On-Farm Food Safety Regulation

On-Farm Food Safety Regulation, M.R. 41/2003 The Livestock and Livestock Products Act , C.C.S.M. c. L170 Regulation 41/2003 Registered March 3, 2003 bilingual version (HTML) Table of Contents 1 Definitions and interpretation 2 Authorized programs 3 Qualifications of an auditing organization 4 Auditors' qualifications 5 Suspension by director 6 Additional duties of auditors 7 Additional duties of inspectors 8 Sharing of information Schedule Definitions and interpretation 1(1) In this regulation, "Act" means The Livestock and Livestock Products Act ; («  Loi  ») "auditing organization" means an organization authorized by an agreement under section 24 of the Act to administer an authorized program; (« organisme de vérification ») "auditing organization representative" means a person in a position of authority or a responsible position with an auditing organization; (« représentant d'organisme de vérification ») "authorized program" means an on-farm food safety program for which the director has granted authorized status under subsection 2(1); (« programme autorisé ») " Codex Alimentarius " means the Codex Alimentarius , 2nd edition, published under the joint FAO/WHO Food Standards Programme by the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and the World Health Organization, as amended from time to time; («  Codex Alimentarius ») "corrective action plan" means a formal written reply to a corrective action request setting out the details of the actions to be taken by the person or organization submitting the plan in order to correct a non-conformity identified in the corrective action request; (« plan de mesures correctives ») "corrective action request" means a formal written request from (a) an auditor to a unit representative, or (b) an inspector to an auditor or auditing organization representative, for action to be taken to correct a non-conformity identified during an audit; (« demande de mesures correctives ») "critical control point" means a point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to an acceptable level; (« point de contrôle critique ») "critical limit" means a value that separates acceptability from non-acceptability; (« limite critique ») "direct or indirect ownership or other financial interest in a unit" does not include providing professional or other services to a unit on a fee for service basis or providing products to or for a unit in exchange for benefits of any kind; (« droit de propriété direct ou indirect ou autre intérêt financier dans une unité ») "family member" means (a) the spouse of an individual, (b) the son, daughter, brother, sister, parent, grandparent, uncle, aunt, niece, nephew or cousin of an individual, and (c) the spouse of a person mentioned in clause (b); (« membre de la famille ») "farm" means a place or facility at or in which primary livestock products are produced or processed, or livestock are raised, kept or processed, or any combination of the foregoing, and includes a unit; (« ferme ») "hazard" means a condition, substance or thing that has the potential to cause harm to living things; (« danger ») "non-conformity" means a failure to meet the requirements of (a) an authorized program, or (b) the Act or the regulations under the Act; (« non-conformité ») "operator" , in relation to a unit that is not directly operated by its owner, means the person who is authorized by the owner to manage the unit's day-to-day operations; (« exploitant ») "primary livestock production" means the production of a primary livestock product; (« production d'un produit primaire de la ferme ») "primary livestock products" means livestock, or primary commodities derived from livestock, that are intended for human consumption; (« produit primaire de la ferme ») "system" means a primary livestock production system containing a series of steps in the food chain leading to a primary livestock product; (« système ») "unit" means a single primary livestock production place that has the following unique characteristics: (a) a distinct geographic location, (b) a specific primary livestock production system, (c) a distinct management team; (« unité ») "unit representative" means a person in a position of authority or a responsible position at a unit. (« représentant d'unité ») 1(2) Except where this regulation provides to the contrary, words used in this regulation have the same meaning as the same words have in Section 7.5 of Supplement 1 to Volume 1 of the Codex Alimentarius . Authorized programs 2(1) The director may grant authorized status for an on-farm food safety program (a) that is based on the Hazard Analysis Critical Control Point (HACCP) System as set out in the Codex Alimentarius ; (b) that is implemented in a manner that is consistent with the Guidelines for the Application of the Hazard Analysis Critical Control Point (HACCP) System set out in Section 7.5 of Supplement 1 to Volume 1 of the Codex Alimentarius ; and (c) that meets or exceeds the following requirements: (i) is specific for a particular primary livestock product, (ii) is based on a generic model of a system for that particular primary livestock product, (iii) involves a set of prerequisite program procedures that effectively create an environment favourable to the production of a safe primary livestock product, (iv) is based on the Canadian Food Inspection Agency (CFIA) Food Safety Enhancement Program (FSEP), (v) is based on a hazard analysis that identifies the physical, chemical and biological food safety hazards reasonably likely to occur in the generic model of the system, (vi) sets out in writing the critical control points for each of the identified physical, chemical and biological food safety hazards, including, without limitation, (A) critical control points designed to control physical, chemical and biological food safety hazards that could be introduced into a typical unit for that primary livestock product, (B) critical control points designed to control physical, chemical and biological food safety hazards that could occur in the system, and (C) critical control points designed to control physical, chemical and biological food safety hazards that, if not controlled in or at the unit, may result in a food safety hazard after the livestock product leaves