[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Rules and Regulations]
[Pages 35542-35571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14186]
[[Page 35541]]
Vol. 77
Wednesday,
No. 114
June 13, 2012
Part III
Department of Agriculture
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Animal and Plant Health Inspection Service
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9 CFR Parts 55 and 81
Chronic Wasting Disease Herd Certification Program and Interstate
Movement of Farmed or Captive Deer, Elk, and Moose; Interim Final Rule
Federal Register / Vol. 77 , No. 114 / Wednesday, June 13, 2012 /
Rules and Regulations
[[Page 35542]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 55 and 81
[Docket No. 00-108-8]
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: Interim final rule and request for comments.
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SUMMARY: We are amending a final rule, which will take effect when
these amendments become effective, that will establish a herd
certification program to control chronic wasting disease (CWD) in
farmed or captive cervids in the United States. Under that rule, owners
of deer, elk, and moose herds who choose to participate in the CWD Herd
Certification Program would have to follow requirements for animal
identification, testing, herd management, and movement of animals into
and from herds. This document amends that final rule to provide that
our regulations will set minimum requirements for the interstate
movement of farmed or captive deer, elk, and moose but will not preempt
State or local laws or regulations that are more restrictive than our
regulations. This document requests public comment on that change. This
document also amends the final rule to require farmed or captive deer,
elk, and moose to participate in the Herd Certification Program and to
be monitored for CWD for 5 years before they can move interstate,
clarify our herd inventory procedures, establish an optional protocol
for confirmatory DNA testing of CWD-positive samples, add a requirement
to continue testing cervids that are killed or sent to slaughter from
Certified herds, and make several other changes. These actions will
help to control the incidence of CWD in farmed or captive cervid herds
and prevent its spread.
DATES: Effective Date: This interim final rule is effective August 13,
2012. Additionally, the effective date of FR Doc 06-6367, published on
July 21, 2006 (71 FR 41682-41707), and delayed by FR Doc E6-14861,
published on September 8, 2006 (71 FR 52983), is now August 13, 2012.
Compliance Date: The date for complying with 9 CFR part 81 is
delayed until December 10, 2012. The compliance date for 9 CFR part 55
is August 13, 2012.
Comment Date: We will consider all comments on the subject of
preemption of State and local laws and regulations regarding chronic
wasting disease that we receive on or before July 13, 2012. We will
consider comments we receive during the comment period for this interim
final rule. After the comment period closes, we will publish another
document in the Federal Register. The document will include a
discussion of any comments we receive and any amendments we are making
to the rule.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2006-0118-0199.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. 00-108-8, Regulatory Analysis and Development, PPD, APHIS,
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2006-
0118 or in our reading room, which 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) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Patrice Klein, Senior Staff
Veterinarian, National Center for Animal Health Programs, Veterinary
Services, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231;
(301) 851-3435.
SUPPLEMENTARY INFORMATION:
Comment Subject Area
This interim final rule with request for comments discusses our
decision not to preempt State and local laws and regulations that are
more restrictive than our regulations with respect to chronic wasting
disease, except to allow transit of deer, elk, and moose that are
otherwise eligible for interstate movement through States with more
restrictive laws and regulations, in section III of the Background
section under the heading ``APHIS' Decision Not to Preempt More
Restrictive State Requirements on Farmed or Captive Cervids With
Respect to CWD.'' We will consider all comments that we receive on this
subject that are received by the date and time indicated in the DATES
section of this interim final rule with request for comments.
Background
I. Purpose of the Regulatory Action
a. Need for the Regulatory Action
Chronic wasting disease (CWD) is a transmissible spongiform
encephalopathy (TSE) of cervids (members of Cervidae, the deer family)
that, as of May 2011, 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. Species currently
known to be susceptible to CWD via natural routes of transmission
include Rocky Mountain elk, mule deer, white-tailed deer, black-tailed
deer, sika deer, and moose.
In the United States, as of March 2012, CWD has been confirmed in
wild deer and elk in 16 States and in 39 farmed elk herds and 15 farmed
or captive white-tailed deer herds in 11 States. The disease was first
detected in U.S. farmed elk in 1997. It was also diagnosed in a wild
moose in Colorado in 2005.
The presence of CWD in cervids causes significant economic and
market losses to U.S. producers. Canada prohibits the importation of
elk from Colorado and Wyoming and now requires that other cervids be
accompanied by a certificate stating that CWD has not been diagnosed in
the herd of origin. The Republic of Korea has suspended the importation
of deer and elk and their products from the United States and Canada.
The domestic prices for elk and deer have also been severely affected
by fear of CWD.
To help producers avoid the losses caused by CWD infection and
risk, we determined that it was necessary to establish a program that
would actively identify herds infected with CWD and allow producers to
manage these herds in a way that will prevent further spread of CWD.
Specifically, on July 21, 2006, we published a final rule in the
Federal Register (71 FR 41682-41707, Docket No. 00-108-3; ``the July
2006 final rule'') that established the Chronic Wasting Disease Herd
Certification Program in 9 CFR subchapter B, part 55. (That part had
previously contained only regulations related to the payment of
indemnity to the owners of CWD-positive captive herds who voluntarily
depopulate their herds.)
Under the July 2006 final rule, owners of deer, elk, and moose
herds who choose to participate would have to
[[Page 35543]]
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 July 2006 final rule also amended 9
CFR subchapter C by establishing a new part 81 containing interstate
movement requirements designed to prevent the spread of CWD through the
movement of farmed or captive deer, elk, or moose.
After publication of the July 2006 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 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 carefully considered
the petitions and the public comments received in response to them.
On March 31, 2009, we published in the Federal Register (74 FR
14495-14506, Docket No. 00-108-7; ``the March 2009 proposed rule'') a
proposal \1\ to amend the July 2006 final rule. We proposed to amend
the July 2006 final rule by recognizing State bans on the entry of
farmed or captive cervids for reasons unrelated to CWD, increasing to 5
the number of years an animal must be monitored for CWD before it may
be moved interstate; restricting the interstate movement of cervids
that originated from herds in proximity to a CWD outbreak; changing
herd inventory procedures; prohibiting the addition of animals to CWD-
positive, -suspect, and -exposed herds; requiring States to conduct
wildlife surveillance for CWD as part of their Approved State CWD Herd
Certification Programs; providing for optional confirmatory DNA testing
of CWD-positive samples; and making several other changes.
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0118.
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This final rule sets an effective date for the July 2006 final rule
and makes changes to it based on the March 2009 proposal and on the
comments we received on that proposal.
b. Legal Authority for the Regulatory Action
Under the Animal Health Protection Act (AHPA, 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. The
regulations in 9 CFR subchapter C establish requirements for the
interstate movement of livestock to prevent the dissemination of
diseases of livestock within the United States.
II. Summary of the Major Provisions of the Regulatory Action
The CWD Herd Certification Program is a cooperative effort between
APHIS, State animal health and wildlife agencies, and deer, elk, and
moose owners. APHIS coordinates with these State agencies to encourage
deer, elk, and moose owners to certify their herds as low risk for CWD
by being in continuous compliance with the CWD Herd Certification
Program standards.
Under subchapter B of part 55, States that participate in the CWD
Herd Certification Program must establish State programs that are
approved by APHIS. We will approve such programs if the State:
Establishes movement restrictions on CWD-positive, CWD-
suspect, and CWD-exposed animals, to prevent the spread of the disease,
and requires testing of such animals.
Conducts traceback on such animals, to determine what
other animals may be affected.
Requires testing of all animals that die or are killed. As
we do not have live-animal tests for CWD, it is important to sample and
test carcasses whenever possible to accurately evaluate the CWD risk in
a herd.
Maintain premises and animal identification for all herds
participating in the CWD Herd Certification Program in the State. This
is an integral part of being able to conduct traceback.
Herd owners will be approved to participate under State CWD Herd
Certification Programs if they:
Identify each animal in their herds through approved means
of identification and maintain a complete inventory of the herd. These
requirements are also integral to conducting traceback. Upon request by
APHIS or the State, owners must also allow officials to conduct a herd
inventory to verify the records.
Add to their herds only animals that are from herds
enrolled in the CWD Herd Certification Program, to ensure that animals
added to herds are of known risk.
Maintain perimeter fencing adequate to prevent ingress or
egress of cervids, to prevent CWD from being spread through contact
with wild cervids.
Report to APHIS or the State all animals that escape or
disappear, and report to APHIS or the State all animals that die or are
killed and make their carcasses available for tissue sampling and
testing.
Herds are given a status based on the date they enrolled in the
program. Herds that do not have any CWD-infected or CWD-exposed animals
for 5 years will be granted Certified status. (Herd owners who
participate in State CWD Herd Certification Programs that are approved
by APHIS will be credited for the time they have participated in such a
program towards the 5-year requirement.) Based on current science, 5
years of surveillance is a reasonable time period to determine whether
the disease is present in the herd, as CWD has an incubation period.
Thus, the movement of animals from a Certified herd poses a low risk of
spreading CWD.
The movement restrictions in 9 CFR part 81 therefore allow deer,
elk, and moose from Certified herds to move interstate. They also allow
the interstate movement of wild animals captured for interstate
movement or release, if identified with two forms of animal
identification, including one official identification, and if the
source population has been documented to be low risk for CWD based on a
surveillance program. The part also allows the interstate movement of
animals moved for slaughter; research animals; and other animals on a
case-by-case basis. Finally, this part includes provisions under which
deer, elk, or moose that are eligible to move interstate may transit a
State that bans or restricts the entry of such animals en route to
another State.
A detailed discussion of the provisions of 9 CFR part 55,
subchapter B, and 9 CFR part 81 is available in the July 2006 final
rule. This document concentrates on the changes we are making to the
July 2006 final rule
[[Page 35544]]
subsequent to the March 2009 proposed rule and in response to comments.
The major changes we are making are:
The March 2009 proposal indicated that the goal of the CWD
program was to eliminate the disease in farmed or captive cervids. We
have now determined that our goal is to control the spread of the
disease. The persistence of CWD in wild cervid populations and our
current lack of knowledge about the transmission of CWD have made the
goal of eliminating CWD from farmed or captive cervids impractical.
Our CWD regulations will set minimum standards for State
CWD Herd Certification Programs and for the interstate movement of
cervids. The March 2009 proposal indicated that we would preempt State
and local laws and regulations that were more restrictive as well.
However, we have since decided that our regulations will not preempt
State and local laws and regulations that are more stringent than our
regulations, except that (as noted earlier) cervids that are eligible
to move interstate may transit a State that bans or restricts the entry
of such animals en route to another State. We are soliciting public
comment on this decision, as described below under the heading ``APHIS'
Decision Not to Preempt More Restrictive State Requirements on Farmed
or Captive Cervids With Respect to CWD.''
The March 2009 proposed rule included some proposed
provisions designed to give States options to regulate CWD within the
context of Federal preemption of State and local laws and regulations,
such as allowing States to prohibit entry of cervids for reasons
unrelated to CWD and because of proximity to findings of CWD in
wildlife. We are not including those provisions in this final rule
because they are no longer necessary given our decision on preemption.
Because our goal is now to control the spread of CWD
rather than to eliminate it, we are not requiring States to conduct
surveillance for CWD in wild cervid populations or requiring States to
prohibit the addition of animals to herds containing CWD-positive, CWD-
exposed, or CWD-suspect animals.
Based on comments on the March 2009 proposed rule, we are
removing an exemption in the July 2006 final rule under which Certified
herds were not required to make animals that were sent for slaughter or
killed on shooter operations available for testing. We are also making
several minor changes to improve the clarity of the changes we proposed
and of the regulations.
III. Discussion of Comments
We solicited comments concerning the March 2009 proposal for 60
days ending July 1, 2009. We received 78 comments by that date. They
were from producers, researchers, and representatives of State
governments. They are discussed below by topic.
General Opposition to the CWD Herd Certification Program
Several commenters recommended that we withdraw the July 2006 final
rule, rather than making changes to it as described in the proposal and
issuing a revised final rule. These commenters stated that designing a
Federal program for control of CWD in captive cervids is about a decade
too late to be useful. The commenters doubted that, at this point in
time, the Federal program as described would materially improve CWD
control beyond what has already been achieved by the collective
coordinated efforts of State animal health and wildlife management
agencies. Rather, the commenters stated, options for providing Federal
assistance to States would be most beneficial and efficient. Commenters
also stated that, under this approach, many of the key elements of the
Federal CWD Herd Certification Program could still be provided by APHIS
to the States as guidance for establishing or refining their respective
CWD control programs.
We have determined that a voluntary Federal CWD program is
necessary to give States from which farmed or captive cervids are moved
interstate and herd owners who move farmed or captive cervids
interstate the opportunity to demonstrate that they meet minimum
standards for CWD management. These minimum standards are necessary for
an effective CWD program. Guidelines for a CWD program, rather than
mandatory requirements, would not be sufficient to ensure that the CWD
program is effective.
Accordingly, this final rule announces our intention to amend the
July 2006 final rule and set an effective date for the amended final
rule of August 13, 2012. The regulatory text at the end of this
document includes the complete text of the July 2006 final rule, as
amended by this final rule. The changes to the July 2006 final rule are
described in the March 2009 proposed rule and the Background section of
this document.
We agree with the commenters that circumstances relevant to a
Federal CWD program have changed over time, necessitating a change in
the objective of the CWD program. In the July 2006 final rule and the
March 2009 proposed rule, as well as all our previous CWD-related
rules, the stated objective of the CWD program was the elimination of
CWD from captive and farmed cervids in the United States. We have now
concluded, however, that our CWD objective should be to establish a
herd certification program for herd owners and States to control the
incidence of CWD in farmed and captive cervids and prevent the
interstate spread of CWD. We have concluded that elimination of CWD
from farmed and captive cervids is not practical given the persistence
of CWD in wild cervid populations and our current lack of knowledge
about how CWD may be transmitted between wild cervid populations and
farmed and captive cervids. The CWD Herd Certification Program will
allow States and herd owners to monitor herds of farmed and captive
cervids to ensure that they are at low risk for CWD, and our
regulations in part 81 will allow only farmed or captive deer, elk, and
moose from herds that have reached Certified status in the CWD Herd
Certification Program, after 5 years of monitoring, to be moved
interstate, with limited exceptions.
A few commenters stated that the position that a Federal CWD
program is unnecessary is in keeping with APHIS' overall intent to
phase out regulatory efforts for ``program diseases'' in the coming
decade.
We assume the commenters are referring to our plans for the
strategic future of APHIS' Veterinary Services (VS) program,\2\ in
which we have stated that VS will increase its focus on disease
prevention, preparedness, detection, and early response. Our plans also
acknowledge that several major disease control and eradication programs
are either complete or nearing completion. However, we do not
contemplate APHIS phasing out administration of the disease control and
eradication programs to which the commenters referred, but rather
redirecting resources as necessary to accomplish new objectives based
on new circumstances. We will continue to administer disease control
and eradication programs, including the CWD Herd Certification Program.
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\2\ For more information on this plan, see http://www.aphis.usda.gov/about_aphis/programs_offices/veterinary_services/vision_science.shtml.
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One commenter stated that the proposed rule will fail to adequately
control CWD in farmed or captive cervids in the United States. The
commenter cited increases in positive tests of farmed and captive
cervids for
[[Page 35545]]
CWD and additional States in which CWD has been found in captive herds
since December 2003, when the initial proposed rule to establish the
CWD Herd Certification Program was published. The commenter stated
that, if the goal of the CWD Herd Certification Program is to eliminate
CWD from captive cervid herds, stricter controls must be in place to
prevent further spread of the disease. For example, the commenter
stated, it is possible for a captive cervid facility to earn Certified
status, thus allowing animals from the herd to be moved interstate,
without testing a single animal for CWD.
The suspension of the effective date of the July 2006 final rule
means that States and herd owners have not been required to comply with
its provisions. The CWD Herd Certification Program we are establishing
imposes new controls on the interstate movement of deer, elk, and
moose. The requirements for interstate movement and herd certification
in the July 2006 final rule, with the modifications discussed in the
March 2009 proposal and in this document, will help prevent the spread
of CWD.
With respect to the commenter's specific concern regarding the July
2006 final rule, Sec. 55.23(b)(3) requires herd owners to inform an
APHIS or State representative regarding all animals that die (including
animals killed on premises maintained for hunting and animals sent to
slaughter) and to make the carcasses of the animals available for
tissue sampling and testing in accordance with instructions from the
APHIS or State representative. We expect that we will test all samples
that will be provided to us. If a herd had no mortality for 5 years,
which is unlikely, it could reach Certified status without having
animals tested. However, given our current knowledge about the biology
of CWD, there is a low risk that CWD will be present in a herd after 5
years of monitoring with no mortality. In addition, continued
surveillance will be required for any Certified herd to retain its
Certified status.
APHIS' Decision Not To Preempt More Restrictive State Requirements on
Farmed or Captive Cervids With Respect to CWD
In the Background section of the July 2006 final rule, under the
heading ``Executive Order 12988,'' we stated that the July 2006 final
rule preempted all State and local laws and regulations that were in
conflict with it. Our intent was to establish uniform requirements that
would apply to the interstate movement of farmed or captive cervids to
each of the States.
The petitions we received and made available with the November 2006
notice indicated strong opposition to Federal preemption of State
restrictions on farmed and captive cervids with respect to CWD. We
considered the petitions, and the comments on the petitions, in
developing the proposed rule we published in the Federal Register on
March 31, 2009. We also received several comments on the March 2009
proposal addressing whether the Federal CWD requirements should preempt
inconsistent State requirements.
As discussed earlier, we have now concluded that our objective with
respect to CWD should be to establish a herd certification program for
herd owners and States to control the incidence of CWD in farmed and
captive cervids and prevent the interstate spread of CWD, as
elimination of CWD from farmed and captive cervids is not practical.
Accordingly, these CWD regulations will set mandatory minimum
requirements for interstate movement of farmed or captive cervids with
respect to CWD; they will not preempt State and local laws and
regulations on CWD in farmed or captive cervids when those laws and
regulations are more restrictive than the Federal regulations. (The
only exception is with respect to the movement of farmed or captive
cervids through a State, as discussed later in this document.)
This approach will ensure that there are minimum requirements
applicable to the interstate movement of farmed or captive cervids,
while also allowing State and local laws, regulations, and policies to
impose additional requirements on farmed or captive cervids as
necessary to address local needs. We believe this approach is
appropriate for CWD, where we have limited methods for diagnosing the
disease and preventing its spread and where the goal of the program is
to control, rather than eradicate, the disease.
Several commenters focused on the issue of State wildlife
management authority. These commenters stated that States must retain
authority to regulate and manage wildlife resources more stringently if
they feel that risks are not adequately mitigated by the Federal
program. The commenters specifically cited banning movement of captive
cervids into a State for any reason, including risks related to CWD.
