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General Standards
September 2019 Version 2.8
Pursuant to the Congressional Review Act
(5 U.S.C. § 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as a non-major rule, as
defined by 5 U.S.C. § 804(2).”
Version 2.8
6/19/2019
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Animal Disease Traceability
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Animal Disease Traceability
General Standards
CONTENTS
PREFACE ................................................................................................................................................................ 3
SECTION A: PROGRAM DATA STANDARDS ............................................................................................................. 4
OFFICIAL IDENTIFICATION NUMBERS – ANIMALS ..................................................................................................................4
Individual Animal Numbers ...................................................................................................................................4
Animal Group Identification Numbers ..................................................................................................................6
Location Numbering Systems ................................................................................................................................7
NUES STATE, TRIBAL, AND TERRITORY CODES .....................................................................................................................9
COUNTRY CODES FOR U.S. TERRITORIES ...........................................................................................................................10
SECTION B: ADMINISTRATION OF OFFICIAL IDENTIFICATION METHODS AND DEVICES FOR ANIMALS ................. 11
Official Ear Tag Specifications .............................................................................................................................11
Distribution of Official Identification Devices......................................................................................................11
Replacement of Official Identification Devices....................................................................................................15
Issuance of Duplicate Official Identification Ear Tags .........................................................................................15
SECTION C: APPROVAL OF OFFICIAL IDENTIFICATION METHODS AND DEVICES FOR ANIMALS ............................ 16
Appendix 1: Field Trial Protocol ...................................................................................................................................... 19
Appendix 2: Animal Identification Device Performance and Quality Controls .............................................................. 26
Appendix 3. Application Packet for Submission ............................................................................................................. 31
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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 general standards 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/animal health/traceability).
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Section A: Program 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 for meeting production management
practices. Group/lot numbers are associated to 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. Official identification numbers are 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 Eartagging 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 uniquely identify individual animals. Official
identification for certain species is based on identification devices (e.g., official ear tags) that have
an official animal number imprinted on them. Official identification devices that adhere to these
numbering systems are listed in Section B of these standards. The following table specifies the
format for each official numbering system used for individual animals.
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Table 1. Official Identification Numbers
Data Element
Animal
Identification
Number (AIN)1
National Uniform
Eartagging System
(NUES)
Flock-based
number with a
herd
management
number
Location-based
number with a
herd
management
number
Length Format
15
Numeric
Example
Comments
840003456789012
840 is the numeric country code
for the United States.
[3]2
840
900 (equine only)3
[12]
003456789012
The last 12 digits are the animal
number. Start number >
003,000,000,000.
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.
[2]
23
PA
Default is State or Tribe numeric
code. The State postal
abbreviation is optional for the 9
alphanumeric NUES format.
[3] or
[2]
ELV
DX
D2 or 2D
3 or 2 letters. Sheep and goats
devices may also use a letter and
a number.
[4]
4574 or 1234
4 digits.
9 or 8
15
Max.
Alphanumeric
Alphanumeric
MN0456 4275
[9]
Max.
MN0456
See Flock Identification
Number (FIN) standard below.
[6]
Max.
4275
Unique herd management
number.
14
Max.
Alphanumeric
IA123456 98765
[8]
Max.
IA123456
See Location Identification
Number (LID) and Premises
Identification Number (PIN)
standard below.
[6]
Max.
98765
Unique herd management
number.
Beginning March 11, 2015, APHIS began recognizing only AINs beginning with numeric country codes (“840”
for the United States) as defined by ISO 3166 as official. AINs with the prefix “USA” or a numeric manufacturer
code assigned by the International Committee for Animal Recording (ICAR) are only considered official
identification if applied to animals prior to March 11, 2015.
2
The number in the brackets designates the sequential order of the alphanumeric characters within the numbering
system.
3
900 manufacturer coded injectable transponders are approved official identification for equine only
1
Note: AINs beginning with the 840 prefix may not be applied to animals known to have been born outside the
United States.
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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).
The following table specifies the format for official animal group identification numbers.
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Table 2. Animal Group Identification Numbers
Data Element
Group/Lot ID
Number (GIN)
- Using a PIN
Group/Lot ID
Number (GIN)
- Using a LID
Flock
Identification
Number (FIN)
Length Format
15
Example
Alphanumeric
Comments
004T56711221805
[7]
004T567
The first 7 characters are the
PIN.
[6]
112218
The next 6 characters are the
date the lot was established:
MM/DD/YY.
[2]
05
The last 2 characters are the
number (count 01-99) of the
group assembled at a premises
on the same day. (01 is the
default when one group is
assembled.)
14 or
16
Alphanumeric
WA123411221805
MN12347811221805
[6] or
[8]
WA1234
MN123478
The first 6 or 8 characters are
the location ID number.
[6]
112218
The next 6 characters are the
date the lot was established:
MM/DD/YY.
[2]
05
The last 2 characters are the
number (count 01-99) of the
group assembled at a
premises on the same day.
(01 is the default when one
group is assembled.)
