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

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Environmental Protection Agency (EPA).


Notice of document availability for public comment.


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 This draft guidance does not represent and should not be construed to represent EPA or USDA/FSIS policy, viewpoint, or determination. Members of the public may obtain the draft guidance from;​ or​raf/​microbial/​index.htm or from Dr. Michael Broder via the contact information below.


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.


Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-0532, by one of the following methods:

  • Follow the on-line instructions for submitting comments.
  • E-mail:
  • 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, 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 or e-mail. The 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, 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 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 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.

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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:

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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.

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Dated: July 15, 2011

Paul T. Anastas,

EPA Science Advisor.

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[FR Doc. 2011-18879 Filed 7-25-11; 8:45 am]