Evaluation of EPA's Tier 1 Endocrine Screening Battery and recommendations for improving the interpretation of screening results

Regulatory Toxicology and Pharmacology

Volumn 59, Issue 3, 2011, Pages 397-411

  Borgert, Christopher J ^a,b   Mihaich, Ellen M ^c   Quill, Terry F ^d   Marty, M S ^e   Levine, Steven L ^f   Becker, Richard A ^g  

^a Applied Pharmacology and Toxicology Inc   (United States)

^b University of Florida College of Veterinary Medicine   (United States)

^c Environmental and Regulatory Resources LLC   (United States)

^d Quill Law Group   (United States)

^e DOW CHEMICAL COMPANY   (United States)

^f MONSANTO COMPANY   (United States)

^g AMERICAN CHEMISTRY COUNCIL   (United States)

Author keywords

Androgen assay; EDSP screening; Endocrine disrupter; Endocrine Screening Battery; Estrogen assay; Pubertal assay; Screening assays; Thyroid assay; Tier 1 assays; Validation

Indexed keywords

ANDROGEN; ENDOCRINE DISRUPTOR; ESTROGEN; PESTICIDE; THYROID HORMONE;

ANALYTIC METHOD; ARTICLE; CHEMICAL INTERACTION; COST EFFECTIVENESS ANALYSIS; DATA ANALYSIS; DECISION MAKING; FINANCIAL MANAGEMENT; IN VITRO STUDY; IN VIVO STUDY; PEER REVIEW; PRIORITY JOURNAL; RELIABILITY; SCREENING TEST; SENSITIVITY AND SPECIFICITY; TOXICITY TESTING;

ANIMALS; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION, PRECLINICAL; ENDOCRINE DISRUPTORS; HUMANS; PRACTICE GUIDELINES AS TOPIC; TOXICITY TESTS; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

EID: 79952696156     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2011.01.003     Document Type: Article

References (54)

