01-19825. 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.

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 [phone] 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; [phone].

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 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 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 [e-mail] 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.