Attachment 02 Animal ID Device Standards.pdf

Animal Disease Traceability Official Animal Identification Device Standards (OAIDs)

Version 3.1

11/5/2024

Animal Disease Traceability Official Animal Identification Device Standards (OAIDS)

Version 3.1 November 5, 2024

Animal Disease Traceability Official Animal Identification Device Standards (OAIDS)

PREFACE

SECTION A: OFFICIAL IDENTIFICATION DATA STANDARDS

OFFICIAL IDENTIFICATION NUMBERS – ANIMALS

INDIVIDUAL ANIMAL NUMBERS

ANIMAL GROUP IDENTIFICATION NUMBERS

LOCATION NUMBERING SYSTEMS

NUES STATE, TRIBAL, AND TERRITORY CODES

COUNTRY CODES FOR U.S. TERRITORIES

SECTION B: ADMINISTRATION OF OFFICIAL IDENTIFICATION METHODS AND DEVICES FOR ANIMALS

OFFICIAL EAR TAG SPECIFICATIONS

DISTRIBUTION OF OFFICIAL IDENTIFICATION DEVICES

RECORDKEEPING REQUIREMENTS

ANIMAL IDENTIFICATION NUMBER (AIN) DEVICES

NATIONAL UNIFORM EAR TAGGING SYSTEM (NUES) DEVICES

APPROVED TAGGING SITES

REPLACEMENT OF OFFICIAL IDENTIFICATION DEVICES

ISSUANCE OF DUPLICATE OFFICIAL IDENTIFICATION EAR TAGS

USDA-APPROVED BACKTAGS

SECTION C: APPROVAL OF OFFICIAL IDENTIFICATION METHODS AND DEVICES FOR ANIMALS

OVERVIEW OF DEVICE APPROVAL PROCESS

APPLICATION FOR APPROVAL OF OFFICIAL IDENTIFICATION DEVICES

APPENDIX 1: FIELD TRIAL PROTOCOL

FIELD TRIAL TIMELINE

APPLICATION AND ASSESSMENT OF TRIAL DEVICES

REPORTING FIELD TRIAL ASSESSMENT RESULTS

APPENDIX 2: ANIMAL IDENTIFICATION DEVICE PERFORMANCE AND QUALITY CONTROLS

PRINTING STANDARDS AND DESCRIPTION FOR ALL OFFICIAL EAR TAGS

PRINTING STANDARDS AND DESCRIPTION FOR PLASTIC AIN AND NUES EAR TAGS

PRINTING STANDARDS AND DESCRIPTION FOR SWINE PIN EAR TAGS

PERFORMANCE OF THE VISUAL COMPONENTS

ELECTRONIC IDENTIFICATION (EID) EAR TAG TRANSPONDER PERFORMANCE

EID INJECTABLE TRANSPONDER PERFORMANCE

QUALITY CONTROL

APPENDIX 3. APPLICATION PACKET FOR SUBMISSION

APPENDIX 4: APHIS REVIEW FOR APPROVAL

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Preface The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has established traceability regulations in 9 CFR part 86, Traceability for Livestock Moving Interstate. The purpose of the regulations is to improve the ability of animal health officials to trace livestock when disease is found.

This document contains the ADT program standards for numbering systems, official identification devices authorized under the final rule, administration of official identification devices, and APHIS approval of official identification devices. Additional information, including listing of official identification devices, is provided at APHIS’ ADT website (https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/traceability).

Section A: Official Identification Data Standards

Official Identification Numbers – Animals Official identification numbering systems are fundamental to animal disease programs.

Identification numbers for both individual animals and groups of animals are defined to support methods of official identification for the various species and to meet production management practices. Group/lot numbers are associated with the animals through records maintained by individuals responsible for the group throughout the production chain.

Official identification numbers are nationally unique numbers permanently associated with individual animals or groups of animals through official identification devices or methods. Official identification numbers in the United States must adhere to one of the following numbering systems:

• Animal Identification Number (AIN).

• National Uniform Ear tagging System (NUES).

• Location-based number system.

• Flock-based number system.

• Any other numbering system approved by the APHIS Administrator to officially identify animals.

Individual Animal Numbers Official animal numbering systems provide a way to identify individual animals with a unique number that can be encoded in a microchip or electronically readable ear tag and imprinted on an official ear tag. Numbering systems for these official identification devices are listed in Section B of this document. All official ear tags are readable visually and some are also readable electronically. The following table specifies the format for each official numbering system used for individual animals.

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/traceability

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Table 1: Official Identification Number Systems

Data Element Length Format Example Comments

Animal Identification Number (AIN)

15 Numeric 840003456789012

First 3 characters 900 (equine only)

Country code or manufacturer code

Last 12 characters 003456789012

The last 12 digits are the animal number.

Start number > 003,000,000,000.

National Uniform Ear tagging System

(NUES)

9 or 8 Alphanumeric

23 ELV 4574

PA ELV 4574

23 DX 1234

Sheep and Goats*:

PA DX 1234

(metal) PA D2 1234 or

PA 2D 1234

(plastic)

The 9 alphanumeric NUES format is for use in cattle and bison only. The 8 alphanumeric NUES format is for use in all other species. *Use of the State postal abbreviation for the 8 alphanumeric NUES format is reserved for use in the scrapie program.