1. Becker R.A., Janus E.R., White R.D., Kruszewski F.H., Brackett R.F. Good laboratory practices and safety assessments. Environ. Health Perspect. 2009, 117:A482-A483.
2. Boobis A.R., Doe J.E., Heinrich-Hirsch B., Meek M.E.B., Munn S., Ruchirawat M., Schlatter J., Seed J., Vickers C. IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit. Rev. Toxicol. 2008, 38(2):87-96.
3. Borgert, C.J., Mihaich, E.M., Ortego, L.S., Bentley, K., Holmes, C., Levine, S.L., Becker, R.A., 2010. The development of a weight of evidence approach for the evaluation of endocrine activity. SETAC North America, 31st Annual Meeting, November 7-11, 2010, Portland, OR.
4. Bus J.S., Becker R.A. Toxicity testing in the 21st century: a view from the chemical industry. Toxicol. Sci. 2009, 112:297-302.
5. CropLife America, 2010. CropLife America/Endocrine Policy Forum Comments on the OPPTS Series 890 Test Guidelines [Docket Number EPA-HQ-OPP-2009-0634-001] 74FR 54422. Regulations.Gov Document ID: EPA-HQ-OPP-2009-0634-0135.1. (accessed 22.09.10). http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480b1a6f1.
6. David R.M. Proposed mode of action for in utero effects of some phthalate esters on the developing male reproductive tract. Toxicol. Pathol. 2006, 34(3):209-219.
7. ECETOC, 2009. European Centre for Ecotoxicology and Toxicology of Chemicals TR 106 - Guidance on Identifying Endocrine Disrupting Effects, 2009.
8. Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), Final Report, 1998. (accessed 18.07.10). http://www.epa.gov/endo/pubs/edspoverview/edstac.htm.
9. Fed. Reg., 2010. 75 US Federal Register. 70248-70254, EPA, Notice, Endocrine Disruptor Screening Program; Second List of Chemicals, November 17, 2010.
10. Freyberger A., Schladt L. Evaluation of the rodent Hershberger bioassay on intact juvenile males - testing of coded chemicals and supplementary biochemical investigations. Toxicology 2009, 262:114-120.
11. Freyberger A., Ellinger-Ziegelbauer H., Krötlinger F. Evaluation of the rodent Hershberger bioassay: testing of coded chemicals and supplementary molecular-biological and biochemical investigations. Toxicology 2007, 239:77-88.
12. Houck, K., 2009. What can ToxCast™ tell us about endocrine disruption? ISRTP Workshop: The Endocrine Disruptor Screening Program - What Can Screening Results Tell us About Potential Adverse Endocrine Effects? September 9-10, 2009. (accessed 18.07.10). http://www.isrtp.org/PASSWORD_PROTECT_SLIDES/HOUCK%20-%20ISRTP%2010Sept09_2010.ppt.
13. ICCVAM, 1997. Validation and regulatory acceptance of toxicological test methods. (accessed 18.07.10). http://iccvam.niehs.nih.gov/docs/about_docs/validate.pdf.
14. Kanno J., Onyon L., Haseman J., Fenner-Crisp P., Ashby J., Owens W. Organisation for Economic Co-operation and Development. The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: phase 1. Environ. Health Perspect. 2001, 109:785-794.
15. Kanno J., Onyon L., Peddada S., Ashby J., Jacob E., Owens W. The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single-dose studies. Environ. Health Perspect. 2003, 111:1550-1558.
16. Kanno J., Onyon L., Peddada S., Ashby J., Jacob E., Owens W. The OECD program to validate the rat uterotrophic bioassay. Phase 2: dose-response studies. Environ. Health Perspect. 2003, 111:1530-1549.
17. Lamb J.L., Hentz K.L. Impact of endocrine disruptor policies and regulations. Endocrine Toxicology 2010, Informa Healthcare, New York. third ed. J.C. Eldridge, J.T. Stevens (Eds.).
18. Laws S.C., Yavanhxay S., Cooper R.L., Eldridge J.C. Nature of the binding interaction for 50 structurally diverse chemicals with rat estrogen receptors. Toxicol. Sci. 2006, 94(1):46-56.
19. National Research Council (NRC), 2007. Committee on Toxicity Testing and Assessment of Environmental Agents, Board of Environmental Studies and Toxicology, Institute for Laboratory Animal Research. Toxicity Testing in the 21st Century. A Vision and a Strategy. National Academies Press, Washington, DC.
20. O'Connor J.C., Cook J.C., Craven S.C., Van Pelt C.S., Obourn J.D. An in vivo battery for identifying endocrine modulators that are estrogenic or dopamine regulators. Fundam. Appl. Toxicol. 1996, 33:182-195.
21. O'Connor J.C., Cook J.C., Frame S.R., Davis L.G. Detection of the environmental antiandrogen p,p'-DDE in Sprague-Dawley and Long-Evans rats using a Tier I screening battery and a Hershberger assay. Toxicol. Sci. 1999, 51:44-53.
