06-2406. Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Technical Amendments

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule; technical amendments.

SUMMARY:

In a final rule published in the Federal Register on January 4, 2005, we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States via live ruminants and ruminant products and byproducts, and added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. In this document, we are clarifying our intent with regard to certain provisions in the final rule and are correcting several inconsistencies within the rule. These technical amendments will clarify the regulations.

DATES:

Effective Date: These amendments are effective March 14, 2006.

FOR FURTHER INFORMATION CONTACT:

For information regarding ruminant products, contact Dr. Karen James-Preston, Director, Technical Trade Services, Animal Products, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231; [phone].

For information concerning live ruminants, contact Lee Ann Thomas, Director, Technical Trade Services, Animals, Organisms and Vectors, and Select Agents, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231; [phone].

SUPPLEMENTARY INFORMATION:

Background

In a final rule published in the Federal Register on January 4, 2005 (70 FR 460-553, Docket No. 03-080-3), we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products and byproducts, and we added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions.

Following publication of the final rule, it came to our attention that certain provisions in the rule either did not make clear our intention or were written in a way that was inconsistent with other provisions in the rule or with the description of such provisions in the preamble of the rule. We addressed two of those issues in an interim rule that was published in the Federal Register and made effective on November 28, 2005 (70 FR 71213-71218, Docket No. 03-080-8). In this document, we are clarifying certain other provisions of the January 2005 final rule, as discussed below.

Certification and Individual Identification of Bovines, Sheep, and Goats Imported for Immediate Slaughter

In this amendment, we are making clear that live bovines, sheep, and goats imported from Canada for slaughter in the United States—whether for immediate slaughter or for feeding and then slaughter—must be accompanied by a health certificate issued in accordance with § 93.405 of the regulations and be individually identified before the animal's arrival at the port of entry into the United States.

As established by the January 2005 final rule, § 93.436(a) of the regulations requires a certificate for bovines imported from BSE minimal-risk regions for immediate slaughter, and § 93.436(b) requires a certificate for bovines imported from BSE minimal-risk regions for feeding and then slaughter. Section 93.419(c) requires a certificate for sheep and goats imported from BSE minimal-risk regions. Section 93.405, which contains general requirements for certificates for ruminants, provides in paragraph (a)(4) that certificates for bovines, sheep, and goats imported from BSE minimal-risk regions include, among other information, the name and address of the importer; the species, breed and number or quantity of ruminants to be imported; the purpose of the importation; individual ruminant identification and any other identification present on the animal, including registration number, if any; a description of the ruminant, including name, age, color, and markings, if any; the region of origin; the address of or other means of identifying the premises of origin and any other premises where the ruminants resided immediately prior to export, including the State or its equivalent, the municipality or nearest city, or an equivalent method, approved by the Administrator, of identifying the location of the premises; the name and address of the exporter; the port of embarkation in the foreign region; and the mode of transportation, route of travel, and port of entry in the United States.

The January 2005 final rule did not amend § 93.405(a), however, which allowed for exemptions to the certificate requirement as provided in § 93.418(a) for cattle imported from Canada for immediate slaughter and as provided in § 93.419(a) for sheep and goats imported from Canada for immediate slaughter.

The language in §§ 93.418(a) and 93.419(a) that exempted cattle, sheep, and goats imported from Canada for immediate slaughter from the certification requirements of § 93.405 was included in the regulations before a BSE-infected cow was diagnosed in Canada in May 2003. It was not removed when BSE was detected in Canada because, following that detection, no live ruminants were allowed importation from Canada, which made the exemptions moot. It was our intention to remove those exemptions once the importation of bovines, sheep, and goats from Canada was allowed to resume. However, by oversight, we neglected to remove those exemptions in our January 2005 final rule. Therefore, in this document, we are amending §§ 93.405(a), 93.418(a), and 93.419(a) to do so.

