USDA/APHIS NAIS DOCUMENTS
     
MEMBERSHIP FORM and PETITION

USDA HANDBOOK addresses Farmers as Uneducated

What is DEPOPULATION?

Points For Opposing Animal ID

Export Myths and Fairytales

NASS Survey Information

ARAPA Statement to the Senate Ag Committee

Codex Alimentarius

FORCED NAIS

Sound Science Killing Us

What Can I Do?

2006 ARKANSAS COOPERATIVE AGREEMENT WITH USDA

What are the vets saying?

BREAKING NEWS

Congressmen Speak Out

International Entanglements

What is COOL?

Mad Cow Madness

CONTACT US

By-Laws

2007 ARKANSAS COOPERATIVE AGREEMENT WITH USDA

Important Links

ARKANSAS ANIMAL PRODUCERS ASSOCIATION

Photos From Conway Meeting

FREEDOM TO FARM ACT UPDATES

ALERTS

Corporate Hostile Takeover

What About The Amish?

CONSTITUTION RULES

How do Packers fit in?

The Real Reason for Animal ID

AUSSIE ANIMAL ID IMPACT STUDY

Endangered Property Rights

Organic & Grassfed Growers Also Affected

DATABASES - How Safe Are They?

Wake Up, Farmers!

USDA/APHIS NAIS DOCUMENTS

CAPTIVE ANIMAL FACTORY FARMING

Technology Behind NAIS

AUSSIE RANCHER SPEAKS OUT

NIAA Conference Reports

Pushing Us Off Our Farms

Ag Lawyer Responds to the NAIS

NAIS SUMMARY

INDUSTRIALIZED FARMING

Uncle Sam Wants YOUR Animals!

HORSE TIMELINE FOR NAIS INCLUSION

NAIS DRAFT STRATEGIC PLAN

What is REAL ID?

"CREATIVE" SIGN-UPS BY THE GOVERNMENT

Animal ID Problems in Other Countries

Farm Bureau Connection

NAIS Threatens Rare Breeds

RFID Tags - Good, Bad & Ugly

R-CALF USA Fights NAIS

Retired Army Colonel Rebuts NAIS

Equine Species Working Group Contacts

BRUCE KNIGHT'S SPEECH

INFO ON USDA'S NEW "USER'S GUIDE"

SCRAPIE ID for Goats/Sheep & the NAIS

NAIS ID Terminology

GETTING OUT OF THE NAIS

The PLUM ISLAND CONNECTION

The Plan is AGENDA 21

4-H, FFA Targeted at Fairs

MICROCHIPS Cause CANCER

Leon's Story - Chipped Dog Died From Cancer

TRACKING ROGUE CHICKENS

Protection From Terrorist Livestock

NAIS NEWS in OTHER STATES

Truth about FOOD CONTAMINATION

TRUTH about Foot & Mouth Vaccines

MICROCHIP PROBLEMS IN DUTCH HORSES

What is DELPHI TECHNIQUE

NEW INFORMATION ON EQUINES

2005 ARKANSAS COOPERATIVE AGREEMENT WITH USDA/APHIS

CONTACT GENERAL ASSEMBLY MEMBERS FOR ARKANSAS

Bird Flu Fowl Play

USDA, INCORPORATED

ECONOMIC IMPACT ON HORSE OWNERS

 

USDA/APHIS NAIS DOCUMENTS


                              USDA - UNITED STATES DEPARTMENT OF AGRICULTURE
                                       MARKETING AND REGULATORY PROGRAMS
                                    ANIMAL AND PLANT HEALTH INSPECTION SERVICE

     "ADMINISTRATION OF OFFICIAL IDENTIFICATION DEVICES WTIH THE ANIMAL IDENTIFICATION NUMBER"

                                                    February 23, 2006

INTRODUCTION

As part of its ongoing efforts to safeguard U.S. animal health, the United States Department of Agriculture (USDA) intiated the implementation of a National Animal Identification System (NAIS) in 2004. The NAIS is a cooperative State-Federal-industry program administered by USDA's Animal and Plant Health Inspection Service (APHIS). The main objective is to develop and implement a comprehensive information system which will:

        *  Support ongoing animal disease monitoring, surveillance, detection, and response capabilities in order to complete current eradication programs;

        *  Enable State and Federal animal health officials to respond rapidly and effectively to animal health emergencies such as foreign animal disease outbreaks or emerging domestic diseases with significant economic, social, or public health consequences;

        *  Enable State and Federal animal health officials to promptly ascertain animal health status for the purpose of issuing intrastate, interstate, or international animal health movement certificates.

When an animal disease is detected, the first question is, "Where has the infected animal been?" Answering this question is critical in determining what other animals were exposed and estimating the size and scope of the outbreak. The more quickly this can be done, the less the disease will spread, and the less impact the outbreak will have.

THE ULTIMATE LONG-TERM GOAL OF THE NAIS IS TO PROVIDE STATE AND FEDERAL OFFICIALS WITH THE CAPABILITY TO IDENTIFY ALL ANIMALS AND PREMISES THAT HAVE HAD DIRECT CONTACT WITH A DISEASE OF CONCERN WITHIN 48 HOURS AFTER DISCOVERY.

The NAIS is a voluntary program. Producers and other stakeholders can now participate in the program to test the system and offer feedback to help ensure that practical solutions evolve. To have a successful animal disease management program, all producers and affected industry segments will have to participate eventually. As the system is further developed, market forces are likely to the the primary "driver" that will encourage participation. While there has been some support from industry for making parts of the system mandatory, the USDA would only consider such an approach in the future if determined to be necessary. At that time, USDA would follow the normal rulemaking process in changing the status of the NAIS from voluntary to mandatory. The public would have the opportunity to comment on any proposed regulations.

The NAIS will be established through a phased-in approach by implementing these key components:

        *  Premises Identification

           The identification of premises (locations that manage or hold animals) provides the foundation of the NAIS; thus, this is the starting point of the program. Each premises that participates in the NAIS will be identified with a unique seven-character identifier, which is recognized as a premises identification number (PIN).