22. O'Connor J.C., Frame S.R., Cook J.C. Detection of thyroid toxicants in a Tier I screening battery and alterations in thyroid endpoints over 28 days of exposure. Toxicol. Sci. 1999, 51:54-70.
23. O'Connor J.C., Davis L.G., Frame S.R., Cook J.C. Evaluation of a Tier I screening battery for detecting endocrine-active compounds (EACs) using the positive controls testosterone, coumestrol, progesterone, and RU486. Toxicol. Sci. 2000, 54:338-354.
24. O'Connor J.C., Cook J.C., Marty M.S., Davis L.G., Kaplan A.M., Carney E.W. Evaluation of the Tier I screening options for detecting endocrine-active compounds (EACs). Crit. Rev. Toxicol. 2002, 32:521-549.
25. O'Connor J.C., Frame S.R., Ladics G.S. Evaluation of a 15-day screening assay using intact male rats for identifying steroid biosynthesis inhibitors and thyroid modulators. Toxicol. Sci. 2002, 69:79-91.
26. O'Connor J.C., Marty M.S., Becker R.A., Snajdr S., Kaplan A.M. Results of the negative control chemical allyl alcohol in the 15-day intact adult male rat screening assay for endocrine activity. Birth Defects Res. B 2008, 83:117-122.
27. OECD, 2009d. Organisation for Economic Cooperation and Development. The OECD (Q)SAR Application Toolbox. (accessed 18.07.10). http://www.oecd.org/document/12/0,3343,en_2649_34379_42930060_1_1_1_1,00.html.
28. OMB, 2009. Office of Management and Budget (OMB), OIRA Action, Terms of Clearance: Tier 1 Screening of Certain Chemicals Under the EDSP. (accessed 18.07.10). http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=2070-0176.
29. Owens J.W., Ashby J. Critical review and evaluation of the uterotrophic bioassay for the identification of possible estrogen agonists and antagonists: in support of the validation of the OECD uterotrophic protocols for the laboratory rodent. Organisation for Economic Co-operation and Development. Crit. Rev. Toxicol. 2002, 32:445-520.
30. Owens W., Koëter H.B. The OECD program to validate the rat uterotrophic bioassay: an overview. Environ. Health Perspect. 2003, 111:1527-1529.
31. Owens W., Ashby J., Odum J., Onyon L. The OECD program to validate the rat uterotrophic bioassay. Phase 2: dietary phytoestrogen analyses. Environ. Health Perspect. 2003, 111:1559-1567.
32. Owens W., Zeiger E., Walker M., Ashby J., Onyon L., Gray L.E. The OECD program to validate the rat Hershberger bioassay to screen compounds for in vivo androgen and antiandrogen responses. Phase 1: use of a potent agonist and a potent antagonist to test the standardized protocol. Environ. Health Perspect. 2006, 114:1259-1265.
33. Owens W., Gray L.E., Zeiger E., Walker M., Yamasaki K., Ashby J., Jacob E. The OECD program to validate the rat Hershberger bioassay to screen compounds for in vivo androgen and antiandrogen responses: phase 2 dose-response studies. Environ. Health Perspect. 2007, 115:671-678.
34. Plunkett L., Becker R.A. Does the standard toxicological testing paradigm for industrial chemicals apply to screening for children's health risks?. Open Toxicol. J. 2008, 2:42-60.
35. Rhomberg, L., 2008. A framework for weight of evidence: application to endocrine effects and the low-dose hypotheses. ISRTP Workshop: Conducting and Assessing the Results of Endocrine Screening, February 19 and 20, 2008. (accessed July 18.07.10). http://www.isrtp.org/endocrine_workshop_02-08/RHOMBERG%20SLIDES.pdf.
36. Schechtman, L.M., 2007. Internationally harmonized processes for test method evaluation, validation and regulatory acceptance: The role of OECD guidance document 34. Proc. 6th World Congress on Alternatives and Animal Use in the Life Sciences: AATEX 14, Special Issue, 475-782. (accessed 18.11.10). http://altweb.jhsph.edu/bin/o/g/paper475.pdf.
37. Seed J., Carney E.W., Corley R.A., Crofton K.M., DeSesso J.M., Foster P.M.D., Kavlock R., Kimmel G., Klaunig J., Meek M.E., Preston R.J., Slikker W., Tabacova S., Williams G.M., Wiltse J., Zoeller R.T., Fenner-Crisp P., Patton D.E. Overview: Using mode of action and life stage information to evaluate the human relevance of animal toxicity data. Crit. Rev. Toxicol. 2005, 35(8-9):664-672.
38. Stevens, J.T., 2009. What can EDSP screening tell us that the FIFRA guidelines cannot? Presentation at the ISRTP 2009 Endocrine Workshop: Conducting the Endocrine Disruptor Screening Program: What Can Screening Results Tell Us About Potential Adverse Endocrine Affects. Available from: presentations at http://www.ISRTP.org.
