EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate A Green Economy ENV.A.3 - Chemicals CA-Sept14-Doc.11.1 56th meeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products Proposal for an OECD Biocide work share programme A proposal from the US EPA discussed at the meeting of the OECD task force on biocides on 5 July 2014 in Rome is included in Annex. The proposal relates to work sharing between different regulatory agencies in the world. The Commission services would welcome the views of the Member States on this proposal with a view to prepare a reply. Commission européenne/europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11 E-mail: ENV-BIOCIDES@ec.europa.eu
Annex 2
For Official Use English - Or. English For Official Use ENV/JM/BCID(2014)6 Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 04-Jul-2014 English - Or. English ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY Biocides PROPOSAL FOR AN OECD BIOCIDE WORK SHARE PROGRAMME 12th Meeting of the Task Force on Biocides 10-11 July 2014, Rome, Italy Mr. Leon VAN DER WAL Tel: +33 1 45 24 93 10 E-mail: Leon.VANDERWAL@oecd.org JT03360165 Complete document available on OLIS in its original format This document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area.
As part of its Work Programme for 2013-2016 [ENV/JM(2012)25/FINAL], under Work area IV, the Task Force on Biocides (TFB) is carrying out activities for facilitating and implementing work sharing among member countries. As agreed by the TFB at its 11 th meeting, a proposal for work sharing activities should be prepared for, and discussed at, the 12 th TFB meeting, focussing on the development of OECD dossier guidance for biocidal products. The US has prepared the following document and proposes the development of a work sharing facilitation programme for biocides. ACTION REQUIRED The Task Force is invited to: (i) (ii) (iii) (iv) (v) Discuss the current proposal; Agree to begin (exploratory) activities on biocides work sharing; Agree to the conceptual framework and its implementation, amended as appropriate; Agree to the timeline for the first two-year period; Agree on a leading country for the activity; 2
Issue: Biocide new active ingredient approval and product registration is carried out by each country individually and thus is resource-intensive and potentially duplicative. In addition, regulatory reviews of biocide active ingredients are not coordinated across countries. Goals of Work Share: Streamline the biocide product submission and approval process. Facilitate information sharing for regulatory reviews. Benefits: Coordinating processes and sharing knowledge between governments will enhance our scientific assessments and result in more efficient government approval of safe, efficacious biocides and resource savings for governments and industry. Conceptual Framework: Proposed Modules of Development of Work Share Program 1) Determine the extent to which data submissions (dossiers) and reviews (monographs) are currently harmonized for end-use products and active ingredients. 2) Build OECD harmonized guideline templates for dossier submissions. 3) Build OECD data review templates for country data reviews (monographs) to enable and facilitate knowledge sharing between countries, joint reviews, and support of independent risk assessments and regulatory decisions. 4) Set up work sharing agreements between regulatory authorities in different member countries for data requirements and review in OECD format (notwithstanding the need for supplementary data submissions to address particular local/national conditions or legal requirements). 5) Work with industry to facilitate and coordinate submissions to maximize work sharing opportunities. Implementation of the Conceptual Framework: Potential Initial Activities Module 1 and Module 5 Determine existing barriers to joint submissions (submission of the same dossier to multiple regulatory authorities) to confirm benefit of streamlining global submission process and priority needs. Module 2 a. New OECD global harmonized submission transport standard (GHSTS) for pesticides could facilitate joint biocide submissions to multiple regulatory authorities Determine need for new OECD harmonized guideline templates for dossier submission a. Developing an OECD harmonized template for efficacy data may be a potential need. 3
Module 3 b. To determine feasibility, compare efficacy data requirements to determine similarities and differences and potential for creating a harmonized template. c. Surveys conducted by TFB will help in this comparison. Develop data review templates/monographs for identified priority studies for sharing Module 4 a. Compare country reviews of 5 biocide end-use products and/or active ingredients to determine the extent to which countries might share the burden of data review by using each other s data review reports. Facilitate information sharing for more efficient regulatory reviews of biocide active ingredients. a. Discuss how countries could use reviews or assessments developed in another country to inform regulatory review. b. Examine regulatory review schedules for good candidates. Proposed timeline for the first two years of implementation (from mid-2014 to mid-2016) TFB discussion of proposal July 2014 Coordinate with industry stakeholders to identify barriers to join submissions by October 2014 Coordination with GHSTS effort to determine suitability for biocides by October 2014 Determine prospects for regulatory review information sharing by December 2014 Identify OECD harmonized template for dossier submission needs by December 2014 via email and teleconference (if necessary) Identify OECD harmonized data review templates priorities by March 2015 Develop OECD harmonized templates for dossier submission, December 2014 December 2015 (depending on scope of needs) Develop OECD harmonized data review templates, March 2015 June 2016 Details of Lead Country/Consortium Country /Organisation: Agency/ministry/Other: Mail Address: U.S.A Phone/fax: +1 703.308.0293 Email: US Environmental Protection Agency Office of Pesticide Programs (MC 7510P), 1200 Pennsylvania Avenue, NW, Washington, DC 20460 mclain.jennifer@epa.gov 4