The CWD Herd Certification Program seeks to control CWD in farmed
or captive cervids. We are not imposing requirements on States with
respect to management of wild cervid populations, except when those
populations could pose a disease risk to farmed or captive cervids,
such as the translocation of wild cervids from wild populations that
have not been assessed for CWD. As long as they do not affect farmed or
captive cervids, State and local laws and regulations related to
management of wild cervid populations are not affected by the CWD
regulations. The only provision of the July 2006 final rule that
relates to wild cervids is a requirement that animals captured from
wild populations for interstate movement and release be accompanied by
a certificate documenting the source population to be low risk for CWD,
based on a CWD surveillance program that is approved by the State
government of the receiving State and by APHIS. This requirement is
directly related to and necessary for preventing the introduction of
CWD into farmed or captive cervid populations, although it provides
some protection for wild cervid populations as well.
Note: The July 2006 final rule contained requirements in Sec.
81.3(b) for interstate movement of captive cervids that were
captured from free-ranging populations. In this final rule, we are
changing the description of these populations to ``wild
populations,'' as farmed or captive cervids may range freely on
their premises without being considered ``free-ranging'' for the
purposes of the regulations. We are also replacing references to
``free-ranging'' in the definitions of farmed or captive in
Sec. Sec. 55.1 and 81.1 with references to ``wild,'' changing the
order of the wording in the phrase ``captured for interstate
movement and release from a wild population'' in Sec. 81.3(b) to
``captured from a wild population for interstate movement and
release,'' and clarifying Sec. 81.3(b) to indicate that it requires
a CWD surveillance program for wild cervid populations in order to
allow the interstate movement of cervids captured from wild
populations. These changes are intended to improve the clarity of
the regulations. Discussions of wild cervid populations in the
remainder of the Background section of this rule reflect this
change.
Several commenters also expressed concern regarding classifying
farmed or captive cervids as livestock. These commenters noted that
APHIS' authority to prevent, control, or eradicate diseases, pursuant
to the AHPA, specifically refers to livestock. These commenters pointed
out that that the legal definition of livestock is highly variable
among States; many States do not define captive native species as
``livestock,'' since livestock is not always within the sole
jurisdiction of their fish and wildlife agencies. Thus, the commenters
stated, in some instances captive cervids of native species may not
fall within the Federal definition of livestock. The commenters
[[Page 35546]]
recommended removing the references to livestock in the regulations or
yielding to a State's definition when referring to cervids in this way.
We appreciate the commenters' concerns. Clearly, farmed and captive
cervids are not traditional livestock; they are often referred to as
alternative livestock. We understand that State fish and wildlife
agencies in many States are responsible for the management of all
cervids within their State, not just those that are wild but also those
held on farms or in other captive situations. Nonetheless, these
agencies may not have experience working within the context of a
program designed to control an animal disease in farmed or captive
animal populations.
The AHPA charges the U.S. Department of Agriculture with the
responsibility of controlling or eradicating any pest or disease of
livestock, and defines ``livestock'' broadly as ``all farm-raised
animals.'' This means that all farmed or captive cervids fall under the
AHPA definition of livestock. Under this authority, we have determined
that it is appropriate to establish requirements for the interstate
movement of farmed or captive cervids to help prevent the spread of
CWD. To the extent that State fish and wildlife agencies are
responsible for farmed or captive cervids in their States, they will
need to cooperate with APHIS in the administration of the CWD
regulations. We will work with State fish and wildlife agencies to help
them to understand their responsibilities and to ensure that we can
cooperate well. It is important to reiterate that States retain the
authority to manage fish and wildlife populations, including wild
cervids, under this final rule.
Several commenters urged the adoption of regulations that would
preempt State and local laws and regulations on farmed or captive
cervids with respect to CWD. Commenters noted that the movement of
farmed and captive deer and elk has been extremely difficult because of
a variety of different rules at the State level, with some States
banning the movement of farmed or captive deer and elk into or through
their States altogether.
We understand the commenters' concerns with regard to facilitating
the interstate movement of farmed and captive cervids. For the reasons
set forth below, however, we have decided that our CWD regulations will
not preempt State and local laws and regulations that are more
restrictive than our regulations.
First, while the herd certification program and the requirements
for interstate movement of farmed and captive cervids in the July 2006
final rule, as amended by this document, are supported by the best
available science, we recognize that the methods for mitigating the
disease are evolving; our current methods are limited by the current
state of scientific knowledge. As such, it is not possible to create a
uniform set of proven mitigations for CWD. We have determined that, in
such circumstances, States should be able to implement more restrictive
laws and regulations if they determine such laws and regulations to be
appropriate.
For example, one commenter stated that States should be able to
impose more restrictive requirements or prohibitions on the interstate
movement of farmed or captive cervids because there is currently no
practical live-animal test validated for white-tailed deer, in contrast
to other diseases mentioned in the March 2009 proposed rule, such as
tuberculosis and brucellosis. The lack of a live-animal test creates
uncertainty about the disease-free status of herds, or animals moved
interstate from herds.
We agree the lack of a live-animal test for CWD creates
uncertainty. Our approach to establishing a greater degree of certainty
involves monitoring all herds enrolled in the CWD Herd Certification
Program for at least 5 years before allowing animals from those herds
to move interstate. This approach uses surveillance over time to
increase the certainty that animals from a herd are low risk; 5 years
of testing all cervids that die in a herd without finding a CWD-
positive animal provides substantial assurance that CWD is not present
in the herd. However, surveillance in the CWD Herd Certification
Program does not provide the same level of certainty with respect to
the disease status of an individual animal that a live-animal test
could provide. Allowing States to impose more restrictive requirements
than our requirements acknowledges that this uncertainty exists.
Another commenter stated that the industry in the commenter's State
considers that State's CWD program to be a benchmark after which other
States' programs could be modeled. The commenter stated that industry
recognizes that a Federal rule is needed for interstate movement of
registered animals, but expressed concern that not allowing the State
to impose stricter requirements in some situations might not be
appropriate.
We agree that States can serve as laboratories for different
regulatory approaches. In the uncertain scientific environment
surrounding CWD, we welcome any additional evidence we can gather about
the effectiveness of regulatory approaches. Our decision to allow
States to impose requirements that are more restrictive than our
regulations will allow States to create and experiment with regulatory
programs.
The other reason to allow States to develop and enforce laws and
regulations that are more restrictive than our regulations is, as we
noted above, inherent in the fact that our program objective has
changed to reflect changes in conditions. When the objective of a
program is to eliminate a disease, we impose requirements that are
sufficient to achieve that objective, based on the best available
science. If a State were to impose requirements that are more
restrictive than our requirements in such a case, the additional State
requirements would impede interstate commerce without advancing the
objective of the program.
However, the objective of our regulations is now to assist in
controlling CWD in farmed and captive cervids, rather than eliminating
CWD in farmed and captive cervids. Eliminating CWD from farmed and
captive cervids is not practical given the persistence of CWD in wild
cervid populations and our current lack of knowledge about how CWD may
be transmitted between wild cervid populations and farmed and captive
cervids. Other gaps in our scientific knowledge we have about CWD also
impair our ability to achieve eradication, including the lack of
certainty regarding the disease status of individual live animals, the
lack of knowledge regarding how the disease is transmitted between wild
and farmed or captive cervid populations, and our lack of knowledge
regarding effective cleaning and disinfection measures for premises on
which CWD has been found. (For example, we do not know any cleaning and
disinfection measures that allow us to effectively address the
persistence of CWD in substrates.)
For these reasons, the CWD Herd Certification Program and our
interstate movement restrictions are designed to prevent the spread of
CWD, rather than to eliminate it. Allowing States to establish more
restrictive laws and regulations on farmed and captive cervids
recognizes that States may want to establish a higher level of
protection against the disease than the Federal program is designed to
provide.
In this final rule, we are also establishing provisions for the
interstate transportation of farmed or captive cervids through States
in response to comments. These provisions will preempt State and local
laws and regulations in addition to or different
[[Page 35547]]
than the requirements set forth in this final rule. These provisions
allow owners of farmed or captive cervids (including animals captured
from wild populations for interstate movement and release) to move
those cervids, without unloading and while en route to another State,
through States that prohibit or restrict the entry of farmed or captive
cervids into their State.
Specifically, 15 commenters asked us to address the issue of State
bans or restrictions on the interstate movement of farmed or captive
cervids through a State to another State of destination. The commenters
stated that States should not have the right to ban interstate movement
through a State to another State when the farmed or captive cervids
being moved meet the entry requirements of the destination State. Ten
of the commenters specifically recommended defining ``entry'' and
``import'' as being received into a specific State and excluding from
State regulation any movement through States that are not receiving
farmed or captive cervids.
We agree with these commenters that the regulations should provide
for movement through a State, even if the State bans movement of farmed
or captive cervids into the State. While, as noted, our scientific
knowledge about CWD is limited, the scientific knowledge we have
suggests that CWD is not highly infectious. In general, the movement of
animals through a State without unloading poses a low risk of spreading
CWD, and the regulations in part 81 ensure that the animals moved
interstate will themselves present a low risk of being infected with
CWD.
Not providing for movement through States that ban or further
restrict the entry of farmed or captive deer, elk, or moose would also
raise several issues. The rerouting required to avoid such States may
make transportation of farmed or captive cervids economically
unfeasible. Even if such transportation is economically feasible, the
additional time necessary to traverse a lengthy route may raise animal
health or welfare issues for the cervids being transported; the cervids
would need regular water, feed, and rest, as required for all livestock
under the Twenty-Eight Hour Law (49 U.S.C. 80502). Captive cervids that
needed to be offloaded for such purposes would not be easy to confine
and to reload onto a conveyance. Given the low risk associated with
this type of movement, we have determined that it is appropriate to
provide for the movement of farmed or captive cervids through States
and localities whose laws or regulations on the movement of captive
cervids are more restrictive than the regulations in part 81.
In this final rule, a new Sec. 81.6 indicates that State and local
laws and regulations that are more restrictive than the regulations in
part 81 are not preempted by part 81, except for the regulations
regarding interstate movement through a State to another State in Sec.
81.5.
Section 81.5 sets out the following provisions for farmed or
captive deer, elk, or moose to move through a State or locality whose
laws or regulations are more restrictive than those in part 81 to
another State:
The farmed or captive deer, elk, or moose must be eligible
to move interstate under Sec. 81.3. This section requires animals that
move interstate to be from Certified herds, to be from wild populations
that have been documented to be low risk for CWD, or to be moved
directly to slaughter. It also provides for movement of research
animals under permit, which will only be issued if the movement
authorized will not result in the interstate dissemination of CWD.
Thus, movement of animals under Sec. 81.3 already presents a low risk
of spreading CWD, even without considering the low risk associated with
the pathway of transportation through a State.
The farmed or captive deer, elk, or moose must meet the
entry requirements of the destination State listed on the certificate
or permit accompanying the animal.
Except in emergencies, the farmed or captive deer, elk, or
moose must not be unloaded until their arrival at their destination.
Emergencies might include a breakdown of the vehicle transporting the
deer, elk, or moose or weather conditions that make it impossible or
extremely unsafe for a vehicle to continue along its scheduled
itinerary.
We recognize that the decision not to preempt State and local laws
and regulations with respect to CWD, except for deer, elk, and moose
that are moved through a State, represents a change in our preemption
policy, as expressed in the July 2006 final rule and the March 2009
proposed rule. We believe the change is appropriate for the reasons
discussed above. However, because the public has not previously had a
chance to comment on this change in policy, we are requesting comment
on our new policy, as well as the specific provisions of Sec. 81.5. We
will consider comments we receive during the comment period for this
interim final rule. After the comment period closes, we will publish
another document in the Federal Register. The document will include a
discussion of any comments we receive and any amendments we are making
to the rule.
Although we may make changes based on comments, the rest of the
Background section of this document assumes that the preemption policy
described above will continue to be effective.
Changes in the March 2009 Proposed Rule That Are Now Unnecessary
Because the objective of the CWD program have changed from
elimination of the disease in farmed and captive cervids to control of
the spread of the disease, several changes we proposed in March 2009
are no longer necessary:
Allowing States to prohibit entry of cervids for reasons unrelated
to CWD. As noted earlier, we proposed to add to the July 2006 final
rule a new Sec. 81.5 indicating that State laws and regulations
prohibiting the entry of farmed or captive cervids for reasons
unrelated to CWD are not preempted by 9 CFR part 81. Since we are
allowing States to prohibit the entry of farmed or captive cervids for
reasons related to CWD, except with respect to movement through a
State, the proposed section is no longer necessary.
Allowing States to prohibit entry of farmed or captive cervids
based on proximity to CWD in wild deer, elk, or moose. We proposed to
add to the July 2006 final rule provisions allowing States to refuse
entry to farmed or captive cervids that originated from 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 of an area, as defined by APHIS
and the State, where CWD has become established in wild deer, elk, or
moose. As States may now impose such requirements, as well as other
additional requirements, under Sec. 81.6, we are not including these
changes in this final rule.
Requiring ongoing wildlife surveillance as part of an Approved
State CWD Herd Certification Program. In the July 2006 final rule,
paragraph (a) of Sec. 55.23 lists aspects of a CWD program that the
Administrator will evaluate when determining whether a State CWD
program qualifies as an Approved State CWD Herd Certification Program.
We proposed to add to this list that the Administrator will evaluate
whether the State conducts monitoring and surveillance activities to
estimate geographic distribution of CWD in the State. This requirement
was included to ensure that States had data allowing them to certify
that farmed or captive cervids moved interstate did not originate from
premises in proximity to a known CWD outbreak, to support the
[[Page 35548]]
proximity provisions in the March 2009 proposed rule. Since we are not
including those provisions in this final rule, specifically requiring
that States conduct monitoring and surveillance activities to estimate
geographic distribution of CWD in the State is no longer necessary.
However, we continue to encourage States to conduct monitoring and
surveillance for CWD in wildlife populations. Knowledge of the
geographic distribution of CWD in wildlife that is generated through
wildlife surveillance is valuable to both wildlife and domestic animal
managers. The information helps both groups assess risk of animal
movement and helps in other disease prevention and management planning.
In addition, for deer, elk, or moose captured from a wild
population for interstate movement and release, the regulations in
Sec. 81.3(b) require the certificate accompanying those animals to
document that the animals are from a source population that is low risk
for CWD, based on a CWD surveillance program that is approved by the
State Government of the receiving State and APHIS. States that want to
facilitate such movement will need to have a CWD surveillance program
in place for their wild populations.
In the past, APHIS has supported surveillance for CWD in wild
cervid populations through cooperative agreements with State wildlife
agencies and tribes. We hope that we will be able to continue to
support wildlife surveillance. We anticipate that APHIS will receive
flat or declining budgets for the next several years, which would
likely substantially limit our support. Nonetheless, we will work with
State wildlife agencies and tribes to develop more efficient and
effective surveillance strategies for the future.
Not allowing herds to participate in the CWD Herd Certification
Program based on proximity to CWD in wild deer, elk, or moose. In the
July 2006 final rule, paragraph (a) of Sec. 55.22, ``Participation and
enrollment,'' sets out procedures for owners to enroll and participate
in the CWD Herd Certification Program. In the March 2009 proposed rule,
we proposed to amend Sec. 55.22(a) to state that an application for
participation may be denied if APHIS or the State determines that the
applicant's herd was established after a subsequent final rule becomes
effective on a premises within 25 miles of a federally or State-
identified case of CWD in wild deer, elk, or moose, or within 25 miles
of an area, as defined by APHIS and the State, where CWD has become
established in wild deer, elk, or moose. The requirement was proposed
in conjunction with the other proximity provisions that we are not
including in this final rule. In the proposal, we also stated that,
while the level of risk associated with maintaining a CWD herd in
proximity to known occurrences of CWD in wild cervids is unknown, the
proposed prohibition on establishing new herds in proximity to CWD
occurrences in the wild would add to the effectiveness of CWD control.
However, commenters presented information indicating that the 25-
mile distance was not necessarily enough to mitigate the risk of
exposure to CWD, given the distribution and variation in home ranges of
wild deer, elk, and moose, meaning that the standard might not
effectively mitigate whatever risk may exist. Given that the primary
impetus for potentially denying the application for participation of a
herd in proximity to known occurrences of CWD in wild herds was to
support the other proximity provisions in the March 2009 proposed rule,
and given the information presented by the commenters, we are not
including this provision in the final rule. However, under this final
rule, States may choose to address the risk associated with premises in
areas in proximity to CWD cases or areas where CWD has become
established by placing their own restrictions on the establishment of
premises in such areas, based on local conditions.
Finally, one commenter opposed preemption and specifically stated
that States should be allowed to require written approval from the
State veterinarian for any consignment of deer, elk, or moose to enter
the State before it is moved interstate from its premises of origin.
Another commenter generally asked us to require the State agency
overseeing captive cervids in the receiving State to be notified when
captive cervids are moved to a State. Our decision to allow States to
impose additional requirements on the entry of captive cervids beyond
those in our regulations allows for States to keep such requirements in
place, or to impose them, as they determine to be necessary.
Overlap of Federal and State Requirements
Two commenters stated that the March 2009 proposed rule included
various provisions for inspections and certification requirements that
are duplicative of their State's rules and regulations. The commenters
asked whether the APHIS requirements are in addition to State
regulations or if the State's current practices would satisfy the
requirements. The commenters expressed concern about the burden that
could result if the APHIS requirements were being imposed in addition
to State requirements.
Another commenter requested that APHIS consider exemptions from
Federal requirements for States which, now or in the future, develop
comprehensive, risk-based regulatory CWD policies pertaining to
confined cervid populations.
Several States already enroll deer and elk herd owners in programs
based on these principles. We believe that it is better to build a
Federal program that recognizes State activities than to replace them
with a strictly Federal program. Therefore, the July 2006 final rule
allows APHIS to recognize State regulations and procedures as
satisfying APHIS requirements. We believe the States that have or are
developing CWD programs can readily incorporate our proposed minimum
criteria with few or no changes to State programs.
Specifically, in Sec. 55.23, paragraph (a) sets out the elements
necessary for a State to have an Approved State CWD Herd Certification
Program. This paragraph sets general standards but does not prescribe
the means for meeting them. If a State's CWD program meets the minimum
requirements in Sec. 55.23(a), we do not impose any further
requirements on the State. Thus, State practices can satisfy APHIS
requirements under the regulations.
It is not necessary to exempt States that have or develop
comprehensive, risk-based CWD regulatory policies from Federal
requirements; such a regulatory policy would be recognized under Sec.
55.23(a) as an Approved State CWD Herd Certification Program. An
Approved State CWD Herd Certification Program allows herds in that
State that reach Certified status to move their animals interstate.
Under this final rule, any farmed or captive cervids moved interstate
will have to come from an Approved CWD Herd Certification Program, with
limited exceptions.
Definition of Official Animal Identification
The July 2006 final rule included in Sec. Sec. 55.1 and 81.1 a
definition of official animal identification. In the March 2009
proposed rule, we proposed to amend this definition to indicate that
the CWD program allows the use of either the eight-character or nine-
character identification number format for cervids.
