al87_31e

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS JOINT OFFICE:

WORLD HEALTH ORGANIZATION

Via delle Terme di Caracalla 00100 ROME Tel.: 57971 Telex:

610181 FAO I Cable.: Foodagri

ALINORM 87/31

JOINT FAO/WHO FOOD STANDARDS PROGRAMMECODEX ALIMENTARIUS COMMISSION Seventeenth Session Rome, 29 June – 10 July 1987

REPORT OF THE FIRST SESSION OF THE CODEX COMMITTEE ON RESIDUES OF VETERINARY DRUGS IN FOODS Washington D.C., 27–31 October 1986

TABLE OF CONTENTS

OPENING OF THE SESSION. APPOINTMENT OF RAPPORTEUR ADOPTION OF THE AGENDA

- Establishment of an Ad-Hoc Working Group on Priority Criteria BACKGROUND TO THE ESTABLISHMENT OF THE COMMITTEE AND MATTERS OF INTEREST ARISING FROM THE 16TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION

ACTIVITIES OF FAO, WHO, OIE AND OTHER INTERNATIONAL ORGANIZATIONS OF INTEREST TO THE COMMITTEE - FAO Activities, WHO Activities and Joint Activities of the Two Organizations..

- International Office of Epizooties (OIE) - Council of Europe

- Association of Official Analytical Chemists (AOAC)

- International Technical Consultation on Veterinary Drug Registration (ITCVDR).

Page11122

INTRODUCTION 1

446666

- European Economic Community (EEC) - International Dairy Federation (IDF)

- Bureau Europeen d'Information pour le Développement de la Santé Animale (DSA).

CONSIDERATION OF TERMS OF REFERENCE OF THE COMMITTEE AS ESTABLISHED BY THE 16TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION - Clause (b) - Clause (d).

- Definition of Veterinary Drugs

- Definition of Residues of Veterinary Drugs

PROPOSALS FOR THE PROGRAMME OF WORK AND ESTABLISHMENT OF WORKING PROCEDURES..

- Matters of Concern Identified by the Expert Consultation

- Matters of Concern Identified by Member Governments and International Organizations

- Establishment of Appropriate Working Procedures within the Codex Framework

- Working Relationship with Other Codex Committees

DETERMINATION OF PRIORITIES FOR THE CONSIDERATION OF VETERINARY DRUGS IN FOODS

- Criteria for the Selection of Veterinary Drugs for the Establishment of Acceptable Residue Levels

- Proposals for Inclusion in the Priority List - Establishment of Priority List

RELATIONSHIP WITH THE JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES

WORKING PROCEDURES FOR THE SELECTION OF ANALYTICAL

METHODS AND SAMPLING FOR THE CONTROL OF VETERINARY DRUG RESIDUES IN FOODS

CODES OF PRACTICE FOR CERTAIN ASPECTS OF THE USE OF VETERINARY DRUGS (RELATED TO RESIDUES OF VETERINARY DRUGS)

INTAKE STUDIES ON RESIDUES OF VETERINARY DRUGS IN FOODS AND GUIDELINES FOR REGULATORY PRINCIPLES CONCERNING RESIDUES OF VETERINARY DRUGS IN FOODS

- Intake Studies - Regulatory Aspects

PROGRAMME OF WORK AND WORK ASSIGNMENTS FOR NEXT

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SESSION

OTHER BUSINESS

- Statement by the Delegation of Senegal DATE AND PLACE OF NEXT SESSION 222223

APPENDIX I APPENDIX II APPENDIX III

APPENDICES- LIST OF PARTICIPANTS

- OPENING ADDRESS BY DR. DONALD L. HOUSTON, ADMINISTRATOR FSIS (USDA) - PROPOSALS FOR INCLUSION IN THE PRIORITY LIST OF VETERINARY DRUGS

253540INTRODUCTION1. The First Session of the Codex Committee on Residues of Veterinary Drugs in Foods was held from 27th to 31st October 1986 in Washington, D.C., by courtesy of the Government of the United States of America. The Chairman of the Session was Dr. Lester M. Crawford, Associate Administrator, Food Safety and Inspection Service, USDA. Representatives and Observers from 34 countries and 10 international organizations were present.

2. A list of participants including officers of FAO and WHO is attached as Appendix I to this Report.

OPENING OF THE SESSION (Item 1)3. The Chairman of the Committee introduced Dr. Donald L. Houston,

Administrator, Food Safety and Inspection Service of the USDA who formally opened the Session.

4. Dr. Houston welcomed delegates to this First Session of an important new Committee. He gave the background to the reasons for the establishment of the

Committee and recalled the international efforts which had been made over the years in various for a to arrive at solutions for the problems related to the residues of veterinary drugs in foods.

5. Dr. Houston underlined the many implications on health and trade matters which required a coordinated international approach and expressed the hope that through the activities of this Committee it would be possible to find common ground on appropriate measures for the control of veterinary residues in foods.

6. The full text of Dr. Houston's presentation is attached as Appendix II to this Report.

7. Mr. Eddie F. Kimbrell, the Chairman of the Codex Alimentarius Commission reminded the Committee of the objectives of the Joint FAO/WHO Food Standards Program me and its wide impact on health and trade issues. He expressed his appreciation for the active participation of FAO and WHO in the work of this new Committee. He further emphasized that the work of Codex also depended to an increasing extent on making the consumer more a ware of Codex work.

8. He joined Dr. Houston in expressing the hope that the Committee which

represented an internationally acknowledged body of expertise would be able to make substantive recommendations to the Commission on all matters related to residues of veterinary drug sin foods.

9. Mr. Kimbrell extended a special welcome to Mr. John R. Lupien, the recently appointed Chief of the Joint FAO/WHO Food Standards Program me.

10. The Committee considered a request to admit a member of the press to its Session and decided that, in line with the Guidelines for Codex Committees, this Session should be closed to the public. Appointment of Rapporteur11. The Committee agreed to appoint Dr. Arpad Somogyi (Federal Republic of Germany) to serve as Rapporteur for the Session. ADOPTION OF THE AGENDA (Item 2)12. The Committee had before it the Provisional Agenda for the meeting (CX/RVDF 86/1).

13. The Delegation of Senegal proposed that the problems associated with the studies of residues of veterinary drugs in foods in the region of Africa should receive specific attention. It was noted that the Coordinating Committee for Africa could play an important role in establishing priorities on a regional basis.

agreed to give further consideration to this matter under Item 10 -14. The Committee \"Other Business\".

adopted the provisional agenda without change. 15. The Committee Establishment of an Ad-Hoc Working Group on Priority Criteria16. The Chairman of the Committee proposed to limit the possible number of Ad-Hoc

working groups in order to achieve full consideration of all items in plenary. He pointed out, however, that in exceptional cases the nature of the problems to be resolved might require the establishment of an Ad-Hoc working group with well defined terms of reference. The Committee agreed with the proposal of the Chairman that a working group w as appropriate to examine the relevant part of the working papers and

proposals by delegations concerning the criteria for including veterinary drugs in the priority list for evaluation by a joint FAO/WHO expert committee.

also agreed that the above Ad-Hoc Working Group should recommend 17. It was such draft criteria for examination in plenary under Item 6(a).

agreed that the priority list would be established by the plenary 18. The Committee session.

19. For details of the report of the Ad-Hoc Working Group on Criteria for the Inclusion of Veterinary Drugs in a Priority List (see paras 148-162).

BACKGROUND TO THE ESTABLISHMENT OF THE COMMITTEE AND MATTERS OF INTEREST ARISING FROM THE 16TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION (Item 3)20. The Committee had before it CX/RVDF 86/2 which provided information on matters relevant to the establishment of the Committee.

21. The Committee noted that the Codex Committee on Pesticide Residues had

established, within its regular program me of work, maximum residue limits and guideline levels in products of animal origin for a large number of pesticides directly applied to animals. How ever, it was only in connection with the elaboration of the Draft International Code of Principles for Ante-Mortem and Post-Mortem Judgment of Slaughter Animals and Meat that the 4th Session of the Codex Committee on Meat

Hygiene (CC/MH) had given consideration to residues in meat in a wider context, arising from the use of pesticides, antibiotics and other veterinary drugs, trace metals and other trace contaminants, anabolic agents, radioactive materials, poisonous plants and other substances (Appendix III to the Revised Draft of 1979).

22. CCMH had referred the substances, with the exception of pesticide residues which were already covered by the work of the Codex Committee on Pesticide

Residues, to the relevant Committees and consequentially the Codex Committees on Food Additives and Pesticide Residues had discussed responsibility for evaluating these substances.

23. The 5th Session of CCMH had decided that the details included in Appendix III of the \"Judgement\" Code should not form part of the Code but be issued as a supplement only. The Committee had urged that, within the Codex framework, work should be undertaken on anabolic agents and antibiotics as well as on pesticide residues which were already covered by the Codex Committee on Pesticide Residues (paras 133-134 of ALINORM 83/32).

24. The Codex Committee on Food Additives (CCFA) had been divided in its view whether the question of veterinary drug residues in foods could be handled within that Committee. It had agreed with CCMH that a consultant should advise the Commission on how to tack let he problem. CCFA had proposed very comprehensive terms of

reference for the consultant's work and had offered to examine the resulting report (par as 234-237 of ALINORM 83/12A).

25. At its 14th Session the Committee on Pesticide Residues had considered a submission from Australia, requesting the Committee to examine the possibility to

evaluate chemicals used for the mass medication of food producing animals. It had been pointed out that these substances could leave residues in meat and meat products, milk and eggs which gave rise to problems in a very extensive area of international trade. The Committee had recognized the need for an appropriate scientific advisory body and had decided to bring the complex matter before the Commission (par as 248-252 of ALINORM 83/24A).

26. The 15th Session of the Commission had considered the views of the three above Committees and agreed that \"the subject was urgent and timely\" and, as

suggested by the 30th Session of the Executive Committee, that in view of the complex scientific and technological aspects, the matter should be examined by a Joint FAO/WHO Expert Consultation.

27. The Commission had also noted that CCFA had already to deal with a very

heavy work load and had agreed that the Consultation's recommendations might be best examined by a new Committee (par as 156-162 of ALINORM 83/43).

28. At the request of the Codex Alimentarius Commission, FAO and WHO had convened an Expert Consultation from 29 October to 5 November 1984 at FAO Headquarters in Rome, Italy. The tasks before the consultation had been:

(i)

To examine the problems associated with residues in foods arising from the use of veterinary drugs and other chemicals in food producing animals.

(ii) To advise the Codex Alimentarius Commission on how to consider these

problems. (iii) To examine the ways and means of regulatory control. (iv) To suggest priorities for substances to be considered.

29. The Consultation had defined \"veterinary drug\" for its considerations and had recognized that a large number of other substances, if they enter food products, could be of public health concern or lead to difficulties in international trade. The Consultation had recommended elaboration of a definition for \"residues of veterinary drugs\".

30. In conclusion the Expert Consultation had recognized the complex nature of

occurrence and safety evaluation of residues of veterinary drugs in foods of animal origin and the world-wide scope of the problem. In view of the significant public health and consumer concern and the problems related to trade originating from residues of

veterinary drugs in foods the Expert Consultation had recommended the establishment

of a Codex Committee on Residues of Veterinary Drugs in Foods to determine priorities in the area, recommend maximum residue levels and to develop codes of practice. 31. Specific recommendations had been directed to WHO and FAO regarding the need for convening an appropriate scientific body with well established responsibilities. The two Organizations had been also requested to provide assistance in the fields of training, information and other support to developing countries.

32. Recommendation to Member Governments concerned regulatory approaches including advice to users of veterinary drugs through labelling and advertising matters related to withdrawal periods and educational programmes.

33. The Consultation had identified the need for reliable analytical methods which should be simple, economic and, as far as possible, validated.

34. The Report of the Joint FAO/WHO Expert Consultation on Residues of

Veterinary Drugs in Foods had been published as Food and Nutrition Paper No. 32 and was distributed as a document for this Session of the Committee.

35. The 16th Session of the Commission had strongly supported the

recommendations of the Expert Consultation and established the Codex Committee on Residues of Veterinary Drugs in Foods. The Commission also established terms of reference for the Committee which will be discussed under Agenda Item 5.

36. The Committee noted the Commission's recommendation to liaise closely with the Codex Committee on Methods of Analysis and Sampling (CC/MAS) and to take into account the work already undertaken by other bodies such as the Council of Europe. 37. The Committee also noted that the Commission had urged FAO/WHO to

convene an appropriate body to provide independent expert advice to the Committee. decided to defer any consideration of its terms of reference 38. The Committee (Appendix I to CX/RVDF 86/2) to Item 5.

expressed its appreciation for the information provided in 39. The Committee CX/RVDF86/2 and agreed to discuss the working relationship with other subsidiary

bodies of the Commission and its proper organizational structure under the next agenda items.

ACTIVITIES OF FAO, WHO, OIE AND OTHER INTERNATIONAL ORGANIZATIONS OF INTEREST TO THE COMMITTEE (Item 4)FAO Activities, WHO Activities and Joint Activities of the Two Organizations40. The Secretariat explained current programmes within the Food Quality and Consumer Protection Group of FAO which assisted countries in developing and implementing their own food laws and regulations. Technical and advisory services for the monitoring and control of food contaminants and residues of chemicals used in agricultural production were available through these programmes. The Group was the focal point within FAO for the Joint FAO/WHO Food Contamination Monitoring Program me, which was associated with the Global Environmental Monitoring System (GEMS) operated by the UNEP; the Joint FAO/WHO Expert Committee on Food Additives; the Joint FAO/IAEA/WHO Expert Committee on Food Irradiation; and the Second

FAO/WHO/UNEP Conference on Mycotoxins to be held in April198 7. The Group was responsible for the organization within FAO of the Joint FAO/WHO Expert Consultation of Residues of Veterinary Drugs in Foods held in Rome in October1984.

41. The Food Quality and Consumer Protection Group of FAO has also assisted thirty developing countries to strengthen their laboratory services specializing in food contamination control in the past few years.

42. The Committee was informed of the working procedures of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). It was noted that the Plant Production and Protection Division of FAO (AGP) provided the Joint Secretary for JMPR and that the working procedures had been under review by the last session of JMPR which had taken place in September this year.

43. The Secretariat further explained that the Joint FAO/WHO Expert Committee on Food Addtives (JECFA) had been established in 1956 by the Food and Agriculture Organization and the World Health Organization following the First Conference on Food Additives held in Rome in 1955. As of June 1986, the Committee had met on 30

occasions, and had considered more than 600 substances used or proposed for use as food additives, and several contaminants. The Committee has a close working

relationship with the Codex Committee on Food Additives, although it was independent of it and was responsible only to the Directors-General of FAO and WHO.

