WORLD HEALTH ORGANIZATION ЕВбб/ю
ORGANISATION MONDIALE DE LA SANTÉ 5 December 1974
EXECUTIVE BOARD INDEXED Fifty-fifth Session
Provisional agenda item 2.10 к a- гЛ^ №
SAFE USE OF PESTICIDES: CLASSIFICATION OF PESTICIDES ACCORDING TO HAZARD
The Executive Board, at its fifty-second session, having considered the recommendations 1 of the Expert Committee, on Insecticides - Safe Use of Pesticides » 2 - adopted resolution EB52.R113 in which the Director—General was requested to take steps to develop a tentative classification of pesticides which would distinguish between the more and less hazardous forms of each pesticide and to submit such a classification for comment to national and international agencies.
A background document was prepared explaining the reasons for a tentative classification, proposing such a classification and making provision for exceptions. Examples of national and international classifications currently in use were annexed. In December 1973, this document was sent for comment to members of the Expert Advisory Panel on Insecticides and of other expert advisory panels with special expertise and interest in pesticide toxicology. The comments of the experts were analysed and the document adjusted accordingly was put in final form as a "Proposal for a WHO Tentative Classification of Pesticides by Hazard" (Annex I). This paper was distributed to all Member States and Associate Members under cover of circular letter C.L.18.1974 dated 22 April 1974, and to international agencies.
At the date of the present document, 14 countries had replied to the circular letter. Eight countries, as shown in Annex II, have expressed approval of the proposal without qualification. The comments of six countries expressing either qualifications of suggestions for amplification are shown in Annex III.
Most countries commented that the multiplicity of existing classifications caused confusion and misunderstanding and all welcomed WHO'S initiative in proposing a standard system of classification by hazard. The hope was expressed (Malta) that the system would be accepted by other international organizations as well as by individual countries.
Specific comments by countries have certain aspects in common. Four countries (Iran, Malta, Sudan and Tunisia) suggested that the classification should be more widely based, taking into account other criteria such as the cumulative effects of prolonged or repeated exposure, inhalation toxicity, etc. It is recognized in the proposal that such toxic effects may need to be taken into account in classifying individual substances, and in due course it may be possible to extend the classification to include additional criteria. However, the present lack of agreement in extrapolating animal data to man, particularly on the effects of long-term exposure, and in some cases the lack of suitable scientific data, makes such an
Off. Rec. Wld Hlth Org,, 1973, No. 211, p. 4, resolution EB52.R3.
Wld Hlth Org, techn. Rep. Ser., 1973, No. 513
Off. Rec. Wld Hlth Org., 1973, No. 211, p. 7. EB55/10 page 2 • extension a matter for continuing review rather than for action at the moment. An examina- tion of the classification suggests that the instances where its application may not adequately reflect the actual hazard, will be the exception rather than the rule. One country (Sudan) suggested that such exceptions may lead to the possibility of a product being classified by various authorities in different classes. It is hoped that the notification procedure suggested in the proposal, similar to that at present followed in the case of drugs, will enable information on exceptions to be satisfactorily promulgated through WHO. The need to adapt the classification to local needs and to keep classifications under constant review in the light of new data, both experimental and clinical, is emphasized in the proposal.
Several comments (Iran, Nigeria, Sudan and Tunisia) suggested that the classification should be more specific .in its advice on labelling. This is a complex subject which many international organizations are currently discussing, delineating symbols and colour codes. It would be premature to anticipate the outcome of these discussions by organizations which are more competent in this field than WHO. While the classification may have an impact on labelling, it seems advisable to limit its recororoendations to general principles at present, with a view to including more specific recommendations when international agreement has been reached.
The suggestion (Sudan) that the classification should draw attention to other symbols which are in international use to denote hazards from materials which are explosive, corrosive, inflammable, etc., is useful, particularly if the classification is used for chemicals other than pesticides.
One country (Iran) suggested an up-to-date list of LD^QS of all pesticides should be prepared for the use of Member States. This would be a large undertaking and in need of constant review. It is suggested that Appendix 6 to the proposal giving examples of the classification of a number of compounds and formulations goes a long way to meeting this suggestion.
An addendum to the present document will be issued nearer the time of the Executive Board session in the event that further comments are received from Member States or inter- national agencies.
Should these comments confirm the views outlined above concerning the proposal as set out in Annex I, the Board may wish to propose to the Twenty-eighth World Health Assembly that it should adopt the classification as a WHO recommendation. For this purpose, the proposal can be edited in such a way that the explanatory and illustrative material is omitted and, taking into account the suggestions made, the classification set out in a concise form which can be widely distributed. The edited document would be based on section 6 (WHO tentative classification by hazard) with the inclusion of relevant parts of sections 5 (Basis of WHO tentative classification by hazard) and 7 (Application of the WHO tentative classification), with the addition of Appendix 6 (Examples of pesticide active ingredients and their formulations classified by the WHO tentative scheme). EB55/10 page 3
ANNEX I
PROPOSAL FOR A WHO TENTATIVE CLASSIFICATION OF PESTICIDES BY HAZARD
CONTENTS
Page
SYNOPSIS 5
1. Introduction 5
2. Purposes and uses of classification ••••• 6
3. Existing classifications 7
3.1 General 7
3.2 National classification 7
3.2.1 Canada 7
3.2.2 Egypt 8
3.2.3 Italy 9
3.2.4 Portugal 9
3.2.5 United Kingdom of Great Britain and Northern Ireland • 9
3.2.6 United States of America 10
3.2.7 USSR 10
3.3 European international agreements •••••••• 11
3.3.1 Council of Europe List of Dangerous Chemical Substances and Proposals Concerning their Labelling (1971) 11
3.3.2 Council of Europe Resolution AP(71)4; On the Classification of Formulated Pesticide Products (1971) • • . 11
3.3.3 European Economic Community 12
3.4 International transport organizations . . . 12
3.4.1 Transport by rail 12
3.4.2 Transport by road 13
3.4.3 Transport by air 14
3.4.4 Transport by sea • 15
3.4.5 United Nations recommendations 15
4. Comment on existing classifications 15
5. Basis of WHO tentative classification by hazard 17 EB55/10 page 4 Annex I
5.1 WHO expert committee guidelines 17
5.2 Obtaining the data for the classification 18
5.3 Differentiation between solids and liquids 18
5.4 Application to chemicals other than pesticides 18
5.5 Significance of dermal toxicity data 18
5.6 Significance of volatility and inhalation toxicity 19
6. WHO tentative classification by hazard 19
7. Application of the WHO tentative classification 20
7.1 Recognition of exceptions 20 7.2 Labelling 20
7.3 Low concentration ready-to-use formulations with toxic ingredients • • • • 21
7.4 Outline of main differences from existing classifications • 21
REFERENCES 23
APPENDICES:
1. Canadian classification scheme 24
2. USSR classification scheme 26
3. United States classification: Public Law 92-516 (Extract) 28
4. Council of Europe Classification of Formulated Pesticides 30
5. IMCO Classification of Pesticides 31
6. Examples of pesticide active ingredients and their formulations, classified by the WHO tentative scheme 35
7. Main differences between existing classifications and WHO tentative scheme • • • 39 EB55/10 page 5 Annex I
SYNOPSIS
The history of the need for a standard classification of pesticides is presented and illustrative examples of various current classifications are outlined. A proposal is made for a tentative WHO classification with the aim of protecting formulators, applicators, transport workers, and the general public. It is based on hazard rather than toxicity, and it recognizes the greater hazards that may arise when a pesticide or a formulation is in liquid state. It also recognizes the hazards of dermal absorption. The few cases in which exceptions may need to be made are outlined, and an indication is given of the effects of the proposal on existing classifications.
1. INTRODUCTION
Pesticides play an important role in the production of food and fibre and in the protection of public health. Some of these compounds present serious toxic hazards in their manufacture, transportation, storage and use. It is therefore important that these hazards should be clearly defined so that effective preventive measures can be promoted. To protect workers who come into contact with pesticides, and to protect the public, many national administrations and various international organizations have introduced legislation or made recommendations on the safe handling of pesticides. In almost all of these instances the concept of classifying pesticides according to toxicity is included.
The multiplicity of existing classifications is confusing to those who have to comply with the various regulations and to developing countries wishing to introduce legislation. A standard classification would therefore appear to be very desirable to assist in the assessment of the hazards to which people who handle pesticides are exposed.
As long ago as 1952, the Economic and Social Council of the United Nations expressed concern at the unnecessary obstacle to trade presented by the arbitrary differences between codes dealing with the carriage of dangerous goods and they appointed a committee of experts to make recommendations on harmonizing the codes as regards classification, labelling, packing and transport documentation. In recent years progress has been made, both towards the acceptance of a single classification for all modes of transport and the harmonization of labelling for transport.
On the other hand, further classifications have been introduced by other authorities, for purposes other than transport, and the overall picture is now, if anything, more complex than before.
In 1968 the WHO Regional Committee for the Eastern Mediterranean (Sub-Committee A), recognizing that in some countries in the Region increasing use of pesticides had not always been matched by a corresponding increase in effort to prevent accidental and occupational poisoning by these compounds, requested the governments to strengthen existing rules and regulations by, inter alia, classifying pesticide formulations as to hazard (EM/RC 18A/R14).
