[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Page 45350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18543]



Notice of Availability of Microbial Risk Assessment Guideline: 
Pathogenic Microorganisms With Focus on Food and Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.


SUMMARY: The U.S. Environmental Protection Agency (EPA) and the Food 
Safety and Inspection Service (FSIS) of the U.S. Department of 
Agriculture are announcing the availability of the Microbial Risk 
Assessment Guideline: Pathogenic Microorganisms with Focus on Food and 
Water (MRA Guideline). The MRA Guideline will improve transparency in 
the way that the two federal agencies conduct microbial risk assessment 
and also promote consistency in approaches and methods. The MRA 
Guideline can be applied to similar scenarios involving microbial 
contamination, and it will serve a resource for federal government risk 
assessors, their agents, contractors, and for other members of the risk 
assessment community. When appropriate, the EPA intends to use the 
guidance prospectively when conducting risk assessments.

DATES: The document, Microbial Risk Assessment Guideline: Pathogenic 
Microorganisms with Focus on Food and Water will be available on July 
31, 2012.

ADDRESSES: A downloadable version and supporting materials are 
available on-line at http://www.epa.gov/raf/microbial.htm.

FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Risk Assessment 
Forum, Office of the Science Advisor (8105R), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460. 
His telephone number is (202) 564-3393. His email address is 
    Internet: The document can be downloaded on-line at http://www.epa.gov/raf/microbial.htm.

SUPPLEMENTARY INFORMATION: Risk assessment is used by federal agencies 
and other entities as a systematic way to prepare, organize, and 
analyze information to help make informed regulatory decisions, 
establish programs, and prioritize research.
    In 1983, Risk Assessment in the Federal Government; Managing the 
Process was published by the National Research Council (NRC) of the 
National Academy of Science to formalize the risk assessment process 
for chemicals in the environment and provide a basic framework that 
federal agencies could apply when conducting risk assessments. As the 
use of risk assessment as a tool to assist the federal government in 
its decision-making process has grown, it became apparent that the 1983 
NRC framework document, which was designed to address chemical 
contaminants, was not as useful for microbial risk assessment. Agencies 
conducting quantitative microbial risk assessment had to individually 
modify the 1983 framework to meet their specific needs. As a result, 
there existed no consistent approach to conducting microbial risk 
assessment among federal agencies.
    The EPA initiated the process of developing a microbial risk 
assessment guideline and engaged FSIS to co-lead the project. They were 
joined by scientists from other federal agencies in establishing a 
collaborative effort to develop this guideline. Clear and credible 
microbial risk assessment methods will leverage limited resources, 
promote efficiencies, improve transparency with stakeholders, and 
encourage joint interaction among agencies.
    The MRA Guideline facilitates the systematic and transparent 
consideration of all relevant factors that impact the risk assessment, 
and also facilitates reproducible risk evaluation. Using this 
guideline, agencies assessing a similar microbial medium or pathogen 
are able to more readily compare and contrast the details and 
assumptions of their assessment to another agency's assessment. 
Although the focus of this guideline is microbial contamination of 
water and food, it will also be useful for microbial risk assessment in 
a wide range of media and scenarios. The MRA Guideline applies to 
viruses, bacteria, protozoa, and fungi that are or maybe pathogenic to 
    EPA released a draft of the document for public comment in July, 
2011(76 FR 44586). EPA received two public comments--one from a member 
of the public and another from a foreign government authority 
responsible for the assessment of similar health risks in their 
country. All comments received by the comment period closing date were 
shared with an external peer review panel for their consideration and 
considered when revising the document. The MRA Guideline is available 
at: http://www.epa.gov/raf/microbial.htm; the peer review panel's 
comments and EPA's response to comments can also be found at the same 

    Dated: July 13, 2012.
Glenn Paulson,
Science Advisor.
[FR Doc. 2012-18543 Filed 7-30-12; 8:45 am]