# Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-14186 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** June 13, 2012 - **Citation:** 77 FR 35542 ## Text 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. 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 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. 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. 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 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. 2 For more information on this plan, see http://www.aphis.usda.gov/about_aphis/programs_offices/veterinary_services/vision_science.shtml. 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 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, § 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 § 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 §§ 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 § 81.3(b) to “captured from a wild population for interstate movement and release,” and clarifying § 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 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 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 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 § 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 § 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 § 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 § 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 § 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 § 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 §§ 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 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 §§ 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 § 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 § 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 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 § 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 § 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 § 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 § 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 § 55.23(b). We will individually review every application for enrollment credit under § 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 § 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 § 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 § 55.23(b). We are also switching the order of paragraph (a) of § 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 § 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 § 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 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 § 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. 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. 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 § 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 § 81.4. Another commenter stated that accredited veterinarians should not be allowed to inspect their own herds to 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 § 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 §§ 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 § 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 § 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, § 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 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 § 55.8(d). We audit third-party laboratories to make sure they comply with the standards set out in § 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 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 § 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 § 55.24, which govern herd status, provide for the creation of a herd in the manner the commenter describes. Specifically, paragraph (a) of § 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 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 § 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 § 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 § 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 § 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 § 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 § 81.3(b) include the alternative requirement to document the animals' source population as low risk for CWD. We are amending § 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 § 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 § 55.24. We are also not including a provision we proposed to add in § 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 § 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 § 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 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 § 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. Som [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-14186. Public record. Not legal advice.