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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

CFR Citation: 9 CFR Part 82

Docket ID: [Docket No. APHIS-2006-0036]

RIN ID: RIN 0579-AC42

NOTICE: RULES

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Exotic Newcastle Disease; Quarantine Restrictions

DATES: Effective Date: June 26, 2008.

DOCUMENT SUMMARY: We are making several changes to the exotic Newcastle disease domestic quarantine regulations, including adding an option for the movement of pet birds; adding restrictions on the interstate movement of live ratites out of quarantined areas; harmonizing our domestic and import regulations regarding the movement of dressed carcasses of dead birds and dead poultry; providing for the use of alternative procedures for treating manure and litter and for composting; and adding an additional surveillance period after the conditions for removing quarantine are met before quarantine is removed. We concluded that these changes are necessary based on our experiences during the eradication programs for the 20022003 outbreaks of exotic Newcastle disease in California, Arizona, Nevada, and Texas. In the event of an exotic Newcastle disease outbreak, these changes will help to ensure that exotic Newcastle disease does not spread from quarantined areas and that exotic Newcastle disease is eradicated within quarantined areas.

SUMMARY: Exotic Newcastle Disease; Quarantine Restrictions,


SUPPLEMENTAL INFORMATION

Background

Exotic Newcastle disease (END) is a contagious and fatal viral disease affecting the respiratory, nervous, and
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digestive systems of birds and poultry. END is so virulent that many birds and poultry die without showing any clinical signs. A death rate of almost 100 percent can occur in unvaccinated poultry flocks. END can infect and cause death even in vaccinated poultry.

The regulations in ``Subpart AExotic Newcastle Disease (END)'' (9 CFR 82.1 through 82.16, referred to below as the regulations) were established to prevent the spread of END in the United States in the event of an outbreak. These regulations specify the conditions under which certain articles, including live birds and live poultry, dead birds and dead poultry, manure and litter, eggs other than hatching eggs, hatching eggs, and vehicles and conveyances, may be moved out of areas listed in Sec. 82.3 as quarantined for END.

On March 27, 2006, we published in the Federal Register (71 FR 1504715059, Docket No. APHIS20060036) a proposal \1\ to amend the regulations by adding an option for the movement of pet birds; adding restrictions on the interstate movement of live ratites out of quarantined areas; harmonizing the domestic and foreign regulations regarding the movement of dressed carcasses of dead birds and dead poultry, including one change to the importation regulations; providing for the use of alternative procedures for treating manure and litter and for composting; and adding an additional surveillance period after the conditions for removing quarantine are met before quarantine is removed.
\1\ To view the proposed rule and the comments we received, go to http://www.regulations.gov/fdmspublic/component/ main?main=DocketDetail&d=APHIS20060036.

The changes we proposed were based on experience we gained during our most recent eradication effort for END. Between November 21, 2002, and September 16, 2003, areas of the States of California, Arizona, Nevada, New Mexico, and Texas were quarantined due to the presence of END. In order to make better decisions on how to eradicate END from those areas, we completed several risk assessments and epidemiological investigations in the context of our activities under the regulations. The experience we gained during those outbreaks in enforcing the regulations and conducting the risk assessments and epidemiological investigations informed the proposed rule. (The risk assessments are available from the person listed under FOR FURTHER INFORMATION CONTACT.)

We solicited comments concerning our proposal for 60 days ending May 26, 2006. We received seven comments by that date. They were from producers and private citizens. They are discussed below by topic. Other Live Birds, Including Ratites

The regulations in Sec. 82.5(b) provide that birds other than pet birds and poultry not known to be infected with or exposed to END are allowed to be moved interstate from an area quarantined for END only if the following conditions are met:

  • They are accompanied by a permit;
  • They are covered in such a way as to prevent feathers and other debris from blowing or falling off the means of conveyance;
  • They are moved in a means of conveyance either under official seal or are accompanied by a Federal representative;
  • They are not unloaded until their arrival at their destination listed on the permit, except for emergencies; and
  • The permit is presented upon arrival at the destination and copies of the permit are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of arrival.

