Dairy Establishment Inspection Manual – Chapter 3 - Registration of Establishments
3.5 New Establishment Registration Procedures
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3.5.1 Registration Package
A complete registration package must be submitted to the local CFIA inspector. All registration documents must be completed and signed by the applicant. A registration package must include the following:
- Application for Registration of an Establishment (CFIA/ACIA 3043) (Appendix 3 - 2). This form must be completed by the applicant in full on both sides following the directions on the form. A copy of the federal/provincial documents of incorporation, partnership or proof of business name must be attached, as indicated on the application. If the company is neither incorporated nor a partnership, a notarized affidavit must be attached showing the name under which the establishment will operate. The name provided on the provincial business registration or affidavit must be the same as identified on all documents presented for registration purposes.
The applicant must provide written assurance, as required, that the location, construction, facilities and nature of operation are in accordance with all municipal, provincial and federal specifications. This may require the submission of a building permit, as well as written assurance from the appropriate authorities indicating compliance with environmental requirements.
- Dairy Plant Information and Registration of an Establishment Record (Appendix 3 - 3). This form must be completed by the applicant.
- Registration Fee. The above two completed forms must be accompanied by:
- validation of volume of milk the establishment will receive or production output during the 12 months following the date of application along with the applicable fee prescribed by the Dairy Product Fees Order.
- the fee will be applied when the application package is received, effective from when the payment is received and will be pro-rated so that no matter when the establishment is registered, the expiry date on the Certificate of Registration will always be March 31 of every year.
- Site plans. A site plan is to show the boundaries of the site and location of the establishment in relation to all buildings, structures, roadways, driveways, parking sites, railway lines, sewer lines, wells, and public utilities on the property. The scale and the north point are to be shown.
- Plans and specifications. Detailed plans and specifications for the establishment must be submitted (as per Dairy Products Regulations Section 10.(2)(a)). A hand drawn plan may be acceptable if it is complete, neat and drawn to scale. The plan should include a legend of the symbols used. The plan must show:
- a floor plan of each level of the establishment showing the dimensions and function of each room or area.
- the location of walls, partitions, windows and doors, stairs and drains.
- a list of the materials used in the construction of all the equipment, floors, walls, ceilings and openings.
- the types and location of the equipment.
- the location of the lighting, refrigeration, ventilation and plumbing systems.
- product flow patterns throughout the establishment.
- Sanitation Program. The sanitation program (as per Dairy Products Regulations Section 10. (2)(b)) is to indicate:
- the person responsible for carrying out the program.
- the equipment and a list of chemical agents to be used to bring about and maintain clean and sanitary conditions. The substances and chemicals used in the establishment are to be approved or listed in CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products, and used and handled in a manner that prevents contamination and in accordance with the manufacturer's instructions;
- the measures proposed to be taken to ensure clean and sanitary conditions.
- Pest Control Program. As per Dairy Products Regulations Section 11.1(10) The pest control program is to indicate the measures to be taken to effectively and safely control insects and rodents and exclude any animals from the registered establishment.
- Recall Program. As per DEIM 1.10.06, a recall program is required to ensure an effective recall of any lot of food from the market. It should indicate the person responsible for carrying out the program, the coding system description and the notification and other procedures to effect the recall.
- Water Analysis. Identification of water source and a satisfactory certificate of water analysis including provincial analysis for potability (bacteriological analysis), and chemical and physical contaminants (DEIM 1.10.01.09).
- A list of products produced by the establishment.
- Microbiological product and environmental monitoring program, including Health Canada's Policy on Listeria monocytogenes in Ready-to-eat Foods (Lm Policy).
When an inquiry from a prospective applicant has been received by a CFIA office they should receive registration information which shall include the following:
- covering letter (Appendix 3 - 1) requesting the items listed in section 3.5 and including:
Validation of volume of milk the establishment will receive or production output during the 12 months following the date of application along with the applicable fee prescribed by the Dairy Product Fees Order;
- Plans and specifications - fully detailed. A hand drawn plan may be acceptable if it is complete, neat and to scale;
- Site plans - showing the establishment in relation to all buildings, structures, roadways, etc. on the property;
- Sanitation program - as per Dairy Products Regulations Section 10.(2)(b). The substances and chemicals used in the establishment are to be used in a manner that prevents contamination;
- Pest Control Program - As per Dairy Products Regulations Section 11.1(10);
- Recall Program - As per DEIM 1.10.06;
- Water source and a satisfactory certificate of water analysis including provincial potability (bacteriological analysis), and chemical and physical contaminants (DEIM 1.10.01.09);
- A list of products produced by the establishment.