           Having the ability to plot locations within a radius of an infected premises helps determine the potential
           magnitude of contagious disease and the resources that are needed to contain it. This can only be done if the infected premises and other premises in the area are registered prior to the outbreak. Otherwise, at the beginning of an outbreak and for weeks after, animal health crews must drive up and down country roads looking for premises containing susceptible species. Meanwhile, the disease may spread and the cost of containment, escalate. Thus, premises information alone, even without animal movement information, is of critical importance to our agency's prime objective of protecting American agriculture.

           Additionally, premises registration is a prerequisite of animal identification and is needed to establish animal movement information. All States and several Tribes became operational on premises registration by mid 2005, with 160,000 premises registered as of December 1, 2005.

        *  Animal Identification

           Animals are identified either individually with a unique animal identification number (AIN) or, if they are
           managed and moved through the production chain as a group, with a group/lot identification number    (GIN). Animal identification associates an animal with a premises and will provide the origin, or birthplace, of the animal.

        *  Animal Tracking

           As animals move from premises to premises, the AIN or GIN will be associated with the new PIN while the animals maintain their original numbers. Only a few basic pieces of information will be collected for each reportable movement: The AIN or GIN, the PIN of the receiving location, and the date of the animal or animals' arrival. The ability to achieve the 48-hour traceback goal is directly related to the percentage of animal movements that are recorded and will require significant infrastructure throughout the preharvest production chain. This component will likely take years to establish.

The basic requirements for official identification devices are defined in the Code of Federal Regulations (CFR). APHIS supports the integration of technologies to automate the collection and/or validation of the AIN and has established a technology-neutral position for such options. APHIS, therefore, will not select specific animal identification technologies for use in the NAIS and believes that the marketplace and stakeholders, within certain constraints, can best determine the most practical animal identification technologies.

Uniformity and compatibility of technology are critical to ensure that collection of animal identification data is practical and cost effective throughout the preharvest production chain. Therefore, it is appropriate that minimal performance and "open" technology standards be established that will allow for compatibility when such technologies are used. Such standards will be recommended by Species Working Groups to the NAIS Subcommittee of the Secretary's Advisory Committee on Foreign Animal and Poultry Diseases (SACFAPD). The NAIS Subcommittee will then report to the SACFAPD, which will make recommendations to the Secretary. APHIS will review the recommendations. The Department also recognizes the need to have compatibility of identification technologies with Canada and Mexico. As the NAIS is phased in, ongoing efforts to harmonize animal identification with other countries will facilitate safe trade in animals with other countries.


OFFICIAL IDENTIFICATION

As noted above, two types or levels of animal identification are necessary to support animal disease management programs; individual animal and "group/lot" identification. Individual animals may be identified in the NAIS by means of the AIN. The identification devices may differ among species. For example, eartags are typical for cattle, while other devices, such as implants, are used for horses, alpacas and llamas. Existing official identification devices recognized in the CFR for use in APHIS' disease control and eradication programs will continue to be available.

Technology that may enhance the utility of the AIN, such as by allowing the number to be collected automatically, will be allowed, but not required. The use of such technology will be market driven. Such options, referred to in this document as supplemental identification, will be discussed later in this document.

Animal Identification Numbers (AIN)

In an interim rule published in the "Federal Register" on November 8, 2004, and effective on that date (69 FR 64644-6451, Docket No. 04-052-1), USDA recognized the AIN as an official numbering system for individual animals reared in the United States. The AIN consists of 15 digits, with the first 3 being the country code (840 for the United States).

Example: 840123456789012

(The interim rule actually recognized not only numbers beginning with the "840" country code but also numbers beginning with the alpha characters "USA" and with the numeric code assigned to the manufactureer of the identification device by the International Committee on Animal Recording (ICAR) as AINs. The latter two formats, which some producers were using prior to the interim rule, are trasitional, however, and will be phased out). The interim rule did not require use of the AIN. The regulations continue to allow the use of numbering systems previously recognized in the CFR, such as the National Uniform Eartagging System.

Official Identification Devices

Eartags are the most commonly used method of individual animal identification for certain species; therefore, the interim rule amended the definition of official eartag. The previous definition of official eartag only allowed for the use of the National Uniform Eartagging System or use of a system using a PIN in conjunction with the producer's livestock production numbering system. The revised definition of official eartag also allowed for the use of the AIN. The revised definition also required that official eartags must bear the U.S. shield in addition to an official identification number and must be tamper-resistant and have a high retention rate in the animal. We have continued, however, to recognize eartags without the shield that feature the transitional "USA" or manufacturer's code AINs so that producers already using such tags would not be forced to retag their animals.

AIN Tags

Participation in the NAIS is voluntary, and eartags using the AIN (referred to in this document as AIN tags) will be an option for use with certain species when individual official animal identification is required by the CFR. Producers that choose to use the AIN must first obtain a PIN. AIN tags must conform to the CFR requirements for official eartags and meet the standards for printing characteristics, readability, durability, etc., that are contained in table 1 of this report. These standards assume the use of AIN tags imprinted with the "840" number and the U.S. shield.

TABLE 1.                        AIN TAG - REQUIREMENTS AND DESCRIPTION

Performance Requirements

   A. One-time use    The tag must be designed for one-time use (tamper evident), making it impossible to remove and reapply the tag without visual evidence of tampering.

   B. Unalterable     The printing on the tag may not be readily altered.

   C. Readability     The AIN must be easily and reliably readable. The printing and color contrast of the U.S. Shield, lettering, and numbers are to be readable at a distance of 30 inches (0.75m).

   D. Tag loss rates  On average, when applied in a manner approved by the manufacturer, not more than 1 percent of tags applied may be lost in the year following application or in any year thereafter under normal field 
conditions over the expected life of the tag.

   E. Expected Tag Life:   The minimum time that a tag shall be expected to remain on an animal in a functional state(physically) is for the expected life of the animal.

   F. Tag Toxicity    Tags may do no harm to an animal or affect its health or well-being.
      and Animal
      Injury          Tags may not cause chemical contamination of meat or edible offal or damage the hide.