9
Max
Alphanumeric
PA723456A
[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 to support their animal disease traceability
program. Three formats, explained below, support the administration of location identifiers that
adhere to the standards defined in Table 3. PINs and non-producer participant numbers (NPN) 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. To avoid confusion in presenting these options in these standards, Stateissued location identifiers are referred to as LIDs, and the location numbers States and Tribes
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obtain through the allocator are referred to as PINs (or standardized PINs). States and Tribes may
choose to use other terms in their materials.
States and Tribes are not required to provide PINs, LIDs, or NPNs to administer their traceability
program. However, if they choose to use location identifiers, they must ensure their information
systems are compatible with other traceability and animal health databases by following the
standards set forth in Table 3 below.
Location Identification Numbers
LIDs are administered through a State’s or Tribe’s internal system. 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 Numbers
States and Tribes may elect to use the PIN in their traceability program. The standardized PIN,
obtained through the APHIS PIN allocator, 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 (for example, 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.
Non-producer Participant Numbers
Manufacturers, managers, and resellers (device distributors) are referred to as non-producer
participants. Each non-producer participant obtains an NPN through the premises registration
system in the State or Territory of the company’s headquarters to receive and distribute AIN
devices. An NPN follows the same alphanumeric format as a PIN as defined in Table 3.
Table 3. Location Identifiers
Data Element
LID
PIN or NPN
Length Format
Example
6
Alphanumeric
MN4321
8
Alphanumeric
CA654321
7
Alphanumeric
A123R69
Comments
First 2 characters are the State
postal abbreviation.
First 2 characters are the State
postal abbreviation.
Last character is a check digit.1
The check digit calculation algorithm is based on ISO/IEC 7064:2003, “Data Processing – Check Character
Systems.”
1
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
ALASKA
AMERICAN SAMOA
ARIZONA
ARKANSAS
CALIFORNIA
COLORADO
COMMONWEALTH OF THE NORTHERN
MARIANAS
CONNECTICUT
DELAWARE
EASTERN CHEROKEE NATION
FLORIDA
GEORGIA
GUAM
HAWAII
HUALAPAI TRIBE
IDAHO
ILLINOIS
INDIANA
IOWA
KANSAS
KENTUCKY
LOUISIANA
MAINE
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
MISSISSIPPI
MISSOURI
MONTANA
NAVAJO NATION
NEBRASKA
NEVADA
NEW HAMPSHIRE
NEW JERSEY
NEW MEXICO
NEW YORK
NORTH CAROLINA
NORTH DAKOTA
OHIO
OKLAHOMA
OREGON
PENNSYLVANIA
PUERTO RICO
RHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTA
TENNESSEE
TEXAS
UTAH
VERMONT
VIRGIN ISLANDS
VIRGINIA
WASHINGTON
WEST VIRGINIA
WESTERN CHEROKEE NATION
AL
AK
AS
AZ
AR
CA
CO
64
96
99
86
71
93
84
MAINE
NEW HAMPSHIRE
VERMONT
MASSACHUSETTS
RHODE ISLAND
CONNECTICUT
NEW YORK
ME
NH
VT
MA
RI
CT
NY
11
12
13
14
15
16
21
MP
98
NEW JERSEY
NJ
22
CT
DE
EC
FL
GA
GU
HI
HT
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NN
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
PR
RI
SC
SD
TN
TX
UT
VT
VI
VA
WA
WV
CN
16
50
80
58
57
97
95
78
82
33
32
42
48
61
72
11
51
14
34
41
65
43
81
77
47
88
12
22
85
21
55
45
31
73
92
23
94
15
56
46
63
74
87
13
59
52
91
54
79
PA
OH
IN
IL
MI
WI
MN
IA
MO
ND
SD
NE
KS
DE
MD
VA
WV
NC
SC
GA
FL
VI
KY
TN
AL
MS
AR
LA
OK
TX
NN
HT
CN
EC
MT
ID
WY
CO
NM
AZ
UT
NV
WA
OR
CA
PR
HI
AK
GU
23
31
32
33
34
35
41
42
43
45
46
47
48
50
51
52
54
55
56
57
58
59
61
63
64
65
71
72
73
74
77
78
79
80
81
82
83
84
85
86
87
88
91
92
93
94
95
96
97
WISCONSIN
WI
35
MP
98
WYOMING
WY
83
PENNSYLVANIA
OHIO
INDIANA
ILLINOIS
MICHIGAN
WISCONSIN
MINNESOTA
IOWA
MISSOURI
NORTH DAKOTA
SOUTH DAKOTA
NEBRASKA
KANSAS
DELAWARE
MARYLAND
VIRGINIA
WEST VIRGINIA
NORTH CAROLINA
SOUTH CAROLINA
GEORGIA
FLORIDA
VIRGIN ISLANDS
KENTUCKY
TENNESSEE
ALABAMA
MISSISSIPPI
ARKANSAS
LOUISIANA
OKLAHOMA
TEXAS
NAVAJO NATION
HUALAPAI TRIBE
WESTERN CHEROKEE NATION
EASTERN CHEROKEE NATION
MONTANA
IDAHO
WYOMING
COLORADO
NEW MEXICO
ARIZONA
UTAH
NEVADA
WASHINGTON
OREGON
CALIFORNIA
PUERTO RICO
HAWAII
ALASKA
GUAM
COMMONWEALTH OF THE NORTHERN
MARIANAS
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
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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 these standards 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 radio frequency identification (RFID) ear tags, visual ear
tags, and RFID 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.