44. It was noted that the members of the JECFA were individual experts appointed in their personal capacity. They did not represent their governments, nor the organizations nor institutions for which they work. Although the numbers varied from meeting to meeting, approximately half of the experts were appointed by FAO and half by WHO. 45. Although within the JECFA the experts appointed by WHO had the principal responsibility for the toxicological evaluation of the substances under consideration,

while the experts appointed by FAO were principally responsible for the establishment of specifications of identity and purity of the food-grade materials and technological aspects of the use of the food additive, it was emphasized that the conclusions of the Committee were collegial decisions arrived at by the Committee as a whole.

46. In most cases a request for the evaluation of a substance was made at a session of CCFA. The CCFA also considered requests made in response to Codex Circular Letters on this subject and consolidated these requests in the form of a Priority List, which might also include substances proposed for inclusion in individual Codex

commodity standards. The Priority List was communicated to the Joint Secretariat of JECFA. JECFA had been unable to evaluate a number of substances due to the lack of data. The CCFA had agreed that in most cases governments or international organizations which propose substances for inclusion in the Priority List should

undertake to ensure that sufficient data would be available for an evaluation to be made. These data not only refer to the toxicological properties of the substance, but also to its chemical identity and use as a food additive.

47. Dr. Vettorazzi of the International Program me of Chemical Safety, Division of Environmental Health of WHO and Joint Secretary of JECFA and JMPR outlined the back ground and working procedures of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)and specifically the WHO contributions to the Committee. He also described the various WHO units and committees which had considered the use and assessed the safety of veterinary drugs and their residues during the past two decades. At its twelfth meeting in 1968, JECFA had evaluated the safety and developed

specifications for certain antibiotics in food of animal origin. In October 1973, a WHO Working Group had considered public health aspects of antibiotics in feedstuff. In 1981, JECFA had devoted considerable attention to the safety assessment of hormones in animal production. Finally in 1982 and 1983, JECFA had carried out a detailed

toxicological evaluation of two xenobiotic anabolic agents, namely, trenbolone acetate and zeranol.

48. Dr. Vettorazzi furthermore informed that provisions have been made by FAO and WHO to hold two meetings of JECFA during 1987, one of which will exclusively deal with the evaluation of the residues of those drugs appearing on the priority list compiled by this Committee.

49. The Chief of the Joint FAO/WHO Food Standards Program me explained that JECFA is an ad hoc expert body constituted by international experts whose membership and agenda can be accommodated to tackle aspects other than direct food additives and whose terms of references have been extended to consider also food contaminants by the Third Joint FAO/WHO Conference on Food Additives and Contaminants in 1973. 50. Dr. J. Debbie, Veterinary Public Health Unit, Division of Communicable Diseases of WHO, expressed the interest of the Unit in matters related to the use of veterinary drugs. In cooperation with other units of WHO, the VPH Unit was particularly concerned with the effects of the use of antibiotics in animal husbandry with emphasis on

standardization of analytical methods to detect drug residue and the mechanisms of resistance transfer.

51. Dr. J. Dunne, Chief, Pharmaceutical Unit of WHO, explained the steps of the normative, advisory and informational activities of WHO with reference to

pharmaceutical products. WHO (and its governing bodies) had become increasingly concerned, in recent years, with promoting the rational use of drugs in human medicine. Activities included: assigning internationally recognized nonproprietary names to drugs; (a) assigning internationally recognized non-proprietary names to drugs; (b) promulgating standards of good manufacturing practice;

(c) providing specifications in the International Pharmacopoeia for assuring the quality of

drug substances ; and (d) promoting international exchange of information on regulatory decisions among

countries. 52. The Secretariat explained the activities of FAO Animal Production and Health Division which had expressed interest in the work of CC/RVDF. Special attention was called to an expert consultation on the use of stimulants of animal growth and lactation which might be held during the 1988/89 biennium.

53. The Secretariat further explained that the Codex Committee on Fish and Fishery Products was considering development of a Code of Practice for Aquaculture. A basic working paper was being prepared by the Fisheries Division of FAO for submission to the next session of that committee. It could be expected that such a code might include reference to veterinary drugs used in aquaculture.

54. The Delegation of Brazil commented on the Statements included in the various parts of CX/RVDF 86/3 and made, in particular, the following remarks: Brazil shared the Concern with the use of anabolic agents (natural steroids) in meat as well as the use of xenobiotic anabolic agents. Concerning pesticides used directly on animals, Brazil has prohibited the use of bendiocarb, captan, fenvalerate, hexochlorobenzene, Lindane, methidathion, phosmet and phokim. International Office of Epizooties (OIE)55. The Observer of OIE described the activities of the International Office of

Epizooties (OIE). Two of the fundamental tasks of OIE were to inform member countries about the means used to control animal diseases and to standardize health regulations applicable to international trade in animal and animal products. OIE had set up a working group to study, in collaboration with the International Technical Consultation on

Veterinary Drug Registration (ITCVDR) the establishment of an information network on the harmful effects of veterinary drugs and an information program me on the control of veterinary drugs and toxicological accidents. At the Third ITCVDR held in Paris in the Spring of 1986, OIE had determined that its program me of work should deal with activities not taken into account by other international organizations. Council of Europe56. The Rapporteur, although not as an official representative of this organization, summarized the activities of the Council of Europe in the field of residues of veterinary drugs. He pointed out that the Public Health Committee (Partial Agreement) of the

Council of Europe established in 1982 a multidisciplinary Expert Committee to deal with the human health aspects of residues of veterinary drugs in food of animal origin.

Between 1982 and 1986, this Expert Committee had held six sessions and had reached consensus on the principles of the safety evaluation of residues. In addition, it had identified issues of special concern such as the use in food-producing animals of nitrofurans, chloramphenicol, neuroleptic drugs as well as beta-adrenergic blocking agents to reduce losses due to the stress of transportation in animals before slaughter. Residue problems related to individual animal species such as the consequence of drug therapy in fish and laying birds have been dealt with by the Expert Committee as well. Recently, the final report of this Committee has been published by the Council of Europeunder the title \"Residues of Veterinary Drugs in Food of Animal Origin\" (Strasbourg,Council of Europe, Publications Section, ISBN 928710907-9, 1986).\" Association of Official Analytical Chemists (AOAC)57. The Observer of AOAC presented the views of the AOAC. The AOAC believed that reliable precise collaborative methods were important and that a requirement should bemade that interlaboratory collaborative studies be performed and published on analytical methods before their use. AOAC was seeking cooperative relationship in developing analytical methods.

International Technical Consultation on Veterinary Drug Registration (ITCVDR)58. The Observer of ITCVDR informed the Committee that ITCVDR had held three consultations for officials concerned with the registration of veterinary drugs to exchange information and experience in the regulation area.

59. After a first meeting held in Columbia, Maryland, United States, in January 1983 and a second meeting in Oslo, Norway, in June 1984, ITCVDR had organized a third session in Paris in June 1986. This meeting had been attended by about 100 participants representing 40 countries and 8 international organizations.

60. The main items on the agenda of the consultation concerned national legislation, public health (safety of residues) and animal health problems. It had been proposed that the fourth session of the ITCVDR would take place in Australia. European Economic Community (EEC)61. The Observer of the EEC summarized the activities of the European Economic Community relating to Residues of Veterinary Medicines in Foods. In accordance with

the objectives of the EEC Treaty, the Community had the task of securing the free movement of both veterinary medicinal products and foodstuffs of animal origin within the Community. A summary of the legislation which had been adopted in this area by the EEC was presented. A Working Party on the Safety of Residues had issued

recommendations on residues of chloramphenicol, sulphonamides and nitrofurans. Particular attention was also being given in the EEC to problems resulting from the use of veterinary medicines in fish and in laying birds and to the quality, safety and efficacy of old veterinary drugs (CRD 7). International Dairy Federation (IDF)62. The Observer of IDF informed the Committee that IDF had more than 30 member countries from all over the world. The work was performed in nearly 100 groups of experts (10-20 members on average) which were partly joint groups of IDF, ISO and AOAC.

63. The work of the following three groups was closely related to residues of veterinary drugs in milk:

a) Residues and Contaminants in Milk and Milk Products (a compendium from 1979

being revised at present) b) Methods for the Detection of Pesticides (including Organophosphorus Compounds). c) Antibiotics.

64. The latter group had worked out a compendium of methods for the detection of inhibitors in milk and the identification of specific antibiotics on a very low level (immunoassays and microbial receptor tests included). 65.

The above publication was expected to be available later this year.

Bureau Européen d'Information pour le Développement de la Sant é Animale ( D.S.A .)66. The Observer of DSA informed the Committee that the Bureau Européen d'Informatlon pour le Développement de la Santé Animale (DSA) was composed of

twenty five research oriented multinational pharmaceutical companies. The objectives of DSA were to identify issues and provide information on questions related to animal

health and production. It was noted that DSA has sponsored two international symposia: (1) Quality and Safety of Wholesome Food (1984)

(2) Future of Production Productivity; Science vs Politics (1986).

67. The Observer stated that DSA maintained contact with regulatory agencies, the animal production industry and consumer organizations. It also sponsored basic research concerning the safety of residues.

68. The Observer further stated that DSA was the nucleus along with national trade organizations of the European Federation of Animal Health Industries (F.E.D.S.A.) which would become operational in 1987.

CONSIDERATION OF TERMS OF REFERENCE OF THE COMMITTEE AS ESTABLISHED BY THE 16TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION (Agenda Item 5)69. The Committee had before it Appendix I to CX/RVDF/86/2 containing the

Committee's terms of reference as established by the 16th Session of the Commission. The paper also contained a definition for the term \"veterinary drug\" elaborated by the

Expert Consultation for the purposes of the Consultation and some advice on a term for \"residues of veterinary drug\".

70. The Secretariat informed the Committee that it was the usual practice for a new Committee to review its terms of reference in the light of its programme of work. 71. The Committee noted that if it were concluded that the present terms of

reference did not adequately cover its work programme, the Committee could propose appropriate amendments to the terms of reference to the Commission.

72. The Committee also noted that an annex to the paper provided a number of basic definitions developed by the Codex Alimentarius Commission for reference purposes. Information on the Committees on Pesticide Residues and Food Additives was provided in Appendices II and III to CX/RVDF 86/2. Terms of ReferencesClause (b)73. The Rapporteur informed the Committee that the terms of reference had been based on the recommendations and conclusions of the Expert Consultation and had, after careful consideration, been approved by the Commission.

74. The Delegation of the Federal Republic of Germany drew attention to the

difficulties which might arise from Clause (b) of the terms of reference which at present referred to maximum residue levels. The Delegation was of the opinion that health considerations should be the determining criteria for the establishment of permissible residue levels; this view was shared by the Committee.

75. The Representative of WHO explained the concept of ADIs and MRLs. ADIs

were established on the basis of a safety evaluation and toxicological data. MRLs on the other hand reflected levels which could be achieved through Good Agricultural Practice. It was the function of the CCPR to as certain through the data derived from intake studies that the MRLs did not represent a hazard to health.

76. There was considerable discussion as to whether the term \"MRLs\" should be redefined for the purposes of this Committee or whether a new term should be

developed. It was also pointed out in this context that the Expert Committee which would be charged with the safety evaluation of veterinary drugs might not be in a position to establish ADIs for all different classes of veterinary drugs and that another approach might have to be taken in some cases.

77. The Committee agreed that it was appropriate to amend Clause (b) to refer to \"acceptable residue levels\". The Committee agreed further to review its terms of reference again at the end of the session after full examination of its programme of work. Clause (d)78. The Delegation of Norway enquired whether Clause (d), as presently drafted, would limit the activities of the Committee to establishing criteria for analytical methods as it did not seem to permit development and consideration of methodology as such. 79. Members of the Expert Consultation informed the Committee of the existence in scientific literature of well-established criteria for the performance of methods. Dr. Ellis of the United States of America expressed the view that appropriate performance

standards and characteristics should be provided by the Committee; however individual methods need not necessarily be identified.

80. The Secretariat pointed out that other Committees such as the Codex

Committees for Methods of Analysis and Sampling and for Food Hygiene had developed criteria for the application of methods of analysis to foods.

81. The Committee was reminded that full consideration to matters pertaining to methods of analysis and sampling would be given under item 6(c) and agreed to consider clause (d) further at a later stage. (See paras 184-193)

agreed that the amended version of the terms of reference 82. The Committee should be provided in full together with a summary of the Committee's programme of work (see para. 211). Definition of Veterinary Drugs83. The Delegation of Poland requested that the definition as given in para 2 of the paper should include specific reference to growth promoting agents.

84. It was pointed out that the term \"modification of physiological function\" covered such substances and there was no need to make specific reference to growth promoting agents.

85. The Delegation of Poland, while agreeing with the above view, thought that the proposed amendment would provide valuable advice to regulatory authorities.

86. The question was also raised of whether vitamins and minerals were covered by the definition. The Committee agreed that under certain circumstances they might be covered and that this could be further discussed under the item dealing with \"codes of practice\".

87. It was also questioned whether disinfectants used in veterinary practice and giving rise to residues in, for example, milk would fall under the definition. The

Committee concurred with the view that disinfectants used directly on animals were covered by the definition; however, if employed in animal quarters, they would not fall under the definition.

88. The Committee, having considered these questions, decided not to include explanatory footnotes to the definition.

89. The Committee considered at great length whether it would be feasible to draw a line in the definition between pesticides used directly on animals and other veterinary drugs. It was noted that there appeared to be differences on how this was dealt with in national regulations.

agreed that, in general, any compound used in or on food-90. The Committee producing animals for the indications enumerated in the definition of veterinary drugs should be considered a veterinary drug and it appeared that certain substances could be classified as both pesticides and veterinary drugs, depending on the purpose for which they were used.

91. Several delegations felt that it might be impracticable to include this concept in the definition and proposed instead that the Committee should closely liaise with CCPR and the appropriate expert body concerning the evaluation of such substances with multiple functions.

92. The Committee recognized that in certain cases where chemical substances had dual functions (additives, pesticides, veterinary drugs) a pragmatic approach should be followed in order to avoid unnecessary duplication in the evaluation of such substance. It

should, however, be kept in mind that some of the criteria for the evaluation might be different depending on the particular application of the chemical concerned.

93. The Committee agreed to make an editorial amendment to the definition. It also recognized that veterinary drugs could consist of a combination of substances; however this was already covered by the present wording. The Committee agreed that the definition, as amended, should read as follows:

\"Veterinary Drug\" is defined as any substance applied or administered to any food-producing animal, such as meat or milk-producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviour.

Definition of Residues of Veterinary Drugs94. The Committee noted that the Expert Consultation had provided advice on certain aspects to be included in the above definition.

95. The attention of the Committee was drawn to the definition of \"pesticide residue\" which appeared to be more comprehensive. The Committee decided that the definition of pesticide residues was not suitable for veterinary drugs and agreed to improve the text as contained in paragraph 3 of the paper.