- Microbiological product and environmental monitoring program, including Health Canada (HC) Lm Policy.
- Application for Registration of an Establishment (CFIA/ACIA 3043) This form must be completed by the applicant in full on both sides following the directions on the form. A copy of the federal/provincial documents of incorporation, partnership or proof of business name must be attached, as indicated on the application.
- Dairy Plant Information and Registration of an Establishment Record
- Copies of Section 10 and 11 of the Dairy Products Regulations
- Copy of the Dairy Fee Information Letter and Schedule of Fees
3.5.2 Procedures, Communication and Documentation Flow
1. Submit a complete registration package as per Section 3.5.1.
2. Arrangements made for a pre-registration establishment inspection.
The inspector could be any one of the following individuals within operations:
- Responsible inspector
- Trained Supervisor (Dairy)
- Regional Program Specialist
- Trained alternative
1. Inquiry from potential applicant received by CFIA office.
2. Registration information sent to prospective applicant.
3. The applicant contacts local inspector to obtain additional information as needed. Where possible, inspector visits the applicant to review the proposed facility, to discuss responsibilities of the operator and review requirements. The role of the reviewer is to evaluate the plans to determine if the submitted proposal will result in a sanitary and hygienic environment for the production and handling of dairy products. It is the responsibility of the applicant to provide all necessary details along with plans to enable reviewers to determine whether the proposed establishment construction will provide a hygienic environment for the sanitary production of dairy products.
4. Applicant forwards the completed registration package to the inspector.
5. Inspector reviews documents for completeness, validates the volume of milk received/production output and contacts the applicant for further information or clarification as required. The inspector requests a pre-assigned registration number from the Area Dairy Specialist.
6. For an existing non-registered (provincially licensed) establishment, once the registration documents are complete and accurate, the inspector conducts an on-site inspection to verify regulatory compliance (to ensure sanitary, structural and operational requirements are met) and completes the Dairy Plant Registration and Review of Plans and Specifications - Check List (Appendix 3 - 4) and a written report which will indicate in detail the nature and extent of any changes or alterations that are required. An in depth inspection must also be completed before recommending registration. The inspector should try to obtain a copy of the most recent provincial inspection report for that establishment. The findings are discussed verbally with the applicant. The applicant is required to provide the CFIA with formal notification of their intent to proceed with registration. If the applicant wishes to proceed, the proposed changes and alterations must be submitted prior to construction. These are then reviewed by the inspector and program specialist with a recommendation for or against acceptability (see section 3.7). All regulatory requirements must be met prior to having their registration approved. If no response is received from the applicant within twelve months, the file will be closed. The fee will not be refunded. If after 12 months the same applicant again wishes to pursue registration he or she will have to re-apply as a new applicant and pay the annual fees.
7. For a facility not yet constructed, once the registration documents are complete and accurate and it has been determined by the inspector and the program specialist that the proposed establishment conforms to the regulatory requirements then construction on the facility can begin. All new registrations (new construction) must meet regulatory requirements prior to having their registration approved.
8. Whether changes need to be made to an existing facility or a new facility needs to be constructed, the inspector monitors construction on a regular basis with respect to the requirements of the DEIM Manual and Section 11 of the Dairy Products Regulations and to ensure that materials used are listed in the CFIA Reference Listing of Accepted Construction Materials, Packaging Materials and Non-food Chemical Products.
9. When all requirements are met (see section 3.7) the completed documents including copies of the plans and specifications are forwarded by the inspector to the area dairy program specialist with a recommendation that the establishment be registered.
Area Dairy Program Specialist or Office Delegate
1. Provides assistance to the inspector during the registration process, if needed.
2. Provides the inspector with a pre-assigned registration number and enters into Client Management System (CMS) the following information: legal name of company (as shown on the certificate of incorporation), physical location of the establishment, mailing address, Applicant's name, Applicant's telephone number, Applicant's fax number and Applicant's e-mail address (if applicable). By entering the client information into the CMS at this time allows for the inspector to print off inspection worksheets in order for the completion of an in depth inspection prior to registration.
