You are here:
STANDARD EVALUATION PROCEDURES FOR SUBMITTED DEVELOPMENTAL NEUROTOXICITY DATA
Citation:
STANDARD EVALUATION PROCEDURES FOR SUBMITTED DEVELOPMENTAL NEUROTOXICITY DATA. U.S. Environmental Protection Agency, Washington, DC.
Impact/Purpose:
To assist regulatory evaluators in their interpretation of developmental neurotoxicity data.
Description:
As a NAFTA-inspired multi-governmental initiative, experts from the US EPA (Office of Research and Development, Office of Pesticide Program, or OPP) and the PMRA (Pest Management Regulatory Agency) of Health Canada formed a working group to create a document that would serve as an internal guidance document for regulatory evaluators. The resulting standard evaluation procedures address each of the neurobehavioral endpoints in developmental neurotoxicology studies conducted according to US EPA and OECD test guidelines. For each, there is a description of the behavior itself followed by pragmatic explanations of what to look for and what it can mean. The information is meant to inform interpretation by the reviewer which may influence policy, but not to dictate policy itself. While this was initially termed an internal guidance document for regulatory evaluators, it has since become apparent that it may be made publicly available by Health Canada, NAFTA, and/or OPP.
URLs/Downloads:
Peer Reviewers (PDF, NA pp, 423 KB, about PDF)Response to Reviewers (PDF, NA pp, 373 KB, about PDF)
Reconciliation Memo (PDF, NA pp, 88 KB, about PDF)
Final Document (PDF, NA pp, 2384 KB, about PDF)
Cover Sheet for Final Document (PDF, NA pp, 271 KB, about PDF)
Reviewer #4 (PDF, NA pp, 304 KB, about PDF)
Reviewer #3 (PDF, NA pp, 99 KB, about PDF)
Reviewer #2 (PDF, NA pp, 272 KB, about PDF)
Reviewer #1 (PDF, NA pp, 356 KB, about PDF)
Peer Review Plan (PDF, NA pp, 33 KB, about PDF)
Charge Questions (PDF, NA pp, 467 KB, about PDF)