96. It was pointed out by the Delegation of the United Kingdom that residues could also be derived from inactive ingredients used for pharmaceutical reasons (i.e. formulation) and a proposal was made to add the following words:

\"or of any inactive ingredient contained in the formulation of a veterinary product\"

97. Several delegations held, however, the view that this approach was not practicable since different formulations resulted in an enormous number of different adjuvants. It was pointed out that many excipients/adjuvants were not harmful and reference should only be made to substances which were considered to be of toxicological significance. A similar phraseology had been used by CCPR. The consideration of this aspect was primarily the responsibility of national authorities. 98. The Representative of WHO expressed the view that the function of the

Committee was to deal with the active substance of the veterinary drug and not with drug preparations.

99. On the other hand, the toxicological significance as applicable to impurities in veterinary drugs was clearly recognized.

100. Several delegations held the view that the definition was still not specific enough in relation as to whether the residues were of toxic or potentially toxic significance or concern.

agreed to amend the definition editorially in the following manner: 101. The Committee \"the term 'residues of veterinary drugs' includes the parent compounds and/or

their metabolites in any edible portion of the animal product, and includes residues of associated impurities of the veterinary drug concerned.\"

recognized that it might be necessary to elaborate other 102. The Committee definitions as the occasion arose.

CONSIDERATION OF PROPOSALS FOR THE PROGRAMME OF WORK AND ESTABLISHMENT OF WORKING PROCEDURES FOR THE COMMITTEE (Agenda Item 6)103. The Committee had before it working paper CX/RVDF 86/4 and Conference Room Documents Nos. 1 and 2 on the above subject.

104. In introducing the document the Secretariat indicated that the Expert

Consultation had provided extensive guidance on possible items for inclusion in the programme of work of the Committee (Part A).

105. In addition, the paper outlined briefly the working mechanisms of other Codex Committees dealing with chemicals in foods. Furthermore it was proposed that the Committee should decide on fundamental procedural and structural matters in order to integrate it fully into the Codex framework. In addition to agreeing on the type of

appropriate residue levels, there appeared to be a need to propose to the Commission procedures for the elaboration of such levels and of an acceptance procedure. It was proposed in the process that it was also essential to arrive at recommendations concerning the working relationship with other Codex Committees (Part C). 106. Since it had been recognized that the most important contributions for the determination of the programme of work were the matters of priorities identified by Governments, a Circular Letter (CL 1986/2) had been issued to Governments and International Organizations requesting information on:

(a) (b) (c)

A listing of veterinary drugs to which priority should be given by the Committee.

Problems with residues of veterinary drugs in food being encountered in their respective countries of organization and Other matters of specific concern.

107. The Committee noted with appreciation that a considerable number of replies had been received which contained detailed proposals to the programme work

(Argentina, Australia, Belgium, Canada, Chile, Cuba, Federal Republic of Germany, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Spain, Trinidad and Tobago, United Kingdom, United States, EFPIA, DSA, Apimondia in Part B of

CX/RVDF 86/4 and CRDs I andII). The Committee agreed that the replies to CL 1986/2 should be considered inconnection with the relevant sub-items of Item 6, where possible; proposals not pertinent to those sub-items would be identified and taken up under this item at a later stage.

Matters of Concern Identified by the Expert Consultation108. The Consultation had identified and included in its report a number of potential problems arising from the use of veterinary drugs including the following:

- Veterinary Drugs in Prophylactic and Therapeutic Medicine - Veterinary Drugs for Growth Promotion - Control of Reproduction - Preslaughter Control of Stress - General Problems

- Safety Evaluation of Veterinary Drugs in Foods - Regulatory Control of Residues

109. The Expert Consultation had recognized the complexity of problems related to residues of drugs in food producing animals and had pointed to the need to provide

recommendations similar to those elaborated to ensure the safe use of pesticides and food additives, including the establishment of Maximum Residue Limits (MRLs). This would imply a need to:

(a) (b) (c)

agree on the nature of the residue to which the MRL applies; define affected commodities in trade for which MRLs are desirable; agree on the residue data needed for the establishment of MRLs.

110. The Expert Consultation had also agreed that, in order to establish internationally applicable MRLs, different requirements in individual countries have to be taken into account and proposed the use of the work carried out on pesticides as a model, having, however, regard to the specific aspects of veterinary drugs.

111. The Expert Consultation had proposed that generally acceptable criteria should be established for the safety evaluation of residues of veterinary drugs in foods. 112. The Expert Consultation had also proposed that veterinary drugs should be

evaluated on a priority basis on their significance in human health and their potential to create problems in international trade. The following substances or groups of drugs had been identified as being of immediate concern: - Antibiotics (specifically chloramphenicol) - Anabolic agents

- Sulfonamldes; e.g., sulfamethazine - Nitrofurans - Benzimidazoles - Nitroimidazoles

- Synthetic dyes used as marker compounds and as therapeutic agents - Carbadox - Cryomazine

agreed that the above points derived from the Expert 113. The Committee Consulation were important for consideration under the programme of work and might indicate some long term concerns to be taken up at future sessions. (For details of the above matters see there port of the Expert Consultation, Food and Nutrition Paper No. 32).

Matters of Concern Identified by Member Governments and International Organizations114. The Committee noted the responses to CL 1986/2 which related to proposals for priority considerations, problems encountered with veterinary drugs and other matters of concern with regard to residues of veterinary drugs in foods. Detailed information on the responses is contained in Part B of CX/RVDF 86/4 and Conference Room Documents Nos. 1and 2. In addition to the above information the following delegations presented further information verbally at the session on matters of priority:

115. The Delegation of Zimbabwe indicated that in African countries in general there was extensive use of trypanocides.

116. The Delegation of Kenya pointed out that problems existed in African countries with residues of acaricides for tick control and that there was therefore a need to consider with some urgency acaricide residues.

117. The Committee was in favour of including trypanocides in the first list of priorities in order to assure that these substances would be dealt with as soon as possible and to keep the acaricides under review. It was agreed to give attention, at a future meeting, to drugs used at a regional level, since they could also cause obstacles to international trade.

118. The Delegations of Argentina, Zimbabwe and Kenya emphasized the need not only for the evaluation of these substances, but also for the establishment of an

appropriate infrastructure to lower the operating costs of control measures in developing countries which are the limiting factor in these countries in controlling the use of veterinary drugs and the presence of their residues in foods. This was especially

important to countries which were exporters of foods of animal origin, to assure that their products would not be rejected by those importing countries which had more detailed regulations on residues of veterinary drugs.

119. It was noted that assistance was needed to provide appropriate training of personnel and analytical equipment. The Committee agreed with the view of the Secretariat that this Committee could serve as a forum for an exchange of information on the needs of member countries for food control measures and any relevant action taken by the parent organizations of the Codex Alimentarius Commission.

120. Several delegations pointed to the need for screening tests that is, rapid in

expensive methodology for the detection of residues of veterinary drugs. It was agreed that this would be further discussed under Item 6(c).

121. The Committee noted that in addition to the specific matters to be discussed under individual sub-items the following points of concern had emerged from the written and oral comments of delegates:

A number of specific commodities had been identified in which residues of

certain drugs presented a problem, for example, residues in fish, eggs and milk,

residues of neuroleptic agents and of beta-blockers used in pigs before transportation to reduce losses due to stress.

agreed that special attention should be given to these problems 122. The Committee when requesting priority evaluation for the above mentioned drugs and their occurrence in foods of animal origin.

123. The Committee noted that it had been proposed to carry out a survey of veterinary drugs permitted in individual countries to establish a list of compounds currently in use in veterinary practice. The Committee recognized that this might be a difficult undertaking because of the enormous number of compounds and even larger number of formulations in use in different countries.

124. The Committee noted that a similar exercise had been contemplated by WHO with regard to human drugs some years ago but this had been discontinued. It was also pointed out in this context that it would be a major undertaking to keep such a list up-to-date and that it could therefore discriminate against new preparations. The

representative of WHO informed the Committee that in the field of human drugs regular exchange of several national drug compendia had been organized. Many countries now notified WHO of new drug information, this information was collected and disseminated

to national registration authorities on a monthly basis. He suggested that this could be extended to cover veterinary drugs as well. The Committee expressed its appreciation to the Representative of WHO for the information provided.

125. The Committee was also informed that a compendium on veterinary drugs was being prepared for the Americas and was nearing completion. Further work on the compendium might be taken over a by a commercial enterprise. The Committee

expressed its interest in the compendium and accepted the kind offer of the Delegation of the United States to make copies available for the information of this Committee. 126. It was agreed that the proposal of a survey or compendium on veterinary drugs should be further discussed after this Committee had had an opportunity to examine the above compendium.

127. The Committee agreed with the Delegation of Canada that it would be useful to develop a glossary of terms of importance to the work of this Committee and accepted the kind offer of the Delegation of Canada to coordinate work on this topic by correspondence between sessions of the Committee. The delegations of Australia,

Ireland, Norway, Netherlands and the United Kingdom offered to participate in the work. 128. It was agreed that the Delegation of Canada would draft terms and definitions and request comments thereon from the delegations which indicated their wish to participate in the exercise.

129. It was further proposed that analogous to the work in CCPR, the Committee might consider establishing a classification of those commodities and parts of food in which residues of veterinary drugs could occur and that the task undertaken by several delegations and coordinated by Canada might include such classification. The

Committee was of the opinion that such an exercise was valuable but not as urgent as in the case of pesticide residues. The Committee, therefore, agreed to await the deliberations of the Expert Committee at its 1987 session and to reconsider this question at a future date.

130. The Committee recalled that several delegations had expressed concern at the consequences of adding antibiotics to feed stuffs in low doses to increase feed efficiency. It was noted that the Expert Consultation had thoroughly considered the problems arising from such practices and had thus identified matters of public health concern.

agreed that it should deal only with problems related to the 131. The Committee residues of veterinary drugs in foods and not to the possibility of transferring resistant strains to human beings. It was agreed that the latter was a matter of food hygiene which could be referred to the appropriate Codex Committee. The Committee noted that this subject had been the subject of several expert consultations in WHO.

132. The Committee recognized that there was concern regarding numerous aspects of methods of analysis for veterinary drugs in foods and acceptable residue levels. The Committee agreed that these matters should be taken up under the relevant Items 6(b) and 6(c).

133. In connection with the elaboration of residue levels, several delegations and observers expressed concern with regard to the availability of data for the evaluation of veterinary drugs. It was pointed out by delegations that, in some cases, experience in the field of pesticide residues had shown that lack of data and reluctance to provide data had seriously handicapped the evaluation of pesticide residues. The failure to obtain

data was often related to the fact that industry would not provide proprietary data without a guarantee of proper handling and security of these data.

134. The Committee was informed that procedures had been developed between the industry association (GIFAP) and WHO (International Programme on Chemical Safety) to deal with the commercial sensitivity of data on pesticide residues. The Committee agreed that similar arrangememts should also be made for the evaluation of veterinary drugs.

135. The Committee noted that several delegations had been in favour of developing codes of practice on the use of veterinary drugs either in general or for specific purposes(for example, aquaculture). It was agreed to refer the matter to Item 7. 136. Furthermore, governments had indicated their concern on appropriate monitoring of certain veterinary drugs, such as hormonal growth promotors.

137. The Committee recalled that information had been supplied under Item 4 on international monitoring efforts; however the Committee agreed that matters related to monitoring activities could also be examined in connection with consideration of intake studies under Item 8(a).

138. Having regard to the concerns expressed by the Delegations of Argentina and Brazil with regard to realistic control measures by importing countries, the Committee decided to take up this issue under Item 8(b). (See also para 119) 139. The Committee identified several topics which appeared to be outside its terms of reference, such as the need for acceptable residue levels for disinfectants in milk and matters related to material aspects of the control of residues of veterinary drugs

(requests for training facilities, provision of analytical equipment and standard reference material, designation of reference centres, etc.)

agreed that the above topics should be brought to the attention 140. The Committee of the relevant units of FAO and WHO.

agreed to exchange information on these matters by including an 141. The Committee appropriate item in future agendas. In this context it was pointed out that countries wishing to receive assistance on food control matters should direct their requests to FAO/WHO through their government authorities. The Committee noted that assistance was already provided by the UN agencies, frequently involving bilateral assistance. Establishment of appropriate Working Procedures within the Codex Framework142. The Committee was informed by the Secretariat that the Commission had not yet considered specific working procedures for the new Committee which were necessary, since residues of veterinary drugs were not covered by the existing procedures as e.g. for MRLs for pesticides and provisions for food additives.

143. The Committee noted that relevant adjustments had to be made to several

sections of the Procedural Manual to include specific reference to residues of veterinary drugs in foods.

144. It was pointed out that in addition there to, a procedure had to be developed on the action to be taken on the acceptable residue levels elaborated by the Expert

Committee (Step Procedure) and on appropriate acceptance procedures for the finalized levels.

concluded that there was a need to elaborate recommendations 145. The Committee on the above matters for submission to the Commission; however, this could be done

only after further discussion of the subsequent agenda items. The Committee agreed to take a decision on this point under Item 9.

Working relationships with other Codex Committees146. The Committee noted that the 16th Session of the Commission had

recommended close relations with CCMAS; while agreeing in principle with these recommendations, the Committee deferred a decision until the involvement of this

Committee in the development of methods of analysis and sampling had been clarified (Item 6(c)). The Committee recalled that it had already referred to the Codex Committee on Food Hygiene certain matters related to antibiotic resistance. The Committee also noted that it had agreed to a pragmatic approach concerning the direct use of pesticides on animals (see paras 89-93) but agreed that the relationship with CCPR might have to be further considered to avoid duplication of work.

agreed that the same principle should be applied to potential 147. The Committee relationships with other Committees and requested the Secretariat to prepare a working paper for the next session of the Committee on proposals as to how the drafts concerning procedural and organizational matters should be presented to the Commission for inclusion in the Procedural Manual.

DETERMINATION OF PRIORITIES FOR THE CONSIDERATION OF RESIDUES OF VETERINARY DRUGS IN F OODS (Item 6(a))148. The Committee had before it a list of veterinary drugs proposed by Codex

member countries (CX/RVDF 86/4 Add I parts 1 and 2 and CRD's 1 and 2) and a paper concerning the establishment of criteria for the determination of priorities (CX/RVDF 86/4 Add 2).

agreed that the first step to be taken was to establish the criteria 149. The Committee and subsequently examine the list of government proposals in the light of these criteria. 150. As decided earlier in the Session, an Ad-Hoc Working Group was convened to develop criteria for selection of veterinary drugs by this Committee for consideration by the Expert Committee. The Working Group under the chairmanship of Dr. G. Guest (United States) proposed that the following criteria be accepted by the plenary body of the CC/RVDF:

\"Criteria for the Selection of Veterinary Drugs for the Establishment of Acceptable Residue Levels*In order to be placed on the CC/RVDF's priority list for the development of an

acceptable residue level*, the candidate veterinary drug, when used in accordance with Good Veterinary Practices*, should meet some, but not necessarily all, of the following criteria:

(i) (ii) (iii) (iv) (v)

the drug results in residues in the food commodity;

the drug or its residues are a matter of public health concern;

the residues of the drug affect international trade to a significant degree; the residues of the drugs are creating or have a potential to create commercial problems;

the drug is available for use as a commercial product. In addition,

In addition,

(a) (b)

*

there must be a firm indication that relevant data will be made available for evaluation.