First 2 23

PA

Default is State or Tribe numeric code. The State postal abbreviation is optional for the 9 alphanumeric NUES format.

Middle 3 or 2

ELV

DX

D2 or 2D

3 or 2 letters. Sheep and goat devices may also use a letter and a number.

Last 4 4574 or 1234 4 digits.

Flock-based number with a herd management number

15 Max. Alphanumeric MN0456 4275

First 9 Max. MN0456 See Flock Identification Number (FIN) standard below.

Last 6 Max. 4275 Unique herd management number.

Location-based number with a herd

14 Max. Alphanumeric IA123456 98765

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First 8 Max. IA123456

See Location Identification Number (LID) and Premises Identification Number (PIN) standard below.

Last 6 Max. 98765 Unique herd management number.

Note: 900 manufacturer coded injectable transponders are approved official identification for equine spp. only.

Note: AINs beginning with the 840 prefixes may not be applied to animals known to have been born outside the United States.

Animal Group Identification Numbers Group/Lot Identification Numbers (GINs)

The use of GINs provides a way to uniquely identify a unit of animals of the same species managed as one group throughout the preharvest production chain. The GIN consists of the following:

• One of the location identifiers (premises identification number [PIN] or location identification number [LID]) defined in the following pages.

• A six-digit representation of the date the group or lot of animals was assembled or date the group was initiated if more than one day (MM/DD/YY).

• Two additional digits, ranging from 01 to 99, to number different groups or lots of animals assembled on the same premises on the same day. When more than one group of animals is assembled, the groups would be designated consecutively as 01, 02, 03, etc.

The GIN format for sheep and goats is defined in 9 CFR Part 79 Scrapie in Sheep and Goats.

Flock Identification Numbers (FINs)

The numbering system for the National Scrapie Eradication Program combines a nationally unique flock identification number (FIN) with the producer’s unique livestock production numbering system. This flock-based numbering system represents an animal group associated with one or more locations. A State or Federal animal health authority assigns the FIN to a group of animals managed as a unit on one or more premises under the same ownership. FINs must be linked to a PIN or LID in the National Scrapie Database (see Location Numbering Systems).

Table 2. Animal Group Identification Numbers Data Element Length Format Example Comments

Group/Lot ID Number (GIN) Using a PIN

15 Alphanumeric 004T56711221805

First 7 004T567 The first 7 characters are the premises ID number (PIN).

Middle 6 112218 The next 6 characters are the date the lot was established:

MM/DD/YY.

Last 2 05

The last 2 characters are the group number (count 01-99) (01 is default if only one group is assembled)

Group/Lot ID Number (GIN) Using a LID

14 or 16 Alphanumeric

WA123411221805

MN12347811221805

First 6 or

WA1234

MN123478

The first 6 or 8 characters are the location ID number (LID).

Middle 6 112218 The next 6 characters are the date the lot was established:

MM/DD/YY.

Last 2 05

The last 2 characters are the group number (count 01-99) (01 is default if only one group is assembled)

Flock Identification Number (FIN)

9 Max Alphanumeric PA723456A

First [2] PA State postal abbreviation required as the first two characters.

Max of [7] 723456A

FINs exclude the letters I, O, or Q from the characters following the State abbreviation.

Location Numbering Systems

States and Tribes may elect to use location identifiers, such as a LID (location identification number) or a PIN (premises identification number), to support their animal disease traceability

Version 3.1 November 5, 2024 programs. A PIN or LID is a unique code that is permanently assigned to a single physical location and is required to purchase official animal identification tags. Each state administers PIN or LID registration. These formats support the administration of location identifiers that adhere to the standards defined in Table 3 below. PINs are available through the APHIS PIN allocator, a software application that assigns a unique location identifier/number to a specific geographic location for States and Tribes electing to use it. States or Tribes may also use their own processes for administering unique State- or Tribal-issued location identifiers. In these situations, the State or Tribe has its own local system and process for issuing location numbers. State-issued location identifiers are referred to as LIDs, and the location numbers States and Tribes obtain through the allocator are referred to as PINs (or standardized PINs). States and Tribes may choose to use other terms in their materials.

Location Identification Number (LID)

A nationally unique number issued by a State, Tribal, and/or Federal animal health authority to a location as determined by the State or Tribe in which it is issued. The LID number may be used in conjunction with a producer's own unique livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may also be used as a component of a group/lot identification number (GIN). All LIDs start with the State or Tribal code, which make the LIDs nationally unique. They consist of six or eight alphanumeric characters. The LID data standards are defined in Table 3.

Premises Identification Number (PIN)

A nationally unique number assigned by a State, Tribal, and/or Federal animal health authority to a premises that is, in the judgment of the State, Tribal, and/or Federal animal health authority a geographically distinct location from other premises. The PIN may be used in conjunction with a producer's own livestock production numbering system to provide a nationally unique and herd-unique identification number for an animal. It may be used as a component of a group/lot identification number (GIN). States and Tribes may elect to use the PIN in their traceability program. The standardized PIN consists of seven alphanumeric characters. The last character is a check digit based on ISO/IEC 7064:2003. States may use the State’s postal abbreviation as the first two of the seven characters (e.g., OH341T4). Tribes may also have codes reserved for use with PINs they administer. APHIS assigns Tribal codes on request. States and Tribes obtaining PINs from the PIN allocator may use either the Standardized Premises Identification System or a Compliant Premises Identification System. The PIN data standards are defined in Table 3.

