(A) General HACCP
requirements.
(1) 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.
(2) 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) Except as specified in paragraph (A)(2)(c) of this rule, each
kind of shellfish product processed by the dealer.
(c) 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 (A)(3) of this rule are identical for all shellfish
products so grouped or for all production methods so grouped.
(3) 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 (A)(1) of this rule for 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. At a minimum, the critical control points shall
include those identified in paragraph (A) of rule 901:3-8-04, paragraph (A) of
rule 901:3-8-05, paragraph (A) of rule 901:3-8-06, and paragraph (A) of rule
901:3-8-07 of the Administrative Code, as applicable;
(ii) Critical control
points designed to control food safety hazards that could be introduced in the
processing plant environment. At a minimum, the critical control points shall
include those identified in paragraph (A) of rule 901:3-8-04, paragraph (A) of
rule 901:3-8-05, paragraph (A) of rule 901:3-8-06, and paragraph (A) of rule
901:3-8-07 of the Administrative Code, as applicable.
(c) 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 rules 901:3-8-04, 901:3-8-05, 901:3-8-06, and 901:3-8-07 of the
Administrative Code, as applicable. The critical limits identified in rules
901:3-8-04, 901:3-8-05, 901:3-8-06, and 901:3-8-07 of the Administrative Code,
shall be met as components of good manufacturing practices.
(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
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 paragraph (A)(6) of this
rule.
(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 paragraph (A)(6) of this rule.
(5) 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 paragraph (A)(5)(b) of this rule.
(b) 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 paragraph
(A)(5)(b)(ii) and paragraph (A)(5)(b)(iii) of this rule 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 been
trained in accordance with paragraph (A)(8) of this rule, or experience, to
perform such a review;
(iii) 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;
(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 (A)(8) of this rule, 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.
(c) All corrective actions taken in accordance with this section
shall be fully documented in records that are subject to verification in
accordance with paragraph (A)(6) of this rule and the record keeping
requirements of paragraph (A)(7) of this rule.
(6) 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. The
reassessment shall be performed by an individual or individuals who have been
trained in accordance with paragraph (A)(8) of this rule. 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 (A)(3) of this
rule;
(ii) Ongoing verification
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 (A)(8) of this rule, 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 (A)(5) of this rule. This
review shall occur within one week of the day that the records are made;
and
(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 dealers verification activities. The purpose of these reviews shall
be to ensure that the records are complete, and that these activities occurred
in accordance with the processors written procedures. These reviews
shall occur within a reasonable time after the records are made.
(b) Dealers shall immediately follow the procedures in paragraph
(A)(5) of this rule 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 paragraph (A)(6)(a)(ii)(b) and paragraph (A)(6)(a)(ii)(c) of this rule
shall be documented in records that are subject to the record keeping
requirements of paragraph (A)(7) of this rule.
(7) Records.
(a) All records required by paragraph (A) and paragraph (B) of
this rule 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 paragraph (A) and paragraph (B) of
this rule 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 paragraph (A) and paragraph (B) of
this rule and HACCP plans required by paragraph (A)(2) and paragraph (A)(3) of
this rule shall be available for official review and copying at reasonable
times.
(f) Tags on containers of shellstock are not subject to the
requirements of this rule unless they are used to fulfill the requirements of
paragraph (E) of this rule.
(g) 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.
(8) 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 to perform these
functions:
(i) Developing a HACCP
plan;
(ii) Reassessing and
modifying the HACCP plan in accordance within the corrective action procedures
specified in paragraph (A)(5)(b)(v) of this rule, and the HACCP plan in
accordance with the verification activities specified in paragraph (A)(6)(a)(i)
of this rule; and
(iii) Performing the
record review required by paragraph (A)(6)(a)(iii) of this rule.
(b) An individual described in paragraph (A)(8) of this rule
shall provide the director, upon request, a copy of their certificate of
completion of training for the application of HACCP principles for shellfish
processing.
(c) Job experience may qualify an individual to perform these
functions specified in paragraph (A)(8) of this rule. The trained individual
need not be an employee of the dealer.
(B) General sanitation
requirements.
(1) Each dealer shall
monitor general sanitation conditions and practices that are both appropriate
to the plant and the food being processed to ensure, at a minimum, conformance
with the applicable requirements specified in Chapter 901:3-17 of the
Administrative Code; and paragraph (B) of rule 901:3-8-04, paragraph (B) of
rule 901:3-8-05, paragraph (B) of rule 901:3-8-06, and paragraph (B) of rule
901:3-8-07 of the Administrative Code. The requirements specified in these
rules 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;
(b) Condition and cleanliness of food contact surfaces, including
utensils, gloves, and outer garments, and from raw product to cooked
product;
(c) Prevention of cross contamination from unsanitary objects to
food, food packaging materials, and other food contact surfaces, including
utensils, gloves, and outer garments, and from raw product to cooked
product;
(d) Maintenance of hand washing, hand sanitizing, 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;
(f) Proper labeling, storage, and use of toxic
compounds;
(g) Control of employee health conditions that could result in
the microbiological contamination of food, food packaging materials, and food
contact surfaces; and
(h) Exclusion of pests from the food plant.
