11170 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

1To view the proposed rule, supporting 

documents, and the comments we received, go to 

http://www.regulations.gov/#!docket

Detail;D=APHIS-2007-0127. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 54 and 79 

[Docket No. APHIS–2007–0127] 

RIN 0579–AC92 

Scrapie in Sheep and Goats 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the scrapie 

regulations by changing the risk groups 

and categories established for individual 

animals and for flocks, increasing the 

use of genetic testing as a means of 

assigning risk levels to animals, 

reducing movement restrictions for 

animals found to be genetically less 

susceptible or resistant to scrapie, and 

simplifying, reducing, or removing 

certain recordkeeping requirements. We 

are also providing designated scrapie 

epidemiologists with more alternatives 

and flexibility when testing animals in 

order to determine flock designations 

under the regulations. We are changing 

the definition of high-risk animal, 

which will change the types of animals 

eligible for indemnity, and to pay higher 

indemnity for certain pregnant ewes and 

does and early maturing ewes and does. 

The changes will also make the 

identification and recordkeeping 

requirements for goat owners consistent 

with those for sheep owners. These 

changes affect sheep and goat 

producers, persons who handle sheep 

and goats in interstate commerce, and 

State governments. 

DATES: Effective April 24, 2019. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Diane Sutton, National Scrapie Program 

Coordinator, Sheep, Goat, Cervid & 

Equine Health Center, Strategy and 

Policy, VS, APHIS, 4700 River Road 

Unit 43, Riverdale, MD 20737–1235; 

(301) 851–3509. 

SUPPLEMENTARY INFORMATION: 

Background 

Scrapie is a degenerative and 

eventually fatal disease affecting the 

central nervous systems of sheep and 

goats. Scrapie belongs to the family of 

diseases known as transmissible 

spongiform encephalopathies (TSEs). In 

addition to scrapie, TSEs include, 

among other diseases, bovine 

spongiform encephalopathy (BSE) in 

cattle, chronic wasting disease in deer 

and elk, and variant Creutzfeldt-Jakob 

disease in humans. Control of scrapie is 

complicated because the disease has an 

extremely long incubation period 

without clinical signs of the disease. 

To control the spread of scrapie 

within the United States, the Animal 

and Plant Health Inspection Service 

(APHIS), United States Department of 

Agriculture (USDA), administers 

regulations at 9 CFR part 79, which 

restrict the interstate movement of 

certain sheep and goats. APHIS also has 

regulations at 9 CFR part 54, which 

describe a voluntary scrapie-free flock 

certification program. 

On September 10, 2015, we published 

in the Federal Register (80 FR 54660– 

54692, Docket No. APHIS–2007–0127) a 

proposal 1 to amend the regulations in 

parts 54 and 79 by changing the 

requirements for records needed to trace 

animals, and by adding provisions to 

link official individual animal 

identification applied by persons other 

than the flock owner to the flock of 

origin in the National Scrapie Database 

rather than just the person who applied 

the official identification. The current 

regulations address tracing exposed 

animals moved from a flock to another 

flock primarily in § 54.8(f) (regarding 

the responsibility of flock owners to 

disclose records to APHIS 

representatives or State representatives 

for the purpose of tracing animals), in 

§ 79.2(b) (regarding the responsibility of 

persons applying eartags to maintain 

appropriate records that permit 

traceback of animals to the flock in 

which they originated), and in 

§ 79.6(a)(5) (regarding State 

responsibilities to do epidemiologic 

investigations of source and infected 

flocks that include tracing animals). The 

changes we proposed would ensure that 

better records are available for tracing 

animals by adding requirements in new 

§ 54.8(b), ‘‘Records for flocks under a 

flock plan or PEMMP,’’ § 79.2(f), 

‘‘Records required of persons who 

purchase, acquire, sell, or dispose of 

animals,’’ and § 79.2(g), ‘‘Records 

required of persons who apply official 

identification to animals.’’ 

We also proposed to reduce some 

recordkeeping, primarily by eliminating 

the requirement in many cases to read 

and record individual identification that 

was applied before a new owner or 

shipper receives the animal. Further, by 

making the regulations easier to 

understand we hope to eliminate cases 

where owners and markets 

unnecessarily keep records or apply 

unneeded identification, or fail to do so, 

when required through lack of 

understanding. Also, in cases where 

genetic testing allows us to determine 

that all exposed animals in a flock are 

genetically resistant, use of genetic 

testing would allow some flocks to 

avoid being placed under a flock plan or 

post-exposure management and 

monitoring plan (PEMMP), thus 

avoiding the substantial recordkeeping 

requirements of § 54.8. 

We solicited comments concerning 

our proposal for 60 days ending 

November 9, 2015. We reopened and 

extended the deadline for comments 

until December 9, 2015, in a document 

published in the Federal Register on 

November 16, 2015 (80 FR 70718, 

Docket No. APHIS–2007–0127). We 

received 59 comments by that date. The 

comments were from private citizens, 

sheep and goat breeders, operators of 

livestock markets, a foreign government, 

and industry associations. Two 

commenters supported the rule as 

proposed. Four commenters were 

generally opposed to the proposed rule 

but did not address any specific 

provisions. The remaining commenters 

raised a number of concerns related to 

the proposed rule and program 

standards. Those concerns are discussed 

below. 

Definitions 

One commenter asked us to clarify the 

definition of exposed animal, which 

appears in both §§ 54.1 and 79.1. The 

commenter stated that the phrase ‘‘or in 

an enclosure off the premises of the 

flock’’ is particularly confusing. 

We agree with the commenter and 

have amended the definition to specify 

that an exposed animal is any animal or 

embryo that: 

• Has been in a flock with a scrapiepositive female animal; 

• Has been in an enclosure with a 

scrapie-positive female animal at any 

location; 

• Resides in a noncompliant flock; or 

• Has resided on the premises of a 

flock before or while it was designated 

an infected or source flock and before a 

flock plan was completed. 

One commenter recommended the 

definition of exposed animal be revised 

to clarify that ‘‘a date 2 years before the 

birth of the oldest scrapie-positive 

animal(s)’’ means ‘‘a date 2 years before 

the birth of the oldest scrapie-positive 

animal(s) born in that flock.’’ We agree 

and have made the requested change. 

One commenter stated that the flock 

identification number could be issued 

in a State database and then recorded in 

the National Scrapie Database. The 

commenter recommended amending the 

definition of flock identification number 

to reflect this. 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11171 

We agree with the commenter and 

will amend the definition in § 79.1 to 

read ‘‘recorded in’’ instead of ‘‘issued 

through.’’ 

One commenter stated that the 

definition of genetically less susceptible 

exposed sheep was unclear. 

Specifically, the commenter stated that 

currently most sheep are only 

genotyped at codon 171, so starting the 

definition with the words ‘‘An exposed 

sheep or sheep embryo of genotype AA 

QR’’ does not make sense. The 

commenter also asked why AA was 

used in the definition since most sheep 

are only genotyped at codon 171 and 

what ‘‘where Q represents any genotype 

other than R at codon 171’’ means and 

what it relates to. 

AA QR is used in the definition 

because exposed sheep that are 

epidemiologically linked to a positive 

animal that has valine at codon 136 are 

tested at codon 136 and AV QR sheep 

may be treated differently than AA QR 

sheep when this occurs. All positive 

sheep are tested at a minimum for 

codon 171 and 136. The statement 

‘‘where Q represents any genotype other 

than R at codon 171’’ means that sheep 

that have H, K or any other amino acid 

other than R will be treated the same as 

sheep that are Q at codon 171. 

We do agree that the definition could 

be more clearly written, however, and 

are changing the definition in §§ 54.1 

and 79.1 to define a genetically less 

susceptible exposed sheep as any sheep 

or sheep embryo that is: 

• An exposed sheep or sheep embryo 

of genotype AA QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a 

scrapie type to which AA QR sheep are 

not less susceptible; or 

• An exposed sheep or sheep embryo 

of genotype AV QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that 

the Administrator has determined may 

be affected by valine-associated scrapie 

(based on an evaluation of the genotypes 

of the scrapie-positive animals linked to 

the flock), or to another scrapie type to 

which AV QR sheep are not less 

susceptible; or 

• An exposed sheep or sheep embryo 

of a genotype that has been exposed to 

a scrapie type to which the 

Administrator has determined that 

genotype is less susceptible. In this 

definition R refers to codon 171 and A 

refers to codon 136, and Q represents 

any genotype other than R at codon 171 

and V represents any genotype other 

than A at codon 136. 

One commenter stated that the 

definition of genetically susceptible 

animal was unclear and that the phrase 

‘‘or sheep or sheep embryo of 

undetermined genotype where Q 

represents any genotype other than R at 

codon 171’’ does not make sense. 

We agree that this can be more clearly 

written and are amending the definition 

in §§ 54.1 and 79.1 to read ‘‘Genetically 

susceptible animal. Any goat or goat 

embryo, sheep or sheep embryo of a 

genotype other than RR or QR, where Q 

represents any genotype other than R at 

codon 171 or a sheep or sheep embryo 

of undetermined genotype.’’ 

One commenter asked what is meant 

by ‘‘under continuous inspection’’ in 

the definition for slaughter channels. 

Continuous inspection means an 

inspector examines each animal before 

slaughter (antemortem inspection) and 

the carcass and parts after slaughter 

(postmortem inspection). For clarity we 

are amending the definition to specify 

that official slaughter establishments are 

under Food Safety and Inspection 

Service (FSIS) jurisdiction per the 

Federal Meat Inspection Act or under 

State inspection that FSIS has 

recognized as at least equal to Federal 

inspection or to a custom exempt 

slaughter establishment as defined by 

FSIS (9 CFR 303.1) for immediate 

slaughter, or to an individual for 

immediate slaughter for personal use or 

to a terminal feedlot. 

One commenter asked if a definition 

for tamper-resistant sampling kit 

needed to be included in part 79 as well 

as part 54. 

The term tamper-resistant sampling 

kit is used only in part 54. Since it is 

not used in part 79, it does not need to 

be defined in that part. 

We have made minor changes to other 

definitions. Specifically, we have 

amended the definition of destroyed in 

§ 54.1 to remove the portion of the 

definition that allowed for animals to be 

moved to quarantine facilities because 

we do not use the word in that sense in 

the regulations. We note that § 54.7(a)(3) 

provides for the movement of scrapiepositive and suspect animals for which 

indemnification is sought to an 

approved research facility. 

We have amended the definition of 

flock identification (ID) number in 

§ 79.1 to specify that APHIS may assign 

Tribal codes to any federally recognized 

Tribe that maintains sheep or goats on 

Tribal lands. We made this change to be 

consistent with the provisions of a final 

rule published in the Federal Register 

on January 9, 2013 (78 FR 2040, Docket 

No. APHIS–2009–0091) that established 

official identification and 

documentation requirements for the 

traceability of livestock moving 

interstate. 

We have amended the definition of 

genetically resistant sheep to specify 

that the sheep or sheep embryo is of 

genotype RR at codon 171. We made 

this change because we had not 

specified the codon in the proposed 

rule. We have also amended the 

definition of official identification 

device or method to refer to § 79.2(a)(2), 

since that is where the requirements for 

sheep and goat identification are found. 

We have also amended the definition 

of slaughter channels in § 79.1 to 

remove provisions regarding the sale of 

animals in slaughter channels. Those 

provisions now appear in § 79.3(g). We 

have also amended the definition of 

slaughter channels in § 54.1 to be 

consistent with the changes in § 79.1. 

In addition, we have made 

nonsubstantive editorial changes to the 

definitions of high-risk animal and 

owner/hauler statement to improve 

clarity. 

Non-Classical Scrapie 

One commenter recommended that 

any reference to genetic resistance and 

susceptibility to scrapie, especially in 

the definitions, should prominently 

specify that the relationship between 

genotype and scrapie pertains to 

classical scrapie and not non-classical 

scrapie. 

APHIS disagrees. While it is true that 

genetic susceptibility is different for 

classical and non-classical scrapie, the 

current language addresses this by 

including the words ‘‘or to a scrapie 

type to which the sheep are 

susceptible.’’ Leaving the text as 

currently written allows maximum 

flexibility in addressing all types of 

scrapie. We are making no changes in 

response to this comment. 

One commenter recommended 

continuing monitoring of animals 

exposed to non-classical scrapie because 

non-classical scrapie has been shown to 

be transmitted through oral inoculation 

and has a peripheral distribution of 

infectivity despite the absence of the 

scrapie prion protein. 

APHIS agrees that continued 

monitoring of animals exposed to nonclassical scrapie is warranted. We 

intend to continue monitoring animals 

exposed to non-classical scrapie by 

requiring that they be officially 

identified with official identification 

devices or methods assigned to the flock 

of origin in the National Scrapie 

Database. 

Four commenters recommended that 

APHIS continue to require identification 

of Nor98-like scrapie-exposed animals, 

and flockmates and offspring of these 

11172 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

2https://www.osha.gov/pls/imis/industry.search?

p_logger=1&sic=0214&naics=&State=

All&officetype=All&Office=All&endmonth=

01&endday=01&endyear=2011&startmonth=

12&startday=31&startyear=2015&owner=&scope=

&FedAgnCode=. 

animals, for a period of 5 years after the 

positive animal left the flock. 

APHIS agrees that animals that are in 

Nor98-like scrapie infected and source 

flocks and animals originating from 

these flocks should be identified for a 

period of 5 years, and the flocks 

monitored through reporting and testing 

of clinical suspects and mature animals 

that die. We note that we have provided 

for this in the program standards in Part 

VIII: Flock Cleanup Plans and PEMMPs, 

so there is no need to make changes to 

the program standards in response to 

this comment. 

Official Identification 

Several commenters expressed 

concern that the rule would prohibit the 

use of registry tattoos as official 

identification. This is not the case. The 

rule, through the accompanying 

program standards, does allow the use 

of registry tattoos as official 

identification when the sheep or goat is 

legibly tattooed and accompanied by a 

copy of their registration certificate in 

the name of the current owner or a copy 

of a completed application for transfer 

of ownership dated within 60 days of 

the change in ownership or when 

accompanied by an interstate certificate 

of veterinary inspection that lists the 

flocks of origin and birth, the registry, 

and the registry tattoo. 

Two commenters asked that we 

confirm that registration/recordation 

tattoos will continue to be allowed for 

animals in exhibition, educational 

events, in registry sales, private treaty 

transfer, and other movements not in 

slaughter channels or auction markets. 

Yes, these animals may move with 

registry tattoos as currently allowed. 

The only change is that the registry 

prefix must be recorded in the premises 

record for the flock in the National 

Scrapie Database and documentation of 

this must accompany the animal, or the 

registry organization must be approved 

based on their ability and willingness to 

assist APHIS in tracing animals during 

a disease investigation. 

One commenter asked, that for tattoo 

prefixes containing letters that are 

prohibited, that the prefix be linked in 

the National Scrapie Database with the 

flock identification. 

APHIS notes that this rule allows, and 

the program standards encourage, the 

cross referencing of flock identification 

numbers with registry prefixes. No 

change is being made in response to this 

comment. 

Several commenters expressed 

concern about how the identification 

requirements would apply to certain 

goat breeds. One commenter expressed 

concern that tail tags would cause 

unnecessary medical issues for smalleared or earless breeds of goats, such as 

La Mancha goats. 

The rule states that the requirements 

for use of official identification devices 

will be maintained on the APHIS 

website. These requirements are posted 

on the website as part of the Scrapie 

Program Standards. There are no 

approved tags for application to the tail, 

and the application of an official eartag 

to any tissue other than the ear is 

specifically prohibited in the Scrapie 

Program Standards. APHIS provides for 

tail fold tattoos, Electronic Implantable 

Devices (EIDs), and neck collars as 

acceptable means of identification for 

very small-eared or earless goats. 

One commenter expressed the 

concern that neck collars may pose a 

strangulation risk. 

APHIS notes that neck collars are 

commonly used for dairy goats. We 

believe that, given this usage, the risk of 

strangulation is likely minimal or neck 

collars would not be in general use. 

Further, because the expectation of 

durability is the same as for eartags, 

using collars that will break before 

causing strangulation is allowed and 

considered desirable. Also, as we 

explain below, we are amending the 

program standards to allow the use of 

back tags for earless animals moving 

directly to slaughter as an alternative to 

using a neck collar. 

One commenter requested that earless 

goats be exempted from the ID 

requirements. 

We recognize that using tail fold 

tattoos, EIDs, or neck collars for earless 

goats may present some challenges for 

breeders; however, using these devices 

will result in being able to trace a higher 

percentage of the animals. Not using 

them will reduce the traceability of 

these animals. We agree that allowing 

the use of back tags for earless animals 

moving direct to slaughter is an 

acceptable option and are amending the 

program standards to reflect this. 

One commenter stated that eartags are 

too big for miniature goat breeds and 

that tattoos should be allowed. 

As we explained above, the use of 

registry tattoos and flock identification 

tattoos as official identification will be 

allowed. We also note that very small 

official eartags are available for use on 

miniature breeds. 

Some commenters stated that we 

should not require a specific ear to be 

used for the eartag. One commenter 

recommended that the right ear forward 

edge be used for metal tags. Several 

other commenters recommended that 

APHIS standardize the placement of 

eartags in wool sheep to the left ear half 

way between base and tip of ear and in 

the middle between the ridges towards 

the lower edge. The commenters also 

stated that metal tags should be avoided 

in wool or fiber animals to minimize the 

risk of injury to shearers or damage to 

shearing equipment. 

The rule does not require that a 

specific ear be used for the eartag. We 

agree that placement on the lower edge 

of the left ear is preferred for wool or 

fiber animals and will provide this 

guidance in the program standards. 

However, we will not make it a 

requirement because it would be overly 

burdensome to producers given the 

minimal improvement in traceability 

that would likely result. 

One commenter asked that 

epidemiological evidence be 

independently compiled by an entity 

such as the Occupational Safety and 

Health Administration (OSHA) 

regarding the relative safety risk to 

shearers in flocks using metal vs. plastic 

tags. 

OSHA makes information about 

planned and accident-related 

inspections, searchable by Standard 

Industrial Classification (SIC) codes, 

available on its website. There are only 

17 incidents reported from all causes 

related to sheep and goat farms (SIC 

code 0214) in the last 5 years.2 Given 

this small number of incidents, we do 

not believe there is sufficient data 

provided to OSHA on shearing injuries 

for a meaningful comparison. We will 

include a question on eartag-related 

shearing problems in the next sheep 

National Animal Health Monitoring 

System (NAHMS) study, which we 

anticipate doing in Fiscal Year 2022. 

The prior NAHMS was conducted under 

OMB control number 0579–0188. 

One commenter recommended use of 

a uniform tag color to assist regulatory 

personnel to quickly and efficiently 

identify officially tagged sheep and 

goats. 

We agree that a uniform official tag 

color would be beneficial in rapidly 

identifying official eartags. However, we 

also believe that there is a significant 

benefit for producers to have access to 

multiple tag colors for purposes of 

sorting their animals by age, sex, or 

other characteristics, so we will 

continue to allow the use of various 

colors of eartags. APHIS changed the 

color of metal tags provided by APHIS 

in 2018 to orange to make them more 

visible. 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11173 

3Historically, prevalence rates of scrapie varied 

by face color and our prevalence estimate is 

appropriately weighted to match the face color 

distribution within the U.S. sheep population. 

Two commenters asked that the 

program standards be revised to require 

all sheep and goats at exhibitions be 

tagged, regardless of whether they come 

from in or out of State, as an exhibition 

is a concentration or commingling 

point. 

For practical purposes, sexually intact 

sheep and goats of any age and wethers 

18 months of age and older that are 

exhibited are required to be officially 

identified. There is an exclusion, which 

would rarely apply, for animals that 

have never been in interstate commerce 

and that have not resided on a premises 

where animals that have been in 

interstate commerce have been received 

or from which animals are moved in 

interstate commerce, where the animals 

being moved for exhibition are not 

owned by a person who engages in the 

interstate commerce of animals, that are 

moved to exhibitions that are conducted 

at premises where the interstate 

commerce of animals does not occur, 

and where none of the animals 

exhibited has been in interstate 

commerce. We believe that this 

exclusion is required since if such an 

exhibit were to occur it would fall 

within the State’s authority. We are 

revising the Scrapie Program Standards 

to clarify this. 

One commenter opposed requiring 

identification for all sheep because it 

would be costly not only to producers, 

but also to auction markets and the 

veterinary personnel working at 

markets. Other commenters also 

opposed requiring identification for 

goats because of the additional costs. 

We are aware that there are costs 

associated with the application of 

official identification for both producers 

and markets. However, the use of 

official identification is essential for the 

eradication of scrapie. To achieve 

scrapie-free status, we must be able to 

trace mature animals in order to 

conduct effective slaughter surveillance. 

Eradication is the goal because 

achieving scrapie-free status in the 

United States would significantly 

enhance trade opportunities and help to 

stabilize prices for sheep and goats and 

their products. Since the goal of the 

program is eradication and not just 

control of scrapie, maintaining a low 

prevalence in goats is not an option. 

Three commenters raised concerns 

regarding the safety of applying eartags 

to range goats, particularly mature bucks 

that have horns. The commenters stated 

that these goats are wild animals, and 

that applying eartags to them presents a 

risk to both the animals and the people 

applying the eartags. 

