Current through Register Vol. 50, No. 9, September 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.
B. [formerly paragraph 9:028] Employee
Health. The requirements of Part I,
§117 and Part II, §501-503 C of this Code
shall be met.
C. [formerly
paragraph 9:029] During the operating season, the plant shall be used for no
purpose other than the handling of shellfish or other marine or fresh water
animal foods. Materials and equipment not used in the processing of seafood
shall not be stored within the operating part of the plant. All abandoned
equipment shall be removed from the plant and the floors shall be kept clear
for thorough cleaning. The unoccupied portion of the storage bins, the shucking
benches, work tables and all the floors shall be swept and flushed until they
are thoroughly cleaned, at least once every day, at the completion of the day's
run, with water from a source approved by the state health officer.
Refrigeration rooms or ice boxes shall be washed out and thoroughly cleaned
once a week or more often if necessary. At least once a week the cleansing
shall include the washing of walls.
D. [formerly paragraph 9:030] All employees
shall wash their hands thoroughly with running water and soap on beginning work
and after each visit to the toilet. Signs to this effect shall be posted by the
proprietor in conspicuous places in the plant and in each toilet.
1. The outer clothing worn by persons engaged
in handling these food products shall be of such material as to be readily
cleaned, and shall be kept clean. Persons engaged in cleaning, shucking,
peeling, picking or packing marine or fresh water animal food products to be
consumed without further cooking or processing shall be required to wear outer
garments that are clean at the start of each day's employment. If finger cots
or shields for protecting the palm of the hand are worn, they shall be of
waterproof, nonabsorbent material, preferably of rubber (when
available).
E. [formerly
paragraph 9:031] Spitting and smoking in a marine or fresh water animal food
product establishment is strictly prohibited.
F. [formerly paragraph 9:032] All utensils
and tools in use, such as opening knives, shucking pails, measures, skimmers,
colanders, tanks, tubs, and paddles, which come in contact with oysters, cooked
shrimp or cooked and picked crabs, shall each day be thoroughly scoured until
clean, using detergent or an alkali cleanser and then sanitized either:
1. by exposure for at least 15 minutes to a
temperature of not less than 170°F, or for not less than five minutes to a
temperature of at least 200°F, in a steam cabinet equipped with an indicating
thermometer located in the coldest zone;
2. by exposure to a steam jet for at least
one minute;
3. by immersion in or
exposure to a flow of a chlorine solution of not less than 100 parts of free
chlorine per million parts of water for not less than two minutes;
4. by immersion in an iodine solution
concentration between 12.5 mg/L and 25 mg/L(ppm); or
5. by immersion in a quarternary ammonium
compound solution concentration of 200 mg/L (ppm) or as indicated by the
manufacturer's use directions included in labeling; or.
6. by immersion in hot water at a temperature
of 170 degrees F or more for not less than two minutes; or
7. by exposure to hot air at a temperature of
not less than 180 degrees F for not less than 20 minutes, in a properly
designed oven or hot air cabinet equipped with an indicating thermometer
located in the coldest zone or other method of eliminating pathogenic bacteria
as approved by the state health officer.
G. [formerly paragraph 9:033] All equipment
used in the shucking, picking, packing or other handling of seafoods, including
shucking buckets, knives breaking blocks, finger cots and so forth, shall be
stored in such a manner as not to become contaminated after cleaning and
bactericidal treatment. Equipment in daily use during operating seasons shall
not be removed from the plant for storage, but sufficient room or space shall
be provided to store equipment that is not being used.
H. [formerly paragraph 9:034] Shucking,
picking, peeling, packing, or other work operations shall be carried out on
tables, counters, etc., above floor-level; such operations shall not be
performed on the floor. Where marine or fresh water animal food products are
stored, adequate protection shall be provided within the storage space to
prevent possible contamination from fresh water, wastes, and from foot traffic.
Utensils, for handling marine or fresh water animal food products that are to
be consumed without further cooking or processing, shall be so placed as to
prevent handling of drippings from the food by the workers.
I. [formerly paragraph 9:035] The "nesting"
of empty pails shall not be permitted during the operating season. When not in
use, pails shall be inverted on racks or benches provided for this
purpose.
J. [formerly paragraph
9:036] The cooling to a temperature of 45°F or less of shucked shellfish,
picked crabs, cooked, peeled shrimp or other seafoods which are to be consumed
without further cooking or processing shall be effected as promptly as
possible, and in no case shall the time exceed two hours after shucking,
picking or cooking; provided that crabs or similar seafoods, which are picked
after cooking, shall be cooled as rapidly as possible after cooking to a
temperature of 45°F or less and held at such temperature until ready to be
picked, after which the picked material shall again be cooled, as specified
above.
K. [formerly paragraph
9:037] Water for washing any marine or fresh water animal used as a food, or
any food products derived from them, shall be from an approved source as
defined in Part XII, Water Supplies, of this Code.
L. [formerly paragraph 9:038] Shells,
washings and other wastes shall be disposed of in such manner defined in Part
XIII of the state sanitary code.
M.
[formerly paragraph 9:039] All persons handling shucked shellfish, picked
crabs, cooked, peeled shrimp, or other marine or fresh water animal food to be
consumed without further cooking or processing, shall keep their hands
scrupulously clean. A solution of at least 50 parts per million (ppm) of free
chlorine should be provided in which such persons can frequently rinse their
hands and forearms.
N. [formerly
paragraph 9:040] When necessary in the interest of the public health, a duly
authorized representative of the state health officer shall attach a tag to any
equipment or utensil which is insanitary, or the use of which would be in
violation of these regulations. Any equipment or utensil so tagged shall not be
used again until made sanitary and approved by the state health officer. Tags
so placed shall not be removed by anyone other than a duly authorized
representative of the state health officer.
O. [formerly paragraph 9:041] A single
individual shall be designated by the management to supervise the shucking and
packing of shellfish, the packing of peeled and cooked shrimp and picked crabs.
They shall be responsible for the cleanliness the shucking, picking, or packing
rooms and shall see that the requirements with reference to washing of hands
after interruption of working operations is carried out by all persons engaged
in the establishment. They shall be responsible at the end of each day's
operations for the thorough cleansing and sanitizing of all equipment such as
pails, knives, breaking blocks, finger cots, aprons, and so forth.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:4.A.(1) and
R.S.
40:5.3.