Table 3. Location Identifiers Data Element Length Format Example Comments

LID

6 Alphanumeric MN4321 First 2 characters are the State or

Tribal postal abbreviation.

LID 8 Alphanumeric CA654321 First 2 characters are the State or Tribal postal abbreviation.

PIN 7 Alphanumeric A123R69 Last character is a check digit.

The check digit calculation algorithm is based on ISO/IEC 7064:2003, “Data Processing – Check Character Systems.”

Note: To avoid confusion with the numbers 0 and 1, the LID and PIN will not contain the letters O or I except when the letters are contained in the State or Tribal code.

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NUES State, Tribal, and Territory Codes State, Tribal, and Territory codes used with NUES tags and location identifiers are listed below.

Table 4. State, Tribal, and Territory Codes Sort by Name

Sort by Numeric Code

ALABAMA AL 64 MAINE ME 11

ALASKA AK 96 NEW HAMPSHIRE NH 12

AMERICAN SAMOA AS 99 VERMONT VT 13

ARIZONA AZ 86 MASSACHUSETTS MA 14

ARKANSAS AR 71 RHODE ISLAND RI 15

CALIFORNIA CA 93 CONNECTICUT CT 16

COLORADO CO 84 NEW YORK NY 21

COMMONWEALTH OF THE NORTHERN MARIANAS MP 98 NEW JERSEY NJ 22

CONNECTICUT CT 16 PENNSYLVANIA PA 23

DELAWARE DE 50 OHIO OH 31

EASTERN CHEROKEE NATION EC 80 INDIANA IN 32

FLORIDA FL 58 ILLINOIS IL 33

GEORGIA GA 57 MICHIGAN MI 34

GUAM GU 97 WISCONSIN WI 35

HAWAII HI 95 MINNESOTA MN 41

HUALAPAI TRIBE HT 78 IOWA IA 42

IDAHO ID 82 MISSOURI MO 43

ILLINOIS IL 33 NORTH DAKOTA ND 45

INDIANA IN 32 SOUTH DAKOTA SD 46

IOWA IA 42 NEBRASKA NE 47

KANSAS KS 48 KANSAS KS 48

KENTUCKY KY 61 DELAWARE DE 50

LOUISIANA LA 72 MARYLAND MD 51

MAINE ME 11 VIRGINIA VA 52

MARYLAND MD 51 WEST VIRGINIA WV 54

MASSACHUSETTS MA 14 NORTH CAROLINA NC 55

MICHIGAN MI 34 SOUTH CAROLINA SC 56

MINNESOTA MN 41 GEORGIA GA 57

MISSISSIPPI MS 65 FLORIDA FL 58

MISSOURI MO 43 VIRGIN ISLANDS VI 59

MONTANA MT 81 KENTUCKY KY 61

NAVAJO NATION NN 77 TENNESSEE TN 63

NEBRASKA NE 47 ALABAMA AL 64

NEVADA NV 88 MISSISSIPPI MS 65

NEW HAMPSHIRE NH 12 ARKANSAS AR 71

NEW JERSEY NJ 22 LOUISIANA LA 72

NEW MEXICO NM 85 OKLAHOMA OK 73

NEW YORK NY 21 TEXAS TX 74

NORTH CAROLINA NC 55 NAVAJO NATION NN 77

NORTH DAKOTA ND 45 HUALAPAI TRIBE HT 78

OHIO OH 31 WESTERN CHEROKEE NATION CN 79

OKLAHOMA OK 73 EASTERN CHEROKEE NATION EC 80

OREGON OR 92 MONTANA MT 81

PENNSYLVANIA PA 23 IDAHO ID 82

PUERTO RICO PR 94 WYOMING WY 83

RHODE ISLAND RI 15 COLORADO CO 84

SOUTH CAROLINA SC 56 NEW MEXICO NM 85

SOUTH DAKOTA SD 46 ARIZONA AZ 86

TENNESSEE TN 63 UTAH UT 87

TEXAS TX 74 NEVADA NV 88

UTAH UT 87 WASHINGTON WA 91

VERMONT VT 13 OREGON OR 92

VIRGIN ISLANDS VI 59 CALIFORNIA CA 93

VIRGINIA VA 52 PUERTO RICO PR 94

WASHINGTON WA 91 HAWAII HI 95

WEST VIRGINIA WV 54 ALASKA AK 96

WESTERN CHEROKEE NATION CN 79 GUAM GU 97

WISCONSIN WI 35 COMMONWEALTH OF THE NORTHERN

MARIANAS MP 98

WYOMING WY 83 AMERICAN SAMOA AS 99

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Country Codes for U.S. Territories ISO 3166 establishes country codes. The country code for the United States is 840. U.S. Territories may use either the 840 prefix or their ISO country code as the first three characters of the AIN.

The following table lists the ISO country codes for the U.S. Territories.

