E6-12944. Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

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 (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. In this document, we are proposing to remove several restrictions regarding the identification of animals and the processing of ruminant materials from BSE minimal-risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. We do not believe these restrictions are necessary to prevent the introduction of BSE into the United States.

DATES:

We will consider all comments that we receive on or before October 10, 2006.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the lower “Search Regulations and Federal Actions” box, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select APHIS-2006-0026 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-2006-0026, 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-2006-0026.

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 [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

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 added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. These regulations are in 9 CFR parts 93, 94, 95, and 96.

On November 28, 2005, we published in the Federal Register an interim rule (70 FR 71213-71218, Docket No. 03-080-8) that (1) broadened who is authorized to break the seals on a means of conveyance carrying certain ruminants from Canada and (2) amended the regulations regarding the transiting through the United States of certain ruminant products from Canada to allow for limited direct transloading of the products from one means of conveyance to another in the United States.

On March 14, 2006, we published in the Federal Register a technical amendment (71 FR 12994-12998, Docket No. 03-080-9) that clarified our intent with regard to certain provisions in the January 2005 final rule and corrected several inconsistencies within the rule.

In this proposed rule, we are proposing to further amend the BSE regulations to remove several restrictions related to the provisions of the January 2005 final rule that we believe are unnecessary to prevent the introduction of BSE from minimal-risk regions into the United States. We discuss those proposed changes below.

Means of Identification of Bovines, Sheep, and Goats Imported From BSE Minimal-Risk Regions

In our March 2006 technical amendment, we clarified that it was the intent of our January 2005 final rule that all live bovines, sheep, and goats imported from a BSE minimal-risk region be accompanied by a health certificate in accordance with § 93.405 and be individually identified in the region of export before being shipped to the United States. Because Canada was the only country categorized as a BSE minimal-risk region in our final rule, and because the standard means of individual livestock identification in Canada is an eartag, we specified in § 93.436 of the final rule that live bovines imported from a BSE minimal-risk region—in this case, Canada—must be individually identified by means of an official eartag of the country of origin. The eartag must be determined by the Administrator to meet standards equivalent to those for official eartags in the United States, as defined in 9 CFR part 71, and to be traceable to the premises of origin of the animal. We included a similar requirement in § 93.419(d)(2) for sheep and goats, but because, even before our January 2005 final rule, § 93.419 referred only to sheep and goats from Canada, we specified that the sheep and goats must be individually identified by an official Canadian Food Inspection Agency eartag.

We recognize that there are effective means of individual identification other than eartags. However, as stated above, we provided in our January 2005 final rule that the means of individual identification must be an eartag because eartags are the required means of identification under Canada's national livestock identification program and Canada was the only country we were categorizing as a BSE minimal-risk region in the final rule. We now consider it advisable to amend the regulations in a way that allows for means of individual identification other than eartags. This change would make it clear to any other regions requesting BSE minimal-risk status what we consider acceptable with regard to individual identification and would give exporters the option of individually identifying bovines, sheep, and goats being exported to the United States by means other than eartags.

Therefore, instead of requiring in § 93.436 that live bovines imported into the United States from a BSE minimal-risk region must be individually identified by means of an official eartag of the country of origin, and instead of requiring in § 93.419 that sheep and goats imported into the United States from Canada must be individually identified by an official Canadian Food Inspection Agency eartag, we are proposing to provide instead in §§ 93.419(c) and 93.436(a)(3) and (b)(4) that the animals must be officially identified with individual identification before the animals' arrival at the port of entry into the United States. We are also proposing to amend § 93.405(a)(4), which currently requires that the health certificate accompanying cattle, sheep, or goats imported from a BSE minimal-risk region record the eartag required under § 93.419 or § 93.436. We are proposing to require instead that the health certificate record the required official identification.

We are proposing to define officially identified in § 93.400 of the regulations to mean “individually identified by means of an official identification device or method.” In § 93.400, official identification device or method is currently defined as a means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority.

