Comparative Risk Assessment Consultation

Please reply by 21 September 2001 to: Debbie Hussey at the above address. Telephone: 01914 455769 Fax: 01904 455733 E-mail: debbie.hussey@hse.gsi.gov.uk

1. The Advisory Committee on Pesticides (ACP) has been asked by Ministers to consider the value of comparative risk assessment in pesticide regulation in the UK. I should emphasise at the outset that no decision has been made to introduce – or to reject – comparative risk assessment. That decision will be taken by Ministers following the ACP’s report.
2. Comparative assessment is not applied under FEPA (Food and Environment Protection Act 1985) and COPR (Control of Pesticides Regulations 1986, as amended). Neither is comparative risk assessment included in Directive 91/414/EEC concerning the placing of plant protection products on the market: this Directive is implemented in Great Britain by PPPR (Plant Protection Products Regulations 1995, as amended).
3. The attached paper provides some background to comparative assessment and substitution. It describes how comparative assessment will apply to active substances and biocidal products under Directive 98/8/EC. The paper also draws on the experiences of other European countries in implementing this approach for the registration of plant protection products. Some questions and difficulties raised by the practical application of these principles are discussed, and possible alternative approaches outlined.
4. This consultation seeks the views of manufacturers, users, consumer and environmental interests, and others on the value of taking comparative assessment on board as part of the pesticide approval process. We would welcome your ideas on the pros and cons of this approach. Do you have suggestions on how to overcome some of the practical difficulties that are described in the attached paper? Are there alternative approaches that you would prefer? We would be happy to receive any additional information that you may wish to provide. In the meantime, PSD will seek further details from Member States and other regulatory authorities.
5. We hope as many recipients as possible will take the opportunity to comment. In this way, we can ensure that the discussion document submitted to the ACP will be as informed and comprehensive as possible.

Access to Responses to this Consultation Exercise

6. In order to inform public debate on the issue raised by this consultation, PSD intends to make copies of the comments received publicly available after the consultation period ends on 21 September.
7. The main Defra Library at 3 Whitehall Place, London, SW1A 2HH (telephone 0645 335577 – local call rates will be charged) will supply, on request, copies to personal callers or telephone enquirers. It will be assumed, therefore, that your reply can be made publicly available in this way, unless you indicate clearly that you wish all or part of it to be excluded from this arrangement. If you have no objection to your reply being made available for public examination, it would be helpful if you could supply an additional copy.
8. For those wishing to obtain copies of comments, an administrative charge to cover copying and postage will be made. To enable the request to be dealt with efficiently and to avoid undue delay for those calling at the Library in person, it would be appreciated if personal callers could give the Library at least 24 hours notice of their requirement.
9. This letter has been sent to the individuals and organisations given in the attached list: it will also be posted on the PSD Website

T J DAVIS

Consumer Safety and European Policy Branch

Distribution list

All Approval Holders

Members of the Pesticides Forum

Contacts in Government Departments

Association of Independent Crop Consultants

British Crop Protection Council

British Beekeepers Association

British Ecological Society

British Pest Control Association

British Trust for Ornithology

Chartered Institute of Environmental Health

Council for the Protection of Rural England

English Nature

Forest Research

Freshwater Biological Association

Friends of the Earth

Greenpeace (UK) Ltd

Hawk and Owl Trust

Horticultural Development Council

Joint Nature Conservation Committee

Local Authorities Co-ordinating Body on Trading Standards (LACOTS)

Local Government Association

National Association of Agricultural Contractors

National Council of Women of Great Britain

National Farmers Union of Scotland

National Farmers Union of Wales

National Trust

Northern Ireland Agricultural Producers Association

Royal Society for the Promotion of Health

Royal Society for the Prevention of Cruelty to Animals

Scottish Environment Protection Agency

The Bat Conservation Trust

The British Wood Preserving Association

The Countryside Agency

The Farming Union of Wales

The Wildlife Trusts

UK Agricultural Supply Trade Association

Ulster Farmers Union

UK Register of Organic Food Standards

Wildlife and Countryside Link

Woodland Trust

World Wide Fund for Nature

Comparative Risk Assessment (Substitution) in the Regulation of Pesticides: Background paper

1. Introduction

Comparative risk assessment (or substitution) for pesticides aims to optimise the choice of product for a particular use, taking into account potential risks to health, wildlife and the environment. The objective is essentially to replace ‘higher risk’ products by ‘lower risk’ products where this is possible. It is applied, in one form or another, to the approval of pesticides and biocides in a small number of overseas countries. However, the regulatory framework for pesticides in the UK does not currently require that one pesticide be compared with another when deciding whether its use should be allowed.