the unit, (vii) sets out in writing the critical limits that must be met at each of the critical control points, (viii) sets out in writing the procedures to be performed to ensure compliance with the critical limits, the frequency with which those procedures will be performed, and how they will be monitored, (ix) requires the keeping of records that document the scientific monitoring of critical control points in the system, (x) sets out in writing all corrective actions that are to be followed in response to any deviation from a critical limit at a critical control point, (xi) requires the performance of verification procedures, (xii) sets out in writing the verification procedures and the frequency with which the verification procedures shall be performed, (xiii) provides a standard manual that allows an individual unit to design a written, individual on-farm food safety program to address for that unit all the physical, chemical and biological food safety hazards identified in the generic model of the system. 2(2) The director may refuse to grant authorized status for an on-farm food safety program that does not meet the requirements of subsection (1). 2(3) When the director grants authorized status for an on-farm food safety program, he or she shall issue an authorized program certificate for it. An authorized program certificate shall be in the form set out in the Schedule. 2(4) No authorized on-farm food safety program shall be changed without the director's prior written approval. 2(5) The director shall review each authorized program on a triennial basis to determine if the program continues to meet the requirements of subsection (1). 2(6) If after a review, or otherwise, the director determines that an authorized program is not continuing or has failed to meet the requirements of subsection (1), the director may suspend or terminate the program's authorization. 2(7) If the director suspends or terminates the authorization of an on-farm food safety program, he or she shall (a) notify in writing the person or organization that obtained the authorization; and (b) publish a notice of the suspension or termination in one issue each of The Manitoba Co-operator and another newspaper of general circulation in Manitoba. 2(8) If the director suspends or terminates the authorization of an on-farm food safety program, the person or organization, if any, that is in possession of the authorized program certificate shall return it to the director on demand. Qualifications of an auditing organization 3 In order to qualify to be an auditing organization under section 24 of the Act, an organization must, at a minimum, (a) be a body corporate or other legal entity and provide the director with proof of its legal status satisfactory to the director; (b) have general liability and errors and omissions insurance acceptable to the director in the following minimum amounts: (i) $5 million as to general liability, and (ii) $5 million as to errors and omissions; (c) not have a direct or indirect ownership or other financial interest in a unit that is or may be recognized under the program or the primary livestock product of such a unit; (d) have a governing board or council whose decisions are incapable of being controlled by the owner of an individual unit that is or may be recognized under the program; (e) have a written policy acceptable to the director that requires a board or council member to disqualify himself or herself from voting on any decision about the recognition, or the suspension or cancellation of recognition, of a unit in which he or she or a member of his or her family has a direct or indirect ownership or other financial interest; (f) demonstrate the ability to be impartial in carrying out its duties and functions as an auditing organization, including the recognition of units and the accreditation of auditors, and carry out those duties and functions impartially; (g) have the financial and human resources, stability and organizational structure that the director considers necessary to carry out the duties and functions of an auditing organization; (h) have a procedure acceptable to the director for evaluating the competence and performance of outside experts; (i) have policies and procedures that clearly distinguish among unit recognition, auditor accreditation and the other functions and duties of the organization as an auditing organization; (j) have a management system acceptable to the director, including a management manual for delivery of the program; (k) have detailed, written procedures for the key elements of its operation, including recognition of units, accreditation of auditors, revocation or suspension of recognition or accreditation, training, and handling appeals, disputes and complaints; (l) maintain a comprehensive system of records in relation to its operation; and (m) be able to process applications for unit recognition from any part of Manitoba in both official languages. Auditors' qualifications 4(1) No person may be designated as an auditor under subsection 4(2) of the Act for the purpose of auditing an authorized program unless that person (a) holds a two-year technical diploma or higher degree in a science or agricultural discipline acceptable to the director; (b) successfully completes a course of instruction approved by the director (i) in the application of the seven HACCP principles set out in Section 7.5 of Supplement 1 to Volume 1 of the Codex Alimentarius , and (ii) in auditing techniques for HACCP programs; (c) successfully completes a training course on the on-farm food safety program approved by the director; (d) is accredited with the auditing organization responsible for the administration of the on-farm food safety program; (e) declares in writing that he or she is not disqualified under subsection (3); and (f) has general liability and errors and omissions insurance acceptable to the director in the following minimum amounts: (i) $2 million as to general liability, and (ii) $1 million as to errors and omissions. 4(2) An auditor may satisfy the requirements of clause (1)⁠(f) by providing the director with evidence acceptable to the director that the auditor is covered under the auditing organization's insurance under clause 3(b) and that the coverage is equivalent to that required under clause (1)⁠(f). 