Regulatory Impact Analysis and Final Regulatory Flexibility Analysis. Final Rule Docket No

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1 United States Department of Agriculture Animal and Plant Health Inspection Service March 2012 Regulatory Impact Analysis and Final Regulatory Flexibility Analysis Final Rule Docket No RIN 0579-AB35 Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose Policy & Program Development Policy Analysis & Development

2 Summary This final rule amends a suspended final rule published in July 2006, for the control of chronic wasting disease (CWD) in farmed or captive cervids (deer, elk, and moose) in the United States. The July 2006 final rule established a voluntary Herd Certification Program that included CWD monitoring and testing requirements, and set interstate movement restrictions. APHIS suspended indefinitely the July 2006 final rule, to reconsider several of its requirements in response to petitions from the public and comments on those petitions. In this document, we examine expected benefits and costs of the July 2006 final rule, as amended by this final rule. With publication of this final rule and concurrent removal of the suspension of the July 2006 final rule, farmed or captive deer, elk, and moose herd owners who choose to participate in the Herd Certification Program will have to meet program requirements for animal identification, testing, and herd management. With certain exceptions, only deer, elk, and moose from Certified herds will be eligible for interstate movement. Amendments to the July 2006 final rule include the following: (i) the Federal CWD regulations will set minimum requirements for interstate movement, while States will be allowed to impose additional requirements; (ii) cervids allowed to be moved interstate (other than ones moving to slaughter or for research), must be from certified herds that have been monitored for a period of at least 5 years and that have not been epidemiologically linked to herds where CWD has been diagnosed, or captured from a wild cervid population that has been documented to be low risk for CWD based on a surveillance program; (iii) farmed or captive cervids, when en route to another State, will be allowed to transit through States that otherwise ban or restrict their entry; (iv) a physical inventory of the animals will be required at the time a herd is enrolled in a CWD certification program and thereafter the animals will need to be physically assembled i

3 for inventory within 3 years of the last physical inventory; (v) certified cervids that die or are killed at slaughter or on shooter operations will be required to be tested for CWD; and (vi) there will be optional confirmatory DNA test provisions for animals that test CWD-positive. Implementation of the July 2006 final rule as amended by this final rule is expected to result in both positive and negative economic effects for herd owners and States, with benefits and costs depending on herd owners existing management practices and marketing activities and States current provisions with respect to CWD control. Overall benefits of the rule are expected to exceed its costs. Foremost, the July 2006 rule, as amended, will help to prevent the spread of CWD among States and facilitate interstate movement of healthy cervids. The Herd Certification Program will also promote U.S. producers access to international markets for cervid products such as antler velvet. The Federal regulations will provide uniform minimum requirements for interstate movement. This final rule will allow States to enact and administer stricter CWD status requirements for cervids entering from other States. As at present, herd owners interstate marketing decisions may need to account for dissimilar State CWD certification regulations. Some herd owners also may be adversely affected by the 5-year monitoring requirement for interstate movement; however, available research indicates that this minimum period of monitoring is necessary to provide an adequate level of protection against the spread of CWD. Most researchers agree that CWD manifests itself within 5 years if the disease is present in a herd of farmed or captive cervids. Many herd owners have been participating in state level CWD HCP s for at least 5 years and will have met this requirement as a result of being enrolled in a state program that becomes an Approved State HCP in the national CWD HCP program. ii

4 Producers who participate in the Herd Certification Program will be required to maintain a complete inventory of their herds, with verification by APHIS or State officials. The annual inventory cost is estimated to average about $25 to $30 per deer or elk, including the animals physical inventory once every three years and use of eartags for identification. (We do not know of any farmed or captive moose herds.) Values of farmed or captive deer and elk range widely, depending on the type of animal and market conditions. Based on average per animal values of $2,000 for deer and $2,200 for elk, annual inventory costs are estimated to average between 1.25 and 1.50 percent of the value of a farmed or captive deer and to between 1.14 and 1.36 percent of the value of a farmed or captive elk. The requirement that cervids from herds participating in the certification program be tested for CWD when they die or are killed (including slaughter) will entail submission of the carcass or whole head for tissue sampling and testing or collection of the tissue sample by an approved veterinarian. The estimated cost is about $150 per sample, equivalent to about 8 percent of the average value of a farmed or captive deer and about 7 percent of the average value of a farmed or captive elk. CWD testing of cervids is recognized by APHIS, the States, and cervid herd owners as essential to successful control of this disease. Herd owners will have the option of using confirmatory DNA testing provisions to verify that the sample tested is from the animal in question, although APHIS is confident that the existing chain-of-custody processes for CWD testing are effective. Owners who choose confirmatory DNA testing will consider it a benefit, as evidenced by their voluntary payment for this test. Most cervid operations are small entities. The rule will have a positive overall economic impact on affected entities large and small, and the U.S. cervid industries generally, in iii

