This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

14495 

Vol. 74, No. 60 

Tuesday, March 31, 2009 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 55 and 81 

[Docket No. 00–108–7] 

RIN 0579–AB35 

Chronic Wasting Disease Herd 

Certification Program and Interstate 

Movement of Farmed or Captive Deer, 

Elk, and Moose 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing further 

amendments that would establish a herd 

certification program to eliminate 

chronic wasting disease from farmed or 

captive cervids in the United States. 

Under the 2006 Chronic Wasting 

Disease (CWD) rule, participating deer, 

elk, and moose herds would have to 

follow CWD Herd Certification Program 

requirements for animal identification, 

testing, herd management, and 

movement of animals into and from 

herds. This document proposes 

additional changes to the program 

regarding recognition of State bans on 

the entry of farmed or captive cervids 

for reasons unrelated to CWD, the 

number of years an animal must be 

monitored for CWD before it may move 

interstate, interstate movement of 

cervids that originated from herds in 

proximity to a CWD outbreak, herd 

inventory procedures, and several other 

matters. These actions are intended to 

help eliminate CWD from the farmed or 

captive cervid herds in the United 

States. 

DATES: We will consider all comments 

that we receive on or before June 1, 

2009. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS– 

2006–0118 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. 00–108–7, Regulatory 

Analysis and Development, PPD, 

APHIS, Station 3A–03.8, 4700 River 

Road Unit 118, Riverdale, MD 20737– 

1238. Please state that your comment 

refers to Docket No. 00–108–7. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

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

FOR FURTHER INFORMATION CONTACT: Dr. 

Dean E. Goeldner, Senior Staff 

Veterinarian, Ruminant Health 

Programs, VS, APHIS, 4700 River Road 

Unit 43, Riverdale, MD 20737–1231; 

(301) 734–4916. 

SUPPLEMENTARY INFORMATION: 

Background 

Chronic wasting disease (CWD) is a 

transmissible spongiform 

encephalopathy (TSE) of cervids 

(members of Cervidae, the deer family) 

that, as of October, 2008, has been found 

only in wild and captive animals in 

North America and in captive animals 

in the Republic of Korea. First 

recognized as a clinical ‘‘wasting’’ 

syndrome in 1967, the disease is 

typified by chronic weight loss leading 

to death. There is no known 

relationship between CWD and any 

other TSE of animals or people. Species 

known to be susceptible to CWD via 

natural routes of transmission include 

Rocky Mountain elk, mule deer, whitetailed deer, black-tailed deer, and 

moose. 

In the United States, CWD has been 

confirmed in free-ranging deer and elk 

in Colorado, Illinois, Kansas, Nebraska, 

New Mexico, New York, South Dakota, 

Utah, West Virginia, Wisconsin, and 

Wyoming, and, as of October 2008, in 32 

farmed elk herds and 11 farmed or 

captive white-tailed deer herds in 

Colorado, Kansas, Michigan, Minnesota, 

Montana, Nebraska, New York, 

Oklahoma, South Dakota, and 

Wisconsin. The disease was first 

detected in U.S. farmed elk in 1997. It 

was also diagnosed in a wild moose in 

Colorado in 2005. 

Under the Animal Health Protection 

Act (7 U.S.C. 8301 et seq.), the Secretary 

of Agriculture has the authority to issue 

orders and promulgate regulations to 

prevent the introduction into the United 

States and the dissemination within the 

United States of any pest or disease of 

livestock. The Animal and Plant Health 

Inspection Service’s (APHIS’) 

regulations in 9 CFR subchapter B 

govern cooperative programs to control 

and eradicate communicable diseases of 

livestock. 

On July 21, 2006, we published a final 

rule in the Federal Register (71 FR 

41682, Docket No. 00–108–3; ‘‘the CWD 

final rule’’) amending 9 CFR subchapter 

B by establishing regulations in part 55 

for a Chronic Wasting Disease Herd 

Certification Program to help eliminate 

chronic wasting disease (CWD) from the 

farmed or captive cervid herds in the 

United States. Under that rule, owners 

of deer, elk, and moose herds who 

choose to participate would have to 

follow the program requirements of a 

cooperative State-Federal program for 

animal identification, testing, herd 

management, and movement of animals 

into and from herds. The CWD final rule 

also amended 9 CFR subchapter C by 

establishing a new part 81 containing 

interstate movement requirements to 

prevent the spread of CWD. 

After publication of the CWD final 

rule, but before its effective date, APHIS 

received three petitions requesting 

reconsideration of several requirements 

of the rule. On September 8, 2006, we 

published a notice in the Federal 

Register (71 FR 52983, Docket No. 00– 

108–4) that delayed the effective date of 

the CWD final rule while APHIS 

considered those petitions. On 

November 3, 2006, we published 

another notice in the Federal Register 

(71 FR 64650–64651, Docket No. 00– 

108–5) that described the nature of the 

petitions and made the petitions 

available for public review and 

comment, with a comment period 

closing date of December 4, 2006. We 

subsequently extended that comment 


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1For interstate movement requirements for 

cervids and other animals with respect to these 

diseases, see 9 CFR part 77 for tuberculosis, 9 CFR 

part 78 for brucellosis, and 9 CFR part 81 for CWD. 

period until January 3, 2007, in a 

Federal Register notice published on 

November 21, 2006 (71 FR 67313, 

Docket No. 00–108–6). 

We received 77 comments by that 

date. They were from cervid producer 

associations, individual cervid 

producers, State animal health agencies, 

State wildlife agencies, and others. 

We have carefully considered the 

merits of the petitions and of the public 

comments received in response to them. 

We believe that the petitioners and 

commenters identified several areas 

where the CWD final rule could be more 

effective or less burdensome, and we 

believe the CWD final rule could be 

improved by making several changes to 

its requirements. We are therefore 

proposing certain changes to the CWD 

final rule, described below. We plan to 

withdraw the 2006 CWD final rule 

published on July 21, 2006 and issue a 

revised final rule based on this proposal 

and on the CWD final rule, after 

evaluating public comments on this 

proposal. 

Reconciling Federal and State 

Requirements for the Interstate 

Movement of Captive Cervids 

One goal of the CWD final rule was 

to provide a consistent, nationwide 

standard for the interstate movement of 

cervids, when such animals are allowed 

to move in interstate commerce. For that 

reason, the CWD final rule provided a 

single set of CWD requirements to 

follow when moving cervids interstate. 

These requirements, developed with 

input from States and producers, were 

meant to standardize a variety of 

differing CWD requirements and 

restrictions imposed by States that 

regulate the entry of cervids from other 

States. For example, different States 

have different requirements for how 

long a cervid must have been in a herd 

subject to CWD monitoring in order to 

move, and different requirements for the 

type of animal identification required 

for cervids moving interstate. 

APHIS continues to believe that the 

Federal CWD regulations should 

provide a consistent, nationwide set of 

requirements designed to address CWD 

risk for cervids that move interstate. 

Where the Federal CWD final rule 

establishes a standard for a particular 

aspect of interstate movement of 

cervids—identification requirements, 

for example—the requirement in the 

Federal CWD final rule will preempt 

any inconsistent State requirement. 

However, as the petitions and several 

comments on the petitions stated, the 

CWD final rule did not clearly resolve 

the issue of whether a State has 

authority to ban the movement of any 

farmed or captive cervids into the State 

due to reasons other than CWD risks. 

APHIS has sought and received 

further information from States on the 

nature of their State CWD regulations 

and the reasons States have determined 

such requirements to be necessary. In 

States that allow farmed or captive 

cervids from other States to enter under 

restrictions, rather than prohibiting their 

entry entirely, we found that the 

purpose of the CWD restrictions and the 

methods they employed were similar to 

the purpose and methods of the CWD 

final rule. In almost all cases, we believe 

that the requirements in the FederalState cooperative CWD final rule will 

achieve the State goal of allowing 

interstate movement of farmed or 

captive cervids under conditions 

sufficient to prevent the spread of CWD. 

In one case, discussed in the next 

section of this document titled 

‘‘Monitoring Period Required to Move 

Cervids Interstate,’’ we believe the 

‘‘monitoring period’’ requirement 

currently employed by some States is 

superior to the requirement in the CWD 

final rule, and accordingly we propose 

to revise the CWD final rule with 

respect to the length of time a farmed or 

captive cervid moved interstate must 

have spent in an approved CWD herd 

certification program, and thus the 

length of time it has been subject to 

monitoring for CWD and other herd 

requirements. 

However, in the course of considering 

the petitions and comments on them, 

APHIS has found that a number of 

States prohibit the entry of farmed or 

captive cervids for a variety of reasons, 

and to control a variety of risks, which 

are unrelated to CWD. State-imposed 

bans on the movement of cervids that 

are unrelated to CWD risks will not be 

affected by the CWD final rule. While 

Federal CWD requirements preempt 

State CWD requirements when interstate 

movement of cervids is allowed, we do 

not believe it is necessary to preempt 

State laws or regulations that prohibit 

the entry of farmed or captive cervids 

for other reasons when States have 

articulated sound reasons for such bans. 

This would include a State that bans 

entry of cervids because the State does 

not have or is phasing out a farmed or 

captive cervid industry and States that 

impose restrictions to address diseases 

for which APHIS does not prohibit or 

restrict interstate movement. 

