| About the Microbial Risk Assessment Guideline |
Both USDA/FSIS and the Environmental Protection Agency (EPA) have an established history of conducting human health risk assessments on microbial agents. USDA/FSIS, EPA, and other Federal agencies often conduct microbial risk assessments on similar pathogens albeit in different media and under different scenarios (e.g., food and water). A common approach to conducting these assessments will foster better interaction among participating agencies leading to a more efficient and consistent process.
In order to better harmonize the way agencies conduct their assessments across programs, USDA/FSIS and EPA agreed to initiate a collaborative effort and were joined by scientists from other Federal agencies to develop guidelines to promote greater consistency within the government and provide more transparency to stakeholders and other interested parties. This cross-agency activity generated this Microbial Risk Assessment Guideline. This document discusses the full range of microbial risk assessment topics, e.g., definition of the roles and responsibilities, planning and scoping, the four components of a risk assessment, and sections discussing risk management and communication.
This document reflects the combined experience and expertise of risk assessors from these participating agencies and will promote a consistent approach to conducting microbial risk assessments.
U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) and U.S. Environmental Protection Agency (EPA) (2012). Microbial Risk Assessment Guideline: Pathogenic Organisms with Focus on Food and Water. FSIS Publication No. USDA/FSIS/2012-001; EPA Publication No. EPA/100/J12/001.
The Microbial Risk Assessment Guideline was developed via a collaborative effort among its participating agencies. During the drafting of the guideline, there were many internal reviews in these agencies. In addition, the draft guideline was circulated for interagency review via the Federal government's Interagency Risk Assessment Consortium (IRAC; http://foodrisk.org/irac/) for a fuller Federal government review. As the final interagency review, the draft guideline was submitted to the Office of Management and Budget (OMB) for a formal Federal government review as per the OMB processes in early 2011. Once the OMB review process was complete, the draft document was made publicly available for public comment and external peer review (see below).
Public Comment Period
The draft document (PDF) was released on July 26, 2011 for public comment by the EPA (c.f., Federal Register Volume 76, Number 143 Pages 44586-7).
External Peer Review
The draft document was reviewed by subject matter experts on November 7, 2011. The external peer review was conducted under the auspices of the EPA. Full details, including the peer review report and response to peer reviewers' comments, are found on the EPA website.
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