Table 5. Country Codes for U.S. Territories

Territory Code Territory Code America Samoa 016 Northern Mariana Islands 580

Guam 316 Palau 585

Marshall Islands 584 Puerto Rico 630

Micronesia, Federated States of 583 Virgin Islands 850

Section B: Administration of Official Identification Methods and Devices for Animals Official identification methods and devices officially identify an animal or group of animals by applying an official identification number to an animal or associating an official identification number with an animal or group of animals. Tables 1 and 2 in Section A of this document list official animal numbering systems for livestock.

Official identification devices and methods are listed in title 9, Code of Federal Regulations (9 CFR) part 86 by species and include electronic ear tags, visual ear tags, and injectable transponders.

Official Ear Tag Specifications

Official ear tags approved for certain species are APHIS-Approved tags that provide official identification numbers for individual animals. APHIS must approve the tag before a manufacturer can produce and sell ear tags bearing the official ear tag shield (see Section C, Approval of Official Identification Methods and Devices for Animals)1. APHIS has posted a description of the types of official ear tags with the specifications and options as well as lists of currently approved official ear tags on the ADT website at:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/SA_Traceability.

Official ear tags must:

• Be imprinted with an official identification number (see Table 1).

• Be imprinted with the official ear tag shield.

• Be tamper evident with high retention.

1 See definition of Official ear tag at 9 CFR Part 86.1 Definitions https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/SA_Traceability

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• Have other characteristics specified in Appendix 2.

States obtaining official ear tags direct from manufacturers may imprint their State postal abbreviation inside the official ear tag shield in lieu of the letters “US”. Likewise, Tribes may imprint their alpha code (see Table 4).

Distribution of Official Identification Devices Official identification devices must be properly administered to support animal disease traceability. State and Tribal animal health officials may provide official identification devices to accredited veterinarians who wish to use them as official identification for specific disease control programs (e.g., brucellosis calfhood vaccination or official disease testing). In addition, State and Tribal animal health officials may provide official identification devices to accredited veterinarians, approved tagging sites2, or directly to producers for other purposes (e.g., to meet the requirements for interstate movement). In either case, the State or Tribal animal health officials will maintain complete oversight for the integrity of official identification device distribution information.

Distribution records and records of official identification devices applied are to be administered as explained below with the exception of sheep and goats. Requirements for administering official Scrapie Program identification tags are explained in the Scrapie Program Standards Volume 1: National Scrapie Eradication Program, here (or https://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/nsep-program-standards-final-rule.pdf.)

Recordkeeping Requirements For the purposes of animal disease traceability, device distribution records must be recorded in a readily accessible record system and made available to state or federal animal health officials within 48 hours of receipt of request or earlier if warranted by an emergency disease response. At a minimum, device distribution records need to be maintained for 5 years and must include:

• The name of the person the tags are issued to or the owner or person responsible for the animals being tagged by accredited veterinarians or tagging site operators.

• The street address, city, State, and ZIP code where the tags are distributed or the premises where the animals that are being tagged reside.

• The identification numbers issued.

• The date the tags were issued.

• The name and contact information of the person issuing the tags.

• For AIN numbers, a LID or a PIN is required to distribute tags

Animal Identification Number (AIN) Devices APHIS, through an application and approval process, approves AIN devices that meet established standards (see Section C, Approval of Official Animal Identification Methods and Devices).

Approved AIN manufacturers are allocated the “840” numbers through the Animal Identification Management System (AIMS) and are authorized to encode and/or imprint the AIN only on their

2 See “Approved Tagging Sites” description on p. 12.

https://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/nsep-program-standards-final-rule.pdf https://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/nsep-program-standards-final-rule.pdf https://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/nsep-program-standards-final-rule.pdf

Version 3.1 November 5, 2024 approved devices. AIN device manufacturers distribute AIN devices through AIN device managers or may act as AIN device managers themselves. AIN device managers and resellers distribute AIN devices to producers and accredited veterinarians.

All distribution records of AIN devices administered by AIN manufacturers, device managers, resellers (e.g., accredited veterinarian, online retailer, feed store, etc.), and Federal animal health officials must be reported to APHIS’ tag management data system (AIMS or future system that replaces AIMS functions) by the person possessing the device when distributing the device to the next individual, whether it is a producer or another reseller. AIN device recipients must have a PIN or LID as defined in Section A and provide that number to the person distributing the devices.

The record includes the AINs, date of distribution, and PIN or LID where the devices were distributed. The AIN Management System User Guide provides details of the processes available for completing these distribution records. The Guide can be found under the Public Tools – Help section at the following link: https://vsapps.aphis.usda.gov/aims/

If a state or tribal animal health official maintains complete AIN device distribution records through their own system, APHIS does not require them to record the distributions in the AIMS database. A State or Tribe may use APHIS’ tag management system (AIMS or future systems that replace AIMS functionality) as the information system of record to meet this requirement or may use their internal animal health information system if it is searchable and supports tag distribution recording and electronic data sharing. These tag records must be maintained for a minimum of 5 years.

Information stored in the current AIMS management system (or in future data systems designated by APHIS to replace AIMS functionality) will meet all recordkeeping requirements of this section.

Producers electing to use AIN devices may acquire them from local or online resellers or directly from manufacturers. The complete listing of AIN devices and the AIN device manufacturer’s information is at https://www.aphis.usda.gov/traceability/downloads/ADT_device_ain.pdf.