   G. Tag             There may be no diffusion of colorant from tags.
      Deterioration
                      There may be no apparent physical deterioraton (other than color) due to detrimental effects by UV light, rain, heat (45C) and cold (-30C) or other environmental influences such as chemicals, mud, urine, or manure for at least 5 years of wear.

   H. Tag Plasticity  Devices may not split or crack under normal use.

   I. Tag Coupling/Tensile Strength:   Tag coupling/tensile strength: Evaluation standards must conform to ICAR testing standards and, at minimum, should comply with ISO standards 37 and 527. 

   J. Tag Abrasion Resistance:   Tag abrasion resistance: Tags shall not exhibit damage or change due to wear, may be subjected to ICAR testing standards and, at minimum, should comply with ISO standard 9352.

Description of Printing

      * The tag must have the U.S. Shield imprinted on its surface. Two-piece tags must have the U.S. Shield and the AIN with the "840" country code imprinted on both pieces.

      * The tag must bear the entire 15-digit AIN.

      * The U.S. Shield must have a minimum width of 0.2 inches (5mm).

      * The font for all characters imprinted on the tag must be Arial or, if different, approved by APHIS.

      * Print size for bovine tags must be a minimum height of 0.2 inches (5 mm) for numbers and letters.

      * An indentation of the manufacturer's unquie, copyrighted logo or trademark must be easily observed on the tag. Having such information permanently imprinted on the tag is also acceptable.

      * The text "Unlawful to Remove" should be imprinted on the tag.

      * A space should be inserted between each 3rd digit of the AIN imprinted on the AIN tag: for example, 850 003 123 456 789.

      * Printing of other information may be authorized if it does not compromise the readability of the required
        information.


Authorization of AIN Tags

*  USDA Approval Pending

We are establishing the "USDA Approval Pending" designation to support the use of the "840" AIN in conjunction with approved tags during the initial, voluntary phase of NAIS. AIN tags that meet the parameters described in Table 1 of this document will qualify for USDA Approval Pending status. The applicant must provide documentation when submitting the application that comfirms that the tags meet or exceed the requirements.

*  USDA Approved

When the NAIS becomes fully operational, more complete testing and evaluation procedures and an approval process for official identification devices will be available. At such time, a designation of "USDA Approved" will be established. Manufacturers of AIN tags, regardless of prior permission to use the devices in the NAIS, will have to submit new or appended applications to be considered for USDA Approved status.

USDA/AHPIS reserves the right to independently evaluate identification devices using resources within the agency or through contractual services with universities or private research firms. Evaluations may include laboratory and/or field studies to verify compliance with tag criteria and tag specification standards. Loss of USDA Approval Pending or USDA Approved status may occur at any time if USDA evaluations reveal that manufacturing and/or performance measures do not meet the standards and criteria listed in Table 1. These studies may include controlled experiments comparing USDA Approval Pending and USDA Approved devices as well as individual device performance in varying environments across the United States.

Supplemental Identification

Producers may elect to incorporate supplemental identification methods or technologies they prefer with the AIN tag. In such cases, the AIN tag, or device with the AIN, will remain the official identifier.

International standards, or standards that achieve a base of conformity, must be established and incorporated for the integration of technologies when used to supplement the primary or basic identification tag. For example, if radio frequency identification (RFID) devices are to be used for supplemental identification, the devices' transponders will need to conform to ISO 11784 and 11785. Such compliance allows for one reader to interrogate transponders manufactured by various companies. This approach will also allow RFID of other frequencies, biometrics (DNA, retinal imaging, etc.), and othe desired technologies to be used as supplemental identification with the AIN tag or device.

*  Supplemental Identification for Bison and Cattle

The identification technology and/or method used to integrate the AIN may vary among species. Cattle are a priority in the initial roll-out of the AIN. The use of RFID eartags with the AIN was discussed in the NAIS Draft Program Standards, published May 2004. Prior to the publication of that document, the NAIS Subcommittee had recommended the useof an RFID tag as the standard identification tag for cattle in the NAIS. Commenters on the Draft Program Standards who discussed the issue of cattle identification methods, while acknowledging the need to integrate new technologies as they develop, also supported the use of RFID ISO compliant eartags.

At this time, USDA views visual identification tags as a starting point for the identification of cattle to ensure greater participation among all producers. Table 1, above, provides minimum standards for such tags. However, producers preferring RFID may opt to use additional technology as supplemental identification devices; thus RFID tags, as described in the Draft Program Standards, remain an option for official identification in the NAIS.

    -  AIN/RF ISO Tags for Bison and Cattle

    The combination of an ISO-compliant RFID transponder encased in a visual tamper-evident eartag with the AIN imprinted is called an AIN/RF ISO tag. The AIN imprinted on the AIN/RF ISO tag must also be encoded in the transponder.

    To provide an open market for the transponders, yet ensure compatibility of the technology across vendors, ISO 11784 (Radio frequency identification of animals - Code structure) and 1185 (Radio frequency identification animals - Technical concept) must be used for AIN/RF ISO tags in order for those tags to be recognized as supplemental identification devices in the NAIS. Therefore, all transponders must be certified for conformance with ISO 11784 and 11785 by ICAR.  ICAR is a world-wide organization with over 40 member countries dedicated to the standardization of animal recording and productivity evaluation. The organization's goal is to promote improvement of farm animal recording and evaluation through the formulation of definitions and standards. ICAR administers the testing procedures to determine compliance of RFID transponders with ISO 11784 and 11785.

    ISO 11784 defines the code structure of the transponder while ISO 11785 defines technical (communication) protocols and allows transceivers (readers) to be compatible with transponders manufactured by different companies. However, ISO standards are not performance standards, and, thus, not all ISO-compliant transponders perform equally. The performance standards for AIN/RF ISO tags are contained in Table 2. These standards must be met, in addition to the requirements for the visual components of the tag described in Table 1. As we have noted already, RFID tags are not required for use in the NAIS but may be used as supplemental identification devices. Tags that meet the requirements contained in Tables 1 and 2 will receive "USDA Approval Pending" authorization as described earlier.