Some States that ban the entry of 

farmed or captive cervids have cited 

concerns about the potential spread of 

CWD, brucellosis, and tuberculosis as 

one reason for the bans. This is not, in 

the agency’s view, a persuasive reason 

to maintain a ban, because Federal 

regulations1 are specifically designed to 

allow the interstate movement of 

cervids without disseminating these 

diseases. We believe that the proposed 

Federal CWD requirements would be 

effective and, if finalized, would 

preempt conflicting State requirements. 

However, States also cite other reasons 

for their bans on the entry of farmed or 

captive cervids, such as risks from a 

number of diseases and parasites 

associated with cervids. Excluding 

examples for which there are already 

mandatory Federal testing or interstate 

movement requirements, the diseases 

and parasites that support the need for 

a ban in some States include epizootic 

hemorrhagic disease/bluetongue, 

Johne’s disease, malignant catarrhal 

fever, and the meningeal worm 

(Parelaphostrongylus tenuis). States also 

base cervid bans on concerns that 

farmed or captive cervids could contain 

undesirable gene sequences that could 

be introduced into wild cervid 

populations if the cervids escape 

captivity. These States noted that 

maintaining the genetic purity of their 

native elk and deer populations was 

important to sportsmen and natural 

resource interests. More generally, 

States with bans cited concerns that 

escaped farmed or captive cervids 

would compete with wild populations 

for food and habitat. Some States also 

cited laws making it illegal to hold in 

captivity certain species or breeds of 

cervids covered by the CWD final rule. 

Some States imposed a ban partly to 

discourage high-fence trophy hunting 

operations that depend on continual 

restocking from out-of State sources. 

Finally, some States cited 

environmental concerns, including 

ecosystem degradation resulting from 

cervids maintained in captivity or 

escaped cervids. 

APHIS has concluded that many of 

the above concerns are substantive and 

that we should propose a way to 

accommodate State interests in these 

areas. APHIS believes that we can best 

address the concerns of States that have 

imposed a ban on the entry of farmed 

or captive cervids for reasons unrelated 

to CWD by changing the CWD final rule 

to recognize such a ban for those States. 

Therefore, we propose to add a new 

§ 81.5 to the CWD final rule to clarify 

that state laws and regulations 

prohibiting the entry of farmed or 

captive cervids for reasons unrelated to 

CWD are not preempted by this part. 


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2Miller et al., 1998. Epidemiology of Chronic 

Wasting Disease in Captive Rocky Mountain Elk, 

Journal of Wildlife Diseases, 34:532–538. 

3Miller, personal communication. 

4Williams et al. 2002. Chronic Wasting Disease 

of Deer and Elk: A Review With Recommendations 

for Management. Journal of Wildlife Management 

66(3): 551–563. 

Monitoring Period Required To Move 

Cervids Interstate 

Under the CWD final rule, during its 

first year of implementation, cervids 

would be allowed to move interstate if 

they have been in an approved CWD 

Herd Certification program, and thus 

subject to monitoring for CWD and other 

requirements, for at least 1 year. The 

CWD final rule increased this length-oftime requirement in succeeding years of 

implementation, so the time animals 

would have had to be in a herd 

certification program in order to move 

interstate gradually increased to 2 years, 

then 3, then 4, then 5 years. It was the 

intent of the CWD final rule to provide 

a consistent, nationwide standard for 

the interstate movement of cervids. 

Existing State laws and regulations 

addressing movement of cervids vary in 

the amount of time that the animals 

must have been in a certification 

program prior to entry, and some States 

do not allow the entry of any cervids for 

non-CWD-related reasons, as discussed 

earlier. The gradual escalation of the 

Federal standard in the CWD final rule 

to 5 years was intended to achieve the 

desired level of risk control represented 

by 5 years of program participation and 

disease-free surveillance and 

monitoring, but to do so in a gradual 

manner that would not cause 

widespread economic harm to 

producers by making it impossible for 

some of them to move animals interstate 

until 5 years after they join the CWD 

Herd Certification Program. 

The petitioners and many 

commenters on the petitions questioned 

whether the gradual approach reflected 

in the rule’s Federal standard provided 

adequate protection, especially during 

the first 2 years of program 

implementation. The petitioners and 

most commenters suggested that the 

available science and the known 

epidemiology of CWD indicate that 

animals should be monitored for CWD 

for approximately 5 years before they 

can be considered safe to move 

interstate. Some commenters stated that 

studies of the natural incubation period 

in the wild are difficult to conduct and 

no comprehensive studies have been 

done; therefore, APHIS should not 

assume that most cervids will develop 

CWD within a year or two after 

infection. They noted that while 

animals developed signs of CWD within 

1–2 years of infection in several cited 

research studies, these were studies of 

confined animals that were directly 

infected with large quantities of the 

CWD agent. This type of direct 

experimental infection is known to 

result in minimum incubation periods 

for diseases in general. 

In view of these uncertainties about 

the range of incubation periods for 

CWD, the commenters suggested that it 

would be prudent for the CWD program 

to monitor animals for 5 years before 

they can be considered safe to move 

interstate. The 5-year period was 

suggested because it is the period that 

most researchers and State CWD 

programs agree is a reasonable outer 

boundary for the incubation period for 

CWD. 

In addition, comments on the 

petitions revealed that most State 

governments and industry 

representatives agree that many cervid 

producers who rely on moving animals 

interstate for the success of their 

businesses have already participated in 

a State CWD herd certification and 

monitoring program for 5 years or 

longer, would not be adversely affected 

by the adoption of a 5-year standard, 

and believe a 5-year standard would 

provide better protection against the 

spread of CWD than a lesser monitoring 

standard. 

After considering comments, APHIS 

has concluded that the CWD program 

would be enhanced by requiring that 

farmed or captive cervid herds must 

have been monitored for at least 5 years 

before animals from such herds may be 

moved interstate. The CWD final rule 

discussed why it is important to 

consider possible exposure to CWD up 

to 5 years in the past when evaluating 

the CWD risk of a herd. The CWD final 

rule would have required 5 years of 

monitoring for a herd to reach the 

Certified level in the CWD program, 

although it would have established a 

gradually increasing timetable that, in 

early years of program implementation, 

would have allowed interstate 

movement of animals from herds with 

as little as 1 year of monitoring. We now 

believe that CWD incubation periods 

have not been sufficiently studied to 

justify using shorter monitoring periods 

initially and ‘‘ramping up’’ the 

monitoring requirement over time. Also, 

upon reexamining several research 

reports, we believe that they support the 

conclusion that natural incubation 

periods may last up to 5 years in enough 

cases to warrant revising the CWD 

program as designed in the CWD final 

rule. For example, the CWD final rule 

referred to a study 2 at the Colorado 

Division of Wildlife, Foothills Wildlife 

Research facility, which found that for 

a studied group of elk that were 

naturally exposed to CWD in a 

contaminated environment, the average 

incubation time was 26 months and the 

incubation times ranged from 18 to 36 

months. After the study ended, in the 

same group of elk held in the same 

pens, there was a case of CWD in an 

individual animal that occurred 5 years 

after the last CWD death in the herd.3

This could have been the result of a 

later environmental exposure, or it 

could represent a 5-year incubation 

period. 

Further supporting the points made 

by the commenters, in other 

pathogenesis studies in mule deer and 

elk at the University of Wyoming,4 high 

dose oral inoculation in mule deer 

produced an incubation period range of 

15 months to over 25 months, with an 

average of 23 months. The researchers 

acknowledged that experimental 

infection (single-dose oral exposure to 

brain material) probably underestimates 

natural incubation times, as it is likely 

that greater exposure results in shorter 

duration of incubation. This supports 

the conclusion that incubation times for 

experimental infections most likely 

represent the range of minimum 

incubation times, so regulatory risk 

considerations should not be based 

solely on incubation periods 

demonstrated by experimental direct 

inoculations. 

Based on our reevaluation of 

incubation studies, we believe that the 

longest incubation periods for regulated 

cervids will likely fall between 3 and 5 

years. While a CWD program with a 3- 

year monitoring period might catch a 

large majority of infected animals, it 

appears that there would be enough 

animals that would become infected 

after a 4- or 5-year incubation period 

that a 3-year monitoring period would 

allow continued spread of CWD and 

reduce the effectiveness of the program. 

Therefore, we are proposing to 

remove the gradual-escalation approach 

from the CWD final rule and replace it 

with a requirement that farmed or 

captive cervids moved interstate must 

be from herds that have had at least 5 

years’ monitoring for CWD (i.e., herds 

that have achieved ‘‘Certified’’ status in 

the certification program). This 

requirement is based on our 

interpretation of currently available 

research, and we may propose to modify 

it in the future if additional research 

provides a basis for doing so. This 

change would affect the requirements 


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5The final rule allows farmed or captive deer, elk, 

or moose to be moved to slaughter regardless of 

whether or not their herds are enrolled in the 

certification program, or, if enrolled in the program, 

regardless of their status relative to movement 

requirements, if they have two forms of animal 

identification and are accompanied by a certificate 

issued in accordance with § 81.4. 

6Later in this document, we also propose a 

change that would redesignate this paragraph (a) as 

paragraph (b). 

