[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Pages 44586-44587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18879]



[EPA-HQ-ORD-2011-0532; FRL-9443-9]

Notice of Availability of the External Review Draft of the 
Microbial Risk Assessment Guideline: Pathogenic Microorganisms With 
Focus on Food and in Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for public comment.


SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a 
60-day public comment period for the External Review Draft of 
``Microbial Risk Assessment Guideline: Pathogenic Microorganisms with 
Focus on Food and in Water.'' EPA developed the Guideline in 
collaboration with the U.S. Department of Agriculture, Food Safety 
Inspection Service (USDA/FSIS) and with scientists from other Federal 
agencies. This draft document is being released solely for the purpose 
of seeking public comment prior to peer review. The document will 
undergo independent peer review during an expert peer review meeting, 
which will be convened, organized, and conducted by an EPA contractor 
in 2011. The date of the external peer review meeting will be announced 
in a subsequent Federal Register notice. All comments received by the 
docket closing date September 26, 2011 will be shared with the external 
peer review panel for their consideration. Comments received after the 
close of the comment period may be considered by the two agencies when 
they finalize the document. This document has not been formally 
disseminated by EPA or USDA/FSIS. This draft guidance does not 
represent and should not be construed to represent EPA or USDA/FSIS 
policy, viewpoint, or determination. Members of the public may obtain 
the draft guidance from http://www.regulations.gov; or http://www.epa.gov/raf/microbial/index.htm or from Dr. Michael Broder via the 
contact information below.

DATES: All comments received by the docket closing date September 26, 
2011 will be shared with the external peer review panel for their 
consideration. Comments received beyond that time may be considered by 
EPA and USDA/FSIS when it finalizes the document.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2011-0532, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: [email protected].
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, 
Attention Docket ID EPA-HQ-ORD-2011-0532. Deliveries are only accepted 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. Special arrangements should be made for deliveries of boxed 
    Instructions: Direct your comments to Docket ID EPA-HQ-ORD-2011-
0532. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected by statute through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA, without 
going through http://www.regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA 
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the ORD 
Docket is (202) 566-1752.

[[Page 44587]]

FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Office of the 
Science Advisor, Mail Code 8105-R, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone 
number: (202) 564-3393; fax number: (202) 564-2070, E-mail: 
[email protected].

history of conducting human health risk assessments on chemical agents 
but less experience on microbial agents. EPA conducts microbial risk 
assessment on agents under a number of different statutes for a variety 
of purposes. These include both naturally occurring and genetically 
modified microorganisms with the potential for environmental exposure. 
USDA/FSIS is charged with ensuring the safety of food from the farm to 
the consumer.
    Microbial risk assessment entails addressing issues that are not 
considered in chemical risk assessment (e.g., die off and regrowth of 
bacteria, effects of prior exposure and immune status). EPA, USDA/FSIS 
and other Federal agencies often conduct risk assessments on similar 
pathogens albeit in different media and under different scenarios. A 
common approach to conducting these assessments will foster better 
interaction among participating agencies leading to a more efficient 
and consistent process. In order to better harmonize the way that EPA 
conducts its assessments across programs, EPA initiated and was joined 
by USDA/FSIS and scientists from other Federal agencies to develop 
guidelines to promote greater consistency within the government and 
provide more transparency to stakeholders and other interested parties. 
This cross-agency activity has generated the draft Guideline.
    This document addresses the full range of microbial risk assessment 
topics: Definition of the roles and responsibilities, planning and 
scoping, the four components of a risk assessment, and sections 
discussing risk management and communication. The Guideline identifies 
differences in issues and processes between chemical and microbial risk 
assessment such as secondary transmission (person to person), increases 
and decreases in microbial populations both in the environment and host 
individuals, and the role of prior exposure on disease manifestation.
    Collectively this document reflects the combined experience and 
expertise of risk assessors and will promote a consistent approach to 
conducting microbial risk assessments.

    Dated: July 15, 2011
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-18879 Filed 7-25-11; 8:45 am]