The use of comparative risk assessment in the regulation of pesticides has arisen in various European fora in recent years. For example:

1. The principle is included in Directive 98/8/EC concerning the placing of biocidal products on the market.
2. The European Commission will shortly submit its Report to the European Parliament and the Council on the operation of Directive 91/414/EEC concerning the marketing of plant protection products. This Report addresses the need to modify the Directive in certain respects and comparative assessment is listed as one area for consideration. The Report acknowledges that this approach is already encompassed in the biocides legislation and states that ‘the idea that plant protection products may not be authorised if there are safer alternatives (substances and/or methodologies) available is an attractive one that merits elaboration’;
3. Comparative risk assessment for pesticides features in the 5^th European Community Environmental Action Programme (EAP) and is currently included in the proposal for the 6^th EAP;

2. Comparative Assessment (Substitution)

In a broad sense, substitution can be described as taking steps to avoid products for which less hazardous alternatives are available. Substitution must be based on comparative assessment, making it possible to demonstrate whether there is another active substance, product or method available for the same use area which:

1. presents significantly less risk to human or animal health or the environment;
2. is sufficiently effective, also taking into account the risk of development of resistance;
3. can be used without unreasonable economic or practical disadvantages for the user.

However, such an approach is far from straightforward to deliver in practice. There are obvious questions as to how potential adverse effects should be weighed against each other. How should the comparative risk of active substances, products or methods be assessed? It is understood that having a range of pesticide chemicals available for treating a particular pest or disease contributes to resistance management – how should this aspect be taken into consideration? How should unreasonable disadvantages for the user be quantified? In addition, the optimal choice of a pesticide may vary according to the local situation, and according to what other products happen to be on the market at the time.

3. Regulation Process – Biocidal Products Directive

Comparative risk assessment is included in Directive 98/8/EC, covering the registration of biocidal products. This Directive is similar to Directive 91/414/EEC in many respects, and it will eventually include a list of active substances in its Annex I that have been agreed at Community level for inclusion in biocidal products. Article 10(5) of Directive 98/8/EC allows for an active substance to be refused entry in, or removed from, Annex I if there is another active substance for the same product type which presents significantly less risk to health or the environment. This Article also requires that that such an assessment should encompass the following:

1. it should allow for adequate chemical diversity to minimise the occurrence of resistance
2. it should only be applied to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different level of risk;
3. it should be applied only to active substances used in products of the same product type (e.g. food and feed area disinfectants, wood preservatives, embalming and taxidermist fluids);
4. it should be applied only after allowing the possibility, where necessary, of acquiring experience from use in practice, if it is not already available.

In addition, a decision to remove an Annex I entry can be delayed for a period, up to a maximum of four years.

Article 10(5) of 98/8/EC is reproduced in full at Annex 1

4. Active Substance Versus Product

The current practice in those Member States that undertake comparative assessment is to compare products rather than active substances. At first sight this may appear difficult to introduce into the EC regulatory systems since Community level decisions focus on active substances rather than products. However, it is the risks created by the active substances when products containing them are used in equivalent circumstances that are likely to be compared. Thus, as indicated above, for biocides the approach is being applied to active substances (but with the special provision that substitution can only occur within the same ‘product type’ and where there is a significantly different level of risk).

5. Regulation Process – Experiences in Sweden

Some further information on how substitution can operate, based on a paper provided by the Swedish authorities for EC discussion, is provided in Annex 2. This provides some practical examples and illustrates the potential uses and some of the limitations of substitution.

6. Alternative Approaches

Comparative risk assessment and substitution may of course be elements of wider-ranging strategies to reduce potential risks arising from the use of pesticides, e.g. regulatory reviews supported by increasing precautionary risk assessment, stewardship campaigns to manage use, or integrated crop management. In the UK, the proposals in the package produced by the Crop Protection Association (CPA)), the National Farmers Union and others aim at minimising the environmental impact of pesticide products will be important in this respect.

In addition, there are other options that may be worth developing as part of the regulatory process, e.g. reduced fees and/or fast track registration for low risk products and biologicals.

Alternatively, the responsibility for substitution could remain with pesticide users. Farmers and advisers already exercise a degree of comparative assessment on a case-by-case basis (e.g. through COSHH (Control of Substances Hazardous to Health Regulations 2002 (The Green Code)) assessment. The provision of more information could provide a basis for a system under which farmers played the major role in bringing about substitution.