7 In ‘‘Protocol Respecting The Importation Of 

Cervids From Other Provinces Or Countries Into 

Quebec Under The Animal Health Protection Act 

(R.S.Q., c. P–42)’’ and ‘‘Protocol For the Importation 

of Farmed Cervids From Canada,’’ USDA, APHIS, 

Veterinary Services, National Center for Import and 

Export. 

for cervids moved interstate for nonslaughter purposes on the basis of their 

participation in the certification 

program; it would not affect the 

movement of cervids to slaughter.5

To make this change, we propose to 

amend paragraph (a) of § 81.3 as 

published at 71 FR 41706, which deals 

with interstate movement of animals 

from cervid herds that are enrolled in 

the CWD Herd Certification Program 

and are eligible for a certification status 

level based on the length of time they 

have successfully met program 

standards. We propose to amend this 

paragraph to state that the farmed or 

captive cervid must be enrolled in the 

CWD Herd Certification Program in a 

herd that has achieved Certified status, 

and must be accompanied by a 

certificate that states this and that also 

identifies the herd of origin and states 

that the animal does not show clinical 

signs associated with CWD.6

The change to the certificate 

requirement to indicate that the animal 

does not show clinical signs associated 

with CWD replaces a required statement 

that the animal is not a CWD-positive, 

CWD-exposed, or CWD-suspect animal. 

Requiring that the certificate state that 

the animal does not show clinical signs 

associated with CWD would be 

consistent with the information that can 

be obtained from an examination and 

with other interstate animal movement 

regulations. To complement this change, 

we would also remove the definitions of 

the terms CWD-positive animal, CWDexposed animal, and CWD-suspect 

animal from § 81.1, because these terms 

would no longer be used in part 81. 

Proximity of Herd of Origin to CWD 

Occurrences and CWD History of an 

Animal’s Herd 

Some commenters also raised the 

concern that the CWD final rule would 

disrupt State program efforts to provide 

an additional level of protection against 

the spread of CWD by prohibiting entry 

of farmed or captive cervids from those 

areas where CWD has been detected. 

Several States currently implement such 

policies in various forms. The form of 

the State requirement is usually to list 

either counties, regions within a State, 

or entire States where CWD has been 

detected and ban entry of cervids from 

the listed areas. 

We believe this is a useful risk 

reduction approach for States that wish 

to add another level of protection to the 

requirements in the CWD final rule. 

However, not all States believe they 

need the additional risk reduction. Also, 

although all the States that use this 

method agree that its purpose is to 

prohibit entry of cervids from areas in 

proximity to occurrences of CWD, there 

is substantial variation in the details of 

such requirements for different States. 

Therefore, we propose to change the 

CWD final rule to allow States to elect 

not to receive farmed or captive cervids 

from areas in proximity to occurrences 

of CWD in wild cervids. We also 

propose to establish a single Federal 

standard for such proximity in order to 

make the standard consistent among all 

States with such restrictions. We 

propose to do this by (1) establishing a 

list of States that do not accept entry of 

farmed or captive cervids from herds of 

origin in proximity to CWD occurrences 

in wild cervids and (2) changing the 

certificate requirement for interstate 

movement of farmed or captive cervids 

to document when animals are from 

herds that are in proximity to CWD 

occurrences in wild cervids. 

Section 81.3(a)(2) of the CWD final 

rule requires that farmed or captive 

cervids that are moved interstate based 

on their participation in the CWD Herd 

Certification Program must be 

accompanied by a certificate issued by 

a State or Federal official or an 

accredited veterinarian. The certificate 

must contain information to help 

identify the animals and document their 

status in the certification program. The 

contents required for a certificate are set 

out in § 81.4 as published at 71 FR 

41706. 

To be consistent with the change 

discussed above that animals moved 

interstate must be from herds with 

Certified status, we propose to change 

the references in § 81.4 to herds 

‘‘participating in the CWD Herd 

Certification Program’’ to instead refer 

to herds ‘‘that have achieved Certified 

status in the CWD Herd Certification 

Program.’’ We also propose to add the 

following requirements to this 

paragraph: 

• The certificate would have to 

include a statement by the issuing 

accredited veterinarian, State 

veterinarian, or Federal veterinarian that 

the animals are not from farmed or 

captive herds where CWD has been 

diagnosed within the past 5 years or 

epidemiologically linked to herds where 

CWD has been diagnosed within the 

past 5 years. 

The proposal to have a time limit of 

5 years when considering CWD 

infection or epidemiological linkage is 

based on the same evidence cited in the 

CWD final rule and in this proposal to 

support the requirement for 5 years of 

monitoring before a cervid may be 

moved interstate. That decision was 

based on several factors, including the 

probable maximum incubation time for 

CWD and timespans realistically needed 

for reporting and evaluation of CWD 

occurrences. 

• The certificate would have to also 

include a statement by the issuing 

accredited veterinarian, State 

veterinarian, or Federal veterinarian as 

to whether or not the animals’ premises 

are within 25 miles (40 km) of a 

federally or State-identified case of 

CWD in wild deer, elk, or moose, or 

within 25 miles (40 km) of an area 

where CWD has become established in 

wild deer, elk, or moose, as defined by 

APHIS and the State. 

We believe that this proposed 

requirement provides a reasonable 

standard that can be consistently 

applied and that provides the level of 

additional risk reduction that meets or 

exceeds that of similar current State 

requirements. The proposal to set the 

limits of proximity to CWD cases in the 

wild at 25 miles (40 km) is consistent 

with proximity guidelines used in some 

State CWD programs applicable to both 

captive and wild cervids, and is also 

consistent with the current international 

practice of several countries for 

importing and exporting elk. For 

example, the Quebec Department of 

Agriculture, Fisheries and Food requires 

a statement on certificates 

accompanying elk imported into Quebec 

that they are from a farm that ‘‘is located 

more than 40 km from an enterprise 

with an epidemiological link to a case 

of CWD.’’ The United States regulations 

for importing elk from Canada call for 

a similar statement.7

In addition to adding this proximity 

certification for moving farmed or 

captive cervids interstate, we propose to 

establish a list of States that do not 

accept entry of farmed or captive 

cervids from areas in proximity to CWD 

occurrences. This list, called ‘‘States 

That Limit Cervid Entry Based on 

Proximity to CWD Occurrences,’’ would 

be maintained and revised by APHIS, 

and would be made available by APHIS 

on its Web site and by mail upon 


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request. The initial list would include 

all States that currently have State laws 

or regulations that ban entry of farmed 

or captive cervids from areas in 

proximity to CWD occurrences in the 

wild. At any time, a State could request 

to be removed from the list if it changes 

to allow entry of farmed or captive 

cervids from areas in proximity to CWD 

occurrences in the wild. Any State not 

on the list could request to be added to 

the list by sending the Administrator a 

written request to be added and a copy 

of the State law or regulation that bans 

entry of farmed or captive cervids from 

areas in proximity to CWD occurrences 

in the wild. 

This list of States, in conjunction with 

the new requirement of a certification 

regarding proximity, will allow State 

and Federal representatives to 

determine when a shipment of cervids 

may not be moved to a destination State 

due to proximity restrictions. To make 

it clear that these new requirements 

apply in two ways—animals that do not 

meet them may not be moved interstate 

to listed States, and animals that do 

meet them must have that fact 

documented in the certificate—we 

propose to redesignate the current 

introductory text of § 81.3 as paragraph 

(a) and add the new requirements in 

subparagraphs (a)(1) and (a)(2) as set out 

in the proposed regulatory text of this 

document. 

We are proposing one more change 

related to the risks associated with 

maintaining a CWD herd in proximity to 

known occurrences of CWD in wild 

cervids. While the level of such risk is 

uncertain, it appears prudent to mitigate 

the risk. A number of herds have been 

long established in proximity to known 

occurrences of CWD in the wild; in most 

cases, the herd was established before 

CWD was found in wild animals in the 

area. Most of these herds have 

participated in State CWD programs and 

are eligible for the Federal-State 

cooperative CWD program. It would be 

very difficult to bar such herds from 

participation in the program. It would 

also be unnecessary if the herds have 

already effectively complied with 

program requirements for some years. 

However, we have determined that it 

would add to the effectiveness of CWD 

control if, in the future, no new herds 

were established in proximity to CWD 

occurrences in the wild. 

Therefore, we propose to amend 

§ 55.22(a), Participation and enrollment, 

by adding a provision that an 

application for participation may also be 

denied if APHIS or the State determines 

that the applicant’s herd was 

established after the effective date of a 

final rule following this proposal on a 

premises within 25 miles (40 km) of a 

Federally or State-identified case of 

CWD in wild deer, elk, or moose, or 

within 25 miles (40 km) of an area, as 

defined by APHIS and the State, where 

CWD has become established in wild 

deer, elk or moose. 

Monitoring and Surveillance of CWD in 

Wild Cervids 

The proposed changes discussed 

above concerning proximity of herds to 

known occurrences of CWD in wild 

cervids would only be practical if 

reliable data is available to identify 

areas where CWD occurs in the wild. 

States with significant wild cervid 

populations currently conduct 

monitoring and surveillance activities 

for CWD in the wild. These activities are 

often conducted by State wildlife 

agencies, though some involve 

agriculture agencies, and often Federal 

agencies provide assistance or technical 

support when resources are available to 

do so. The types and extent of 

surveillance for CWD in the wild vary. 

The most extensive surveys rely on 

testing samples submitted by hunters. 

Some States also employ surveillance 

methods such as harvesting and testing 

a geographically targeted random 

sampling of wild deer and elk, or testing 

vehicle-killed cervids, to estimate CWD 

distribution. 

