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Draft Risk Assessment for the Public Health Impact of Highly Pathogenic Avian Influenza Virus in Poultry, Shell Eggs, and Egg Products

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Food Safety and Inspection Service, USDA.


Notice of request for comment.


The Food Safety and Inspection Service (FSIS) is requesting public comment on a draft quantitative food safety risk assessment for highly pathogenic avian influenza (HPAI) virus associated with the consumption of poultry products, shell eggs, and egg products. The purpose of this risk assessment is to: (1) Estimate the public health impact from human exposure to HPAI virus through the consumption of contaminated poultry products, shell eggs, and egg products, and (2) evaluate the relative effectiveness of strategies to reduce or prevent exposure to HPAI virus from the consumption of poultry meat, shell eggs, and egg products.


Submit written comments by February 2, 2009.


FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods:

* Federal eRulemaking Portal: Go to and follow the instructions.

* Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, 1400 Independence Avenue, SW., Room 2534 South Building, Washington, DC 20250.

All submissions received must include the Agency name and docket number FSIS-2007-0001.

All comments submitted in response to this notice will be posted to Agency's Web site at​regulations/​2008_​Notices_​Index/​. Individuals who do not wish FSIS to post their personal contact information—mailing address, e-mail address, telephone number—on the Internet may leave this information off of their comments. Comments will also be available for public inspection in the FSIS Docket Room at the address listed Start Printed Page 73241above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

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Neal J. Golden, Office of Public Health Science, FSIS, 1400 Independence Avenue, SW., Aerospace Center, Washington, DC 20250-3700; Telephone: (202) 690-6419; Fax: (202) 690-6337; Electronic mail:

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I. Background

Avian influenza viruses are Influenza A viruses of the family Orthomyxoviridae and are endemic in birds of many countries. Avian influenza has been shown to infect mammalian species including cats, horses, pigs, seals, and whales. Avian influenza varies in its ability to cause disease in both humans and birds. Most strains are classified as low pathogenic avian influenza (LPAI) which causes mild disease in infected domestic poultry characterized by low morbidity and low mortality rates. LPAI virus rarely infects humans and does not pose a significant human health threat. HPAI virus, however, causes a more severe clinical disease in infected poultry, with high morbidity and mortality rates. HPAI virus can occasionally infect humans and other mammalian species. For more information on avian influenza viruses see​wps/​portal/​usdahome?​contentidonly=​true&​contentid=​2005/​11/​0511.xml.

The majority of known human cases of HPAI are epidemiologically linked to close contact with live or dead poultry, resulting in occasional infection of poultry workers, poultry cullers, and poultry farmers (​foodsafety/​micro/​avian/​en/​). Possible routes of infection include respiratory inhalation of infective droplets or self-inoculation (e.g., by a human handler touching mucous membranes or conjunctiva after contact with avian fecal contamination, avian respiratory secretions, or avian body fluids), rather than consumption of poultry products, shell eggs, or egg products (​en/​science/​biohaz/​biohaz_​documents/​1412.html).

There are no reported epidemiological data linking the consumption of poultry products, eggs, or egg products to human illness from HPAI virus. Despite this lack of evidence, the possibility of consumption as an exposure route remains a concern to food safety experts. In Asia, two cases of HPAI infection may be related to food consumption of infected raw duck blood products, although contact with live or dead HPAI-infected poultry could not be epidemiologically excluded.

In light of the recent HPAI poultry and human outbreaks in Asia, Africa, Europe, and the Middle East, and of the lack of clear evidence of a risk from exposure through consumption of poultry products, shell eggs, and egg products, a draft risk assessment was developed by an Interagency Workgroup formed from representatives of each of these three agencies: FSIS, the Department of Health and Human Services' (DHHS) Food and Drug Administration (FDA), and USDA's Animal and Plant Health Inspection Service (APHIS). The purpose of this quantitative risk assessment is to: (1) Estimate the public health impact from human exposure to HPAI virus through the consumption of contaminated poultry products, shell eggs, and egg products, and (2) evaluate the relative effectiveness of strategies to reduce or prevent exposure to HPAI virus from the consumption of poultry products, shell eggs, and egg products.

Other routes of exposure such as inhalation, mucosal contact, wound exposures by food preparers, and consumer contact with contaminated raw poultry and eggs, as well as farm and processing occupational exposures, are not addressed in this risk assessment.

II. The Draft Risk Assessment

This draft risk assessment has undergone an independent external peer review consistent with the requirements in OMB's “Final Information Quality Bulletin for Peer Review” and substantial review by various government agencies. This quantitative risk assessment provides a science-based, analytical approach to collate and incorporate available data into a mathematical model. It provides risk managers with a decision-support tool to evaluate the effectiveness of preparedness and current and future interventions to reduce or prevent foodborne illness. This risk assessment can also be used to target risk communication messages, identify and prioritize research needs, and provide a framework for coordinating efforts with stakeholders.

Potential human exposure was modeled separately for poultry products and for shell eggs. Egg products were qualitatively addressed. The draft exposure models for poultry products and for shell eggs estimated human exposure from the HPAI contamination of a single chicken, turkey, or hen flock and considered the farm-to-fork continuum including the farm, transportation, slaughter, consumer cooking, and consumer cross-contamination during preparation.

As part of an evaluation of the draft risk assessment, FSIS is seeking comments that can be used to improve:

(1) The assumptions made,

(2) The modeling techniques,

(3) The data used, and

(4) The clarity of the draft risk assessment document.

It is FSIS's intent to review and evaluate all public comments and make modifications to the assessment, as appropriate. The draft risk assessment is available electronically on the FSIS Web site (​Science/​Risk_​Assessments/​index.asp).

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at​regulations/​2008_​Notices_​Index/​. FSIS also will 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 our constituents and stakeholders. The Update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The Update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at​news_​and_​events/​email_​subscription/​. Options range from recalls, export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

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Done at Washington, DC on November 25, 2008.

Alfred V. Almanza,


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[FR Doc. E8-28598 Filed 12-1-08; 8:45 am]