5 controlling the spread of CWD and facilitating interstate and international trade in cervids and cervid products. iv

6 Table of Contents Summary... i Introduction... 1 Overview of the Action and Affected Entities... 2 Expected Benefits and Costs of the Rule... 6 Overview of Principal Effects... 6 Federal Regulations as Minimum Requirements for Interstate Movement... 8 Five-Year Certified Status for Cervids Moved Interstate... 9 En Route Interstate Movement Herd Inventories Testing of Certified Cervids When They Are Killed At Slaughter or on Shooter Operations Optional Confirmatory DNA Tests Identification of Animals in Certified Herds Effects for States Effects for APHIS Final Regulatory Flexibility Analysis Need for and Objectives of the Rule Significant Issues raised by Public Comment in response to the Initial Regulatory Flexibility Analysis Comments filed by the Small Business Administration in response to the Proposed Rule Potentially Affected Small Entities Projected Reporting, Recordkeeping, and Other Compliance Requirements Steps taken by APHIS to minimize Significant Economic Impacts on Small Entities 20 References v

7 Introduction Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy (TSE) of cervids. 1 TSEs are caused by abnormal proteins known as prions. First recognized as a clinical "wasting" syndrome in 1967 in mule deer in a wildlife research facility in northern Colorado, CWD was identified as a TSE in It is characterized by chronic weight loss leading to death. There is no known relationship between CWD and other TSEs of animals or people. The disease was first detected in U.S. farmed elk in The disease was also diagnosed in a wild moose in Colorado in CWD has been found in free-ranging deer and elk in 16 States, and, as of March 2012, CWD was confirmed in 11 states in a total of 54 farmed cervid herds 39 farmed elk herds, and 15 farmed deer herds. This final rule amends a suspended final rule published in July 2006 that established a Federal CWD Herd Certification Program to control this disease in farmed or captive cervids (deer, elk, and moose) in the United States. The July 2006 final rule set forth for participating deer, elk, and moose herd owners herd management regulations, including CWD monitoring and testing requirements, and set interstate movement restrictions. The amendments included in this final rule are the result of a reconsideration of certain provisions of the July 2006 final rule, in response to petitions received on that rule and to comments received on the notice of proposed rulemaking for this action. The July 2006 final rule will become effective at the same time as this final rule. Because the July 2006 final rule never went into effect, this document provides a costbenefit analysis of the July 2006 final rule, as amended by this final rule. (For brevity, we will 1 The Cervidae (cervids) family, which includes deer, elk, and moose, is distinguished from the Bovidae family by the males having solid deciduous antlers. 1

8 refer to the July 2006 final rule and the amendments to it collectively in this document as "this final rule.") The analysis conforms to Executive Orders and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Benefits of the July 2006 final rule, as amended by this final rule, are expected to exceed costs overall. This analysis also examines potential economic effects on small entities, as required by the Regulatory Flexibility Act. Overview of the Action and Affected Entities The number of cervids in the United States that have died as a result of contracting CWD is unknown. However, sampling has suggested infection rates ranging from less than 1 percent among wild white-tailed deer in Wisconsin to up to 15 percent among wild mule deer in northeastern Colorado. 2 For farmed animals, the number of deaths has been relatively low. APHIS estimates that through FY2011, approximately 140 farmed cervid premises involving approximately 7,500 animals that were either CWD positive or CWD exposed have been depopulated using APHIS indemnity funding. Deer and elk are farmed for breeding stock, velvet antler, meat, and sales to game parks and exhibits. Velvet antler, considered a medical/dietary aid, is produced primarily for Asian markets. Deer and elk meat, or venison, is a low-fat, low-cholesterol product that is marketed primarily to gourmet restaurants, for consumption by health conscious dieters. The breeding stock market satisfies the need for semen to be used for artificial insemination, replacement and 2 Source: Rob Werge (APHIS). 2

