Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Identification of Ruminants, and Processing and Importation of Commodities, 3379-3385 [E8-883]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Rules and Regulations]
[Pages 3379-3385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-883]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 95

[Docket No. APHIS-2006-0026]
RIN 0579-AC45


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the importation of 
animals and animal products to remove several restrictions regarding 
the identification of animals and the processing of ruminant materials 
from regions that present a minimal risk of introducing bovine 
spongiform encephalopathy into the United States. We are removing these 
restrictions because they are not necessary to prevent the introduction 
of bovine spongiform encephalopathy into the United States.

DATES: Effective Date: February 19, 2008.

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; (301) 734-
4356.
    For information concerning live ruminants, contact Dr. Freeda 
Isaac, Director, AOVSA, National Center for Import and Export, VS, 
APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231; (301) 734-
8364.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture regulates the importation of 
animals and animal products into the United States to guard against the 
introduction of animal diseases not currently present or prevalent in 
this country. The regulations in 9 CFR parts 93, 94, and 95 prohibit or 
restrict the importation into the United States of specified animals 
and animal products to prevent the introduction into the United States 
of various animal diseases, including bovine spongiform encephalopathy 
(BSE).
    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 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 provisions 
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.
    On August 9, 2006, we published in the Federal Register a proposed 
rule \1\ (71 FR 45439-45444, Docket No.

[[Page 3380]]

APHIS-2006-0026) to amend the regulations in 9 CFR parts 93, 94, and 95 
to remove several restrictions regarding the identification of 
ruminants and the processing of ruminant materials from BSE minimal-
risk regions, as well as BSE-based restrictions on gelatin derived from 
bovine hides.
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    \1\ To view the proposed rule and the comments we received, go 
to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2006-0026.
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    We solicited comments concerning our August 2006 proposed rule 
(referred to below as the ``proposed rule'') for 60 days ending October 
10, 2006. In a document published in the Federal Register on November 
9, 2006 (71 FR 65758-65759, Docket No. APHIS-2006-0026), we reopened 
and extended the deadline for comments until November 24, 2006.
    We received 10 comments in response to our proposed rule. They were 
from organizations representing U.S. producers of livestock and 
livestock products, renderers, and other members of the public. The 
comments dealt with live animals as well as animal products. We discuss 
the comments below by topic.

Changes to This Final Rule Based on a September 2007 Final Rule

    On September 18, 2007, we published in the Federal Register a final 
rule (72 FR 53113-53379, Docket No. APHIS-2006-0041; effective November 
19, 2007) that established conditions for the importation into the 
United States from BSE minimal-risk regions of certain bovines and 
bovine commodities that had not been made eligible for importation by 
our January 2005 final rule. Some of the changes we made to the 
regulations in our September 2007 final rule affected regulatory text 
we had proposed to change in our August 2006 proposed rule, either by 
rewording text, deleting provisions that would have been changed by our 
August 2006 proposed rule, or redesignating CFR paragraph references. 
Consequently, we have made changes to this final rule to reflect the 
changes made by our September 2007 final rule. In our discussion of 
this final rule, we identify where those changes occur.

Comments Received in Response to Our August 2006 Proposed Rule

Identification of Live Ruminants Exported to the United States From BSE 
Minimal-Risk Regions

