[Federal Register Volume 66, Number 152 (Tuesday, August 7, 2001)]
[Notices]
[Pages 41195-41197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19825]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-064-1]


Animal Disease Risk Assessment, Prevention, and Control Act

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of public meeting and request for comments.

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SUMMARY: We are seeking comments and suggestions regarding the 
development of a report required by the Animal Disease Risk Assessment, 
Prevention, and Control Act of 2001. The report will discuss the 
economic impacts that would be associated with the potential 
introduction of foot-and-mouth disease, bovine spongiform 
encephalopathy, and related diseases into the United States; the 
potential risks posed by those diseases to public and animal health; 
and recommendations to protect the health of animal herds and U.S. 
citizens from those risks. We will use the information gathered through 
this notice and a public meeting to assist us in developing this 
report.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by September 6, 2001. We will also consider 
comments made at a public meeting that will be held on August 24, 2001 
from 9:00 a.m. to 12:00 p.m.

ADDRESSES: Please send your postal comment and three copies to: Docket 
No. 01-064-1, Regulatory Analysis and Development, PPD, APHIS, Suite 
3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238 We will also 
accept comments electronically via the Animal Disease Risk Assessment, 
Prevention and Control website at http://comments.aphis.usda.gov. 
Please state that your comment refers to Docket No. 01-064-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    The public meeting will be held at the Animal and Plant Health 
Inspection Service, 4700 River Road, Riverdale, MD, Conference Rooms C 
and D.

FOR FURTHER INFORMATION CONTACT: Mr. William O. Macheel, Policy and 
Program Development, APHIS, 4700 River Road Unit 120, Riverdale, MD 
20737-1236; (301) 734-4420.

SUPPLEMENTARY INFORMATION:

Background

Foot-and-Mouth Disease

    Foot-and-mouth disease (FMD) is a severe and highly contagious 
viral infection affecting cattle, deer, goats, sheep swine, and other 
animals. The most effective means of eradicating FMD is by the 
slaughter of affected animals. Although FMD was eradicated in the 
United States in 1929, the virus could be reintroduced by a single 
infected animal, animal product, or person carrying the virus. Once 
introduced, FMD can spread quickly through exposure to aerosols from 
infected animals, direct contact with

[[Page 41196]]

infected animals, contact with contaminated feed or equipment, or 
contact with humans harboring the virus or carrying the virus on their 
clothing. FMD is endemic to more than two-thirds of the world and is 
considered to be widespread in parts of Africa, Asia, Europe, and South 
America. FMD virus occurs in at least 7 different serotypes and over 60 
subtypes. As FMD outbreaks have occurred, the United States has banned 
the importation of live ruminants and swine as well as many animal 
products, from countries affected by FMD. Recently, the United States 
implemented bans in response to outbreaks in Argentina, the European 
Union, and Taiwan.
    It appears that FMD is primarily spread among livestock through 
aerosol, direct contact, and ingestion of animal products including 
milk products. FMD could be introduced into the United States if animal 
products carrying the FMD virus that have not been properly processed 
are imported into the United States from regions where FMD exists and 
are ingested by ruminants or other livestock in the United States. 
Current outbreaks in a number of formerly FMD-free regions have 
demonstrated both the speed with which an FMD outbreak can spread and 
the magnitude of its consequences.
    An FMD outbreak in the United States could be devastating, given 
the Nation's extensive livestock holdings. Besides the direct economic 
effects on ruminant and swine producers, consequences of the disease 
would ripple through the economy, causing indirect costs in sectors 
beyond agriculture. International movement of many commodities would be 
disrupted by restrictions imposed by trading partners. Preliminary 
results of an APHIS simulation model indicate that costs of an FMD 
outbreak to the national economy could range from several hundred 
million dollars to billions of dollars.