One commenter stated that approval for the animal identification
tag in the commenter's State has been requested several times since
2008, without
[[Page 35549]]
confirmation that the request has been received or is being considered.
The commenter noted that the tag in question is a nine-character tag.
Another commenter expressed general concern that our approval of State
tags has not been forthcoming.
Until the publication of this final rule, there has been no CWD
Herd Certification Program in place in the regulations, and we have
been concentrating on determining the appropriate objectives and
provisions of the overall program. We plan to evaluate State animal
identification for use as official identification as part of the CWD
Herd Certification Program implementation process. We will reach out to
these commenters to ensure that we are addressing their concerns, and
we invite others who may have similar concerns to contact the person
listed under FOR FURTHER INFORMATION CONTACT.
Definition of National Uniform Eartagging System
The definition of official animal identification in the July 2006
final rule referred to the National Uniform Eartagging System as one of
three systems of nationally unique animal identification that fulfilled
the requirements of the definition. In the March 2009 proposed rule, we
included a definition of National Uniform Eartagging System to help
provide more information about this system, supporting the goal of
standardizing animal identification and increasing animal traceability.
Several commenters expressed concern that State-approved animal
identification might not be recognized as official animal
identification under the definition of National Uniform Eartagging
System. These commenters stated that all State-approved official
identification that is in use should be approved, and updates to animal
identification systems should be required for new herds only.
The proposed National Uniform Eartagging System definition did not
affect the definition of official animal identification in the July
2006 final rule. The National Uniform Eartagging System is a numbering
system, not a tagging system. With respect to identification devices,
animals in herds enrolled in the CWD Herd Certification Program must
have at least two forms of animal identification attached to the
animal, approved by APHIS. As stated above, we will evaluate State
animal identification systems for approval as official identification
as part of the implementation process for the CWD Herd Certification
Program.
Definition of Premises Identification Number
The July 2006 final rule defined premises identification number
(PIN) in Sec. Sec. 55.1 and 81.1 as a unique number assigned by a
State or Federal animal health authority to a premises that is, in the
judgment of the State or Federal animal health authority, a
geographically distinct location from other livestock production units.
The PIN is associated with an address or legal land description and may
be used in conjunction with a producer's own livestock production
numbering system to provide a unique identification number for an
animal. The definition stated that the PIN may consist of:
The State's two-letter postal abbreviation followed by the
premises' assigned number; or
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.
The definition of official animal identification, in turn, allows
the use of a premises-based number system in which an official PIN is
combined with a producer's livestock production numbering system to
provide a unique identification number.
In the March 2009 proposed rule, we proposed to amend this
definition by, among other things, removing the option to use the
State's two-letter postal abbreviation followed by the premises'
assigned number as a PIN. Under the proposed rule, PINs issued after
the effective date of a final rule following the March 2009 proposal
would have had to consist of the seven-character alphanumeric code with
the characteristics described above.
Four commenters raised concerns about this change. One stated that
producers who use eartags numbered with a premises-based number system
containing PINs with State two-letter postal abbreviations and unique
identifiers can now purchase eartags from the company of their choice
without the involvement of an accredited veterinarian. Under the
proposed rule, the commenter stated, such purchases would have to
involve an accredited veterinarian, which would make the system
unnecessarily cumbersome.
Two commenters expressed concern that all currently used tags would
need to be replaced. These commenters stated that the State identifier
was preferable. One stated that the State authority issuing identifiers
can more easily add to and update the system than the Federal
Government can. The other stated that the State identifier can be
tracked and updated better than a Federal identifier. A third commenter
stated that, when State identifiers are used, purchasers can easily
identify the State of origin of an animal, and stated that tracebacks
are better handled by State veterinarians than by searching through a
huge grouping of animals from all States.
It is important to note that the proposal would not have required
any currently issued tags to be replaced; it only would have required
that all new PINs conform to the seven-character alphanumeric standard,
thus requiring newly issued official identification to reflect the new
PINs. In addition, we do not agree that using the seven-character
alphanumeric standard poses any difficulties for verification of
origin, traceback, or modifications to the system; the seven-character
alphanumeric standard has been in use for many years without
encountering these problems. Finally, the changes we proposed would not
have required producers to purchase tags from an accredited
veterinarian.
However, we appreciate that some States may want the flexibility to
continue using their PIN issuance system in the future. As long as PINs
issued by States meet the other standards in the revised definition of
PIN, we do not anticipate any problems with allowing States to do so.
Therefore, in this final rule, we are including the option from the
June 2006 final rule to use a PIN that consists of the State's two-
letter postal abbreviation followed by the premises' assigned number.
Credit for Herd Participation in States Without Approved State CWD Herd
Certification Programs
In the July 2006 final rule, paragraph (a) of Sec. 55.22 sets out
procedures and conditions for herd owner participation and enrollment
in the Federal CWD Herd Certification Program. Paragraph (a)(1)(ii)
sets out the procedures and conditions for enrollment of herds that are
in a State that does not have an Approved State CWD Herd Certification
Program.
Under paragraph (a)(1)(ii)(B), 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 enrollment
date will be 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. This type of constructed enrollment date will
be unavailable for herds that
[[Page 35550]]
apply to enroll 1 year after the implementation of the CWD program, and
herds that apply to enroll after that date will have an enrollment date
of the date APHIS approves the herd participation.
In the March 2009 proposed rule, recognizing the delays in
implementing the CWD program, we proposed to grant an additional year
of credit for herds that had been maintained in a manner that
substantially meets the conditions specified in Sec. 55.23(b) for herd
owners, for a total of 3 years' credit.
Four commenters stated that we should allow for 5 years' credit to
be granted to herds whose owners have maintained them in a manner that
substantially meets the conditions specified in Sec. 55.23(b). Doing
so would allow those herds to enter the program in Certified status and
thus be eligible to move interstate. One commenter stated that
providing a maximum of 3 years' credit would essentially shut down the
industry for 2 years and that States have written rules that provide
adequate CWD surveillance status and disease control in their captive
cervids, allowing for the interstate movement of animals with an
extremely low risk of CWD.
Three commenters stated that providing only 3 years' credit for
herd owner participation outside the context of an Approved State CWD
Herd Certification Program discriminates against persons or farms that
have a proactive approach to testing and recordkeeping but have a
laggard or nonexistent CWD program in their States. These commenters
stated that herds meeting the standards of the certification program
for any time period should be enrolled in the Federal CWD Herd
Certification Program on the date they began meeting such standards, as
shown in accurate herd records.
We appreciate the efforts of herd owners who maintain their herds
in a manner that substantially meets the conditions specified in Sec.
55.23(b) outside the context of a State CWD program, and we realize
that limiting credit for such efforts to 3 years will temporarily
prevent the interstate movement of animals from such herds until the
herds can achieve Certified status. However, as discussed in the June
2006 final rule, only State programs have the extensive infrastructure,
enforcement mechanisms, and record systems that verify participation
and support reasonable confidence that herds in these programs can
fully meet the program requirements over long periods of time. (In
response to the first commenter, if a State has put in place adequate
rules for CWD surveillance and disease control, that State's CWD
program would be eligible for recognition as an Approved State CWD Herd
Certification Program under Sec. 55.23(a), thus allowing participating
herds to receive 5 years' credit.)
While individual herd owners may also devise or join non-State
programs that meet the necessary animal identification, monitoring, and
other requirements, and their compliance may be documented through herd
records and animal records in various State and market records
collections, it would be very difficult to establish with confidence
that such herds comply with requirements over lengthy periods.
It should also be noted that herd owners who have been practicing
CWD control and testing measures may not necessarily meet the criterion
for granting credit that the herd has been maintained in a manner that
substantially meets the conditions specified in Sec. 55.23(b). We will
individually review every application for enrollment credit under Sec.
55.22(a)(1)(ii)(B) to determine whether credit should be granted.
We are making two changes to provisions involving enrollment dates
in this final rule. In the July 2006 final rule, we provided in Sec.
55.22(a)(1)(i) for herds to receive credit for having been enrolled in
a State program that APHIS determines qualifies as an Approved State
CWD Herd Certification Program. We indicated that such a ``constructed
enrollment date'' would be unavailable for herds that applied to enroll
1 year after the effective date of the final rule.
However, such a determination would be contingent on a State
applying for approval of its CWD program. If a herd participated in a
CWD program that was eventually determined to qualify as an Approved
State CWD Herd Certification Program, but that State did not apply to
have its program approved within 1 year of the effective date of this
rule, the herd owner would receive no credit for participation due to
the State's inaction, despite the herd having been maintained
consistent with the CWD Herd Certification Program. Accordingly, we are
removing the provision in paragraph (a)(1)(i) that limited the
availability of constructed enrollment dates. This will allow States to
become approved at any time after the effective date of this final
rule; herds enrolled and in good standing in their State program will
maintain their State enrollment date in the Federal CWD Herd
Certification Program provided they continue to meet our requirements.
Similarly, we are removing the provision limiting constructed
enrollment dates in paragraph (a)(1)(ii)(B), which indicated that herds
maintained in a manner that substantially meets the conditions
specified in Sec. 55.23(b) would receive credit for up to 3 years of
program participation only if they apply to enroll within 1 year after
the effective date of this final rule. There is no reason to deny a
herd owner credit based on the date of enrollment if the herd has been
maintained in a manner that substantially meets the conditions
specified in Sec. 55.23(b).
We are also switching the order of paragraph (a) of Sec. 55.23,
which discusses owner participation, and paragraph (b), which discusses
State participation. As the provisions for owner participation discuss
State participation, switching the order of these paragraphs will
result in a more logical presentation.
Movement of Animals Into CWD-Positive, CWD-Exposed, and CWD-Suspect
Herds
In the July 2006 final rule, paragraph (a) of Sec. 55.23 lists
aspects of a CWD program that the Administrator will evaluate when
determining whether a State CWD program qualifies as an Approved State
CWD Herd Certification Program. Paragraph (a)(4) stated that the
Administrator will evaluate whether the State has placed all known CWD-
positive, CWD-exposed, and CWD-suspect animals and herds under movement
restrictions, with movement of animals from them only for destruction
or under permit. (Movement under permit could include research animal
movement, as provided in Sec. 81.3(d) of the July 2006 final rule, or
movement from a breeding herd to a shooter facility.)
In the March 2009 proposed rule, we proposed to amend this
paragraph to require that States allow no movement of animals into such
herds. We stated that such movement 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
[[Page 35551]]
infected animals, and the risk of CWD spread (e.g., more animals means
more opportunities for an animal to escape confinement).
Several commenters stated that owners of some CWD-positive, CWD-
exposed, or CWD-suspect herds that are part of hunting operations have
in the past added animals to their herds and need to continue adding
animals in order to remain in business. These commenters stated that
prohibiting movement of farmed or captive cervids to these farms would
require these farms to breed all their animals, which in turn would
require increasing the density of their cervid populations, to provide
for both breeding cows and their male offspring. This would greatly
increase the cost of doing business for these herds.
A few owners of such herds stated that they would be put out of
business if they could not add animals to their herds. One expressed
concern that meat producers might be affected by such a restriction as
well.
Two commenters expressed concern that Certified herds might lose a
valuable business opportunity if sales to herds with CWD-positive, CWD-
exposed, and CWD-suspect animals were prohibited.
With respect to traceback, two commenters stated that epidemiologic
investigations could be conducted from herds containing CWD-positive,
CWD-exposed, or CWD-suspect animals in the same way that they are
conducted to and from other herds.
With respect to transmission from the facility containing the CWD-
positive, CWD-positive, CWD-exposed, or CWD-suspect animals, one
commenter stated that State herd plans implemented at such facilities
typically require double fences and double barriers designed to prevent
contact between the farmed or captive cervids in the facility and wild
cervids. Another commenter stated that the risk associated with escape
of animals from a large herd containing CWD-positive, CWD-exposed, or
CWD-suspect animals does not change when animals are added to that
herd.
With respect to indemnity, three commenters suggested that animals
introduced into herds containing CWD-positive, CWD-exposed, or CWD-
suspect animals should not be eligible for indemnity. Another commenter
suggested that we allow herds to apply for indemnity only within a
certain timeframe following the identification of a CWD-positive, CWD-
exposed, or CWD-suspect animal from the herd.
Based on these comments, we are not including this proposed change
in this final rule. Our intent is to provide flexibility in the
regulations to allow the operations described by commenters to remain
economically viable. However, we note that, under this final rule,
States will be allowed to restrict or prohibit the addition of animals
to herds containing CWD-positive, CWD-exposed, or CWD-suspect animals.
We also note that, when paying indemnity for a whole herd, we only make
indemnity available for the animals that were part of the herd at the
time we confirm the CWD diagnosis that leads us to pay indemnity for a
herd.
We agree that epidemiologic investigations can be conducted from
and to animals added to herds containing CWD-positive, CWD-exposed, or
CWD-suspect animals, in the same way epidemiologic investigations are
conducted in other circumstances. However, the owners of Certified
herds need to be aware that selling animals to herds containing CWD-
positive, CWD-exposed, or CWD-suspect animals (or selling to a third
party who may sell to such herds) increases their risk of being linked
to CWD-positive animals and herds. Owners of Certified herds that sell
animals to herds containing such animals need to make sure that they
have accurate, complete, and up-to-date inventories and records.
Without such inventories and records, it will be difficult to determine
with reasonable confidence whether a Certified herd was a source of
infection, which could result in movement restrictions being placed on
that herd and the suspension or loss of the herd's status in the CWD
Herd Certification Program. We will work with herd owners and States to
ensure that all herd owners are aware of the type of information we
need to facilitate successful epidemiological investigations.
With respect to additions to herds containing CWD-positive, CWD-
exposed, or CWD-suspect animals increasing the density of the herd and
therefore increasing the risk of spreading CWD to neighboring or
surrounding populations, we agree that there are mitigations available
for this risk, such as the double fencing that the commenters cite. For
herds that are enrolled in the CWD Herd Certification Program, we would
require such mitigations to be contained in a herd plan. Again, under
this final rule, States will have the option to require such
mitigations when animals are moved into herds containing CWD-positive,
CWD-exposed, or CWD-suspect animals. States can also ban such movement
altogether.
Herd Inventories
In the July 2006 final rule, paragraph (b) of Sec. 55.23 lists
responsibilities of herd owners who enroll in the CWD Herd
Certification Program. Paragraph (b)(4) describes requirements for herd
recordkeeping and annual inventories. Among other things, paragraph
(b)(4) requires the owner to allow an APHIS employee or State
representative access to the premises and herd, upon request, to
conduct an annual physical herd inventory with verification reconciling
animals and identifications with the records maintained by the owner.
The owner must present the entire herd for inspection under conditions
where the APHIS employee or State representative can safely read all
identification on the animals. The owner will be responsible for
assembling, handling and restraining the animals and for all costs
incurred to present the animals for inspection.
In response to comments on the July 2006 final rule, we proposed in
March 2009 to make changes to the annual inventory requirements to
address their practicality. The changes we proposed were intended to
clarify our intention to conduct an actual physical inventory of
assembled animals when an APHIS employee or State representative finds
it to be needed for program purposes. However, an actual physical
inventory is not always necessary.
We proposed to indicate that 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, we proposed to require the owner to 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. The proposed rule indicated that
inventory of a herd would 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.
Ten commenters opposed removing the requirement for an annual
physical herd inventory. Some cited specific issues. Two cited past
experience in inspecting farmed or captive cervid herds as indicating
that, without annual physical inspections, it is difficult to ensure
that herds are in compliance.
[[Page 35552]]
One stated that in the absence of annual inspections, recordkeeping
issues escalate rapidly. The other stated that we should require two
inspections per year, one physical and one nonphysical inventory.
Another commenter stated generally that the physical inventory
requirement will help to ensure that adequate records are maintained,
which will be vital in doing any necessary trace when an outbreak of
CWD in a captive cervid herd occurs.
Another commenter stated that, when two of the acceptable forms of
unique identification that may be used include microchips and tattoos,
there can be no substitute for handling the animals if their true
identity is to be verified.
The provisions we proposed give APHIS employees and State
representatives the ability to require an annual complete physical herd
inventory. The proposed provisions simply provide for an inventory of
records as another option if no changes in the circumstances of a
captive cervid herd indicate that a complete physical herd inventory is
necessary. If an inventory indicates that a specific herd is not
complying fully with the requirements of the program, the proposed
regulations allow for more frequent physical inventories, at the
discretion of APHIS employees and State representatives.
We have determined that a review of herd records will be adequate
for an annual inventory, assuming that the herd owner maintains
adequate records and that there have been no major changes in the
composition of the herd. In addition, three commenters stated that
physical inventories impose a significant financial impact on
producers, suggesting that, to the extent possible, complete physical
herd inventories should be conducted no more often than necessary.
Under this final rule, States have the option of requiring more
frequent physical inventories for all herds in their States.
One commenter stated that a complete physical herd inventory should
be required only when there is sufficient reason to expect that poor
records are being kept.
We disagree. Although poor recordkeeping would be one reason we
might require a complete physical herd inventory, there are other
reasons as well. For example, if the facility containing the herd had
experienced a fence breach, we might conduct a physical inventory.
Large movements of animals in or out of the herd may result in enough
uncertainty with respect to recordkeeping to warrant a physical
inventory. Finally, physical inventories should be performed at
intervals of no more than 3 years in order to ensure that recordkeeping
is accurate. There may be other reasons to perform physical inventories
as well.
In the March 2009 proposed rule, we stated in the Background
section that complete physical herd inventories would usually be
several years apart; we did not propose to include any provisions
regarding the frequency of physical inventories in the regulatory text.
To communicate our expectations more clearly, we are adding in this
final rule a requirement that a complete physical herd inventory be
performed for all herds enrolled in the CWD Herd Certification Program
no more than 3 years after the last complete physical herd inventory
for the herd.
In the Background section of the proposed rule, we stated 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. Several
commenters asked questions regarding whether inventories or inspections
required by States could satisfy the requirement for an initial
complete physical herd inventory. Twelve commenters stated that an
initial physical inventory should only be required for those herds
entering the CWD program that do not have a baseline record already on
file with their State regulatory agency. Another commenter stated that
it seems redundant and costly to require a physical inventory if a herd
is already enrolled in a State CWD program. Another commenter stated
that the requirement for an initial physical inventory should apply to
new breeders only and not to existing breeders. One commenter asked
whether herds that are enrolled in a compliant State CWD Herd
Certification Program but have never had a physical inventory need to
have a physical inventory done retroactively.
In order to provide a reliable baseline record for the herd's
participation, a herd on which a complete physical herd inventory had
never been performed would need to undergo a physical inventory before
beginning participation in the Federal CWD Herd Certification Program.
However, we would accept a complete physical herd inventory performed
by an APHIS employee, State representative, or accredited veterinarian
not more than 1 year before the enrollment date of the herd as
fulfilling the requirement for an initial physical inventory. Such
inventories might be performed as part of an official herd test for
tuberculosis or brucellosis, or as part of a State CWD Herd
Certification Program.
