Archived Rule Revisions for 1995
DEPARTMENT OF AGRICULTURE
FOOD AND DAIRY DIVISION
REGULATION NO. 569. SMOKED FISH
(By authority conferred on the Department of Agriculture by section 23 of act
No. 39 of the Public Acts of 1969, as amended, being S289.723 of the Michigan
Compiled Laws)
R 285.569.1 Definitions.
Rule 1. (1) As used in these rules:
(a) "Cold process smoked fish" means a smoked fish that has not been
subjected to sufficient heat to coagulate the protein throughout the fish.
(b) "Critical control point" means a point, step, or procedure in a food
process at which control can be applied and, as a result, a food safety
hazard can be prevented, eliminated, or reduced to acceptable levels.
(c) "Critical limit" means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a critical
control point to prevent, eliminate, or reduce to an acceptable level the
occurrence of the identified food safety hazard.
(d) "Fish" means all freshwater or saltwater finfish, mollusks,
crustaceans, and other aquatic organisms, other than birds or mammals, that
are intended for human consumption.
(e) "Fish product" means any article of food or any other article
intended for, or capable of being used as, human food that is derived or
prepared, in whole or in part, from any portion of any fish.
(f) "Hazard analysis and critical control point (HACCP) plan" means a
food processing plan under which a food processing plant operator effectively
prevents food safety hazards by monitoring food safety variables at critical
control points and by controlling the variables within critical limits.
(g) "Hot process smoked fish" means a smoked fish that has been subjected
to sufficient heat for a sufficient period of time to coagulate the protein
throughout the fish.
(h) "Liquid smoke" means an aqueous solution of wood smoke that, when
suitably diluted, may be used to impart a smoke flavor.
(i) "Loin muscle" means the longitudinal quarter of the great lateral
muscle of the fish that is free from skin, scales, visible blood clots,
bones, gills, and nonstriated parts.
(j) "Process authority" means a person who has expert knowledge of the
commercial processing of fish and fishery products based on a combination of
education, training, and experience.
(k) "Reduced oxygen packaging" means packaging that reduces the amount of
oxygen in a package by mechanical evacuation of the oxygen, displacing the
oxygen with another gas or combination of gases, or otherwise controlling the
oxygen content in a package to a level below the level of 21% normally found
in the surrounding atmosphere. "Reduced oxygen packaging" includes altered
atmosphere, modified atmosphere, controlled atmosphere, low oxygen and vacuum
packaging.
(l) "Smoked fish" means a freshwater or saltwater finfish that is
prepared by treating it with salt (sodium chloride) and subjecting it to the
direct action of the smoke from burning wood, wood sawdust, or similar
burning material or from liquid smoke flavoring applied to the surface in a
gaseous, liquid, or vaporized state with or without heat. The term includes
products composed in whole or in part from smoked fish, such as sausage,
pate, or snack dip.
(m) "Temperature-indicating device" means an accurate, standard thermometer
or equivalent device, such as a resistance temperature device or thermocouple.
(n) "Temperature-recording device" means a device that is capable of
providing a continuous record of the temperature conditions being monitored.
(o) "Water phase salt" means the percentage of salt (sodium chloride) in
the water phase of the finished fish product. It is calculated by
multiplying the percentage of salt (sodium chloride) by 100 and dividing that
number by the sm of the percentage of salt (sodium chloride) and the
percentage of moisture in the finished product. Moisture and salt content
shall be determined in accordance with the method described in the
publication entitled "Official Methods of Analysis of AOAC, International"
16th edition. The publication is adopted in these rules by reference and may
be obtained from AOAC, International, 2200 Wilson Boulevard, Suite 400-GG,
Arlington, Virginia 22207-3301, at a cost as of the time of adoption of these
rules of $359.00 (print version), or from the Department of Agriculture, Food
Division, Ottawa Building, Fourth Floor, P.O. Box 30017, Lansing, MI 4 48909,
at cost.
(2) Terms defined in Act No. 39 of the Public Acts of 1968, as amended,
being §289.701 et seq. of the Michigan Compiled Laws, have the same meanings
when used in these rules.
History: 1997 AACS.
R 285.569.2 Exemptions from rules.
