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Terms of Reference for the Microbiological Methods Committee

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Terms of Reference
June 2010

Micro_methods_committee@hc-sc.gc.ca

Introduction:

The purpose of this document is to provide interested parties with information on the mandate, structure and roles of the Microbiological Methods Committee (MMC) and its components, (i.e., the Steering Committee [SC] and Technical Groups [TG]).

Mandate of the MMC:

To provide methodology which can be used in support of Health Canada (HC) and Canadian Food Inspection Agency (CFIA) mandates (as described on their respective websites: www.hc-sc.gc.ca and Next link will take you to another Web site www.inspection.gc.ca) in overseeing the safety of the Canadian food supply.

Objective of the MMC:

To ensure that methodology is reviewed in a timely, objective and transparent manner, and has undergone appropriate validation and testing for ruggedness based on sound science and is fit for purpose.

The term MMC refers to the whole committee, which is comprised of two components; the SC and TGs. There is representation from both HC and CFIA in the SC and TGs. See Diagram in Appendix 1 and later sections describing membership of the SC and TG.

Roles of the Steering Committee:

  1. To represent their Department or Agency, acting as liaison between the SC and members of their respective Department or Agency.
  2. To obtain necessary management approvals from respective departments, if required.
  3. To attend SC meetings1 as required. The representatives should be fully aware of the issues to be discussed.
  4. To regularly assess and determine which methods should be considered for inclusion in the Compendium of Analytical Methods2 and/or upgrading, archiving, in consultation with SC member=s management,science committees, TGs, etc. See Procedure for the Development and Management of Food Microbiological Methods Part 1: Definitions and Explanations of Methods and General Procedures in the Compendium of Analytical Methods2.
  5. To define, publish and communicate criteria for acceptance of methods and other supporting documents for the Compendium of Analytical Methods3.
  6. To review and endorse final reports and recommendations submitted by TGs against approved criteria for completeness and scientific soundness. As required, the SC will consider policies and other documents when finalizing recommendations. HC and CFIA management will be consulted at the discretion of the SC members.
  7. To determine if a method meets specific criteria that support its upgrade to a higher status in the Compendium of Analytical Methods, as recommended by the TG.
  8. To endorse requests for comparative and collaborative studies4.
  9. To solicit input and review methodology needs and concerns from stakeholders5.
  10. To establish TGs, identify appropriate representation from their respective Department or agency, and to ensure that the TGs remain active in the performance of their tasks.
  11. To ensure a process is in place for a re-assessment of methods at least every five years.
  12. To resolve any outstanding issues that may arise from the work of a TG.
  13. To identify methods that may require a priority review, e.g., based on health and safety issues.

Roles of the Chair of the Steering Committee:

  1. To facilitate SC meetings and SC-related activities.
  2. To coordinate the development and publication of material in the Compendium of Analytical Methods.
  3. To identify to the SC, methods that require review (e.g., have not been reviewed for 5 years, methods of concern, etc.).
  4. To arrange for appropriate and timely publication of methods on the HC website.
  5. To assign a Secretary for the recording, editing and distribution of the Minutes.
  6. To draft meeting agendas, based on Minutes and to forward all new activities and requests to the SC. Coordinate the recording, distribution and editing of the drafts and final Minutes of the SC meeting.
  7. A Vice-Chair (an SC member, appointed by the SC) may assist in all of the above duties if needed, and may perform all these duties when the Chair is unavailable.
  8. To process submissions received from various stakeholders.

Roles of Members of the Technical Groups:

Using standardized protocols approved by the SC:

  1. To provide technical expertise to the SC. The TGs will be formed on demand, and may be set up for a short period of time (e.g., review of a specific method) or be involved in the set up of a long-term comparative work and collaborative studies. E.g., developing criteria for validation, criteria for validation packages, etc.
  2. To elect a lead from the core TG, among the HC and CFIA members. The lead will be responsible for meeting deadlines and time frames established by the TG in consultation with the SC. The lead will be responsible for submitting the final report and recommendations of the TG to the SC. SC members should not be the lead of a TG, unless there are exceptional circumstances that require them to be a lead.
  3. As required, identify and include appropriate representation of qualified scientific experts from across the country.
  4. The TGs will be assigned the task of planning, monitoring, evaluating and reporting the findings of comparative work and collaborative studies and other method related projects.
  5. To review, evaluate, edit and provide assessment of methods (and supporting documents) in their specific area of expertise, including recommending to the SC whether the methods meet the established criteria.  Comments and recommendations to the SC will be based upon scientific data.
  6. Complete all aspects of the method review (e.g., review of data, review of method write-up etc.) within the time frame established by the SC.
  7. To take into account the need to harmonize with domestic and international standards whenever possible.
  8. The lead of a TG will document and tabulate the recommendations and concerns of TG members.  The final recommendations, which will be forwarded to the SC, will be based upon consensus6 within the TG as long as concerns have been addressed by a scientific rationale.
  9. If consensus cannot be reached, the lead of the TG will consult with the Chair of the MMC, who will discuss the issues with SC members. If the SC still cannot reach consensus, the issue may need to be discussed with management outside of the MMC.

Duties of the Secretary of the MMC:

The Secretary assists:

  1. In facilitating the semi-annual SC meeting and/or interactions via e-mail or teleconference.
  2. In the recording, distribution and editing of the drafts and final Minutes of the SC meeting. Also collates and follows-up on all activities and action items from the SC meetings.
  3. In recording and maintaining proper documentation arising from the leads of the TGs. The Secretary may also act as a liaison between the TG and the Chair of the SC.
  4. In drafting the SC meeting agendas and soliciting new agenda items from TGs.

Membership:

Membership of MMC/SC:

The SC consists of the Chair, in addition to 2 appointed members from each of HC and CFIA. A Secretary may be appointed from within this group, or be an additional person appointed as a non-voting member.

Membership of TGs

The TG should consist of at least one CFIA contact and one HC contact as identified by their respective departments. Other TG members may be identified by the respective agencies as appropriate. At a minimum, it will consist of scientific expert(s) within CFIA and HC, and could include scientific experts from Federal and Provincial agencies, academia, as well as international organizations etc. All TG members should be subject matter experts appropriate to the document/issue under discussion. The TG members identified by CFIA and HC would appoint a lead and determine the appropriate additional representation.

Invited Guests to the MMC (both SC AND TG):

Guests (TG members, scientists, management, etc.) could be invited to provide data, technical and other expertise pertaining to method development. Guests will be listed as participants on the agenda.


1 Extensive consultation (via E-mail and telephone) will be done between meetings, when appropriate.

2 http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/index-eng.php

3 http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/index-eng.php

4 A Collaborative study is designed to evaluate the performance of a method through the analysis of a number of identical samples by a number of different laboratories. A comparative study is used to select a method from a number of apparently equivalent methods, provided the purpose is known beforehand. See the document on 'method development' for further explanation.

5 Stakeholders include, but are not limited to, those organizations using or that have interest in the methods described in the Compendium of Analytical Methods. These organizations include federal and provincial laboratories, trade and industry associations, private laboratories, the food industry and commercial developers of methods.

6 Consensus: decision process that takes into account all data, information, views available at the time and reconcile, if needed, any conflicting argument so that a general science-based agreement can be reached by the group

Appendix 1 - MMC Structure