9 start-up animals. There are no known commercial moose farming operations in the United States, although such operations may emerge in the future. Hard statistical data on the deer and elk farming industries is, at best, limited. The two major industry associations the North American Elk Breeders Association (NAEBA) and the North American Deer Farmers Association (NADFA) compile very little data apart from their own membership, and only sparse data on deer and elk farms are included in Census of Agriculture data. In 2007, there were 68,251 elk on 1,917 elk farms, compared to 97,901 elk on 2,371 farms in 2002, that is, there were 5-year declines of 30 percent and 19 percent in the number of elk and number of farms, respectively. 3 According to NAEBA, the number of elk per farm varies, from a high of 500 plus for commercial farms to a low of about 10 for hobby farms. The value of each elk held also varies, depending on the type of animal (e.g., bull, cow, calf), market conditions, and other factors. In 2012, NAEBA estimated the average value of an elk at $2,200, with a typical high-end value of about $6,500. Based on the estimated average of $2,200 per animal, the value of all 68,251 elk on U.S. farms in 2007 is estimated to have been about $150 million (68,251 x $2,200). In 2007, there were 269,537 deer on 5,654 deer farms, compared to 286,863 deer on 4,901 farms in 2002, that is, over this 5-year period, the number of farmed deer declined by 6 percent, but the number of farms increased by 15 percent. 4 The number of deer per farm varies, from a high of about 3,000 for commercial farms to a low of about 5 for hobby farms. The value of deer also varies, depending on the type and breed (e.g., red, white-tailed, fallow) and market conditions. A NADFA estimate reported in the economic analysis for the July 2006 final rule 3 Source: 2002 and 2007 Census of Agriculture (NASS). 4 Source: 2002 and 2007 Census of Agriculture (NASS). 3

10 put the average per animal value of all deer on member farms at $1,687, with the high-end value at $4,000 and the low-end value at $375. Based on an average of $2,000 5 per animal, the value of all 269,537 deer on U.S. farms in 2007 is estimated to have been about $539 million (269,537 x $2,000). With publication of this final rule and concurrent removal of the suspension of the July 2006 final rule, farmed or captive deer and elk herd owners who choose to participate in the voluntary national CWD Herd Certification Program will have to meet program requirements for animal identification, testing, and herd management. The Program will be a cooperative effort by APHIS, State animal health and wildlife agencies, and cervid herd owners. State responsibilities will include restricting interstate movement of farmed or captive deer and elk; imposing quarantine and movement restrictions; and conducting traceback and epidemiological investigation of CWD-positive, CWD-exposed, and CWD-suspect cervids; requiring premises identification and animal identification of all participating herd owners; and testing of all animals that die or are killed and requiring appropriate disposal of the carcasses. Herd owners will be responsible for identifying each animal in their herds through approved means of identification before they reach 12 months of age, they are moved off the premises, or when a herd inventory is conducted. They must also maintain an inventory that includes records on the species, age, and sex of each animal; the date of acquisition and source of each animal that was not born into the herd; the date of disposal and destination of animals removed from the herd; and the animal identification associated with each animal. A physical inventory will be required at the time a herd is enrolled in a CWD program, after which a physical inventory will need to be performed within 3 years of the previous 5 Based on prices reported on various deer trading websites such as bucktrader.com and coldcreekranch.com 4

11 physical inventory. An annual herd inventory including a review of owner records and an observation of the herd s unrestrained animals in a viewable, enclosed area will continue to be required, but the animals will not necessarily need to be physically assembled and restrained. Herd owners must also maintain perimeter fencing adequate to prevent CWD from being spread through contact with wild cervids, and introduce into the herd only animals from other herds enrolled in the Herd Certification Program so that those animals pose a known risk of infection with CWD. Herd owners will be required to report to APHIS or the State all animals that escape or disappear, and all animals that die or are killed and make their carcasses available for tissue sampling and testing. The regulations will allow for optional confirmatory DNA test provisions for animals that test CWD-positive. Participating herds will be assigned a herd status based on how long they have conducted continuous CWD surveillance in the program without any CWD positive findings. Herds already participating and in compliance in an Approved State Herd Certification Program will receive credit. After 5 years of participation with no CWD-positive or CWD-exposed animals, the herd will be designated a Certified herd. Herds that contain CWD-positive or CWD-exposed animals will lose their status and may only reenroll in the program after entering into a herd plan designed to address possible sources of infection and monitor the animals for CWD. Herds containing CWD-suspect animals will be placed in suspended status and further investigated to determine appropriate actions. A herd may add animals of the same or higher status without changing its status, but if it adds animals of a lower status, the receiving herd reverts to the program status of the sending herd. Adding animals from a nonparticipating herd restarts the herd's participation in the program. 5

