[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Rules and Regulations]
[Pages 72979-73008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28228]



[[Page 72979]]

Vol. 78

Wednesday,

No. 233

December 4, 2013

Part II





 Department of Agriculture





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Animal and Plant Health Inspection Service





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9 CFR Parts 92, 93, 94, et al.





 Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine 
Products; Final Rule

Federal Register / Vol. 78 , No. 233 / Wednesday, December 4, 2013 / 
Rules and Regulations

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 92, 93, 94, 95, 96, and 98

[Docket No. APHIS-2008-0010]
RIN 0579-AC68


Bovine Spongiform Encephalopathy; Importation of Bovines and 
Bovine Products

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations that govern the importation of 
animals and animal products to revise the conditions for the 
importation of live bovines and products derived from bovines with 
regard to bovine spongiform encephalopathy (BSE). We are basing 
importation conditions on the inherent risk of BSE infectivity in 
specified commodities, as well as on the BSE risk status of the region 
in which the commodities originate. We are establishing a system for 
classifying regions as to BSE risk that is consistent with the system 
employed by the World Organization for Animal Health (OIE), the 
international standard-setting organization for guidelines related to 
animal health. The conditions we are adopting for the importation of 
specified commodities are based on internationally accepted scientific 
literature, and are, in general, consistent with guidelines set out in 
the OIE's Terrestrial Animal Health Code. We are also classifying 
certain specified countries as to BSE risk and are removing BSE 
restrictions on the importation of cervids and camelids and products 
derived from such animals. We are making these amendments after 
conducting a thorough review of relevant scientific literature and a 
comprehensive evaluation of the issues and concluding that the changes 
to the regulations will continue to guard against the introduction of 
BSE into the United States, while allowing the importation of 
additional animals and animal products into this country.

DATES: This rule is effective March 4, 2014. The incorporation by 
reference of the material described in the rule is approved by the 
Director of the Federal Register as of March 4, 2014.

FOR FURTHER INFORMATION CONTACT: For information concerning live 
ruminants, contact Dr. Betzaida Lopez, Import Animal Staff 
Veterinarian, Technical Trade Services, Animals, Organisms and Vectors, 
and Select Agents, National Center for Import and Export, VS, APHIS, 
4700 River Road, Unit 39, Riverdale, MD 20737-1231; 301-851-3300.
    For information regarding ruminant products and for other 
information regarding this rule, contact Dr. Christopher Robinson, 
Assistant Director, Technical Trade Services, Animal Products, National 
Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, 
Riverdale, MD 20737-1231; 301-851-3300.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

Need for the Regulatory Action

    The conditions we are adopting for the importation of specified 
bovine commodities are based on internationally accepted scientific 
literature and are, in general, consistent with World Organization for 
Animal Health (OIE) guidelines. We are making these amendments after 
conducting a thorough review of relevant scientific literature and a 
comprehensive evaluation of the issues and concluding that the changes 
we are making to the regulations will continue to guard against the 
introduction of bovine spongiform encephalopathy (BSE) into the United 
States, while allowing the importation of additional animals and animal 
products into this country.
    The OIE recognizes three classifications of countries for BSE: 
Negligible risk, controlled risk, and undetermined risk. The OIE 
guidelines recommend that countries allow trade in certain bovine 
commodities from all three classifications under conditions 
commensurate with their BSE risk. This final rule generally aligns U.S. 
regulations with the OIE guidelines and demonstrates to the 
international community the commitment of the United States to base its 
BSE regulations on internationally accepted scientific literature.

Legal Authority for the Regulatory Action

    Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et 
seq.), the Secretary of Agriculture has the authority to issue orders 
and promulgate regulations to prevent the introduction into the United 
States and the dissemination within the United States of any pest or 
disease of livestock. The Animal and Plant Health Inspection Service's 
(APHIS') regulations in title 9 of the Code of Federal Regulations, 
subchapter D, govern the exportation and importation of animals 
(including poultry) and animal products from and into the United 
States.

Summary of the Major Provisions of the Regulatory Action

    The current regulations prohibit the importation of live ruminants 
and most ruminant products from regions that have BSE or that present 
an undue risk for BSE. The regulations are less restrictive for 
ruminants and ruminant products from BSE minimal-risk regions 
(currently only Canada). Additionally, the regulations allow the 
importation of boneless beef from Japan even though Japan is listed as 
a region that has BSE. We are replacing the current BSE regulations 
that apply to bovines (cattle and bison) with import conditions based 
on the inherent risk of BSE infectivity in specified commodities, as 
well as on the BSE risk status of the region in which the commodities 
originate. We are establishing a system for classifying regions as to 
BSE risk that is consistent with the system employed by the OIE, the 
international standard-setting organization for guidelines related to 
animal health. We are also classifying certain specified countries as 
to BSE risk. We are also removing BSE restrictions on the importation 
of cervids and camelids and products derived from such animals.

Costs and Benefits

    Consumers benefit from imports to the extent that consumer choice 
is broadened and the increased supply of the imported commodity leads 
to a price decline. We anticipate that the rule will have little impact 
on consumer choice or import volumes, and therefore little or no impact 
on U.S. businesses as well. Although the impact of this rule on U.S. 
consumers and producers is expected to be minimal, the benefits of the 
rule are expected to justify its costs.

II. Background

    In order to guard against the introduction and spread of animal 
diseases, APHIS, an agency of the U.S. Department of Agriculture (USDA 
or Department), regulates the importation of animals and animal 
products into the United States. The regulations in 9 CFR parts 92, 93, 
94, 95, 96, and 98 (referred to below as the regulations) govern the 
importation of certain animals, meat, other animal products and 
byproducts, hay, and straw into the United States in order to prevent 
the introduction of various animal diseases.
    On March 16, 2012, we published in the Federal Register (77 FR 
15848-15913, Docket No. APHIS-2008-0010) a proposal \1\ to amend the 
regulations that

[[Page 72981]]

govern the importation of animals and animal products to revise the 
conditions for the importation of live bovines and products derived 
from bovines with regard to BSE. Specifically, we proposed to base our 
importation conditions on the inherent risk of BSE infectivity in 
specified commodities, as well as the BSE risk status of the region in 
which the commodities originate, consistent with the OIE's Terrestrial 
Animal Health Code. We proposed to establish a system for classifying 
regions as to BSE risk that is consistent with the system employed by 
the OIE. The conditions we proposed for the importation of specified 
commodities are based on internationally accepted scientific literature 
and, are, in general, consistent with the guidelines set out in the 
OIE's Terrestrial Animal Health Code. We also proposed to classify 
certain specified countries as to BSE risk and proposed to remove BSE 
restrictions on the importation of cervids and camelids and products 
derived from such animals.
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    \1\ To view the proposed rule, supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010.
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    In the same document we also affirmed the position we took in 
removing the delay of applicability of certain provisions of the rule 
titled ``Bovine Spongiform Encephalopathy; Minimal-Risk Regions and 
Importation of Commodities,'' published in the Federal Register on 
January 4, 2005 (70 FR 460-553, Docket No. 03-080-3). The delay of 
applicability was removed in a final rule titled ``Bovine Spongiform 
Encephalopathy; Minimal Risk Regions; Importation of Live Bovines and 
Products Derived from Bovines,'' published in the Federal Register on 
September 18, 2007 (72 FR 53314-53379, Docket No. APHIS-2006-0041). 
However, as ordered by the U.S. District Court on July 3, 2008, APHIS 
provided additional opportunity for public comment on this action in a 
notice published in the Federal Register on September 18, 2008 (73 FR 
54083-54089, Docket No. APHIS-2008-0093). We responded to comments 
received on that notice in our March 2012 proposed rule.
    We solicited comments concerning our proposal for 60 days ending 
May 15, 2012. We reopened and extended the deadline for comments until 
June 14, 2012, in a document published in the Federal Register on May 
21, 2012 (77 FR 29914, Docket No. APHIS-2008-0010). We received 60 
comments by that date. They were from private citizens, domestic and 
foreign industry associations, importers, exporters, and 
representatives of State and foreign governments. The commenters raised 
a number of questions and concerns about the proposed rule. These 
comments and concerns are discussed below by topic.