We expect States would continue 

such surveillance activities. Because 

several changes in this proposed rule 

rely on identifying areas where CWD 

occurs in the wild, we also propose to 

make such continued surveillance a 

requirement for a State program to 

become an Approved State CWD Herd 

Certification Program. Specifically, we 

propose to add this requirement to the 

list in § 55.23, Responsibilities of States 

and enrolled herd owners, as paragraph 

(a)(12). 

Herd owners and Federal and State 

representatives would use reports from 

these monitoring and surveillance 

activities to determine, for purposes of 

the changes discussed above, when a 

premises is ‘‘within 25 miles (40 km) of 

a Federally or State-identified case of 

CWD in wild deer, elk, or moose, or 

within 25 miles (40 km) of an area, as 

defined by APHIS and the State, where 

CWD has become established in wild 

deer, elk, or moose.’’ 

Additional Changes to Responsibilities 

of States and Enrolled Herd Owners 

(§ 55.23) 

We propose to make several changes 

to § 55.23 to clarify the responsibilities 

of States and owners participating in the 

cooperative Federal-State CWD 

program, and to reduce the compliance 

burden where it is practical to do so. 

State Enforcement of Quarantines 

Paragraph (a)(4) of § 55.23 requires 

States to place all known CWD-positive, 

CWD-exposed, and CWD-suspect 

animals and herds under movement 

restrictions, with movement of animals 

from those herds only for destruction or 

under permit. We now propose to 

expand this requirement to prohibit 

CWD-positive, CWD-exposed, and 

CWD-suspect herds from adding 

animals to the herd from outside 

sources. The CWD final rule did not 

include such a requirement because it 

seemed unlikely that many owners 

would choose to expand herds that were 

under restrictions and possibly destined 

for destruction. However, there have 

been some cases where the owners of 

CWD-positive, CWD-exposed, and 

CWD-suspect herds have added new 

animals. This affects the CWD 

indemnity program, which makes 

indemnity available for eligible animals 

based on the inventory at the time the 

movement restrictions are imposed. An 

increase in the size of a herd under 

restriction due to CWD also causes a 

corresponding increase in the program 

resources devoted to the herd, and in 

the amount of work for Federal and 

State representatives working with the 

herd. For instance, if animals from 

several additional herds are added to a 

CWD-exposed or CWD-suspect herd that 

is later found positive for CWD, those 

additional herds must also be evaluated 

during traceback as possible sources of 

CWD. Also, increasing the herd size 

potentially increases the total number of 

infected animals, and the risk of CWD 

spread (e.g., more animals means more 

opportunities for an animal to escape 

confinement). 

To address this problem, we propose 

to change § 55.23(a)(4) to specifically 

state that no movement of animals into 

CWD-positive, CWD-exposed, and 

CWD-suspect herds is allowed. 

Herd Inventory Procedures 

We are also proposing to make 

changes to § 55.23 to address issues 

concerning the practicality and the 

burden on owners associated with 

paragraph (b)(4), which describes herd 

recordkeeping and annual inventory 

requirements. 

Section 55.23(b)(4) of the CWD final 

rule requires owners to maintain herd 

records that include a complete 

inventory of animals, the age and sex of 

each animal, the date of acquisition and 

source of each animal that was not born 

into the herd, the date of disposal and 

destination of each animal, and all 


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individual identification numbers (from 

tags, tattoos, electronic implants, etc.) 

associated with each animal. We do not 

propose to change this requirement. 

However, we do propose to change 

other requirements in this paragraph, 

which currently state that the owner 

must allow an APHIS employee or State 

representative access to the premises 

and herd to conduct an annual physical 

herd inventory to reconcile animals and 

identifications with the records 

maintained by the owner. The CWD 

final rule currently requires that the 

owner, when this physical inventory 

occurs, must assemble, restrain, and 

present the entire herd for inspection 

under conditions where the APHIS or 

State official can safely read all 

identification on the animals. The 

owner would be responsible for all costs 

incurred to present the animals for 

inspection. 

Several commenters noted that it was 

unclear whether an actual physical 

inventory of assembled animals was 

required each year, or only ‘‘upon 

request.’’ They also suggested that a 

physical inventory would impose a 

considerable burden if conducted on an 

annual basis. The CWD final rule 

estimated that for a herd of 50 elk, the 

annual physical inventory cost would 

be approximately $1,000, including 

veterinary fees of approximately $500 

and hired labor costs of approximately 

$500. This cost could be significantly 

higher in some cases; for example, labor 

costs for skilled cervid handlers are 

higher in some areas, and the physical 

assembly and restraint could cause 

injury to some cervids, with further 

costs to the owner for subsequent 

veterinary care or loss of the animal. 

We agree that the CWD final rule 

language is unclear on the requirement 

for physical inventories. Our intention 

is to conduct an actual physical 

inventory of assembled animals when 

an APHIS employee or State 

representative finds it to be needed for 

program purposes. We propose that a 

physical assembly would be required at 

the time a herd is enrolled in the 

Federal-State cooperative CWD 

program, in order to provide a reliable 

baseline record for the herd’s 

participation. After this initial physical 

assembly for inventory purposes, further 

physical inventories would be 

scheduled when the APHIS employee or 

State representative finds it necessary to 

verify herd compliance with program 

standards — for example, if there has 

been significant movement of animals 

into or from the herd, or if other 

conditions warrant a physical inventory 

to confirm the herd records. Physical 

inventories would usually be several 

years apart, and would never be ordered 

more than once per year, unless we 

determine that more frequent 

inventories are needed based on 

indications that the herd may not be in 

compliance with CWD Herd 

Certification Program requirements. 

However, some type of herd inventory 

would be performed annually. When the 

inventory does not include physical 

assembly of the entire herd, it would 

include, at a minimum, review of all 

owner records documenting animal 

identification and records of animals 

added to or removed from the herd. It 

would also include observation of the 

herd’s unrestrained animals in a 

viewable, enclosed area or space where 

the inspector could reconcile all visible 

identification devices with prior records 

and check for any obvious 

inconsistencies between the number, 

age, and gender of animals observed and 

the animals documented in the owner 

records. During such inventories, the 

owner and the person performing the 

inventory would work together to 

resolve any discrepancies to the 

satisfaction of the person performing the 

inventory. 

This proposed change should also 

make it possible in many cases to plan 

the timing of a physical assembly of a 

herd for inventory so that it is 

coordinated with cervid testing for 

brucellosis and tuberculosis. Such 

testing occurs for cervid herds 

participating in the cooperative State– 

Federal Cervid Brucellosis Program or 

Cervid Tuberculosis Program. The 

Uniform Methods and Rules for these 

programs describe when such herds 

must be assembled and tested for these 

diseases. For example, to maintain a 

herd’s Certified status with regard to 

brucellosis, or its Accredited status with 

regard to tuberculosis, the herd must be 

retested for the relevant disease every 21 

to 27 months under current brucellosis 

and tuberculosis regulations. This 

timetable may change in the future. We 

expect that, in many cases, when a 

cervid herd participates in the CWD 

program and one or both of the 

tuberculosis and brucellosis programs, 

any required physical assembly of the 

herd can be planned so that during a 

single assembly, requirements for all of 

the programs can be met. For example, 

the initial physical assembly would 

serve to establish and confirm the 

required inventory, records, and 

individual animal identification 

requirements for CWD, but it could also 

be used to conduct testing and any other 

requirements for the tuberculosis or 

brucellosis programs. If the APHIS 

employee or State representative later 

finds it necessary to schedule another 

physical assembly for inventory, it is 

likely that it could be scheduled to 

allow any required tuberculosis or 

brucellosis testing to occur during the 

assembly. 

APHIS plans to develop additional 

guidance in the future, after we gain 

additional experience working with 

herd inventories, to clarify when an 

actual physical inventory of assembled 

animals will be required, and to provide 

more information on the different 

activities involved in the different levels 

of a physical inventory of assembled 

animals. When developed, such 

guidance will be made available in the 

CWD program Uniform Methods and 

Rules or in other program guides. 

Readers should also note that in 

addition to Federal regulations 

concerning inventory requirements, 

individual States may have 

requirements in this area in State law or 

regulations. 

In § 55.23(b)(4) on page 41704 of the 

final rule, we also inadvertently omitted 

accredited veterinarians as one of the 

types of officials authorized to conduct 

the herd inventory. Since accredited 

veterinarians play an important role in 

implementing the CWD program, we 

propose to change this reference to also 

allow access to the premises by an 

accredited veterinarian who has been 

designated to conduct an inventory. To 

implement these changes to inventory 

requirements, we propose to revise all 

but the first sentence of § 55.23(b)(4). 

Enrollment Dates 

Section 55.22(a)(1)(ii)(B) concerns 

setting an enrollment date for herds that 

enroll directly in the Federal CWD Herd 

Certification Program, and ensuring that 

the enrollment date gives some credit 

for the time period during which herds 

substantially met Certification Program 

standards before they could enroll in the 

Program. This paragraph reads, in part, 

‘‘If APHIS determines that the herd 

owner has maintained the herd in a 

manner that substantially meets the 

conditions specified in § 55.23(b) for 

herd owners, the first day that the herd 

participated in such a program. 

However, in such cases the enrollment 

date may not be set at a date more than 

2 years prior to the date that APHIS 

approved enrollment of the herd.’’ 