12 The following animals will be eligible for interstate movement: farmed cervids from Certified herds, if accompanied by a certificate; free-ranging (wild) cervids 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; cervids moved for slaughter, if identified and accompanied by a certificate; research animals, if accompanied by a permit granted by the Administrator; and animals approved on a case-by-case basis by the Administrator. The July 2006 final rule, as amended, will set minimum requirements for interstate movement of farmed or captive cervids with respect to CWD, but will not preempt more restrictive State laws and regulations, with the exception of cervids transiting a State en route to another State. Expected Benefits and Costs of the Rule Overview of Principal Effects Cervid industries, cervid product consumers, herd owners, and States will benefit from the July 2006 final rule, as amended. Foremost, it will help to prevent the spread of CWD among States and facilitate interstate movement of cervids from herds that participate in this program and are thus at low risk of CWD infection. By allowing only Certified elk, moose, and deer (with limited exceptions) to be moved interstate, the rule will help prevent the spread of CWD among both farmed and wild populations. 6 Participation in a certification program reduces the risk of CWD transmission among States, because only deer, elk, and moose that have been subject to certain minimum surveillance and other criteria will be allowed to be moved interstate. Although APHIS is aware that a number of States already have programs for managing the risk 6 Based on epidemiology, the mode of transmission is thought to be from animal to animal. Accordingly, it is possible that the disease may be passed from infected farmed animals to adjacent wild deer and elk. 6

13 of CWD in farmed or captive cervids, there is no national minimum standard, and some States may not have controls for CWD in place at all. To the extent that a State has no active CWD program or currently has standards that are less restrictive than those in this final rule, APHIS s program will help to control the spread of CWD to these areas. Preventing the spread of CWD offers a number of benefits, economic and otherwise. It benefits entities and individuals that rely on those animals for their income, e.g., deer and elk farms, State agencies that sell hunting licenses, and employees of motels and restaurants in hunting areas. 7 It benefits individuals that rely on those animals for recreation and food. A study by a sociologist in Wisconsin cited in the economic analysis for the July 2006 final rule found that if the disease seems contained there is little effect on hunter activity. However, if the disease becomes widespread, hunter participation may decline. Deer hunting in Wisconsin generates $1.4 billion for the economy each year. 8 At this time, there are no common interstate movement standards being applied. Nor are there standards that would ensure equivalency between State CWD programs. This situation has hindered the development of a nation-wide marketing system under which healthy farmed elk and deer can be bought and sold throughout the United States. Many producers of elk and deer are limited to sales in their local marketing areas. For herd owners with infected cervids, CWD losses can extend far beyond the direct loss of livestock for which APHIS no longer provides indemnity. Producers can also incur costs for the disposal of the animal carcasses, as well as costs for cleaning and disinfecting their premises. In some areas, positive animals have to be disposed of through costly incineration or digestion. 7 As indicated earlier, deer and elk are farmed for breeding stock, velvet antler, meat, and sales to game parks and exhibits. 8 Wisconsin s Chronic Wasting Disease Response Plan: , Retrieved from: 7

14 Perhaps most important of all, owners of infected herds may also face State-imposed quarantines and State-imposed restrictions on the subsequent agricultural use of their land, actions which many view as tantamount to closure. This final rule will also promote herd owners access to international markets for cervid products such as antler velvet. To the extent that the Herd Certification Program will provide minimum certification standards, increased opportunities for international sales are likely. The cost of complying with certification requirements will vary among herd owners, depending on their circumstances. Costs may be incurred in meeting animal identification, inventory, and testing requirements. Many herd owners, especially the larger ones, are likely to already be in at least partial compliance with State CWD Herd Certification Program requirements since they constitute sound management practices. Perimeter fencing is a case in point. It is likely for a herd owner to have perimeter fencing already in place, if for no other reason than to keep animals from escaping. Federal Regulations as Minimum Requirements for Interstate Movement The Federal regulations will not preempt more restrictive State and local laws and regulations with respect to interstate movement of farmed or captive cervids. The only exception will be with respect to the movement of farmed or captive cervids through a State en route to another State. This approach is appropriate for CWD, where the methods for diagnosing the disease and preventing its spread are not well-established and where the goal of the program is to control, rather than eradicate, the disease. However, the final rule requests comment on whether APHIS regulations for CWD should preempt State and local laws and regulations that are more restrictive. 8