General Concerns

    One commenter stated that APHIS did not give appropriate 
consideration to, and in some cases did not address at all, some of the 
concerns raised by the public on the notice requesting comment on the 
delay of applicability of certain provisions of the rule titled ``BSE; 
Minimal-Risk Regions and Importation of Meat, Meat Byproducts, and Meat 
Food Products Derived from Bovines 30 Months of Age or Older'' (the OTM 
[i.e., over 30 months] rule) (73 FR 54083-54089, Docket No. APHIS-2008-
0093).
    APHIS disagrees. In the proposed rule, we responded to comments on 
our removal of the delay of applicability of provisions of our January 
2005 final rule. We are confident that we responded to all the 
comments.
    The commenter stated that in the September 2008 request for 
comments, APHIS mischaracterized its document published in the Federal 
Register on March 8, 2004 (69 FR 10633-10636, Docket No. 03-080-2), as 
proposing to allow the importation from BSE minimal-risk regions of 
beef derived from cattle of any age. The March 2004 document reopened a 
comment period for a proposed rule published on November 4, 2003 (68 FR 
62386-62405, Docket No. 03-080-1) and invited public comment on 
changing that proposed rule to allow the importation of beef from 
bovines 30 months of age and older based on new requirements issued by 
USDA's Food Safety and Inspection Service (FSIS). The commenter stated 
that the March 2004 document contained no reference to the importation 
of beef from cattle of any age and instead continued to propose a 
restriction on the age of cattle by retaining the requirement contained 
in the November 2003 proposed rule that the beef be derived from 
animals that are not known to have been fed ruminant protein, other 
than milk protein, during their lifetime.
    When we stated in our September 2008 request for comments that our 
March 2004 document proposed to allow the importation of beef derived 
from cattle of any age, we meant that the derivation of beef from 
bovines 30 months of age or older when slaughtered would not in itself 
preclude the commodities from being imported. We stated further that we 
were not referring to any effect the feed ban requirement might have on 
the import eligibility of the commodities.
    The terminology regarding ``cattle of any age'' that we used in our 
September 2008 request for comments was consistent with that which we 
used in the risk analysis for our January 2005 final rule. The 
commenter stated that this terminology was not consistent with the risk 
assessment which supported the January 2005 final rule.
    We note that the risk analysis that accompanied the January 2005 
final rule stated: ``It is important to note the following change in 
the final rule. In its proposed rule, APHIS restricted beef imported 
from Canada to meat derived from cattle under 30 months of age. This 
requirement has been removed in the final rule, and beef from animals 
of any age will be allowed to be imported from a Minimal Risk region.'' 
In the January 2005 final rule, we explained that we did not believe 
this requirement was necessary, provided that measures equivalent to 
those of FSIS regarding specified risk material (SRM) removal are in 
place in the exporting region and other such measures as are necessary 
(e.g., a prohibition on the use of air injection stunning devices and 
controls to prevent cross-contamination) are in place. We believe that 
this clearly lays out the intent that APHIS did not apply any specific 
age limitation to the import of beef.
    One commenter stated that, despite the fact that APHIS stated in 
the proposed rule that it is not necessary to revise any provisions in 
the OTM rule, the proposed rule makes substantive revisions to the OTM 
rule, including revisions to the provisions that APHIS stated were 
essential to its affirmation of the OTM rule.
    The commenter is correct in noting that this rule revises the 
existing regulations, including the existing regulations that addressed 
the importation of animals and products from BSE minimal risk regions. 
As described in the proposed rule, APHIS noted that the existing 
regulations contain provisions that are not yet fully consistent with 
the latest scientific literature. APHIS regulations have changed over 
time, as we gain increased understanding of the science of BSE and 
conduct further risk assessments. The changes we proposed reflected 
internationally accepted scientific literature and, in general, are 
consistent with the OIE Code.
    We assume that the commenter is referring to the specific issue of 
whether or not certification about a feed ban is necessary in the 
conditions for beef imports. APHIS initially imposed such a 
certification requirement, noted in both the 2003 proposed rule and the 
January 2005 final rule. This

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requirement was not amended in our 2007 final rule when we lifted the 
delay of applicability on certain imports from Canada. In contrast, our 
regulations for the importation of boneless beef from Japan do not 
include any certification about the feeding practices for the animals 
from which the beef was derived. In both instances, however, we 
considered the significant overall risk reduction achieved in each 
country by their respective feed bans. Such feed bans decrease the 
overall prevalence of BSE and therefore reduce the risk that any 
individual animal may be exposed to potentially infected feed. They 
continue to be a crucial risk mitigation measure that is considered in 
any overall risk assessment for BSE. However, since they are crucial to 
the consideration of the overall status of the country, requiring 
specific certification to that effect for individual animals from which 
meat for export is derived is redundant. The feed ban requirement is 
covered in that consideration of the country's BSE risk. Therefore, in 
line with OIE recommendations, we did not include that specific 
certification statement in the proposed requirements for beef imports 
from controlled risk regions. Such certification is, however, required 
for beef imports from undetermined risk regions. For these regions, 
either no information is available about any feed ban requirements or 
other risk mitigation measures, or they have not maintained the 
relevant risk mitigation measures sufficient to meet the standards for 
controlled or negligible risk. Therefore, we cannot rely on the overall 
country evaluation to ensure that a feed ban is in place and will 
require certification that the animals from which the meat was derived 
were never fed meat-and-bone meal or greaves derived from ruminants. 
These requirements are consistent with our risk assessments that 
demonstrate that an effective feed ban is a critical risk mitigation 
measure that must be in place in regions that have a potential risk of 
BSE.
    One commenter stated that the OIE Code is not universally 
recognized as the international standard for BSE prevention, 
mitigation, and surveillance. The commenter noted that some countries, 
such as Japan and Australia, have established their own standards, 
which are stricter than those of the OIE. The commenter stated that 
APHIS should provide better justification for adopting OIE standards.
    As we explained in the proposed rule, the World Trade Organization 
recognizes the OIE as the international forum for setting animal health 
standards, reporting global animal disease events, and presenting 
guidelines and recommendations on sanitary measures relating to animal 
health. As an OIE Member country, the United States reviews and, where 
appropriate, comments on all draft OIE chapters and revisions. As part 
of the United States' consideration of OIE drafts, APHIS distributes 
these drafts to the U.S. livestock and aquaculture industries, 
veterinary experts in various U.S. academic institutions, and other 
interested persons for review and comment. Furthermore, the United 
States, represented by APHIS, has been actively involved in the 
development of the OIE Code and fully supports the OIE position that 
gradations in BSE risk among regions should be recognized and that 
trade should be commensurate with risk.
    One commenter stated that surveillance for BSE in the United States 
is inadequate. The commenter stated that U.S. surveillance has 
decreased 90 percent since 2005, and that the United States only tests 
cattle showing symptoms of BSE. The commenter stated that all cattle 
should be tested for BSE at slaughter and that such testing would not 
be prohibitively expensive.
    APHIS disagrees with the commenter. BSE surveillance programs in 
the United States focus on obtaining quality samples from targeted 
subpopulations rather than looking at the entire adult cattle 
population. Targeted animals are cattle older than 30 months of age 
that exhibit signs of central nervous disorders or any other signs 
associated with BSE, such as emaciation or injury. Dead cattle and non-
ambulatory cattle are also targeted. The experience in the United 
Kingdom (UK) has shown that those populations are most likely to test 
positive for BSE in the event that the animals were exposed to the 
agent and lived long enough to develop the disease. We note that 
surveillance is not a BSE mitigation; that is, it does not provide a 
level of protection against the disease. It only allows us to 
understand disease trends such as prevalence and evolution of the 
disease, and to evaluate the effectiveness of risk mitigation measures. 
The removal of SRMs and the ruminant-to-ruminant feed ban are the 
primary safeguards to human and animal health.
    One commenter stated that the proposed testing rates are too low. 
The commenter asked how a region can be considered negligible risk if 
only a small percentage of cattle are tested for BSE.
    Surveillance is only one part of the evaluation. A region applying 
for negligible risk status must show compliance with BSE-related 
mitigations for a period of at least 7 or 8 years. In addition, the 
region must show that the likelihood of release and exposure to the BSE 
agent is negligible. As we explained above, BSE surveillance provides 
information regarding prevalence, changes in the epidemiology of the 
disease, and effectiveness of the BSE risk mitigation measures.
    One commenter stated that the United States typically imports more 
than 2 million head of cattle each year. The commenter asked how APHIS 
supported the statement that imported cattle represent only a small 
portion of cattle in U.S. feedlots.
    According to data from the National Agricultural Statistics Service 
(NASS), of the approximately 2.2 million bovine animals imported 
annually for the years 2009-2011, about 1.3 million were feeder cattle. 
NASS data also show that an average of 25.8 million cattle was marketed 
annually by feedlots in the years 2009-2011. Based on this information, 
APHIS estimates that approximately 5 percent of cattle in U.S. feedlots 
were imported.
    One commenter stated that APHIS did not address the lack of 
reported BSE cases in regions where cattle are primarily grass-fed, nor 
did APHIS evaluate the import and export standards of these countries.
    Under Chapter 11.5.2 of the OIE Code, a release assessment must be 
conducted as the first step in determining the BSE risk status of a 
region. The release assessment considers the likelihood that the BSE 
agent has either been introduced into the region via commodities 
potentially contaminated with it, or is already present in the region. 
The elements considered include production of meat-and-bone meal or 
greaves from the indigenous ruminant population, imported meat-and-bone 
meal or greaves, and imported animal feed and feed ingredients in a 
region. Furthermore, if the release assessment identifies a risk 
factor, an exposure assessment is conducted, which considers the 
likelihood of cattle being exposed to the BSE agent by reviewing such 
elements as recycling and amplification of the BSE agent through 
consumption by cattle of meat-and-bone meal or greaves of ruminant 
origin, or other feed or feed ingredients contaminated with these; the 
use of ruminant carcasses (including from fallen stock), by-products, 
and slaughterhouse waste; the parameters of the rendering processes and 
the methods of animal feed manufacture; and the feeding or not of 
ruminants with meat-and-bone meal and greaves derived from ruminants, 
including