We agree that certain goats may pose 

a hazard to those applying eartags if 

appropriate equipment is not available 

to restrain the animals. The provisions 

in § 79.3(a)(2) allow these goats to move 

in single source groups to slaughter 

without official individual 

identification including through 

markets. This is one option for handling 

these goats. We will also revise the 

program standards to allow such goats 

to move direct to slaughter with official 

backtags as less restraint is required to 

apply backtags. We are also amending 

§ 79.3(k) to allow compliance 

agreements or market agreements to 

include alternative methods for 

maintaining traceability or achieving 

acceptable surveillance levels when the 

Administrator and the State Animal 

Health Official agree that the 

application of an allowed official 

identification device or method is 

unsuitable for a specific circumstance. 

Further, we have amended the 

definition of group/lot identification 

number (GIN) in § 79.1 to provide that 

a group lot comprised of animals from 

a single flock of origin may be 

subdivided after leaving the premises on 

which the group lot was formed by 

adding an S followed by a sequential 

number to the end of the GIN to create 

a GIN for each sub group. This will 

provide additional flexibility in 

handling unidentified animals moving 

to slaughter as a single source lot. 

Three commenters stated that 

veterinarians should be able to order 

and use official scrapie tags for use in 

regulatory testing, interstate certificates 

of veterinary inspection (ICVI), or any 

other reason requiring official 

identification. The commenters also 

stated that APHIS should maintain this 

traceability information in a userfriendly database. The commenters also 

stated that county 4-H sheep and goat 

offices should be assigned official 

scrapie tags. 

In § 79.2(b) of the proposed rule, we 

proposed to continue to allow State 

Animal Health Officials and APHIS 

personnel responsible for States to issue 

sets of unique serial numbers or flock 

identification/production numbers for 

use on official individual identification 

devices or methods (such as eartags or 

tattoos). In § 79.2(b)(2), we also 

proposed to continue to allow the 

official responsible for issuing eartags in 

a State to assign serial numbers of 

official eartags to other responsible 

persons, such as 4–H leaders, if the 

State Animal Health Official and APHIS 

personnel responsible for the State 

involved agree that such assignments 

will improve scrapie control and 

eradication within the State. 

Distribution of tags is currently 

managed in the scrapie program utility 

of the Animal Identification 

Management System and in certain 

cases redistributed in the Surveillance 

Collaboration Services Scrapie (SCS 

SCR) system. APHIS intends to continue 

to work to improve the user experience 

with these systems. 

One commenter sought clarification 

regarding whether the proposed rule 

would require individual animal 

identification numbers to be read more 

than once at approved livestock 

facilities. 

This requires that eartags be read only 

when an ICVI is required for movement 

of the animals from the market in cases 

where flock identification tags were not 

used to identify the animals or the flock 

identification of the animals is 

unknown and the tags must be read to 

determine the flock of origin. If flock 

identification tags are present, the flock 

identification may be listed instead of 

the individual tag numbers. In the case 

of animals that arrive at a market on an 

ICVI, when allowed by the States 

involved, the original document may be 

attached to the new ICVI if the animal 

IDs of any animals not included in the 

shipment are struck off the old ICVI. 

Recordkeeping 

Several commenters had concerns 

regarding the recordkeeping associated 

with goat sales and our ability to trace 

goats based on these requirements. 

This rule makes the identification 

requirements for goats in interstate 

commerce similar to those currently in 

place for sheep. The requirements for 

sheep have been in place since 2002 and 

have resulted in 82 percent of positive 

sheep being traced and a 98 percent 

decrease in the prevalence of scrapiepositive adult sheep slaughtered 

adjusted for face color.3 We are 

confident that these requirements will 

be similarly successful with goats. 

Several commenters asked that APHIS 

provide templates with required fields 

marked for owner/hauler statements and 

for any other required information or 

data as in the case of entities that 

acquire or dispose of animals. 

We agree that such templates would 

be useful and will post templates on the 

APHIS Scrapie Program website when 

they have been approved. 

Two commenters opposed the 

requirement to submit eartagging 

records to APHIS. Several other 

commenters indicated that the 

requirement to submit tagging records 

could be burdensome if not 

11174 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

implemented prudently following 

successful piloting, and that an option 

should be provided for electronic 

storage of required documents in an 

APHIS system rather than requiring the 

market to store the records long-term. 

One commenter stated that the 

regulations should clearly state that 

maintaining physical copies of these 

records at the market for 5 years also 

meets this requirement. 

We agree with the commenters and 

have amended § 79.2(b)(3) to indicate 

that submission is required only when 

requested by APHIS. This will allow 

APHIS to work through issues that may 

negatively impact stakeholders in small 

pilots and to implement the requirement 

through the program standards when 

the process has been tested and the 

technology allows for efficient 

compliance. APHIS will also consider 

the feasibility of providing electronic 

document storage. With this change 

maintaining physical copies of these 

records at the market for 5 years meets 

the requirement unless the records are 

requested. 

Some commenters recommended 

using an owner/hauler statement and 

lot/group identification for lots of sheep 

or goats moving directly to slaughter 

without official ID. 

APHIS notes that § 79.3(a)(2) allows 

single source lots of cull sheep or goats 

to move unidentified direct to slaughter 

using an owner/hauler statement 

without official ID so no changes are 

being made in response to this 

comment. We will amend the program 

standards to improve clarity. 

One commenter requested that we 

allow unidentified animals in interstate 

commerce that do not cross State lines 

to move unidentified to markets that are 

not approved markets. 

APHIS notes that as currently written, 

the regulations allow unidentified 

animals to move to unapproved in-State 

markets for sale, provided that the 

markets tag the animals once they 

arrive. However, if the person selling 

the animal through an unapproved inState market engages in the interstate 

commerce of animals, they must 

identify the animals before loading them 

at their premises. In response to the 

comment, we are amending 

§ 79.2(a)(1)(iv) to allow producers not 

already allowed to move animals 

unidentified to unapproved in-State 

markets under the regulations to do so 

if the animals’ owner provides tags 

assigned to his or her flock for the 

market to apply. As an alternative, such 

markets may request approval under 

§ 71.20. 

We are also amending § 79.2(a)(1)(iv) 

to add ‘‘or the owner of the animal’’ 

after ‘‘the owner of the premises’’ since 

it would be inequitable to apply a 

different standard to people who rent as 

opposed to own the premises on which 

their animals reside. 

In § 79.2(a)(1), we had proposed to 

remove paragraph (vi) because the 

newly amended paragraph (iv) included 

animals moved across a State line. 

However, from questions received 

during the comment period it became 

apparent that the removal of this 

paragraph reduced clarity. Therefore, 

we will not be removing paragraph (vi). 

We have made nonsubstantive, editorial 

changes to the paragraph to update and 

simplify its language. 

One commenter indicated support for 

the opportunity for markets to enter into 

agreements with USDA to receive 

unidentified animals that cannot be 

traced to their flock of birth or origin if 

they place a slaughter only tag on them 

and sell them through slaughter 

channels, but did not support the 

reporting requirement for noncompliant shipments. The commenter 

stated that this requirement asks 

markets to act against the interests of 

their customers. 

APHIS recognizes that this presents a 

conflict for markets. Markets may either 

decline to handle non-compliant 

shipments or report such shipments to 

USDA as part of a compliance 

agreement. No change is being made in 

response to this comment. 

Interstate Certificates of Veterinary 

Inspection 

One commenter recommended that 

each copy of an ICVI be signed by the 

issuing veterinarian. 

We agree with the commenter and are 

amending § 79.5(a)(4) to specify that the 

ICVI must be signed by the issuing 

State, Federal, Tribal or accredited 

veterinarian and the signature must be 

legible on each copy of the ICVI. 

One commenter asked us to clarify the 

flock identification exception in 

§ 79.5(a)(2). The commenter specifically 

asked what animals could move with 

flock identification that is assigned to 

the flock of origin and to explain how 

‘‘flock of origin tags’’ differ from tags 

issued to flock owners with individual 

flock identification numbers. 

We amended that paragraph to refer to 

‘‘official identification devices or 

methods that include the flock 

identification number assigned to the 

flock of origin in the National Scrapie 

Database and an individual animal 

number unique within the flock,’’ to 

clarify the requirements. 

One commenter asked for clarification 

of the requirement to record official 

genotype tests on an ICVI. Another 

commenter recommended eliminating 

the requirement to record official 

genotyping tests on an ICVI in 

§ 79.5(a)(3) as the value of doing so is 

small and would be impractical to 

enforce. 

We agree with the second commenter 

that recording official genotype test 

information on the ICVI is not needed 

and have removed the requirement. 

Surveillance 

One commenter stated that the 

proposed rule does not encourage 

slaughter surveillance and expressed 

concern that focus on achieving State 

sampling minimums will adversely 

impact slaughter surveillance efforts. 

We agree that sampling animals at 

slaughter is critical and needs to be 

maintained. This work is currently 

being done almost entirely by APHIS 

and its contractors. This final rule 

requires Consistent States to assist 

APHIS in sampling in slaughter 

establishments that are under State 

inspection or that do not engage in 

interstate commerce and to meet 

sampling minimums for animals 

originating in their State. It is critical to 

get adequate sampling from all areas of 

the United States to minimize the risk 

that cases will go undetected. Further, 

should the State sampling minimums 

adversely impact overall surveillance, 

APHIS has the ability under the rule to 

reduce the minimums. For these reasons 

no change is being made in response to 

the comment. 

Three commenters stated that APHIS 

should help States ensure their 

Consistent State status by promoting 

Regulatory Scrapie Slaughter 

Surveillance (RSSS) for interstate 

testing, especially for those States not 

able to do adequate surveillance testing. 

The commenters also stated that APHIS 

should work with State officials to reach 

out to producers and enlist producer 

support to alert producers when 

surveillance levels are not meeting 

expected levels to retain Consistent 

State status. The commenters further 

stated that APHIS or State employees 

should actively select and test older 

goats in poor condition for RSSS. 

APHIS is committed to working with 

States to exceed State sampling 

minimums, and we have prioritized 

RSSS collections. Goats in a thin or 

wasted condition are among those 

targeted for collection. 

One commenter recommended that 

the breed of exposed animals be 

considered in deciding whether an 

animal is designated as a high-risk 

animal. 

There is insufficient evidence to 

demonstrate that any breed of sheep or 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11175 

4 ‘‘Elimination of natural scrapie in sheep by sire 

genotype selection,’’ Nature 277 (1979): 127–129, 

and Scrapie Disease in Sheep (London: Academic 

Press, 1983). 

5 ‘‘Evaluation of associations between prion 

haplotypes and growth, carcass, and meat quality 

traits in a Dorset × Romanov sheep population’’, 

Journal of Animal Science 84 (2013): 783–788; 

‘‘Influence of Prion Protein Genotypes on Milk 

Production Traits in Spanish Churra Sheep’’, 

Journal of Dairy Science 89 (2006): 1784–1791; 

‘‘Investigation of farmer regard for scrapiesusceptible sheep’’, The Veterinary Record 158 

(2006): 732–734; ‘‘Associations between genotypes 

at codon 171 and 136 of the prion protein gene and 

production traits in market lambs’’, American 

Journal of Veterinary Research 68 (2007): 1073– 

1078; ‘‘Is there a relationship between prion protein 

genotype and ovulation rate and litter size in 

sheep?’’, Animal Reproduction Science 101(2007): 

153–157; ‘‘Analysis of prion protein genotypes in 

relation to reproduction traits in local and 

cosmopolitan German sheep breeds’’, Animal 

Reproduction Science 103 (2008): 69–77; ‘‘Scrapie 

resistance and production traits in Rambouillet 

rams: Ram performance test 2002–2006’’, Research 

in Veterinary Science 85 (2008): 345–348; and 

‘‘Characterization of the PRNP gene locus in Chios 

dairy sheep and its association with milk 

production and reproduction traits’’, Animal 

Genetics 42 (2011): 406–414. 

6 ‘‘Association of the prion protein gene with 

individual tissue weights in Scottish Blackface 

sheep’’, Journal of Animal Science 86 (2008): 1737– 

1746. 

7 ‘‘The incidence of genotypes at codon 171 of the 

prion protein gene (PRNP) in five breeds of sheep 

and production traits of ewes associated with those 

genotypes’’ Journal of Animal Science 83 (2005): 

455–459. 

8 ‘‘Predicting the consequences of selecting on 

PrP genotypes on PrP frequencies, performance and 

inbreeding in commercial meat sheep populations’’, 

Genet. Sel. Evol. 39 (2007): 711–729. 

goat is resistant to scrapie; therefore, no 

change is being made in response to this 

comment. 

One commenter expressed concern 

that when APHIS lists a breed as having 

had a case of scrapie, the animal may 

not be purebred despite being 

registered, and that this could have a 

negative impact on the breed. 

APHIS does rely on registry records to 

determine the breed of an animal and 

this may result in animals with 

incorrect pedigrees being considered 

purebred. The science is not sufficiently 

mature to reliably and cost-effectively 

determine the breed of a sheep based on 

genotype. We note, however, that the 

breed of a sheep does not affect the 

regulatory requirements in any way. 

One commenter recommended 

excluding rare breeds that have been 

historically free of scrapie from being 

considered high-risk if they are scrapie 

exposed. The commenter referenced the 

work of H.B. Parry 4 in support of this 

recommendation. 

APHIS notes that rare breeds are by 

definition few in number. Therefore, 

they would not be frequently tested for 

scrapie and would appear to be 

‘‘historically free’’ as a result; however, 

this appearance could be misleading 

because of the small sample size. 

Parry’s work did not include the 

genotypes of the sheep involved and it 

is unclear if his observations were a 

widespread breed trait separate from the 

genotype at codons 171 and 136 or the 

result of the genotype at these codons. 

Further, Parry’s work was done in the 

United Kingdom where the 

predominant scrapie type is valine 

dependent, strains to which AA QQ 

sheep are resistant. As a result, his work 

may not be relevant to the United States 

where the predominant scrapie type is 

valine independent, strains to which 

AA QQ sheep are susceptible. As the 

commenter noted, three breeds 

considered resistant by Parry have 

contracted scrapie in the United States. 

We are making no change in response to 

this comment as there is adequate 

flexibility through the pilot project 

provision and the low-risk exposed 

animal definition to allow such sheep to 

be exempted if there is sufficient 

scientific evidence available to warrant 

an exemption. 

One commenter raised the concern 

that selecting for genes associated with 

resistance may be adversely impacting 

the sheep industry and may be 

encouraging crossbreeding to add 

resistance genes to breeds in which they 

are rare. 

Several scientific articles have 

indicated that there is little, if any, 

difference in production traits between 

QQ, QR and RR sheep.5 One article 

indicated that there is an association 

between QQ at codon 171 and the 

ability to mobilize fat reserves in 

Scottish Blackface sheep.6 Another 

study showed that within one flock 

there was a higher litter size in QQ 

Suffolks than in QR or RR Suffolks but 

no difference in pounds of lamb 

weaned.7 In the same study, no 

difference was shown for Columbia, 

Hampshire, Rambouillet, or western 

white face sheep. Also, a study showed 

that as in selecting for any trait, 

selecting for scrapie resistance may 

delay progress on other traits, 

particularly in breeds where R at codon 

171 is rare.8 APHIS only requires 

genetic selection in exposed flocks and 

other higher risk flocks as part of 

PEMMPs. Further, breeders wishing to 

retain Q genes can do so with little 

impact on genetic resistance to scrapie 

by breeding RR ewes to QR rams and QR 

ewes to RR rams. Regarding 

unacknowledged cross breeding, this 

has occurred on other occasions when a 

breed is believed to be lacking a 

desirable trait and will occur anytime 

there are unscrupulous breeders and a 

financial incentive. We are not making 

any changes to the regulations based on 

this comment. 

The commenter stated that, in the 

case of 400 dairy sheep seized and 

euthanized in 2000–2001, none tested 

positive for scrapie. The commenter 

therefore requested that we provide the 

history, by year, of the number of 

positives, breed and percentage of 

individuals of infected/source flocks 

that were positive after laboratory 

testing. 

APHIS notes that in the case of the 

dairy sheep, the disease of concern was 

not scrapie but BSE. The information 

requested by the commenter is provided 

in the charts in the document titled 

‘‘Scrapie Case Information By Breed, 

Face Color or Type and or Sampling 

Stream FY 1999 to 2015’’ that 

accompanies this final rule. Copies of 

the document are available on the 

Regulations.gov website (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

One commenter agreed with genetic 

testing to determine risk level and also 

that AA QR (GLS) & AA RR (GR) should 

be exempt from destruction and noted 

that Canada does not exempt AV QR. 

The commenter stated that male animals 

are lower risk for transmitting scrapie 

but are at equal risk of becoming 

infected and noted that the World 

Organization for Animal Health does 

not differentiate male and female 

animals in their guidelines. 

No changes are being made in 

response to this comment. We believe 

that there is sufficient flexibility in the 

definitions for high-risk animals, the 

genetically susceptible exposed animals, 

and low risk exposed animals for the 

Administrator to address any issues that 

may arise with exposed male animals 

and exposed AV QR sheep. 

One commenter stated that for rare 

breeds APHIS should consider KK at 

codon 171 the same as QR for 

determining scrapie susceptibility. 

Unpublished work by USDA 

Agricultural Research Service has 

shown that KK171 Barbado sheep are 

susceptible to scrapie by intracerebral 

inoculation. A complimentary study 

using an oronasal route showed that at 

70 months post inoculation and at 5 

years post inoculation there was no 

evidence of scrapie in these KK171 

sheep. This indicates that KK171 sheep 

are likely less susceptible to classical 

scrapie. This rule will give the 

Administrator the flexibility to address 

KK171 sheep and any other genotypes 

in sheep or goats that may prove to be 

less susceptible or resistant to classical 

11176 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

scrapie through the low-risk animal 

definition, the genetically lesssusceptible animal definition, or 

through a pilot project once there is 

sufficient scientific evidence to support 

such action. 

In § 79.4, paragraph (c) provides for 

testing of scrapie-positive animals, highrisk animals, exposed animals, suspect 

animals, exposed flocks, infected flocks, 

noncompliant flocks, and source flocks, 

and paragraph (c)(1) provides for actions 

that may be taken if a flock owner fails 

to make animals available for testing. 

One commenter stated that in 

§ 79.4(c)(1) the statement ‘‘or as 

mutually agreed’’ was unclear. 

We agree that this statement could be 

clearer. We are changing ‘‘or as 

mutually agreed’’ to ‘‘or as mutually 

agreed in writing by the Administrator 

and the owner,’’ to clarify the 

conditions under which an owner could 

be considered in violation. 

Markets and Tagging 

Seven commenters supported 

allowing markets to continue to apply 

white serial tags issued to them to 

potential breeding sheep and goats. Six 

commenters stated that markets should 

be limited to applying only ownerprovided official eartags or blue 

slaughter-only serial eartags provided by 

the markets in order to reduce the 

number of untraceable animals. One 

commenter opposed these suggestions 

to limit tagging by markets to slaughteronly tags. That commenter was 

concerned that markets would have 

regulatory action taken against them if 

a blue tagged animal went back to the 

farm despite being sold for slaughter 

only. The commenter stated that many 

smaller-scale sheep and goat producers 

have limited marketing opportunities 

and often rely on livestock markets to 

sell their animals. The commenter 

stated further that for some of these 

markets, the profit margin is so small 

they offer this more as a public service 

than a business opportunity. Any 

additional burden on these markets may 

result in them no longer accepting sheep 

and goats. The commenter stated that as 

long as required records are utilized it 

should be left up to the individual 

markets whether they will accept 

unidentified animals, whether they will 

apply owner-supplied identification, or 

whether they choose to apply serial or 

slaughter-only eartags. 

The same commenter supported 

continuing to allow livestock markets to 

receive official tags directly from animal 

health officials and apply these tags to 

sheep and goats coming into the market 

untagged. 

APHIS believes that while on-farm 

tagging is ideal, there is a certain 

percentage of producers who will not 

choose to do this, whether their 

reasoning be based on difficulty of 

tagging, privacy, or other reasons. The 

model in this rule addresses this 

concern by allowing these animals to be 

identified by the market and for records 

to be kept regarding their movement. 

Additionally, this model provides a 

reasonable expectation that the 

movements will be able to be tracked 

because the option only applies to sheep 

and goats direct from a farm. 

Commingled lots would already have to 

be identified prior to arriving at the 

market as is called for in § 79.2(a)(1)(i). 

In response to these comments we are 

amending the regulations to allow the 

State Animal Health Official or the 

Administrator to limit the assignment of 

official identification devices or 

numbers to persons or classes of persons 

for use on animals that did not originate 

in a breeding flock owned by them to 

slaughter-only devices or numbers. This 

will give the States flexibility to 

improve traceability, and also give the 

Administrator the ability to establish a 

nationwide policy on official eartag 

distribution should such State programs 

prove to be successful in increasing 

traceability. 

One commenter expressed concern 

that some owners and haulers will not 

abide by the requirement for owner/ 

hauler statements and asked how 

animals received without an owner/ 

hauler statement should be handled by 

markets. 

Since either an owner or a hauler may 

complete the statement, the owner or 

hauler could complete the owner/hauler 

statement once they arrive at the market. 