We are not proposing to change that wording. However, we are proposing to add a sentence at the end of the definition to make it clear that, for animals intended for importation into the United States, the particular device or method of identification must have been approved by the Administrator for that type of import before the animal is exported to the United States.

We are proposing to add that wording in order to clarify that, although a particular kind of identification may have been approved by the Administrator for use in particular situations or for particular types of animals, that doesn't necessarily mean it can be used for all types of animals and in all situations. For instance, due to an animal's anatomy, it might not be possible to affix certain types of tags to the animal in a way that ensures the tags will not fall off. As another example, although the current definition of official identification device or method includes “registered brands” as an example of such identification, a brand in itself might not provide adequate identification with regard to BSE. Although a registered brand would enable traceback of an animal to its herd of origin, in the case of BSE form of identification that provides more detailed information about an individual cow, such as an eartag, would be necessary.

In the event that an importer or importing country seeks and is granted approval to use a device or method of identification other than one specifically provided for in the regulations, the record of that approval and the requirements, if any, for that device or method will be included in the protocol for imports from the exporting region, which will be made available on the APHIS Web site at http://www.aphis.usda.gov/​vs/​ncie.

Hide-Derived Gelatin

The regulations at § 94.18(c) address the importation of gelatin derived from ruminants from regions listed in § 94.18(a) as regions in which BSE exists (§ 94.18(a)(1)), regions that present an undue risk of introducing BSE into the United States (§ 94.18(a)(2)), and BSE minimal-risk regions (§ 94.18(a)(3)).

With certain specified exceptions, § 94.18(c) prohibits the importation of gelatin derived from ruminants that have been in any region listed in § 94.18(a). One of the exceptions is for gelatin derived from the bones of bovines 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 from which specified risk materials (SRMs) and small intestine were removed. We set forth the conditions for that exception in § 94.19(f) of the January 2005 final rule.

As currently written, the exception in § 94.19(f) applies exclusively to gelatin derived from the bones of bovines and not to gelatin derived from bovine hides, even the hides of the same bovines whose bones are used for gelatin that is allowed importation into the United States. However, we believe there is no scientific reason to prohibit the importation of gelatin derived from the hides of bovines. Bovine hides have not demonstrated BSE infectivity, even in infected animals. The safety of bovine hides with regard to BSE is recognized internationally. The World Organization for Animal Health (commonly referred to as the OIE) recommends in Article 2.3.13.1 of the OIE Terrestrial Animal Health Code, 2005, that gelatin derived exclusively from the hides of bovines not be subject to import restrictions. The European Commission Scientific Steering Committee's Updated Opinion on the Safety with Regard to TSE Risk of Gelatine Derived from Ruminant Bones or Hides (adopted by the Scientific Steering Committee at its December 5-6, 2002, meeting) states in section B(c) of that document:

“When ruminant hides are used for the production of gelatine, they are usually obtained from bovines. On the basis of current knowledge, it can be considered that the parts of the bovine hides used for the production of gelatine do not present a risk with regard to TSE's [transmissible spongiform encephalopathies, which include BSE], provided contamination with potentially infected materials is avoided.”

Although APHIS considers gelatin derived from bovine hides a commodity that does not present a risk of transmitting the BSE agent, by oversight we did not include in our January 2005 final rule such gelatin as an exception to the general prohibition on the importation of gelatin derived from ruminants from BSE minimal-risk regions. Because there appears to be no scientific reason to prohibit the importation of such gelatin from BSE minimal-risk regions, we are proposing to amend § 94.19(f) to add that gelatin derived from the hides of bovines that have been in any region listed in § 94.18(a)(3) may be imported into the United States. In order to help ensure that such gelatin is not contaminated with the BSE agent, we are also proposing as a condition for such importation that the gelatin was not commingled with materials ineligible for entry into the United States. We would also apply the non-commingling requirement to gelatin derived from bones from bovines from BSE minimal-risk regions. Such gelatin is already allowed importation, with specified conditions, under § 94.19(f).