    One of the changes to the regulations we proposed in our August 
2006 proposed rule was a broadening of the options of acceptable forms 
of individual identification of bovines, sheep, and goats exported to 
the United States from BSE minimal-risk regions (currently only 
Canada). Under the current regulations in Sec.  93.436, live bovines 
imported from a BSE minimal-risk region must be individually identified 
by means of an official eartag of the country of origin. The eartag 
must be determined by the APHIS 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. There is a similar requirement for sheep and goats in Sec.  
93.419. However, because Sec.  93.419 refers specifically to sheep and 
goats from Canada, that section requires that sheep and goats from 
Canada be individually identified by an official Canadian Food 
Inspection Agency eartag.
    In our proposed rule, we proposed to allow for means of individual 
identification other than eartags for the imported bovines, sheep, and 
goats. We proposed to provide that the animals must be officially 
identified with individual identification before the animals' arrival 
at the port of entry into the United States. We proposed to define 
officially identified to mean ``individually identified by means of an 
official identification device or method.'' In Sec.  93.400 of the 
current regulations, official identification device or method is 
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 proposed to add a sentence at 
the end of that 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.
    Several commenters expressed concern that our proposed change 
regarding animal identification would hinder the ability to conduct 
rapid traceback of cattle to their herd of origin in the event BSE is 
diagnosed in an animal imported from a BSE minimal-risk region. One of 
the commenters recommended that the identification requirements in the 
current regulations be retained. Another commenter recommended that the 
regulations explicitly require that all cattle from a BSE minimal-risk 
region be individually identified with a device or method that is 
visible and readable and that includes a unique animal identification 
number that enables traceback to the herd of origin.
    We agree with the commenters that the individual identification of 
cattle--and sheep and goats--imported from a BSE minimal-risk region 
must be unique to individual animals and allow for rapid traceback of 
an animal to its herd of origin. The intent of the change we proposed 
was not to remove that requirement from the regulations, but simply to 
allow, in addition to eartags, other forms of individual identification 
that meet those criteria. That is the reason we proposed to provide in 
the definition of official identification device or method that the 
identification used must have been approved by the Administrator for 
that type of import before the animal is exported to the United States.
    To ensure that there is no misunderstanding of our intent, in this 
final rule we are specifying in Sec.  93.436(a)(2) and (b)(3) that, 
before arrival at the port of entry into the United States, each bovine 
imported into the United States from a BSE minimal-risk region must be 
officially identified with unique individual identification that is 
traceable to the premises of origin of the animal.\2\ In Sec.  
93.419(c), we are including a similar identification requirement for 
sheep and goats imported from Canada.
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    \2\ Note: Paragraphs (a)(2) and (b)(3) of Sec.  93.436 were 
designated as paragraphs (a)(3) and (b)(4), respectively, in our 
proposed rule, but are redesignated in this final rule to reflect 
the changes made in our September 2007 final rule.
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    In our August 2006 proposed rule, we proposed to replace the word 
``eartag'' with the term ``official identification'' in what, at that 
time, were paragraphs (b)(8) and (b)(11) of Sec.  93.436. However, our 
September 2007 final rule removed Sec.  93.436(b)(8) and (b)(11).
    In addition to addressing the issue of the types of allowable 
individual identification, two commenters expressed support for 
identification provisions of the current regulations that we did not 
propose to change. These are: (1) The provision that 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; and (2) the requirement that cattle imported from 
a BSE minimal-risk region for other than immediate slaughter be 
identified, before export to the United States, with a permanent mark 
that indicates the country of origin.

[[Page 3381]]

Gelatin

    In Sec.  94.19(f)(2) of our proposed rule, we proposed to allow the 
importation into the United States of gelatin derived from the hides of 
bovines from BSE minimal-risk regions, provided the gelatin has not 
been commingled with materials ineligible for entry into the United 
States. In accordance with the regulations as amended by our September 
2007 final rule, gelatin imported into the United States from a BSE 
minimal-risk region must either (1) be 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 were removed (Sec.  94.19(f)), 
or (2) be imported for use in human food, human pharmaceutical 
products, photography, or some other use that will not result in the 
gelatin coming into contact with ruminants in the United States (Sec.  
94.18(c)).
    A number of commenters supported allowing the importation of 
gelatin derived from the hides of bovines from BSE minimal-risk 
regions.
    One commenter stated that it does not make sense to allow the 
importation of gelatin derived from hides of bovines from BSE minimal-
risk regions at the same time the regulations restrict the importation 
of gelatin derived from bones. We disagree that it does not make sense 
to allow the importation of gelatin derived from hides. Bovine hides 
have not demonstrated BSE infectivity, even in infected animals, and 
the safety of bovine hides with regard to BSE is recognized 
internationally. The World Organization of Animal Health (commonly 
referred to as the OIE) supported that conclusion in its recommendation 
that gelatin derived exclusively from the hides of bovines not be 
subject to import restrictions (OIE Terrestrial Animal Health Code (the 
Code), 2006, Article 2.3.13.1). The European Commission Scientific 
Steering Committee reached a similar conclusion regarding the lack of 
BSE infectivity in hide-derived gelatin, provided contamination with 
potentially infected materials is avoided (European Commission's 
Updated Opinion on the Safety with Regard to TSE Risk of Gelatine 
Derived from Ruminant Bones or Hides, December 2002).
    In contrast, gelatin derived from the bones of bovines from BSE 
minimal-risk regions can pose a risk of infectivity unless the risk 
mitigation measures in Sec. Sec.  94.18(c) and 94.19(f), described 
above, are taken. The higher BSE risk of bone-derived gelatin is 
recognized internationally. The OIE Code contains BSE risk mitigation 
guidelines for gelatin derived from bovines (Article 2.3.13.15). The 
European Commission Scientific Steering Committee concluded in its 
Updated Opinion that ``the risk of transmissible spongiform infectivity 
is much higher with bones, as compared to hides.''
    Therefore, we are making no changes based on this comment.