15 Owners will be restricted from moving animals from States with CWD certification programs having requirements less stringent than those minimum standards set forth in the Federal program or from States that do not have CWD certification programs, if funding is not available to provide for participation with APHIS. At this time, APHIS does not know which States these are or the extent to which herd owners in these States engage in the interstate movement of farmed or captive cervids. More generally, herd owners may continue to bear non-monetary costs because of some States having more restrictive CWD regulations than other States. As at present, herd owners will need to be knowledgeable of multiple State requirements. Interstate movement of cervids may be constrained to the extent that owners marketing decisions have to account for dissimilar State CWD certification regulations. Distinctions between the Federal and State programs and among differing State programs may become apparent through interstate movement patterns. Five-Year Certified Status for Cervids Moved Interstate APHIS is requiring that farmed or captive deer, elk, or moose moved interstate come from herds that have been monitored for CWD for at least 5 years, that is, herds that have achieved Certified status and that have not been epidemiologically linked to herds where CWD has been diagnosed. The 5-year minimum requirement will prevent cervid herd owners that have participated fewer than 5 years in a CWD certification program from moving animals interstate. The number of such herd owners is unknown, although it is estimated that many, if not most, herd owners who rely on interstate movement for the success of their businesses already meet the 5-year standard through participation in a State program. It is estimated that at least 23 States have such programs in place. Five years of testing all cervids in a herd that die or are killed 9

16 without finding a CWD-positive animal provides substantial assurance that the herd is at low risk for CWD infection. For those herd owners adversely affected by a shift to a 5-year monitoring period requirement, the economic impact will vary depending on the circumstances of each such as the number and value of animals that would otherwise be moved interstate and alternative opportunities to sell the animals within the State. Although data for individual herd owners are not available, those who are located in States that do not now have a CWD certification program and do not have an established history of CWD monitoring are likely to be most affected, since they would have to participate in the Federal CWD Herd Certification Program (or a newly established State program) for 5 years before they can move their cervids interstate. The 5-year monitoring period requirement could impact prospective new entrants into the cervid farming business, to the extent that that they will not be able to move animals interstate until the 5-year monitoring period has been completed, unless the herd is stocked with certified animals, which would allow them to begin moving animals interstate immediately. Costs of this amendment are not expected to be significant, particularly when compared to the risk mitigation it provides in reducing the possible interstate movement of animals infected with or exposed to CWD. En Route Interstate Movement States that want a higher level of protection against CWD than the Federal program is designed to provide can establish more restrictive rules regulating the entry of farmed or captive cervids. However, owners of farmed or captive cervids that are otherwise eligible to move interstate will be allowed to move their animals through (transit) States that ban or restrict the entry of farmed or captive cervids, if the animals are being moved without unloading en route to another State. 10

17 States through which the cervids are moved and cervid herd owners in those States will not incur additional costs or risks of CWD spread because of this provision, while owners of the animals that are moved en route to another State will be able to choose routes that are most time efficient and economical, and that minimize transport stress to the animals. Herd Inventories A physical inventory of assembled and restrained cervids will be required at the time a herd is enrolled in a CWD program, and thereafter within 3 years of the previous physical inventory. An annual herd inventory will be required including a review of owner records and an observation of the unrestrained animals in a viewable, enclosed area but it will not necessarily require that the animals be physically assembled and restrained. For the July 2006 final rule, it was estimated that the annual physical inventory costs for a herd of 50 elk (with animals assembled and restrained) is approximately $1,000, including veterinary fees of approximately $500 and hired labor costs of approximately $500. It was observed that this cost could be significantly higher depending on local labor costs for skilled cervid handlers. In addition, physical assembly and restraint can cause injuries to the animal, resulting in further costs to the owner for subsequent veterinary care or animal loss. One commenter on the notice of proposed rulemaking for this final rule stated that for farms without a handling facility, a physical inventory could cost as much as $30 per animal just for the drugs and darts needed to tranquilize an animal in order to verify identification. For a herd size of 50 animals, this would amount to $1,500. Another commenter observed that the physical inventory of his 350 deer would come to $7,000, based on the unit cost of $20 used by APHIS. A third commenter stated that in some instances the cost of an annual physical inventory could force some breeders out of business. 11