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.
1
2
See definition of Official eartag at 9 CFR Part 86.1 Definitions
See “Approved Tagging Sites” description on p. 12.
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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-programstandards-final-rule.pdf.)
Animal Identification Number 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
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 840 and 900 (equine injectable transponders only) 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 AIMS 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, LID, or NPN 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, LID, or NPN 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/
APHIS does not require State or Tribal animal health officials to be AIN device managers if they
maintain complete distribution records of 840 AIN devices. A State or Tribe may use AIMS 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.
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.
When accredited veterinarians obtain 840 AIN devices direct from an AIN device manufacturer
or device manager for further distribution or application to animals, they must report the device
distribution or application records in AIMS. In this case, they are acting as AIN device managers
and must establish a marketing arrangement with the device manufacturer.
When accredited veterinarians obtain 840 AIN devices or 900 manufacturer coded injectable
transponders for equine from a State or Tribal or Federal animal health official they must report
records of devices applied or distributed as directed by the animal health official who provided the
tags.
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National Uniform Eartagging System
NUES tags have historically been used by animal health officials in animal disease programs. The
animal disease traceability framework allows producers to use NUES tags, commonly referred to
as “brite” tags, when authorized by the State or Tribal animal health official.
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. At a minimum, tag 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.
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 the AIMS to maintain NUES tag distribution records. The use of the
AIMS requires the use of either a LID or PIN for each distribution record entered into AIMS.
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 Eartagging System (4/13/2014).
Producers and accredited veterinarians should contact their State or Tribal animal health officials
regarding the availability of NUES tags.
Premises Identification Number Ear Tags for Slaughter Swine
PIN tags for slaughter swine provide an option to officially identify sows and boars to the premises
where they were kept immediately before entering harvest channels. PIN tags for slaughter swine
may be obtained from authorized manufacturers. As with the USDA back tag applied at markets,
the PIN tag will be collected as an official form of identification to be associated with any blood
or tissue samples collected for disease surveillance at slaughter. If a PIN tag includes a
manufacturer imprinted number unique within a herd, the tag would also qualify as an official ear
tag for interstate movement of individual animals.
Manufacturers distributing swine PIN tags directly to producers must report the records of PIN
tags distributed as directed by the State or Federal Animal Health Official.
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Approved Tagging Sites
Approved tagging sites are locations authorized by APHIS, State, or Tribal animal health officials
where livestock may be officially identified 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
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:
Obtain official identification devices only as directed by APHIS, State, or Tribal animal
health officials.
Unload animals requiring official identification only when the owner or the person in
possession, care, or control of the animals when they are brought to the tagging site
agrees to have the animals officially identified in accordance with approved tagging site
protocols.
Maintain tagging records using forms or electronic systems as directed by APHIS, State,
or Tribal animal health officials to include, at a minimum:
o The name of the owner or person responsible for the animals tagged and their street
address, city, State, and ZIP code
o The official identification numbers of the tags applied associated with the owner or
person responsible for the animals.
o The date the official identification ear tags were applied.
Submit the records of tags applied in an acceptable electronic format to the designated
animal health official as directed by APHIS, State, or Tribal animal health officials within
7 days of application.
Ensure the security of official identification devices and distribution records by:
o Maintaining a record of all official identification devices received, distributed, and
applied at the tagging site.
o Keeping the inventory of tags and records in a secure place accessible only to tagging
site personnel.
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 identified.
o Only tag animals not already officially identified. 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).
When animals are moved to an approved tagging site to fulfill the official identification
requirements, the interstate certificate of veterinary inspection or other movement document must
contain a statement verifying that the official identification devices are to be applied at an approved
tagging site along with the name and complete address of the tagging site. States will provide
public lists of tagging sites.
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Entities interested in becoming approved tagging sites should contact their APHIS, State, or Tribal
animal health official.
Use of More Than One Official Identification Device
After March 13, 2013, no animal should have more than one official identification device, except
in the following circumstances:
The animal may have a second official identification device if device bears the same
official identification number as the existing one.
In specific cases when the need to maintain the identity of an animal is intensified (e.g.,
export shipments, quarantined herds, field trials, experiments, or disease surveys), a State
or Tribal animal health official or an Area Veterinarian in Charge may approve the
application of an additional official identification device to an animal that already has one
or more.
An ear tag with an 840 AIN may be applied to an animal already officially identified with
one or more NUES tags and/or an official vaccination ear tag used for brucellosis.
A brucellosis vaccination ear tag with a NUES number may be applied to an animal
already officially identified with one or more official ear tags.
