[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Page 45329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18752]

[[Page 45329]]



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.


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: 
[email protected]; 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: [email protected]; phone: (202) 564-


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,
[FR Doc. 2012-18752 Filed 7-27-12; 4:15 pm]