18 An annual herd inventory consisting of review of herd records and general inspection would add only minimally to herd owner s operating costs, since most of the activities required for such an inventory are performed from time to time as part of routine herd management. Owners will be able to better coordinate the timing of a 3-year physical herd inventory with cervid testing for other disease control programs, such as brucellosis or tuberculosis, or with other husbandry management activities. If the CWD herd inventory is conducted at the same time as other scheduled inventories, the additional cost associated with the CWD inventory will be minimal. We estimate the annual inventory cost to average about $25 to $30 per animal, including the animals physical assembly and restraint once every three years and use of eartags for identification. As discussed in the Overview of the Action and Affected Entities, values of farmed or captive deer and elk range widely, depending on the type of animal and market conditions. Based on average per animal values of $2,000 for deer and $2,200 for elk, annual inventory costs of $25 to $30 per animal are estimated to average between 1.25 and 1.50 percent of the value of a farmed or captive deer and to between 1.14 and 1.36 percent of the value of a farmed or captive elk. Testing of Certified Cervids When They Are Killed At Slaughter or on Shooter Operations As attested to by commenters on the proposed rule, CWD can be difficult to detect. An animal s CWD-positive status may not be suspected while it is alive, but discovered only through testing following its death. Testing of all certified animals at death is necessary in order to provide additional evidence that certified herds contain only animals that are low risk for CWD. 12

19 APHIS no longer has funding to support CWD testing of farmed cervids, therefore, herd owners are responsible for the costs of testing cervid tissue samples for CWD which currently range from $25 to $60 per sample. In addition, there are related costs, namely, the submission of the carcass or whole head for tissue sampling and testing (or its collection when the animal is sent for slaughter). The cost of collecting tissue samples for CWD testing varies, depending on such factors as the age and health of the animals in the herd, herd management practices, and the type of herd (hunting vs. non-hunting). As an alternative, herd owners can have accredited veterinarians collect tissue samples from their premises. We estimate the testing cost to be about $150 per sample. This estimated cost is equivalent to about 8 percent of the value of a farmed or captive deer and about 7 percent of the value of a farmed or captive elk, based on average per animal values of $2,000 for deer and $2,200 for elk. While this cost is not small, CWD testing of cervids from certified herds when they are killed at slaughter or on shooter operations, in addition to when they die otherwise, is recognized by APHIS, the States, and the cervid herd owners as an essential component for the successful control of this disease. Optional Confirmatory DNA Tests A small, unknown number of herd owners may choose, at their expense, to have optional confirmatory DNA testing performed for animals that test CWD-positive. While APHIS is confident that the existing chain-of-custody processes for CWD testing are effective, herd owners will have the option of using confirmatory DNA testing provisions to verify that the sample tested is from the animal in question. Owners who choose confirmatory DNA testing will consider it a benefit, as evidenced by their voluntary payment for this test. 13

20 Identification of Animals in Certified Herds Participation in the Herd Certification Program will require that herd owners adhere to certain minimum disease preventative measures established by APHIS. 9 Specifically, herd owners will be required to identify each animal using two approved forms of identification, including one form with a nationally unique animal identification number. The cost of identifying an animal will vary, depending on the type of identification used and other factors, including any costs associated with gathering the animals for attaching the identification device. The rules will allow for the multiple use of the same form of identification. Conceivably, each animal could have two eartags, potentially the least costly form of identification. Eartags cost about $2 each. By comparison, veterinarians could be expected to charge herd owners at least $20 to $25 to implant a deer or elk with a microchip for identification. Herd owners are likely to already be using some form of identification in line with best management practices. Effects for States All States have some form of CWD regulations. As a result of the July 2006 final rule, as amended, it is expected that many States that permit cervid farming will make program participation mandatory. States that have not already established certification programs will incur costs of setting up and administering such programs, including costs of developing legislative/regulatory authority, surveillance and monitoring, disease research, and education and outreach to farmers. As a point of reference in this regard, it was reported in the economic analysis for the July 2006 final rule that costs for establishing and maintaining a CWD program for farmed elk was conservatively estimated at $47,000 per year States could make program standards more stringent than the minimum criteria established by APHIS. 10 Source: Rob Werge (APHIS). 14