Bovine Spongiform Encephalopathy

    Bovine spongiform encephalopathy (BSE) is a neurological disease of 
bovine animals and possibly other ruminants and is not known to exist 
in the United States. It appears that BSE is primarily spread though 
the use of ruminant feed containing certain protein products from 
ruminants infected with BSE. Currently, the U.S. Food and Drug 
Administration (FDA) regulations at 21 CFR 589.2000 prohibit the 
feeding of protein products that contain or may contain certain protein 
derived from mammalian tissues to cattle and other ruminants. However, 
BSE could be introduced into the United States if foreign-source 
protein materials carrying the BSE agent, such as meat, animal 
products, animal byproducts, and related materials are imported into 
the United States from regions where BSE exists, or from regions that 
present an undue risk of introducing BSE into the United States, and 
are ingested by cattle or other ruminants in the United States. BSE 
could also be introduced into the United States if ruminants from 
regions where BSE exists, or ruminants from regions that present an 
undue risk of introducing BSE into the United States, are imported into 
the United States.
    A ban on the feeding of ruminant products to other ruminants was 
enacted in the United Kingdom in 1988 and in certain other European 
countries in the early 1990's. A ban on the feeding of all mammalian 
products to ruminants was enacted in the European Union (EU) in 1994. 
However, several EU countries have identified cases of BSE in animals 
born after these bans were imposed. This has led to the conclusion 
among experts studying these cases that feed that was not prohibited by 
the bans was cross-contaminated by feed of ruminant origin. It appears 
likely that such cross-contamination occurred at facilities that 
process both prohibited and nonprohibited products.
    Opinions issued in July and November 2000 by the European 
Commission's (EC's) Scientific Steering Committee stated that such 
cross-contamination has prolonged the BSE epidemic in Europe. In 
December 2000, the EC announced a temporary prohibition on the feeding 
of processed animal protein to all farmed animals. This prohibition 
became effective on January 1, 2001.

The Animal Disease Risk Assessment, Prevention, and Control Act

    The Animal Disease Risk Assessment, Prevention, and Control Act of 
2001 (Pub. L. 107-9 referred to below as the Act) directs the Secretary 
of Agriculture to provide the people of the United States and Congress 
with information concerning actions by Federal agencies to prevent FMD, 
BSE, and related diseases in the United States; the sufficiency of 
legislative authority to prevent or control FMD, BSE, and related 
diseases in the United States; the economic impacts that would be 
associated with the potential introduction of FMD, BSE, and related 
diseases into the United States; and the risks to public health from 
possible links between BSE and other spongiform encephalopathies to 
human illness.
    The Act requires the Secretary of Agriculture, after consultation 
with other Federal agencies, to submit to the committees and 
subcommittees designated by the Act a preliminary report concerning 
coordinated interagency activities to assess, prevent, and control the 
spread of FMD and BSE in the United States; sources of information from 
the Federal government available to the public on FMD and BSE; and any 
immediate needs for additional legislative authority, appropriations, 
or product bans to prevent the introduction of FMD or BSE into the 
United States. The preliminary report has been prepared and will be 
submitted to Congress in the near future. The committees and 
subcommittees designated by the Act to receive the report are the 
Committee on Agriculture of the House of Representatives; the Committee 
on Agriculture, Nutrition, and Forestry of the Senate; the Subcommittee 
on Agriculture, Rural Development, and Related Agencies of the 
Committee on Appropriations of the Senate; and the Subcommittee on 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies of the Committee on Appropriations of the House of 
Representatives.
    The Act also requires the Secretary of Agriculture to submit to the 
same committees and subcommittees of Congress a final report that 
discusses the economic impacts that would be associated with the 
potential introduction of FMD, BSE, and related diseases in the United 
States; the potential risks to public and animal health from FMD, BSE, 
and related diseases; and recommendations to protect the health of 
animal herds and citizens of the United States from those risks, 
including, if necessary, recommendations for additional legislation, 
appropriations, or product bans.
    The Act requires the Secretary, in preparing the final report, to 
consult with other Federal agencies; private and nonprofit sector 
experts in infectious disease research, prevention, and control; 
international, State, and local governmental animal health officials; 
private, nonprofit, and public sector livestock experts; 
representatives of blood collection and distribution entities; 
representatives of consumer and patient organizations; and other 
interested members of the public.

