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The Codex View on Veterinary Drug Residues

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Veterinary Drug Residues 4th International Symposium on Food Safety Sao Paulo, SP June 13-14, 2005 Richard Ellis, Ph.D. FDA-CVM A view of Codex, CCRVDF and Food ... – PowerPoint PPT presentation

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Title: The Codex View on Veterinary Drug Residues


1
The Codex View on Veterinary Drug Residues
  • 4th International Symposium on Food Safety
  • Sao Paulo, SP
  • June 13-14, 2005
  • Richard Ellis, Ph.D. FDA-CVM

2
A view of Codex, CCRVDF and Food Safety
  • Codex principles and objectives
  • Codex Committee on Residues of Veterinary Drugs
    in Food (CCRVDF)
  • Terms of reference and working principles
  • CCRVDF Risk Analysis - CCRVDF and JECFA roles
  • Current areas of interest in CCRVDF Substances
    without ADI and MRLs

3
Codex Alimentarius Commission (CAC)
  • The Joint FAO/WHO Food Standards Program
  • Three objectives
  • Consumer protection
  • Fair practices in food trade
  • Co-ordination of all food standards work
  • 172 Member Governments (gt98 world population)
  • Meets annually
  • Adopts draft Codex standards
  • Reviews the Program of Work
  • Reviews the budget

4
FOOD AGRICULTURE ORGANIZATION OF THE UNITED
NATIONS
ECONOMIC SOCIAL DEPARTMENT
FOOD NUTRITION DIVISION
FOOD QUALITY STANDARDS SERVICE
FOOD STANDARDS GROUP (CODEX)
FOOD QUALITY LIAISON GROUP (JECFA)
5
Codex General Subject Committees
  • General Principle (France)
  • Import/Export Inspection and Certification
    Systems (Australia)
  • Food Labeling (Canada)
  • Methods of Analysis Sampling (Hungary)
  • Food Hygiene (USA)
  • Residues of Veterinary Drugs in Food (USA)
  • Pesticide Residues (Netherlands)
  • Food Additives Contaminants (Netherlands)

6
Active Commodity Committees
  • Nutrition and Foods for Special Dietary Uses
    (Germany)
  • Fats and Oils (UK)
  • Fish and Fishery Products (Norway)
  • Milk and Milk Products (New Zealand)
  • Fresh Fruits and Vegetables (Mexico)
  • Cocoa Products Chocolate (Switzerland)
  • Meat Hygiene (New Zealand)
  • Processed Fruits and Vegetables (USA)

7
Codex Committees Task Forces
  • Ad hoc Inter-governmental Task forces
  • Fruit and Vegetable Juices (Brasil)
  • Food Derived from Biotechnology (Japan)
  • Animal Feeding (Denmark)
  • Regional Coordinating Committees
  • Asia (Korea)
  • Africa (Morocco)
  • Europe (Slovak Republic)
  • Latin America and Caribbean (Dominican Republic)
  • Near East (Jordan)
  • North America Southwest Pacific (Samoa)

8
Codex Standard Development Process
  • Always initiated by CAC
  • Normal Procedure
  • Eight (8) Steps
  • 2 rounds of written comments
  • 1 round of comments can be omitted (by vote)
  • Accelerated Procedure
  • Five (5) Steps
  • 1 round of written comments
  • 1. Decision of CAC
  • 2. Proposed draft standard
  • 3. Request for written comments
  • 4. Amendments/Session
  • 5. Adoption of draft standard
  • 6. Request for written comments
  • 7. Amendments/Session
  • 8. Adoption as a Codex standard

9
Major Codex (CAC) Accomplishments
  • Food standards for commodities 237
  • Codes of hygienic/technology practice 41
  • Food Additives evaluated 1005
  • Guidelines for contaminants 25
  • Pesticides evaluated
    185
  • Pesticide MRLs
    3274
  • Veterinary drugs evaluated (1986-date) 80
  • Veterinary drug MRLs (39 to 28th CAC) 393
  • Veterinary drugs without ADI
    29

10
Codex Publications
  • http//www.codexalimentarius.net/web/index_en.jsp

11
GATT, WTO and Codex
  • 1994 General Agreement on Tariffs and Trade
    attached significant importance to food safety
    agreements
  • Referenced specific steps to protect the sanitary
    status of member countries and reduce barriers to
    trade
  • Elaborated food safety agreements for the
    Sanitary and Phytosanitary (SPS) and Technical
    Barriers to Trade (TBT) measures
  • Established the World Trade Organization