We propose to change that 

requirement to allow APHIS to set an 

enrollment date for such herds that is 

up to 3 years prior to the date APHIS 

actually processed and approved 

enrollment. We propose this revision 

because implementation of the 

Certification Program has proceeded 

more slowly than planned, in part due 

to the need to resolve the issues 


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8The effective date of the CWD final rule, which 

was published in the Federal Register on July 21, 

2006 (71 FR 41682–41707, Docket No. 00–108–3), 

has been delayed pending consideration of the 

changes proposed in this document. 

discussed in this proposed rule. To 

minimize possible losses to herd owners 

who have managed their herds in 

compliance with program requirements 

but could not be formally enrolled 

because no State CWD program was 

available and the CWD final rule was 

not in effect, we propose to allow up to 

3 years’ credit instead of 2. Since this 

rule also proposes to limit interstate 

movement to cervids that have been 

enrolled for 5 years and have achieved 

Certified status, we expect this change 

would affect a small number of herds 

that become enrolled directly in the 

Federal CWD program after the effective 

date of a final rule. If such herds qualify 

for 3 years’ credit upon enrollment, 

animals from the herd could be moved 

interstate approximately 2 years later if 

and when the herd achieves Certified 

status. 

Confirmatory DNA Testing of Official 

Test Samples 

On page 41685 of the CWD final rule, 

we responded to comments that 

suggested that, after an animal tests 

positive for CWD, the owner should 

have the opportunity to have the 

sample’s DNA matched to DNA from the 

owner’s animal to prove that the correct 

sample was tested. In response, we 

stated, ‘‘With regard to DNA matching 

to confirm that positive samples are 

indisputably associated with the correct 

animal, we plan to allow such 

confirmation, at the owner’s expense, 

when the owner of the CWD-positive 

animal requests it. DNA verification will 

be possible because our instructions on 

how to collect and submit tissue 

samples will require submission of all 

manmade identification devices on the 

animal, with part of the ear or skin to 

which they are attached, in a manner 

that preserves the chain of custody.’’ 

Since the CWD final rule was 

published, APHIS has discussed this 

issue with owners and laboratories and 

has developed procedures to work with 

owners who wish to order such 

confirmatory DNA testing. In this NPRM 

we propose to change paragraph (c)(1) of 

§ 55.24 (71 FR 41705) of the final rule 

so that such testing would be available 

through the following arrangements. 

At the time an owner allows tissues 

samples to be collected from an animal 

for official CWD testing, the owner 

would be able to reserve the option for 

DNA comparison testing by informing 

the Federal or State representative or 

accredited veterinarian who collects the 

tissues. To allow for later DNA 

comparison testing, the person 

collecting the tissues would have to also 

collect from the animal some somatic 

tissue (usually an ear) that contains an 

official identification device, along with 

the tissue samples routinely collected 

for CWD testing (brain stem, lymph 

nodes, etc.). Submitting tissues attached 

to an official ID device establishes a 

reliable chain of custody that allows 

later DNA tests to be compared to a 

tissue sample that verifiably comes from 

the owner’s animal in question. 

If the CWD official tests show that 

owner’s animal is CWD-positive, the 

owner could employ the appeal 

provisions of § 55.24(c) to request that 

the tissue samples that were tested for 

CWD be compared to the ear or other 

tissues submitted with the animal ID 

attached. If the DNA in the tissues 

tested for CWD and the DNA in the 

tissues attached to the ID device match, 

there is confidence that the positive 

CWD tests do in fact pertain to the 

correct animal. If the DNA in the 

respective test results does not match, 

that may justify the Administrator 

granting the appeal. In such cases the 

animal would be redesignated CWDsuspect pending further investigation to 

establish the final proper status of the 

animal and its herd. 

We propose that if an owner requests 

confirmatory DNA testing, the owner 

would pay for the cost of the test. If this 

proposed rule is adopted as final, 

APHIS will publish additional guidance 

on how to request confirmatory DNA 

testing and how to arrange payment for 

such tests. 

To recognize this procedure in the 

regulations, we propose making changes 

to the CWD final rule to document the 

owner’s right to order and pay for 

confirmatory DNA testing when one or 

more of the owner’s animals tests 

positive for CWD. We would change 

paragraph (c)(1) of § 55.24, which deals 

with an owner’s right to appeal the 

designation of their herd’s status, by 

adding a provision for appeals based on 

the results of a DNA test requested and 

paid for by the owner to determine 

whether previous official CWD test 

results were correctly associated with an 

animal that belonged to the owner. 

Miscellaneous Changes 

We also propose to change the 

definition of premises identification 

number (PIN) in parts 55 and 81 and to 

add a definition for National Uniform 

Eartagging System to both parts. These 

proposed changes are intended to 

achieve greater standardization and 

uniformity of official numbering 

systems and eartags used in the National 

Animal Identification System and in 

animal disease programs and to enhance 

animal traceability. We also propose to 

add the following sentence to the 

definition of official animal 

identification: ‘‘The CWD program 

allows the use of either the eightcharacter or nine-character format for 

cervids.’’ This proposed change would 

allow use of either larger eartags with 

nine-character unique numbers, or 

smaller eartags with eight-character 

numbers. We propose to allow use of 

both size tags because the use of the 

smaller eartags is sometimes advisable 

to reduce stress on younger elk and 

deer. 

Executive Order 12866 and Regulatory 

Flexibility Act (RFA) 

This proposed rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be not 

significant for the purposes of Executive 

Order 12866 and, therefore, has not 

been reviewed by the Office of 

Management and Budget. 

In accordance with 5 U.S.C. 603, we 

have performed an initial regulatory 

flexibility analysis, which is set out 

below, regarding the potential effects of 

the proposed action on small entities. 

This initial analysis indicates that the 

benefits of the proposed action would 

exceed its costs. We do not currently 

have all the data necessary for a 

comprehensive analysis of the effects of 

this rule on small entities. Therefore, we 

are inviting comments concerning 

potential effects. 

The changes proposed in this 

document would, if adopted, modify the 

requirements set forth in the CWD final 

rule.8 For that reason, the economic 

analysis that follows considers the 

impact of the proposed changes using 

the CWD final rule as a baseline. An 

economic analysis was prepared for the 

CWD final rule, and that analysis is 

incorporated in this document by 

reference. 

The proposed changes would have the 

most impact on cervid farms, most of 

which are believed to be small in size 

under the U.S. Small Business 

Administration’s standards. 

The proposal to remove the gradualescalation monitoring period 

requirement for interstate movement 

and replace it with a 5-year minimum 

requirement would adversely impact 

current farmers with less than 5 years in 

the program who wish to ship at least 

some of their animals interstate for 

purposes other than slaughter. The 

number of such farmers is unknown, 

although it is estimated that many, if not 

most, herd owners who rely on 

interstate movement for the success of 


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9Herd owners who are not in a State program but 

who can demonstrate that they have maintained 

their herds in a manner that would substantially 

meet the program conditions established by APHIS 

may qualify for up to 3 years’ enrollment credit. 

10These activities are often conducted by State 

wildlife agencies, though some involve agriculture 

agencies, and often receive assistance or technical 

support from Federal agencies. If Federal assistance 

or support is reduced or withdrawn altogether in 

the future, the States would have to bear more or 

all of the cost of surveillance activities if they 

wanted to remain an approved State CWD program. 

At this time, there is no reason to believe that 

Federal assistance or support will be reduced or 

withdrawn in the future. 

their businesses already meet the 5-year 

standard by way of their participation in 

an existing State CWD certification 

program. Under the proposal, time spent 

in an APHIS-approved State program 

would count towards the time needed to 

satisfy the 5-year requirement, and 

many farmers have participated in a 

State program for at least 5 years. It is 

estimated that at least 20 States have 

formal CWD certification programs for 

cervids in place. 

Any adverse impact of the proposed 

5-year standard on current farmers 

would be further muted to the extent 

that a number of States have already 

adopted that standard themselves. 

Currently, States have the authority to 

regulate farmed cervids, including the 

authority to establish requirements for 

entry of cervids. In response to APHIS’ 

CWD proposed rule published in 

December 2003, and its CWD final rule 

published in July 2006, several States 

have decided to adopt a 5-year 

monitoring period requirement for 

cervids entering those States. Both the 

December 2003 proposed rule and the 

July 2006 final rule included an 

eventual 5-year monitoring period 

requirement for interstate movement. 

For those farmers who would be 

adversely affected by a shift to a 5-year 

monitoring period requirement, the 

economic impact would vary depending 

on the circumstances of each—such as 

the time, if any, already spent in a State 

program, the number and value of 

animals that would otherwise be 

shipped interstate, and the alternative 

opportunities available for sales within 

the State. Although data for individual 

herd owners are not available, those 

who are located in States that do not 

now have a State program and who 

cannot qualify for a herd status upgrade 

would likely suffer the most severe 

economic consequences, since they 

would have to participate in the Federal 

program (or a newly established State 

program) for 5 years before they could 

move their cervids interstate.9 Under 

the CWD final rule, these same herd 

owners would have been able to move 

their animals interstate after only 1 year 

in the program. (For these and other 

herd owners who do not meet the 5-year 

monitoring requirement, the only 

alternative under the proposal that 

would allow for earlier interstate 

movement would be to sell or otherwise 

dispose of their existing cervids and 

replace them with animals from a herd 

with higher status. However, this 

alternative would not come without a 

price; all else being equal, the cost of 

each replacement cervid is likely to 

exceed the proceeds from the sale or 

disposition of each existing animal, 

given the former’s higher status.) It is 

conceivable that the shift to a 5-year 

monitoring requirement could 

effectively force some farmers out of the 

cervid business, especially those with 

little or no time in State programs. On 

the other hand, the change that would 

allow APHIS to set an enrollment date 

for herds that is up to 3 years prior to 

the date APHIS actually processed and 

approved enrollment should preclude 

this outcome for most herds. 