Processing of Non-Ruminant Material in BSE Minimal-Risk Regions

    The current regulations in Sec.  95.4(c) allow the importation of 
certain materials derived from nonruminants from BSE minimal-risk 
regions only if 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 Sec.  94.18(a) of the regulations. The regions listed 
in Sec.  94.18(a) include BSE minimal-risk regions, as well as regions 
in which BSE exists and regions that present an undue risk of 
introducing BSE into the United States.
    In our proposed rule, we proposed to amend Sec.  95.4(c) so that 
nonruminant materials processed or stored in BSE minimal-risk regions 
would no longer need to be processed or stored in facilities separate 
from those used to process or store materials derived from ruminants 
from BSE minimal-risk regions.
    Several commenters supported the proposed change to Sec.  95.4(c).
    One commenter stated that our intent regarding the proposed change 
to Sec.  95.4(c) was not easily understandable from the wording we used 
in the regulatory text of the proposed rule. In Sec.  95.4(c)(2) and 
(3) of the proposed rule, we made reference to regions listed in Sec.  
94.18(a)(1), (a)(2), and (a)(3). Those paragraphs list the following 
types of regions: Sec.  94.18(a)(1) lists regions in which BSE exists; 
Sec.  94.18(a)(2) lists regions that, because of import requirements 
less restrictive than those that would be acceptable for import into 
the United States and/or because of inadequate surveillance, present an 
undue risk of introducing BSE into the United States; and Sec.  
94.18(a)(3) lists BSE minimal-risk regions (currently only Canada). The 
commenter stated that the regulations would be clearer if, when 
referring to Sec.  94.18(a)(1), (a)(2), and (a)(3), we also indicated 
the BSE category of regions listed in those paragraphs.
    Because in Sec.  95.4(c) as proposed we reference paragraphs that 
contain lists that can be easily described, we agree it would be useful 
to the reader if those references included a description of the content 
of each of those paragraphs. Therefore, we are including such 
descriptions in Sec.  95.4(c)(2) and (c)(3) in this rule.

Tallow

    One commenter addressed the provisions in Sec.  95.4 regarding the 
importation of tallow. The commenter stated that APHIS should follow 
the OIE guideline of allowing the importation from BSE minimal-risk 
regions of tallow with no more than 0.15 percent impurities.
    We did not propose to make any changes to the regulations regarding 
the importation of tallow from BSE minimal-risk regions. However, the 
commenter is correct that the wording in Sec.  95.4 regarding tallow 
differs from the OIE guidelines in one respect. One of the criteria in 
Sec.  95.4 for the importation of tallow derived from bovines from BSE 
minimal-risk regions is that the tallow be composed of less than 0.15 
percent insoluble impurities. This differs slightly from the OIE 
guidelines, which recommend allowing the importation of tallow with a 
maximum level of insoluble impurities of 0.15 percent in weight.
    The intent of our January 2005 final rule, as indicated on page 501 
of the preamble to that rule, was to allow the importation of tallow 
composed of a maximum level of insoluble impurities of 0.15 percent in 
weight. However, the amendatory text of that rule incorrectly used the 
phrase ``less than 0.15 percent.'' Therefore, to make the wording of 
the regulations consistent with our stated intent, in this rule we are 
amending Sec.  95.4 to require that bovine-derived tallow imported from 
a BSE minimal-risk region be composed of a maximum level of insoluble 
impurities of 0.15 percent in weight.

Other Comments

    In our proposed rule, we proposed to specify in Sec.  94.19(f)(1) 
(redesignated as Sec.  94.19(g)(1) in our September 2007 final rule) as 
one of the conditions for the importation of gelatin derived from the 
bones of bovines from BSE minimal-risk regions that the gelatin not 
have been commingled with materials ineligible for entry into the 
United States. Other than that, we did not propose to change the 
provisions regarding gelatin derived from bones. One commenter, 
however, objected to the current regulations that allow the importation 
of bone-derived gelatin from BSE minimal-risk regions (currently only 
Canada). The commenter contended that the current regulations