TABLE 2.                                  BOVINE AND CATTLE AIN/RF ISO TAG STANDARDS

   A. ISO Compliant    All transponders must be certified by ICAR for conformance with ISO-11784 and 11785.

   B. Electonic Read Rates and Ranges:  In a laboratory with a neutral electromagnetic environment: Transponders must have a 100 percent read rate in best orientation at 24 inches (60 cm) in a stationary test and a moving test of 1 m/sec over a passage length of at least 20 inches (50 cm).

   C. Expected Tag Life:    The minimum time that a tag shall be expected to remain functional (electronically) is for the expected life of the animal.

   D. Transponder  Security:    The official number encoded within each transponder must not be able to be altered and must be contained within the tag.

                       Tags will be tamper-evident and impossible to unseal without visible evidence of tampering.

   E. Transponder Failure Rates:     The transponder within the tag shall be reliable and machine-readable for the expected lifetime of the animal.


The AIN Management System

The AIN Management System is a Web-based program that administers AINs. The AINs are allocated to companies that manufacture official idenfication devices or technologies. Other individuals and organizations may perform roles that support the distribution of official identification devices to producers. The complete and accurate recording of the AINs distributed and assigned to each premises is imperative. The AIN Management System allows for many participants in various roles and provides the means to record AIN allocations to manufacturers and distribution to premises. Key roles in the intial roll-out of the AIN Management System include AIN tag manufacturers, managers, and resellers.

Manufacturers have specific roles and responsibilites regarding the maufacturing of AIN tags; managers and resellers have roles that support the distribution of AIN tags to producers' premises. The manufacturers, managers, and resellers (distributors) are referred to as nonproducer participants (see page 4 of the Draft Program Standards). Each nonproducer participant will obtain a nonproducer participant number (NPN) through the premises registration system in the State in which the company will obtain an NPN through the Kansas premises registration system. All NPN's are unique seven-character numbers similar to PINs.

Manufacturers, managers and resellers must obtain a Level 2 eAuthentication account to have access to the authorized user options of the AIN Management System. eAuthentication is an identity verification system used by the USDA to provide a single authorization for multiple USDA accounts. To begin the process, go to the eAuth website at

http://www.eauth.egov.usda.gov/eauthWhatisAccount.html.

*  AIN Tag Manufacturers

AIN tag manufacturers are companies authorized by APHIS to manufacture approved identification devices and are responsible for the overall production and quality of the official identification devices that contain the AIN. Potential AIN tag manufacturers must submit an AIN tag manufacturer application to USDA. AIN tag manufacturers may only produce AIN tags with the AINs that have been allocated to them by APHIS. AIN tag manufacturers may also be AIN tag managers.

   Note: For the purposes of the NAIS, companies that acquire the ID tag from another source and are responsible for imprinting the devices are considered the manufacturers and assume all responsibility for the product. In such cases, the company that imprints the tag submits the AIN tag manufacturer application and is the sole contact for APHIS regarding tag quality issues.

   AIN tag manufacturers must:

    1. Abide by the terms and conditions set forth in the AIN tag manufacturer agreement;

    2. Complete the AIN tag manufacturer training program provided by USDA;

    3. Imprint the "840" AINs allocated to them with the U.S. Shield on identification devices approved by APHIS;

    4. Maintain the uniqueness of the AINs allocated to them;

    5. Imprint approved tags according to the specifications listed in Table 1 of this document;

    6. Report the shipment of all AIN tags to the AIN Management System according to established protocols prescribed in the NAIS Technical Supplement (provided on www.usda.gov/nais) within 24 hours of shipment;

    7. Have an operational computerized system that communicates with the AIN Management System and is compatible with NAIS standards to maintain the necessary information, including a database of the manufacturer product codes for all devices that contain an AIN;

    8. Furnish official identification devices to AIN tag managers;

    9. Have a means to support the distribution of AIN devices through marketing agreements with AIN tag managers or be AIN tag managers themselves;

   10. Provide a record (if applicable) to APHIS of all "transitional" AINs produced with a "USA" prefix (this format is referred to as the American ID numbering system) and their ICAR manufacturer number;

   11. Agree to discontinue the printing of any identification numbering system as directed to do so by USDA if USDA terminates and phases out an official numbering system;

   12. Maintain a record of inventoried AIN tags and have such records available to the USDA upon request; and
 
   13. Enter the names of nonproducer participants that they wish to utilize as AIN managers into the AIN Management System, advising them that such designation requires participation in AIN manager training provided by USDA.

Note: One AIN tag is required to meet the definition/criteria for official identification. A second AIN tag for the same animal with the same AIN may be used when double tagging is preferred. Regarding AIN/RF tags, only one tag with the AIN encoded in the transponder is permissible.

*  AIN Tag Managers

   AIN tag managers are individuals, organizations, or companies that provide AIN tags to another AIN tag manager or reseller, or to a premises. The AIN tag manager must have an AIN tag distribution agreement with an AIN tag manufacturer(s).

   In order to be an authorized AIN tag manager, the individual or firm must agree to abide by the following:

       1. Complete the AIN tag manager training provided by USDA;
 
       2. Distribute AIN tags only to a premises or entity that has either a PIN or NPN and validate the accuracy of the PIN or NPN;

       3. Provide the validated PIN or NPN to the entity that ships the AIN tags when not completing the delivery themselves;

       4. Maintain a record of inventoried AIN tags received from an authorized AIN tag manufacturer or another authorized AIN tag manager or returned from a premises, and have such records available to the USDA upon request;

       5. Submit to the AIN Management System within 24 hours (or close of next business day), in accordance with prescribed protocols, a record of all AINs shipped or delivered; and

       6. Educate producers receiving AIN tags on the proper use of official animal identification devices.

   The AIN tag manager confirm on-line, using the AIN Management System, that they have a marketing agreement with a specific AIN tag manufacturer(s). USDA will recognize the individual or entity as an AIN tag manager upon confirmation of the marketing agreement(s) and upon the AIN tag manager completing training.