In its twentieth report, the WHO Expert Committee on Insecticides (1973) noted the overall situation with concern and was informed that WHO has received several requests from Member countries and United Nations bodies for assistance in classifying pesticides. The Committee supported the development by WHO of a recommended classification of pesticides according to hazard. The WHO Executive Board subsequently requested the Director-General "to take steps to develop a tentative classification of pesticides which would distinguish between the more and less hazardous forms of each pesticide and that this should be submitted for comment to national and international agencies" (resolution EB52.R11). EB55/10 page 6 Annex I
2. PURPOSES AND USES OF CLASSIFICATION
The purposes and uses of classifications fall into two main groups• Firstly as part of a registration procedure classification to subsequently control use patterns and the occupa- tion and training of persons to whom certain products are made available; through labelling the purchaser or user may be informed as to the nature and degree of risk by symbols and/or phrases which may also cover precautions necessary in use.
Secondly, it has become essential that those who are concerned with the transport of chemical have adequate information on the hazards involved, and the precautions necessary to eliminate or at least reduce these risks. With this in mind the authorities associated with the various modes of transport have sought to frame regulations for the transport of dangerous goods.
Although there are recognized differences in the requirements of the different modes of transport, these are small in importance in comparison with the advantages of a uniform labelling system for all modes of transport. Most transport systems have already or may soon come into line with the United Nations recommendation on this subject and it would obviously enhance the value of this agreement if the United Nations classification was harmonized with other classifications.
Classification depends on the determination of criteria to define classes, bearing in mind the objectives, i.e.
(1) the use of classification to control distribution by recommending certain restrictions on sale and use;
(2) the use of classification in labelling the product appropriately: (a) to identify hazards to transport workers and dangers of possible food contamination, and (b) to identify user hazards and hence to indicate the protection required.
Most of the existing classifications are used for a single purpose, for example, the minimizing of transport hazards : however, with only minor possible exceptions, all of the classifications are aimed at preventing acute hazards to man.
The selection of the exact numerical boundaries as LD50 values"^" in mg/kg to define the commonly used classes describing the degrees of toxicity must be artificial since the spectrum of toxicity is a continuum.
Most present classifications divide the whole rang© into several classes of toxicity, usually three or four, Class I being designated as the most toxic class and Class IV being the least toxic.
Recently the recognition of environmental risks attached to the use of some pesticides has resulted in some authorities proposing criteria to include the indirect effects of pesticides on man through his environment, although it is recognized that these effects depend on the user and his knowledge of proper application and use of such pesticides.
This paper is limited to a proposal to harmonize classifications dealing primarily with hazards to man.
1 The LD50 value is a statistical estimate of the number of milligrams of toxicant per kilogram of body-weight required to kill 50% of a large population of test animals.
Unless otherwise stated, all oral LD50 values quoted in this paper are obtained by a single acute oral dose administered to the rat. Dermal LD50 figures used in some existing classifications presumably refer to the rabbit since this has been the experimental animal roost frequently used for this test in the past. In the WHO proposal the criteria for dermal toxicity are based on values in rat LD50 # EB55/10 page 7 Annex I
A distinction has to be made between hazard to an individual man actually handling a specific pesticide and hazard used as a general term in this paper. The former is a summation of all the influences that impinge on the man, including wind direction and the state of maintenance of application equipment. The hazard referred to in this paper is the acute risk to health that might be encountered by any person handling the product in accordance with the directions for handling given by the manufacturer.
3. EXISTING CLASSIFICATIONS
3•1 General
General numerical toxicity ratings were proposed originally for the use of industrial toxicologists to fill a long-felt need for a simple understandable expression of the degree of toxicity. Physicians and clinical toxicologists also needed a simple scale of reference for describing and comparing grades of toxicity. A numerical scale, with a parallel set of descriptive phrases, was devised by Hodge (1949) as the report of the work of a "Toxicological Round-Table". The classification intervals were offered not as ideal examples, but as the best at hand. The numerical scale was subsequently modified by Gosselin (1957).
Hodge к Sterner (1949) Gosselin (1957)
LD 。/kg body-weight LDgo/kg body-weight 5 Extremely toxic less than 1 mg Less than 5 rag super toxic
Highly toxic 1 - 50 mg 5 - 50 mg extremely toxic
Moderately toxic 20 - 500 mg 50 - 500 mg very toxic
Slightly toxic 500 - 5000 mg 500 - 5000 mg moderately toxic
Practically non-toxic 5 - 15 g 5 - 15 g slightly toxic
Relatively harmless over 15 g Over 15 g practically non-toxic
Gosselin*s criteria were established with the object of preventing poisoning, especially in children, and were designed to apply to "consumer goods" i.e. formulations and not to industrial chemicals as were the criteria of Hodge.
Gradually over the years, one or other of these classifications has found its way in whole or in part into many systems of classifying pesticides.
3.2 National classification
Examples of existing national systems of classifying pesticides are summarized below, These examples have been chosen at random. They are summarized briefly to illustrate their diversity, and no attempt has been made to examine any of them critically. More detail on some classifications is set out in the appendices.
3.2.1 Canada
The Pest Control Products Regulations (1972) facilitate the classification or categori- zation of pesticides according to the nature and degree of hazard and risk inherent in their use. This is a part of the registration procedure and has two basic objectives: ЕВ55/Ю page 8 Annex
(a) to alert adequately the purchaser or user as to the nature and degree of risk inherent in the product； and
(b) to determine the occupation and qualifications of persons to whom certain products may be made available and the conditions under which the products may be used.
Products registered under the Act are subject to classification as to the proposed type of marketing, i.e. domestic, commercial or restricted. The classification takes into account hazards to man and to the environment. A summary of criteria is given in Appendix 1 and includes the following:
Class Oral LD50 Dermal LD50
Restricted Less than 50 Less than 100
Commercial Over 50 Over 100
Domestic Over 500 Over 1 000
Further criteria are given to distinguish poison hazards and to control labelling symbols (see Appendix 1). The skull and crossbones is required on Categories I, II and III, the traffic signal shapes of octagon (DANGER), diamond (WARNING) and triangle (CAUTION) being used to differentiate between degrees of hazard.
Category Oral LD50 Dermal LD50
Skull and crossbones I Less than 500 Less than 1 000 DANGER
Skull and crossbones II 500-2 000 1 000-2 000 WARNING
Skull and crossbones III 2 000-5 000 2 000-5 000 CAUTION
NO SYMBOL IV Over 5 000 Over 5 000
3.2.2 Egypt
Egypt divides pesticides into three classes with the following label requirements :
Class Oral LD50 Label requirements
Red label, black frame, 1 Less than 50 skull and crossbones
2 50-1 000 Red label, skull and crossbones 3 Over 1 000 Red label EB55/10 page 9 Annex I
3.2.3 Italy
The details of the method of classifying pesticides in Italy were published by Spina (1969). Active ingredients are basically divided into four classes:
Class Oral LD50
I Less than 50
II 50-500
III Over 500
IV Negligible risk to man
Class II is subdivided into three subclasses. However, account can be taken of the nature and concentration of individual formulations and "transfers" from one group to a higher group is permitted, except that products containing active ingredients with an LD50 of less than 25 mg/kg are non-transferable and are always in Class I. This classification is part of the registration procedure.
3.2.4 Portugal
Pesticide active ingredients are divided into four classes as follows, mainly for the purpose of labelling:
LI)5 0 Class Label requirements Oral Dermal
Skull and Highly toxic 1 Less than 50 Less than 100 crossbones POISON
Skull and Toxic 2 50-250 100-500 crossbones DANGER
3 250-1 250 500-2 500 • St Andrew*s . ^ CAUTION 4 Over 1 250 Over 2 500 Cross
3,2 5 United Kingdom of Great Britain and Northern Ireland #
When registrations of new pesticides are considered under the Pesticides Safety Precautions Scheme a decision is made as to whether the compound should be regulated under the Agriculture (Poisonous Substances) Act, 1952. Although decisions are made individually and there are no published criteria, the table below summarizes the general boundaries of the scheduling of active ingredients over 20 years.
LD 50 Schedule Oral Dermal
Parts I and II substances Less than 20 Less than 40
Part III substances 20-100 40-200 EB55/10 page 10 Annex 1
With the formulations of scheduled materials not exceeding 50% active ingredient the limit of oral LD50 for formulations of Part III substances is therefore 200 mg/kg.
3.2.6 United States of America
Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) four general categories of toxicity of economic poisons are recognized. The main effect of this classi- fication is on labelling as shown below:
Class Oral LD50 Label
POISON 1 Less than 50 Skull and crossbones and antidote statement
2 50-500 POISON
3 500-5 000 CAUTION
4 Over 5 000 No labelling requirements
The regulations also require special "child proof" packaging of Class I and II compounds. A recent amendment of the Act provides for a classification of pesticides for general use, restricted use, or both. Criteria for these are not available at the time of writing. An extract from Public Law 92-516 is shown in Appendix 3.
3.2.7 USSR
At a conference in Kiev in June 1971 (Modern Trends in the Prevention of Pesticide Intoxication, Kiev, 1971, WHO Regional Office for Europe, Copenhagen), Professor Medved presented a paper on the toxicological assessment of pesticides including the classification system used in the USSR. The overall classification is reproduced in Appendix 2, but for the purposes of this summary, only oral and dermal criteria are given.
Class Oral LD50
I Highly active poisonous Less than 50
II Highly toxic 50-200
III Moderately toxic 200-1 000
IV Slightly toxic Over 1 000
Class Dermal LD50
I Highly toxic Less than 300
II Toxic 300-1 000
III Slightly toxic Over 1 000 EB55/10 page 11 Annex I
3.3 European international agreements
3.3.1 Council of Europe List of Dangerous Chemical Substances and Proposals Concerning their Labelling (1971) — ~
In its early work on the classification of dangerous substances, the Council of Europe Sub-committee on Industrial Safety and Health used as its guide, the International Labour Organisation (ILO) Standard Safety Regulations for Government or Other Industrial Establishments It later used amplified provisions when the Chemical Industries Committee # of ILO unanimously adopted a resolution to study the classification, labelling and inter- national safety symbols for dangerous, harmful and toxic chemical substances. The current book, published in 1971, deals with the symbols in the table below, applicable to over 600 dangerous chemical substances (including many pesticides), to denote the risks they present, the labelling and the safety advice which should be given to all who handle them.
