Guidelines for the derivation of Biomonitoring Equivalents: report from the Biomonitoring Equivalents Expert Workshop.
Biomonitoring Equivalents (BEs) are defined as the concentration of a chemical (or metabolite) in a biological medium (blood, urine, human milk, etc.) consistent with defined exposure guidance values or toxicity criteria including reference doses and reference concentrations (RfD and RfCs), minimal risk levels (MRLs), or tolerable daily intakes (TDIs) [Hays, S.M., Becker, R.A., Leung, H.W., Aylward, L.L., Pyatt, D.W., 2007. Biomonitoring equivalents: a screening approach for interpreting biomonitoring results from a public health risk perspective. Regul. Toxicol. Pharmacol. 47(1), 96-109]. The utility of the BE is to provide a screening tool for placing biomonitoring data into a health risk context. A Panel of experts took part in the Biomonitoring Equivalents Expert Workshop to discuss the various technical issues associated with calculating BEs and developed a set of guidelines for use in the derivation of BEs. Issues addressed included the role of the point of departure (POD) in BE derivation, the appropriate application of human and animal kinetic data and models, consideration of default uncertainty factor components in the context of internal dose-based extrapolations, and relevance of mode of action to technical choices in kinetic modeling and identification of screening values. The findings from this Expert Panel Workshop on BE derivation are presented and provide a set of guidelines and considerations for use in BE derivation.
Hays
Sean M
SM
Summit Toxicology, LLP, 165 Valley Road, Lyons, CO 80540, USA. shays@summittoxicology.com
Aylward
Lesa L
LL
LaKind
Judy S
JS
Bartels
Michael J
MJ
Barton
Hugh A
HA
Boogaard
Peter J
PJ
Brunk
Conrad
C
DiZio
Stephen
S
Dourson
Michael
M
Goldstein
Daniel A
DA
Lipscomb
John
J
Kilpatrick
Michael E
ME
Krewski
Daniel
D
Krishnan
Kannan
K
Nordberg
Monica
M
Okino
Miles
M
Tan
Yu-Mei
YM
Viau
Claude
C
Yager
Janice W
JW
D000818:Animals; D004305:Dose-Response Relationship, Drug; D004784:Environmental Monitoring / Q000379:methods*; D006801:Humans; D023421:Models, Animal; D008954:Models, Biological; D011634:Public Health; D018570:Risk Assessment / Q000379:methods; D015262:Xenobiotics / Q000032:analysis* / Q000493:pharmacokinetics / Q000633:toxicity
D015262:Xenobiotics