Drug Testing

Research article and Analysis

Received: 13 August 2015 Accepted: 4 January 2016 Published online in Wiley Online Library

(www.drugtestinganalysis.com) DOI 10.1002/dta.2014

Effective management tools for participants at

Codex Committee on Residues of Veterinary
Drugs meetings
Jack F. Kay*
The Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) fulfils a number of functions revolving around standard
setting. The core activities of the CCRVDF include agreeing priorities for assessing veterinary drug residues, recommending max-
imum residue limits for veterinary drugs in foods of animal origin, considering methods of sampling and analyses, and developing
codes of practice. Draft standards are developed and progress through an agreed series of steps common to all Codex
Alimentarius Commission Committees. Meetings of the CCRVDF are held at approximately 18-month intervals. To ensure effective
progress is made with meetings at this frequency, the CCRVDF makes use of a number of management tools. These include circular
letters to interested parties, physical and electronic drafting groups between plenary sessions, meetings of interested parties
immediately prior to sessions, as well as break out groups within sessions and detailed discussions within the CCRVDF plenary
sessions. A range of these approaches is required to assist advances within the standards setting process and can be applied to
other Codex areas and international standard setting more generally. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords: Codex; CCRVDF; management tools; veterinary drugs; food safety

Introduction
The Codex Alimentarius Commission (CAC) supports the Food Stan-
dards Programme of the Joint Food and Agriculture Organization
(FAO) of the United Nations and the World Health Organization
(WHO). The CAC was established in 1961 and the first session was
held in July 1963 with the principal aims being to protect consumer
trade whilst ensuring fair practices in international food trade. FAO
statistics for 2003 suggest that the value of trade in agricultural
products is $(USA)5 x 1011. The CAC has since been recognized by
the World Trade Organization (WTO) as an international reference
point for resolution of food safety and consumer protection
disputes.[1]
Specialist areas of the CAC’s work are undertaken by a
number of task or topic related committees such as the Co-
dex Committee on Methods of Analysis and Sampling
(CCMAS) and the Codex Committee on Residues of Veterinary
Drugs in Food (CCRVDF). All committees work to common
procedures set out in the Codex Procedural Manual[2] to
achieve their respective aims and inform discussions and deci-
sions at the CAC. This paper highlights the work of the
CCRVDF, a risk management committee, and a number of
tools used by delegations and participants to illustrate how
this assists effective committee working.
The key activities of the CCRVDF are[3]:
• Developing codes of practice related to veterinary drugs and
their associated residues in food of animal origin.
• Agreeing priorities for the assessment of veterinary drugs.
• Recommending Maximum Residue Limits (MRLs) for veteri-
nary drugs used in food producing animals.
• Considering sampling protocols and methods of analysis for
In carrying out these tasks, the committee interacts with a num-
ber of bodies both within and without the Codex Alimentarius. For
example, when considering analytical methods for veterinary drug
residues it may discuss specific issues with the CCMAS or the Codex
Committee on Residues of Pesticides (CCPR). As the risk manager
responsible for recommending MRLs to the CAC, the CCRVDF draws
on the independent expert risk assessments undertaken by the
Joint Expert Committee for Food Additives (JECFA) of the UN Food
and Agriculture Organization and World Health Organization.
Discussion
The work of the CCRVDF began in 1986 and the committee meets
approximately every 18 months. The chair of the committee is pro-
vided by the USA and liaises closely with the Codex secretariat to
ensure progress and continuity between meetings. The manage-
ment tools used in two cases are discussed to illustrate how differ-
ent tools may be needed, changing when necessary, to help the
CCRVDF and the CAC achieve consensus if at all possible when try-
ing to reach agreement on issues leading to standards being set.
The CCRVDF identifies the need for new standards through dis-
cussions in plenary sessions, breakout sessions around the plenary
session and from general requests for input sent by correspon-
dence following meetings. It takes action to develop the standards
in the most efficient and effective manner. Where necessary,
* Correspondence to: Jack F. Kay, 24 Highview Gardens, Edgware, Middlesex, HA8
9UE, UK. E-mail: ysbem@netscape.net
Travel by the Lead Author to present this manuscript at SASKVAL III was funded by
the OECD.
445