[[Page 3382]]

are erroneously based on the determination that Canada is a BSE 
minimal-risk region, and that Canada should instead be considered a 
country of undetermined BSE risk according to OIE recommendations.
    For similar reasons, a commenter opposed our proposal to no longer 
require that nonruminant materials processed or stored in BSE minimal-
risk regions be processed or stored in facilities separate from those 
used to process or store materials derived from ruminants from BSE 
minimal-risk regions. The commenter expressed concern regarding what 
the commenter termed the ``undetermined prevalence'' of BSE in Canada 
and the detection of BSE in cows that were born after Canada 
implemented its feed ban. The commenter stated that APHIS should 
reconsider the proposed change on the basis that BSE infectivity is 
known to have circulated in Canada as recently as 2002.
    We are making no changes based on these comments. APHIS recognized 
Canada as a BSE minimal-risk region in our January 2005 final rule that 
was published following notice-and-comment rulemaking. We did not 
propose to revisit that determination in our August 2006 proposed rule 
and do not consider such a change to the BSE risk status of Canada to 
be scientifically supportable or appropriate. One of the conditions for 
being recognized by APHIS as a BSE minimal-risk region is that the 
region have in place and maintain risk mitigation measures adequate to 
prevent widespread exposure and/or establishment of the disease. In 
classifying Canada as a BSE minimal-risk region in our January 2005 
final rule, we determined that such mitigation measures are in place 
and are maintained in Canada.
    We do not consider the diagnosis of BSE in several cows born after 
the establishment of the Canadian feed ban to be unexpected. Experience 
worldwide has demonstrated that, even in countries with an effective 
feed ban in place, BSE has occurred in cattle born after a feed ban was 
implemented. No regulatory effort can ensure 100 percent compliance. 
Isolated incidents, such as feed made from nonprohibited material being 
contaminated with prohibited material during processing, can occur due 
to human error. However, such isolated incidents are not 
epidemiologically significant and do not contribute to further spread 
of BSE, especially when considered in light of the entire risk pathway 
and its attendant risk mitigations.
    One commenter made the general request that APHIS delete from the 
regulations the provisions regarding imports from BSE minimal-risk 
regions until further research and surveillance is done regarding all 
transmissible spongiform encephalopathies. The commenter did not 
address any specific provision of our proposal, and we are making no 
changes based on the comment.
    One commenter requested that APHIS not require that products 
imported from a BSE minimal-risk region under the provisions of Sec.  
95.4 be accompanied by original signed certification, provided certain 
specified risk mitigation measures are in place. We consider the issue 
raised by the commenter to be outside the scope of the proposed rule, 
and are making no changes based on the comment. However, we will take 
the commenter's request into consideration in assessing the need for 
future rulemaking.
    Several commenters expressed general opposition to the importation 
of ruminants from Canada, but did not specifically address provisions 
of the proposed rule. We are making no changes based on those comments.

Additional Nonsubstantive Changes

    In addition to those discussed above, we are making several other 
nonsubstantive changes in this final rule to be consistent with wording 
changes and paragraph redesignations made in our September 2007 final 
rule.

Adoption of the Proposed Rule With Changes

    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

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 a final 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 that category. We also established 
conditions for the importation of certain live ruminants and ruminant 
products and byproducts from such regions. A final rule published in 
September 2007 included conditions for the importation of additional 
commodities from BSE minimal-risk regions.
    In this rule, we are removing 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 have determined these restrictions are not 
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 allowing unique 
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 and the 
identification is traceable to the premises of origin of the animal.
    Instead of limiting the importation of bovine-derived gelatin from 
BSE minimal-risk regions to gelatin derived from bones, we are allowing 
the importation of hide-derived gelatin, provided certain conditions 
are met.
    We are also allowing 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, as long as the chosen device or method has been approved by 
the APHIS Administrator before the animal is exported to the United 
States. The unique individual identification must be traceable to the 
premises of origin of the animal (as is required of the eartags 
currently used), a disease control

[[Page 3383]]

measure that will benefit all U.S. cattle producers, the majority of 
which are small entities.

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 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 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. In the 
initial regulatory flexibility analysis we conducted for our August 
2006 proposed rule, we requested information that would allow us to 
better understand the number and size of entities that might be 
affected by allowing hide-derived bovine gelatin to be imported from 
BSE minimal-risk regions (currently only Canada), but we received no 
information of this type.

