INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 23
Prepared by:
The 32th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1988
(c) World Health Organization 1988
First published 1988
Printed in Great Britain at the University Press, Cambridge
Library of Congress cataloguing in publication data available.
British Library cataloguing in publication data
Joint FAO/WHO Expert Committee on Food Additives.
Meeting (32nd: 1987: Rome, Italy).
Toxicological evaluation of certain veterinary drug residues in food.
(WHO food additives series; 23).
1. Food. Additives & contaminants. Toxic effects.
I. Title II. World Health Organization III. Series
ISBN 0 521 37916 4
The preparation of this document was supported by the International
Programme on Chemical Safety (IPCS), Geneve, Switzerland.
CONTENTS
Preface
Chloramphenicol
Trenbolone acetate
Zeranol
Annexes
Annex 1 Reports and other documents resulting from
meetings of the Joint FAO/WHO Expert Committee
on Food Additives
Annex 2 Abbreviations used in the monographs
Annex 3 1987 JECFA participants
Annex 4 Acceptable daily intakes, other toxicological
recommendations and information on specifications
PREFACE
The monographs contained in this volume were prepared by the
thirty-second Joint FAO/WHO Expert Committee on Food Additives
(JEFCA), which met in Rome, Italy, 15-23 June 1987. These monographs
summarize the safety data on selected veterinary drug residues
reviewed by the Committee. The data reviewed in these monographs form
the basis for acceptable daily intakes (ADIs) established by the
Committee.
The thirty-second report of JECFA has been published by the World
Health Organization as WHO Technical Report Series, No. 763. The
participants in the meeting are listed in Annex 3 of the present
publication and a summary of the conclusions of the Committee is
included as Annex 4.
Specifications established at the thirty-second meeting of JEFCA
will be issued separately by FAO under the title, Specifications for
the identity and purity of certain veterinary drug residues in the
FAO Food and Nutrition Paper Series. These toxicological monographs
should be read in conjunction with the specifications and the report.
Reports and other documents resulting from previous meetings of
the Joint FAO/WHO Expert Committee on Food Additives are listed in
Annex 1.
JEFCA serves as a scientific advisory body to FAO, WHO, their
Member States, and the Codex Alimentarius Commission, primarily
through the Codex Committee on Food Additives and the Codex Committee
on Residues of Veterinary Drugs in Foods, regarding the safety of food
additives, residues of veterinary drugs, and contaminants in food.
Committees accomplish this task by preparing reports of their meetings
and publishing specifications and toxicological monographs, such as
those contained in this volume, on substances that they have
considered.
The toxicological monographs contained in this volume are based
upon working papers that were prepared by temporary advisers in
advance of the thirty-first JECFA meeting. A special acknowledgement
is given to those who prepared these working papers, Dr S.
Fitzpatrick, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA; Dr C.L. Galli, Professor of
Experimental Toxicology, University of Milan, Milan, Italy; Dr S.I.
Shibko, Associate Director for Regulatory Evaluation, Center for Food
Safety and Applied Nutrition, Food and Drug Administration,
Washington, DC, USA; and Dr K.N. Woodward, Division of Toxicology and
Environmental Protection, Department of Health and Social Security,
London, England.
Many proprietary unpublished reports are referenced. These were
voluntarily submitted to the Committee by various producers of the
veterinary drugs under review and in many cases these reports
represent the only safety data available on these substances. The
temporary advisers based the working papers they developed on all the
data that were submitted, and all these studies were available to the
Committee when it made its evaluations.
From 1972 to 1975 the toxicology monographs prepared by Joint
FAO/WHO Expert Committees on Food Additives were published in the WHO
Food Additives Series; after 1975 this series became available only in
the form of unpublished WHO documents provided upon request by the
Organization. Beginning with the 1985 monographs, they are published
by the Cambridge University Press, which should ensure that these
monographs are more widely known and available.
The preparation and editing of the monographs included in this
volume have been made possible through the technical and financial
contributions of the Participating Institutions of the International
Programme on Chemical Safety (IPCS), which support the activities of
JECFA. IPCS is a joint venture of the United Nations Environment
Programme, the International Labour Organization, and the World Health
Organization, which is the executing agency. One of the main
objectives of the IPCS is to carry out and disseminate evaluations of
the effects of chemicals on human health and the quality of the
environment.
The designations employed and the presentation of the material in
this publication do not imply the expression of any opinion whatsoever
on the part of the organizations participating in the IPCS concerning
the legal status of any country, territory, city, or area or its
authorities, or concerning the delimitation of its frontiers or
boundaries. The mention of specific companies or of certain
manufacturers' products does not imply that they are endorsed or
recommended by those organizations in preference to others of a
similar nature that are not mentioned.
Any comments or new information on the biological or
toxicological data on the compounds reported in this document should
be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert
Committee on Food Additives, International Programme on Chemical
Safety, World Health Organization, Avenue Appia, 1211 Geneva 27,
Switzerland.