Cleaning up Europe – a message for developing countries

Industrialised countries are well placed to take early action to ban or severely restrict pesticides of concern. Europe is removing over 320 old pesticides from the market. While some have simply lapsed or been replaced by more efficient products, others have clear health and environmental problems. The Rotterdam Convention on Prior Informed Consent provides an international framework for warning developing countries of these concerns. Robin Schoeps Lewis reviews developments.

Maria Celina de Azevedo Rodrigues, Chair of the PIC Intergovernmental Negotiating Committee and Barbara Dinham, PAN UK, at the Intergovernmental meeting of October 2002. By May 2003, 42 countries had made PIC legally binding. Another eight are needed for the Convention to enter into force. Photo: Carl Smith

In 2003, the European Union (EU) took positive steps to regulate the safety of pesticides. Several hundred pesticide active ingredients will be withdrawn from the European marketplace in accordance with Council Directive 91/41/EEC (Directive)(1). In addition, European Regulation No 304/2003, which implements the Rotterdam Convention on Prior Informed Consent (PIC Convention) requiring certain notifications for banned or severely restricted pesticides, was finalised. Both of these actions represent positive steps towards promoting pesticide safety and working together can be even more effective. The next step for the European Commission is to act upon Regulation 304/2003 and submit notifications for those withdrawn and essential usage pesticides that are hazardous to human health and the environment.

The EU Directive 91/414 and product withdrawal process
The Directive regulates the registration, sale, and approval of plant protection products in the European Union. One of the key objectives is to review all active substances used in pesticides to determine the risk or harm to human health and the environment.
    Responsibility for conducting health and safety testing lies with the producer. Whoever sponsors the active must provide data and information on the following endpoints – identity, physical and chemical properties, impact on human and animal health, fate and behaviour in the environment, ecotoxicology, and residues(2). If no notification is provided, the active will lose its registration and must be withdrawn from the market(3).
    Currently 320 active ingredients are being withdrawn rather than being tested. The rationale for not sponsoring an active ingredient varies. Some of the actives are considered obsolete by the World Health Organization (WHO) – such as benodanil, carbophenothion, and prothiocarb (see table). Others are no longer profitable for the manufacturers or are no longer registered in individual Member States. In addition, some of the actives have known environmental or health effects that would preclude them from being re-registered, and therefore the manufacturers have decided it is not in their interest to conduct further testing but simply to withdraw the registrations.
    Active ingredients that are withdrawn from registration are to be phased out in Europe. These active ingredients may no longer be sold after 24 July 2003(4). Farmers and users have until 31 December 2003 to either use or dispose of stocks. An active ingredient can qualify as an essential use product, and may still be used for a limited purpose if ‘additional technical evidence has been provided demonstrating the essential need for further use of the active substance and the absence of an efficient alternative . . . [use] should be restricted to the control of harmful organisms for which no efficient alternatives exist.’(5) According to the European Union an essential use product may be used until 30 June 2007 provided that:

• it does not have any harmful effect on human or animal health and no unacceptable influence on the environment
• it is relabelled in order to match the restricted conditions
• Member States impose all appropriate risk mitigation measures to reduce any possible risks
• alternatives are being seriously sought(6)

Many of the non-sponsored active ingredients are dangerous to both human health and the environment and will still be exported or sold in other areas of the world. Information regarding the hazards of these active ingredients should be shared with other countries so that they too may make informed decisions about registration. The ideal mechanism to do so is through Regulation No 304/2003 and the PIC Convention.

Overview of PIC and listing criteria for chemicals/pesticides
The PIC Convention creates a system of information exchange regarding human health, safety, and environmental hazards pertaining to certain chemicals that are imported and exported around the world. The goal of the PIC Convention is to alert governments to chemicals which have been banned or severely restricted by other countries. Shared information will allow countries with less well-developed regulatory schemes to benefit from those that have more sophisticated regimes. The PIC Convention requires that a Party (a government) submit a notification, containing specified information, on all chemicals banned or severely restricted within the country. Information is posted in the PIC Circular, which is published every June and December. Two notifications of a ban or severe restriction from two regions will trigger consideration for ‘PIC Listing’ in Annex III of the Convention, as will recognition of a ‘severely hazardous pesticide formulation’. A developing country or country with an ‘economy in transition’ may also propose the listing of a severely hazardous pesticide formulation that is causing health or environmental concerns under the conditions of use in its country.
    If a chemical/pesticide is listed on Annex III, specific import and export obligations attach to the Parties. Parties submit a response to the Secretariat regarding the future import of the chemical. Parties must ensure that exporters comply with the decisions of the responses.

