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CANADIAN WINERY INSPECTION MANUAL VERSION 3 Revised November 24, 2006

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CANADIAN WINERY INSPECTION MANUAL

VERSION 3

Revised November 24, 2006

INTRODUCTION Introduction Program Objective Program Emphasis Responsibilities Definitions

Introduction The primary purpose of this manual is to provide inspectors with guidelines to focus their work. It will also be of assistance in training new personnel and in maintaining uniformity in inspection work. The manual provides transparency to winery operators in showing how inspectors will assess their premises, operations and products. It provides an outline of the basic principles and practices that should be followed in the wineries to ensure that safe, wholesome, quality products are produced. In the following chapters are guidelines for the inspection of all registered wine establishments and their production. This manual is meant to serve as guidance in the traditional method of food/beverage processing establishment inspection. Wine is considered a food and therefore must be produced under sanitary and safe conditions. It is recognized that wine has some inherent safety built in, due to the high acidity and alcohol content. For that reason wine is not high risk for microbiological hazards like many other foods. However, wine is subject to the same potential chemical and physical hazards as other food products, so most of the same food inspection principles guiding chemical and physical safety as well as hygiene conditions and correct labelling apply to wine. This inspection manual is meant to cover all of the components that are necessary to make an effective winery and wine product inspection program that fosters the production of safe, wholesome, high quality, Canadian wine products. The manual cannot cover all situations that may develop from time to time. When issues not covered by the manual arise, the National Wine Desk Officer (NWDO) should be consulted for assistance. The Winery Inspection Manual is not meant to serve as a Hazard Analysis Critical Control Point (HACCP) document, but the manual could be used as a reference in the development of such a safety management system. The manual suggests what is required rather than, as HACCP systems do, provide the “how to” approach by analyzing the hazards and then formulating the controls for critical hazards. The manual should be regarded as a minimum set of requirements that provides interpretation to the Wine Regulations under the Canada Agricultural Products Act. IMPORTANT NOTE: This manual has no precedence over any federal regulations. For legal requirements, consultation of the appropriate set of regulations is recommended. Program Objective The objective of this inspection manual is to evaluate the registered wineries’ control over the wine itself with its label, as well as the equipment, premises, operations and environmental conditions under which the wine is produced, in order to effect compliance with the Wine Regulations and to produce safe, wholesome correctly-labelled wine products.

Some of the specific program goals include:

To confirm that grape wines are processed under safe and sanitary conditions by identifying and requiring compliance to hygienic principles and safety standards as well as other regulatory requirements.

To confirm that grape wines are produced and bottled in accordance with appellation requirements by verifying the origin and content of the wines.

To establish clear national standards and procedures for wine products and winery inspection.

Program Emphasis The winery inspection manual is based on the Canadian Common Inspection Approach (CIA) standards. CIA standards describe the Canadian requirements to ensure compliance with the proposed Good Manufacturing Practices (GMP) regulations for foods/beverages and other food/beverage requirements under the Food and Drugs Act and Regulations. The CIA standards are based on the Codex Alimentarius’ Recommended International Code of Practices - General Principles of Food Hygiene. The format containing the principles and assessment criteria of this inspection manual were written to interpret the requirements of the Wine Regulations and other applicable Canadian regulations, standards and policies. As mentioned above, wine is considered a food and therefore the Food and Drugs Act sections 4 and 5 of Part I of the Act states:

FOOD Prohibited sales of food

4. No person shall sell an article of food that (a) has in or on it any poisonous or harmful substance; (b) is unfit for human consumption; (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; (d) is adulterated; or (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. R.S., c. F-27, s. 4.

Deception, etc., regarding food

5. (1) No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

Food labelled or packaged in contravention of regulations

(2) An article of food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). R.S., c. F-27, s. 5.

The above sections of the Act apply to all foods sold in Canada. They form the basis of the all other hygiene and safety requirements including the registration and operational requirements of the Wine Regulations. Chapter 4 of the Winery Inspection Manual interprets section 4 above and the Wine Regulations under the Canada Agricultural Products Act. They relate to the hygienic conditions and traceback requirements under which the product must be produced. Chapter 5 of the Manual interprets section 4 and 5 above and the Wine Regulations with regard to chemical and physical hazards and wine label misrepresentation. Wine also is subject to various other requirements and standards in the Food and Drug Regulations and Consumer Packaging and Labelling and Regulations. Responsibilities a) The wine industry Wineries are responsible for:

the hygiene, safety and quality of wines produced and offered for sale; compliance with applicable government acts and regulations.

Since the inspection program measures the achievement of these responsibilities, individual wineries are encouraged to actively participate in the inspection of their establishment. As well, they are further encouraged to implement the same inspection program and self-monitor their performance on an ongoing basis. Winery operators should:

accompany the inspection team; provide any assistance, if required; assist in record and program reviews.

This will facilitate an accurate and thorough evaluation of items. Wine hygiene and safety are matters of demonstrating due diligence. Demonstrating due diligence means taking every precaution reasonable in the given circumstances to avoid harm or loss. It also means having controls in place to deal with non-compliance and for being accountable for decisions and actions taken. As a due diligence measure, operators of registered wine establishments are encouraged to ensure that wine prepared in the establishment meet the guidelines provided in this manual. b) Canadian Food Inspection Agency and the Provincial Wine Authority The Canadian Food Inspection Agency (CFIA) and the Provincial Wine Authority are jointly responsible for seeing that the delivery of the program is carried out as designed. Two of the objectives of the CFIA are protecting consumers and facilitating market access. To accomplish these objectives through inspection, CFIA has the responsibility

to all consumers of food and beverages produced in Canada, to work diligently to see that Canadian food and beverages are safely prepared by clean, healthy workers in a hygienic environment and that those products are clearly labelled in a manner that does not misrepresent them in any way. Definitions Audit – a systematic examination to determine whether what is actually happening complies with documented procedures. (FAO/WHO*) Communicable disease – means a disease that is listed in the World Health Organization (WHO) Technical Report Series 785 entitled Health Surveillance and Management Procedures for Food-Handling Personnel: Report of a WHO Consultation. (Draft Canadian Wine Regulations) Food – includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever. (Food and Drugs Act) Food contaminant – any biological or chemical agent, foreign matter or other substance not intentionally added to food which may compromise food safety or suitability. (FAO/WHO) Food Control – a mandatory regulatory activity of enforcement by national or local authorities to provide consumer protection and ensure that all foods during production, handling, storage, processing and distribution are safe, wholesome and fit for human consumption; conform to quality and safety requirements; and are honestly and accurately labelled as prescribed by law. (FAO/WHO) Food hygiene – comprises conditions and measures necessary for the production, processing, storage and distribution of food designed to ensure a safe, sound, wholesome product fit for human consumption. (FAO) Food Inspection – the examination by an agency empowered to perform regulatory and/or enforcement functions of food products or systems for the control of raw materials, processing and distribution. This includes in-process and finished product testing to verify that they conform with regulatory requirements. (FAO/WHO) Food safety – assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. (FAO) Hazard – a biological, chemical or physical agent in, or condition of, food with the potential to cause and adverse health effect. (FAO)

Potable water – water fit for human consumption. Standards of potability should not be lower than those contained in the latest edition of the Health Canada Guidelines for Canadian Drinking Water Quality. (Adapted FAO) Risk – a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard in food. (FAO) Unsanitary conditions – means such conditions or circumstances as might contaminate with dirt or filth or render injurious to health a food, drug or cosmetic. (Food and Drugs Act) Wholesome – conducive to sound health or well-being; salutary. (Dictionary) * Note: the name in brackets at the end of each definition indicates the source of the definition. FAO is the Food and Agriculture Organization and WHO is the World Health Organization. Both are agencies of the United Nations.

CHAPTER 1 - REGISTRATION OF ESTABLISHMENT 1.1 Legal Requirements…………………………………………………………………1

1.1.1 Registration Requirements………………………………………………1 1.1.2 Products Regulated Under the WR……………………………………...2

1.2 Applicant’s Steps for Registration………………………………………………….2 1.2.1 Applicants Forms………………………………………………………..2 1.2.2 Construction and Equipment Requirements…………………………….6

1.2.3 Written Program Document……………………………………………..6 1.2.4 Suggested References…………………………………………………...7 1.2.5 Establishment’s Management Inspection……………………………….8 1.2.6 Application Submission…………………………………………………8

1.3 CFIA Responsibilities……………………………………………………………...8

1.3.1 Inspector Registration Package Review………………………………...8 1.3.2 Establishment Inspection……………………………………………….8 1.3.3 Recommendation to Register…………………………………………...9 1.3.4 Certificate of Registration………………………………………………9 1.3.5 Provincial Wine Authority’s Responsibilities…………………………..9

1.4 Registered Establishment’s Responsibilities……………………………………….10

1.4.1 Responsibilities………………………………………………………….10 1.4.2 Establishment Registration Renewal Procedure…………………………..11

ANNEX - Example of Notice of Pending Expiry of Wine Establishment Registration……12 - Example of Notice of Expiry of Wine Establishment Registration……………..14 - Example of Letter of Cancellation of Expired Wine Establishment Registration.15

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CHAPTER 1 - REGISTRATION OF ESTABLISHMENT 1.1 Legal Requirements 1.1.1 Registration Requirements Registration is required to enable an establishment preparing grape wines regulated under the Wine Regulations (WR): 1) trade them internationally (either under its own label or that of a buyer or first dealer), 2) trade them interprovincially (either under its own label or that of a buyer or first

dealer), 3) apply a Canadian trade mark to the applicable products. The following terms are defined in the Section 2. (1) of the Wine Regulations:

a) "Establishment" means any place in which grape wines are prepared for human consumption;

b) "Registered Establishment" means an establishment that is registered pursuant to subsection 11(1)

c) "First dealer" means any person operating as a wholesaler, retailer or distributor

who buys and sells under his own private label any grape wine prepared for him in a registered establishment.

Part 7 of the WR outlines the procedures and requirements under which an establishment will be registered. Part 7 of the WR also outlines the conditions that an establishment must meet in order to become and remain registered. Section 13 of the CAP Act outlines the conditions of registration and operation of an establishment as a registered establishment under this Act, and outlines the condition that the establishment and all agricultural products in it are subject to this Act and Regulations. All grape wines standardized under WR must be produced in a registered establishment and subject to trade marks and standard containers, even if they are to be distributed within the province of manufacture only. Please note that all local and provincial ordinances and codes must also be observed. Determining which establishments need to be registered

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Registration is required when regulated grape wines (standardized) are traded inter provincially, internationally or when a Canadian trade mark is applied. The main processing activities associated with the application of the WR include preparation, fermentation, aging, blending and packaging. Preparation consists of crushing grapes into grape juice for fermentation. Fermentation consists of giving the yeast proper conditions and time to convert the sugar in the grape must into ethyl alcohol and other by-products Aging consists of allowing the wine to age in steel, or wooden, plastic, glass or concrete containers (given that appropriate food grade requirements are met). Blending consists of mixing two or more grape wines Packaging consists of filling, sealing and labelling bottles and/or plastic/foil bags in cardboard containers. 1.1.2 Products Regulated under the Wine Regulations All regulated products are indicated in WR Schedules I, II and III. An establishment processing or applying a grade to any of these products must be registered. Depending on the schedule in which the product is included, different regulatory requirements apply: SCHEDULE I: Grape Wines VQA product: For these products, the VQA marks are required. The product

must meet the compositional and quality standards defined under the VQA mark. Certain terms are restricted for use on VQA products only.

Regional product: The product must meet the compositional and quality standards defined under the regional mark. Certain terms are restricted for use on Regional and VQA products only or on Regional products only.

SCHEDULE II:

Standard Containers: Contains all standard containers for grape wines. Packaging other than glass bottles are not permitted for VQA wines.

There are 3 sets of regulations comprised in the WR; the VQA Wine Regulations, the Regional Wine Regulations and the Canadian Wine, Imported Wine Packaged in Canada and Wine Cellared in Canada from Domestic and Imported Wines Regulations. All establishments preparing grape wines using the VQA and Regional names as well as any other terms protected by these Regulations must be registered. All establishments

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shipping grape wine outside the province in which it was prepared also must be registered. 1.2 Applicant’s Steps for Registration 1.2.1 Applicant Forms The following two forms must be submitted to the local CFIA inspection office: (A) APPLICATION FOR REGISTRATION OF AN ESTABLISHMENT (CFIA

3043) (B) DESCRIPTIVE PROFILE OF APPLICANT ESTABLISHMENT FOR WINE

(CFIA ????) Following are instructions on completing the forms. (A) APPLICATION FOR REGISTRATION OF AN ESTABLISHMENT (CFIA 3043) 1. Type of Application Check the appropriate box. New: For a new establishment; Renewal: For the annual renewal of the registration (as per the 12 month anniversary date of that on which the registration was issued); Revision: For any changes made to the legal name of the establishment or the address of the processing establishment (the location of the establishment has moved). 2. Preferred Language of Correspondence Check the appropriate box. 3. Existing Registration Number (if applicable) For renewal or revision, indicate the registration number assigned to the establishment. 4. Legal Status of Business Check the appropriate box. □ Corporation or Limited Company: This consists of a legally registered or

incorporated entity. The business name usually includes Ltd. or Inc. in the title. The business may be federally or provincially registered. Copies of official articles of incorporation or other registered documents are required.

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□ Partnership: When two or more people operate a business, they may form a partnership. This partnership must be registered.

□ Individual: This consists of one person operating a business. This person can operate

without a business registration or documentation as long as the person’s first name and surname are used in the business name. An individual can operate a business without using their own name in the business name but in that case the name should be registered.

□ Co-operative: This is a business such as a farmer co-operative that has been created

under the Co-operative Act. This business must provide legal documents establishing the co-operative.

5. Legal Name of Business as Registered Please ensure that the company name recorded on the form is exactly the same as the partnership documents or the articles of incorporation. In cases where an operating name is not registered, the complete name of the individual requesting registration must be used in establishing the legal status of the business. The operating name should be added as additional information under “Also doing business as”. Under the “Also doing business as” heading, the applicant should indicate each commercial name used or the name of each business which will be using the premises (shared facilities) and the establishment numbers for which the applicant will be responsible and which will be using their registration numbers. Applicants should also include all “brand” names that will be used on wine packaging as an operating name. 6. Street Address or Legal Description of Location of Establishment Please note that there is a separate box to indicate the mailing address. When a postal box number is available it must be shown in the box assigned for the mailing address. Urban Areas The street number, street name, town and province are acceptable as the legal address to be indicated in this box. Rural Areas The street number, street name, town and province are acceptable as the legal address to be indicated in this box. However, where street numbers and names are not available, the legal address in use in the province must be identified. The Ontario format is as follows:

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lot, concession, township and municipality or county. In the Atlantic provinces, some places are still only identified by a registered survey number. 7. Name and mailing address including postal code as well as e-mail address (if available) Please indicate the mailing address which may be different or the same as the legal address. When a P. O. box number is available it must be shown in this box. To facilitate communication, an e-mail address should be provided if available. 8. Signature The person who signed the form must be a responsible person within the company i.e. a director or shareholder. In addition to the signature, please print the name, date of request, and identify the title or official capacity of the person within the company. 9. Telephone and Facsimile Provide the telephone and facsimile of the establishment or operator. 10. Name and Address of Applicant If this is exactly the same as in the above fields, indicate same as above. This may be the establishment or personal address for the smaller businesses. For larger corporations, this may be the establishment address or address of head office. 11. Telephone and Facsimile Provide the telephone and facsimile number if different from the establishment’s numbers. 12. Partnership/Individual Ownership This only needs to be completed for partnerships or individual ownerships to show the names, titles, and addresses of all parties involved in the business. This can be attached on another page if more room is required for this information. 13. Agency Use Only This area is reserved for agency officials to sign, date, and make any necessary comments after reviewing the applications. 14. Reverse Side of Application Please check the appropriate section for the Regulation and Act that applies to the operation.

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(B) DESCRIPTIVE PROFILE OF APPLICANT ESTABLISHMENT FOR WINE The descriptive profile should always accompany the application form for registration. It is important to complete this form properly. This information provided from this profile is required to identify the type of the establishment and the type of grape wines packed. This information is essential in planning the inspection schedule. 1. Name of the establishment The name of the establishment must correspond with the name on the "Application for Registration of an Establishment" form. Also the address for the processing establishment must be provided. 2. Type of Establishment Winery 3. Products Packed At least one product must be indicated. Indicate intended production of grape wines and whether VQA, Regional and/or other wines will be produced. 4. Direction (Map) to Location of Establishment Please make a schematic drawing of the location when the establishment may be difficult to find. 5. For Internal Use Comments: Note changes required to a registration or request certain registration numbers be reserved if an existing business has been sold or has more than one registration. Registration Recommended: Check the appropriate box. The recommendation should be signed and dated by the responsible inspector and/or officer. 1.2.2 Construction and Equipment Requirements Buildings exterior, interior and surrounding areas must be designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of wine. More details on construction and equipment requirements can be obtained from the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-

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Food Chemical Products (http://www.inspection.gc.ca/english/ppc/reference/cone.shtml) and refer to Chapter 4 of this manual. 1.2.3 Written Program Documents There is a legal requirement for establishments to have developed, documented and implemented programs to control factors not directly related to manufactured hygiene controls and recall capability, but and are essential in any food/beverage establishment. They are procedures that control operational conditions within a food and beverage establishment allowproviding for environmental conditions that are favourable to the production and distribution of safe food/beverages wine products. These five programs must describe briefly all activities in the establishment related to the following program subjects. The written programs need not be pages of detail but must demonstrate that the operator understands the desired environmental conditions and has put in place activities that ensure those conditions prevail in the establishment. The amount of detail in the written documentation normally varies with the size, volume or complexity of an establishment. These programs must be reviewed and approved by the inspectors before the registration is issued. The inspector may require changes to the programs if they are incomplete or if improvements are needed. Each program must be based on the standards and regulations as stated in the Canada Agricultural Products Act and the WR. The five written programs are: I. Sanitation Program (required under WR) II. Water Quality Control Program (include steam and ice if applicable) III. Pest Control Program (required under WR) IV. Recall Plan V. Training Program More details on these programs can be obtained through your local wine authority or CFIA inspection office. 1.2.4 Suggested References a) Acts and Regulations - Canada Agricultural Products Act (CAP Act) - Wine Regulations (under CAP Act) - Food and Drugs Act and Regulations - Consumer Packaging and Labeling Act and Regulations The Regulations are available at the following address: CFIA Website: http://www.inspection.gc.ca

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b) Reference Listing of Accepted Construction Materials, Packaging Materials and Non-

food Chemical Products, CFIA This is a current list of materials and non food chemicals which have been found by Health Canada and CFIA to be acceptable for use in establishments operating under the authority of the CFIA. The primary purpose of this publication is to provide a ready made reference for both inspection personnel and representatives of the managerial staff of establishments, to indicate “non objection” status for products intended for use in establishments. The inclusion of the name of a product in this list is not to be construed as an endorsement for that product. This document is available at the following addresses: CFIA Website: http://www.cfia acia.agr.ca/english/reg/rege.shtml or you can contact your local CFIA inspection office for information on how to obtain approval for the use of new materials and agents in establishments. Other useful information (e.g. Food Safety Enhancement Programme (FSEP) and HACCP) can be found on the CFIA Website 1.2.5 Establishment’s Management Inspection The establishment management is expected to carry out independent their own regular in-house sanitation audits of their wine-making facility, based on the CFIA program requirements, and to make appropriate corrections based on their findings. 1.2.6 Application Submission A complete registration package must include the following: 1. Application for registration of an establishment (CFIA 3043) 2. Sanitation Program (as required by Section 10. (2) of the WR)* 3. Corporate Registration Papers (if applicable, photocopies are permitted) 4. Registration Fees 5. Letter of proof of production (from provincial authority??) or estimated production for

the coming year for establishments requesting reduced inspection fee * An approval note from the inspector is acceptable for lengthy programs. These forms are available at the following address: CFIA Website: http://www.inspection.gc.ca/english/for/mpppe.shtml The application package should be forwarded to the CFIA National Wine Desk Officer and arrangement will be made for a pre-registration establishment inspection.