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measures to prevent cross-contamination of animal feed. APHIS notes 
that those countries where cattle are primarily raised on grass, such 
as Argentina and Brazil, are considered negligible risk in part because 
livestock practices in those regions contribute a very low likelihood 
of exposure to ruminant materials through bovine feed.
    One commenter stated that the proposed rule is full of exceptions 
that would allow importation of live cattle and bovine products from 
all three risk categories, which presents an unacceptable amount of 
risk to consumers.
    The commenter is incorrect that under the provisions of the 
proposed rule, live cattle could be imported from regions of all three 
risk categories. Only cattle born after the date of effective 
enforcement of a ruminant-to-ruminant feed ban would be allowed entry 
from controlled risk regions, and live cattle from regions of 
undetermined risk would be allowed only on a case-by-case basis when 
the Administrator determines that they do not present a risk of 
introducing BSE into the United States. While the rule provides for the 
importation of deboned skeletal meat from all regions, that provision, 
as well as the provisions for the importation of other products, is 
closely aligned with international standards, particularly as they 
require SRM removal and steps to prevent the contamination of the 
products with SRMs.
    Four commenters noted that the phrase ``full-time salaried 
veterinary officer of the national government of the exporting region'' 
is used throughout the rule. One commenter stated that the phrase was 
not in alignment with the provisions in Chapter 5.2.2 of the OIE Code. 
The commenter asked if a veterinarian employed part-time as a 
government veterinary officer would be excluded from signing the 
required certificates. Another commenter asked that we consider 
eliminating the requirement, noting that in the joint initial action 
plan for the Regulatory Cooperation Council announced by Canadian Prime 
Minister Harper and President Obama on December 7, 2011, the current 
requirement for a veterinary signature for meat export certificates was 
cited as an example of a requirement which creates a burden for 
regulators as well as for industry. A third commenter stated that APHIS 
should build in suitable flexibility to allow certificates to be signed 
by inspectors who are under the supervision of the official 
veterinarian. This commenter also suggested that APHIS ensure there is 
sufficient flexibility to allow for the use of various forms of 
certification, such as paper and electronic certification.
    In the proposed rule, we provided for certificates to be signed 
either by a full-time salaried veterinary officer of the national 
government of the exporting region or issued by a veterinarian 
designated or accredited by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer. When 
evaluating a country we consider whether or not it has the 
infrastructure and veterinary authority to comply with the APHIS 
certification requirements. If, as a result of our evaluation, we 
conclude that the country has the necessary infrastructure, and if the 
competent veterinary authority can attest to APHIS that the competent 
official has oversight over certifying a process or product, then APHIS 
can accept that signature. We have amended the requirements in 
Sec. Sec.  94.18, 94.19, 94.20, and 94.21 to require that certificates 
must be issued and signed by a full-time salaried veterinary officer of 
the national government of the exporting region or signed by a person 
authorized to issue such certificates by the veterinary services of the 
national government of the exporting region. APHIS recognizes the need 
to move to electronic certification in the trade environment, and is 
working to find ways to implement it in the future.

Regions of Negligible Risk, Controlled Risk, and Undetermined Risk for 
BSE

    One commenter stated that OIE's risk categorizations of regions are 
based on self-reported data, and that a scientific committee assesses 
applications for compliance with OIE standards only after a 
recommendation for a risk designation is made. The commenter stated 
that this process is inherently unreliable and not subject to rigorous 
verification.
    The OIE recommendation for a region's BSE risk categorization is 
based on the decision reached by the Scientific Commission after 
receiving a recommendation from the OIE BSE ad hoc group. The members 
of both groups are aware of BSE trends and geographic impacts related 
to trade among regions. Consequently, the scientific commission's 
decision is based not only on the country's self-reported data, but 
also on the potential impact on the country's BSE status of its trading 
partners' BSE status, the country's historical trade in specific 
commodities, and the impact of BSE-related risk mitigation in the 
region.
    One commenter asked what the justification was for considering a 
region to be ``negligible risk'' if it has at least one indigenous case 
of BSE, but the BSE-positive animal was born more than 11 years ago, is 
officially identified, is controlled in its movements, and completely 
destroyed at slaughter or death. The commenter also asked for an 
explanation of the 11-year limitation.
    To achieve negligible risk status, the country must comply with 
stringent criteria, including the requirement that the youngest case 
reported by the country has to be older than 11 years. This requirement 
relates to the likelihood that contaminated feed that the BSE case was 
potentially exposed to 11 years ago (during its first year of life) 
will no longer be circulating. This is in line with classical BSE data 
showing that cattle developed disease between 4.5 and 6 years of age 
following the 1990-early 2000 European BSE experience. By year 11 after 
exposure, over 95 percent of the BSE cases in Europe experienced 
disease. Therefore we expect most cases would be detected within 11 
years.
    One commenter stated that the definitions of ``negligible risk'' 
and ``controlled risk'' status in the proposed rule are substantively 
the same as those of the OIE, and are therefore superfluous in the 
proposed rule. The commenter stated that OIE classification and 
interpretation should be sufficient.
    The OIE Code consists of guidelines for international trade in live 
animals and their parts and products. While these guidelines are 
recognized as international standards, they do not have the force or 
effect of law within the United States. For this reason we need to 
establish these definitions in our regulations.
    One commenter stated that in the proposed rule, we proposed to 
establish a notice-based approach for recognizing OIE risk 
categorization for countries, but then we also solicited comment on 
certain countries before the process was established. The commenter 
opposed recognizing the OIE risk categorization for the countries 
listed before the notice-based approach was established in the 
regulations.
    In the proposed rule, we announced that we were giving preliminary 
concurrence to the OIE risk classifications of several countries and 
gave the public opportunity to comment, just as we would have done in a 
rulemaking. We received no comments that opposed this concurrence for 
any of the countries we discussed in the proposed rule.
    Several commenters noted that the OIE recognizes Singapore and 
India as countries of negligible risk for BSE, and Taiwan as a region 
of controlled risk,

[[Page 72984]]

but that those countries were not included on the list of regions for 
which APHIS concurred with the OIE classification.
    Singapore was omitted from the list by mistake. In the cases of 
India and Taiwan, we were not able to complete our review of 
information in support of concurrence with the OIE designation before 
the publication of the proposed rule. We have since concluded our 
review of information for Taiwan and are announcing preliminary 
concurrence with the OIE designations for Singapore and Taiwan in a 
notice published today in the Federal Register in accordance with the 
process we are adopting in this final rule. The OIE recommendations 
regarding Singapore and Taiwan can be viewed at http://www.oie.int/en/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/. This notice will also announce preliminary concurrence 
with the most recent OIE designations for Austria, Belgium, Bulgaria, 
Brazil, Colombia, Costa Rica, Croatia, Israel, Italy, Japan, the 
Netherlands, Nicaragua, and Slovenia.
    Our review of information in support of concurrence with the OIE 
designation for India is ongoing. When our review is complete, if the 
findings support concurrence with the OIE designation, we will publish 
a notice in the Federal Register announcing our preliminary concurrence 
with the OIE's designation for India and provide the public with an 
opportunity to comment.
    One commenter asked if we intended to announce in the final rule 
the concurrence decision for countries that have already received OIE 
classification.
    Yes. Those regions for which we announced preliminary concurrence 
will be recognized accordingly.
    Two commenters stated that the United States should accept OIE risk 
classification without conducting duplicative reviews. One of these 
stated that the United States, as a member of the OIE, should give 
automatic recognition to the OIE risk classification.
    APHIS will not be conducting duplicative reviews, but will verify 
that the information is provided or is publicly available to support 
our concurrence with the OIE classification. APHIS' intention is to 
follow the OIE's BSE guidelines while ensuring that OIE-recognized 
countries apply adequate BSE risk mitigation measures assuring that 
bovines and bovine commodities destined for export pose a negligible 
risk for BSE, and that the country complies with OIE requirements for 
the specific BSE country recognition. APHIS will thus have greater 
confidence in the outcomes of the evaluations and will have the 
necessary documentation to support or defend recognition decisions. The 
process we will use is described in the regulatory text in this 
document for Sec.  92.5.
    One commenter asked if APHIS would proactively update its lists of 
regions of negligible and controlled risk according to future changes 
in the OIE lists, or if APHIS would act only after receiving an 
official request from the country.
    APHIS will automatically look to concur with future OIE 
recognitions of a region's BSE status.
    One commenter asked if APHIS intends to actually reassess each 
dossier before proposing to concur with OIE classification.
    It is not APHIS' intention to do a separate evaluation apart from 
the OIE's evaluation. Rather, APHIS will confirm that there is 
information available to support our concurrence with the OIE 
classification.
    One commenter asked if APHIS will accept dossiers written in 
languages other than English.
    No, APHIS will not accept dossiers in languages other than English.
    Two commenters expressed concern that APHIS plans to determine the 
BSE risk designation of any country or region via a rulemaking process. 
One commenter stated that the length of the rulemaking process is 
unpredictable and that use of a rulemaking process would introduce 
uncertainty. The other commenter suggested that APHIS maintain a list 
on a Web site and harmonize notification with that of the OIE.
    Since this final rule establishes our system for classifying 
regions as to BSE risk be consistent with the OIE's BSE risk 
categorization of regions, APHIS does not plan to use a rulemaking 
process to announce concurrence with OIE recognition of BSE status. 
Instead, when we concur with the OIE decision on the BSE status of a 
region, we will publish a notice in the Federal Register announcing our 
intention to concur and to solicit public comment. If we do not receive 
comments that require us to reconsider our decision to concur, we will 
publish a subsequent notice to announce our concurrence with the OIE 
classification and we will update our Web site. Announcing our 
concurrence through this notice process, which includes obtaining and 
evaluating public comments, among other information, before making a 
final decision on our concurrence, is an appropriate process to use.
    One commenter asked if countries that have received an OIE risk 
designation will be required to submit any particular information to 
APHIS in order to receive concurrence.
    In order to determine whether we concur with OIE's classification, 
APHIS will review publicly available information. If sufficient 
information is not publicly available, we will ask countries to provide 
us with the documentation submitted to the OIE when that country 
requested official recognition of its BSE risk status. We will then 
review the documentation provided and make our evaluation available to 
the public for comment.
    Four commenters noted that we would require regions evaluated by 
APHIS for BSE risk to submit updated information every year. Some of 
these commenters asked whether APHIS will rely on OIE's annual review 
for countries originally classified by OIE, or whether we would expect 
these countries to provide updated information to APHIS on a yearly 
basis. One commenter expressed concern that if APHIS requires this 
information from trading partners classified by OIE, it may set a 
precedent for other trading partners to ask for the same information, 
which would undermine OIE's categorization process.
    We proposed to allow for APHIS recognition of a region as a region 
of negligible risk or controlled risk in one of two ways. The first way 
would be for APHIS to concur with the OIE classification of the region 
of either negligible or controlled risk. The second way would be for a 
region that has not been classified by the OIE as either negligible or 
controlled risk for BSE to submit a request to the Administrator for 
either classification, along with documentation sufficient to allow the 
USDA to evaluate whether the region meets the criteria for either 
classification. The requirement that updated information be submitted 
every year would apply only to countries that APHIS has evaluated for 
BSE risk upon the request of those countries and not to countries that 
have already been classified as negligible or controlled risk by the 
OIE.
    One commenter noted that in proposed Sec.  93.436(b)(2)(iii), the 
proposed regulatory text mentions ``BSE minimal risk regions.'' The 
commenter suggested correcting this to ``region of negligible risk for 
BSE in which there has been an indigenous case of BSE/region of 
controlled risk for BSE.''
    The commenter is correct. We have corrected this error in the final 
rule.