CC/RVDF should take into account any work on residues of the drug undertaken or completed by other Codex Committees.

NOTE: These terms remain under consideration by the Committee.

151. The Working Group further recommended that the selection of drug substances be conducted in the plenary session.

152. In the course of the Working Group discussion, the following items were identified as requiring additional discussion in the plenary session: -

In the future, the absence of current and relevant data may become a more

important issue than the presence of current and relevant data when considering a drug substance for review.

Whether as a minimum, both public health and trade issues must be apparent in order for a drug substance to be selected for consideration.

-

153. The Committee had a lengthy discussion on the proposed criteria and especially on whether criterion (i) should always be complied with or whether all the criteria should have equal weight. It was agreed that the chemical substance under consideration should meet some but not necessarily all of the five criteria listed.

was of the opinion that in certain cases criteria other than health 154. The Committee or trade issues could determine the inclusion of the substance in the priority list and decided therefore not to introduce the aspect as a minimum requirement health and trade issues.

155. The Delegation of Finland enquired whether under the criteria veterinary drugs used for treating dairy cows against mastitis and their residues would be considered to fulfill the criteria since in its view the presence of those residues were in most cases of technological importance rather than of public health concern. It was also noted that for technological reasons lower levels might be necessary than for health reasons. It was agreed that the use of the milk from treated cows constituted a technological and public health problem which would be best considered by the Joint FAO/WHO Committee of Government Experts on the Code of Principles Concerning Milk and Milk Products. 156. The Committee noted the working procedures of that Committee which included cooperation between IDF and the Secretariat.

157. The Committee placed emphasis on the need to observe provision (b) of the criteria which required that work undertaken by other committees should be taken into account when selecting priority drugs.

158. Concerning the question raised by the Working Group on the availability of data, the Committee was informed that CCPR had long standing experience with obtaining suitable data related to the above criteria and that a similar approach (the issue of circular letters to governments) could be taken up by this Committee.

159. Several delegations expressed concern about the availability of data for the evaluation of veterinary drugs.

160. The Representative of WHO informed the Committee that established procedures existed by which manufacturers could supply the necessary data. He

outlined the problems arising from ownership of data encountered particularly with new

drugs covered by patents. Another problem might arise where the patents on old drugs had expired and no sponsors were available to supply up-to-date data. It was also noted that the Expert Committee finalized the evaluation of substances only when it was

satisfied with the available data and sometimes requested the submission of additional data on specific points.

161. The Committee agreed that it was advantageous if submissions for inclusion of veterinary drugs in the priority list were accompanied by a firm indication that relevant data were available for their evaluation. (See also para. (b) of the Criteria)

adopted the above Criteria for the Selection of Veterinary Drugs 162. The Committee for the Establishment of Acceptable Residue Levels and agreed that they should be used for the establishment of the priority list. Proposals for Inclusion in the Priority List163. The Committee examined in detail the proposals made in writing and contained in the above mentioned documents (see para. 148) and decided that the list of

substances proposed by member countries should be appended to this report for future reference (Appendix III). Additional proposals were submitted by the following delegations: Sweden:

Benzimidazoles, carbadox, chloramphenicol, anabolic agents, sulphonamides

Agreed with paras 15-17 of CX/RVDF 86/4 Add 1, but does not feel that tranquilizers and betablocking agents should be on priority list

Australia: Febantel, Clobantel Brazil:

People's Rep. of Antibiotics (chloramphenicol, penicillins, streptomycin, tetracyclines, China oxytetracyclines) sulphonamides (sulphadiazine, sulphamethazine,

sulphaquinoxaline) nitrofurans, clopidol, amprolium, anthelmintics, levamisole, pesticides (including DDT and chlorinated hydrocarbons) France

Agrees with list of the Expert Consultation (Section 8) and proposed: antibiotics, sulphonamides, nitrofurans, benzimidazoles, tranquilizers and betablockers.

Kenya (speaking Acaricides (organophosphates and chlorinated hydrocarbons) for countries of the African region

Zimbabwe ) Senegal ) Kenya ) Ghana

)trypanocides: isometamidium, prothidium, pro salt of quinuronium sulphate, diminazene aceturate, imidocarb, trypan blue.

164. Before proceeding to establishing a priority list for submission to JECFA the Committee discussed extensively whether the list should include single substances or categories of veterinary drugs. The Representative of WHO expressed the view that for the safety evaluation it might be favourable to consider a category of veterinary drugs with similar characteristics since this would make better use of the limited resources

available. However, attention was drawn to the fact that acceptable residue levels would have to be established for individual drugs and, in order to achieve this, governments and interested parties would have to be informed exactly which drugs were under consideration.

165. The Committee also noted that zeranol and trenbolone acetate had already received a partial evalution by JECFA and that it might be appropriate to finalize the evaluation of these drugs as a first step.

166. The Committee was also informed that JECFA had to develop procedures for the establishment of acceptable residue levels in individual foods which was a new task for the Expert Committee. Establishment of Priority List167. The Delegation of the United Stated stated that it had carefully studied the written proposals from governments and had prepared a list containing the ten most frequently proposed substances. The next 10 most frequently proposed had also been identified. It was noted that the US list referred to individual substances.

168. Several delegations were of the opinion that this first priority list should relate to individual compounds of immediate concern and should include other substances as categories to facilitate their evaluation. Proposals were made to include also beta-lactam antibiotics because of their allergenic properties and the sulphonamides since they were of considerable health concern. The Committee decided not to include beta-lactam antibiotics in this first list. 169. list:

The Committee agreed that the following substances be included in the priority chloramphenicol

anabolic agents (estradiol, progesterone, testosterone, trenbolone acetate,

zeranol) sulphonamides nitrofurans nitroimidazoles quinoxaline-di-N-oxides trypanocides

170. The Observer of AHI speaking on behalf of the veterinary drugs industries (DSA,EFPIA and AHI) expressed satisfaction with the decision of the Committee to

focus its attention on those priority compounds which were causing both an international trade problem and a public health concern.

He endorsed the decision to give high priority to the group of hormonal analbolic

agents and expressed the opinion that the recent EEC hormone ban was an example of a non-tariff trade barrier which had no scientific basis whatsoever.

Other compounds, such as antibacterials etc., were considered by the industry to

be of secondary priority.

171. The Observer of the International Union of Consumer Unions (IOCU) made a statement on IOCU's concern with the use of certain veterinary drugs (hormonal growth promoters, sub-therapeutic use of antibiotics in animal feed).

She pointed out the need for consumer protection as IOCU's primary

consideration but recognized that unharmonized regulation could constitute barriers to trade.

The Observer emphasized the important role that Codex could play in the field of

residues of veterinary drugs in foods.

RELATIONSHIP WITH THE JOINT FAQ/WHO EXPERT COMMITTEE ON FOOD ADDITIVES, (Item 6(b))172. The Committee had before it working paper CX/RVDF 86/4 ADD 3 which

provided selected information on the working procedures of JECFA and the JMPR. The Committee noted that further information on these Committees was also contained in CX/RVDF 86/2 Appendices II and III and in Part I of CX/RVDF 86/3.

173. The Committee recalled that it has received information that a specific session of JECFA held in summer 1987 will evaluate residues of veterinary drugs. The Committee noted that the experts for the committee would be chosen on the grounds of their

specific expertise on the compounds to be evaluated. The Committee thought that it was not within its competence to advise the Expert Committee on working procedures. The Committee confirmed, however, that it wished to receive from the Expert Committee recommendations for acceptable residue levels of individual drugs in specific foods. 174. While there was general appreciation that provisions had been made for an extra session of JECFA, the Committee expressed the view that JECFA was not the

appropriate body for the evaluation of residues of veterinary drugs in foods and that the number of experts would have to be considerably increased for that purpose, adding to the cost of holding the meeting. Concern was also expressed that the additional work could delay JECFA's action on additives and contaminants. The Committee felt that it was appropriate to establish a new expert committee for the evaluation of veterinary drugs in foods.

175. The Representative of WHO explained the procedures used by WHO to select experts for the WHO part of the JECFA activities. He also pointed out that proposals for evaluation were submitted not only by Codex but also by other bodies. The

representative indicated the way in which the agenda of JECFA was drafted, how data were obtained and processed and the timing of submissions to the Committee. 176. Attention was drawn to the general criteria for the selection of methods of analysis included in the procedural manual (5th Edition page 78).

177. The Chief of the Joint FAO/WHO Food Standards Programme informed the Committee that budgetary constraints might not permit at present the establishment of an additional expert committee and that any such request would have to be reviewed by the World Health Assembly and the FAO Conference. He also pointed out that the 3rd Joint FAO/WHO Food Additives Conference (1973) had expanded the terms of reference of JECFA beyond food additives.

178. The Committee recognized the difficulties outlined above, but concluded that, in view of the importance of residues of veterinary drugs in foods, strong representations should be made to the Commission to pursue with FAO and WHO the establishment of a new expert committee.

179. The Secretariat recalled that JMPR was setting MRLs based on Good Agriculture Practice and invited the Committee to consider whether there was a need to define \"Good Practices for the Use of Veterinary Drugs\".

180. The Committee agreed that it was necessary to elaborate such a definition and invited the views of WHO on this matter because of that Organization's experience in similar guidelines for human drugs.

181. The Delegation of the Netherlands kindly offered to prepare, in cooperation with WHO, a first draft of a definition for \"Good Practices for the Use of Veterinary Drugs\" for consideration by the Committee at its next session. It was noted that the Expert

Committee would also give attention to what constituted good practices. It was agreed that the paper to be prepared by the Netherlands and WHO, would also incorporate the Expert Committee's views.

182. The attention of the Committee was also drawn to an Appendix to CX/RVDF 86/4 Add 3 which outlined the type of data required for the evaluation of pesticide residues by JMPR (user practices and residues) and by JECFA for the evaluation of food additives. This provided an indication of the type of data which might be required for the setting of acceptable residue levels.

ESTABLISHMENT OF WORKING PROCEDURES FOR THE SELECTION OF ANALYTICAL METHODS AND SAMPLING FOR THE CONTROL OF VETERINARY DRUG RESIDUES IN FOODS (Item 6(c))183. The Committee had before it a working paper on this matter (CX/RVDF 86/4 Add 4) which outlined the views of the Expert Consultation on different types of methods for the detection of residues of veterinary drugs in foods of animal origin. The Committee had also before it the main working paper on this issue presented to the Expert Consultation.

184. The Author, Dr. R. Ellis (United States) highlighted the important issues before the Committee. It was noted that the methods could be classified as screening methods, quantitative methods and confirmatory methods. Dr. Ellis stated that \"the most important performance characteristics are demonstrated by evaluating accuracy, precision, reliability, cost effectiveness, ruggedness and sensibility in multi-laboratory validation studies.\"

185. It was noted that the Expert Consultation had recommended that the Expert

Committee should also deal with certain aspects of analytical methods, in particular their availability.

186. Replies to CL 1986/2 indicated the interest of governments in the development of internationally recognized methods which had a high reliability. A proposal had also been made to establish a Working Group to deal with criteria for analytical methods and the sampling of drug residues.

187. The Committee was informed that CCMAS exercised an endorsement function for methods of analysis and sampling in Codex commodity standards; however, methods for pesticide residues, additives and microbiological criteria had been exempted from endorsement. The Committee proposed that methods for residues of veterinary drugs should also be exempted for the reasons given above.

188. The Committee recalled that the Delegation of Norway had required clarification of clause (d) of the terms of reference which related to methods of analysis. The

Committee agreed that it should also deal not only with criteria but also with the methods of analysis and sampling concerned and that clause (d) should be amended accordingly. Several delegations also pointed out that it was necessary to establish the relationship visà-vis CCMAS. They emphasized the highly specialized expertise which was

necessary to deal with methods of analysis and sampling for residues of veterinary drugs.

decided to establish an Ad Hoc Working Group on Methods of 189. The Committee Analysis and Sampling under the Chairmanship of Dr. Ellis (United States) to elaborate and recommend to the plenary session methods of analysis and sampling, as

appropriate. It was agreed that the Working Group should also consider the suitability of the criteria referred to above.

190. The Delegations of Australia, Canada, People's Republic of China, France, Federal Republic of Germany, Ireland, Netherlands, New Zealand, Norway, Poland, Switzerland, United Kingdom, United States of America and the observers of AOAC offered to participate in the Working Group. It was also agreed that other member countries could indicate their interest to the Chairman of the Working Group.

191. Dr. Ellis agreed to coordinate the preparatory work for the meeting of the

Working Group. Details of the first meeting which would be held in conjunction with the next session of the Committee would be communicated by Circular Letter.

CONSIDERATION OF NEED FOR AND FEASIBILITY OF ELABORATING CODES OF PRACTICE FOR CERTAIN ASPECTS OF THE USE OF VETERINARY DRUGS (RELATED TO RESIDUES OF VETERINARY DRUGS) (Item 7)192. The Committee had before it a document on the above subject (CX/RVDF 86/6) which reported that the Codex Alimentarius Commission had adopted a considerable number of Codes of Practice, covering hygienic and/or technological aspects of

processed foods. The documents were advisory texts and not subject to acceptance under the Codex Procedure. The purpose of codes of practice was, in general, to assist governments to ensure that foods are prepared under conditions of good manufacturing practice, in particular under sound hygienic conditions, and to facilitate international trade.

193. Member countries had indicated that they attached great importance to the

Codex Codes of Practice for use in industry, by government regulatory authorities and in the drafting of new laws on foods. In particular, the Codex Codes of Practice were considered valuable in meat and fish inspection by national food control authorities. 194. The Secretariat proposed that, if a Code was elaborated, particular attention should be paid to the terms of reference of the Committee when selecting matters for inclusion in the Code. The Secretariat also drew attention to the comments made by FAO Divisions for Fisheries and Animal Production and Health concerning their possible involvement.

195. Comments received from governments supported the development of appropriate codes of practice or guidelines for the use of veterinary drugs.

196. Delegations present at the Session supported the proposal to develop a Code of Practice for the Use of Veterinary Drugs which should be directed to the farmer/producer of foods as well as veterinarians. It was suggested that the code might consist of two different sections to accommodate both producers and supervisers. 197.