Nonruminant Material

The regulations in § 95.4 prohibit the importation of certain materials derived from nonruminants, as well as materials derived from ruminants. Specifically, the following nonruminant materials may not be imported into the United States from regions listed in § 94.18(a)—or be derived from nonruminant animals that have been in a region listed in § 94.18(a)—unless certain conditions are met:

• Processed animal protein, tankage, and offal;
• Tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed; and
• Processed fats and oils, and derivatives of processed animal protein, tankage, and offal.

Among the conditions for the importation of these nonruminant materials is that all steps of processing and storing the material must have been carried out in a foreign facility that has not been used for the processing and storage of materials from ruminants that have been in any region listed in § 94.18(a). The purpose of this requirement is to eliminate the possibility that the nonruminant material could become commingled with or contaminated by ruminant material containing the BSE agent and therefore itself become contaminated with the BSE agent.

We continue to consider this restriction necessary with regard to nonruminant materials that are processed in regions listed in § 94.18(a)(1) or (2) (regions in which BSE exists and regions that present an undue risk of introducing BSE into the United States). However, requiring that nonruminant materials be processed in separate facilities from ruminant materials in BSE minimal-risk regions is inconsistent with other provisions in our January 2005 final rule. Therefore, we are proposing to eliminate that inconsistency, for the reasons explained below.

Our January 2005 final rule allowed the importation of certain ruminant meat, products, and byproducts from Canada (at this time Canada is the only region recognized by APHIS as a BSE minimal-risk region). APHIS determined that such commodities present a low risk of introducing BSE into the United States, based on a number of factors. These factors include the measures Canada has in place to detect and prevent BSE within Canadian cattle and the commodity-specific mitigation measures in the final rule. For meat (including whole or half carcasses), meat byproducts, and meat food products derived from bovines, the regulations require that the bovines be subject to a ruminant feed ban, prohibit the use of an air-injected stunning process at slaughter, and require that SRMs and the small intestine of the bovines be removed at slaughter. Research has shown that BSE infectivity in infected bovines is localized in specific tissues, and removal of SRMs is an effective risk mitigation measure for bovines. Therefore, the regulations do not require that bovine meat eligible for entry into the United States from a BSE minimal-risk region be processed in a facility that processes only bovine commodities eligible for entry into the United States.^[1]

In sheep and goats, research has not identified SRMs that could be removed to eliminate any potential infectivity from infected animals. Infectivity has not been demonstrated in most tissues in sheep and goats until at least 16-months post-exposure to the BSE agent. Therefore, for meat (including whole or half carcasses), meat byproducts, and meat food products from sheep or goats or other ovines or caprines, the regulations require that the animals, among other things, be less than 12 months of age when slaughtered and be slaughtered at a facility that either slaughters only sheep and/or goats or other ovines and caprines less than 12 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States.

In both cases, however—for products derived from bovines and for products derived from sheep or goats—the regulations do not require that the animals necessarily be slaughtered in a facility dedicated only to ruminant products eligible for entry into the United States. Because products derived from nonruminants pose even less of a BSE risk than those derived from ruminants, it is inconsistent with the January 2005 final rule to require in § 95.4 that, in a region listed in § 94.18(a)(3) (i.e., a BSE minimal-risk region), all steps of processing nonruminant protein, tankage, offal, and tallow other than tallow derivatives, as well as processed fats and oils, and derivatives of processed animal protein, tankage, and offal derived from nonruminants, be carried out in a facility that has not been used for the processing and storage of materials from ruminants that have been in any region listed in § 94.18(a)(3) (a BSE minimal-risk region). Therefore, we are proposing to amend § 95.4 by adding a new paragraph (c)(3) to require that, for facilities in regions listed in § 94.18(a)(3), steps of processing and storing the nonruminant material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a)(1) or (a)(2).

Executive Order 12866 and Regulatory Flexibility Act

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

The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations, and small governmental jurisdictions. We have prepared an initial regulatory flexibility analysis, which is set forth below.

In a final rule published in January 2005, we established a category of regions that present a minimal risk of introducing BSE 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 proposed rule, we are proposing to remove certain restrictions on imports from BSE minimal-risk regions that concern animal identification, the derivation of bovine gelatin, and the processing of ruminant and nonruminant materials. We do not believe these restrictions are necessary to prevent the introduction of BSE into the United States.