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1.3 CFIA Responsibilities 1.3.1 Inspector Registration Package Review The registration package, as described in section 1.2.6, will be reviewed by CFIA and any missing information required will be requested from the establishment. Following the registration package review and confirmation of fee payment, an inspection time will be arranged with the establishment managers. 1.3.2 Establishment Inspection The establishment will be inspected for compliance with Part 7 of the Grape Wine Regulations. If the establishment is in full operation, an in-depth inspection will be undertaken. If the establishment is not in full operation, a partial inspection can be undertaken to recommend registration. Once this establishment is in full operation, a full in-depth inspection must be scheduled as soon as operations begin. For either inspection, the requirements stated in Chapters 4 and 5 of this manual will be observed and assessed for compliance before registration. The registration inspections will be carried out on the applying establishment by a CFIA inspector. Inspectors will discuss results with establishment management. An establishment inspection report will be left with the applicant. An action plan will be requested from management for the correction of identified infractions. At this stage, the inspector and applicant will review the application package and complete or correct it, if needed. 1.3.3 Recommendation to Register When CFIA has reviewed the required documents and the inspection report, and is satisfied that the applicant-establishment meets all the registration requirements, the package is be sent to the CFIA National Wine Desk Officer along with the proof of fee payments. A reserved registration number may unofficially be distributed to the applicant-establishment who wishes to prepare in advance cartons for printing, however the applicant-establishment must be informed that no inter provincial and/or international trade of grape wine is allowed prior to the issuance of the final registration. The reserved number may be obtained from the CFIA National Desk Officer. When the CFIA National Wine Desk Officer is satisfied that all the necessary requirements have been met for registration, a registration number is issued and the operating name and address of the establishment is officially recorded on the registration list in Ottawa. 1.3.4 Certificate of Registration

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Formal acknowledgement of the processed products establishment’s registration is confirmed through the issuance of a Certificate of Registration. The Certificate of Registration is sent to the establishment and is accompanied by a letter explaining the meaning and conditions of registration. Certificates of Registration have to be renewed annually with fee payment unless registration suspension or cancellation is invoked or registration is revoked. 1.3.5 Provincial Wine Authority’s Responsibilities The provincial wine authority is responsible for on going inspections (after registration), audits and product approvals. Once registered, the establishment must contact the provincial wine authority to obtain approval to use appellation terms and renewal of registration. The provincial authority will administer the provisions of the CAP Act and Wine Regulations for all products produced within the relevant provincial jurisdiction. 1.4 Registered Establishment’s Responsibilities 1.4.1 Responsibilities After the winery becomes registered, its operator has several obligations and responsibilities. a) Operational Changes As soon as possible, the operator must inform the local inspector of a significant change that may impact on the safety of the wine or the status of the registration to the items (see examples below: - Construction changes (expansion, major renovation, important process line changes) - Major process changes or addition - Closing of the establishment - Ownership or company name changes - Moving of the establishment or part of the establishment The inspector will indicate to the operator if new documents or forms must be submitted and if a new certificate will be issued. An inspection of the new installation/establishment may be required. b) Maintenance and Operation The establishment must be maintained and operated in accordance with the Wine Regulations. c) Certificate of Registration

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The Certificate of Registration must be kept posted in a conspicuous place in the establishment, for the period during which it remains in force. It must not be assigned or transferred to another establishment. d) Establishment Registration Number The registration number assigned to the establishment must may be marked on one panel (not the bottom) of the shipping cartons. for all wine products falling under the authority of the Wine Regulations When it may be necessary to follow up on complaints, recalls etc., this registration number could assist in tracing any wine product at retail back to the winery where it was packed. See chapter 4.6.2.2. e) Label Requirements All labels of wines falling under the authority of the Wine Regulations must meet the marking requirements of those Regulations. All VQA and Regional labelled wines and must be approved certified by the Provincial Wine Authority, as stated in Part IV 5 of those Regulations. Each registered establishment must should maintain on file in that establishment, a copy of the product approval certification documents and associated label for each certified VQA and Regional wine lot. that is used f) Assistance to Inspectors During an inspection, investigation, or sampling activity, the registered operator must provide to the inspector reasonable assistance to enable him to carry out his duties and furnish him the information required as stated in Section 21 (3) of the Canada Agricultural Products Act. g) Sampling The operator must supply, without charge, samples for quality testing and analysis as stated in the Wine Regulations. h) Establishment Registration and Product Approval Certification Fees The establishment registration and product approval certification fees must be paid upon application and upon the renewal due date. 1.4.2 Establishment Registration Renewal Procedure The Provincial Wine Authority will issue registration renewal notices before the registration expires (see example notices in annex). Registrations will be renewed providing that the following documents are submitted:

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1. Application for registration is received on a fully completed Application for Registration (CFIA 3043)

2. Sanitation Program, if different from the previous year 3. Corporate Papers, if different from the previous year 4. Registration fees 5. Statement of production volume for establishments paying reduced fees The renewal documents and fees must be forwarded to the Provincial Wine Authority.

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Address March 13, 2001

2820-1- Reg. #

Adresse Le 13 mars 2001

2820-1- no d’agrément

Name and Address of establishment

Nom et adresse

SUBJECT: NOTICE OF PENDING EXPIRY OF WINE ESTABLISHMENT REGISTRATION - (Date)

OBJET : PRÉ-AVIS D’EXPIRATION DE L’AGRÉMENT D’UN ÉTABLISSEMENT DE VIN (date)

Please be advised that the registration for your federally registered establishment to operate under Wine Regulations (WR) expires on April 6, 200?. Federal registration is required for all establishments that prepare wine products standardized under WR and trade internationally and/or inter provincially or are marked with a Canadian trade mark. Establishments that allow their registration to lapse, will lose their ability to seek approval for VQA and Regional wines and sell their wines in other provinces and countries. If the registration is not reinstated within 60 days of the expiry date, the establishment may continue to sell previously approved wines for a monthly fee of $200.00. Failure to pay the sales fee will result in existing approvals being revoked. A renewal package which includes the necessary application forms and the current fee structure should be enclosed with this letter. Please include any changes to your business on these application forms. A change in the registered business name should be supported by copies of the necessary legal documents. The completed application forms for renewal along with the fee payment

Veuillez prendre note que l’agrément de votre établissement agréé auprès du gouvernement fédéral en vue d’une exploitation conforme au Règlement sur les vins (Règlement) expire le 06 avril 2001. Tous les établissements qui préparent des produits transformés normalisés en vertu du Règlement et commercialisés à l’échelle internationale ou interprovinciale ou portant une marque canadienne sont tenus de s’agréer auprès du gouvernement fédéral. Les établissements qui laissent périmer leur agrément verront ce dernier annulé de même que les privilèges commerciaux qu’il confère. Les formulaires de demande de renouvellement remplis de même que le paiement des droits (par chèque ou mandat-poste ) doivent être retournés avant le 06 avril 200? à l’adresse. Nom et adresse du En outre, les établissements qui ne désirent plus être agréés auprès du gouvernement fédéral doivent en aviser maintenant le Une trousse de renouvellement incluant les formulaires d’inscription nécessaires ainsi que le barème de droits actuel est joint à la présente lettre. Veuillez indiquer tout changement à votre entreprise sur ces formulaires de demande. Un changement

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(cheque or money order) must be returned to the following Provincial Wine Authority before April 6, 200?: Name and Address of Provincial Wine Authority Establishments no longer requiring federal registration should also notify the Provincial Wine Authority at this time. If you have any questions, please do not hesitate to contact the undersigned or your inspector for more information. Yours truly,

de nom d’une entreprise agréée doit être appuyé de copies des documents juridiques requis. Si vous avez des questions n’hésitez pas à communiquer avec le soussigné ou avec votre inspecteur afin d’obtenir plus d’information. Veuillez agréer l’expression de mes salutations distinguées.

Provincial Wine Authority Officer Provincial Wine Authority Officer

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Address March 13, 2001

2820-1- Reg. #

Adresse Le 31 mars 2001

2820-1- no d’agrément

Name and Address of establishment

Nom et adresse de l’établissement

SUBJECT: NOTICE OF EXPIRY OF WINE ESTABLISHMENT REGISTRATION- (Date)

OBJET : AVIS D’EXPIRATION DE L’AGRÉMENT D’UN ÉTABLISSEMENT DE VIN (date)

Please be advised that the registration for your federally registered establishment to operate under Wine Regulations (WR) expired on April 6, 2001. Federal registration is required for all establishments that prepare wines standardized under WR and trade internationally and/or inter provincially or are marked with a Canadian trade mark. Establishments that allow their registration to lapse, will lose their registration and associated trade privileges. Effective immediately, your establishment is not entitled to apply for or receive product approvals for VQA or Regional wines. If the registration is not reinstated within 60 days, the establishment may continue to sell previously approved wines for a monthly fee of $200.00. Failure to pay the sales fee will result in existing approvals being revoked. If you have any questions, please do not hesitate to contact the undersigned or your inspector for more information. Yours truly,

Veuillez prendre note que l’agrément de votre établissement agréé auprès du gouvernement fédéral en vue d’une exploitation conforme au Règlement sur les vins (Règlement) a expiré le 06 avril 2001. Tous les établissements qui préparent des vins normalisés en vertu du Règlement et commercialisés à l’échelle internationale ou interprovinciale ou portant une marque canadienne sont tenus de s’agréer auprès du gouvernement fédéral. Les établissements qui laissent périmer leur agrément verront ce dernier annulé de même que les privilèges commerciaux qu’il confère. Si vous avez des questions n’hésitez pas à communiquer avec le soussigné ou avec votre représentant local de l’ACIA afin d’obtenir plus d’information. Veuillez agréer l’expression de mes salutations distinguées.

Provincial Wine Authority Officer Provincial Wine Authority Officer

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CANCELLATION OF EXPIRED REGISTRATION Date 2820-1- Reg.# Operator Name Name and Address of registered establishment Dear Operator: SUBJECT: CANCELLATION OF EXPIRED WINE ESTABLISHMENT

REGISTRATION Please be advised that the registration for your establishment to operate under the Wine Regulations (WR) expired on DATE. As we have not yet received your renewal application for FISCAL YEAR, we are interpreting this as your intention to let your establishment’s federal registration lapse. The name and address of your establishment will be deleted from our list of registered wine establishments. Part 7 of the WR state that establishments that prepare wine under WR and trade these products internationally and/or inter provincially, or mark these products with a Canadian trade mark must be registered. Therefore, your establishment is no longer entitled to apply for or receive product approvals for VQA or Regional wines or engage in inter provincial or international sale of any wines. If the registration is not reinstated within 60 days, the establishment may continue to sell previously approved wines for a monthly fee of $200.00. Failure to pay this fee in advance of each month sales will result in existing approvals being revoked and product withdrawn from all sales channels. Violating these regulations may result in enforcement action being taken by the Canadian Food Inspection Agency (CFIA). If it is your intention to maintain your registration, please notify us immediately and send a completed application and payment to the above noted office. If you require further information and/or application forms, please do not hesitate to contact the undersigned or your inspector. Yours truly, Provincial Wine Authority Officer

CHAPTER 2 - ESTABLISHMENT INSPECTION PROCEDURES 2.1 Establishment Inspection Guidelines………………………………………....1

2.1.1 Principle Statement……………………………………………………2 2.1.2 Assessment Criteria…………………………………………………...2 2.1.3 Rating Category System………………………………………………2

2.1.3.1 Rating Categories and Definitions…………………………….3 2.1.3.2 Risk Assessment………………………………………………3 2.1.3.3 Rating Guide Examples……………………………………….5 2.1.3.4 Concerns (Hazards)…………………………………………...5 2.1.3.5 Override Provision…………………………………………….7

2.2 Preparation for an Establishment Inspection and Audit………………………7

2.2.1 Frequencies……………………………………………………………7 2.2.2 Notification of the Establishment……………………………………..7 2.2.3 Who Inspects………………………………………………………….7

2.2.3.1 Inspector / Auditor…………………………………………….7 2.2.3.2 Establishment Representative………………………………....8 2.2.3.3 Other Government Agencies………………………………….8

2.2.4 Documentation Review……………………………………………….8 2.2.4.1 A Establishment’s File – Inspection…………………………..8 2.2.4.1 B Establishment’s File – Audit………………………………..8 2.2.4.2 Regulations and Manuals…………………………………...8 2.2.4.3 Other Documentation………………………………………8

2.2.5 Inspection Equipment…………………………………………………9 2.2.6 Safe Work Practices…………………………………………………..9 2.2.7 Professionalism……………………………………………………….12

2.3 Pre Inspection…………………………………………………………………12

2.3.1 Establishment File Review……………………………………………12 2.3.2 Inspection Planning…………………………………………………...12

2.3.2.1 Arrival at Establishment and Introductions…………………...12 2.3.2.2 Establishment Representative…………………………………13 2.3.2.3 Scheduling…………………………………………………….13 2.3.2.4 Order…………………………………………………………..13

2.3.3 General Inspection Considerations……………………………………13 2.4 In-depth Establishment Inspection…………………………………………….15 2.5 Post Inspection…………………………………………………………………15

2.5.1 Inspection Team Review………………………………………………15 2.5.2 Reporting Inspection Results…………………………………………..15 2.5.3 Exit Meeting with Management……………………………………….16 2.5.4 Final Report and Covering letter………………………………………16 2.5.4.1 Written Action Plan……………………………………………………17

2.6 Directed Establishment Inspection…………………………………………….17 ANNEX Example of a Covering Letter………………………………………………………….19

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2.1 Establishment Inspection and Product Audit Guidelines There are two types of establishment inspections conducted, an in-depth inspection and a directed inspection. A product audit is performed to verify that the products produced in the establishment meet the Wine Regulations with respect to origin, content and quality. A product audit can be carried out on its own or as part of an in depth or directed establishment inspection. A full in-depth inspection includes inspecting all aspects of the establishment. This means that all generic type inspection criteria from Chapter Four, as well as all process specific criteria from Chapter Five are assessed. A directed inspection draws selectively from Chapters 4 and 5 and should focus on: - serious infractions noted during the previous in-depth inspection - one element (random or chosen) related to manufacturing control (chapter five),

as well as a generic inspection standards specific element, such as recall - product inspection, such as origin, content and quality verification Chapter 4 includes generic inspection standards which may be applied to all wine establishments and consists of seven sections: Premises; Transportation and Storage; Equipment; Personnel; Sanitation and Pest Control; Complaints and Recall; General Records. Chapter 5 contains the Manufacturing Controls inspection assessment criteria. Chapters 4 and 5 are laid out in table format. The tables contain the general areas in an establishment to be inspected. The tables are broken down as follows: Section Inspection Example 4 (Chapter) Generic Inspection Standards 4.1 (Section) Premises 4.1.1 (Subsection) Building Exterior 4.1.1.1 (Task Code) Outside Property 0001 (Task Number) Buildings and surrounding ... The task number is followed by a principle statement; assessment criteria; rating examples and regulatory references. Each principle statement is followed by assessment criteria descriptions. The assessment criteria identify factors which determine if the situation being assessed is in compliance with the principle statement. The assessment criteria are accompanied by rating examples for each of the three classification categories which can be assigned against the principle statement. It is

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important to note that the rating examples presented are only some examples and that more or none can exist depending on the inspection situation. Each task included in the inspection is accompanied by a source list of regulatory and general guideline references. Further explanation on the use of the inspection assessment criteria and the establishment rating system follows. 2.1.1 Principle Statement Principle statements are generic, broad, outcome based statements which are similar in style to the Codex Alimentarius Commission General Principles of Food Hygiene and the International Standards Organization (ISO) standards. These statements imply that the manufacturer controls all factors impacting on health and safety and compliance with the product origin, content and quality requirements of the WR. Principle statements are absolute and do not allow variance. Under each task number, principle statements express the intent of the Canada Agricultural Products Act (CAPA), Wine Regulations (WR), Food and Drug Act and Regulations (FDA&R) and Consumer Packaging and Labelling Act and Regulations (CP&L) and are written to permit flexibility with respect to the introduction of new technologies. A principle may have more than one set of assessment criteria however, a principle can only be assessed once. 2.1.2 Assessment Criteria Assessment criteria list most of the factors that will be evaluated by an inspector to determine if a manufacturer is in compliance with the principle statement of each sub item. Where appropriate, examples are used to clarify assessment criteria. Assessment criteria provide transparency to the food industry with respect to the specific factors required and assessed by the Government of Canada. As new technologies become available, evaluation of additional criteria may become necessary. For this reason, assessment criteria given in this standard should not be regarded as exhaustive. 2.1.3 Risk Rating Category System The risk rating system is a means for the inspector to record and communicate to the winery operator, the assessment of hygiene requirements, food safety risks as well as the economic risks, by inspecting to the assessment criteria of the principles stated in chapters 4 and 5. The objectives of the rating system are uniformity and transparency with respect to risk assessment and evaluation of compliance against regulatory requirements.

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The main components of this system are: the rating categories and definitions, risk assessment, the rating guide examples, concerns and the override provision. Each component is explained below. 2.1.3.1 Rating Categories and Definitions Each principle stated in chapter 4 and 5 is rated as satisfactory or if not satisfactory as a risk classification category I, category II, category III, not available, or not applicable according to the following definitions: Satisfactory (Sa) - No deficiencies related to a particular principle were noted which would result in a health risk, a hygiene violation, or contravention of any product origin, content and quality requirements of the Wine Regulations. Category I – A deficiency relating to a principle which would result in a risk with a high likelihood of occurrence and serious health or economic consequences. This category of deficiency is of critical importance and would normally require immediate corrective action. Category II – A deficiency relating to a principle which could result in a moderate risk, a major hygiene violation, or misrepresentation of the product’s origin, content or quality that has a significant impact on the consumer or a potential impact on the integrity of the Canadian appellation system. This category of deficiency is of major importance and would normally require short term corrective action. Category III – A deficiency relating to a principle which could result in a low risk, a minor hygiene violation, or a minor error in labelling. This category of deficiency is of minor importance and would normally require longer term corrective action. Not Available - The task cannot be performed due to the equipment or information not being available for inspection in the winery. Not Applicable - The specific task is not being performed in the winery. There may be instances in individual establishments where a principle cannot be assessed because the item does not exist or is not operational. In such cases, the item can be categorized as not applicable. 2.1.3.2 Risk Assessment The model uses likelihood of occurrence and severity of consequences to determine the rating for all deficiencies which impact on health/safety and economic fraud. The severity of consequences for a particular concern is fixed whereas the likelihood of occurrence varies with the degree of control exercised by the winery. The rating guide examples and the discussion in this chapter are intended to be a source of guidance for inspectors in assessing risk. The following Health Risk Assessment

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Model (Figure I) and the Economic Risk Assessment Model (Figure II) may be used by the inspector when additional consideration is required. Health Risk Assessment Model (Figure I) Likelihood of High Sa III II I Occurrence Medium Sa III II II (refers to lack Low Sa III III III of control of hygiene requirements or safety risks by winery)

Remote Sa Sa Sa Sa

Low Medium High Severity of Consequences

(refers to chemical or physical contamination resulting in consequences from poor hygiene practices to severe illness).

Economic Risk Assessment Model (Figure II) Likelihood of High Sa III II I Occurrence Medium Sa III II II (refers to lack Low Sa III III III of control [correctness] of label declarations by winery)

Remote Sa Sa Sa Sa

Low Medium High Severity of Consequences

(refers to misrepresentation resulting in consequences from misleading the consumer to potential damage to the integrity of the Canadian appellation system).

Likelihood of occurrence relates to the level of control the winery exercises to eliminate the hazard that would exist if the principles stated in chapters 4 and 5 were not adhered to. For example: Remote - Where the winery operator has well established control measures over

hygiene practices, safety and labelling matters.

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Low- Where the winery operator has established good control measures, but

minor infractions can be found. Medium - Where the winery operator has established some control measures, but

gaps or inconsistencies exist. Minor infractions and major infractions can be found.

High - Where the operator has little or no control. Major and critical infractions

can be found. Severity of consequences relates to the type of hazard that would result if a particular principle stated were not adhered to. For example: Low - Where the hygiene of the wine is compromised or consumers could be

misled due to slight labelling errors. Medium - Where the hygiene of the wine is severely compromised or consumers

could experience temporary illness or could be misled due to major labelling errors.

High - Where consumers (especially vulnerable populations) could experience

serious health problems or where the integrity of the Canadian appellation system could be jeopardized due to misrepresentation of the wine.

