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Development of a preventive control plan for hatcheries

November 9, 2022

Amendments to the Health of Animals Regulations (HAR) relating to hatcheries and supply flocks have been published in the Canada Gazette, Part II. The transitional provision allows operators to comply with current regulations or new regulations for 1 year after coming into force.

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Introduction

This guidance document aims to assist operators of hatcheries in preparing a preventive control plan (PCP) that will meet the requirements of the Health of Animals Regulations (HAR) – Hatcheries and Supply Flocks.

Operators must read, understand, and comply with the provisions of the Canadian hatchery and supply flock testing standards and the National Farm Animal Care Council's (NFAACC) Code of Practice for the Care and Handling of Hatching Eggs, Breeders, Chickens and Turkeys which are incorporated by reference (IBR) in the HAR.

This document offers high level guidance on what constitutes a PCP, its main components and its requirements. Hatchery operators will find the information they need about the procedures, instructions and records they will create to demonstrate how their PCP is implemented.

This document indicates the different elements that a hatchery PCP must include. The operator has the option to modify the elements, but all the possible hazards or risks must be identified. The hatchery operator must then indicate how the hazards in these elements are identified and monitored and then describes how these could be prevented, eliminated or reduced to acceptable levels.

Preventive control plan and general requirements

A PCP describes a systems-based approach that focusses on prevention and control as a way to achieve regulatory compliance. It is based on the concept of the Hazard Analysis Critical Control Point (HACCP) program that is recognized internationally as an effective method to minimize hazards and mitigate risks.

The operator has the flexibility to design their PCP according to their risks. The requirements found in a PCP are similar to any system that identifies hazards and aims to prevent or control them. As such, existing systems (for example, Quality Management Program, Food Safety Enhancement Program) may only require minimal changes or no change at all to align with the PCP requirements.

Furthermore, a PCP must address regulatory requirements as applicable to the hatchery operation, including prescribed requirements for animal health, animal welfare, food safety, and product quality. To meet these requirements, a PCP must be a written plan and be implemented at the hatchery.

The operator must design, document and implement a system that addresses the following PCP elements:

Each element listed above must address the following criteria:

Through this document, we will review each criterion and then the elements contained in a PCP. We will be using the example of Salmonella Enteritidis (SE) as a hazard, along with possible control measures, to help operators understand the principles of a PCP. SE is chosen as an example since it is a recognized biological food safety hazard and it is included in the HAR, through the testing standards.

Hazards and controls

Identifying biological, chemical and physical hazards, and determining appropriate and valid controls are the foundations of a prevention-based system.

A practical method to identify hazards is to make a list of all inputs (eggs and chicks) and other incoming materials (chick pads, vaccines, etc.) and processes pertaining to the hatchery operation. Inputs may include, but not limited to hatching eggs, non-settable or surplus hatching eggs that are temporarily transiting through the hatchery (before going to further processing), vaccines, cleaning and disinfection products, antibiotics, boxes, chick pads, and others. Making a list of all items (for example eggs, water, feed [if applicable] and hydration products, chick pads, pharmaceuticals, chemicals, brooding supplies, egg and chick boxes, disposable items, air, and others) and indicating which hazard may be associated with each material and associated process. For example, a biological hazard like Salmonella in eggs; a chemical hazard like residual preservative in vaccines; and a physical hazard like glass in chick pads. A table format is typically helpful.

  1. Identify and describe hazards at any stage in an operation and/or in the commodity, and specify control measures for these hazards

    For example, SE as a biological hazard in eggs. This is a food safety hazard.