The person applying the second official identification device must record the date the device is
added, the official identification numbers of both the existing official identification device and the
new official identification device, and must maintain those records for 5 years.
Replacement of Official Identification Devices
Replacement official identification devices (for applying a new identification number to animals
that lose their official identification device) 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 AIMS 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
RFID technology, the manufacturer encodes the number in accordance with the existing ISO or
the existing APHIS-approved standard for administering transponders.
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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 RFID, 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.
Non-U.S. manufacturers seeking approval of an identification device must have a representative
within the United States who 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 will need to follow the process outlined below:
Perform required ICAR conformance and performance testing.
Submit initial device application including, results of ICAR testing and certification, device
approval and sales data from other countries or proposed field trial protocol for APHIS
approval, sample devices, and device applicator to APHIS.
After receiving APHIS approval produce devices for field trial according to the
specifications provided in these standards.
Initiate field trials and complete required assessments.
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.
Complete field trials with successful results and submit final application with compiled
field trial data for APHIS review.
APHIS reviews data and determines if the device meets the criteria for full 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, until the manufacturer resolves performance issues, APHIS terminates the
approval process, or revokes approval.
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Application for Approval of Official Identification Devices
Manufacturers seeking APHIS approval of an identification device must document that they have
successfully tested, produced, and marketed the identification device submitted for approval with
favorable results. Such documentation must show at a minimum that the device has been either:
Approved for a national identification program in at least one other country with
comparable or more stringent requirements than the performance criteria outlined in these
standards (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.
APHIS may consider requests for approval of alternative field testing or previously generated data.
Alternative field testing must provide verifiable data and demonstrate that the outcome conclusions
are at minimum equivalent to the field trial protocols and standards described in this document.
Requests will be evaluated on a case by case basis.
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 [email protected].
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Figure 1. Initial - Official Identification Device Approval Process
Manufacturer
completes
required ICAR
conformance and
performance
testing
Manufacturer
submits
application,
sample devices &
ICAR reports to
APHIS
Meets criteria?
Advise
manufacturer of
deficiencies - may
resubmit when
corrected
NO
YES
Manufacturer
provides proposed
field trial protocol
with locations
NO
Existing
approval in
another country
for review?
NO
YES
APHIS evaluates
application and
data provided
Meets criteria
for full
approval?
YES
APHIS and
Manufacturer
finalize field trial
protocol – APHIS
approves
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See Figure 2.
Field Trial Process for
Official Identification
Device Approval
Version 2.8
APHIS grants
full approval
and enters into
Device
Manufacturer
agreement
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Appendix 1: Field Trial Protocol
Identification devices without approval in another country with comparable or more stringent
standards must undergo field trials for 3 years in covered species3 with the exception of 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 12
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 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 initial field trials,
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 24 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 if they maintain 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
0-12 months
Trial
NONE
Preliminary
500,000
Conditional
Unlimited
12-24 months
(limited sales)
24-36 months
(unlimited sales)
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, 18,
24, 30, 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. 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.
Field trial locations must represent the variety of livestock management systems and
environmental settings found in the United States. Select at least six locations that represent both
hot and cold climates in the United States (e.g., Arizona and Wisconsin). At least two trial locations
will be in hot climates and at least two in cold climates. If a location needs to be excused from the
field trial, APHIS will consider the inclusion of additional locations at the manufacturer’s request.
The manufacturer must evaluate trial devices in each species for which device approval is
requested according to Table 7 below. Select field trial production settings and number of animals
per location to ensure sufficient animals remain available to assess device performance over the
field trial period.
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Table 7. Field Trial Requirements by Species
Species
Minimum Total Number of devices/animals
(minimum per trial location)
Management Settings
Cattle
and Bison
1500 (250)
At least one commercial dairy
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 1-2 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.
600 white-tailed deer and elk (65% whitetailed deer and 35% elk distribution if
possible) (40)
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.
Sheep
and
Goats
Captive
Cervids
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
Llamas
and
Alpacas
Field trials in sheep, goats or captive cervids suffice for testing of devices to be approved for use
on llamas, and alpacas
Manufacturers requesting approval of identification devices for species not listed above should contact
[email protected]
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 AIMS 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.
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
4
For sheep and goats also provide manufacturers agreement.
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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 AIMS.
To distinguish devices used in field trials from fully 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.
Devices marketed during the approval period must be imprinted with “US Trial” as described for
field trial devices, but may be manufactured using colors determined by the manufacturer.
However, devices imprinted with the “US Trial” may not be applied for the purpose of identifying
animals for disease control programs; i.e., brucellosis testing and vaccination.
The maximum number of devices that may be produced for field trials is 5000 per device
application.
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 equine, 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 ear tags shall be removed and a new device can then be applied to the
animal. For injectable transponders a new device may be implanted in the same or a replacement
animal.
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For electronic identification devices, conduct at least one assessment using a stationary reader
(excluding injectable transponders) and one assessment using a handheld reader at each trial
location. All readers used in the field trials must be commercially available in the United States.
