The Codex
Committee on Methods of Analysis and Sampling (CCMAS) held its
29th Session from March 10-14, 2008 in Budapest, Hungary. The 29th
Session was attended by 160 delegates and observers representing
59 Member Countries, one Member Organization (EC), and 9 international
organizations. The United States was represented by the Delegate,
Dr. Gregory Diachenko, and Dr. Gregory Noonan, U.S. Food and Drug
Administration; Mr. Larry Freese, Grain Inspection, Packers and
Stockyards Administration, USDA; and Dr. Michael Sussman, Agricultural
Marketing Service, USDA.
The United States fully participated on all agenda items and was
successful in achieving many of its objectives and goals during
this Session. The U.S. was instrumental in obtaining Committee consensus
to stop consideration of efforts to expand the role of CCMAS with
respect to methods without specific provisions in Codex standards.
Significant U.S. input was also provided on revising the text of
the Draft Guidelines for Settling Disputes on Analytical (Test)
Results and returning them to Step 6 in order to allow for
additional government comments. Additionally, 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 adoption at
Step 5 by the 31st Session of the Codex Alimentarius Commission.
These Codex texts may have significant impact on international trade
and the work of CCMAS.
The U.S. was unsuccessful in convincing the Committee to forward
the document on Methods for the Detection and Identification
of Foods Derived from Biotechnology - General Approach and Criteria
(CX/MAS 08/29/8) to FAO as the basis for an expert consultation
and guidance for Governments. CCMAS proposed the development of
guidelines on criteria for methods for the detection and identification
of foods derived from biotechnology to the 31st Session of the Commission,
as part of the working document including all proposals for new
work. Subject to the decision of the Commission, the Proposed Draft
Guidelines as presented in the working document (CX/MAS 08/29/8)
would be circulated at Step 3 for comments and consideration by
the next session of the Committee. The Delegations of the United
States, Australia and New Zealand expressed their opposition to
this decision to undertake new work, since there was no clearly
defined need in Codex for methods as no provisions existed and development
of these guidelines was not in line with Codex strategic objectives.
More detailed summaries on several Agenda items are listed below.
Criteria for the Methods for the Detection and Identification
of Foods Derived from Biotechnology
The Delegation of Germany, as co-lead of the electronic working
group, introduced the document and informed the committee that the
document had been revised taking into consideration comments received
and that changes made were not too substantial. The Delegation also
reminded the committee that the ad hoc Task Force on Foods
Derived from Biotechnology had encouraged the Committee to proceed
with work in this regard. The Delegation of the United States, supported
by the Delegation of Australia, referring to its comments in CRD
13, expressed the view that there was no clearly defined need in
Codex for methods as no provisions existed. It was also stated that
development of methods criteria was not in line with Codex strategic
objectives, in particular as ISO had active work in this area and
such work in the Committee could lead to duplication. The Delegation
proposed to forward the paper to FAO who could convene an expert
consultation to use the paper as a basis for a guidance document
for Governments. The Delegation further stated that only once specific
provisions requiring detection and identification of foods derived
from biotechnology had been established in Codex should development
of guidelines be considered.
The Delegation of the EC expressed support for new work as presented
in CRD 21 emphasizing that the development of guidelines was essential
for future work of Codex, that it would be useful to have methods
to assess the foodstuffs entering the market to ensure fair practices
in the food trade, and that this was important work particularly
for developing countries. Following some discussion, the Committee
agreed to the proposal for new work and to submit the revised project
document to the 31st Session of the Commission, as part of the working
document including all proposals for new work. Subject to the decision
of the Commission, the Proposed Draft Guidelines as presented in
the working document (CX/MAS 08/29/8) would be circulated at Step
3 for comments and consideration by the next session of the Committee.
The Delegations of the United States, Australia and New Zealand
expressed their opposition to this decision to undertake new work
(para 87-93 of Alinorm 08/31/23).
Proposed Draft Guidelines for Settling Disputes over Analytical
(Test) Results
An in-session working group was formed and made major revisions
in the Draft Guidelines developed at the last CCMAS session and
circulated as part of CL 2007/10-MAS at Step 6 of the Codex process.
The Committee considered the document and made a number of revisions
in each section. It was agreed to include as a pre-requisite the
need for both countries to agree on using the guideline in order
to clarify that these guidelines would only apply if both countries
agreed to their use. The U.S. and other delegations highlighted
the need to stipulate a timeline for settling of disputes since
some consignments could lose their integrity and value upon storage.
The Committee agreed to re-insert a section from the original document
recognizing that disputes could be settled without further analysis,
through the sharing of results and procedures between the laboratories
of the importing and exporting countries. A major focus of the new
document was on the analyzing of reserve samples. The Committee
agreed to language indicating that agreement should be between competent
authorities on analysis of reserve samples and to insert a footnote
regarding the timeline to indicate that disputes should be resolved
within the shortest possible time so as to avoid adversely affecting
the quality of the commodity during storage.
The U.S. and several other delegations noted that the document
had been considerably changed from the previous version and that
in view of the short time to thoroughly consider the revised version
it could not be sent for final adoption, but should be re-circulated
for comments at Step 6. The Delegation of Germany speaking on behalf
of the EC member states present at the meeting was of the view that
the document was a much simpler, clearer and understandable document
and should be considered and finalized at the Session. The Committee
agreed to return the Draft Guidelines, as amended at the present
session, to Step 6 for further comments and consideration at the
next session (para 20-34 and Appendix IV of Alinorm 08/31/23) with
a view to its finalization by that session.
Review of Analytical Terminology for Codex Use
The U.S. Delegation presented a document that had been revised by
an electronic working group based on comments received on CL 2007/10-MAS
at Step 3 of the Codex process. 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 was
informed that all definitions from international standard development
organizations that had been under revision were now harmonizable
since they had reached the final publication stage. CCMAS considered
the list of definitions and accepted most of them without changes.
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 adoption at Step 5 by the 31st Session of the Codex Alimentarius
Commission (para 35-51 and Appendix V of Alinorm 08/31/23).
Endorsement of Methods of Analysis for Provisions in Codex
Standards
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
52-61 and Appendix III of Alinorm 08/31/23).
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. It was proposed to amend
the section in the Procedural Manual on the working instructions
for the implementation of the criteria approach, including a table
of numerical values for the minimum applicable range, LOD, LOQ,
precision, recovery and trueness, according to the value of the
maximum level. These instructions will be useful to CCMAS and other
Committees when considering the methods submitted or to be submitted
for endorsement. The Committee agreed to send the amendment to the
General Principles Committee for its endorsement. The Committee
also agreed to future work on developing more detailed guidelines
for establishing methods criteria for the identification of relevant
analytical methods, which would include a step by step procedure
to decide on the applicability of the method (para 64-86 and Appendix
II of Alinorm 08/31/23).
Role of CCMAS With Respect to Methods Without Specific
Provisions in Codex Standards
The Delegation of Netherlands presented a discussion paper indicating
that the Committee faced difficulties in developing or endorsing
methods of analysis for which there were no provisions in Codex
Standards (e.g., methods for foods derived from biotechnology).
The paper informed the Committee that there were three existing
phrases in the Procedural Manual that put limitations on the work
of the Committee (e.g., in the CCMAS terms of reference) and proposed
language changes to eliminate these restrictions. The U.S. and some
other delegations did not support the proposed amendments and were
of the opinion that the terms of reference should not be too open-ended
and that the current terms of reference were sufficient to allow
the Committee to conduct its work. In view of the discussion the
Committee agreed not to make any amendments as proposed (para 121-125
of Alinorm 08/31/23). |