Instead of limiting the type of allowable individual identification on bovines, sheep, and goats imported from a BSE minimal-risk region to an official eartag of the country of origin, we are proposing to allow individual identification of animals by means other than eartags, provided the APHIS Administrator has approved the manner of identification for the type of animal intended for importation.

Instead of limiting the importation of bovine-derived gelatin from BSE minimal-risk regions to gelatin derived from bones, we are proposing to also allow the importation of hide-derived gelatin, provided certain conditions are met.

We are also proposing to allow nonruminant material that is processed in BSE minimal-risk regions—such as processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal—to be processed in facilities that also process material derived from ruminants from the minimal-risk region.

We address below the potential economic effect of each of these changes.

Animal Identification

Giving owners of bovines, sheep, and goats in BSE minimal-risk regions the option of individually identifying animals being exported to the United States by means other than eartags is not expected to affect U.S. small entities. This amendment simply acknowledges that there are effective means of individual identification other than eartags. However, APHIS welcomes information that the public may offer on ways this amendment may impact small entities, and the type and number of small entities that would be affected.

Hide-Derived Gelatin

This amendment, by allowing the importation of gelatin derived from bovine hides, in addition to gelatin derived from bovine bones, could affect U.S. entities by providing for an additional source of gelatin imported from Canada.

Gelatin is derived from collagen, an insoluble fibrous protein that is the principal constituent of connective tissues and bones. The main raw materials used in gelatin production are cattle bones, cattle hides, and porkskins. Gelatin recovered from bone is used primarily in photographic applications. Porkskin is currently the most significant raw material source for production of edible gelatin in North America. Cattle hides are the least used raw material for gelatin in North America today. Cattle hides sourced by member companies of the Gelatin Manufacturers Institute of America for the production of gelatin for food use are purchased from a small number of tanneries in the United States.

We do not have information about the quantity of hide-derived gelatin that would be imported from Canada because of this proposed rule, nor do we have an estimate of the number of U.S. small entities that would be affected. Production of animal hides is classified by the North American Industry Classification System (NAICS) under “Animal (except Poultry) Slaughtering” (NAICS 311611), for which the small entity definition is businesses with not more than 500 employees. We welcome information that would allow us to better understand the number and size of entities that could be affected by allowing the importation of hide-derived bovine gelatin from Canada, and the extent of the possible impact.

Nonruminant Material

This amendment would remove the requirement that nonruminant material that is processed in BSE minimal-risk regions be processed in a facility that does not also process material derived from ruminants from the minimal-risk region. If this amendment were to result in changes in the amounts of nonruminant material imported by the United States, then U.S. entities could be affected. Affected nonruminant material may include processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal.

Facilities that produce these commodities are classified under “Rendering and Meat By-product Processing” (NAICS 311613), for which the small entity definition is businesses with not more than 500 employees. We do not have a basis for estimating the change in imports of Canadian nonruminant materials that may result from the proposed rule, nor do we know the number or size of U.S. entities that would be affected. APHIS welcomes information that the public may provide regarding the number of small entities that could be affected and the likely magnitude of the effect.

APHIS has not identified any Federal rules that may duplicate, overlap, or conflict with this proposed rule, and believes there are no significant alternatives to this proposed rule that would accomplish the stated objectives.

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 inconsistent 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

This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects

9 CFR Part 93

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

9 CFR Part 94

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

9 CFR Part 95

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

Accordingly, we are proposing to amend 9 CFR parts 93, 94, and 95 as follows:

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 would continue 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 would be amended by revising the definition of official identification device or method and adding a definition of officially identified, in alphabetical order, to read as follows:

§ 93.400

Definitions.

* * * * *

Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. For animals intended for importation into the United States, the device or method of identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States.

* * * * *

Officially identified. Individually identified by means of an official identification device or method.

* * * * *

3. In § 93.405, paragraph (a)(4) would be amended by removing the word “eartag” and adding in its place the words “official identification.”