    Examples of control measures can be:

    • sourcing eggs from a supply flock that meets the regulations
    • maintaining egg storage temperature within an acceptable range
    • cleaning and disinfecting egg storage room and egg vacuum system, if used

  2. Identify requirements (establishing acceptable limits) and specify measures to ensure that compliance is achieved and maintained

    For example:

    • an acceptable temperature range in an egg storage room can be sourced from scientific literature and from generally accepted practices, and a measure to achieve compliance can be "taking temperature reading of the egg storage room at regular intervals, using a calibrated thermometer"
    • an acceptable limit for cleaning and disinfection of egg storage room can be "visibly clean" (absence of organic matter on the surface, such as feces, blood, shavings, and others), and measures to achieve compliance can be "cleaning and disinfection of the areas at regular intervals, or more frequently as needed"

  3. Identify the control measures that are to be validated

    For example:

    • a safe temperature range of the egg storage room
    • selection of chemicals that are approved for their intended use, as per label directions

  4. Describe how the operator would validate the control measures and the outcomes

    For example:

    • determining an acceptable temperature range from existing literature for the prevention of Salmonella growth
    • inspecting the egg storage room after cleaning and disinfection to ensure they are "visibly clean"

  5. Describe how the control measures would be revalidated whenever there is a change that may impact the process parameters

    For example:

    • if new scientific data regarding safe temperature storage of hatching eggs becomes available, adjust temperature of the egg storage room accordingly.
    • following a change of chemical for the cleaning and disinfection of an egg storage room, inspect the surfaces to ensure they are "visibly clean".

Monitoring procedures

Establishing monitoring procedures is an integral part of preparing an effective PCP. Monitoring confirms that all control measures are followed. In other words, monitoring activities confirm that established acceptable limits are maintained within an operation on an ongoing basis. An operator's monitoring procedures in their PCP should:

  1. identify appropriately trained and qualified individual(s) that will do the monitoring. Identify the job title of the person, if possible, who is responsible for conducting the different activities under your monitoring procedures and evaluating the results

    Typically, monitoring activities are conducted by those responsible for applying the control measures

  2. identify appropriate monitoring procedures

  3. provide a detailed description of how the activities are carried out

    For example:

    • test methods
    • temperature readings
    • chemical concentration and contact time, and temperature of the chemical solution
    • instructions on how to conduct and record measurements or observations

  4. establish and follow a monitoring frequency that is appropriate to ensure hazards are controlled

    Set a frequency for carrying out the monitoring procedure. Monitoring can be continuous or intermittent. If intermittent, set a frequency that is sufficient to guarantee that the hazard I controlled.

    For example:

    • egg storage room: daily temperature reading
    • chemical use: right before use
  5. use accepted sampling (as per testing standard) and test methodologies that provide accurate and valid results

  6. record the monitoring results

    List the records used to document the results of the monitoring activities.

Verification procedures

Verification activities are used to confirm and demonstrate that all control measures and related procedures outlined in your PCP are consistently implemented and effective in achieving the intended outcome. Describe the verification activities to be conducted and then provide examples of what that could look like. Directly observe, or even interview, an employee performing monitoring activities as well as corrective actions if needed, to ensure that the written procedures are being followed. Review records documenting the monitoring activity to ensure the proper version of the record is used, records are complete and filled out as per the written procedures.

An operator's verification procedures in their PCP should:

  1. identify an appropriately trained, and qualified person to conduct the verification, other than the person who conducts the monitoring and corrective actions

    Verifiers can be individuals familiar with the hatchery operations such as a technician, veterinarian, trained family member, or others

  2. establish the verification frequency

  3. use accepted sampling (as per testing standard) and test methodologies that provide accurate and valid results

    The verifier may have to sample the environment or product to confirm the safety or acceptability of the product. For example, swab equipment to verify the effectiveness of a sanitation program or testing final product for compliance to the microbiological standard.

  4. review records documenting the actions taken in response to a deviation

    For example, verify that the calibration of equipment (for example, thermometers) have been recorded

  5. record the results of verification

  6. establish procedures to follow when deviations occur

    For example, a trained individual other than the person doing the monitoring observes the person performing the task and conducts a brief interview to confirm knowledge on the procedures. The trained individual also verifies:

    • the temperature records of the egg storage room at regular intervals

    • the cleanliness of the egg storage room, visually and/or from environmental test results

      In each case, the corrective actions must be taken and documented when deviations occur.

Corrective action procedures

If a hazard is not controlled, implementing and analyzing corrective actions are important to maintaining an effective PCP. The hatchery operator is responsible for overseeing corrective actions by identifying who is responsible for implementing the corrective actions as well as documenting them. The PCP should outline the steps the operator intends to take to appropriately correct a deviation. See record keeping.

