Importation of Table Eggs From Regions Where Exotic Newcastle Disease Exists, 45177-45181 [E7-15815]

Download as PDF 45177 Proposed Rules Federal Register Vol. 72, No. 155 Monday, August 13, 2007 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. APHIS–2007–0014] RIN 0579–AC47 Importation of Table Eggs From Regions Where Exotic Newcastle Disease Exists Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. sroberts on PROD1PC70 with PROPOSALS AGENCY: SUMMARY: 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. DATES: We will consider all comments that we receive on or before October 12, 2007. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://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) VerDate Aug<31>2005 19:04 Aug 10, 2007 Jkt 211001 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 https://www.aphis.usda.gov. 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. SUPPLEMENTARY INFORMATION: Background 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 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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.1 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 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 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. E:\FR\FM\13AUP1.SGM 13AUP1 sroberts on PROD1PC70 with PROPOSALS 45178 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules 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. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 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 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 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. Miscellaneous 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 E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules sroberts on PROD1PC70 with PROPOSALS 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 falsepositive 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.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 2 USDA, Chickens and Eggs 2003 Summary. Washington, DC: National Agricultural Statistics Service, January 2004. Estimates cover the period from December 1, 2002–2003. 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. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 November 30, 2003, totaled 74.4 billion eggs.4 Economic Effects 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 $709,000.5 Total imports of table eggs for 2003 represented less than 0.02 percent of the total domestic supply for that year.6 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.7 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 4 USDA, Chickens and Eggs 2003 Summary. Washington, DC: National Agricultural Statistics Service, January 2004. 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. 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. 7 USDA, Livestock, Dairy, and Poultry Outlook. Washington, DC: Economic Research Service, February 17, 2004. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 45179 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 eggproducing companies with flocks of 75,000 hens or more. These 260 companies represent about 95 percent of all the layers in the United States.8 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 8 U.S. Egg Industry Fact Sheet. Illinois: American Egg Board, February 2004. E:\FR\FM\13AUP1.SGM 13AUP1 45180 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules determined that this action would not have a significant economic impact on a substantial number of small entities. sroberts on PROD1PC70 with PROPOSALS Executive Order 12988 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. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 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. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR part 94 as follows: PART 94—RINDERPEST, FOOT-ANDMOUTH 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: Authority: 7 U.S.C. 450, 7701–7772, 7781– 7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. 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: § 94.6 Carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds; importations from regions where exotic Newcastle disease or highly pathogenic avian influenza subtype H5N1 is considered to exist. * * * * * (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. * * * * * E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules (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 21day 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. * * * * * sroberts on PROD1PC70 with PROPOSALS §§ 94.8 and 94.9 [Amended] 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. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 § 94.12 Pork and pork products from regions where swine vesicular disease exists. * * * (b) * * * (3) * * * 12 12 See § 94.16 * * footnote 9 in § 94.9. [Amended] 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. § 94.17 Dry-cured pork products from regions where foot-and-mouth disease, rinderpest, African swine fever, classical swine fever, or swine vesicular disease exists. * * * (p) * * * (1) * * * (i) * * * 15 * * 15 See footnote 14 in paragraph (e) of this section. §§ 94.18 and 94.24 [Amended] 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. Cindy Smith, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7–15815 Filed 8–10–07; 8:45 am] BILLING CODE 3410–34–P NUCLEAR REGULATORY COMMISSION 10 CFR Parts 32 and 35 RIN 3150–AI14 Medical Use of Byproduct Material— Minor Corrections and Clarifications Nuclear Regulatory Commission. ACTION: Proposed rule. AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to correct or clarify the rule language in several sections in the regulations that govern specific domestic licenses to manufacture or transfer certain items containing byproduct material and medical use of byproduct material. The regulations that govern medical use of byproduct materials were amended in PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 45181 their entirety on April 24, 2002 (67 FR 20249). Subsequently, these regulations were amended again to revise the training and experience requirements for the medical use of byproduct material on March 30, 2005 (70 FR 16336). Through implementation of these revised regulations, the NRC has identified additional changes that need to be made to these regulations. This action is necessary to clarify certain provisions and to make certain conforming changes to the regulations. DATES: Comments on the proposed rule must be received on or before September 12, 2007. ADDRESSES: You may submit comments by any one of the following methods. Please include the following number (RIN 3150–AI14) in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including personal information such as social security numbers and birth dates in your submission. Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff. E-mail comments to: SECY@nrc.gov. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at (301) 415–1966. You may also submit comments via the NRC’s rulemaking Web site at https://ruleforum.llnl.gov. Address questions about our rulemaking website to Carol Gallagher (301) 415– 5905; email cag@nrc.gov. Comments can also be submitted via the Federal eRulemaking Portal https:// www.regulations.gov. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 am and 4:15 pm Federal workdays. (Telephone (301) 415–1966). Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415–1101. Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC’s Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including comments, may be viewed and downloaded electronically via the NRC rulemaking Web site at https:// ruleforum.llnl.gov. E:\FR\FM\13AUP1.SGM 13AUP1