Content of Final Report

    The Act provides that the final report shall contain:
     An assessment of the risks to the public presented by the 
potential

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presence of FMD, BSE, and related diseases in domestic and imported 
livestock, livestock and animal products, wildlife, and blood products;
     Recommendations to reduce and manage the risks of FMD, 
BSE, and related diseases;
     Any plans of the Secretary to identify, prevent, and 
control FMD, BSE, and related diseases in domestic and imported 
livestock, livestock products, wildlife, and blood products;
     A description of the incidence and prevalence of FMD, BSE, 
variant Creutzfeldt-Jakob (vCJD) disease and related diseases in other 
countries;
    A description and an analysis of the effectiveness of the measures 
taken to assess, prevent, and control the risks of FMD, BSE, vCJD, and 
related diseases in other countries;
     A description and an analysis of the effectiveness of the 
measures that the public, private, and nonprofit sectors have taken to 
assess, prevent, and control the risk of FMD, BSE, and related diseases 
in the United States, including controls of ports of entry and 
conveyances;
     A description of the measures taken to prevent and control 
the risk of BSE and vCJD transmission through blood collection and 
transfusion; and
     A description of any measures (including any planning or 
managerial initiatives such as interagency, intergovernmental, 
international, and public-private sector partnerships) that any Federal 
agency plans to initiate or continue to assess, prevent, and control 
the spread of FMD, BSE, vCJD, and related diseases in the United states 
and other countries.
    The final report shall also provide plans and recommendations in 
the following areas:
     Plans by Federal agencies (including the Centers for 
Disease Control and Prevention) to monitor the incidence and prevalence 
of the transmission of FMD, BSE, vCJD, and related diseases in the 
United States and to assess the effectiveness of efforts to prevent and 
control the spread of FMD, BSE, vCJD, and related diseases in the 
United States;
     Plans by Federal agencies (including the Agricultural 
Research Service, the Cooperative State Research, Education, and 
Extension Service, and the National Institutes of Health) to carry out, 
in partnership with the private sector, research programs into the 
causes and mechanism of transmission of FMD and BSE and diagnostic 
tools and preventative and therapeutic agents for FMD, BSE, vCJD, and 
related diseases; and
     Plans for providing appropriate compensation for affected 
animals in the event of the introduction of FMD, BSE, or related 
diseases into the United States.
    Provisions for the final report also include recommendations to 
Congress for legislation that will improve efforts to assess, prevent, 
or control the transmission of FMD, BSE, vCJD, and related diseases in 
the United States and in other countries.
    We welcome all comments on the issues discussed above and encourage 
the submission of ideas on any associated topics or other suggestions 
for the evaluation of disease risk assessment, prevention, and control 
processes. We will use the information gathered through this notice and 
the public meeting to assist us in developing the report to Congress.
    You may submit your postal or electronic comments to the addresses 
provided at the beginning of this notice under the heading ADDRESSES. 
In addition, we will be hosting a public meeting to provide interested 
persons a full opportunity to orally present any data, views, 
suggestions, and questions. The public meeting will be held on Friday 
August 24, 2001, at the Animal and Plant Health Inspection Service, 
4700 River Road, Riverdale, MD, Conference Rooms C and D, from 9:00 
a.m. to 12:00 p.m.
    A representative of APHIS will preside at the public meeting. Any 
interested person may appear and be heard in person, by attorney, or by 
other representative. Written statements may be submitted and will be 
made part of the meeting record. Persons who wish to speak at the 
meeting will be asked to provide their name and organization. We ask 
that anyone who reads a statement or submits a written statement 
provide two copies to the presiding officer at the meeting.
    If you wish to speak at the meeting, please register in advance by 
sending an e-mail message to [email protected] or by 
calling Mr. Macheel (see FOR FURTHER INFORMATION CONTACT). The message 
should contain your name, telephone number, organization, if any, and 
an estimate of the time you need to speak.
    On-site registration for the public meeting will take place outside 
the meeting room from 8:30 a.m. to 9:00 a.m. The public meeting will 
begin at 9:00 a.m. and is scheduled to end at 12:00 p.m., local time. 
However, the meeting may be terminated at any time after it begins if 
all persons desiring to speak have been heard. If the number of 
speakers at a meeting warrants it, the presiding officer may limit the 
time for presentations so that everyone wishing to speak has the 
opportunity.

Parking and Security Procedures

    Please note that a fee of $2 is required to enter the parking lot 
at the USDA Center. The machine accepts $1 bills or quarters.
    Upon entering the building, visitors should inform security 
personnel that they are attending the Animal Disease Risk Assessment, 
Prevention, and Control public meeting. Identification is required. 
Security personnel will direct visitors to the registration tables 
located outside of Conference Rooms C and D. Registration upon arrival 
is necessary for all participants.

    Done in Washington, DC, this 2nd day of August 2001.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-19825 Filed 8-6-01; 8:45 am]
BILLING CODE 3410-34-U