What Must Be Included on the Certification Regarding Sheep and Goats Imported for Immediate Slaughter

As discussed above, we are making clear in this technical amendment that sheep and goats imported from Canada for immediate slaughter must be accompanied by the health certificate required in accordance with § 93.405. However, only parts of § 93.405 are applicable to sheep and goats imported from Canada for immediate slaughter. Paragraphs (b) and (c) of § 93.405 include import conditions with regard to scrapie that are not applicable to sheep and goats imported from Canada for immediate slaughter, due to the very restricted movement of such animals in the United States. In this document, we are adding wording to § 93.405(b)(1) and (c)(2) to make clear which sheep and goats those paragraphs apply to.

Individual Identification

Among the information required on the health certificate under § 93.405(a)(4) is the individual identification of the animal being imported from a BSE minimal-risk region. To make the requirement for individual identification more explicit, in this document we are amending §§ 93.419(c) and 93.436(a)(3) and (b)(4) to specify that each sheep, goat, and bovine imported from a BSE minimal-risk region—both those imported for immediate slaughter as well as those imported for feeding and then slaughter—must be identified before the animal's arrival at the port of entry into the United States by means of an official eartag of the country of origin (in this case a Canadian Food Inspection Agency eartag) that is determined by the APHIS Administrator to meet standards equivalent to those for official eartags in the United States as defined in 9 CFR 71.1 and to be traceable to the premises of origin of the animal. We are also specifying that no person may alter, deface, remove, or otherwise tamper with the official eartag while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter.

Remove Requirement for Name of Animal on Health Certificate

As noted above, among the information required on the health certificate under § 93.405(a)(4) of the January 2005 final rule is the name of the animal. It is not our intent to require the name of the animal on the health certificate. The wording of § 93.405(a)(4) of the January 2005 final rule was taken in part from information that is usually supplied for purebred animals imported for shows or for breeding. Many animals of this type have been given a name, unlike ruminants imported for immediate slaughter or for feeding and then slaughter. Because the January 2005 final rule does not allow the importation of bovines, sheep, and goats from Canada for shows or breeding, a requirement that the name of the animal be included on the health certificate is not necessary or useful. Therefore, consistent with our intent, we are removing the requirement in § 93.405(a)(4) that a bovine, sheep, or goat imported from Canada be identified by name on the health certificate required under § 93.405.

Change to the Heading to § 93.405

Consistent with the content of § 93.405, we are changing the heading to that section from “Certificate for ruminants” to “Health certificate for ruminants.”

Reformatting of § 93.418

Section 93.418 of the regulations contains certification requirements regarding the tuberculosis and brucellosis status of cattle from Canada. These requirements were in effect before Canada reported a case of BSE in May 2003. However, from May 2003 until the January 2005 final rule became effective, the provisions in § 93.418 were moot, because no live cattle were imported from Canada. With the resumption of the importation of cattle from Canada, and our making explicit in this technical amendment that all cattle from Canada must be accompanied by a health certificate in accordance with § 93.405, we are rewording and reformatting § 93.418 to be consistent with § 93.405 and to remove redundant language.

Paragraph (b) of § 93.418 has required that cattle imported from Canada for other than immediate slaughter be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government stating that the cattle meet specified requirements regarding their tuberculosis status. Similarly, § 93.418(c) has required that certain cattle imported from Canada for other than immediate slaughter be accompanied by a certification that the cattle meet specified requirements regarding their brucellosis status.

As noted above under the heading “Certification and Individual Identification of Bovines, Sheep, and Goats Imported for Immediate Slaughter,” in this technical amendment we are removing the language in § 93.418(a) that has said that cattle imported from Canada for immediate slaughter do not need to be accompanied with the health certificate required under § 93.405. Consistent with this change to § 93.418(a), we are rewording § 93.418(b) and (c) to make it clear that, although all cattle imported from Canada must be accompanied by a health certificate in accordance with § 93.405, § 93.418 requires specific information regarding tuberculosis and brucellosis only for certain cattle (i.e., for cattle other than those imported for immediate slaughter and, with regard to brucellosis, for cattle other than steers).