The Delegation of Kenya proposed the development of guidelines as a first step.

198. Several delegations expressed the opinion that a Code of Practice for the Safe Use of Veterinary Medicines on Farms already developed in the United Kingdom

provided guidance and could be used as a model for an international Code of Practice for the Use of Veterinary Drugs. The Committee accepted the kind offer of the Delegation of the United Kingdom to prepare a first draft of such a Code for consideration by the Committee at its next session.

CONSIDERATION OF NEED TO COMMENCE WORK ON; (A) INTAKE STUDIES ON RESIDUES OF VETERINARY DRUGS IN FOODS; and (B) GUIDELINES FOR REGULTORY PRINCIPLES CONCERNING RESIDUES OF VETERINARY DRUGS IN FOODS (Agenda Items 8(a) and (b)) (A) Intake Studies199. The Committee had before it the above paper CX/RVDF 86/7 which provided some information on the work undertaken by and on the experience of the CCFA and CCPR concerning dietary intake studies particularly in the field of contaminants and pesticide residues. These data were necessary to apply the maximum residue level s established by the relevant committees to individual foods. It was also recalled that earlier in the Session concern had been expressed on appropriate international monitoring of veterinary drugs in foods (see paras 136-137).

200. It was suggested that the Committee give consideration to the need to consider dietary intake studies in the context of its work and review already existing international activities related to dietary intake studies. Attention was drawn to the WHO Guidelines for the Study of Dietary Intake of Chemical Contaminants and to the work of the Joint FAO/WHO Food Contamination Monitoring Programme.

201. The Delegation of Australia informed the Committee of the work on intake studies undertaken by CCPR and indicated that at each Session of that Committee there was are port from individual countries on such studies which was received with great interest by participating countries. It also pointed to the work on monitoring carried out by WHO which provided a large amount of international data. The Delegation proposed that such studies should be extended to cover veterinary drugs. The Delegation of the United States of America agreed with the view expressed above and suggested that a survey be carried out of the monitoring activities of member countries concerning residues of veterinary drugs in foods. This was supported by other delegations.

202. The Committee accepted the kind offer of the Delegation of the United States of America to initiate such a survey in cooperation with the Secretariat and to evaluate the data for the next session of the Committee. (B) Regulatory aspects204. The Committee noted the work undertaken by CCPR which was contained in the \"Guide to Codex Recommendations concerning Pesticide Residues\" and, in particular, Part 9 of the document entitled \"Recommended National Regulatory Practices to facilitate Acceptancé and Use of Codex Maximum Limits for Pesticide Residues in Foods\".

205. The Committee also recalled that the Delegations of Argentina and Brazil had expressed concern about restrictive regulatory measures in importing countries and had recommended that international guidance be provided on these matters.

206. The Committee expressed the opinion that it might be premature to consider the elaboration of regulatory guidance documents at such an early stage of the Committee's work programme, reminding the Committee that CCPR had elaborated these guidelines at only a very advanced stage of its work.

agreed to keep this item on its programme of work but to defer 207. The Committee consideration to a future session, when appropriate.

PROGRAMME OF WORK AND WORK ASSIGNMENTS FOR NEXT SESSION (Item 9)208. The Committee agreed that the agenda for its next session should include the following items: - - -

Matters of interest

Activities of International Organizations

Working paper on Procedural Matters (Proposal for Amendment of Procedural Manual, Step Procedure, Acceptance Procedure and Working Relationships with other Codex Committees)(Secretariat)

Report on Progress concerning Glossary of Terms and Definitions (coordinated by Canada)

Report on Definitions for Good Practice in the Use of Veterinary Drugs(Netherlands/WHO)

Review of Priority List based on replies to circular letter

Report of JECFA including consideration of Acceptable Residue Levels, if available

First Draft of a Code of Practice for the Use of Veterinary Drugs (United Kingdom)

Discussion on Compendium of Veterinary Drugs for the Americas (to be distributed by the Delegation of USA) Survey of Intake Studies (USA/Secretariat).

- - - -

Ad Hoc Working Group on Methods of Analysis and Sampling - Report of - - -

209. The Committee agreed with the following amended terms of reference and

decided that they be brought to the attention of the 16th Session of the Commission for approval:

(a) (b) (c) (d)

to determine priorities for the consideration of residues of veterinary drugs in foods;

to establish acceptable residue levels for such substances: to develop codes of practice and/or guidelines as may be required; to consider methods of sampling and analysis for the determination of residues of veterinary drugs in foods.

OTHER BUSINESS (Item 10) Statement by the Delegation of Senegal210.

The Delegation of Senegal presented the following statement:

\"At the request of the Delegation of Senegal it had been agreed earlier at the

session that consideration would be given to certain specific aspects of the situation in Africa with regard to veterinary drug residues.

As the Delegation of Senegal had emphasized during the session the detection

of residues was a heavy task which required: - Equipment

- and well trained personnel.

Human health was of the first importance but unfortunately the need for the

monitoring of veterinary drug residues in animal food was not yet widespread; public authorities were at present more concerned with increased production.

The Delegation of Senegal though that at the present time, with the exception of

a few countries, they were at a stage where education was needed. As much information as possible was required on: - - -

Essential veterinary drugs

Types of toxicity and consequent secondary effects Need for regulation for the use of these drugs.

The Delegation of Senegal proposed that a seminar should be organized in

Africa to discuss: -

Secondary effects and dangers associated with the misuse of veterinary drugs.

It was proposed that this Committee recommend that international organizations

concerned organize such a seminar.

211. The concern of the Delegation of Senegal was shared by the Delegations of Ghana, Kenya, Côte d'Ivoire and Zimbabwe. Furthermore, the Delegation of the Côte d'Ivoire expressed the following two wishes:

(1) To see the Coordinating Committee for Africa involved more closely in the preparation for an auspicable holding of a Seminar on Veterinary Residues. (2) To re-activate the Coordinating Committee for Africa, at least concerning the Codex Committee on Residues of Veterinary Drugs in Foods, in such a way that an African regional study plan shall be developped and studied in advance, if necessary. This would avoid a duplication of work and give the possibility to better expose to this Committee the problems which are of main concern at the moment in due time.

In this instance we give our support to the Delegation of Senegal on the

necessity of paying a special attention to the problems submitted by the Study of Veterinary Residues.

212. The Delegation of the People's Republic of China completely supported the

statement made by the Delegation of Senegal. In the past few years WHO, FDA and the Food Quality and Consumer Protection Group has assisted thirty developing countries to strengthen their laboratory services specializing in food contamination control. China as a developing country would like to receive some information and educational advice, for example through seminars, expert consultations from the Codex Committee. China would also like to get some assistance to strengthen laboratory services specializing in food contamination control in the form of analytical equipment and appropriately trained personnel. The country needs to establish regulations for food practice in the use of veterinary drugs including feed additives, including tolerance levels of residues in the tissues and products of food-producing animals, withdrawal times of veterinary drugs and feed additives for different kinds of food-producing animals.

213 The Secretariat informed the Committee that a possible way of organizing a seminar of the type proposed by the delegation of Senegal would be to arrange to hold such a meeting in conjunction with the Codex Coordinating Committee for Africa.

214. This approach had already proved to be useful and successful in the region of Latin America and the Caribbean where workshops dealing with topics related to food hygiene had been held sponsored by PAHO in conjunction with the sessions of the Codex Coordinating Committee for Latin America and the Caribbean.

215. The delegations of the African region were informed that their national authorities should approach the regional offices of FAO and WHO.

216. The Committee as a whole expressed strong support to the request of the African countries present and urged the two Agencies to take appropriate action. 217. The Chief of the Joint FAO/WHO Food Standards Programme and the Chairman of the Committee undertook to pursue the matter. DATE AND PLACE OF NEXT SESSION (Item 11) 218. The delegations present at the Session expressed the view that annual sessions were necessary at least in the initial stages of the Committee to achieve viable results as quickly as possible. Caution was expressed by some delegations that considerable time was needed for efficient preparation of sessions of this Committee.

219. The Committee was informed that only one session had been foreseen for the biennium86/87 and that the Commission would have to decide on any substitution or addition of meetings of Codex Committees.

agreed that it favoured holding its Second Session in 1987 and 220. The Committee decided to request the Host Country and the Secretariat to make appropriate recommendations to the Commission.

221. It was noted that the Second Session could be held in Washington D.C. at a date to be communicated.

ALINORM 87/31

APPENDIX ILIST OF PARTICIPANTS 1/ LISTE DES PARTICIPANTS LISTA DE PARTICIPANTESChairman: Presidente: Dr. Lester M. Crawford

Food Safety and Inspection Service U.S. Department of Agriculture

Roon 331-E/ Administration Building Washington, D.C. 20250, USA

Prof. Dr. Arpad Somogyi

Président: Associate Administrator

Rapporteur:Relator: Director Dept. of Drugs, Animal Nutrition and Residue Research Bundesgesundheitsamt Postfach 33 00 13

Federal Republic of Germany

ARGENTINA ARGENTINE

Dr. Victoriano Tolosa

Director Laboratorios Ganaderos Secretaría Agricultura, Ganadería y Pesca

Paseo Colón 922

Buenos Aires, Argentina

Mr. Gustavo Ferrari Second Secretary

Embassy of the Argentine Republic 1676 K St., N.W., 610

Washington, D.C. 20006, USA AUSTRALIA AUSTRALIE

Dr. Gardner Murray Acting Director

Bureau of Rural Science

Department of Primary Industry Canberra, 2600, Australia Mr. G.N. Hooper

Pesticides Coordinator Bureau of Rural Science

Department of Primary Industry Canberra, 2600, Australia Dr. A.L. Black

Adviser in Toxicology Department of Health P.O. Box 100

Dcden A.C.T., Australia Dr. L. Valentine

Principal Veterinary Officer

NSW Department of Agriculture Sydney, NSW 2001, Australia Mr. A. Morley

Executive Director

Agricultural and Veterinary

Chemicals Association of Australia GPO Box 3968

Sydney NSW 2001, Australia Dr. R. Biddle

Veterinary Counsellor Embassy of Australia Washington, D.C, USA BRAZIL BRESIL BRASIL

Mr. Jose Roberto Procopiak Brazilian Embassy

3006 Massachusetts Ave., N.W. Washington, D.C. 20008, USA Mr. Tomaz de Aquino Porfirio

Chefe do Setor de Alimentos e Racoes Laboratorio Nacional de Referencia Animal

33600 - Pedro Leopoldo - MG, Brazil

Ms. Marta Fonseca Veloso De Lima Ministry of Health

SNVS/DINAL 20 Andar Sala 204 Brasilia-DF, Brazil

1/The Heads of Delegations are listed first. Les Chefs de délégations figurent en tête. Figuran en primer lugar los Jefes de las Delegaciones.

CANADA

Dr. G.A. Mitchell Director

Bureau of Veterinary Drugs Drugs Directorate

7th Floor Jeanne Mance Building Tunney's Pasture Ottawa, Ontario -K1A 1B7, Canada

Dr. R. J. Moir

Associate Director

Scientific & Technical Programs

Meat Hygiene Division Agriculture Canada 2255 Carling Avenue Ottawa, Ontario K1A OY9, Canada

Dr. P. Saschenbrecker Chief, Residue Analysis Meat Hygiene Division

Food Production & Inspection Branch Agriculture Canada 2255 Carling Avenue Ottawa, Ontario K1A 0Y9, Canada

Dr. Julius Frank (Industry Advisor) Executive Secretary

Canadian Animal Health Institute P. 0. Box 291 42A Main Street Manotick, Ontario KOA 2NO , Canada CHINA, People's Rep. of CHINE, Rep. pop. de la CHINA, Rep. pop. de

Mr. Chen Bingzheng Senior Veterinarian

Bureau of Animal Husbandry MAAF

Beijing, People's Rep. of China

Ms. Zhu Beilei

Associate Professor

Department of Veterinary Pharmacology and

Toxicology

College of Veterinary Medicine Beijing Agricultural University Beijing, People's Rep. of China Mr. Shen Zhichang Assistant Researcher

The National Control Institute of Veterinary Bioproducts and Pharmaceuticals

Beijing, People's Rep. of China CÔTE D'IVOIRE

Dr. Daniel Sess Essiagne

Médecin Nutritionniste à l'Institut

National de Santé Publique d' Abidjan CÔte d'Ivoire

Dr. Guilloueme Dakouri

Pharmacien Microbiologiste a l'Institut National de Santé Publique d'Abidjan CÔte d'Ivoire

Dr. Fofana Coulibaly Pharmacien

Chef de Division Produits Alimentaires au

Lanetia

Abidjan, Cdte d'lvoire CUBA

Dr. Celso Rodriguez García

Specialist of National Department of Food

Hygiene and Nutrition Ministry of Public Health Calle 3 esC. N, Vedado

Ciudad de la Habana 32-39, Cuba Dr. Emilio Del Pozo Saniz

Investigator of Nutrition and Food Hygiene

Ministry of Public Health Infanta 1158

Ciudad de la Habana 3, Cuba DENMARK DANEMARK DINAMARCA

Mr. Kaj Andreasen

Senior Veterinary Officer Veterinary Services Frederiksgade 21

1265 Kobenhavn K., Denmark EGYPT EGYPTE EGIPTO

Dr. Mahmoud Elawady Abdel Rahman

Director General

Veterinary Department

Ministry of Agriculture and Food Security Dokki

Cairo, Egypt

Dr. Ahmed Abdel Raquf Rashwan Veterinarian

Mechanical Abbattoir Bastin

Cairo, Egypt FINLAND FINLANDE FINLANDIA

Dr. Kalevi Salminen

Ministry of Agriculture and Forestry Box 232

00171 Helsinki, Finland Prof. Dr. Jornia Hirn

National Veterinary Institute Box 368

00101 Helsinki, Finland

Mr. Jukka Loimaranta

Valio, Finnish Cooperative Dairies' Association

Research and Development Department Analytical Division Box 390

00101 Helsinki, Finland Mr. Pekka Pakkala Senior Health Officer National Board of Health Haapaniemenkatu 3-5 00530 Helsinki, Finland FRANCE FRANCIA

Dr. Jacques Boisseau Chairman

International Consultation on Veterinary Products Registration

Laboratoire National des Médicaments Vétérinaires

Direction de la Qualité Services Vétérinaires Ministère de l'Agriculture La Haute-Marche - Javené 35133 Fougères, France Dr. R. Cheippe

Animal Health Division Manager UPJOHN Cie, France

SIMV: Syndicat de l'Industrie du Médicament Vétérinaire 6, Rue de la Trémoille 75008 Paris, France

