[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Page 45350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18543]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
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
broder.michael@epa.gov.
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
humans.
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
link.
Dated: July 13, 2012.
Glenn Paulson,
Science Advisor.
[FR Doc. 2012-18543 Filed 7-30-12; 8:45 am]
BILLING CODE 6560-50-P