At markets where owners or haulers do 

not have the required information to 

complete the statement, the market may 

either refuse such animals or the market 

may enter into a compliance agreement 

as described in § 79.3(k). To clarify the 

requirements, we have amended 

§ 79.3(k) as follows: ‘‘APHIS may enter 

into compliance agreements with 

persons such as dealers and owners of 

slaughter establishments and markets 

whereby animals may be received 

unidentified or without a required 

owner/hauler statement even if they 

cannot be identified to their flock of 

birth or origin because they were moved 

or commingled while unidentified, in 

violation of this part or a State 

requirement as provided by § 79.6.’’ 

One commenter requested that APHIS 

allow use of other documents that 

contain the information required on the 

owner/hauler statement. 

The current definition of an owner/ 

hauler statement allows for the use of 

other documents if they contain the 

same information as the owner/hauler 

statement. However, we have amended 

the definition to clarify that this is 

intended. 

One commenter asked that the 

animals which would qualify to move 

for purposes other than slaughter be 

allowed to be tagged after sale, so that 

only those animals that are moving for 

purposes other than slaughter at under 

18 months of age would need to be 

eartagged. 

In response to this comment, we are 

amending §§ 79.2(a)(1)(ii) and 79.3(a)(5) 

to permit approved markets that have 

the ability to maintain the identity of 

single source lots through the sale 

process to tag such animals after sale. 

Movement, Premises ID, Group Lot 

Number 

Several commenters requested 

clarification of the requirement to 

provide additional premises of a flock 

before unidentified animals were moved 

between those premises. In response we 

are adding the following clarification to 

§ 79.3(a)(4): ‘‘A request to APHIS to 

enter additional flock premises in the 

National Scrapie Database is required 

before animals are first moved to the 

premises. Notification is not required 

for each subsequent movement of 

animals to that premises. Neither group 

lot ID nor an owner/hauler statement is 

required for movements of a flock or its 

members for flock management 

purposes within a contiguous premises 

spanning two or more States. This 

provision does not include the 

transiting or sale of animals through 

such a premises in circumvention of the 

other requirements of this part.’’ 

Several commenters requested 

additional clarification on how group/ 

lot IDs may be used. 

Group/lots IDs are used to (1) 

associate a unique number with 

movements of single source lots direct 

to slaughter or to a market to simplify 

identifying relevant records during a 

disease investigation, (2) to be able to 

easily differentiate groups of animals 

moved for management purposes such 

as grazing, and (3) to be able to quickly 

identify the sources of animals in multisource lots such as slaughter lambs to 

assist in tracing exposed animals out of 

infected and source flocks to slaughter. 

One commenter asked for clarification 

of the requirements in § 79.3(a). The 

commenter stated that the relationship 

between paragraph (a) and how that 

relates to animals over 18 months of age 

in slaughter channels was confusing. 

For example, the statement in (a) says 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11177 

that the animals in (1) through (5) may 

move with an owner/hauler statement 

and group lot ID, but then in (3) it refers 

to animals that have individual 

identification. The commenter asked if 

these requirements could be reworded. 

We agree that this can be worded 

more clearly and have revised 

§ 79.3(a)(3) to clarify that an owner/ 

hauler statement may be used instead of 

an ICVI for such animals. 

Indemnity 

Four commenters noted that most 

American ewe lambs can be managed in 

a way that they can conceive at a young 

enough age to lamb as yearlings. The 

commenters believe that indemnifying 

for ewes that are verified as pregnant, 

regardless of their age, satisfies the 

general intention of age and 

reproduction status of the animals and 

that would apply to ewe lambs under 12 

months of age. The commenters further 

stated that the proposed categorization 

of early maturing ewe lambs as yearlings 

could lead to disputes and mistakes 

with indemnity payments. The 

commenters therefore recommended 

removing the indemnity provision for 

early-maturing ewes and suggested 

indemnifying them based on their 

pregnancy status instead. 

We agree with the commenters and 

have revised the program standards to 

reflect this by allowing animals under 

12 months of age to be classified as 

yearlings only if they are visibly 

pregnant or have an offspring and not 

based on owner records indicating that 

the flock has a history of lambing or 

kidding at an early age. No changes to 

the regulations are necessary. 

While preparing this final rule, we 

noted that there was substantial overlap 

between the provisions regarding 

indemnity in §§ 54.3(b) and 54.6(d). To 

improve clarity, we have consolidated 

the provisions in § 54.3(b) and have 

removed § 54.6(d). We have also moved 

the provision allowing for the 

Administrator to waive the requirement 

for a flock plan or PEMMP from 

§§ 54.8(j)(3) to 54.8(l). 

Paperwork 

One commenter was concerned about 

the paperwork burden associated with 

the proposed rule. The commenter also 

expressed concern that the rule would 

require markets to provide seller 

information to all buyers. 

The rule does increase the paperwork 

burden associated with maintaining 

tagging records, but we believe that 

maintaining these records for additional 

classes of goats and animals in slaughter 

channels is necessary to increase 

traceability of goats and sheep, which in 

turn is critical for eradicating scrapie. 

The rule does not require markets to 

provide seller information to buyers in 

most cases; the exception is that markets 

must provide the group lot numbers 

when the animals are moving 

unidentified as part of a single source 

lot in slaughter channels. 

Program Standards 

One commenter noted that there are 

references to the Scrapie SharePoint site 

throughout the program standards 

document. The commenter noted that 

State officials cannot currently access 

information on this site so another 

resource needs to be readily available 

and should replace all references to the 

Scrapie SharePoint site. 

A SharePoint site accessible to State 

employees is now available. 

One commenter noted that there are 

many references throughout the 

document to PEMMPs, particularly in 

Part VII and VIII and the flowcharts. The 

commenter stated that sometimes the 

term ‘‘full PEMMP’’ is used, sometimes 

the term ‘‘basic PEMMP’’ is used, and 

sometimes it is not specified. The 

commenter asked that APHIS clearly 

spell out what the requirements are for 

each type of PEMMP, which type is 

required for each situation, and be 

consistent with terminology. 

We have replaced the term ‘‘full 

PEMMP’’ with ‘‘retained susceptible 

animal PEMMP’’ throughout the 

program standards. 

One commenter stated that some of 

the program standards definitions are 

slightly different from those in the rule. 

Some of the definitions were not 

updated in the program standards and 

this has been corrected. Other 

definitions are slightly different because 

they need to reference the Code of 

Federal Regulations, and in some cases 

they include more specific information 

to assist the reader. Information that is 

subject to frequent change, such as the 

components currently included in the 

National Scrapie Database, was not put 

into the regulations. 

One commenter asked what the 

purpose of entering low-risk exposed 

animals into the National Scrapie 

Database is. 

The purpose of putting low-risk 

exposed animals in the database is to be 

able to search against the database if 

they should later be determined to be 

infected so that we can understand 

whether the criteria for redesignating 

animals as low-risk are effective and to 

be able to search against these animals 

when required for an export certificate 

or ICVI. 

One commenter recommended not 

using Emergency Management and 

Response System (EMRS) for scrapie 

tracing. 

We disagree. EMRS allows a higher 

degree of accountability for completing 

scrapie trace investigations and the 

number of trace outs is currently low 

enough that use of this system should 

not be overly burdensome. 

One commenter asked what ‘‘when an 

insufficient number of QQ sheep and 

goats are available . . .’’ in the 

introduction to the Part VII: 

Epidemiology A section of the program 

standards meant. 

We agree that this can be worded 

more clearly and are revising the 

Scrapie Program Standards to read 

‘‘When the number of QQ sheep and 

goats in the flock is insufficient to 

conduct a reliable flock test, or . . .’’ 

One commenter indicated that, in the 

Part VII: Epidemiology B section, the 

review provision in the note 

contradicted the table in that it indicates 

the Sheep and Goat Health Specialist for 

Epidemiology (SGHSE) must concur 

with decisions made by the designated 

scrapie epidemiologist. 

The commenter is correct. We have 

corrected the table to list those 

situations when the SGHSE must 

approve the designation or redesignation and deleted the note. 

One commenter stated that Part VII: 

Epidemiology F. Procedures for 

Investigation and Monitoring a Flock 

that Received a High-Risk Animal was 

hard to follow and should be revised for 

clarity. 

We agree that there was room for 

improvement and have made edits for 

clarity. 

One commenter stated that the term 

‘‘status’’ had not been updated in places 

to conform with the change to SCS SCR. 

We agree and have corrected the 

terminology to reflect the new 

nomenclature, which resulted from the 

migration of the Scrapie Program data 

from the Scrapie National Generic 

Database (SNGD) to SCS SCR, 

throughout the document. What was 

termed ‘‘status’’ in the SNGD is called 

a ‘‘program’’ or a ‘‘restriction’’ in SCS 

SCR. 

One commenter recommended 

moving Part VIII: Flock Cleanup Plans 

and PEMMPs B.3(a)(12), Steps for 

completing a standard genetic based 

flock plan for source and infected flocks 

that retain only AR, HR, KR, and RR 

ewes and male sheep and male goats, to 

Part VII: Epidemiology, E. B.3(b)(4) 

because that section seems procedural 

and would fit better in Part VII. 

We agree that this section could 

reasonably be moved to Part VII; 

however, we do not believe that it 

results in an improvement, so no change 

11178 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

is being made in response to this 

comment. 

One commenter requested that we 

provide VS Form 5–19c as an appendix 

to the program standards. The 

commenter also requested that we allow 

a State equivalent form. 

We did not add the form as an 

appendix to the document to minimize 

the need to update the standards 

whenever a form is revised. The form 

has been approved under OMB control 

number 0579–0101 and will be available 

on the APHIS website. We agree that 

State equivalent forms may also be used 

and have updated the program 

standards accordingly. 

One commenter asked APHIS to work 

with new and emerging registries to 

assure that their tattoo and radio 

frequency identification device implant 

systems are unique within the registry, 

retrievable, traceable, and that the 

registry rules allow for release of 

information to APHIS for regulatory 

disease purposes before these registry ID 

systems are accepted for the National 

Scrapie Eradication Plan. 

APHIS intends to work with any new 

and emerging registries to ensure that 

their systems meet these requirements. 

We have also updated Part III: 

Identification Requirements 

A(3)(b)(2)(a) of the program standards to 

clarify the requirements for registry 

identification devices and methods. 

Miscellaneous 

While preparing this final rule, APHIS 

noted that we had used the phrase 

‘‘premises that engages in interstate 

commerce’’ in several places in §§ 79.2 

and 79.3. Since a premises cannot 

engage in an action, we have replaced 

that phrase with ‘‘premises where 

animals are received that have been in 

interstate commerce or from which 

animals are moved in interstate 

commerce.’’ 

We have made nonsubstantive 

editorial changes to several sections to 

improve clarity. For the same reason we 

have divided § 54.8(j)(3) into two 

paragraphs. The provisions that 

appeared in that paragraph now appear 

in paragraphs (j)(3) and (l). 

We have moved paragraph (3) of the 

definition of Consistent State in § 79.1 

to a new paragraph (c) in § 79.6 because 

the provisions in that paragraph are 

more appropriately placed in that 

section. 

One commenter recommended 

changing the name of the Scrapie Free 

Flock Certification Program to the 

Scrapie Certification Program to be 

consistent with the names of other 

disease certification programs. 

We believe that changing the name of 

the program would be confusing and are 

making no changes in response to this 

comment. 

Three commenters stated that they 

appreciate APHIS’ outreach efforts to 

producers, and that APHIS should 

increase access to educational resources 

for goat producers and veterinarians. 

The commenters stated that additional 

goat-specific resources would help to 

achieve best participation in the 

voluntary program and compliance with 

the regulations. The commenters further 

stated that APHIS should encourage onfarm submissions for scrapie 

surveillance and adequate records by 

producers for possible traceback. 

APHIS agrees that goat-specific 

resources should be valuable and is 

working with the American Goat 

Federation to improve our education 

efforts directed to goat producers. 

Comments Outside the Scope of the 

Rulemaking 

One commenter expressed concern 

that scrapie poses a human health risk 

and stated that scrapie should be 

regulated in the same way as BSE. The 

commenter also stated that U.S. 

regulations governing BSE are too lax. 

There is no epidemiologic evidence 

that scrapie of sheep and goats is 

transmitted to humans, such as through 

consumption, contact on the farm, at 

slaughter plants, or butcher shops. The 

regulations for control of scrapie and 

BSE are generally consistent with 

international guidelines. BSE is a 

separate disease from scrapie and can be 

distinguished using laboratory tests or 

mouse inoculation. 

Some commenters made 

recommendations for changes to Scrapie 

Flock Certification Plan standards. We 

did not propose to make changes to 

those standards in this action; however 

they were taken into consideration 

when working on the revision of those 

standards. 

Some commenters stated that APHIS 

should encourage future goat and sheep 

research and continue to collaborate 

with the Agricultural Research Service 

(ARS) to research scrapie diagnostic 

tests in live goats and scrapie control 

methods specific to goats. The 

commenters also stated that ARS should 

continue to research genetic resistance 

and susceptibility in goats and the 

pathogenesis and transmission of 

scrapie in goats and sheep. 

We agree that these are important 

fields for research and have 

communicated these priorities to ARS. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Orders 12866, 13563, 13771, 

and Regulatory Flexibility Act 

This final rule has been determined to 

be significant for the purposes of 

Executive Order 12866 and, therefore, 

has been reviewed by the Office of 

Management and Budget. This final rule 

is considered an Executive Order 13771 

deregulatory action. Details on the 

estimated cost savings of this final rule 

can be found in the rule’s economic 

analysis. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis, 

as required by Executive Orders 12866 

and 13563, which direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and equity). Executive Order 

13563 emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The 

economic analysis also provides a final 

regulatory flexibility analysis that 

examines the potential economic effects 

of this rule on small entities, as required 

by the Regulatory Flexibility Act. The 

economic analysis is summarized 

below. Copies of the full analysis are 

available on the Regulations.gov website 

(see footnote 1 in this document for a 

link to Regulations.gov) or by contacting 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

APHIS is amending the scrapie 

regulations to relieve certain restrictions 

associated with the interstate movement 

of sheep and goats, reduce the number 

of exposed sheep and goats that are 

destroyed, and improve overall program 

effectiveness. More specifically, genetic 

testing will be used to identify 

genetically resistant or less susceptible 

sheep for exemption from destruction 

and as qualifying for interstate 

movement; designated scrapie 

epidemiologists will be given greater 

flexibility in determining the testing 

needs of flocks; the indemnity 

regulations will be changed to apply 

only to those animals that are found to 

be genetically susceptible to scrapie; 

official identification of goats produced 

for meat or fiber or that are slaughtered 

at over 18 months of age will be 

required; submission of tagging records 

by individuals who tag sheep or goats 

that do not originate on their premises 

will be required when requested; and 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11179 

certain recordkeeping requirements will 

be reduced, changed, or removed. 

The primary benefits of this rule for 

producers and the public will be more 

rapid progress toward scrapie 

eradication and the related boost to the 

Nation’s animal health status, decreased 

losses for producers, and increased 

export opportunities for sheep and goats 

and their products. Most segments and 

marketing channels of the sheep and 

goat industries will benefit from being 

able to operate under the new 

requirements and by the eradication of 

scrapie. By enhancing traceability, the 

rule will shorten the time and reduce 

the cost of eradication. 

Producers of goats for meat or fiber 

and slaughter goats over 18 months of 

age will incur costs of official 

identification as a result of the rule. 

However, we note that close to one-half 

of goat farms (that is, all dairy and 

breeding goat farms except low-risk 

commercial operations) are already 

required to be in compliance with the 

identification requirements under 

current regulations. 

The rule will affect sheep and goat 

producers, marketers and dealers, most 

of which are small entities. As noted in 

the regulatory impact analysis, 

individuals may spend about 2 hours a 

year on recordkeeping, at a time cost of 

about $34.50, but in fact many of these 

records of sales and purchases are 

typically already kept as a normal 

business practice. Based on 2012 Census 

of Agriculture data, this cost if incurred 

would equal about 1.5 percent of 

average revenue for meat goat 

producers. We expect these entities to 

find the rule’s official identification 

requirements and other conditions well 

worth the cost. This rule will not pose 

a large cost burden for entities, large or 

small. 

Eradication of scrapie will enable 

APHIS to negotiate removal of the 

varying current restrictions and allow 

an expansion of exports. Based on cited 

simulation modeling of the economic 

benefits of eradication of scrapie and 

certain other animal diseases, gains 

from trade are expected to exceed the 

recordkeeping, tagging, and other costs 

that producers and other entities will 

incur. 

The trade gains realized can be 

interpreted as cost savings from no 

longer being subject to certain import 

restrictions imposed by other countries. 

Based on measures of increased welfare 

due to expanded exports, and in 

accordance with guidance on complying 

with Executive Order 13771, the 

primary estimate of the rule’s annual 

cost savings is $115,000, the mid-point 

estimate annualized in perpetuity using 

a 7 percent discount rate. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 2 CFR 

Chapter IV.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are in conflict with this rule; (2) has 

no retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Executive Order 13175 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175 ‘‘Consultation 

and Coordination with Indian Tribal 

Governments.’’ Executive 13175 

requires Federal agencies to consult and 

coordinate with tribes on a governmentto-government basis on policies that 

have Tribal implications, including 

regulations, legislative comments or 

proposed legislation, and other policy 

statements or actions that have 

substantial direct effects on one or more 

Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

APHIS has assessed the impact of this 

rule on Indian Tribes and determined 

that this rule does not, to our 

knowledge, have tribal implications that 

require Tribal consultation under 

Executive Order 13175. If a tribe 

requests consultation, APHIS will work 

with the USDA Office of Tribal 

Relations to ensure meaningful 

consultation is provided where changes, 

additions, and modifications identified 

herein are not expressly mandated by 

Congress. 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), some of the 

information collection requirements 

included in this final rule are approved 

under Office of Management and Budget 

(OMB) control number 0579–0101. The 

new information collection 

requirements included in this final rule, 

which were filed with comment under 

OMB control number 0579–0469, have 

been submitted for approval to OMB. 

When OMB notifies us of its decision, 

if approval is denied, we will publish a 

document in the Federal Register 

providing notice of what action(s) we 

plan to take. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Ms. Kimberly 

Hardy, APHIS’ Information Collection 

Coordinator, at (301) 851–2483. 

List of Subjects 

9 CFR Part 54 

Animal diseases, Goats, Indemnity 

payments, Scrapie, Sheep. 

9 CFR Part 79 

Animal diseases, Quarantine, Sheep, 

Transportation. 

Accordingly, we are amending 9 CFR 

parts 54 and 79 as follows: 

PART 54—CONTROL OF SCRAPIE 

■ 1. The authority citation for part 54 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 2. Section 54.1 is amended as follows: 

■ a. By removing the definition for 

Approved test; 

■ b. In the definition for Breed 

association and registries, by removing 

the words ‘‘listed in § 151.9 of this 

chapter’’; 

■ c. By removing the definition for 

Certificate; 

■ d. By adding in alphabetical order a 

definition for Classification or 

reclassification investigation; 

■ e. In the heading of the definition for 

Designated scrapie epidemiologist, by 

adding the acronym ‘‘DSE’’ immediately 

after ‘‘epidemiologist’’; 

■ f. By revising the definitions for 

Destroyed, Exposed animal, and 

Exposed flock; 

■ g. In the definition for Flock, 

paragraph (2)(v), by adding the word 

‘‘Free’’ between the words ‘‘Scrapie’’ 

and ‘‘Flock’’; 

■ h. In the definition for Flock plan, by 

removing the paragraph designation 

‘‘(f)’’ and by adding the paragraph 

designation ‘‘(j)’’ in its place; 

■ i. By revising the definition for Flock 

sire; 

■ j. By adding in alphabetical order 

definitions for Flock under 

11180 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

investigation, Genetically less 

susceptible exposed sheep, Genetically 

resistant exposed sheep, Genetically 

resistant sheep, Genetically susceptible 

animal, and Genetically susceptible 

exposed animal; 

■ k. By revising the definition for Highrisk animal; 

■ l. By adding in alphabetical order a 

definition for Interstate certificate of 

veterinary inspection (ICVI); 

■ m. In the definition for Limited 

contacts, by adding the word ‘‘Free’’ 

between the words ‘‘Scrapie’’ and 

‘‘Flock’’ in the last sentence; 

■ n. By adding in alphabetical order a 

definition for Low-risk exposed animal; 

■ o. In the definition for National 

Scrapie Database, by adding the word 

‘‘Free’’ between the words ‘‘Scrapie’’ 

and ‘‘Flock’’; and 

■ p. By amending the definition for 

Noncompliant flock as follows: 

■ i. In paragraph (1), by removing the 

words ‘‘source or infected flock’’ and 

adding the words ‘‘source, infected, or 

exposed flock or flock under 

investigation’’ in their place; 

■ ii. In paragraph (2), by adding the 

words ‘‘or flock under investigation’’ 

immediately after the words ‘‘exposed 

flock’’; and 

■ iii. In paragraph (3), by removing the 

words ‘‘owner statement’’ and adding 

the words ‘‘owner/hauler statement’’ in 

their place. 