General hazard Class 4 deals with toxicity aspects and divides hazardous substances into two classes, "Toxic" and "Harmful". Assessments were made individually over many years “ it with very few exceptions compounds fit into the classification shown in the table.
Class Oral LD50 Symbol Label
Toxic Less than 200 T Skull and crossbones
Harmful 200-2 000 X or St Andrews Cross n Xi
The classification at present deals with "chemical substances" which it defines as covering both pure substances and technical materials as manufactured； it does not deal with formulations.
3.3.2 Council of Europe Resolution AP(71)4; On the Classification of Formulated Pesticide Products (1971) 一 —
The work (Appendix 4) of another Council of Europe subcommittee, the Sub-Committee on Poisonous Substances used in Agriculture, has resulted in Resolution AP(71)4 from the Committee of Ministers, dealing with the classification of formulated pesticide products. The Sub- committee felt that a valuable step towards harmonization of safety measures in member countries would be the adoption of an international system of classification and consequent labelling requirements The aim was uniformity in stating the nature of risk (by phrases # and/or symbol) on the label of the product, irrespective of the country of origin. An in- depth study of the risks of most pesticide products on the European market resulted in a classification which primarily divides all products into four classes as follows : ЕВ55/Ю page 12 Annex I
Class Oral LD50 for formulation Label
(a) All products regardless of concentration if containing Skull and crossbones I an active ingredient with an oral LD^Q 25 or less and "POISON" (b) Other products less than 200
St Andrews Cross II 200-2 000 and "HARMFUL" III 2 000-5 000 PRECAUTIONS
IV More than 5 000 -
Allowance is made for the use in the classification of other important properties of the formulations, and for other criteria in special cases.
3.3.3 European Economic Community
EEC have adopted most of the Council of Europe*s recommendations outlined in 3.3.1 in the EEC Directive on the Classification, Packaging and Labelling of Dangerous Substances.
A further draft directive on the classification, packaging and labelling of dangerous substances (pesticides) deals with formulated pesticides and the criteria proposed in the Council of Europe*s Resolution AP(71)4 will be considered for adoption in the directive.
3.4 International transport organizations
Although the four main transport codes for the carriage of dangerous goods have been in existence for some tiro© it is possible that all four wi11 now adopt the recoromenciations of the United Nations Economic and Social Council * s (UNESOC) Committee of Experts on the Transport of Dangerous Goods. This will also include harmonization of the hazard symbols for all modes of transport. The present codes are summarized as a further illustration of differences in approach to the problem of classification.
3.4.1 Transport by rail
The International Convention Concerning the Carriage of Goods by Rail, Berne, 1961, deals with the carriage of dangerous goods in its Annex I (RID). It has been adopted by most continental European countries for the international carriage of dangerous goods by rail, and their domestic rules are generally based on it.
Moreover, negotiations are proceeding under the Economic Commission for Europe aimed at the conclusion of corresponding agreements for other modes of inland transport. Thus RID may be regarded as the standard European code for the transport of dangerous goods. Sub- stances and articles are arranged in general classes into which all hazardous goods are divided, and nearly all pesticide products fall under Class IVa (toxic substances). These are further divided into three groups of substances and preparations :
R ID = Règlement international concernant le transport des marchandises dangereuses par chemin de fer. EB55/10 page 13 Annex I
(1) with a very serious poisoning risk;
(2) with a serious poisoning risk;
(3) which are harmful #
A fourth group covers cereal grains and other seeds impregnated with one or more pesticides or other poisonous substances.
No toxicological criteria for this classification are laid down in the regulations but percentage limits are put on most chemicals, for example:
Percentage of active ingredient Chemical Class I Class II Class III
Dimefox Parathion 10-100 2.5-10 0-2.5 TEPP
Aldrin 10-100 — 2.5-10 Dieldrin
Dinoseb 50-100 10-50 2.5-10
Binapacryl - 50-100 10-50
Ethion - 25-100 2.5-25
Diazinon - - 5-100
Malathion - - 5-100
Although this classification does not classify actual formulations it does, as shown by the table, produce an approximate grading of pesticide formulations according to concentra- tion. The RID also contains regulations on the conditions of carriage, and warning labels on packages.
3.4.2 Transport by road
The European Agreement concerning the International Carriage of Dangerous Goods by 1 Road (ADR) was prepared by a Working Part of the Inland Transport Committee of the Economic Commission for Europe (ECE). The parties of the Agreement undertake that the transport by road of dangerous goods through their territories will be permitted provided the goods are packed and labelled in accordance with Annex A to ADR and are carried in vehicles complying with the provisions of Annex B. The provisions of the Annexes are similar, by design, to those which are incorporated in RID.
Pesticides are in Class IVa (toxic substances). The classification into three groups of pesticides according to the amount of active ingredient, plus a dressed grain class is identical to that in RID.
ADR = Agreement European concernant le transport international des marchandises dangereuses par route. EB55/10 page 14 Annex I
3.4.3 Transport by air
1 The International Air Transport Associations (IATA) Regulations relating to the 1 Carriage of Restricted Articles by Air are based mainly on the ICC Regulations. Most pesticides come into the categories of Poisonous Articles Class В or Other Restricted Articles/Class A (ORA/A). Some may also be covered by the classes dealing with flammable or compressed gases.
Poisonous Articles Class A consists of extremely dangerous gases, or liquids with a vapour hazard, e.g. methyl bromide. Class В are less poisonous liquids and solids with an oral or dermal hazard and the criteria used are :
Oral toxicity 50 mg ,kg or less y Dermal toxicity 200 mg Acg or less 7 Inhalational toxicity 2 mg//litr e air�
Other restricted articles, Class A include materials whose toxic properties do not justify classification as Poisonous Articles Class B. The only criteria used (as a guide only) is an acute oral LD50 to the rat of 50-500 mg/kg.
Certain substances (e.g. organophosphates) and most groups of pesticides (weedkillers, insecticides, etc.) are starred (see table). This means that although the substances are classified according to their most dangerous form, if a shipper can prove that the substance is not being shipped in its most dangerous form, it can be reclassified, or shipped with less restrictive conditions. For example, all non-gaseous insecticides are classed as poisons В substances because the most dangerous active ingredients (e.g. parathion) are so classified. If however, a formulation with a low concentration of active ingredient was submitted, the insecticide could be reclassified ORA/A or even unrestricted.
Unfortunately, there is no indication in the Scheme of the criteria on which this reclassification would be done in practice; the decision would probably be an ad hoc one.
Examples are :
Poisonous Articles Class В Other Restricted Articles/Class A
Aldrin dry 65-100% Aldrin dry 0-65%
Aldrin liquid 60-100% Aldrin liquid 0-60%
Dimefox 2,4-D : DDT
Dinoseb : endrin
*Insecticides poisonous liquid Malathion
•Insecticides dry Pentachlorophenol
Mercury compounds Thiram
For explanation of asterisk, see text above.
1 ICC - Interstate Commerce Commission of the United States of America. EB55/10 page 15 Annex I
3.4.4 Transport by sea
The Inter-governmental Maritime Consultative Organization (IMCO) publishes its recom- mendations for the transport of dangerous goods in its International Maritime Dangerous Goods Code. Poisonous (toxic) substances defined as "substances liable to cause death or serious injury to human health if swallowed, inhaled or by skin contact" are included in Class 6.1.
Pesticides of low hazard are included in Class 9 of the Code with other miscellaneous dangerous substances• Most of those in the high hazard category come in the low hazard category if the concentration is low enough. Lists have been prepared indicating which pesticides are in each category and at which dilution the change of categories is allowed. The lists of pesticides in the current code are reproduced in Appendix 5.
These are defined labelling, packing and segregation requirements for these pesticides.
3.4.5 United Nations recommendations
The recent recommendations of the United Nations Economic and Social Council*s (UNESOC) Committee of Experts on the Transport of Dangerous Goods have been published (ST/ECA/81/RGV.I/ Amend.1 : E/CN.2/C0NF.5/10/Rev.2/Amend.l)• These include criteria for defining toxicity in order to allocate pesticides into groups according to their toxic hazards in transport. The criteria for the three routes of exposure are as follows :
Inhalational toxicity LC50 Oral toxicity Dermal toxicity Group LD mg/kg Vapours Dusts and mists LD mg/kg 50 50 ml/m^ mg/l
I Less than 5 Less than 40 Less than 50 Less than 0.5
II 5-50 40-200 50-200 0.5-2 Solids 50-500 III 200-1 000 200-1 000 2-10 Liquids 50-2 000
The practically-based classified list of pesticides by principal formulation, however, differs from the expected classification according to the above criteria in over 30 cases. These exceptions exist because it was recognized that liquid formulations classified in Group II by the criteria offer hazards more appropriate to a Group I classification, should leakages occur resulting in contamination of food during transport.
4. COMMENT ON EXISTING CLASSIFICATIONS
The above examples illustrate the great variety in the approach of administrations and bodies to the purposes for which classifications are used and criteria adopted for the separation of the compounds into classes. Fig. 1 (p. 16) illustrates this: the WHO proposals are also included for comparison.