    Birds other than poultry are required to be moved to a site approved by the Administrator. Poultry are required to be moved to a recognized slaughtering establishment and must be slaughtered within 24 hours of arrival at such an establishment; the required permit must be presented to a State or Federal representative upon arrival at such an establishment.

    We proposed to amend the regulations to place the same requirements on ratites moved interstate from a quarantined area as we do on poultry. The term ``ratites'' encompasses cassowaries, emus, kiwis, ostriches, and rheas. Surveillance of these birds for infection with END is more difficult than surveillance of poultry. Detection of virus shedding in live ratites is unpredictable. Examiners may not always be able to detect END infection by examination or testing of swabs for virus, which are the standard procedures for testing other birds whose movement is regulated under Sec. 82.5(b). Tissue samples can provide additional certainty in diagnosing END; however, while the death loss rates in production flocks of poultry mean that tissue samples are normally available for testing, the death loss rates in flocks of ratites are much lower, meaning that tissue samples of ratites may be unavailable. The relative lack of dead ratites for surveillance purposes also means that tests on tissues of dead ratites are less reliable than tests on tissues of dead poultry. For these reasons, no consensus exists on optimal surveillance techniques for END in live ratites. This means that any determination that ratites to be moved interstate from a quarantined area are not known to be infected with END is, at best, uncertain.

    In addition, it is often difficult to determine whether ratites have been exposed to END; they are mostly maintained in outdoor pens or in backyard flocks, which are often less biologically secure than the facilities in which commercial flocks of poultry are maintained. Ratites that have been kept in these conditions within a quarantined area may, therefore, be more likely to have been exposed to END than other birds kept under more biologically secure conditions. Finally, ratites typically live in highly concentrated populations, meaning that END could be spread quickly by an infected or exposed ratite moved interstate from a quarantined area.

    Slaughtering and disposing of live poultry moved interstate from a quarantined area, as required by Sec. 82.5(b), ensures that END virus is not spread from any poultry that, despite not being known to be infected with or exposed to END, may pose a risk of spreading the END virus during interstate movement. We proposed to require that ratites be moved to slaughter under the same conditions as live poultry to ensure that the END virus would not be spread through the movement of ratites from quarantined areas.

    We received three comments on this proposed change. All three of the commenters opposed the change, stating instead that ratites should be treated similarly to other birds and allowed to move from the quarantined area without moving directly to slaughter. Instead, the commenters favored testing and holding the ratites under quarantine until they were proved not to be infected with END. Two of the commenters stated that there are tests that can identify END in ratites, making such a policy feasible.

    We agree that there are methods that can be used to test ratites for END. As discussed in the proposed rule, however, surveillance of these birds for infection with END is more difficult than surveillance of poultry. Detection of virus shedding in live ratites is unpredictable. Examiners may not always be able to detect END infection by examination or testing of swabs for virus, which are the standard procedures for testing other birds whose movement is regulated by Sec. 82.5(b). Tissue samples can provide additional
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    certainty in diagnosing END; however, while the death loss rates in production flocks of poultry mean that tissue samples are normally available for testing, the death loss rates in flocks of ratites are much lower, meaning that tissue samples of ratites may be unavailable. For these reasons, no consensus exists on optimal surveillance techniques for END in live ratites. Given that and the other risk factors described above, we believe that the risk associated with the interstate movement of ratites is similar to that associated with the interstate movement of poultry, and that the same restrictions on that movement are warranted.

    One commenter stated that her own research had not shown ostrich to be especially susceptible to END or to have been a factor for the spread of END during the 20022003 END outbreaks.

    During the 20022003 END outbreaks, we required ratites moved interstate from the quarantined area to be moved directly to slaughter, based on a risk assessment we conducted. This risk assessment and our experience in the 20022003 END outbreak led us to propose this change. The fact that ratites were not a factor for the spread of END during the 20022003 outbreak is therefore not inconsistent with the change we proposed.

    Two of these commenters provided additional information for the section of our economic analysis that addressed the potential economic impact of this change, mostly related to the size of the ratite industry. We have used this information to update our economic analysis.