Each device included in the field trial will be evaluated for device retention, durability, and
readability (electronic and visual) at each assessment. APHIS calculates retention rates based on
all remaining animals presented for assessment. If animals are removed from the trial (sold or
died), read their devices on exiting the trial and report them at the next scheduled assessment.
Approved trial devices may not be removed once applied, as they are official identification.
After initial device application and each assessment, manufacturers must submit their results and
high-resolution photographs of at least 10 trial devices that have been applied to animals in the
trial clearly demonstrating the information imprinted on the device. The manufacturer must
provide USDA with representative samples of recovered trial devices that did not remain attached
to the animal throughout the field trial.
Reporting Field Trial Assessment Results
The manufacturer will ensure APHIS receives results within 10 days of each assessment. Include
an electronic file in Excel (.xlsx) format detailing the:
Device name and product code.
Date, location, and production type of the facility where the assessment was conducted.
Identification numbers of the trial devices initially applied and the corresponding
reference tags (all trial devices initially applied must be accounted for at each
assessment).
Age, sex, species and breed of animals associated with each trial device.
Identification numbers and total number of trial devices that:
o Fail to be successfully applied.
o Read at each assessment.
o Are not retained (device loss determined using remaining reference device).
o Demonstrate visible damage affecting legibility.
o Experience transponder failure (RFID only).
o The imprinted identification number does not match the encoded AIN (RFID only).
o Experienced transponder migration or breakage.
RFID reader used (if applicable).
Disposition of animals not presented at each assessment, including reason not presented.
Manufacturers must maintain all assessment results throughout the field trial and submit a final
summary report of all assessment results and final VS Form 1-64 to APHIS at
[email protected] at the end of the field trial period to be considered for full approval of the
trial device. Include a brief description of the field trial locations, design, and any deviations from
the protocol in the final summary report.
APHIS will share performance, conformance and field trial data for trial devices with other
countries upon request.
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Figure 2. Field Trial Process for Official Identification Device Approval
Manufacturer
receives field
trial approval
from APHIS
Manufacturer/
APHIS enter into
Field Trial Device
Manufacturing
Agreement
Manufacturer
produces devices
for field trial per
Standards – enters
Trial Approval
Status
Manufacturer
enters Preliminary
Approval Status
and allowed
Limited sales of
device
Manufacturer
completes
Preliminary
Approval Status
timeline and
assessments
Manufacturer
requests
advancement to
Conditional
Approval Status
Assessments
meet criteria for
advancement?
YES
NO
Manufacturer
completes Trial
Approval Status
timeline and
assessments
Assessments
meet criteria for
advancement?
Manufacturer
requests
advancement to
Preliminary
Approval Status
NO
Remain in Trial
Approval Status
until issues
resolved –
reassess
Remain in
Preliminary
Approval Status
until issues
resolved –
reassess
YES
Manufacturer
enters Conditional
Approval Status
and allowed
unlimited sales of
device
See Figure 3.
Final
Approval
Process Flow
Diagram
Manufacturer
completes
Conditional
Approval Status
timeline and
assessments
APHIS Review for Approval
APHIS will notify the applicant in writing of the approval review outcome within 4 weeks of
receiving the completed application and field trial summary report. APHIS reserves the right to
assess field trial results, including those that do not fully conform to this protocol, and approve or
disapprove trial devices based on our assessment of the data provided.
Once APHIS fully approves a device, the manufacturer needs to enter into an APHIS Approved
Official Identification Device Manufacturer Agreement recertifying 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.
APHIS may withdraw approval of any device that fails to meet the performance criteria specified
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in this Standard at any time with 30 days’ written notice5. Upon termination of approval, the
manufacturer will provide APHIS copies of all records regarding the production and distribution
of the approved identification device. APHIS will direct the disposition of any formerly approved
identification devices marked with the U.S. shield in the possession of the manufacturer and
resellers on the date of termination.
5
60 days written notice to withdraw approval for sheep and goat devices. Revocation of approval of a sheep or goat
device may be appealed by following the procedures in Scrapie Program Standards Volume 1: National Scrapie
Eradication Program.
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Appendix 2: Animal Identification Device Performance and
Quality Controls
Printing Standards and Description for All Official Ear Tags
Official Ear Tag Shield and “UNLAWFUL TO REMOVE”:
For producers, market operators, and animal health officials to recognize ear tags as
“Official,” the official ear tag shield must be visible on the animal after it is tagged.
o For PIN ear tags for slaughter swine: The official ear tag shield must be a minimum
of 33 percent larger than the PIN print size (see Printing Standards and Description
for Swine PIN tags, below). The shield must be at least 0.33 inches (8 mm) high
and wide.
o For all other ear tags: The official ear tag shield must be must be visibly imprinted
on the surface of the tag at a minimum height of 5 mm (0.2 inches) and must be
visibly imprinted on both parts of a two-part tag, and on the back portion of the tag
(outside the ear) for a one-piece tag.
o For a copy of the official shield please contact [email protected].