* AIN Tag Resellers

The AIN tag reseller has a marketing agreement with an AIN tag manager instead of the manufacturer. He or she assumes the same responsibility as an AIN tag manager, validating PINs and reporting the distribution of the AIN tags he or she ships or delivers to a premises. In order to be an authorized AIN tag reseller, the individual or firm must agree to abide by the following:

      1. Complete the AIN tag reseller training provided by USDA;

      2. Distribute AIN tags only to a premises or entity that has either a PIN or NPN and validate the accuracy of the PIN or NPN;

      3. Provide the validated PIN or NPN to the entity that ships the AIN tags when not completing the delivery themselves;

      4. Maintain a dated record of inventoried AIN tags received from an authorized AIN tag manager or another authorized  AIN Tag Reseller, or returned from a premises, and have such records available to the USDA upon request;

      5. Submit to the AIN Management System within 24 hours (or close of next business day), in accordance with prescribed protocols, a record of all AINs shipped or delivered; and

      6. Educate producers receiving AIN tags on the proper use of official animal identification devices.

The AIN tag reseller must confirm on-line, using the AIN Management System, that they have a marketing agreement with a specific AIN tag manager(s). USDA will recognize the indivdual or entity as an AIN tag reseller upon confirmation of the marketing agreement(s) and upon the AIN tag reseller completing training.

                                     NATIONAL ANIMAL IDENTIFICATION SYSTEM (NAIS)

                                      STRATEGIES FOR THE IMPLEMENTATION OF NAIS

                                                    April 2006

INTRODUCTION AND EXECUTIVE SUMMARY

As part of its ongoing efforts to safeguard U.S. animal health, the U.S. Department of Agriculture (USDA) initiated the implementation of a National Animal Identification System (NAIS) in 2004. The NAIS is a cooperative State-Federal-industry program administered by USDA's Animal and Plant Health Inspection Service (APHIS). The main objective is to develop and implement a comprehensive information system, which will support ongoing animal disease programs and enable State and Federal animal health officials to respond rapidly and effectively to animal health emergencies such as foreign animal disease outbreaks or emerging domestic diseases. Some components of the NAIS are already operational and available  for producer participation, the final component will be operational in early 2007. The ultimate long-term goal of the NAIS is to provide State and Federal officials with the capability to identify all animals and premises that have had direct contact with a disease of concern within 48 hours afte discovery.

The NAIS is a voluntary program. Producers and other stakeholders can now participate in the program to test the system and offer feedback to help ensure that practical solutions evolve. The NAIS establishes standards for producers to identify their animals and to report animal movements that will support the needs of animal health officials to track animals for the purposes of managing animal diseases. Animal movement information will be maintained by the industry and will provide the traceback and trace forward information for animal health officials while, at the same time, maintaining other information the industry deems necessary for marketing purposes.

The NAIS is being established through a phased-in approach by implementing these key components:

     *  Premises Identification
     *  Animal Identification
     *  Animal Tracking

Premises registration, the foundation of NAIS, is critical to rapidly detecting and evaluating the scope of animal disease outbreaks and improving emergency response efficiency. The availability of nationwide premises registration data provides for a more timely gathering of information to help manage animal diseases and saves manpower, time, and logistical support. Fifty States, five Tribes, and two Territories, as of March 2006, registered 235,000 premises accounting for approximately 10 percent of the national total.

Animal identification will streamline emergency response efforts and enhance existing disease surveillance, control, and eradication programs. Identifying each animal, with a unique identifier, at its birthplace and linking that identifier to the premises of origin gives animal health officials a "starting point" for epidemiologic investigations. Group/lot identification also provides equivalent capabilites for species that typically move through the production chain as a group of animals. Without that starting point, weeks and, too often, months of manual tracebacks are required to determine the source of the disease.

Animal tracking databases that maintain the movement records of animals will be owned and managed by the industry and States. These information systems will provide the locations of a subject animal and the records of other animals that the subject animal came into contact with at each premises. The data collection infrastructure is a major element of the animal tracking component. The completeness of animal movement records will directly affect the effectiveness of the response to a detected disease and the reliability for achieving the long-term 48-hour traceback/trace forward goal.


                                               IMPLEMENTATION PLAN

Immediate Participation Milestones

Much of the NAIS, from a systems perspective, is operational; remaining systems elements soon will be. The following are key

NAIS milestones:

    *  June 2004:   Cooperative agreements established with the States and Tribes
    *  August 2005: Premises registration systems operational in 50 States and 2 Territories
    *  March 2006:  Individual animal identification begins
    *  June 2006:   Cooperative Agreements (CA) with Private/State Animal Tracking Databases (ATDs)
    *  Early 2007:  Private/State ATDs operational

Premises registration, the foundation of the system, has been implemented in all 50 States and 2 Territories. Several Tribes are also registering their premises. An enchancement to the Standardized Premises Registration System will be deployed mid-year 2006 that will provide the opportunity for more Tribes to administer premises registration activity on their reservations.

The animal identification phase is being implemented in March 2006. The animal identification number (AIN) will be authorized for use on AIN tags to support individual animal identification. The use of the Group/Lot identification number is also a viable option when animals move through the production chain as a group or lot of animals.

The next phase of NAIS implementation relates to animal tracking. To facilitate the integration of private and State animal tracking databases with the NAIS, APHIS has developed, as part of the implementation process, a portal that will allow interested organizations to participate in early 2006. APHIS' Veterinary Services (VS) has initiated the design of the portal, referred to as the Animal Trace Processing System (ATPS); its design, development, and testing of the system will continue throughout 2006, with deployment anticipated in early 2007. APHIS will enter into a CA with organizations that have databases that meet the ATD requirements and that wish to participate in the advancement of the private and State ATDs with the NAIS. Producers may participate in this industry-administered component in the very near future.

APHIS will work with stakeholders throughout 2006 to develop the complete requirements for the integration of private and State animal tracking databases with the NAIS. It is anticipated that the requirements for compliance will be completed by late 2006, and the actual integration of such systems with the ATPS is targeted for early 2007.