An operator's corrective action procedures in their PCP should:

  1. control the commodity by:
    • determining if the affected or potentially affected commodity is in compliance with the program
    • bringing an affected commodity into compliance (including validation) or disposing of it as appropriate
  2. determine the root cause of the deviation and prevent reoccurrence
  3. record corrective actions taken

  4. establish timely procedures to follow when deviations occur

    Here are some examples:

    • the root cause of an egg storage room outside of the acceptable temperature range might be a thermometer that is not calibrated, giving incorrect temperature readings
      • The operator must determine if the hatching eggs are in compliance with the program (acceptable storage temperature)
      • The temperature of the egg storage room must be corrected and brought back to the acceptable range and the faulty thermometer can be replaced or calibrated
      • Also, to prevent recurrence of the deviation, once per month, the person responsible for the monitoring procedure will confirm the thermometer is calibrated
      • All of these steps must be recorded
    • isolation of potentially SE infected hatching eggs or birds
    • improper mixing of vaccines
    • improper mixing of disinfectants

Annual review (by the hatchery operator)

Regularly reviewing the PCP and its associated records allows the operator to assess its ongoing effectiveness. For easier reference, any future amendments to the hatchery's PCP must show the date and the section that was amended.

The annual program review should:

  1. identify qualified individual(s) who will conduct the review

    For example: hatchery owner, trained personnel, veterinarian, agronomist, quality assurance personnel, and technical service personnel

  2. determine whether the PCP has achieved the desired outcomes

    Documents to be reviewed to make this determination may include Standard Operating Procedures (SOP), test results, deviations and corrective actions and complaint records

  3. identify and implement necessary changes for continuous improvement

    For example:

    updating SOPs

  4. record the results of the review

Record keeping

Records are evidence that the operator has implemented the preventive controls as designed and that they are effective to meet the program requirements. The operator will generate a number of different types of records suitable to their operations, for example, attestation letter from the supply flock farm. If requested, they must be available for review by the Canadian Food Inspection Agency (CFIA).

The PCP will need to identify all records associated with each element of the system's design (as described below), and will need to note where the records are kept. These records must be kept for at least 2 years as per the HAR. A participant's PCP for records should also include:

Elements and sub-elements of a preventive control plan

The performance criteria and general requirements of a PCP may be best practices or regulatory requirements.

As indicated earlier in the document, below is the list of elements contained in a PCP:

  1. process and product controls
  2. sanitation/biosecurity/biocontainment, pest control, and chemicals
  3. hygiene, biosecurity, and employee training
  4. equipment design and maintenance
  5. physical structure, surroundings, and maintenance
  6. receiving, transportation, and storage
  7. traceability, control, and complaints

1. Process and product controls

Sub-element 1.1(a): Incoming inputs

The hatchery receives a lot of products and materials. Examples of inputs are eggs, chick boxes and chick pads, other packaging materials for eggs and chicks, feed (if used) and/or hydration products, vaccines, pharmaceuticals, sanitizers and disinfectants, etc. Inadequate input controls could lead to pathogenic organisms, toxins, pests, disease, and other hazards. The control of inputs as well as their storage conditions are both important.

Incoming inputs should:

Documented procedures to prevent hazard introduction, contamination, and to maintain integrity and animal welfare (where applicable) are available. For example, procedures are available on the response to SE positive samples. A reminder to refer to the regulations and CFIA policy and programs.

For microbiological assessment:

Sub-element 1.1(b) (c): Product formulation, specifications and processing

Hatchery incoming and outgoing products and other inputs are to be evaluated on the various processes that are followed. There should be a written description of:

If available, critical limits should be validated by industry using available industry or scientific data/standards. CFIA will work with industry, if necessary.