4. Section 93.419 would be amended by revising paragraph (c), introductory text, and paragraphs (d)(2), (d)(5), (d)(7)(i), and (d)(7)(iii) to read as follows:

§ 93.419

Sheep and goats from Canada.

* * * * *

(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 officially identified with individual identification before the animal's arrival at the port of entry into the United States. 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. 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:

* * * * *

(d) * * *

(2) The animals may be moved from the port of entry only to a feedlot designated in accordance with paragraph (d)(7) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation deemed acceptable by the Administrator, which must identify the physical location of the feedlot, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any:

* * * * *

(5) The animals must be accompanied to the recognized slaughtering establishment by APHIS Form VS 1-27 or other documentation deemed acceptable by the Administrator, which must identify the physical location of the recognized slaughtering establishment, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any;

* * * * *

(7) * * *

(i) Will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records;

* * * * *

(iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feed lot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For Canadian animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass;

* * * * *

5. Section 93.436 would be amended as follows:

a. Paragraphs (a)(3) and (b)(4) would be revised to read as set forth below.

b. In paragraphs (b)(8) and (b)(11), the word “eartag” would be removed and the words “official identification” would be added in its place.

§ 93.436

Ruminants from regions of minimal risk for BSE.

* * * * *

(a) * * *

(3) Each bovine must be officially identified with individual identification before the animal's arrival at the port of entry into the United States. 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 slaughter;

* * * * *

(b) * * *

(4) Each bovine must be officially identified with individual identification before the animal's arrival at the port of entry into the United States. 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 slaughter;

* * * * *

PART 94—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

6. The authority citation for part 94 would continue 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.

7. In § 94.19, paragraph (f) would be revised to read as follows:

§ 94.19

Restrictions on importation from BSE minimal-risk regions of meat and edible products from ruminants.

* * * * *

(f) Gelatin other than that allowed importation under § 94.18(c). The gelatin is derived from:

(1) The bones of bovines 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 from which SRMs and small intestine were removed, and the gelatin has not been commingled with materials ineligible for entry into the United States; or

(2) The hides of bovines, and the gelatin has not been commingled with materials ineligible for entry into the United States.

* * * * *

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

8. The authority citation for part 95 would continue 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.

9. Section 95.4 would be amended as follows:

a. Paragraph (c)(2) would be revised to read as set forth below.

b. Paragraphs (c)(3) through (c)(7) would be redesignated as paragraphs (c)(4) through (c)(8), respectively.

c. A new paragraph (c)(3) would be added to read as set forth below.

d. Newly designated paragraph (c)(7) would be revised to read as set forth below.

§ 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.

(c) * * *

(2) Except for material processed or stored in regions listed in § 94.18(a)(3) of this subchapter, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a) of this subchapter.

(3) For material processed or stored in regions listed in § 94.18(a)(3) of this subchapter, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a)(1) or (a)(2) of this subchapter.

* * * * *

(7) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of export certifying that the conditions of paragraphs (c)(1) through (c)(4) of this section have been met; except that, for shipments of animal feed from a region listed in § 94.18(a)(3) of this subchapter, the certificate may be signed by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin.

* * * * *

Done in Washington, DC, this 3rd day of August 2006.

Elizabeth E. Gaston,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  Pursuant to an announcement by the Secretary of Agriculture on February 9, 2005, APHIS published in the Federal Register on March 11, 2005, a document (70 FR 12112-12113, Docket No. 03-080-6) delaying until further notice the applicability of the provisions of the final rule as they apply to the importation from Canada of certain commodities derived from bovines 30 months of age or older. While the delay in applicability is in effect, commodities from Canada derived from bovines less than 30 months of age when slaughtered will be required to be processed in an establishment that operates in compliance with an approved Canadian Food Inspection Agency program to prevent commingling of ruminant products eligible for export to the United States with ruminant products ineligible for export to the United States. This is to ensure that only products from bovines less than 30 months of age are exported to the United States, however; not to prevent contamination.