12
Implications of WTO Agreements
  • SPS Measures
  • Discourage the use of SPS measures as barriers to
    international trade
  • Recognizes Codex as a reference on food safety
  • Codex may be used to settle trade disputes
  • Calls for harmonization based on Codex
    (standards)
  • TBT Measures
  • Prevents the use of technical requirements as
    barriers to trade
  • Covers all consumer protections not covered by
    SPS
  • Places emphasis on international standards for
    foods

13
Food Safety Provisions Recognized by SPS
  • Maximum residue limits for pesticides and
    veterinary drugs
  • Maximum level of use of food additives
  • Maximum levels of contaminants
  • Food hygiene requirements of Codex standards

14
Codex Provisions Recognized by TBT
  • Food labeling
  • Quality provisions
  • Nutritional requirements
  • Methods of analysis and sampling

15
National Regulations and Codex
  • National regulations that are consistent with
    Codex standards meet the requirements of the SPS
    and TBT measures

16
Codex Committee Residues of Veterinary Drugs in
Food
  • CCRVDF established 1986, 15 sessions to date
  • CCRVDF has four responsibilities
  • Priorities for veterinary drug residues in food
  • Recommend maximum residue levels
  • Consider methods of analysis and sampling
  • Develop codes of practice
  • CCRVDF has three ad hoc working groups
  • Priorities, methods of analysis and sampling and
    drugs without ADI and MRLs
  • Role of Science and scientific principles

17
Role of Science in Codex-Statements of Principle
  • Food standards based on scientific analysis and
    evidence to assure quality and safety of foods
  • Regard other legitimate factors relevant to
    health protection of consumers
  • Food labeling is important for protection of
    consumers and promoting fair food trade practices
  • When members agree on level of protection but
    differ on other concerns, they may abstain from
    but not prevent decisions by Codex

18
Statement of Codex Principle onRole of Food
Safety Risk Analysis
  • CCRVDF endorses the statements of principle in
    standards development (MRLs and codes of
    practice)
  • Health and safety aspects of Codex decisions and
    recommendations should be based on a risk
    analysis appropriate to the circumstances
  • The risk analysis should be soundly based on
    science and incorporate the four steps of the
    risk assessment process and documented in a
    transparent manner
  • There should be a functional separation of risk
    assessment and risk management recognizing
    pragmatic interactions

19
Major New CCRVDF Accomplishments
  • Codex Alimentarius Volume 3 Residues of
    Veterinary Drugs in Food (parts being revised)
  • List of MRLs (1995)
  • Code of practice for control of use of veterinary
    drugs
  • Guidelines for establishing a regulatory program
    for control of veterinary drug residues (methods
    and sampling guidelines)
  • Glossary of terms and definitions
  • Code of practice to minimize antimicrobial
    resistance (at step 8)
  • New initiative on substances without an ADI or
    MRLs (new working group established)
  • New risk management policy under development
  • Revision on analytical methods sections in Volume
    3
  • Revision of guidelines for residue control
    programs

20
CCRVDF Risk Assessment Risk Management
  • Risk assessment expert advice provided by JECFA
    Joint FAO/WHO Expert Committee on Food Additives

CCRVDF proposes vet drug for MRLs
CAC approves new work
JECFA receives request for evaluation
Determination of ADI and MRLs
JECFA Secretariats invite experts
CCRVDF reviews and decides on MRLs
21
JECFA - The Risk Assessors
  • Members are invited by WHO and FAO as experts in
    their independent, personal capacity
  • Meetings are ad hoc, meeting only when needed
  • For reasons of confidentiality and prevention of
    external influences, meetings are closed sessions
  • Results are made public immediately thereafter
  • Provide scientific advice on specific issues for
  • FAO and WHO member countries
  • FAO and WHO governing bodies
  • Codex Alimentarius Commission and subsidiary
    Codex Committees (e.g., CCRVDF)

22
First Things First The ADI
  • Adverse systemic effects
  • Reproduction and developmental effects
  • Mutagenic effects
  • Carcinogenic effects
  • Effects on human intestinal flora
  • Immunologic effects
  • Pharmacological properties
  • Endocrine effects