Many classifications are based on toxicity and not on hazards, in that they fail to distinguish between the different risks of handling the different physical forms and concentrations of pesticides and their formulations. Since all classifications are the 1 result of applying judgements to the range of toxic products none are "right' and none are "wrong". All are expressions of opinion, but the need for some kind of classification is demonstrated by the fact that many countries have developed them independently and given them the force of law. The object of this paper is to combine the best features of several EB55/10 page 16 Annex I
FIG. COMPARISON OF ACUTE ORAL CRITERIA IN CLASSIFICATIONS OUTLINED IN THE TEXT
(Л 5000 一 coalnbll Q hH D СУ t-H kJ
2000 — v salios salios 1250 — 0Ю 1000 — aiI-4BJO
500 一
Э+Jnüv
250 — 200 -
50 一
20 - ь
5 一
ccpcoucco EB55/10 page 17 Annex I classifications already in use, with the hope of developing a single classification that: (a) can serve all of the separate functions that individual classifications now serve; (b) can offer maximal protection to all classes of^persons subject to risk from the use or transport of chemicals, or from the inadvertent contamination of food or clothing by these materials during shipment; (c) can promote (by its uniformity) desirable exchange of chemicals from one country to another; and, if adopted, (d) will offer a minimal disruption of national and international regulations and agreements now in effect.
One big disadvantage in assessing the value of and interpretation of existing classifi- cations is a lack of information on how they are applied in practice. Some are clearly based on the active ingredient data only. If this is rigidly applied it is unsatisfactory since, for example, the risks from ethion 5% granules, both in transport and in use, are obviously different from ethion 40% emulsifiable concentrate; endrin, 20% emulsifiable concentrate, presents different hazards to 1% endrin granules. In nearly all cases of poisonings due to leakage and contamination of food or clothing during transportation liquid formulations have been implicated. Liquids also present a greater hazard than solids when clothing of workers who handle leaking pesticide containers is contaminated, with possible absorption by, and passage of the liquid through the material. It therefore seems logical to recognize in a classification the greater hazards offered by liquids as compared with solids.
5. BASIS OF WHO TENTATIVE CLASSIFICATION BY HAZARD
5.1 WHO expert committee guidelines
In supporting the development of WHO of a tentative classification of pesticides according to the hazard they present, the Expert Committee on the Safe Use of Pesticides recommended certain guidelines. These are:
(1) the classification should distinguish between the more and the less hazardous forms of each pesticide and should permit formulations to be classified according to the concentration of the active ingredient and the physical state of the formulation；
(2) the classification should be in a form that it could be applied not only to pesticides but also to other chemicals；
(3) the classification should be based on the oral and dermal LD50 for the rat as a starting point. Although this is not entirely reliable as a measure of toxicity, particularly where a wide species variation has been demonstrated in toxicity tests, its determination is a standard procedure in toxicology. Adequate allowance should be made for dermal hazard where this exceeds oral hazards.
(4) in assessing the level of hazard, three or more stages should be used based on a logarithmic progression;
(5) provision should be made for the classification of a compound to be modified if: (a) it has an unusual or severe toxicological effect； (b) its effects are irreversible； (с) its inhalation hazard exceeds that of the oral or dermal hazard; or (d) it is known to be substantially more dangerous to people than animal tests would indicate；
(6) the classification should be based on a study of existing classifications and should differ as little as possible from those in current use.
All these guidelines have been followed in the tentative classification proposed in this paper. EB55/10 page 18
Annex I
5.2 Obtaining the data for the classification
Whenever possible, toxicological data should be obtained for the compound or formulation to be classified. However, if such data are not available, then the classification of formulations may be based on calculations from the LD_ (s) of the ingredient(s). 50
This is calculated according to the formula :
LD50 active ingredient x 100 Percentage of active ingredient in formulation
Calculations may be made separately for oral and dermal LD^q(s) although their ratio for a given active ingredient will remain the same.
5.3 Differentiation between solids and liquids
The differentiation between solids and liquids referred to in this classification refers to the physical state of the active ingredient or the formulation being classified. In the accepted techniques of oral toxicity testing a solid product is administered in solution or in a slurry. In dermal testing, it is dissolved in a suitable solvent. Although such necessary techniques may tend to produce lower values, particularly in the case of dermal testing, classification according to the physical state of the product gives an added safeguard.
Any assessment of hazard must deal as fairly as possible with all products and care must be taken to avoid penalizing formulations designed to minimize hazards. Thus for example, granular products offer a lesser risk to humans than liquid formulations containing the same percentage active ingredient.
On the other hand, a classification scheme should be able to identify most products which have given or are likely to offer an unusual hazard or a recognized hazard to an unusual degree. Exceptions to the general rule of classification will always occur and must be identified. Unusual dermal hazards or inhalation problems with light fluffy powders will need special assessments before classification. Thus the classification should be on the basis of the actual product handled.
5.4 Application to chemicals other than pesticides
The availability of a pesticide implies that it has been registered in at least on© country and this in turn assures that a considerable amount of basic toxicological data exists and any registration authority should require these as a minimum. Therefore, there are probably adequate data to tentatively classify all pesticide formulations currently in use.
Since pesticides have been selected from the wide range of chemicals known for their high biological activity there appears little justification in treating pesticides separately from other toxic chemicals, from the point of view of classification by hazard.
5.5 Significance of dermal toxicity data
In examining the criteria already in use which relate oral toxicity to dermal toxicity, no distinct pattern emerges In practice, the majority of decisions have been made on acute # oral data. However, dermal toxicity must be considered since it has been found that under practical conditions of handling pesticides in any way, a high proportion of total absorption is by the dermal route. A reclassification based on dermal data to a class indicating a greater risk is necessary when the dermal LD values indicate greater hazard than oral LD 0\J ou values• EB55/10 page 19 Annex I
5.6 Significance of volatility and inhalation toxicity
With a few exceptions, pesticides have low volatility and few studies have been carried out in inhalation toxicity. Therefore, no criteria are at present set out for volatility in the tentative classification. The inclusion of such criteria is unlikely to affect the classification of pesticides by hazard except in the case of volatile fumigants used in agriculture and food storage. Only a few other pesticides have any appreciable volatility, e.g. dimefox, nicotine, dichlorvos, and mevinphos. Allowances should be made for these in the individual classifications. If the classification is applied to other chemicals, particularly solvents, then of course appropriate account must be taken of volatility and consequent inhalation toxicity.
6. WHO TENTATIVE CLASSIFICATION BY HAZARD
The proposal distinguishes between the more and less hazardous forms of each pesticide in that the classification is based on the toxicity data obtained on the product or formulation to be classified. In particular, allowance is made for the lesser hazards from solids a compared with liquids. The classification is based primarily on the acute oral and dermal LD50 to the rat since its determination is a standard procedure in toxicology. Where the dermal LD50 of the product being classified is such that it places the product in a more restrictive class than the oral LD50 would indicate, the product should always be classified in the more restrictive class Provision is made for the classification to be modified if, # for any reason, the actual hazard to man differs from that indicated by LD50 assessments alone•
The proposal is summarized in this table:
LD rat mg/mg 50
Class Oral Derma1 a a Solids色 Liquids— Solids邑 Liquids—
la Extremely hazardous 5 or less 20 or less 10 or less 40 or less
lb Highly hazardous 5-50 20-200 10-100 40-400
II Moderately hazardous 50-500 200-2 000 100-1 000 400-4 000
III Slightly hazardous Over 500 Over 2 000 Over 1 000 Over 4 000
—The terms "solid and liquid" refer to the physical state of the product being classified.
The classification is based initially on the acute oral toxicity of the formulation itself on the rat. Whenever possible, toxico!ogical data should be obtained from the formulation to be classified. However, if such data are not available, then the classifi- cation may be based on proportionate calculations from the LD5q(s) of the technical ingredient(s). If the formulation contains more than one ingredient (including solvents, wetting agents, etc. of significant toxicity enhancing properties) then the classification should correspond to the toxicity of the mixed ingredients.
Where it is shown that for a particular compound the rat is not the most suitable test animal, for example, if another species is conspicuously more sensitive or more closely resembles man in its reactions, then the classification of that compound should take this into account. If the active ingredient produces irreversible damage to vital organs, readily penetrates the skin, is highly volatile, is markedly cumulative in its effect or is EB55/10 page 20 Annex I found, after direct observations to be particularly hazardous or significantly allergenic to man, then adjustments to the classification can be made by classifying the compound in a class indicating a higher hazard. Alternatively, if it can be shown that the preparation is less toxic or hazardous than expected from consideration of the LD5Q(S) of the ingredient(s) or any influence on toxicity, adjustments to the classification can be made by classifying the compound in a class indicating a lower hazard.
In certain special cases the acute oral or dermal LD50 of the formulation should not be used as the main basis for classification. In such cases, for example aerosol preparations, fumigants and special formulations or where human experience indicates that susceptibility may differ in either direction from the data obtained in rats, more appropriate criteria should be used.
7. APPLICATION OF THE WHO TENTATIVE CLASSIFICATION
Any classification by hazard can only be based on information available and in this sense is necessarily provisional and should never be treated as constant. As with all judgement values, honest differences of opinion are inevitable and most borderline products could be readily reclassified in an adjacent class. Variability or inconsistency in toxicity data could also result in debatable classifications. The classification criteria are guide- points intended to supplement but never to substitute for special knowledge, sound clinical judgement or experience with a product. Reappraisal might be necessary from time to time. Examples of classifications of some pesticide active ingredients and their formulations are shown in Appendix 6.
