IN VIVO BIOACCUMULATION DATABASE WORKSHOP
NOVEMBER 11-12, 2005
Baltimore, Maryland
WORKSHOP DESCRIPTION
Program Links:
Participant's List
Workshop Program
Background Materials
Background
Assessing the bioaccumulation potential of chemical substances is an important issue that will impact international chemical management policies and public-health decision-making. However, limited bioaccumulation (B) data are available for many chemicals and generation of new data using traditional test protocols is time consuming, costly and requires considerable animal use. Therefore, new advances
in bioaccumulation science are needed to reliably assess this substance-specific property in an efficient manner. Recognizing this challenge, an international workshop of industry, academic and regulatory scientists was convened in April 2005 to review the state of the science in this field and develop work plans that could strategically improve bioaccumulation assessment for chemical management decisionmaking in the short term.1 One cross-cutting element that was identified in this workshop was the need to develop a database of reliable in-vivo B data. The benefits of developing such a database are severalfold. First, this database would provide a globally harmonized set of reliable B data to support consistent assessments of specific chemicals. Second, this database would serve as the basis for developing and/or validating alternative in-vivo or in-silco (i.e. QSAR) predictive methods that are faster, cheaper and avoid animal use. The availability of such a database would also provide an opportunity to gain new insights regarding inter-species and lab-field extrapolation of B data and guide future research that logically builds upon analysis of existing information.
To progress the development of a B in-vivo database, a workshop sponsored by ILSE-HESI(/SETAC) will be conducted following the Society of Environmental Toxicology meeting on November 11 and 12, 2005.
Purpose & Audience
The broad objective of this workshop is to develop expert guidance on the development and design of an in-vivo bioaccumulation database. To prioritize efforts, this workshop will be primarily focused on fish. However, the results from this workshop are expected to be generally applicable to other species and thus provide a technical basis for future expansion of the database.
Workshop participants will be selected from academic, industry and regulatory sectors and provide expertise as either B data "generators" or "users" or both. Users include not only decision-makers but also model developers. In addition, participants will be selected to provide different global perspectives across regions (e.g. North America, Europe, Asia).
Format
The workshop will be divided into a series of sessions that will address specific aspects of in-vivo B database development and design.
The first session will provide an overview of existing databases that provide compilation of either lab or field related in-vivo bioaccumulation information on fish. The session will include short presentations from a number of participants that are familiar with the specific databases. To keep presentations focused, speakers will be provided with a common template for summarizing the key features of their
respective database (e.g. bioaccumulation endpoint assessed, number of chemicals included, data quality criteria considered; how to access data). Other sources of B data not covered by presenters will be captured via input from the remaining participants.
The second session will focus on identifying the key data quality criteria that should be considered when judging the reliability of a lab or field B study. A specific objective of this session will be to develop general consensus guidance for defining study quality using the following reliability classes: i. Reliable; ii. Reliable with Restrictions; iii. Unreliable, iv. Not Assignable (i.e. not enough information provided to decide on data quality). This session also will address how test data uncertainty might be considered. Toward the end of this session, a break-out session will be included to allow participants to work in small groups and apply the data quality criteria that have been developed in evaluating a few example
data sources.
The third session will focus on defining the content (i.e. recommended data fields) to be included in the in-vivo B database. This session will address what chemical, organism, test design and test result-related information should be included in the database. The principal focus of this session is on lab data since
this is judged to be the most immediate priority for advancing in-vivo and in-silico model development. However, additional considerations that should be included in the development of a field bioaccumulation database for fish will also be identified.
A fourth session will address database implementation. In this session, a number of practical issues will be discussed including hardware/software considerations; database population, maintenance and updates; data confidentiality; public accessibility; user-related features such as searching capabilities. In addition, a short brain-storming session will be held regarding leveraged funding opportunities to support database implementation.
A final session will be held to develop a draft workshop report that provides the deliverables described in the next section.
Deliverables
- Proposed catalog of existing data compilations/sources of in-vivo B data for fish
- Recommended data quality criteria for judging reliability of lab and field studies
- Recommended content (data fields) to be included in an in-vivo database of laboratory fish
- studies
- List of additional considerations to be included in an in-vivo database of field studies
- Proposed plan for database implementation