[[Page 72985]]

Conditions for Importation of Commodities

Live Animals
    One commenter stated that adopting the changes in the proposed rule 
could result in BSE-infected cattle entering the United States and 
cause the loss of export markets. Another commenter expressed concern 
that detection of BSE in imported cattle could cause domestic consumers 
to lose confidence in beef, resulting in economic harm to the U.S. 
cattle industry.
    We disagree with the commenters. We will be conducting our own 
evaluations of the date of effective enforcement of the feed ban in any 
region that would export live cattle to the United States, and we will 
accept exports of live cattle from regions of undetermined risk for BSE 
only on a case-by-case basis when the Administrator determines that 
they do not present a risk of introducing BSE into the United States. 
We are confident that these and the other risk mitigation measures in 
this rule will be effective at preventing BSE-infected cattle from 
being imported into the United States.
    Additionally, we note that economic effects of the most recent BSE 
case in the United States, confirmed on April 24, 2012, in a dairy cow 
in California, were not significant, as evidenced by U.S. beef price 
levels and beef and cattle exports. Monthly retail prices of choice 
beef averaged $4.93 per pound for the 12 months between April 2011 and 
March 2012.\2\ For the following 12 months, April 2012 through March 
2013, the average monthly retail price of choice beef was $5.03 per 
pound. Comparing narrower time frames, for the 4-month period January 
2012 through April 2012, the average monthly retail price was $5.04 per 
pound, compared to an average monthly price of $4.96 per pound for the 
4 months between May 2012 and August 2012; that is, choice beef prices 
over the 4 months following the BSE discovery were less than 2 percent 
lower than prices during the 4 months preceding the discovery. A 
variety of marketing factors influence price movements, and this small 
percentage decline in 4-month average price levels is well within 
normal market fluctuations.
---------------------------------------------------------------------------

    \2\ http://www.ers.usda.gov/data-products/meat-price-spreads.aspx.
---------------------------------------------------------------------------

    With respect to U.S. beef exports, for the 12 months before the BSE 
discovery, monthly exports averaged about 71,500 metric tons (MT), 
valued at about $383 million, compared to a monthly average of about 
64,300 MT, valued at about $391 million, during the 12 months following 
the discovery.\3\ It appears unlikely that much of this year-on-year 
quantity decline can be attributed to the BSE discovery when one 
compares average monthly U.S. beef export levels during the 2 months 
before and 2 months after the BSE discovery. The quantity of beef 
exported by the United States in March and April, 2012, averaged about 
63,800 MT per month, valued at about $384 million, compared to an 
average for May and June 2012 of 65,700 MT per month, valued at about 
$394 million.
---------------------------------------------------------------------------

    \3\ U.S. Census Bureau, as reported by Global Information 
Services, Inc. This is the source of all trade data reported here.
---------------------------------------------------------------------------

    U.S. monthly cattle exports averaged about 16,700 head, valued at 
$32.4 million, during the year preceding the 2012 BSE discovery, 
compared to a monthly average of about 15,100 head, valued at $30.9 
million, during the year following the BSE discovery. Again, this small 
difference falls well within the range of monthly variation. 
Considering only the 2 months before and 2 months after the BSE 
discovery, exports for March and April 2012 averaged about 12,100 head 
per month, valued at $20.9 million, compared to about 17,900 head per 
month for May and June 2012, valued at $39.0 million.
    One commenter stated that it was unclear if the provisions of the 
proposed rule would be applicable to domesticated water buffaloes 
(Bubalus bubalis). The commenter stated that the definition of 
``bovines'' should be extended to include the domesticated water 
buffalo, which is commonly raised as a farmed animal in some European 
Union (EU) Member States.
    APHIS disagrees with the commenter that the domesticated water 
buffalo should be included in the definition of bovines. Current trade 
in water buffalo products is primarily in semen and embryos and in 
dairy products; this rule will not affect trade in these articles.
    Three commenters noted that the proposed rule addressed only 
bovines and bovine products, and that BSE-related restrictions on 
ovines and caprines were not addressed in the proposal. The commenters 
stated that APHIS should publish a rule lifting BSE-related 
restrictions on ovines and caprines as soon as possible. One commenter 
specifically requested that APHIS remove BSE-related import 
restrictions on ovine casings.
    As we explained in the proposed rule, we are in the process of 
developing a proposal to amend the BSE regulations as they affect the 
importation of ovines and caprines and products derived from those 
animals. Upon completion of the proposal, we will publish it in the 
Federal Register for public comment.
    One commenter asked that APHIS reconsider its policy on importation 
of zoo ruminants from Canada. The commenter stated that, since zoo 
ruminants cannot be imported from Canada, U.S. zoos are reluctant to 
send animals to Canada on breeding loans because they cannot get them 
back. The commenter stated that zoo ruminants have no history of BSE 
and will never come into contact with any domestic livestock in the 
United States food chain, and therefore they pose little, if any, risk 
to U.S. agriculture. The commenter stated further that North American 
zoos are losing tremendous genetic resources due to the inability to 
exchange hoofstock across the U.S. border. The commenter stated that 
this could lead to the collapse of valuable captive ruminant 
populations.
    The commenter is incorrect that zoo ruminants have no history of 
BSE. BSE has been reported in several species of exotic ruminants, 
including nyala (Tragelaphus angasi), kudu (Tragelaphus strepsiceros), 
gemsbok (Oryx gazella), eland (Taurotragus oryx), Arabian oryx (Oryx 
leucoryx), scimitar-horned oryx (Oryx dammah), Ankole cattle, and bison 
(Bison bison). As we explained above, we are in the process of 
developing a proposal to amend the BSE regulations as they affect the 
importation of ovines and caprines and products derived from those 
animals. That proposal will also address the importation of zoo 
ruminants. Upon completion of that proposal, we will publish it in the 
Federal Register for public comment.
    One commenter requested that APHIS add the ear tag system as 
established in the EU as an acceptable means of permanent 
identification.
    While APHIS could recognize an ear tag system like the one used in 
the EU as an official identification method, for live bovines imported 
from BSE-affected countries we also require a permanent identification 
such as a brand or tattoo. For example, we require a C[square]N brand 
or tattoo on cattle imported from Canada. This permanent identification 
allows APHIS to trace an animal back to the country of origin in the 
event that the animal shows symptoms of a transmissible spongiform 
encephalopathy.
    One commenter noted that the proposed rule maintains the current 
policy that any cattle imported from Canada be born after March 31, 
1999. The commenter stated that when this requirement was implemented 
in 2007, it was estimated that 11 percent of the cattle in Canada were 
born before that

[[Page 72986]]

date, but that according to a January 2012 inventory of cattle in 
Canada, that number is now approximately 2 percent. The commenter 
stated that because this number will continue to decline, and because 
classical BSE is mostly found in cattle between the ages of 4 and 7 
years, and is rare in cattle aged over 9 years, APHIS should consider 
eliminating this requirement, either by adoption in the final rule or 
by incorporating a reasonable sunset provision in the final rule.
    APHIS disagrees with the commenter. We believe that we should keep 
the date in the regulations because this rule recognizes Canada as a 
controlled risk region. Live cattle may be safely imported from 
controlled risk regions provided that the cattle were born after the 
date the ruminant-to-ruminant feed ban was effectively enforced. In 
2007, after a thorough evaluation of several factors contributing to 
enforcement and compliance of the feed ban, APHIS concluded that the 
Canadian feed ban was effectively enforced by March 31, 1999.
    One commenter noted that while the rule removes BSE-related import 
restrictions on in vivo-derived embryos, it does not address 
restrictions on in vitro-derived embryos. The commenter stated that, 
consistent with international standards, there should be no BSE-related 
restrictions on either in vivo- or in vitro-derived embryos and that 
APHIS should revise the provisions for embryos accordingly.
    The commenter is correct that the OIE does not recommend 
restrictions on in vitro-derived embryos with respect to BSE. Our 
regulations in Sec.  98.3(h) currently require that ruminant and swine 
embryos have an intact zona pellucida, which effectively prohibits the 
importation of in-vitro derived and processed embryos. This restriction 
is not related to BSE risk, but to the risks of other livestock 
diseases, such as bovine viral diarrhea, foot-and-mouth disease, 
infectious bovine rhinotracheitis, leptospirosis, leukosis, and 
mycoplasmosis.
    One commenter noted that APHIS proposed to amend the definition of 
``recognized slaughter establishment'' to mean a slaughtering 
establishment operating under the provisions of the Federal Meat 
Inspection Act or a State meat inspection act. The commenter asked for 
clarification of whether ``State'' refers only to States of the United 
States or to territories or nations as well.
    The word ``State'' in this definition refers to a State of the 
United States. The definition specifically addresses slaughter 
establishments in the United States that are under State inspection 
rather than Federal inspection. Facilities in the United States that 
receive imported animals for slaughter must operate under the 
provisions of the Federal Meat Inspection Act, and overseas facilities 
approved to export to the United States must be approved by USDA's 
FSIS.
Feed Bans
    One commenter stated that APHIS has been inconsistent in how it 
characterizes the usefulness of the feed ban. The commenter stated that 
APHIS now argues that the feed ban serves a different role in BSE 
mitigation than does SRM removal, and denies that its current 
requirement that animals from which eligible beef exports are derived 
must be subject to a feed ban is to prevent the importation of products 
derived from Canadian cattle that had been exposed to BSE infectivity. 
The commenter stated that APHIS is positing either that the feed ban 
serves no role in protecting human health, or that the feed ban's 
effectiveness in ensuring that food entering the food chain is not 
derived from infected animals is nonessential to human health.
    APHIS believes that the ruminant-to-ruminant feed ban serves an 
important role in ensuring that live animals are not exposed to the BSE 
agent, which helps ensure that the disease does not appear in the U.S. 
cattle population. SRM removal mitigates risk in meat products. Our BSE 
risk assessments examine the five barriers that must be compromised 
before BSE could be introduced into the U.S. cattle population: U.S. 
import restrictions; slaughter controls; rendering inactivation 
factors; feed manufacturing controls; and dose response. We consider 
that any feed ban may not have perfect compliance but if the risk of 
release were to be negligible, the likelihood of amplification or 
perpetuation within the system would also be considered insignificant. 
As no indigenous cases of classical BSE \4\ have ever been detected in 
the United States, APHIS remains confident that the risk of release and 
exposure to BSE in the United States remains negligible.
---------------------------------------------------------------------------

