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Endocrine Disruptors

According to the 2002 World Health Organization definition, “an Endocrine Disruptor (ED) is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.” A wide range of substances, both natural and man-made, may be classified as endocrine disruptors.

In Europe, new hazard-based criteria for ED identification were introduced by EFSA (European Food Safety Authority)/ECHA (European Chemicals Agency) in 2018 under Regulation (EU) No 2018/605 (Plant Protection Products) and Regulation (EU) No 2017/2100 (Biocidal Products). These criteria apply to all substances including those already undergoing evaluation as part of the approval or renewal process. Under REACH (Regulation (EC) 1907/2006), endocrine disruptors can be identified as substances of very high concern alongside chemicals known to cause cancer, mutations and toxicity to reproduction.

In North America, the US Environmental Protection Agency (EPA) uses a risk-based approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on estrogen, androgen, thyroid and steroidogenesis (EATS) pathways under the Endocrine Disruptor Screening Program (EDSP).

Our staff in both Europe and North America have considerable practical and regulatory experience in conducting ED assessments under both EU and US legislation, including the provision of advice on assessment strategies, the design, conduct and interpretation of studies to support ED evaluations and the analysis of evidence.

Experienced Support For:

  • Development of ED Assessment Strategies & Advice on Testing Options
  • Study Design, Placement & Monitoring
  • Literature & Database Searching & Systemic Review
  • Evaluation of Non-Test Data (e.g. (Q)SAR profiling) & Bioassays
  • Evidence Assembly & Assessment
  • Evaluation of EATS Mediated Adversity, Activity & Mode of Action Analysis

Development of ED Assessment Strategies & Advice on Testing Options

  • Preparation of ED assessment strategies to support EU/UK legislation including Plant Protection Products, Biocidal Products and REACH.
  • Provide advice to registrants regarding data requirements and testing options to evaluate potential ED effects in humans, mammals and other non-target organisms in accordance with the Organisation for Economic Co-Operation and Development (OECD) Conceptual Framework and OECD Guidance Document No. 150.
  • Agency/Member State liaison to define regulatory and technical approach.

Study Design, Placement & Monitoring

  • Design, placement, and monitoring of studies to support ED assessments at contract research organizations.
  • Advice on validated versus non-validated testing options.
  • Review and interpretation of study results.
  • Advice on compliance with Good Laboratory Practice (GLP) and OECD Test Guidelines.

Preparation of ED Assessments in Accordance with 2018 EFSA/ECHA Guidance

  • EU active substance approval/renewal, as well as co-formulant assessments to support product authorisations, for both plant protection products and biocidal products.
  • Literature searching, systematic review and assessment of studies and published literature.
  • Searching and evaluation of non-test data (e.g. (Q)SAR profiling) and in vitro bioassays (e.g. US EPA CompTox).
  • Assembly and evaluation of evidence.
  • Evaluation of EATS mediated adversity, activity and Mode of Action analysis.
  • Preparation of ED assessment review reports and expert statements.

Endocrine Disruptors Experts

Anna Rowbotham's Picture

Anna Rowbotham

Principal Consultant

Scotland

Endocrine Disruptors

Steven Andrews

Senior Consultant

Scotland

Cliff Habig's Picture

Cliff Habig

Principal Consultant

Maryland/Maine

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Anna Rowbotham
Principal Consultant

Expertise: Toxicology & Agrochemistry

Anna is a member of the UK management team who provides consultancy support and strategic advice for registration dossiers, toxicology, and human health risk assessments for plant protection products, biocides, and industrial and specialty chemicals.

Anna has over 25 years of experience in toxicology, exposure modelling, and human health risk assessment gained in senior scientific and management positions in consultancy, regulatory (HSE), the agrochemical industry, LGC Ltd., and the MRC Institute for Environment and Health. She has led multi-disciplined teams of specialists to deliver high quality technical and scientific services and advice to clients in the different industrial sectors and has managed programmes of technical support and research for the UK Competent Authority. Anna has authored high quality critical reviews on contemporary chemical risk assessment issues and has provided training in the field of human health risk assessment. Anna is a Member of the British Toxicology Society.

EDUCATION
BSc (Hons), Biochemistry, University of Wales.
PhD, Neurotoxicology, University of Aston.

Steven Andrews
Senior Consultant

Expertise: Chemistry & Environmental Science

Steven provides regulatory support of biocides, chemicals, and plant protection products with a focus on analytical methods and environmental risk assessment.

Steven previously served as Good Laboratory Practice (GLP) Study Director at Charles River Laboratories, specializing in Environmental Fate studies across a range of environmental matrices and conditions, and a range of compounds including agrochemicals, human pharmaceuticals, and veterinary products. As a GCP Laboratory Data Manager at Quintiles, Steven managed clinical trial data for therapeutic studies ranging in complexity and scale from 20 to >10,000 patients.

EDUCATION
BSc (Hons), Chemistry with Management, University of Edinburgh.

Cliff Habig
Principal Consultant

Expertise: Ecotoxicology & Environmental Fate

Cliff provides consulting expertise for ecological risk assessments, endangered species analyses, and endocrine disruptor (EDSP) evaluations.

Cliff has over 25 years of experience in ecotoxicology, environmental fate, and strategic support to US and international clients for conventional crop protection products, biochemicals, microbials, biotechnology products, and HPV chemicals. Cliff previously worked at Novigen, JSC, and Exponent, focusing on environmental toxicology, ecological risk assessment, higher-tier ecotoxicology evaluations, and probabilistic chemical fate and transport modeling and risk analysis. Cliff participated in numerous chemical industry workshops and expert panels.

EDUCATION

BS, Biology, University of Southern Maine.
MS, Biology, University of Georgia.
PhD, Environmental Toxicology, Duke University.