Nonruminant Material

    This amendment removes 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 results 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 might result from this rule, nor 
do we know the number or size of U.S. entities that will be affected. 
In our initial regulatory flexibility analysis, we requested 
information from the public regarding the number of small entities that 
might be affected and the likely magnitude of the effect, but we 
received no information of this type.
    We do not foresee any significant economic effects on small 
entities because of this rule. There are no significant alternatives to 
this rule that would accomplish the stated objectives. Without the 
rule, unnecessary restrictions on certain exports to the United States 
from BSE minimal-risk regions will continue. With the rule, animal 
exporters in BSE minimal-risk regions will have the option of 
individually identifying bovines, sheep, and goats being exported to 
the United States by means other than eartags; U.S. entities will be 
allowed to import hide-derived, in addition to bone-derived, gelatin 
from BSE minimal-risk regions; and ruminant and nonruminant materials 
that are processed in the same facility in a BSE minimal-risk region 
will be allowed to be exported to the United States.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This 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.

0
Accordingly, we are amending 9 CFR parts 93, 94, and 95 as follows:

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

0
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.

0
2. Section 93.400 is 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:


Sec.  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.
* * * * *


Sec.  93.405  [Amended]

0
3. In Sec.  93.405, paragraph (a)(4) is amended by removing the word 
``eartag'' and adding in its place the words ``official 
identification''.

0
4. Section 93.419 is amended by revising paragraph (c) and paragraphs 
(e)(2), (e)(5), (e)(7)(i), and (e)(7)(iii) to read as follows:

[[Page 3384]]

Sec.  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, before the 
animal's arrival at the port of entry into the United States, must be 
officially identified with unique individual identification that is 
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. The animals must be accompanied by the certification 
issued in accordance with Sec.  93.405 that states, in addition to the 
statements required by Sec.  93.405, that the conditions of this 
paragraph have been met. Additionally, for sheep and goats imported for 
immediate slaughter, the certificate must state that the conditions of 
paragraphs (d)(1) through (d)(3) of this section have been met, and, 
for sheep and goats imported for other than immediate slaughter, the 
certificate must state that the conditions of paragraphs (e)(1) and 
(e)(2) of this section have been met.
* * * * *
    (e) * * *
* * * * *
    (2) The animals may be moved from the port of entry only to a 
feedlot designated in accordance with paragraph (e)(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;
* * * * *

0
5. Section 93.436 is amended by revising paragraphs (a)(2) and (b)(3) 
to read as set forth below.


Sec.  93.436  Ruminants from regions of minimal risk for BSE.

* * * * *
    (a) * * *
    (2) Before the animal's arrival at the port of entry into the 
United States, each bovine imported into the United States from a BSE 
minimal-risk region must be officially identified with unique 
individual identification that is 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 slaughter;
* * * * *
    (b) * * *
    (3) Before the animal's arrival at the port of entry into the 
United States, each bovine imported into the United States from a BSE 
minimal-risk region must be officially identified with unique 
individual identification that is 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 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

0
6. 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.


0
7. In Sec.  94.19, paragraph (f) is revised to read as follows:


Sec.  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 Sec.  
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 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

0
8. 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.


0
9. Section 95.4 is amended as follows:
0
a. Paragraph (c)(2) is revised to read as set forth below.
0
b. Paragraphs (c)(3) through (c)(7) are redesignated as paragraphs 
(c)(4) through (c)(8), respectively.
0
c. A new paragraph (c)(3) is added to read as set forth below.

[[Page 3385]]

0
d. Newly redesignated paragraph (c)(7) is revised to read as set forth 
below.
0
e. Paragraph (g)(2) is revised to read as set forth below.


Sec.  95.4  Restrictions on the importation of processed animal 
protein, offal, tankage, fat, glands, certain tallow other than tallow 
derivatives, and blood and blood products due to bovine spongiform 
encephalopathy.

* * * * *
    (c) * * *
    (2) In regions listed in Sec.  94.18(a)(1) or (a)(2) of this 
subchapter as regions in which BSE exists or that present an undue risk 
of introducing BSE into the United States, 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 Sec.  94.18(a) of this 
subchapter.
    (3) In regions listed in Sec.  94.18(a)(3) of this subchapter as 
BSE minimal-risk regions, 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 Sec.  94.18(a)(1) or (a)(2) of this 
subchapter as a region in which BSE exists or a region that presents an 
undue risk of introducing BSE into the United States.
* * * * *
    (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 Sec.  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.
* * * * *
    (g) * * *
    (2) The tallow is composed of a maximum level of insoluble 
impurities of 0.15 percent in weight;
* * * * *

    Done in Washington, DC, this 14th of January 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-883 Filed 1-17-08; 8:45 am]
BILLING CODE 3410-34-P