[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Page 45329]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2012-18752]
[[Page 45329]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2012-0023]
Availability of Microbial Risk Assessment Guideline: Pathogenic
Microorganisms With Focus on Food and in Water
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of availability.
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SUMMARY: The Food Safety and Inspection Service (FSIS) and
Environmental Protection Agency (EPA) are announcing the availability
of a guideline for conducting microbial risk assessment (MRA). The
guideline will improve transparency in the way the two Federal agencies
conduct MRA and will promote consistency in approaches and methods. The
guideline can apply in varied situations and will be a resource for
Federal Government risk assessors, their agents, contractors, and other
members of the risk assessment community.
DATES: The guideline is effective July 31, 2012.
ADDRESSES: A downloadable version of the guideline and additional
related materials, including the external peer review panel's comments
and associated responses, is available to view or print at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp. No hard copies of the guideline have been published.
FOR FURTHER INFORMATION CONTACT: Kerry Dearfield, U.S. Department of
Agriculture, Food Safety and Inspection Service, 1400 Independence Ave.
SW., Mail Stop 3766, Washington, DC 20250; email:
kerry.dearfield@fsis.usda.gov; phone: (202) 690-6451; or, Michael
Broder, Office of the Science Advisor, Mail Code 8105-R, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; Email: broder.michael@epa.gov; phone: (202) 564-
3393.
SUPPLEMENTARY INFORMATION:
I. Background
Risk assessment is widely recognized as a systematic way to
prepare, organize, and analyze information to help make regulatory
decisions, establish programs, and prioritize research and development
efforts. In 1983, Risk Assessment in the Federal Government; Managing
the Process (NRC 1983 report), published by the National Research
Council of the National Academics of Science, helped unify the risk
assessment process for chemicals in foods and the environment and
provided a basic framework that Federal agencies could apply when
conducting risk assessments. During the 1990s, it became apparent that
the NRC 1983 report had some shortcomings with respect to conducting a
MRA for microorganisms. Agencies conducting quantitative microbial risk
assessments had to individually adapt and make adjustments to the
method described in the NRC 1983 report to meet their specific needs.
As a result, there existed no consistent approach to conducting MRA
among Federal agencies.
FSIS and EPA, joined by scientists from other Federal agencies,
initiated a collaborative effort to develop guidelines that would
improve consistency in the way MRA is conducted. The agencies thought
that clear and credible risk assessment methods would leverage limited
resources, improve efficiencies, improve transparency with
stakeholders, and promote joint interaction. This cross-agency activity
generated the MRA Guideline.
The guideline facilitates systematic and transparent consideration
of all relevant factors that impact the risk assessment and facilitates
reproducible risk evaluation. Using the guidelines, agencies assessing
similar media or pathogens are able to more readily compare and
contrast the details and assumptions of their assessment to another
Agency's assessment. The guideline can apply in varied situations and
provides for the flexibility necessary for any Agency that chooses to
do so to use it effectively.
EPA released a draft of the document for public comment in July
2011 (76 FR 44586). EPA received two 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. The external peer
review panel's comments and associated responses are available for
review at: http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.) Persons with disabilities who require
alternative means for communication of program information (Braille,
large print, audiotape, etc.) should contact USDA's Target Center at
202-720-2600 (voice and TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
Additional Public Notification
FSIS will announce this notice online through the FSIS Web page
located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. In addition, FSIS offers an electronic mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/.
Options range from recalls to export information to regulations,
directives, and notices.
Customers can add or delete subscriptions themselves, and have the
option to password protect their accounts.
Done at Washington, DC, on: July 26, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-18752 Filed 7-27-12; 4:15 pm]
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