■ q. By revising the definition for 

Official genotype test; 

■ r. By adding in alphabetical order 

definitions for Program approved test 

and Restricted animal sale or restricted 

livestock facility; 

■ s. In the heading of the definition for 

Scrapie Flock Certification Program 

(SFCP), by adding the word ‘‘Free’’ 

immediately after the word ‘‘Scrapie’’; 

■ t. In the heading of the definition for 

Scrapie Flock Certification Program 

standards, by adding the word ‘‘Free’’ 

immediately after the word ‘‘Scrapie’’ 

and, in footnote 2, by removing the 

internet address ‘‘http://

www.aphis.usda.gov/vs/scrapie’’ and 

adding the internet address ‘‘http://

www.aphis.usda.gov/animal-health/ 

scrapie’’ in its place; 

■ u. In the definition for Scrapiepositive animal, in paragraph (2), by 

adding the words ‘‘, and/or ELISA,’’ 

immediately after the word 

‘‘immunohistochemistry’’ and, in 

paragraph (5), by removing the words 

‘‘test method’’ and adding the words 

‘‘method or combination of methods’’ in 

their place; 

■ v. By removing the definition for 

Separate contemporary lambing group; 

■ w. By revising the definition for 

Slaughter channels; 

■ x. By revising paragraph (1) in the 

definition of Suspect animal; and 

■ y. By adding in alphabetical order 

definitions for Tamper-resistant 

sampling kit and Terminal feedlot. 

The additions and revisions read as 

follows: 

§ 54.1 Definitions. 

* * * * * 

Classification or reclassification 

investigation. An epidemiological 

investigation conducted or directed by a 

DSE for the purpose of designating or 

redesignating the status (e.g., scrapiepositive, exposed, high-risk, suspect, 

infected, noncompliant, source, etc.) of 

a flock or animal. In conducting such an 

investigation, the DSE will evaluate the 

available records for flocks and 

individual animals and conduct or 

direct any testing needed to assess the 

status of a flock or animal. The status of 

an animal or flock will be determined 

based on the applicable definitions in 

this section and, when needed to make 

a designation under § 79.4 of this 

chapter, official genotype test results, 

exposure risk, scrapie type involved, 

results of official scrapie testing on live 

or dead animals, or any combination of 

these. 

* * * * * 

Destroyed. Euthanized and the carcass 

disposed of by means authorized by the 

Administrator that will prevent its use 

as feed or food. 

* * * * * 

Exposed animal. Any animal or 

embryo that: 

(1) Has been in a flock with a scrapiepositive female animal; 

(2) Has been in an enclosure with a 

scrapie-positive female animal at any 

location; 

(3) Resides in a noncompliant flock; 

or 

(4) Has resided on the premises of a 

flock before or while it was designated 

by a DSE an infected or source flock and 

before a flock plan was completed. An 

animal shall not be designated an 

exposed animal if it only resided on the 

premises before the date that infection 

was most likely introduced to the 

premises as determined by a Federal or 

State representative. If the probable date 

of infection cannot be determined based 

on the epidemiologic investigation, a 

date 2 years before the birth of the 

oldest scrapie-positive animal born in 

that flock will be used. If the actual 

birth date is unknown, the date of birth 

will be estimated based on examination 

of the teeth and any available records. 

If an age estimate cannot be made, the 

animal will be assumed to have been 48 

months of age on the date samples were 

collected for scrapie diagnosis. Exposed 

animals will be further designated as 

genetically resistant exposed sheep, 

genetically less susceptible exposed 

sheep, genetically susceptible exposed 

animals, or low-risk exposed animals. 

An animal will no longer be an exposed 

animal if it is redesignated in 

accordance with § 79.4 of this chapter. 

Exposed flock. (1) Any flock that was 

designated by a DSE as an infected or 

source flock that has completed a flock 

plan, and that retained a female 

genetically susceptible exposed animal; 

(2) Any flock under investigation that 

retains a female genetically susceptible 

exposed animal or a suspect animal, or 

whose owner declines to complete 

genotyping and live-animal and/or postmortem scrapie testing required by the 

APHIS or State representative 

investigating the flock; or 

(3) Any noncompliant flock or any 

flock for which a PEMMP is required 

that is not in compliance with the 

conditions of the PEMMP. 

* * * * * 

Flock sire. A sexually intact male 

animal that has produced offspring in 

the preceding 12 months or that was 

used for breeding during the current 

breeding cycle. 

Flock under investigation. Any flock 

in which an APHIS or State 

representative has determined that a 

scrapie-suspect animal, high-risk 

animal, or scrapie-positive animal 

resides or may have resided. 

Genetically less susceptible exposed 

sheep. Any sheep or sheep embryo that 

is: 

(1) An exposed sheep or sheep 

embryo of genotype AA QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a 

scrapie type to which AA QR sheep are 

not less susceptible; or 

(2) An exposed sheep or sheep 

embryo of genotype AV QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that 

the Administrator has determined may 

be affected by valine-associated scrapie 

(based on an evaluation of the genotypes 

of the scrapie-positive animals linked to 

the flock), or to another scrapie type to 

which AV QR sheep are not less 

susceptible; or 

(3) An exposed sheep or sheep 

embryo of a genotype that has been 

exposed to a scrapie type to which the 

Administrator has determined that 

genotype is less susceptible. 

In this definition R refers to codon 

171 and A refers to codon 136, and Q 

represents any genotype other than R at 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11181 

codon 171 and V represents any 

genotype other than A at codon 136. 

Genetically resistant exposed sheep. 

Any exposed sheep or sheep embryo of 

genotype RR at codon 171 unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type 

to which RR sheep are not resistant. 

Genetically resistant sheep. Any 

sheep or sheep embryo of genotype RR 

at codon 171 unless the Administrator 

determines that it is epidemiologically 

linked to a scrapie-positive RR sheep or 

to a scrapie type that affects RR at codon 

171 sheep. 

Genetically susceptible animal. Any 

goat or goat embryo, sheep or sheep 

embryo of a genotype other than RR or 

QR, where Q represents any genotype 

other than R at codon 171 or sheep or 

sheep embryo of undetermined 

genotype. 

Genetically susceptible exposed 

animal. Excluding low-risk exposed 

animals, any exposed animal or embryo 

that is also: 

(1) A genetically susceptible animal; 

or 

(2) A sheep or sheep embryo of 

genotype AV QR that the Administrator 

determines is epidemiologically linked 

to a scrapie-positive RR or QR sheep, to 

a flock that the Administrator has 

determined may be affected by valineassociated scrapie (based on an 

evaluation of the genotypes of the 

scrapie-positive animals linked to the 

flock), or to a scrapie type to which AV 

QR sheep are susceptible; or 

(3) A sheep or sheep embryo of 

genotype AA QR that the Administrator 

determines is epidemiologically linked 

to a scrapie-positive RR or AA QR sheep 

or to a scrapie type to which AA QR 

sheep are susceptible; or 

(4) A sheep or sheep embryo of 

genotype RR that the Administrator 

determines is epidemiologically linked 

to a scrapie-positive RR sheep or to a 

scrapie type to which RR sheep are 

susceptible. 

(5) Note: In this definition R refers to 

codon 171 and A refers to codon 136, 

and Q represents any genotype other 

than R at codon 171 and V represents 

any genotype other than A at codon 136. 

High-risk animal. The female 

offspring or embryo of a scrapie-positive 

female animal, or any suspect animal, or 

a female genetically susceptible exposed 

animal, or any exposed animal that the 

Administrator determines to be a 

potential risk. The Administrator may 

base the determination that an exposed 

animal poses a potential risk on the 

scrapie type, the epidemiology of the 

flock or flocks with which it is 

epidemiologically linked, including 

genetics of the positive sheep, the 

prevalence of scrapie in the flock, any 

history of recurrent infection, and other 

flock or animal characteristics. An 

animal will no longer be a high-risk 

animal if it is redesignated in 

accordance with § 79.4 of this chapter. 

* * * * * 

Interstate certificate of veterinary 

inspection (ICVI). An official document 

issued by a Federal, State, Tribal, or 

accredited veterinarian certifying the 

inspection of animals in preparation for 

interstate movement or other uses as 

described in this part and in accordance 

with § 79.5 of this chapter. 

* * * * * 

Low-risk exposed animal. Any 

exposed animal to which the 

Administrator has determined one or 

more of the following applies: 

(1) The positive animal that was the 

source of exposure was not born in the 

flock and did not lamb in the flock or 

in an enclosure where the exposed 

animal resided; 

(2) The Administrator and State 

representative concur that the animal is 

unlikely to be infected due to factors 

such as, but not limited to, where the 

animal resided or the time period the 

animal resided in the flock; 

(3) The exposed animal is male and 

was not born in an infected or source 

flock; 

(4) The exposed animal is a castrated 

male; 

(5) The exposed animal is an embryo 

of a genetically resistant exposed sheep 

or a genetically less susceptible exposed 

sheep unless placed in a recipient that 

was a genetically susceptible exposed 

animal; or 

(6) The animal was exposed to a 

scrapie type and/or is of a genotype that 

the Administrator has determined poses 

low risk of scrapie transmission. 

* * * * * 

Official genotype test. A test to 

determine the genotype of a live or dead 

animal conducted at either the National 

Veterinary Services Laboratories or at an 

approved laboratory. The test subject 

must be an animal that is officially 

identified and the test accurately 

recorded on an official form supplied or 

approved by APHIS, with the samples 

collected and shipped to the laboratory 

using a shipping method specified by 

the laboratory by: 

(1) An accredited veterinarian; 

(2) A State or APHIS representative; 

or 

(3) The animal’s owner or owner’s 

agent, using a tamper-resistant sampling 

kit approved by APHIS for this purpose. 

* * * * * 

Program approved test. A test for the 

diagnosis of scrapie approved by the 

Administrator for use in the scrapie 

eradication or certification program in 

accordance with § 54.10. 

Restricted animal sale or restricted 

livestock facility. A sale where any 

animals in slaughter channels are 

maintained separate from other animals 

not in slaughter channels unless they 

are from the same flock of origin and are 

sold in lots that consist entirely of 

animals sold for slaughter only, or a 

livestock facility at which all animals 

are in slaughter channels, and where the 

sale or facility manager maintains a 

copy of, or maintains a record of, the 

information from the owner/hauler 

statement for all animals entering and 

leaving the sale or facility. A restricted 

animal sale may be held at a livestock 

facility that is not restricted. 

* * * * * 

Slaughter channels. Animals in 

slaughter channels include any animal 

that is sold, transferred, or moved either 

directly to or through a restricted animal 

sale or restricted livestock facility to an 

official slaughter establishment that is 

under Food Safety and Inspection 

Service (FSIS) jurisdiction per the 

Federal Meat Inspection Act (FMIA) or 

under State inspection that FSIS has 

recognized as at least equal to Federal 

inspection or to a custom exempt 

slaughter establishment as defined by 

FSIS (9 CFR 303.1) for immediate 

slaughter or to an individual for 

immediate slaughter for personal use or 

to a terminal feedlot. 

* * * * * 

Suspect animal. * * * 

(1) A mature sheep or goat as 

evidenced by eruption of the first 

incisor that has been condemned by 

FSIS or a State inspection authority for 

central nervous system (CNS) signs, or 

that exhibits any of the following 

clinical signs of scrapie and has been 

determined to be suspicious for scrapie 

by an accredited veterinarian or a State 

or USDA representative, based on one or 

more of the following signs and the 

severity of the signs: Weakness of any 

kind including, but not limited to, 

stumbling, falling down, or having 

difficulty rising, not including those 

with visible traumatic injuries and no 

other signs of scrapie; behavioral 

abnormalities; significant weight loss 

despite retention of appetite or in an 

animal with adequate dentition; 

increased sensitivity to noise and 

sudden movement; tremors; star gazing; 

head pressing; bilateral gait 

abnormalities such as but not limited to 

incoordination, ataxia, high stepping 

gait of forelimbs, bunny-hop movement 

of rear legs, or swaying of back end, but 

not including abnormalities involving 

11182 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

only one leg or one front and one back 

leg; repeated intense rubbing with bare 

areas or damaged wool in similar 

locations on both sides of the animal’s 

body or, if on the head, both sides of the 

poll; abraded, rough, thickened, or 

hyperpigmented areas of skin in areas of 

wool/hair loss in similar locations on 

both sides of the animal’s body or, if on 

the head, both sides of the poll; or other 

signs of CNS disease. An animal will no 

longer be a suspect animal if it is 

redesignated in accordance with § 79.4 

of this chapter. 

* * * * * 

Tamper-resistant sampling kit. A 

device or method for collecting DNA 

samples from sheep or goats that is 

approved by the Administrator and that 

identifies both the sample and the 

animal at the time the sample is 

collected. These devices or methods 

must ensure that the sample, its 

corresponding label, and the official ID 

device or method applied to the animal 

meets the requirements of § 79.2(k) of 

this chapter and that the sample is from 

the same animal to which the official ID 

device or method was applied. The kit 

must include an APHIS-approved 

official form or another form, device, or 

method acceptable to APHIS for 

transmitting the information required to 

APHIS and the approved laboratory. 

Terminal feedlot. (1) A dry lot 

approved by a State or APHIS 

representative or an accredited 

veterinarian who is authorized by the 

Administrator to perform this function 

where animals in the terminal feedlot 

are separated from all other animals by 

at least 30 feet at all times or are 

separated by a solid wall through, over, 

or under which fluids cannot pass and 

contact cannot occur and must be 

cleaned of all organic material prior to 

being used to contain sheep or goats that 

are not in slaughter channels, where 

only castrated males are maintained 

with female animals and from which 

animals are moved only to another 

terminal feedlot or directly to slaughter; 

or 

(2) A dry lot approved by a State or 

APHIS representative or an accredited 

veterinarian who is authorized by the 

Administrator to perform this function 

where only animals that either are not 

pregnant based on the animal being 

male, an owner certification that any 

female animals have not been exposed 

to a male in the preceding 6 months, an 

ICVI issued by an accredited 

veterinarian stating the animals are not 

pregnant, or the animals are under 6 

months of age at time of receipt, where 

only castrated males are maintained 

with female animals, and all animals in 

the terminal feedlot are separated from 

all other animals such that physical 

contact cannot occur including through 

a fence and from which animals are 

moved only to another terminal feedlot 

or directly to slaughter; or 

(3) A pasture when approved by and 

maintained under the supervision of the 

State and in which only nonpregnant 

animals are permitted based on the 

animal being male, an owner 

certification that any female animals 

have not been exposed to a male in the 

preceding 6 months, or an ICVI issued 

by an accredited veterinarian stating the 

animals are not pregnant, or the animals 

are under 6 months of age at time of 

receipt, where only castrated males are 

maintained with female animals, where 

there is no direct fence-to-fence contact 

with another flock, and from which 

animals are moved only to another 

terminal feedlot or directly to slaughter. 

(4) Records of all animals entering 

and leaving a terminal feedlot must be 

maintained for 5 years after the animal 

leaves the feedlot and must meet the 

requirements of § 79.2 of this chapter, 

including either a copy of the required 

owner/hauler statements for animals 

entering and leaving the facility or the 

information required to be on the 

statements. Records must be made 

available for inspection and copying by 

an APHIS or State representative upon 

request. 

* * * * * 

§ 54.2 [Amended] 

■ 3. Section 54.2 is amended by adding 

the word ‘‘Free’’ between the words 

‘‘Scrapie’’ and ‘‘Flock’’ each time they 

appear. 

■ 4. Section § 54.3 is amended by 

revising paragraph (b) and adding an 

OMB citation at the end of the section 

to read as follows: 

§ 54.3 Animals eligible for indemnity 

payments. 

* * * * * 

(b) Indemnity will be paid to an 

owner only for animals actually in a 

flock at the time indemnity is first 

offered in writing, and for offspring born 

to animals in that flock within 60 days 

after the time indemnity is first offered 

in writing. Animals removed from the 

flock as part of an investigation or a 

post-exposure management and 

monitoring plan (PEMMP) will be paid 

indemnity based on the calculated 

prices at the time an APHIS 

representative designates, in writing, the 

animals for removal. If an owner 

declines to remove an animal within 60 

days of when indemnity is first offered 

the owner will receive the lower value 

of when indemnity was first offered in 

writing or when the animal was actually 

removed. APHIS may withdraw an 

indemnity offer if an owner does not 

make animals available for inventory, 

gestational assessment, and testing 

within 30 days, does not remove an 

animal within 60 days of the written 

indemnity offer or by the date specified 

in a flock plan or PEMMP, or fails to 

provide APHIS animal registration 

certificates, sale and movement records, 

or other records requested in accordance 

with § 54.5. No indemnity will be paid 

for any animal, or the progeny of any 

animal, that has been moved or handled 

by the owner in violation of the 

requirements of the Animal Health 

Protection Act or the regulations 

promulgated thereunder. No indemnity 

will be paid for an animal added to the 

premises while a flock is under 

investigation or while it is an infected 

or source flock other than natural 

additions. No indemnity will be paid for 

natural additions born more than 60 

days after the owner is notified they are 

eligible for indemnity unless the 

Administrator makes a determination 

that the dam could not be removed 

within the allowed time as a result of 

conditions outside the control of the 

owner. No indemnity will be paid 

unless the owner has signed and is in 

compliance with the requirements of a 

flock plan or post-exposure management 

and monitoring plan (PEMMP) as 

described in § 54.8 unless the 

requirement for a flock plan or PEMMP 

has been waived by the Administrator. 

No indemnity will be paid until the 

premises, including all structures, 

holding facilities, conveyances, and 

materials contaminated because of 

occupation or use by the depopulated 

animals, have been properly cleaned 

and disinfected in accordance with 

§ 54.7(e), unless premises or portions of 

premises have been exempted from the 

cleaning and disinfecting requirements 

per § 54.8(j)(1); Except that, partial 

indemnity may be paid when the 

Administrator determines that weather 

or other factors outside the control of 

the owner make immediate disinfection 

impractical. No indemnity will be paid 

to an owner for any animals if the owner 

established or increased his flock for the 

purpose of collecting or increasing 

indemnity. 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

■ 5. Section 54.4 is amended by revising 

paragraph (a)(5) and adding an OMB 

citation at the end of the section to read 

as follows: 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11183 

§ 54.4 Application by owners for indemnity 

payments. 

(a) * * * 

(5) A copy of the registration papers 

issued in the name of the owner for any 

registered animals in the flock 

(registration papers are not required for 

the payment of indemnity for animals 

that are not registered); and 

* * * * * 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

■ 6. Section 54.5 is amended as follows: 

■ a. In paragraph (d), by removing the 

word ‘‘slaughtered,’’; and 

■ b. By adding an OMB citation at the 

end of the section. 

The addition reads as follows: 

§ 54.5 Certification by owners. 

* * * * * 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

■ 7. Section 54.6 is revised to read as 

follows: 

§ 54.6 Amount of indemnity payments. 

(a) Indemnity. Indemnity paid for 

sheep and goats in accordance with 

§ 54.3 will be the fair market value of 

the animals. APHIS’ determination of 

fair market value will be based on 

available price report data that most 

accurately reflect the type of animal 

being indemnified and the time at 

which the animal was indemnified. 

Premiums will be paid for certain types 

of sheep and goats, including, but not 

limited to: Registered animals, flock 

sires, pregnant animals and earlymaturing ewes; Except that, no premium 

will be added for animals of any age that 

were in slaughter channels when 

indemnity was offered. To calculate 

indemnity, APHIS will use price 

information provided by the 

Agricultural Marketing Service (AMS) 

or other available price information and 

any other data necessary to establish the 

value of different types of sheep and 

goats. A detailed description of the 

methods APHIS uses to calculate 

indemnity for sheep and goats is 

available at http://www.aphis.usda.gov/ 

animal-health/scrapie. 

(b) Age and number of animals. If 

records and identification are 

inadequate to determine the actual age 

of animals, an APHIS or State 

representative will count all sexually 

intact animals that are apparently under 

1 year of age, and those that are 

apparently at least 1 and under 2 years 

of age, based on examination of their 

teeth, and the indemnity for these 

animals will be calculated. The total 

number of these animals will be 

subtracted from the total number of 

sexually intact animals in the group to 

be indemnified, and indemnity for the 

remainder will be calculated based on 

the assumption that the remainder of 

the flock is 80 percent aged 2 to 6 years 

and 20 percent aged 6 to 8 years. 

(c) Animal weights. If the owner 

disagrees with the average weight 

estimate, he may have the animals 

weighed at a public scale at his own 

expense, provided that the animals may 

not come in contact with other sheep or 

goats during movement to the public 

scales, and will be paid based on the 

actual weight multiplied by the price 

per pound for the class of animal as 

calculated in paragraph (a) of this 

section. 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

■ 8. Section 54.7 is amended as follows: 

■ a. By revising paragraphs (a) and (d); 

■ b. In paragraph (e), introductory text, 

by removing the words ‘‘Scrapie Flock 

Certification Program standards and the 

Scrapie Eradication Uniform Methods 

and Rules’’ adding in their place 

‘‘Scrapie Program Standards Volume 1: 

National Scrapie Eradication Program 

and Scrapie Program Standards Volume 

2: Scrapie Free Flock Certification 

Program (SFCP)’’; 

■ c. In paragraph (e)(1), by removing the 

words ‘‘animals or wildlife’’ and adding 

in their place the words ‘‘or wild 

ruminants’’; 

■ d. By revising paragraph (e)(2) 

introductory text; 

■ e. By removing paragraph (e)(2)(i), 

redesignating paragraphs (e)(2)(ii) and 

(iii) as paragraphs (e)(2)(i) and (ii), 

respectively, and by adding new 

paragraphs (e)(2)(iii) and (iv); and 

■ f. By adding an OMB citation at the 

end of the section. 

The revisions and additions read as 

follows: 

§ 54.7 Procedures for destruction of 

animals. 