2.1.3.3 Rating Guide Examples The rating guide examples are intended to be a source of guidance for inspectors in assessing the risk associated with a deficiency in a principle. The rating guide examples are located in the table immediately after the assessment criteria which interpret the principle. Rating guide examples provide benchmarks to inspectors and promote uniformity and transparency in the assessment of conditions and operations in wine establishments. The examples illustrate a range within which most deficiencies can be classified. They do not cover all possible deficiencies or concerns. Unusual circumstances are evaluated against the Health Risk Assessment Model or the Economic Risk Assessment Model. 2.1.3.4 Concerns (Hazards) In general, concerns associated with a deficiency, can be classified as:

hygiene violations safety risks economic risks

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The above concerns fall into four broad types of hazards: biological, chemical, physical, and regulatory. Biological Biological hazards refer to pathogenic microorganisms that could contaminate wine or the wine production environment. Due to the acidity and alcohol content of wine, there is very little likelihood of any biological hazards of even low severity in wine. Chemical Chemical hazards refer to chemical compounds used or found in the winery that could contaminate the wine or the wine production environment. Chemical hazards can be assessed as category I, category II or category III depending on the severity of consequences (nature of the hazard) and likelihood of occurrence (quantity). Chemical hazards could be residues of pesticides or heavy metals in incoming raw product, contamination by cleaning chemicals, insecticides, rodenticides used or stored in or around the winery, adulteration by known allergens or non permitted additives or processing aids used in the winery. These chemical hazards could range from a concern of critical safety consequence that could cause discomfort, pain or illness to a consumer to a concern of fairly low health consequence like the misuse of a permitted additive, depending on the quantity, nature and the type of deficiency found. Physical Physical hazards refer to objectionable foreign materials used or found in the winery that could contaminate the wine or a wine production environment. Physical hazards can be assessed a category I, category II or category III, depending on the likelihood of occurrence and severity of consequences of the contamination situation. Physical hazards could be small sharp fragments of glass, metal, plastic or wood that could come from packaging materials, winery equipment or premises or utensils used in the winery as well as filth caused by poor hygienic conditions. These physical hazards could range from a concern of critical safety consequence that could cause discomfort or pain to a consumer to a concern of fairly low consequence like unclean walls in a winery, depending on the nature, quantity and type of deficiency found. Regulatory Regulatory violations include all of the economic risk deficiencies related to misrepresenting the wine by the label as well as other deficiencies that contravene regulations not associated with any contamination hazards of hygiene or safety risk. Regulatory violations can be assessed a category I, category II or category III, depending on the likelihood of occurrence and the severity of consequences of the situation. Regulatory violations can be misuse of registered wine trademarks, inaccuracies of wine label declarations (such as, geographical indication, vintage year, technical terms, alcohol content, net quantity, etc.), as well as absence of required hygiene practices, records,

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documents and label declarations. These regulatory violations could range from a concern of serious economic consequence that could jeopardize the integrity of the Canadian appellation system to a concern of fairly low consequence like the absence of a specific hygiene practice depending on the nature, quantity and type of violation found. 2.1.3.5 Override Provision During an inspection, some conditions or combinations of conditions may be found to increase or decrease the likelihood of occurrence of a hazard as defined within the rating examples. In such cases, the inspector may choose to override the prescribed assigned rating. Overrides, when used, must be clearly identified in the inspection worksheet together with a written justification for the change. 2.2 Preparation for an Establishment Inspection and Audit The importance of proper and adequate preparation can not be overemphasized. As with almost any task or project, good preparation will not only make the job easier and the inspector more confident but it will ensure better results. 2.2.1 Frequencies Each federally registered establishment, producing wine should be subject to an in-depth establishment inspection and product audit at least once a year. Note: Frequencies and establishment size categories to be discussed 2.2.2 Notification of the Establishment Under normal circumstances the inspector should not notify the establishment's management of the in-depth inspection's date. If production is irregular the inspector may wish to verify that the establishment is operating. Note: Inspections will likely have to take place during crush and bottling periods to cover operations – this will be a problem if wineries have to deal with inspectors every year at crush. We’ll have to find a way to stagger these to manage both inspector and winery schedules so they are not at the same period for everyone. Inspectors must carry out their in-depth establishment inspections while the winery is operating. In-depth inspections can be carried out when the winery is crushing grapes, bottling wine or doing major cleaning and sanitizing. It will be the decision of the local inspector as to what time of the year or what operations are to be inspected in any particular registered establishment. Inspectors should contact the establishment operator some time before the inspection to find out what operations will be carried out around the time of the intended visit. If the in-depth inspection is to be done during the crush season the date should be indicated to the operator and every effort will be made by the inspector not to slow down operations at this time.

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2.2.3 Who Inspects 2.2.3.1 Inspector/Auditor Depending on the complexity of the manufacturing processes, the size of the establishment and the time frame in which the establishment inspection and the product audit are conducted, one or more inspectors/auditors will be required. Establishment inspections and product audits may be carried out by different individuals or by multiple personnel. 2.2.3.2 Establishment Representative It is helpful if an establishment representative accompanies the establishment inspection team. The presence of an establishment representative should be encouraged, if not expected (see section 2.3.2.2 for more details). 2.2.3.3 Other Government Agencies Other government agencies or authorities may be involved in the inspection. 2.2.4 Documentation Review Once the registered establishment to be inspected has been determined, the inspectors should then review the following documentation before leaving the office: 2.2.4.1 A Establishment’s File – Inspection • Identify establishment manager and key personnel by name. • Review previous in-depth inspection reports, action plans and follow-up actions. • Review directed inspection summaries, consumer complaints. • Have an understanding of the size and age of the establishment as well as products

packed or processed. • If available, consult the establishment’s flow diagram showing the general movement

of raw, in process, and finished product within the establishment. • Take note of any unique features of establishment (e.g. equipment, processing

schedules, size, product lines). • If possible, decide where the inspection will begin, identify when a major clean up

will be observed and find out when a second shift (if applicable) can be observed. 2.2.4.1 B Establishment’s File - Audit • Identify establishment manager and key personnel by name. • Review previous audit reports, approvals in force, suspensions or revocations,

previous or pending compliance actions. • Have an understanding of the production and sales of the establishment.

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2.2.4.2 Regulations and Manuals • Wine Regulations • Wine inspection Manual and appropriate cheklists. • Establishment Inspection Manual and the applicable process to be inspected. 2.2.4.3 Other Documentation in CFIA Files • Reference Listing of Accepted Construction Materials, Packaging Materials and Non-

Food Chemical Products • Any available information on file in the CFIA office on any unique equipment being

employed by utilized in the establishment. 2.2.5 Inspection Equipment Each inspector must have the following equipment and use or wear them in the appropriate situations: (a) Identification

• inspector's identification card or business cards

(b) Clothing

• white, clean lab coat with snap or velcro fasteners with no pockets above the waist (or equivalent)

• hair covering for areas where wine is in open containers • head, ear and eye protection (as appropriate when equipment is in operation) • clean clothes and non-slip footwear

(c) Equipment

• Case • a flashlight in good working order • a light meter • an accurate thermometer with steel shaft • an electronic calculator

(d) Forms and References

• inspection checklist and/or audit worksheet (as appropriate) • detention and release forms • an appropriate writing tool (clip board) that could help write on the work

sheets and reports • a copy of the regulations

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• a copy of the inspection manual 2.2.6 Safe Work Practices All inspection staff must be aware of the hazards in the environment in which they will be working. Unsafe conditions and situations must be corrected immediately or the inspector should work with establishment management to reduce or eliminate the safety risk before the inspection or sampling is started. Following safe work practices combined with on the job training will help reduce the chance of an injury happening to an inspector. a) Manual Material Handling Have a client representative assigned to assist you at all times while selecting samples as per Section 21 (3) of the Canada Agricultural Products Act. Use proper lifting techniques when loading and unloading samples:

• size up the load before lifting • ensure that the travel way is clear of obstructions • keep feet at least a foot apart to provide a stable base • with a straight back, bend the knees to lift load • keep load as close to your body as possible • turn by pivoting at the feet, not by twisting at the waist

Guidelines for manual material handling (Canadian Centre for Occupational Health and Safety - Office Ergonomics):

• plan your lift • reduce the size of the load • reduce the distance a load is carried • make multiple trips with smaller load sizes • assign more people to lift extra heavy loads • use more than one person or a mechanical device to move the load

When conducting an inspection at a workstation, ensure that table height is adequate to perform the inspection, lighting is at least 540 lux and a chair is made available. b) Moving Vehicles Be aware of all moving vehicles (tow motors, forklifts, trucks etc.) while traveling around and within the clients workplace. Use designated walkways when possible. Do not assume that the pedestrian has the right of way, try to remain visible to any vehicle operators. Be aware of the dangers associated with exhaust fumes from vehicles. c) Personal Protective Equipment

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Ensure you wear and are trained in the use, care and maintenance of the personal protective equipment as per your scales of entitlement. Often, personal protective equipment requirements and safety measures are recommended and are listed on products or substances encountered in the workplace. The Workplace Hazardous Material Information System (WHMIS) is a nationwide system intended to provide information on hazardous materials used in the workplace. There are three key elements to WHMIS: labels, material safety data sheets (MSDS) and worker education. The WHMIS label and, in its absence, the product label are sources of information on the relative toxicity (flammability, corrosivity, etc.) of a substance , the first-aid measures that should be taken if and when exposure does occur, recommended personal protective equipment that should be worn and a statement to refer to the MSDS. A system of symbols and risk phrases indicates the toxicity of the substance. The MSDS site has more specific information about the product or substance and should be consulted if it is available at the site. Personal protective equipment may include but is not limited to:

• coveralls/ lab coat/ hair net • CSA approved safety hat (white) • CSA approved non-slip footwear • CSA approved eye protection • CSA approved hearing protection • nuisance dust mask

d) Slip and Fall Prevention Reduce the risk of slip, trip and fall accidents by:

• wearing CSA approved protective footwear • keeping footwear tread in good condition- replace at 30% wear • practicing good housekeeping • keeping work area and walkways free from debris • following safe work practices

e) Establishment Premises Hazards During plant inspection or product sampling, be aware of environmental conditions and any structural concerns (e.g., unprotected holes, overhead beams). Inform Warehouse Manager/ Supervisor on duty of any hazards found during inspection. f) Climbing Inspectors must not climb any skids, equipment or materials. Inspectors must not stand on any platform being hoisted by a lift truck or on the lift trucks forks. Ask the company for assistance to obtain samples or items beyond the reach of the inspector. g) Emergency Procedures

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Inspectors must be familiar with the emergency procedures of the establishment they are working in and the following:

• know the emergency plan of the worksite you are in • if such a plan does not exist, you must ensure you have your own plan of

escape if an emergency occurs • you must be aware of the emergency exits in your immediate work area, these

exits must remain unlocked and unobstructed. • refer to appropriate Material Safety Data Sheets when dealing with chemical

hazards h) Right to Refuse Inspectors always have the right to refuse to perform an inspection for occupational safety and health reasons. If you have doubts about your safety, or a co-worker’s safety, notify your supervisor and identify the safety issue. The safety issue will be addressed and resolved before you begin work. 2.2.7 Professionalism A tidy, neatly-dressed, properly-equipped image exemplifies the professionalism expected from the Agency. Cleanliness and tidiness is practising what we are preaching about sanitation. The inspector is an official representative of the agency and must exhibit a professional image when dealing with establishment officials. This includes respect for establishment policies and good interpersonal skills. All information discussed and obtained from a specific company must remain confidential. However, this does not preclude inspection reports being made available under the provisions of the Access to Information Act. 2.3 Pre Inspection 2.3.1 Establishment File Review The inspection team should review the establishment file. A customized establishment worksheet should first be created for the inspection (for information on how to select a specific establishment and on the creation of process specific worksheets, refer to the MCAP user manual). The preprinted inspection worksheet will serve as the main reference during the actual inspection. 2.3.2 Inspection Planning 2.3.2.1 Arrival at Establishment and Introductions The inspection team should park in an appropriate area and ensure that their clothing (see Section 2.2.5b) and behaviour is appropriate.

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To demonstrate courtesy and professionalism, the inspection team head should: • Ask for the establishment manager or person in charge • Present his/her identification card or business card and introduce the team

members • Explain what the team will do and agree on an inspection time frame. • Inform management that the results will be discussed once the inspection has

been completed and arrange for a tentative time to meet and discuss the results. • Invite an establishment representative to accompany the inspection team. • Ask for any special protective equipment requirements and safety measures

specific for that particular plant 2.3.2.2 Establishment Representative Some establishment managers will insist on accompanying the inspection team or have a foreman or quality assurance person with the inspection team at all times. This situation is preferable to being left on one's own because questions can be asked on the spot and serious infractions can be pointed out as observed; this way immediate action can be undertaken. Some help is also needed to assist in record and program reviews. Some guidance may be needed if the facility is a new establishment. As well, establishment personnel are encouraged to carry out their own in-depth inspections with the inspection team and independently as required by their establishment. Inspectors must be careful not to allow accompanying plant personnel rush the inspection or lead them away from infractions. 2.3.2.3 Scheduling The inspection team must determine what the establishment working schedule will be during the course of inspection (i.e., shiftwork, hours of work, etc.). To facilitate the best order of inspection, the inspection team and establishment management should formulate an inspection schedule. All effort must be made to assess the items in an operational condition. 2.3.2.4 Order The in-depth inspection should usually:

a) begin with the most critical steps where control must be applied and areas of major problems revealed during the last inspection(s)

b) finish with the less critical areas, and the retail store if applicable. 2.3.3 General Inspection Considerations A basic set of rules is essential for carrying out an inspection at a food processing establishment. When these rules are followed, a meaningful inspection report will result, accurately reflecting conditions of the establishment.

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a) When there is more than one inspector, all team members are to write up their own

worksheet and ratings. b) Where an establishment representative is present during an inspection, infractions

are pointed out to the representative as the inspection is conducted through the establishment. These infractions are documented and assessed even if they are taken care of immediately, however, it is also noted that the infraction has been corrected.

c) Ask establishment management questions rather than the workers. An exception

may be when you might want to determine if a worker understands what he/she is doing or what procedures he/she has been directed to follow during regular production or when there is a problem or deviation.

d) Set a good example to workers (e.g., when a wash basin is present in the inspection

area, wash your hands).

e) The inspection team must observe the general cleanliness of the equipment/facility before start-up and if necessary, observe a major clean-up before start-up (pre-operation) or after shut-down (post-operation).

f) If more than one shift is operating, try to observe the change over conditions

between shifts. Monitor the change over routine between as many shifts as possible.

g) In the storage, mixing and blending areas, take note of all ingredients, additives,

and processing aids, so that they can be verified with the Wine Regulations and the Food and Drug Regulations.

h) In the labelling area(s), obtain a sample label of the product currently being

processed and packed. Review the required approval for the product and the label declarations for accuracy and completeness while in the establishment. Attach the label to a worksheet so it can be reviewed more closely back at the office.

i) When in the boiler room make a note of the boiler additives being used, especially

if live steam is being used on any product in the establishment.

j) While in the establishment, locate the area where cleaning chemicals are stored. Make note of the cleaning compounds so they can be reviewed against the establishment sanitation program and also against the CFIA’s Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical (accessible via CFIA Internet site). These chemicals should be stored centrally, away from the main traffic stream and away in a different place than from raw materials ingredients and packaging materials. Other poisonous chemicals such as pesticides must be stored in a separate area (another building preferably with

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restricted access) away from all cleaning chemicals, ingredients, additives and processing aids food products. This is to avoid potential cross contamination of chemicals and worker confusion resulting in contamination of the wine.

k) During or after an in-depth or directed inspection, product samples may be

obtained. Always notify establishment management of exactly what samples are required and the purpose of sampling. Draw the samples randomly, and according to the sampling plans. Wherever possible, the types of checks or analysis carried out on those samples should be a reflection of the infractions observed in the establishment.

l) Review and record grape tickets, all inventory, new stock, transfers and sales to

confirm compliance with origin, content and quality requirements of the Wine Regulations.

m) If the establishment operates a retail store, record all products available for sale,

including all trade mark terminology being used. Confirm that these terms are used under an approval certificate as part of the follow up to the inspection.

2.4 In-depth Establishment Inspection The inspector should inspect the facility in the order previously agreed upon with the establishment management. The inspector should evaluate all applicable generic inspection standards as per chapter four and specific manufacturing controls inspection criteria as per chapter five. The inspection team should note infractions as they are found. All category I and II infractions must be immediately brought to the attention of the establishment management and a corrective action plan should be implemented. Records are verified and rated within the appropriate section of Chapter 4 or 5. 2.5 Post Inspection 2.5.1 Inspector Review All infractions/deviations found during the establishment inspection that require corrective action should be identified in writing. The inspector should review each deficiency and assign an overall task rating per assessed inspection task (principle statement). It is important that establishment management understand the inspection findings and the reason why certain items are unsatisfactory and require correction or improvement. 2.5.2 Reporting Inspection Results The establishment reporting system consists of an Inspection Worksheet, a database, and a Non-Compliance Report

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The inspection results are inputted onto a wine inspection checklist in which the rating for each inspection task (principle statement) is recorded along with a description of the deficiencies found during the on site inspection. The Non-Compliance Report summarizes the infractions into categories I, II, and III. Further information may be added to a report as warranted by verification of the status of a wine upon return to the office. 2.5.3 Exit Meeting with Management After the establishment inspection, the inspection team must meet with the appropriate member(s) of the establishment management team to review the inspection, highlight the unsatisfactory conditions and to discuss and decide on a time period or a date for the correction of unsatisfactory conditions. The time and location should be carefully considered when discussing inspection reports with the plant management. Ample time should be made available to discuss unsatisfactory conditions with the plant management. A quiet area, preferably within the plant, would be an acceptable environment to discuss the inspection results. At the meeting with management, the inspector should explain the purpose of the inspection, making it as positive as possible, giving the establishment a third party view of the status of the establishment and its operations from a regulatory perspective. The session should begin with general remarks pointing out any positive comments that are appropriate, then, explain that the report contains only the infractions noted during the inspection. Where applicable, also explain that further investigation may be done at the wine authority office (e.g. confirming the status of a product) and an addendum to the report issued. Anything that is observed to be satisfactory, good and in compliance is not mentioned on the report. Next, proceed through the report mentioning category I and II infractions. Finally, describe the follow-up action expected (i.e., action plan). Corrective action should always include planning with front-line management so that the problem will not recur. Urgency of corrective actions must always be measured by the degree of existing hazard related to health and safety issues or, in the case of label infractions, to the degree that the label is fraudulent or misleading to the consumer. An action plan identifying all infractions with acceptable corrective actions is required from establishment management. Each infraction should be clearly identified with a definite correction date. This action plan is to be reviewed with and signed by a responsible party from management who shall retain a copy of this document. The manuals, regulations and guidelines identify some sanitation requirements and indicate some responsibilities, but many times a specific problem and how to react to that problem is not specified. It is therefore necessary to employ good judgment and common

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sense relevant to health and safety and consumer/industry protection implications of observations noted in a particular establishment. Everything possible should be done to reach agreement on the violations noted by the inspector and the proposed corrective action plan during the exit meeting. This is the reason for encouraging a winery representative to accompany the inspector during the establishment inspection. However, winery establishment management has the right to appeal any violation or any corrective action deadline suggested by the inspector. Notation of such appeal will be made on the inspection report and/or corrective action plan. All appeals on critical infractions or corrective action deadlines must be immediately brought to the attention of the inspector’s supervisor or to the attention of the CFIA National Wine Desk Officer. Appeals on serious (major) or continuous minor violations of the Regulations must be dealt with by the inspector’s supervisor or ultimately with the CFIA National Wine Desk Officer within a time appropriate with the seriousness of the violation. It is the inspector’s responsibility to see that the appeals are handled expeditiously. 2.5.4 Final Report and Covering letter If not presented during the exit meeting, the registered establishment must forward a printed copy of the Non-Compliance Report. A signed copy should be kept in the Wine Authority’s file. The report must be accompanied by a covering letter (see example letter #1) requesting a written action plan by a certain date (See Section 2.7.1). 2.5.4.1 Written Action Plan The written action plan submitted by the company must address all infractions reported in the Non-Compliance Report according to a reasonable time frame. An incomplete action plan is not acceptable and should be returned to the company for correction. If the action plan is not submitted within an appropriate time frame, the inspector should contact the company as a reminder and follow up with enforcement action. Further action should be taken if the establishment management is uncooperative (see Chapter 3). 2.6 Directed Establishment Inspection Prior to the arrival at the establishment, the inspector should review the establishment file to determine the outstanding tasks. A Directed Inspection is a partial inspection of an establishment and should be conducted to review deficiencies noted during previous in-depth inspections. The priority is to review the corrective actions taken for category I and II infractions, according to the action plan. Product inspection as outlined in work plan requirements can also be conducted as a component of a Directed Inspection. A Directed Inspection draws selectively from Chapters 4 and 5 and must focus on:

• Serious establishment infractions noted during the previous in-depth inspection

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• one element (random or chosen) related to a manufacturing control (Chapter 5), such as product origin, content and quality verification,

A specific checklist or worksheet should be created for the Directed Inspection. The preprinted inspection checklist will serve as the main reference during the actual inspection. The inspection team should observe and record infractions as they are found and/or obtain product samples as required. Infractions of a serious nature must be immediately brought to the attention of the establishment management and corrective action should be implemented.