Rule 2. The following fish products are exempt from the requirements of
these rules:
(a) Finnan haddie, smoked cod fillet, smoked Scottish kipper, or other
smoked fish that is clearly labeled to be cooked before consumed.
(b) Boneless, smoked salted herring; smoked, dry salted herring; smoked
blind robbin; or other smoked fish that has a water phase salt content of not
less than 10%.
(c) Commercially sterile smoked fish, either canned or in sterile
packaging.
History: 1997 AACS.
R 285.569.3 Fish-smoking establishment; requirements; temperature-indicating
devices and temperature-recording devices generally.
Rule 3. (1) A fish-smoking establishment shall be in compliance with the
requirements of R 285.553.1 to R 285.553.26 in addition to the requirements
of these rules.
(2) When reference is made to a temperature-indicating device and
temperature-recording device, the following conditions shall apply:
(a) A temperature-indicating device shall be installed where it can be
easily read and the sensor for the device shall be located to ensure that it
accurately measures the warmest temperature of the refrigeration equipment
and the coldest temperature of the smoking equipment, as appropriate. The
sensor shall be protected from mechanical damage. A temperature-indicating
device shall be calibrated at the routine operating temperature of the
refrigeration, cooling, or smoking equipment against a known accurate
standard thermometer upon installation and at least once a year thereafter or
more frequently if necessary to ensure its accuracy. Records of accuracy
checks for a temperature- indicating device shall be maintained and shall
specify the date, standard used, method used, results, and the person
performing the test. A temperature- indicating device that has a divided
fluid column or that cannot be adjusted to the standard shall be immediately
repaired or replaced.
(b) A temperature-recording device shall be installed where it can be
easily read and the sensor for the device shall be installed to ensure that
it accurately measures the warmest temperature of the refrigeration equipment
and the coldest temperature of the smoking equipment, as appropriate. Each
temperature-recording device shall be checked for accuracy against a known
accurate temperature-indicating device upon installation and at least once a
year thereafter or more frequently if necessary to ensure its accuracy. A
record of the accuracy checks shall be maintained that specifies all of the
following information:
(i) The time and date of each check.
(ii) The temperatures indicated by both devices before adjustment.
(iii) The corrective action taken, where applicable.
(iv) The person who performed the accuracy check.
History: 1997 AACS.
R 285.569.4 Fish, fish products, and ingredients; condition; processing,
handling, storing, preparing, and transporting at certain temperature
required; inspection and washing before processing; thawing; evisceration.
Rule 4. (1) All fish, fish products, and ingredients shall be clean and
wholesome, free from any deterioration, spoilage, adulteration, or foreign
odors, and processed, handled, stored, prepared, and transported at or below
38 degrees Fahrenheit (3.3 degrees Celsius) so as to be safe for human
consumption.
(2) Fresh fish received shall be inspected and adequately washed with
potable water before processing. Only sound, wholesome fish that are free
from adulteration and organoleptically detectable spoilage shall be processed.
(3) All fish received in a frozen state shall be either thawed promptly
and processed or stored at a temperature that will maintain the fish in a
frozen state. Thawing shall be carried out in as rapid a manner as possible
so that the internal temperature of the fish does not exceed 38 degrees
Fahrenheit (3.3 degrees Celsius). After thawing, the fish shall be
adequately washed with potable water before processing.
(4) All fish destined for smoking shall be eviscerated. The evisceration
of fish shall be conducted in an area that is separate from other processing
operations. The evisceration shall be performed with minimal disturbance of
the intestinal tract contents. Upon evisceration, the fish, including the
body cavity, shall be washed thoroughly with a continuous flow or vigorous
spray of potable water that may be chlorinated at safe levels.
History: 1997 AACS.
R 285.569.5 Brining.
Rule 5. (1) Before smoking, fish shall be dry-salted or brined in a
manner that will ensure an adequate and consistent water phase salt content
of the finished product.
(2) Brining of fish for smoking shall be carried out so that the
temperature of the brine does not exceed 60 degrees Fahrenheit (16 degrees
Celsius) at the start of brining. If the brining time is more than 4 hours,
then the brining shall take place in a refrigerated area that is at a
temperature of 38 degrees Fahrenheit (3.3 degrees Celsius) or below
immediately after the salting step.