Additionally, in this technical amendment, we are removing § 93.418(d) because its provisions are contained elsewhere in the regulations. Section 93.418 has contained language requiring that the health certificate accompanying cattle to the United States indicate the names of the consignor and consignee, as well as a description of the cattle to be imported. This language is duplicative of language contained in § 93.405. Also, § 93.418(d)(3) has required that the certification accompanying certain cattle from Canada indicate the dates and places of tuberculosis and brucellosis tests required under § 93.418(b) and (c). That requirement is duplicative of language already set forth in § 93.418(b) and (c). Finally, we are removing the language from § 93.418(d) that says that, for brucellosis vaccinations required under § 93.418, the required certificate must indicate the date of vaccination, dosage of vaccine, and age of each animal, and are including it instead in § 93.418(c).

Certification That Bovines, Sheep, and Goats Are Not Pregnant

Section 93.436 of our January 2005 final rule allows, under certain conditions, the importation of bovines under 30 months of age and sheep and goats under 12 months of age. One of the conditions is that the animals must be imported either for immediate slaughter or for movement to a feedlot for subsequent movement to slaughter. The final rule does not allow the importation of breeding cattle and breeding sheep and goats from BSE minimal-risk regions. This prohibition was discussed in the preamble (see 70 FR 484-485 and 487), and the rule allows the importation of bovines, sheep, and goats for slaughter only.

However, the regulatory text of the final rule does not explicitly address whether pregnant bovines, sheep, or goats may be imported for immediate slaughter or for movement to a feedlot for subsequent movement to slaughter.

We did not intend to allow the importation of pregnant bovines, sheep, and goats under the final rule. Calves, lambs, and kids born in the United States from animals imported under the January 2005 final rule would not have been imported in compliance with the final rule, in that they would not have been identified as being of Canadian origin by means of a brand, they would not be individually identified in a way that is traceable to their herd or flock of origin, and they would not be specifically covered by a certificate. Further, the importation of fetal bovine serum (FBS) from BSE minimal-risk regions was not evaluated for the January 2005 final rule, and the regulations do not allow the importation FBS from BSE minimal-risk regions. It would be inconsistent to prohibit the importation of FBS from BSE minimal-risk regions, while at the same time allow the importation of pregnant bovines from whose fetuses FBS could be obtained.

Therefore, we are amending § 93.436(a)(1) and (b)(1) to prohibit explicitly the importation of pregnant bovines from BSE minimal-risk regions. Similarly, we are amending § 93.419(c) to prohibit the importation of pregnant sheep and goats from Canada (at this time the only country listed as a BSE minimal-risk region). As we have been requiring since the January 2005 final rule was implemented, certificates accompanying bovines, sheep, and goats imported from Canada must state that the animals covered by the certificate are not pregnant.

Definition of Camelids

In the preamble of the January 2005 final rule, we stated that we were adding a definition of camelid to § 93.400 to mean all species in the family Camelidae, including camels, llamas, alpacas, guanacos, and vicunas. However, in the regulatory text of our rule, we inadvertently neglected to include guanacos in the definition of camelid. In this document, we are correcting that oversight by adding guanacos to the definition of camelid in § 93.400.

Pet Food and Similar Commodities

Paragraphs (a)(1) and (a)(2) of § 95.4 contain lists of commodities that are prohibited importation from regions listed in § 94.18(a) unless certain conditions are met. The regions listed in § 94.18(a) include regions in which BSE is known to exist (listed in § 94.18(a)(1)), regions that present an undue risk of introducing BSE into the United States (listed in § 94.18(a)(2)), and BSE minimal-risk regions (listed in § 94.18(a)(3)).

The lists of prohibited items in § 95.4(a)(1) and (a)(2) include processed animal protein, tankage, offal, and tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed. Also listed are glands and unprocessed fat tissue derived from ruminants, and derivatives of glands from ruminants, as well as processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material was derived.

Further, § 95.4(a)(3) specifies that products containing any of the materials listed above are prohibited importation from regions listed in § 94.18(a). In § 95.4(f) and (g) of the January 2005 final rule, however, we added exceptions to the prohibitions set forth in § 95.4(a) for tallow and offal imported from a BSE minimal-risk region, provided certain risk-mitigating conditions are met.