To emphasize the need to maintain this identification for the life of the animal, the text,
“UNLAWFUL TO REMOVE” must be clearly visible on the tag. The text must be
imprinted:
o For small button tags: On the back piece of the tag (outside of ear).
o For panel tags: On the back piece (outside of ear), but may also be printed on the front
piece (inside of ear). The text must be imprinted on the tag at a minimum height of 3
mm (0.12 inches).
o For one-piece tags: On the back portion of the tag (outside of the ear).
o For PIN ear tags for slaughter swine: On the back piece (outside of ear), but may also
be imprinted on the front piece (inside of ear).
o For sheep and goats “UNLAWFUL TO REMOVE is not required on very small
tags.
Printing Standards and Description for Plastic AIN and NUES Ear Tags
For RFID tags the entire official identification number must be imprinted on the portion
of the tag containing the transponder encoded with the identical official identification
number. Two-piece tags may have the official identification number imprinted on the
portion of the tag that does not contain the transponder. When this is the case, the tag set
must be packaged in containers or trays so that the two pieces are maintained as a pair
until they are applied.
For visual-only tags the entire official identification number must be imprinted on the
portion of the tag inside the animal’s ear. The official identification number may also be
imprinted on the portion of the tag on the outside of the animal’s ear.
All official identification numbers must be imprinted at a minimum height of 5 mm (0.2
inches) and easily readable with 20/20 vision at a distance of 30 inches (0.75 m). An
exception may be made for small RFID ear tags that do not allow the imprinting of the
official identification number at 5 mm but are clearly read at the required distance. For
AIN tags a space must be inserted after each third digit of the AIN imprinted on the AIN
tag (e.g., 840 003 123 456 789.
The font for all characters for required information imprinted on the tag must be Arial.
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APHIS must approve any different font.
An indentation of the manufacturer’s unique, copyrighted logo or trademark must be
clearly visible on the tag. Having such information permanently imprinted on the tag is
also acceptable.
APHIS may approve printing of other information if it does not compromise the
readability of the required information. Manufacturers should include requests for
additional print specifications with their applications.
AIN tags that contain RFID technology must have the 2D Data Matrix that conforms with
the ECC200 Data Matrix protocol imprinted on the portion of the tag that contains the
transponder unless APHIS waives this requirement at the manufacturer’s request. The
data matrix is to be imprinted on the device in a square approximately 5mm x 5mm and
should be a two-dimensional representation of the official animal number imprinted on
the tag. Readability (percent of data matrix read) on new tags being shipped from the
manufacturing plant must be at 100 percent when read with a camera-based image reader
(bar code reader).
Printing Standards and Description for Swine PIN Ear Tags
The portion of the ear tag most visible to animal handlers and used as the primary identifier of the
animal must:
Be at least 2 square inches in size.
Bear the entire 7-digit PIN of the premises.
Bear the official ear tag shield.
Bear the PIN and corresponding bar code on the reverse side (APHIS prefers Code 128
symbology).
The portion of the ear tag most visible to animal handlers and used as the primary identifier of the
animal may:
Include a management number. If a management number is applied by the manufacturer or
at the premises, the PIN and management number must be imprinted on separate lines.
Include a management number in the bar code if the first seven alphanumeric characters of
the bar code correspond to the PIN.
All characters must be imprinted on the tag in Arial font. APHIS must approve any different font.
Ear tag print size must be a minimum height of 0.25 inches (6 mm) for PIN numbers and letters.
An indentation of the manufacturer’s unique, copyrighted logo or trademark must be easily
observed on the tag. Having such information permanently imprinted on the tag is also acceptable
if the print is on the back of the visual portion of the tag. APHIS may authorize printing of other
information if it does not compromise the readability of required information.
Performance of the Visual Components
Visual-only identification devices must have ICAR certification in accordance with Procedure 4
of Section 10 of ICAR Guidelines – Testing of Conventional Plastic Ear Tags. The manufacturer
must document that the device submitted for approval meets or exceeds the following criteria:
One-time use - tamper evident: The device contains a tamper-evident locking
mechanism designed for one-time use, and cannot be removed from one animal and
reapplied to another animal without evidence that this action has occurred.
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Tag coupling/tensile strength: Evaluation standards must conform to ICAR testing
standards and, at a minimum, with ISO standards 37 and 527.
Unalterable printing: The imprinting on the tag may not be readily altered.
Readability: The imprinted device must be easily and reliably readable with 20/20
vision. The printing and color contrast of the official ear tag shield, lettering, and
numbers are to be easily and reliably readable at a distance of 30 inches (0.75 m).
Submission of sample tags suffices for documentation of readability.
