Committee on Methods of Analysis and Sampling (CCMAS) held its
30th Session from March 9-13, 2009 in Balatonalmadi, Hungary. The
30th Session was attended by 140 delegates and observers representing
48 Member Countries, one Member Organization (EC), and 9 international
organizations. The United States was represented by the Delegate,
Dr. Gregory Diachenko, Dr. Michael Wehr and Dr. Gregory Noonan,
U.S. Food and Drug Administration; Mr. Larry Freese, Grain Inspection,
Packers and Stockyards Administration, USDA; Mr. Jack Bobo, U.S.
State Department; Dr. Michael Sussman, Agricultural Marketing Service,
USDA and Ms. Shannon Cole, Grocery Manufacturers Association.
The United States fully participated on all agenda items and was
successful in achieving many of its objectives and goals during
this Session. The Committee, recognizing that substantial progress
had been made by the U.S. led efforts on the revision of the analytical
definitions, agreed to advance the Proposed Draft Guidelines
on Analytical Terminology for final adoption at Step 8 by the
32nd Session of the Codex Alimentarius Commission. Significant U.S.
input was also provided on revising the text of the Draft Guidelines
for Settling Disputes on Analytical (Test) Results and moving
them forward to final adoption at Step 8. These Codex texts may
have significant impact on international trade and the work of CCMAS.
The U.S. was partially successful in convincing the Committee to
change the title and broaden the scope of the Proposed Draft
Guidelines on Criteria for Methods for the Detection and Identification
of Foods Derived From Biotechnology. The Committee agreed to
somewhat broaden the scope and change the title. The Committee also
returned the document to Step 2 and established an electronic working
group, co-chaired by Argentina, Germany and the United Kingdom,
to revise the proposed draft guidelines, taking into account comments
previously submitted and those raised at the present session. The
revised text will be circulated for comments at Step 3 and consideration
at the next CCMAS session.
More detailed summaries on several Agenda items are provided below.
Proposed Draft Guidelines on Criteria for Methods for the
Detection and Identification of Foods Derived From Biotechnology
As a result of the U.S. intervention at the last meeting of the
Codex Commission and the current CCMAS session, the Committee agreed
to a significant revision of the Proposed Draft Guidelines on
Criteria for Methods for the Detection and Identification of Foods
Derived From Biotechnology and the following broadening of
the scope for these guidelines:
These guidelines provide information for the validation of methods
for the detection, identification, and quantification of specific
DNA sequences and specific proteins in foods derived from modern
biotechnology. These Guidelines may also provide information on
the validation of methods for other specific DNA sequences and
proteins of interest in other foods. Information relating to general
considerations for the validation of methods for the analysis
of specific DNA sequences and specific protein in foods is given
in the first part of these Guidelines. Specific annexes are provided
that contain information on definitions, validation of quantitative
PCR methods, validation of qualitative PCR methods, validation
of protein-based methods, and proficiency testing.
The Committee considered two options of the proposed title and
agreed to replace the current title with the following: "Proposed
draft guidelines on criteria for methods for detection, identification
and quantification of specific DNA sequences and specific proteins,
in particular in foods derived from modern biotechnology". The Delegation
of Australia reserved its position to the decision on the amendments
to the title as it did not support any extension of the scope and
particularly did not want mention of allergens or pathogens in the
scope, which were removed at the request of their delegate and Canada's
delegate. The Delegation of the United States expressed its reservation
regarding the inclusion of the term "modern biotechnology" in the
title. The United States preferred the second title option, which
included biotechnology and several other applications in a footnote
to the title in order to clarify the broadened scope of the document
and the many applications of these method criteria.
After much discussion and several interventions by the U.S., the
Committee agreed to return the text to Step 2 and to establish an
electronic working group, co-chaired by Argentina, Germany and the
United Kingdom, to revise the proposed draft guidelines, taking
into account comments submitted on the previous document and discussions
at the present session. The revised text will be circulated for
comments at Step 3 and consideration at the next CCMAS session.
Proposed Draft Guidelines for Settling Disputes over Analytical
An in-session working group was formed and made revisions in the
Draft Guidelines for Settling Disputes over Analytical (Test) Results
based on the comments received when it was circulated at Step 6
of the Codex process. The Committee considered the document and
made a number of additional revisions in each section. The Guidelines
address how to deal with disputes related to test results, but do
not address questions of sampling and the text was amended to allow
flexibility in solving disputes. These guidelines can only be applied
in the situation where both importing and exporting countries are
in agreement to use them.
The Committee finalized the document and agreed to send the Draft
Guidelines, as amended at the present session, to Step 8 for approval
by the next session of the Codex Commission.
Proposed Draft Guidelines on Analytical Terminology
The U.S. Delegation presented a document entitled Proposed Draft
Guidelines on Analytical Terminology that had been circulated
for comments at Step 6 of the Codex process. The Committee considered
the document section by section and made a number of amendments
and comments. What was originally developed as updated analytical
terminology for inclusion in the Codex Procedural Manual will be
removed from the Procedural Manual and placed in a guideline for
governments in order to facilitate future changes and reduce expansion
of the Procedural Manual. The Committee, recognizing that substantial
progress had been made by the U.S. led efforts on the revision of
the definitions, agreed to advance the Proposed Draft Guidelines
on Analytical Terminology for final adoption at Step 8 by the
32st Session of the Codex Alimentarius Commission.
Endorsement of Methods of Analysis for Provisions in Codex
A report of the ad hoc Working Group on endorsement of
methods was presented by the Chair, Dr. Roger Wood (United Kingdom).
The Committee endorsed several methods of analysis in Codex Standards
at different steps of the Procedure as proposed by the ad hoc Working
Group, but with a few minor amendments and comments (para 46-82
and Appendix IV of Alinorm 09/32/23).
Proposed Amendment to the Working Instructions for the
Implementation of the Criteria Approach in Codex The criteria
approach allows analysts flexibility in selecting validated methods
of analysis that meet Codex requirements. CCMAS proposed to amend
the section in the Procedural Manual on the working instructions
for the implementation of the criteria approach to add a new section
on guidelines for establishing numeric values for method criteria
and/or assessing methods for compliance with the criteria. This
added section includes prescribed acceptance requirements for establishment
of numerical values; criteria for applicability associated with
concentration values; levels and minimum applicable ranges; criteria
for precision and included an example of assessing methods for compliance.
The Committee agreed to send the amendment to the General Principles
Committee for its endorsement. (ALINORM 09/32/23, para. 92, Appendix