Development of Methods

July 2012

Health Products and Food Branch

Ottawa

Guidelines for Modifying or Revoking Food Microbiological Methods

Microbiological Methods Committee

Bureau of Microbial Hazards, Food Directorate
Health Products and Food Branch, Postal Locator: 2204E
Ottawa, Ontario K1A 0K9

Contact the Microbiology Methods Committee: mmc-cmm@hc-sc.gc.ca

1. Scope

This document outlines the process that will be used by the Microbiological Methods
Committee (MMC) to revoke methods published in the Compendium of Analytical Methods
that are no longer current, available, accurate as published, or do not perform as written.
These guidelines can also be used by method developers who wish to submit a modification
to a method published in the Compendium of Analytical Methods. These guidelines are not
applicable to Official Methods (MFOs).

2. Review of Published Methods

MFHPB and MFLP methods are to be reviewed every 5 years. During the process of this
review, the original developer of the method will be contacted to provide a written record of
any changes that have been made to the method, as published, or to its equipment, supplies,
reagents, or package insert. Additional stakeholders, such as current users of the method or
subject matter experts, may also be contacted as appropriate.

It is the responsibility of the method developer to submit any modification to their method to
the MMC in writing for consideration, before distribution of the modified product.

Methods for which this information is not made available could be subject to removal or
revocation as outlined below.

3. Modifications of Validated Methods

When a modification to an already published validated method is brought to the attention of

the MMC, the modification will be considered if there is documented evidence that the
modification has no detrimental effect. The magnitude of work needed to provide the
appropriate documented evidence is related to the type of the proposed modification.
Contact the MMC for further information on the classification of method modifications.

The modification should be provided along with all relevant documentation, including the
rationale for the modification, supporting data and accompanying documentation, current and

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proposed revision of package inserts, and the written method indicating the proposed
changes.

In certain situations, the MMC receives method modifications from third parties. The MMC
will notify or consult with the method developer in these situations, as appropriate, depending
upon the specific circumstances and the urgency and severity of the problem.

3.1 Substantial revision

This is a major change that significantly affects the performance parameters of the
method, such as a modified enrichment procedure. The substantially revised (new)
method replaces the old method.

Substantially revised MFHPB methods must be subjected to a comparative study or a

collaborative study. Substantially revised MFHPB methods may not be able to retain
their status and could be downgraded to MFLP-status. A substantially revised MFLP
method must be subjected to a pre-collaborative study and be reviewed and
accepted by the MMC before re-publication.

3.2 Addition of target analyte(s) or organism(s)

This modification involves a change in the applicability statement to include an

additional target analyte(s) or organism(s). An MFLP method would retain its status if
sufficient data is supplied that meets the requirements. In the case of an MFHPB
method, a new MFLP method would be published with the new target and the
MFHPB method would remain unchanged. The MFLP method could be upgraded to
an MFHPB method once all the requirements of an MFHPB method were met.

3.3 Addition of food matrices

Method extensions in which new food matrices are added change the applicability
statement. A method with an extension retains its status if sufficient data is supplied
that meets the requirements for the appropriate level. A method with an extended
applicability statement will retain its status, or based on the recent data may receive a
higher status.

3.4 Procedure modification

This is a change in a procedure, instrument, reagent or other parameter that does not
change the principle of the method but may affect the performance parameters. A
study to support the procedure modification may be performed "in-house" or multi-
laboratory, but must be of sufficient scope to establish equivalency of performance as
previously determined. Perform a minimum of 30 comparative analyses per food
category, preferably at the levels tested in the original pre-collaborative, comparative
or collaborative study. Refer to the Development of Methods in Volume 1 of the
Compendium of Analytical Methods for additional requirements for study design.

3.5 Minor change

Minor changes of procedural parameters are those which do not affect method
performance. If a minor change is made to a method, it retains its status. Minor
changes may include the addition of coloured indicators to facilitate observation of
end-points, or the combination of two reagents that simplifies the use of the method.
Literature, historical data, or in-house data may provide adequate rationale that its

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effect on method performance is insignificant. In some cases, additional data may be

required to support the changes (e.g., 10 samples in one food matrix).

3.6 Editorial changes

Editorial changes are the correction of errors and clarification of language which do
not affect a method's status. Editorial changes may add non-technical information for
consistency; update non-technical footnote or reference information; change titles of
sections, tables, etc.; rearrange or renumber sections; make minor changes to
sentences that do not change the original intent or provide clarification; correct
spelling or punctuation; add general QC and QA caveats (safety, etc.); and correct
typographical errors that do not otherwise affect technical interpretations. No method
validation is required, but written record of action is noted by the MMC.

4. Revoking of Validated Methods

The Microbiological Methods Committee maintains the Compendium of Analytical Methods to

provide methodology which can be used in support of Health Canada and Canadian Food
Inspection Agency mandates in overseeing the safety of the Canadian food supply, deriving
authority from section A.01.012 of the Food and Drugs Regulations.

The process to revoke a method will be determined on a case-by-case basis. Depending

upon the severity of the issue and its impact on the method, it may be revoked immediately.
All of the following situations could result in the revocation of a method:

Performance Issues
In the event that data becomes available indicating that the method does not meet MMC
criteria, the method developer will be notified.

Lack of Notification of Method Modifications

Methods published in the Compendium of Analytical Methods are accepted based on the
original method validation package. Communicate all modifications to the MMC as
described above.

Method Developer not Assisting with Method Review Process

The method developer may be unable or unwilling to assist with MMC requests for
information during the periodic review of a method.

Obsolete Method
In some cases, a published method may no longer be useful, current, or the reagents or
materials are no longer available.

5. References

5.1. AOAC Research Institute. 2009. Performance Tested Methods Program. Policies and
Procedures.

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