Mr. C. Roussel SYNPA

Syndicat National des Producteurs d'Additifs

41 bis, Boulevard Latour Maubourg

75007 Paris, France GERMANY, Fed. Rep. of ALLEMAGNE, Rep. fed d' ALEMANIA, Rep. Fed. de

Dr. Friedrich Heuner Ministerialrat

Bundesministerium fur Jugend, Familie, Frauen und Gesundheit Deutschherrenstrasse 87 D-5300 Bonn 2

Fed. Rep. of Germany

Prof. Dr. Arpad Somogyi Director

Dept. of Drugs, Animal Nutrition and Residue Research

Bundesgesundheitsamt Postfach 33 00 13 D-1000 Berlin 33

Fed. Rep. of Germany Dr. Dieter Arnold ederal Health Office Bundesgesundheitsamt Postfach 33 00 13 D-1000 Berlin 33

Fed. Rep. of Germany

Dr. Michael Petz

Association of German Chemists Food Chemistry Section University of Muenster Institute of Food Chemistry Piusallee 7

D-4400 Muenster Fed. Rep. of Germany Dr. Peter Altreuther

Bayer AG. Werk Elberfeld Pharma-Forschungszentrum Postfach 10 17 09 D-5600 Wuppertal 1 Fed. Rep. of Germany Dr. Hubert Tiefenbacher Head

Regulatory Affairs BASF AG

Abt. ME/Z-D 205

D-6700 Ludwigshafen Fed. Rep. of Germany

Dr. Otto Kern Head

Product Development Boehringer Ingelheim Vetmedica GmbH Postfach 200

D-6507 Ingelheim/Rhein Fed. Rep. of Germany GHANA

Dr. John K. Obinim Deputy Director

Veterinary Services Department Ministry of Agriculture P.O. Box M161 Accra, Ghana HUNGARY HONGRIE HUNGRIA

Mr. Litre Takacs

First Secretary of Agriculture Affairs Embassy of Hungary

3910 Shoemaker St., N.W. Washington, D.C., 20008 USA IRELAND IRLANDE IRLANDA

Mr. John Ferris

Senior Superintending Veterinary Inspector

Department of Agriculture Agriculture House Kildare Street Dublin 2, Ireland

Dr. Thomas B. Barragry

Lecturer in Veterinary Pharmacology, Toxicology and Therapeutics Faculty of Veterinary Medicine University College Dublin Ballsbridge

Dublin 4, Ireland JAPAN JAPON

Mr. M.D. Hiroshi Inaba Chief

Office of Health Food Management Food Sanitation Division

Environmental Health Bureau Ministry of Health and Welfare 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, Japan

Mr. Kiyotaka Mukai Chief

Feed Additives Section

Pharmaceutical Affairs Office Animal Health Division Livestock Industry Bureau

Ministry of Agriculture, Forestry and Fisheries

No. 1, 2-chcme, Kasumigaseki Chiyoda-ku Tokyo, Japan

Mr. Yasumasa Kido Director

Analytical Chemistry Department Research Institute Foundation for Animal

Science in Biochemistry and Toxicology 2277 Shimokuzawa Sagamihara City

Kanagawa Prefecture, Japan Dr. Hiroshi Tachi Technical Adviser

Corporation Japan Veterinary Pharmaceutical Association

Baji-Chikusan Kaikan 1-2 Kanda Surugadai

Chiycdaku, Tokyo, Japan

Mr. Kenji Ishii

Adviser of Japanese Ministry of Health and Welfare

Embassy of Japan

1001 Connecticut Avenue, N.W. Suite 704

Washington, D.C, USA KENYA KENIA

Mr. J.M. Nganga Chief

Hygiene Officer

Veterinary Laboratories P.O. Kabete Nairobi, Kenya KOREA, Rep. of COREE, Rep. de COREA, Rep. de

Dr. Sang-Woo Park Agricultural Attaché

Embassy of Republic of Korea 2320 Massachusetts Ave., N.W. Washington, D.C. 20008, USA

KUWAIT KOWEIT

Dr. Jaafar Suleiman Dawood

Deputy Chief Preventive Medicine Ministry of Health - Kuwait P.O. Box 48999 Alsabahxia, Kuwait

Mr. Yacoub Khalid Almutawa

Director of Public Health Laboratory Ministry of Health - Kuwait P.O. Box 5

Alsabahxia, Kuwait

Dr. Sultan Ahmed Al-Sultan

Director of Animal Health Department Agriculture affairs and Fish Resources Authority

P.O. Box 21422 Safat, Kuwait MADAGASCAR

Mr. Ralison Rene Gilbert Counselor for Economic and Commercial Affairs

Embassy of Madagascar

2374 Massachusetts Ave., N.W. Washington, D.C. 20008, USA MEXICO MEXIQUE

Mr. Jorge L. Ymay Seemann

Secretaria de Agricultura y Recursos Hidráulicos

Jefe del Departamento de Productos Químico-Farmacéuticos y Determinación de Tóxicos

Guillermo Perez Valenzuela No. 127 Coyoacan, 04000 D.F., Mexico NETHERLANDS PAYS-BAS PAISES BAJOS

Mr. C.C.J.M. van der Meijs

Ministry of Agriculture and Fisheries Director, Nutrition and Quality Affairs P.O. Box 20401

2500 EK The Hague, Netherlands Mr. L. Zegers

Ministry of Welfare, Health and Cultural Affairs

Chief Officer, Veterinary Inspection P.O. Box 439

2260 AK Leidschendam, Netherlands NEW ZEALAND

NOUVELLE-ZELANDE NUEVA ZELANDIA

Mr. A.I. McKenzie

Assistant Director (Technical Services) Meat Division

Ministry of Agriculture and Fisheries Private Bag

Wellington, New Zealand

Mr. D.E. Easingwood Registrar

Animal Remedies Board Animal Health Division

Ministry of Agriculture and Fisheries Private Bag

Wellington, New Zealand NORWAY NORVEGE NORUEGA

Dr. J.A. Race

Food Control Board Codex Alimentarius P.O. Box 8139

Dep. 0033 Oslo 1, Norway Dr. M. Yndestad Professor

Directorate of Health P.O. Box 8128

Dep. 0032 Oslo 1, Norway

Mr. S.O. Roald Regional Manager

Norwegian Government Fish Inspection

Quality Control Service Directorate of Fisheries P.O. Box 168

6001 Alesund, Norway POLAND POLOGNE POLONIA

Dr. Teodor Juszkiewicz

Professor of Pharmacology and Toxicology

Veterinary Research Institute Partyzantow 57

24-100 Pulawy, Poland

Dr. Janusz Mazurek Director

Department of Veterinary Medicine Ministry of Agriculture, Forestry and Food

Economy

St. Wspolna 30

00-930 Warszawa, Poland SENEGAL

Mr. François Abiola

Minister of Public Health

Office of Hygiene and Sanitary Protection

Division of Food and of Applied Nutrition of Senegal Ecole Inter-Etats de Science et Médécine Vétérinaire B.P. 5077

Dakar, Senegal SPAIN ESPAGNE ESPAÑA

Mr. José Luís Gomez Lopez Consejero Técnico

Secretaría de Estado para la CEE Ministerio de Asuntos Exteriores C1. Francisco Silvela No. 82 Madrid, Spain

Mr. Francisco Montalvo

Jefe del Servicio de Alimentos de Origen Animal

Ministerio de Sanidad y Consumo Paseo del Prado, 18-20 Madrid 28014, Spain SWEDEN SUEDE SUECIA

Mr. Erland Paajarvi

Head of Hygiene Department National Food Administration Box 622

S-751 26 Uppsala, Sweden Mr. Ake Rutegard Veterinary Surgeon

Swedish Farmers' Meat Marketing Association

S-121 86 Johanneshow, Sweden Mr. Eric Skoglund Veterinary Counselor

Head of General Veterinary Division National Board of Agriculture S-551 83 Jonkoping, Sweden SWITZERLAND SUISSE SUIZA

Dr. St. Hasler Vicedirecteur

Office Vétérinaire Fédéral Schwarzenburgstrasse 161 CH-3097 Liebefeld, Switzerland Mr. O. Bindschedler

Regulatory Affairs Department NESTEC SA

CH-1800 Vevey, Switzerland Dr. B. Schmidli

Hoffmann-La Roche & Co. AG CH-4002 Basel, Switzerland

THAILAND THAILANDE TAILANDIA

Dr. Malinee Limpoka Associate Professor

Departitent of Pharmacology Kasetsart University

Bangkok 10900, Thailand TURKEY TURQUIE TURQUIA

Mr. Orhan Turkoz Agricultural Counselor Embassy of Turkey

2523 Massachusetts Ave., N.W. Washington, D.C. 20008, USA UNITED KINGDOM ROYAUME-UNI REINO UNIDO

Mr. C.A. Cockbill

Head of Food Standards Division

Ministry of Agriculture, Fisheries & Food Great Westminster House Horseferry Road

London SW1P 2AE, United Kingdom Mr. A.N. Christie

Senior Veterinary Officer Meat Hygiene Section M.A.F.F. Tolworth Tower

Surbiton Surrey, United Kingdom Dr. Geoffrey E. Diggle Senior Medical Officer Toxicology Division DHSS, Hannibal House Elephant & Castle

London SEl, United Kingdom Mr. Bryan Harding Agricultural Attaché British Embassy

3100 Massachusetts Ave., N.W. Washington, D.C. 20008, USA

Mr. A.R.M. Kidd

Head, Medicines Unit

Central Veterinary Laboratory, New Haw Weybridge, Surrey United Kingdom

Dr. M.E. Knowles

Head of Food Science Division

Ministry of Agriculture, Fisheries & Food Great Westminster House Horseferry Road

London SWlP 2AE, United Kingdom Mr. G.A. Morris

NAOH Representative Head of Regulatory Affairs Coopers Animal Health Ltd. Berkhamsted Hill

Berkhamsted, United Kingdom UNITED STATES OF AMERICA ETATS-UNIS D'AMERIQUE

ESTADOS UNIDOS DE AMERICA Dr. Gerald B. Guest Director, HFV- 1

Center for Veterinary Medicine Food and Drug Administration 5600 Fishers Lane

Rockville, Maryland 20857, USA Dr. Richard Ellis

Director, Chemistry Division

Food Safety and Inspection Service, Science

U.S. Department of Agriculture Room 405, Annex Building 300 12th Street, SW

Washington, DC 20250, USA Dr. Suzanne Fitzpatrick Special Assistant, HFV-1 Office of the Director

Center for Veterinary Medicine Food. and Drug Administration 5600 Fishers Lane

Rockville, Maryland 20857, USA Dr. Robert Livingston Director, Division of Drug

Manufacturing and Controls, HFV-140 Office of New Animal Drug Evaluation Center for Veterinary Medicine Food and Drug Administration 5600 Fishers Lane

Rockville, Maryland 20857, USA Dr. Gerald Moy

Multilateral Desk, HFY-50 International Affairs Staff

Food and Drug Administration 5600 Fishers Lane

Rockville, Maryland 20857 , USA Dr. William H. Dubbert

Assistant Deputy Administrator

Food Safety and Inspection Service, Science

U.S. Department of Agriculture . Room 404, Annex Building 300 12th Street, S.W.

Washington, D.C. 20250 , USA Dr. Alex Apostolou

Director, Division of Drug

and Environment Toxicology, HFV-150 Office of New Animal Drug Evaluation CVM/FDA

5600 Fishers Lane

Rockville, Maryland 20857, USA Ms. Adrienne Dern Director of International and Section Activities Animal Health Institute Box 1417-D50

Alexandria, Virginia 22313, USA Mr. John T. Craig AHI Representative

Director, Corporate Regulatory Affairs Animal Products Group

International Minerals & Chemical Corp. P.O. Box 207

Terre Haute, Indiana 47808 . USA Mr. C. W. McMillan President

McMillan and Farrell Associates 2021 K Street, N.W.

Suite 306

Washington, D.C. 20006 , USA Dr. Steve Sundlof

American Veterinary Medical Association

College of Veterinary Medicine Box J-137

University of Florida

Gainesville, Florida 32610, USA Philip C. Olsson, Esquire. U.S. Meat Export Federation. Washington Counsel Olsson and Frank, P.C. Suite 400

1029 Vermont Avenue, N.W. Washington, D.C. 20005, USA Dr. Frank Mulhern

National Pork Producers Council Suite 200

1015 Fifteenth Street, N.W. Washington, D.C. 20005, USA Dr. George D. Wilson Vice President

Science and Prepared Meats American Meat Institute P.O. Box 3556

Washington, D.C. 20007, USA Dr. Donald L. Houston Administrator

Food Safety and Inspection Service U.S. Department of Agriculture

14th and Independence Avenue, S.W. Washington, D.C. 10150, USA Mr. Eddie Kimbrell Deputy Administrator for Commodity Services

Agricultural Marketing Service U.S. Department of Agriculture

14th and Independence Avenue, S.W. Washington, D.C. 20250, USA Mr. Charles W. Cooper Assistant Director, HFF-1

Center for Food Safety and Applied

Nutrition

Food and Drug Administration 200 C Street, S.W.

Washington, D.C. 20204, USA Dr. Herbert Blumenthal

Director, Division of Toxicolody, HFF-150

Center for Food Safety and Applied Nutrition

Food and Drug Administration 200 C Street, S.W.

Washington, D.C. 20204, USA Dr. Larry Miller

American Veterinary Medical Association Suite 828

1522 K Street, N.W.

Washington, D.C. 20005, USA Ms. Sharon Sachs

Public Affairs Specialist

Information and Legislative Affairs Food Safety and Inspection Service U.S Department of Agriculture

14th and Independence Avenue, S.W. Washington, D.C. 20250 , USA Mr. Yuen-Gi Yee

Head, Audiovisual Unit

Information and Legislative Affairs Food Safety and Inspection Service U.S. Department of Agriculture

14th and Independence Avenue, S.W. Washington, D.C. 20250 , USA Mr. James R. Brooker

Fishery Products Inspection and Safety Division

U.S. Department of Commerce 1825 Connecticut Ave. N.W. Suite 814

Washington, D.C. 20235 , USA Dr. Robert W. Weik

Assistant to the Center Director, HFF-4 Food and Drug Administration 200 C Street, S.W.

Washington, D.C. 20204 , USA

ZIMBABWE

Dr. D. Knottenbelt

Lecturer Veterinary Sciences University of Zimbabwe

Department of Clinical Veterinary Studies

P.O. Box M.P. 167, Mount Pleasant, Harare, Zimbabwe

INTERNATIONAL ORGANIZATIONS ORGANISATIONS INTERNATIONALES ORGANIZACIONES INTERNACIONALESINTERNATIONAL FEDERATION OF GLUCOSE

INDUSTRIES (IFG)

Mr. Charles Feldberg CPC International, Inc.

