(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.