(2) Each dealer shall
maintain sanitation control records that, at a minimum, document the monitoring
and corrections prescribed by paragraph (B)(1) of this rule. These records are
subject to the requirements of paragraph (A)(7) of this rule.
(C) Physical facilities.
Each dealer shall comply with the requirements in
Chapter 901:3-17 of the Administrative Code and the physical facility
requirements contained in paragraph (C) rule 901:3-8-04, paragraph (C) of rule
901:3-8-05, paragraph (C) of rule 901:3-8-06, and paragraph (C) of rule
901:3-8-07 of the Administrative Code that are applicable to the plant and the
food being processed.
(D) Certification
requirements.
(1) General.
(a) No person shall act as a dealer prior to obtaining
certification from the director.
(b) Any person who wants to be a dealer shall:
(i) Make application to
the director for certification or recertification and provide all identifying
information required on the application form;
(ii) Have and implement a
HACCP plan, and have a program of sanitation monitoring and record keeping in
compliance with Chapter 901:3-7 of the Administrative Code, except for the
requirement for harvester identification on a dealer's tag.
(c) Each dealer shall have a business address at which
inspections of facilities, activities, or equipment can be
conducted.
(d) Upon receipt of such application and upon approval of the
facilities and sanitary condition of the establishment or area, a certification
shall be issued by the director.
(e) All shellfish certifications shall expire on December
thirty-first of each year and shall be renewed. In no case shall a shellfish
processing establishment operate without a valid certification issued by the
director. The certification shall not be transferable with respect to persons
or locations.
(f) Current certifications shall be kept on file and open to
inspection by the director.
(g) The director, after notice and hearing, held in accordance
with Chapter 119. of the Revised Code may refuse to issue or may revoke the
certification for failure to comply with this chapter and applicable provisions
of Chapter 901:3-7 of the Administrative Code pertaining to
shellfish.
(h) If the director determines that an emergency exists that
presents a clear and present danger to the public health, the director may
suspend a certification, effective without a hearing. Thereafter, without
delay, the director shall afford the shellfish operator an opportunity for a
hearing. On determining that there is no longer a clear and present danger to
the public health, the director may rescind the suspension without a
hearing.
(2) Types of
certification.
(a) Any person who shucks shellfish shall be certified as a
shucker-packer.
(b) Any person who repacks shucked shellfish shall be certified
as a shucker-packer or repacker.
(c) Any person who repacks shellstock shall be certified as a
shellstock shipper, shucker-packer, or repacker.
(d) Any person who ships and receives the shellstock in
interstate commerce shall be certified as a shellstock shipper, repacker, or
shucker-packer.
(e) Any person who purchases shellstock or shucked shellfish from
dealers and sells the product without repacking or relabeling to other dealers,
wholesalers, or retailers shall be certified as a reshipper.
(f) A repacker shall not shuck shellfish.
(E) Shellstock
identification.
(1) The dealer shall buy
shellfish only from sources certified by the director or listed in the
ICSSL.
(2) The dealer shall keep
the harvester's tag affixed to each container of shellstock until the
container is:
(a) Shipped; or
(b) Emptied to wash, grade, or pack the shellstock.
(3) Tags.
(a) The dealer's tags shall:
(i) Be durable,
waterproof, and sanctioned by the director prior to use; and
(ii) Be at least two and
five eights inches by five and one-fourth inches in size.
(b) The dealer's tag shall contain the following indelible,
legible information in the order specified below:
(i) The dealer's
name and address;
(ii) The dealer's
certification number as assigned by the director and the original shellstock
shipper's certification number;
(iii) The date of
harvest;
(iv) The most precise
identification of the harvest location as is practicable including the initials
of the state of harvest, and the designation of the growing area by indexing,
administrative or geographic designation. If growing areas have not been
indexed then an appropriate geographical or administrative designation must be
used;
(v) When the shellstock
has been transported across state lines and placed in wet storage in a
dealer's operation, the statement: "This product is a product of
(name of state) and was wet stored at (facility certification number) from
(date) to (date)";
(vi) The type and
quantity of shellstock; and
(vii) The following
statement in bold capitalized type on each tag "This tag is required to be
attached until container is empty or is retagged and thereafter kept on file
for ninety days";
(viii) All shellstock
intended for raw consumption shall include a consumer advisory. The following
statement, or an equivalent statement, shall be included on all shellstock:
"Retailers, inform your customers, 'Consuming raw or undercooked meats,
poultry, seafood, shellfish or eggs may increase your risk of foodborne
illness, especially if you have certain medical conditions'."
(c) When both the dealer and harvester tags appear on the
container, the dealer's tag is not required to duplicate the information
on the harvester's tag.