21 In addition, States may also incur costs stemming from a possible disease discovery, such as costs for the maintenance of quarantines, diagnostic testing, disposition of positive/exposed herds, and carcass disposal. The costs associated with a discovery of the disease can vary significantly, depending on the number of animals in an affected herd, the type of carcass disposal, and other factors. As reported in the economic analysis for the July 2006 final rule, the cost of responding to a disease finding was estimated at $20,285 per herd, on average, based on experiences of 5 States with farmed elk that tested positive for CWD. 11 Effects for APHIS Under the July 2006 final rule, as amended, APHIS may incur costs associated with establishing and administering the Herd Certification Program for herd owners who wish to participate but who are located in States without certification programs, depending on available funding. APHIS may also assist in the design and implementation of State programs established in response to the July 2006 final rule, as amended, depending on available funding. Final Regulatory Flexibility Analysis The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions. This final regulatory flexibility analysis describes expected impacts of this rule on small entities, as required by section 604 of the Act. Need for and Objectives of the Rule CWD is a disease of cervids typified by chronic weight loss and debilitation that leads to death. While States have established varying CWD-related regulations, a Federal Herd 11 Source: Rob Werge (APHIS). 15

22 Certification Program that provides uniform standards and minimum interstate movement requirements is needed to control the spread of CWD. This final rule amends a July 2006 final rule, in response to petitions that were received on the earlier final rule and comments received on the proposed rule. Objectives are to establish a national Herd Certification Program and minimum standards for interstate movement of farmed or captive deer, elk, and moose. Significant Issues raised by Public Comment in response to the Initial Regulatory Flexibility Analysis Several commenters questioned some of the figures and assumptions in the economic analysis for the December 2003 proposal that preceded the July 2006 final rule. As discussed in the economic analysis that accompanied that final rule, most of these commenters expressed concern that the analysis underestimated the degree of adverse impact; some were concerned that the additional costs of program participation would drive many cervid producers out of business. Some commenters suggested the analysis overestimated the price owners can currently get when they sell animals, and underestimated the annual costs of compliance, when it stated that there would be: increased direct costs totaling about $1,600 annually for the average elk herd owner (i.e., one with a herd of 50 elk). 12 One commenter stated that, based on his experience, it was possible to participate in his State herd surveillance program for CWD at an annual cost of a fraction of $1,600. Several commenters stated that herds participating in the program would essentially be unable to sell animals or conduct business for 5 years, until the herd achieved certified status, and that herds could not survive without income for that long. 12 The annual cost of $1,600 was estimated in the economic analysis for the July 2006 final rule. It includes $1,000 for the annual inventory, $100 for the maintenance of program records, $250 for tagging, and $200 for sample collection by a veterinarian. The annual inventory cost of $1,000 assumes veterinary fees to read tags ($500) and hired labor ($500). The sample collection cost of $200 assumes that 2 animals over 12 months of age die per year. 16

23 The most current publicly available information has been used in this analysis, including data from the 2002 and 2007 Census of Agriculture. While some dollar estimates in the analysis have changed from previous years, the overall conclusion of the present analysis remains the same. The rule should have a positive economic effect on deer and elk farmers, both large and small, over the long term, with collateral benefits due to a decreased risk of spreading CWD from farmed or captive to wild cervids. The effects on herd owners will vary depending on their circumstances. In many cases, the annual costs for an owner will not increase significantly because the herd is already participating in a State CWD program with similar requirements and costs. It is not true that participating herd owners will be unable to generate any income until 5 years pass and their herds are certified. Many herds that participate will enter at a higher herd status than First Year because they will retain their status from a comparable State program. Also, animals moved interstate for slaughter are exempted from certification requirements. Those herd owners who have the option and elect not to participate would avoid the Program s annual costs but they will likely see the value of their animals discounted in the marketplace, since non-program animals will be restricted from interstate movement and likely carry a stigma of inferiority. The discount is likely to exceed the program s annual cost for most herd owners, making participation mandatory from a practical economic standpoint for those who are not required by their respective State to participate. We did not receive any significant comments on the economic analysis prepared for the March 2009 proposal to amend the July 2006 final rule. One comment that was received observed that there is much less certainty as to the number of farmed or captive cervids than is suggested by the data that was presented by APHIS in the March 2009 proposed rule. The commenter noted that in discussions among wildlife biologists at the most recent Northeast 17

