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| Report of the U.S. Delegate, 1st Session of the Codex ad hoc
Intergovernmental Task Force on Antimicrobial Resistance |
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The First Session of the Codex ad hoc Intergovernmental Task Force on Antimicrobial Resistance was
held October 23-27, 2007, in Seoul, Republic of Korea. One-hundred-thirty-eight delegates from 36 Member
countries and 1 Member organization, as well as Observers from 9 international organizations attended.
The session was very productive and resulted in the development of 3 project documents on risk assessment,
risk management and risk profiling based upon project proposals submitted in response to the Circular Letter
request for proposals for new work, CL 2006/38-AMR.
The Task Force acknowledged the importance of developing internationally harmonized approaches and guidance
to minimize the spread of antimicrobial resistance at all stages of the food chain. Discussion on broadening the
"Terms of Reference" ended in the Task Force deciding against changes given the limited time assigned
the Task Force to complete work; however, the Task Force did elect to clarify the "Objectives" to state
that the Task Force should attempt to put into perspective the risk of increase of antimicrobial resistance in
human beings and animals generated by different areas of use of antimicrobials, such as veterinary applications,
plant protection or food processing, without adding a reference to human medicine. The World Health Organization
(WHO) Representative stated that the Task Force's activities should focus on aspects related to the nonhuman
use of antimicrobials and to the development of antimicrobial resistance in human pathogens in and through food,
including both animal (including aquaculture) and vegetable products. The WHO Representative explained that it
was the responsibility of WHO to consider risks from human use and the Task Force could refer such work back to
WHO if needed. The proposed amendment in the "Objectives" will be forwarded to the 31st Session of
the Commission for consideration and approval.
The Task Force noted work related to antimicrobial resistance conducted by the Food and Agriculture Organization
(FAO), World Organization for Animal Health (OIE), and WHO, and agreed to build on all previous work. In addition,
the Task Force was invited to make use of the following: information provided in the international workshop held in
Seoul on October 22, 2007, immediately prior to the Task Force session; the Global Initiative for Food-related
Scientific Advice (GIFSA) launched by FAO and WHO in July 2007; and information from the upcoming Joint FAO/WHO/OIE
Expert Meeting on Critically Important Antimicrobials, to be held in November 2007 in Rome, Italy.
The Task Force noted that work proposed in the twelve project documents and other proposals forwarded by members and
observers in response to CL 2006/38-AMR fell into three main areas: risk assessment, risk management and risk
profiling/prioritization. Three in-session working groups were formed to prepare project documents corresponding to
each area for consideration by the plenary. Canada chaired the In-session Risk Assessment Working Group; the European
Community chaired the In-session Risk Management Working Group; the U.S. chaired the In-session Risk Profiling Working
Group. The Codex Secretariat offered additional clarification of the work to be undertaken by these Working Groups
by stating that all guidance developed by this Task Force must encompass "risk management" activities and
that "risk assessment" is outside the purview of Codex Committees or Task Forces. The Codex Secretariat
further stated that risk profiling/priority setting, risk assessment policy, and risk management options are all
functions of risk management as defined by the Codex Alimentarius Commission.
For the In-Session Risk Assessment Working Group, the Task Force agreed to use the project document prepared by the U.S.
as a starting point and included, as appropriate, elements from other proposals submitted in response to CL 2006/28-AMR.
The working group disagreed on the inclusion of a reference to "the positive effects of the use of antimicrobial
drugs in animals" and instead agreed to use the phrase "to determine the overall risk to human health".
The working group also expressed the desire to avoid duplication of existing work from other international organizations
and discussed the importance of assistance to member countries with limited capacity to undertake risk assessments.
In considering the In-Session Risk Assessment Working Group document, the Task Force discussed the appropriateness of
inclusion of plant protection and human use of antimicrobials in the Terms of Reference. The Task Force was informed
that it could refer, particularly in reference to plants, any technical matters or questions to other Codex subsidiary
bodies having competence in such technical areas, including the Codex Committee on Pesticide Residues. The Task
Force agreed that the use of antimicrobial resistance genes as marker genes in the development of recombinant-DNA
plants is outside the scope of work for the ad hoc Intergovernmental Task Force on Antimicrobial Resistance;
such work is under the purview of the Task Force on Foods derived from Biotechnology.
The Task Force agreed to amend the sections involving information on the relation between the proposal and other
existing Codex documents, identification of any need for technical input for scientific advice, and identification
of any need for technical input to the standard from external bodies after seeking counsel from the Codex Secretariat
on appropriate inclusions. The Task Force agreed to cite available references leaving open the possibility to request
additional scientific input from international organizations, if required. The timeline format proposed by Canada
was adopted and the Task Force agreed to amend, for consistency, the same sections of the other 2 project documents.
The In-session Risk Management Working Group agreed to use the U.S. project documents contained in CX/AMR 017/1/4 and
CX/AMR 07/1/4 Add.1 as a starting point for its discussion. The list of risk management options was integrated with
elements from other proposals, while noting that the list was not meant to be prescriptive or exhaustive. Highlights
from discussions of the Working Group include: 1) a discussion on the need for the project document to address
aspects of risk communication between risk assessors and risk managers, taking into account the guidance in the
FAO/WHO document, Food Safety Risk Analysis, A Guide for National Food Safety Authorities, and 2) the need for
addressing risk management guidance when there is evidence of the existence of a risk to human health but scientific
data are insufficient to support management decisions.
The In-Session Risk Profiling Working Group, using a combination of the U.S. and Canadian project documents as
starting points, agreed that the purpose of the proposed work was to develop guidance on:
- Identifying food safety issues related to antimicrobial resistant foodborne microorganisms;
- Identifying the data needed for creation of risk profiles; and
- Identifying how to set priorities with respect to risks related to antimicrobial resistant foodborne microorganisms.
The guidance developed is intended for use by the Joint FAO/WHO Meetings on Microbiological Risk Assessment (JEMRA)
and/or national/regional authorities when undertaking possible full risk assessments. The Working Group agreed that
the intent of the project was to offer guidance, rather than set priorities, which would be left to individual
national/regional authorities or to JEMRA.
The Task Force recognized there could be instances where it may be appropriate for countries to select a provisional
risk management option when the risk profile indicates that a risk to human health exists but there is insufficient or
incomplete scientific data. If such is the case, however, the Task Force viewed it as important for the risk manager
to actively seek additional information, communicate the provisional nature of the decision, and establish a timeframe
under which the provisional decision will be reconsidered, such as after the completion of a risk assessment.
The Task Force, after consideration of and deliberation on each project
document agreed to forward the project documents, as amended, to the
61st Session of the Executive Committee for Critical Review and to
the 31st Session of the Commission for approval as new work. Further,
the Task Force agreed to establish combination electronic and physical
working groups under the leadership of Canada (Risk Assessment Working
Group), the European Community (Risk Management Working Group), and
the U.S. (Risk Profiling Working Group) open to all delegations and
observers and working in English, French, and Spanish in the physical
working groups. A request was made that physical meetings of the working
groups take place at the same time and place for ease of attendance.
It is anticipated that elements for consideration for the proposed
draft documents will be sent electronically around December 2007,
to the lead country, that physical meetings, if conducted, will take
place in spring 2008, and proposed draft guidance documents will be
prepared for circulation at Step 3 for further consideration at Step
4 at the Second Session of the Task Force in October-November 2008
in Seoul. |
Last Modified:
November 21, 2007 |
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