V. P. Health, Safety and Quality Assurance

Englewood Cliffs

New Jersey 07632, USA

INTERNATIONAL FEDERATION OF GROCERY

MANUFACTURERS OF AMERICA (IFGMA)

Mr. Sherwin Gardner Vice President

Science and Technology

Grocery Manufacturers of America, Inc. 1010 Wisconsin Ave., Suite 800 Washington, D.C. 20007, USA Dr. Crystal Willis Science Associate

Grocery Manufacturers of America, Inc. 1010 Wisconsin Ave., Suite 800 Washington, D.C. 20007, USA INTERNATIONAL DAIRY FEDERATION (IDF)

Prof. Dr. W. Heeschen Institute fur Hygiene

Bundesanstalt fur Milchforschung

Postfach 6069 D-2300 Kiel 14

Fed. Rep. of Germany

ASSOCIATION OF OFFICIAL

ANALYTICAL CHEMISTS (AOAC) Mr. David MacLean Executive Director

Association of Official Analytical Chemists (AOAC)

1111 North 19th Street Suite 210 Arlington, VA 22209 USA

Ms. Rita Comotto Banner Assistant Executive

Association of Official Analytical Chemists (AOAC)

1111 North 19th Street Suite 210 Arlington, VA 22209 USA

Ms. Nancy Palmer Publications Manager

Association of Official Analytical Chemists (AOAC)

1111 North 19th Street Suite 210

Arlington, VA 22209, USA

ANIMAL HEALTH INSTITUTE (AHI) INTERNATIONAL

Dr. Gordon Kemp

Director, Scientific Liaison

Agricultural Products Research and Development

Pfizer Central Research Groton, Connecticut 06340 USA

Dr. Brian Bagnall AHI Representative

Director, Applebrook Research Center and Technical Services

Smithkline Animal Health Products 1600 Paoli Pike

West Chester, Pennsylvania 19380 USA

Dr. Jerry Brunton, V.M.D.

Vice President - Scientific Activities Animal Health Institute 119 Oronoco Street Box 1417-D50

Alexandria, Virginia 22313 USA

BUREAU EUROPEEN D' INFORMATION POUR LE

DEVELCPPEMENT DE LA SANTE ANIMALE (DSA)

Dr. Jean-Claude Bouffault Vice-President of DSA Rue Defacqz, 1/Box 8 B-1050 Brussels, Belgium Dr. Mireille Chaton-Schaffner Smithkline AHP

Avenue Louise, 287/Bte 13 B-1050 Brussels, Belgium

Dr. Jean-Pierre Raynaud

Director Research and Development Pharmaceuticals Rhóhe Merieux

4, Chemin du Calguet F-31057 Toulouse Cedex France

EUROPEAN FEDERATION OF PHARMACEUTICAL

INDUSTRIES' ASSOCIATIONS (EFPIA) Dr. D.J.S. Miller

Chairman Animal Health Canmittee Sandoz Pharmaceuticals

Animal Health and Nutrition International 98 The Centre FELTHAM

Middlesex TW13 4 EP, United Kingdom COMMISSION OF THE EUROPEAN COMMUNITIES (EEC)

Dr. Gerald Hudson Head of Division

Directorate-General for Agriculture Commission of the European Communities

200 Rue de la Loi

B-1049 Brussels, Belgium

Mr. R. Hankin Administrator

Directorate-General for Internal Market and Industrial Affairs

Commission of the European Communities

200 Rue de la Loi

B-1049 Brussels, Belgium Mr. Luigi Cisnetti

Principal Administrator

General Secretariat of the E.E.C. Council

170, Rue de la Loi

B-1098 Brussels, Belgium

INTERNATIONAL ORGANIZATION OF CONSUMERS' UNIONS (IOCU)

Ms. Ellen Haas Executive Director

Public Voice for Food and Health Policy 1001 Connecticut Avenue, N.W., Suite 522

Washington, D.C. 20036, USA

Ms. Patricia B. Kelly

Director of Communications

Public Voice for Food and Health Policy 1001 Connecticut Avenue, N.W., Suite 522

Washington, D.C. 20036, USA OFFICE INTERNATIONAL DES EPIZOOTIES (OIE)

Dr. Louis Blajan Director General

Office International des Epizooties 12, Rue de Preny

F-75017 Paris, France

WORLD HEALTH ORGANIZATION (WHO) REPRESENTATIVESDr. J. Dunne Chief

Pharmaceutical Unit WHO

1211 Geneva 27 Switzerland

Dr. J. Debbie

Veterinary Public Health WHO

1211 Geneva 27 Switzerland

Dr. G. Vettorazzi Senior Toxicologist

International Programme on Chemical Safety

Division of Environmental Health WHO

1211 Geneva 27 Switzerland

PAN AMERICAN HEALTH ORGANIZATION (PAHO)

Ms. Sania Delgado

Pan-American Health Organization (PAHO)

525 23rd St., N.W.

Washington, D.C. 20023 USA

JOINT FAQ/WHO SECRETARIATMrs. Barbara Dix

Food Standards Officer

Joint FAO/WHO Food Standards Programme

Food and Agriculture Organization of the

United Nations

Via delle Terme di Caracalla 00100 Rome, Italy

Mr. James M. Hutchinson Food Standards Officer

Joint FAO/WHO Food Standards

Programe

Food and Agriculture Organization of the

United Nations

Via delle Terme di Caracalla 00100 Rome, Italy

Mr. John Lupien Chief

Joint FAO/WHO Food Standards Programme

Food and Agriculture Organization of the

United Nations

Via delle Terme di Caracalla 00100 Rome, Italy U.S. SECRETARIATMrs. Rhonda Nally

Office of the Administrator Policy and Planning Staff

Food Safety and Inspection Service U.S. Department of Agriculture Room 4435, South Building Washington, D.C. 20250 USA

ALINORM 87/31 APPENDIX II OPENING ADDRESS BY DR. DONALD L. HOUSTON, ADMINISTRATOR FSIS (USDA)Good morning and welcome to the United States. It is truly a pleasure for me to

open this historic first meeting of the Codex Committee on Residues of Veterinary Drugs in Foods - established little more than a year ago by the 16th Session of the Codex Alimentarius Commission.

The healthy attendance is a measure of the importance of our task. We expect

that the final count will show representation from at least 33 countries, 10 observer

organizations, and a total of at least 130 attendees. This strong participation speaks well for the importance of the issue and the desire of many countries to help find solutions for the problems now facing us.

The Codex Alimentarius Commission is the internationally recognized forum for resolving food trade issues that are also food safety issues, and today's meeting is of course not the first Codex effort to deal with the issue of veterinary drug residues. Two United Nations Organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) - as well as the Commission itself -have long recognized the significance of the issue from many perspectives. Public Health, Trade and Consumer ConcernsFirst, veterinary drug residues are a persistent public health concern about which

we should never become complacent. Second, differences among nations in the use and regulation of various animal drugs and hormones present troubling implications for world trade. As the Commission has recognized, the use of increasingly more sensitive methods of analysis can inhibit trade to those countries that needlessly impose a \"zero\" tolerance for certain residues. Unfortunately, advances in science can be used punitively - as technical barriers to trade.

Perhaps if this Committee had been formed five years ago, my country - and

potentially yours - would not be faced with resolving the trade difficulties now before us. Finally, residues of veterinary drugs are a major concern to consumers. Many of

those consumers are very uninformed, and may be too quick to define residues as always a \"problem\" rather than a necessary \"concern\". Yet who can really blame them for their perceptions in the wake of the unaccountable use of diethylstilbestrol (DES) some 30 years ago? It was not until 1979 that the last major nation banned the use of DES, and today we are still dealing with the \"public health residue\" of DES use. This problem therefore casts a much greater shadow in the minds of many consumers than the decades of proper and judicious use of veterinary preparations which have followed. We cannot ignore that shadow; we must find a way to clear it away through education. Laying the GroundworkRecognizing the importance of harmonious and positive international approaches

to the prevention of unsafe levels of drug residues in animal food products, international scientific and technical groups have held discussions over the past 25 years on various aspects of the issue.

Many of these meetings have been held under the umbrella of Codex,

particularly the Joint FAO/WHO Expert Committee on Food Additives. The Expert Committee has considered the toxicological implications of the use of several of the

substances we are concerned about today. For example, the Committee issued a report addressing the toxicology of antibiotic residues as far back as 1969.

However, as public concern and world trade implications have assumed more

prominence, the interest of the international scientific and regulatory community in

veterinary drug residues has intensified in this decade. Perhaps of singular importance have been the three meetings of the International Consultation on Veterinary Product Registration, held at Columbia, Maryland (1983); Oslo (1984) and Paris (1986). The alliance between that Group and the OIE is also welcomed.

Also, the Expert Committee on Food Additives addressed veterinary hormones in

1981 and 1984 reports. The 1981 report of a World Health Organization Working Group summarized certain health aspects of residues of anabolics in meat. Likewise, the OIE Symposium on Anabolics in Animal Production helped pave the way toward international cooperation.

Many of you here today have been involved in that earlier foundational work-whether it was performed in connection with Codex or not-and you deserve to be

commended for it. In that regard, I am particularly pleased to see Doctors Crawford and Somogyi as Chairman and Rapporteur of this Session. Joint FAQ/WHO Expert ConsultationThat groundwork culminated in the 1984 Rome Meeting of the Joint FAO/WHO

Expert Consultation on Residues of Veterinary Drugs in Foods. The Consultation, requested by the 15th Session of the Commission, was charged with considering the \"urgent and timely\" subject of veterinary drug residues and providing independent technical and scientific advice to the Commission. The specific tasks before the Consultation were:

To examine the problems associated with residues in foods arising fromthe use of veterinary drugs and other chemicals in food producing animals;

(a) To advise the Codex Alimentarius Commission on how to consider these problems;

(b) To examine the ways and means of regulatory control; and (c) To suggest priorities for substances to be considered.

Formation of the CC/RVDFThe Consultation recommended the formation of a new Codex Standing

Committee on Veterinary Drug Residues as the best vehicle for accomplishing these objectives, and the Commission unanimously approved the formation of this Committee in July of last year.

This week the Committee will consider the terms of reference, or scope of work,

approved by the Commission. Those terms of reference are:

(1) To determine priorities for the consideration of residues of veterinary drugs in

foods; (2) To recommend maximum residue levels of such substances; (3) To develop codes of practice as may be required; and

(4) To determine criteria for analytical methods used for the control of veterinary

drug residues in foods.

The Commission also called upon FAO and WHO to consider formation of an

appropriate expert body to provide independent scientific advice to the Committee from time to time, as recommended by the Consultation.

This request recognizes the interdisciplinary nature of the study of veterinary

drug residues, which is not the same as the science of veterinary medicine. In the days before mass medication of food animals, the veterinarian may have been the best analyst of animal drug residues. But today, answering the many questions about the ramifications of veterinary drug use - including hormones - is perhaps best described as a young subdiscipline of pharmacology. The study also requires the skills of

toxicologists, animal scientists, microbiologists, immunologists, analytical chemists, biochemists, endocrinologists, physiologists, and others. AgendaAnd so we are here today to begin our mission. The proposed agenda for the

week is broad and ambitious, but I believe that we can accomplish it.

Priority List of Drugs. The eyes of the world are upon us, and I believe that the development of a first list of veterinary drugs for priority review is a vital objective if the Committee is to be effective over the long term. Obviously, many if not most of you agree. Many of the countries represented today have submitted your priority lists of veterinary drugs. A few examples of the preparations on those lists are hormones such as trenbolone and estradiol; drugs such as chloramphenicol; certain anthelmintics and antibiotics; and even the sulfonamides.

However, before we can establish the Committee's priority list, we must agree on

the criteria for a veterinary drug to \"make the list\". Those criteria will no doubt include considerations of public health, trade, and practicality.

Once we have agreed on criteria and the actual list of priority drugs for review,

we will have taken a pivotal step toward the sane and orderly determination of Average Daily Intakes (ADI's).

Expert Advisory Committee. Another agenda item of critical importance is the nature of the expert advisory committee and our working relationship with the group. Continuing progress toward Codex Maximum Residue Levels (MRL's) for drugs of public health and trade significance will be inextricably linked with the progress of this group. For the expert advisory body will be expected to determine:

(1) (2) (3) (4)

an acceptable daily intake for total residues of the drug;

a maximum residue level for each commodity in which the drug might appear;

a withdrawal time, if necessary, for each species; and

a recommended analytical method for monitoring residues of the drug.

In order to refine the Committee's views on the constitution of the expert body as

well as our relationship with it, we will ask many questions this week. For example, is it feasible to convene a new separate joint expert committee on veterinary drugs? Or

should we continue to rely on the Joint Expert Committee on Food Additives, at least for the time being? Can the expert group meet annually? Should the expert group be expected to evaluate the drugs in the priority order we agree upon? And how can we best ensure the timely publication of monographs that will be necessary for the

Committee on Veterinary Drug Residues to maintain its momentum in dealing with this issue that has come of age?

It should also be stated that arriving at appropriate Codex ADI's may require

access to proprietary data. Much of the data on the safety of food products from animals that have received veterinary drug preparations is unpublished, although it has been submitted to governments for their consideration in registering and licensing the drugs. We do not anticipate problems in this respect. Industry representatives participating in Codex as observers have ably demonstrated their full commitment to this forum, which seeks to balance the interests of health, nutrition, agriculture and trade.

Analytical Methods and Sampling. We also plan to establish working procedures for the selection of analytical methods and sampling for the control of veterinary drug residues in foods. The Commission has recommended that we maintain close liaison with the

Committee on Methods of Analysis and Sampling, and that we consider the work already undertaken by other bodies, such as the Council of Europe.

What is our starting point? Can we proceed to development and testing of

methodology for directly evaluating the toxicity of small amounts of residues? Do questions remain about the appropriate level of uncertainty in establishing sampling plans? How can we be sensitive to the limited resources and experience of developing countries in analysis, while incorporating the best available methodology? These are some of the questions we will deal with this week.

If you will allow me, I would like to take a slight detour here to discuss public

education. The Commission has recommended more public education about residues, and it is in the arena of analysis and sampling that the public is perhaps most

misinformed - and therefore frightened. Perhaps the greatest misconception is that if there is any residue in the food, that residue must be unsafe. Because the residue would not be present if veterinary drugs were not used, the consumer falsely concludes that products from animals raised without these drugs might be safer.

In the United States, a number of consumers are buying products allegedly from

animals raised without the use of antibiotics or hormones. This trend, while it may be harmless, presents its own regulatory problems. Are consumers getting what the label or advertisement says they are getting? Are any of them (persons with hypersensitivities, for example) placing too much faith in the \"residuefree\" product? Unfortunately, while we are not yet aware of any problems, the trend offers great opportunities for the unscrupulous.