Agencies

[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Proposed Rules]
[Pages 45177-45181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15815]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / 
Proposed Rules

[[Page 45177]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2007-0014]
RIN 0579-AC47


Importation of Table Eggs From Regions Where Exotic Newcastle 
Disease Exists

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: We will consider all comments that we receive on or before 
October 12, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
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 https://www.aphis.usda.gov.

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.

SUPPLEMENTARY INFORMATION:

Background

    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 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.\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 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

[[Page 45178]]

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 
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.

Miscellaneous

    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 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

[[Page 45179]]

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 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.\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, 2002-2003.
    \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.
    \4\ USDA, Chickens and Eggs 2003 Summary. Washington, DC: 
National Agricultural Statistics Service, January 2004.
---------------------------------------------------------------------------

Economic Effects

    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 Sec.  
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.\5\ Total imports of table eggs for 2003 represented 
less than 0.02 percent of the total domestic supply for that year.\6\ 
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.\7\ 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.
---------------------------------------------------------------------------

    \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.
    \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.
    \7\ USDA, Livestock, Dairy, and Poultry Outlook. Washington, DC: 
Economic Research Service, February 17, 2004.
---------------------------------------------------------------------------

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.\8\ 
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.
---------------------------------------------------------------------------

    \8\ U.S. Egg Industry Fact Sheet. Illinois: American Egg Board, 
February 2004.
---------------------------------------------------------------------------

    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has

[[Page 45180]]

determined that this action would not have a significant economic 
impact on a substantial number of small entities.

Executive Order 12988

    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.

List of Subjects in 9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR part 94 as follows:

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:

    Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    3. In Sec.  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:


Sec.  94.6  Carcasses, parts or products of carcasses, and eggs (other 
than hatching eggs) of poultry, game birds, or other birds; 
importations from regions where exotic Newcastle disease or highly 
pathogenic avian influenza subtype H5N1 is considered to exist.

* * * * *
    (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.
* * * * *

[[Page 45181]]

    (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.
* * * * *


Sec. Sec.  94.8 and 94.9  [Amended]

    5. In Sec. Sec.  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.


Sec.  94.12  Pork and pork products from regions where swine vesicular 
disease exists.

* * * * *
    (b) * * *
    (3) * * * \12\

    \12\ See footnote 9 in Sec.  94.9.


Sec.  94.16  [Amended]

    7. In Sec.  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.


Sec.  94.17  Dry-cured pork products from regions where foot-and-mouth 
disease, rinderpest, African swine fever, classical swine fever, or 
swine vesicular disease exists.

* * * * *
    (p) * * *
    (1) * * *
    (i) * * * \15\

    \15\ See footnote 14 in paragraph (e) of this section.


Sec. Sec.  94.18 and 94.24  [Amended]

    9. In Sec. Sec.  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.
Cindy Smith,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-15815 Filed 8-10-07; 8:45 am]
BILLING CODE 3410-34-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.