3. Reviews documents for accuracy and completeness. The inspector is asked to obtain additional information or updated document(s) if necessary. When everything is in order the area specialist will sign the Application for Registration of an Establishment (CFIA/ACIA 3043) in the Agency use only section.
4. The Area Office Delegate will deposit the payment upon receipt and get a cash blotter number (the blotter number will serve as proof of payment), complete the Payment Due for a New Dairy Processing Establishment Registration form and send a copy to the AR Centre. This form is designed to prorate the payment so that Certificates of Registration all expire on the same date (March 31) beginning with the very first year of registration.
5. If after a period of one year from the date the establishment first applied for registration, the establishment has either not proceeded forward with registration or has not achieved registration, a letter (Appendix 3 - 5) will be forwarded to the establishment advising them of options to proceed.
6. When the registration package is complete and accurate the area specialist changes the status of the registration file in the Client Management System (CMS) to activate the new registration.
7. The area specialist issues the Certificate of Registration.
8. The area specialist forwards the Certificate of Registration accompanied by a letter (Appendix 3 - 6) explaining the meaning and conditions of registration to the applicant.
9. The area specialist provides the inspection office with of a copy of the Certificate of Registration and the accompanying letter.
10. The Area Office Delegate enters the establishment information in the National Registration Excel Spreadsheet
1. Headquarters is notified by the area specialist of the new or renewed registration.
In consultation with the inspector, the Regional Office will review the application form, initial inspection results, plans and specifications, sanitation program, the Dairy Plant Information and Registration of an Establishment Record form, and the validation of volume of milk received/production output to determine acceptability for registration.
A registration inspection of the establishment is then completed using the Dairy Plant Registration and Review of Plans and Specifications - Check List to determine eligibility for registration. The inspection is the final step in the registration process and is completed prior to start up. The purpose of the inspection is to examine the structure of the plant, the equipment, the lab facilities, the sanitation and pest control programs, proposed records to be kept, surroundings of the plant, label file and other aspects that can be observed prior to start up to ensure these items will meet the requirements of the regulations for registration. This inspection is not an in depth plant inspection. Any changes or corrections must be made by the establishment before registration is recommended. In the case of an existing provincially licensed establishment an in depth inspection must also be done in conjunction with the registration inspection and must meet the criteria of a satisfactory inspection (100% in Health and Safety Category 1, ≥ 75% in Health and Safety Category 2, ≥ 60% in Health and Safety Category 3 and ≥ 50% in Health and Safety Category 4 as described in Section 5.5). For a new facility an in depth inspection must be completed no later than 3 months following registration.
When using the checklist, please note that most of the documents, plans, protocols and other informational requests are on the form because they are either identified in the Canada Agricultural Products Act and the Dairy Products Regulations or are part of the agency's goals. Therefore it is imperative that all of the requirements are fulfilled prior to registration.
Part I of the form outlines the requirements as stated in the Dairy Products Regulations. All requirements must be discussed with the respective registrant, informing them of their responsibility. Section 11.1 (29) of the Dairy Products Regulations must be discussed to ensure that they are aware of their obligations in the event that changes are going to be made to their establishment. The implementation of HACCP must be discussed with plant personnel, including discussions on the implementation of the Food Safety Enhancement Program. The development and implementation of the seven prerequisite programs must also be discussed. The cost recovery fees for federal inspection services must be reviewed with plant personnel at this time.
Part II of the form is completed following the registration inspection and completion of Part I. The form must be dated and signed and either recommends or does not recommend the plant be registered. All documents will be sent to the regional and/or area office. The information is then reviewed by the regional program officer/specialist.
After the establishment's documentation is accurately completed and the registration inspection is performed and found to be satisfactory, plant registration is recommended. A registration number is issued to the establishment by the area program specialist. The numbers are to be assigned based upon the following breakdown by Province:
Ontario - 0 to 1599
Quebec - 1600 to 3599
PEI - 3600 to 3699
Nova Scotia - 3700 to 3799
New Brunswick - 3800 to 3899
Manitoba - 3900 to 3999
Saskatchewan - 4000 to 4099
Alberta - 4200 to 4399
BC - 4400 to 4599
Newfoundland - 4600 to 4699
A Certificate of Registration is then issued by the area program specialist accompanied by a letter explaining the meaning and conditions of registration. An example copy of the letter can be found in Appendix 3 - 6 of this section. The Chief of the Dairy Program, Agrifood Division is then notified of the new or renewed registration.
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