(a) Animals for which 

indemnification is sought must be 

destroyed on the premises where they 

are held, pastured, or penned at the time 

indemnity is approved or moved to an 

approved research facility, unless the 

APHIS representative involved approves 

in advance of destruction moving the 

animals to another location for 

destruction. 

* * * * * 

(d) APHIS may pay the reasonable 

costs of disposal for animals that are 

indemnified. To obtain reimbursement 

for disposal costs, animal owners must 

obtain written approval of the disposal 

costs from APHIS, prior to disposal. For 

reimbursement to be made, the owner of 

the animals must present the Veterinary 

Services, Field Operations, Area 

Veterinarian in Charge (AVIC) 

responsible for the State involved with 

a copy of either a receipt for expenses 

paid or a bill for services rendered. Any 

bill for services rendered by the owner 

must not be greater than the normal fee 

for similar services provided by a 

commercial hauler or disposal facility. 

(e) * * * 

(2) Cement, wood, metal and other 

non-earth surfaces, tools, equipment, 

instruments, feed, hay, bedding, and 

other materials. Organic and/or 

inorganic materials may be disposed of 

by incineration or burial. Inorganic 

material and wood structures may be 

cleaned and disinfected. To disinfect, 

remove all organic material and 

incinerate, bury, till under, or compost 

the removed organic material in areas 

not accessed by domestic or wild 

ruminants until it can be incinerated, 

buried, or tilled under. Clean and wash 

all surfaces, tools, equipment, and 

instruments using hot water and 

detergent. Allow all surfaces, tools, 

equipment, and instruments to dry 

completely before disinfecting and 

sanitizing using one of the following 

methods: 

* * * * * 

(iii) Use a product registered by the 

U.S. Environmental Protection Agency 

(EPA) specifically for reduction of prion 

infectivity at these sites in accordance 

with the label. 

(iv) Use a product in accordance with 

an emergency exemption issued by the 

EPA for reduction of prion infectivity at 

these sites. 

(Approved by the Office of Management and 

Budget under control number 0579–0469) 

■ 9. Section 54.8 is revised to read as 

follows: 

§ 54.8 Requirements for flocks under 

investigation and flocks subject to flock 

plans and post-exposure management and 

monitoring plans. 

(a) For animals in a flock under 

investigation, flock plan, or postexposure management and monitoring 

plan (PEMMP), the official 

identification must provide a unique 

identification number that is applied by 

the owner of the flock or his or her agent 

and must be linked to that flock in the 

National Scrapie Database. APHIS may 

specify the type of official identification 

that may be used in order to maximize 

retention of the means of identification, 

identify restricted or test positive 

animals or to facilitate the testing or 

inventory of the animals. The owner of 

the flock or his or her agent must 

officially identify and maintain the 

identity of: 

11184 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

(1) All animals in the flock while it is 

subject to a flock plan or PEMMP; 

(2) Any high-risk or genetically 

susceptible exposed animals in the flock 

and any other restricted animals; 

(3) Any animals designated for testing 

by an APHIS representative or State 

representative until testing is 

completed, results reported, and 

animals classified; and 

(4) All sexually intact animals, all 

exposed animals, and animals 18 

months of age and older (as evidenced 

by the eruption of the second incisor) 

prior to a change in ownership and 

before they are moved off the premises 

of the flock. 

(b) For flocks under a flock plan or 

PEMMP, the flock owner must maintain 

the following records for 5 years or until 

the flock plan and/or PEMMP is 

completed, whichever is longer. 

(1) For acquired animals, the date of 

acquisition, name and address of the 

person from whom the animal was 

acquired, any identifying marks, or 

identification devices present on the 

animal including but not limited to the 

animal’s individual official 

identification number(s) from its 

electronic implant, flank tattoo, ear 

tattoo, tamper-resistant eartag, or, in the 

case of goats, tail fold tattoo, and any 

secondary form of identification the 

owner of the flock may choose to 

maintain and the records required by 

§ 79.2 of this chapter. 

(2) For animals leaving the premises 

of the flock, the disposition of the 

animal, including, any identifying 

marks or identification devices present 

on the animal, including but not limited 

to the animal’s individual official 

identification number from its 

electronic implant, flank tattoo, ear 

tattoo, tamper-resistant eartag, or, in the 

case of goats, a tail fold tattoo, and any 

secondary form of identification the 

owner of the flock may choose to 

maintain, the date and cause of death, 

if known, or date of removal from the 

flock and name and address of the 

person to whom the animal was 

transferred and the records required by 

§ 79.2 of this chapter. 

(c) Upon request by a State or APHIS 

representative or as required in a 

PEMMP, the owner of the flock or his 

or her agent must have an accredited 

veterinarian collect tissues from animals 

for scrapie diagnostic purposes and 

submit them to a laboratory designated 

by a State or APHIS representative or 

collect and submit samples by another 

method acceptable to APHIS. 

(d) Upon request by a State or APHIS 

representative, the owner of the flock or 

his or her agent must make animals in 

the flock available for inspection and or 

testing and the records required to be 

kept as a part of these plans available for 

inspection and copying. 

(e) The owner of the flock or his or 

her agent must meet requirements found 

necessary by a DSE to monitor for 

scrapie and to prevent the recurrence of 

scrapie in the flock and to prevent the 

spread of scrapie from the flock. These 

other requirements may include, but are 

not limited to: Utilization of a liveanimal screening test; reporting animals 

found dead and collecting and 

submitting test samples from them; 

restrictions on the animals that may be 

moved from the flock; use of genetically 

resistant rams; segregated lambing; 

cleaning and disinfection of lambing 

facilities; and/or education of the owner 

of the flock and personnel working with 

the flock in techniques to recognize 

clinical signs of scrapie and to control 

the spread of scrapie. 

(f) The owner of the flock or his or her 

agent must immediately report the 

following animals to a State 

representative, APHIS representative, or 

an accredited veterinarian; ensure that 

samples are properly collected for 

testing if the animal dies; allow the 

animals to be tested, and not remove 

them from a flock without written 

permission of a State or APHIS 

representative: 

(1) Any sheep or goat exhibiting 

weight loss despite retention of appetite; 

behavioral abnormalities; pruritus 

(itching); wool pulling; wool loss; biting 

at legs or side; lip smacking; motor 

abnormalities such as incoordination, 

high stepping gait of forelimbs, bunny 

hop movement of rear legs, or swaying 

of back end; increased sensitivity to 

noise and sudden movement; tremor; 

star gazing; head pressing; recumbency; 

rubbing, or other signs of neurological 

disease or chronic wasting illness; and 

(2) Any sheep or goat in the flock that 

has tested positive for scrapie or for the 

proteinase resistant protein associated 

with scrapie on a live-animal screening 

test or any other test. 

(g) An epidemiologic investigation 

must be conducted to identify high-risk 

and exposed animals that currently 

reside in the flock or that previously 

resided in the flock, and all high-risk 

animals, scrapie-positive animals, and 

suspect animals must be removed from 

the flock except as provided in 

paragraph (h) of this section. The 

animals must be removed either by 

movement to an approved research 

facility or by euthanasia and disposal of 

the carcasses by burial, incineration, or 

other methods approved by the 

Administrator and in accordance with 

local, State, and Federal laws, or upon 

request in individual cases by another 

means determined by the Administrator 

to be sufficient to prevent the spread of 

scrapie. 

(h) The Administrator may allow 

high-risk animals that are not suspect 

animals to be retained under restriction 

if they are not genetically susceptible 

animals or if they have tested ‘‘PrPsc not 

detected’’ on a live animal scrapie test 

approved for this purpose by the 

Administrator and are maintained in a 

manner that the Administrator 

determines minimizes the risk of scrapie 

transmission, e.g., bred only to 

genetically resistant sheep, segregated 

for lambing, and cleaning and 

disinfection of the lambing area. Such 

animals may be retained only if the 

exempted animal’s official identification 

and the requirements for minimizing the 

risk of scrapie transmission are 

documented in the PEMMP and the 

owner is in compliance with the 

PEMMP. All such animals must be 

tested for scrapie when they are 

euthanized or die or if they are later 

determined to be suspect animals. 

(i) The owner of the flock, or his or 

her agent, must request breed 

associations and registries, livestock 

facilities, and packers to disclose 

records to APHIS representatives or 

State representatives, to be used to 

identify source flocks and trace exposed 

animals, including high-risk animals. 

(j) The flock plan will include a 

description of the types of animals that 

must be removed from a flock, the 

timeframes in which they must be 

removed and any other actions that 

must be accomplished in order for the 

flock plan to be completed. Flock plans 

shall require an owner to agree to: 

(1) Clean and disinfect the premises 

in accordance with § 54.7(e). Premises 

or portions of premises may be 

exempted from the cleaning and 

disinfecting requirements if a 

designated scrapie epidemiologist 

determines, based on an epidemiologic 

investigation, that cleaning and 

disinfection of such buildings, holding 

facilities, conveyances, or other 

materials on the premises will not 

significantly reduce the risk of the 

spread of scrapie, either because 

effective disinfection is not possible or 

because the normal operations on the 

premises prevent transmission of 

scrapie. No confined area where a 

scrapie-positive animal was born, 

lambed or aborted may be exempted; 

(2) Agree to conduct a post-exposure 

management and monitoring plan 

(PEMMP); and 

(3) Comply with any other conditions 

in the flock plan; 

(k) A PEMMP will be required for 

exposed flocks and may be required for 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11185 

flocks under investigation that were not 

source or infected flocks. A PEMMP 

may also be required for flocks that 

formerly were exposed flocks or flocks 

under investigation as a condition for 

being redesignated. A designated 

scrapie epidemiologist shall determine 

when to require a PEMMP and the 

monitoring requirements for these flocks 

based on the findings of the 

classification or reclassification 

investigation. 

(l) Provided that, the Administrator 

may waive the requirement for a flock 

plan or PEMMP or waive any of the 

requirements in a flock plan or PEMMP 

after determining that the flock poses a 

low risk of scrapie transmission. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0101 

and 0579–0469) 

■ 10. Section 54.10 is revised to read as 

follows: 

§ 54.10 Program approval of tests for 

scrapie. 

(a) The Administrator may approve 

new tests or test methods for the 

diagnosis of scrapie conducted on live 

or dead animals for use in the Scrapie 

Eradication Program and/or the Scrapie 

Free Flock Certification Program. The 

Administrator will base the approval or 

disapproval of a test on the evaluation 

by APHIS and, when appropriate, 

outside scientists, of: 

(1) A standardized test protocol that 

must include a description of the test, 

a description of the reagents, materials, 

and equipment used for the test, the test 

methodology, and any control or quality 

assurance procedures; 

(2) Data to support repeatability, that 

is, the ability to reproduce the same 

result repeatedly on a given sample; 

(3) Data to support reproducibility, 

that is, data to show that similar results 

can be produced when the test is run at 

other laboratories; 

(4) Data to support the diagnostic and 

in the case of assays the analytical 

sensitivity and specificity of the test; 

and 

(5) Any other data or information 

requested by the Administrator to 

determine the suitability of the test for 

program use. This may include but is 

not limited to past performance, cost of 

test materials and equipment, ease of 

test performance, generation of waste, 

and potential use of existing equipment. 

(b) To be approved for program use, 

a scrapie test must be able to be readily 

and successfully performed at the 

National Veterinary Services 

Laboratories. 

(c) The test must have a reliable, 

timely, and cost effective method of 

proficiency testing. 

(d) The Administrator may decline to 

evaluate any test kit for program 

approval that has not been licensed for 

the intended use and may decline to 

evaluate any test or test method for 

program use unless the requester can 

demonstrate that the new method offers 

a significant advantage over currently 

approved methods. 

(e) A test or combination of tests may 

be approved for the identification of 

suspect animals, or scrapie-positive 

animals, or for other purposes such as 

flock certification. For a test to be 

approved for the identification of 

scrapie-positive animals, the test must 

demonstrate a diagnostic specificity 

comparable to that of current programapproved tests, and the sensitivity of the 

test will also be considered in 

determining the approved uses of the 

test within the program. For a test to be 

approved for the removal of high-risk, 

exposed, or suspect animal designations 

the test must have a diagnostic 

sensitivity at least comparable to that of 

current program-approved tests used for 

this purpose. Since the purpose of a 

screening test is usually to identify a 

subset of animals for further testing, for 

a test to be approved as a screening test 

for the identification of suspect animals, 

the test must be usually reliable but 

need not be definitive for diagnosing 

scrapie. 

(f) Specific guidelines for use of 

program-approved tests within the 

Scrapie Eradication Program or Scrapie 

Free Flock Certification Program will be 

made available on the scrapie website at 

http://www.aphis.usda.gov/animalhealth/scrapie. Guidelines will be based 

on the characteristics of the test, 

including specificity, sensitivity, and 

predictive value in defined groups of 

animals. 

(g) If an owner elects to have an 

unofficial test conducted on an animal 

for scrapie, or for the proteinase 

resistant protein associated with 

scrapie, and that animal tests positive to 

such a test, the animal will be 

designated a suspect animal, unless the 

test is conducted as part of a research 

protocol and the protocol includes 

appropriate measures to prevent the 

spread of scrapie. 

(h) The Administrator may withdraw 

or suspend approval of any test or test 

method if the test or method does not 

perform at an acceptable level following 

approval or if a more effective test or 

test method is subsequently approved. 

The Administrator shall give written 

notice of the suspension or proposed 

withdrawal to the director of the 

laboratories using the test or method or 

in the case of test kits to the 

manufacturer and shall give the director 

or manufacturer an opportunity to 

respond. Such action shall become 

effective upon oral or written 

notification, whichever is earlier, to the 

laboratory or manufacturer. If there are 

conflicts as to any material fact 

concerning the reason for withdrawal, a 

hearing may be requested in accordance 

with the procedure in § 79.4(c)(3) of this 

chapter. The action under appeal shall 

continue in effect pending the final 

determination of the Administrator, 

unless otherwise ordered by the 

Administrator. The Administrator’s 

final determination constitutes final 

agency action. 

(Approved by the Office of Management and 

Budget under control number 0579–0469) 

■ 11. Section 54.11 is revised to read as 

follows: 

§ 54.11 Approval of laboratories to run 

official scrapie tests and official genotype 

tests. 

(a) State, Federal, and university 

laboratories, or in the case of genotype 

tests, private laboratories will be 

approved by the Administrator when he 

or she determines that the laboratory: 

(1) Employs personnel assigned to 

supervise and conduct the testing who 

are qualified to conduct the test based 

on education, training, and experience 

and who have been trained by the 

National Veterinary Services 

Laboratories (NVSL) or who have 

completed equivalent training approved 

by NVSL; 

(2) Has adequate facilities and 

equipment to conduct the test; 

(3) Follows standard test protocols 

that are approved or provided by NVSL; 

(4) Meets check test proficiency 

requirements and consistently produces 

accurate test results as determined by 

NVSL review; 

(5) Meets recordkeeping requirements; 

(6) Will retain records, slides, blocks, 

and other specimens from all cases for 

at least 1 year and from positive cases 

and DNA from all genotype tests for at 

least 5 years and will forward copies of 

records and any of these materials to 

NVSL within 5 business days of request; 

Except that, NVSL may authorize a 

shorter retention time in a standard 

operating procedure or contract; 

(7) Will allow APHIS to inspect the 

laboratory without notice during normal 

business hours. An inspection may 

include, but is not limited to, review 

and copying of records, examination of 

slides, review of quality control 

procedures, observation of sample 

handling/tracking procedures, 

observation of the test being conducted, 

and interviewing of personnel; 

(8) Will report all test results to State 

and Federal animal health officials and 

11186 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

record them in the National Scrapie 

Database within timeframes and in the 

manner and format specified by the 

Administrator; and 

(9) Complies with any other written 

guidance provided to the laboratory by 

the Administrator. 

(b) A laboratory may request approval 

to conduct one or more types of 

program-approved scrapie test or 

genotype test on one or more types of 

tissue. To be approved, a laboratory 

must meet the requirements in 

paragraph (a) of this section for each 

type of test and for each type of tissue 

for which they request approval. 

(c) The Administrator may suspend or 

withdraw approval of any laboratory for 

failure to meet any of the conditions 

required by paragraph (a) of this section. 

The Administrator shall give written 

notice of the suspension or the proposed 

withdrawal to the director of the 

laboratory and shall give the director an 

opportunity to respond. Such action 

shall become effective upon oral or 

written notification, whichever is 

earlier, to the laboratory or 

manufacturer. If there are conflicts as to 

any material fact concerning the reason 

for withdrawal, a hearing may be 

requested in accordance with the 

procedure in § 79.4(c)(3) of this chapter. 

The action under appeal shall continue 

in effect pending the final determination 

of the Administrator, unless otherwise 

ordered by the Administrator. The 

Administrator’s final determination 

constitutes final agency action. 

(d) The Administrator may require 

approved laboratories to reimburse 

APHIS for part or all of the costs 

associated with the approval and 

monitoring of the laboratory. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0101 

and 0579–0469) 

■ 12. The heading for subpart B is 

revised to read as set forth below: 

Subpart B—Scrapie Free Flock 

Certification Program 

■ 13. Section 54.21 is revised to read as 

follows: 

§ 54.21 Participation. 

Any owner of a sheep or goat flock 

may apply to enter the Scrapie Free 

Flock Certification Program by sending 

a written request to a State scrapie 

certification board or to the Veterinary 

Services, Field Operations, AVIC 

responsible for the State involved. A 

notice containing a current list of flocks 

participating in the Scrapie Free Flock 

Certification Program, and the 

certification status of each flock, may be 

obtained from the APHIS website at 

http://www.aphis.usda.gov/animalhealth/scrapie. A list of noncompliant 

flocks and a list of flocks that sold 

exposed animals that could not be 

traced may also be obtained from this 

site, and these lists may be obtained by 

writing to the National Scrapie Program 

Coordinator, Strategy and Policy, VS, 

APHIS, 4700 River Road Unit 43, 

Riverdale, MD 20737–1235. 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

PART 79—SCRAPIE IN SHEEP AND 

GOATS 

■ 14. The authority citation for part 79 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 15. Section 79.1 is amended as 

follows: 

■ a. By revising the definition for 

Animal identification number (AIN); 

■ b. In the definition for Breed 

association and registries, by removing 

the words ‘‘listed in § 151.9 of this 

chapter’’; 

■ c. By removing the definition for 

Certificate; 

■ d. By adding in alphabetical order a 

definition for Classification or 

reclassification investigation; 

■ e. By revising the definitions for 

Consistent State, Exposed animal, and 

Exposed flock; 

■ f. By adding in alphabetical order a 

definition for Flock identification (ID) 

number; 

■ g. In the definition for Flock plan, by 

removing the citation ‘‘§ 54.8(a)(f)’’ and 

by adding the words ‘‘§ 54.8(a) through 

(j)’’ in its place; 

■ h. By adding in alphabetical order 

definitions for Flock under 

investigation, Genetically less 

susceptible exposed sheep, Genetically 

resistant exposed sheep, Genetically 

resistant sheep, Genetically susceptible 

animal, Genetically susceptible exposed 

animal, Group/lot identification number 

(GIN); 

■ i. By revising the definition for Highrisk animal; 

■ j. By adding in alphabetical order 

definitions for Interstate certificate of 

veterinary inspection (ICVI) and Lowrisk commercial flock; 

■ k. By removing the definition for Lowrisk commercial sheep; 

■ l. By adding in alphabetical order a 

definition for Low-risk exposed animal; 

■ m. By removing the definition for 

Low-risk goat; 

■ n. By adding in alphabetical order a 

definition for National Uniform 

Eartagging System (NUES); 

■ o. In the definition for Noncompliant 

flock, in paragraph (3), by removing the 

words ‘‘owner statement’’ and adding 

the words ‘‘owner/hauler statement’’ in 

their place; 

■ p. By revising the definitions for 

Official eartag, Official genotype test, 

and Official identification device or 

method; 

■ q. By adding in alphabetical order 

definitions for Official identification 

number, Officially identified, and 

Owner/hauler statement; 

■ r. By removing the definition for 

Owner statement; 

■ s. By adding in alphabetical order a 

definition for Person; 

■ t. By revising the definition for 

Premises identification number (PIN); 

■ u. By adding in alphabetical order a 

definition for Restricted animal sale or 

restricted livestock facility; 

■ v. In the heading of the definition for 

Scrapie Flock Certification Program 

(SFCP), by adding the word ‘‘Free’’ 

immediately after the word ‘‘Scrapie’’; 

■ w. In the heading of the definition for 

Scrapie Flock Certification Program 

standards, by adding the word ‘‘Free’’ 

immediately following the word 

‘‘Scrapie’’ and, in footnote 2, by 

removing the internet address ‘‘http://

www.aphis.usda.gov/vs’’ and adding the 

internet address ‘‘http://

www.aphis.usda.gov/animal-health/ 

scrapie’’ in its place; 

■ x. In the definition for Scrapiepositive animal, in paragraph (2) by 

adding the words ‘‘, and/or ELISA,’’ 

immediately after the word 

‘‘immunohistochemistry’’ and in 

paragraph (5) by removing the words 

‘‘test method’’ and adding the words 

‘‘method or combination of methods’’ in 

their place; 

■ y. By removing the definition for 

Separate contemporary lambing groups; 

■ z. By revising the definition for 

Slaughter channels; 

■ aa. By revising paragraph (1) of the 

definition for Suspect animal; 

■ bb. By revising the definition for 

Terminal feedlot; and 

■ cc. By adding in alphabetical order a 

definition for Test eligible. 