However, § 95.4(a)(3), read literally, appears to prohibit the importation of products containing any of the materials listed in § 95.4(a)(1) or (2), even those products containing materials that are allowed to be imported from BSE minimal-risk regions. Specifically, the wording in § 95.4(a)(3) prohibits the importation of “[p]roducts containing any of the items listed in paragraphs (a)(1) and (a)(2) of this section,” and does not go on to acknowledge that § 95.4(a) allows for certain exceptions for items from a BSE minimal-risk region. Our intention, however, was to prohibit the importation of only those products containing any items that themselves are prohibited importation under § 95.4(a)(1) and (2). To make clear our intent, we are rewording § 95.4(a)(3) so that it prohibits the importation of “products containing any of the items prohibited importation under paragraphs (a)(1) and (a)(2) of this section.”

List of Subjects

9 CFR Part 93

• Animal diseases
• Imports
• Livestock
• Poultry and poultry products
• Quarantine
• Reporting and recordkeeping requirements

9 CFR Part 95

• Animal feeds
• Hay
• Imports
• Livestock
• Reporting and recordkeeping requirements
• Straw
• Transportation

Accordingly, 9 CFR parts 93 and 95 are corrected by making the following technical amendments:

PART 93—IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

1. The authority citation for part 93 continues to read as follows:

Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

2. Section 93.400 is amended by revising the definition of camelid to read as follows:

§ 93.400

Definitions.

* * * * *

Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.

* * * * *

3. Section 93.405 is amended as follows:

a. By revising the section heading to read as set forth below.

b. In paragraph (a), by removing the words “§§ 93.418(a), 93.419(a), 93.423(c), and 93.428(d),” and by adding in their place the words “§§ 93.423(c) and 93.428(d),”.

c. By revising paragraph (a)(4), the introductory text to paragraph (b)(1), and paragraph (c)(2) to read as set forth below.

§ 93.405

Health certificate for ruminants.

(a) * * *

(4) If the ruminants are bovines, sheep, or goats from regions listed as BSE minimal-risk regions in § 94.18(a)(3) of this subchapter, the certificate must also include the name and address of the importer; the species, breed, number or quantity of ruminants to be imported; the purpose of the importation; individual ruminant identification, which includes the eartag required under §§ 93.419(c) and 93.436(a)(3) and (b)(4) of this subchapter, and any other identification present on the animal, including registration number, if any; a description of the ruminant, including age, color, and markings, if any; region of origin; the address of or other means of identifying the premises of origin and any other premises where the ruminants resided immediately prior to export, including the State or its equivalent, the municipality or nearest city, or an equivalent method, approved by the Administrator, of identifying the location of the premises, and the specific physical location of the feedlot or recognized slaughtering establishment where the ruminants are to be moved after importation; the name and address of the exporter; the port of embarkation in the foreign region; and the mode of transportation, route of travel, and port of entry in the United States.

(b) Goats. (1) In addition to the statements required by paragraph (a) of this section, the certificate accompanying goats from any part of the world, except for goats imported from Canada for immediate slaughter, must state:

* * * * *

(c) * * *

(2) In addition, except for sheep imported from Canada for immediate slaughter, the certificate accompanying sheep intended for importation from any part of the world except Australia and New Zealand must state that the sheep have not been in any flock nor had contact with sheep or goats that have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years immediately prior to shipment.

* * * * *

4. Section 93.418 is amended as follows:

a. By revising paragraphs (a) and (b)(2)(i), the introductory text of paragraph (b)(2)(ii), and paragraphs (c)(2)(i) and (c)(2)(iii) to read as set forth below.

b. By removing paragraph (d).

§ 93.418

Cattle from Canada.

(a) Health certificates. Cattle intended for importation from Canada must be accompanied by a certificate issued in accordance with § 93.405(a). The certificate must state that the cattle have been inspected and were found to be free from any evidence of communicable disease and that, as far as can be determined, they have not been exposed to any such disease during the preceding 60 days. Cattle found unqualified upon inspection at the port of entry will be refused entry into the United States.