23
Specific Considerations -ADI
  • The extent of data needed depends on dietary
    exposure
  • Determine if residues are normally present in
    edible tissues
  • If drug is also used in humans, data from human
    case reports and epidemiological studies
  • Special studies to investigate specific effects
    of mechanisms of toxicity
  • An effect and no-effect dose level should be
    determined from these studies and tests

24
Studies for Recommending MRLs
  • Chemical identity and properties
  • Uses and recommended doses in food animals
  • Pharmacokinetic, metabolism and pharmacodynamic
    data
  • Total residue (radiolabel) studies
  • Residue depletion studies in food animals
  • Available routine method of analysis including
    method performance
  • Special studies on residue effects as necessary

25
Residue Depletion and MRLs
CONCENTRATION
liver
kidney
fat
muscle
T I M E
26
From an ADI to MRLs
ADI
MRLT
If MRLU gt MRLT No MRL recommended
If MRLU lt MRLT
If MRLM gt MRLU and MRLM lt MRLT use MRLM
If MRLM MRLU Use MRLU
If MRLT MRLM use MRLT
If MRLT lt MRLM No MRL recommended
27
JECFA Publications
http//www.codexalimentarius.net/web/jecfa.jsp
28
CCRVDF Recommendation Process
  • CCRVDF receives JECFA recommendation at Step 3
    and proceeds through Step 8 with a recommendation
    to Codex Alimentarius

1. Decision of CAC 2. Proposed draft standard 3.
Request for written comments ? 4.
Amendments/Session 5. Adoption of draft
standard 6. Request for written comments 7.
Amendments/Session 8. Adoption as a Codex standard
29
Codex Alimentarius Commission Options
  • Adopt CCRVDF recommendation as a standard
  • Hold the recommendation pending additional
    information from CCRVDF or JECFA
  • Request CCRVDF reconsideration based on CAC
    comments on matters of concern (e.g., new
    scientific studies)
  • Reject CCRVDF recommendation (e.g., due to a lack
    of consensus)

30
Current Matters of CCRVDF Interest
  • Report of 15th Session Alinorm 05/28/31

http//www.codexalimentarius.net/web/reports.jsp?l
angen
  • MRLs from JECFA recommendations
  • Code of Practice to Minimize and Contain
    Antimicrobial Resistance
  • Revised guidelines for establishing a regulatory
    program for control of veterinary drug residues
    in food
  • Revised General considerations on analytical
    methods
  • Rounding of ADIs for veterinary drugs
  • Veterinary drugs without ADI/MRL

31
MRLs Recommended for 28th CAC
  • Step 8
  • Cyhalothrin cattle, pigs, sheep muscle, liver,
    kidney, fat and cattle milk
  • Flumequine cattle, pig, chicken, sheep muscle,
    liver, kidney, fat and trout muscle
  • Neomycin cattle liver, kidney and milk
  • Dicyclanil sheep muscle, liver, kidney and fat
  • Step 5/8
  • Imidocarb cattle muscle, liver, kidney, fat
    and milk (recommended MRLs in sheep withdrawn)

32
CCRVDF Antimicrobial Resistance
  • Responsibilities of regulatory authorities
  • Assessment of efficacy and safety, surveillance,
    distribution, advertising, training, research,
    etc.
  • Responsibilities of veterinary pharmaceutical
    industry
  • Marketing authorization, export, advertising,
    etc.
  • Responsibilities of wholesale/retail distributors
  • Responsibilities of veterinarians
  • Off-label use, records, training
  • Responsibilities of producers

33
CCRVDF Revised GuidelinesRegulatory Program
  • Revision of current Codex Volume 3 regulatory
    control guidelines (published 1995) needed
  • Current document precedes Codex adoption of HACCP
    food safety principles
  • CCRVDF scope will be a more holistic approach
  • Risk based approaches to regulatory programs
  • Residue control programs for food producing
    animals and food producing animal products (e.g.,
    milk)
  • Early in development (Step 2)

34
CCRVDF Methods of Analysis
  • Similar activity for Codex Volume 3 - review and
    amend Part II on General Considerations
  • Coordinated by ad hoc Working Group Methods of
    Analysis and Sampling
  • Update following the recent Codex decisions on
    analytical method performance
  • e.g., method validation procedures
  • Expand compendia of analytical methods for review
    by ad hoc working group