    The commenters additionally expressed concern that the change would have catastrophic economic effects on the ratite industry.

    Whenever END is detected in the United States, we will pursue eradication of the disease. Any quarantine for END would be temporary and local, thus minimizing the number of ratite operations affected by the requirement that ratites that are moved from the quarantined area be moved directly to slaughter. (Ratite flock owners whose flocks are not known to be infected with or exposed to END could also keep their flock in place during the quarantine.) The potential economic effects of this change, in the event of an END outbreak, are discussed in more detail under the heading ``Executive Order 12866 and Regulatory Flexibility Act'' later in this document.

    Our proposed changes classified birds that could be moved from the quarantined area as pet birds, other birds, and poultry and ratites. One commenter, a racing pigeon association, recommended that racing pigeons be considered ``other birds'' rather than pet birds. The commenter stated that pets are essentially animals that are kept by humans for companionship; pigeon fanciers do not keep racing pigeons as pets, but as the necessary element in their hobby of breeding and racing pigeons. Racing pigeons are highly trained, fed careful diets, kept on a strict sanitary and medical regimen, and much prized for their athletic accomplishments. Pigeon fanciers do not look to their loft of birds, typically 60 to 100 in number, for companionship. The commenter also stated that racing pigeons are thoroughbreds and that championship birds can be worth thousands of dollars.

    We agree with the commenter. During the 20022003 END outbreak, we considered racing pigeons to be ``other birds,'' and we will do so if another END outbreak occurs in the United States. Because the definition of pet bird in Sec. 82.1 reads ``Any bird that is kept for personal pleasure and is not for sale,'' and because the commenter has presented convincing evidence that racing pigeons meet neither of these criteria, we believe that the regulations already accommodate the policy suggested by the commenter.

    Other Comments

    One commenter stated that the proposed rule was not in accord with the Terrestrial Animal Health Code published by the World Organization for Animal Health (OIE), specifically Chapter 2.7.13, Newcastle Disease, and Chapter 1.3.5, Zoning and Compartmentalization.\2\ \2\ The Terrestrial Animal Health Code can be viewed on the Internet at http://www.oie.int/eng/normes/mcode/en_sommaire.htm.

    The Terrestrial Animal Health Code is designed to provide a sciencebased reference document for international trade in animals and animal products. OIE guidelines are not intended to be prescriptive; each member nation sets its regulatory policy based not only on the Code but also on, among other things, local conditions. The commenter did not specify what provisions of the proposed rule were inconsistent with the Terrestrial Animal Health Code. We believe the changes we proposed are appropriate for eradicating END within the United States. We are making no changes in response to this comment.

    One commenter stated that poultry become infected with END when they are kept in conditions that adversely affect their welfare. This commenter also stated that the interstate movement of poultry should not be allowed for any reason.

    Poultry become infected with END when they are exposed to its causal virus. We may restrict the movement of poultry or any other animal only to the extent that such restrictions are necessary to prevent the introduction or spread of a pest or disease of livestock.

    One commenter recommended that we require the complete and immediate incineration of all poultry carcasses known to be infected with END. The commenter recommended that we accomplish this by requiring all poultry producers to have a dualchambered,
    environmentally safe incinerator on their premises. The commenter stated that such a requirement would eliminate the risk associated with moving the carcasses of infected poultry from a premises to an incinerator.

    The commenter is correct that such a policy would directly address the risk associated with the movement of carcasses of infected poultry. However, we believe that the movement of such carcasses to an incinerator can be done safely if biological security protocols are followed. Therefore, an onpremises incinerator requirement is unnecessary. We will continue to work with States and industry to determine the safest and most efficient ways to dispose of carcasses of poultry infected with or exposed to END and other highly virulent poultry diseases.

    Miscellaneous Change

    The regulations in 9 CFR 94.6 address the importation into the United States of carcasses of game birds from regions where END is considered to exist. Paragraph (b)(1) of this section allows the carcasses of game birds to be imported into the United States as long as they are eviscerated and their heads and feet have been removed. In the proposed rule, we stated that the importation of such carcasses poses a high risk of introducing END into the United States and proposed to remove and reserve paragraph Sec. 94.6(b)(1).