The additions and revisions read as 

follows: 

§ 79.1 Definitions. 

* * * * * 

Animal identification number (AIN). 

This term has the meaning set forth in 

§ 86.1 of this subchapter, except that 

only AIN devices approved and 

distributed in accordance with § 79.2(k) 

and methods approved for use in sheep 

and goats in accordance with 

§ 79.2(a)(2) are included. 

* * * * * 

Classification or reclassification 

investigation. An epidemiological 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11187 

investigation conducted or directed by a 

DSE for the purpose of designating or 

redesignating the status (e.g., exposed, 

high-risk, infected, source, suspect, etc.) 

of a flock or animal. In conducting such 

an investigation, the DSE will evaluate 

the available records for flocks and 

individual animals and conduct or 

direct any testing needed to assess the 

status of a flock or animal. The status of 

an animal or flock will be determined 

based on the applicable definitions in 

this section and, when needed to make 

a designation under § 79.4, official 

genotype test results, exposure risk, 

scrapie type involved, and/or results of 

official scrapie testing on live or dead 

animals. 

* * * * * 

Consistent State. (1) A State that the 

Administrator has determined conducts 

an active State scrapie control program 

that meets the requirements of § 79.6 or 

effectively enforces a State designed 

plan that the Administrator determines 

is at least as effective in controlling 

scrapie as the requirements of § 79.6. 

(2) A list of Consistent States can be 

found on the internet at http://

www.aphis.usda.gov/animal-health/ 

scrapie. 

* * * * * 

Exposed animal. Any animal or 

embryo that: 

(1) Has been in a flock with a scrapiepositive female animal; 

(2) Has been in an enclosure with a 

scrapie-positive female animal at any 

location; 

(3) Resides in a noncompliant flock; 

or 

(4) Has resided on the premises of a 

flock before or while it was designated 

an infected or source flock and before a 

flock plan was completed. An animal 

shall not be designated an exposed 

animal if it only resided on the premises 

before the date that infection was most 

likely introduced to the premises as 

determined by a Federal or State 

representative. If the probable date of 

infection cannot be determined based 

on the epidemiologic investigation, a 

date 2 years before the birth of the 

oldest scrapie-positive animal born in 

that flock will be used. If the actual 

birth date is unknown, the date of birth 

will be estimated based on examination 

of the teeth and any available records. 

If an age estimate cannot be made, the 

animal will be assumed to have been 48 

months of age on the date samples were 

collected for scrapie diagnosis. Exposed 

animals will be further designated as 

genetically resistant exposed sheep, 

genetically less susceptible exposed 

sheep, genetically susceptible exposed 

animals, or low-risk exposed animals. 

An animal will no longer be an exposed 

animal if it is redesignated in 

accordance with § 79.4. 

Exposed flock. (1) Any flock that was 

designated an infected or source flock 

that has completed a flock plan and that 

retained a female genetically susceptible 

exposed animal; 

(2) Any flock under investigation that 

retains a female genetically susceptible 

exposed animal or a suspect animal, or 

whose owner declines to complete 

genotyping and live-animal and/or postmortem scrapie testing required by the 

APHIS or State representative 

investigating the flock; or 

(3) Any noncompliant flock or any 

flock for which a PEMMP is required 

that is not in compliance with the 

conditions of the PEMMP. A flock will 

no longer be an exposed flock if it is 

redesignated in accordance with § 79.4. 

* * * * * 

Flock identification (ID) number. A 

nationally unique number assigned by a 

State, federally recognized Tribal or 

Federal animal health authority to a 

group of animals that are managed as a 

unit on one or more premises and are 

under the same ownership. The flock ID 

number must begin with the State postal 

abbreviation or APHIS-assigned Tribal 

code, must have no more than nine 

alphanumeric characters, and must not 

contain the characters ‘‘I’’, ‘‘O’’, or ‘‘Q’’ 

other than as part of the State postal 

abbreviation or another standardized 

format authorized by the administrator 

and recorded in the National Scrapie 

Database. APHIS may assign Tribal 

codes to any federally recognized Tribe 

that maintains sheep or goats on Tribal 

lands. The flock ID number must be 

recorded in and linked to one or more 

PINs or LIDs in the National Scrapie 

Database. 

* * * * * 

Flock under investigation. Any flock 

in which an APHIS or State 

representative has determined that a 

scrapie suspect animal, high-risk 

animal, or scrapie-positive animal 

resides or may have resided. A flock 

will no longer be a flock under 

investigation if it is redesignated in 

accordance with § 79.4. 

Genetically less susceptible exposed 

sheep. Any sheep or sheep embryo that 

is: 

(1) An exposed sheep or sheep 

embryo of genotype AA QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a 

scrapie type to which AA QR sheep are 

not less susceptible; or 

(2) An exposed sheep or sheep 

embryo of genotype AV QR, unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that 

the Administrator has determined may 

be affected by valine-associated scrapie 

(based on an evaluation of the genotypes 

of the scrapie-positive animals linked to 

the flock), or to another scrapie type to 

which the Administrator has 

determined AV QR sheep are not less 

susceptible; or 

(3) An exposed sheep or sheep 

embryo of a genotype that has been 

exposed to a scrapie type to which the 

Administrator has determined that 

genotype is less susceptible. 

(4) Note: In this definition R refers to 

codon 171 and A refers to codon 136, 

and Q represents any genotype other 

than R at codon 171 and V represents 

any genotype other than A at codon 136. 

Genetically resistant exposed sheep. 

Any exposed sheep or sheep embryo of 

genotype RR at codon 171 unless the 

Administrator determines that it is 

epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type 

to which RR sheep are not resistant. 

Genetically resistant sheep. Any 

sheep or sheep embryo of genotype RR 

at codon 171 unless it is 

epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type 

that affects RR at codon 171 sheep. 

Genetically susceptible animal. Any 

goat or goat embryo, sheep or sheep 

embryo of a genotype other than RR or 

QR, where Q represents any genotype 

other than R at codon 171 or sheep or 

sheep embryo of undetermined 

genotype. 

Genetically susceptible exposed 

animal. Excluding low-risk exposed 

animals, any exposed animal or embryo 

that is also: 

(1) A genetically susceptible animal; 

or 

(2) A sheep or sheep embryo of 

genotype AV QR that the Administrator 

has determined is epidemiologically 

linked to a scrapie-positive RR or QR 

sheep, to a flock that the Administrator 

has determined may be affected by 

valine-associated scrapie (based on an 

evaluation of the genotypes of the 

scrapie-positive animals linked to the 

flock), or to a scrapie type to which AV 

QR sheep are susceptible; or 

(3) A sheep or sheep embryo of 

genotype AA QR that the Administrator 

has determined is epidemiologically 

linked to a scrapie-positive RR or AA 

QR sheep or to a scrapie type to which 

AA QR sheep are susceptible; or 

(4) A sheep or sheep embryo of 

genotype RR that the Administrator has 

determined is epidemiologically linked 

to a scrapie-positive RR sheep or to a 

11188 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

scrapie type to which RR sheep are 

susceptible. 

(5) Note: In this definition, R refers to 

codon 171 and A refers to codon 136, 

and Q represents any genotype other 

than R at codon 171 and V represents 

any genotype other than A at codon 136. 

Group/lot identification number 

(GIN). The identification number used 

to uniquely identify a unit of animals 

that is managed together as one group. 

The format of the GIN may be either as 

defined in § 86.1 of this chapter, or the 

flock identification number followed by 

a six-digit representation of the date on 

which the group or lot of animals was 

assembled (MM/DD/YY). If more than 

one group is created on the same date 

a sequential number will be added to 

the end of the GIN. A group lot 

comprised of animals from a single flock 

of origin may be subdivided after 

leaving the premises on which the 

group lot was formed by adding an S 

followed by a sequential number to the 

end of the GIN to create a GIN for each 

sub group. If a flock identification 

number is used, the flock identification 

number, date, and sequential number(s) 

will be separated by hyphens. 

High-risk animal. The female 

offspring or embryo of a scrapie-positive 

female animal, or any suspect animal, or 

a female genetically susceptible exposed 

animal, or any exposed animal that the 

Administrator determines to be a 

potential risk. The Administrator may 

base the determination that an exposed 

animal poses a potential risk on the 

scrapie type, the epidemiology of the 

flock or flocks with which it is 

epidemiologically linked, including 

genetics of the positive sheep, the 

prevalence of scrapie in the flock, any 

history of recurrent infection, and other 

animal or flock characteristics. An 

animal will no longer be a high-risk 

animal if it is redesignated in 

accordance with § 79.4. 

* * * * * 

Interstate certificate of veterinary 

inspection (ICVI). An official document 

issued by a Federal, State, Tribal, or 

accredited veterinarian certifying the 

inspection of animals in preparation for 

interstate movement or other uses as 

described in this part and in accordance 

with § 79.5. 

* * * * * 

Low-risk commercial flock. A flock 

composed of commercial whitefaced, 

whitefaced cross, or commercial hair 

sheep or commercial goats that were 

born in, and have resided throughout 

their lives in, flocks with no known risk 

factors for scrapie, including any 

exposure to female blackfaced sheep 

other than whiteface crosses born on the 

premises; that has never contained a 

scrapie-positive female, suspect female, 

or high-risk animal; and that has never 

been an infected, exposed, or source 

flock or a flock under investigation. The 

animals are identified with a legible 

permanent brand or ear notch pattern 

registered with an official brand registry 

or with an official flock identification 

eartag. The term ‘‘brand’’ includes 

official brand registry brands on eartags 

in those States whose brand law or 

regulation recognizes brands placed on 

eartags as official brands. Low-risk 

commercial flocks may exist only in a 

State where in the previous 10 years no 

flock that had met the definition of a 

low-risk commercial flock prior to a 

classification investigation was 

designated a source or infected flock. 

Low-risk exposed animal. Any 

exposed animal to which the 

Administrator has determined one or 

more of the following applies: 

(1) The positive animal that was the 

source of exposure was not born in the 

flock and did not lamb in the flock or 

in an enclosure where the exposed 

animal resided; 

(2) The Administrator and State 

representative concur that the animal is 

unlikely to be infected due to factors 

such as, but not limited to, where the 

animal resided or the time period the 

animal resided in the flock; 

(3) The exposed animal is male and 

was not born in an infected or source 

flock; 

(4) The exposed animal is a castrated 

male; 

(5) The exposed animal is an embryo 

of a genetically resistant exposed sheep 

or a genetically less susceptible exposed 

sheep unless placed in a recipient that 

was a genetically susceptible exposed 

animal; or 

(6) The animal was exposed to a 

scrapie type and/or is of a genotype that 

the Administrator has determined poses 

low risk of transmission. 

* * * * * 

National Uniform Eartagging System 

(NUES). This term has the meaning set 

forth in § 86.1 of this subchapter. 

* * * * * 

Official eartag. This term has the 

meaning set forth in § 86.1 of this 

subchapter, except that only eartags 

approved and distributed in accordance 

with § 79.2(k) are included. 

Official genotype test. A test to 

determine the genotype of a live or dead 

animal conducted at either the National 

Veterinary Services Laboratories or at an 

approved laboratory. The test subject 

must be an animal that is officially 

identified and the test accurately 

recorded on an official form supplied or 

approved by APHIS, with the samples 

collected and shipped to the laboratory 

using a shipping method specified by 

the laboratory by: 

(1) An accredited veterinarian; 

(2) A State or APHIS representative; 

or 

(3) The animal’s owner or owner’s 

agent, using a tamper-resistant sampling 

kit approved by APHIS for this purpose. 

* * * * * 

Official identification device or 

method. This term has the meaning set 

forth in § 86.1 of this subchapter, except 

that only devices approved and 

distributed in accordance with § 79.2(k) 

and methods approved for use in sheep 

and goats in accordance with 

§ 79.2(a)(2) are included. 

Official identification number. This 

term has the meaning set forth in § 86.1 

of this subchapter. 

Officially identified. Identified by 

means of an official identification 

device or method approved by the 

Administrator for use in sheep and goats 

in accordance with this part. 

* * * * * 

Owner/hauler statement. (1) A signed 

written statement by the owner or 

hauler that includes: 

(i) The name, address, and phone 

number of the owner and, if different, 

the hauler; 

(ii) The date the animals were moved; 

(iii) The flock identification number 

or PIN assigned to the flock or premises 

of the animals; 

(iv) If moving individually 

unidentified animals or other animals 

required to move with a group/lot 

identification number, the group/lot 

identification number and any 

information required to officially 

identify the animals; 

(v) The number of animals; 

(vi) The species, breed, and class of 

animals. If breed is unknown, for sheep 

the face color and for goats the type 

(milk, fiber, or meat) must be recorded 

instead; and 

(vii) The name and address of point 

of origin, if different from the owner’s 

address, and the destination name and 

address. 

(2) An existing document that 

includes the information required in 

paragraphs (1)(i) to (vii) of this 

definition and that is signed by the 

owner or the hauler may be used as an 

owner/hauler statement. 

* * * * * 

Person. An individual, partnership, 

company, corporation, or any other legal 

entity. 

* * * * * 

Premises identification number (PIN). 

This term has the meaning set forth in 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11189 

4 You need not identify an animal to its flock of 

birth or its flock of origin if this information is 

unknown because the animal changed ownership 

while it was exempted from flock of origin 

identification requirements in accordance with 

§ 79.6(a)(10)(i). Such animals may be moved 

interstate with individual animal identification that 

is only traceable to the State of origin and to the 

owner of the animals at the time they were so 

identified. To use this exemption the person 

applying the identification must have supporting 

documentation indicating that the animals were 

born and had resided throughout their life in the 

State. 

§ 86.1 of this subchapter. APHIS may 

also maintain historical and/or State 

premises numbers and link them to the 

premises identification number in 

records and databases. Such secondary 

or historical numbers are typically the 

State’s two-letter postal abbreviation 

followed by a number assigned by the 

State. 

Restricted animal sale or restricted 

livestock facility. A sale where any 

animals in slaughter channels are 

maintained separate from other animals 

not in slaughter channels other than 

animals from the same flock of origin 

and are sold in lots that consist entirely 

of animals sold for slaughter only or a 

livestock facility at which all animals 

are in slaughter channels and where the 

sale or facility manager maintains a 

copy of, or maintains a record of, the 

information from, the owner/hauler 

statement for all animals entering and 

leaving the sale or facility. A restricted 

animal sale may be held at a livestock 

facility that is not restricted. 

* * * * * 

Slaughter channels. Animals in 

slaughter channels include any animal 

that is sold, transferred, or moved either 

directly to or through a restricted animal 

sale or restricted livestock facility to an 

official slaughter establishment that is 

under Food Safety and Inspection 

Service (FSIS) jurisdiction per the 

Federal Meat Inspection Act (FMIA) or 

under State inspection that FSIS has 

recognized as at least equal to Federal 

inspection or to a custom exempt 

slaughter establishment as defined by 

FSIS (9 CFR 303.1) for immediate 

slaughter or to an individual for 

immediate slaughter for personal use or 

to a terminal feedlot. 

* * * * * 

Suspect animal. * * * 

(1) A mature sheep or goat as 

evidenced by eruption of the first 

incisor that has been condemned by 

FSIS or a State inspection authority for 

central nervous system (CNS) signs, or 

that exhibits any of the following 

clinical signs of scrapie and has been 

determined to be suspicious for scrapie 

by an accredited veterinarian or a State 

or USDA representative, based on one or 

more of the following signs and the 

severity of the signs: Weakness of any 

kind including, but not limited to, 

stumbling, falling down, or having 

difficulty rising, not including those 

with visible traumatic injuries and no 

other signs of scrapie; behavioral 

abnormalities; significant weight loss 

despite retention of appetite or in an 

animal with adequate dentition; 

increased sensitivity to noise and 

sudden movement; tremors; star gazing; 

head pressing; bilateral gait 

abnormalities such as but not limited to 

incoordination, ataxia, high stepping 

gait of forelimbs, bunny-hop movement 

of rear legs, or swaying of back end, but 

not including abnormalities involving 

only one leg or one front and one back 

leg; repeated intense rubbing with bare 

areas or damaged wool in similar 

locations on both sides of the animal’s 

body or, if on the head, both sides of the 

poll; abraded, rough, thickened, or 

hyperpigmented areas of skin in areas of 

wool/hair loss in similar locations on 

both sides of the animal’s body or, if on 

the head, both sides of the poll; or other 

signs of CNS disease. An animal will no 

longer be a suspect animal if it is 

redesignated in accordance with § 79.4. 

* * * * * 

Terminal feedlot. (1) A dry lot 

approved by a State or APHIS 

representative or an accredited 

veterinarian who is authorized by the 

Administrator to perform this function 

where animals in the terminal feedlot 

are separated from all other animals by 

at least 30 feet at all times or are 

separated by a solid wall through, over, 

or under which fluids cannot pass and 

contact cannot occur and must be 

cleaned of all organic material prior to 

being used to contain sheep or goats that 

are not in slaughter channels, where 

only castrated males are maintained 

with female animals and from which 

animals are moved only to another 

terminal feedlot or directly to slaughter; 

or 

(2) A dry lot approved by a State or 

APHIS representative or an accredited 

veterinarian authorized by the 

Administrator to perform this function 

where only animals that either are not 

pregnant based on the animal being 

male, an owner certification that any 

female animals have not been exposed 

to a male in the preceding 6 months, an 

ICVI issued by an accredited 

veterinarian stating the animals are not 

pregnant, or the animals are under 6 

months of age at time of receipt, where 

only castrated males are maintained 

with female animals, and all animals in 

the terminal feedlot are separated from 

all other animals such that physical 

contact cannot occur including through 

a fence and from which animals are 

moved only to another terminal feedlot 

or directly to slaughter; or 

(3) A pasture when approved by and 

maintained under the supervision of the 

State and in which only nonpregnant 

animals are permitted based on the 

animal being male, an owner 

certification that any female animals 

have not been exposed to a male in the 

preceding 6 months, or an ICVI issued 

by an accredited veterinarian stating the 

animals are not pregnant, or the animals 

are under 6 months of age at time of 

receipt, where only castrated males are 

maintained with female animals, where 

there is no direct fence-to-fence contact 

with another flock, and from which 

animals are moved only to another 

terminal feedlot or directly to slaughter. 

(4) Records of all animals entering 

and leaving a terminal feedlot must be 

maintained for 5 years after the animal 

leaves the feedlot and must meet the 

requirements of § 79.2, including either 

a copy of the required owner/hauler 

statements for animals entering and 

leaving the facility or the information 

required to be on the statements. 

Records must be made available for 

inspection and copying by an APHIS or 

State representative upon request. 

Test eligible. An animal that meets a 

test protocol’s age and post-exposure 

elapsed time requirements for the test to 

be meaningfully applied. 

* * * * * 

■ 16. Section 79.2 is revised to read as 

follows: 

§ 79.2 Identification and records 

requirements for sheep and goats in 

interstate commerce. 

(a) No sheep or goat that is required 

to be individually identified or group 

identified by § 79.3 may be sold, 

disposed of, acquired, exhibited, 

transported, received for transportation, 

offered for sale or transportation, 

loaded, unloaded, or otherwise handled 

in interstate commerce or commingled 

with such animals or be loaded or 

unloaded at a premises or animal 

concentration point (including premises 

that exhibit animals) where animals are 

received that have been in interstate 

commerce or from which animals are 

moved in interstate commerce unless 

each sheep or goat has been identified 

in accordance with this section. 

(1) The sheep or goat must be 

identified to its flock of origin and to its 

flock of birth 4 by the owner of the 

animal or his or her agent, at whichever 

of the following points in interstate 

commerce comes first: 

(i) Prior to the point of first 

commingling of the sheep or goats with 

11190 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

sheep or goats from any other flock of 

origin; 

(ii) Upon unloading of the sheep or 

goats at a livestock facility approved in 

accordance with § 71.20 of this 

subchapter and that has agreed to act as 

an agent for the owner to apply official 

identification and prior to commingling 

with animals from another flock of 

origin. Such facilities may identify 

animals after sale if the facility 

maintains unidentified animals from 

different flocks of origin or, when 

required, different flocks of birth in 

separate enclosures until officially 

identified. The animals must be 

accompanied by an owner/hauler 

statement that contains the information 

needed for the livestock facility to 

officially identify the animals to their 

flock of origin and, when required, their 

flock of birth; 

(iii) Upon transfer of ownership of the 

sheep or goats; 

(iv) If the owner of the premises or the 

owner of the animal engages in the 

interstate commerce of animals, then 

prior to moving a sheep or goat from the 

premises on which it resides, unless the 

animals are moving to a livestock 

facility approved to handle the species 

and class of animal to be moved as 

described in § 71.20 of this subchapter 

that has agreed to act as an agent for the 

owner to apply official identification 

and in accordance with paragraph 

(a)(1)(ii) of this section or to a slaughter 

plant listed in accordance with § 71.21 

of this subchapter as part of a group lot. 