One possible system would be for the regulatory process to classify products into, say, 3 risk categories according to a traffic-light type system. These could be designated: first line (green products), second line (amber products) and third line (red products). The relevant category would be conveyed to users through the label. Farmers would be encouraged to use first line, or failing that, second line products. Third line products should only be used where no suitable lower risk product was available.

Such a scheme might be strengthened by requiring farmers to make and keep a written justification (rather like a COSHH assessment) whenever a third line product was used. Under this system higher risk products would not be substituted entirely (which has potential drawbacks) but their use would be strongly discouraged.

A third less regulatory variation of this approach would be to rely on the environmental information sheets on pesticide products which member companies of the CPA have agreed to produce.

Finally, a form of substitution could be said to be practised already by some food companies and retailers. They operate a system of ‘pesticide preference’ based on ‘profiles’ and encourage or require their growers/suppliers to use only a restricted range of products meeting their specifications.

There is thus a case for arguing that alternatives on these lines offer a better option that could deliver equivalent or even better outcomes than the use of the regulatory system.

7. Biocidal Products

This consultation is directed mainly at plant protection products since the expected re-negotiation of Directive 91/414/EEC provides an opportunity to seek to introduce provisions on comparative risk assessment and substitution if Ministers wish to do so. The Biocidal Products Directive, which already contains such provisions, is unlikely to be amended for many years. However, it would be open to Ministers to consider using some form of comparative risk assessment/substitution system for biocidal products that are currently approved under national rather than EC arrangements. Comments on any of the questions and issues raised in this paper in relation to biocidal products would, therefore, also be welcome. These should be sent to the contact point (Debbie Hussey) and will be forwarded to the Health and Safety Executive.

8. Questions

Comments are welcome on any of the issues raised in this document. However, it would be particularly useful to have your views on the following key issues:

1. The value, in principle, of including comparative risk assessment and substitution into the current UK and incoming EC pesticide authorisation regimes and the potential advantages and disadvantages of such an approach.
2. How the risk posed by particular active substances/products should be compared. How to define a ‘significant difference in the level of risk’. Additionally how dissimilar risks (e.g. environmental versus human health) can be weighed, or whether the system should only substitute actives/products with those that are ‘lower risk’ in all areas where they differ.
3. How the benefits of an active/product in terms of efficacy and economic or practical advantage might be taken into account.
4. How a substitution system might cater for the need to retain a range of actives/products for resistance management purposes.
5. The impact on the UK or EC pesticide markets if substitution were introduced. How a substitution system might address the situation where an approved product in which a company had made a large investment could potentially be replaced by a newer ‘better’ product.
6. Whether the approach adopted in the Biocidal Products Directive (98/8/EC) is the best one.
7. Whether it is realistic to make it a feature of the regime that chemicals might be substituted by non-chemical methods and how the comparison might be made.
8. Whether there are alternative ways (such as those in section 6 above) of meeting the overriding objective of risk reduction than the introduction of substitution into the regulatory process. (If you favour a particular system like ‘traffic-light labelling’ it would be helpful if you could give details of how it might work.)
9. The approvals system examines a wide range of different risk factors (e.g. mobility in soil, persistence in soil, acute and chronic mammalian toxicity, toxicity to fish and other aquatic organisms). It would probably not be realistic to compare all the possible risks. So which are the key risks on which a comparative risk assessment system might operate?
10. Whatever form of system might be agreed at either national or EU level it would have to be phased in. Do you have any views on how this might be done?

Annex 1

Directive 98/8/EC, Article 10(5)

5.

1. An entry of an active substance in Annex I and, where relevant, IA or 1B may be refused or removed,

   - if the evaluation of the active substance in accordance with Article 11(2) shows that, under normal conditions under which it may be used in authorised biocidal products, risks to health or the environment still give rise to concern, and

   - if there is another active substance on Annex I for the same product type which, in the light of scientific or technical knowledge, presents significantly less risk to health or to the environment.

   When such a refusal or removal is considered, an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk for health or for the environment.

   The assessment shall be circulated in accordance with the procedures in Article 11(2) for decision in accordance with the procedures laid down in Articles 27 and 28(3).

2. The refusal or removal of an Annex I and, where relevant, 1A or 1B entry shall be carried out under the following conditions:

   1. the chemical diversity of the active substances should be adequate to minimise occurrence of resistance in the target organism;
   2. it should be applied only to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different level of risk;
   3. it should be applied only to active substances used in products of the same product type;
   4. it should be applied only after allowing the possibility, where necessary, of acquiring experience from use in practice, if it is not already available;
   5. the complete data dossiers of the evaluation serving or having served for entry in Annex I, 1A or 1B shall be put at the disposal of the Committee referred to in Article 28(3).