veterinary drug residues. 24 Highview Gardens, Edgware, Middlesex, UK

Drug Test. Analysis 2016, 8, 445–447 Copyright © 2016 John Wiley & Sons, Ltd.
 Drug Testing
and Analysis J. F. Kay

standards are kept under review and updated as required. For exam-
ple, standard CAC/MRL 2[4] lists the MRLs considered by the CCRVDF
to date and their current status. This list is updated following CCRVDF
meetings and subsequent discussion at CAC meetings. A complete
list of the standards prepared to date by the CCRVDF to date is given
in Table 1 and the current list can be found on the CCRVDF website.[5]
Development of standard CAC/GL 71-2009[6]
The purpose of this standard is to prepare guidelines for the design
and implementation of national regulatory food safety assurance
programmes associated with the use of veterinary drugs in food
producing animals. Previous guidelines on residue monitoring
programmes and analytical methods were published as CAC/GL
16-1993 by the CCRVDF.[7] It was subsequently recognized that
these guidelines should be updated to reflect changing practices
and advances in analytical technology. This led to the formation
of two multinational working groups, one of which led on prepar-
ing an amended text for monitoring programmes whilst the other
updated the analytical section on residue detection.
The leaders of each section initially co-ordinated their work with
collaborators using a combination of physical meetings and email
exchanges whilst also liaising with each other to ensure minimum
duplication of effort and repetition within the texts. At a later stage,
both texts were merged and an electronic forum was established
by a working group chair to facilitate progress. A combination of
physical and virtual meetings led to the successful adoption of
the standard in 2009 almost a decade after the work began.
However, in the time taken to prepare CAC/GL 71-2009, analytical
technology had continued to advance apace. These changes meant
that analytical laboratories no longer analyzed a single sample for a
single veterinary drug residue. To increase laboratory efficiency and
minimize analytical costs, the common practice had become analyz-
ing individual samples for multiple analytes in a single analysis. As a
result, the CCRVDF agreed to immediately begin work on updating
the new standard to include this in the most generic way possible.
By working on generic guidelines, the CCRVDF sought to ensure
the maximum working life for the standard after adoption. Work-
ing entirely by physical meetings at CCRVDF sessions and using
a dedicated electronic forum set up by a working group leader
between plenary sessions together with international telephone
conference calls as required, the revised standard was adopted in
2014. This was ahead of the originally scheduled completion date.
Whilst in development, this standard also informed discussions
within other Codex committees which sought to develop similar
generic guidelines. It also informs regional discussions in the prep-
aration of new and updated regulations and guidelines. Wider dis-
cussions and consultations were also taken into account as the
standard was developed which has made it more useful to a larger
audience than Codex alone.
Maximum residue limits for ractopamine
Standard CAC/MRL 2-2015 lists the current status of all maximum
residue limits (MRLs) either considered or under consideration by
the CCRVDF and is routinely updated to reflect the latest discussions
on setting MRLS by the CCRVDF. However, what this document
does not show is the work taken to reach consensus on any veteri-
nary drug and the difficulties encountered in reaching agreements.
The process for this work begins with the identification of drugs
to be put forward for consideration and their prioritization. This is
managed by a combination of letters from the secretariat calling
for drug nominations and requests for nominations at physical
meetings of the CCRVDF. Meetings immediately prior to CCRVDF
sessions and/or breakout meetings during CCRVDF sessions are
used to inform discussions at the CCRVDF to identify and prioritize
any new candidate drugs. Once accepted as a priority drug and a
commitment made by a CCRVDF member country to provide the
dossier of information needed for further consideration, the drug
will be referred to JECFA for completing an independent risk assess-
ment and proposing an MRL. The CCRVDF considers the report and
recommendations provided by JECFA and the draft MRL suggested.
The MRL setting procedure at the CCRVDF will progress through the
eight-step process set out in the Codex Procedural Manual,[2] which
is common to all standard setting exercises. At all stages, progres-
sion should be dependent on the science under consideration
and should be by consensus.
However, whilst consensus is the ideal, for some veterinary drugs
other issues (e.g. regional concerns about the use of a particular vet-
erinary medicine or class of medicines) will prevent agreement and
can delay or stop progress. One such example of where other con-
cerns influenced discussions (ractopamine) is discussed further as
this clearly demonstrates how a wide range of tools was required
to reach agreement on the MRL for this veterinary drug.
Ractopamine[8] is a beta agonist drug used to promote weight
gain in animals and was first accepted as a priority drug for consid-
eration in 2003. At this time it was in veterinary use in a number of
countries. However, the use of beta agonists for the express purpose
of growth promotion is prohibited in some jurisdictions, such as the
European Union.[9] Ractopamine was referred to JECFA for a risk as-
sessment and the report was submitted to the CCRVDF in 2004.[10]
Questions raised in discussions at the CCRVDF plenary session led
to a further referral to JECFA in 2006 and ractopamine was advanced
to Step 8, the final step of the Codex procedure in 2008 but most un-
usually without agreement to refer the recommendation to the CAC
for adoption as consensus could not be reached. A further referral
was made to JECFA for clarification on additional points in 2010 with
subsequent referral of the decision to the CAC. Such was the
strength of opinion and division within the CCRVDF and the CAC
on ractopamine that this led unusually to a vote on the adoption
of the MRL. This was carried by 69 votes in favour and 67 against.