The adoption of the proposed 5-year 

monitoring period requirement could 

also impact prospective new entrants 

into the cervid farming business, to the 

extent that it requires them to acquire 

higher status, and presumably more 

costly, animals when initially stocking 

their herds. Under the proposal, for 

example, new entrants would be eligible 

to ship their animals interstate 

immediately only if they stocked their 

herds with cervids from certified herds. 

By contrast, the CWD final rule would 

have allowed new entrants to ship 

interstate immediately with animals 

acquired from herds having as low as 

Second Year status. 

Relative to the CWD final rule, the 

impact on farmers of the proposal to 

give States the option to ban the entry 

of certain farmed and captive cervids is 

uncertain. We propose to allow States 

that completely prohibit the entry of 

farmed or captive cervids for reasons 

which are unrelated to CWD (e.g., for 

genetic purity or environmental reasons) 

to continue to do so. We also propose 

that States may decline to accept cervids 

from areas in proximity to CWD 

outbreaks. In both cases, impacts on 

States that have either type of ban 

would be nonexistent or minimal. The 

difference in impacts regarding State 

bans between this proposal and the final 

rule may be considered as follows. On 

the one hand, the CWD final rule would 

have given farmers with potentially 

risky animals access to markets in other 

States that are currently closed to them. 

On the other hand, there is no 

assurance, even if the CWD final rule 

had been in effect, that farmers would 

have been able to sell a significant 

number of their high-risk animals in 

those markets anyway. The market for 

cervids that are near CWD occurrences 

is limited, given the animals’ added 

disease risk, and the absence of a ban 

option in the CWD final rule would not 

have removed that risk. 

Relative to the current situation, the 

proposal to give States the option to ban 

the entry of certain cervids would have 

no impact, since all States have that 

option now. Currently, several States 

have elected not to accept cervids if 

they came from areas in proximity to 

CWD in the wild. 

The proposal to prohibit the program 

participation of herds established in the 

future in areas in proximity to CWD 

occurrences in wild cervids should have 

little or no impact. There are two 

reasons. First, the proposal affects 

newly established herds only, so no 

current farmers would be affected. 

Second, it is likely that few, if any, 

farmers would want to establish a new 

herd in areas in proximity to CWD in 

the wild, given the added disease risk 

and the attendant adverse marketing 

consequences noted above. 

The proposal to define ‘‘proximity’’ as 

within 25 miles (40 km) of a CWD 

occurrence should benefit herd owners 

and the States, to the extent that it 

removes uncertainty that may now exist 

surrounding the definition of that term. 

The proposed definition is also 

consistent with current international 

practice for importing and exporting elk. 

The proposal to require States to 

conduct monitoring and surveillance for 

CWD in wild cervids in order to become 

an approved State CWD program should 

have little or no impact. This is because 

such monitoring and surveillance is 

already being conducted by those States 

with significant cervid populations, 

including those without a CWD 

program.10

The proposal to prohibit CWDpositive, -exposed, and -suspect herds 

that are under State quarantine from 

adding animals to the herd from outside 

sources should have little impact, since 

few herds would be affected. It is 

estimated that, over the last several 

years, no more than about two or three 

cervid herds under quarantine have 

added animals from outside sources, 

usually for hunting purposes. 

The proposal to modify the herd 

inventory requirements has the 

potential to favorably impact herd 

owners. Under the CWD final rule, herd 

owners would be required to conduct a 

physical inventory of assembled and 

restrained cervids annually. Under this 

proposed revision to the final rule, a 

physical inventory would be required at 


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11APHIS has not yet developed guidelines for 

determining when a post-initial enrollment 

physical inventory would be required. The agency 

plans to do so in the future, after it gains additional 

experience working with herd inventories. When 

developed, such guidance will be made available in 

the CWD program Uniform Methods and Rules or 

in other program guides. 

the time a herd is enrolled in a CWD 

program, and then only on an as-needed 

basis thereafter to verify compliance 

with program standards.11 The 

proposed rule would still require an 

annual herd inventory—including a 

review of owner records and an 

observation of the herd’s unrestrained 

animals in a viewable, enclosed area— 

but it would not require that the animals 

be physically assembled and restrained. 

Since herd owners are responsible for 

all costs incurred in conducting a herd 

inventory, the proposal has the potential 

to offer them significant ongoing annual 

savings. This is because a herd 

inventory that does not require that the 

animals be physically assembled and 

restrained is less costly than one that 

does. The CWD final rule estimated that 

for a herd of 50 elk, the annual physical 

inventory (with the animals assembled 

and restrained) would cost 

approximately $1,000, including 

veterinary fees of approximately $500 

and hired labor costs of approximately 

$500. This cost could be significantly 

higher in some cases; for example, labor 

costs for skilled cervid handlers are 

higher in some areas, and the physical 

assembly and restraint could cause 

injury to some cervids, with further 

costs to the owner for subsequent 

veterinary care or loss of the animal. By 

contrast, a ‘‘nonphysical’’ herd 

inventory can be scheduled at a time 

when it is likely to add only minimally 

to herd owner operating costs, since 

most of the activities required for such 

an inventory are performed from time to 

time as part of routine herd 

management. 

This proposed change to the herd 

inventory requirements should also 

make it possible in many cases to plan 

the timing of a physical inventory so 

that it is coordinated with cervid testing 

for brucellosis and tuberculosis. Such 

testing occurs for cervid herds 

participating in the cooperative StateFederal Cervid Brucellosis Program or 

Cervid Tuberculosis Program. The 

Uniform Methods and Rules for these 

programs describe when such herds 

must be assembled and tested for these 

diseases. For example, to maintain a 

herd’s Certified status with regard to 

brucellosis, or its Accredited status with 

regard to tuberculosis, the herd must be 

retested for the relevant disease every 21 

to 27 months (under current brucellosis 

and tuberculosis regulations; this 

timetable may change in the future). We 

expect that, in many cases, when a 

cervid herd participates in the CWD 

program and one or both of the 

tuberculosis and brucellosis programs, 

any required physical inventory can be 

planned so that the requirements for all 

of the programs can be met during a 

single animal assembly. The initial and 

any subsequent physical inventories 

required for CWD purposes could also 

be used to conduct testing and any other 

requirements for the tuberculosis or 

brucellosis programs. 

A very small number of herd owners 

may benefit from the new confirmatory 

DNA test provisions for animals that test 

CWD positive, in cases where a low-cost 

confirmatory test shows that positive 

test results were not associated with the 

correct animal. The number of herd 

owners who would benefit from the 

proposal to modify the herd inventory 

requirements is unknown. 

The changes proposed in this 

document could be expected to have 

both positive and negative economic 

consequences for cervid farmers. 

Potentially, more cervid farmers stand 

to benefit than not, given that the 

proposal to modify the herd inventory 

requirements has the potential to offer 

significant ongoing annual cost savings 

to all program participants, but any 

adverse impact stemming from the 

proposed shift to a 5-year monitoring 

period requirement would be temporary 

and probably affect far fewer farmers. 

The proposed rule has no new 

mandatory reporting, recordkeeping, or 

other compliance requirements for U.S. 

entities. Requirements associated with 

the earlier final rule were discussed in 

that rule. 

The RFA requires agencies to identify, 

to the extent practicable, any Federal 

rule that may duplicate, overlap, or 

conflict with the proposed rule. APHIS 

has not identified any duplication, 

overlap, or conflict of the proposed rule 

with other Federal rules. 

Finally, the RFA requires agencies to 

describe any significant alternatives to 

the proposed rule that accomplish the 

stated objectives of applicable statutes 

and that minimize any significant 

economic impact of the proposed rule 

on small entities. We do not have details 

about the size of the 2,371 elk farms and 

4,901 deer farms in the United States. 

However, it is reasonable to assume that 

most are small in size, under the U.S. 

Small Business Administration’s (SBA) 

standards. This assumption is based on 

composite data for providers of the same 

and similar services. In 2002, there were 

41,238 U.S. farms in NAICS 11299, a 

classification comprised solely of 

establishments primarily engaged in 

raising certain animals (including deer 

and elk but excluding cattle, hogs and 

pigs, poultry, sheep and goats, animal 

aquaculture, apiculture, horses and 

other equines, and fur-bearing animals). 

For all 41,238 farms, the per farm 

average gross receipts in 2002 was 

$39,868, well below the SBA’s small 

entity threshold of $750,000 for farms in 

that NAICS category. 

Of the proposed changes, the shift to 

a 5-year monitoring period requirement 

for interstate movement has the 

potential to have the most significant 

adverse impact on both small and large 

cervid farmers. However, leaving the 

gradual-escalation monitoring period 

requirement in place would be 

unsatisfactory, because the available 

research suggests that it may not 

provide an adequate level of protection 

against the spread of CWD. Most 

researchers and State CWD programs 

agree that 5 years is a reasonable upper 

bound for the incubation period for 

CWD. 

APHIS invites public comment on the 

rule’s expected economic impacts, 

including any comment on the impact 

for small entities. 

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 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. If this proposed rule is 

adopted: (1) All State and local laws and 

regulations that are in conflict with this 

rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

Paperwork Reduction Act 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

Lists of Subjects 

9 CFR Part 55 

Animal diseases, Cervids, Chronic 

wasting disease, Deer, Elk, Indemnity 

payments, Moose. 