    \4\ Immunohistochemistry and Western blot tests at USDA's 
National Veterinary Services Laboratories confirmed that the most 
recent case of BSE in the United States was atypical BSE, not 
classical BSE. The report of the case investigation can be viewed on 
the APHIS Web site at http://www.aphis.usda.gov/animal_health/animal_diseases/bse/downloads/BSE_Summary_Report.pdf.
---------------------------------------------------------------------------

    One commenter stated that the feed ban requirements do not specify 
how long after the date of effective enforcement live cattle may be 
imported. The commenter suggested that allowing the importation of live 
cattle too soon after the date of effective enforcement could result in 
BSE-exposed cattle entering the United States. The commenter also 
stated that it was unclear whether the proposal to require 
documentation of effective enforcement of feed bans would actually 
provide greater protection against a BSE introduction.
    The feed ban requirements apply to animals born at any time after 
the date of effective enforcement. APHIS notes that at present, the 
certification statement must only say that the animals were born after 
the effective enforcement of a feed ban; by requiring documentation of 
the date of effective enforcement, we will be better able to verify 
that the bovines were in fact born after that date.
    One commenter stated that our proposed standards for determining 
the date of effective enforcement of a feed ban represent an 
unnecessary burden because the effectiveness of feed ban enforcement is 
already assessed as part of the OIE procedure for determining the risk 
status of a country. The commenter suggested that instead of using a 
rulemaking process, APHIS should either accept the dates recognized by 
the EU, or allow, without a rulemaking for the determination of the 
date of effective enforcement of a feed ban, cattle born after the date 
of classification of the country.
    In the event that an EU Member State wishes to export live cattle 
to the United States, APHIS will consider using the date recognized by 
the EU of effective enforcement of the feed ban in that Member State 
after evaluating publicly available data or data provided by the EU 
Member State to support such recognition. If the data supports the EU-
recognized date of enforcement, then APHIS will accept such date as the 
date the ruminant-to-ruminant feed ban was effectively enforced in the 
region. For other regions, APHIS will make a determination based on the 
information received from the country, which can also include the 
specific date of feed ban enforcement considered by the country or 
region.
    One commenter stated that determination of the date of effective 
enforcement of the ruminant-to-ruminant feed ban should be a matter for 
the OIE, not for the United States.
    The OIE ad hoc group evaluation does not determine the date of feed 
ban enforcement. The OIE assesses whether the feed ban was effectively 
enforced through audit and compliance for a particular period of time. 
For controlled risk countries, this time period is for

[[Page 72987]]

less than 8 years, and for negligible risk countries, it is for at 
least 8 years.
    The commenter stated that there are dates generally accepted for 
the effective enforcement of the feed ban in the UK (August 1, 1996) 
and the EU (January 1, 2001). The commenter asked if APHIS will accept 
these dates.
    As we explained above, in the event that an EU Member State wishes 
to export live cattle to the United States, APHIS will consider using 
the date of effective enforcement of the feed ban recognized by the EU 
after evaluating publicly available data or data provided by the EU 
Member State to support such recognition. If the data supports the EU-
recognized date of enforcement, then APHIS will accept that date as the 
date the ruminant-to-ruminant feed ban was effectively enforced in the 
Member State. For other regions, APHIS will make a determination based 
on the information received from the country, which can also include 
the specific date of feed ban enforcement considered by the region.
Edible and Inedible Products
    One commenter asked if the conditions applying to deboned skeletal 
muscle in Sec.  94.18(b)(2) would also apply to meat food products and 
byproducts made from deboned skeletal meat and containing no restricted 
commodities.
    The conditions for deboned skeletal muscle will apply to meat food 
products made from such, but, as we explained in the proposed rule, 
imported products must meet all relevant agency requirements, including 
those of FSIS and the U.S. Food and Drug Administration (FDA). Each 
agency has the capability to deny imports based on their individual 
authorities and concerns.
    One commenter stated that the proposed rule reaffirms in Sec.  
94.25(a)(2) that ovine or caprine meat can derive only from animals 
that were less than 12 months of age when slaughtered. The commenter 
stated that the OIE Code does not recommend any restrictions on the 
import of sheep and goat meat with respect to BSE or scrapie. The 
commenter asserted that the restriction is unjustified and asked APHIS 
to confirm that it will be removed in a future rulemaking.
    As we explained above, we are in the process of developing a 
proposal to amend the BSE regulations as they affect the importation of 
ovines and caprines and products derived from those animals. Upon 
completion of that proposal, we will publish it in the Federal Register 
for public comment.
    One commenter noted that in proposed Sec.  94.23(b), we proposed to 
allow the importation of gelatin derived from hides and skins 
regardless of BSE risk classification of the region of origin. The 
commenter asked why, then, in Sec. Sec.  94.23(e) and 95.7(e), that the 
certificate accompanying these commodities is required to indicate the 
BSE risk category for the exporting region. The commenter also asked 
what a region not yet classified should indicate on the certificate. 
The commenter suggested using the language of Sec.  95.8(e) for tallow 
with 0.15 percent of insoluble impurities.
    As we explained in the proposed rule, gelatin and collagen derived 
from hides and skins do not present a risk for the transmission of BSE. 
We believe, however, that additional risk mitigations are warranted for 
gelatin and collagen derived from bones, based on the risk 
classification of the region of origin. For this reason we are 
requiring gelatin and collagen imported into the United States be 
accompanied by an original certificate that indicates the BSE risk 
classification of the exporting region and that states that the 
required conditions have been met. Regions not yet classified for BSE 
risk are considered to be regions of undetermined risk. We agree with 
the commenter, however, that requiring hide-derived gelatin and 
collagen to indicate the BSE risk category for the exporting region is 
unwarranted if the products can be demonstrated to be hide-derived and 
have amended Sec. Sec.  94.23(e) and 95.7(e) accordingly.
    The commenter asked APHIS to elaborate on the circumstances where 
the provision for gelatin and collagen from bones that will have no 
contact with ruminants in the United States could be imported, and 
under what conditions the gelatin or collagen would be allowed 
importation.
    APHIS believes that the rule is clear in what the criteria are for 
importing gelatin and collagen; specifically, such products may be 
imported if the Administrator determines that the gelatin and collagen 
will not come into contact with ruminants in the United States and that 
the conditions under which it will be imported will prevent the 
introduction of BSE into the United States. Examples of these uses 
would include products for human or industrial use, such as film, 
cosmetics, manufacturing for glue purposes, and so on. Persons wishing 
to import gelatin and collagen would also need to obtain a United 
States Veterinary Permit for the Importation and Transportation of 
Controlled Materials and Organisms and Vectors,\5\ and the uses would 
have to be stated on the permit application. The importation of gelatin 
and collagen intended solely for human use must still meet the 
requirements established by other agencies that regulate for public 
health.
---------------------------------------------------------------------------

    \5\ Application for a permit must be filed on VS Form 16-3 
(available from APHIS, Veterinary Services, National Center for 
Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application must state the intended use of the 
material and the name and address of the consignee in the United 
States.
---------------------------------------------------------------------------