7•1 Recognition of exceptions
Hayes (1969) has listed 79 different pesticides known to have produced poisoning in man. Most of those producing occupational poisoning are of high toxicity such as parathion, endrin, dieldrin, mevinphos, nicotine and mercury compounds. These are readily classified in their correct class by the WHO classification but not by all existing classifications. In most of the cases involving less toxic compounds, poisoning was due to accidental or deliberate ingestion. While no classification can be expected to be perfect, the WHO tentative classification appears to produce fewer anomalies than most other systems now in use. If the WHO proposal is accepted there is still a possibility of variation in the application of a single system. It is expected that exceptions in the cases of pesticides will be few but when these occur, the authority responsible for the classification can be asked to notify them. WHO can publish such exceptions, with reasons, in a suitable form, as is the practice at present with respect to national restrictions on drug availability. To gain acceptance a classification must be capable of general application for all the purposes for which existing classifications are used. In some situations the introduction of subclasses may be thought desirable or for other purposes a combination of classes can be treated identically. For example, in the assessment of industrial health risks all pesticides with an acute oral LD50 of less than 200 mg/kg may be regarded as toxic and those with an acute oral LD50 of 200-2000 mg/kg as harmful. A comparison of the WHO tentative classification with the Gosselin and CE classification is shown in Fig. 2 (p. 22).
7.2 Labelling
The subject of labelling is one that requires further international study to introduce harmonization. The following are general principles :
(a) only a few symbols should be used and the meaning of these should be well publicized;
(b) a symbol expressing a high degree of hazard (usually a type of skull and crossbones) should be restricted to Classes I and II. A similar restriction should be applied to the use of the word "Poison" or its equivalent； EB55; page Annex I
(c) text should be in local language, and for all classes, should include the approved name of the active ingredient(s), method of use, and precautions to be taken. For Classes I and II, symptoms and immediate treatment of poisoning should also be included.
The detailed precautions necessary for the use of a pesticide depend on the nature of the formulation and the use pattern and are best decided by the registration authority when accepting a commercial label.
7.3 Low concentration ready-to-use formulations with toxic ingredients
Some classifications have a "non—transferable" category in which any formulation of a Class I product cannot be classified below Class II, regardless of the LD5Q of very low concentrations. This concept has not been used in this classification but note must be taken that prolonged or careless exposure to such very low concentrations has caused cases of poisoning. For example, 1% parathion dust which is classified in Class III, must still be handled with appropriate protection and the fact that it may be Supplied in a "ready-to- use" formulation does not alter its hazard, although it may appear to the handlers that fewer precautions are required than in the handling of concentrates which are diluted for use.
7.4 Outline of main differences from existing classifications
The diagram in paragraph 4 above, shows the WHO class limits in relation to those of several examples of existing classifications and the diagram on page 22 summarizes the principal changes that are involved using the CE classification as an example. Details of the formulations affected by these changes are listed in Appendix 7.
It will be noted that the new proposals are close to the United Nations classification criteria in differentiating between the hazards of solids ancj liquids in Class III and in the boundaries between Classes III and IV. The anomalies in the United Nations recommendations (3.4.5) would be removed entirely by the adoption of the WHO proposal. EB55/10 page 22 Annex I
FIG. 2. COMPARISON OF THE WHO TENTATIVE CLASSIFICATION WITH GOSSELIN AND COUNCIL OF EUROPE CLASSIFICATIONS
WHO tentative Gosselin Council of Europe classification classification classification (oral criteria)
over 5000 IV
The restriction on products containing an active ingredient with LD_ below 25 mg/kg is not included in this table. 50
Z EB55/10 page 23
Annex I
REFERENCES
1. World Health Organization (1973) Safe use of pesticides. Twentieth Report of the WHO
Expert Committee on Insecticides, Wld Hlth Org, techn. Rep, Ser., No. 513
2. Hodge H. C, & Sterner, J. J. (1949) Amer, industr, Hyg, Ass, Quart,, December, pp. 93-96
3. Gosselin, R. E. (1957) J. Amer, med. Ass., 163, 1333-1337
4. Spina, A. IVU, Gandolfo, N., Ramelli, G. C. , Sampaolo, A. Camoni, I. (1969) Estratto da Rassegna Chimica N4 - Luglio-Agosto, pp. 191-214
5. Modern trends in the prevention of pesticide intoxication (1971) Report on a Conference in Kiev, WHO Regional Office for Europe, Copenhagen
6. Dangerous chemical substances and proposals concerning their labelling (1971) Council of Europe, Strasbourg
7. Resolution AP9(71)4 on the Classification of Formulated Pesticides (1971) Council of Europe, Strasbourg
8. Hayes, W. J. (1969) Pesticides and human toxicity, Ann, N,Y Acad. Sci•， 160, 40. # 181 refs EB55/10 Add.l page 24 Annex I APPENDIX 1
EXTRACTS FROM GUIDELINES FOR REGISTERING PESTICIDES IN CANADA
Product Classification
Control products registered under the Pest Control Products Act are subject to classifica- tion as to the proposed type of marketing, i.e. domestic, commercial, or restricted There # is an ascending degree of hazard associated with these terms from the safest domestic class to the most hazardous restricted class.
Each product is subject to classification by taking into account its hazard to humans and to the environment.
Domestic class. To fall within this class, a product would have the following characteristics
a acute oral LD^Q is over 500 mg/kg； b acute dermal LD^^ is over 1000 mg/kg;
с no special precautions or equipment required for inhalation hazard ;
d eye irritation may occur but no special precautions are necessary;
e no irreversible effects from repeated exposures；
f there must be no confusion with food or feed； g disposal of product and containers can safely be done by placing in garbage；
h package should contain enough product for about one year；
no significant persistence in the environment one year after application (except for soil sterilants).
Commercial class. To fall within this class, a product would have the following characteristics :
(a) acute oral LD^Q is over 50 mg/kg；
(b) acute dermal LD^Q is over 100 mg/kg； (c) environmental effects possible in limited regions.
Restricted class, To fall within this class, a product would have the following characteristics :
(a) acute oral LD50 is less than 50 mg/kg;
(b) acute dermal LD^ is less than 100 mg/kg； 0 (с) environmental risks are significant and will be judged accordingly. EB55/10 page 25
Annex I Appendix 1
Precautionary symbols
POISON HAZARD
Require this Products with any of the following properties warning symbol
is (i) acute oral LD less than 500 mg/kg; 50 (ii) acute dermal LD is less than 1000 mg/kg; 5Q (iii) where a respirator is required for preparation and application； (iv) where eye protection is required during preparation and application (corrosive and irreversible effects on eyes); (V) where fatal or irreversible chronic detrimental effects (g) may result from repeated exposure； (vi) contains 10% or more petroleum distillate (except for pressurized products). DANGER POISON
(i) acute oral LD 500-1000 mg/kg; 50 (ii) acute dermal LD5Q 1000-2000 mg/kg; (iii) where a respirator is not required but fumes and dust must be avoided； (iv) where eye protection is required during preparation and application (severe but reversible effects on eyes); (V) where non-fatal irreversible chronic detrimental effects may result from repeated exposure.
(i) acute oral LD 1000-2500 mg/kg; 50 (ii) acute dermal LD50 2000-5000 mg/kg; (iii) where a respirator is not required but exposure to fumes and dust in confined spaces must be avoided； (iv) where eye irritation is a possibility but eye protection is not required ; (V) where reversible chronic detrimental effects may result from repeated exposure. CAUTION POISON
(i) acute oral LD^Q over 2500 mg/kg； (ii) acute dermal LD50 over 5000 mg/kg； (iii) where a respirator is not required ; (iv) where effect on eyes is negligible； (V) where repeated exposure results in negligible chronic detrimental effects. NO SYMBOL REQUIRED EB55/10 Add.l page 26 Annex I APPENDIX 2
TOXICOLOGICAL ASSESSMENT OF PESTICIDES
1 In a paper on this subject submitted to the Conference by Academician Medved, of the USSR, the following classification of pesticides was presented.
I. On the basis of the toxicity on ingestion
1. Highly active poisonous substances LD_ < 50 mg/kg 50 '
2. Highly toxic substances 50-200 mg/kg 3. Moderately toxic substances LD^ 200-1000 mg/kg o 4. Slightly toxic substances 〉 1000 mg/kg 50 ' II. On the basis of the toxicity on absorption through the skin
Highly toxic LD 〇 < 300 mg/kg 5
Ratio of dermal LD to oral LD < : 50 50
LD Toxic 50 300-1000 mg/kg
Ratio of dermal LD^^ to oral LD — 1-3 50 50
3. Slightly toxic LD > 1000 mg/kg 50 and
Ratio of dermal LD— to oral LD 〉3 50 50
III. On the basis of the volatility
1. Highly dangerous substances Saturation concentration > toxic concentration
2. Dangerous substances Saturation concentration > threshold concen- tration
3. Slightly dangerous substances Saturation concentration does not produce threshold effects
IV. On the basis of the cumulative toxicity
1. Extremely high cumulative toxicity Coefficient of cumulative toxicity <1
2. High cumulative toxicity Coefficient of cumulative toxicity 1-3
3. Moderate cumulative toxicity Coefficient of cumulative toxicity 3-5
4. Slight cumulative toxicity Coefficient of cumulative toxicity > 5
1 Conference on Modern Trends in the Prevention of Pesticide Intoxication. EB55/10 page 27
Annex I Appendix 2
V. On the basis of stability
1. Very stable Time for decomposition to non-toxic products > 2 years
2. Stable Time for decomposition to non-toxic products 6 months - 1 year
3. Moderately stable Time for decomposition to non-toxic products 1-6 months
Low stability Time for decomposition to non-toxic products 〈1 month
If a substance is classified as belonging to the first group in respect of any of the above indices, it should not be used. There is then, as a rule, no need for any further investigations.
If there are no grounds for objecting to a pesticide on the basis of the study of its physico-chemical and toxic properties, its toxicity to the embryo, cancerogenicity, allergic effects, etc., are studied.
