What is OECD doing to promote harmonization of biocide regulations
M Paneli, N Grandy
OECD began work on biocides in 1997 to help Member countries co-operate in the assessment and registration of these products. The work is a part of OECD's Pesticide Programme, and is co-ordinated by the Biocides Steering Group. The goal is to harmonize regulatory approaches to allow countries to conduct evaluations of biocides more efficiently. More efficient evaluations can advance the protection of human health and the environment and result in more timely decisions for industry.
The first activity done was the Survey of OECD Member Countries' Approaches to the Regulation of Biocides performed in 1997-1998. The survey collected information on countries' regulatory procedures covering the following aspects:
· categorisation, regulation and responsibilities (which ministries are involved)
· data requirements (detailed information for each use category)
· regulatory procedures
· labelling requirements
· human exposure assessments
· environmental exposure assessments
· risk assessment
· other issues (minor uses, low risk products and biological biocides).
It focused on the following seven broad biocide groups: (1) disinfectants/sanitizers; (2) preservatives/ microbiocides; (3) anti-fouling products; (4) wood preservatives and structural treatments; (5) microbiocides for waste disposal and strip mine sites; (6) products used in aquatic non-food sites (molluscides, lampricides, algicides..) and, (7) products used for vertebrate and invertebrate pest control.
The new work programme
Following completion of the survey, a work programme was agreed by the Pesticide Forum in November 1998. It includes activities in the following six areas:
· harmonization of data requirements;
· efficacy - testing and acceptability criteria;
· development of test guidelines for human health and environmental fate and effects;
· hazard/risk assessment - with an emphasis on exposure assessment;
· co-operation between countries in biocide reviews;
· risk reduction - focusing on information exchange.
OECD Specific Activities on Wood Preservatives
Activities specific to wood preservatives include:
1. Identification of data requirements for wood preservatives through descriptions of (a) use patterns (b) tasks involved in application, handling methods, etc, and (c) other exposure scenarios that underlie data requirements
2. Exposure assessment of wood preservatives. The objectives of the work on exposure assessment are to (a) exchange information on current approaches in Member countries, and (b) to develop, to the extent possible, a harmonized approach for future use. Two workshops will be held, one related to human exposure, the other to environmental exposure of wood preservatives. The workshops are scheduled to take place in the first half of 2000.
3. The development of a guidance document on efficacy testing and assessment for biocides including wood preservatives.
4. Test guidelines for leaching/migration from treated materials.