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COVERING LETTER - EXAMPLE Provincial Wine Authority Address of Office Date Mr. Grape Wine Manager Vineyard Ltd. 123 Anywhere Street Somewhere, Canada Subject: Establishment Inspection Results Mr. Wine: Please find enclosed the Establishment Inspection Report, generated from your in-depth inspection of date . The Wine Establishment Inspection Manual was used to assess your establishment during this inspection. During the exit interview all deficient items were discussed with you and your staff. Attached to the report is a follow-up checklist/worksheet which may be used to indicate corrective dates for those items found not satisfactory. Please forward your written and signed action plan to this office no later than date (not more than one month after the date of the inspection) . We would like to thank you and your staff for the cooperation shown to us during this inspection. Please do not hesitate to contact me if you have any questions. Yours truly, Wine Establishment Inspector cc: Area Program Officer/Specialist or others as appropriate

CHAPTER 3 - ENFORCEMENT & COMPLIANCE ACTIONS 3.0 Scope…………………………………………………………………………..1 3.1 Authorities……………………………………………………………………..1 3.2 Responsibility for Enforcement Actions………………………………………1 3.3 General Enforcement and Compliance Principles……………………………..2 3.4 Inspection Powers and Authorities…………………………………………….2

3.4.1 Canada Agricultural Products Act…………………………………...2 3.4.2 Food and Drugs Act………………………………………………….3 3.4.3 Consumer Packaging and Labelling Act……………………………..4 3.4.4 Indirect Powers……………………………………………………….5 3.4.5 Direct Powers………………………………………………………...5

3.5 Responses to Non-Compliance………………………………………………...5

3.5.1 Warning……………………………………………………………...6 3.5.2 Prosecution Action…………………………………………………...6 3.5.3 Product Detention……………………………………………………7 3.5.4 Forfeiture…………………………………………………………….7 3.5.5 Suspension or revocation of product approval………………………8

3.6 Suspension or Cancellation of Registration……………………………………9

3.6.1 Establishment Closure………………………………………………9 3.6.2 Non Operating Status………………………………………………..9 3.6.3 Critical Problems of Public Health Significance……………………9 3.6.4 Serious or Continuous Violations to the Regulations during Establishment Inspection…………………………………………………………………..10

3.7 Suspension of Registration……………………………………………………10

3.7.1 Regulatory Authority………………………………………………...10 3.7.2 Steps for Suspension of Registration………………………………...11

3.8 Cancellation of Registration…………………………………………………..12

3.8.1 Regulatory Authority………………………………………………..12 3.8.2 Step for Cancellation………………………………………………...12

EXAMPLE OF LETTERS

• Notice of Suspension of Registration…………………………………...14 • Covering Letter………………………………………………………….15 • Hearing Convocation Letter……………………………………………..17 • Hearing Confirmation Letter…………………………………………….19 • Hearing Follow-up Letter………………………………………………..20 • Notice of Cancellation of Registration…………………………………..21

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3.0 Scope This Compliance and Enforcement Strategy provides a framework that outlines the principles and actions that will be followed by inspectors designated by the Canadian Food Inspection Agency (CFIA) in verifying that registered establishments operate in compliance with the Wine Regulations (WR) under the Canada Agricultural Products Act (CAP Act), and other applicable legislation. This program specific strategy is consistent with the CFIA’s revised Enforcement and Compliance Policy developed and maintained by the Enforcement and Investigation Services (EIS) Division. The CFIA Enforcement and Compliance Policy provides the overarching policy for enforcement and compliance activities across all commodity programs. The CFIA’s Enforcement and Compliance Policy may be reviewed on the CFIA intranet site (http://cfia acia.intranet.agr.ca/english/policy_proc/operations/enforcement/enforcement_policy.html). Compliance is normally achieved through a co-operative approach between the regulated party and CFIA inspectors or those designated by CFIA in correcting non-conformities through the development of appropriate Corrective Action Plans or other methods. However, when this co-operative approach has ceased, or when the regulated party is incapable of correcting non-conformities, this Compliance and Enforcement Strategy provides CFIA inspectors or those designated by CFIA with enforcement options that are to be used in responding to infractions of the Wine Regulations (WR) under the Canada Agricultural Products Act (CAP Act), and other relevant applicable legislation. This policy also defines discretionary parameters for inspectors and establishes principles for fair and consistent enforcement. 3.1 Authorities Canada Agricultural Products Act, R.S., c.20 Wine Regulations, Food and Drug Act, R.S., c. F-27 Food and Drug Regulations, C.R.C., c. 870 Consumer Packaging and Labelling Act, R.S., c. 38 Consumer Packaging and Labelling Regulations, C.R.C., c. 417 3.2 Responsibility for enforcement actions The CFIA-designated inspectors and the provincial Wine Authority are accountable for enforcement actions taken in their respective Areas including refusal, suspension and revocation of certificates of registration. They are also responsible for the approval of all recommendations to prosecute. The CFIA National Wine Desk Officer (NWDO) must also be consulted and informed when significant enforcement actions are being considered. Inspectors may recommend prosecution under the CAP Act to the CFIA NWDO when other enforcement actions have failed to achieve compliance.

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3.3 General enforcement and compliance principles Compliance will be encouraged with the WR under the CAP Act, other applicable legislation through consultation, education and enforcement. These activities are based on the following guiding principles: Canada’s grape wines must comply with applicable legislation;

a) application and enforcement of the WR under the CAP Act, and other applicable legislation are to be carried out in a fair, consistent and uniform manner in accordance with this strategy and the provincial wine authority’s Enforcement and Compliance Policies;

b) CFIA-designated inspectors, who are fully conversant with the WR under the CAP

Act, and other applicable legislation, will conduct inspections, audits, compliance and enforcement and other regulatory activities;

c) Inspectors will consider the facts and circumstances of non-compliance incidents

with objectivity and take appropriate corrective action;

d) Inspectors will take an active role in promoting and monitoring compliance and responding to non-compliance;

e) Education measures used to promote compliance will include the publication of

information and consultation with regulated parties. Inspectors administering and enforcing legislation and the regulated parties who must comply with the legislation, need to understand why legislation exists, why compliance is necessary, and how enforcement will be carried out; and

f) Inspectors will be available to explain the requirements of the legislation and

maintain open lines of communication to regulated parties. 3.4 Inspection powers and authorities The following identifies the appropriate legal authorities that are available to inspectors designated under the Canada Agricultural Products Act, the Food and Drugs Act, the Consumer Packaging and Labelling Act and their regulations. 3.4.1 Canada Agricultural Products Act Inspectors may:

a) enter and inspect any place in which the inspector believes on reasonable grounds there is any agricultural product or other thing in respect of which this Act or the regulations apply;

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b) stop any vehicle in which the inspector believes on reasonable grounds there is any agricultural product or other thing in respect of which this Act or the regulations apply;

c) open any container that the inspector believes on reasonable grounds contains an

agricultural product;

d) inspect any agricultural product or other thing and take samples of it free of charge;

e) require any person to produce for inspection or copying, in whole or in part, any record or other document that the inspector believes on reasonable grounds contains any information relevant to the administration of this Act or the regulations; and

f) seize and detain any agricultural product or other thing which the inspector believes

on reasonable grounds is in contravention of the Act or regulations. In exercising the above authorities, inspectors may:

a) use or cause to be used any data processing system at the place to examine any data contained in or available to the data processing system;

b) reproduce any record or cause it to be reproduced from the data in the form of a

printout or other intelligible output and take the printout or other output for examination or copying; and

c) use or cause to be used any copying equipment at the place to make copies of any

record or other document. 3.4.2 Food and Drugs Act Inspectors may:

a) enter any place where the inspector believes on reasonable grounds any food is manufactured, prepared, preserved, packaged or stored;

b) examine any food and take samples thereof, and examine anything that the

inspector believes on reasonable grounds is used or capable of being used for that manufacture, preparation, preservation, packaging or storing;

c) enter any conveyance that the inspector believes on reasonable grounds is used to

carry any food and examine any food found therein and take samples thereof;

d) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any food;

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e) examine and make copies of, or extracts from, any books, documents or other records found in any place referred to in this subsection that the inspector believes on reasonable grounds contain any information relevant to the enforcement of this Act with respect to food; and

f) seize and detain for such time as may be necessary any food by means of or in

relation to which the inspector believes on reasonable grounds any provision of this Act or the regulations has been contravened.

In exercising the above authorities, inspectors may also take photographs of::

a) any food; b) any place where, on reasonable grounds, the inspector believes any food is

manufactured, prepared, preserved, packaged or stored; and

c) anything that, on reasonable grounds, the inspector believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any food.

3.4.3 Consumer Packaging and Labelling Act Inspectors may:

a) enter any premises of a dealer or any other place in which the inspector believes on reasonable grounds there is any prepackaged product that is owned by a dealer;

b) examine any prepackaged product found therein;

c) open and examine any package found therein that he believes on reasonable

grounds contains any prepackaged product;

d) examine any documents or papers, including books, reports, records, shipping bills and bills of lading, or any data entered or recorded by any system of mechanical or electronic data processing or by any other information storage device, that he believes on reasonable grounds contain any information relevant to the enforcement of this Act and make copies thereof or extracts therefrom;

e) at the request of the person from whom a product or other thing was seized, allow

that person or any person authorized by that person to examine the product or other thing so seized and, where practicable, furnish a sample thereof to such person; and

f) seize and detain any product or any labelling, packaging or advertising material by

means of or in relation to which the inspector believes on reasonable grounds the contravention was committed.

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When exercising their powers and authorities, inspectors may be requested to produce their certificates of designation and shall produce them upon request. Inspectors may not enter a dwelling place to conduct an inspection unless a search warrant has been issued or where legislative authority allows them to enter without a warrant under exigent circumstances. Use of the authority to enter under exigent circumstances will only be exercised where there is an immediate threat to the health and safety of the public or environment, or a serious threat or risk of disease to humans, establishments or animals. 3.4.4 Indirect Powers All reasonable assistance will be provided to an inspector, or any person acting under the authority of the inspector, by the owner or person in charge of a place, including a conveyance, and every person found in the place that is entered by an inspector. In addition, they will also provide the inspector with any information relevant to the administration of any of the CFIA’s Acts. 3.4.5 Direct Powers During the course of an inspection, inspectors have the power and authority to respond to non compliance. They may:

• recommend license or registration withdrawal; • restrict or prohibit the movement or sale of products regulated by the CFIA; • seize and detain products or other things; • order the disposal of products (to be exercised only in severe circumstances or

upon receipt of a court order). • require the relabelling or correction to a label of any product

3.5 Responses to non-compliance Where inspectors have reasonable grounds to believe there has been a contravention of theWR under the CAP Act, or other applicable legislation, they will conduct inspections to determine the facts of the alleged infraction(s). Inspectors may seek the advice, guidance and assistance of the CFIA NWDO, who can in turn access CFIA Enforcement and Investigation Services, particularly in instances involving circumstances of a complex nature that require specialized investigational expertise. If there is sufficient evidence to proceed with enforcement action, the inspector should gather and preserve evidence. Once non-compliance has been verified, the inspector will complete a non-compliance report and submit it to the provincial wine authority and the NWDO. Instances of non-compliance will be evaluated by the provincial wine authority prior to proceeding with enforcement action. The following factors, along with other applicable information, will be considered when deciding upon the most appropriate action:

a) the offender’s history of compliance with the legislation;

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b) a willingness to achieve compliance; c) evidence of corrective action taken; d) the intent of the non-compliant party (alleged violator); and e) the seriousness of harm or potential harm (heath and economic) that the non-

compliant products could inflict on the consumer. 3.5.1 Letters on violations 3.5.1.1 Letters of warning A written warning letter may be used in instances where the non-compliance is unintentional, easily corrected, the accused winery demonstrates due diligence and the individual or company has made reasonable efforts to remedy or mitigate the consequences of the contravention violation, and compliance has been achieved 3.5.1.2 Letters of revocation of certification The WR provides for an evaluation and certification of wines that apply to use trade marks regulated for use by wines meeting the standard for VQA and Regional wines. Wines may not be labelled with these terms names unless they have successfully completed the evaluation process and received written confirmation from the provincial wine authority that the wine is certified under the appropriate regulation. An inspector has the authority to revoke certification issued in relation to a given wine. A product certification revocation letter may be issued when sufficient evidence has been gathered to determine that a violation has occurred. When a letter of revocation of certification is received by a winery, the wine lot in violation must be removed from the winery stores as well as all liquor board controlled stores. There would be no consumer or export recall unless there were health implications or dire misrepresentation and/or fraud. After the letter is issued an inspector would check retail locations within a few days. The violation would be monitored until corrections were completed. While under revocation, a wine shall not be sold using trade marks for which it has been found not to qualify. Failure to act on a product certification revocation letter could result in prosecution, product detention or forfeiture (see below). The certification is reinstated by letter once the inspector is satisfied that there is no longer a violation. The corrective actions resulting from the letter of revocation of certification would be followed up during the next audit. 3.5.2 Prosecution Action Prosecutions shall be considered for offences under the Acts and regulations enforced by the CFIA except where, in accordance with the enforcement and compliance policy, it has been determined that:

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a) warning under this policy is the most effective means of achieving compliance; or b) license or registration suspension or cancellation is the most effective means of

achieving compliance. Prosecution will always be pursued when the offence involves:

a) death of, or injury to, a person and the evidence indicates that the death or injury was directly attributed to failure to comply with any of the provisions of the Acts or regulations administered and/or enforced by the CFIA or CFIA-designated inspectors;

b) serious harm or risk to the environment; c) risk to the health and safety of humans, animals; d) the prohibited sale of food; e) the unsafe manufacturing of wine; f) economic fraud; g) forging, altering or tampering with an inspection certificate; h) knowingly providing false or misleading information, or making a false or

misleading statement to an inspector; i) obstructing or interfering with an inspector exercising his/her powers or carrying

out his/her duties and functions; j) removing, altering or interfering with any thing seized and detained or the

movement of which is restricted or prohibited; k) producing records, documents or electronic data that knowingly contains false or

misleading information; l) refusal to comply with the directions of an inspector, a detention order or a recall

order; or m) a conviction for a previous similar offence, a repeated offence or a continuing

offence. The Acts administered by the CFIA allow offences to be prosecuted by either summary conviction or as an indictable offence. It is determined by the Crown prosecutor whether to prosecute by way of summary conviction or indictment. 3.5.3 Product Detention An inspector has the authority, under Section 23 of the CAP Act, to seize and detain non-compliant agricultural products. The detention of agricultural products or other things is generally appropriate when a violation is suspected and when:

a) the violation poses a health and safety risk; b) the violation creates unfair competition to other compliant products; or

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c) the person demonstrates an unwillingness to comply by failing to remove the product from the market or failing to take corrective action to bring the product into compliance.

d) the product has been illegally imported into Canada (NOTE: this type of infraction cannot be brought into compliance by means of a corrective action); or

e) the product is labeled with a declaration that is untrue, misleading to the consumer or using terms to which it is not entitled; or

f) the product is not in compliance with the CAP Act and/or WR Detention of the products can be maintained until:

a) the product is brought into compliance; b) court proceedings have been instituted; or c) the statutory time limitation expires (Subsection 27(1), CAP Act allows for 180

days, unless legal proceedings have been initiated). Detention of product is considered one of the most expeditious and effective tools to promote compliance. 3.5.4 Forfeiture Forfeiture can occur in the following instances:

a) when a person consents to forfeiture; or b) when the Court makes such an order.

Forfeited products will be disposed of as provided for by the Court, or as directed by the Minister where provided for in the Acts. This will generally be at the expense of the person from whom the product was seized. The CAP Act allows for the disposal of perishable products, as well as the disposal of a seized product that has been forfeited. 3.5.5 Suspension or revocation of product approval The WR provides for an evaluation and approval of wines that apply to use trade marks regulated for use by wines meeting the standard for VQA and Regional wines. Wines may not be labelled with these terms names unless they have successfully completed the evaluation process and received written confirmation from the provincial wine authority that the wine is approved under the appropriate regulation. An inspector has the authority, under Section xx of the CAP Act, to suspend or revoke an approval issued in relation to a given wine. A product approval suspension may be issued when a violation is suspected and when:

a) the violation poses a health and safety risk;

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b) the violation is misleading to the consumer as to the origin, content, quality or appellation status of the wine;

c) the violation creates unfair competition to other compliant products; or d) the product is not in compliance with the WR under the CAP Act.

Suspension of the product approval can be maintained until:

a) the product is brought into compliance; b) the product approval has been revoked c) court proceedings have been instituted; or d) the statutory time limitation expires (Subsection 27(1), CAP Act allows for 180

days, unless legal proceedings have been initiated). A product approval revocation may be issued when sufficient evidence has been gathered to determine that a violation has occurred and when:

a) The non-compliance is of a nature that is not correctable b) the person continues to demonstrate an unwillingness to comply by failing to

remove the product from the market or failing to take corrective action to bring the product into compliance.

While under suspension or revocation, a wine shall not be sold using trade marks for which it has been found not to qualify. Failure to act on a product approval suspension or revocation will result in product detention or forfeiture. Note: The language to be used around the national quality/appellation trade marks (grades, legends) will have to be discussed and decided upon. 3.6 Suspension or cancellation of registration There are four circumstances where deregistration procedures will be considered:

a) establishment closure, for reasons such as fire, flood but not including labour management disputes;

b) non-operating status (12 consecutive months) or failure to pay fees; c) critical problems of a public health significance; or d) serious or continuous violations to the Act and/or Regulations

3.6.1 Establishment Closure

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Where a registered establishment closes due to a decision of the operators and owners (e.g. bankruptcy), the inspector or the provincial wine authority must be informed as soon as possible. It is the inspector’s responsibility to verify that the registration certificate is removed from the establishment, and the establishment’s management have been informed of what the cancellation of the registration means in a letter acknowledging the cancellation. The name and address of that establishment will then be removed from the central list of registered establishments. The registration number normally will be held (e.g. not reissued) for a period of two (2) years to avoid any possible confusion. 3.6.2 Non Operating Status Where a registered establishment has not operated for a period of twelve consecutive months, the provincial wine authority may suspend or revoke a product approval. The records will be updated to indicate the inactive status of the establishment. The name and address of the establishment will be removed from the central list of registered establishments and the registration number will be held (not reissued) for a period of two (2) years. 3.6.3 Critical Deficiencies of Public Health Significance Where an inspection of a registered establishment determines that the Act and/or Regulations are being violated to the extent that the health of the public is being jeopardized by the finished products being produced, and the operator fails, or is unable, to take immediate corrective actions, steps to suspend the registration will be taken immediately (see Sections 3.7). Cancellation of registration procedures are also initiated (see Section 3.8). 3.6.4 Serious or Continuous Violations to the Regulations During Establishment

Inspection Where an in-depth inspection of a registered establishment results in critical or serious infractions of the regulations which are not corrected immediately, the documented results of the inspection will be utilized to possibly effect the cancellation of their registration or aide in prosecution. Where there are serious or continuous non-compliance issues that are not corrected quickly and cooperatively, the following procedures should be carried out:

a) the provincial wine authority must keep the appropriate CFIA NWDO apprised of any developments;

b) each suspension or cancellation step must be followed and fully documented (see

Section 3.7 or 3.8);

c) the necessary enforcement actions must be taken;

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d) any product affected by the non-compliant conditions in the establishment must not

present a potential health hazard or any product found in the establishment must not seriously misrepresent the origin, content or quality of the product.