35
CCRVDF Risk Management IssueRounding of JECFA
ADIs
  • Potential differences with ADI calculation by
    JECFA and member governments (e.g., very small
    ADI)
  • JECFA rounding ADI to one significant figure
  • Numerous examples - 11 higher, 14 lower
  • Related issue with differences in MRLs
  • Three recommendations considered preferences
  • JECFA use calculated ADI, round ADI for
    publication of JECFA recommendation
  • CCRVDF use calculated ADI and publish the
    calculated ADI as the JECFA recommendation ?
  • CCRVDF will apply to future evaluations and
    recalculations of substances already considered
    by JECFA case-by-case

36
Veterinary Drugs Without ADI and MRLs
  • Growing concern with significant consequences

With no ADI/MRL
National action levels based on detection
limits Significant increases in detection
capabilities Increased dependence on MS and
LC-MS/MS A technology imbalance between primarily
import and export countries
Increased prevalence of residues of
concern Rejection of imported products
Result International Trade Disruption
37
CCRVDF and FAO/WHO Response
  • Seriousness of issue raised primarily by
    developing countries highly dependent on export
    trade at CCRVDF
  • Thailand and Argentina highlighted issues with
    emphasis on nitrofuran and chloramphenicol in
    food products
  • CCRVDF and FAO/WHO agreed to hold a technical
    workshop on the issue
  • Held in Bangkok in September 2004

38
Bangkok Consultation
  • Risk assessments/Analytical methodologies
  • Progress of analytical methods and impact on
    international trade
  • Analysis and management of risk of low level
    residues
  • Risk assessments by JECFA
  • Regulatory framework/Capacity building
  • Regulatory framework at the national and regional
    level
  • International regulatory framework provided by
    Codex and WTO
  • Capacity building

39
Analytical Methods Impact on Trade
  • National action levels based on detection limits
  • Detection capabilities based on best science and
    latest technology
  • Best (and costly) instrumentation
  • Development of methods in
  • a regional laboratory
  • National action limits based on hazard or risk
    estimates
  • Detection capability based on hazard or risk
  • Instrumentation to accomplish regulatory need
  • Availability of methods across laboratories

40
Management of Risk - No ADI/MRLs
Use conditions not consistent with ADI
Toxicological data did not support an ADI
No suitably validated analytical method
No ADI/MRL
Good agricultural practice could result in
exceeding possible MRL
Residue data are insufficient to support an MRL
No valid sponsor
41
Management of Risk - Low Level Residues
  • In the absence of an ADI and MRLs
  • National authorities may regulate to no
    detectable residues
  • The prevalence of residues of concern changes as
    analytical method detection capability improves
  • Changes in technology and improved detection
    capability results in previously non-detectable
    residues becoming reportable
  • Change in reported amounts of residues is
    independent of toxicological risk

42
CCRVDF and JECFA Critical Issue of Managing Risk
of Low Levels of Residues
Considering the close relationship between the
nature and extent of available data and the
ability to establish an ADI and MRLs
How does JECFA obtain the necessary data to
establish an ADI and recommend MRLs?
What data does JECFA need to establish an ADI and
MRLs?
  • Need alternate approaches to evaluate data for an
    ADI
  • Need alternate approaches to an ADI to evaluate
    risk and safety

43
JECFA Risk Assessments - Current Scenario
No ADI/MRL
Developed countries
Major uses
Large number of substances currently used in
veterinary medicine
ADI and MRLs recommended
No sponsor no data
Minor uses? Developing country needs? Regional
needs?
Substances evaluated by JECFA
44
Regulatory Framework/Capacity Building
  • 12 of the 23 discussion papers addressed
    regulatory frameworks on six continents
  • Three had unique features and many others
    provided general nature details the unique
  • Margin of Exposure concept
  • Positive lists for agricultural chemicals in food
  • Spectrum of residue control programs and
    capability within a continent

45
Regulatory Lessons Learned
  • No ADI/MRL No detectable residues
  • Risk communication Difficulties with managing
    perceptions of foods not being legal, yet of
    low risk to public health and safety