39. The Keystone Center, October 1996. Keystone Convening Report Regarding the Formation of the Endocrine Disruptor Screening And Testing Advisory Committee. Available from: http://www.epa.gov/endo/pubs/edsparchive/keystone.htm.
40. US EPA, 1996. Food Quality Protection Act. Public Law 104-170, 104th Congress. (accessed 18.07.10). http://www.epa.gov/scipoly/oscpendo/pubs/fqpa.pdf.
41. US EPA, 1998. Endocrine Disruptor Screening Program; Proposed Statement of Policy. Federal Register, vol. 63, No. 248, 71541-71568, December 28, 1998. (accessed 18.07.10). http://www.epa.gov/scipoly/oscpendo/pubs/122898frnotice.pdf.
42. US EPA, 1999a. Review of the EPA's Proposed Environmental Disruptor Screening Program; Review of the Endocrine Disruptor Screening Program by a Joint Subcommittee of the Science Advisory Board and Scientific Advisory Panel. EPA-SAB-EC-99-013. (accessed 18.07.10). http://yosemite.epa.gov/sab/sabproduct.nsf/C8ABD410E357DBCF85257193004C42C4/$File/ec13.pdf.
43. US EPA, 2005b. Validation of assays in the EDSP: draft version 3.3 - for discussion at the EDMVAC, November 9, 2005. (accessed 18.11.10). http://www.epa.gov/endo/pubs/edmvac/edsp_validation_paper_110905.pdf.
44. US EPA, 2008a. Docket: EPA-HQ-OPPT-2007-1080. 4-Day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Endocrine Disruptor Screening Program (EDSP) Proposed Tier-1 Screening Battery. (accessed 18.07.10). http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPP-2008-0012.
45. US EPA, 2008b. Comments of the Chemical Producers and Distributors Association et al., on EPA's Information Collection Request. Submitted May 22, 2008. Docket: EPA-HQ-OPPT-2007-1081-0020 (accessed 18.07.10). http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064809c90edanddisposition=attachmentandcontentType=pdf.
46. US EPA, 2008c. Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held on March 25-26, 2008 to review and consider the Endocrine Disrupter Screening Program (EDSP) Proposed Tier 1 Screening Battery. (accessed 18.07.10). http://www.epa.gov/scipoly/sap/meetings/2008/march/minutes2008-03-25.pdf.
47. US EPA, 2009a. Environmental Protection Agency Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of the Tier 1 Screening Battery and Related Test Guidelines. Federal Register, vol. 74, No. 202, 54415-54422, October 21, 2009. (accessed 18.07.10). http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a4732danddisposition=attachmentandcontentType=html.
48. US EPA, 2009b. Endocrine Disruptor Screening Program; Tier 1 Screening Order Issuing Announcement. 74 Fed. Reg. 54422, Oct. 2, 2009. (accessed 18.07.10). http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a472c5anddisposition=attachmentandcontentType=html.
49. US EPA, 2009c. EPA's Approach for Considering Other Scientifically Relevant Information (OSRI) under the Endocrine Disruptor Screening Program, March 26, 2009. (accessed 18.07.10). http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480947a79anddisposition=attachmentandcontentType=pdf.
50. US EPA, 2009d. Series 890-Endocrine Disruptor Screening Test Guidelines OPPTS Number OPPTS 890.1100 Amphibian Metamorphosis (Frog). http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a41cbaanddisposition=attachmentandcontentType=pdf.
51. US EPA, 2009n. Series 890-Endocrine Disruptor Screening Test OPPTS 890.1600: Uterotrophic Assay. (accessed 18.07.10). http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a41d00anddisposition=attachmentandcontentType=pdf.
52. US EPA, 2009p. Meeting Minutes of the FIFRA SAP Meeting Held August 25-27, 2009 on the Scientific Issues Associated with "The Use of Structure Activity Relationships of Estrogen Binding Affinity to Support Prioritization of Pesticide Inert Ingredients and Antimicrobial Pesticides for Screening and Testing." November 19, 2009. (accessed 18.07.10). http://www.epa.gov/scipoly/sap/meetings/2009/august/082509minutes.pdf.
53. US EPA, 2010. EPA's Endocrine Disruptor Screening Program (EDSP). (accessed 18.07.10). http://www.epa.gov/scipoly/oscpendo/index.htm.
54. US House of Representatives, 2009. Appropriations Committee report for EPA's FY 2010 appropriations (H.R. 2996, H. Rept. 111-180), June 23, 2009.