For this reason, the following classification system has also been worked out :
On the basis of the toxicity to the embryo
1. Selective toxicity Toxic to the embryo at doses non-toxic to the mother
2. General toxicity Toxic to both embryo and mother
3. Non-toxic Non-toxic to the embryo, but toxic to the mother
II• On the basis of the cancerogenicity
1. Substances cancerogenic to man Substances known to cause cancer in man and highly cancerogenic in animal experiments
2. Substances highly cancerogenic Substances producing cancer rapidly in a high to animals percentage of animals； cancerogenicity to man not proved, but probable
Slightly cancerogenic substances Substances producing cancer in less than 20% of animals over a long period
4. Substances suspected of being Substances for which animal experiments have cancerogenic given doubtful results EB55/10 Add.l page 28 Annex I APPENDIX 3
UNITED STATES LEGISLATION
EXTRACT FROM
Pub. Law 92-516 October 21, 1972
(d) CLASSIFICATION OF PESTICIDES -
"(1) CLASSIFICATION FOR GENERAL USE, RESTRICTED USE, OR BOTH -
M (A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use, provided that if the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, he shall classify it for both general use and restricted use. If some of the uses of the pesticide are classified for general use and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses: Provided, however, That the Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses.
"(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, he will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.
"(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator, he shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use:
"(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified applicator.
"(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that its use without additional regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form. EB55/10 page 29
Annex I Appendix 3
"(2) CHANGE IN CLASSIFICATION - If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, he shall notify the registrant of such pesticide of such determination at least 30 days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek M relief from such determination under section 6(b). EB55/10 page 30
Annex I APPENDIX 4
COUNCIL OF EUROPE
PROPOSED CLASSIFICATION OF PESTICIDES (FOR SAFETY IN HANDLING FORMULATED PRODUCTS)
Class I (a) All formulated products, regardless of concentration, containing active ingredients with an oral LD for the rat of 25 mg/kg or less. 50 '
(b) All other formulated products with an oral LD^ for the rat of 200 mg/kg ， 50 ' or less.
(c) Any product, which on the basis of LD^Q to the rat alone would be classified in Classes II, III or IV, but, whose normal uses may present a serious hazard to man, particularly if, in addition, no effective antidote is available.
Class II (a) All formulated products other than those in Class I (a) with an oral LD 50 for the rat of between 200 and 2000 mg/kg.
(Ъ) Any product which, on the basis of LD^Q for the rat alone, would be classified in Classes III or IV, but whose normal use may present a hazard to man.
Class III (a) All formulated products other than those in Class I (a) with an oral LD 50 for the rat of between 2000 and 5000 mg/kg.
(b) Any product which on the basis of LD^Q for the rat alone, would be classified in Class IV, but whose normal use may present a slight hazard to man.
Class IV All formulated products with an oral LD^Q of over 5000 mg/kg, other than those products containing an active ingredient with an oral LD for the / ou rat of 200 mg/kg or less. EB55/10 Add.l page 31 Annex I APPENDIX
IMCO CLASSIFICATION OF PESTICIDES
PESTICIDES - CLASS 6 (HIGH HAZARD)
Organophosphorus compounds, such as
Azinphos-ethyl Azinphos-methyl Demeton Dimefox Disulfoton Dioxathion Endothion HETP Mecarbam all concentrations Mevinphos Parathion and mixtureá Parathion-шеthy1 Phorate Phosphamidon Schradan Sulfotep Tetraethyl Pyrophosphate (TEPP)
Demeton-methyl ••DibronT Diazinon ( Ethion concentrations greater than 2.5 Fenthion Phenkapton Thiometon
Bromophos Chlorthion Dimethoate concentrations greater than 5% Fenitrothion Malathion Trichlorfon
Organochlorine compounds, such as
Aldrin and Aldrin mixtures Dieldrin all concentrations Endrin mixtures Heptachlor
Gamma BHC DDT Lindane Toxaphene concentrations greater than 10% Pentachlorophenol Chlorophenates, Chlorophenols, solid or liquid EB55/10 page 32
Annex I Appendix 5
Carbamates, such as
ANTU "Isolan’， concentrations greater than 1% "Dimetilan”
••Urbazid,, concentrations greater than 2.5% Propoxur
Carbaryl concentrations greater than 10%
Substituted Nitrophenols, such as
Dinoseb concentrations greater than 2.5% 4, 6-DINITR0orthoCRES0L(DN0C)
Binapacryl concentrations greater than 10% Dinobuton
Dinocap concentrations greater than 20%
Alkaloids, such as
Brucine Nicotine concentrations greater than 2.5% Strychnine
Organomercury compounds, including:
Mercury Benzoate Mercury Gluconate all concentrations Mercury Nucleate Mercury Oleate and Mercury Salicylate
Organotin compounds, such as
Fentin acetate concentrations greater than 1% Fentin hydroxide
Miscellaneous compounds, such as
Thallium compounds Arsenic compounds, including all concentrations Arsenic acid, dry or liquid, and Arsenical dust
Warfarin Coumachlor concentrations greater than 1% Pindone Sodium fluoroacetate
Endothal Paraquat concentrations greater than 5% Diquat Ioxynil EB55/10 Add.l page 33 Annex I Append i X
IMCO CLASSIFICATION OF PESTICIDES
PESTICIDES t CLASS 9 (LOW HAZARD)
Organophosphorus compounds, such as
Demeton-Methyl Diazinon "Dibrom" Ethion concentrations less than 2.5% Fenthion Phenkapton Thiometon —
Bromophos Chlorthion Dimethioate concentrations less than 5% Fenitrothion Malathion Trichlorfon 一
Organochlorine compounds, such as
Gamma BHC Lindane DDT concentrations less than 10% Toxaphene Pentachlorophenol Chlorophenates, Chlorophenols, solid or liquid_
Carbamates and derivatives of Urea, such as
ANTU "Isolan" concentrations less than 1% Dimetilan
"Urbazid" concentrations less than 2.5°*c Propoxur
Carbaryl concentrations less than 10%
Substituted Nitrophenols, such as
Dinoseb concentrations less than 2.5% 4,6-Dinitro-ortho-Cresol (DNOC)
Binapacryl concentrations less than lO^c Dinobuton
Dinocap concentrations less than 20% EB55/10 Page 385 Annex 1 Appendix 5 Alkaloids, such as nj Brucine Nicotine concentrations less than 2.5% Strychnine
Miscellaneous compounds, such as
Warfarin Coumachlor _ …， concentrations less than 1% Pindone Sodium fluoroacetate
Endothal Paraquat ^ concentrations less than 5% Diquat Ioxynil EB55/10 Page 386 Annex I APPENDIX 6
EXAMPLES OF PESTICIDE ACTIVE INGREDIENTS AND THEIR FORMULATIONS CLASSIFIED BY THE WHO TENTATIVE SCHEME
CLASS la (EXTREMELY HAZARDOUS) aldicarb carbophenothion (80% ec), chlorfenvinphos, chlorpicrin demephion, demeton (50% ec), dichlorvos, dicrotophos, dimefox, disulfoton endrin (24% ec), EPN, ethion
fensulfothion (40%), fonofos
isodrin, isobenzan mecarbam, methyl bromide, mevinphos (20% ec) parathion, parathion-methyl (80% ec), phorate, phosphamidon
schradan (60% ec and 30% ec)
TEPP (20% ec), thionazin (48% ec)
CLASS lb (HIGHLY HAZARDOUS)
aldrin (30% ec), aldicarb 10% granules, aminocarb (75% WP), azinphos-methyl (25% WP, 20% ec)
binapacryl (40% ec)^ "Bomyl" (40% ec)
carbophenothion (40% ec， 25% WP), chlorfenvinphos 32% seed dressing and 24% ec, crotoxyphos demephion 30% ec, demeton-methyl (50%), demeton-s-methyl (50%), dieldrin (20% ec), DNOC, dinoseb acetate (50% ec), dinobuton (50% WP), dioxathion (40% ec), disulfoton 10% granules, "Dursban" (35% ec) endosulfan (35% ec), endothal (20% aq.solution), endothion (50% ec), endrin 50% WP, EPN 25% ec and WP, ethion 80% ec and 40% ec fensulfothion 25% WP and 10% dust and 5% granules, fonofos 10% granules "Imidan", isodrin 50% WP, 25% ec mecarbam 40% ec and 68% WP, medinoterb (acetate), methidothion and 40% ec and 20% ec monocrotophos (60%, 20% ec) methomyl, methyltrithion, mevinphos 5% ec, "Mocap", morphothion nicotine 90% ec
Note : For example endrin (24% ec) means endrin and endrin (24% ec). EB55/10 Add.l page 36 Annex I Appendix 6 oxydemeton-methyl 50% ec parathion 20% ec, parathion-methyl 40% ec, phenkapton, phorate 5% granules, phosalone, phosphamidon 50% WP and 20% ec rotenone thiometon (25% ec), thionazin 10% granules, 5% granules, triamiphos and 25% WP, trichloronate and 20% ec vamidothion (40% ec)
"Zectran" (22% ec)
CLASS II (MODERATELY HAZARDOUS) aldrin 50%, allidochlor 40% ec, aminocarb 50% WP, amidothion 30% ec, azinphos-methyl 5% dust bensulide 40% ec, benquinox, binapacryl (25% WP), bromophos-ethyl (80% ec), "Bomyl" 25% WP, bromoxynil (20% ec) carbaryl, carbophenothion 2% dust, chlordane (50% ec), chlordecone (50% WP), chlorfenvinphos 5% dust, chlormequat (chloride) 40% aq, solution, chlorobenzilate 50% ec, chlorphenamid, chlorphenamidine
2,4-D dazomet (85% dust), 2,4-DB 40% ec, DDT, di-allate (40% ec) diazinon (60% ec), dichlo- fluanid, dieldrin 50% WP, dimethoate, dimexan, dinoseb acetate (40% WP), dinoterb acetate (25% WP), diquat (20% sol.), disulfoton 5% granules, drazoxalon (40% aq. suspension), , ’ Dursban" 50% WP endrin 57o granules and 2% dust, ethion 25% WP, ethoate-methyl (40% ec, 25% WP) fenitrothion (50% ec), fentin compounds (60% WP), fenthion (50% ec and 40% WP), formothion (25% ec), fonofos 5% granules heptachlor