An accredited veterinarian may obtain AIN devices direct from an AIN device manufacturer or device manager for further distribution. The distribution of these devices must be reported in APHIS’ tag management system (AIMS or future systems that replace AIMS functionality). In this case they are acting as AIN device managers or tag resellers and must establish a marketing arrangement with the device manufacturer. As a device reseller or distributor, they must record the transaction in APHIS’ tag management system (AIMS or future systems that replace AIMS functionality)

An accredited veterinarian may obtain AIN devices from a State, Tribal, or Federal animal health official or from another device manager, for application to client animals. The veterinarian must maintain tagging records of the devices applied in a readily accessible record system and make these records available within 48 hours of receipt of request or earlier if warranted by an emergency disease response.

Entering the records in APHIS’ tag management system (AIMS or future systems that replace AIMS functionality) is one option that fulfills this requirement. If an accredited veterinarian distributes the AIN devices, (giving them away or selling them) then they must become an AIN Device Manager in the AIMS system and record that transaction.

https://vsapps.aphis.usda.gov/aims/ https://www.aphis.usda.gov/traceability/downloads/ADT_device_ain.pdf

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Tag distribution or application records must be maintained for a minimum of 5 years.

National Uniform Ear tagging System (NUES) Devices NUES visual official ID tags have historically been used by animal health officials in animal disease programs. Proposed changes to 9 CFR Part 86 would no longer recognize visual tags applied after implementation of the rule as official ID for cattle and bison covered by the regulations unless approved by sending and receiving state officials. Pending the proposed changes, the following applies to the visual tags:

Animal health officials are responsible for ensuring that sufficient contact information is collected and maintained by accredited veterinarians applying NUES tags directly to animals to qualify for interstate movement or specific disease control programs, or when distributing NUES tags directly to producers who wish to use them for official identification and purposes other than through a specific disease control program. For the purposes of animal disease traceability, tag distribution records must be made available to state or federal animal health officials upon request. At a minimum, tag distribution records need to be maintained for 5 years and must include all elements as listed in the recordkeeping requirements section of this document. A PIN or LID is not required for the purposes of distributing visual NUES tags.

Manufacturers and resellers distributing NUES tags directly to producers must report the records of NUES tags distributed as directed by the State or Federal Animal Health Official. Animal Health Officials must ensure the NUES number sequence is carefully coordinated with the manufacturer to avoid duplicate tag numbers.

States and Tribes may use APHIS’ tag management data system (AIMS or future systems that replace AIMS functions) to maintain NUES tag distribution records; however, this is not required by the current regulation. The use of AIMS does require the use of either a LID or PIN for any distribution records entered into AIMS but eliminates the need for further records management of tag distribution.

More specific details on the administration of NUES ear tags are available in Veterinary Services (VS) Guidance 10000.1: Distribution and Use of Official Identification Ear Tags with Numbers Conforming to the National Uniform Ear tagging System (4/13/2014).

Producers and accredited veterinarians should contact their State or Tribal animal health officials regarding the availability of NUES tags.

Approved Tagging Sites Approved tagging sites are locations authorized by APHIS, State, or Tribal animal health officials where livestock without official identification may have official identification applied on behalf of their owner or the person in possession, care, or control of the animals when they are brought to the tagging site. In these cases, livestock required to be officially identified may move interstate to an approved tagging site for the application of official identification.

The animals must be officially identified at the tagging site before they are commingled with animals from other premises or identified by other practices that will accurately maintain the animals’ identity until tagging. This will ensure the official identification numbers correlate to the

Version 3.1 November 5, 2024 owner of the animals (or person responsible) when the animals are shipped to the tagging site. For example, a livestock market acting as an approved tagging site may use back tags to temporarily identify the animal on unloading. The approved tagging site, at a minimum, must:

• Maintain tagging records (as required under the recordkeeping requirements section)

• Ensure the security of official identification devices and distribution records by:

o Maintaining a record of all official identification devices distributed and applied at the tagging site.

o Reporting any tags lost or stolen immediately to the appropriate State, Tribal, or Federal animal health official.

• Tag all animals in accordance with 9 CFR part 86:

o Tag all animals required to be officially identified.

o Only tag animals not already officially identified unless replacing an older official ID technology with more advanced technology, i.e., retagging animals that have metal NUES tags with EID). Do not apply additional official ear tags except as provided in 9 CFR 86.4(c).

o Remove and/or replace official identification devices in accordance with 9 CFR 86.4(d) and (e).

Entities interested in becoming approved tagging sites should contact their APHIS, State, or Tribal animal health official.

Replacement of Official Identification Devices Replacement official identification devices are defined in 9 CFR 86.4 (d), Removal or loss of official identification devices.

Issuance of Duplicate Official Identification Ear Tags Duplicate official identification ear tags may only be obtained from approved manufacturers by an organization authorized (e.g., breed registries or genetic companies) to order reissued tags when an official ear tag is lost and the owner or person responsible for the animal needs to retag the animal with the official identification number of the lost ear tag. For AIN ear tags, the manufacturer submits a record to APHIS’ tag management data system (AIMS or future systems that replace AIMS functions) with the information on the reissuance and distribution of the duplicate ear tag.