But the trend also indicates that all of us in the veterinary drug community need

to more seriously consider this problem of public perception. Rather than commiserating about the lack of knowledge by consumers who do not understand the difference between a qualitative and a quantitative method, between an action level and a tolerance, we need to try to begin to explain the practical and necessary aspects of residue analysis and sampling. In the past, public perception has played a role in the development of technical barriers to trade, and it could do so again.

Codes of Practice. Illegal or improper use of veterinary drugs can also have a very direct effect on trade. This week we will begin consideration of the need for codes of practice for users of veterinary drugs. Such codes would of course apply to producers as well as veterinarians. Veterinary drugs are used for disease treatment, but they are also used for such disparate uses as disease prevention, growth promotion, control of reproduction, and control of pre slaughter stress.

Codex codes of practice - basically good manufacturing practice - have been

used all over the world to train food personnel. Many believe that the codes of practice will stand as the Commission's most significant contribution to food safety. Yet codes of practice for veterinary drug use would have a very different character than the existing codes of practice, which are very oriented toward hygiene and sanitation.

Codes of practice for users of veterinary drugs could, within the framework of a

solid regulatory system, be very helpful in deterring unintentional misuse of veterinary drugs, though they would be unlikely to halt deliberate misuse. They would advise primarily on procedures to achieve the lowest residue content possible, and on

appropriate measures to control residues. However, delegations have varying views on the need for formal codes of practice, their scope, and the practical difficulties involved in developing them. This week, we hope to find the common ground on which we can all agree. ClosingThe Codex Alimentarius Commission has for nearly a quarter of a century

provided an international forum where regulators, scientists, and business people could find a common ground on the food trade issues that are also food safety issues. The success of Codex has in a sense reflected the number of committees

adjourned because their work is complete. Yet its success is also measured in new beginnings. Any institution must change to reflect the needs of the time, or it will not survive. And while some might argue that Codex is not really an institution but a

community, I think few of us would disagree that the formation of this Committee is a signal that the Codex Alimentarius Commission is as vital - as essential and as alive -as it was in 1962.

We have work to do, so let's proceed. Thank you very much.

ALINORM 87/31 APPENDIX IIIPROPOSALS FOR INCLUSION IN THE PRIORITY LIST OF VETERINARY DRUGSIn reply to CL 1986/2 (RVDF) and during the First Session of the Codex

Committee on Residues of Veterinary Drugs in Foods the following countries and

international organizations proposed veterinary drugs for inclusion in the priority list of veterinary drugs to be evaluated:

Argentina, Australia, Belgium, Brazil, Canada, Chile, People's Republic of China, Cuba, France, Federal Republic of Germany, Ghana, Ireland, Japan, Kenya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Senegal, Spain, Sweden, Trinidad and Tobago, United Kingdom, Unites States of America, Zimbabwe.

The following veterinary drugs were proposed for inclusion in the list (CX/RVDF

86/4-Add. 1 and Part II, CRDs 1 and 2 and para. 163 of the Report). 1.

ARGENTINASulphonamides: - Sulphadimethoxine - Sulphamethazine - Sulphathiazole - Sulphaquinoxaline Antibiotics: - Chloramphenicol - Neomycin - Erythromycin - Penicillin - Tetracycline - Oxytetracycline - Chlortetracycline HormonesIt is suggested that a definition should be made of the chemical compound and

its substrate, where it is necessary to determine quantities, in the following groups of substances: oestrogens, androgens, progesterons, corticosteroids and prostaglandins.

Anthelmintics: - AlbendazoleCryomazine - Fenbendazole

- IvermectinLosalocid - Levamisole

2.

AUSTRALIA- Antibiotics, especially chloramphenicol - Hormonal growth promotants - Sulphonamides

- Nitrofurans - Anthelmintics - Dimetridazole - Tranquilizers - Cryomazine - Febantel - Clobantel

3.

BELGIUM- Antibiotics and antimicrobial compounds susceptible of triggering hypersensitivity reactions and appearance of resistence phenomena. - Nitrofurans

- Chloramphenicol (aplastic anemia) - Neuroleptic drugs and betablockers - Hormones

- Anthelmintics (embryotoxic properties of benzimidazoles).

4.

BRAZIL- Antibiotics (specifically Chloramphenicol) - Anabolic agents

- Sulphonamides; e.g., sulphamethazine - Nitrofurans

- Benzimidazoles - Nitroimidazoles

- Synthetic dyes used as marker compounds and as therapeutic agents - Carbadox - Cryomazine

5.

CANADA- Quinoxaline (carbadox)

- 5-nitro-imidazole (dimetridazole, ipronidazole and ronldazole) - Hormones used for anabolic purposes - Nitrofurans

- Sulphamethazine

6.

CHILE- Anabolic substances based on synthetic hormones and xenobiotics such as zeranol,trenbolone and melengesterol.

- Antiparasitic agents for external and internal use especially organophosphates and chlorinated hydrocarbons. - Coccidiostats - Antibiotics

7.

PEOPLE'S REPUBLIC OF CHINA- Antibiotics (chloramphenicol, penicillins, streptomycin, tetracyclines,oxytetracyclines).

- Sulphonamides (sulphadiazine, sulphamethazine, sulphaquinoxaline) - Nitrofurans - Clopidol - Amprolium

- Anthelmintics (levamisole)

- Pesticides (including DDT and chlorinated hydrocarbons)

8.

CUBACuba agrees with the list established by the Expert Consultation (Section 8 of

Food and Nutrition Paper No. 32):

- Antibiotics (specifically Chloramphenicol) - Anabolics

- Sulphonamides; e.g., sulphamethazine - Nitrofurans

- Benzimidazoles - Nitroimidazoles

- Synthetic dyes used as marker compounds and as therapeutic agents - Tranquilizers and betaadrenogenic blocking agents

and - Carbadox

- Cryomazine 9. FRANCEAgrees with list of the Expert Consultation (see para. 8 (Cuba) above) and

proposed:

- Antibiotics

- Sulphonamides - Nitrofurans

- Benzimidazoles

- Tranquilizers and betablockers

10.

FEDERAL REPUBLIC OF GERMANY(a)

Substances of First Priority: - Chloramphenicol

- Betalactam Antibiotics - Ampicillin, amoxicillin, cloxacillin, dicloxacillin,oxacillin, benzylpenicillin, phenoxymethylpenicillin, phenethamate hydriodide,clemizole penicillin. - Tetracyclines - Tetracycline, chlortetracycline, rolitetracycline,oxytetracycline. - Macrolide Antibiotics - Erythromycin, oleandomycin, splramycin, tylosin,kitasamycin.

- Sulphonamides - Sulphamethazine, sulphaquinoxaline, sulphachlorpyridazine, sulphadiazine, sulphamerazine, sulphathiazole, sulphadoxine, sulphadimethoxine, sulphamethoxypyridazine, sulphaloxic acid, sulphaguanidine, formosulphathiazole, succinylsulphathiazole,

phthalylsulphathiazole, sulphamethizole, sulphamethoxazole, sulphapyridine, sulphanilamide, sulphaphenazole, sulphatolamide, sulphisomidine, sulphaethoxypyrldazlne, sulphalene, sulphaperine. - Aminoglycoside Antibiotics - Destomycin A, streptomycin, dihydrostreptomycin,gentamycin, kanamycin, neomycin, paromomycin, spectinomycin, apramycin. - Nitrofurans - Nitrofurathiazide, furazolidone, nitrofurantoin, nitrofurazone, furaltadone, nifurprazine.

- Trimethoprim

- Polypeptide Antibiotics - Polymyxin B, colistin - Lincomycin - Rifamycin - Tiamulin

- Phenothlazines - Acepromazine, chlorpromazine, propionylpromazine,triflupromazine, prothipendyl. - Griseofulvin - Pyrimethamine

- Imidazoles - Levamisole, tetramisole - Anthelmintlcs - Dichlorvos, trichlorfon - Nitro imldazoles - Ronidazole, ipronidazole, dimetridazole, metronidazole. - Glucocorticoides - Dexamethasone, triamcinolone acetonolde, flumethasone. - Azaperone (tranquilizer)

- Carazolol (beta-adrenergic blocker)

- Antihlstaminlc3 - Mepyramine, methapyrilene - Pyrazolones - Aminophenazone, dlpyrone, phenylbutazone, phenazone - Methyl violet

- Benzlmidazoles - (Thiabendazole), parbendazole, cambendazole, albendazole,fenbendazole, oxfendazole, mebendazole, flubendazole. - Febantel - Xylazin - Dapsone

- Fasciolicldes - Oxyclozanide, rafoxanide, brotianide, bromfenofos, niclofolan,bithlonol, hexachlorophen, nitroxynil, hexachloroethane. - Dlaveridine

- Nystatin, amphoterlcin B - Tetrachlorvinphos (b)

Substances of Second Priority: - Phoxim, coumafos

- Hexachlorcyclohexane, bromocyclen - Plperonyl butoxyde, dlazlnon = dimpylate

- Arecoline, praziquantel, piperazlne, diethylcarbamazine, kamala (Endoparasitic agents). - Cyclic Amides - Morantel, pyrantel - Prednisolon, prednison

- Ethinyl-Oestradiol (VO)

- 19-Norandrostenolone dodecanoate, medroxyprogesterone acetate,19-norandrosterolone decanoate. - Chlormadinone acetate

- Prostaglandines - Prostalene, tiaprost, fluprostenol, cloprostenol, prostianol. - Benzothiadlazlnes - Hydrochlorothlazide, benzylhydroflumethiazide,trichlormethiazide.

- Acetanillde, phenacetin, acetaminophen, paracetamol (Aniline Derivatives). - Arsanilic acid, 8-hydroxyquinoline, mercury, clenbuterol, furosemide, isoxsuprine, strychnine, veratrum viride, ergotamine.

11.

GHANATrypanocides: Isometamidium, prothidium, pro salt of quinuronium sulphate, diminazene aceturate, imidocarb, trypan blue.

12.

IRELAND- Prohibited hormones: stilbenes, thyreostatics, trenbolone, zeranol,

othersubstances having an oestrogenic, androgenic or gestagenic effect. - Chloramphenicol

- Other antibiotic and substances with antimicrobial effect.

13.

JAPANAntibiotics; - Oxytetracycline - Chlortetracycline - Tylocine - Penicillin - Spiramycin

- Chloramphenicol Antibacterial Substances: - Furazolidone (nitrofurans) - Sulphamonomethoxine - Sulphadimethoxine - Thiamphenicol - Olaquindox - Carbadox

Hormone Growth Promoters and Corticosteroids Antimycotics and Antiparasitic Agents:- Clopidol

- Thiabendazoles

14.

KENYAKenya (speaking for countries of the African Region) proposed acaricides

(organophosphates and chlorinated hydrocarbons) and supported Ghana on trypanocldes (see para. 11 (Ghana) above). 15.

MALAYSIA- Antibiotics (e.g., tetracycllnes, chloramphenicol) - Anabolic agents - Sulphonamides - Nitrofurans

- Acaricides including DDT and other chlorinated hydrocarbons.

16.

MEXICO- Antibiotics (penicillin, streptomycin, tetracycline, erythromycin,chloramphenicol, novobiocin)

- Hormon-Based Anabolic Agents

- Synthetic Colours used as Therapeutic Agents or as Feed Additives

17. NETHERLANDS- Antibiotics (chloramphenicol, tetracycline, oxytetracycline, chlortetracycline) - Sulphonamides

- Nitrofurans (furazolidone, furaltadone) - Quinoxalines (carbadox, olaquindox)

18.

NEW ZEALAND- Endogenous hormones, the active ingredient of which is a naturally occurring substance, e.g. oestradiol - 17 B, progesterone and testosterone (all of which are prohibited for sale in New Zealand as growth promotants, but are allowed for veterinary therapeutic purposes);

- oestrogenic stilbenes and their derivatives (which are prohibited for sale in New Zealand);

- exogenous substances or xenobiotics, e.g. zeranol and trenbolone acetate (zeranol only is on sale in New Zealand). - Antibiotics

- Other Antimicrobial Drugs

19.

NORWAYAntibiotics and Other Antiinfective Drugs: - Oxytetracyclines - Sulphadiazine - Trimetroprin - Nifurazolidone

- Chloramphenicol (the question of completely banning this drug for veterinary use should be considered)

Anabolic agents including:

- Penicillins

- Streptomycines - Sulphonamides

Antiparasitic Agents, especially: - Coccidiostats (Amprolium, etc.) - Ivermectin

- Hexicide and other agents against mange

- Imidazothiol derivatives, benzimidazoles and tetrahydropyrimidines - Organophosphates, including metrifonate

Substances Acting on the Central Nervous System - Amperozid 20.

POLAND- Chloramphenicol - Sulphonamides - Anticoccidial agents

- Hormonal growth promoters

21. 22.

SENEGALSenegal proposed the evaluation of trypanocides (see para. 11 (Ghana) above). SPAIN- Anabolic agents

- Antibiotics (chloramphenicol and betalactam antibiotics) - Sulphonamides - Nitrofurans - Nitroimidazoles - Benzimidazoles - Carbadox

- Antibiotics used as additives in EEC countries.

23.

SWEDEN- Benzimidazoles - Carbadox

- Chloramphenicol - Anabolic Agents - Sulphonamides

24.

TRINIDAD AND TOBAGO- Chloramphenicol - Tetracycline - Tylosin

- Penicillin and Streptomycin - Stilbestrol

- Diethylstilbestrol

- Thyreostatic drugs and associated mastitis preparations.

25. UNITED KINGDOM(a)

Assessment of dietary exposure to residues of:

- Antimicrobial agents: chloramphenicol, sulphonamides, nitrofurans

- Benzimidazole anthelmintic agents - Nitroimidazoles - Carbadox

- Those tranquilizers and beta-adrenogenic blocking agents used to facilitate the transport of animals, notably pigs, prior to slaughter. (b)

Assessment of residues of:

- Olaquindox - Coccidiostats

- Antimicrobial agents not listed under (a) above which are widely used In food-producing animals.

26.

UNITED STATES- Anabolic Agents - Nitroimidazoles - Carbadox

- Chloramphenicol - Sulphamethazine

27. 28.

ZIMBABWEZimbabwe proposes evaluation of trypanocides (see para. 11 (Ghana) above). EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES' ASSOCIATIONS (EFPIA)- Effects of sub-bacteriostatic levels of oral tetracycline in-vivo and ln-vitro,and the relevance, if any, to fixing acceptable safe residue levels for theseantibiotics.

- Antibacterials of the nitrofuran and nitrolmidazole group. - Chloramphenicol and thioamphenlcol - Carbaquindox and olaquindox.

29.

BUREAU EUROPEEN D'INFORMATION POUR LE DEVELOPPEMENT DE LA SANTE ANIMALE (DSA)- Growth Promoters (natural hormones and synthetic compounds which have an effecton the metabolism).