We are making two changes related to this issue. To make our
expectations clear, we are indicating in the regulations that a
complete physical herd inventory must be performed at the time a herd
enrolls in the CWD Herd Certification Program. We are also providing
that APHIS may accept a complete physical herd inventory performed by
an APHIS employee, State representative, or accredited veterinarian not
more than 1 year before the herd's date of enrollment in the CWD Herd
Certification Program as fulfilling the requirement for an initial
inventory. We would not accept such an inventory if the inventory did
not appear to provide an accurate and complete accounting of the
animals in the herd, or if the composition of the herd had changed
substantially since the inventory was performed (for example, with
large additions to or sales from the herd).
One commenter asked whether inventories or inspections required by
a State could satisfy the requirement for continuing inventories. In
the commenter's State, unrestrained inventories are performed yearly
with record verification.
We would accept a yearly State inventory of a herd in the Herd
Certification Program as fulfilling this requirement, as it would be
conducted by a State representative. The inventory would have to meet
the other requirements of paragraph (b)(4). We will work with States as
we implement the CWD Herd Certification Program to establish inventory
procedures, where necessary. However, an inventory consisting of record
verification would not satisfy the requirements for a physical
inventory at the time of enrollment and once every 3 years thereafter.
In the Background section of the proposed rule, we stated that the
proposed changes should also make it possible in many cases to plan the
timing of a physical assembly of a cervid herd for inventory so that it
is coordinated with testing for brucellosis and tuberculosis. We noted
that, 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.
Several commenters emphasized that, to have a successful program
with producer buy-in, complete physical herd inventories should
coincide with other industry animal health programs.
[[Page 35553]]
These commenters stated that the recertification frequency for cervids
in the tuberculosis and brucellosis programs is 33 to 39 months.
The commenters are correct that the frequency at which captive
cervid herds that are accredited for tuberculosis are tested for that
disease is 33 to 39 months, under Sec. 77.35(d). However, in the
Uniform Methods and Rules for brucellosis in cervids,\3\ all test-
eligible animals in Certified Brucellosis-Free herds are required to
have a negative test at intervals between 21 and 27 months. Both of
these intervals may change in the future. Our intent was to indicate
that there are already occasions at which the animals in a herd must be
assembled, handled, and restrained, which are occasions at which a
complete physical herd inventory could be conducted with minimal
additional cost and disruption to the herd.
---------------------------------------------------------------------------
\3\ Available at http://www.aphis.usda.gov/animal_health/animal_diseases/brucellosis/.
---------------------------------------------------------------------------
Commenters raised other concerns with respect to timing. Several
commenters stated that whole herd assembly for handling should be
consistent and within the established husbandry timeframe practiced by
the industry for the species in question. One commenter stated that
physical inventories inspections should be limited to those periods
where animal health will not be endangered, e.g., cows in late stage of
pregnancy and bulls in velvet or hard antler. Two commenters stated
that complete physical herd inventories could be done during weaning
and/or breeding. One commenter noted generally that there are many
times during a year that it would be dangerous to handle deer.
We agree with these commenters that these issues should be taken
into account when scheduling a complete physical herd inventory. We
already take these issues into account when scheduling whole-herd tests
for brucellosis and tuberculosis in farmed or captive cervids. In all
cases, when scheduling a complete physical herd inventory, we will work
with the owner of the herd to find a time that takes all relevant
factors into account. We are providing a 3-year span in which a
physical inventory may be conducted in order to allow for such
flexibility of scheduling.
Several commenters stated that, if herd records indicate that a
specific number of animals are in a pen, and the inspector can verify
that amount, there should be no need for a visual inspection of each
tag.
We disagree. Records could indicate that the number of animals in a
pen was correct, but without verifying that the identification on each
animal matches that reflected in the records, we cannot be certain that
the animals in the pen are the same as the animals in the records.
Another commenter noted that most forms of identification will not be
readable from any distance unless the animal is restrained, which makes
a hands-on physical inventory necessary.
The regulations in this final rule do provide for an inventory
based on records, but we will need to conduct complete physical herd
inventories occasionally, for the reasons discussed earlier.
Several commenters stated that whole herd inventories should be
conducted during routine herd health procedures. If APHIS or another
agency orders a physical inventory, these commenters stated, then APHIS
or the ordering agency should be responsible for the costs, risks, and
animal losses associated with handling the animals in the herd.
As discussed earlier, we will make every effort to conduct complete
physical herd inventories at times coincident with whole-herd testing
or other times when the herd is being restrained for another purpose.
However, we will not guarantee that all complete physical herd
inventories will be conducted at such times; when there are reasons to
suspect that recordkeeping is deficient, for example, we may need to
conduct a complete physical herd inventory in order to provide
assurance that the herd is in compliance with the CWD Herd
Certification Program. In that case, owners will be responsible for all
costs incurred to present the animals for inspection, a provision of
the July 2006 final rule that we did not propose to change in March
2009. The CWD Herd Certification Program is a voluntary program for
herd owners who wish to avail themselves of the opportunity presented
by the program to demonstrate that the animals in their herds are low-
risk for CWD. It is not appropriate to pay costs of participation in
this voluntary program.
We note that keeping accurate, complete, and up-to-date records
will make APHIS employees more confident that an inventory conducted by
reviewing records, as opposed to a physical inventory, may be
sufficient to fulfill the yearly inventory requirement.
Several commenters stated that the frequency of complete physical
herd inventories must be consistent with animal health programs for
other species, and that currently there is no annual herd inventory
required for cattle herds in the tuberculosis or brucellosis programs.
For the other programs to which the commenters refer, complete
physical herd inventories are conducted at the time the whole-herd test
is conducted. As discussed in this document, we plan to schedule
complete physical herd inventories so that they coincide with other
occasions when the herd is assembled, such as whole-herd tests for
tuberculosis and brucellosis. However, unlike brucellosis and
tuberculosis, there is no approved ante-mortem test for CWD, meaning
that we cannot use testing to determine the health status of individual
animals when they are moved interstate. Instead, we establish that
animals in a herd are at low risk of being infected with CWD through
surveillance over time. As the animals' low-risk status is thus tied to
their membership in a herd that has undergone 5 years of surveillance
without finding CWD, an annual inventory of the herd's records is
necessary to validate those records. We note that the records inventory
should be much less labor- and time-intensive than the physical herd
inventory.
We also proposed to amend paragraph (b)(4) to include accredited
veterinarians as people who can conduct a herd inventory, along with
APHIS employees and State representatives. The July 2006 final rule
allows accredited veterinarians to perform many other Herd
Certification Program functions; allowing them to conduct inventories
would be consistent with the rest of the program.
One commenter stated that States should be able to specify when and
under what conditions accredited veterinarians are approved to conduct
inventories. The commenter's State requires that a regulatory
veterinarian conduct the first inventory; accredited veterinarians can
conduct subsequent inventories.
Under this final rule, States are free to put in place requirements
regarding when an accredited veterinarian is allowed to conduct a herd
inventory, such as the one the commenter describes.
Several commenters expressed concern that the proposed rule did not
prevent an accredited veterinarian from inventorying his or her own
herd. Some of these commenters also stated that accredited
veterinarians should not be able to issue certificates for the movement
of animals from their own herds, as allowed by the July 2006 final rule
under Sec. 81.4.
Another commenter stated that accredited veterinarians should not
be allowed to inspect their own herds to
[[Page 35554]]
determine whether they are in compliance.
We disagree that such provisions are necessary for the regulations
governing the CWD Herd Certification Program. Accredited veterinarians
routinely perform accredited duties on their own animals in other
Veterinary Services programs. Under our regulations in 9 CFR part 161,
to maintain their accreditation, accredited veterinarians must comply
with the standards for accredited veterinarian duties in Sec. 161.4.
If an accredited veterinarian conducted an irregular inventory of his
or her own cervid herd, we would suspend or revoke the accreditation of
that veterinarian. Although our experience indicates that the
commenters' concerns are misplaced, nonetheless, under this final rule,
States are free to impose restrictions on what duties an accredited
veterinarian performs on his or her own animals in the State's CWD
program should they choose to.
One commenter requested that we add a definition of accredited
veterinarian.
We concur that providing such a definition would improve the
clarity of the regulations, particularly when other, similar parts in
subchapters B and C include such a definition. Accordingly, we are
adding a definition of accredited veterinarian to Sec. Sec. 55.1 and
81.1 in this final rule. The definition indicates that an accredited
veterinarian is approved by the Administrator in accordance with 9 CFR
part 161 to perform functions specified in subchapters B, C, and D of 9
CFR chapter I.
One commenter stated that the annual inspection of captive cervid
facilities should include participation from wildlife professionals as
well as accredited veterinarians.
Wildlife professionals could conduct inventories if they were State
representatives with authority over farmed or captive cervids and
involved in the oversight of the CWD Herd Certification Program. We
note that the commenter is a representative of a State in which the
wildlife authority has jurisdiction over farmed and captive cervids, so
it is likely that, in this commenter's State, wildlife professionals
would conduct or assist in inventories.
One commenter recommended that we propose common inventory
datasheets, allowing for States to design their own as localized issues
may require some reasonable modifications.
The regulations in paragraph (b)(4) of Sec. 55.23 already state
the information that is required for an inventory: 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. Under paragraph (a)(10) of Sec. 55.23, States are required to
maintain this information in a State database, pending the creation of
the CWD National Database administered by APHIS.
In this final rule, we are amending the list of information
required for each animal to include the species of the animal. This
information will be useful in conducting inventories and confirming the
accuracy of herd records.
One commenter noted that, in hunting preserves, there is no way
possible to assemble the animals for inventory because they are lost in
many acres of woodland, and there is no way to track births inside of a
hunting preserve. The commenter stated that these premises should be
exempt from the inventory requirements, as the animals never leave the
preserve alive anyway.
Participation in the voluntary CWD Herd Certification Program will
require maintenance of accurate, complete, and up-to-date herd records,
and verifying those records when necessary. Such records are essential
to allow a herd owner to demonstrate that animals in the herd are low
risk for CWD. As discussed earlier, the CWD Herd Certification Program
establishes that animals are low risk through surveillance over time,
making it crucial that we know which animals are included in the
surveillance. Herd owners should consider whether they can comply with
the requirements of the CWD Herd Certification Program before applying
to enroll in the program.
One commenter stated that the regulations should require an
adequate review of facility maintenance, animal health, and regulatory
compliance during the nonphysical inventory.
We do not believe it is necessary to indicate in the regulations
that such a review will take place. APHIS employees and State
representatives will evaluate these facility conditions during
inventories, as well as at other times. If we discover that the
requirements of the regulations are not being complied with, we will
take appropriate action.
Confirmatory DNA Testing of Official Test Samples
In the July 2006 final rule, Sec. 55.24 sets out provisions for
determining the status of a herd of farmed or captive cervids enrolled
in the CWD Herd Certification Program. Paragraph (c)(1) provides for an
owner to appeal cancellation of enrollment or suspension or loss of
herd status. We proposed to amend paragraph (c)(1) to provide a process
by which herd owners can appeal the designation of an animal as CWD-
positive, based on DNA test results.
Several commenters stated that any process for confirmatory DNA
testing should include not just the current owner of an animal but also
the original owner of the animal, if any. Some commenters stated that,
in the event of a traceback, original owners should be allowed to
submit their own samples. Two commenters stated that many herd owners
conduct DNA testing on their animals at birth, allowing for the use of
these records. Commenters also stated generally that many herd owners
already have their animals' DNA profiled or recorded in a registry,
meaning the confirmatory DNA testing process could make use of this
information. Two commenters stated that owners should be allowed to
keep DNA samples of animals they have sold for use in confirmatory DNA
testing.
Other commenters stated that tissue for DNA testing should be
required to accompany all samples sent for CWD testing, to protect
previous owners who cannot submit tissues when animals are tested but
who will be implicated in the event of a positive CWD test result.
We understand the concerns of the commenters that previous owners
of an animal may be implicated in a traceback resulting from a CWD-
positive animal, since such implication may lead to the suspension or
loss of a herd's CWD status. However, the goal of the confirmatory DNA
testing provisions is only to verify that the sample tested is a match
for a particular animal.
The recordkeeping requirements in the regulations, if followed,
will allow us to conduct tracebacks in the event of a positive CWD test
result. As discussed earlier, we require an annual inventory in part to
ensure that we can conduct an appropriate traceback.
Our regulations do not prevent owners of animals from retaining DNA
samples of animals they sell. Sellers of animals are also free to
contract with their buyers to provide that the buyers will submit a DNA
sample for confirmatory testing if the animal is tested for CWD.
As discussed in the proposed rule, we have added the option of
confirmatory DNA testing in response to commenters. However, we should
note that we currently maintain rigorous chain-of-custody procedures
for samples that are submitted for CWD testing, and we will continue to
maintain these procedures
[[Page 35555]]
both for samples that are not accompanied by tissue for confirmatory
DNA testing and those that are. We are confident that our current
processes ensure that test results are correctly assigned to individual
animals, as they do in other APHIS animal health programs.
We stated that our guidance on confirmatory DNA testing would allow
an owner to reserve the option for confirmatory DNA testing by
informing the Federal or State representative or accredited
veterinarian who collects the tissues. To allow for later confirmatory
DNA testing, we proposed that the person collecting the tissues would
also collect from the animal some somatic tissue 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 identification 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.
One commenter stated that the requirement to maintain an official
identification device with every DNA sample is an absurd requirement
designed to impede confirmatory activities, particularly if the samples
are held by an independent third party. The commenter stated that APHIS
itself does not require samples to be accompanied by official
identification. Another commenter stated that, if an accredited
veterinarian is submitting all samples, there should be no need to have
tissue attached to the official identification.
The official identification device is necessary in order to ensure
that there is an incontestable association between the tissue whose DNA
is tested and the animal being tested. Without official identification
attached to the tissue being tested, both APHIS and the owner would
rely on APHIS' chain-of-custody processes to ensure that the identity
of the animal is associated properly with the DNA test results of the
tissue sample.
As discussed earlier, we are confident that our chain-of-custody
processes are effective. However, as a request for confirmatory DNA
testing indicates that the owner wants additional assurance regarding
the effectiveness of those processes (including the submission of
samples by an accredited veterinarian), it would not make sense to rely
on that chain of custody for confirmatory DNA testing as well.
We discuss other comments related to third parties conducting CWD
tests and holding samples later under this heading.
Several commenters expressed concern regarding the requirement to
include somatic tissue with an official identification device. These
commenters stated that it would be difficult to fulfill such a
requirement, especially for male animals, where taxidermy work requires
the head, shoulder, and neck areas to be left intact for the mounting
process. In the trophy market, a missing piece of ear would devalue the
animal. These commenters also stated that the requirement for tissue to
be attached to the official identification is not practical when a
microchip is the official identification device.
As explained earlier, we need an official identification device to
be attached to the somatic tissue in order to establish an
incontestable link between the two. The confirmatory DNA testing
process is optional for owners. If owners believe that supplying the
tissue necessary to conduct confirmatory DNA testing will result in an
economically unacceptable devaluation of their animals, they should not
choose to use this optional process.
Microchips that are used as official identification devices are
designed so that some tissue adheres to the microchip. This is to
prevent a person from moving an official identification microchip from
one animal to another. The somatic tissue that adheres to such
microchips when removed from the animal will be usable in our
confirmatory DNA testing process.
As an alternative to providing somatic tissue with official
identification attached, several commenters suggested that accredited
veterinarians collect DNA samples for each animal during the complete
physical herd inventory and store them until the animals are tested for
CWD. Some of these commenters stated that such samples should be held
by a third party.
Our program resources are not sufficient to allow us to build or
lease space in which to store sample tissue for DNA testing for each
farmed or captive cervid that is identified in a complete physical herd
inventory, or to contract for such storage. In any case, using DNA
samples stored by APHIS or a third party for confirmatory testing would
create chain-of-custody issues, rather than resolve them.
Several commenters stated that a neutral third party should
maintain the tissue to be used for confirmatory DNA testing.
Most CWD samples are tested by third-party laboratories, either
State or university laboratories. These third-party laboratories are
approved to conduct CWD testing under Sec. 55.8(d). We audit third-
party laboratories to make sure they comply with the standards set out
in Sec. 55.8(d).
If an owner decides that DNA testing is necessary to confirm the
identity of the animal that tested positive for CWD, tissue attached to
an official identification device would be used for the testing, to
ensure that the brain or lymph node sample that tests positive for CWD
has the same DNA as the tissue attached to the official identification
device. The sample used for confirmatory DNA testing would accompany
the sample of brain and lymph node tested for CWD to ensure that chain
of custody is not broken.
The National Veterinary Services Laboratories (NVSL) is the only
laboratory authorized to confirm a CWD-positive test result from a
third-party laboratory, so any tissue to be used for confirmatory DNA
testing for an animal that tested positive for CWD would have to
accompany the suspect sample to NVSL from the third-party laboratory,
in order to maintain chain of custody. We are planning to conduct the
optional confirmatory DNA testing at NVSL or at a third-party
laboratory authorized to perform such testing. The sample for CWD
testing will be accompanied by the tissue for confirmatory DNA testing
at all times. Therefore, the involvement of a neutral third party is
not necessary and would in fact increase complications in maintaining
chain of custody.
One commenter recommended that the cost of DNA testing be borne
initially by APHIS, to show that positive tests truly came from the
animals for which the positive test results were reported. If the
association of the animal with the positive test results is confirmed,
the commenter recommended, the owner's indemnity would be reduced by
the cost of the testing. If the association is not confirmed, the
animal would no longer be a CWD suspect and APHIS should be held
responsible for all costs associated with such confirmatory testing and
herd disruption. This commenter also stated that confirmatory DNA
testing should be performed on all CWD-positive cervids, so as to
remove the onus of possible Government error.
The commenter's recommendations are impractical in several
respects. Not all herds in which animals are diagnosed as CWD-positive
are subsequently depopulated, as discussed earlier in this document
under the heading ``Movement of Animals into CWD-Positive, CWD-Exposed,
and CWD-Suspect Herds.'' A CWD diagnosis in those herds would not
result in the payment of indemnity, meaning that we could not recover
the costs of
[[Page 35556]]
confirmatory DNA testing. Performing confirmatory DNA testing on every
CWD-positive sample we receive could thus require substantial
resources. In addition, as discussed earlier, providing the necessary
somatic tissue attached to official identification could be difficult
for some herd owners, meaning they might not want to participate in
confirmatory DNA testing.
Confirmatory DNA testing is an optional service we proposed to
provide, based on the requests of commenters, only when herd owners
request the service. We are confident that our chain-of-custody
processes are effective. We do not believe it is an appropriate use of
APHIS' limited resources to pay for confirmatory DNA testing. As noted
earlier, the CWD Herd Certification Program is a voluntary program for
herd owners who wish to avail themselves of the opportunity presented
by the program to demonstrate that the animals in their herds are low-
risk for CWD. It is not appropriate to pay any of the costs of
participation in this voluntary program, such as costs associated with
herd disruption. In any case, disruption in the circumstances the
commenter cites would be temporary, as the herd's status would be
restored after the error was found.