Tag loss rates: When ear tags are applied in a manner approved by the manufacturer, on
average the maximum tag loss rates per species may not exceed the values listed in Table
8 below:
Table 8. Device Retention by Species
6
Species
Maximum Device Loss Rates
Cattle and Bison
Sheep and Goats
Captive Cervids
Swine
No more than 1 percent annually or 3 percent in a 3-year period
No more than 2.7 percent annually or 8 percent in a 3-year period
No more than 2 percent annually or 6 percent in a 3-year period
No more than 5 percent annually when applied just prior to entering and
no more than 1 percent while swine are in slaughter channels, or no more
than 12.5 percent when applied prior to entering and 2.5 percent while
swine are in slaughter channels in a 2.5 year period respectively
Expected tag life: The tag is expected to remain on the animal in a physically functional
state for the animal’s expected lifetime.6
Tag toxicity and animal injury: In accordance with Appendix B5 of Section 10 part
1.2.2 of the ICAR Guidelines – Laboratory Test for Conventional Plastic Ear Tags, tags
may do no harm to an animal or affect its health or well-being. Tags may not cause
chemical contamination of meat or edible offal or damage the hide.
Tag deterioration: There may be no diffusion of colorant from tags in accordance with
Appendix B5 of Section 10 part 3.2 of the ICAR Guidelines – Laboratory Test for
Conventional Plastic Ear Tags. There may be no apparent physical deterioration (other
than color) due to detrimental effects by UV light, rain, heat (113°F/45°C) and cold (22°F/-30°C) or other environmental influences such as chemicals, mud, urine, or manure
for at least 5 years of wear.
Tag plasticity: Tags may not split or crack under normal use.
Tag abrasion resistance: Tags shall not exhibit damage or change due to wear, and at a
minimum, shall comply with ISO standard 9352.
15 years for cattle, bison, sheep, goats and captive cervids, 3 years for swine and 25 years for equine.
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RFID Transponder Performance
RFID Ear Tag Performance
The manufacturer must document that the RFID ear tag submitted for approval meets or exceeds
the following criteria:
Low Frequency devices:
o Transponders must conform to ISO 11784 and ISO 11785 and must have ICAR
certification in accordance with Procedure 1 of Section 10 of ICAR Guidelines Conformance of Transponders with ISO Standards and Procedure 5 of Section 10 of
ICAR Guidelines – Testing of External RFID Devices.
Ultra High Frequency devices must comply with:
o ISO 18000-6C (EPC Gen 2) and the USDA Interim Tag Data Standard available on
the ADT website at
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/traceability.
o Ear tags must have ICAR device composition and environmental performance testing
in accordance with Appendix B4 of Section 10 of the ICAR Guidelines – Preliminary
Test of Conventional Plastic Ear Tags and Appendix B5 of Section 10 of the ICAR
Guidelines – Laboratory Test of Conventional Plastic Ear Tags.
o ISO UHF conformance and performance standards once approved. All UHF
identification devices will be required to be fully certified by the governing
registration authority for UHF devices.
Electronic Read Rates and Ranges:
o Low frequency devices: Transponders must be reliably machine read at a rate of 95
percent without regard to orientation by a compatible reader commercially available
in the United States, as cattle (or other species) move by in a single file passage at 4
mph (1.8 meters/second).
o Ultra-high frequency devices: Transponders must be reliably machine read at a rate of
95 percent without regard to orientation by a compatible reader commercially available
in the United States at the read distance designated by the device manufacturer.
Expected transponder life: The transponder within the tag shall be reliable and
machine-readable for the animal’s expected lifetime6 with a failure rate of less than 0.2
percent annually and no more than 0.5 percent in 3 years.
Transponder security: The unique official identification number encoded within each
transponder must be one-time programmable and must be identical to the number
imprinted on the device.
RFID Injectable Transponder Performance
All transponders must have ICAR Conformance Certification and performance testing according
to Procedure 1 of Section 10 of the ICAR Guidelines – Conformance of Transponders with ISO
Standards. The manufacturer must document that the injectable transponder submitted for
approval meets or exceeds the following criteria:
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Read range: The transponder must have a minimum read range of 4 inches with a
handheld transceiver (reader).
Anti-migration: The transponder must be constructed to prevent migration after
implantation. No more than 1 percent of transponders may exhibit migration annually
and no more than 3 percent in 3 years.
Expected transponder life: The transponder shall be reliable and machine-readable for
the animal’s expected lifetime6 with a failure rate of less than 0.2 percent annually and no
more than 0.5 percent in 3 years.
Transponder security: The unique official identification number encoded within each
transponder must be one-time programmable.
Breakage: The transponder must not break under normal animal husbandry conditions.
No more than 1 percent breakage may occur annually and no more than 3 percent in 3
years.
Harmless to the animal: The implant, when injected and maintained as an implanted
device, must not harm the animal.
Quality control
The manufacturer must have documented quality control measures in place to ensure the ability
to produce the device consistently according to specification including, a full quality control plan
and flow diagram for the identification device from manufacturing of all components, through
encoding and/or imprinting, shipment and addressing consumer complaints. Procedures must
ensure the uniqueness of the AIN or NUES is maintained, that only AINs allocated to the
manufacturer are encoded in devices, and that processes to ensure distribution records of 840
AIN devices are reported to AIMS. If more than one company is involved with the
manufacturing of device components a full quality control plan is required for each entity.
