List of References Available Online or Provided with PDF Files by TCEQ
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List of References Available Online
USEPA Cancer Guidelines
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USEPA 2007. Framework for Determining a Mutagenic Mode of Action for
Carcinogenicity. Review Draft. EPA 120/R-07/002-A, Sep 2007.
http://www.epa.gov/osa/mmoaframework/pdfs/MMOA-ERD-FINAL-83007.pdf
USEPA. 2005. Guidelines for Carcinogen Risk Assessment. EPA/630/P-03/001F, Mar
2005. http://www.epa.gov/cancerguidelines/
USEPA. 2005. Supplemental Guidance for Assessing Susceptibility from Early-Life
Exposure to Carcinogens. EPA/630/R-03/003F, Mar 2005.
http://www.epa.gov/cancerguidelines/guidelines-carcinogen-supplement.htm
USEPA. 1999. Guidelines for Carcinogen Risk Assessment Review draft. NCEA-F-0644,
Jul 1999. http://www.epa.gov/cancerguidelines/draft-guidelines-carcinogen-ra-1999.htm
USEPA. 1996. Proposed Guidelines for Carcinogen Risk Assessment (PDF). EPA/600/P92/003C, Apr 1996. http://www.epa.gov/raf/publications/pdfs/propcra_1996.pdf
USEPA. 1986. Guidelines for Carcinogen Risk Assessment. EPA/630/R-00/004, Sep
1986. http://www.epa.gov/cancerguidelines/guidelines-carcinogen-risk-assessment1986.htm
USEPA Risk Guidelines (Other than Cancer)
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USEPA. 2000. Supplementary Guidance for Conducting Health Risk Assessment of
Chemical Mixtures. EPA/630/R-00/002, Aug 2000.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=20533
USEPA. 1998. Guidelines for Neurotoxicity Risk Assessment. EPA/630/R-95/001F, Apr
1998. http://www.epa.gov/raf/publications/guidelines-neurotoxicity-risk-assessment.htm
USEPA, 1996. Guidelines for Reproductive Toxicity Risk Assessment. EPA/630/R96/009, Oct 1996. http://www.epa.gov/raf/publications/guidelines-reproductive-tox-riskassessment.htm
USEPA. 1991. Guidelines for Developmental Toxicity Risk Assessment. EPA/600/FR91/001, Dec 1991. http://www.epa.gov/raf/publications/guidelines-dev-toxicity-riskassessment.htm
USEPA. 1986. Guidelines for Mutagenicity Risk Assessment. EPA/630/R-98/003, Sep
1986. http://www.epa.gov/raf/publications/guidelines-mutagenicityl-risk-assessment.htm
USEPA. 1986. Guidelines for the Health Risk Assessment of Chemical Mixtures (PDF).
EPA/630/R-98/002, Sep 1986.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=22567
USEPA Science Policy Council Guidelines
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USEPA. 2006. Science Policy Council Handbook: Peer Review. Third edition. Office of
Science Policy, Office of Research and Development, Washington, DC. EPA/100/B06/002. http://www.epa.gov/spc/2peerrev.htm
List of References Available Online or Provided with PDF Files by TCEQ
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USEPA. 2000. Science Policy Council Handbook: Risk Characterization. Office of
Science Policy, Office of Research and Development, Washington, DC. EPA 100-B-00002. http://www.epa.gov/spc/2riskchr.htm
USEPA. 2000. Science Policy Council Handbook: Peer Review (PDF) Second edition.