Defining a ban
The PIC Convention defines a banned chemical as a chemical all uses of which, within one or more categories, have been prohibited by final regulatory action in order to protect human health or the environment. It includes a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the domestic market or from further consideration in the domestic approval process and where there is clear evidence that such action has been taken in order to protect human health or the environment(7).    
    Regulation 304/2003 implementing the PIC Convention defines a banned chemical as a chemical that . . . has been withdrawn by industry either from the Community market or from further consideration in a notification, registration, or approval process and where there is evidence that the chemical raises concerns for human health and the environment(8). This definition takes in many of the actives being withdrawn in 2003.
    Even an active still permitted under the essential usage exemption may qualify for incorporation into the PIC Convention if it poses health or environmental problems. Under the Regulation 304/2003, an active ingredient restricted to an essential use falls within the definition of a severely restricted chemical:
A severely restricted chemical is a chemical that has, for virtually all uses, been ... withdrawn by industry either from the Community market or from further consideration in a notification, registration or approval process; and where there is evidence that the chemical raises concern for human health or the environment(9). On this basis, the EU should be encouraged to move forward with the incorporation into the PIC Convention of many of the chemicals being withdrawn in 2003.

Example of pesticides that should be included in PIC
Several of the active ingredients being withdrawn under 91/414 already have health and environmental safety data available. One of the active ingredients being withdrawn is metolachlor, a herbicide. Information regarding health hazards already exists for metolachlor. The California Department of Pesticide Regulation lists it as a ground water contaminant. The WHO assigned a Class III Slightly Hazardous rating for acute toxicity. Metolachlor has an acute rating of ‘slightly toxic’ by the United States Environmental Protection Agency (US EPA) in addition to being listed as a potential carcinogen. Two scientific sources consider metolachlor to be a suspected endocrine disruptor(10). Ecotoxicity data also exists for metolachlor. An example of a few of the numerous published studies show accumulation(11) and mortality(12) for fish, and accumulation(13), intoxication(14), mortality(15), and reproductive(16) effects for zooplankton. In spite of these known and suspected hazards, metolachlor continues to be registered in Burkina Faso, Cape Verde, Chad, the Gambia, Guinea-Bissau, Madagascar, Mali, Mauritania, Niger, Senegal, Tanzania, Australia, India, New Zealand, Canada, and the United States. Many of these countries lack the financial resources to conduct health and safety evaluations and would benefit greatly from shared information.
    Under Regulation 304/2003, metolachlor qualifies as a banned chemical. Metolachlor has been withdrawn from the European marketplace by the refusal of the producer to sponsor the active under Directive 91/414. There is also clear evidence in the studies cited above of the hazards metolachlor presents to human health as a potential carcinogen and as a suspected endocrine disruptor. In addition, metolachlor is hazardous to groundwater and the aquatic environment. As metolachlor meets the definition of ‘banned’ under Regulation 304/2003, the European Commission should provide notification to the PIC Secretariat and require exporters to provide notifications in line with the regulation.
    Another active being delisted (with essential uses) is triazophos, an organophosphate. Available safety data shows that triazophos, classified by the WHO as Class Ib Highly Hazardous, has a high acute toxicity and is a highly toxic cholinesterase inhibitor17. It is still registered in Burkina Faso, Cape Verde, Chad, Gambia, Guinea-Bissau, Mali, Mauritania, Niger, Senegal, South Africa, India, Philippines, and Hungary. Like metolachlor, triazophos meets the definition of a banned chemical under Regulation 304/2003. It has been withdrawn and clearly there are related health and environmental concerns. Therefore, the notification requirements of Regulation 304/2003 should be followed.
    Active ingredients that qualify under the essential uses exemption should also be notified under the European regulations to the PIC Convention Secretariat. Although still being used, many of these chemicals are very dangerous. One example that meets the ‘severely restricted’ definition is omethoate. Omethoate has for virtually all use been withdrawn from further consideration under the Directive. There is evidence of concern for human health and the environment. The WHO classified omethoate as Class Ib Highly Hazardous acute toxin, as did the US EPA. Omethoate is classified by the European Union as a water dangerous substance, List II(18) and by the California Department of Pesticide Registration as a highly toxic cholinesterase inhibitor. Available ecotoxicity data includes noted effects on fish(19), amphibians(20), phytoplankton(21), and zooplankton(22). Even though omethoate will be withdrawn from the European marketplace, the following countries maintain omethoate registrations: South Africa, Tanzania, Australia, New Zealand, Philippines, and India. Export notifications and notifications to the PIC Secretariat should be submitted under the European regulation.
    The EU also has the opportunity to include a notification of several actives that have already been included in or notified under the PIC Convention: 2,4,5-T, chlorfenvinphos, chlorthiophos, dimefox, EPTC, fenoprop, fonofos, hexazinone, imazapyr, mephospholan, monocrotophos, pentachlorophenol, phorate, phosphamidon, prothoate, sodium arsenite, sulfotep, and tribufos. A notification by Europe may provide the second regional notification required to include the chemical in Annex III of the Convention. If the active is already on Annex III, additional notification will serve to illustrate the dangers associated with that chemical.
    By including notifications on the withdrawn actives, Europe will be acting to assist in the dissemination of pertinent health and environmental information. This information is especially important for developing countries that do not have the resources to gather such information themselves and are often those still importing hazardous active ingredients. By taking this step in implementing Regulation 304/2003 in conjunction with the Directive, the European Commission will be taking a positive step toward providing relevant information that promotes human health and safety on a worldwide scale.

