F.B.14.18 Alternative, new, novel or unique process controls
Chapter: Operations and Documentation
Section: Process Controls
Sub-Section: F.B.14.18 Alternative, New, Novel or Unique Process Controls
Elements
The regulatory requirements contained in this guideline will be met when:
F.B.14.18 (01) Effective control procedures are developed and implemented for each type of fish product to control or mitigate microbial growth, or other contamination. (Risk Ranking: High)
Rationale
Fish processing operations may process a variety of fish products, using a variety of processes and procedures. Some processes and procedures are described in the Fish Plant Guidelines (FPGs) (i.e., Thawing, Eviscerating, Drying, Salting, Pickling and Acidifying, Cooking or Pasteurizing, Parasite Control, Smoking, Cooling, Final Product Controls); however, others are not.
For example, processes and procedures for the following fish products are not described in the FPGs:
- low-acid foods in hermetically-sealed containers (e.g. canned fish products),
- acidified low-acid foods in hermetically-sealed containers (e.g. shelf-stable pickled fish),
- fermented fish products,
- fish oil,
- fresh shellfish (e.g. clams, mussels, oysters, scallops, octopus, snails, squid)
- fresh crustaceans (e.g. crab, crayfish, lobster, prawns and shrimp)
- eggs (roe), sperm, spawn, larvae, sprat and juvenile stages of fish, shellfish, and crustaceans,
- pasteurized crustaceans,
- fish harvested from the Pacific tropical reef (e.g. barracuda),
- un-eviscerated fish products that do not follow the guidance in FPG F.B.14.13 Eviscerating.
The operator of a licensed fish processing operation is required to ensure that written process control procedures are developed, implemented and monitored to effectively identify any risk of contamination of fish products, ingredients, labelling materials and packaging materials and to prevent, eliminate or minimize any identified risk (O. Reg. 465/19 s.51(1)).
This can be achieved by:
- Following the processes or procedures described in the relevant FPGs where applicable, or
- Using an existing scientifically validated study that is specific to the product/process and has been published in scientific literature, or
- Validated process controls don't need to be re-validated, provided the conditions of application are the same.
- Following control measures issued by provincial, national, or international governments, including the Canadian Food Inspection Agency (CFIA), or
- Validating the processes or procedures using a validation study specific to the product/process (See “Evaluating Novel or Unique Processes” Fact sheet. Contact your inspector to request a copy of the Fact sheet), or
- Validation studies are used for process controls that are new, alternative, novel or unique. These are process controls for which there is no current knowledge or history of effectiveness and no references available to show that they are effective at controlling risks that have been identified for the specific product. Completing a scientific validation study (involving study design and collecting/analyzing scientific data) can generate the evidence needed to prove that these process controls are effective.
- Where appropriate, working with a competent process authority.
- E.g., for canned fish products, a process authority is a competent person with an expert knowledge of thermal processing and access to adequate facilities for making such determinations. It is absolutely necessary to establish the required thermal process with accepted scientific methods. Because there may be unexpected deviations in heat transfer and product cooling characteristics, only persons with expert knowledge and experience in thermal processing should use laboratory simulators to develop scheduled processes.
Definitions
Acidified low-acid food: means a low-acid food which has been treated in a manner so that all components have attained an equilibrium pH of 4.6 or below by the time thermal processing and cooling is completed.
Low-acid food: means a food, other than an alcoholic beverage, where any component of that food has a pH greater than 4.6 and a water activity above 0.85.
Hermetically sealed container: means a container, designed and intended to be secure against the entry of microorganisms including spores.
Regulatory References
Food Safety and Quality Act, 2001; O. Reg. 465/19 s. 1, 5, 51, 52, 53, 56, 61
“contaminated” means,
- in respect of food,
- containing or having been treated with or exposed to a substance not permitted by or in an amount in excess of limits prescribed under the Canadian Environmental Protection Act, 1999 (Canada), the Food and Drugs Act (Canada) or the Pest Control Products Act (Canada),
- containing or having been treated with or exposed to an ingredient, a food additive or any source of ionizing radiation not permitted by or in excess of limits prescribed under the Food and Drugs Act (Canada),
- containing or having on it any decomposed matter, foreign matter or visible extraneous material, or
- containing or having been exposed to a biological, chemical or physical agent or factor that may cause a fish product to be unsafe for human consumption, or
“ready-to-eat fish product” means a fish product that does not require any cooking, heating, processing or preparation to make it safe; (“produit de poisson prêt à manger”)
- (1) No operator, employee or contractor of a fish processing operation in respect of which a licence is required under this Regulation shall sell, offer for sale, hold in possession for sale, transport or distribute any fish product processed, packaged, labelled, stored or handled at a fish processing plant that is intended for human consumption if the fish product is contaminated.
(2) The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that no employee or contractor of the operation sells, offers for sale, holds in possession for sale, transports or distributes any fish product described in subsection (1).
- (1) The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that written process control procedures are developed, implemented and monitored to effectively identify any risk of contamination of fish products, ingredients, labelling materials and packaging materials and to prevent, eliminate or minimize any identified risk.
(2) The operator shall ensure that at the time the process control procedures referred to in subsection (1) are performed and monitored, a record is created that includes,
- the date the procedure was performed and monitored;
- the results of the monitoring, including any deviations from the process control procedures; and
- the actions taken in response to any deviations from the process control procedures, including disposing of the fish product or taking measures to produce a safe fish product.
(3) The operator shall ensure that the process control procedures referred to in subsection (1),
- are reviewed as needed in order to,
- evaluate whether the procedures are being properly implemented, and
- verify the effectiveness of the implemented procedures with respect to producing a safe fish product; and
- are updated as needed.
(4) The operator shall ensure that at the time a review referred to in clause (3) (a) is undertaken, a record is created that includes,
- the date the review was performed; and
- the results of the review.
(5) The operator shall ensure that every record created under this section,
- is kept for at least one year from the date the record is created; and
- is readily accessible.
- The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that any regulatable activities engaged in by the operation are performed in a manner that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials and produces fish products that are safe.
- (1) The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that an up-to-date recipe is maintained in written form for each fish product prepared by the operation.
(2) The operator shall ensure that each recipe referred to in subsection (1) is,
- legible;
- complete;
- includes the percentage by weight of fish in the final product;
- includes the processing instructions; and
- is readily accessible.
(3) The operator shall ensure that each fish product referred to in subsection (1) is prepared in accordance with its corresponding recipe.
- The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that every fish product processed, labelled or packaged by the operation is,
- processed, packaged, labelled or stored in accordance with this Regulation; and
- safe.
- Any records required to be created and stored under this Regulation must be legible, complete and kept in chronological order.