Additionally, the ear tag manufacturer imprints the designated symbol on the ear tag to reflect that the tag is a duplicate of a previously issued tag. When the duplicate ear tag contains EID technology, the manufacturer encodes the number in accordance with the existing ISO or the existing APHIS-Approved standard for administering transponders.

USDA-Approved Backtags Although not considered official identification, the traceability rule at 9 CFR Part 86.4 (b) Official Identification Requirements for Interstate Movement allows for the use of USDA-approved backtags in the interstate movement of cattle and bison only when they are moved directly to slaughter. Cattle and bison may be moved interstate without official identification if they are moved directly to a recognized slaughtering establishment or directly to no more than one approved livestock facility and then directly to a recognized slaughtering establishment.

When moved interstate under these specific circumstances, cattle and bison will move to slaughter with a USDA approved backtag, which must be applied before the animals are comingled with https://www.ecfr.gov/current/title-9/chapter-I/subchapter-C/part-86#p-86.4(d)(1)

Version 3.1 November 5, 2024 any other groups of animals. For example, animals should be tagged with a USDA approved backtag upon arrival at a livestock market. If movement direct-to-slaughter is from a farm, ranch or other location that does not have access to USDA-approved backtags, USDA-approved backtags must be applied by the recognized slaughtering establishment prior to commingling with other animals.

A record of the backtags applied to the animals must be maintained for a minimum of 5 years and should include the name and address of the owner, the location the where the backtag was applied, the date of application, and the name and contact information of the purchaser. In the event of a disease outbreak, these records must be made available to state or federal animal health officials.

Additionally, if cattle engaged in a direct-to-slaughter movement do not end up being slaughtered within 3 days of arrival at the recognized slaughtering facility, animals must be officially identified at that point in time.

Definitions as listed in the 9 CFR Part 86.1 applicable here include:

Approved livestock facility. A stockyard, livestock market, buying station, concentration point, or any other premises under State or Federal veterinary inspection where livestock are assembled and that has been approved under §71.20 of this chapter.

Directly. Moved in a means of conveyance, without stopping to unload while en route, except for stops of less than 24 hours to feed, water, or rest the animals being moved, and with no commingling of animals at such stops.

Interstate movement. From one State into or through any other State.

Officially identified. Identified by means of an official identification device or method approved by the Administrator.

Recognized slaughtering establishment. Any slaughtering facility operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts that is approved in accordance with 9 CFR 71.21.

United States Department of Agriculture (USDA) approved backtag. A backtag issued by APHIS that provides a temporary unique identification for each animal.

Section C: Approval of Official Identification Methods and Devices for Animals An official identification device or method is a means approved by the Administrator for:

• Applying an official identification number to an animal of a specific species.

• Associating an official identification number with an animal or group of animals of a specific species.

• Otherwise officially identifying an animal or group of animals.

APHIS must approve an official identification device before a manufacturer can produce and sell it.

APHIS provides species-specific approval of electronic ID, (e.g., EID), visual ear tags, and injectable transponders as official identification devices (see 9 CFR 86.4 (a), Official identification devices and methods approved for covered species). The appendices following this section provide detailed information on the requirements for approving official identification devices.

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Non-U.S. manufacturers seeking approval of an identification device must have a representative who is authorized to access a federal database and can serve as a device manager in accordance with Distribution of Official Identification Devices in Section B: Administration of Official Identification Methods and Devices for Animals and the AIN Management System User Guide.

Overview of Device Approval Process Manufacturers seeking approval of a new device or modification of an existing approved official identification device should follow the process outlined below:

1. Complete the required ICAR testing or equivalent, which includes materials and electronics (if applicable) testing.

a. For visual only ear tags, complete Procedure 4 of Section 10 of ICAR Guidelines – Testing of Conventional Plastic Ear Tags.

b. For low frequency EID ear tags, complete Procedure 5 of Section 10 of ICAR Guidelines – Testing of External RFID devices. Equivalent testing may be considered for the materials testing portion of Procedure 5, but all low frequency EID ear tags must conform with ISO standards 11784/11785.

c. See page 27 for information on Ultra-High frequency devices.

2. Submit initial device application including results of ICAR testing and certification, device approval from other countries as well as sales data for previously marketed tags, or proposed field trial protocol for APHIS approval of new tags. Sample devices and device applicator should also accompany the submission to APHIS.

3. For new devices (i.e., those with no prior sales data or country approval as official ID) APHIS will approve the production of field trial devices according to the details specified in the standards.

4. Initiate field trials and complete required assessments.

5. Request APHIS approval for controlled device sales if the device meets all specifications and performance standards at assessments according to the field trial protocol timelines outlined in Appendix 1.

6. Provide adverse event and tag failure reports during field trial period.

7. Conduct field trials, submit results at each evaluation point, and submit final application with compiled field trial data for APHIS review.

8. APHIS reviews data and determines if the device meets the criteria for approval.

APHIS will place a hold on field trials and sales (if applicable) of devices failing to meet acceptable performance criteria at any point in the approval process or post approval if the device fails to perform as expected. If the manufacturer does not satisfactorily resolve the performance issues, APHIS will terminate the approval process, or revoke approval.