3. A decision to remove an Annex I entry shall not have immediate effect but shall be delayed for a period of up to a maximum of four years from the date of that decision.

Annex 2

Regulation Process – Experiences in Sweden

This section outlines the process of comparative risk assessment and substitution in Sweden and the opinion of the regulatory authority there on the merits of the approach taken.

With regard to the registration process

The preferred approach is to examine substances or products with similar use patterns at the same time, as part of a regular pesticide review programme. If the area of use and mode of application are identical for the substances being compared, the exposure conditions can normally be assumed to be the same. Under these circumstances regulators can essentially base the comparative assessments on the intrinsic properties of the substances. This approach gives regulators an effective tool in risk reduction, since it is generally easier to compare and rank than to quantify potential risks.

A review in which examination of all substances/products with similar use patterns occurs at the same time is probably the simplest circumstance in which to apply comparative risk assessment. However, substitution is also used in other regulatory situations and can involve the replacement of a chemical by a non-chemical method of pest control.

With Regard to Users

Users expect that pesticides which are less efficient or more hazardous than available alternatives will not be authorised. The Swedish authorities believe that a changeover from higher risk substances to lower risk ones, has generally not, in the long run, led to higher costs for the user. However, they acknowledge that initially this might be the case if cheap higher-risk substances are withdrawn from the market.

With Regard to Industry

A sensible application of comparative assessment with respect to risks promotes the uses of existing, and also the development of new, less hazardous alternatives. In a dynamic perspective this is favourable both to industry and trade, giving incentives for product development and creating markets for new products, chemical as well as non-chemical. There are many examples in practice of how manufacturers/applicants with more favourable alternatives from a risk perspective have been encouraged to establish themselves on the market or increase their market shares as a result of regulatory action based on comparative assessments.

Significantly Less Risk

A prerequisite for substitution is that there is a significant difference between the potential risks to human and animal health or the environment between the substances/methods compared. If the difference is not significant or is unclear, substitution will not be carried out. The latter may be the case in situations when an assessment shows significant differences between two substances but with different parameters, for which no satisfactory methods exist to make a reliable comparison possible. In other words, a product which poses a higher risk to aquatic organisms could be substituted by another with lower risk in this area, but the same in all other respects. But a product with a higher risk to aquatic organisms, would not normally be substituted by another with a lower risk in that area but a higher risk in a different area e.g. to birds.

Significantly less risk may exist either for the entire use area or only for a part of the use area (certain crops or use situations), leading to different regulatory actions.

Special attention should be given to substances with significantly higher hazard/risk with regard to two or more parameters, so-called multi-problem substances, compared to mono-problem substances.

Sufficiently Effective

To secure sufficient control of a target organism, e.g. to minimise the risk of developing resistance, it is desirable to have a number of active substances on the market with different modes of action. Some substances may for this reason be indispensable and not interchangeable. When such situations occur and just a few substances are available on the market, the possibility to remove or restrict the use of these substances may be limited. In these situations, the applicants will normally have to justify why their substance(s) are indispensable.

Unreasonable Economic or Practical Disadvantages

When considering unreasonable economic and/or practical problems for users to use products with other active substances or to use non-chemical methods, the magnitude of what is unreasonable should be compared with the possible gain for the environment and/or for human health. This means that big advantages with regard to risks are allowed to cost more.

However, there is no easy answer to whether substitution can lead to economic disadvantages or not for farmers, since this depends on several circumstances at the time of decision. One important circumstance is whether a monopolistic position (only one manufacturer involved) can arise, leading to increased product prices.

Some general examples of comparative risk assessment, which were based on real situations, provided by the Swedish regulatory authority are given below.

Example 1

There is an application for approval of a selective herbicide intended for pre- and post-emergence weed control in spring and winter cereals. The product contains an active substance A, belonging to a group of chemically related substances included in herbicide products approved for use in cereals. The four substances in question have similar properties with regard to weed control, thus being replaceable with each other. However, assessment of the environmental properties of the substances also taking into account the main metabolites revealed that substance A differs significantly from the others, since it is considered to be far more mobile and degraded more slowly in soil. Substance A is also, unlike the other substances, associated with risk for ground water contamination.

Decision Approval of the product containing substance A is rejected.

