Health & Environmental Research Online (HERO)


Print Feedback Export to File Download
1466 
Technical Report 
Guidelines for mutagenicity risk assessment 
U.S. Environmental Protection Agency :: U.S. EPA 
1986 
Yes 
Federal Register
ISSN: 0097-6326
EISSN: 2167-2520 
U.S. Environmental Protection Agency, Risk Assessment Forum 
Washington, DC 
EPA/630/R-98/003 
51 
185 
1-17 
English 
The guidelines published today are products of a two-year Agency-wide effort, which has included many scientists from the larger scientific community. These guidelines set forth principles and procedures to guide EPA scientists in the conduct of Agency risk assessments, and to inform Agency decision makers and the public about these procedures. In particular, the guidelines emphasize that risk assessments will be conducted on a case-by-case basis, giving full consideration to all relevant scientific information. This case-by-case approach means that Agency experts review the information on each agent and use the most scientifically appropriate interpretation to assess risk. The guidelines also stress that this information will be fully presented in Agency risk assessment documents, and that Agency scientists will identify the strengths and weaknesses of each assessment by describing uncertainties, assumptions, and limitations, as well as the scientific basis and rationale for each assessment.

Finally, the guidelines are formulated in part to bridge gaps in risk assessment methodology and data. By identifying these gaps and the importance of the missing information to the risk assessment process, EPA wishes to encourage research and analysis that will lead to new risk assessment methods and data. 
• Ammonia
     Literature Search – March 2012 (private)
     Literature Search Results
     Not Chemical Specific
          Guidance, notices
• Asbestos
• Benzo(a)pyrene (BaP)
     Considered
     Cited
          Guidance
• Biphenyl
     Considered
     Cited References
          Guidance
• tert-Butanol
     Cited in Document
• n-Butanol
     • Cited 2016 Public Comment Draft
          Tox Review
• tert-Butanol
     Cited in Public Comment Draft – May 2016
          Toxicological Review
• Chloroform Combined (current)
     Chloroform (original)
• Chloroprene
     Cited 2009 Draft
     Cited 2010 Final
• Chromium VI
     Cited in Document
• DCM (Dichloromethane) (Final, 2011)
• 1,4-Dioxane - with inhalation update
     Final (2013)
     External Review Draft (2011)
• Formaldehyde
     Cited in text
     Retroactive RIS import
          Pre2013
               Formaldehyde IRIS 2011
                    Old references
• Libby Amphibole Asbestos (Draft, 2011)
• Methanol (Non-Cancer)
     Cited in Final (2013)
     Cited in External Review Draft (2013)
• PCBs
     Cited (Nov 2012)
• RDX (121-82-4)
     Cited 2015 (private)
• Tetrachloroethylene (Perc) (Final, 2012)
     All References
• Trichloroacetic acid (TCA) (Final, 2011)
• Trichloroethylene (TCE) (Final, 2011)
     All References
• Trimethylbenzenes (TMB)
     Considered Studies
          Other
     Cited Studies
          Guidance
          EPA
     Cited in Tox Review – Revised TMBs Draft
     Cited in Revised TMBs Draft - All
• Vanadium Compounds - Problem Formulation
     Manual review of existing IRIS and PPRTV assessments
          IRIS 2011/2014
     Combined data set
          Dataset for title/abstract screening
               Excluded- PECO criteria not met (TIAB)
• Vanadium Pentoxide (Draft, 2011)
OPPT REs
• OPPT_1,4-Dioxane_C. Engineering
     Data screening total
          Screening: Excluded
• OPPT_1,4-Dioxane_D. Exposure
     Total – title/abstract screening
          Off topic
• OPPT_1,4-Dioxane_E. Fate
     Total – title/abstract screening
          Off topic
• OPPT_1,4-Dioxane_F. Human Health
     Total – title/abstract screening
          Off topic
• OPPT_Methylene Chloride_C. Engineering
     Total – title/abstract screening
          Off topic
• OPPT_Methylene Chloride_D. Exposure
     Total – title/abstract screening
          Off topic
• OPPT_Methylene Chloride_E. Fate
     Total – title/abstract screening
          Off topic
• OPPT_Methylene Chloride_F. Human Health
     Total – title/abstract screening
          Off topic
• OPPT_Perchloroethylene (Perc)_C. Engineering
     Total – title/abstract screening
          Off topic
• OPPT_Perchloroethylene (Perc)_D. Exposure
     Total – title/abstract screening
          Off topic
• OPPT_Perchloroethylene (Perc)_E. Fate
     Total – title/abstract screening
          Off topic
• OPPT_Perchloroethylene (Perc)_F. Human Health
     Total – title/abstract screening
          Off topic
• OPPT_Trichloroethylene (TCE)_C. Engineering
     Total – title/abstract screening
          Off topic
• OPPT_Trichloroethylene (TCE)_D. Exposure
     Total – title/abstract screening
          Off topic
• OPPT_Trichloroethylene (TCE)_E. Fate
     Total – title/abstract screening
          Off topic
• OPPT_Trichloroethylene (TCE)_F. Human Health
     Total – title/abstract screening
          Off topic
• Project 9 – Soil and Dust Ingestion
     Cited October 2016
          Carcinogenicity Assessment- Cited