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