[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Pages 73240-73242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28598]



Food Safety and Inspection Service

[Docket No. FSIS 2007-0001]

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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of request for comment.


SUMMARY: 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.

DATES: Submit written comments by February 2, 2009.

ADDRESSES: 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 http://www.regulations.gov 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 http://www.fsis.usda.gov/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

[[Page 73241]]

above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: 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: neal.golden@fsis.usda.gov.


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 
    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 (http://www.who.int/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 (http://www.efsa.europa.eu/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 (http://www.fsis.usda.gov/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 http://www.fsis.usda.gov/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 
    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 http://www.fsis.usda.gov/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.

[[Page 73242]]

    Done at Washington, DC on November 25, 2008.
Alfred V. Almanza,
[FR Doc. E8-28598 Filed 12-1-08; 8:45 am]