"Imidan" (50% WP, 30% ec, 20% ec), ioxynil (25% ec), isodrin 5% granules, 2% dust lindane (BHC) (50% WP and 20% ec) malathion 50% ec, MCPA 50% ec, mecarbam 25% dust, mecoprop 50% solution, medinoterb (acetate) 25% WP, methidothion 40% WP and 20% WP, methiocarb (75% WP and 50%), methomyl 10% granules, methyltrithion 40% ec, "Mirex", "MobanT, morfamquat (dichl) (20% solution) paraquat (20% solution), parathion 5% dust, pentachlorophenol (10% ec), phenkapton 20% ec, phosalone 35% ec and 30% WP, pirimicarb (50% WP), propoxur (50% WP and 20% ec)
"Ruelene" (25% ec) sulfallate 40% ec
2,4,5-T (80% ec, 50% ec, 40% ec) thiram (80% WP), tríllate 40% ec, toxaphene (60% ec, 40% WP, 20% granules), tricamba, trichlorfon (50% ec), tridemorph 75% ec
"Zectran" 25% WP EB55/10 Add.l page 37 Annex I Appendix 6
CLASS III (SLIGHTLY HAZARDOUS) aldrin 5% dust, allethrin barban (50% WP), binapacryl 4% dust bromophos-ethyl 25% WP chlordecone 10% dust
DDT 50%, diazinon 40% WP dichlofluanid 50% WP dimethoate 20% WP, dithianon 75% WP dodine acetate 80% WP, endosulfan 5% dust ethion 4% dust fenitrothion 40% WP malathion 50% WP nicotine 11% smokes paraquat 5% granules parathion 1% dust propachlor 65% WP trichloronate 5% granules trichlorfon 50% WP
PESTICIDE ACTIVE INGREDIENTS WITH ACUTE ORAL LD TO THE RAT 50 GREATER THAN 2000 mg/kg
Not Classified by WHO Tentative Classification
aluminium ammonium sulphate aluminium sulphate ammonium sulphanate anilazine anthraquinone asulam atrazine aziprotryne azobenzene benazolin benfluralin benefin benomyl benzoylprop-ethyl bioresmethrin bromacil bromophos buturon camphor captafol captan carbetamide carboxin chloramben chloranil chlorbenside chlorbromuron chlorbufam chlorfenson chlorpropham chlorthai-methyl chlorothalonil chlortoluron cufraneb chloropropylate chloroxuron dalapon daminozide dichlobenil dichlorophen dimethirimol dimethrin diphenyl diuron dodemorph dodicin p-dichlorobenzene ethephon ethirimol ЕВ55/ page Annex Appendix 6 fenuron ferbam ferrous sulphate fluometuron fluorodifen flurecol folpet gibberellic acid griseofulvin glyphosate hexachlorobenzene iodofenphos isonoruxon lenacil maleic hydrazide mancozeb maneb mebenil methabenzthiazuron metiram methiuron methoprotryne methoxychlor metobromuron ’，Milbex’， monalide naphthalene 2-naphthoxyacetic acid 1-naphthylacetic acid nitrofen neburon oxine-copper oxycarboxin oxytetrасуline pentanochlor "Perthane" phenmedipham picloram prometon prometryne propazine propham propineb pyrazon pyridinitrile quinazamid quassia quintozene resmethrin salicylanilide siduron simazine disodium borate streptomycin sulphur tecnazene terbacil terbuthylazine terbutryne tetrachlorvinphos tetradifon tetramethrin tetrasul thiabendazole thiophanate thiophanate-methyl tricuron trifluralin zineb EB55/10 Add.l page 39 Annex I APPENDIX 7
MAIN DIFFERENCES BETWEEN EXISTING CLASSIFICATIONS AND WHO TENTATIVE SCHEME
The group of liquids В classified by the 50-500 mg/kg criteria but included as HIGHLY HAZARDOUS under the new proposal include products such as: aldrin 30% ec, binapacryl 40% ec, technical crotoxyphos, dieldrin 20% ec, dioxathion 40% ec, chlorpyriphos 35% ec, ethion 40% ec, endosulfan 35% ec, technical nicotine and nicotine 90% ec, oxydemeton-methyl 50% ec, phosphamidon 20% ec, technical thiometon and thiometon 25% ec, technical vamidothion and vamidothion 40% ec.
The group of liquids С classified by the over 500 mg/kg criteria but included as MODERATELY HAZARDOUS by the WHO proposal include products (all ec's) such as: allidochlor 40%, bromoxynil 20%, chlordane 50%, 2,4-DB 40%, di-allate 40%, fenitrothion 50%, formothion 25%, malathion 80%, MCPA 50%, 2,4,5-T 50%, tri-allate 40%, trichlorfon 50%, as well as diquat 20% aqueous solution and morfamquat 20% aqueous solution.
On the other hand the main differences from the CE classification are in the relaxation of the classification for a group of solids D with acute oral LD^Q(S) between 50-200 mg/kg; for example : aldrin 50% wp, aminocarb 50% wp, technical benquinox, technical binapacryl, technical chlordecone, dieldrin 50% wp, dinobuton 50% wp, disulfoton 5% granules, technical drazoxalon, endrin 5% granules, ethion 25% wp, fonofos 5% granules, technical heptachlor, mecarbam 25% dust, medinoterb acetate 25% wp, methiocarb 75% and 50% wp, parathion 5% dust, propoxur 50% wp, which would now be classified as MODERATELY HAZARDOUS as opposed to "toxic" by the "200" criteria.
The other group E affected are solids which under the CE criteria would be classified in the 200-2000 mg/kg class which are now moved to a class indicating a lesser hazard; examples are : aldrin 5% dust, allidochlor, barban 60% wp, technical bensulide, binapacryl 4% dust, technical benzthiazuron, technical bromofenoxin, carbaryl 50% wp, chlordecone 10% dust, DDT 20% wp, dichlofluamid 50% wp, technical dicofol, dimethoate 20% wp, dithionon 75% wp, dodine acetate 80% wp, endosulfan 5% dust, ethion 4% dust, fenitrothion 40% wp, malathion 50% wp, technical MCPA; technical methachlor, nicotine 11% smokes, paraquat 5% granules, parathion 1% dust, propachlor 65% wp, trichlorfon 50% wp.
This group includes most.of the low concentration dusts of toxic active ingredients mostly ready-for-use and referred to earlier. These, as a subgroup, need careful attention and certainly cannot be regarded as offering little hazard to the operator in every case. COUNTRIES EXPRESSING APPROVAL OF THE PROPOSAL WITHOUT QUALIFICATION
Bahamas
Bulgaria
Burma
Egypt
India
Madagascar
Singapore
Zaire EB55/10 Add.l page 41
ANNEX III
COUNTRIES EXPRESSING QUALIFICATIONS OR SUGGESTIONS FOR AMPLIFICATION
I ran
"1. WHO proposal in tentative classification of pesticides is confirmed.
2. An up-to-date LD50 list of all pesticides should be prepared and submitted to all members.
3. Some colour or symbol should be selected for each pesticide and be marked on an especial column of table in page 19.
4. It is proposed that the relation between the rate of toxicity and probability of hazards, and the size of each package of pesticides and their particulars be mentioned on their trade marks.
5. Proper symbols should be selected for pesticides with carcinogen, cumulative and teratogenic virtue and be marked on the LD5Q list,
6. The up-to-date treatment methods in regard to poisoning from each pesticide should be prepared and made available to member country."
Malta
"(a) The system should be acceptable not only to individual countries, but also to other international organizations who are also, in some way or other, interested in the problem. There is already a wide overlap in this field.
(b) If the proposed classification is intended to cover all aspects of pesticide use 一 handling transport application, etc 一 it is suggested that in preparing the provisional classes, apart from active ingredient concentration and physical formulation, other factors, such as chronic (as distinct from acute) toxicity and environmental persistence, should be considered.
1 (c) Considering the wide range of pesticide 'uses and the similarly wide variations in conditions between individual countries, one would consider the proposed WHO Scheme of Classification immensely useful. The details, however, would necessarily have to be modified to suit local requirements in each individual case."
Nigeria
"I am directed to inform you that the WHO Tentative Classification by Hazard (para. 6) is noted and supported. However, on the application of the classification with regard to labelling (para. 7.2), a high degree of hazard (Class I & II) should not only be indicated by a symbol of skull and crossbones but also a background of red colour should be included. For the Class III group of hazards, a symbol of skull alone on an orange colour background would be appropriate.” EB55/10 Add.l page 42
Annex III
Sudan
’’（1) The objectives of the classification (section 2) is to control distribution and recommend certain restrictions on the sale and use of hazardous preparations； and to identify hazards to transport workers and dangers of possible food contamination and identify user hazards, while at the same time the WHO proposed classification is based only on acute hazards while prolonged exposure (section 6) is only very lightly mentioned
This is contraindicating and in our opinion the above objectives cannot be attained with only the acute hazards as basis of the classification since chronic toxicity and particularly when the material accumulates in tbe body comprises high of the risks of dangerous materials. Hence we suggest that the classification to be extended to cover preparations hazardous after repeated exposure and those which have cumulative effects.
(2) In the general principles laid down for labelling (section 7.2) all symbols cover only the poisonous materials. Since the classification covers not only pesticides but also hazardous chemicals (section 5.1(2)) other symbols (most of which are already agreed upon) to indicate inflammable materials, corrosives, explosives, etc., should also be mentioned.