    One commenter stated that the definition of ``offal'' in Sec.  95.1 
leads the reader to believe that offal is exclusively inedible in the 
United States and will not be allowed to be imported for human 
consumption. The commenter stated that this is not true and that it is 
well known that liver, tripe, and other organ meats are found on the 
U.S. market. The commenter asked that we clarify that meat by-products 
may include edible parts of a butchered animal, including brains, 
thymus, pancreas, liver, heart, and kidneys. The commenter also asked 
that we define in Sec.  94.0 what products are included in ``meat by-
products'' and amend the definition of offal in Sec.  95.1 to make it 
clear that the parts mentioned, when edible, are not covered by the 
definition.
    FSIS, which has the primary authority for regulating meat and meat 
products intended for human consumption, does not define offal but does 
refer to products such as organ meats as ``meat by-products'' when used 
for human consumption. However, we agree with the commenter that the 
definition of ``offal'' in Sec.  95.1 may be confusing and have revised 
it to read ``the inedible parts of a butchered animal.''
    One commenter noted that the proposed rule says that APHIS concurs 
with OIE's recommendations regarding trade of dicalcium phosphate. The 
commenter stated that Article 11.5.17 of the OIE Code recommends the 
same conditions for dicalcium phosphate originating in regions of 
controlled or undetermined risk, and that APHIS should justify its 
reasons for prohibiting dicalcium phosphate from regions of 
undetermined risk.
    The commenter is correct that the OIE Code recommends no BSE-
related restrictions for dicalcium phosphate that is free of protein or 
fat. However, the OIE Code does recommend that dicalcium phosphate that 
is not free of protein or fat should originate only in negligible risk 
or controlled risk regions, and that, if the material originates in a 
region of controlled risk for BSE,

[[Page 72988]]

additional risk mitigation measures be applied. Furthermore, as we 
explained in the proposed rule, there is evidence that dicalcium 
phosphate produced from bones under normal manufacturing processes can 
contain a small residual proteinaceous fraction, and would therefore 
present a risk of transmission for BSE. For these reasons we proposed 
to limit the importation of dicalcium phosphate that is not free of 
traces of protein or fat from regions of undetermined risk to a case-
by-case basis when the Administrator determines that the dicalcium 
phosphate will not come into contact with ruminants in the United 
States and can be imported under conditions that will prevent the 
introduction of BSE. We have amended the regulatory text in Sec.  95.10 
to make these requirements clearer.
    One commenter stated that the OIE Code does not provide any 
conditions for the importation of tallow from regions of undetermined 
risk other than tallow with a maximum level of insoluble impurities of 
0.15 percent in weight and derivatives made from this tallow, which are 
considered safe commodities. The commenter stated that APHIS' proposed 
prohibition on tallow other than tallow with maximum level of insoluble 
impurities of 0.15 percent in weight from regions of undetermined risk 
would not make sense from a technical point of view. The commenter 
stated that APHIS should either apply the same conditions for the same 
product from regions of controlled risk or justify why it intends to 
prohibit the importation of tallow other than tallow with maximum level 
of insoluble impurities of 0.15 percent in weight from regions of 
undetermined risk.
    While the OIE Code does recommend unrestricted trade in tallow with 
a maximum level of insoluble impurities of 0.15 percent, the Code also 
recommends that tallow with more than 0.15 percent of insoluble 
impurities by weight requires certification that it is sourced from a 
negligible risk country or, if it is sourced from a controlled risk 
country, that it is derived from cattle that have passed ante-mortem 
and post-mortem inspections and does not contain SRMs. We will allow 
all tallow if it is determined that it will not come in contact with 
ruminants, for example, if the tallow is intended for use in 
manufacturing candles and soaps. The importation of tallow intended 
solely for human use must still meet the requirements established by 
other agencies that regulate for public health.
    One commenter noted that we proposed to prohibit the importation of 
processed animal protein from regions of controlled risk for BSE unless 
it can be demonstrated that the product has not been commingled or 
contaminated with ruminant meat and bone meal or greaves. The commenter 
stated that the second and third options presented in Sec.  95.5(a) are 
compatible with an export region of controlled and even undetermined 
risk, but that the certificate required in Sec.  95.5(b) must state 
that the exporting region is of negligible risk. The commenter asked 
APHIS to clarify what risk statuses are allowed for both the exporting 
regions and the regions in which the ruminants from which the processed 
animal protein is derived are born and raised, and what the 
restrictions are in each case. The commenter also stated that the 
certificate should be able to accommodate each available option.
    APHIS agrees with the commenter. Our intention is to allow 
processed animal protein from all regions if it can be demonstrated 
that the products are not contaminated with prohibited material, i.e. 
ruminant meat-and-bone meal and greaves or SRMs. Most of these 
products, if not all, would need an import permit once it has been 
demonstrated to APHIS that these products do not contain prohibited 
material. We have amended Sec.  95.5(a) and (b) to clarify this. We 
have also amended Sec.  95.13 and Sec.  95.14(g) to require that 
nonruminant processed animal proteins imported from any region would 
have to be accompanied by an original certificate and an import permit 
that indicates that the material is of nonruminant origin.
    In addition, we have amended Sec. Sec.  94.19, 94.20, and 95.5 to 
remove the requirement that the commodities be derived from bovines 
that were born and raised in regions of negligible or controlled risk 
for BSE, respectively. The OIE risk assessment evaluation takes into 
consideration the risk of release (importation of cattle and cattle 
products for a particular time period) and the exposure (likelihood 
that potentially contaminated/infected cattle derived product contain 
the BSE agent could be recycled into the system). OIE importation 
standards for countries recognized as either negligible or controlled 
risk for BSE take into consideration that the risk of importing 
particular commodities (including live cattle) has already been 
mitigated and as such contributed to an insignificant risk. For this 
reason, we do not believe the requirement that the products be derived 
from bovines born and raised in regions of negligible or controlled 
risk is necessary. Instead, we will only require that these commodities 
be exported from regions of negligible or controlled risk for BSE, 
respectively, and, in the case of processed animal proteins, that the 
commodity has not been commingled or contaminated with meat and bone 
meal or greaves from a region of controlled or undetermined risk for 
BSE.
    In the proposed rule, we noted that, of the types of animal 
products derived from bovines, processed ruminant protein that either 
contains or has been contaminated by the BSE agent is the means of 
transmission of BSE. Therefore, in conducting an assessment of the BSE 
risk in a country, it is important to know the origin of processed 
animal protein, or feedstuffs containing processed animal protein, that 
have been imported into the country. Processed animal protein 
originating from high-risk countries for BSE presents a higher release 
risk than that originating from low-risk countries. One commenter asked 
for clarification of the term feedstuffs, and asked specifically if it 
applies only to feed intended for livestock or is used in a broader 
sense to apply to pet foods as well.
    Yes, the term feedstuffs could apply to pet foods as well as 
livestock feed. It is possible that pet foods could be used for cattle 
feed, either by accidental misfeeding of pet foods to cattle or by 
misusing salvage pet food for cattle. Farms that raise multiple species 
(e.g. dogs, swine, and cattle) present a particular risk for 
misfeeding. We would consider both the origin of pet food and pet food 
ingredients, and the likelihood of exposure through misfeeding or the 
likelihood of misuse of salvage pet food when evaluating a region for 
BSE risk.

Specified Risk Materials

    Three commenters expressed concern that while the OIE requires 
removal of SRMs from animals older than 30 months of age, the proposed 
rule calls for removal of SRMs from animals 30 months of age or older. 
The commenters stated that while this may not appear to be a 
significant difference, it will still have a major impact on trade. One 
commenter noted that the EU uses the OIE wording and would not be able 
to guarantee compliance with the proposed rule. Another commenter noted 
that the use of ``thirty months of age or older'' is consistent with 
FDA regulations and with the rules of Canada and Mexico, and stated 
that adopting the OIE's language in this rulemaking would be helpful 
only if the FDA, Canada, and Mexico also adopted it. The commenter 
suggested that a possible solution would be for USDA

[[Page 72989]]