(d) If the shellstock is removed from the original container, the
tag on the new container shall meet the requirements in paragraph (E)(2) of
this rule.
(4) Tagging of a lot of
shellstock during intermediate processing.
(a) When the shellstock is removed from the original container,
the dealer shall:
(i) Keep the harvester
tag for ninety days;
(ii) Keep track of the
growing area and date of harvest for shellstock; and
(iii) Maintain the lot
identity of all shellstock during any intermediate stage of
processing.
(b) A dealer receiving bulk tagged lots of shellstock must have
an intermediate processing plan approved by the director to ensure that each
lot of shellstock is kept separate and identified in a way which prevents
commingling or misidentification.
(c) In order for a dealer to tag a lot container of shellstock in
lieu of meeting the requirement in paragraph (E)(2) of this rule for a
harvester or dealer tag on each individual container, the dealer shall have an
intermediate processing plan approved by the director which establishes the
procedures the dealer shall use to tag the lot during the washing, packing or
staging of shellfish.
(5) If shellstock are
sold in bulk, the dealer shall provide a transaction record prior to shipment.
This transaction record shall contain all the information required in paragraph
(G)(2) of this rule with the addition of the name of the
consignee.
(F) Shucked shellfish
labeling.
(1) Shellfish
labeling.
(a) If the shucker-packer uses returnable containers to transport
shucked shellfish between dealers for the purpose of further processing or
packing, the returnable containers are exempt from the labeling requirements in
this rule. When returnable containers are used, the shipment shall be
accompanied by a transaction record containing:
(i) The original
shucker-packer's name and certification number;
(ii) The shucking date;
and
(iii) The quantity of
shellfish per container and the total number of containers.
(b) If the dealer uses master shipping cartons, the master
cartons are exempt from these labeling requirements when the individual
containers within the carton are properly labeled.
(c) At a minimum, the dealer shall label each individual package
containing fresh or frozen shucked shellfish meat in a legible and indelible
form in accordance with 21 CFR 161.30 and 21 CFR 161.136 (2018).
(d) The dealer shall assure that each package containing less
than sixty-four fluid ounces of fresh or frozen shellfish shall
have:
(i) The
shucker-packer's or repacker's certification number on the label;
and,
(ii) A "Sell by
date" which provides a reasonable subsequent shelf-life or the words
"Best if used by" followed by a date when the product would be
expected to reach the end of its shelf-life. The date shall consist of the
abbreviation for the month and number of the day of the month. For frozen
shellfish, the year will be added to the date.
(e) The dealer shall assure that each package containing more
than sixty-four fluid ounces of fresh or frozen shellfish shall
have:
(i) The
shucker-packer's or repacker's certification number on the label;
and,
(ii) A "Date
shucked" which shall:
(a) For fresh shellfish,
consist of the number of the day of the year or the month and the number of the
day of the month;
(b) For frozen shellfish,
include the year; and,
(c) Appear on the lid and
sidewall or bottom of disposable containers.
(f) If the dealer thaws and repacks frozen shellfish, the dealer
shall label the shellfish container as previously frozen.
(g) The dealer shall provide all label information in a legible
and indelible form.
(2) If the dealer elects
to repack shellfish, the dealer shall pack and label all shellfish in
accordance with paragraph (F) of this rule except that the original date of
shucking shall be used in establishing the sell by date.
(G) Shipping documents and
records.
(1) Shipping
documents.
(a) Each shellfish shipment shall be accompanied by a shipping
document.
(b) The shipping document shall contain:
(i) The name, address,
and certification number of the shipping dealer;
(ii) The name and address
of the major consignee; and
(iii) The kind and
quantity of the shellfish product.
(c) The receiving dealer shall:
(i) Maintain in a file a
copy of the completed shipping document; and
(ii) Make the shipping
document available to the director upon request.
(d) If the shipment is subdivided to different dealers, each
receiving dealer shall maintain records sufficient to trace the portion
received back to the original shipment.
(2) Transaction and
shipping records.
(a) Each dealer shall have a business address at which
transaction records are maintained.
(b) Each dealer shall maintain complete, accurate, and legible
records of the director's required information in a form authorized by the
director.
(c) Transaction records shall be sufficient to:
(i) Document that the
shellfish are from a source authorized under this chapter;
(ii) Permit a container
of shellfish to be traced back to the specific incoming lot of shucked
shellfish from which it was taken;
(iii) Permit a lot of
shucked shellfish or a lot of shellstock to be traced back to the growing
area(s), date(s) of harvest, and if possible, the harvester or group of
harvesters.
(d) Purchase and sales shall be recorded:
(i) In a permanently
bound ledger book; or
(ii) Using other
recording methods acceptable to and authorized by the director.
(e) The transaction records shall be retained:
(i) In the case of fresh
shellfish, for a minimum of one year; and
(ii) In the case of
frozen shellfish, for at least two years or the shelf-life of the product,
whichever is longer.
(f) If computer records are maintained, the director shall
approve the format and its use.
