EU community-level authorization of technical grade active ingredients

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14.2.1.5. Pesticide or biocide registration at various regulatory levels

In the United States, each of the 50 states registers pesticides at the state level. California and New York have their own pesticide evaluation and registration programmes that in some instances result in re-evaluation of data reviewed by the EPA. With regard to pes- ticide use in Europe, the United States and Canada, states or provinces can be more res- trictive than the federal or EU registering authority.

14.2.1.6. Pesticide enforcement, applicator training and licensing activities

In North America, enforcement of pesticide regulations is generally delegated to state and local jurisdictions, even if the function is a federal mandate. The same is true of pes- ticide applicator training and licensing. The EU does not enforce pesticide regulations at the EU level, but instead enforcement takes place at the national level.

14.2.1.7. WHO and the Organisation for Economic Co-operation and Development

The WHO International Programme on Chemical Safety IPCS, established in 1980, implements international activities related to chemical safety. WHO is the Executing Agency of the IPCS, whose main roles are to establish the scientific basis for safe use of chemicals and to strengthen national capabilities and capacities for chemical safety Licari, Nemer Tamburlini, 2005; WHO IPCS, 2005. Many developing countries are poorly equipped to respond to existing and emerging chemical safety issues. Strengthening the capacity of countries to soundly manage the chemicals they use is a theme that underpins most IPCS activities. In the Organisation for Economic Co-operation and Development OECD, the pesti- cide programme is one of 12 subprogrammes in the Environment, Health and Safety Programme. The goals of the programme are to help OECD countries share the work of developing pesticide risk assessments and to find new approaches to reducing the risk of pesticides. IPCS also works in the areas of international harmonization of pesticide risk and hazard assessments, not to mention labelling and classification. The IPCS and OECD have developed a framework for cooperation in the field of risk assessment methods, which ensures mutual support and involvement in the projects conducted by each organization. IPCS is not a regulatory authority, but rather an advi- sory organization that provides expertise in the area of chemical safety. WHOPES was set up in 1960. It promotes and coordinates the testing and evaluation of pesticides for public health use. Its objectives are: to facilitate the search for alternative pesticides and application methods that are safe and cost effective; to develop and promote policies, strategies and guidelines for the selective and judicious application of pesticides for public health use; and to assist and monitor their implementation by Member States.

14.2.2. All-embracing principles and approaches to pesticide regulation

Pesticide regulation involves a number of principles, doctrines and approaches. In parti- cular, it involves the precautionary principle, the substitution doctrine, special conside- ration of children’s health, and exposure assessments based on use patterns. Pesticides: risks and hazards 482 REACH system: it will run the databases necessary to operate the system, coordinate the in-depth evaluation of suspicious chemicals and run a public database that will provide consumers and professionals with information on chemical hazards. REACH aims to improve the protection of human health and the environment by improving the identi- fication and understanding of chemical properties. Also, chemical manufacturers will be responsible for demonstrating the safety of chemicals produced and distributed and, in doing so, for substituting less hazardous chemicals for dangerous ones when suitable alternatives are identified. REACH affects the risk assessment and regulatory status of all chemicals.

14.2.1.4. EU community-level authorization of technical grade active ingredients

Under EU regulations, pesticides are not defined as described by the North American PCPA or FIFRA. Instead, they are divided into two major regulatory categories: plant protection products and biocidal products. Biocidal products, as defined by Directive 988EC, provide protection against public health pests and include insecticides, repel- lents, attractants, rodenticides, wood preservatives, veterinary hygiene and pet protec- tion products, food and feed disinfectants and most antimicrobial products whether for public heath use or not, film preservatives, and molluscicides. Plant protection products, as defined under Directive 91414EEC, include insecticides, fungicides, herbicides and growth regulators. Under Directive 200118EC, on the release into the environment of genetically modified organisms, crops can be insect or herbicide resistant. Pharmaceuticals and cosmetics are regulated under the authority of other directives not related to pesticides. Directive 988EC enables harmonization of legislation among EU Member States. The scope of the Directive is very broad, covering 23 different product types. Risk assessment of biocidal products is required before these can be placed on the European market. The EU has designated the ECB, together with experts from EU Member States, as the par- ties responsible for assessing whether or not the biocide data submitted fulfil the requi- rements of the Directive. These decisions are based on outcomes from technical meetings with all EU Member States. The Technical Guidance Document Human exposure to bio- cidal products – guidance on exposure estimation EC, 2002 is used as a basis for conduc- ting the risk assessment. The risk assessment methods for biocides and plant protection products are in accordance with the corresponding national legislation and as much as possible with the corresponding EU legislation. Essentially, a new biocide active ingredient AI has to meet data requirements similar to those in the United States and Canada, and most test guidelines have been harmonized. Risk assessment and evaluation are similar, but the basis for accepting or rejecting a dos- sier can differ between EU and North American regulatory agencies. EU Member States may require additional data from that required for Annex I listing – that is, Annex I to the Directive is a list of active substances that have been successfully evaluated at the EC level and are considered to meet the requirements of Directive 91414. The EU encou- rages work sharing in reviewing submissions and mutual recognition of approval. Public Health Significance of Urban Pests 485

14.2.2.4. Basing risk and exposure assessments on use patterns