Animal and Plant Health Inspection Service, USDA.
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.
We will consider all comments that we receive on or before October 12, 2007.
You may submit comments by either of the following methods:
- Federal eRulemaking Portal: Go to http://www.regulations.gov and, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2007-0014 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
- Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2007-0014, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0014.
Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.Start Further Info
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 20737-1231; (301) 734-7837.End Further Info End Preamble Start Supplemental Information
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 § 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 vaccine-induced 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.
Disease biology is an important consideration in testing for the presence of END. Of the three strains of END—mesogenic, lentogenic, and velogenic—we 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 non-velogenic 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 Start Printed Page 45178may 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 21-day 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 shell-less 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 full-time 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, Foot-and-Mouth 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 § 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 § 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 Start Printed Page 45179Order 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 vaccine-induced 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. 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. Table egg production during the year ending November 30, 2003, totaled 74.4 billion eggs.
The potential scope of any domestic effects of these proposed changes is somewhat uncertain. As the compliance costs for the flock testing requirements would decrease for producers exporting eggs to the United States due to the decrease in the number of birds required to be tested to demonstrate flock freedom from END, there is a potential for a small increase in the volume of table egg imports. In 2003, table egg imports from regions considered free of END, as listed in § 94.6(a)(2), totaled 77,861 dozen with an overall cash value of $411,000. For that same year, table egg imports from regions where END is considered to exist totaled 1,088,341 dozen, with an overall cash value of $709,000. Total imports of table eggs for 2003 represented less than 0.02 percent of the total domestic supply for that year. Usually, an increase in supply drives down the price of commodities. When both the retail and wholesale sectors of a market are inelastic, as is the case with table eggs, a small change in supply has the potential to have a large effect on price. Consequently, if there is an increase in table egg imports as a result of the proposed changes, this could have an effect on the domestic market price of table eggs, causing the price to decrease as the supply of table eggs increases. In this case, there could be a slightly negative effect on domestic producers of table eggs due to declining price receipts. By contrast, if there is a slight increase in supply due to increased imports, the declining price will be a benefit to domestic consumers. Of course, any discernable changes in domestic prices of table eggs are also affected by domestic production, population changes, and changes in demand. Ultimately, as imports of table eggs represent less than 0.02 percent of the domestic supply available, we are confident that any increase in supply resulting from this proposed rule would not cause a significant change in the domestic market.
Impact on Small Entities
The Regulatory Flexibility Act requires agencies to consider the economic impact of their regulations on small entities. According to the guidelines established by the Small Business Association (SBA), domestic companies engaging in chicken egg production come under the North American Industry Classification System code 112310. The SBA defines a small chicken egg-producing entity as one that nets no more than $10.5 million per year. As of February 2004, the American Egg Board reported that there were approximately 260 egg-producing companies with flocks of 75,000 hens or more. These 260 companies represent about 95 percent of all the layers in the United States. The exact number of operations engaged in table egg production is unclear. However, the 2002 agricultural census estimated that there were 83,381 domestic poultry and egg farms. While concrete information on the size distribution is unknown, the census does indicate that only 29,393 of those poultry operations have annual sales of $50,000 or more. As such, it is safe to assume that the majority of operations engaged in table egg production would be considered small entities by SBA standards. In the case of this proposed change, there are no direct effects on small entities, but the possibility of increased imports of table eggs does could result in an indirect effect. As mentioned previously, if there is an increase in table egg imports as a result of lower testing costs for exporters, thereby increasing supply to the domestic market, there is the potential for the domestic price of table eggs to decrease. However, given the fact that imports constitute such a small percentage of the domestic supply (0.02 percent) and because price is also affected by other factors including domestic production levels, population changes, and domestic demand, the prospects for any decrease in price as a direct result of the changes we are proposing are uncertain. Even if this potentiality is realized, we believe it is unlikely that the proposed changes would result in any significant economic effects on small entities.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has Start Printed Page 45180determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2007-0014. Please send a copy of your comments to: (1) Docket No. APHIS-2007-0014, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.
APHIS is proposing to amend the regulations regarding 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 conditions for importation require, among other things, certification from a salaried veterinary officer of the national government of the region of origin, or a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico, thereby indicating that the veterinarian is authorized to issue the certificate. The certificate must also state that egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate.
APHIS is asking the Office of Management and Budget (OMB) to approve its use of these information collection activities for 3 years.
We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).
Estimate of burden: Public reporting burden for this collection of information is estimated to average 1.3 hours per response.
Respondents: Veterinarians accredited by the Mexican Government.
Estimated annual number of respondents: 5.
Estimated annual number of responses per respondent: 2.
