- Email: [email protected]
Introduction to the Biomonitoring Equivalents Pilot Project: Development of guidelines for the derivation and communication of Biomonitoring Equivalents
Regulatory Toxicology and Pharmacology 51 (2008) S1–S2
Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph
Introduction to the Biomonitoring Equivalents Pilot Project: Development of guidelines for the derivation and communication of Biomonitoring Equivalents S.M. Hays a,*, L.L. Aylward b, J.S. LaKind c a
Summit Toxicology, LLP, Colorado, 165 Valley Road, Lyons, CO 80540, USA Summit Toxicology, LLP, Falls Church, VA, USA c LaKind Associates, LLC, Catonsville, MD, USA b
a r t i c l e
i n f o
Article history: Received 25 February 2008 Available online 6 March 2008
Most existing chemical risk assessment procedures rely on external exposure metrics to set exposure guidance values such as reference doses or tolerable daily intakes, and few screening tools are currently available to interpret the increasing amount of available human biomonitoring data. The basic concept of Biomonitoring Equivalents (BEs)—biomonitored blood or urine concentrations of chemicals consistent with existing exposure guidance values—was introduced in Hays et al. (2007) as a method for integrating pharmacokinetic data with existing chemical risk assessments to provide such a screening tool. While that paper outlined the conceptual basis for deriving BE values, guidance on specific approaches and implementation for derivation and communication of BEs remained to be developed. We launched the Biomonitoring Equivalents Pilot Project to implement the concept for case study chemicals and to develop an initial set of guidelines for the derivation and communication of BE values. The Pilot Project consisted of two main components: development of case studies for several example chemicals, and consultation in a workshop with a panel of experts on the technical and communications issues identified in the process of BE development for the case study chemicals. The Biomonitoring Equivalents Pilot Project was designed from the outset to engage interested parties in a collaborative effort. Sponsors of the Biomonitoring Equivalents Pilot Project included; Health Canada (HC), United States Environmental Protection Agency (USEPA), American Chemistry Council (ACC), Crop Life America (CLA), Responsible Industry for Sound Environment, Soap and Detergent Association, and the American Petroleum Institute. A Steering Committee was recruited to guide the direction of the BE Pilot Project and included: Babasaheb Sonawane (USEPA), David Miller (USEPA), Bette Meek (HC), David Moir (HC), John Duffus (International Union of Pure and Applied Chemistry), George John* Corresponding author. E-mail address: [email protected] (S.M. Hays). 0273-2300/$ - see front matter Ó 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.yrtph.2008.02.007
son (Department of Defense), Mike Kaplan (DuPont, representing ACC), Monty Eberhart (Bayer CropScience, representing CLA), Judy LaKind, Lesa Aylward, and Sean Hays. In addition, Larry Needham (Centers for Disease Control and Prevention) and Bruce Fowler (Agency for Toxic Substances and Disease Registry) served as advisors to the project. It was recognized that working through several case studies would help elucidate the technical challenges with deriving and communicating BEs. Therefore, the Steering Committee selected four chemicals based on a range of toxicological effects (non-cancer, cancer and reproductive/developmental) and pharmacokinetic characteristics (e.g., short versus long-lived compounds; compounds that result in toxicity related to parent compound and metabolites; compounds that have biomarkers in blood and urine) and for compounds with exposure guidance values derived from animal toxicology and human epidemiology studies. The four compounds that were selected by the Steering Committee, and for which BE dossiers are included in this volume, include acrylamide, 2,4-dichloroacetic acid, cadmium, and toluene. The project team also developed a BE dossier for trihalomethanes in parallel to the BE Pilot Project; this dossier is included in this collection of papers as well. As we worked through the process of deriving BEs and developing approaches for communicating BEs, we identified charge questions related to derivation and communication that were used to guide the discussions during the Workshop. A group of experts in risk assessment and communication, pharmacokinetics (PK) and PK modeling, and medicine and medical ethics participated in the Workshop, which was held June 24–27, 2007 in Estes Park, Colorado. The panel deliberations on the charge questions led to the preparation of the manuscripts presenting guidelines for the derivation and communication of BEs presented in this issue, which were co-authored by all of the panel participants. We developed the individual BE case study dossiers, which were then peer-reviewed and in some cases co-authored by
2
S.M. Hays et al. / Regulatory Toxicology and Pharmacology 51 (2008) S1–S2
members of the expert panel to ensure that the methods employed in deriving the BEs used the best available science and adhered to the agreed-upon guidelines for the derivation and communication of BEs. This supplemental issue of Regulatory Toxicology and Pharmacology presents the two guidelines manuscripts (one each for the derivation and communication of BE values) as well as the BE dos-
siers for each of the case study compounds identified above. We hope that these guidelines for the derivation and communication of BEs will inform the development and use of future BE values as tools for the screening of human biomonitoring data in a health risk context. We wish to thank the project sponsors, the Steering Committee and advisors, and the members of the expert panel for their support, advice, guidance, and hard work.
Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph
Introduction to the Biomonitoring Equivalents Pilot Project: Development of guidelines for the derivation and communication of Biomonitoring Equivalents S.M. Hays a,*, L.L. Aylward b, J.S. LaKind c a
Summit Toxicology, LLP, Colorado, 165 Valley Road, Lyons, CO 80540, USA Summit Toxicology, LLP, Falls Church, VA, USA c LaKind Associates, LLC, Catonsville, MD, USA b
a r t i c l e
i n f o
Article history: Received 25 February 2008 Available online 6 March 2008
Most existing chemical risk assessment procedures rely on external exposure metrics to set exposure guidance values such as reference doses or tolerable daily intakes, and few screening tools are currently available to interpret the increasing amount of available human biomonitoring data. The basic concept of Biomonitoring Equivalents (BEs)—biomonitored blood or urine concentrations of chemicals consistent with existing exposure guidance values—was introduced in Hays et al. (2007) as a method for integrating pharmacokinetic data with existing chemical risk assessments to provide such a screening tool. While that paper outlined the conceptual basis for deriving BE values, guidance on specific approaches and implementation for derivation and communication of BEs remained to be developed. We launched the Biomonitoring Equivalents Pilot Project to implement the concept for case study chemicals and to develop an initial set of guidelines for the derivation and communication of BE values. The Pilot Project consisted of two main components: development of case studies for several example chemicals, and consultation in a workshop with a panel of experts on the technical and communications issues identified in the process of BE development for the case study chemicals. The Biomonitoring Equivalents Pilot Project was designed from the outset to engage interested parties in a collaborative effort. Sponsors of the Biomonitoring Equivalents Pilot Project included; Health Canada (HC), United States Environmental Protection Agency (USEPA), American Chemistry Council (ACC), Crop Life America (CLA), Responsible Industry for Sound Environment, Soap and Detergent Association, and the American Petroleum Institute. A Steering Committee was recruited to guide the direction of the BE Pilot Project and included: Babasaheb Sonawane (USEPA), David Miller (USEPA), Bette Meek (HC), David Moir (HC), John Duffus (International Union of Pure and Applied Chemistry), George John* Corresponding author. E-mail address: [email protected] (S.M. Hays). 0273-2300/$ - see front matter Ó 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.yrtph.2008.02.007
son (Department of Defense), Mike Kaplan (DuPont, representing ACC), Monty Eberhart (Bayer CropScience, representing CLA), Judy LaKind, Lesa Aylward, and Sean Hays. In addition, Larry Needham (Centers for Disease Control and Prevention) and Bruce Fowler (Agency for Toxic Substances and Disease Registry) served as advisors to the project. It was recognized that working through several case studies would help elucidate the technical challenges with deriving and communicating BEs. Therefore, the Steering Committee selected four chemicals based on a range of toxicological effects (non-cancer, cancer and reproductive/developmental) and pharmacokinetic characteristics (e.g., short versus long-lived compounds; compounds that result in toxicity related to parent compound and metabolites; compounds that have biomarkers in blood and urine) and for compounds with exposure guidance values derived from animal toxicology and human epidemiology studies. The four compounds that were selected by the Steering Committee, and for which BE dossiers are included in this volume, include acrylamide, 2,4-dichloroacetic acid, cadmium, and toluene. The project team also developed a BE dossier for trihalomethanes in parallel to the BE Pilot Project; this dossier is included in this collection of papers as well. As we worked through the process of deriving BEs and developing approaches for communicating BEs, we identified charge questions related to derivation and communication that were used to guide the discussions during the Workshop. A group of experts in risk assessment and communication, pharmacokinetics (PK) and PK modeling, and medicine and medical ethics participated in the Workshop, which was held June 24–27, 2007 in Estes Park, Colorado. The panel deliberations on the charge questions led to the preparation of the manuscripts presenting guidelines for the derivation and communication of BEs presented in this issue, which were co-authored by all of the panel participants. We developed the individual BE case study dossiers, which were then peer-reviewed and in some cases co-authored by
2
S.M. Hays et al. / Regulatory Toxicology and Pharmacology 51 (2008) S1–S2
members of the expert panel to ensure that the methods employed in deriving the BEs used the best available science and adhered to the agreed-upon guidelines for the derivation and communication of BEs. This supplemental issue of Regulatory Toxicology and Pharmacology presents the two guidelines manuscripts (one each for the derivation and communication of BE values) as well as the BE dos-
siers for each of the case study compounds identified above. We hope that these guidelines for the derivation and communication of BEs will inform the development and use of future BE values as tools for the screening of human biomonitoring data in a health risk context. We wish to thank the project sponsors, the Steering Committee and advisors, and the members of the expert panel for their support, advice, guidance, and hard work.