3.7 Suspension of Registration 3.7.1 Regulatory Authority The regulation is detailed and self-explanatory. Section 78 of the Wine Regulations states: “(1) The President of the Agency shall suspend the Certificate of Registration of a registered establishment if

a) the establishment does not meet the requirements of the Act or these Regulations; b) the operator does not comply with the provisions of the Act or these Regulations; or

c) it is reasonable to believe that public health will be endangered or the integrity of

the Canadian appellation system will be damaged if the establishment is allowed to continue operating; and

d) the wine producer has failed or is unable to take immediate corrective measures to

remedy any situation referred to in paragraph (a), (b) or (c) or continues to sell products in violation of the Wine Regulations.

(2) No Certificate of Registration shall be suspended unless

a) an inspector has, at the time of an inspection, notified the operator of the existence of grounds for suspension under paragraph (1)(a), (b) or (c);

b) an inspector has provided the operator with a copy of an inspection report

prepared by the inspector that specifies the grounds for suspension, the required corrective measures and the dates by which those measures must be implemented to avoid the suspension or cancellation; and

c) a notice of suspension of the Certificate of Registration is delivered to the operator.

(3) A suspension of a Certificate of Registration shall remain in effect

a) until the required corrective measures have been taken and have been verified by an inspector; or

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b) if a cancellation procedure has begun under section 79, until the resolution of the cancellation issue.”

3.7.2 Steps for Suspension of Registration Registered establishments having critical or serious infractions of the regulations which are not corrected immediately and where the evidence shows that allowing the establishment to continue operating would constitute a public health hazard or would damage the Canadian appellation system, the following procedures must be followed:

a) The NWDO is consulted by the provincial wine authority before the suspension is initiated.

b) The inspector prepares a written report setting out the reasons for the suspension

procedures being initiated. The inspector must ensure that the operator of the establishment receives a copy of the written report.

c) The provincial wine authority initiates the suspension by providing the NWDO

with the details of the file and recommending proceeding with suspension.

d) Any product(s) affected by the non-compliance in the establishment is (are) immediately detained; and any product on the market is evaluated for recall in conjunction with CFIA.

e) A decision is made by the NWDO to proceed or not to proceed with suspension.

f) A Notice of Suspension of Registration (see example letter #1) signed by the

NWDO is delivered to the operator of the establishment. The establishment can no longer ship regulated products outside of the province or apply a national trade mark. Compliant products in the marketplace, e.g. those already shipped to vendors or in retail inventory may continue to be sold.

In all instances of suspended establishments not immediately correcting critical or serious infraction(s), the provincial wine authority will inform the NWDO of the intent to cancel the establishment’s registration. 3.8 Cancellation of Registration 3.8.1 Regulatory Authority Section 79 of the Wine Regulations states: “(1) The President of the Agency shall cancel the Certificate of Registration of a registered establishment if

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a) the operator has not implemented the required corrective measures within the 30-day period after the day on which the registration was suspended or within any longer period permitted under subsection (2);

b) there is a change in ownership that involves a change of management of the

establishment;

c) subject to subsection 71.(4), a trustee, receiver or receiver-manager takes possession or control of the establishment or any portion of it;

d) the application for registration is found to contain false or misleading information;

or (2) If it is not possible for the operator to implement the required corrective measures within the 30 day period, the President of the Agency shall, on the request of the operator, permit the operator a longer period that is adequate to implement those measures. (3) No Certificate of Registration shall be cancelled unless

a) the operator was advised of an opportunity to be heard in respect of the cancellation and was given that opportunity; and

b) a notice of cancellation of registration was delivered to the operator.”

3.8.2 Steps for Cancellation

a) The directed inspection(s) reveal that the company has not brought about improved compliance or no action plan or a non satisfactory action plan is received from the establishment.

b) An in-depth inspection is carried out by the inspector with the NWDO to reassess

the level of compliance and to discuss the appropriateness of the actions and target dates of the corrective action plan if received.

c) If the in-depth inspection results show critical or serious infractions that still have

not been corrected, or, if no written action plan or a non-satisfactory action plan from the first in-depth has been received from the establishment, the inspector will convene a meeting with senior managers of the establishment.

d) At this meeting, outstanding Category I, II and III violations will be identified and a

written commitment will be requested from the establishment’s management within a mutually agreeable time frame. Minutes of the meeting will be recorded and distributed by the inspector with copies to the provincial wine authority and the CFIA NWDO.

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e) When the above steps have been taken and it is obvious that the operators can not or will not correct the infractions, a “Covering Letter” (example letter #2) will be delivered to the establishment indicating that a cancellation is being considered and arrangements will be made for a Hearing prior to cancellation.

f) The establishment’s management is invited in writing to a Hearing (see example

letter #3). If the establishment agrees to a Hearing, it is confirmed in writing (see example letter #4) at a mutually agreed-to location, date and time and they are also informed that they have the right to bring legal representation or technical support. The inspector, a representative of the provincial wine authority, the CFIA NWDO and a CFIA legal advisor, if required.

g) At the end of the hearing, a decision will be made to proceed with cancellation of

the registration or to carry out another in-depth inspection (see example letter #5).

h) If the cancellation option is chosen, a Notice of Cancellation of Certificate of Registration (see example #6) will be signed by the CFIA NWDO and delivered to the establishment.

i) If the in-depth inspection option is chosen and it is found during the inspection that

the operator has taken corrective measures to bring the plant into compliance, a letter notifying the establishment of the decision not to cancel the registration will be sent by the CFIA NWDO.

j) If a cancellation occurs all provincial wine authorities will be notified by copy of

the Notice of Cancellation of Registration. If the inspector has reason to believe that wine from the establishment whose registration has been cancelled is being marketed outside the province or is using a national trade mark, the appropriate provincial wine authority and the NWDO should be contacted.

15

EXAMPLE LETTER #1 Address [DATE]

2820-1- Reg. #

Adresse [DATE]

2820-1- Enr. no

Name and Address of establishment

Nom et adresse de l’établissement

SUBJECT: NOTICE OF SUSPENSION OF REGISTRATION

OBJET : AVIS DE SUSPENSION DE L’ENREGISTREMENT

Registered under the Canada Agricultural Products Act

Établissement enregistré en vertu de la Loi sur les produits agricoles du Canada

This is to advise you that, in accordance with subsection 78(1) of the Wine Regulations, the registration for the above establishment is suspended, effective _____________________.

Vous êtes avisé que, conformément au paragraphe 78(1)) du Règlement sur les vins, l’enregistrement de l’établissement nommé ci-dessus est suspendu à compter du ________________.

The Certificate of Registration issued pursuant to subsection 70(1) of the said Regulations is to be surrendered to an inspector upon receipt of this notice.

Le certificat d’enregistrement délivré conformément au paragraphe 70(1) du même Règlement doit être remis à un inspecteur dès réception du présent avis.

Agent

CFIA National Wine Desk Officer

16

EXAMPLE LETTER #2 COVERING LETTER AFTER SECOND IN-DEPTH (SERIOUS VIOLATIONS)

[DATE] Double Guaranteed Delivery

Vineyard Ltd. 123 Anywhere Street Somewhere, Canada Attn: Mr. John Smith

Establishment Manager Subject: Establishment Inspection Results - Follow-up Inspection Mr. Smith: The following is a summary of the results of two recent inspections performed on your establishment. On [DATE] an inspection was carried out. Several serious infractions were identified at that time and discussed with you following the inspection. A letter, dated [DATE], was sent to you confirming these unsatisfactory conditions and you were requested to provide a written plan of corrective action. To date, your corrective action plan has not been received. On [DATE] a follow-up inspection was carried out by the undersigned to review the establishment conditions again and check the progress of your corrective actions. You will find a copy of that inspection report enclosed. While it was noted that some of the serious infractions had been brought into compliance, there still remains several infractions which require immediate attention:

List major violations (serious infractions) in order of priority e.g. Manufacturing Control

Unauthorized and misleading use of regulated terminology Establishment Sanitation

Upon completion of the inspection, we discussed the above infractions, as well as the fact that a written corrective action plan has not yet been received. We request your immediate attention to the correction of the infractions and to providing us with a written corrective action plan outlining these corrections.

17

As you are aware, these infractions contravene sections 72 to77 inclusive of the Wine Regulations, as established under the Canada Agricultural Products Act. Registered establishments must be in compliance with both the Act and the Regulations to maintain their registration, to allow shipment of wine outside the province. If these infractions are not corrected immediately and a corrective action plan is not received within ten (10) business days of your receipt of this letter, a hearing will be convened for the purpose of determining whether to cancel your establishment's registration. If you have any questions on any of the matters covered by this letter, please do not hesitate to contact this office (123-4567). Sincerely, Dave Functionnaire Inspector c.c.: Mr. Ron Roy

President, Vineyard Ltd.

18

EXAMPLE LETTER #3 HEARING CONVOCATION LETTER [DATE] Double Guaranteed Delivery Vineyard Ltd. 123 Anywhere Street Somewhere, Canada Attn: Mr. John Smith

Establishment Manager Subject: Establishment Inspection Results - Hearing Convocation Mr. Smith: Thank you for the corrective action plan submitted [DATE] addressing a number of the infractions pointed out in my letter of [DATE]. Upon review, however, we note that four (4) critical infractions are not mentioned in your plan (see below) and time frames suggested for corrections of five infractions (see below) are not satisfactory.

List of missing infractions List of infractions for which unsatisfactory time frames were received

In view of the above, we feel that it is necessary to convene a hearing to discuss your establishment’s registration. This will provide you and your representatives with an opportunity to indicate what corrective action you have taken to achieve compliance with the Regulations. Subsection 79(3) of the Wine Regulations states: “No Certificate of registration shall be cancelled unless

a) the operator was advised of an opportunity to be heard in respect of the cancellation and was given that opportunity”

If you wish to have a hearing, please contact the undersigned before [DATE], so that a place, date and time may be scheduled. If we do not receive notification by [DATE], it will be assumed that you do not wish to have a hearing, and a recommendation to cancel your registration will be forwarded to the CFIA National Wine Desk Officer.

19

If you have questions about any of the matters covered by this letter, please do not hesitate to contact me (123-4567). Sincerely, Dave Functionnaire Inspector cc.: Mr. Ron Roy

President, Vineyard Ltd.

20

EXAMPLE LETTER #4 HEARING CONFIRMATION LETTER [DATE] Guaranteed Delivery Vineyard Ltd. 123 Anywhere Street Somewhere, Canada Attn: Mr. John Smith

Establishment Manager Subject: Hearing Confirmation Mr. Smith: Thank you for your letter requesting a hearing to discuss the registration of your establishment and the maintenance of your registration under the Wine Regulations. Please be advised that you have the right to bring legal representation and/or technical advisors to this meeting. It has been agreed that the hearing will be held at:

[LOCATION] Room 777, 1234 Main Street Somewhere, Canada

on [DATE], at 13:30 hrs. Sincerely, Dave Functionnaire Inspector

21

EXAMPLE LETTER #5 HEARING FOLLOW-UP LETTER

[DATE] Double Guaranteed Delivery

Vineyard Ltd. 123 Anywhere Street Somewhere, Canada Attn: Mr. John Smith

Establishment Manager Subject: Hearing Follow-up Mr. Smith: This will confirm our discussion on [DATE], of your establishment and the actions you have taken, and will be taking, to bring your establishment into compliance with the Wine Regulations under the Canada Agricultural Products Act. At the hearing you indicated that, to date, corrections have been made to all infractions outlined in the letter of [DATE], except for the following four (4) items:

List outstanding major infractions It is understood that item #1 and #2 will be corrected by [DATE], and #3 and #4 will be corrected before [DATE]. After [DATE], another inspection will be performed at your establishment. If the corrections made in your establishment are satisfactory , your registration will be maintained. If critical or serious infractions still have not been corrected in your establishment, a recommendation to cancel your registration will be sent to CFIA National Wine Desk Officer. Cancellation of registration will result in a loss of privilege to sell your wine outside the province or to use national trade marks on the labels of your wine. Sincerely, Dave Functionnaire Inspector c.c.: Mr. Ron Roy

President, Vineyard Ltd

22

EXAMPLE LETTER #6 Address [DATE]

2820-1- Reg. #

Adresse [DATE]

2820-1- Enr. no

Name and Address of establishment

Nom et adresse de l’établissement

SUBJECT: NOTICE OF CANCELLATION OF REGISTRATION

OBJET : AVIS D’ANNULATION DE L’ENREGISTREMENT

Registered under the Canada Agricultural Products Act Établissement enregistré en vertu de la Loi sur les produits agricoles du Canada This is to advise you that, in accordance with subsection 79(1) of the Wine Regulations, the registration for the above establishment is suspended, effective _____________________.

Vous êtes avisé que, conformément au paragraphe 78(2) du Règlement sur les vins, l’enregistrement de l’établissement nommé ci-dessus est suspendu à compter du ________________.

The Certificate of Registration issued pursuant to subsection 70(1) of the said Regulations is to be surrendered to an inspector upon receipt of this notice.

Le certificat d’enregistrement délivré conformément au paragraphe 70(1) du même Règlement doit être remis à un inspecteur dès réception du présent avis.

Agent CFIA National Wine Desk Officer

CHAPTER 4 – Generic Inspection Standard 4.1 PREMISES Page No 4.1.1 Building Exterior 4.1.1.1 001 Outside Property and Building 1 4.1.2 Building Interior 4.1.2.1 101 Design, Construction and Maintenance 2 4.1.2.2 102 Lighting 4 4.1.2.3 103 Ventilation 5 4.1.2.4 104 Waste Disposal 6 4.1.3 Sanitary Facilities 4.1.3.1 201 Employee Facilities 7 4.1.3.2 202 Equipment Cleaning and Sanitizing Facilities 8 4.1.4 Water/Ice/Steam Quality 4.1.4.1 301 Water 9 4.1.4.2 302 Ice 10 4.1.4.3 303 Steam 11 4.1.4.4 304 Water/Ice/Steam Quality Records 12 4.2 TRANSPORTATION AND STORAGE 4.2.1 Transportation 4.2.1.1 401 Food Carriers 13 4.2.1.2 402 Temperature Controls 14 4.2.2 Storage 4.2.2.1 501 Incoming Materials Storage 15 4.2.2.2 502 Non Food Chemicals - Receiving and Storage 16 4.2.2.3 503 Finished In-Process Product Storage 17 4.2.2.4 504 Finished Product Storage – Frozen 18 4.3 EQUIPMENT 4.3.1 General Equipment 4.3.1.1 601 Design and Installation 19 4.3.1.2 602 Wine Contact Surfaces 20 4.3.1.3 603 Equipment Maintenance Program 21 4.4 PERSONNEL 4.4.1 Training 4.4.1.1 1001 General Food Hygiene Training 22 4.4.1.2 1002 Technical Training 23 4.4.2 Hygiene and Health Requirements 4.4.2.1 1101 Cleanliness and Conduct 24 4.4.2.2 1102 Communicable Diseases/Injuries 25 4.5 SANITATION (AND PEST CONTROL)

4.5.1 Sanitation 4.5.1.1 1201 Written Sanitation Program and Effectiveness

Evaluation 26

4.5.1.2 1202 Equipment Cleanliness 28 4.5.1.3 1203 Premises Cleanliness 29 4.5.1.4 1204 Sanitation Records 30 4.5.2 Pest Control 4.5.2.1 1301 Written Pest Control Program 31 4.5.2.2 1302 Pest Control Records 32 4.6 COMPLAINTS AND RECALLS 4.6.1 Complaint Handling 4.6.1.1 1401 Product Complaints 33 4.6.1.2 1402 Complaint Records 34 4.6.2 Recalls 4.6.2.1 1501 Recall Plan 35 4.6.2.2 1502 Product Code Identification 36 4.6.2.3 1503 Recall Capability 37 4.6.2.4 1504 Distribution Records 38 4.7 RECORDS 4.7.1 General Records 4.7.1.1 1601 General Record Requirements 39 4.7.1.2 1602 General Regulatory Requirements 40

1

4.1 PREMISES 4.1.1 BUILDING EXTERIOR 4.1.1.1 Outside Property and Building 001 Task PRINCIPLE Buildings and surrounding areas are designed, constructed and

maintained in a manner to prevent conditions which may result in the contamination of wine.

Assessment Criteria

Grounds, Roadways and Drainage immediately surrounding winery • The surrounding land is maintained to control sources of

contamination such as debris and pest harbourage areas. • The building is not located in close proximity to any environmental

contaminants. • To prevent dust and minimize insects in the winery, roadways are

properly graded, compacted, dust proofed and drained. • The surrounding property is adequately drained to keep stagnant

water from attracting insects to the building. Exterior Building Structure • The building exterior is designed, constructed and maintained to

prevent entry of contaminants and pests, e.g., no unprotected openings in the building, air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage.

Rating Examples I N/A II exterior of building in poor condition with broken foundation and

evidence of small openings allowing entry of pests pest harbourage evidence in shrubs on both sides of employee entrance

accumulation of stagnant/pooled water resulting in obnoxious odours, close to raw material close to receiving door.

sizeable compost of grape skins, stems within close proximity to the winery left for extended time period (>2 days).

untidy pallet and bin storage along outside wall of building close to receiving entrance.

III inadequate drainage and pooling of water around building - no obnoxious odours

exterior of building in poor condition showing cracks in the foundation but no signs of pest entry

roadways immediately adjacent to the winery not properly graded, compacted, dust proofed or drained

untidy pallet and bin storage along outside walls but not close to any openings in the building.

References

2

4.1 PREMISES 4.1.2 BUILDING INTERIOR 4.1.2.1 Design, Construction and Maintenance 101 Task PRINCIPLE Building interiors and structures are designed, constructed and

maintained in a manner to prevent conditions which may result in the contamination of wine.

Assessment Criteria

Floors, Walls, Ceilings • Floors, walls, and ceilings are constructed of material that is durable,

impervious, smooth, cleanable, and suitable for the production conditions in the area.

• Where appropriate, wall, floor and ceiling joints are sealed to prevent contamination and facilitate cleaning.

• Floors, walls and ceilings are composed of materials that will not result in the contamination of the environment or wine.

• Floors are sufficiently sloped to permit liquids to drain to trapped outlets or floors are squeegeed often enough to prevent stagnant water from pooling in critical areas where wine may be exposed.

• Ceilings, overhead structures, stairs, and elevators are designed, constructed and maintained to prevent contamination.

Windows and Doors • Windows are sealed or equipped with close fitting screens. • Where there is a likelihood of breakage of glass windows that could

result in the contamination of wine with glass and dirt, the windows are constructed of alternative materials or are adequately protected.

• Doors are close fitting and self-closing where appropriate. Openings that are in frequent use are protected by other devices such as vertical plastic strapping or air curtains.

Process Flow Separation • Buildings and facilities are designed to facilitate hygienic operations

by means of a regulated flow in the process from the arrival of the raw material at the premises to the finished product.

Rating Examples I N/A II windows and doors improperly screened and sealed and evidence of

bird roosting and bird droppings observed in the establishment evidence of dirt and mould on unpainted wood wall near filling machine.

flaking paint or rust on overhead structures and wall in areas where product is exposed that may result in contamination

inadequate drainage causing stagnant/pooled water and obnoxious odours in close proximity to bottle filling operation.

III floors not properly sloped, and pooling of water - no obnoxious odours

windows and doors improperly sealed and pest entry possible. raw product spilling off belts onto floor – product flow too heavy.

3

References

4

4.1 PREMISES 4.1.2 BUILDING INTERIOR 4.1.2.2 Lighting 102 Task PRINCIPLE Light is adequate for the activity being conducted. Where appropriate,

light bulbs and fixtures are protected to prevent contamination of wine. Assessment Criteria

• Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and should not be less than the following intensity;

540 lux (50 foot candles) in inspection and bottling areas 220 lux (20 foot candles) in work areas 110 lux (10 foot candles) in other areas

(Inspection areas are defined as any point where the wine or container is visually inspected or instruments are monitored, e.g., empty container evaluation).

• Light bulbs and fixtures located in areas where there is exposed product are of a safety type or are protected to prevent contamination of wine in case of breakage.

Rating Examples I N/A II unprotected lighting over exposed wine

light intensity is not sufficient to conduct process control activities, e.g., reading critical instruments, bottle filling

III light intensity is below minimum requirements in areas where inspection and bottling are not being carried out.