4(3) A designated auditor shall every three years after his or her designation successfully update the instruction and training required under clauses (1)⁠(b) and (c). 4(4) No person may be designated as an auditor under subsection 4(2) of the Act in relation to an authorized program if that person (a) has a direct or indirect ownership or other financial interest in a unit that is or may be recognized under the program or the primary livestock product of such a unit; or (b) is employed by a person who has such an ownership or other financial interest. Suspension by director 5(1) The director may suspend designation of an auditor who fails to comply with subsection 4(2) or to carry out his or her functions as an auditor in accordance with this regulation and the authorized program in relation to which the auditor has been designated. 5(2) Where the director suspends the designation of an auditor in relation to an authorized program, he shall without delay notify the auditing organization of the fact of the suspension. Additional duties of auditors 6(1) For the purposes of section 9 of the Act, an auditor has the following duties in relation to an authorized program in respect of which the auditor has been designated: (a) to audit the compliance status of a unit recognized, or seeking to be recognized, as being in compliance with the program by doing the following or any other examination, observation, audit, analysis, evaluation, study or verification under the program: (i) determining if the unit manual for the unit on file with the auditing organization is in compliance with the program, (ii) determining if a unit manual, dated and signed by a unit representative, has been received from the unit (A) at the time the unit initially seeks recognition under the program, (B) at any time that there is or ought to be a modification in any of the information set out in the unit manual, (C) at any time that there is a change in the unit's operations requiring a modification of any of the information set out in the unit manual, and (D) at any other time required under the program, (iii) interviewing as many unit representatives as the auditor considers necessary to effectively carry out his or her duties and functions as an auditor, (iv) auditing the unit's system in relation to the authorized program, (v) examining and studying the records that the unit is required to keep under the program in order to determine if the records accurately reflect the daily operations of the unit, (vi) collecting product samples for further investigation in order to determine if critical limits are being met, (b) to assess the compliance of a unit with the requirements of the program on the basis of the results of the audit referred to in clause (a) and to provide the auditing organization with a complete and accurate report on the audit and assessment; (c) to issue a corrective action request to the unit in relation to any non-conformity identified as a result of the audit; (d) where a corrective action request is issued, to obtain a corrective action plan from the unit, dated and signed by a unit representative, and, if the auditor is unable to obtain such a plan, to advise the auditing organization of that failure; (e) to assess each corrective action plan received from the unit and determine whether the plan resolves the unit's non-conformity and, if the plan is deficient, to obtain an appropriately amended plan from the unit that will have the effect of resolving the non-conformity; (f) to determine whether the unit fully executes each corrective action plan it submits within the time required by the auditing organization and, where the unit fails to do so, to advise the auditing organization of that failure; (g) to send all completed documents including audit reports, corrective action requests and corrective action plans to the auditing organization within 24 hours of their completion or the auditor's receipt of them; (h) to provide all files on units audited to the auditing organization without delay if the auditor's designation or accreditation in relation to the program is cancelled or suspended; (i) where the auditor is audited by an inspector, to submit to the inspector without delay a corrective action plan in relation to any non-conformity identified as a result of the audit; (j) to ensure that all corrective action requests made by an inspector to the auditor are complied with within the required time and to the satisfaction of the inspector; (k) to carry out such other duties and functions as are required by the auditing organization of the program for the purposes of the program; (l) to perform all the duties set out or provided for in clauses (a) to (k) in a professional and competent manner in accordance with the standards of the program. 6(2) A designated auditor (a) shall impartially carry out his or her duties and functions as a auditor; (b) without limiting the generality of clause (a), shall not carry out his or her duties and functions as auditor in relation to a unit (i) in which, or in the primary livestock product of which, a family member of the auditor has a direct or indirect ownership or other financial interest, (ii) to or for which the auditor, a professional or business partner of the auditor, or the auditor's employer provides (A) professional or other services on a fee-for-service basis, or (B) products in exchange for benefits of any kind, or (iii) with the owner or manager of which the auditor has a business or financial relationship other than as an auditor; and (c) shall not carry out his or her functions and duties as an auditor in relation to an authorized program while (i) his or her designation, or accreditation, in relation to that program is suspended or cancelled, or (ii) he or she does not have insurance coverage that meets the requirements of clause 4(f). 