One commenter stated that allowing for confirmatory DNA testing
would be contrary to current accepted procedures that allow for the
immediate depopulation of herds in the event of a serious livestock
disease outbreak. The commenter stated that delays inherent in DNA
retesting potentially allow for continued disease exposure both to
cohort animals, but also the continued contamination of the
environment; in addition, the longer depopulation is delayed, the
greater the risk that animals may escape or be illegally moved.
The available scientific evidence indicates that CWD is not an
acute infectious disease; typically, by the time it is diagnosed in an
animal, the disease has been present on a premises for a year or more.
In addition, the confirmatory DNA testing is not expected to take more
than a few days. Accordingly, we have determined that the risks the
commenter identifies with respect to disease spread are unlikely. As
the commenter notes, any movement from a herd in which an animal has
been identified as CWD-positive would be illegal; we work with our
State counterparts to ensure effective enforcement of this requirement.
We are making no changes in response to this comment.
However, we are making two changes to the proposed protocol in this
final rule. As proposed, the protocol indicated that a Federal or State
veterinarian or accredited veterinarian would collect the tissue for
testing. However, we do not plan to require that a veterinarian collect
samples for CWD testing, so it would be inappropriate to require that a
veterinarian also collect tissue for DNA testing. Therefore, we are
removing the references in the proposed rule to the persons who can
collect the samples. In addition, we are clarifying that the tissue
tested for comparison to a CWD sample must have been collected from the
same animal.
Monitoring Period Required To Move Deer, Elk, and Moose Interstate
In the July 2006 final rule, part 81 contains restrictions on the
interstate movement of farmed or captive deer, elk, and moose that are
designed to prevent the spread of CWD. Paragraph (a) of Sec. 81.3
contains general restrictions on the interstate movement of deer, elk,
and moose in the CWD Herd Certification Program. Under the July 2006
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.
In response to the petitions and many comments we received on the
petitions, and based on a review of the available scientific evidence
regarding the range of incubation periods for CWD, we proposed to
remove the gradual escalation of the length-of-time requirement for
farmed or captive deer, elk, or moose moved interstate. We instead
proposed to require farmed or captive deer, elk, or moose moved
interstate to be from herds that have had at least 5 years' monitoring
in the CWD Herd Certification Program and have achieved Certified
status. We stated that 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.
One commenter stated that the 5-year monitoring period seems
reasonable at this time, but there should be flexibility to immediately
extend that period should science dictate such an extension is
warranted. Another commenter stated that any regulation, Federal or
State, should allow for rapid modification of such a requirement as new
scientific information becomes available.
We agree. If the scientific evidence regarding the range of
incubation periods for CWD advances and indicates that the 5-year
monitoring requirement is either longer than necessary or not long
enough, we will promptly propose appropriate changes to the
regulations.
One commenter supported the 5-year monitoring requirement, but
stated that there needs to be a way a new farmer can immediately
achieve Certified status by purchasing a new herd from a farm or farms
that are certified 5 years or more.
The regulations in Sec. 55.24, which govern herd status, provide
for the creation of a herd in the manner the commenter describes.
Specifically, paragraph (a) of Sec. 55.24 states that when a herd is
first enrolled in the CWD Herd Certification Program, if the herd is
composed solely of animals obtained from herds already enrolled in the
program, the newly enrolled herd will have the same status as the
lowest status of any herd that provided animals for the new herd.
Therefore, if a new farmer purchased only farmed or captive cervids
from herds that have achieved Certified status, and if the new herd met
the other requirements in part 55 for herd participation, that herd
would enter the program at Certified status.
One commenter stated that, in 9 years of raising elk, no CWD cases
have been found in his herds. The commenter currently has a small herd
that was established in 2006. The commenter stated that he would like
to begin selling breeding stock and hunting bulls to other ranches, but
the new 5-year requirement would prevent his ranch and all other
ranches from doing this.
As discussed in response to the previous comment, if the
commenter's herd is composed solely of animals obtained from herds
already enrolled in the CWD Herd Certification Program, he may be able
to get credit for those animals' statuses that would allow him to reach
Certified status and thus move his animals interstate. We believe 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, and
thus would not be adversely affected by the adoption of a 5-year
standard. In any case, in our review of the scientific evidence
regarding the range of incubation periods for CWD, we determined that
requiring 5 years of monitoring in order for animals in the CWD Herd
Certification Program to move interstate
[[Page 35557]]
was appropriate. The commenter did not provide any evidence to the
contrary.
In a related change, we proposed to add two general requirements in
a new Sec. 81.3(a) for certification of all deer, elk, and moose moved
interstate, not just those in the CWD Herd Certification Program. One
requirement was that no deer, elk, or moose originating from a premises
that was 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, could be moved into a State that did
not accept such animals. We are not including this requirement in the
final rule for reasons discussed in the section ``Changes in the March
2009 Proposed Rule That Are Now Unnecessary.''
The other requirement, which we proposed to add as a new paragraph
(a)(1), was that no farmed or captive deer, elk, or moose may be moved
interstate from farmed or captive herds infected with CWD, or
epidemiologically linked to herds infected with CWD within the past 5
years.
Several commenters asked us to clarify the meaning of the term
``epidemiologically linked'' in proposed paragraph (a)(1). Two
commenters expressed specific concerns regarding the scenario of a
Certified herd selling animals to another herd, following which CWD is
discovered in the receiving herd; the commenters wanted to know whether
the Certified source herd would qualify as ``epidemiologically linked''
in this case. Two other commenters asked whether, if an animal is
linked through epidemiological investigation to a CWD-positive herd,
but the animal in question is tested for CWD and found not to be CWD-
positive, the herd containing that animal would be epidemiologically
linked to the herd infected with CWD.
We understand the potential confusion associated with our use of
the term ``epidemiologically linked'' in proposed Sec. 81.3(a)(1). For
herds in the CWD Herd Certification Program, we have a full description
of how epidemiological linkages are investigated and how herd status
may be suspended or lost in Sec. 55.24(b), but our proposed
requirement in paragraph (a)(1) would have applied to all deer, elk,
and moose moved interstate.
In light of our not including the proposed proximity provisions in
the final rule, we examined proposed paragraph (a)(1) and found it to
be unnecessary. The regulations provide for the interstate movement of
farmed or captive deer, elk, and moose in five circumstances. In each
of these circumstances, it is unnecessary to require separately that
the animal being moved interstate not be from a herd where CWD has been
diagnosed in the past 5 years or that is epidemiologically linked to
herds where CWD has been diagnosed in the past 5 years.
Animals in the CWD Herd Certification Program. We proposed
to require that such animals come from herds that have achieved
Certified status. In order to achieve Certified status, the herd must
not contain CWD-positive animals or be epidemiologically linked to a
CWD-positive herd, as described in Sec. 55.24. Therefore, having a
separate requirement regarding epidemiological linkage is superfluous
for these animals.
Animals captured from wild populations for interstate
movement or release. The July 2006 final rule requires that such an
animal must have two forms of animal identification, one of which is
official animal identification, and a certificate accompanying the
animal must document the source population to be low risk for CWD,
based on a CWD surveillance program that is approved by the State
Government of the receiving State and by APHIS. As such animals do not
originate from farmed or captive herds, it would be impossible to
certify that they are not from a CWD-positive herd or that they are not
epidemiologically linked to such a herd.
We are making changes related to the movement of animals captured
for interstate movement or release in this final rule. In the July 2006
final rule, the requirements for issuance of certificates for all
captive cervids in Sec. 81.4(a) included a requirement that the
certificate include a statement 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; no exception was made for
animals captured from wild populations for interstate movement and
release. However, it is impossible to provide that information for such
animals, which is why the regulations in Sec. 81.3(b) include the
alternative requirement to document the animals' source population as
low risk for CWD. We are amending Sec. 81.4 to remove the requirement
for documentation of the captured wild animals' Certified status in the
CWD program. We are also making minor editorial changes to Sec.
81.3(b) to indicate that the certificate must state that the source
population has been documented to be low risk for CWD, rather than
indicating that the certificate itself must provide this documentation.
Animals moved to slaughter. The July 2006 final rule
requires that these animals have two forms of identification and be
moved interstate with a certificate. There is no need for further
restriction of animals moved to slaughter based on epidemiological
linkage, as animals moved to slaughter are a low-risk pathway for the
spread of disease.
Research animals. Such animals are moved under special
permits for research purposes. It may well be valuable to move animals
interstate for research that are from or are epidemiologically linked
to CWD-positive herds.
Interstate movements approved by the Administrator. It
would be inappropriate to limit the Administrator's authority to
approve interstate movement of animals to animals that are not from
CWD-positive herds or epidemiologically linked to CWD-positive herds.
Therefore, we are not including proposed paragraph (a)(1) in this
final rule. Section 81.3 in this final rule resembles the section as it
appeared in the July 2006 final rule, except that paragraph (a), the
paragraph describing interstate movement restrictions for farmed or
captive deer, elk, and moose in the CWD Herd Certification Program, now
indicates that such animals must come from a herd that has achieved
Certified status in accordance with Sec. 55.24. We are also not
including a provision we proposed to add in Sec. 81.4 that would have
required a certificate for the interstate movement of deer, elk, or
moose to include a statement that the animal being moved interstate are
not from farmed or captive herds infected with CWD, or
epidemiologically linked to herds infected with CWD within the past 5
years.
Certification That Deer, Elk, and Moose Moved Interstate Do Not Show
Clinical Signs of CWD
In the July 2006 final rule, paragraph (a)(2) of Sec. 81.3
requires a farmed or captive deer, elk, or moose that is moved
interstate and that is from a herd in the CWD Herd Certification
Program to be accompanied by a certificate issued in accordance with
Sec. 81.4 that identifies its herd of origin and its herd's CWD Herd
Certification Program status, and states that it is not a CWD-positive,
CWD-exposed, or CWD-suspect animal.
We proposed to change these requirements. Because we proposed to
[[Page 35558]]
require that all animals from the CWD Herd Certification Program moved
interstate to be monitored for 5 years, we proposed to change the
requirement to indicate that the herd status must be Certified. We also
proposed to require that the certificate indicate that the animal does
not show clinical signs associated with CWD, rather than that the
animal is not a CWD-positive, CWD-exposed, or CWD-suspect animal.
Requiring the certificate to state that the animal does not show
clinical signs associated with CWD is consistent with information that
can be obtained from an examination and with other interstate animal
movement regulations.
One commenter asked whether fulfilling this requirement would
necessitate a veterinary inspection prior to movement. If so, the
commenter stated, then the requirement is extremely burdensome. The
commenter's State requires a brand inspector to inspect all animals
prior to movement, meaning that having a veterinarian conduct an
additional inspection is unnecessary if the herd has been certified.
The commenter stated that the brand inspector would easily recognize
CWD symptoms.
Requiring a veterinarian to inspect animals moved interstate is
standard in all APHIS disease programs, and a veterinary inspection for
farmed or captive deer, elk, and moose moved interstate is essential to
ensure that the animal being moved interstate is apparently healthy and
meets the requirements of the regulations. Both State veterinarians and
accredited veterinarians who perform this certification must comply
with certain standards of practice and are accountable to APHIS.
Allowing some other agency to inspect and certify animals for
interstate movement would not provide the assurance that the
requirement for a veterinary inspection does. (We note that the July
2006 final rule also required the certificate accompanying a farmed or
captive deer, elk, or moose moved interstate to be issued by a Federal
veterinarian, State veterinarian, or accredited veterinarian, as
discussed in Sec. 81.4, ``Issuance of certificates.'')
Comments Not Related to the March 2009 Proposed Rule
Commenters on the March 2009 proposed rule raised several issues
not related to the changes discussed in that document.
Some commenters stated that it was difficult to understand the full
scope and content of the proposed CWD Herd Certification Program from
the March 2009 proposed rule because the full text of the rule was not
included. The commenters stated that they had raised concerns regarding
aspects of the July 2006 final rule that were not addressed in the
March 2009 proposed rule. The commenters stated that the incomplete
text left uncertainty about other aspects of the program.
We developed the March 2009 proposed rule to address issues with
respect to the July 2006 final rule that were raised in the petitions
or in response to the petitions. Accordingly, the March 2009 proposed
rule set out only the changes that we proposed to make to the July 2006
final rule. However, we understand that this could be confusing. To aid
the reader, in this final rule we are setting out the entirety of the
regulatory text in the July 2006 final rule, with the changes discussed
in the March 2009 proposed rule and in this document. When this final
rule becomes effective, the provisions in the regulatory text at the
end of this document will be added to the Code of Federal Regulations.
In addition, we are responding in this document to the comments we
received on aspects of the July 2006 final rule that were not included
in the March 2009 proposed rule, as well as other aspects of the
regulations.
The regulations currently include in Sec. 55.1 a definition of
herd. A herd is defined as a group of animals that are under common
ownership or supervision and are grouped on one or more parts of any
single premises (lot, farm, or ranch), or all animals under common
ownership or supervision on two or more premises which are
geographically separated but on which animals have been interchanged or
had direct or indirect contact with one another.
One commenter stated that this definition permits the intrastate,
and depending on proximity to a State border perhaps even the
interstate, transportation of animals from one facility to another
regardless of their status in the program.
Any deer, elk, or moose moved interstate must meet the requirements
of part 81. If they are moved intrastate, they must meet applicable
State requirements; Federal regulations do not restrict intrastate
movement, although we do require States that participate in the CWD
Herd Certification Program to have the authority to restrict intrastate
movement of cervids. The definition of herd in part 55 does not have
any bearing on the movement restrictions in part 81.
The July 2006 final rule included a definition of herd plan. Such a
plan sets out steps to be taken to eradicate CWD from a CWD-positive
herd, to control the risk of CWD in a CWD-exposed or CWD-suspect herd,
or to prevent the introduction of CWD into that herd or any other herd.
Several commenters stated that herd plans should not allow
reintroduction of cervids into a facility previously inhabited by CWD-
positive animals, given evidence about the persistence of CWD in the
environment and the lack of validated methods for decontaminating
facilities that have housed CWD-positive animals.
One commenter expressed concern about the threat a premises that
has held CWD-positive animals poses to wild cervids. This commenter
stated that fences should remain in place on CWD-positive farms until a
scientifically proven method has been developed for decontaminating
facilities. Another stated that any premises that has held a CWD-
positive animal should be quarantined for 5 years after the herd is
depopulated, with no livestock allowed on the premises, followed by a
reevaluation of the land and any environmental risk factors.
We note that all herds that participate in the CWD Herd
Certification Program are required to have perimeter fencing under
Sec. 55.23(b)(2). As discussed in the July 2006 final rule, the
definition's language will allow a herd plan to prohibit cervids from a
premises for an appropriate period based on the specific risks and
conditions of the individual herd. Ongoing and future research may help
resolve many questions about environmental transmission of CWD and
establish reasonable standards for when it is safe to repopulate a
previously contaminated premises.
We do not consider it necessary to require permanent fencing of
premises that contained CWD-positive herds for the purposes of
preventing the interstate spread of CWD through the movement of farmed
or captive cervids. However, under this final rule, States may impose
requirements that are more restrictive.
As discussed earlier in this document, in the July 2006 final rule,
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 them only for destruction
or under permit.
One commenter stated that all CWD-positive herds should be
immediately quarantined and automatically depopulated upon verification
of CWD-positive test results from two USDA-approved laboratories, as
well as any herds traced forward or backward from a CWD-positive herd.
The commenter stated that all cervids in such herds and
[[Page 35559]]
on such premises should be destroyed on site. Another commenter stated
that all animals on game farms should be tested for CWD, with any
positive test resulting in complete herd eradication.
We do not consider it necessary to immediately depopulate CWD-
positive herds for the purpose of preventing the interstate spread of
CWD through the movement of farmed or captive cervids. Animals from
such herds will not be allowed to be moved interstate under this final
rule, except directly to slaughter or under a research animal permit.
We note that, under this final rule, States may require depopulation of
CWD-positive and CWD-exposed herds.
In the July 2006 final rule, paragraph (b)(3) of Sec. 55.23
requires herd owners participating in the CWD Herd Certification
Program to make the carcasses of all animals that die (including
animals killed on premises maintained for hunting and animals sent to
slaughter) available for tissue sampling and testing in accordance with
instructions from the APHIS or State representative.
One commenter asked us to consider herd plans that do not require
100 percent testing of all animals that die or are killed when
developing the guidance for implementing the CWD regulations. The
commenter stated that 100 percent compliance may not always be
possible, and expressed concern that Certified herds would lose their
status by failing to provide samples. Another commenter stated that the
regulations need to provide allowances for when animals escape or other
factors make it impossible to provide a sample.
Testing all animals that die for CWD is necessary to establish,
through surveillance over time, that animals in a particular herd are
low risk for CWD. However, the regulations in Sec. 55.23(b)(3) do
provide that, in cases where animals escape or disappear and thus are
not available for tissue sampling and testing, an APHIS representative
will investigate whether the unavailability of animals for testing
constitutes a failure to comply with program requirements and will
affect the herd's status in the CWD Herd Certification Program, meaning
we have provided the appropriate degree of program discretion in cases
where a herd owner finds it impossible to provide samples.
In this final rule, we are amending Sec. 55.23(b)(3) to indicate
that we will also investigate program compliance when the samples
provided are of poor quality, thus making it impossible to test them
for CWD. Providing samples of poor quality causes the same problems as
not providing a sample, and we need to be able to test all animals that
die in a herd that is enrolled in the CWD Herd Certification Program.
One commenter stated that the regulations should provide a maximum
time limit within which carcasses must be tested. In the commenter's
State, for example, all licensees must submit carcasses for testing
within 48 hours of the cervid's death to ensure that our agency can
collect acceptable tissue samples for laboratory testing.
APHIS and the States are responsible for collecting the sample,
once the owner makes it available, and testing it. We do so in
accordance with guidelines that ensure that we have usable samples. The
regulations in Sec. 55.23(b)(3) require herd owners to immediately
report deaths of deer, elk, or moose 12 months of age or older, which
will give us adequate time to collect and test samples.
One commenter stated that the July 2006 final rule does not prevent
the owner from removing animal identification prior to making cervid
carcasses available to the State for CWD testing. The commenter stated
that, if tags are removed before testing, cervid carcasses cannot be
accurately identified nor can the movement history of individual
animals be determined.
The regulations in Sec. 55.23(b)(1) require all animals in a herd
that is participating in the CWD Herd Certification Program to be
identified. Paragraph (b)(3) requires all reports of animals that die
to include the identification numbers of the animals involved. Section
55.25 requires animals in the program to be identified with an
electronic implant, flank tattoo, ear tattoo, tamper-resistant ear tag,
or another device approved by APHIS. Such identification cannot be
removed from the animal without leaving evidence that the
identification has been removed, thus indicating noncompliance with the
regulations. These requirements, taken together, address the
commenter's concern.