24 Deer Technical Committee annual meeting, it was apparent that most northeastern States do not completely know the extent of the captive deer industry within their own boundaries. Also, we have found evidence that long-time established and known facilities can claim to be unaware of existing mandatory disease prevention programs. If a State is unaware of a deer farm, it can be safely assumed that the deer farm is either unaware or non-compliant with existing mandatory disease prevention programs. The commenter concludes that this situation speaks to the need for States to customize their own regulations regarding farmed or captive cervids. This comment supports APHIS decisions for the Federal CWD regulations to only preempt State and local laws and regulations that are less restrictive, allow each State to establish a CWD monitoring program that best suits its particular circumstances, and allow only farmed or captive deer, elk, and moose from herds that have reached Certified status after 5 years' monitoring to move interstate, with limited exceptions, in order to minimize the risk of CWD spread. Comments filed by the Small Business Administration in response to the Proposed Rule proposed rule. There were no comments filed by the Small Business Administration in response to the Potentially Affected Small Entities This rule will directly affect cervid herd owners. We do not have details about the size distribution in 2007 of the 1,917 elk farms that had a total elk population of 68,251, or the 5,654 deer farms that had a total of 269,537 deer, as reported in the Census of Agriculture. However, it is reasonable to assume that most of these operations were small in size, based on the Small Business Administration's (SBA) standard of annual gross receipts of not more than $750,000 for the industry category NAICS , All Other Animal Production. In 2007, there were 61,973 18

25 U.S. farms categorized within NAICS , a classification composed of establishments primarily engaged in raising certain animals (including deer and elk, but excluding cattle, hogs and pigs, poultry, sheep and goats, animal aquaculture, apiculture, horses and other equines, and fur-bearing animals). For all 61,973 farms, the average market value of agricultural products sold in 2007 was about $38,205, well below the SBA's small-entity threshold of $750, To the extent that the rule prevents the spread of CWD in farmed cervids in the United States, herd owners will benefit over the long term. While helping to prevent disease spread, the rule will provide herd owners with another important, perhaps more immediate, benefit: increased access to out-of-state markets. By providing a minimum basis for equivalency between State programs, the rule should facilitate the safe movement of animals between States. This Herd Certification Program is designed to allow for safe interstate trade. It is also designed to signal that a safe cervid market exists in the United States and that this can be tapped for highly specialized international markets, such as that in antler velvet. Even herd owners who sell their cervids in-state will benefit, since the Herd Certification Program will reduce their disease risk when receiving animals from other States. Projected Reporting, Recordkeeping, and Other Compliance Requirements In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C et seq.), we published a notice in the Federal Register on January 24, 2012 (77 FR , Docket No. APHIS ), announcing our intention to reinstate the information collection associated with the July 2006 final rule and soliciting comments on it. We are asking the Office of Management and Budget (OMB) to approve our use of this information collection 13 Retrieved from 2007 Census of Agriculture: 19

26 for 3 years. When OMB notifies us of its decision, we will publish a document in the Federal Register providing notice of the assigned OMB control number or, if approval is denied, providing notice of what action we plan to take. The changes made to the July 2006 final rule themselves have no new mandatory reporting, recordkeeping, or other compliance requirements for U.S. entities. Steps taken by APHIS to minimize Significant Economic Impacts on Small Entities The July 2006 final rule, as amended, provides minimum requirements to prevent the interstate spread of CWD, while allowing States to impose additional requirements as they determine are necessary. Implementation of the rule is expected to result in both positive and negative economic effects for herd owners, with benefits and costs depending on herd owners existing management practices and marketing activities. In general, costs attributable to the rule relative to the value of the farmed or captive cervids should be relatively minor. For all herd owners, control of CWD will be a positive outcome. In the absence of expected significant economic impacts, we have not identified alternatives that would minimize such impacts. 20

27 References Census of Agriculture, 2007, Census of Agriculture, 2002, Economic Census, 2002, Small Business Administration. A Guide for Government Agencies How to Comply with the Regulatory Flexibility Act. Small Business Administration. Small Business Standard Match to North American Industry Classification System 21