Federal Register: August 13, 2007 (Volume 72, Number 155)
DOCID: fr13au07-15 FR Doc E7-15815
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
CFR Citation: 9 CFR Part 94
Docket ID: [Docket No. APHIS-2007-0014]
RIN ID: RIN 0579-AC47
NOTICE: PROPOSED RULES
ACTION: Exportation and importation of animals and animal products:
DOCUMENT ACTION: Proposed rule.
Importation of Table Eggs From Regions Where Exotic Newcastle Disease Exists
DATES: We will consider all comments that we receive on or before October 12, 2007.
We are proposing to amend the regulations regarding the importation of animal products in order to modify the requirements concerning the importation of eggs (other than hatching eggs) from regions where exotic Newcastle disease (END) exists. This action is necessary in order to provide a more efficient and effective testing option for determining the END status of flocks producing eggs (other than hatching eggs) for export to the United States.
Table eggs from regions where exotic Newcastle disease exists,
The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. The regulations in 9 CFR parts 93, 94, and 95 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including exotic Newcastle disease (END).
Egg Importation Requirements
Currently, the regulations at Sec. 94.6(c) provide two mechanisms by which flocks in foreign regions where END is considered to exist can be found free of END and thus approved for the purpose of exporting eggs (except hatching eggs) to the United States. One method requires the placement of sentinel birds (at least 1 per 1,000 birds) at the rate of at least 30 sentinel birds per house. These sentinel birds must remain free of clinical and immunological evidence of END as demonstrated by tests performed by a salaried veterinary officer of the national government of the region of origin. The second method requires weekly testing of any carcasses of poultry from the flock in question that died in that week as well as other testing performed on at least 10 percent of live birds.
These two options have proven problematical. Many foreign egg producers cannot use sentinel birds because their flocks are vaccinated with strains of Newcastle disease. Even though the sentinel birds themselves cannot be vaccinated against END, they may nevertheless develop antibodies as a result of exposure to birds vaccinated with a live virus. Sentinel birds may therefore produce false positives when tested for END, necessitating the expense of further testing to differentiate a vaccineinduced response from a field infection. In such a situation, 10 percent flock testing becomes the only available option; however, many foreign egg producers find this approach to be time consuming, costly, and potentially statistically excessive.
We are proposing to amend the regulations in order to provide for
the use of a statistically valid testing regimen that would ensure the
detection of infected birds in a timely and effective way while eliminating the need for potentially excessive testing.\1\
\1\ While these proposed provisions are specific to END, we recognize that a testing regimen similar to that described in this document could be useful in addressing the risks presented by highly pathogenic avian influenza (HPAI) in egg production flocks in regions affected with HPAI. We are currently developing regulations specific to HPAI and welcome any comments on the subject of targeted testing for HPAI in egg production flocks that are submitted in response to this proposed rule.
Disease biology is an important consideration in testing for the
presence of END. Of the three strains of ENDmesogenic, lentogenic,
and velogenicwe are concerned only with the velogenic strain. General
sampling results (i.e., samples taken from live, apparently healthy
birds as well as dead or sickly birds) may prove inaccurate, as
sampling of birds infected with nonvelogenic strains of END, which
produce a minimal mortality rate, and birds that have been vaccinated
against the disease may result in false positives. Additionally, clinically normal birds
may shed virus only intermittently. If the choice of testing is to look for the presence of the virus in clinically normal flocks, the prevalence of birds shedding virus at any given time may be expressed in fractions of a percent. In order to derive an accurate picture of infection rates in this situation, the sample size required would be prohibitively large with very poor confidence of detecting the virus. In comparison, the proposed approach utilizing only sick or dead birds is a more efficient and accurate testing method. The prevalence of velogenic END is likely to be quite high in the population of sick or dead birds if the flock is, in fact, infected and the needed sample size would be quite small. According to our research and other available information, sampling 5 sick or dead birds in a group of up to 50,000 birds provides a 95 percent confidence of detecting infection in a house.
Therefore, we propose to replace the current options for flock testing with a requirement that at least 1 cull (sick or dead) bird for each 10,000 live birds occupying each poultry house certified for exporting table eggs be tested for END virus at days 7 and 14 of the 21day period before the certificate is signed and tested using a virus isolation test at a laboratory approved by the veterinary services organization of the national government of the region of origin. The tests must present no clinical or immunological evidence of END by either embryonated egg inoculation technique from tissues of dead birds or negative hemagglutination inhibition tests conducted on blood samples of sick birds collected by a salaried veterinary officer of the national government of the region of origin, or by an accredited veterinarian.
We have prepared a risk assessment document titled ``Justification for the proposed changes to the current 9 CFR 94.6 regulations governing the importation of table eggs from regions where exotic Newcastle disease exists into the United States.'' This document assesses the effectiveness of sentinel birds, random sampling, and targeted sampling of sick or dead birds as surveillance methods. You may view the document on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.
The risk assessment document explains why the sentinel bird approach currently required does not provide the desired level of assurance that END virus is absent in a flock. It assesses random sampling as an alternative method of disease detection, and concludes that targeted sampling of cull (sick or dead) birds detects infections more efficiently and effectively than either sentinel birds or random sampling. It also concludes that targeted sampling provides more biological assurances about the absence of END virus when infection is absent than random sampling and the use of sentinel birds combined.