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Appendix 3. Application Packet for Submission
Manufacturers applying for device approval must mail one hard copy of the VS Form 1-64
application and supporting materials to:
USDA APHIS Veterinary Services
c/o Animal Traceability Staff
4700 River Road, Unit 200
Riverdale, MD 20737
On the date they submit the hard copy application, manufacturers must also email a Portable
Document Format (PDF) version of the VS Form 1-64 and a high-quality digital photograph of
the device in JPG format to [email protected] including a photo of each number format and
color for which approval is requested if applicable. The device photo will be used in the listing of
devices on the ADT website.
(https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/traceability). This email alerts ADT
staff that the manufacturer’s application packet has been shipped.
Supporting Materials
Initial application and supporting materials:
o Submit documentation demonstrating approval in another country with comparable or
more stringent standards, and sales data OR proposed field trial protocol.
o Ear tags:
Include in the submission packet at least 20 samples of the trial device submitted
for approval (marked with “US Trial” on the portion of the tag containing the
wording “Unlawful to Remove” and green in color (R:120 G:180 B:50) with
black print). In addition, include at least 20 samples of the trial device in a color
and package intended for retail sale for APHIS review of print specifications and
encoding validation for RFID (if applicable). Imprint/encode devices with the
following numbers (examples shown):
AIN RFID tags: 840003123456770 – 840003123456789
NUES RFID tags: 60ABC0001 – 60ABC0020
PIN tags: Premises Number: ABC1234; State abbreviation: IA
For sheep and goat tags the numbering systems for which approval is being
requested:
o Serial metal (NUES): STAA0001 – STAA0020
o Serial plastic (NUES): STA10001 – STA10020
o Slaughter only serial (NUES): STAA0001 – STAA0020 must be medium
blue tag and include “Slaughter Only” or for small tags “MEAT”
o Flock ID: ST1234567 123456 to ST1234567 123476
o AIN RFID tags: 840003123456770 – 840003123456789
o NUES RFID tags: STAA0001 – STAA0020
o AIN RFID tags with Flock ID: ST1234567 and 840003123456770 –
840003123456789
If the device application is for a two-piece tag or a pair set, provide at least five
tag sets in one container or package in the numerical sequence being used to
reflect how the male tag and female tag will be distributed as a matched pair. For
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one or two-piece visual only tags provide at least five tags in the packaging they
will be provided in. Packaging must maintain the tags in sequential order.
Provide three applicators used to apply the device submitted for approval. If the
applicator functions with other devices for which the company is applying for
AIN tag authorization, list those tags by product name (additional taggers will not
be required for those tags).
o RFID injectable transponder:
Provide at least 10 samples of the injectable transponder submitted for approval in
the package intended for retail sale encoded with the following AIN range:
840003123456770 – 840003123456779 (these numbers have been designated for
use in sample AIN devices.) The sample retail package must include individually
packaged sterile transponder with injection device and instructions for compliant
use of the injectable transponders.
The instructions provided in the retail package must include:
The manufacturer’s recommendation for sterile handling and administration of
the injectable transponder.
Any VS program guidelines/requirements for the species involved.
The FDA guidelines/requirements regarding the use of injectable transponders
in food animals in the packaging of all AIN injectable transponder shipments.
Recommendations regarding the disclosure of the injectable transponder at the
time of harvest or rendering and the recommendations for removal at the time
of harvest must be in bold print on the enclosed product packaging directions
insert.
When the device is intended for use in food animals, the manufacturer must
include a copy of the U.S. Food and Drug Administration (FDA) approval
letter for use of the specific injectable transponder in the food animal species
addressed in the manufacturer’s application.
Modification of an existing approved official identification device:
o Submit detailed information regarding both the original official identification device
or component and the proposed modification including complete specifications
(composition, diagrams, schematics, etc.). For ear tags, explain any impacts the
proposed modification would have on the use of existing recommended tag
applicator(s). Include field trial data or device approval and sales data of the modified
device or component from other countries as applicable.
o Provide 10 sample devices that incorporate the proposed modification and 10 devices
representing the existing approved device. If the modification requires a new
applicator, submit three new applicators with the sample devices.
Final application and supporting materials:
o Submit the field trial summary report, including all assessment results and a brief
description of the field trial locations, design, and any deviations from the protocol.
o Submit 20 sample devices in the format and package intended for retail sale. For
sheep and goat ear tags, if multiple colors and print formats will be offered provide
one sample of each color and print format. For AIN devices, encode and/or imprint
the sample official identification devices with numbers allocated to the manufacturer
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in AIMS. Manufacturers or their device manager must record shipment of the 20
devices to NPN 0034P2K in AIMS.
Direct questions regarding the application process to [email protected].
General Standards
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| File Type | application/pdf |
| File Title | Animal Disease Traceability |
| Subject | General Standards |
| Author | Gary J Moore |
| File Modified | 2020-04-07 |
| File Created | 2020-04-07 |