Application for Approval of Official Identification Devices Manufacturers seeking APHIS approval of an identification device must document that they have successfully tested (required ICAR testing or equivalent), produced, and marketed the identification device submitted for approval with favorable results. Such documentation must show at a minimum that the device has been:

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• Approved for a national identification program in at least one other country with comparable or more stringent requirements than the criteria outlined in these standards.

The device must also meet the criteria for conformance and performance listed in Appendix

2. (APHIS will review the approval documentation and sales data provided to determine equivalency); or

• Tested in field trials in accordance with the protocol outlined in Appendix 1. The device must also meet the criteria for conformance and performance listed in Appendix 2. The manufacturer must document how the criteria have been met in the device field test report presented with the application for approval; or

• APHIS may consider requests, on a case-by-case basis, for approval of alternative field trials or ear tags with previously generated verifiable data if equivalency to these standards is demonstrated. For example, APHIS may consider a fast track preliminary, conditional, or full approval for an ear tag with the required ICAR certification (or equivalent) and substantial sales data.

Modification of approved devices may require new field trials or laboratory testing depending on the type of modification requested. Manufacturers seeking to modify an approved device should contact ADT staff at traceability@usda.gov.

Manufacturer completes required ICAR or equivalent testing.

Manufacturer submits application , sample devices & ICAR reports to

APHIS

Manufacturer provides proposed field trial protocol with locations

Meets criteria ? NO

Advise manufacturer of deficiencies - may resubmit when corrected

YES

APHIS and Manufacturer finalize field trial protocol – _ APHIS approves

NO

Approval or sales in another country?

YES

APHIS evaluates application and data provided

Meets criteria for approval ?

NO

Figure 1 . Initial - Official Identification Device Approval Process

APHIS grants approval and enters into Device

Manufacturer agreement

YES

See Figure 2 Field Trial Process for Official Identification

Device Approval

Manufacturer provides field trial protocols or current sales data equaling 36 months of field trials mailto:traceability@usda.gov

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Appendix 1: Field Trial Protocol Identification devices without approval in another country with comparable or more stringent standards, or substantial sales data, must undergo field trials for 3 years in covered species3 except for 2.5 years in swine before APHIS will consider fully approving the device. The field trials help ensure the devices are of high quality and meet industry needs while providing traceability; and provide data on the device’s physical performance (application, durability, and retention) and transponder performance (if applicable). Field trials must be supervised by an independent third party who knows the management practices for the species used to test the trial device, and who has no conflict of interest with the trial locations or manufacturer. Field trial supervisors must be on site to monitor each assessment and certify results, and ensure that field trials comply with all State, Tribal, and Territory regulations.

While APHIS is committed to only approving identification devices with a proven history of retention and durability, we also want to encourage new identification devices meeting preliminary standards to enter a controlled marketplace until the remaining requirements are met for full approval. Therefore, the field trial protocol provides for preliminary device approval after 6 months to promote the introduction of new devices and technologies into the market. APHIS reserves the right to terminate or extend a field trial with 30 days’ written notice if the approved device fails to meet the minimum performance requirements contained in these standards.

Manufacturers must submit the proposed identification device field trial protocol outlined in this Appendix, receive approval of the protocol from APHIS, and enter into a Field Trial Device Manufacturer Agreement with APHIS prior to commencing the field trials. The Field Trial Device Manufacturer Agreement certifies that manufacturers will adhere to the responsibilities regarding the production and distribution of official identification devices for animals to support the implementation of animal disease traceability activities.

APHIS may consider requests to assess field trials currently in progress that do not fully conform to the protocol contained in this document and/or existing field trial or sales and performance data and approve or disapprove the identification device based on our assessment of the data provided.

Field Trial Timeline Devices undergoing the approval process must first complete initial field trials, which include successfully meeting all required performance standards. Upon completing the ICAR certification and initial field trial testing, device manufacturers may request preliminary approval status with the ability to sell a limited number of devices to the public. Subsequently, manufacturers with devices assessed for a minimum of 12 months and meeting the required performance standards in the preliminary status period may request conditional APHIS approval and the ability to sell unlimited devices to the public for the remainder of the required field trial period provided the device maintains acceptable performance.

3 Cattle and bison, sheep and goats, captive cervids, equine and swine per 9 CFR Part 86. While swine are covered under the traceability regulation the field trial timeline is limited to 2.5 years to account for the shorter production life in relation to the other species.

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Table 6 below outlines the process devices must undergo during the 3-year approval process.

Table 6. Field Trial Timeline

Timeline Approval Status Number of Devices Approved for Sale as Official Identification

0-6 months Trial NONE

6-12 months

(Limited sales) Preliminary 250,000

12-36 months

(Unlimited sales) Conditional Unlimited

Full approval upon successful completion of 36-month field trial (30-month for swine)

Manufacturers must ensure that all field trial devices are assessed at application and at 6, 12, 24, and 36 months (the 36-month assessment is not applicable in swine). Devices must meet the minimum performance standards at each assessment to advance in the field trial. During the preliminary and conditional approval periods, manufacturers must have a mechanism in place to collect and report tag failure data to APHIS. APHIS encourages manufacturers to conduct performance assessments beyond 36 months (30 months in swine) and report results to APHIS.

Trial devices will be evaluated in a variety of livestock management systems and environmental settings for the appropriate species, e.g., beef/dairy/wool, confinement/grazing, hot/cold climate.

