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Extended impact assessment study of the human health and environment criteria for endocrine disrupting substances proposed by HSE , CRD. - PS2812

Description
The Defra Invitation to Tender “HSE 1104 - Extended impact assessment study of the human health and environmental criteria for endocrine disrupting substances” is seeking to understand the number of Authorised Substances that could be affected by the endocrine disrupter (ED) criteria proposed under the new European Union Plant Protection Products (PPP) Regulation. This information is needed in advance of the European Commission definition in order to aid discussions in setting appropriate criteria. Endocrine disrupters are substances of concern because they can cause effects on the health of humans and wildlife species by affecting processes such as reproduction through adverse effects on normal endocrine function. Furthermore, their effects may not be identified by normal procedures for assessing the potential hazards presented by plant protection products.
The successful delivery of this project requires a detailed knowledge of the PPP Regulation but also a comprehensive understanding of the issues associated with the assessment of endocrine disruption in human and environmental (wildlife) species. WRc has assembled a team which has the necessary expertise and experience that has been developed over the last twenty years working with regulators in the United Kingdom and Europe.
The general aim of the study is: “to determine which active substances from the PPP Approved List can be regarded as EDs of very high regulatory concern, which substances require further information, which substances are considered EDs of low concern and which substances are not EDs”.
Since the PPP Approved List contains over 400 active substances WRc considers that the project would be achieved most effectively by adopting a staged approach, namely:
1) Stage 1 – Conduct of a feasibility study to:
• assess the effectiveness of the assessment approach with a limited number of substances, from different regulatory sources. It is proposed that 20 substances, identified in consultation with Defra, are initially evaluated.
• identify any issues that need to be addressed before the evaluation of a wider group of substances is conducted. The knowledge gained from the feasibility study will be used to simplify the approach adopted in Stage 2 whilst maintaining its scientific rigour.
2) Stage 2 – Application of the finalised and simplified methodology to address the complete list of substances in the Approved List or a sub-set selected by Defra in a cost-effective manner.
The project has an eight month duration and will be completed by September 2012 at the latest.
Objective
The general aim of the study is: “to determine which active substances from the Approved List of the Plant Protection Products (PPP) Regulation can be regarded as Endocrine Disruptors of very high regulatory concern, which substances require further information, which substances are considered EDs of low concern and which substances are not EDs”.

The specific objectives are:
1. To develop a methodology to carry out human health and environment assessments of the endocrine disrupting properties of substances and apply this in a feasibility study using an initial group of 20 substances from the Approved List which have been agreed in consultation with Defra (This comprises Stage 1 of the project and encompasses Milestones 1 to 6 as described in Section 2.3a).
2. To apply the finalised and simplified methodology resulting from the feasibility study to the remaining active substances on the Approved List and report the conclusions on endocrine disrupting properties for human health and the environment (This comprises Stage 2 of the project and encompasses Milestones 7 to 9 as described in Section 2.3a). The achievement of this objective will depend on the successful completion of Objective 1 and the identification of a cost-effective approach for dealing with the remaining substances.
Project Documents
• FRP - Final Report : PS2812 final report full   (5763k)
Time-Scale and Cost
From: 2012

To: 2012

Cost: £67,174
Contractor / Funded Organisations
WRc plc
Keywords
Ecotoxicology              
Environmental Protection              
Public Health              
Regulatory policy              
Fields of Study
Pesticide Safety