    Since the publication of the proposed rule, we have completed a more thorough risk assessment of the risk associated with importing carcasses of game birds, as part of a risk assessment supporting the development of regulations for the importation of poultry and poultry products from regions where highly pathogenic avian influenza exists. This risk assessment, which will be published in completed form along with a rule proposing such regulations, indicates that the risk of disease introduction associated with the importation of game bird carcasses under the conditions specified in
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    Sec. 94.6(b)(1) is actually low. The carcass preparation process for game birds makes the tissue unsuitable for virus survival, and game bird carcasses typically do not come into contact with poultry populations, because the carcasses are intended for home display. Therefore, this final rule withdraws that proposed amendment and leaves Sec. 94.6(b)(1) unchanged.

    Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed in this document.

    This final rule also serves to affirm the last 4 interim rules in a series of 10 interim rules we published between November 2002 and September 2003. The first six interim rules amended the regulations in part 82 by adding portions of Arizona, California, Nevada, New Mexico and Texas to the list in Sec. 82.3 of areas quarantined for END; the final four interim rules subsequently removed all those areas from that list. The 10 interim rules elicited a total of 11 comments, only 2 of which were germane to the action taken in the interim rule (i.e., the addition or removal of an area from quarantine). In both cases, the commenters pointed out the need for adequate surveillance to ensure the complete eradication of END in an area before it is removed from quarantine. In this final rule, we supplement the conditions for removing an area from quarantine by requiring an additional surveillance period after those conditions have been met before the quarantine will be removed. As noted in the proposed rule, we made that amendment based on information gained during the 20022003 END outbreak, which includes the information contained in the comments we received on the interim rules.

    Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

    We are making several changes to the END domestic quarantine regulations, including adding an option for the movement of pet birds; adding restrictions on the interstate movement of live ratites out of quarantined areas; harmonizing our domestic and import regulations regarding the movement of dressed carcasses of dead birds and dead poultry; providing for the use of alternative procedures for treating manure and litter and for composting; and adding an additional surveillance period after the conditions for removing quarantine are met before quarantine is removed. We concluded that these changes are necessary based on our experiences during the eradication programs for the 20022003 outbreaks of END in California, Arizona, Nevada, and Texas. In the event of an END outbreak, these changes will help to ensure that END does not spread from quarantined areas and that END is eradicated within quarantined areas.

    END, also known as velogenic viscerotropic Newcastle disease, is a highly contagious and fatal viral disease affecting all species of birds. END is one of the most infectious and virulent diseases of poultry in the world, and the infection often results in many birds dying before demonstrating any clinical signs of infection. In unvaccinated poultry flocks, END has a death rate of close to 100 percent. Moreover, the mortality rates in vaccinated flocks are 10 to 20 percent, clearly showing that vaccination does not guarantee complete protection against END.

    END was first identified in the United States in 1950 in California. The outbreak was traced to game birds and pheasants imported from Hong Kong. The disease spread to five poultry farms in Contra Costa County, but was quickly eliminated by destroying infected chickens. In 1971, a major outbreak of END occurred in California commercial poultry and lasted for 2 years. As a result of that outbreak 1,341 infected flocks were identified, and almost 12 million birds were destroyed. The eradication program cost taxpayers $56 million ($228 million in 2002 dollars), severely disrupted the operations of many producers, and increased the prices of poultry and poultry products to consumers.

    On October 1, 2002, END was confirmed in backyard poultry in Southern California. The disease spread from backyard poultry to commercial poultry operations in California, backyard poultry in Nevada and Arizona, and poultry in Texas. The U.S. Department of Agriculture (USDA)'s Animal and Plant Health Inspection Service (APHIS) took the lead in END eradication efforts. Immediately a task force of over 1,500 people from APHIS, the California Department of Food and Agriculture, and other State and Federal agencies combined forces to fight this devastating disease. Almost 4 million birds were destroyed to contain the spread of END.

