1. THE OECD WORK SHARING WORK PROGRAMME FOR BIOCIDES
57th Competent Authorities Meeting for Biocidal Products – September 2014
Sylvie Poret - OECD Secretariat

2. Current work programme (2013-2016)
Work Area I – Efficacy Determination
Work area II – Evaluation of other criteria than efficacy
Physical chemical properties, Persistent, bio-accumulative, toxic and long-range transport (PBT/LRT) properties, Bio-pesticides used as biocides
Work Area III – Exposure Assessment (ESDs)
Work Area IV – Work Sharing
Work Area V – Risk Reduction
Work Area VI – Monitoring Emerging Scientific and Policy Areas
Reference: ENV/JM(2012)25/FINAL

3. Why a work sharing activity in the TFB work programme?
Benefits of work sharing activities:
Quality of decisions and public confidence
enhanced
Scarce resources released for more refined
assessment -> sounder scientific conclusions
Review time for new and existing registrations
reduced –> reduction in backlog
Reduced uncertainty for industry
+ Quantitative benefits

4. Published in 2010

5. Benefits per year for governments from harmonised OECD monographs for pesticides  
Example of the benefits for pesticides:
Cost without OECD harmonised dossier: (12 x EUR ) + 12 x EUR (second dossier costs 65% of the original one) x 2 (regions)
Cost with OECD harmonised dossier: (12 x EUR ) + 12 x EUR (second dossier costs 32% of the original one) x 2 (regions)

6. Benefits per year for industry from harmonised OECD dossiers for pesticides  
We have done the same calculations to assess the benefits for industry

7. Work sharing possible activities [ENV/JM(2012)25/FINAL]
Work towards an easier use of national reviews
Work towards global joint reviews
Work towards harmonisation of data requirements in member countries
Develop a scheme that would allow mutual recognition of national evaluations
Facilitate the registration of biocidal bio-control agents
Develop activities on topics other than biocide risk evaluations
E. Facilitate the registration of biocidal bio-control agents, through the development of Guidance Documents
F. Develop activities on topics other than biocide risk evaluations, e.g.:
a. Fight against illegal trade.
b. Other compliance and enforcement issues.
c. Harmonise ways in which residue testing in food is carried-out.
d. Facilitate the development of safer application technologies.
e. Facilitate registration of biocidal bio-control agents, e.g. by defining waivers for registration.

8. The US proposal
Proposes activities in relation to sub-activity A. “Work towards an easier use of national reviews”
Module 1  Section A. d of ENV/JM(2012)25/FINAL
Module 2  Section A. b. ii of ENV/JM(2012)25/FINAL
Module 3  Section A. b. i of ENV/JM(2012)25/FINAL
A. Work towards an easier use of national reviews
b. Develop harmonised format guidance documents for :
i. country data review reports on biocidal products and their active substances (monograph guidance for government use).
ii. industry data submissions on biocidal products and their active substances (dossier guidance for industry use).
d. Review possible activities related to the electronic exchange of data.

9. Thank you!