Achieving a Successful Level of Participation

Producers and affected industry segments will need to participate in NAIS for it to be successful in supporting the animal disease management programs. Market demands (age, source and process verification, traceability, etc.) are becoming of greater importance for certain species and could become a primary "driver" for achieving a successful level of participation in the NAIS. Allowing market forces and industry needs to drive producer participation in the NAIS is preferable to mandatory Federal regulations. As more producers participate in the system, and as the number of animals registered in the system increases, our ability to track animals will increase as well. The system will require a high degree of producer participation in order to achieve its goal of 48-hour traceability. The animal movement information maintained by the industry will provide the traceback and trace forward information for animal health officials.

Measurable benchmarks of participation rates for key program activities are defined with timelines necessary to reach full participation by the target dates. Participation levels will be evaluated and studies will be conducted to determine factors affecting participation.

Contingency Plan

This NAIS inplementation strategy provides the opportunity for the stakeholders to take a proactive approach to achieve full industry participation in the NAIS. If the marketplace, along with State and Federal identification programs, does not provide adequate incentives for achieving complete participation, USDA may be required to implement regulations. USDA will evaluate whether the participation levels are increasing at rates that will achieve full participation by 2009. Based on that analysis, USDA will determine if the market-driven incentives, along with industry "buy-in" for improved animal disease programs, is resulting in adequate participation and growth rates for NAIS to be successful by the established target dates.

If participation rates are not adequate, the development of regulations through normal rulemaking procedures will be considered to require participation in certain aspects of the program. The public would have the opportunity to comment on any proposed regulations.

Summary of Operational Milestones and Participation Benchmarks

The following summarizes APHIS estimates of the key operational milestones and benchmarks for participation. The chart illustrates the timelines for the implementation plan for the NAIS.

Operational Milestones:
      August 2005:     Achieved Operational Premises Registration Systems
      March 2006:      AIN Management System Operational
      June 2006:       Cooperative Agreements with Private/State ATDs
      February 2007:   Private and State ATDs and ATPS Operational

Benchmarks for Progress:
      January 2007:    25% of premises registered
      January 2008:    70% of premises registered
                              40% of animals identified
      January 2009:    100% of premises registered
                              100% of "new" animals identified
                              60% of animal<1 year of age have complete movement data

These benchmarks are participation level APHIS believes are necessary for the industry, State and Federal partnership to successfully achieve the goals and objectives of NAIS.


Benchmarks for Progress

The following charts reflect participation levels that USDA believes necessary to meet full participation in the NAIS to achieve the 48-hour traceback goal. While outreach and promotional efforts do encourage greater levels of participation in the NAIS, it is acknowledged that market incentives will be required to achieve these particpation levels.

1. Premises Registration

It is APHIS' estimate that 2 million premises exist in the United States that need to be registered by 2009. This includes all locations that manage and/or hold livestock and poultry. As of March 2006, over 235,000 premises have been registered and it is projected that 475,000 premises will be registered by year's end. The plan reflects annual registration rates to achieve 2 million premises registered by January 2009.

2. Animal Identification

Two typs or levels of animal identification are necessary to support animal disease management programs: individual animal and "group/lot" identification. Individual animals may be identified in the NAIS by means of the AIN. Group/Lot identification is accomplished through the use of a Group/Lot Identification Number (GIN). The GIN is created by the producer using the premises identification number of the location where the animals are found and the date the group or lot was created.

*  Allocation of AINs

The AINs are allocated to companies that manufacture and/or provide official identification devices or technologies. Other individuals and organizations may perform roles that support the distribution of official identification devices to producers. The complete and accurate recording of the AINs distributed and assigned to each premises is imperative. The allocation of AINs to a premises, in most cases, provides the point of origin of the animal, and therefore is another activity that warrants the establishment of goals. It is assumed that producers will apply AIN devices to their animals as the devices are purchased. The cattle industry represents the species with the largest population with approximately 33 million calves born each year. Other species groups that will identify animals individually (primarily sheep, goats, deer and elk) with visual AIN tags account for another 7 million animals. A benchmark of 40 million AIN tags distributed to premises in the calendar year of 2009 has been established. This benchmark reflects having all new animals officially identified that are born in 2009. The following provides benchmarks in the distribution of AIN tags to achieve the 2009 goal.

Benchmarks for AIN Distribution to Premises

Total Annual New Born Animals Estimate:  40,000,000

Annual Goal:
2006     % New animals ID'd - 5%     New Animals ID'd Annually - 2,000,000    
2007       New Animals ID'd - 35%    New Aniamls ID'd Annually - 14,000,000
2008       New Animals ID'd - 60%    New Animals ID'd Annually - 24,000,000
2009       New Aniamls ID'd - 100%   New Animals ID'd Annually - 40,000,000

Timeline Projections:
2006       July               Accumulative Total: 1,000,000
2007       Jan.                                   2,000,000
              July                                   9,000,000
2008       Jan.                                  16,000,000
              July                                  28,000,000
2009       Jan.                                  40,000,000

*  Termination Records

The collection of termination records can provide another critical piece of information. Determing the number of animals with AINs at termination will help determine the rate at which the AIN devices are maintained on the animals and comfirm the number of animals actually identified with an AIN. Approximately 35,000,000 cattle are harvested each year. The measure for this activity will be specific to the cattle industry and the benchmarks are provided in the following chart reflecting the goal of having all cattle identified at harvest with an AIN.

Benchmarks for Animals ID'd with AINs at Termination

Total Annual Animal Slaughtered Projection:    35,000,000

Annual Goal:
2006       % New Animals ID'd - 2%      New Animals ID'd Annually - 700,000
2007                          - 20%                               - 7,000,000
2008                          - 50%                               - 17,500,000
2009                          - 80%                               - 28,000,000

Timelines Projections:
2006       July               Accumulative Total: 350,000
2007       Jan.                                   700,000
              July                                   4,200,000
2008       Jan.                                   7,700,000
              July                                   16,450,000
2009       Jan.                                   25,200,000


3. Animal Tracking

To achieve high reliability with the 48-hour traceback goal, a high percentage of animal movement records need to be collected and available electronically. The ATPS will be in development in 2006 and will be used to evaluate the completenessof animal movement records.