Several commenters noted that, under Sec. 55.24(a), Certified
herds are not required to conduct slaughter surveillance and
surveillance of animals killed in shooter operations. One commenter
recommended that we require all animals that die to be tested for CWD
in order to ensure that any CWD present in captive cervid facilities is
detected.
Some commenters focused on shooter operations as a potential risk,
stating that such facilities tend to be large, which creates more
potential for ingress and egress of cervids, and are difficult to
accurately inventory. These commenters stated that such circumstances
make it even more important to maintain surveillance in those
facilities.
Another commenter noted generally that there are data indicating
that CWD prevalence is higher in adult male deer.\4\ Since CWD can
occur at a low prevalence and is difficult to detect, the commenter
stated, excluding any animal from the testing requirement decreases the
chances of detecting the disease when present. Thus, the commenter
stated, excluding adult male deer that die or are killed on a premises
would not be appropriate.
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\4\ Miller, M. W., and M. M. Conner. 2005. Epidemiology of
chronic wasting disease in free-ranging mule deer: spatial,
temporal, and demographic influences on observed prevalence
patterns. Journal of Wildlife Diseases 41: 275-290.
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We agree that CWD can be difficult to detect even in infected
animals. For example, in one herd that was depopulated in Minnesota,
multiple elk that had shown no clinical signs of CWD turned out to be
CWD-positive after testing. Animals in such a circumstance and in a
Certified herd would not have been required to be tested for CWD under
Sec. 55.24(a). This indicates that we need to continue slaughter
surveillance and surveillance of animals killed in shooter operations
in order to provide additional certainty that Certified herds contain
only animals that are low risk for CWD. Therefore, we are removing the
provision in Sec. 55.24(a) allowing Certified herds not to conduct
slaughter surveillance and surveillance of animals killed in shooter
operations.
We will, however, continue to evaluate the effectiveness of these
regulations and will revisit this issue after the program has been
established for some reasonable period of time. More scientific
research may become available that guides our thinking on the most
efficient, cost-effective forms of CWD surveillance.
With respect to the concerns specific to shooter operations, we
note that, for herds in the CWD Herd Certification Program, herd
premises must have perimeter fencing adequate to prevent ingress and
egress of cervids under Sec. 55.23(b)(2). The herd owner must also
allow for an inventory, as described in Sec. 55.23(b)(4). Herds that
cannot meet these requirements would not be eligible for the program.
One commenter stated that the final rule requires testing only of
cervids 16 months of age or older. The commenter stated that cervids
are apparently susceptible to CWD at birth and CWD has been documented
in cervids as young as 9 months of age. In the commenter's State,
licensees are required to test all captive cervids 6
[[Page 35560]]
months of age or older that die for any reason. The commenter suggested
that we change our requirement to apply to all cervids 6 months of age
or older.
As mentioned earlier, our regulations require that herd owners
report the deaths of all cervids 12 months of age or older, not 16
months, and make the carcasses of those animals available for tissue
sampling and testing. As discussed in the July 2006 final rule, the 12-
month standard is based on our best approximation of the point where
the value of additional epidemiological information exceeds the costs
to producers and to program administration of testing younger animals.
We will continue to review this standard as we gain more experience
with the CWD Herd Certification Program and as new scientific
information becomes available.
One commenter stated that paragraph (b)(3) of Sec. 55.23 in the
July 2006 final rule identifies APHIS employees and State
representatives as people who can collect CWD test samples. The
commenter stated that there is no definition of a State representative.
Facing large volumes of CWD test samples, the commenter's State has
established a formal program to certify private-sector collectors to
provide routine surveillance samples for CWD program herds. The
commenter stated that this program has the full confidence of APHIS
staff in the State and that the regulations should recognize the
program by defining ``State representative'' as a designated individual
trained by the State in addition to accredited veterinarians and State
or Federal officials.
The commenter is mistaken about the requirements of paragraph
(b)(3); they do not discuss sample collection or testing, but merely
require the owner to notify an APHIS employee or State representative
of animals that escape, disappear, or die, and to make the carcasses of
animals that die available for tissue sampling and testing in
accordance with instructions from the APHIS or State representative.
However, we will work out procedures for sample collection and
testing with States that have Approved State CWD Herd Certification
Programs under Sec. 55.22(b). In general, we would require that any
private-sector collectors of CWD samples operate within a structure
that provides accountability to the State and APHIS, as the program in
the commenter's State does.
It should also be noted that Sec. 55.1 does contain a definition
of State representative, which reads as follows: ``A person regularly
employed in the animal health work of a State and who is authorized by
that State to perform the function involved under a cooperative
agreement with the United States Department of Agriculture.'' We are
amending this definition in this final rule to remove the reference to
performing functions under a cooperative agreement, as not all
functions performed by a State representative under the regulations
will be performed under a cooperative agreement.
In the July 2006 final rule, paragraph (c) of Sec. 55.24 provides
that the Administrator may cancel enrollment after determining that the
herd owner failed to comply with any requirements of Sec. 55.24.
One commenter stated that the final rule does not include
definitive actions or mechanisms to decertify captive herds if the
owners fail to meet the program's requirements after they have been
certified. These should include actions that will be taken if, for
example, animals are not properly tagged, animals are not tested,
fences are not maintained, or if the required records are incorrect,
mishandled, or not provided.
We intended that paragraph (c) indicate that the Administrator may
cancel enrollment after determining that the herd owner failed to
comply with any requirements of subpart B in part 55. This would
include failure to comply with the requirements the commenter
mentioned, as well as failure to comply with herd plans and other
important provisions of the CWD Herd Certification Program.
Accordingly, this final rule corrects that provision of the
regulations.
As the commenter implies, sometimes we may take actions short of
cancellation in response to a failure to comply with the regulations.
Because individual cases of failure to comply with the regulations will
be different, we believe it is appropriate to make decisions on a case-
by-case basis. However, with this change, we will make clear that the
consequences of violations of the requirements can include cancellation
of enrollment if the Administrator should determine that it is
necessary and appropriate.
Paragraph (c) also provides that, in the event that a herd's
enrollment is canceled, the herd owner may not reapply to enroll in the
CWD Herd Certification Program for 5 years from the effective date of
the cancellation. One commenter expressed concern that, because it
takes 5 years for a herd to achieve Certified status, a herd owner
whose enrollment was canceled would need 10 years to return a herd to
Certified status. The commenter recommended allowing re-enrollment of
canceled herds immediately.
We have reevaluated the provision and determined that the 5-year
enrollment waiting period is not necessarily appropriate. While the
animals from a herd whose enrollment has been canceled should not be
moved interstate, it increases the strength of the CWD Herd
Certification Program to have monitoring in place for those animals
through the program. In addition, under the July 2006 final rule, after
the 5-year waiting period is up, the owner of a herd whose enrollment
is canceled could assemble a new herd composed of animals from
Certified herds and thus be granted Certified status immediately, with
no opportunity to monitor the owner's compliance before animals begin
moving interstate from the herd.
To provide for monitoring of both types of herds, we are changing
Sec. 55.24(c) to indicate that any herd enrolled in the CWD Herd
Certification Program by an owner whose herd's enrollment has been
canceled may not reach Certified status until 5 years after the herd
owner's new application for enrollment is approved by APHIS, regardless
of the status of the animals of which the herd is composed. This change
will provide for herds whose enrollment is canceled to immediately re-
enter the program and thus be subject to monitoring. It will also
ensure that newly assembled herds whose owners' enrollment was
previously canceled are subject to thorough monitoring before animals
from those herds can move interstate.
In the July 2006 final rule, Sec. 55.25 set out requirements for
animal identification for herds enrolled in the CWD Herd Certification
Program. One commenter stated that the identification of individual
cervids could be problematic, especially if animals have to be
physically or chemically restrained. The commenter stated that animals
would be put at serious risk of stress and injury, and identification
could be cost-prohibitive if large quantities of immobilizing drugs are
necessary. The commenter asked that we consider a redundant system of
two industry-accepted herd identification methods, which may include
ear notches, ear tattoos, ear tags, and transponders.
As discussed earlier, identification of animals in herds enrolled
in the CWD Herd Certification Program is essential in order to allow
for accurate inventory and tracking of the interstate movement of
animals moved from enrolled herds. Without such information, we cannot
conduct the surveillance and epidemiological investigations that are
[[Page 35561]]
necessary to determine whether animals from a herd are low risk for
CWD. We consider the requirements in Sec. 55.23 for two approved forms
of identification, one of which meets the definition of official animal
identification in Sec. 55.1, essential to ensure the integrity of the
animal identification used by herds enrolled in the program. Herds that
cannot comply will not be eligible to participate in the voluntary CWD
Herd Certification Program.
In the July 2006 final rule, part 81 contained restrictions on the
interstate movement of deer, elk, and moose. The July 2006 final rule
included in Sec. 81.1 a definition of deer, elk, and moose that
includes all animals of the genera Odocoileus, Cervus, and Alces and
their hybrids. This definition is important in part 81 because the
movement restrictions in that part apply only to deer, elk, and moose.
One commenter stated that all species in the family Cervidae should
be included in the rule and in the CWD Herd Certification Program,
stating that it is prudent to include all cervids until further
research indicates that such deer cannot be infected with or spread
CWD.
We have not expanded coverage to genera in which no species has
demonstrated susceptibility via natural routes of transmission. To do
so would extend the requirements of this rule without a sound basis,
unnecessarily increasing the burden on regulated parties, especially
zoos with large and varied animal collections. We are prepared to
extend the definition in the future if new research demonstrates
additional species in other genera are susceptible to CWD by natural
routes of transmission. For example, we made a change in the July 2006
final rule to add moose to the animals covered by the regulations.
One commenter asked why all deer, elk, and moose herds need to be
enrolled in the CWD program in order to move interstate when only a
limited number of cervid species within those respective genera have
been identified as being CWD susceptible.
As discussed in the July 2006 final rule, the definition of deer,
elk, and moose was developed by identifying the species known to be
susceptible to natural spread of CWD and then expanding coverage to the
complete genera that include these species, under the assumption that
related animals in a genus may share similar susceptibility to CWD even
when all species in the genus have not been shown to be susceptible.
Based on the progress of knowledge about susceptible species over
recent years, we believe this to be a scientifically sound and prudent
assumption. We will continue to evaluate scientific evidence on this
issue; if necessary at some point in the future, we will adjust the
scope of our regulations.
One commenter suggested that we include in Sec. 81.1 a definition
of certificate, to complement the requirements for a certificate in
part 81. The commenter suggested that the definition be similar to the
definition of origin health certificate in 9 CFR part 91, which deals
with export certification.
The regulations in Sec. 81.4(a) describe in detail the information
required on certificates issued for interstate movement in accordance
with part 81. The definition of origin health certificate in part 91 is
largely devoted to explaining what information must be included on such
a certificate. Consequently, we do not see a need to add such a
definition to part 81.
In the July 2006 final rule, Sec. 81.3 contains general
restrictions on the interstate movement of deer, elk, and moose.
Paragraph (b) of Sec. 81.3 contains restrictions on the interstate
movement of captive deer, elk, or moose that are captured from a wild
population for interstate movement and release. Such animals must have
two forms of animal identification, one of which is official animal
identification, and a certificate accompanying the animal must document
the source population to be low risk for CWD, based on a CWD
surveillance program that is approved by the State Government of the
receiving State and by APHIS.
Several commenters expressed concerns about these provisions. These
commenters largely stated that the interstate movement of animals from
wild populations should be subject to the same requirements as the
interstate movement of animals from farmed or captive herds. Some
commenters stated that captive animals are more thoroughly and
continually monitored and restricted in their movement, and the
percentage of infection with CWD in wildlife is much higher than in
captive cervids. Another commenter noted that State fish and wildlife
agencies may lack the funding and manpower necessary to conduct
surveillance, meaning that some States may not be able to monitor the
animals once they are released in the destination State.
The requirements for translocation are minimum requirements
intended to regulate a practice that has been occurring. Without the
provisions in Sec. 81.3(b), there would have been no Federal CWD-
related restrictions on the interstate movement of such animals. As one
commenter pointed out, translocation can spread CWD; therefore, we
determined that it was appropriate to put in place some restrictions on
this movement.
We do not consider it practical to make the interstate movement of
animals from wild populations subject to the same requirements as the
interstate movement of animals from farmed or captive herds. Animals
moved interstate from farmed or captive herds must come from a
Certified herd, meaning they have been inventoried and monitored for 5
years to determine that they are low risk for CWD. It would be
impossible to monitor wild animals in the same way we monitor farmed or
captive animals. We note that, under this final rule, any State will be
able to further restrict, or prohibit, the movement of animals captured
from wild populations into the State.
As discussed earlier in this document, we encourage States to
continue to perform surveillance in wild populations, both to
facilitate the interstate movement of animals from wild populations and
to understand the presence of CWD in their States generally.
In the July 2006 final rule, paragraph (c) of Sec. 81.3 contained
requirements for the interstate movement of deer, elk, and moose to
slaughter. Two commenters asked that States be allowed to place
additional requirements on such movement; one asked for a requirement
that States be notified of such movement, and another asked that States
be allowed to require a permit to ensure that the animals are moved
directly to a slaughter facility.
Under this final rule, States can impose both of these additional
requirements, as well as any other additional requirements they
determine to be necessary, on movement to slaughter.
Some commenters asked questions regarding participation in the
program. One requested that all nonsusceptible species be permitted to
participate in the CWD Herd Certification Program on a voluntary basis,
as movement restrictions imposed by States have had economic impacts on
industry. If this change was made, the commenter asked that visible
identification not be required for reindeer used for exhibition
purposes. Another asked why reindeer are not included in the indemnity
provisions in part 55.
We did not provide for the participation of species not known to be
susceptible to CWD in the CWD Herd Certification Program because their
interstate movement does not pose a risk of spreading CWD. Under this
final rule, States will continue to be free to
[[Page 35562]]
impose restrictions on the interstate movement of farmed or captive
cervids for any reason, not just related to CWD.
We recognize that the regulations may have created some confusion
on this point. We published an interim rule in the Federal Register on
February 8, 2002 (Docket No. 00-108-1, 67 FR 5925-5934) that
established part 55. This rule defined animal as any captive cervid and
stated that we would pay indemnity for CWD-positive animals, CWD-
exposed animals, and CWD-suspect animals. However, of the animals in
the family Cervidae, only deer, elk, and moose are known to be
susceptible to CWD. We have not provided in our regulations for payment
of indemnity for animals that are not susceptible to CWD, and we do not
provide for their participation in the CWD Herd Certification Program,
which is limited to deer, elk, and moose.
Accordingly, this final rule amends the definition of animal in
Sec. 55.1 to read: ``Any farmed or captive deer, elk, or moose.'' This
clarifies the regulations in part 55 and makes the definition of animal
in that part consistent with the definition of animal in Sec. 81.1.
The February 2002 interim rule also defined cervid as all members
of the family Cervidae and hybrids, including deer, elk, moose,
caribou, reindeer, and related species. While this is an accurate
definition of the word ``cervid,'' it may have created confusion; the
provisions of part 55 contain several references to cervids in the
context of payment of indemnity, but only animals that are susceptible
to CWD are eligible for indemnity. Accordingly, we are amending the
definition of cervid as well, to indicate that for the purposes of part
55, the term ``cervid'' refers to animals in the genera Odocoileus,
Cervus, and Alces and their hybrids, i.e., deer, elk, and moose. As the
July 2006 final rule included an identical definition of cervid in part
81, we are amending that definition as well.
Two commenters expressed concern that the July 2006 final rule and
the March 2009 proposed rule did not include specific details on how
the CWD Herd Certification Program will operate. One stated that the
rule should refer to a document that specifies the proper management of
captive herds. Both of these commenters expressed specific concern
about the lack of information about sample collection and testing.
Another commenter asked that we provide detailed information on how
infected herds will be dealt with, i.e., quarantine and testing,
depopulation, cleaning and disinfection, and fence maintenance
requirements.
The optimal methods for most specific aspects of the CWD Herd
Certification Program will vary among States. For States that already
have CWD programs, we will review their specific methods and determine
whether they are adequate to meet the performance standards set out in
Sec. 55.23(a). We will also develop a program standards document that
will provide detailed guidance on the implementation of and compliance
with the regulations, including sample collection and testing and the
actions taken when a herd is quarantined. This approach gives States
and herd owners flexibility to achieve performance-based standards and
will allow us to update the guidance whenever it becomes necessary. For
example, in the future, new scientific evidence about CWD may indicate
that different testing or cleaning and disinfection methods are
appropriate; we will update our guidance if such evidence becomes
available.
With respect to sample collection and testing, these activities
will be overseen by APHIS employees and State representatives. We will
have systems in place to ensure that people who collect samples are
performing these activities correctly. Standards for approval of CWD
testing laboratories are already found in Sec. 55.8(d).
One commenter expressed concern about zoos' continued ability to
hold and transport deer, elk, and moose for the purposes of public
display, outreach education, and cooperative breeding programs. The
commenter stated that the proposed rule is specific to the deer, elk,
and moose farming community and does not address the specific needs and
unique circumstances of the accredited zoo community. The commenter
proposed that a method be developed to allow the movement of captive
deer, elk, and moose by and between zoos that are accredited by the
Association of Zoos and Aquariums, based on that association's
guidelines for CWD surveillance in captive cervids in zoos.
The regulations in Sec. 81.3(e) provide for the Administrator to
issue a permit for the interstate movement of captive deer, elk, or
moose in cases where the Administrator determines that adequate survey
and mitigation procedures are in place to prevent dissemination of CWD.
If a zoo presents evidence establishing that its survey and mitigation
procedures are adequate to prevent dissemination of CWD, we will allow
the interstate movement of animals from that zoo. We plan to work with
zoos on how such movement might occur, and we may develop a proposal
for stakeholder consideration to establish a zoo movement protocol in
the future.
We note that, as this final rule does not preempt State laws and
regulations that are more restrictive than our regulations, the
interstate movement of captive deer, elk, and moose between zoos may be
subject to additional State restrictions or prohibitions.
One commenter stated that the interstate movement of deer body
parts should be restricted so that hunted deer parts from areas where
CWD is endemic do not enter nonendemic areas.
The movement of deer parts in interstate commerce for human or
animal consumption is regulated by the Food and Drug Administration.
States may also have restrictions on the entry of deer parts and
products.
One commenter, noting that we stated in the July 2006 final rule
that there exists no live animal test for CWD, stated that there are
two live-animal tests available: Tonsillar and rectal biopsies. The
commenter stated that the tests are currently not recognized by all
government entities, but could be a beneficial tool for research and
whole herd surveillance. The commenter also recommended that we require
all deer, elk, and moose moved interstate to have a live-animal test
performed at least 30 days before transport. Two commenters stated that
the regulations should take into account the possibility of an accepted
live-animal test becoming available.
These tests have not yet been determined to be effective at
detecting CWD in live animals, and thus we do not recognize them as
official tests for use in the CWD Herd Certification Program. We
certainly encourage research into methods for live-animal CWD
detection. If and when an official live-animal test becomes available,
we will amend the regulations to take its availability into account.