References

5

4.1 PREMISES 4.1.2 BUILDING INTERIOR 4.1.2.3 Ventilation 103 Task PRINCIPLE Adequate ventilation is provided to prevent excessive heat, steam,

condensation, and dust, and to remove contaminated air. Assessment Criteria

• Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust, excessive heat or contaminated air.

• Ventilation openings are equipped with close fitting screens or filters as appropriate to prevent the intake of pests or contaminated air. Filters are cleaned or replaced as necessary.

Rating Examples I N/A II inadequate ventilation where high risk of contamination, i.e.,

infestation, condensation, etc. III inadequate ventilation, condensation/mould evident, contamination

not likely screens, filters not tight fitting

References

6

4.1 PREMISES 4.1.2 BUILDING INTERIOR 4.1.2.4 Waste Disposal 104 Task PRINCIPLE Sewage, effluent and waste storage and disposal systems are designed,

constructed and maintained to prevent contamination. Assessment Criteria

• Drainage and sewage systems are equipped with appropriate traps and vents . Drains are easily cleanable in processing area.

• Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment.

• Effluent or sewage lines do not pass directly over or through production areas unless they are controlled to prevent contamination.

• Adequate facilities and equipment are provided and maintained for the storage of waste prior to removal from the establishment. These facilities are designed to prevent contamination.

• Containers used for waste are clearly identified, leak proof and where appropriate are covered.

• Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize contamination potentials.

Rating Examples I N/A II leaking waste lines over production areas

accumulation of garbage/waste resulting in obnoxious odours and /or potential cross contamination

waste effluent backing up into food handling areas III cross connections identified between sewage and other waste

effluent system(s) accumulation of raw product, garbage, waste; no obnoxious odours or potential for cross contamination

waste containers not clearly identified inadequate cleaning of waste containers drains not easily cleanable

References

7

4.1 PREMISES 4.1.3 SANITARY FACILITIES 4.1.3.1 Employee Facilities 201 Task PRINCIPLE Employee facilities are designed, constructed and maintained to permit

effective employee hygiene and to prevent contamination. Assessment Criteria

• Preparation areas where product is exposed are provided with an adequate number of conveniently located hand-washing stations with trapped waste pipes to drains.

• Washrooms have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle.

• Lavatories are separate and do not open close to where wine is exposed.

• Washrooms, lunchrooms and change rooms are maintained in a clean condition and are adequately ventilated.

• Hand-washing notices are posted in prominent places in the establishment. instructing employees engaged in the preparation of wine to clean their hands immediately after using toilet facilities.

Rating Examples I N/A II no potable water and soap for hand-washing for employees working

with open vats. III no soap, no hot water for hand-washing

no hand-washing notices posted not adequately ventilated lavatories not separated from preparation areas untidy and unclean - poor housekeeping

References

8

4.1 PREMISES 4.1.3 SANITARY FACILITIES 4.1.3.2 Equipment Cleaning and Sanitizing Facilities 202 Task PRINCIPLE Facilities for cleaning and sanitizing equipment are adequately

designed, constructed and maintained to prevent contamination. Assessment Criteria

• Facilities are constructed of corrosion resistant materials capable of being easily cleaned and are provided with potable water at temperatures appropriate for the cleaning chemicals used.

• Equipment cleaning and sanitizing facilities are adequately separated from raw product storage, and bottle filling areas where the product is exposed to prevent contamination.

Rating Examples I N/A II no separation between facilities for cleaning and sanitizing

equipment and raw product storage. Cleaning and sanitizing equipment

III a lack of adequate separation that could result in a low risk of contamination.

facilities not properly constructed , i.e. not easily cleaned, surfaces cannot withstand cleaning chemicals which are being used.

References

9

4.1 PREMISES 4.1.4 WATER/ICE/STEAM QUALITY 4.1.4.1 Water 301 Task PRINCIPLE The potability of hot and cold water is controlled to prevent

contamination. Assessment Criteria

• Water meets the requirements of Health Canada's "Guidelines for Canadian Drinking Water Quality." Water is analyzed by the manufacturer at a frequency adequate to confirm it’s potability. The testing is based on the specifications described in Appendix

• Establishments should have a written water quality control program if the establishment water source is other than municipal treated and delivered in a closed system.

• There are no cross-connections between potable and non-potable water supplies or all hoses, taps and other similar sources of possible contamination are designed to prevent back-flow or back siphonage.

• Where it is necessary to store water, storage facilities are adequately designed, constructed and maintained to prevent contamination, e.g., covered.

• Water treatment chemicals, where used, are listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products", published by CFIA or the Manufacturer has a "letter of no objection" from Health Canada.

• The chemical treatment is monitored and controlled to deliver the desired concentration and to prevent contamination.

• Re-circulated water is treated, monitored and maintained as appropriate to the intended purpose. Re-circulated water has a separate distribution system which is clearly identified.

Rating Examples I N/A II water does not meet the safety requirements of Health Canada's

"Guidelines for Canadian Drinking Water Quality” water is not tested cross-contamination of potable and non-potable water use of non-approved chemicals for water treatment which may be hazardous

III water treatment chemicals not approved but not hazardous no written water control program for well water on premises

References

10

4.1 PREMISES 4.1.4 WATER/ICE/STEAM QUALITY 4.1.4.2 Ice 302 Task PRINCIPLE The potability of ice used in the establishment is controlled to prevent

product contamination. Assessment Criteria

• Ice made or brought into the establishment and used on wine contact surfaces is made from potable water.

• Ice stored or used in the establishment is kept in a clean closed container.

Rating Examples I N/A II N/A III source of ice not known

ice not tested References

11

4.1 PREMISES 4.1.4 WATER/ICE/STEAM QUALITY 4.1.4.3 Steam 303 Task PRINCIPLE The potability of steam in direct contact with wine or wine contact

surfaces is controlled to prevent product contamination. Assessment Criteria

• Boiler treatment chemicals used should be listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products" published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.

• Boiler feedwater is tested regularly and the chemical treatment is controlled to prevent contamination.

• The steam supply where there is contact with wine contact surfaces is generated from potable water.

• Traps are provided as necessary to ensure adequate condensate removal and elimination of foreign materials.

Rating Examples I N/A II N/A III possible carryover of chemicals with steam

wine bottle line equipment cleaned with steam made from non potable water

References

12

4.1 PREMISES 4.1.4 WATER/ICE/STEAM QUALITY 4.1.4.4 Water/Ice/Steam Quality Records 304 Task PRINCIPLE Written records that adequately reflect control of water, ice and steam

quality and treatment are available upon request. Assessment Criteria

• The manufacturer has records available to demonstrate the adequacy of the microbiological and/or chemical safety of the water, ice and steam supply as follows:

Water Potability Records water source sample site and date analytical results analyst analysis date

Water Treatment Records method of treatment sample site and date analytical results analysis date analyst

Ice Records source analytical results analysis date analyst

Boiler Feedwater Treatment Records method of treatment analytical results analyst date

Rating Examples I N/A II N/A III records are incomplete References

13

4.2 TRANSPORTATION AND STORAGE 4.2.1 TRANSPORTATION 4.2.1.1 Carriers 401 Task PRINCIPLE Carriers used for grapes, grape juice, grape must and wine are

designed, constructed, maintained, cleaned and utilized in a manner to prevent contamination.

Assessment Criteria

• The winery verifies that all carriers and containers used for to deliver grapes are suitable for the transportation of juice/wine raw product. For example:

• Carriers Tankers are inspected by the winery on receipt arrival and prior to loading to ensure they are free from contamination and suitable for the transportation of grape juice/grape must/wine.

• The winery has a program in place to demonstrate the adequacy of cleaning and sanitizing for bulk grape juice/grape must/wine carriers tankers e.g., a written cleaning and sanitizing procedure is available.

• Where the same carriers are used for juice/wine and non-food loads (e.g. dual use), procedures are in place to restrict the type of non-food loads to those that do not pose a risk to subsequent juice/wine loads after an acceptable cleanout. For example:

The winery receives a cleaning certificate and a record of the previous material transported prior to loading or unloading wine from dual use tankers.

The winery has a program in place to verify the adequacy of cleaning, e.g. tanker inspections,

• Carriers are loaded and unloaded in manner that prevents contamination of the grapes/grape juice/grape must/wine.

• Bulk tankers are designed and constructed to permit complete drainage and to prevent contamination.

• Where appropriate, materials used in carrier construction are suitable for grapes/grape juice/grape must/wine contact.

Rating Examples I tankers used for wine and hazardous materials, without a cleaning

certificate, no record of previous material transported and adequacy of cleaning not verified.

II tankers or carriers are inspected, but are not rejected for unacceptable conditions, e.g. smell of gas, pesticides, hazardous foreign material, etc.

use of dual tankers not adequately designed for complete drainage. III no cleaning certificate provided with tanker used for food and non-

hazardous, non-food materials no program to verify adequacy of cleaning but cleaning certificate provided with tanker used for wine and non-hazardous, non-food materials

inadequate inspection of carriers for cleanliness and maintenance

14

obnoxious odours around bulk grape carrier and no inspection References

15

4.2 TRANSPORTATION AND STORAGE 4.2.1 TRANSPORTATION 4.2.1.2 Temperature Controls 402 Task PRINCIPLE Ingredients and finished product requiring temperature controls are

transported in a manner to prevent temperature abuse that could result in deterioration affecting product wholesomeness.

Assessment Criteria

• Raw product is Grapes are transported at a temperatures that assures the maintenance of grape maintain the raw product quality.

• Finished product Grape juice/grape must/wine is are transported in tankers under conditions to minimize deterioration.

Rating Examples I N/A II N/A III grapes/Wine is transported under elevated temperature conditions

which result in minimal product spoilage - no provisions made to prevent overheating or temperature variations that will affect product quality

References

16

4.2 TRANSPORTATION AND STORAGE 4.2.2 STORAGE 4.2.2.1 Incoming Materials Storage 501 Task PRINCIPLE Storage and handling of incoming ingredients and packaging materials

is controlled to prevent damage and contamination. Assessment Criteria

• Ingredients and packaging materials are handled and stored in a manner to prevent damage and/or contamination.

• Ingredient, and where appropriate, packaging material rotation, is controlled to prevent deterioration and spoilage.

• Humidity sensitive ingredients are stored under appropriate conditions to prevent deterioration.

Rating Examples I N/A II open/damaged containers of ingredients not covered to prevent

contamination III inadequate rotation of ingredients or packaging materials resulting in

possible deterioration or spoilage, References

17

4.2 TRANSPORTATION AND STORAGE 4.2.2 STORAGE 4.2.2.2 Non Food Chemicals - Receiving and Storage 502 Task PRINCIPLE Non-food chemicals are received and stored in a manner to prevent

contamination of food, packaging materials and wine contact surfaces. Assessment Criteria

• Chemicals are received and stored in a dry, well ventilated area. • Non-food chemicals are stored in designated areas such that there is

no possibility for cross-contamination of wine or wine contact surfaces.

• Where required for on-going use in food handling areas, these chemicals are stored in a manner that prevents contamination of wine or wine contact surfaces or packaging materials.

• Chemicals are stored and mixed in clean, correctly labeled containers.

• Chemicals are dispensed and handled only by authorized and properly trained personnel.

Rating Examples I N/A II hazardous non-food chemicals stored in an unlabelled container in a

preparation area III chemicals stored in corroded containers

storage conditions inadequate, e.g., damp or insufficient ventilation, not directly affecting finished product or equipment

non food chemicals in unlabelled containers in the preparation areas References

18

4.2 TRANSPORTATION AND STORAGE 4.2.2 STORAGE 4.2.2.3 In-process Storage 503 Task PRINCIPLE Wine products are stored and handled to prevent damage and

contamination. Assessment Criteria

• Wine is stored and handled under conditions to minimize deterioration.

• Clean instruments are used to sample wine in the barrel or tank rooms.

• Wine sampling from barrels or tanks is carried out in a hygienic manner.

• Returned defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

• A properly designed spittoon held close to a wine taster’s mouth may be used when wine samples are not swallowed.

Rating Examples I N/A II wine samples taken from barrels are returned to barrels or tanks

unclean sampling instruments are used to take samples from wine barrels or tanks

III insufficient identification of product in inventory sampled wine is spit into drain in barrel room.

References

19

4.2 TRANSPORTATION AND STORAGE 4.2.2 STORAGE 4.2.2.4 Finished Product Storage 504 Task PRINCIPLE Finished products are stored and handled to prevent damage and

contamination. Assessment Criteria

• Finished product is stored and handled under conditions to minimize deterioration.

• Finished product is stored and handled in a manner to minimize damage,

• Returned defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

Rating Examples I N/A II No evaluation of customer returns

Returned defective or suspect product is not clearly identified and isolated (e.g. glass, insects, etc.).

III inadequate control of finished product handling, e.g., damaged containers evident

insufficient identification of product in inventory References

20

4.3 EQUIPMENT 4.3.1 GENERAL EQUIPMENT 4.3.1.1 Design and Installation 601 Task PRINCIPLE All equipment and utensils are designed, constructed and installed to

function as intended, to permit effective cleaning and sanitation, and to prevent contamination of wine and to avoid damage to its wine containers.

Assessment Criteria

• The above principle is particularly important to the following preparation and handling equipment from a health and safety of wine standpoint:

transfer equipment filtering equipment container cleaning equipment filling equipment closing equipment

• Equipment is designed, constructed and installed: to ensure that it is capable of delivering the requirements of the process

to be accessible for cleaning, sanitizing, maintenance and inspection

to prevent contamination of the wine during operations, e.g., location of lubricant reservoirs

to avoid damage to wine containers (bottles, bags) • Equipment and utensils used to handle contaminated waste

materials or non-food chemicals (other than cleaning chemicals) shall be properly identified and shall be used for its only for their intended purpose

Rating Examples I N/A II frequent contamination due to poor design/installation, e.g., product

residues of a putrid, filthy, rotten, disgusting nature potential contamination of a chemical nature due to poor design/installation, e.g., by dripping of lubricants from bearings, gears, motors, and other overhead equipment

III design, construction and/or installation does not permit adequate cleaning (e.g. equipment installed too close to walls and ceilings)

manually cleaned equipment not easily disassembled welded joints not even, continuous and smooth in keeping with industry standard.

utensils used to handle contaminated materials are not properly identified

tanks improperly covered References

21

4.3 EQUIPMENT 4.3.1 GENERAL EQUIPMENT 4.3.1.2 Wine Contact Surfaces 602 Task PRINCIPLE Wine contact surfaces are constructed of appropriate materials and are

maintained in a manner to prevent contamination of the wine. Assessment Criteria

• Wine contact surfaces of equipment and utensils are smooth, non-corrosive, non-absorbent, non-toxic, free from pitting, cracks or crevices, with the exception of wooden containers routinely used in winemaking, and can withstand repeated cleaning and sanitation.

• Coatings, paints, chemicals, lubricants and other materials used for wine contact surfaces or equipment where there is a possibility of contact with wine should be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer should have "a letter of no objection" from Health Canada.

Rating Examples I N/A II use of a non approved material when the risk from using the material

is unknown III surfaces are pitted, cracked, absorbent

welded joints not even, continuous and smooth use of coatings, paints not listed in the CFIA reference listing or reviewed by Health Canada , known to be non-hazardous (e.g., The use of a plastic pipe that is not on the approved list)

utensils/equipment not stored on clean, rust-resistant racks References

22

4.3 EQUIPMENT 4.3.1 GENERAL EQUIPMENT 4.3.1.3 Equipment Maintenance Program 603 Task PRINCIPLE An effective maintenance program is in place to ensure that equipment

performs consistently as intended and prevents contamination of the wine.

Assessment Criteria

• The operator has an effective preventative maintenance program and that the program is adhered to.

• Equipment is maintained to ensure that no physical or chemical hazard potentials result, e.g., inappropriate repairs, excessive lubrication

• Maintenance of equipment is performed by appropriately trained personnel.

• Records of maintenance of equipment listed under task 601 are kept. Rating Examples I N/A II N/A III information in maintenance records not complete

no maintenance records for filling and closing corking machines improper maintenance of non-critical equipment

References

23

4.4 PERSONNEL 4.4.1 TRAINING 4.4.1.1 General Food Hygiene Training 1001 Task PRINCIPLE Every winery worker is trained in personal hygiene and hygienic

handling of wine-making and wine equipment such that they understand the precautions necessary to prevent the contamination of wine.

Assessment Criteria

• The winery has a written training program for employees which is delivered as follows:

Appropriate training in personal hygiene and hygienic handling of wine is provided to all workers in the establishment at the beginning of their employment.

The original food hygiene training is reinforced and updated at appropriate intervals.

Rating Examples I N/A II no employee training III employees trained with no written program References

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4.4 PERSONNEL 4.4.1 TRAINING 4.4.1.2 Technical Training 1002 Task PRINCIPLE Personnel are trained such that they have adequate technical knowledge

and understanding of the operation(s) or process(es) for which they are responsible to ensure wine safety.

Assessment Criteria

• Training is appropriate to the complexity of the wine-making process and the tasks assigned, e.g.:

Personnel are trained to understand the importance of the tasks for which they are responsible; the critical limits, the procedures for monitoring, the action to be taken if the limits are not met, and the records to be kept.

Personnel responsible for maintenance have been appropriately trained to identify deficiencies and to take the appropriate corrective action. Individuals performing maintenance on specific equipment are appropriately trained.

Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.

Additional training is provided as necessary to ensure current knowledge of equipment and process technology, e.g., specific technical training, apprenticeship programs, etc.

Rating Examples I N/A II personnel do not understand the importance of the tasks for which

they are responsible maintenance staff responsible for critical equipment have not received appropriate training

III employee follows the method of sanitation but has not been trained in the principles for cleaning and sanitation

References

25

4.4 PERSONNEL 4.4.2 HYGIENE AND HEALTH REQUIREMENTS 4.4.2.1 Cleanliness and Conduct 1101 Task PRINCIPLE All persons entering wine-making areas where product is exposed

maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of wine.

Assessment Criteria

• All persons wash their hands upon entering wine-making areas, before starting work, after handling contaminated materials, after breaks and after using toilet facilities.

• Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation in which the employee is engaged, are worn and maintained in a sanitary manner, e.g., employees in production areas where product is exposed wear effective hair coverings.

• Any behaviour which could result in contamination of food wine, such as eating, use of tobacco, chewing gum, or unhygienic practices such as spitting are prohibited in areas where product is exposed.

• All persons entering areas where product is exposed remove jewelry and other objects which may fall into or otherwise contaminate wine. Jewelry which cannot be removed (including wedding bands and medical alerts) is covered.

• Personal effects and street clothing are not kept in wine-making areas and are stored in a manner to prevent contamination.

• Access of personnel and visitors is controlled to prevent contamination.

• The traffic pattern of employees prevents cross-contamination of the product.

Rating Examples I N/A II N/A III personal effects at the work station

personnel wearing jewelry, e.g., earrings uncontrolled visitor access unclean and improper clothing items in breast pockets employees eating, smoking, chewing gum no or improperly worn hair covering

References

26

4.4 PERSONNEL 4.4.2 HYGIENE AND HEALTH REQUIREMENTS 4.4.2.2 Communicable Diseases/Injuries 1102 Task PRINCIPLE No person while known to be infected with a communicable disease, or

with open cuts or wounds, is permitted to work in wine-making areas. Assessment Criteria

• The winery has a training program on worker health requirements. • The winery makes appropriate use of pre-employment health

interviews and forms (see Health Surveillance and Management Procedures For Food Handling Personnel, /WHO, Geneva, 1989).

• The winery has and enforces a policy to prevent personnel known to be suffering from, or known to be carriers of a communicable disease from working in areas where the product may be exposed (e.g., bottling line, transfer to barrels, crush pad.

• The winery requires that employees advise management when they are suffering from a communicable disease.

• Employees having open cuts or wounds do not work near wine contact surfaces unless the injury is completely protected by a secure waterproof covering, e.g., rubber gloves.