Unless prohibited by State law or 

regulation, this does not preclude a 

person from moving animals as part of 

a group lot directly to another site in the 

same State to have official eartags that 

have been assigned to the animal’s flock 

of origin in the National Scrapie 

Database applied to the animals; 

(v) In the case of animals that have 

only resided on premises and in flocks 

owned by persons that do not engage in 

interstate commerce, upon unloading a 

sheep or goat at a livestock facility or 

other premises where animals are 

received that have been in interstate 

commerce or from which animals are 

moved in interstate commerce and prior 

to commingling with animals from 

another flock of origin. Such animals 

must be accompanied by an owner/ 

hauler statement that contains the 

information needed to officially identify 

the animals to their flock of origin and, 

when required, their flock of birth; or 

(vi) Before moving a sheep or goat 

across a State line, unless moving to an 

approved livestock facility that is 

approved to handle that species and 

class of animals as described in § 71.20 

of this subchapter that has agreed to act 

as an agent for the owner to apply 

official identification, and prior to 

commingling with animals from another 

flock of origin. Such animals must be 

accompanied by an owner/hauler 

statement that contains the information 

needed for the livestock facility to 

officially identify the animals to their 

flock of origin and, when required, their 

flock of birth. 

(2) The sheep or goats must be 

identified and remain identified using a 

device or method approved in 

accordance with paragraph (k) of this 

section. All animals required to be 

individually identified by § 79.3 shall be 

identified with official identification 

devices or methods. A list of approved 

identification devices and methods, 

including restrictions on their use, is 

available at http://www.aphis.usda.gov/ 

animal-health/scrapie. Written requests 

for approval of sheep or goat 

identification device types or methods 

not listed at http://www.aphis.usda.gov/ 

animal-health/scrapie should be sent to 

the National Scrapie Program 

Coordinator, Strategy and Policy, VS, 

APHIS, 4700 River Road Unit 43, 

Riverdale, MD 20737–1235. If the 

Administrator determines that an 

identification device or method will 

provide an effective means of tracing 

sheep and goats in interstate commerce, 

APHIS will provide public notice that 

the device type or method, along with 

any restrictions on its use, has been 

added to the list of approved devices 

and methods of official sheep and goat 

identification. 

(3) No person shall buy or sell, for his 

or her own account or as the agent of the 

buyer or seller, transport, receive for 

transportation, offer for sale or 

transportation, load, unload, or 

otherwise handle any animal that is in 

or has been in interstate commerce that 

has not been identified as required by 

this section including loading or 

unloading at a premises (including 

premises that exhibit animals) where 

animals are received that have been in 

interstate commerce or from which 

animals are moved in interstate 

commerce. No person shall commingle 

animals with any animal that is in or 

has been in interstate commerce that has 

not been identified as required by this 

section. If the person transporting 

animals is aware of any animal in the 

shipment that loses its identification to 

its flock of origin while in interstate 

commerce, the person transporting the 

animal is required to inform the 

receiving party of this fact, and it is the 

responsibility of the person who has 

control or possession of the animal 

upon unloading/delivery to identify the 

animal or have the animal identified 

prior to commingling it with any other 

animals. This shall be done by applying 

individual animal identification to the 

animal as required in paragraph (a)(2) of 

this section and recording the means of 

identification and the corresponding 

animal identification number on the 

waybill or other shipping document. If 

the flock of origin cannot be 

determined, all possible flocks of origin 

shall be listed on the record, or if this 

cannot be done, the animal must be 

identified with a slaughter only eartag 

and may only move in slaughter 

channels or, in the case of sheep, may 

be officially identified and moved for 

other purposes if the animal is 

inspected by an accredited veterinarian, 

found free of evidence of infectious or 

contagious disease and officially 

genotyped as AA QR or AA RR. 

(b) The State Animal Health Official 

or Veterinary Services, Field 

Operations, Area Veterinarian in Charge 

(AVIC) responsible for the State 

involved, whoever is responsible for 

issuing official identification devices or 

numbers in that State and for assigning 

flock identification numbers and 

premises identification numbers in that 

State in the National Scrapie Database, 

may issue sets of unique serial numbers 

or flock identification/production 

numbers for use on official individual 

identification devices (such as eartags or 

tattoos). Flock identification/production 

numbers may only be assigned to 

owners of breeding flocks. 

(1) Animals not in slaughter channels. 

Official identification numbers for use 

on animals not in slaughter channels 

may only be assigned either directly to 

the owner of a breeding flock for 

application to animals that originated in 

a breeding flock owned by them or, in 

the case of official serial numbers or 

serial number devices, to APHIS or State 

representatives or accredited 

veterinarians or other responsible 

individuals as described in paragraphs 

(b)(2) and (3) of this section APHIS or 

State representatives may apply official 

identification to animals or issue official 

identification to owners of breeding 

flocks for application to animals in 

those flocks. APHIS and State personnel 

who apply or issue official 

identification must provide to APHIS, in 

a manner acceptable to APHIS, 

assignment data associating the serial 

numbers applied to animals or issued to 

owners, to the flock of origin and, when 

required, the flock of birth. Accredited 

veterinarians who apply official serial 

numbers or devices when requested by 

APHIS a must provide to APHIS, in a 

manner acceptable to APHIS, 

assignment data associating the serial 

sequences applied to animals to the 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11191 

flock of origin and, when required, the 

flock of birth. One such method would 

be to enter the data into the National 

Scrapie Database. Such requests may be 

made directly to a person or persons or 

to accredited veterinarians as a group 

through amendment of the Scrapie 

Program Standards Volume 1: National 

Scrapie Eradication Program. 

(2) Assignment of serial numbers. The 

official responsible for issuing eartags in 

a State may also assign serial numbers 

of official eartags to other responsible 

persons, such as 4–H leaders, if the 

State Animal Health Official and 

Veterinary Services, Field Operations, 

AVIC responsible for the State involved 

agree that such assignments will 

improve scrapie control and eradication 

within the State. Such persons assigned 

serial numbers may either directly apply 

eartags to animals, or may reassign 

eartag numbers to producers. Such 

persons must maintain appropriate 

records in accordance with paragraph 

(g) of this section that permit traceback 

of animals to their flock of origin, or 

flock of birth when required, and must 

either reassign the tags in the National 

Scrapie Database or, if permitted by the 

Veterinary Services, Field Operations, 

AVIC responsible for the State involved, 

provide a written record of the 

reassignment to the Field Office or the 

State Office for entry into the National 

Scrapie Database. 

(3) Persons handling sheep and goats 

in commerce. Sets of unique individual 

identification serial numbers may be 

assigned to persons who handle sheep 

and goats, that did not originate in a 

breeding flock owned by them, if they 

apply to and are approved by the State 

Animal Health Official or the Veterinary 

Services, Field Operations, AVIC 

responsible for the State in which the 

person maintains his or her business 

location, whichever is responsible for 

issuing official identification devices or 

numbers in that State and for assigning 

flock identification numbers and 

premises identification numbers in that 

State in the National Scrapie Database. 

When requested by APHIS, persons who 

apply official identification to sheep or 

goats that did not originate in a breeding 

flock owned by them must provide, in 

a manner acceptable to APHIS, 

assignment data associating assigned 

serial sequences to the flock of origin 

and, when required, the flock of birth. 

One such method would be to enter the 

data into the National Scrapie Database. 

The request may be made directly to a 

person or persons or to a class of 

persons through amendment of the 

Scrapie Program Standards Volume 1: 

National Scrapie Eradication Program. 

The State Animal Health Official or the 

Administrator may limit the assignment 

of official identification devices or 

numbers to persons, or classes of 

persons, for use on animals that did not 

originate in a breeding flock owned by 

them to slaughter only devices or 

numbers. 

(4) Breed registries. Sets of unique 

individual identification numbers may 

also be assigned by the Administrator to 

breed registries that agree to reassign the 

sequences to the flock of origin and, and 

when required, the flock of birth and to 

provide associated registry identifiers 

such as registry tattoo numbers to 

APHIS in the National Scrapie Database. 

(5) Noncompliance. In addition to any 

applicable criminal or civil penalties 

any person who fails to comply with the 

requirements of this section or that 

makes false statements in order to 

acquire official identification numbers 

or devices shall not be assigned official 

identification numbers or official 

identification devices for a period of at 

least 1 year. If a person who is not in 

compliance with these requirements has 

already been assigned such numbers, 

the Administrator may withdraw the 

assignment by giving notice to such 

person. Such withdrawal or failure to 

assign official identification numbers 

may be appealed in accordance with 

§ 79.4(c)(3). A person shall be subject to 

criminal and civil penalties if he or she 

continues to use assigned numbers that 

have been withdrawn from his or her 

use. 

(c) No person shall apply a premises 

or flock identification number or a 

brand or earnotch pattern to an animal 

that did not originate on the premises or 

flock to which the number was assigned 

by a State or APHIS representative or to 

which the brand or earnotch pattern has 

been assigned by an official brand 

registry. This includes individual 

identification such as USDA eartags that 

have been assigned to a premises or 

flock and registration tattoos that 

contain prefixes that have been assigned 

to a premises or flock for use as 

premises or flock identification. Unless 

the number sequence was issued 

specifically for use on animals born in 

a flock, this would not preclude the 

owner of a flock from using an official 

premises or flock identification number 

tag assigned to that flock on an animal 

owned by him or her that resides in that 

flock but that was born or previously 

resided on a different premises as long 

as the records required in paragraph (g) 

of this section are maintained. 

(d) No person shall sell or transfer an 

official identification device or number 

assigned to his or her premises or flock 

except when it is transferred with a 

sheep or goat to which it has been 

applied as official identification or as 

directed in writing by an APHIS or State 

representative. 

(e) No person shall use an official 

identification device or number 

provided for the identification of sheep 

and goats other than for the 

identification of a sheep or goat. 

(f) Persons who engage in the 

interstate commerce of animals 

including persons that handle or own 

animals that have been in interstate 

commerce or that purchase, acquire, 

sell, or dispose of sheep and/or goats 

from or to persons who engage in the 

interstate commerce of animals, whether 

or not the animals are required to be 

officially identified, must maintain 

business records (such as yarding 

receipts, sale tickets, invoices, and 

waybills) for 5 years. These persons 

must make the records available for 

inspection and copying by any 

authorized USDA or State representative 

upon that representative’s request and 

presentation of his or her official 

credentials. The records must include 

the following information: 

(1) The number of animals purchased 

or sold (or transferred without sale); 

(2) The date of purchase, sale, or other 

transfer; 

(3) The name and address of the 

person from whom the animals were 

purchased or otherwise acquired or to 

whom they were sold or otherwise 

transferred; 

(4) The species, breed, and class of 

animal. If breed is unknown, for sheep 

the face color and for goats the type 

(milk, fiber, or meat) must be recorded 

instead; 

(5) A copy of the brand inspection 

certificate for animals officially 

identified with brands or ear notches; 

(6) A copy of any certificate or owner/ 

hauler statement required for movement 

of the animals purchased, sold, or 

otherwise transferred; and 

(7) If the flock of origin or the 

receiving flock is under a flock plan or 

post-exposure management and 

monitoring plan, any additional records 

required by the plan. 

(g) Persons who apply official 

individual or group/lot identification to 

animals must maintain records for 5 

years. These persons must make the 

records available for inspection and 

copying by any authorized USDA or 

State representative upon that 

representative’s request and 

presentation of his or her official 

credentials. The records must include 

the following information: 

(1) The flock identification number of 

the flock of origin, the name and 

address of the person who currently 

owns the animals, and the name and 

11192 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

address of the owner of the flock of 

origin if different; 

(2) The name and address of the 

owner of the flock of birth, if known, for 

animals in another flock and not already 

identified to flock of birth; 

(3) The date the animals were 

officially identified; 

(4) The number of sheep and the 

number of goats identified; 

(5) The breed and class of the animals. 

If breed is unknown, for sheep the face 

color and for goats the type (milk, fiber, 

or meat) must be recorded instead; 

(6) The official identification numbers 

applied to animals by species or the GIN 

applied in the case of a group lot; 

(7) Whether the animals were 

identified with ‘‘Slaughter Only’’ or 

‘‘Meat’’ identification devices; and 

(8) Any GIN with which the animal 

was previously identified. 

(h) Official identification devices are 

intended to provide permanent 

identification of livestock and to ensure 

the ability to find the source of animal 

disease outbreaks. Removal of these 

devices, including devices applied to 

imported animals in their countries of 

origin and recognized by the 

Administrator as official, is prohibited 

except at the time of slaughter, at any 

other location upon the death of the 

animal, or as otherwise approved by the 

State or Tribal animal health official or 

the Veterinary Services, Field 

Operations, AVIC responsible for the 

State involved when a device needs to 

be replaced. 

(1) All man-made identification 

devices affixed to sheep or goats moved 

interstate must be removed at slaughter 

and correlated with the carcasses 

through final inspection by means 

approved by the Food Safety and 

Inspection Service (FSIS). If diagnostic 

samples, including whole heads, are 

taken, the identification devices must be 

packaged with the samples and must be 

left attached to approximately 1 inch of 

tissue or to the whole head to allow for 

identity testing and be correlated with 

the carcasses through final inspection 

by means approved by FSIS. Devices 

collected at slaughter must be made 

available to APHIS and FSIS. 

(2) All official identification devices 

affixed to sheep or goat carcasses moved 

interstate for rendering must be 

removed at the rendering facility and 

made available to APHIS. If diagnostic 

samples, including whole heads, are 

taken, the identification devices must be 

packaged with the samples and must be 

left attached to approximately 1 inch of 

tissue or to the whole head to allow for 

identity testing. 

(3) If a sheep or goat loses an official 

identification device except while in 

interstate commerce as described in 

paragraph (a)(3) of this section and 

needs a new one, the person applying 

the new official identification device 

must record the official identification 

number from the old device, if known, 

in addition to the information required 

to be recorded in accordance with 

paragraph (g) of this section. 

(i) Replacement of official 

identification devices for reasons other 

than loss include: 

(1) Circumstances under which a 

State or Tribal animal health official or 

the Veterinary Services, Field 

Operations, AVIC responsible for the 

State involved may authorize 

replacement of an official identification 

device include, but are not limited to: 

(i) Deterioration of the device such 

that loss of the device appears likely or 

the number can no longer be read; 

(ii) Infection at the site where the 

device is attached, necessitating 

application of a device at another 

location (e.g., a slightly different 

location of an eartag in the ear); 

(iii) Malfunction of the electronic 

component of a radio frequency 

identification (RFID) device; or 

(iv) Incompatibility or inoperability of 

the electronic component of an RFID 

device with the management system or 

unacceptable functionality of the 

management system due to use of an 

RFID device. 

(2) Any time an official identification 

device is replaced, as authorized by the 

State or Tribal animal health official or 

the Veterinary Services, Field 

Operations, AVIC responsible for the 

State involved, the person replacing the 

device must record the following 

information about the event and 

maintain the record for 5 years: 

(i) The date when the device was 

removed; 

(ii) The address of the location and 

the name, phone number and email 

address of the person responsible for the 

location where the device was removed; 

(iii) The official identification number 

(to the extent possible) on the device 

removed; 

(iv) The type of device removed (e.g., 

metal eartag, RFID eartag); 

(v) The reason for the removal of the 

device; 

(vi) The new official identification 

number on the replacement device; and 

(vii) The type of replacement device 

applied. 

(j) Beginning on April 24, 2019, no 

more than one official eartag may be 

applied to an animal; except that: 

(1) Another official eartag may be 

applied providing it bears the same 

official identification number as an 

existing one. 

(2) In specific cases when the need to 

maintain the identity of an animal is 

intensified (e.g., such as for export 

shipments, quarantined herds, field 

trials, experiments, or disease surveys), 

a State or Tribal animal health official 

or the Veterinary Services, Field 

Operations, AVIC responsible for the 

State involved may approve the 

application of a second official eartag. 

The person applying the second official 

eartag must record the following 

information about the event and 

maintain the record for 5 years: The date 

the second official eartag is added; the 

reason for the additional official eartag 

device; and the official identification 

numbers of both official eartags. 

(3) An eartag with an animal 

identification number (AIN) beginning 

with the 840 prefix (either radio 

frequency identification or visual-only 

tag) may be applied to an animal that is 

already officially identified with 

another eartag. The person applying the 

AIN eartag must record the date the AIN 

tag is added and the official 

identification numbers of all official 

eartags on the animal and must 

maintain those records for 5 years. 

(4) An official eartag that utilizes a 

flock identification number may be 

applied to a sheep or goat that is already 

officially identified with an official 

eartag if the animal has resided in the 

flock to which the flock identification 

number is assigned. 

(k) Requirements for approval of 

official identification devices include: 

(1) The Administrator may approve 

companies to produce official 

identification devices for use on sheep 

or goats. Devices may be plastic, metal, 

or other suitable materials and must be 

an appropriate size for use in sheep and 

goats. Devices must be able to legibly 

accommodate the required 

alphanumeric sequences. Devices must 

resist removal and be difficult to place 

on another animal once removed unless 

the construction of the device makes 

such tampering evident, but need not be 

tamper-proof. Devices must be readily 

distinguishable as USDA official sheep 

and goat identification devices; must 

carry the alphanumeric sequences, 

symbols, or logos specified by APHIS; 

must be an allowed color for the 

intended use, and must have a means of 

discouraging counterfeiting, such as use 

of a unique copyrighted logo or trade 

mark. Devices for use only on animals 

in slaughter channels must be medium 

blue and marked with the words ‘‘Meat’’ 

or ‘‘Slaughter Only’’. Devices that use 

RFID must conform to ISO 11784 and 

ISO 11785 standards unless otherwise 

approved. The Administrator may 

specify the color, shape or size of a 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11193 

5 You need not identify an animal to its flock of 

birth or its flock of origin if this information is 

unknown because the animal changed ownership 

while it was exempted from flock of origin 

identification requirements in accordance with 

§ 79.6(a)(10)(i). Such animals may be moved 

interstate with individual animal identification that 

is only traceable to the State of origin and to the 

owner of the animals at the time they were so 

identified. To use this exemption the person 

applying the identification must have supporting 

documentation indicating that the animals were 

born and had resided throughout their life in the 

State. 

device for an intended use to make them 

readily identifiable. 

(2) Written requests for approval of 

official identification devices for sheep 

and goats should be sent to the National 

Scrapie Program Coordinator, Strategy 

and Policy, VS, APHIS, 4700 River Road 

Unit 43, Riverdale, MD 20737–1235. 

The request must include: 

(i) The materials used in the device 

and in the case of RFID the transponder 

type and data regarding the lifespan and 

read range. 

(ii) Any available data regarding the 

durability of the device, durability and 

legibility of the identification numbers, 

rate of adverse reactions such as ear 

infections, and retention rates of the 

devices in animals, preferably sheep 

and/or goats. 

(iii) A signed statement agreeing to: 

(A) Send official identification 

devices only to a State or APHIS 

representative, to the owner of a 

premises or to the contact person for a 

premises at the address listed in the 

National Scrapie Database, or as 

directed by APHIS; 

(B) When requested by APHIS, 

provide a report by State of all tags 

produced, including the tag sequences 

produced and the name and address of 

the person to whom the tags were 

shipped, and provide supplemental 

reports of this information when 

requested by APHIS; 

(C) Maintain the security and 

confidentiality of all tag recipient 

information acquired as a result of being 

an approved tag manufacturer and 

utilize the information only to provide 

official identification tags; and 

(D) Enter the sequences of tags 

shipped in the National Scrapie 

Database through an internet web page 

interface or other means specified by 

APHIS prior to shipping the 

identification device. 

(iv) Twenty-five sample devices. 

Additional tags must be submitted if 

requested by APHIS. 

(3) Approval will only be given for 

devices for which data have been 

provided supporting high legibility, 

readability (visual and RFID), and 

retention rates in sheep and goats that 

minimize injury throughout their 

lifespan, or for which there is a 

reasonable expectation of such 

performance. Approval to produce 

official identification devices will be 

valid for 1 year and must be renewed 

annually. The Administrator may grant 

provisional approval to produce devices 

for periods of less than 1 year in cases 

where there is limited or incomplete 

data. The Administrator may decline to 

renew a company’s approval or suspend 

or withdraw approval if the devices do 

not show adequate retention and 

durability or cause injury in field use or 

if any of the requirements of this section 

are not met by the tag company. 

Companies shall be given 60 days’ 

written notice of intent to withdraw 

approval. Any person who is approved 

to produce official identification tags in 

accordance with this section and who 

knowingly produces tags that are not in 

compliance with the requirements of 

this section, and any person who is not 

approved to produce such tags but does 

so, shall be subject to such civil 

penalties and such criminal liabilities as 

are provided by 18 U.S.C. 1001, 7 U.S.C. 

8313, or other applicable Federal 

statutes. Such action may be in addition 

to, or in lieu of, withdrawal of approval 

to produce tags. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0101 

and 0579–0469) 

■ 17. Section 79.3 is revised to read as 

follows: 

§ 79.3 General restrictions. 

The following prohibitions and 

movement conditions apply to the 

movement of or commingling with 

sheep and goats in interstate commerce, 

and no sheep or goat may be sold, 

disposed of, acquired, exhibited, 

transported, received for transportation, 

offered for sale or transportation, 

loaded, unloaded, or otherwise handled 

in interstate commerce, or commingled 

with such animals, or be loaded or 

unloaded at a premises or animal 

concentration point (including premises 

that exhibit animals) where animals are 

received that have been in interstate 

commerce or from which animals are 

moved in interstate commerce except in 

compliance with this part. 

