards, including as appropriate:
i. 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. As an alternative, the dealer may establish other critical control
				points which the dealer can demonstrate that provides equivalent public health
				protection. If the dealer can demonstrate 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;
ii. 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 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 like to occur, the critical control point is not
				required;
c. list the
				critical limits that must be met at each of the critical control points. 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;
d. 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;
e. include any corrective action plans that
				have been developed in accordance with Subparagraph 6.b to be followed in
				response to deviations from critical limits at critical control
				points;
f. 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;
g. list the
				verification procedures, and frequency thereof, that the dealer will use in
				accordance with Subparagraph 7.a.
4. Signing and Dating the HACCP Plan
a. 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.
b. The HACCP plan shall be signed and dated:
i. upon initial acceptance;
ii. upon any modification; and
iii. upon verification of the plan in
				accordance with Clause 7.a.i.
5. Sanitation. Sanitation controls may be
				included in the HACCP plan. However, to the extent that they are monitored in
				accordance with Paragraphs 10, 11, and 12. They need not be included in the
				HACCP plan, and vice versa.
6.
				Corrective Actions
a. Whenever a deviation
				from a critical limit occurs, a dealer shall take corrective action either by:
i. following a corrective action plan that is
				appropriate for the particular deviation; or
ii. following the procedures in Subparagraph
				6.c.
b. Dealers may
				develop written corrective action plans, which become part of their HACCP plans
				in accordance with Subparagraph 3.e, 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:
i. no
				product enters commerce that is either injurious to health or is otherwise
				adulterated as a result of the deviation; and
ii. the cause of the deviation is
				corrected.
c. 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:
i. segregate and hold the affected
				product, at least until the requirements of Clauses 6.c.ii and iii are
				met;
ii. 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 Paragraph 9;
iii. take corrective action, when necessary,
				with respect to the affected product to ensure that no product to ensure that
				no product enters commerce that is either injurious to health or is otherwise
				adulterated as a result of the deviation;
iv. take corrective action, when necessary,
				to correct the cause of the deviation;
v. perform or obtain timely reassessment by
				an individual or individuals who have been trained in accordance with Paragraph
				9, 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.
d. All
				corrective actions taken in accordance with this Section shall be fully
				documented in records that are subject to verification in accordance with
				Paragraph 7 and the record keeping requirements of Paragraph 8.
7. Verification
a. 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:
i. 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 Paragraph 9. The HACCP plan shall be modified
				immediately whenever a reassessment reveals that the plan is no longer adequate
				to fully meet the requirements of Paragraph 3;
ii. ongoing verification of activities
				including:
(a) 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;
(b) the calibration of process-monitoring
				instruments; and
(c) At the option
				of the dealer, the performing of periodic end-product or in-process
				testing;
iii. a review,
				including signing and dating, by an individual who has been trained in
				accordance with Paragraph 9, of the records that document:
(a). 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;
(b). 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 Paragraph 6. This review shall
				occur within one week of the day that the records are made;
(c). 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.
b. Dealers shall immediately
				follow the procedures in Paragraph 6. Whenever any verification procedure,
				including the review of a consumer complaint, reveals the need to take a
				corrective action.
c. The
				calibration of process-monitoring instruments, and the performing of any
				periodic end product and in-process testing, in accordance with Subclauses
				7.a.ii.(b) and (c) shall be documented in records that are subject to the
				record keeping requirements of Paragraph 8.
8. Records
a. All records required by Paragraphs 1-12
				shall include:
i. the name and location of
				the dealer;
ii. the date and time
				of the activity that the record reflects;
iii. the signature or initials of the person
				performing the operation; and
iv.
				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.
b. All
				records required by Paragraphs 1-12 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.
c. 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 after their applicability to the
				product being produced at the facility.
d. 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.
e. All records required by
				Paragraphs 1-12 and HACCP plans required by Paragraphs 2 and 3 shall be
				available for official review and copying at reasonable times.
f. 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.
9. Training
a. 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
				FDA or who is otherwise qualified through job experience to perform these
				functions:
i. 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 Paragraph
				3;
ii. reassessing and modifying
				the HACCP plan in accordance with the corrective action procedures specified in
				Clause 6.c.v, and the HACCP plan in accordance with the verification activities
				specified in Clause 7.a.i; and
iii.
				performing the record review required by Clause 7.a.iii.
b. Job experience will quality an individual
				to perform these functions if it has provided knowledge at least equivalent to
				that provided through the standardized curriculum.
c. The trained individual need not be an
				employee of the dealer.
10. Sanitation Monitoring. Each dealer shall
				monitor conditions and practices that are both appropriate to the plant and the
				food being processed with sufficient frequency. The requirements relate to the
				following sanitation items:
a. safety of the
				water that comes into contact with food or food contact surfaces, or is used in
				the manufacture of ice, hereinafter referred to as: safety of water for
				processing and ice production;
b.
				condition and cleanliness of food contact surfaces, including utensils, gloves,
				and outer garments, and from raw product to cooked product, hereinafter
				referred to as: Condition and cleanliness of food contact surfaces;
c. prevention of cross contamination from
				insanitary objects to food, food packaging materials, and other food contact
				surfaces, including utensils, gloves, and outer garments, and from raw product
				to cooked product, hereinafter referred to as: prevention of cross
				contamination;
d. maintenance of
				hand washing and toilet facilities, hereinafter referred to as: maintenance of
				hand washing and toilet facilities;
e. protection of food, food packaging
				material, and food contact surfaces from adulteration with lubricants, fuel,
				pesticides, cleaning compounds, sanitizing agents, condensate, and other
				chemical, physical, and biological contaminants, hereinafter referred to as:
				protection from adulterants;
f.
				proper labeling, storage, and use of toxic compounds, hereinafter referred to
				as: proper labeling storage, use of toxic compounds;
g. control of employee health conditions that
				could result in the microbiological contamination of food packaging materials,
				and food contact surfaces, hereinafter referred to as: control of employees
				with adverse health conditions; and
h. exclusion of pests from the food plant,
				hereinafter referred to as: Exclusion of pests. While monitoring of those
				specified conditions and practices that are not appropriate to the plant and
				the food being processed is not required, compliance with such conditions and
				practices remains mandatory.
11. Sanitation Monitoring Records. Each
				dealer shall maintain sanitation control records that, at a minimum, document
				the monitoring and corrections prescribed by Paragraph 10. These records are
				subject to the requirements of Paragraph 8.
12. Relationship to HACCP Plan. Sanitation
				controls may be included in the HACCP plan, required by Paragraph 2. However,
				to the extend that they are monitored in accordance with Paragraph 10. they
				need not be included in the HACCP plan, and vice versa.