Sub-element 1.2: Product controls

  1. Eggs:
    • identify the procedures to evaluate eggs that are cracked, dirty, or not suitable to be incubated
    • keep records of egg sorting
    • identify the procedures to inform supply flock producers in case of sub-standard eggs sent
    • have a written procedure for egg washing or sanitation procedures, if performed in the hatchery
    • properly identify the supply flocks and date of lay of eggs placed on clean incubator racks or clean boxes
  2. Egg transfer:
    • have a procedure to visually identify contaminated eggs
    • when applicable, have a procedure followed at transfer to remove eggs with no live embryos
    • when applicable, have a procedure followed to clean and disinfect in-ovo machine
    • when applicable, have a procedure followed at transfer to ensure that vaccines and/or antibiotics are properly administered
  3. Chicks:
    • identify the procedures to evaluate chicks' small, weak, abnormal/deformed, and others
    • keep records of cull chicks
    • keep records of any medications and/or vaccines administered at day of hatch

Sub-element 1.3: Import controls

Have a procedure for products that are imported. Imported products must meet regulatory requirements (that is, CFIA import reference document). Commodities that do not meet Canadian requirements could harm the local market. For example, hatching eggs or chicks from the United States (U.S.) must meet import requirements to enter Canada.

Sub-element 1.4: Export controls

Have a procedure for products that are going to be exported. Exported products must meet foreign country import requirements and conditions, where applicable. Commodities that do not meet these requirements could jeopardize trade and international obligations.

2. Sanitation, biosecurity, biocontainment, pest control, and chemicals

Sub-element 2.1: Sanitation, biosecurity, and biocontainment

Sub-element 2.2: Pest control

An effective control program is in place for pests, including vectors, to prevent entry, to detect and eliminate pests and to prevent contamination of the birds and eggs. There must be a documented program for prevention, control, and removal of pests (such as rodents) including vectors (such as flies.). There must be a schedule for monitoring for evidence of pest and vector activity. If using a pest-control company, indicate the name of the company and keep records of the reports. If using own pest control plan identify procedures for checking and replenishing rodent traps and bait stations as well as the location of rodent traps and bait stations in and around the building.

Sub-element 2.3: Chemicals

Chemicals must be stored and used in a manner and under conditions that do not impact negatively on human, animal health, or the environment.

The operator shall:

3. Hygiene, biosecurity and employee training

Sub-element 3.1: Hygiene and biosecurity

The hatchery must have biosecurity procedures developed and implemented to prevent employees and visitors as sources of contamination. For example, a procedure for hatchery entry. Clean and appropriate clothing, good grooming and habits reduce the possibility of product becoming contaminated.

The operator shall:

Sub-element 3.2: Employee training

Employees must have adequate technical knowledge and understanding of operations or processes for which they are responsible and of how they may impact human, animal health, the environment, and other regulatory requirements.

Keep records for the following examples:

For reference, see the National Farm Animal Care Council (NFACC) Code of Practice for the Care and Handling of Hatching Eggs, Breeders, Chickens and Turkeys.

4. Equipment design and maintenance

Sub-element 4.1: Equipment design and maintenance

Equipment such as incubators, hatchers, in-ovo machine, trolleys, trays, chick boxes, trucks, heaters and fans are designed, used, and maintained in a manner that does not result in contamination of eggs and birds and are effective for the purpose for which they are intended. If needed, develop and maintain a maintenance program. Keep records of maintenance activities, both routine and non-routine repairs. Have a daily verification procedure, responsibilities, supervision, records.

5. Physical structure, surroundings and maintenance

Sub-element 5.1: Hatchery and surroundings

The surroundings and roadways must be maintained to minimize refuse, dust, fumes, and other environmental contaminants and pest harbourage areas. Explain how the structure of the building, its maintenance, and the surroundings (proximity to a slaughter plant, feed mills, poultry farms, sources of open water, and others) limit the risk of contamination from these sources.

Sub-element 5.2: Building

Building is designed, constructed, and maintained to support the activity being conducted; support cleaning and disinfection and prevent the entry of pests and contaminants.

For example, old machines or even wooden hatchery walls can be difficult to sanitize effectively. A procedure must be in place to minimize or control the built-up of organisms in these types of surfaces.