Table 1. Standards prepared by the CCRVDF.

Standard Title Published Last updated

CAC/MISC5- Glossary of terms and definitions (veterinary drugs residues in food) 1993 2003
1993
CAC/RCP 61-2005 Code of Practice to minimize and contain antimicrobial resistance 2005
CAC/MRL 2-2015 Maximum Residue Limits for veterinary drugs in food 2015
CAC/GL Guidelines for the design and implementation of national 2009 2014
71-2009 regulatory food safety assurance programmes associated with
the use of veterinary drugs in food producing animals
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Effective management tools for Veterinary Drugs meetings
At all stages of the discussions on ractopamine MRLs, all possible
means of communications including telephone, email, and per-
sonal meetings were used in addition to the formal procedures
set out in the Codex Procedural Manual in an attempt to broker
an understanding between sides, which became progressively
more entrenched as discussions continued. This included using var-
ious independent intermediaries to facilitate exchanges of views
and possible points of agreement. In addition, informal discussions
were held between various parties and advisors in different
countries by telephone. Participants took part in such calls whilst
negotiations were held abroad, often in different time zones.
Considerable personal commitment and networking skills were
required on the part of many to keep the dialogue alive and the
lines of communication open and this was ultimately rewarded
with an internationally agreed MRL for ractopamine.
Conclusions
A suite of tools is essential for effectively managing the successful
development of standards within the CCRVDF. By analogy, these
tools can also assist in the wider development of CAC standards
and standards more generally by other standard setting bodies.
These tools include:-
• Uninhibited discussion within committee.
• Appropriate and timely use of written and verbal
communication.
• Appropriate use of formal physical and electronic working
groups as well as informal groups if necessary.
• Fostering good relationships and communications with the
chair of the committee and the secretariats for both the Chair
and the Codex Alimentarius.
• Being prepared to think unconventionally about how best to
facilitate an understanding between parties with apparently
differing viewpoints.
Drug Test. Analysis 2016, 8, 445–447 Copyright © 2016 John Wiley & Sons, Ltd.
Drug Testing
and Analysis
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