|Report of the U.S. Delegate, Codex Committee on Residues of Veterinary Drugs in Foods, 20th Session
The 20th Session of the Codex Committee on Residues of Veterinary Drugs (CCRVDF)
was held in San Juan, Puerto Rico, May 7-11, 2012. The Session was attended by 177 delegates from 47 Member Countries and one Member
organization and observers from 10 international organizations and FAO and WHO. The United States was represented by Delegate Kevin
Greenlees and Alternate Delegate Charles Pixley.
This session was very productive, resulting in resolution of some key issues as well as critical questions for clarification by the
Codex Alimentarius Commission (CAC).
The Committee discussed possible changes to the terms of reference for CCRVDF. It agreed that there was no need to include "feed"
in the terms of reference, and that possible changes related to risk management matters related to the safety of residues of veterinary
drugs in food would be circulated for comment.
The Committee advanced full MRLs for residues of narasin in cattle tissue to the 35th Session of the CAC for adoption at step 8.
Similarly, MRLs for amoxicillin residues in cattle, sheep and pig tissues were advanced to the CAC for adoption at step 5/8.
Concerns were raised for the proposed MRLs for residues of apramycin and derquantel. Concern was expressed over the proposed temporary MRL,
and only having an MRL in kidney. The Committee agreed to hold MRLs for residues of apramycin in chicken kidney at step 4 until JECFA
considers additional data and completes an evaluation of the new information. Similarly, and in response to specific questions by Australia
regarding the results of the JECFA evaluation, most notably
in the ratio of analytical marker residue to total residues, MRLs for derquantel residues in sheep were held at step 4, and derquantel
was added to the priority list for re-evaluation by the JECFA. Questions were also raised regarding the proposed MRLs for monepantel in
sheep, particularly regarding the residue following good practices of veterinary drugs across a wide range of international uses.
The Committee held this veterinary drug at step 5 while requesting a JECFA evaluation of available residue data. These interactions
reflect the active risk management role of CCRVDF in its relationship to its risk assessment body, the JECFA.
The Committee discussed the report of the electronic working group on risk analysis principles for CCRVDF and risk assessment policy for
setting maximum limits for residue of veterinary drugs in food and the report of the physical working group that met just prior to the
20th CCRVDF. The Committee agreed to revisions in the risk analysis principles for CCRVDF and risk assessment policy and forwarded the
document for adoption by the 35th CAC. However, the "concern form" (similar to a form used by the Codex Committee on Pesticide
Residues) that was under discussion was not included, and an electronic working group, led by Brazil and Australia, was created for further
discussion on what such a form might look like and how it might be implemented by CCRVDF. A physical working group meeting is planned
just prior to the 21st Session.
The Committee considered the report of the electronic Working Group on proposed draft sampling plans for residue control for aquatic animal
products and derived edible products of aquatic origin (Table C, Annex B of CAC/GL 71-2009), and the report of an intersession working group,
both led by the United States. The Committee agreed to advance the proposed draft Sampling Plan to the 35th Session of the CAC for
adoption at Step 5/8.
The Committee considered the reports of the electronic Working Group on the policy for the establishment of MRLs or other limits for honey
and the electronic Working Group on guidelines on performance characteristics for multi-residue methods (Appendix to CAC/GL 71-2009).
The Committee agreed to continue work on guidances for honey and for multi-residue analytical methods through electronic Working Groups,
but with direction to refine and focus the product guidelines. Honey will be chaired by the United Kingdom, and multi-residue analytical
methods will be co-chaired by the United Kingdom and Canada. The United States will participate in these electronic working groups.
There will also be a physical working group on multi-residue methods prior to the 21st Session.
The Committee agreed to circulate the questions posed by the electronic working group for comment.
The Committee agreed to establish a physical Working Group, led by Canada, to continue the work begun on extrapolation of data for the
development of MRLs based on the comments received. The United States will participate in this Working Group.
The Committee discussed additions to the priority list of veterinary drugs for JECFA evaluation as reported by the Priorities working group.
The Committee agreed to include gentian violet, lasalocid, phenylpyrazole, emamcetin benzoate, derquantel, monepantel, and apramycin in the
The Committee was sharply divided over the inclusion of zilpaterol HCl in the priority list, and could not come to consensus. Zilpaterol
is a beta-adrenergic agonist drug for use in cattle as a production aid. It is approved for use in the United States and a number of other
countries. The addition of this veterinary drug was strongly defended by a number of countries, most notably the United States and Brazil.
Zilpaterol's proposed addition to the priority list of veterinary drugs for evaluation by JECFA was strongly opposed by the European Union
and a number of other allied countries. A key rationale identified was that there would not likely be consensus and that the Committee
should save its resources for veterinary drugs that would be less controversial. The EU delegate stated that the reasons for objection
were not based on science, but rather on domestic legislation, consumer preference, and trade. Other countries added concern for animal
welfare. The CCRVDF Chair will forward the issue to the CAC along with the proposed addition of zilpaterol to the priority list.
The Committee also discussed ivermectin, which had been proposed for re-evaluation of the ADI at the 19th CCRVDF and was considered in the
75th JECFA. It was agreed to hold ivermectin for discussion at the 21st Session. It was included in part C in the priority list on the
basis of an offer by Brazil to provide the results of a search of relevant information to the JECFA in support of the evaluation. Also
included in Part C of the priority list for later discussion at the 21st session were flumequine and oxolinic acid.
The Committee agreed to continue the electronic Working Group on the database for needed MRLs (led by the United States) and the physical
Working Group on priorities, led by Australia.
The dire financial constraints for funding of JECFA meetings were discussed. CCRVDF members were encouraged by the joint JECFA secretariats
and by the CCRVDF chair to make efforts to provide funding to support the expert, scientific risk assessments made possible through the JECFA
The Committee discussed in detail the report of the electronic Working Group on risk management recommendations for drugs for which JECFA
could not recommend ADI and/or MRLs due to specific human health concerns. Risk management recommendations were drafted for chloramphanicol
and malachite green, with language that was very close to that proposed by the United States. Further, the United States asked that an
objection be included in the report on the development of risk management language by CCRVDF for veterinary drugs other than those for
which the JECFA had completed a risk assessment and for which JECFA had determined that MRLs could not be recommended due to specific
human health concerns. The other veterinary drugs identified by the electronic Working Group were referred to a new electronic working
group to further develop risk management advice based on the discussion of the Committee. Risk management recommendations for these
veterinary drugs, and in general by the CCRVDF is a topic of considerable interest and the United States will be an active participant
in the electronic working group.
The United States recognizes the importance of CCRVDF in recommending standards and developing guidelines that protect consumers and while
ensuring fair trade practice.
The next meeting of the Committee is scheduled for August 2013, in a location to be named.
May 17, 2012