We additionally propose to amend the requirements for importing eggs (other than hatching eggs) in order to require that the accompanying health certificate contain a specific additional certification that egg drop syndrome (EDS) is notifiable in the region of origin and that there have been no reports of EDS in the flocks of origin, or within a 50 kilometer radius of the flocks, for 90 days prior to export. EDS is characterized by soft shelled and shellless eggs produced by otherwise healthy looking birds. The virus is spread horizontally, primarily in commercial flocks, via contaminated eggs, droppings, and needles used to draw blood and administer vaccinations. There is no known treatment for EDS. Vaccines administered during the bird's growth phase (14 to 18 weeks of age) have been successful at reducing, but not eliminating, virus shedding. Since the United States is the only area in the world free of EDS, we believe that the proposed certification requirements are warranted to help prevent the introduction of the disease into domestic flocks.
Currently, the regulations provide that flock inspections be conducted by a salaried veterinary officer of the national government of the region of origin. However, Mexico's Ministry of Agriculture developed a system for accrediting veterinarians who are not salaried employees of the national government of Mexico to perform official work in connection with the export of animals and animal products from Mexico. This work includes testing, examining, and certifying animals for export to the United States. Since 1992, we have allowed Mexican accredited veterinarians to perform certain necessary services detailed in 9 CFR part 93. These services, which were previously performed only by salaried veterinarians of the Mexican Government, are required by our regulations to prevent the introduction of communicable animal diseases into the United States through the entry of animals and animal products.
We are therefore proposing to amend the regulations to allow veterinarians accredited by the Mexican Government to inspect the flocks of origin and issue animal health certificates as required by the regulations for the importation of eggs from Mexico into the United States. However, we also propose that each certificate issued by a veterinarian accredited by the Mexican Government must also be endorsed by a fulltime salaried veterinary officer of the national government of Mexico. Under this system, the accredited veterinarian would make the necessary determinations about the health of the flock of origin and issue the certificate, and the Mexican Government veterinarian would endorse it, indicating that the issuing veterinarian is properly accredited and that the certificate is properly completed. These proposed provisions are identical to the provisions in part 93 that allow veterinarians accredited by the national government of Mexico to perform certain functions related to the export of animals to the United States.
The title of part 94 is ``Rinderpest, FootandMouth Disease, Fowl Pest (Fowl Plague), Exotic Newcastle Disease, African Swine Fever, Classical Swine Fever, and Bovine Spongiform Encephalopathy: Prohibited and Restricted Importations.'' We would update the part heading so that it also refers to swine vesicular disease, a disease that is addressed in several sections of the regulations. Conversely, we would remove the part heading's reference to ``fowl pest (fowl plague),'' as the regulations in part 94 currently contains no provisions regarding fowl pest (fowl plague).
The regulations in Sec. 94.6(c)(1) set out the information to be included on certificates accompanying shipments of table eggs. We would make editorial changes to paragraphs (c)(1)(v) and (c)(1)(ix) to clarify that we expect the certificate to confirm compliance with the specific requirements of those paragraphs.
Finally, the removal of the sentinel bird provisions and footnote 7 in Sec. 94.6(c)(ix)(C) would make it necessary to renumber the remaining footnotes in part 94.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
We are proposing to amend the regulations regarding the importation of animal products in order to modify the requirements concerning the importation of eggs (other than hatching eggs) from regions where END exists. This action is necessary in order to provide a more sound testing option for determining the END status of flocks producing eggs (other than hatching eggs) for export to the United States.
The ultimate goal of this proposed rule is to make our import regulations more effective, more consistent with the available science, and less restrictive while continuing to protect domestic poultry from END. One mechanism by which foreign producers located in regions affected with END can currently export table eggs into the United States is to place sentinel birds within their flocks and then test these birds for presence of the disease. As many of these foreign producers vaccinate their flocks, such testing may produce false positive results. Sentinel birds may therefore produce false positives when tested for END, necessitating the expense of further testing to differentiate a vaccineinduced response from a field infection. The second mechanism currently authorized, testing 10 percent of the flock, is viewed by foreign egg producers as problematic and potentially an excessive requirement. As such, this proposed rule seeks to replace the current options for flock testing with one that more accurately directs testing at those birds most likely to be infected.
The United States is the world's largest producer of poultry meat
and the second largest egg producer after China. Statistics indicated
there was a domestic inventory of 449 million chickens in 2003,
excluding commercial broilers, with a total cash value of $1.11
billion.\2\ In 2004, broilers, which are raised specifically for meat
production, had a total cash value of $20.4 billion, the total number
produced being 8.74 billion. Also in 2004, turkey production totaled
7.3 billion pounds, with a cash value of $3.07 billion.\3\ Table egg
production during the year ending November 30, 2003, totaled 74.4 billion eggs.\4\
\2\ USDA, Chickens and Eggs 2003 Summary. Washington, DC: National Agricultural Statistics Service, January 2004. Estimates cover the period from December 1, 20022003.
\3\ USDA, PoultryProduction and Value 2004 Summary. Washington,
FOR FURTHER INFORMATION CONTACT
Dr. Christopher Robinson, Senior Staff Veterinarian, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 40, Riverdale, MD 207371231; (301) 7347837.