ITERate Review Program
TERA instituted a new program in 2011 to screen and load chemical risk values from peer-reviewed publications onto ITER. This program is available to all, and is particularly encouraged for chemicals that currently have no federal risk value. Through this process, TERA arranges for a small group of toxicology and risk assessment experts to evaluate the basis and derivation of the risk value and determine whether it is appropriate to include on ITER. Five risk values have been reviewed since February 2011 and are now available on ITER.
The next ITER Web Value Review meeting planning is underway!
Next meeting to be held in 2013.
Meeting limited to the 4 chemical risk values, any submissions over 4 will be placed in the next meeting.
We currently have multiple interested parties, and spots are filling up quickly. To submit your publication for an ITER Web Value Review, or to volunteer to be on our review panel, please contact Nance@tera.org of 513-542-7475 x 25.
August 23, 2012 – Meeting Report
Hexavalent Chromium - Cr(VI) (CAS RN 18540-29-9)
Crump, C., Crump, K., Hack, E., Luippold, R., Mundt, K., Liebig, E., Panko, J., Paustenbach, D., Proctor, D.M. (2003). Dose-response and risk-assessment of airborne hexavalent chromium and lung cancer mortality. Risk Anal 23, 1147-1163. Available online for a fee at: http://onlinelibrary.wiley.com/doi/10.1111/j.0272-4332.2003.00388.x/abstract
ToxStrategies, Inc. 2012. ITER White Paper –In Support of the Inhalation Cancer Risk Assessment of Hexavalent Chromium. Rancho Santa Margarita, CA. Available at: http://www.tera.org/iter/iterate/chromium.pdf
June 29, 2011 – Meeting Report
Manganese Oxide (CAS RN 1344-43-0)
Bailey L.A, Goodman J.E., and Beck B.D. (2009). Proposal for a revised Reference Concentration (RfC) for manganese based on recent epidemiological studies. Regul. Toxicol. Pharmacol. 55: 330-339. Available online for a fee at: http://www.ncbi.nlm.nih.gov/pubmed/19686793
February 15-16, 2011 – Meeting Report
2,3,7,8-tetrachlorodibenzo-(p)-dioxin (TCDD) (CAS RN 1746-01-6)
Simon, T. , Aylward, L.L., Kirman, C.R., Rowlands, J.C. and Budinsky, R.A. (2009) Estimates of Cancer Potency of 2,3,7,8-Tetrachlorodibenzo(p)dioxin Using Linear and Nonlinear Dose-Response Modeling and Toxicokinetics. Toxicol. Sci. 112(2): 490-506. Available online for free at: http://toxsci.oxfordjournals.org/content/112/2/490.long.
2,2′,3,3′,4,4′,5,5′,6,6′-decabromodiphenyl ether (BDE-209) (CAS RN 1163-19-5)
Hardy M.L., Banasik M., and Stedeford T (2009). Toxicology and human health assessment of decabromodiphenyl ether. (2009) Crit. Rev. Toxicol. 39(S3):1-44. Available online for a fee at: http://www.ncbi.nlm.nih.gov/pubmed/19874087.
Acrylamide (CAS RN 79-06-1)
Dourson M., Hertzberg R., Allen B., Haber L., Parker A., Kroner O., Maier A., Kohrman M. (2008) Evidence-based dose-response assessment for thyroid tumorigenesis from acrylamide. Regul. Toxicol. Pharmacol. 52(3):264-89. Available online for a fee at: http://www.ncbi.nlm.nih.gov/pubmed/18775759.
The purpose of the ITER data base is to provide risk assessors and managers across the world with the latest human health risk values. ITER includes values from major environmental organizations including U.S. EPA, NSF, RIVM, ATSDR, IARC, Health Canada, and others. In addition, risk values that have undergone an independent peer review may be included on ITER. Since 1996, TERA has convened expert panels to review assessment documents for a various sponsors, including government, industry and consulting groups. Values that are acceptable to the review panel have been included in the ITER column.
The peer reviewed literature contains many more risk values that may be of value to risk practitioners. Therefore TERA has begun an initiative to include some of these “literature-based”, previously published values on the ITER database. Authors of peer reviewed publications that document the derivation of human health risk values are invited to submit their publications for an additional peer review by a small panel of risk experts. Those that the panel finds acceptable (i.e., scientifically sound) are then loaded on the ITER database to make these values more widely available.
TERA will organize and manage this review process.
Publication values may be nominated by their authors or others, or identified by TERA through literature searches. TERA staff will screen the publication to determine if it is appropriate for review.
TERA will discuss the process and fees associated with the review with the authors.
A small panel of experts will be convened to review the value. A pool of qualified experts will be identified by TERA to serve as the reviewers. Interested scientists may nominate themselves. TERA will screen each candidate to insure they have the needed qualifications to review the risk values. The pool of experts will be sent a list of publications and meeting dates, and experts will volunteer for an ad hoc panel to provide a review of the selected literature values. Because panel members are self-selecting, TERA will evaluate whether volunteers have any conflict of interest with the value(s) and decline participation to those that have a conflict or a bias. A minimum of three reviewers would be required.
The small panel will review the publication and supporting documentation provided by the authors, and participate in a review meeting. They will evaluate whether the risk value was derived correctly using commonly accepted risk methods, that these methods were applied appropriately, and if the value is useful to ITER users. The authors provide supporting documentation for panel review and attend the meeting to answer panel questions. The panel may request the authors provide additional explanation/documentation/revision prior to approval for loading on ITER.
Those values that are approved by the panel will be included on ITER in the ITER PR column.
A brief summary of the panel’s review and recommendations will be included in the ITER entry and on the ITER Review Webpage.
TERA will charge a minimal fee for the review to cover costs associated with organization of the panel, running of the meeting, and finalization and loading onto ITER. Please contact firstname.lastname@example.org for more information regarding programs fees.
Experts in toxicology, risk assessment and related fields are invited to volunteer to serve on review panels. Contact email@example.com
Authors of publications that include derivation of human health risk values are invited to submit their publication for consideration. Contact firstname.lastname@example.org.