[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Proposed Rules]
[Pages 14495-14506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7026]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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

[[Page 14495]]



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:
    <bullet> 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.
    <bullet> 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, white-tailed 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

[[Page 14496]]

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 Federal-State 
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 
regulations\1\ 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.
---------------------------------------------------------------------------

    \1\ For 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.
---------------------------------------------------------------------------

    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 Sec.  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.

[[Page 14497]]

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-of-time 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.
---------------------------------------------------------------------------

    \2\ Miller et al., 1998. Epidemiology of Chronic Wasting Disease 
in Captive Rocky Mountain Elk, Journal of Wildlife Diseases, 34:532-
538.
    \3\ Miller, personal communication.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \4\ Williams et al. 2002. Chronic Wasting Disease of Deer and 
Elk: A Review With Recommendations for Management. Journal of 
Wildlife Management 66(3): 551-563.
---------------------------------------------------------------------------

    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

[[Page 14498]]

for cervids moved interstate for non-slaughter purposes on the basis of 
their participation in the certification program; it would not affect 
the movement of cervids to slaughter.\5\
---------------------------------------------------------------------------

    \5\ The 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 Sec.  
81.4.
---------------------------------------------------------------------------

    To make this change, we propose to amend paragraph (a) of Sec.  
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\
---------------------------------------------------------------------------

    \6\ Later in this document, we also propose a change that would 
redesignate this paragraph (a) as paragraph (b).
---------------------------------------------------------------------------

    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, CWD-exposed animal, and CWD-suspect animal 
from Sec.  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 Sec.  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 Sec.  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:
    <bullet> 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.
    <bullet> 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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 14499]]

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 Sec.  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 Sec.  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 Sec.  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 (Sec.  55.23)

    We propose to make several changes to Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 14500]]

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 Sec.  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 Sec.  
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 Sec.  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

[[Page 14501]]

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 Sec.  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 Sec.  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 
CWD-suspect 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 
Sec.  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 eight-character 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.
---------------------------------------------------------------------------

    \8\ The 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.
---------------------------------------------------------------------------

    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 gradual-escalation 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

[[Page 14502]]

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.
---------------------------------------------------------------------------

    \9\ Herd 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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \10\ These 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.
---------------------------------------------------------------------------

    The proposal to prohibit CWD-positive, -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

[[Page 14503]]

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.
---------------------------------------------------------------------------

    \11\ APHIS 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.
---------------------------------------------------------------------------

    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 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 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

[[Page 14504]]

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.


Sec.  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.


Sec.  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.


Sec.  55.23  Responsibilities of States and enrolled herd owners.

    (a) * * *
    (4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect 
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 Sec.  55.24, paragraph (c)(1) is revised to read as follows:


Sec.  55.24  Herd status.

* * * * *
    (c) * * *
    (1) Herd owners may appeal designation of an animal as CWD-
positive, 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

[[Page 14505]]

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 CWD-suspect 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.


Sec.  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.


Sec.  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.
---------------------------------------------------------------------------

    \1\ This list will be maintained on the APHIS Web site at http://www.aphis.usda.gov.
---------------------------------------------------------------------------

    (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 Sec.  55.24 of this 
chapter; and
    (2) Is accompanied by a certificate issued in accordance with Sec.  
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 Sec.  81.4, paragraph (a) is revised to read as follows:


Sec.  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,

[[Page 14506]]

where CWD has become established in wild deer, elk or moose.
* * * * *
    10. A new Sec.  81.5 is added to read as follows:


Sec.  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