6(3) Clause 6(b) does not apply to an auditor who is a member in good standing of a self-governing professional organization that has a code of professional ethics that is acceptable to the director. Additional duties of inspectors 7 For the purposes of section 9 of the Act, an inspector has the following duties in relation to an authorized program: (a) to audit the compliance status of the auditing organization by doing the following or any other examination, observation, audit, analysis, evaluation, study or verification under the program: (i) determining if the auditing organization is in compliance with section 3, (ii) interviewing as many auditing organization representatives as the inspector considers necessary to effectively carry out his or her duties and functions as an inspector, (iii) examining and studying the auditing organization's records in relation to the program to determine if the records are in accordance with the requirements of the program and this regulation; (b) to assess the compliance of the auditing organization with the requirements of the program on the basis of the results of the audit referred to in clause (a) and to provide the director with a complete and accurate report on the audit and assessment; (c) to notify each unit recognized by the auditing organization if the auditing organization ceases to be authorized to administer the on-farm food safety program in relation to which the unit was recognized; (d) to notify each designated auditor accredited by the auditing organization if the auditing organization ceases to be authorized to administer the on-farm food safety program in relation to which the auditor was accredited and designated; (e) to issue a corrective action request to the auditing organization in relation to any non-conformity identified as a result of an audit of the auditing organization; (f) where a corrective action request is issued to an auditing organization, to obtain a corrective action plan from the auditing organization and, if the inspector is unable to obtain a plan, to advise the director of that failure; (g) to assess each corrective action plan received from the auditing organization and determine whether the plan resolves the organization's non-conformity and, if the plan is deficient, to obtain an appropriately amended plan from the organization that will have the effect of resolving the non-conformity; (h) to determine whether the auditing organization fully executes each corrective action plan it submits within the time required by the director and, where the organization fails to do so, to advise the director of that failure; (i) to audit the compliance status of each auditor designated and accredited in relation to the program by doing any of the following or any other examination, observation, audit, analysis, evaluation, study or verification under the program: (i) determining if the unit manuals of units audited by the auditor are in compliance with the program, (ii) interviewing the auditor, (iii) conducting an on-site audit of a number of units, determined by the director, audited by the auditor in the previous year, to determine if the unit manuals, audit reports, corrective action requests and corrective action plans submitted by the auditor in relation to those units accurately reflect the daily operations of the units and the auditor's activities, by doing the following or any other examination, observation, audit, analysis, evaluation, study, or verification under the program: (A) interviewing as many unit representatives as the inspector considers necessary to carry out his or her duties and functions as inspector, (B) auditing the system of each unit in relation to the authorized program, (C) examining and studying the records that the units are required to keep under the program to determine if the records accurately reflect the daily operations of the units, (D) collecting product samples for further investigation in order to determine if critical limits are being met, (E) determining if the bio-security protocols of the units are being followed; (j) to assess the compliance of each auditor with the requirements of the program on the basis of the results of the audit referred to in clause (i) and to provide the auditing organization with a complete and accurate report on the audit and assessment; (k) to issue a corrective action request to an auditor in relation to any non-conformity identified as a result of an audit of the auditor; (l) where a corrective action request is issued, to obtain a corrective action plan from the auditor, dated and signed by the auditor, and, if the inspector is unable to obtain a plan, to advise the auditing organization and the director of that failure; (m) to assess each corrective action plan received from an auditor and determine whether the plan resolves the auditor's non-conformity and, if the plan is deficient, to obtain an appropriately amended plan from the auditor that will have the effect of resolving the non-conformity; (n) to determine whether an auditor fully executes each corrective action plan he or she submits within the time required and, where the auditor fails to do so, to advise the auditing organization and the director of that failure; (o) to audit the compliance status of each auditor at least once per year; (p) to provide a copy of the audit report and any corrective action request to the auditor being audited; (q) to ensure all audit reports, corrective action requests and corrective action plans relating to auditors are sent to the auditing organization within 24 hours of their completion; (r) to complete reports and records, and retain copies of those reports and records, as required under the program; (s) to inform the director in the event that (i) an auditor obstructs or attempts to obstruct the inspector in the performance of the inspector's duties and functions; or (ii) it has been 13 months or more since the last audit of an auditor. Sharing of information 8 When the director believes on reasonable grounds that sharing information will promote the safety and integrity of primary livestock products, the director may share information about an audit, examination, observation, analysis, evaluation, study or verification of a unit, designated auditor, auditing organization or authorized program with one or more of the following: (a) another department or agency of the Government of Manitoba; (b) another government, including a municipality; (c) an agency of another government; (d) an auditing organization; (e) an organization that represents the interests of producers; (f) a person, organization or entity. SCHEDULE Authorized Program Certificate