References
1. Some actives scheduled for withdrawal may continue to be used under the essential uses exemption.
2. For a full discussion of the data package and testing requirements see Directive 91/414/EEC Annexes II and III.
3. Commission Regulation (EC) No 1112/2002, Official Journal of the European Communities (OJ), 27 June 2002, L.168/16.
4. Pesticides Safety Directorate, All Approval Holders Letter 25/2002, 31 October 2002, http://www.pesticides.gov.uk/applicant/cahip/aahlo225.htm
5. Commission Regulation (EC) No 2076/2002, Official Journal (OJ), 23 November 2002, L 319/3.
6. Official Journal of the European Communities (OJ), 23 November 2002, L 319/4.
7. Rotterdam Convention on Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, UNEP, FAO, January 1999.
8. Regulation (EC) No 304/2003, Official Journal (OJ), 6 March 2003, L 63/5.
9. Ibid.
10. Colborn T, Vom Saal FS and Soto AM, Developmental Effects of Endocrine-Disrupting Chemicals in Wildlife and Humans, Environmental Health Perspectives, 1993, 101:378-384. Keith LH, Environmental Endocrine Disruptors: A Handbook of Property Data, Wiley Interscience, New York, 1997.
11. Journal of Agricultural and Food Chemistry, 1993, 41:4 662-668.
12. Environmental Fate and Effects Division, US EPA, Washington, DC, 2000.
13. Ecotoxicology and Environmental Safety, 1980, 4:2 134-157.
14. US EPA, op. cit. 12.
15. Ibid.
16. Archives of Environmental Contamination and Toxicology, 1994, 27:1 103-106.
17. California Department of Pesticide Registration ChE-inhibiting pesticides list.
18. European Council Directive 76/464/EEC.
19. PAN Pesticides Database, www.pesticideinfo.org, citing, Arch. Inst. Pasteur Tunis 56:3 307-342, (FRE).
20. PAN Pesticides Database, www.pesticideinfo.org, citing J. Human Agricult. Coll. 19:1 47-54, (CHI).
21. PAN Pesticides Database, www.pesticideinfo.org, citing Umweltfors chungsplan Des Bundesministers des Innern (OECDG Data File) 1982.
22. PAN Pesticides Database, www.pesticideinfo.org, citing Rep.No. 121/80, National Institute of Public Health and Environmental Hygiene, 6p (DUT).

Robin Schoeps Lewis is a visiting US lawyer advising PAN UK on international conventions.

[This article first appeared in Pesticides News No. 60, June 2003, pages 8-10]