(3) There are a number of cases in which the classification cannot be applied and assessment of the (section 6 & 7) hazard depends on judgement.
The criteria for judgement mentioned are very general. This will lead to classification of the same product into quite different classes, and hence the aims of the classification will be defeated. We feel that study should be made aiming at laying fixed rules or guidelines which can be followed in assessing the class of the hazardous preparation, which do not follow the classification as it stands. Rules for classifying hazards other than poisons should be laid down."
Tunisia (original French)
"This tentative classification calls for certain comments :
1. Page 6, para. 2, and page 17, para, 5.1
The use as starting point of the oral and dermal LD50 toxicity for the rat or other laboratory animal, although it may be a classic test in toxicology, can only be an approximation especially in Tunisia and other developing countries where, apart from the fact that pesticides can be more toxic for man than for animals, e.g. because of idiosyncrasy or personal hypersensitivity, the danger of pesticides may be influenced by other factors, such as nutritional ones, etc.
We feel that, if any classification is to be valid, there must be a possibility of constantly reviewing it in the light of clinical observations in cases of accidental or occupational poisoning with pesticides. These findings should be collected and grouped together in the antipoison centres of the different countries, while a central body attached to WHO could centralize the observations and use them to determine the actual toxicity for man. Such a body could be similar to the one set up for the study of drug monitoring. The use of a standard form for collecting observations could be proposed to the different Member States. This type of procedure would make it possible to transfer a product from one class to another. EB55/10 Add.l page 43
Annex III
2. Although the LD50 of a certain number of pesticides is relatively low, as in the case of Paraquat and related products, clinical experience has shown that the toxic effect of these products on man is irreversible in the very great majority of cases. We therefore feel that such products should be systematically placed in the 'extremely hazardous' class whatever the concentration and mode of presentation of the formulation, for study of the world literature has shown us that cases of human poisoning by Paraquat and its derivatives where there has been a favourable outcome are extremely rare, not to say nonexistent.
3. Page 18, para, 5,5
It is, of course, essential to take account of dermal toxicity but the conditions under which pesticides are handled must also be borne in mind, particularly climatic conditions (heat, perspiration, etc.) when determining toxicity by the dermal route.
In hot countries, whatever the time of day advocated or imposed for the use of certain pesticides, dermal toxicity is considerably increased by unavoidable and profuse perspiration.
4. Page 19, para. 5,6
y 'Significance of volatility and inhalation toxicity
Although it is true, as mentioned in the document, that most pesticides are not very volatile it is none the less certain that the repeated use of some pesticides, in the form of fogging or aerosols in towns or urban areas by municipalities or private individuals for the control of certain insects such as flies or mosquitos, involves a considerable danger of inhalation toxicity for the users and for the general public. It would therefore seem that these special inhalation hazards should be taken into account, all the more so since fairly volatile products such as dichlorvos are much used in this form.
5. If it is to be valid a classification must definitely allow for the nature of the solvent employed in liquid preparations.
Certain observations on human poisoning by pesticides which we have collected show, in fact, that the toxicity of the solvent is at least as great, if not greater, than that of the pesticides themselves. It therefore seems desirable not only to make allowance in the classification for this additional risk but also to make it compulsory to indicate the nature of the solvent used.
6. Labelling
As concerns labelling it is desirable to use only a few symbols, whose meaning should be well publicized. In addition, the size of these symbols in relation to that of the container should be clearly indicated or clearly determined.
Furthermore, the text giving the name of the product, the active ingredient, precautions, etc. should be not only in the local language, but also in the vehicular language of the country.
In Tunisia, for example, pesticides are offered for sale with a text drawn up solely in English or German, although these two languages are little used by the medical profession and even less by the users of pesticides and the general public." EB55/10 Add.l page 44
Annex III
United Kingdom of Great Britain and Northern Ireland
"In the last paragraph of section two I should like to see this expanded just a little more to explain the influences that do impinge on man. In the first paragraph of 3.1 I think the reference should be made Hodge and Sterner.
At the end of section 5.3.1 I think it would be desirable to place more emphasis on the final sentence. It is the key to the whole problem of classification. At the beginning of 5.6 I am not sure that I accept the statement that only a few studies have been done.
Finally, I think sections 6 and 7 should stand out better in the document as the main proposals and be incorporated with Appendix 7. The latter deserves a higher status than as an appendix. If the document is accepted, then perhaps the preamble can be reduced in size and the examples of national legislation systems be put in the end as an essential and interesting appendix. This would help the main WHO proposals ,f to stand out better in the document. EB55/10 Add.l WORLD HEALTH ORGANIZATION 19 January 1975 ORGANISATION MONDIALE DE LA SANTÉ
EXECUTIVE BOARD
Fifty-fifth Session
Agenda item 2,10
SAFE USE OF PESTICIDES: CLASSIFICATION OF PESTICIDES ACCORDING TO HAZARD
Since document EB55/lO was prepared, replies to Circular Letter C.L.18.1974 have been received from seven additional Member States and two international organizations as shown in Annex 1. With one exception, the Members have accepted the proposal in principle, most making qualifications and suggestions and giving descriptions of national legislation. One Member State, the Federal Republic of Germany, has expressed its disagreement with the proposal; the full text of the letter is attached as Annex 2.
Texts of the qualifications and suggestions received since 15 October 1974 are available in their original languages to the members of the Board. In general, these fall into the same categories as the comments received earlier and discussed in paper EB55/lO. The additional replies are from countries who already operate comprehensive systems of pesticide control, and it is natural that their systems of classification are more detailed than that proposed by the Organization. However, it is not possible to incorporate these more elaborate systems into the WHO Proposal since there are many points of difference between them. It is expected that the proposal, with its provision for exceptions, will be of use chiefly to developing countries, many of whom are in the process of formulating rules for pesticide control, and to other countries and international organizations when they decide that a revision of rules is necessary.
Should the Board agree with the proposal it might wish to adopt a resolution along the following lines :
"The Executive Board,
RECALLING its resolution EB52.R11 in which the Director-General was requested to take steps to develop a tentative classification of pesticides which would distinguish between the more and less hazardous forms of each pesticide and to submit this for comment to national and international agencies,
HAVING CONSIDERED the document 'Proposal for a WHO Tentative Classification of 1 Pesticides by Hazard ,
NOTING that this has been circulated by the Director-General to Member States and international agencies and that there has been general agreement thereto,
1. RECOMMENDS the use of the Classification of Pesticides by Hazard to Member States and international agencies；
2. REQUESTS Member States using the Classification to inform the Director-General when an exception is made to the Classification and the reason therefore； and
1 3. REQUESTS the Director-General to circulate such information to other Member States/ ЕВ55/Ю Add.l page 2
ANNEX 1
COMMENTS RECEIVED AFTER 15 OCTOBER 1974
(a) Countries expressing approval of the Proposal, without qualification:
Switzerland
(b) Countries expressing approval with qualification or suggestions for amplification
Czechoslovakia
Denmark
Hungary
Union of Soviet Socialist Republics
United States of America
(c) Countries expressing disapproval of the Proposal:
Federal Republic of Germany
(d) International organizations replying but making no comments :
General Agreement on Tariffs and Trade International Maritime Consultative Organization EB55/10 Add.l page 3
ANNEX 2
ORIGINAL： ENGLISH
TEXT OF LETTER RECEIVED FROM THE FEDERAL REPUBLIC OF GERMANY
"With reference to your Circular Letter of 22 April 1974 (C.L.18.1974) I regret having to inform you that, unfortunately, we can not agree to your proposal concerning the tentative classification of pesticides in the form outlined on page 17 of document VBC/74.3
1• The presently valid regulation of the trade in poisonous pesticides within the Federal Republic of Germany is very similar to the Canadian one (page 14):
0 - 500 mg/kg rat orally : Skull symbol = classes 1 and 2 500 - 2000 mg/kg rat orally: No symbol, instead the word "Caution" = class 3
Substances and preparations bearing the skull symbol are once more subdivided :
0 50 mg Skull, white on black ground = class 1 50 - 500 mg Skull, red on white ground = class 2
This arrangement has proved its value• There is no need to modify it for health policy reasons•
2. The Federal Republic of Germany has agreed to Resolution AP(71)4 of the Council of Europe (see pages э/lO of the document).
3. Together with other member states, the Federal Republic of Germany has proposed that the Resolution of the Council of Europe be integrated into the Directives of the European Communities• This objective is being opposed, for commercial reasons, only by France and Italy. On the other side, this Resolution constitutes a first step towards a supra- regional classification and labelling. If this step would meet with success, a 2Q years long development in the direction of a uniform classification system would be completed• This development started in the fifties concerning the field of occupational safety, first within the WEU and later within the framework of the Council of Europe, until it finally attained, in the Directive on the harmonization of legislation concerning the classification, labelling and packaging of dangerous substances, dated 27 June 1967, a form which will have to be taken over by the legislation of the member states.
Since, in the Federal Republic of Germany, the legal harmonization of above Directive has been almost completed, the principle of this classification scheme may no longer be deviated from without very strong reasons.
Furthermore, it should be noted that the warning phrases are not customary in German language and are, therefore, not defined in any legal regulation•
At present, a directive on the licensing of dangerous substances - pesticides - is being prepared in Brussels• Pursuant to the wish of most member states also this directive shall be orientated towards the Resolution of the Council of Europe, as far as classification and labelling with symbols and warning phrases are concerned• Apart from totally different views of the Italian delegation it appears that, according to most recent information, the British delegation intends to submit the proposal made by WHO, It may be taken for granted that this proposal will be rejected.“