[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44586-44587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18879]
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ENVIRONMENTAL PROTECTION AGENCY
[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.
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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 This draft guidance does not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the draft guidance from http://www.regulations.gov; or http://www.epa.gov/raf/microbial/index.htm or from Dr.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
information.
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].
SUPPLEMENTARY INFORMATION: Both EPA and USDA/FSIS have an established
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]
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