9 CFR Part 81 

Animal diseases, Cervids, Deer, Elk, 

Moose, Quarantine, Reporting and 


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14504 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Proposed Rules 

recordkeeping requirements, 

Transportation. 

Accordingly, we propose to amend 9 

CFR parts 55 and 81 as previously 

amended at 71 FR 41682–41707 on July 

21, 2006, as follows: 

PART 55—CONTROL OF CHRONIC 

WASTING DISEASE 

1. The authority citation for part 55 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

2. Section 55.1 is amended as follows. 

a. By adding a definition for National 

Uniform Eartagging System, in 

alphabetical order, to read as set forth 

below. 

b. In the definition of official animal 

identification, by adding at the end of 

paragraph (1) the sentence ‘‘The CWD 

program allows the use of either the 

eight-character or nine-character format 

for cervids.’’ 

c. By revising the definition for 

premises identification number (PIN) to 

read as set forth below. 

§ 55.1 Definitions. 

* * * * * 

National Uniform Eartagging System. 

A numbering system for the official 

identification of individual animals in 

the United States providing a nationally 

unique identification number for each 

animal. The National Uniform 

Eartagging System employs an eight- or 

nine-character alphanumeric format, 

consisting of a two-number State or 

territory code, followed by two or three 

letters and four additional numbers. 

Official APHIS disease control programs 

may specify which format to employ. 

* * * * * 

Premises identification number (PIN). 

A nationally unique number assigned by 

a State, Tribal, and/or Federal animal 

health authority to a premises that is, in 

the judgment of the State, Tribal, and/ 

or Federal animal health authority, a 

geographically distinct location from 

other premises. The premises 

identification number is associated with 

an address, geospatial coordinates, and/ 

or location descriptors which provide a 

verifiably unique location. The premises 

identification number may be used in 

conjunction with a producer’s own 

livestock production numbering system 

to provide a unique identification 

number for an animal. It may also be 

used as a component of a group/lot 

identification number. Premises 

identification numbers issued on or 

after [Insert effective date of final rule] 

shall consist of a seven-character 

alphanumeric code, with the right-most 

character being a check digit. The check 

digit number is based upon the ISO 

7064 Mod 36/37 check digit algorithm. 

* * * * * 

3. Section 55.22 is amended as 

follows: 

a. In the introductory text of 

paragraph (a), by adding a sentence 

following the third sentence to read as 

set forth below. 

b. In paragraph (a)(1)(ii)(B), by 

removing the words ‘‘2 years prior’’ and 

adding the words ‘‘3 years prior’’ in 

their place. 

§ 55.22 Participation and enrollment. 

(a) * * * An application for 

participation may also be denied if 

APHIS or the State determines that the 

applicant’s herd was established after 

[insert effective date of final rule] on a 

premises within 25 miles (40 km) of a 

Federally or State-identified case of 

CWD in wild deer, elk, or moose, or 

within 25 miles (40 km) of an area, as 

defined by APHIS and the State, where 

CWD has become established in wild 

deer, elk, or moose. * * * 

* * * * * 

4. Section 55.23 is amended as 

follows: 

a. By revising paragraph (a)(4) to read 

as set forth below. 

b. By adding a new paragraph (a)(12) 

to read as set forth below. 

c. By revising paragraph (b)(4) to read 

as set forth below. 

§ 55.23 Responsibilities of States and 

enrolled herd owners. 

(a) * * * 

(4) Has placed all known CWDpositive, CWD-exposed, and CWDsuspect animals and herds under 

movement restrictions, with no 

movement of animals allowed into such 

herds and with movement of animals 

from them only for destruction or under 

permit. 

* * * * * 

(12) Conducts monitoring and 

surveillance activities to estimate 

geographic distribution of CWD in the 

State. 

(b) * * * 

(4) The owner must maintain herd 

records that include a complete 

inventory of animals that states the age 

and sex of each animal, the date of 

acquisition and source of each animal 

that was not born into the herd, the date 

of disposal and destination of any 

animal removed from the herd, and all 

individual identification numbers (from 

tags, tattoos, electronic implants, etc.) 

associated with each animal. Upon 

request by an APHIS employee or State 

representative, the owner must allow 

either of these officials or a designated 

accredited veterinarian access to the 

premises and herd to conduct an 

inventory. The owner will be 

responsible for assembling, handling, 

and restraining the animals and for all 

costs incurred to present the animals for 

inspection. The APHIS employee or 

State representative may order either an 

inventory that consists of review of herd 

records with visual examination of an 

enclosed group of animals, or a 

complete physical herd inventory with 

verification to reconcile all animals and 

identifications with the records 

maintained by the owner. In the latter 

case the owner must present the entire 

herd for inspection under conditions 

where the APHIS employee, State 

representative, or accredited 

veterinarian can safely read all 

identification on the animals. During 

inventories, the owner must cooperate 

with the inspector to resolve any 

discrepancies to the satisfaction of the 

person performing the inventory. 

Inventory of a herd will be conducted 

no more frequently than once per year, 

unless an APHIS employee, State 

representative, or accredited 

veterinarian determines that more 

frequent inventories are needed based 

on indications that the herd may not be 

in compliance with CWD Herd 

Certification Program requirements. 

* * * * * 

5. In § 55.24, paragraph (c)(1) is 

revised to read as follows: 

§ 55.24 Herd status. 

* * * * * 

(c) * * * 

(1) Herd owners may appeal 

designation of an animal as CWDpositive, cancellation of enrollment of a 

herd, or loss or suspension of herd 

status by writing to the Administrator 

within 10 days after being informed of 

the reasons for the action. The appeal 

must include all of the facts and reasons 

upon which the herd owner relies to 

show that the reasons for the action are 

incorrect or do not support the action. 

Specifically, to appeal designation of an 

animal as CWD-positive, the owner may 

present as evidence the results of a DNA 

test requested and paid for by the owner 

to determine whether previous official 

CWD test results were correctly 

associated with an animal that belonged 

to the owner. If the owner intends to 

present such test results as evidence, he 

or she shall request the tests and state 

this in the written notice sent to the 

Administrator. In such cases the 

Administrator may postpone a decision 

on the appeal for a reasonable period 

pending receipt of such test results. To 

this end, approved laboratories are 

authorized to conduct DNA tests to 

compare tissue samples tested for CWD 


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Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Proposed Rules 14505 

1This list will be maintained on the APHIS Web 

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

to samples from tissues that were 

collected at the same time by the 

accredited veterinarian or Federal or 

State veterinarian and are attached to an 

official identification device. Such DNA 

tests are available only if the animal 

owner arranged to submit animal tissue 

attached to an official identification 

device along with the other tissues that 

were collected for the official CWD test. 

The Administrator will grant or deny 

the appeal in writing as promptly as 

circumstances permit, stating the reason 

for his or her decision. If the 

Administrator grants an appeal of the 

status of a CWD-positive animal, the 

animal shall be redesignated as CWDsuspect pending further investigation to 

establish the final status of the animal 

and its herd. 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. 

* * * * * 

PART 81—CHRONIC WASTING 

DISEASE IN DEER, ELK, AND MOOSE 

6. The authority citation for part 81 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

7. Section 81.1 is amended as follows: 

a. By removing the definitions for 

CWD-positive animal, CWD-exposed 

animal, and CWD-suspect animal. 

b. By adding a definitions for National 

Uniform Eartagging System, in 

alphabetical order, to read as set forth 

below. 

c. In the definition of official animal 

identification, by adding at the end of 

paragraph (1) the sentence ‘‘The CWD 

program allows the use of either the 

eight-character or nine-character format 

for cervids.’’ 

d. By revising the definition of 

premises identification number (PIN) to 

read as set forth below. 

§ 81.1 Definitions. 

* * * * * 

National Uniform Eartagging System. 

A numbering system for the official 

identification of individual animals in 

the United States providing a nationally 

unique identification number for each 

animal. The National Uniform 

Eartagging System employs an eight- or 

nine-character alphanumeric format, 

consisting of a two-number State or 

territory code, followed by two or three 

letters and four additional numbers. 

Official APHIS disease control programs 

may specify which format to employ. 

* * * * * 

Premises identification number (PIN). 

A nationally unique number assigned by 

a State, Tribal, and/or Federal animal 

health authority to a premises that is, in 

the judgment of the State, Tribal, and/ 

or Federal animal health authority, a 

geographically distinct location from 

other premises. The premises 

identification number is associated with 

an address, geospatial coordinates, and/ 

or location descriptors which provide a 

verifiably unique location. The premises 

identification number may be used in 

conjunction with a producer’s own 

livestock production numbering system 

to provide a unique identification 

number for an animal. It may also be 

used as a component of a group/lot 

identification number. Premises 

identification numbers issued on or 

after [Insert effective date of final rule] 

shall consist of a seven-character 

alphanumeric code, with the right-most 

character being a check digit. The check 

digit number is based upon the ISO 

7064 Mod 36/37 check digit algorithm. 

8. Section 81.3 is amended as follows: 

a. By redesignating paragraphs (a), (b), 

(c), (d), and (e) as paragraphs (b), (c), (d), 

(e), and (f), respectively. 

b. By redesignating the introductory 

text as paragraph (a) introductory text 

and adding new paragraphs (a)(1) and 

(a)(2) to read as set forth below. 

c. By revising newly designated 

paragraph (b) to read as set forth below. 