and FDA to develop an equivalency agreement with the OIE/EU.
    The commenter is correct that the use of ``thirty months of age or 
older'' is consistent with FSIS and FDA regulations as well as with 
Canadian regulations. We note that anyone wishing to import bovine 
products into the United States would have to meet FSIS or FDA 
requirements as well as APHIS requirements. We do not anticipate that 
this difference will have a significant impact on trade.
    One commenter expressed concern that the definitions of SRMs in the 
proposed rule are not consistent with those in the FDA interim rule 
``Use of Materials Derived from Cattle in Human Food and Cosmetics'' 
(69 FR 42256-42274, Docket No. 2004N-0081) and the FDA proposed rule 
``Use of Materials derived from Cattle in Medical Products Intended for 
Use in Humans and Drugs Intended for Use in Ruminants'' (72 FR 1582-
1619, Docket No. 2005N-0373). The commenter stated that while the 
APHIS' proposed rule would allow for the importation of some bovine 
gelatins, the same bovine gelatins would be prohibited on the U.S. 
market under the FDA rules, or could not further be exported outside 
the United States due to the inconsistency between the regulations.
    As we explained in the proposed rule, APHIS is adopting the 
definition of SRMs already established by FSIS. APHIS and FSIS carry 
out their programs in close coordination with the FDA. The USDA 
coordinates with FDA's Center for Veterinary Medicine regarding animal 
feed and veterinary pharmaceuticals; the Center for Food Safety and 
Applied Nutrition regarding foods other than meat, poultry, and egg 
products; and other Centers regarding drugs, biologics, and devices 
containing bovine material. These agencies collaborate, issuing 
regulations under their respective authorities. Imported products must 
meet all relevant agency requirements. Each agency has the capability 
to deny imports based on their individual authorities and concerns.
    One commenter suggested that in the proposed definitions for 
``region of controlled risk for bovine spongiform encephalopathy 
(BSE)'' and ``region of negligible risk for bovine spongiform 
encephalopathy (BSE)'' in Sec.  92.1, the wording ``the same feed that 
potentially contained SRM material'' be rephrased as ``the same 
potentially contaminated feed.'' The commenter stated that this 
rephrasing would more closely align with international standards the 
provisions for identifying and controlling the movements of bovines 
that, during their first year of life, were reared with a bovine 
determined to be infected with BSE during its first year of life.
    We agree with the commenter and have made those suggested changes 
in this final rule.
    One commenter stated that the requirements in proposed Sec.  94.23 
for the importation of bone-derived gelatin are different from the 
requirements in FDA's interim final rule ``Use of Materials Derived 
From Cattle in Human Food and Cosmetics'' (70 FR 53063-53069 and 73 FR 
20785-20794, Docket No. FDA-2004-N-0188) and also the provisions in 
FDA's proposed rule ``Use of Materials Derived From Cattle in Medical 
Products Intended for Use in Humans and Drugs Intended for Use in 
Ruminants'' (72 FR 1582-1619, Docket No. 2005N-0373). The commenter 
stated that under the provisions of our proposed rule, gelatin imported 
from regions of controlled or undetermined BSE risk would have to be 
manufactured from bovine bones free from skulls of animals of all ages, 
but that FDA's SRM definition allows the use of skulls of animals below 
30 months of age. The commenter was concerned that some gelatin that 
could be imported under APHIS' regulations could not be used within the 
United States under the provisions of FDA's requirements.
    The commenter is correct that under FDA's interim final rule 
pertaining to human food and cosmetics, imported gelatin must not be 
manufactured from skulls and vertebral columns from cattle 30 months of 
age or older, regardless of the OIE BSE risk categorization of the 
exporting country. FDA's regulations that govern the manufacture of 
gelatin and collagen are found at 21 CFR 189.5 and 21 CFR 700.27. FDA's 
regulations in Sec.  189.5(e) do allow a process for designating 
countries as exempt from the restrictions contained in the regulations. 
A country seeking designation must send a written request to the Office 
of the Center Director, Center for Food Safety and Applied Nutrition. 
FDA will respond in writing to any such request and may impose 
conditions in granting any such request.
    The medical products proposed rule that FDA published in 2007 would 
have the same restrictions for gelatin in medical products intended for 
use in humans, and drugs intended for use in ruminants. FDA has not 
finalized the medical products proposed rule.
    One commenter expressed concern that APHIS' list of SRMs differs 
from the OIE list and the EU list. The commenter noted especially the 
inclusion of the trigeminal ganglia in the list of SRMs and asked APHIS 
to explain why the trigeminal ganglia were included.
    As we explained in the proposed rule and in supporting scientific 
documentation, APHIS is adopting the definition of SRMs already 
established by FSIS. FSIS has designated as SRMs the brain, skull, 
eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse process of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia 
of cattle 30 months of age or older, and the tonsils and distal ileum 
of the small intestine of all cattle because these tissues have 
demonstrated BSE infectivity.
    One commenter stated that APHIS' list of SRMs is stricter than 
FSIS' list with respect to regions of undetermined risk in that the SRM 
list applies at 12 months instead of 30. The commenter asked if this 
list would supersede FSIS' for commodities imported from regions of 
undetermined risk.
    The list of SRMs in our proposed rule is consistent with FSIS' 
list; however, the commenter is correct that we proposed that the SRM 
removal requirements apply to cattle 12 months of age and older from 
undetermined risk regions. This requirement is consistent with the OIE 
recommendations for the importation of meat and meat products from 
regions of undetermined risk. If an undetermined risk region wants to 
export beef to the United States then the product must meet the 
requirements of this rule for removal of SRMs.

Blood and Blood Products

    Three commenters raised concerns about the proposed requirements 
for blood and blood products. The commenters stated that neither OIE 
nor EU regulations require that blood be collected in a hygienic 
manner. The commenters also stated that the OIE recommendation that 
blood be collected from cattle which were not subject to a stunning 
process, prior to slaughter, with a device injecting compressed air or 
gas into the cranial cavity, or to a pithing process is meant to 
prevent the contamination of the blood with SRMs. One commenter stated 
that the additional requirement that blood be collected in a hygienic 
manner was therefore unjustified and that APHIS should either remove 
the requirement or provide further justification and details regarding 
what the Administrator would consider a hygienic manner to collect 
blood at slaughter. The other two commenters stated that the inclusion 
of dried plasma and blood products in the definition of ``processed 
animal

[[Page 72990]]

proteins'' was inconsistent with Chapter 11.5 of the OIE Code.
    While we agree with the OIE recommendations, we also recognize that 
there are various methods that can be used for blood collection. It is 
not our intent to dictate which methods can be used, but it must be 
demonstrated that the method used in any given case does not result in 
contamination of the blood with SRMs. We recognize blood being 
collected in a closed system as one such method.
    APHIS included dried plasma and other blood products in the 
definition of ``processed animal proteins'' to allow the agency to 
address the potential of such products to be commingled with materials 
that would be prohibited.
    One commenter stated that APHIS should provide details regarding 
what the Administrator would consider to be a hygienic manner to 
collect blood from live donors.
    The risk with blood collection at slaughter is potential 
contamination of the blood with SRMs through brain emboli or cross-
contamination after slaughter. While these risks are not associated 
with the collection of blood from live donors, we want to ensure that 
there is no cross-contamination in the collection process with blood 
from slaughtered animals that was not collected via a closed system or 
some other hygienic method. In our September 2007 final rule, we 
recognized a closed system as one hygienic method of blood collection 
from live donors.
    One commenter stated that proposed Sec.  95.5 appears internally 
inconsistent with proposed Sec.  95.12 on the subject of blood and 
blood products.
    The commenter is mistaken. Section 95.5 refers to processed animal 
proteins derived from ruminants. Section 95.12 refers to bovine blood 
and products derived from bovine blood. These are different commodities 
and represent a different risk with respect to BSE.
    One commenter asked why, in Sec.  95.15(b), which contains 
provisions for processed animal proteins from nonruminants, it was 
necessary to exempt eligible blood meal, blood plasma, and other blood 
products from the prohibition. The commenter stated that it seemed 
contradictory for processed animal proteins derived from nonruminants 
to possibly contain protein from ruminant blood. The commenter stated 
that either the product is a processed animal protein from nonruminants 
and does not include any ruminant origin protein, or it should be 
designated as a mixed processed animal protein from nonruminants and 
ruminants.
    We note that these provisions actually appear in Sec.  95.14(c), 
not Sec.  95.15(b), and disagree that they are contradictory. APHIS 
wants to ensure that nonruminant processed animal protein mixed with 
products derived from ruminant blood meets the requirements we have for 
blood and blood products derived from bovines.

Date of Effective Enforcement of Feed Ban in Mexico

    In the proposed rule, we announced that we had conducted an 
evaluation to determine the date of effective enforcement of a feed ban 
in Mexico, and that based on that evaluation, we consider the date of 
effective enforcement of a feed ban in Mexico to be November 30, 2007. 
We received no comments on either the evaluation or on the date of 
effective enforcement on the feed ban in Mexico. Therefore, we are 
recognizing November 30, 2007, as the date of effective enforcement of 
the feed ban in Mexico in this document.

Miscellaneous Changes

    One commenter noted that proposed Sec.  95.4(c)(7) refers to ``the 
conditions of paragraphs (d)(1) through (d)(5) of this section.'' The 
commenter asked if the reference should be to paragraphs (c)(1) through 
(c)(5) of the section instead.
    The commenter is correct. We have corrected the reference in this 
final rule.
    We proposed in Sec.  92.7 to incorporate by reference Article 
11.6.22 of the OIE Code, effective 2009. This article of the OIE Code 
sets out guidelines for surveillance activities related to BSE. We are 
updating this to incorporate by reference Article 11.5.22 of the OIE 
Code, effective 2013. In 2013, the OIE updated these guidelines to 
adjust the surveillance points required for risk status recognition of 
countries with small populations of cattle. The OIE made these changes 
at the request of the BSE ad hoc group, supported by the scientific 
commission and endorsed by the OIE member states.
    We proposed in Sec.  94.27(a) to require that, meat, meat products, 
and other edible products derived from bovines, ovines, or caprines 
that are otherwise prohibited importation into the United States may 
transit ports in the United States for immediate export, or transit the 
United States by overland transport if certain conditions were met. We 
have decided to remove the requirement that the person moving these 
articles must obtain a United States Veterinary Permit for Importation 
and Transportation of Controlled Materials and Organisms and Vectors. 
We have also amended the transit shipment requirements in Sec.  95.15 
to remove the permit requirement for prohibited articles transiting air 
and ocean ports in the United States for immediate export. We are 
making these changes in order to be consistent with the existing 
requirements for meat and other products of ruminants and swine in 
Sec.  94.15(d).