Office of Science Policy, Office of Research and Development, Washington, DC. EPA
100-B-00-001. http://www.epa.gov/iris/pdfs/Policy_IRIS_Peer_Reviews.pdf
NCEA Guidelines for Peer Review
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NCEA 2009. Policy and Procedures for Conducting IRIS Peer Reviews (PDF).
http://www.epa.gov/iris/pdfs/Policy_IRIS_Peer_Reviews.pdf
Other Guidance Documents and Technical Panel Reports
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USEPA 2011. Recommended Use of BW3/4 as the Default Method in Derivation of the
Oral Reference Dose. EPA/100/R11/001. Office of the Science Advisor.
http://www.epa.gov/raf/publications/pdfs/recommended-use-of-bw34.pdf
USEPA 2005. Pollution Prevention (P2) Framework. EPA-748-B-04-001. Office of
Pollution Prevention and Toxics. http://www.epa.gov/oppt/sf/pubs/p2framejune05a2.pdf.
USEPA. 2002. A Review of the Reference Dose and Reference Concentration Processes.
EPA/630/P-02/002F, Dec 2002. http://www.epa.gov/raf/publications/review-referencedose.htm
USEPA. 2000. Benchmark Dose Technical Guidance Document (PDF) External Review
Draft. EPA/630/R-00/001, Oct 2000. http://www.epa.gov/nceawww1/pdfs/bmds/BMDExternal_10_13_2000.pdf
USEPA. 1994. Methods for Derivation of Inhalation Reference Concentrations and
Application of Inhalation Dosimetry. EPA/600/8-90/066F, Oct 1994.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=71993
USEPA. 1994. Interim policy for particle size and limit concentration issues in inhalation
toxicity studies: Notice of availability. Federal Register Notice 59(206): 53799.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=186068
USEPA. 1988. Recommendations for and Documentation of Biological Values for use in
Risk Assessment. EPA 600/6-87/008, Feb 1988.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=34855
References Cited in Older Assessment Documents but Superseded by More
Recent Guidance
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USEPA. 1993. Reference Dose (RfD): Description and Use in Health Risk Assessments
Mar 1993. http://www.epa.gov/iris/rfd.htm
USEPA. 1992. EPA's Approach for Assessing the Risks Associated with Chronic
Exposures to Carcinogens Jan 1992. http://www.epa.gov/iris/carcino.htm
References from other State and Federal Agencies
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ATSDR. 2007. Guidance for the Preparation of a Twenty First Set Toxicological Profile.
http://www.atsdr.cdc.gov/toxprofiles/guidance/set_21_guidance.pdf
List of References Available Online or Provided with PDF Files by TCEQ
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FDA 2002 Guidance for Industry Immunotoxicology Evaluation of Investigational New
Drugs,
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/ucm079239.pdf
NRC 2001. Standing Operating Procedures (SOP) of the National Advisory Committee
on Acute Exposure Guideline Levels for Hazardous Substances (PDF).
http://www.epa.gov/opptintr/aegl/pubs/sop.pdf
NRC. 2007. Scientific Review of the Proposed Risk Assessment Bulletin from the Office
of Management and Budget. http://www.nap.edu/catalog/11811.html
OEHHA. 2008. Technical Support Document for the Derivation of Noncancer Reference
Exposure Levels. http://www.oehha.ca.gov/air/hot_spots/2008/NoncancerTSD_final.pdf
References from International Agencies
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European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). 2003.
Derivation of Assessment Factors for Human Health Risk Assessment. ECETOC TR No.
86. Brussels, Belgium. http://members.ecetoc.org/Documents/Document/TR%20086.pdf
Health Canada 2008. Science Policy Note: The Application of Uncertainty Factors and
the Pest Control Products Act Factor in the Human Health Risk Assessment of Pesticides
(http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_pol-guide/spn2008-01/index-eng.php)
International Programme on Chemicals Safety (IPCS 2005). Chemical-specific
adjustment factors for interspecies differences and human variability: guidance document
for use of data in dose/concentration-response assessment. Harmonization Project
Document No. 2. World Health Organization, Geneva.
http://whqlibdoc.who.int/publications/2005/9241546786_eng.pdf
International Programme on Chemicals Safety (IPCS 2001). Guidance Document for the
Use of Data in Development of Chemical-Specific Adjustment Factors (CSAFs) for
Interspecies Differences and Human Variability in Dose/Concentration-Response
Assessment. WHO/PCS/01.4. Geneva: World Health Organization.