Have a risk level map for both clean and unclean areas taking into consideration the following:

In the event of a major hatchery facility renovation, the hatchery operator must inform the CFIA in writing of any structural and/or equipment changes that significantly alter the incubation capacity and/or the floor plan and that affect product flow. The hatchery operator must submit the plans and specifications of new or additional construction and must be approved by the CFIA prior to the start of work. The designated inspector reviews all the appropriate supporting documentation and performs an on-site verification at the next planned Preventive Control Inspection. The hatchery operator needs to update the Hatchery profile information (My CFIA portal), along with the hatchery PCP, according to the modifications.

Examples are:

Sub-element 5.3: Water

Water that comes in contact with birds or eggs must be safe for its intended use. Identify the source of water supply and have control procedures to ensure that the water used meets the requirements from Health Canada. If well-water is the source, test the water at least once a year or whenever the source was compromised, for example, flooding.

Sub-element 5.4: Waste disposal

A procedure must be in place that details how culled eggs and chicks, garbage and other hatchery refuse are properly disposed of according to current provincial and municipal regulations. The procedure must prevent and control contamination of other animals and the environment.

The operator should:

6. Receiving, transportation and storage

Sub-element 6.1: Receiving, transportation and storage, and best management practices

Sub-element 6.2: Animal transportation

Animals must be transported in accordance with the CFIA Humane Transport regulatory provisions (Part XII of the HAR – Transport of Animals) as well as per the NFACC Code of Practice for the Care and Handling of Hatching Eggs, Breeders, Chickens and Turkeys.

7. Traceability, control, and complaints

Sub-element 7.1: Traceability and control

Flocks and their fertilized eggs must be properly identified for traceability purposes. Records must be kept as to the dates of lay, date of receipt to the hatchery, date and identities of incubators and hatchers, and other similar information. For example, since SE can be vertically transmitted, the breeder flock source must be identifiable when taking fluff samples. Keep records of egg and chick placement schedules and identities of recipients. Labels or invoices and records must be in compliance with the HAR.

Sub-element 7.2: Complaints

Complaints related to diseases, pests, food safety, and animal welfare are investigated to determine root cause and that corrective actions are taken.

Disease monitoring, surveillance, and testing

The hatchery operator must comply with the disease monitoring, surveillance, and testing requirements under the CFIA's testing standards document. This covers monitoring and testing requirements for Salmonella Pullorum, Salmonella Gallinarum, and SE. The operator must also ensure that they get the attestation letter from the supply flock operator attesting to their adherence to the testing requirements and PCP. All samples must be submitted to a CFIA approved laboratory. It is required to have the response to a positive SE be written and made readily available when SE is confirmed in the hatchery and/or the supply flock.

How to write procedures/instructions for your hatchery

Writing a procedure or set of instructions

A procedure generally contains the following elements for the user of the procedure:

Include headings

The following headings may be included in each written procedure, although not all are necessary every time. For example, the ‘why' in the introduction may be documented in policy documents or business plans rather than in the procedure. You may also wish to add additional sections or information, for example, scientific studies that support the selection of a critical threshold for a measurement, or a section on safety concerns for employees carrying out the procedure or if the procedure will affect their health and well-being. The procedure must contain tasks that are mandated by federal, provincial or municipal laws, such as notification of a reportable disease to the CFIA.

Creating a diagram of your hatchery and property

A schematic diagram of the inside of the hatchery is required when applying for a licence. Further, any major renovation that affects operation (for example product flow) would also require a submission of the proposed new floor plan. These diagrams must show the different rooms, egg room, incubator rooms, hatcher rooms, chick processing rooms, laboratory, vaccine preparation room, storage room, office, break rooms, and others. The diagram should also include product flow and delineating clean from unclean areas.

Although not mandatory to include in the PCP, it is highly recommended that a diagram of the hatchery site be created. The purpose of the site diagram is to provide a visual overview of the physical and functional layout of the hatchery. A diagram also helps to establish biosecurity measures and evaluate where there is potential for cross-contamination.

Site diagrams can be hand drawn or computer-generated. It is recommended that you create a base diagram of your physical layout which is less likely to change over time (placement of buildings, ground slope, and others) upon which the other elements that are more likely to change can be superimposed (for example traffic flow patterns).

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