Example 2

There are a few products with different active substances approved for total weed control in non-crop areas and in willow plantations. Two of the products contain an active substance B, for which several concerns have been raised during the first review of old substances. Substance B and the main metabolite show very slow degradation in soil. The metabolite is also very mobile and frequently detected in ground water monitoring. Furthermore, substance B is very volatile and has been identified to cause very specific toxic effects in the olfactory nasal mucosa in experimental animals, giving rise to concerns for operator safety. There is another substance available on the market for the same use, also sufficiently effective, but considered to present significantly less risk in all aspects compared with substance B.

Decision: Re-approval of the two products containing substance B is rejected.

Example 3

A product is approved for use as a soil disinfectant. Main use is for the control of potato cyst nematodes. The active substance included shows high mobility and long-term studies also indicate carcinogenic properties. The use is associated with risk of ground water pollution, which has been confirmed in monitoring studies. Progress in regional advisory programmes has at the same time made it possible to reduce the dependence upon soil disinfectants by promoting other plant protection practices such as crop rotation, use of resistant crop varieties and by avoiding cultivation of susceptible crops in infected areas. Adopting these strategies can on a short term involve economic or practical disadvantages for the farmers. However, crop rotation does have a beneficial influence on the control of other plant diseases and is on a long-term strategy in line with sustainable agriculture.

Decision: Re-approval of the soil disinfectant is rejected.

Example 4

A herbicide product is approved for use in cereals and some vegetable crops. It contains an active substance C showing high persistence in soil, high bioaccumulating potential and which is volatile and highly toxic to different groups of aquatic organisms. There are several alternative products (including five different actives) available on the market considered to be equally or more efficacious, for use in cereals. However, no equally efficacious alternatives are available for use in onions, carrots and beans.

Decision: The use areas for the substance C are restricted to onions, carrots and beans. If better chemical or non-chemical alternatives become available for the remaining uses, re-approval will not be granted.

Example 5

In a review of existing herbicides it is concluded that four out of a total of six sugar-beet herbicides containing the same active substance are based on an organic solvent D. The remaining two are instead based on an oil-miscible flowable concentrate (OF) containing vegetable oil. Solvent D is known to be a severe irritant to the skin, eyes, nose and throat of exposed workers. The OF formulations show significantly better properties with regard to worker health, but are identical with regard to efficacy compared with the solvent D based formulations.

Decision: Re-approvals of the four solvent D based products are rejected. Re-approvals are only granted for the two OF formulations.

Example 6

A group of chemically related substances (E) used in potatoes are subjected to phase out activities due to risks of chronic health effects associated with repeated exposure to farmers and the probable leakage of a mobile metabolite of health concern to groundwater. These particular fungicides have dominated the use in potatoes for a very long time in the struggle against late blight. They are efficacious, show no risk for the development of resistance and represent relatively low costs in plant protection management. Due to these circumstances, an immediate ban has not been possible to put into effect without far-reaching negative consequences on potato production. Out of eight products containing substance E, five are mono-component formulations and the other three are mixed formulations containing substance E in combination with other non-chemically related substances having other modes of action. A comparative assessment reveals that the risks associated with the mixed formulations are almost solely based on their content of substance E. The use of the mixed formulations involves considerable lower amounts of substance E applied per treatment and also a reduced number of treatments due to longer treatment intervals, which means a reduced number of occasions where workers are exposed to substance E. There are also indications saying that the use of mixed formulations (mixture between contact and systemic fungicides) is the best chemical strategy available for control of the new mating type of Phytophthora infestans. Possibilities for a continued efficient control of late blight is therefore not considered to be affected, if only mixed formulations containing substance E are approved.

Decision: The applications for re-approval of the five mono-component formulations containing substance E are withdrawn. Re-approvals for a limited period are only granted for the three mixed formulations in line with the ongoing phase out plan.

Example 7

There is an application for approval of a fungicide product intended for use in cereals. The product contains an active substance F, which is chemically related to another substance already approved for the same use. Substance F show significantly better environmental properties compared to the existing substance, particularly regarding persistence and bioaccumulation. However, since the new substance is a severe irritant, only a gel formulation in water-soluble plastic bags is considered to be acceptable. The comparative assessment leads to an approval of the gel formulation of substance F, with the intention to substitute the existing chemically related substance at its next periodical review. The gel formulation of substance F has shown to be sufficiently effective in earlier trials, but after being used in practice some technical problems become apparent.

Decision: The application for renewal of the existing chemically related substance is not rejected. The gel formulation of substance F is voluntarily withdrawn by the registration holder.