One commenter encouraged us to work with the U.S. Department of the
Interior to develop disease eradication plans in U.S. wildlife, since
it is obvious that domestic animal diseases, such as brucellosis in
bison and elk, bovine tuberculosis in deer and elk, CWD in cervids, and
scrapie in Big Horn sheep, can greatly impact wildlife and result in
devastating economic loss to domestic livestock industries and business
communities that depend on hunting for an economic base.
Wild deer and elk, as well as other wild animals, are State
resources, unless they are on Federal land, in which case the
Department of the Interior may be involved. We work with the States and
with the Department of the Interior on research and mitigation
development to help prevent disease transmission between wildlife and
livestock.
[[Page 35563]]
Two commenters addressed importation of deer, elk, and moose. One
stated that we should prohibit the importation of cervids from
countries where CWD is present until those countries develop a herd
monitoring and certification program that is equivalent to our program.
The other stated that CWD-free countries are not likely to have an
ongoing CWD surveillance program, meaning that it would be appropriate
to allow the importation of cervids from CWD-free countries without
requiring a herd surveillance program in the country of origin.
We restrict the importation of ruminants generally in 9 CFR part
93, Subpart D, which covers the importation of all ruminants. We plan
to implement CWD-specific import requirements in the future; when we
do, they will be equivalent to our requirements for interstate
movement, in keeping with our commitments as a member of the World
Trade Organization. Therefore, we agree with the first commenter. With
respect to the second commenter's recommendation, one component of
maintaining disease-free status is performing ongoing surveillance to
confirm continued freedom from the disease, and we would require such
surveillance for imported cervids.
Miscellaneous Changes
In the July 2006 final rule, paragraph (b) of Sec. 55.22 indicated
that owners of farmed or captive deer, elk, or moose herds could apply
to enroll in a Federal CWD Herd Certification Program if no State CWD
Herd Certification program exists in the herd's State. Although we were
prepared to establish such a program in 2006, changes in appropriated
funds for the CWD program may make it impossible to do so in the
future. We are amending paragraph (b) to indicate that the option of a
Federal CWD Herd Certification Program will be subject to the
availability of appropriated funds. If a Federal CWD Herd Certification
Program cannot be made available to herd owners, they will have to
participate in an Approved State CWD Herd Certification Program in
order for their herds to achieve Certified status and thus be eligible
to move interstate under part 81.
In the July 2006 final rule, paragraph (a)(10) of Sec. 55.23
indicates that States are responsible for maintaining certain data in
the CWD National Database administered by APHIS, or in a State database
approved by the Administrator as compatible with the CWD National
Database. However, references to the CWD National Database in
Sec. Sec. 55.25 and 81.2 do not also provide for the use of a State
database that is compatible with the CWD National Database.
Accordingly, we are amending those references to the CWD National
Database to indicate that the required data may be found either in the
CWD National Database or in an approved State database.
In this final rule, we are revising the definition of Administrator
in Sec. 55.1 to read: ``The Administrator, Animal and Plant Health
Inspection Service, or any person authorized to act for the
Administrator.'' The definition of Administrator in Sec. 55.1
currently limits those who can act for the Administrator to APHIS
employees, but State representatives may be authorized in some cases to
fulfill tasks assigned to the Administrator in the context of operating
their State CWD Herd Certification Programs. We are also adding this
definition of Administrator to Sec. 81.1.
In the July 2006 final rule, we revised the definition of CWD-
positive animal to state that such an animal must have its diagnosis
confirmed by means of two official CWD tests. In the Background section
of that final rule, we stated that we expect that, in most cases, the
first test would be conducted by a State, Federal, or university
laboratory approved to conduct CWD official tests in accordance with
Sec. 55.8, and, if the first test was positive, a second, confirmatory
test would be conducted at NVSL to confirm the diagnosis of CWD. In
some cases, both the initial and confirmatory test may be conducted at
NVSL.
However, stating that two official tests are conducted could
indicate to readers that two different types of official tests must be
conducted in order for an animal to be determined to be CWD-positive,
which is not correct; our intent was to indicate that there must be two
positive results, which may be from the same type of test. The
definition also does not indicate that NVSL is the confirmatory
laboratory. The intent behind our changes was to indicate that an
animal will be determined to be a CWD-positive animal only after an
initial positive result and subsequent official confirmatory testing
conducted by NVSL. As indicated in the July 2006 final rule, official
confirmatory testing by NVSL is required whether the initial test was
conducted by an approved laboratory or by NVSL itself. Therefore, we
are amending the definition of CWD-positive animal to indicate that
such an animal must have its diagnosis of CWD established through
official confirmatory testing conducted by NVSL.
We are also reorganizing Sec. 55.25 by moving the second sentence
to the end of the section, to improve clarity.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
IV. Compliance With Other Statutes and Executive Orders
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
This final rule has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also provides a final regulatory flexibility analysis that examines the
potential economic effects of this rule on small entities, as required
by the Regulatory Flexibility Act. The economic analysis is summarized
below. Copies of the full analysis are available on the Regulations.gov
Web site (see footnote 1 in this document for a link to
Regulations.gov) or by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
This final rule amends a suspended final rule published in July
2006, for the control of chronic wasting disease (CWD) in farmed or
captive cervids (deer, elk, and moose) in the United States. The July
2006 final rule established a voluntary Herd Certification Program that
included CWD monitoring and testing requirements and set interstate
movement restrictions. APHIS suspended the July 2006 final rule
indefinitely to reconsider several of its requirements in response to
petitions from the public and comments on those petitions. In this
document, we examine expected benefits and costs of the July 2006 final
rule, as amended by this final rule. With publication of this final
rule and concurrent removal of the
[[Page 35564]]
suspension of the July 2006 final rule, farmed or captive deer, elk,
and moose herd owners who choose to participate in the Herd
Certification Program will have to meet program requirements for animal
identification, testing, and herd management. With certain exceptions,
only deer, elk, and moose from Certified herds will be eligible for
interstate movement.
Amendments to the July 2006 final rule include the following: (i)
The Federal CWD regulations will set minimum requirements for
interstate movement, while States will be allowed to impose additional
requirements; (ii) cervids allowed to be moved interstate (other than
ones moving to slaughter or for research), must be from Certified herds
that have been monitored for a period of at least 5 years and that have
not been epidemiologically linked to herds where CWD has been
diagnosed, or captured from a wild cervid population that has been
documented to be low risk for CWD based on a surveillance program;
(iii) farmed or captive cervids, when en route to another State, will
be allowed to transit through States that otherwise ban or restrict
their entry; (iv) a physical inventory of the animals will be required
at the time a herd is enrolled in a CWD certification program and
thereafter the animals will need to be physically assembled for
inventory within 3 years of the last physical inventory; (v) certified
cervids that die or are killed at slaughter or on shooter operations
will be required to be tested for CWD; and (vi) there will be optional
confirmatory DNA test provisions for animals that test CWD-positive.
Implementation of the July 2006 final rule as amended by this final
rule is expected to result in both positive and negative economic
effects for herd owners and States, with benefits and costs depending
on herd owners' existing management practices and marketing activities
and States' current provisions with respect to CWD control. Overall
benefits of the rule are expected to exceed its costs. Foremost, the
July 2006 rule, as amended, will help prevent the spread of CWD among
States and facilitate interstate movement of healthy cervids. The Herd
Certification Program will also promote U.S. producers' access to
international markets for cervid products such as antler velvet.
The regulations will provide uniform minimum requirements for
interstate movement. This final rule will allow States to enact and
administer stricter CWD status requirements for cervids entering from
other States. As at present, herd owners' interstate marketing
decisions may need to account for dissimilar State CWD certification
regulations.
Some herd owners also may be adversely affected by the 5-year
monitoring requirement for interstate movement; however, available
research indicates that this minimum period of monitoring is necessary
to provide an adequate level of protection against the spread of CWD.
Most researchers agree that CWD manifests itself within 5 years if the
disease is present in a herd of farmed or captive cervids. Many herd
owners have been participating in state level CWD HCP's for at least 5
years and will have met this requirement as a result of being enrolled
in a state program that becomes an Approved State HCP in the national
CWD HCP program.
Producers who participate in the Herd Certification Program will be
required to maintain a complete inventory of their herds, with
verification by APHIS or State officials. The annual inventory cost is
estimated to average about $25 to $30 per deer or elk, including the
animals' physical inventory once every three years and use of eartags
for identification. (We do not know of any farmed or captive moose
herds.) Values of farmed or captive deer and elk range widely,
depending on the type of animal and market conditions. Based on average
per animal values of $2,000 for deer and $2,200 for elk, annual
inventory costs are estimated to average between 1.25 and 1.50 percent
of the value of a farmed or captive deer and to between 1.14 and 1.36
percent of the value of a farmed or captive elk.
The requirement that cervids from herds participating in the
certification program be tested for CWD when they die or are killed
(including slaughter) will entail submission of the carcass or whole
head for tissue sampling and testing or collection of the tissue sample
by an approved veterinarian. The estimated cost is about $150 per
sample, equivalent to about 8 percent of the average value of a farmed
or captive deer and about 7 percent of the average value of a farmed or
captive elk. CWD testing of cervids is recognized by APHIS, the States,
and cervid herd owners as essential to successful control of this
disease.
Herd owners will have the option of using confirmatory DNA testing
provisions to verify that the sample tested is from the animal in
question, although APHIS is confident that the existing chain-of-
custody processes for CWD testing are effective. Owners who choose
confirmatory DNA testing will consider it a benefit, as evidenced by
their voluntary payment for this test.
Most cervid operations are small entities. The rule will have a
positive overall economic impact on affected entities large and small,
and the U.S. cervid industries generally, in controlling the spread of
CWD and facilitating interstate and international trade in cervids and
cervid products.
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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts State and local laws and
regulations that are in conflict with this rule; (2) has no retroactive
effect; and (3) does not require administrative proceedings before
parties may file suit in court challenging this rule.
Executive Order 13175
APHIS sent a letter notifying all 565 federally recognized Tribes
of the proposed changes to the CWD regulations. APHIS requested from
Tribes all comments based on potential impacts and outcomes concerning
the March 2009 proposed rule. APHIS offered to conduct conference calls
or formal consultations with Tribal leaders if requested. APHIS did not
receive any comments from Tribes regarding the March 2009 proposed
rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), we published a notice in the Federal
Register on January 24, 2012 (77 FR 3434-3435, Docket No. APHIS-2011-
0032), announcing our intention to reinstate the information collection
associated with the July 2006 final rule and soliciting comments on it.
We are asking the Office of Management and Budget (OMB) to approve our
use of this information collection for 3 years. When OMB notifies us of
its decision, we will publish a document in the Federal Register
providing notice of the assigned OMB control number or, if approval is
denied, providing notice of what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and
[[Page 35565]]
other information technologies, to provide increased opportunities for
citizen access to Government information and services, and for other
purposes. For information pertinent to E-Government Act compliance
related to this rule, please contact Mrs. Celeste Sickles, APHIS'
Information Collection Coordinator, at (301) 851-2908.
List 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 recordkeeping requirements, Transportation.
Accordingly, for the reasons set forth in the preamble under the
authority at 7 U.S.C. 8301-8317 and 7 CFR 2.22, 2.80, and 371.4, we are
announcing the effective date of the final rule published on July 21,
2006 (71 FR 41682) and further amending 9 CFR Chapter I as follows:
PART 55--CONTROL OF CHRONIC WASTING DISEASE
0
1. The authority citation for part 55 is revised to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 55.1 is amended as follows:
0
a. In the definition of State representative, by removing the words
``under a cooperative agreement with the United States Department of
Agriculture''.
0
b. By revising the definitions of Administrator, animal, cervid, CWD-
exposed animal, CWD-positive animal, CWD-suspect animal, herd plan,
official animal identification, and premises identification number
(PIN) to read as set forth below.
0
c. By adding definitions for accredited veterinarian and National
Uniform Eartagging System, in alphabetical order, to read as set forth
below.
Sec. 55.1 Definitions.
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health
Inspection Service, or any person authorized to act for the
Administrator.
Animal. Any farmed or captive deer, elk, or moose.
* * * * *
Cervid. All members of the family Cervidae and hybrids, including
deer, elk, moose, caribou, reindeer, and related species. For the
purposes of this part, the term ``cervid'' refers specifically to
cervids susceptible to CWD. These are animals in the genera Odocoileus,
Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
CWD-exposed animal. An animal that is part of a CWD-positive herd,
or that has been exposed to a CWD-positive animal or contaminated
premises within the previous 5 years.
CWD-positive animal. An animal that has had a diagnosis of CWD
established through official confirmatory testing conducted by the
National Veterinary Services Laboratories.
* * * * *
CWD-suspect animal. An animal for which an APHIS employee or State
representative has determined that unofficial CWD test results,
laboratory evidence or clinical signs suggest a diagnosis of CWD, but
for which official laboratory results have been inconclusive or not yet
conducted.
* * * * *
Herd plan. A written herd and/or premises management agreement
developed by APHIS in collaboration with the herd owner, State
representatives, and other affected parties. The herd plan will not be
valid until it has been reviewed and signed by the Administrator, the
State representative, and the herd owner. A herd plan sets out the
steps to be taken to eradicate CWD from a CWD-positive herd, to control
the risk of CWD in a CWD-exposed or CWD-suspect herd, or to prevent
introduction of CWD into that herd or any other herd. A herd plan will
require specified means of identification for each animal in the herd;
regular examination of animals in the herd by a veterinarian for
clinical signs of disease; reporting to a State or APHIS representative
of any clinical signs of a central nervous system disease or chronic
wasting condition in the herd; maintaining records of the acquisition
and disposition of all animals entering or leaving the herd, including
the date of acquisition or removal, name and address of the person from
whom the animal was acquired or to whom it was disposed; and the cause
of death, if the animal died while in the herd. A herd plan may also
contain additional requirements to prevent or control the possible
spread of CWD, depending on the particular circumstances of the herd
and its premises, including but not limited to depopulation of the
herd, specifying the time for which a premises must not contain cervids
after CWD-positive, -exposed, or -suspect animals are removed from the
premises; fencing requirements; selective culling of animals;
restrictions on sharing and movement of possibly contaminated livestock
equipment; premises cleaning and disinfection requirements; or other
requirements. A herd plan may be reviewed and changes to it suggested
at any time by any party signatory to it, in response to changes in the
situation of the herd or premises or improvements in understanding of
the nature of CWD epidemiology or techniques to prevent its spread. The
revised herd plan will become effective after it is reviewed by the
Administrator and signed by the Administrator, the State
representative, and the herd owner.
* * * * *
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.
* * * * *
Official animal identification. A device or means of animal
identification approved for use under this part by APHIS to uniquely
identify individual animals. Examples of approved official animal
identification devices are listed in Sec. 55.25. The official animal
identification must include a nationally unique animal identification
number that adheres to one of the following numbering systems:
(1) National Uniform Eartagging System. The CWD program allows the
use of either the eight-character or nine-character format for cervids.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system
combines an official premises identification number (PIN), as defined
in this section, with a producer's livestock production numbering
system to provide a unique identification number. The PIN and the
production number must both appear on the official tag.
[[Page 35566]]
(4) Any other numbering system approved by the Administrator for
the identification of animals in commerce.
* * * * *
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. The premises identification number may consist
of:
(1) The State's two-letter postal abbreviation followed by the
premises' assigned number; or
(2) 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.
* * * * *
0
3. In part 55, subpart B is revised to read as follows:
Subpart B--Chronic Wasting Disease Herd Certification Program
Sec.
55.21 Administration.
55.22 Participation and enrollment.
55.23 Responsibilities of States and enrolled herd owners.
55.24 Herd status.
55.25 Animal identification.
Subpart B--Chronic Wasting Disease Herd Certification Program
Sec. 55.21 Administration.
The CWD Herd Certification Program is a cooperative effort between
APHIS, State animal health and wildlife agencies, and deer, elk, and
moose owners. APHIS coordinates with these State agencies to encourage
deer, elk, and moose owners to certify their herds as low risk for CWD
by being in continuous compliance with the CWD Herd Certification
Program standards.
Sec. 55.22 Participation and enrollment.
(a) Participation by States. Any State that operates a State
program to certify the CWD status of deer, elk, or moose may request
the Administrator to designate the State program as an Approved State
CWD Herd Certification Program. The Administrator will approve or
disapprove a State program in accordance with Sec. 55.23(a). In States
with an Approved State CWD Herd Certification Program, program
activities will be conducted in accordance with the guidelines of that
program as long as the State program meets the minimum requirements of
this part. A list of Approved State CWD Herd Certification Programs may
be obtained by writing to the National Center for Animal Health
Program, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
(b) Participation by owners. Any owner of a farmed or captive deer,
elk, or moose herd may apply to enroll in an Approved State CWD Herd
Certification Program by sending a written request to the appropriate
State agency. Subject to the availability of appropriated funds for a
Federal CWD Herd Certification Program, the owner may apply to the
APHIS veterinarian in charge if no Approved State CWD Herd
Certification Program exists in the herd's State. APHIS or the State
will determine the herd's eligibility, and if needed will require the
owner to submit more details about the herd animals and operations. An
application for participation may be denied if APHIS or the State
determines that the applicant has previously violated State or Federal
laws or regulations for livestock, and that the nature of the violation
indicates that the applicant may not faithfully comply with the
requirements of the CWD Herd Certification Program. If the enrolling
herd is a CWD-positive herd or CWD-exposed herd, immediately after
enrollment it must begin complying with a herd plan developed in
accordance with Sec. 55.24. After determining that the herd is
eligible to participate in accordance with this paragraph, APHIS or the
appropriate State agency will send the herd owner a notice of
enrollment that includes the herd's enrollment date. Inquiries
regarding which herds are participating in the CWD Herd Certification
Program and their certification should be directed to the State
representative of the relevant State.
(1) Enrollment date. With the exceptions listed in this paragraph,
the enrollment date for any herd that joins the CWD Herd Certification
Program after August 13, 2012 will be the date the herd is approved for
participation.
(i) For herds already participating in State CWD programs, the
enrollment date will be the first day that the herd participated in a
State program that APHIS subsequently determines qualifies as an
Approved State CWD Herd Certification Program in accordance with Sec.
55.23(a) of this part.
(ii) For herds that enroll directly in the Federal CWD Herd
Certification Program, which is allowed only when there is no Approved
State CWD Herd Certification Program in their State and which is
subject to the availability of appropriated funds, the enrollment date
will be the earlier of:
(A) The date APHIS approves enrollment; or
(B) 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 3 years prior to the date that APHIS approved
enrollment of the herd.
(iii) For new herds that were formed from and contain only animals
from herds enrolled in the CWD Herd Certification Program, the
enrollment date will be the latest enrollment date for any source herd
for the animals.
(2) [Reserved]
(Approved by the Office of Management and Budget under control
number 0579-0237)
Sec. 55.23 Responsibilities of States and enrolled herd owners.