http://www.who.int/ipcs/publications/methods/harmonization/en/csafs_guidance_doc.pdf
International Programme on Chemicals Safety (IPCS 1999). Principles for the
Assessment of Risks to Human Health from Exposure to Chemicals. Environmental
Health Criteria 210, World Health Organization, Geneva.
http://www.pic.int/secEdoc/Environmental%20Health%20Criteria%20210.pdf
Nagata, Y. 2003. Measurement of odor threshold by triangle odor bag method. Odor
Measurement Review, Japan Ministry of the Environment. Pp. 118-127.
http://www.env.go.jp/en/air/odor/measure/02_3_2.pdf
Organisation for Economic Co-operation and Development (OECD) 2010. Draft OECD
Guidance document for the derivation of an acute reference concentration (ARfC), Paris,
France. http://www.oecd.org/dataoecd/13/49/45799595.pdf
Ruijten, MW, R van Doorn, and APhVan Harreveld. 2009. Assessment of odour
annoyance in chemical emergency management. RIVM Report 609200001. National
Institute for Public Health and the Environment, the Netherlands.
http://www.rivm.nl/bibliotheek/rapporten/609200001.pdf
List of References Available Online or Provided with PDF Files by TCEQ
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van Harreveld, AP. 2003. Odor Regulation and the History of Odor Measurement in
Europe. Odor Measurement Review, Japan Ministry of the Environment. Pp. 54-61.
http://www.env.go.jp/en/air/odor/measure/02_1_3.pdf
List of References Provided with PDF Files
Boobis, A. R., S. M. Cohen, V. Dellarco, D. McGregor, M. E. Meek, C. Vickers, D.
Willcocks, and W. Farland. 2006. IPCS framework for analyzing the relevance of a
cancer mode of action for humans. Crit Rev Toxicol 36 (10):781-92.
Cimino, M. C. 2006. Comparative overview of current international strategies and guidelines
for genetic toxicology testing for regulatory purposes. Environ Mol Mutagen 47 (5):36290.
Clewell, H. J., P. R. Gentry, T. R. Covington, R. Sarangapani, and J. G. Teeguarden. 2004.
Evaluation of the potential impact of age- and gender-specific pharmacokinetic
differences on tissue dosimetry. Toxicol Sci 79 (2):381-93.
Daston, G., E. Faustman, G. Ginsberg, P. Fenner-Crisp, S. Olin, B. Sonawane, J. Bruckner,
W. Breslin, and T. J. McLaughlin. 2004. A framework for assessing risks to children
from exposure to environmental agents. Environ Health Perspect 112 (2):238-56.
Dearfield, K. L., and M. M. Moore. 2005. Use of genetic toxicology information for risk
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H. Kim, D. Kirkland, D. D. Levy, E. Lorge, M. M. Moore, G. Ouedraogo-Arras, M.
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Dorne, J. L., K. Walton, and A. G. Renwick. 2005. Human variability in xenobiotic
metabolism and pathway-related uncertainty factors for chemical risk assessment: a
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Eastmond, D. A., A. Hartwig, D. Anderson, W. A. Anwar, M. C. Cimino, I. Dobrev, G. R.
Douglas, T. Nohmi, D. H. Phillips, and C. Vickers. 2009. Mutagenicity testing for
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European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC). 2002. Adverse
and nonadverse effects in toxicity studies. ECETOC Technical Report 85. Brussels,
Belgium.
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Foos, B., M. Marty, J. Schwartz, W. Bennett, J. Moya, A. M. Jarabek, and A. G. Salmon.
2008. Focusing on children's inhalation dosimetry and health effects for risk assessment:
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Ginsberg, G. L., B. Asgharian, J. S. Kimbell, J. S. Ultman, and A. M. Jarabek. 2008.
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Grant, R.L., Kadlubar, B.J., Erraguntla, N.K., Honeycutt, M. 2007. Evaluation of acute
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