(3) Brining tanks shall be cleaned and sanitized before each use. Brines
shall not be reused unless there is an adequate process available to return
the brine to an acceptable microbiological level.
(4) After removal from a brining solution, fish shall be rinsed with
potable water.
History: 1997 AACS.
R 285.569.6 Application of smoke.
Rule 6. (1) Fish to be smoked shall be arranged without overcrowding or
touching each other within the smokehouse oven or chamber to allow for
uniform smoke absorption, heat exposure, and dehydration. Liquid smoke,
generated smoke, or a combination of liquid smoke and generated smoke shall
be applied to all surfaces of the fish. The surfaces of the fish to be
smoked shall be moist or tacky to the touch at the beginning of the smoking
step.
(2) If only liquid smoke or only generated smoke is used, then it shall be
applied before the surface protein on the fish has been allowed to dry to the
point of forming a pellicle or barrier to smoke uptake.
(3) If a combination of liquid smoke and generated smoke is used, then the
liquid smoke shall be applied before the surface protein on the fish has been
allowed to dry to the point of forming a pellicle or barrier to smoke uptake
and the generated smoke may be applied at any stage of the process.
History: 1997 AACS.
R 285.569.7 Process time and temperature; records of heat treatment.
Rule 7. (1) All smoking shall be accomplished so that the internal
temperature of the coldest part of the fish remains at or above 145 degrees
Fahrenheit (62.8 degrees Celsius) for not less than 30 continuous minutes.
The temperature measurement shall be obtained by inserting the sensor of the
temperature-recording device into the thickest flesh portion of one of the
largest fish being smoked that is located at the coldest area of the
smokehouse.
(2) An accurate record of the entire process time and internal
temperature shall be taken for each smokehouse load.
(3) The record specified in subrule (2) of this rule shall indicate the
date, including month, day, and year.
(4) Each smokehouse load shall be assigned a lot number that corresponds
to, and can be easily identified with, the record of the thermal process time
and temperature produced by the temperature-recording device.
(5) A record for each load shall also indicate the smokehouse or
compartment number, the type or species of fish, and the quantity of fish
smoked.
(6) The plant manager shall review and certify by initialing the entry
for each load made on the recording chart or in the smoking record before
distribution or sale of any smoked fish within the load.
History: 1997 AACS.
R 285.569.8 Finished fish product.
Rule 8. (1) Immediately after the thermal process, the smoked fish shall
be cooled to a temperature of 38 degrees Fahrenheit (3.3 degrees Celsius) or
below and shall remain at or below that temperature at all times, including
through all storage, marketing, and sales channels. If smoked fish is to be
frozen, the freezing shall occur immediately after the thermal process and
cooling step, and the smoked fish shall remain frozen at all times, including
through all storage, marketing, and sales channels. Each room, compartment,
or holding device for the storage of smoked fish shall be equipped with an
accurate temperature-indicating device. Every person responsible for
handling smoked fish up to the time it reaches the consumer shall have and
use an accurate temperature-indicating device to check for compliance with
the temperature requirements in these rules.
(2) All air-packaged smoked fish shall be processed so that the content
in the fish of water phase salt is not less than 3%. The determination of
salt and moisture content shall be made using the loin muscles of the fish.
An operator shall chemically analyze the finished fish product with
sufficient frequency using an official method to ensure that the required
level of water phase salt is achieved. If a sample of the operator’s smoked
fish has been analyzed by the department and has been found not to contain
the required levels of an ingredient, including water phase salt, then the
director of the department may require additional analyses to be conducted by
the operator. The results of the analyses shall immediately be made
available to the director of the department upon request.
History: 1997 AACS.
R 285.569.9 Segregated packaging, handling, and storage area.
Rule 9. Smoked fish product packaging, handling, and storage areas shall
be established that are sufficiently segregated within the facility apart
from unprocessed fish and equipment, objects, and employees who have come
into contact with waste, raw product, or other unsanitary objects. Packaging
material, equipment, employees, and in-process materials that enter product
packaging, handling, and storage areas shall be treated so as to minimize the
risk of introducing microorganisms. Air handling systems shall be designed
to minimize the risk of airborne contamination into product packaging,
handling, and storage areas and to provide positive air pressure relative to
the surrounding areas.