*  Animal Movement Records

Random audits will be conducted on animals terminated to determine the number of animals with AINs that have full traceability.

Benchmarks for Animals with Complete Movement Records

Total Annual New Born Animals Estimate:    40,000,000

Annual:

2006           % New Animals w/Complete Records - 5%         New Animals w/Complete Records Annually - 2,000,000
2007                                            - 15%                                                - 6,000,000
2008                                            - 35%                                                - 14,000,000
2009                                            - 60%                                                - 24,000,000

Timeline Projections:

2006       July          Accumulative Total:  1,000,000
2007       Jan.                               2,000,000
              July                               5,000,000
2008       Jan.                               8,000,000
              July                              15,000,000
2009       Jan.                              22,000,000

Protecting American agriculture is the basic charge of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS has employees stationed across the country and around the world to accomplish this mission. APHIS works to safeguard American agriculture by keeping destructive foreign pests and diseases out of the United States. Should an exotic disease threaten U.S. borders, it's APHIS' role to combat the threat and prevent an outbreak. By ensuring the health and well-being of animals and plants nationwide, APHIS helps improve agriculture productivity and competitiveness and contributes to the national economy and the public health.

APHIS' dedicated workfoce strives to meet the needs of an ever-expanding customer base. We use state-of-the-art technology to keep up with trends in agriculture and international trade as well as other pertinent issues. All of our work enhances the United States' ability to buy and sell agricultural products in the international marketplace, fortifies our abundant, safe and diverse food supply, and contributes to the health of U.S. public and private lands.

GLOBAL TRADE AGREEMENTS

(OUR NOTE: PLEASE PAY CLOSE ATTENTION TO THIS SEGMENT ABOUT THE TREATIES - IT'S ABOUT TRADE...NOT ABOUT DISEASE!)

Several global trade agreements help APHIS to carry out its mission, the most important of which are the North American Free Trade Agreement (NAFTA) and the World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement, the successor to the General Agreement on Tariffs and Trade (GATT). Both have helped the United States become more competitive in the international trade arena, especially in the area of agriculture.

This growing interest in agricultural trade has created a more visible role for APHIS and expanded our mission to ensure that new trade opportunities benefit the United States without creating new threats from harmful exotic pests and diseases. APHIS is delegated as the primary negotiator for SPS-related trade issues. In that role, APHIS has the responsibility for regulating the importation of food and agricultural commodities into the United States as well as establishing SPS requirements that set the boundaries for safe international agricultural trade. The need for such SPS requirements is fully recognized by NAFTA and the WTO.

NAFTA, a trilateral trade pact between the United States, Canada, and Mexico, went into effect in January 1994. The GATT was established in the wake of World War II, and its successor organization, the WTO, was created in 1995 after a series of trade negotiations known as the Uruguay Round. Collectively, the WTO's more than 140 member countries account for more than 90 percent of world trade. Decisions are made based on the consensus of the entire WTO membership.

During NAFTA and WTO negotiations, countries embarked on a historic effort to reform agricultural trade. Under both agreements, countries are required to base their SPS measures on scientific evidence. In short, countries are now required to scientifically justify their reasons for impeding the free flow of trade. With the reductions in quotas and tariffs that are a result of WTO and NAFTA, there is a greater potential for countries to use pests and diseases as artificial barriers to trade. In order to exclude agricultural products presented for importation, a country must be able to scientifically document that allowing such importation would create an unacceptable risk of introducing foreign pests or disease. To be designated as quarantine significant, a pest or disease must not exist in the importing country or be present only in a limited area that is under official control.

NAFTA and WTO requirements for risk assessments are intended to make countries' SPS regulations more transparent and scienctifically based. Countries also are required to be consistent in their risk management practices. Agricultural officials cannot treat one country different from another when the importation of their goods would result in the same pest risk. It is important to note, however, that NAFTA and WTO clearly recognize the rights of countries to set their own levels of protection.

Regionalization

In addition, the WTO and NAFTA commit countries to recognizing disease- and pest-free areas *within* a country even if a particular pest or disease exists elsewhere in the nation. This concept is perhaps the most significant policy and regulatory issue facing APHIS and our trade partners. It has, however, created new opportunities for the United States, as well as other countries that may have a pest in one region but be free of it elsewhere.

The concept of regionalization is founded on the longstanding idea that import requirements should be based on geography and science rather than on politics. The political borders between countries and delimiting states within a country are invisible; geographic boundaries, such as mountains and rivers, are not. Pests and diseases must be able to travel in order to spread. If the path is blocked by a mountain range down the middle of a country, then the disease is naturally confined to one side of that country.

The states of Sonora and Yucatan in Mexico are prime examples. While other regions in Mexico still have outbreaks of classical swine fever (CSF), the prevalence of the disease in Sonora and Yucatan is low. Based on the principle of regionalization and a risk analysis, the United States accepts imports of fresh (chilled or frozen) pork from Sonora and Yucatan even though other regions of the country are not allowed to export pork to the United States because of the presence of CSF.

Plant health officials refer to regionalization as "area freedom". The name is different, but the results are the same. When Pennsylvania officials discovered an outbreak of plum pox in October 1999, area freedom kept the entire State, and perhaps the entire Nation, from being quarantined. Under area freedom, the disease, which infects stone fruit, resulted in a quarantine only in the Adams County, PA, area where plum pox was detected. Other major U.S. stonefruit-producing areas, such as Washington, can continue to export peaches, apricots, plums and almonds.

Should one nation disagree with another's trade requirements, the requirements can be challenged through NAFTA and the WTO's dispute settlement processes. A disagreement arising between Mexico, Canada or the United States could be first addressed through NAFTA. In both NAFTA and the WTO, a panel is appointed to review the situation and make a ruling. If a country fails to recognize the panel's ruling, the WTO provides a mechanism for proceeding.

International Standards

The WTO and NAFTA encourage countries to base their SPS regulations on international standards. Countries are required to publish proposed regulations in order to give other nations a chance to comment before the regulations go into effect. This process is intended to reduce unnecessary variance between countries' technical health standards - differences that are often the cause of trade disputes. It is a top priority of APHIS to work with our trading partners to develop internationally acceptable standards. We've already made great progress in this area with some nations, especially Canada and Mexico. APHIS works with and recognizes a number of standards-setting organizations that help determine the rules for international trade.