(a) Approval of State programs and responsibilities of States. In
reviewing a State program's eligibility to be designated an Approved
State CWD Herd Certification Program, the Administrator will evaluate a
written statement from the State that describes the State's CWD control
and deer, elk, and moose herd certification activities and that cites
relevant State statutes, regulations, and directives pertaining to
animal health activities and reports and publications of the State. In
determining whether the State program qualifies, the Administrator will
determine whether the State:
(1) Has the authority, based on State law or regulation, to
restrict the intrastate movement of all CWD-positive, CWD-suspect, and
CWD-exposed animals.
(2) Has the authority, based on State law or regulation, to require
the prompt reporting of any animal suspected of having CWD and test
results for any animals tested for CWD to State or Federal animal
health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a
memorandum of understanding with APHIS that delineates the respective
roles of the State and APHIS in CWD Herd Certification Program
implementation.
(4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect
animals and herds under movement restrictions, with movement
[[Page 35567]]
of animals from them only for destruction or under permit.
(5) Has effectively implemented policies to:
(i) Promptly investigate all animals reported as CWD-suspect
animals;
(ii) Designate herds as CWD-positive, CWD-exposed, or CWD-suspect
and promptly restrict movement of animals from the herd after an APHIS
employee or State representative determines that the herd contains or
has contained a CWD-positive animal;
(iii) Remove herd movement restrictions only after completion of a
herd plan agreed upon by the State representative, APHIS, and the
owner;
(iv) Conduct an epidemiologic investigation of CWD-positive, CWD-
exposed, and CWD-suspect herds that includes the designation of suspect
and exposed animals and that identifies animals to be traced;
(v) Conduct tracebacks of CWD-positive animals and traceouts of
CWD-exposed animals and report any out-of-State traces to the
appropriate State promptly after receipt of notification of a CWD-
positive animal; and
(vi) Conduct tracebacks based on slaughter or other sampling
promptly after receipt of notification of a CWD-positive animal at
slaughter.
(6) Effectively monitors and enforces State quarantines and State
reporting laws and regulations for CWD.
(7) Has designated at least one State animal health official, or
has worked with APHIS to designate an APHIS official, to coordinate CWD
Herd Certification Program activities in the State.
(8) Has programs to educate those engaged in the interstate
movement of deer, elk, and moose regarding the identification and
recordkeeping requirements of this part.
(9) Requires, based on State law or regulation, and effectively
enforces identification of all animals in herds participating in the
CWD Herd Certification Program;
(10) Maintains in the CWD National Database administered by APHIS,
or in a State database approved by the Administrator as compatible with
the CWD National Database, the State's:
(i) Premises information and assigned premises numbers;
(ii) Individual animal information on all deer, elk, and moose in
herds participating in the CWD Herd Certification Program in the State;
(iii) Individual animal information on all out-of-State deer, elk,
and moose to be traced; and
(iv) Accurate herd status data.
(11) Requires that tissues from all CWD-exposed or CWD-suspect
animals that die or are depopulated or otherwise killed be submitted to
a laboratory authorized by the Administrator to conduct official CWD
tests and requires appropriate disposal of the carcasses of CWD-
positive, CWD-exposed, and CWD-suspect animals.
(b) Responsibilities of enrolled herd owners. Herd owners who
enroll in the CWD Herd Certification Program agree to maintain their
herds in accordance with the following conditions:
(1) Each animal in the herd must be identified using means of
animal identification specified in Sec. 55.25. All animals in an
enrolled herd must be identified before reaching 12 months of age. In
addition, all animals of any age in an enrolled herd must be identified
before being moved from the herd premises. In addition, all animals in
an enrolled herd must be identified before the inventory required under
paragraph (b)(4) of this section, and animals found to be in violation
of this requirement during the inventory must be identified during or
after the inventory on a schedule specified by the APHIS employee or
State representative conducting the inventory;
(2) The herd premises must have perimeter fencing adequate to
prevent ingress or egress of cervids. This fencing must also comply
with any applicable State regulations;
(3) The owner must immediately report to an APHIS employee or State
representative all animals that escape or disappear, and all deaths
(including animals killed on premises maintained for hunting and
animals sent to slaughter) of deer, elk, and moose in the herd aged 12
months or older; Except that, APHIS employees or State representatives
may approve reporting schedules other than immediate notification when
herd conditions warrant it in the opinion of both APHIS and the State.
The report must include the identification numbers of the animals
involved and the estimated time and date of the death, escape, or
disappearance. For animals that die (including animals killed on
premises maintained for hunting and animals sent to slaughter), the
owner must inform an APHIS or State representative and must make the
carcasses of the animals available for tissue sampling and testing in
accordance with instructions from the APHIS or State representative. In
cases where animals escape or disappear and thus are not available for
tissue sampling and testing, or when the owner provides samples that
are of such poor quality that they cannot be tested for CWD, an APHIS
representative will investigate whether the unavailability of animals
or usable samples for testing constitutes a failure to comply with
program requirements and will affect the herd's status in the CWD Herd
Certification Program;
(4) The owner must maintain herd records that include a complete
inventory of animals that states the species, 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.
A complete physical herd inventory must be performed on a herd in
accordance with this paragraph at the time a herd is enrolled in the
CWD Herd Certification Program; Except that, APHIS may accept a
complete physical herd inventory performed by an APHIS employee, State
representative, or accredited veterinarian not more than 1 year before
the herd's date of enrollment in the CWD Herd Certification Program as
fulfilling the requirement for an initial inventory. In addition, a
complete physical herd inventory must be performed for all herds
enrolled in
[[Page 35568]]
the CWD Herd Certification Program no more than 3 years after the last
complete physical herd inventory for the herd;
(5) If an owner wishes to maintain separate herds, he or she must
maintain separate herd inventories, records, working facilities, water
sources, equipment, and land use. There must be a buffer zone of at
least 30 feet between the perimeter fencing around separate herds, and
no commingling of animals may occur. Movement of animals between herds
must be recorded as if they were separately owned herds;
(6) New animals may be introduced into the herd only from other
herds enrolled in the CWD Herd Certification Program. If animals are
received from an enrolled herd with a lower program status, the
receiving herd will revert to that lower program status. If animals are
obtained from a herd not participating in the program, then the
receiving herd will be required to start over in the program.
(Approved by the Office of Management and Budget under control
number 0579-0237)
Sec. 55.24 Herd status.
(a) Initial and subsequent status. When a herd is first enrolled in
the CWD Herd Certification Program, it will be placed in First Year
status; except that, if the herd is composed solely of animals obtained
from herds already enrolled in the Program, the newly enrolled herd
will have the same status as the lowest status of any herd that
provided animals for the new herd. If the herd continues to meet the
requirements of the CWD Herd Certification Program, each year, on the
anniversary of the enrollment date the herd status will be upgraded by
1 year; i.e., Second Year status, Third Year status, Fourth Year
status, and Fifth Year status. One year from the date a herd is placed
in Fifth Year status, the herd status will be changed to Certified, and
the herd will remain in Certified status as long as it is enrolled in
the program, provided its status is not lost or suspended in accordance
with this section.
(b) Loss or suspension of herd status. (1) If a herd is designated
a CWD-positive herd or a CWD-exposed herd, it will immediately lose its
program status and may only reenroll after entering into a herd plan.
(2) If a herd is designated a CWD-suspect herd, a trace back herd,
or a trace forward herd, it will immediately be placed in Suspended
status pending an epidemiologic investigation by APHIS or a State
animal health agency. If the epidemiologic investigation determines
that the herd was not commingled with a CWD-positive animal, the herd
will be reinstated to its former program status, and the time spent in
Suspended status will count toward its promotion to the next herd
status level.
(i) If the epidemiologic investigation determines that the herd was
commingled with a CWD-positive animal, the herd will lose its program
status and will be designated a CWD-exposed herd.
(ii) If the epidemiological investigation is unable to make a
determination regarding the exposure of the herd, because the necessary
animal or animals are no longer available for testing (i.e., a trace
animal from a known positive herd died and was not tested) or for other
reasons, the herd status will continue as Suspended unless and until a
herd plan is developed for the herd. If a herd plan is developed and
implemented, the herd will be reinstated to its former program status,
and the time spent in Suspended status will count toward its promotion
to the next herd status level; Except that, if the epidemiological
investigation finds that the owner of the herd has not fully complied
with program requirements for animal identification, animal testing,
and recordkeeping, the herd will be reinstated into the CWD Herd
Certification Program at the First Year status level, with a new
enrollment date set at the date the herd entered into Suspended status.
Any herd reinstated after being placed in Suspended status must then
comply with the requirements of the herd plan as well as the
requirements of the CWD Herd Certification Program. The herd plan will
require testing of all animals that die in the herd for any reason,
regardless of the age of the animal, may require movement restrictions
for animals in the herd based on epidemiologic evidence regarding the
risk posed by the animals in question, and may include other
requirements found necessary to control the risk of spreading CWD.
(3) If an APHIS or State representative determines that animals
from a herd enrolled in the program have commingled with animals from a
herd with a lower program status, the herd with the higher program
status will be reduced to the status of the herd with which its animals
commingled.
(c) Cancellation of enrollment by Administrator. The Administrator
may cancel the enrollment of an enrolled herd by giving written notice
to the herd owner. In the event of such cancellation, any herd enrolled
in the CWD Herd Certification Program by that herd owner may not reach
Certified status until 5 years after the herd owner's new application
for enrollment is approved by APHIS, regardless of the status of the
animals of which the herd is composed. The Administrator may cancel
enrollment after determining that the herd owner failed to comply with
any requirements of this subpart. Before enrollment is canceled, an
APHIS representative will inform the herd owner of the reasons for the
proposed cancellation.
(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, laboratories
approved under Sec. 55.8 are authorized to conduct DNA tests to
compare tissue samples tested for CWD to samples from tissues that were
collected at the same time from the same animal 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.
(2) [Reserved]
(d) Herd status of animals added to herds. A herd may add animals
from herds with the same or a higher herd status in the CWD Herd
Certification
[[Page 35569]]
Program with no negative impact on the certification status of the
receiving herd.\5\ If animals are acquired from a herd with a lower
herd status, the receiving herd reverts to the program status of the
sending herd. If a herd participating in the CWD Herd Certification
Program acquires animals from a nonparticipating herd, the receiving
herd reverts to First Year status with a new enrollment date of the
date of acquisition of the animal.
---------------------------------------------------------------------------
\5\ Note that in addition to this requirement, Sec. 81.3 of
this chapter restricts the interstate movement of farmed and captive
deer, elk, and moose based on their status in the CWD Herd
Certification Program.
(Approved by the Office of Management and Budget under control
---------------------------------------------------------------------------
number 0579-0237.)
Sec. 55.25 Animal identification.
Each animal required to be identified by this subpart must have at
least two forms of animal identification attached to the animal. One of
the animal identifications must be official animal identification as
defined in this part, with a nationally unique animal identification
number that is linked to that animal in the CWD National Database or in
an approved State database. The second animal identification must be
unique for the individual animal within the herd and also must be
linked to that animal and herd in the CWD National Database or in an
approved State database. The means of animal identification must be
approved for this use by APHIS, and must be an electronic implant,
flank tattoo, ear tattoo, tamper-resistant ear tag, or other device
approved by APHIS.
(Approved by the Office of Management and Budget under control
number 0579-0237)
0
4. Part 81 is revised to read as follows:
PART 81--CHRONIC WASTING DISEASE IN DEER, ELK, AND MOOSE
Sec.
81.1 Definitions.
81.2 Identification of deer, elk, and moose in interstate commerce.
81.3 General restrictions.
81.4 Issuance of certificates.
81.5 Movement of deer, elk, or moose through a State to another
State.
81.6 Federal preemption of State and local laws and regulations with
respect to CWD.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 81.1 Definitions.
These definitions are applicable to this part:
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator, Animal and Plant Health
Inspection Service, or any person authorized to act for the
Administrator.
Animal. Any farmed or captive deer, elk, or moose.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
Animal identification. A device or means of animal identification
approved for use under this part by APHIS. Examples of animal
identification devices that APHIS has approved are listed in Sec.
55.25 of this chapter.
Animal identification number (AIN). A numbering system for the
official identification of individual animals in the United States. The
AIN contains 15 digits, with the first 3 being the country code (840
for the United States), the alpha characters USA, or the numeric code
assigned to the manufacturer of the identification device by the
International Committee on Animal Recording.
APHIS employee. Any individual employed by the Animal and Plant
Health Inspection Service who is authorized by the Administrator to do
any work or perform any duty in connection with the control and
eradication of disease.
Cervid. All members of the family Cervidae and hybrids, including
deer, elk, moose, caribou, reindeer, and related species. For the
purposes of this part, the term ``cervid'' refers specifically to
cervids susceptible to CWD. These are animals in the genera Odocoileus,
Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
Chronic wasting disease (CWD). A transmissible spongiform
encephalopathy of cervids. Clinical signs in affected animals include,
but are not limited to, loss of body condition, behavioral changes,
excessive salivation, increased drinking and urination, depression, and
eventual death.
CWD Herd Certification Program. The Chronic Wasting Disease Herd
Certification Program established in part 55 of this chapter.
Deer, elk, and moose. All animals in the genera Odocoileus, Cervus,
and Alces and their hybrids.
Farmed or captive. Privately or publicly maintained or held for
economic or other purposes within a perimeter fence or confined area,
or captured from a wild population for interstate movement and release.
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.
Official animal identification. A device or means of animal
identification approved for use under this part by APHIS to uniquely
identify individual animals. Examples of approved official animal
identification devices are listed in Sec. 55.25 of this chapter. The
official animal identification must include a nationally unique animal
identification number that adheres to one of the following numbering
systems:
(1) National Uniform Eartagging System. The CWD program allows the
use of either the eight-character or nine-character format for cervids.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system
combines an official premises identification number (PIN), as defined
in this section, with a producer's livestock production numbering
system to provide a unique identification number. The PIN and the
production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for
the identification of animals in commerce.
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. The premises identification number may consist
of:
(1) The State's two-letter postal abbreviation followed by the
premises' assigned number; or
(2) 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.
[[Page 35570]]
Sec. 81.2 Identification of deer, elk, and moose in interstate
commerce.
Each animal required to be identified by this part must have at
least two forms of animal identification attached to the animal. The
means of animal identification must be approved for this use by APHIS,
and must be an electronic implant, flank tattoo, ear tattoo, tamper-
resistant ear tag, or other device approved by APHIS. One of the animal
identifications must be an official animal identification as defined in
this part, with a nationally unique animal identification number that
is linked to that animal in the CWD National Database or in an approved
State database. The second animal identification must be unique for the
individual animal within the herd and also must be linked to that
animal and herd in the CWD National Database or in an approved State
database.
(Approved by the Office of Management and Budget under control
number 0579-0237)
Sec. 81.3 General restrictions.
No farmed or captive deer, elk, or moose may be moved interstate
unless it meets the requirements of this section.
(a) Animals in the CWD Herd Certification Program. The 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.
(b) Animals captured for interstate movement and release. If the
captive deer, elk, or moose was captured from a wild population for
interstate movement and release, each animal must have two forms of
animal identification, one of which is official animal identification,
and the certificate issued in accordance with Sec. 81.4 that
accompanies the animal must state that the source population has been
documented to be low risk for CWD, based on a CWD surveillance program
in wild cervid populations that is approved by the State Government of
the receiving State and by APHIS.
(c) Animals moved to slaughter. The farmed or captive deer, elk, or
moose must be moved directly to a recognized slaughtering establishment
for slaughter, must have two forms of animal identification, one of
which is official animal identification, and must be accompanied by a
certificate issued in accordance with Sec. 81.4.
(d) Research animal movements and permits. A research animal permit
is required for the interstate movement of cervids for research
purposes. The permit will specify any special conditions of the
movement determined by the Administrator to be necessary to prevent the
dissemination of CWD. The Administrator may, at his or her discretion,
issue the permit if he or she determines that the destination facility
has adequate biosecurity and that the movement authorized will not
result in the interstate dissemination of CWD.
(1) To apply for a research animal permit, contact an APHIS
employee or State representative and provide the following information:
(i) The name and address of the person to whom the special permit
is issued, the address at which the research cervids to be moved
interstate are being held, and the name and address of the person
receiving the cervids to be moved interstate;
(ii) The number and type of cervids to be moved interstate;
(iii) The reason for the interstate movement;
(iv) Any safeguards in place to prevent transmission of CWD during
movement or at the receiving location; and
(v) The date on which movement will occur.
(2) A copy of the research animal permit must accompany the cervids
moved, and copies must be submitted so that a copy is received by the
State animal health official and the veterinarian in charge for the
State of destination at least 72 hours prior to the arrival of the
cervids at the destination listed on the research animal permit.
(e) Interstate movements approved by the Administrator.
Notwithstanding any other provision of this part, interstate movement
of farmed or captive deer, elk, and moose may be allowed on a case-by-
case basis when the Administrator determines that adequate survey and
mitigation procedures are in place to prevent dissemination of CWD and
issues a permit for the movement.
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. The certificate must also include a statement 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, with the following exceptions:
(1) Certificates issued for animals captured from a wild population
for interstate movement and release do not need to state that the
animals are from a herd that has achieved Certified status in the CWD
Herd Certification Program but must include the statement required in
Sec. 81.3(b); and
(2) 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.
(b) Animal identification documents attached to certificates. As an
alternative to typing or writing individual animal identification on a
certificate, another document may be used to provide this information,
but only under the following conditions:
(1) The document must be a State form or APHIS form that requires
individual identification of animals;
(2) A legible copy of the document must be stapled to the original
and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved
with the certificate, but any information pertaining to other animals,
and any unused space on the document for recording animal
identification, must be crossed out in ink; and
(4) The following information must be typed or written in ink in
the identification column on the original and each copy of the
certificate and must be circled or boxed, also in ink, so that no
additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document
is not imprinted with a serial number, both the name of the person who
issued the document and the date the document was issued.
(Approved by the Office of Management and Budget under control
number 0579-0237)
Sec. 81.5 Movement of deer, elk, or moose through a State to another
State.
Farmed or captive deer, elk, or moose may be moved through a State
or
[[Page 35571]]
locality whose laws or regulations on the movement of those animals are
more restrictive than this part to another State under the following
conditions:
(a) The farmed or captive deer, elk, or moose must be eligible to
move interstate under Sec. 81.3.
(b) The farmed or captive deer, elk, or moose must meet the entry
requirements of the destination State listed on the certificate or
permit accompanying the animal.
(c) Except in emergencies, the farmed or captive deer, elk, or
moose must not be unloaded until their arrival at their destination.
Sec. 81.6 Federal preemption of State and local laws and regulations
with respect to CWD.
State and local laws and regulations on farmed or captive deer,
elk, or moose with respect to CWD that are more restrictive than the
regulations in this part are not preempted by this part, except as
described in Sec. 81.5.
Done in Washington, DC, this May 31, 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-14186 Filed 6-12-12; 8:45 am]
BILLING CODE 3410-34-P