Estimated annual number of responses: 10.
Estimated total annual burden on respondents: 13 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response).
Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.Start List of Subjects
List of Subjects in 9 CFR Part 94
- Animal diseases
- Meat and meat products
- Poultry and poultry products
- Reporting and recordkeeping requirements
Accordingly, we propose to amend 9 CFR part 94 as follows:Start Part
PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS
1. The heading of part 94 is revised to read as above.
2. The authority citation for part 94 continues to read as follows:
3. In § 94.6, the introductory text of paragraph (c)(1), paragraph (c)(1)(v), paragraph (c)(1)(viii), the introductory text of paragraph (c)(1)(ix), and paragraph (c)(1)(ix)(C) are revised and a new paragraph (c)(1)(ix)(D) is added to read as follows:
(c) * * *
(1) With a certificate. The eggs may be imported if they are accompanied by a certificate signed by a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, and:
(v) The certificate states that no more than 90 days before the certificate was signed, a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, by a veterinarian accredited by the national government of Mexico, inspected the flock of origin and found no evidence of communicable diseases of poultry.
(viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian of the national government of the region of origin who signed the certificate or, if exported from Mexico, by the veterinarian accredited by the national government of Mexico who signed the certificate.
(ix) In addition, if the eggs were laid in any region where END is considered to exist (see paragraph (a) of this section), the certificate must also state:
(C) The eggs are from a flock of origin found free of END as follows: On the seventh and fourteenth days of the 21-day period before the certificate is signed, at least 1 cull (sick or dead) bird for each 10,000 live birds occupying each poultry house certified for exporting table eggs was tested for END virus using a virus isolation test. The weekly cull rate of birds of every exporting poultry house within the exporting farm does not exceed 0.1 percent. The tests 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. All examinations and virus isolation tests were conducted in a laboratory located in the region of origin, and the laboratory was approved to conduct the examinations and tests by the veterinary services organization of the national government of that region. All results were negative for END.
(D) The certificate must state that egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in the flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate.
5. In §§ 94.8 and 94.9, footnotes 8 through 11 are redesignated as footnotes 7 through 10, respectively.
6. Section 94.12 is amended as follows:
a. In paragraph (b)(1)(iii)(B), by redesignating footnote 12 as footnote 11.
b. In paragraph (b)(3), by redesignating footnote 13 as footnote 12 and revising newly redesignated footnote 12 to read as set forth below.
(b) * * *
(3) * * * 12
12 See footnote 9 in § 94.9.
7. In § 94.16, footnote 14 is redesignated as footnote 13.
8. Section 94.17 is amended as follows:
a. In paragraph (e), by redesignating footnote 15 as footnote 14.
b. In paragraph (p)(1)(i), by redesignating footnote 16 as footnote 15 and revising newly redesignated footnote 15 to read as set forth below.
(p) * * *
(1) * * *
(i) * * * 15
15 See footnote 14 in paragraph (e) of this section.
9. In §§ 94.18 and 94.24, footnotes 17, 18, 20, and 21 are redesignated as footnotes 16 through 19, respectively.
Done in Washington, DC, this 8th day of August 2007.
Acting Administrator, Animal and Plant Health Inspection Service.
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.Back to Citation
2. USDA, Chickens and Eggs 2003 Summary. Washington, DC: National Agricultural Statistics Service, January 2004. Estimates cover the period from December 1, 2002-2003.Back to Citation
3. USDA, Poultry-Production and Value 2004 Summary. Washington, DC: National Agricultural Statistics Service, April 2005. This is the most recent annual statistic for broiler production.Back to Citation
4. USDA, Chickens and Eggs 2003 Summary. Washington, DC: National Agricultural Statistics Service, January 2004.Back to Citation
5. USDA, HS 10-Digit Imports. Washington, DC: Foreign Agricultural Service, 2004. Import quantities and cash value estimates of table eggs for regions where END is considered to exist were approximated by subtracting the quantity and value of imports from regions free of END from the “world total” query.Back to Citation
6. Domestic supply of table eggs found by examining domestic table egg production for 2003, 74.4 billion eggs, less total exports in 2003, 490.6 million eggs, plus total imports of 13.9 million eggs. USDA, HS 10-Digit Imports. Washington, DC: Foreign Agricultural Service, 2004.Back to Citation
7. USDA, Livestock, Dairy, and Poultry Outlook. Washington, DC: Economic Research Service, February 17, 2004.Back to Citation
8. U.S. Egg Industry Fact Sheet. Illinois: American Egg Board, February 2004.Back to Citation
[FR Doc. E7-15815 Filed 8-10-07; 8:45 am]
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