L'Office International des Epizooties (OIE) and Animal Health

One of the most important standards-setting organizations, Paris-based OIE has more than 150 member countries. It was started in the 1920's in response to the appearance of rinderpest in Europe from Pakistan. Each member country has one vote and one delegate. Its major functions are to collect and disseminate information on the distribution and control of animal diseases, coordinate research on contagious animal diseases, and standardize rules for international trade in animals and animal products.

OIE aims to ensure that scientifically justified measures are used to govern international trade in animals and animal products. The WTO has designated the OIE as the international forum for setting animal health standards, reporting global animals health situtaions and status, and presenting guidelines and recommendations on animal health issues.

International and North American Organizations for Plant Health

The WTO recognizes the International Plant Protection Convention (IPPC) when it comes to setting plant health standards. In effect since 1952, the IPPC is a multilateral treaty that promotes "...common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote measures for their control." The treaty is administered by the Food and Agriculture Organization (FAO) of the United Nations. Currently, more than 100 countries adhere to the IPPC.

In 1989, an IPPC Secretariat was created to coordinate activities for the IPPC and to support the development and administration of international phytosanitary standards. Given the importance of international standards to future agricultural trade, the technical and regulatory nature of plant health issues covered by the IPPC, and APHIS' scientific expertise in this area, APHIS has assumed the role of lead U.S. agency participating in activities of the IPPC.

The IPPC objectives are to develop international plant health standards, promote the harmonization of plant quarantine activities with emerging standards, facilitate the dissemination of phytosanitary information. support plant health assistance to developing countries, and resolve disputes.

The North American Plant Protection Organization (NAPPO) - a regional plant protection organization of the IPPC created in 1976 - coordinates the efforts among Canada, the United States, and Mexico to protect their plant resources from the entry, establishment, and spread of plant pests while ensuring the free flow of trade between the three nations. APHIS employees are frequently assigned to NAPPO committees charged with reviewing technical standards or reviewing new methods for pest control.

For example, APHIS employees worked with NAPPO to develop guidelines for the release of nonnative organisms to control weeds.

In addition to establishing plant quarantine standards, NAPPO also has developed a pest risk analysis (PRA) standard. PRAs are generally done for every agricultural commodity entering the United States. The PRA identifies foreign pests that could harm U.S. agriculture and the level of risk related to a particular commodity. By adhering to the PRA standard developed by NAPPO, the United States, Mexico and Canada can all be assured they're using the same approach to evaluate pest risks.

Codex and Free Trade Areas for the Americas

The Codex Alimentarius Commission for food safety standards is the third international standards-setting organization recognized by the WTO. Jointly managed by the World Health Organiztion and the FAO, Codex, established in 1963, facilitates world food trade by establishing international standards based on accepted scientific knowledge. Codex deals with subjects such as food additives, pesticide residues, and food labeling. Codex expert committees are composed of representatives from government regulatory agencies, such as USDA's Food and Safety and Inspection Service, the international scientific community, and industry.

The OIE, NAPPO, and Codex have earned prominent roles in determing the substance, direction, priorities, and outcomes of SPS requirements. Domestic groups have grown increasingly aware of these organizations and the importance of their activities, resulting in increased interest and expectations concerning the development, establishment, and amendment of international standards, particularly from the standpoint of dispute resolution.

In addition to working with such standards-setting organizations as the OIE, IPPC, and Codex, the United States is also involved in the proposed negotiation of Free Trade Areas for the Americas (FTAA). In January 1995, the United States and 33 governments from Central and South America and the Caribbean established the foundation for the FTAA, making a joint declaration of their committment to the hemispheric integration of economics and trade by 2005. FTAA has the potential of accelerating greater intrahemispheric trade, particularly in agriculture, given the significant role that agriculture plays in the economies of most Latin American and Caribbean countries. The FTAA initiative reflects current U.S. trade policy aimed at deepening our trade relations with newly emerging or developing economies of our hemisphere.

As a result of WTO and the pending FTAA, Latin America has evolved into an important region in terms of new markets for U.S. agricultural goods. APHIS has played an instrumental role in establishing trade relationships with these countries.

Asia-Pacific Economic Cooperation

Another example of U.S. efforts to broaden commercial relations beyond Europe and Canada is APHIS' participation in the Asia-Pacific Economic Cooperation (APEC). APEC was established in 1989 to promote cooperation in trade and other economic issues. What started out as an organization with 12 member countries has nearly doubled in size to encompass countries as diverse as Australia, Brunei, and China. As a member of APEC, the United States attends regular meetings to discuss such issues as trade liberalization, technology transfer, investment, energy, and other topics of mutual interest. It was not until 1995, however, that APEC members agreed to address agricultural trade. At this time, a group of agricultural technical experts was formed to discuss issues, including biotechnology and quarantine and pest management.

APHIS recognizes the countries in the Pacific Rim region as strategically important agricultural markets and plays a key role in meetins of the APEC agricultural technical experts. In recent years, APHIS has worked hard to develop technical working relationships with such nations as Japan, South Korea, and China. These relationships have been instrumental in creating new markets for U.S. agricultural commodities. APHIS was successful in March 2000 with helping to open up the Chinese market to U.S. citrus. Besides being economically significant, this agreement also helps pave the way for future market opportunities.

Without the creation of the WTO and NAFTA, such trade relationships would not be possible. It's a principle role of APHIS to make sure the United States and our trading partners adhere to the SPS rules set forth by the WTO and NAFTA as well as the other relevant standars-setting organizations. While trade agreements have helped to open up new markets for the United States and other countries, APHIS must ensure that U.S agriculture is protected in all endeavors and that agricultural imports from foreign countries do no create new pathways for pests. APHIS' role in the global marketplace will continue to increase as the United States expands current trade relationships and establishes new partnerships with developing countries.

http://www.aphis.usda.gov