Rating Examples I N/A II N/A III employees working with open cuts and wounds handling corks and

bottles. employees with uncovered bandages on hands working on bottle filler. winery does not have a policy for personnel suffering from communicable diseases

References

27

4.5 SANITATION (AND PEST CONTROL) 4.5.1 SANITATION 4.5.1.1 Written Sanitation Program and Effectiveness Evaluation 1201 Task PRINCIPLE An effective sanitation program for equipment and premises is in place

to prevent contamination of wine. Assessment Criteria

• winery has a written sanitation program for all equipment which includes:

the identification of responsible person the frequency of the activity chemicals and concentration used temperature requirements procedures for cleaning and sanitizing as follows:

• Cleaned Out of Place Equipment (C.O.P., e.g., hand-cleaned) identify equipment and utensils disassembly/reassembly instructions as required for cleaning and inspection

areas on equipment requiring special attention are identified method of cleaning, sanitizing and rinsing

• Cleaned in Place Equipment (C.I.P) identify lines and/or equipment CIP setup instructions method of cleaning, sanitizing and rinsing disassembly/reassembly instructions as required for cleaning and inspection

• The winery has a written cleaning and sanitation program for premises (production and storage areas) which specifies areas to be cleaned, method of cleaning, person responsible and the frequency of the activity. Special sanitation and housekeeping

• procedures required during production are specified within the document, e.g., removal of product residues during breaks.

• Chemicals are used in accordance with the manufacturer's instructions and should be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer should have a "letter of no objection" from Health Canada.

• Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.

• The sanitation program is carried out in a manner that does not contaminate the wine or packaging materials during or subsequent to cleaning and sanitizing, e.g., aerosols, chemical residues.

• Effectiveness of the sanitation program is monitored and verified (e.g., by routine inspection of premises and equipment and/or microbiological testing) and where necessary, the program is adjusted accordingly.

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• Operations begin only after sanitation requirements have been met. Rating Examples I N/A II incomplete sanitation program resulting in improper rinse of wine

contact surface and a contamination of wine with concentrated cleaning material

III incomplete sanitation program chemical used in sanitation program not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA.

chemical used for cleaning wine contact surface not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA

no written sanitation program effectiveness of the sanitation program is not monitored and verified

References

29

4.5 SANITATION (AND PEST CONTROL) 4.5.1 SANITATION 4.5.1.2 Equipment Cleanliness 1202 Task PRINCIPLE The sanitation program is being followed so that the equipment and

utensils are cleaned and maintained in a sanitary condition that prevents contamination of wine.

Assessment Criteria

• The equipment, utensils and other tools are maintained in a clean and sanitary manner.

• Wine contact surfaces are maintained in a sanitary manner, free from accumulations of waste, dust, grease, grime

• Sanitation program as written is followed - frequency; equipment is disassembled as required; correct chemicals and concentrations are used; etc.

• Utensils and tools are stored on conveniently located rust-resistant racks

• Sanitation is carried out in a manner that does not contaminate wine or packaging materials (remove, cover or other adequate protection)

• Equipment is cleaned and sanitized in a location where grapes/grape juice/grape must/wine are not exposed or at a time when the products are not being prepared.

Rating Examples I N/A II clean up not done as scheduled - some build up of waste materials

and/or foul odour incomplete rinsing after cleaning resulting in chemical contamination of wine.

poor sanitation cleaning practices e.g. splashing of cleaning chemicals and wash up water onto operating lines or packaging material

III utensils are sitting on the floor clean up not done as scheduled - light build up of waste and no odour

References

30

4.5 SANITATION (AND PEST CONTROL) 4.5.1 SANITATION 4.5.1.3 Premise Cleanliness 1203 Task PRINCIPLE The sanitation program is being followed so that the interior of the

building and all other physical facilities are maintained in a sanitary and tidy condition that prevents contamination of wine.

Assessment Criteria

• The building and physical facilities are maintained in a clean and sanitary manner.

the premises are kept free of debris and refuse floor, wall and ceiling surfaces are maintained in a sanitary manner, free from accumulations of waste, dust, grease, grime

Rating Examples I N/A II poor sanitation practices e.g., splashing of cleaning chemicals and

wash up water onto empty bottles. III build-up of mould or waste on windows, doors, walls, ceilings etc

and filth in tank and filling areas walls, ceilings, floors, doors, windows and/or unclean - light build up of mould or waste materials

dusty overhead beams throughout the establishment poor housekeeping which may result in potential harbourage of pests

References

31

4.5 SANITATION (AND PEST CONTROL) 4.5.1 SANITATION 4.5.1.4 Sanitation Records 1204 Task PRINCIPLE Records are available to demonstrate the effectiveness of the sanitation

program. Assessment Criteria

• The records of sanitation activities include the date, person responsible, the findings, corrective action taken.

Rating Examples I N/A II N/A III no sanitation records

missing dates or initials on a daily sanitation record isolated instance of missing information on a daily sanitation record

References

32

4.5 SANITATION (AND PEST CONTROL) 4.5.2 PEST CONTROL 4.5.2.1 Written Pest Control Program 1301 Task PRINCIPLE Effective pest control programs are in place to prevent entry, detect and

eliminate pests and to prevent the contamination of wine. Assessment Criteria

• There is an effective written pest control program for the premises and equipment that includes:

The identification of the person at the manufacturer assigned responsibility for pest control.

Where applicable, the name of the pest control company or the name of the person contracted for the pest control program.

The list of chemicals used, the concentration, the location where applied, method and frequency of application.

A map of trap locations. The type and frequency of inspection to verify the effectiveness of the program.

• Pesticides used are registered under the Pest Control Products Act and Regulations and are listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA. Pesticides are used in accordance with the label instructions.

• Treatment of equipment, premises or ingredients to control pests is conducted in a manner to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded, e.g., limiting the number of fumigation treatments per lot.

• Birds and animals are excluded from establishments. • Pallets and materials are stored at a sufficient distance from the wall

to avoid potential harbourage of pests. Congested storage conditions are avoided.

Rating Examples I N/A II major infestation with a high risk of contamination

pesticide used inappropriately and risk of direct contamination (spraying during operations where product may be exposed)

III pesticides not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA

no map of trap locations no person designated for pest control low level infestation no written pest control program materials stored too close to walls - possible harbourage

References

33

4.5 SANITATION (AND PEST CONTROL) 4.5.2 PEST CONTROL 4.5.2.2 Pest Control Records 1302 Task PRINCIPLE Records are available to demonstrate the effectiveness of the pest

control program. Assessment Criteria

• Minimum pest control records include: Results of the inspection programs and the corrective action taken e.g., findings in traps, location of insect infestation.

Record of pest control activities, e.g., pesticide used, method and location of application, dates of fumigation, etc.

Date, person responsible. Rating Examples I N/A II N/A III no pest control records

missing dates or initials on pest control record isolate instance of missing information on pest control record

References

34

4.6 COMPLAINTS AND RECALLS 4.6.1 COMPLAINT HANDLING 4.6.1.1 Product Complaints 1401 Task PRINCIPLE The establishment has an effective system for handling and

investigating complaints. Assessment Criteria

A system is in place to handle and investigate product complaints as follows: • The winery has identified the person or persons responsible for

receiving, evaluating, categorizing and/or investigating complaints. • Complaints are accurately categorized according to health and safety

and consumer fraud risks. • Potentially serious complaints are forwarded immediately to

appropriate personnel for action. • Safety and contamination complaints are investigated by

appropriately trained technical personnel. • Examination of the complainant's specimen, retail product or other

product of the same code is conducted on complaints related to wine safety.

• The depth of the investigation is appropriate to the risk and similar complaint trends.

• Appropriate corrective action is taken for deviations identified during the investigation.

Rating Examples I N/A II complaints affecting food safety (allergies, glass, etc.), are not

referred to appropriate personnel for action complaints not investigated thoroughly and records not reviewed potentially serious complaints are not investigated promptly

III no investigation of complaints involving quality References

35

4.6 COMPLAINTS AND RECALLS 4.6.1 COMPLAINT HANDLING 4.6.1.2 Complaint Records 1402 Task PRINCIPLE Records of product complaints, investigation findings and action taken

are available upon request. Assessment Criteria

• Detailed records of consumer complaints received, investigation, findings and corrective action taken are maintained. The minimum information required for complaint records related to health and safety issues are as follows:

Consumer Information name, address, telephone number, date received details of complaint and/or illness product name, code, size retail outlet

Investigation name of person responsible for investigation date investigated findings of investigation corrective action taken

Rating Examples I N/A II no records of health and safety complaints and investigations III records are incomplete but there is sufficient information to verify

the adequacy of complaint investigation, e.g., consumer name, address, date, retail outlet, etc.

no records of complaints about quality References

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4.6 COMPLAINTS AND RECALLS 4.6.2 RECALLS 4.6.2.1 Recall Plan 1501 Task PRINCIPLE Every winery establishes a written recall plan to permit the complete,

rapid recall of any lot of wine from the market. Assessment Criteria

• The written recall plan includes: The person or persons responsible, e.g., recall coordinator(s) including after hours name and contact.

The roles and responsibilities for coordination and implementation of a recall.

Methods to identify, locate and control recalled product. A requirement to investigate other products that may be affected by the hazard and that should be included in the recall.

Procedure for monitoring the effectiveness of the recall, e.g., effectiveness check to the appropriate level of distribution specified in the recall notice.

Immediate notification of the Office of Food Safety Recall, CFIA. This notification includes the following: amount of product produced, in inventory and distributed name, size, code or lot numbers of food recalled area of distribution of product, e.g., local, national,

international reason for the recall Rating Examples I N/A II N/A III incomplete written recall plan

no written recall plan References

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4.6 COMPLAINTS AND RECALLS 4.6.2 RECALLS 4.6.2.2 Product Code Identification 1502 Task PRINCIPLE Each container of wine is may be identified with code marks or lot

numbers either on the label or container for traceability purposes. Assessment Criteria

• Individual wine container coding is not mandatory, but is strongly encouraged to be able to minimize the quantity of wine affected if a recall is necessary.

• For products wines prepared in a registered establishment which are packed for a first dealer under a private label (i.e., without the producing winery name and address), the registration number of the establishment or an identifying code mark should may appear on the label, or ink-jetted on the container or on the shipping container (case).

• For products wines that do contain the name and address of the winery on the label, an identifying time or sub-lot code may be useful when lots are large in the event that a recall is necessary.

• Where used, case codes are legible and represent the container code within.

• All packages in which containers of wine are packed are marked on one panel with the registration number of the establishment in which the product was packed and the name and address of the operator or the first dealer.

Rating Examples I N/A II N/A III case code does not coincide with bottle code

no code illegible code or establishment number on shipping container (case). (where code is mandatory)

References

38

4.6 COMPLAINTS AND RECALLS 4.6.2 RECALLS 4.6.2.3 Recall Capability 1503 Task PRINCIPLE Recall plans are tested periodically to verify the capability to rapidly

identify and remove product from the market. Assessment Criteria

• The winery is capable of providing accurate information on a timely basis to verify that all affected product can be rapidly identified and removed from the marketplace. This can be demonstrated by:

Periodic testing (internal simulations) to verify the capability of the recall plan to rapidly identify and control a code lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution.

Any deficiencies in the recall plan are identified and corrected. Rating Examples I N/A II recall plans tested and found not to be effective. No corrective action

taken III recall plans have never been tested

identified deficiencies have never been corrected References

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4.6 COMPLAINTS AND RECALLS 4.6.2 RECALLS 4.6.2.4 Distribution Records 1504 Task PRINCIPLE Product distribution records are available to enable the winery to recall

any lot of product. Assessment Criteria

• Distribution records contain sufficient information to permit traceability to a particular code or lot number.

• The following minimum information is required for distribution records:

product identification and size lot number or code quantity customer names, addresses, and phone numbers to the initial level of product distribution.

Rating Examples I N/A II no distribution records III information on distribution records incomplete References

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4.7 RECORDS 4.7.1 GENERAL RECORDS 4.7.1.1 General Record Requirements 1601 Task PRINCIPLE Information is recorded in a manner to represent an accurate history of

the product or process. Records are retained for the required period of time.

Assessment Criteria

• The following are requirements for all record keeping activities: Records are legible, permanent and accurately reflect the actual event, condition or activity.

Errors or changes are identified in a manner such that the original record is clear, e.g., strike out with a single stroke and initial the correction/change.

Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.

Critical records are signed by a qualified individual designated by management prior to distribution of product

Records are retained for at least one year after the expiry date on the label or container or if there is no expiry date, for at least two years after the date of sale.

Records are maintained and are available upon request. Rating Examples I N/A II N/A III inadequate record keeping practices References

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4.7 RECORDS 4.7.1 GENERAL RECORDS 4.7.1.2 General Regulatory Requirements 1602 Task PRINCIPLE Current Certificate of Registration is posted in a conspicuous place in

the establishment for the period during which the certificate remains in force.

Assessment Criteria

• Current registration certificate is posted.

Rating Examples I N/A II N/A III current certificate of registration not posted References

CHAPTER 5 – Operations Inspection Standard 5.1 MANUFACTURING CONTROLS Page No 5.1.1 Product Authenticity 5.1.1.1 5101 Grape Origin 1 5.1.1.2 5102 Wine Content 3 5.1.1.3 5103 Ingredients, Additives and Processing Aids 5 5.1.1.4 5104 Label Accuracy 7

5.1.2 Incoming Material Control 5.1.2.1 5201 Ingredients, Additives and Processing Aids 8 5.1.2.2 5202 Packaging Materials 10 5.1.2.3 5203 Incoming Material Control Records 12

5.1.3 In-Package Process Control 5.1.3.1 5301 Empty Container Handling - Bag-in-Box 13 5.1.3.2 5302 Empty Container Handling - Glass 14 5.1.3.3 5303 Container Cleaning - New Bottles 16 5.1.3.4 5304 Container Examination and Cleaning - Barrels 17 5.1.3.5 5305 Empty Container Records 18 5.1.3.6 5306 Glass Breakage Procedure 19 5.1.3.7 5307 Glass Breakage Records 20

5.1.4 Product Preparation 5.1.4.1 5401 Raw Product Cleaning Control 21 5.1.4.2 5402 Transferring Wine 22 5.1.4.3 5403 Filtering Wine 23 5.1.4.4 5404 Quality Specifications Control 24

5.1.5 Container Filling and Closure Control 5.1.5.1 5501 Standard Containers Sizes and Net Quantity 25 5.1.5.2 5502 Filling and Corking/Capping of Glass Containers 26 5.1.5.3 5503 Filling and Sealing of Bag-in-Box Packaging 27

5.1.6 Container Coding 5.1.6.1 5601 Coding Control 28

5.1.7 Verification of Safety and Quality 5.1.7.1 5701 Verification of Product Safety and Quality 29

1

5.1 MANUFACTURING CONTROLS 5.1.1 PRODUCT AUTHENTICITY 5.1.1.1 Grape Origin 5101 Task PRINCIPLE The winery keeps records that show incoming grape and wine receipts

which correctly reflect the winery’s wine production, existing inventory and sales figures since the last authenticity audit.

Assessment Criteria

• Records contain sufficient information to permit the verification of grape origin and eligibility for appellation terms related to origin and traceability of a particular wine.

• The following minimum information is required for records of origin:

A statement from the grape producer detailing the place that the grapes were grown and the associated weight records that meet the requirements of the Weights and Measures Act (Canada) for each grape lot.

The name and location of the specific vineyard or estate where the grapes were grown.

Volumes of juice resulting from each lot of grapes and the dispostion of the juice, must or wine at all times during the vinification process, identified by their geographical indication. This will include details of all transfers to and from tanks, barrels or other containers, blending, and the location of the juice, must or wine at all times.

The quantities of wines intended to be identified by the name of a vineyard or the term "estate-bottled" and their identification throughout the vinification process.

All information respecting sales of wines carrying a geographical indication for which approvals have been issued and the labels used on these wines.

All information respecting wine that has been transferred to the manufacturer, by sale or otherwise, that is intended to use a geographical indication on its label

• All information is reviewed to verify that claims of origin can be substantiated.

• Inventory of wine in tanks, barrels, bottles in cases are measured against grape tickets, wine inventory figures from last authenticity audit, wine production reports and monthly product sales reports.

• Wine production and yields are appropriate for weight of grapes received according to the grape tickets.

• All VQA wines and their labels being offered for sale in the winery’s on-site store have been approved by the provincial wine authority

Rating Examples I using restricted terms of origin without approval

2

wine is labeled with incorrect or misleading claims of origin II no records available at time of inspection

records are not sufficient to verify compliance with regulations or to substantiate label claims

III records are incomplete, non-material mistake on label. References

3

5.1 MANUFACTURING CONTROLS 5.1.1 PRODUCT AUTHENTICITY 5.1.1.2 Wine Content 5102 Task PRINCIPLE The winery keeps records that show product preparation to support the

declared content of the wine and eligibility to use appellation terminology.

Assessment Criteria

• Winery keeps records that contain sufficient information to permit the verification of the varietal content, the vintage content and process treatments of particular codes or lot numbers of wine production

• The following minimum information is required for appellation records:

Weight records for each grape lot that meet the requirements of the Weights and Measures Act (Canada).

records of grape purchases, including quantities and vintage of each grape variety, and the results of a brix reading performed by an employee or agent of the wine authority for each lot of grapes.

the varieties, vintage and volumes contained in each tank or lot of wine produced; identified in relation to each lot of grape harvested or purchased

tank records and racking orders and, if racking orders are not used, a daily journal that records the quantity and content of each wine produced;

records of the complete vinification process including the bottling stage; that detail all processes, blending and transfers to which the wine is subjected.

records of outdoor temperatures during the harvesting and pressing of icewine, and the date and time that harvest and pressing occurred

Registration records show the grapes used for Icewine were registered with the wine authority prior to harvest.

All information respecting sales of wines for which approvals have been issued.

All information respecting wine that has been transferred to the winery, by sale or otherwise, that is intended for use in appellation wines, supported by audited transfer records or through records available at the originating winery.

• All information is reviewed to verify that entitlement to appellation terms.

Rating Examples I using restricted appellation terms without approval

wine content is misrepresented or in material violation of regulationsII no records available at time of inspection

records are not sufficient to verify compliance with regulations or to

4

substantiate label claims III records are incomplete, non-material mistake on label. References

5

5.1 MANUFACTURING CONTROLS 5.1.1 PRODUCT AUTHENTICITY 5.1.1.3 Ingredients, Additives and Processing Aids 5103 Task PRINCIPLE Wine ingredients, additives and processing aids are controlled to meet

the requirements of all applicable regulations. Assessment Criteria

• The winery ensures that all food additives and processing aids used are permitted for use in grape wine and meet the requirements of all applicable regulations.

• The winery has specifications for all food additives and processing aids

• Where there are no requirements in the Food and Drugs Act and Regulations, the wine-maker requires that all food additives/processing aids be Food Chemical Codex (FCC) grade or equivalent, e.g., specification sheets, clear identification of the grade on the additive package, or blanket guarantees.

• The wine maker has verified and can demonstrate through calculations that food additives are used within the maximum level specified in the Food and Drug Regulations

• The winery has a letter of no objection from Health Canada for non regulated processing aids.

• Processing Aids are used as per manufacturer’s instructions. • The following minimum information is required for verification of

process standards: Records of sufficient grapes harvested to substantiate that fresh grapes are used

Records of type and quantity of sugar additions and where applicable, corresponding inventory records of sugar types and quantities.

Records of acidification and deacidification, including types and quantities of additives used

Records of types and quantities of all additives, including the quantity of water used for the purpose of making aqueous solutions to aid the use of additives

• All information is reviewed to verify that all regulations are complied with.

Rating Examples I records show that concentrate has been used or that water has been

added to increase the volume of the a Regional wine. II winery is not using FCC grade or equivalent.

level of additive/processing aids is violative and safety may be affected.

processing aids are not used according to manufacturer's instructions and safety may be affected.

III level of additive/processing aids is violative but safety is not

6

affected. additive/processing aids used are not permitted but safety is not affected.

records are insufficient. References

7

5.1 MANUFACTURING CONTROLS 5.1.1 PRODUCT AUTHENTICITY 5.1.1.4 Label Accuracy 5104 Task PRINCIPLE The winery ensures that all required label information is declared and

accurately represents the contents of the wine container. Assessment Criteria

• All labels are checked to ensure that the trade marks and declarations related to the appellation, variety, origin, per cent alcohol and net quantity by responsible personnel are in compliance with the Wine Regulations, the Food & Drug Regulations and the Consumer Packaging & Labelling Regulations.

• Labels are kept in an organized manner to prevent mixing of unlike labels during storage.