Field trials must be practical and incorporate trial device assessment into normal management practices.

At least two locations should be selected. Field trial locations must represent the variety of livestock management systems and environmental settings found in the United States, including representation of hot and cold temperatures. The trial cattle must provide a representative sample of beef and dairy cattle and must reflect pasture/range as well as confinement rearing management environments.

The manufacturer must evaluate trial devices in each species for which device approval is requested according to Table 7 below. Field trial production settings and number of animals per location should ensure that sufficient animals remain available to assess device performance over the field trial period. The initial evaluation of field trial results will consider the ICAR certification as well as field trial results, while additional test point assessments will include information from sales and adverse performance data.

Table 7. Field Trial Requirements by Species

Species Minimum Total Number of animals (minimum per trial location) Management Settings

Cattle and Bison 300 (at least 2 locations) At least one commercial dairy

Represent both hot and cold climate conditions

Sheep and Goats**

300 (150 sheep and 150 goats) (50) At least 50 sheep and 50 goats must be < 8 weeks of age at device application. Breeding replacement lambs/kids and 1to2-year-old breeding animals are the preferred animals for the trial. 150 sheep and 150 goats and 50 sheep and 50 goats < 8 weeks of age at device application will need to complete the trial so additional animals will be required at the outset.

At least one commercial goat dairy, one commercial meat goat herd and one commercial sheep flock. In addition, devices must be assessed in settings with 4” woven wire fence, regular use of feed bunks or hay bunks for at least 3 months of the year, and moderate to high levels of brush a minimum of 50 goats and 50 sheep in each of these environments, same animal may be exposed to more than one of these conditions.

Captive Cervids

600 white-tailed deer and elk (65% white-tailed deer and 35% elk distribution if possible) (40)

Properties representative of typical production settings

Swine 1,000 sows and boars (250)

Assess devices in the following settings: Outdoor in low-density pens (pasture), outdoor in high-density pens (concrete feeding floor), and indoor in confined pens (groups of 25+).

Equine 200 equids (horses, mules, and donkeys) (20)

Properties representative of typical production settings

Manufacturers requesting approval of identification devices for species not listed above should contact traceability@usda.gov.

** Sheep and goat tags will need to be approved under the scrapie program rules (9 CFR 79,2). Tags that meet approval for scrapie program status can be approved under the ADT rule without additional field trials required.

Manufacturers must submit an initial device application form (VS Form 1-64) to initiate the approval process (see Appendix 3)4. Once APHIS initially approves the application and device, the manufacturer needs to enter into an APHIS Field Trial Identification Device Manufacturer Agreement certifying that it will adhere to the responsibilities regarding the production and distribution of official identification devices for animals to support the implementation of animal disease traceability activities during the field trial period. APHIS will assign the manufacturer a product code for use in APHIS’ tag management data system when the manufacturer produces the devices for field trials and for any devices produced during the field trial period. APHIS will provide a permanent product code once it fully approves a device.

4 For sheep and goats also provide manufacturers agreement.

APHIS will authorize devices applied to animals included in the field trials and those marketed during the approval period as official identification for the life of the animal. These devices must meet the performance and quality control standards detailed in Appendix 2. AIN devices must be encoded and/or imprinted using the 840 numbers allocated to the manufacturer through APHIS’ tag management data system (AIMS or future systems that replace AIMS functions).

To distinguish devices used in field trials from approved official identification devices, all devices produced for use in field trials must be imprinted with “US Trial” on the portion of the tag containing the wording “Unlawful to Remove” and be green in color (R:120 G:180 B:50) with black print.

The maximum number of devices that may be produced for field trials should not exceed 5,000 per device application without prior approval from APHIS.

All devices to be used in the trials must be produced before the trials start and manufacturers must submit the identification numbers to APHIS in an Excel spreadsheet. In the case of non-840 tags or in the case of companies that are not currently approved device manufacturers the company must use numbers assigned by APHIS to avoid duplicating existing official ID numbers.

Application and Assessment of Trial Devices Manufacturers must notify APHIS at least 5 working days before applying the devices to animals in the trial and each scheduled performance assessment during which devices will be read. An APHIS representative may be present for application and performance assessment and if present shall be given access to monitor the process.

Individuals applying trial devices shall apply them according to the manufacturer instructions using the recommended applicator. Each animal to which a trial device is applied must also be tagged with a secondary device for use as a reference if a trial device is lost. The secondary device can be either an approved official identification device, or a premises unique identification device or tattoo present prior to or applied at the same time as the trial device but must remain in the animal for the duration of the field trial. Tattoos may be used as reference identification but are not required in the case of field trials for injectable transponders in equine.

Trial devices may be applied in either ear; however, all trial devices shall be applied in the same ear for all animals at a field trial location. For injectable transponders in equids, trial devices shall be placed in the nuchal ligament on the left side of the neck.

When applying electronic identification devices for the field trials, all devices will be electronically read after application to ensure they are functioning. Any electronic identification device not functioning immediately following application will be documented as failed during application. For all trial devices, difficulty or failure of proper application of devices must also be documented (e.g., device breakage, failure of the locking mechanism, excessive application force needed to penetrate ear, etc.) Failed devices shall be removed, and a new device can then be applied to the animal.