Public policy
Analytical technology
Public health
46
Regulatory Framework Discussions
Public health objectives
Legislation, regulations and guidance documents
Data and information systems
Regulatory framework components
Suitable analytical methods
Adequate technical resources
Effective surveillance and compliance
Risk based residue control program
Status quo Framework capacity differs
significantly between countries
47
Identified Regulatory Framework Weaknesses
  • Lack of high commitment to national policies
  • Low priority commitment to national food safety
    measures
  • Inadequate resources for food safety programs
  • Lack of coordination among relevant stakeholders
  • Stakeholders not always involved in developing
    food safety programs
  • Limited numbers of safe veterinary drugs with
    Codex MRLs for adoption by national governments
  • Inadequate enforcement to ensure judicious use of
    veterinary drugs

48
Measures to Facilitate Improvement
  • Improved awareness and commitment to public
    health protection and international trade
  • Designing capacity building to meet specific
    national needs
  • Encourage stakeholder involvement in food safety
    programs
  • Improve coordination and communication among
    competent authorities for food safety programs
  • Implement mentoring programs with countries
    having comprehensive food safety programs
  • Improve good veterinary drug practices especially
    at the farm level

49
Promising Factors to Improve Food Safety Programs
  • Marketing access and economic factors
  • Consumer demand for safer foods
  • Export market access increases demand and need
    for safer and higher quality food
  • Ending international trade and market disruptions
  • Increasing attention to substances without an ADI
    or MRL
  • Better attention to WTO/SPS obligations
  • Recognizing that developing countries are not
    receiving full benefit of the SPS provisions

50
Codex and WTO Problems and Gaps
  • Codex (CCRVDF) has not fulfilled its mandate to
    evaluate all veterinary drugs posing a potential
    significant threat to health and consumer risk
  • Where JECFA has evaluated but not established and
    ADI or MRLs, these substances are forgotten and
    disappear from adoption procedures
  • WTO notification procedures seem to be
    inadequate, not assuring sufficient consultation
    and involvement of exporting countries
  • Summary No comprehensive set of standards for
    implementation by member governments results in a
    patchwork of national solutions

51
Capacity Building Issues and Approaches
  • Building capacity is frequently driven by growth
    of consumer demand for safer food
  • Lack awareness of roles and responsibilities of
    international agencies (e.g., FAO) and
    organizations (e.g., Codex) that impedes capacity
    development
  • Ability to provide needed expertise is limited by
    developing country resources and commitment
  • Effective capacity building requires a global
    vision and commitment at the highest levels
  • Needs to be approached in a holistic manner
  • Should be directed to the most appropriate sector
    in recipient countries

52
Bangkok Recommendations
  • Five blocks of recommendations
  • To CCRVDF on risk management
  • To JECFA on issues related to risk assessment
  • To governments
  • To FAO, WHO and other international organizations
  • To organizations addressing capacity building

53
Highlight Recommendations
  • CCRVDF and JECFA should develop a list of
    substances not to be used as veterinary drugs
    (and not condone their illegal use)
  • Develop an approach to prepare a comprehensive
    list of MRLs covering all substances used as
    veterinary drugs within the next ten years
  • CCRVDF should facilitate creation of a list of
    drugs that are seen as important to developing
    countries
  • CCRVDF should complete development of its risk
    management policy and update its guidance
    documents

54
Highlight Recommendations (2)
  • Develop approaches for using techniques
    providing dose-response characteristics and
    estimates of risk when no ADI or MRL
  • Develop new approaches to the risk analysis of
    low level residues
  • Develop a holistic approach to capacity building
    with international organizations

55
CCRVDF Establishes a New Working Group
  • CCRVDF agreed to a Circular Letter to collect
    necessary information on
  • 1) all substances with no Codex MRLs used at the
    national level 2) substances that raise health
    concerns 3) substances that create trade
    problems 4) substances for inclusion on a
    negative list 5) national or regional MRLs and
    6) information on analytical methods detection or
    determination
  • CCRVDF defined the specific tasks
  • 1) establish lists to circular letter request 2)
    prioritize listed compounds for future
    consideration 3) develop recommendations on how
    to proceed with priorities 4) develop risk
    management options and 5) develop a timetable
    for action

56
16th CCRVDF and Beyond
  • The future is not some place we are going to,
    but one we are creatingThe paths are not to be
    found, but made, and the activity of making them
    changes both maker and the destination.
  • JOHN SCHAAR, philosopher
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