scholarly journals The accessibility of data on environmental risk assessment of pharmaceuticals – are environmental risk assessments information on emissions with respect to international and European environmental information law?

2020 ◽  
Vol 111 ◽  
pp. 104571
Author(s):  
Kim Oelkers
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Environmental Information ◽  
Risk Assessments ◽  
Information Law

scholarly journals The accessibility of data on environmental risk assessment of pharmaceuticals: Is the marketing authorisation procedure in conflict with the international right of access to environmental information?

2019 ◽  
Vol 31 (1) ◽  
Author(s):  
Kim Oelkers ◽  
Carolin Floeter
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Marketing Authorisation ◽  
Environmental Information ◽  
The Public ◽  
Accessible Information ◽  
Aarhus Convention ◽  
Information Law ◽  
Right Of Access

Abstract Background For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI? Results According to international and European environmental information law, there is in principal a right of access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active access to information (Art. 5 Aarhus Convention). The conflict between the actual accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the right of access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system. Conclusion The environmental information law requires an improved accessibility of ERAs that could be achieved through an API-based publicly accessible database.

scholarly journals Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
John L. Teem ◽  
Aggrey Ambali ◽  
Barbara Glover ◽  
Jeremy Ouedraogo ◽  
Diran Makinde ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Human Health ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Early Stage ◽  
Problem Formulation ◽  
Risk Assessments ◽  
Gene Drive ◽  
Starting Point ◽  
Protection Goals

Abstract Background Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an organized and ordered process to identify protection goals and potential pathways to harm to the environment, or animal or human health. Recognizing this need, the New Partnership for Africa’s Development (NEPAD), with support from African and international partners, organized four regional consultative workshops in Africa to initiate this process. Methods The workshops were attended by a diverse set of participants and stakeholders, including scientists, ethicists, health professionals, government regulators in the fields of environment health and biosafety as well government policymakers, who met for 4 days to deliberate on protection goals and pathways relevant to the use of gene drive mosquitoes for malaria control. The goal of the workshops was not to produce a comprehensive and detailed environmental risk assessment of gene drive mosquitoes, but rather to introduce problem formulation as a tool to the stakeholder community, and to serve as a starting point for conducting systematic environmental risk assessments in the future, identifying protection goals related to gene drive mosquitoes that are particular to African stakeholders. Results Participants in the workshops frequently identified human health and biodiversity as being relevant broad protection goals. Results of the deliberations provide insight into the concerns of African participants at an early stage in the development of gene drive organism/products that should be instructive to developers using this technology. Conclusions In general, the African participants of the consultations had a precautionary perspective with regard to environmental risk assessment of gene drive technology. As gene drive technology develops, protection goals will become further refined and candidate products will be further defined. These workshops represent only the beginning of a continuing process that will ultimately inform environmental risk assessment for gene drive mosquitoes to control malaria in Africa.

Risk assessment

2018 ◽  
Vol 3 (7) ◽  
Author(s):  
H. Kušić ◽  
A. Lončarić Božić
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Human Health ◽  
Exposure Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Risk Estimation ◽  
Risk Assessments ◽  
Effect Assessment ◽  
Basic Concepts

Abstract The chapter introduces risk assessment and examines the basic concepts of risk and hazard, their causes, consequences and probabilities. The methodology of environmental risk assessment including effect assessment, exposure assessment and risk estimation/characterisation is overviewed. Application of risk assessment for chemicals is described with regard to human health and the environment. Some of the commonly used techniques in risk assessments are introduced and illustrated by examples. Environmental risk assessment should provide input to the risk management so well-informed decisions can be made, to protect human health and the environment.

scholarly journals Environmental risk assessment of transgene products using honey bee (Apis mellifera) larvae

Apidologie ◽  
2003 ◽  
Vol 34 (2) ◽  
pp. 139-145 ◽  
Author(s):  
Henrik F. Brodsgaard ◽  
Camilla J. Brodsgaard ◽  
Henrik Hansen ◽  
G�bor L. L�vei
Keyword(s):  
Risk Assessment ◽  
Apis Mellifera ◽  
Honey Bee ◽  
Environmental Risk ◽  
Environmental Risk Assessment

The zebrafish embryo model in environmental risk assessment—applications beyond acute toxicity testing

2008 ◽  
Vol 15 (5) ◽  
pp. 394-404 ◽  
Author(s):  
Stefan Scholz ◽  
Stephan Fischer ◽  
Ulrike Gündel ◽  
Eberhard Küster ◽  
Till Luckenbach ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Acute Toxicity ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Zebrafish Embryo ◽  
Toxicity Testing ◽  
Acute Toxicity Testing

Recommendations on the Environmental Risk Assessment of Pharmaceuticals - Effect Characterization

2007 ◽  
Vol preprint (2009) ◽  
pp. 1
Author(s):  
Heike Schmitt ◽  
Tatiana Boucard ◽  
Jeanne Garric ◽  
John Jensen ◽  
Joanne Parrott ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment

Glossary of terms used in developmental and reproductive toxicology (IUPAC Recommendations 2016)

2016 ◽  
Vol 88 (8) ◽  
pp. 713-830
Author(s):  
John H. Duffus ◽  
Michael Schwenk ◽  
Douglas M. Templeton
Keyword(s):  
Risk Assessment ◽  
Reproductive Biology ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Primary Objective ◽  
Human Reproduction ◽  
Reproductive Systems ◽  
Teratogenic Effects ◽  
Male And Female ◽  
Medical Practitioners

Abstract The primary objective of this glossary is to give clear definitions for those who contribute to studies relevant to these disciplines, or who must interpret them, but are not themselves reproductive physiologists or physicians. This applies especially to chemists who need to understand the literature of reproductive and teratogenic effects of substances without recourse to a multiplicity of other glossaries or dictionaries. The glossary includes terms related to basic and clinical reproductive biology and teratogenesis, insofar as they are necessary for a self-contained document, particularly terms related to diagnosing, measuring, and understanding the effects of substances on the embryo, the fetus, and on the male and female reproductive systems. The glossary consists of about 1200 primary alphabetical entries and includes Annexes of common abbreviations and examples of chemicals with known effects on human reproduction and development. The authors hope that toxicologists, pharmacologists, medical practitioners, risk assessors, and regulatory authorities are among the groups who will find this glossary helpful, in addition to chemists. In particular, the glossary should facilitate the worldwide use of chemical terminology in relation to occupational and environmental risk assessment.

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