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Microbial Risk Assessment Guideline (External Review Draft)

Risk Assessment Forum
Federal Register Notices

EPA Announces Peer Review Meeting of the Microbial Risk Assessment Guideline (2pp, 24K, About PDF)

U.S. EPA and the U.S. Department of Agriculture Food Safety Inspection Service (FSIS), along with scientists from other agencies, are leading an activity to develop a guideline for conducting microbial risk assessment. This document will improve transparency in how cooperating federal agencies conduct MRA and promote consistency in terms of approaches and methods. The Guideline is intended to be flexible for use in varied situations and to serve as a resource for U.S. Federal Government risk assessors and their agents, contractors, and the general risk assessment community.

The draft Guideline is focused on infectious diseases primarily associated with the gastrointestinal tract and arising from food and water, but it also has utility to a broader variety of scenarios. It applies to a wide range of human pathogens including viruses, bacteria, protozoa, and fungi. In addition to issues in common with chemical risk assessment, the document addresses issues that are unique to MRA such as secondary transmission, variation in immune status, and fluctuation in microbial populations.

Public Comment and External Peer Review
The draft document was released on July 26, 2011 for public comment by the EPA (c.f., Federal Register Volume 76, Number 143 Pages 44586-7). The public comment period closed on September 26, 2011. All comments received by the comment period closing date have been shared with the review panel for their consideration.

External peer review will be conducted by an EPA contractor on Monday November 7, 2011 at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW, Washington, DC 20024. The meeting will start at 8:30 a.m. and end no later than 5 p.m.

To attend the peer review meeting as an observer, you must register no later than November 3, 2011. You may do this by calling ERG on (781) 674-7374 or toll free on (800) 803-2833 (ask for the MRA peer review coordinator, Laurie Waite); sending a facsimile to (781) 674-2906 (reference the “MRA Peer Review Meeting” and include your name, title, affiliation, full address and contact information); or sending an email to meetings@erg.com (reference the `MRA Peer Review Meeting” and include your name, title, affiliation, full address and contact information). You can also register via the Internet at https://www2.ergweb.com/projects/conferences/peerreview/register-mra.htm Exit EPA Disclaimer . Space is limited, and registrations will be accepted on a first-come, first-served basis. There will be a limited amount of time for comments from the public at the peer review meeting. Please inform ERG if you wish to make oral comments during the meeting.

Background
Several offices within EPA and other Federal agencies have been conducting microbial risk assessments for several years using varying approaches to microbial risk assessment. To better harmonize approaches and methods, improve transparency with stakeholders and exploit lessons learned by these entities EPA has teamed with USDA’s Food Safety Inspection Service and scientists from other agencies to develop a guideline that meets the needs of the participating agencies.

This document is another product in the series of deliverables that EPA and its partner agencies have developed to promote the use of microbial risk assessment for meeting programmatic needs.

Downloads and Related Links

Thesaurus The Office of Water also developed, with assistance of a contractor, a comprehensive Thesaurus for microbial risks.

February 2007 Workshop on Challenges to Integrating Immunotoxicological and Microbial Risk Assessment for Susceptible Populations and Life Stages, and Real World Application of Microbial Risk Assessment Methods (30 pp, 225K, About PDF)
The EPA Risk Assessment Forum (RAF) convened a workshop of Agency, interagency and invited experts to address the intersection of human life stages, immunotoxicity impacts, and microbial disease susceptibility. The genesis for this workshop was the recognition that it is difficult to quantify the uncertainty surrounding microbial risks for sensitive groups, populations and lifestages. To complicate risk assessment even further, persons exposed to microbial pathogens are often exposed to chemical stressors, or even immunotoxins. The net effects of these additional stressors, or the effects based on immature immune system, are very real issues to the risk assessors at the EPA. There is also relatively little data on how these factors influence the dose-response to the pathogen(s) of interest. Therefore it was logical to seek out some of the experts in the several fields related to this issue, to determine what the state of the scientific knowledge was in this area.

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