History: 1997 AACS.
R 285.569.10 Packaging and labeling.
Rule 10. (1) Every package, carton, wrapper, or other container used to
ship, wrap, or hold unfrozen smoked fish in any way at any time, including
the packages sold from a bulk display and wrapped at the time of sale, shall
be labeled to indicate all of the following information:
(a) The name of the article of food.
(b) The name and address of the manufacturer, packer, distributor, or
retailer. If the smoked fish product is not manufactured by the person whose
name appears on the label, then the name shall be qualified by a phrase that
reveals the connection the person has with the commodity.
(c) The ingredients and net weight, as required by Act No. 39 of the
Public Acts of 1968, as amended, and Act No. 283 of the Public Acts of 1964,
as amended, being §289.701 et seq. and §290.601 et seq., respectively, of the
Michigan Compiled Laws.
(d) The lot code number that identifies the period when processed and
packaged, as required in R 285.569.6.
(e) The warning statement: "Perishable--Keep under refrigeration at 38
degrees Fahrenheit (3.3 degrees Celsius) or below."
(f) The warning statement: "Not to be sold or consumed after _____," the
blank to be filled with a date, including the month, day, and year. The date
shall be not more than 14 days after date of smoking unless an operator can
demonstrate to the director of the department that a longer period of time
can be achieved that is safe. The director of the department may grant
approval for an operator to use a date greater than 14 days, but may invoke
at any time, the requirements of R 285.569.14 and R 285.569.15.
(2) The labeling requirements for frozen smoked fish shall be the same as
for unfrozen smoked fish, except for the requirements specified in subrule
(1)(e) and (f)of this rule. The statements specified in subrule (1)(e) and
(f) shall be replaced with the warning statements of this rule: "Perishable:
Keep frozen. Thaw in refrigerator before consumption."
(3) All label statements shall appear in a distinctive and plain manner
in English words and Arabic numerals. All statements shall be permanently
affixed to each separate and distinct package or container.
(4) Smoked fish processed on different dates shall not be commingled in
the same container at the processing plant or while the fish is being stored,
distributed, or offered for sale.
History: 1997 AACS.
R 285.569.11 Wholesale sale.
Rule 11. If fish product is sold other than at retail, then all of the
following provisions apply:
(a) All sales shall be accompanied by an invoice or record of sale.
(b) Each invoice shall include the lot number, expiration date, and
warning statement as required in R 285.569.10.
(c) Copies of all invoices or other adequate records shall be maintained
to identify consignments or distributions of designated coded lots.
History: 1997 AACS.
R 285.569.12 Sale of fish product under other than original expiration date
code
prohibited.
Rule 12. Smoked fish product shall not be sold under any expiration date
code other than the original expiration date code that the processor assigned
to the fish product.
History: 1997 AACS.
R 285.569.13 Records; availability; time of retention.
Rule 13. All process time and temperature records, temperature device
standardization records, and all records of sales required by these rules
shall be made available to the director of the department for inspection and
copying upon request and shall be retained at the place of business for a
period of not less than 6 months.
History: 1997 AACS.
R 285.569.14 Modifications and waivers.
Rule 14. The director of the department may grant a variance to a
petitioner by modifying or waiving the requirements of these rules if the
director is shown that the proposed alternative is equally effective in
preventing food safety hazards. If a variance is granted, then the director
of the department shall retain the information specified in R 285.569.16 as
part of the official record.
Proprietary information submitted to satisfy a petition for a variance shall
not be subject to public disclosure.
History: 1997 AACS.
R 285.569.15 Documentation of proposed variance and justification.
Rule 15. Before a variance from these rules is approved by the director of
the department, the information that is provided by the person requesting the
variance shall include all of the following:
(a) A statement of the proposed variance from the rule requirements that
cites the relevant rule numbers.
(b) An analysis of the rationale for how the potential public health
hazards addressed by the relevant rule will be alternatively addressed by the
proposal.
If not included in the analysis, the director may require, but shall not be
limited to requiring, any of the following:
(i) A letter from a process authority.
(ii) Copies of relevant articles from scientific journals.