    Economic Analysis

    The final rule change to the END regulations will have an effect on all persons and entities handling birds of any type, including farm and commercial operations, backyard flock owners and enthusiasts, and pet bird owners in an END quarantined area wishing to engage in interstate movement. While accurate statistics on farm and commercial operations in the United States are readily available, there is a significant information gap on the backyard flocks and pet bird owners. As such, we have no way of quantifying the true number of persons affected by these changes.

    The United States is the world's largest producer of poultry meat and the secondlargest egg producer behind China. Preliminary reports for the year 2005 indicate there were a total of 452.8 million chickens, excluding commercial broilers, with a cash value of over $1.133 billion. In 2004 broiler production, raised for the purpose of meat production, totaled 8.7 billion birds, with a combined live weight of over 45.7 billion pounds. The value of broiler production for that year was over $20.4 billion. In 2004, the last full report available, there were over 89 billion eggs produced with a cash value of over $5.3 billion.\3\ Preliminary statistics for 2004 indicate that turkey production totaled over 264 million birds with a combined live weight of 7.3 billion pounds and a cash value of over $3 billion.\4\ \3\ USDA, Agricultural Statistics 2006. Washington, D.C.: National Agricultural Statistics Service, 2006. Estimates cover the 12month period, December 1 of the previous year through November 30.
    \4\ USDA, Agricultural Statistics 2006. Estimates based on turkeys placed September 1, 2003 through August 31, 2004 and excludes young turkeys lost.

    The U.S. poultry industry plays a significant role in international trade. In fact, the United States is the world's largest exporter of turkey products, and the second largest exporter of broilers. In 2005, broiler exports totaled 5.1 billion pounds, valued at $2.1 billion.\5\ Turkey exports for the same year totaled over 541 million pounds, with a total value of about $369 million. In addition, 61.8 million dozen shell eggs for consumption, and 55 million pounds of egg products were exported in 2005.\6\ The presence of END in the United States would significantly reduce our ability to be competitive in international markets in the trade of poultry and poultry products. By extension, any efforts made to contain and prevent the spread of END throughout the United States would serve to enhance our reputation for providing high quality products. Thus, the changes in this rule
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    will benefit the commercial poultry industry by increasing product marketability, both domestically and internationally.
    \5\ USDAERS, Background Statistics on U.S. Broiler Industry. Washington, D.C.: Economic Research Service, 2006.
    \6\ USDAFAS, U.S. Trade Statistics. Washington, D.C.: Foreign Agricultural Service, 2006.

    This final rule also impacts the movement of ratites out of a quarantined area. Ratites are a family of flightless birds with small wings and flat breastbones. Domestic production of ratites is limited to ostriches and emus. This alternative livestock industry is still in its infancy, so new in fact that ratites have only been under mandatory USDA inspection since April 22, 2002, and were first included as a separate line item in the 2002 USDA Census of Agriculture. Ostrich was the first ratite to be raised in the United States. According to the 2002 Census of Agriculture, there are 5,224 farms raising a total of 48,221 emus, and 1,643 farms holding an inventory of 20,560 ostriches. Additionally, there were 15,682 emus and 16,038 ostriches sold according to Census data.\7\ Ostriches are raised primarily for meat, with an average bird yielding about 75100 pounds of meat, whereas emus are raised primarily for oil. According to American Ostrich Association (AOA) estimates, approximately 500,000 to 750,000 pounds of ostrich meat were processed from domestically produced ostrich in 2005, with a slaughter price of $1 per pound live weight. Due to a fluctuating market for oil, the value of emu production is indeterminate at this time. While U.S. farms raising ratites can have an inventory ranging from 2 to 2,000 birds, the AOA estimates that there are probably less than a dozen farms in the United States with 100 or more birds.\8\ Based on these estimates, as well as Census data, we can assume the majority of ratite farmers would be considered small entities by SBA standards.\9\
    \7\ USDA, 2002 Census of AgricultureTable 27. Washington,

    FOR FURTHER INFORMATION CONTACT Dr. Glen Garris, Director, National Veterinary Stockpile, National Center for Animal Health Emergency Management, VS, APHIS, 4700 River Road Unit 41, Riverdale, MD 20737 1231; (301) 7348073.


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