Health & Environmental Research Online (HERO)

Technical Report 
Guidelines for developmental toxicity risk assessment 
U.S. Environmental Protection Agency :: U.S. EPA 
U.S. Environmental Protection Agency, Risk Assessment Forum 
Washington, DC 
is also published as 732120 Guidelines for developmental toxicity risk assessment
The U.S. Environmental Protection Agency (EPA) is today issuing final amended guidelines for assessing the risks for developmental toxicity from exposure to environmental agents. As background information for this guidance, this notice describes the scientific basis for concern about exposure to agents that cause developmental toxicity, outlines the general process for assessing potential risk to humans because of environmental contaminants, summarizes the history of these guidelines, and addresses public and Science Advisory Board comments on the 1989 “Proposed Amendments to the Guidelines for the Health Assessment of Suspect Developmental Toxicants” [54 FR 9386-9403]. These guidelines, which have been renamed “Guidelines for Developmental Toxicity Risk Assessment” (hereafter “Guidelines”), outline principles and methods for evaluating data from animal and human studies, exposure data, and other information to characterize risk to human development, growth, survival, and function because of exposure prior to conception, prenatally, or to infants and children. These Guidelines amend and replace EPA’s 1986 “Guidelines for the Health Assessment of Suspect Developmental Toxicants” [51 FR 34028-34040] by adding new guidance on the relationship between maternal and developmental toxicity, characterization of the health-related database for developmental toxicity risk assessment, use of the reference dose or reference concentration for developmental toxicity (RfDDT or RfCDT), and use of the benchmark dose approach. In addition, the Guidelines were reorganized to combine hazard identification and dose-response evaluation since these are usually done together in assessing risk for human health effects other than cancer. 
• Ammonia
     Literature Search – March 2012 (private)
     Literature Search Results
     Not Chemical Specific
          Guidance, notices
• Benzo(a)pyrene (BaP)
• Biphenyl
     Cited References
• n-Butanol
     Additional Strategies
     Source – January 2013 (private)
          Additional strategies - 1/2013
          Merged reference set - 1/2013
     Secondary Sources of Health Effects Information
          Regulatory documents
     Cited in Document
     • Cited 2016 Public Comment Draft
          Tox Review
     Cited in Public Comment Draft – May 2016
          Toxicological Review
• Chloroprene
     Cited 2009 Draft
     Cited 2010 Final
• Chromium VI
     Not in Lit Search
• DCM (Dichloromethane) (Final, 2011)
• Diethyl phthalate (DEP)
• Diisobutyl Phthalate (DIBP) Final
• 1,4-Dioxane - with inhalation update
     Final (2013)
     External Review Draft (2011)
     Cited in Document
• Hexabromocyclododecane (HBCD)
     Guidance/contextual references added during assessment development
• Libby Amphibole Asbestos (Draft, 2011)
• Methanol (Non-Cancer)
     Cited in Final (2013)
     Cited in External Review Draft (2013)
     Cited in External Review Draft (2011)
• RDX (121-82-4)
     Cited 2015 (private)
     Guidance documents and contextual references
• Tetrachloroethylene (Perc) (Final, 2012)
• Trichloroacetic acid (TCA) (Final, 2011)
• Trichloroethylene (TCE) (Final, 2011)
     All References
• Trimethylbenzenes (Interagency Science Discussion Draft)
     Primary Literature Search
     Primary Literature Search- Considered
     Cited August 2016
          Cited Toxicological Review
• Trimethylbenzenes (TMB)
     Considered Studies
     Cited Studies
     Cited in Tox Review – Revised TMBs Draft
     Cited in Revised TMBs Draft - All
• Vanadium Pentoxide (Draft, 2011)
          2nd Draft
          Final Cited
     Cited in First ERD Nov2015
     Cited Second ERD Dec2016
     Cited in Final ISA Dec2017
          Chapter 5 – Health