(b) * * *

(2) * * *

(i) The cattle are imported for immediate slaughter in accordance with § 93.420; or

(ii) The cattle are imported for movement to a feedlot and then to slaughter and the certificate accompanying the cattle shows, in addition to the information required under § 93.405, the breed of the animal, and:

* * * * *

(c) * * *

(2) * * *

(i) The cattle are imported for immediate slaughter in accordance with § 93.420;

* * * * *

(iii) The cattle are imported for movement to a feedlot and then to slaughter and the certificate accompanying the cattle shows, in addition to the information required under § 93.405, the breed of the animal, and:

(A) That the cattle are from a brucellosis certified-free herd, province, or territory; or

(B) The date and place the cattle were last tested for brucellosis; that the cattle were found negative for brucellosis on such test; and that such test was performed within 30 days preceding the arrival of the cattle at the port of entry; or

(C) That the female cattle under 18 months of age were vaccinated against brucellosis in accordance with Canadian regulations; the date of such vaccination; the dosage of vaccine used; and the age of each animal on the date of vaccination.

5. Section 93.419 is amended as follows:

a. By revising paragraph (a) and the introductory text of paragraph (c) to read as set forth below.

b. By removing paragraph (d)(2).

c. By redesignating paragraphs (d)(3) through (d)(8) as paragraphs (d)(2) through (d)(7), respectively.

d. In newly redesignated paragraph (d)(2), by removing the words “paragraph (d)(8)” and adding in their place the words “paragraph (d)(7)”, and by removing the words “paragraph (d)(2)” and adding in their place the words “paragraph (c)”.

e. In newly redesignated paragraph (d)(5), by removing the words “paragraph (d)(2)” and adding in their place the words “paragraph (c)”.

§ 93.419

Sheep and goats from Canada.

(a) Sheep and goats intended for importation from Canada must be accompanied by a certificate issued in accordance with § 93.405.

* * * * *

(c) Any sheep or goats imported from Canada must not be pregnant, must be less than 12 months of age when imported into the United States and when slaughtered, must be from a flock or herd subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000, and must be individually identified by an official Canadian Food Inspection Agency eartag, applied before the animal's arrival at the port of entry into the United States, that is determined by the Administrator to meet standards equivalent to those for official eartags in the United States as defined in § 71.1 of this chapter and to be traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the individual identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter. The animals must be accompanied by the certification issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of this paragraph have been met. Additionally, for sheep and goats imported for other than immediate slaughter, the certificate must state that the conditions of paragraph (d)(1) of this section have been met. For sheep and goats imported for immediate slaughter, the certificate must also state that:

* * * * *

6. Section 93.436 is amended as follows:

a. By revising paragraph (a)(1) to read as set forth below.

b. By redesignating paragraphs (a)(3) through (a)(6) as paragraphs (a)(4) through (a)(7), respectively.

c. By adding a new paragraph (a)(3) to read as set forth below.

d. By revising newly redesignated paragraph (a)(4) to read as set forth below.

e. By revising paragraph (b)(1) to read as set forth below.

§ 93.436

Ruminants from regions of minimal risk for BSE.

(a) * * *

(1) The bovines must be less than 30 months of age and must not be pregnant when imported into the United States and when slaughtered;

* * * * *

(3) Each bovine must be individually identified by an official eartag of the country of origin, applied before the animal's arrival at the port of entry into the United States, that is determined by the Administrator to meet standards equivalent to those for official eartags in this chapter and to be traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter;

(4) The bovines must be accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of (a)(1) through (a)(3) of this section have been met;

* * * * *

(b) * * *

(1) The bovines must be less than 30 months of age and must not be pregnant when imported into the United States;

* * * * *

PART 95—SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

10. The authority citation for part 95 continues to read as follows:

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

11. In § 95.4, paragraph (a)(3) is revised to read as follows:

§ 95.4

Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, certain tallow other than tallow derivatives, and serum due to bovine spongiform encephalopathy.

(a) * * *

(3) Products containing any of the items prohibited importation under paragraphs (a)(1) and (a)(2) of this section.

* * * * *

Done in Washington, DC, this 8th day of March 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.