(a) No sexually intact animal of any 

age or castrated animal 18 months of age 

and older (as evidenced by the eruption 

of the second incisor) may be moved or 

commingled with animals in interstate 

commerce unless it is individually 

identified to its flock of birth 5 and is 

accompanied by an ICVI, except that an 

ICVI is not required unless the animal 

is moved across a State line, and except 

for the following, which may move with 

group lot identification and an owner/ 

hauler statement: 

(1) Animals in slaughter channels that 

are under 18 months of age (as 

evidenced by the eruption of the second 

incisor); 

(2) Animals in slaughter channels at 

18 months and older (as evidenced by 

the eruption of the second incisor) if the 

animals were kept as a group on the 

same premises on which they were born 

and have not been maintained in the 

same enclosure with unidentified 

animals from another flock at any time, 

including throughout the feeding, 

marketing, and slaughter process; 

(3) An owner/hauler statement may be 

used instead of an ICVI for mixed source 

animals in slaughter channels 18 

months of age and older (as evidenced 

by the eruption of the second incisor) 

that are identified with official 

individual identification or in the case 

of animals from flocks that are low-risk 

commercial flocks that are identified 

using identification methods or devices 

approved for this purpose; 

(4) Animals moving for grazing or 

other management purposes between 

two premises both owned or leased by 

the flock owner and recorded in the 

National Scrapie Database as additional 

flock premises and where commingling 

will not occur with unidentified 

animals that were born in another flock 

or any animal that is not part of the 

flock. A request to APHIS to enter 

additional flock premises in the 

National Scrapie Database is required 

before animals are first moved to the 

premises. Notification is not required 

for each subsequent movement of 

animals to that premises. Neither group 

lot ID nor an owner/hauler statement is 

required for movements of a flock or its 

members for flock management 

purposes within a contiguous premises 

spanning two or more States. This 

provision does not include the 

transiting or sale of animals through 

such a premises in circumvention of the 

other requirements of this part; and 

(5) Animals moving to a livestock 

facility approved in accordance with 

§ 71.20 of this subchapter and that has 

agreed to act as an agent for the owner 

to apply official identification if the 

animals have been in the same flock in 

which they were born and have not 

been maintained in the same enclosure 

with unidentified animals born in 

another flock at any time. Such facilities 

may identify animals after sale if the 

facility maintains unidentified animals 

from different flocks of origin or when 

required birth in separate enclosures 

until officially identified. 

(b) No scrapie-positive or suspect 

animal may be moved other than by 

11194 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

permit to an APHIS approved research 

or quarantine facility or for destruction 

under APHIS or State supervision. Such 

animals must be individually identified 

and listed on the permit. 

(c) No indemnified high-risk animal 

or indemnified sexually intact 

genetically susceptible exposed animal 

may be moved other than by permit to 

an APHIS approved research or 

quarantine facility or for destruction at 

another site. Such animals that are not 

indemnified and are not scrapie-positive 

or suspect animals may be moved to 

slaughter under permit. Animals moved 

in accordance with this paragraph must 

be individually identified and listed on 

the permit. 

(d) No exposed animal may be moved 

unless it is officially individually 

identified. 

(e) No animal may be moved from an 

infected flock or source flock except as 

allowed by an approved flock plan. 

(f) No animal may be moved from an 

exposed flock, a flock under 

investigation or a flock subject to a 

PEMMP except as allowed in a PEMMP 

or where a PEMMP is not required, as 

allowed by written instructions from an 

APHIS or State representative. 

(g) Animals moved to slaughter: 

(1) Once an animal enters slaughter 

channels the animal may not be 

removed from slaughter channels. An 

animal is in slaughter channels if it was 

sold through a restricted animal sale, 

resided in a terminal feedlot, was sold 

with a bill of sale marked for slaughter 

only, was identified with an 

identification device or tattoo marked 

‘‘Slaughter Only’’ or ‘‘MEAT’’ or was 

moved in a manner not permitted for 

other classes of animals. Animals in 

slaughter channels may move either 

directly to a slaughter establishment 

that is under Food Safety and Inspection 

Service (FSIS) jurisdiction per the 

Federal Meat Inspection Act (FMIA) or 

under State inspection that FSIS has 

recognized as at least equal to Federal 

inspection or to a custom exempt 

slaughter establishment as defined by 

FSIS (9 CFR 303.1) for immediate 

slaughter or to an individual for 

immediate slaughter for personal use or 

to a terminal feedlot, or may move 

indirectly to such a destination through 

a restricted animal sale or restricted 

livestock facility. Once an animal has 

entered slaughter channels it may only 

be officially identified with an official 

blue eartag marked with the words 

‘‘Meat’’ or ‘‘Slaughter Only’’ or an ear 

tattoo reading ‘‘Meat.’’ Animals in 

slaughter channels must be 

accompanied by an owner/hauler 

statement. The statement must also 

include the name and address of the 

person or livestock facility from which 

and where they were acquired, if 

different from the owner; the slaughter 

establishment, restricted animal sale, 

restricted livestock facility or terminal 

feedlot to which they are being moved, 

and a statement that the animals are in 

slaughter channels. A copy of the 

owner/hauler statement must be 

provided to the slaughter establishment, 

restricted animal sale, restricted 

livestock facility or terminal feedlot to 

which the animals are moved. Any bill 

of sale regarding the animals must 

indicate that the animals were sold for 

slaughter only. 

(2) Animals that were in slaughter 

channels before arriving at a sale and 

animals that cannot meet the ID and 

ICVI requirements for unrestricted 

movement prior to leaving a sale may 

not be sold at an unrestricted sale. This 

does not preclude animals sold at an 

unrestricted sale from being moved in 

slaughter channels after sale if 

identified as required for animals in 

slaughter channels. 

(3) Animals in slaughter channels 

may not be held in the same enclosure 

with sexually intact animals from 

another flock of origin that are not in 

slaughter channels. 

(h) No animals designated for testing 

as part of a classification or 

reclassification investigation may be 

moved until testing is completed and 

results reported, except for movement 

by permit for testing, slaughter, 

research, or destruction. Such animals 

must be individually identified and 

listed on the permit. 

(i) The following animals, if not 

restricted as part of a flock plan or 

PEMMP, may be moved to any 

destination without further restriction 

after being officially identified and 

designated or redesignated by a DSE to 

be: 

(1) Genetically resistant exposed 

sheep; 

(2) Genetically less susceptible 

exposed sheep; or 

(3) Low-risk exposed animals. 

(j) Animals moved from Inconsistent 

States must meet the following 

requirements in addition to other 

requirements of this section. 

(1) Sheep and goats not in slaughter 

channels must be enrolled in the 

Scrapie Free Flock Certification Program 

or an equivalent APHIS recognized 

program or be sheep that are officially 

genotyped and determined to be AA QR 

or AA RR, be officially identified, and 

be accompanied by an ICVI that also 

states the individual animal 

identification numbers, the flock of 

origin, and the flock of birth, if different. 

(2) Animals in slaughter channels 

must be officially identified with an 

official blue eartag marked with the 

words ‘‘Meat’’ or ‘‘Slaughter Only’’ and 

may move only directly to slaughter or 

to a terminal feedlot. Animals 18 

months of age and older (as evidenced 

by the eruption of the second incisor) in 

slaughter channels must also be 

accompanied by an ICVI that states the 

individual animal identification 

numbers, and the flock of birth (and the 

flock of origin, if different). 

(k) APHIS may enter into compliance 

agreements with persons such as dealers 

and owners of slaughter establishments 

and markets whereby animals may be 

received unidentified or without a 

required owner/hauler statement even if 

they cannot be identified to their flock 

of birth or origin because they were 

moved or commingled while 

unidentified, in violation of this part or 

a State requirement as provided by 

§ 79.6. Provided that, the agreement 

requires the person signing the 

agreement to report the violation to the 

Veterinary Services, Field Operations, 

AVIC responsible for the State involved 

so that corrective action can be taken 

against the principal violator. In such 

cases the animal must be identified with 

a slaughter only tag, and is moved only 

in slaughter channels or, in the case of 

sheep, moved for other purposes if the 

animal is inspected by an accredited 

veterinarian, found free of evidence of 

infectious or contagious disease, and 

officially genotyped as AA QR or AA RR 

where Q and R refer to codon 171 and 

A refers to codon 136. APHIS may also 

enter into compliance agreements with 

persons or in the case of approved 

livestock facilities may amend an 

approved livestock facility agreement to 

establish alternative methods to 

maintain the traceability of animals in 

slaughter channels to their flock of 

origin or waive the requirement for 

individual official identification of 

animals in slaughter channels if 

adequate surveillance has been 

conducted on the flock of origin or an 

alternative plan is in place to conduct 

surveillance on animals from the flock 

of origin when the Administrator and 

the State Animal Health Official agree 

that the application of an allowed 

official identification device or method 

is unsuitable for a specific 

circumstance. An example of a specific 

circumstance could be large unruly 

horned male goats moving through 

approved livestock facilities. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0101 

and 0579–0469) 

Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 11195 

■ 18. Section 79.4 is revised to read as 

follows: 

§ 79.4 Designation of scrapie-positive 

animals, high-risk animals, exposed 

animals, suspect animals, exposed flocks, 

infected flocks, noncompliant flocks, and 

source flocks; notice to owners. 

(a) Designation. Based on a 

classification investigation as defined in 

§ 79.1, including testing of animals, if 

needed, a designated scrapie 

epidemiologist will designate a flock to 

be an exposed flock, an infected flock, 

a source flock, a flock under 

investigation, and/or a non-compliant 

flock, or designate an animal to be a 

scrapie-positive animal, high-risk 

animal, exposed animal, genetically 

susceptible exposed animal, genetically 

resistant exposed sheep, genetically less 

susceptible exposed sheep, low-risk 

exposed animal, and/or a suspect 

animal after determining that the flock 

or animal meets the criteria of the 

relevant definition in § 79.1. 

(b) Redesignation. A reclassification 

investigation as defined in § 79.1 may be 

conducted to determine whether the 

current designated status of a flock or 

animal may be changed or removed. 

Reclassification investigations will be 

initiated and conducted, and 

redesignation decisions will be made, in 

accordance with procedures approved 

by the Administrator. These procedures 

are available at http://

www.aphis.usda.gov/animal-health/ 

scrapie. 

(c) Testing and notification 

procedures. Any animal that may be a 

high-risk animal, any animal that may 

have been exposed to the lambing of a 

high-risk animal, any suspect animal, 

and any animal that was born in the 

flock after a high-risk animal may have 

lambed may be selected for testing by 

the DSE or an APHIS or State 

representative working under the 

direction of a DSE or the Administrator. 

Which animals are selected and the 

method of testing selected animals will 

be based on the risk associated with the 

flock and the type and number of 

animals available for test. When flock 

records are adequate to determine that 

all high-risk animals that lambed in the 

flock are available for testing, the testing 

may be limited to postmortem testing of 

all high-risk and suspect animals. 

Testing may also include an official 

genotype test, live-animal testing using 

a live-animal official test, the 

postmortem examination and testing of 

genetically susceptible animals in the 

flock that cannot be evaluated by a live 

animal test, postmortem examination of 

other animals, and postmortem 

examination and testing of animals 

found dead or cull animals at slaughter. 

Animals may not be tested for scrapie to 

establish the designation of the flock 

until they are test eligible. Animals are 

generally considered test eligible when 

the animals are over 14 months of age 

if born after the exposure or are 18 

months post exposure. If testing these 

animals is necessary to establish the 

status of a flock they must be held for 

later testing unless sent directly to 

slaughter or a terminal feedlot. 

(1) Noncooperation. If an owner does 

not make his or her animals available 

for testing within 60 days of notification 

by an APHIS or State representative, 

within 60 days of becoming test eligible, 

or as mutually agreed in writing by the 

Administrator and the owner, or fails to 

submit required postmortem samples, 

the flock will be designated a source, 

infected, or exposed flock, whichever 

definition applies and a noncompliant 

flock. 

(2) Notice to owner. As soon as 

possible after making a designation or 

redesignation determination, a State or 

APHIS representative will attempt to 

notify the owner(s) of the flock(s) or 

animal(s) in writing of the designation. 

(3) Appeal. The owner of an animal 

may appeal the designation of an animal 

as a scrapie-positive animal, high-risk 

animal, exposed animal, genetically 

susceptible exposed animal, genetically 

resistant exposed sheep, genetically less 

susceptible exposed sheep, low-risk 

exposed animal, or a suspect animal. 

The owner of a flock may appeal the 

designation of the flock as an exposed 

flock, an infected flock, a source flock, 

a flock under investigation, or a noncompliant flock. The owner of a 

laboratory or test manufacturing facility 

may appeal the suspension or 

withdrawal of approval for a laboratory 

or a test. To do so, the owner must 

appeal by writing to the Administrator 

within 10 days after being informed of 

the reasons for the proposed action. The 

appeal must include all of the facts and 

reasons upon which the owner relies to 

show that the proposed action is 

incorrect or is not supported. The 

Administrator will grant or deny the 

appeal in writing as promptly as 

circumstances permit, stating the reason 

for his or her decision. If there is a 

conflict as to any material fact, a hearing 

will be held to resolve the conflict. 

Rules of practice concerning the hearing 

will be adopted by the Administrator. 

The action under appeal shall continue 

in effect pending the final determination 

of the Administrator, unless otherwise 

ordered by the Administrator. The final 

determination of the Administrator shall 

become effective upon oral or written 

notification, whichever is earlier, to the 

owner. In the event of oral notification, 

written confirmation shall be given as 

promptly as circumstances allow. The 

Administrator’s final determination 

constitutes final agency action. 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

■ 19. Section 79.5 is revised as follows: 

§ 79.5 Issuance of Interstate Certificates of 

Veterinary Inspection (ICVI). 

(a) ICVIs are required as specified by 

§ 79.3 for certain interstate movements 

of sheep or goats and may be used to 

meet the requirements for entry into 

terminal feedlots. An ICVI and all 

copies must be legible and must show 

the following information, except when 

§ 79.3 states that the information is not 

required for the specific type of 

interstate movement: 

(1) The ICVI must show the species, 

breed or, if breed is unknown, the face 

color of sheep or the type of goats (milk, 

fiber, or meat), and class of animal, such 

as replacement ewe lambs, slaughter 

lambs or kids, cull ewes, club lambs, 

bred ewes, etc.; the number of animals 

covered by the ICVI; the purpose for 

which the animals are to be moved; the 

address at which the animals were 

loaded for interstate movement or for 

movement to a terminal feedlot when an 

ICVI is required; the address to which 

the animals are destined; and the names 

of the consignor and the consignee and 

their addresses if different from the 

address at which the animals were 

loaded or the address to which the 

animals are destined; and if different the 

current owner; 

(2) Each animal’s official individual 

identification numbers: Provided, that, 

in the case of animals identified with 

official identifications devices or 

methods that include the flock 

identification number(s) assigned to the 

flock(s) of origin in the National Scrapie 

Database and an individual animal 

number unique within the flock, the 

flock identification number(s) may be 

recorded instead of the individual 

identification numbers, and for animals 

allowed by § 79.3 to move with group 

lot identification, the group lot number 

may be recorded instead of the 

individual identification numbers. An 

ICVI may not be issued for any animal 

that is not officially identified if official 

identification is required. If the animals 

are not required by the regulations to be 

officially identified, the ICVI must state 

the exemption that applies (e.g., sheep 

and goats moving for grazing without 

change of ownership). If the animals are 

required to be officially identified but 

the identification number is not 

required to be recorded on the ICVI, the 

ICVI must state that all animals to be 

11196 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 

moved under the ICVI are officially 

identified and state the exemption that 

applies (e.g. the ewes are identified with 

flock of origin tags so only the flock ID 

must be recorded on the ICVI); and 

(3) A statement by the issuing 

accredited, State, or Federal veterinarian 

to the effect that on the date of issuance 

the animals were free of evidence of 

infectious or contagious disease and 

insofar as can be determined exposure 

thereto. This statement may be made 

with respect to scrapie for animals 

exposed to scrapie that’s movement is 

not restricted that have been designated 

genetically resistant or less susceptible 

sheep or low-risk exposed animals. 

Except as provided in paragraphs (b) 

and (c) of this section, all information 

required by this paragraph must be 

typed or legibly written on the ICVI. 

Note that in accordance with paragraphs 

(a), (b), and (e) of § 79.3, scrapiepositive, suspect, and high-risk animals, 

some exposed animals, and some 

animals that originated in an infected or 

source flock require permits rather than 

ICVIs. 

(4) The ICVI must be signed by the 

issuing State, Federal, Tribal or 

accredited veterinarian and must be 

legible on all copies. 

(b) As an alternative to typing or 

writing individual animal identification 

on an ICVI, if agreed to by the receiving 

State or Tribe, another document may 

be used to provide this information, but 

only under the following conditions: 

(1) The document must be a State 

form or APHIS form that requires 

individual identification of animals or a 

printout of official identification 

numbers generated by computer or other 

means; 

(2) A legible copy of the document 

must be stapled to the original and each 

copy of the ICVI; 

(3) Each copy of the document must 

identify each animal to be moved with 

the ICVI, but any information pertaining 

to other animals, and any unused space 

on the document for recording animal 

identification, must be crossed out in 

ink; and 

(4) The following information must be 

written in ink in the identification 

column on the original and each copy 

of the ICVI and must be circled or 

boxed, also in ink, so that no additional 

information can be added: 

(i) The name of the document; and 

(ii) Either the unique serial number on 

the document or, if the document is not 

imprinted with a serial number, both 

the name of the person who prepared 

the document and the date the 

document was signed. 

(c) Ownership brands documents 

attached to ICVIs. As an alternative to 

typing or writing ownership brands on 

an ICVI, an official brand inspection 

certificate may be used to provide this 

information, but only under the 

following conditions: 

(1) A legible copy of the official brand 

inspection certificate must be stapled to 

the original and each copy of the ICVI; 

(2) Each copy of the official brand 

inspection certificate must show the 

ownership brand of each animal to be 

moved with the ICVI, but any other 

ownership brands, and any unused 

space for recording ownership brands, 

must be crossed out in ink; and 

(3) The following information must be 

typed or written in ink in the official 

identification column on the original 

and each copy of the ICVI and must be 

circled or boxed, also in ink, so that no 

additional information can be added: 

(i) The name of the attached 

document; and 

(ii) Either the serial number on the 

official brand inspection certificate or, if 

the official brand inspection certificate 

is not imprinted with a serial number, 

both the name of the person who 

prepared the official brand inspection 

certificate and the date it was signed. 

(d) If more than one page is used each 

page must be sequentially numbered 

with the page number and the total 

number of pages (for example 1 of 2, 2 

of 2). 

(Approved by the Office of Management and 

Budget under control numbers 0579–0101 

and 0579–0469) 

■ 20. Section 79.6 is amended as 

follows: 

■ a. In paragraph (a) introductory text by 

adding the words ‘‘, including scrapie 

surveillance activities,’’ after the words 

‘‘control activities’’; 

■ b. By redesignating paragraphs 

(a)(10)(i) through (vi) as paragraphs 

(a)(12) through (a)(17), respectively, and 

by revising paragraph (a)(10); 

■ c. By adding paragraph (a)(11); 

■ d. In paragraph (b), by adding the 

words ‘‘from the date the State is 

notified of the deficiency’’ after the 

words ‘‘2-year extension’’; 

■ e. By adding paragraph (c); and 

■ f. By adding an OMB citation at the 

end of the section. 

The revision and additions read as 

follows: 

§ 79.6 Standards for States to qualify as 

Consistent States. 

(a) * * * 

(10) Has effectively implemented 

ongoing scrapie surveillance that meets 

the following criteria: 

(i) Collects and submits surveillance 

samples from targeted animals 

slaughtered in State-inspected 

establishments and from slaughter 

establishments within the State that are 

not covered under § 71.21 of this 

subchapter, or allows and facilitates the 

collection of such samples by USDA 

personnel or contractors; and 

(ii) Transmits required submission 

and epidemiological information for all 

scrapie samples using the electronic 

submission system provided by APHIS 

for inclusion in the National Scrapie 

Database and for transmission of the 

submission information to an approved 

laboratory; and 

(iii) Achieves the annual State-level 

scrapie surveillance minimums for 

sheep and goats originating from the 

State as determined annually by the 

Administrator with input from the 

States and made available to the public 

at http://www.aphis.usda.gov/animalhealth/scrapie at least 6 months before 

the start of the collection period; or 

(iv) Conducts annual surveillance at a 

level that will detect scrapie if it is 

present at a prevalence of 0.1 percent in 

the population of targeted animals 

originating in the State, with a 95 

percent confidence. 

(11) If a State does not meet the 

requirements of paragraph (a)(10) of this 

section as of April 24, 2019, the State 

must provide APHIS with a plan and a 

timeline for complying with all the 

requirements of paragraph (a)(10) by 

April 24, 2020, and must meet the 

requirements of paragraph (a)(10) of this 

section by April 26, 2021. 

* * * * * 

(c) When the Administrator 

determines that a State should be added 

to or removed from the list of Consistent 

States, APHIS will publish a notice in 

the Federal Register advising the public 

of the Administrator’s determination, 

providing the reasons for that 

determination, and soliciting public 

comments. After considering any 

comments we receive, APHIS will 

publish a second notice either advising 

the public that the Administrator has 

decided to add or remove theState from 

the list of Consistent States or notifying 

the public that the Administrator has 

decided not to make any changes to the 

list of Consistent States, depending on 

the information presented in the 

comments. 

(Approved by the Office of Management and 

Budget under control number 0579–0101) 

Done in Washington, DC, this 15th day of 

March 2019. 

Greg Ibach, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. 2019–05430 Filed 3–22–19; 8:45 am] 

BILLING CODE 3410–34–P