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The Codex View on Veterinary Drug Residues. 4 th 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 Safety. Codex principles and objectives Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF)

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The codex view on veterinary drug residues l.jpg

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


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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


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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 (>98% world population)

    • Meets annually

    • Adopts draft Codex standards

    • Reviews the Program of Work

    • Reviews the budget


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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)


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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)


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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)


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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)

Codex Committees & Task Forces


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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

Codex Standard Development Process


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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


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Codex Publications

  • http://www.codexalimentarius.net/web/index_en.jsp


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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


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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


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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


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Codex Provisions Recognized by TBT

  • Food labeling

  • Quality provisions

  • Nutritional requirements

  • Methods of analysis and sampling


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

National Regulations and Codex


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Codex Committee standards meet the requirements of the SPS and TBT measuresResidues 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


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Role of Science in Codex- standards meet the requirements of the SPS and TBT measuresStatements 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


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Statement of Codex Principle on standards meet the requirements of the SPS and TBT measuresRole 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


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Major & New CCRVDF Accomplishments standards meet the requirements of the SPS and TBT measures

  • 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


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CCRVDF Risk Assessment & Risk Management standards meet the requirements of the SPS and TBT measures

  • 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


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JECFA - The Risk Assessors standards meet the requirements of the SPS and TBT measures

  • 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)


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First Things First – The ADI standards meet the requirements of the SPS and TBT measures

  • Adverse systemic effects

  • Reproduction and developmental effects

  • Mutagenic effects

  • Carcinogenic effects

  • Effects on human intestinal flora

  • Immunologic effects

  • Pharmacological properties

  • Endocrine effects


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Specific Considerations -ADI standards meet the requirements of the SPS and TBT measures

  • 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


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Studies for Recommending MRLs standards meet the requirements of the SPS and TBT measures

  • 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


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Residue Depletion and MRLs standards meet the requirements of the SPS and TBT measures

CONCENTRATION

liver

kidney

fat

muscle

T I M E


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From an ADI to MRLs standards meet the requirements of the SPS and TBT measures

ADI

MRLT

If MRLU > MRLT

No MRL recommended

If MRLU < MRLT

If MRLM > MRLU

and MRLM < MRLT

useMRLM

IfMRLM ≤ MRLU

Use MRLU

If MRLT ≥ MRLM

use MRLT

If MRLT < MRLM

No MRL recommended


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JECFA Publications standards meet the requirements of the SPS and TBT measures

http://www.codexalimentarius.net/web/jecfa.jsp


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CCRVDF Recommendation Process standards meet the requirements of the SPS and TBT measures

  • 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


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Codex Alimentarius Commission Options standards meet the requirements of the SPS and TBT measures

  • 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)


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Current Matters of CCRVDF Interest standards meet the requirements of the SPS and TBT measures

  • Report of 15th Session Alinorm 05/28/31

http://www.codexalimentarius.net/web/reports.jsp?lang=en

  • 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


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MRLs Recommended for 28 standards meet the requirements of the SPS and TBT measuresth 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)


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CCRVDF – Antimicrobial Resistance standards meet the requirements of the SPS and TBT measures

  • 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


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CCRVDF Revised Guidelines standards meet the requirements of the SPS and TBT measuresRegulatory 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)


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CCRVDF – Methods of Analysis standards meet the requirements of the SPS and TBT measures

  • 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


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CCRVDF – Risk Management Issue standards meet the requirements of the SPS and TBT measuresRounding 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


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Veterinary Drugs Without ADI and MRLs standards meet the requirements of the SPS and TBT measures

  • 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


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CCRVDF and FAO/WHO Response standards meet the requirements of the SPS and TBT measures

  • 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


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Bangkok Consultation standards meet the requirements of the SPS and TBT measures

  • 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


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National action levels based on detection limits standards meet the requirements of the SPS and TBT measures

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

Analytical Methods Impact on Trade


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Management of Risk - No ADI/MRLs standards meet the requirements of the SPS and TBT measures

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


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Management of Risk - Low Level Residues standards meet the requirements of the SPS and TBT measures

  • 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


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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


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JECFA Risk Assessments - Current Scenario Levels of Residues

Developed countries

No ADI/MRL

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


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Regulatory Framework/Capacity Building Levels of Residues

  • 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


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Regulatory Lessons Learned Levels of Residues

  • 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

Analytical technology

Public policy

Public health


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Regulatory Framework Discussions Levels of Residues

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


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Lack of high commitment to national policies Levels of Residues

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

Identified Regulatory Framework Weaknesses


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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

Measures to Facilitate Improvement


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Marketing access and economic factors protection and international trade

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

Promising Factors to Improve Food Safety Programs


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Codex and WTO Problems and Gaps protection and international trade

  • 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


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Capacity Building: Issues and Approaches protection and international trade

  • 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


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Bangkok Recommendations protection and international trade

  • 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


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Highlight Recommendations protection and international trade

  • 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


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Highlight Recommendations protection and international trade(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


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CCRVDF Establishes a New Working Group protection and international trade

  • 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


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16 protection and international tradeth CCRVDF and Beyond

  • “The future is not some place we are going to, but one we are creating…The 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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