• Controls are in place to ensure that contents of the wine bottles or bags being supplied to the labelling operation correspond to the information declared on the labels in the labelling machine.

• VQA wine labels are submitted to the provincial wine authority with samples and application for certification. Label reviews from the provincial wine authority are filed in the establishment. VQA wines are not shipped from the establishment until the provincial wine authority certification has been received.

• The following minimum information is required for label verification:

Labels, packaging and bottling records for all bottled wines A complete inventory of wine using each label and records detailing its content (see 4.6.1 and 4.6.2)

All information respecting shipments and sales of wines and related certifications issued by the provincial wine authority.

Rating Examples I VQA wines offered for sale using restricted terms before provincial

wine authority approval is received use of labels with inaccurate, misleading information on the label which would undermine the integrity of the appellation system

II no records, or inadequate or inaccurate records in the establishment showing the varieties, vintage or origin of grapes used in the production of the wines

one or more required declarations are not shown on the label III use of labels with declarations which are not the required size of

print or in the wrong position on the label but would not mislead the consumer

no label approval file. References

8

5.1 MANUFACTURING CONTROLS 5.1.2 INCOMING MATERIAL CONTROL 5.1.2.1 Ingredients/Additives and Processing Aids 5201 Task PRINCIPLE The winery controls incoming ingredients, food additives and

processing aids to prevent biological, chemical or physical contamination of the wine.

Assessment Criteria

• The winery has written specifications for ingredients, food additives and processing aids.

• Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations and any other applicable regulations.

• The winery conducts periodic monitoring or obtains a certificate of analysis testing (analysis) to verify adherence to specifications. The manner and frequency of the testing verification should reflect the level of risk posed by the ingredient, additive or processing aid to the safety or compositional integrity of the wine and the past history of adherence to specifications.

• When critical or sensitive ingredients, food additives and processing aids are found not to meet specifications the winery refuses to accept delivery or investigates and identifies the root cause. If the ingredients, food additives and processing aids do not meet specifications but have not been used it is not considered a deviation. However, if it is possible that ingredients, food additives and processing aids not meeting specifications have been used, the winery should initiate deviation/corrective action.

• Ingredients, food additives or processing aids arriving in dirty packaging are either rejected or packaging material cleaned before use.

Rating Examples I N/A II the winery has no specifications for critical ingredients, food

additives and processing aids the winery cannot demonstrate adherence, e.g., no monitoring program.

acceptance of non conforming ingredients, food additives and processing aids contaminated with excessive amounts, non hazardous avoidable material, e.g., insects

acceptance of non conforming ingredients, food additives and processing aids contaminated with hazardous foreign material, e.g., glass.

III no specifications for non critical ingredients, food additives and processing aids

for critical ingredients, food additives and processing aids no certificates of analysis but the winery has written specifications,

9

maintains a documented history of adherence and verifies adherence to specifications.

acceptance of non conforming ingredients, food additives and processing aids contaminated with non hazardous foreign material, e.g., dust, dirt.

References

10

5.1 MANUFACTURING CONTROLS 5.1.2 INCOMING MATERIAL CONTROL 5.1.2.2 Packaging Materials 5202 Task PRINCIPLE The winery controls incoming packaging materials to prevent

biological, chemical or physical contamination of the wine Assessment Criteria

• Packaging material, other than glass should be approved as food grade and listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" as published by the CFIA.

• Packaging materials shall comply with Division 23 - Food Packaging Materials of the Food and Drug Regulations.

• Packaging materials are properly protected on arrival. • Packaging material evaluations are carried out under the control of a

qualified person. • The winery has written specifications for corks, synthetic closures,

screw caps, cask valves and containers other than glass. • The winery verifies the adherence to specifications by each supplier.

A representative sample is taken to visually verify adherence to specifications at a scheduled frequency.

• The winery has a documented history of adherence to specifications for each supplier.

• A new history of adherence to specifications is established when a manufacturer changes suppliers, packaging materials or when spot checks do not agree with specifications.

• When packaging material is found not to meet specifications the manufacturer investigates and identifies the root cause. If the packaging material does not meet specifications but has not been used it is not considered a deviation. However, if it is possible that packaging material not meeting specifications has been used, the winery should initiate deviation/corrective action.

Rating Examples I N/A II packaging material contains substances which may be injurious to

consumers health. The packaging material does not comply with Division 23 of the Food and Drugs Regulations.

protective covering absent and evidence of hazardous extraneous material contamination found.

III periodic evaluation a representative sample is not taken to visually verify adherence to specifications.

the winery has specifications but cannot demonstrate adherence, e.g., no certification from the supplier or monitoring by the manufacturer is deficient.

the winery has no control over incoming packaging materials, e.g., no specifications, certification or monitoring.

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containers not adequately protected. e.g. Protective coverings for packaging materials damaged/missing.

References

12

5.1 MANUFACTURING CONTROLS 5.1.2 INCOMING MATERIAL CONTROL 5.1.2.3 Incoming Material Control Records 5203 Task PRINCIPLE The winery has records available that demonstrate the adequacy of

incoming material control. Assessment Criteria

• The minimum record requirements for the following monitoring and/or certification options are:

History of adherence to specifications, i.e., analytical results. Spot checks, i.e., analytical results.

• When incoming material do not meet specifications, the following information should be recorded;

Identification of the material. Identification of the deficiency. Preventative and corrective action taken.

Rating Examples I N/A II N/A III inaccurate, incomplete or absence of records which do not permit

verification of incoming materials controls. References

13

5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.1 Empty Packaging Material Handling - Bag-in-Box 5301 Task PRINCIPLE Empty packaging material handling is controlled to minimize damage

and to prevent the use of damaged, defective or contaminated packaging material.

Assessment Criteria

• The winery has an effective system in place to minimize damage and/or contamination and to prevent the use of damaged or defective packaging material

• The winery has an effective system in place to prevent the use of contaminated, damaged or defective unformed packaging material e.g., roll stock

• Packaging is handled and transferred in a manner that minimizes damage and contamination, e.g. forklifts, conveyors, transfer points, synchronization of line speed etc.

Rating Examples I N/A II N/A III inappropriate handling of packaging material in the establishment

causing damage/contamination e.g. rough handling, in-plant storage without protection.

References

14

5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.2 Empty Container Handling - Glass 5302 Task PRINCIPLE Empty glass container handling is controlled to minimize damage and

to prevent the use of damaged, defective or contaminated containers. Assessment Criteria

• The winery has an effective system in place to minimize damage and contamination. This must be accomplished through appropriate in-plant container handling:

• Containers are handled and transferred in a manner that minimizes damage and contamination, e.g., conveyors, transfer points.

• The winery must have an effective system in place to prevent the use of damaged, defective or contaminated containers. This can be accomplished through continuous visual monitoring

• Prior to depalletizing, or during the removal from cartons, glass containers are examined for damage, e.g., exterior pallet examination for damage of four sides.

• Empty containers are visually or electronically examined to identify, remove and segregate defective, damaged or contaminated containers during depalletizing or removal from cartons. The manner and frequency of examination should reflect the speed of the line, the ease of detecting probems and the history of finding problems.

• Type and number of defects are recorded (4.6.1.3). Visual inspection system:

adequate lighting is provided at inspection stations and an adequate system or method is in place to inspect containers

Electronic inspection system: defect standards are used to set up the system which reflects the defects expected and found on line

the electronic system is tested at a pre determined frequency using the defect standards to ensure proper operation

there is a back up system in place in case the electronic inspection system fails

Rating Examples I N/A II damaged and defective glass containers not removed. III bottles are not examined prior to depalletizing or removal from

cartons, however, other subsequent visual inspection is satisfactory. glass container handling damage control e.g., the winery has controls in place but does not verify the supplier's controls

the glass container handling damage control or visual monitoring program is absent or deficient such that defective containers may be used.

continuous visual monitoring deficiencies which prevent adequate

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inspection, e.g., insufficient lighting, excessive line speed. container handling damage control e.g., deficiencies in the control program which may result in use of seriously damaged containers.

containers used for purposes other than intended use. electronic inspection equipment is not functioning properly.

References

16

5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.3 Container Cleaning - New Bottles 5303 Task PRINCIPLE New bottle cleaning is controlled prior to filling to remove extraneous

material that may contaminate the wine. Assessment Criteria

• The winery has a system in place to ensure that only clean containers are filled.

• Containers are cleaned by inversion in conjunction with pressured air, water, steam or suction to remove extraneous material. Where water or steam are used, the water or steam shall be potable. Where detergent or sanitizers are used , they are used in accordance with the manufacturer's instructions and are listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.

• A container cleaning system should operate at all times that the line is in operation. It should be efficient in removing harmful extraneous material and be properly maintained, e.g., nozzles not plugged, free from accumulated debris.

• For small operations, manual inversion and examination of every container to ensure they are clean could be sufficient.

Rating Examples I hazardous extraneous material not removed e.g. glass > 2mm. II containers not inverted and evidence of contamination with harmful

extraneous material. no container cleaning system and evidence of major contamination with objectionable material.

III container cleaning system not fully operational, e.g., nozzles partially plugged.

References

17

5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.4 Container Examination and Cleaning - Barrels 5304 Task PRINCIPLE Reusable containers are examined and cleaned prior to filling to ensure

the containers are fit for use. Remove any material that may contaminate the product.

Assessment Criteria

• The winery has controls in place to examine and remove unacceptable reusable containers prior to use.

• Only containers previously used to contain wine products or reconditioned for use in the wine industry are utilized. All suspect containers are discarded.

• Damaged barrels are repaired or discarded. • The winery has a system in place to thoroughly clean bulk

containers before use. In place an effective cleaning system, e.g. High pressure washer, steam, etc.

Where water or steam are used, the water or steam is potable and the containers are inverted

Rating Examples I N/A II no container cleaning system and evidence of major contamination

with objectionable material (wine residues, soil, insects). history of containers is unknown.

III container cleaning system not effective no barrel inspection system.

References

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5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.5 Empty Container Records 5305 Task PRINCIPLE Records of empty container usage and control by lot are maintained. Assessment Criteria

• Empty Container Usage The winery records the date and lot number or retains the pallet tag to permit lot traceability.

• Container Damage Records are kept of the defects identified at the depalletizer or taking from cartons inspection

The winery retains records of internal and vendor audit reports. The winery maintains records of major activities related to container handling damage. For example, investigation reports including identification and scope of problems and the corrective action taken to minimize the possibility of recurrence.

Rating Examples I N/A II N/A III records are incomplete or absent, e.g., no lot traceability. References

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5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.6 Glass Breakage Procedure 5306 Task PRINCIPLE The winery has an effective glass breakage control procedure

developed for their operations. Assessment Criteria

• The winery has a written procedure developed for each line where glass is used (related to the speed of the line, the bottle size).

• The glass breakage procedure specifies: who is responsible the line where it applies the immediate action to initiate when a glass breakage occur (e.g., stop the line);

the number of bottles (or length of conveyor) to reject from the line (empty bottles, filled bottles, closed bottles) depending on where the breakage occurs

the cleaning procedure for the piece of equipment or conveyor and surrounding area where the breakage occurred (e.g., cleaning material to use)

evaluation of the cause of breakage disposal of the glass bottles and affected product

• The glass breakage procedure has to be available to the production employees.

• If product is recycled, any glass particle is effectively removed. • Any other glass breakage occurrences (e.g. from glass bulbs,

thermometers, etc.) are to be covered by this procedure. NOTE: The application of the glass breakage procedure is evaluated within the process step ( filling, closure etc.).

Rating Examples I N/A II no written glass breakage procedure. III glass breakage procedure not available to production employees.

incomplete glass breakage procedure. References

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5.1 MANUFACTURING CONTROLS 5.1.3 IN-PROCESS PACKAGE CONTROL 5.1.3.7 Glass Breakage Records 5307 Task PRINCIPLE Glass breakage records are maintained. Assessment Criteria

• Records are available and demonstrate control of broken glass and affected product.

• Glass breakage records must include: the date/time, where it occurred, corrective action taken, responsible person initials or signature

Rating Examples I N/A II N/A III insufficient information on records (information available does not

permit confirmation of the adequacy of glass clean up). References

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5.1 MANUFACTURING CONTROLS 5.1.4 PRODUCT PREPARATION 5.1.4.1 Raw Product Cleaning Control 5401 Task PRINCIPLE Raw materials and raw material containers are prepared in such a

manner as to prevent contamination that may lead to hazards or contamination in the finished product.

Assessment Criteria

• The winery controls the following hazardous materials, where appropriate, using the following means:

Applying control practices in the vineyard or through assurances/testing by supplier

Metal contamination controls, e.g., magnets. • The winery cleans raw material containers before sending them back

to the grower • The winery removes the non hazardous extraneous materials, e.g.,

vegetative material such as, insects, wood or plastic material, etc. by mechanical means, sorting, or filtering or juice settling.

Rating Examples I N/A II contamination concern, e.g.i.e., high risk of contamination with

avoidable filth, chemical residues, insect material plastic material, metal objects, etc.

III inadequate control of the removal of non hazardous contaminants e.g., filtering of juice is ineffective.

References

22

5.1 MANUFACTURING CONTROLS 5.1.4 PRODUCT PREPARATION 5.1.4.2 Transferring Wine 5402 Task PRINCIPLE Transferring wine is controlled to minimize physical hazards. Assessment Criteria

• The winery has controls in place to prevent physical hazards from contaminating the wine;

all flexible transfer hoses are stored in a manner that allows self-draining

all fixed pipelines are clearly labeled or identified to prevent confusion. They are completely free draining so as to prevent any retention of residual pockets of wine.

connecting ends of transfer hoses or pipes are kept off the floor all transfer hoses and pipes are flushed with potable water before use to ensure freedom from foreign material.

Rating Examples I N/A II transfer hose end lying on floor in puddle of water where drain is

plugged III transfer hose not properly drained after use.

transfer hose not rinsed with potable water before use. References

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5.1 MANUFACTURING CONTROLS 5.1.4 PRODUCT PREPARATION 5.1.4.3 Filtering Wine 5403 Task PRINCIPLE Although filtering is not always necessary in wine production, when

used, filtering is controlled during preparation to minimize physical hazards.

Assessment Criteria

• The winery has controls in place to prevent physical hazards from contaminating the wine;

filters are made of approved material listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada,

filters are the correct size to filter the undesirable extraneous material from the wine,

equipment is set up such that nothing causes the filter to lose its integrity or leak,

filters are cleaned or replaced at an adequate frequency to ensure efficient removal of any undesirable material.

• Fining and settling are sometimes used instead of filtering. • When wine is filtered, it is carried out immediately prior to filling

using suitable filtering materials. Rating Examples I N/A II filters are wrong size or type to remove the undesirable extraneous

material from the wine III lack of control of filtering equipment resulting in filter damage and

leakage frequency of filter cleaning or changing insufficient.

References

24

5.1 MANUFACTURING CONTROLS 5.1.4 PRODUCT PREPARATION 5.1.4.4 Quality Specifications Control 5404 Task PRINCIPLE The winery has controls in place to ensure product VQA and Regional

wines meet quality specifications and regulatory requirements. Assessment Criteria

• The winery controls the preparation and blending activities to ensure the VQA and Regional wines meets the requirements of the following analytical tests, where applicable. The following tests are performed by an accredited laboratory in accordance with the Recueil des methods internationals d’analyse des vins et des moûts, published by the Office international de la vigne et du vin (OIV) and if those publications do not provide the applicable tests, in accordance with the latest edition of Applicable Methods of the Association of Official Analytical Chemists (AOAC)

per cent alcohol by volume (@ 20ºC) total acid level calculated as tartaric acid level of volatile acidity total sulfur dioxide level. residual sugar level

• The winery controls the preparation and blending activities to ensure the wine passes the organoleptic evaluation of the evaluation taste panel meeting the required qualifications, where applicable.

Rating Examples I N/A II wine lot does not meet the requirements of the appellation declared,

according to the analytical results III analysis results meet requirements but the laboratory is not

accredited or the methods used are not those prescribed References

25

5.1 MANUFACTURING CONTROLS 5.1.5 CONTAINER FILLING AND CLOSURE CONTROL 5.1.5.1 Standard Containers Sizes and Net Quantity 5501 Task PRINCIPLE Container sizes and fill are controlled to meet the requirements of the

Consumer Packaging & Labelling Regulations (CP&LR). Assessment Criteria

• The winery uses containers that meet the prescribed container sizes in the CP&LR (unless for export).

• The winery fills the containers in compliance with the requirements in the CP&LR.

Rating Examples I N/A II N/A III winery uses container sizes not prescribed in the CP&LR

fill volume is not controlled to meet the declared net quantity requirements

References

26

5.1 MANUFACTURING CONTROLS 5.1.5 CONTAINER FILLING AND CLOSURE CONTROL 5.1.5.2 Filling and Corking/Capping of Glass Containers 5502 Task PRINCIPLE Controls are in place to prevent damage or breakage of glass containers

during the filling and corking/capping operations, and to ensure an adequate closure.

Assessment Criteria

• The winery controls the glass breakage in the container filling and closing equipment area by:

Checking alignment and timing of filling and closing machines before operation

Monitoring filling and closing areas regularly for broken glass. Removal of any broken glass. Tearing down of equipment to the extent necessary to remove the potential for glass contamination i.e., seal, rubbers, valve blow outs, valve dismantling.

Continuous monitoring of filled containers and closures to eliminate closing area interference, e.g., visual or electronic examination.

Evaluation of the effectiveness of continuous monitoring, e.g., quality assurance checks.

• Bottles are closed immediately after filling. • The winery controls the closing equipment to ensure the integrity of

the container and the closure by protecting the cork/cap hopper from contamination by glass fragments, cork dust or cork/cap bag material.

• Monitoring closures and adjusting closure heads based on the findings of the monitoring.

Rating Examples I broken glass found in bottles II filling area not inspected regularly for broken glass.

no monitoring of filling/closing area for glass III no effectiveness monitoring after closing

paper from the cap bags found in hopper References

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5.1 MANUFACTURING CONTROLS 5.1.5 CONTAINER FILLING AND CLOSURE CONTROL 5.1.5.3 Filling and sealing of Bag-in-Box Packaging 5503 Task PRINCIPLE Controls are in place to prevent contamination of the wine, to avoid

damage to the bag and to effect an adequate seal. Assessment Criteria

• All wine bags and cask valves are handled in a manner to avoid damage during filling.

• All wine bags are evacuated before filling. • Overfill spillage is promptly cleaned up. • Bags are closed immediately after filling. • Sealing surfaces are kept clean and secure. • Closures are monitored and adjustments are made to the closing

operation based on the results. Rating Examples I N/A II N/A III wine bags are being damaged by the filling machine

wine spillage at filler not cleaned up wine leaking from the cask valves at the seal.

References

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5.1 MANUFACTURING CONTROLS 5.1.6 CONTAINER CODING 5.1.6.1 Coding Control 5601 Task PRINCIPLE Coding is controlled to ensure legibility. Assessment Criteria

• Coding on individual containers of wine is not mandatory, but strongly encouraged to be able to minimize the quantity of wine affected if a recall is necessary.

• Batch codes are changed frequently (not less than daily) enough to facilitate trace-back or recall. Where the batch code contains a date, it is checked for accuracy.

• Code marks used and the exact meaning of the code are available to the inspector.

Rating Examples I N/A II N/A III no coding or illegible codes identified observed. References

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5.1 MANUFACTURING CONTROLS 5.1.7 VERIFICATION OF SAFETY AND QUALITY 5.1.7.1 Verification of Product Safety and Quality 5701 Task PRINCIPLE The winery uses supplementary methods of evaluation to verify the

effectiveness of controls affecting product safety and quality. Assessment Criteria

• The winery should verify the effectiveness of controls affecting product safety and quality.

NOTE: Where appropriate, verification applies to all sections of the standard. • Examples of Verification Methods:

Sampling and analysis of in process and finished product for the potential chemical, microbiological or physical hazards.

Independent, external audits. Internal audits. Analysis of consumer complaint trends. Vendor audits.

• Frequency of Verification: The winery conducts verification measures at a sufficient frequency to validate the effectiveness of the winery controls.

• Responsibility for Verification: Individuals or organizations responsible for verification are identified

These individuals or organizations are suitably qualified. Rating Examples I N/A II N/A III frequency of verification is not adequate.

no consumer complaint trend analysis. no verification of the effectiveness of winery controls.

References