CA-May14-Doc.11.1

57thmeeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making availableon the market and use of biocidal products

Proposal for an OECD Biocide work share programme

The Commission services received from the OECD Secretariat a proposal on work sharing, revised further to the discussions held at the July OECD TFB meeting.

The Commission services would welcome the views of the Member States on this proposal with a view to prepare a reply.

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Annex

US Proposal to accomplish OECD Task Force on Biocides (TFB) 2013-2016 Work Programme [ENV/JM(2012)25/FINAL], Work area IV - activities for facilitating and implementing work sharing among member countries. (Revised following discussion at July 2014 12th TFB meeting)

Issue: Although the process and timelines to approve biocide new active ingredients and register biocide products differ globally, many of the data requirements and steps are quite similar. Aligning where possible and sharing information will save resources and benefit governments and industry.

Goals of Work Share: Streamline biocide submission and study review processes and facilitate information sharing across regulatory authorities. Support independent risk assessments and decisions by regulatory authorities.

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)Work with industry to facilitate and coordinate submissions to multiple regulatory authorities to maximize opportunities for information sharing between governments.

2)Build OECD harmonized guideline templates for dossier submissions, as necessary.

3)Build OECD data review templates for study reviews (monographs) to enable and facilitate knowledge sharing between regulatory authorities.

Implementation of the Conceptual Framework: Potential Initial Activities

Module 1

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.

-New OECD global harmonized submission transport standard (GHSTS) for pesticides could facilitate joint biocide submissions to multiple regulatory authorities with additional work (currently IUCLID cannot build or receive a GHSTS package)

Module 2

Determine need for new OECD harmonized guideline templates fordossier submission (most required studies already have an OECD harmonized guideline template for agricultural pesticides that could be used for biocides).

-Develop harmonised template for efficacy study (if an EU template exists, it could be turned into OECD template)

Module 3

Develop harmonised data review templates/monographs for identified priority studies for sharing.

-Discuss how regulatory authorities could use study reviews or assessments developed by another government to inform their own independent review.

-Could start with acute toxicity studies

Proposed timeline for the first two years of implementation (from mid-2014 to mid-2016)

  • First TFB discussion of proposal July 2014
  • TFB approval of a way forward by written procedure or discussion/approval at the 2015 TFB meeting
  • Coordinate with industry stakeholders to identify barriers to joint submissions by mid-2015
  • Coordination with GHSTS effort to determine suitability for biocides by end of 2015
  • Identify gaps for OECD harmonized guideline templates for dossier submission by mid-2015
  • Identify OECD harmonized data review templates priorities by mid-2015
  • Develop OECD harmonized templates for dossier submission (if necessary), mid-2015 to mid-2016
  • Develop OECD harmonized data review templates for selected studies, mid-2015 to mid-2016

Details of Lead Country/Consortium

Country /Organisation: / U.S.A
Agency/ministry/Other: / US Environmental Protection Agency
Mail Address: / Office of Pesticide Programs (MC 7510P), 1200 Pennsylvania Avenue, NW, Washington, DC 20460
Phone/fax: / +1 703.308.0293
Email: /

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