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MATTERS FOR CONSIDERATION BY THE 24TH COMMISSION
The Committee recommended to the Commission:
- Draft MRLs for adoption at Step 8 for danofloxacin, gentamicin, imidocarb
and sarafloxacin (Appendix II);
- Proposed Draft MRLs for adoption at Step 5/8 for dihydrostreptomycin/streptomycin
and doramectin (Appendix III); and
- the Priority List of Veterinary Drugs for which Codex MRLs are to
be elaborated (Appendix VIII).
MATTERS FOR CONSIDERATION BY THE 47TH EXECUTIVE COMMITTEE
The Committee:
- advanced Proposed Draft MRLs for clenbuterol (in cattle milk only),
phoxim, porcine somatotropin and thiamphenicol and Proposed Draft Revised/Amended
MRLs for neomycin to Step 5 for adoption (Appendix V); and
- agreed to revise the definitions of “muscle”, “milk”
and “egg” contained in the Glossary of Terms and Definitions
(Volume 3 of the Codex Alimentarius) and to elaborate a new
definition for “fat” for the sake of harmonization, following
the Accelerated Elaboration Procedure, pending approval of the Executive
Committee (paras 53-58)
MATTERS OF INTEREST TO THE COMMISSION
The Committee:
- had an exchange of opinions regarding other legitimate factors taken
into account in the framework of risk analysis and concluded that the
following factors had been or were taken into account in its work: Good
Practices in the Use of Veterinary Drugs; Good Manufacturing Practices
for veterinary drugs; technical feasibility; substantial changes in
food composition and quality characteristics; the need to minimize exposure;
the ALARA (As Low As Reasonably Achievable) concept; food consumption
estimates; and residues from other sources than animal products (paras
7-14)
- agreed to retain the Draft MRLs for abamectin, carazolol, chlortetracycline/oxytetracycline/tetracycline,
cyfluthrin, eprinomectin and flumequine at Step 7 (Appendix IV);
- agreed to retain the Proposed Draft MRLs for clenbuterol (in cattle
and horse tissues) and deltamethrin at Step 4 (Appendix VI);
- decided to withdraw the Draft Temporary MRLs for alpha-cypermethrin,
cypermethrin and dexamethasone as recommended by JECFA which had not
received data required to extend temporary MRLs or to convert them to
full MRLs (paras 74-75, 79);
- decided not to consider new MRLs proposed by the 52nd JECFA for estradiol-17beta,
progesterone and testosterone as the Committee recognized that it had
not requested the re-evaluation of these substances and these new proposals
did not differ significantly from the current Codex MRLs (para. 84);
- agreed that where JECFA and JMPR had recommended MRLs for the same
chemical with the same residue/marker definition on the same commodity,
the higher MRL should be recommended provided that intake of residues
did not exceed the ADI (para. 59).
- agreed to return the Proposed Draft Guidelines for Residues at Injection
Sites to Step 3 for redrafting by Australia in the light of the comments
received and the discussion at the session for circulation and consideration
at the next session (paras 110-120);
- agreed that the United States would redraft the Proposed Draft Appendix
to the Guidelines for the Establishment of a Regulatory Programme
for Control of Veterinary Drug Residues in Foods concerning control
of veterinary drugs in milk and milk products for circulation for comments
at Step 3 and consideration by the next session (paras 121-124);
- agreed that it would consider (1) the development and application
of risk analysis principles and methodologies appropriate to the specific
mandate within the framework of the Action Plan, and (2) development
of quality criteria for data used for risk assessment; noted, for implementation
as appropriate, the other recommendations of the Codex Alimentarius
Commission regarding risk analysis principles; and agreed that a drafting
group would prepare a discussion paper for consideration by the Committee
containing solid recommendations regarding risk analysis principles
and methodologies including risk assessment policy, use of microbiological
endpoints for the setting of ADIs, and data requirements and the use
of extrapolation for establishing MRLs for “minor” species
(paras 15-19; 65, 142);
- received the reports of OIE and WHO on their activities in the area
of antimicrobial resistance and uses of antimicrobials in animal production
(paras 22-32) and agreed that a discussion paper should be prepared
for consideration at the next session on all aspects on antimicrobial
resistance relevant to the work of the Committee which should take into
consideration activities of other international organizations and identify
specific areas for further action as required including the development
of a code of practice for the containment of antimicrobial resistance
(paras 33-38);
- received reports on activities of OIE including the Harmonization
of Technical Requirements for Registration of Veterinary Medicinal Products;
and reports on the evaluations of veterinary drugs by the 52nd and 54th
JECFA (paras 39-50);
- agreed that a paper should be prepared on the criteria for the selection
of methods of analysis in the light of recent developments in method
validation at the international level (paras 98-101); agreed that the
task groups should proceed with the selection of appropriate methods
of analysis for four drug categories (paras 102-105); and agreed to
a number of new provisional methods and to covert one method from provisional
status to recommended (paras 106-107);
- agreed to consider at the next session whether to initiate work on
additional appendices to the Guidelines for the Establishment of
a Regulatory Programme for Control of Veterinary Drug Residues in Foods
to address the control of veterinary drugs in specific groups of animal
products other than milk and milk products (para. 125); and
- agreed to discuss at the next session mechanisms which would facilitate
progress in the decision making by the Committee (paras 143-144).
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