§ 81.3 General restrictions. 

(a) No farmed or captive deer, elk, or 

moose may be moved interstate unless 

it meets the requirements of this section. 

(1) No farmed or captive deer, elk, or 

moose may be moved interstate from 

farmed or captive herds where CWD has 

been diagnosed within the past 5 years 

or epidemiologically linked to herds 

where CWD has been diagnosed within 

the past 5 years. 

(2) No farmed or captive deer, elk, or 

moose may be moved interstate to any 

State listed on the list of States That 

Limit Cervid Entry Based on Proximity 

to CWD Occurrences 1 unless the 

certificate accompanying the animal 

states that its premises are at least 25 

miles (40 km) from any location where 

a Federal or State agency identified a 

case of CWD in wild deer, elk, or moose, 

and from any area, as defined by APHIS 

and the State, where CWD has become 

established in wild deer, elk, or moose. 

This list is maintained by the 

Administrator, and a State will be added 

to or removed from the list after the 

Administrator receives a written request 

to do so from the State government, 

documenting that State law or 

regulation bans the movement into the 

State of farmed or captive cervids from 

herds in proximity to CWD occurrences, 

or documenting that such a ban in State 

law or regulation has been repealed. 

(b) Animals in the CWD Herd 

Certification Program. The farmed or 

captive deer, elk, or moose is: 

(1) Enrolled in the CWD Herd 

Certification Program and the herd has 

achieved Certified status in accordance 

with § 55.24 of this chapter; and 

(2) Is accompanied by a certificate 

issued in accordance with § 81.4 that 

identifies its herd of origin and that 

states that the animal’s herd has 

achieved Certified status and that the 

animal does not show clinical signs 

associated with CWD. 

* * * * * 

9. In § 81.4, paragraph (a) is revised to 

read as follows: 

§ 81.4 Issuance of certificates. 

(a) Information required on 

certificates. A certificate must show any 

official animal identification numbers of 

each animal to be moved. A certificate 

must also show the number of animals 

covered by the certificate; the purpose 

for which the animals are to be moved; 

the points of origin and destination; the 

consignor; and the consignee. The 

certificate must include a statement by 

the issuing accredited veterinarian, 

State veterinarian, or Federal 

veterinarian that the animals were not 

exhibiting clinical signs associated with 

CWD at the time of examination and 

that the animals are from a herd that has 

achieved Certified status in the CWD 

Herd Certification Program, and must 

provide the herd’s program status; 

Except that, certificates issued for 

animals moved directly to slaughter do 

not need to state that the animals are 

from a herd that has achieved Certified 

status in the CWD Herd Certification 

Program and must state that an APHIS 

employee or State representative has 

been notified in advance of the date the 

animals are being moved to slaughter. 

The certificate must also include a 

statement by the issuing accredited 

veterinarian, State veterinarian, or 

Federal veterinarian that the animals are 

not from farmed or captive herds where 

CWD has been diagnosed within the 

past 5 years or epidemiologically linked 

to herds where CWD has been 

diagnosed within the past 5 years. The 

certificate must also include a statement 

by the issuing accredited veterinarian, 

State veterinarian, or Federal 

veterinarian as to whether or not the 

animals’ premises are within 25 miles 

(40 km) of a Federally or State-identified 

case of CWD in wild deer, elk, or moose, 

or within 25 miles (40 km) of an area, 

as defined by APHIS and the State, 


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14506 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Proposed Rules 

where CWD has become established in 

wild deer, elk or moose. 

* * * * * 

10. A new § 81.5 is added to read as 

follows: 

§ 81.5 State prohibitions on cervid 

movement not related to CWD. 

State laws and regulations prohibiting 

the entry of farmed or captive cervids 

for reasons unrelated to CWD are not 

preempted by this part. 

Done in Washington, DC, this 25th day of 

March 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–7026 Filed 3–30–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Parts 40, 41, 44, 46, and 71 

[Docket No. TTB–2009–0001; Notice No. 93; 

Re: T.D. TTB–75] 

RIN 1513–AB70 

Increase in Tax Rates on Tobacco 

Products and Cigarette Papers and 

Tubes; Floor Stocks Tax on Certain 

Tobacco Products, Cigarette Papers, 

and Cigarette Tubes; and Changes to 

Basis for Denial, Suspension, or 

Revocation of Permits (2009R–118P) 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking; 

cross-reference to temporary rule. 

SUMMARY: Elsewhere in this issue of the 

Federal Register, the Alcohol and 

Tobacco Tax and Trade Bureau is 

issuing a temporary rule implementing 

certain provisions of the Children’s 

Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA). 

The text of the regulations in the 

temporary rule published in the Rules 

and Regulations section of this issue of 

the Federal Register serves as the text 

of the proposed regulations. 

DATES: Comments must be received on 

or before June 1, 2009. 

ADDRESSES: You may send comments on 

this notice to one of the following 

addresses: 

• http://www.regulations.gov (via the 

online comment form for this notice as 

posted within Docket No. TTB–2009– 

0001 at ‘‘Regulations.gov,’’ the Federal 

e-rulemaking portal); 

• Director, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, P.O. Box 14412, 

Washington, DC 20044–4412; or 

• Hand Delivery/Courier in Lieu of 

Mail: Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street, NW., Suite 

200–E, Washington, DC 20005. 

See the Public Participation section of 

this notice for specific instructions and 

requirements for submitting comments, 

and for information on how to request 

a public hearing. 

You may view copies of this notice, 

any comments received, and the related 

temporary rule at http:// 

www.regulations.gov. A direct link to 

the appropriate Regulations.gov docket 

is also available under Notice No. 93 on 

the TTB Web site at http://www.ttb.gov/ 

regulations_laws/all_rulemaking.shtml. 

You also may view copies of these 

documents by appointment at the TTB 

Information Resource Center, 1310 G 

Street, NW., Washington, DC 20220. To 

make an appointment, call 202–927– 

2400. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning floor stocks tax, 

contact the National Revenue Center, 

Alcohol and Tobacco Tax and Trade 

Bureau (FloorStocksTax@ttb.gov, 513– 

684–3334 or 1–877–TTB–FAQS (1–877– 

882–3277)); for other questions 

concerning this document, contact Amy 

Greenberg, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau (202–927–8210). 

SUPPLEMENTARY INFORMATION: 

Background 

In the Rules and Regulations section 

of this issue of the Federal Register, we 

are publishing a temporary rule setting 

forth regulatory amendments to 

implement certain provisions of the 

Children’s Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA). 

The temporary rule amends the existing 

regulations to reflect increases in the tax 

rates on tobacco products and cigarette 

papers and tubes, revising existing floor 

stocks tax regulations to reflect the 

scope of the CHIPRA floor stocks tax 

provisions, and revising existing 

regulations to include the new statutory 

criteria for denial, suspension, or 

revocation of tobacco permits. 

The Alcohol and Tobacco Tax and 

Trade Bureau (TTB) is responsible for 

the administration of the Internal 

Revenue Code of 1986 provisions 

relating to qualification of 

manufacturers of tobacco products and 

cigarette papers and tubes, importers of 

those products, and export warehouses 

for those products. TTB is also 

responsible for collecting the excise 

taxes on tobacco products and cigarette 

papers and tubes removed from 

domestic production facilities and 

brought to the United States from Puerto 

Rico. In addition, TTB is responsible for 

collecting the floor stocks tax imposed 

by CHIPRA on tobacco products (except 

large cigars) and cigarette papers and 

tubes held for sale on April 1, 2009. 

The temporary regulations published 

elsewhere in this issue of the Federal 

Register involve amendments to parts 

40, 41, 44, 46, and 71 of the TTB 

regulations (27 CFR parts 40, 41, 44, 46, 

and 71). The text of the temporary 

regulations serves as the text of these 

proposed regulations. The preamble to 

the temporary regulations explains the 

proposed regulations. 

Public Participation 

Comments Invited 

We invite comments from interested 

members of the public on this proposed 

rulemaking. 

Submitting Comments 

You may submit comments on this 

notice by one of the following three 

methods: 

• Federal e-Rulemaking Portal: You 

may electronically submit comments on 

this notice through ‘‘Regulations.gov,’’ 

the Federal e-rulemaking portal. A 

direct link to the Regulations.gov docket 

containing this notice and its related 

comment submission form is available 

on the TTB Web site at http:// 

www.ttb.gov/regulations_laws/ 

all_rulemaking.shtml under Notice No. 

93. You may also reach this notice and 

its related comment form via the 

Regulatons.gov search page at http:// 

www.regulations.gov. Supplemental 

files may be attached to comments 

submitted via Regulations.gov. For 

complete instructions on how to use 

Regulations.gov, visit the site and click 

on ‘‘User Guide’’ under ‘‘How to Use 

this Site.’’ 

• Mail: You may send written 

comments to the Director, Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau, P.O. 

Box 14412, Washington, DC 20044– 

4412. 

• Hand Delivery/Courier: You may 

hand-carry your comments or have them 

hand-carried to the Alcohol and 

Tobacco Tax and Trade Bureau, 1310 G 

Street, NW., Suite 200–E, Washington, 

DC 20005. 

Please submit your comments by the 

closing date shown above in this notice. 

Your comments must reference Notice 

No. 93 and include your name and 

mailing address. Your comments also 

must be made in English, be legible, and 

be written in language acceptable for 

public disclosure. We do not 


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