(iii) Studies obtained or performed consisting of not less than 3
processing runs showing that under the requested parameters the desired
result is reliably achieved.
(iv) Laboratory analyses that demonstrate both of the following:
(A) For Clostridium botulinum, zero toxin production in the fish product
through a time period beyond the shelf life of the product of not less than
1/3 of the shelf life, demonstrated through inoculated pack studies under
normal and moderate abuse conditions.
(B) No detectable Listeria monocytogenes in the final fish product.
(v) Actual federal, state, or local government regulations or advisories.
(c) A HACCP plan that includes the information specified in R 285.569.17
as it is relevant to the variance requested.
(d) If the person is a processor outside this state, verification of
inspection or licensing by a regulatory agency as an approved source of
smoked fish.
History: 1997 AACS.
R 285.569.16 Operator requirements if variance granted or HACCP plan
required;
revocation of variance; expiration of variance.
Rule 16. (1) If the director of the department grants a variance or if a
HACCP plan is otherwise required, the operator shall comply with all of the
following provisions:
(a) Comply with the HACCP plan and procedures that are submitted as a
basis for the modification or waiver.
(b) Maintain and provide to the director of the department, upon request,
records specified in R 285.569.18 that demonstrate that all of the following
are routinely employed:
(i) Procedures for monitoring critical control points.
(ii) Monitoring of the critical control points.
(iii) Verification of the effectiveness of an operation or process.
(iv) Necessary corrective actions if there is a failure at a critical
control point.
(c) Notify the director of the department, in writing, when any change,
replacement, or modification to the information required under R 285.569.15
has been made which affects any requirement listed under R 285.569.17.
(2) The director of the department may revoke a variance and may require
resubmission of a petition if any inspection, monitoring, analysis, or other
official activity conducted by the department or other regulatory agency
reveals a condition creating a potential food safety hazard that the
petitioner or plans failed to control or address.
(3) The director of the department may set an expiration date for a
variance after which a petition may be resubmitted. The petitioner will be
notified in writing if an expiration date is set.
History: 1997 AACS.
R 285.569.17 Contents of a HACCP plan.
Rule 17. Where not preempted by federal statute, HACCP plans prepared in
accordance with R 285.569.15 shall specify, for each type of fish product,
all of the following information:
(a) The identity of the individual smoked fish product or categorization
of like products that the plan addresses.
(b) The potential food safety hazards, such as microbiological, chemical,
or physical hazards, that may cause a fish product to be unsafe for human
consumption.
(c) A flow diagram that depicts the operator's entire fish processing
procedures and identifies each critical control point.
(d) Employee and supervisory training plans that address the food safety
issues of concern.
(e) A statement of standard operating procedures for the plan under
consideration, including clearly identifying all of the following:
(i) Each critical control point, including all of the following:
(A) Raw material thawing.
(B) Brining or dry salting.
(C) Smoking.
(D) Cooling after smoking.
(E) Post-smoke processing, if any.
(ii) The critical limits that must be met at each critical control point
specified in paragraph (i) of this subdivision to prevent unacceptable food
safety hazards.
(iii) The method and frequency for monitoring and controlling each
critical control point by an employee designated by the operator.
(iv) The method and frequency for the operator to routinely verify that an
employee is following standard operating procedures and monitoring critical
control points.
(5) The action to be taken by the operator if the critical limits for each
critical control point are not met.
(6) The records to be maintained by the operator to demonstrate that the
HACCP plan is properly operated and managed.
(f) Additional scientific data or other information required by the
director.
History: 1997 AACS.
R 285.569.18 Processes requiring variance.
Rule 18. All of the following processes require a variance under R
285.569.15:
(a) The production of cold process smoked fish.
(b) Subjecting smoked fish to reduced oxygen packaging.
(c) The use of additives that reduce the level of, combine with, or
replace, in whole or in part, the sodium chloride used in the smoked fish
product at the required level, such as sodium nitrite, potassium chloride, or
any other approved food additive.
History: 1997 AACS.
R 285.569.19 Rescission.
Rule 19. R 285.541.1 to R 285.541.11 of the Michigan Administrative Code,
appearing on pages 1200 to 1202 of the 1979 Michigan Administrative Code, are
rescinded.
History: 1997 AACS.
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