Issues Outside the Scope of the Rulemaking/Outside APHIS Authority

    One commenter stated that the Geographical BSE Risk rating (GBR) 
for the United States should be raised because there are many different 
prion strains present in North America and those strains are spreading 
and mutating.
    The GBR is a qualitative indicator of the likelihood of the 
presence of one or more cattle within the native population of a 
country being infected with BSE, pre-clinically as well as clinically, 
at a given point in time. Where its presence is confirmed, the GBR 
gives an indication of the level of infection. The GBR methodology was 
developed, and is used, by the European Commission as the basis for 
trade legislation rules for cattle and their products. APHIS is not 
involved with this process.
    One commenter stated that under APHIS' proposed rule, no bovine 
tissues from a negligible risk region are considered to be SRMs. The 
commenter asked why a negligible risk region willing to export products 
other than skeletal meat should have to demonstrate to FSIS that its 
BSE risk status can be reasonably expected to provide the same level of 
protection from human exposure to the BSE agent as prohibiting SRMs for 
use as human food does in the United States. The commenter stated that 
this provision should be removed or amended to bring the regulations in 
line with international standards, and that APHIS should coordinate 
with FSIS toward that end. The commenter also asked what information 
should be provided to FSIS, and what would be the decision procedure, 
should the provision remain unchanged. The commenter asked if this 
demonstration would be required even if the exported cuts do not 
include any of the tissues considered as SRMs in regions of controlled 
or undetermined risk.
    The FSIS regulations in 9 CFR 327.2 provide that, to be eligible to 
export meat and meat products to the United States for human 
consumption, a foreign country must be able to certify that it meets 
FSIS requirements. Therefore, prior to exporting meat and meat products 
to the United States, countries are required to be approved by FSIS as 
having an inspection system equivalent to that in the United States. 
FSIS

[[Page 72991]]

maintains a list of countries eligible to export meat to the United 
States on its Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/eligible-foreign-establishments. In the 
affirmation of its SRM interim rule, published in the Federal Register 
on July 13, 2007 (72 FR 38700-38730, Docket No. 03-025F), FSIS stated 
that it will also consider whether APHIS or FDA imposes any BSE-related 
restrictions on imports from the country and, if so, the basis for 
those restrictions when developing equivalence criteria.
    One commenter stated that APHIS should adopt the same standards 
required by the EU and Japan, including mandatory testing for all 
cattle brought to slaughter and banning the feeding of blood, manure, 
and slaughterhouse waste to animals.
    As we explained above, BSE surveillance programs in the United 
States focus on obtaining quality samples from targeted subpopulations 
rather than looking at the entire adult cattle population. Cattle 
typically only test positive for BSE when they are in the last few 
months of what can be a very long incubation period. Testing all 
animals at slaughter would not improve our understanding of disease 
trend because not all the exposed cattle will be infected, nor would 
all infected cattle test positive. We continue to believe that FDA's 
BSE feed regulations are science based and appropriate for the BSE risk 
in the United States.
    One commenter stated that the United States is covering up the 
scope of BSE and variant Creutzfeldt-Jakob disease (vCJD) in the United 
States by not requiring medical professionals to report vCJD cases and 
not allowing individual producers to test for BSE.
    Requiring medical professionals to report vCJD cases is outside of 
APHIS' statutory authority. With respect to individual producers 
testing for BSE, we note that for a diagnostic test to be considered 
valid anywhere in the world, it must be done by the competent 
veterinary authority of the national government of the region where the 
animals are kept. Furthermore, as we explained above, increased testing 
would not provide better understanding of disease trend, nor would it 
provide better protection against the spread of the disease.
    Three commenters stated that APHIS should also harmonize its other 
import regulations, especially those for foot-and-mouth disease (FMD), 
with OIE standards.
    Amending our other import regulations for consistency with OIE 
standards is outside the scope of this rulemaking.
    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. Additionally, we are adopting as 
final our preliminary BSE risk classifications of countries that were 
announced in the proposed rule, and we are recognizing November 30, 
2007, as the date of effective enforcement of a feed ban in Mexico.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This final rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides a final regulatory flexibility analysis that examines the 
potential economic effects of this rule on small entities, as required 
by the Regulatory Flexibility Act. The economic analysis is summarized 
below. Copies of the full analysis are available on the Regulations.gov 
Web site (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    This rule will make our bovine and bovine product import 
restrictions related to BSE more reflective of current scientific 
thinking while continuing to guard against the introduction of BSE. The 
process for classifying regions with respect to BSE risk will be based 
on the comprehensive review of relevant, internationally accepted 
scientific literature and will be consistent with the process employed 
by the OIE. The rule will also remove BSE-related restrictions on the 
importation of live cervids and camelids and their products.
    While benefits of the rule are expected to justify its costs, 
effects on U.S. imports are expected to be minimal. Potential impacts 
of the rule on U.S. export markets, by influencing trading partners' 
import policies, are not considered in this analysis.

Live Bovines (Cattle and Bison)

    Essentially all U.S. imports of cattle and bison are from Canada 
and Mexico. Over the 10 years 2002-2011, the only live bovine imports 
that did not come from Canada or Mexico were 33 animals from Australia, 
12 from New Zealand, and 1 from Guatemala. APHIS is classifying Canada 
and Mexico as countries of controlled risk for BSE (their 
classification by the OIE).
    Imports from Canada will be unaffected by this rule because the 
requirements will cause no change in the number or type of animals that 
are eligible for importation, based on Canada's status as a BSE 
minimal-risk region under APHIS' existing regulations. Imports from 
Mexico also will be essentially unaffected, since nearly all cattle 
imported from Mexico (98 to 99 percent) are estimated to be less than 
24 months of age; with this rule APHIS is establishing November 30, 
2007, as the date of effective enforcement of a ruminant-to-ruminant 
feed ban in Mexico (the earliest date that bovines imported from Mexico 
could be born).

Products Derived From Bovines

    Six countries, Argentina, Australia, Brazil, Canada, New Zealand, 
and Uruguay, accounted for 91 percent of all U.S. bovine product import 
volume (and 90 percent of the import value) over the 5-year period 
2007-2011. Imports from each of the six countries should continue 
essentially unchanged and without interruption under the rule, because 
the protocols in place in these countries are already in full 
compliance with the rule's criteria. Argentina, Australia, New Zealand, 
and Uruguay will be classified by APHIS as negligible risk regions for 
BSE; they have never reported a case of BSE. Canada and Brazil, which 
will be classified by APHIS as controlled risk regions for BSE, already 
satisfy FSIS inspection requirements and prohibitions on certain animal 
stunning or pithing and mechanically separated meat.
    Imports allowed by the rule from the 36 (primarily European) 
countries listed in 9 CFR 94.18 as prohibited from shipping bovine 
products to the United States likely will be insignificant. In none of 
the years from 1990 through 1996, that is, prior to the prohibition on 
ruminant product imports from all of Europe in 1997, did the volume of 
U.S. bovine product imports from the 36

[[Page 72992]]

countries account for more than 0.6 percent of imports of these 
products.
    Nor does recent EU trade in bovine products suggest a significant 
volume of imports from the 36 countries in the future, at least in the 
near term. While the nominal value of bovine product exports by the 
European Union (EU-27) increased more than four-fold in 5 years, from 
$0.36 billion in 2007 to nearly $1.57 billion in 2011, the value of 
bovine product imports by EU-27 Member States in 2011 ($2.42 billion) 
exceeded the value of their bovine product exports by more than $850 
million. The EU-27 continues to be a large net importer of bovine 
products overall. Emerging markets, such as Russia, are likely to take 
a growing share of Europe's bovine product exports.
    Bovine product imports from other countries that are not currently 
subject to BSE-related restrictions are not expected to be 
significantly affected. Over the 5 years 2007-2011, annual imports from 
such countries as a group averaged 8 to 9 percent of all U.S. bovine 
product imports by volume (10 to 11 percent by value), with over 95 
percent of these products coming from Mexico, Nicaragua, and Costa 
Rica. Imports from Mexico already meet the requirements of a region of 
controlled risk for BSE largely by way of FSIS requirements. The 
potential impact on imports from Nicaragua and Costa Rica, which APHIS 
is classifying as regions of undetermined risk for BSE, should be 
minimal at most. Almost all imports from those two countries are of 
boneless beef that already satisfy the rule's requirements, again, 
largely by way of FSIS requirements.

Live Cervids and Camelids and Their Products

    Removal of the prohibition on the importation of live cervids and 
camelids and their products from the 36 countries listed in 9 CFR 94.18 
will likely have little or no economic impact on the United States. The 
United States has not imported any live cervids or camelids from these 
countries since at least 1990. In none of the years from 1990 through 
1996, before the prohibition of ruminant meat, meat products, and other 
edible products from all of Europe in 1997, did the volume of U.S. 
imports of meat and edible offal of deer from the 36 countries account 
for more than 3.3 percent of total imports. Over the 5 years 2007-2011, 
more than 99 percent of U.S. imports of meat and edible offal of deer 
have come from New Zealand, and that country's dominance of this market 
is unlikely to change as a result of this rule. The volume of U.S. 
imports of camelid products is very small. Their annual value averaged 
less than $50,000 over the 5-year period 2006-2010 (most recent data 
available), and 90 percent of those imports were supplied by Canada and 
China.

Benefits, Costs, and Alternatives

    Consumers benefit from imports to the extent that consumer choice 
is broadened and the increased supply of the imported commodity leads 
to a price decline. We anticipate that the rule will have little impact 
on consumer choice or import volumes, and therefore little or no impact 
on U.S. businesses as well.
    Although the impact of this rule on U.S. consumers and producers is 
expected to be minimal, the benefits of the rule are expected to 
justify its costs. Leaving the bovine regulations unchanged would be 
unsatisfactory because it would perpetuate the current situation in 
which our BSE-related import conditions are not consistent with current 
scientific evidence. Additionally, by maintaining the status quo APHIS 
would forgo the opportunity to establish a process for classifying a 
region's BSE risk status in a more timely fashion than is possible 
under current regulations.
    Another alternative, amending the BSE regulations related to the 
importation of bovines and bovine-derived products to match precisely 
the OIE Code would also be unsatisfactory because it would not allow 
APHIS to independently interpret the scientific literature and findings 
that underlie OIE risk categorization recommendations. Making no 
changes to the regulations that govern the importation of cervids and 
camelids would also be unsatisfactory because it would perpetuate an 
unnecessary constraint on trade in those commodities.

Effects on Small Entities

    Small entities prevail among the industries that may be affected by 
this rule, including cow-calf producers, cervid and camelid producers, 
feedlot establishments, slaughtering establishments, meat packing and 
processing establishments, meat wholesalers, importers and exporters, 
grocery stores and meat markets, and manufacturers of cosmetics and 
pharmaceuticals. However, as has been described, any changes because of 
this rule in U.S. imports of live bovines, cervids, camelids, or their 
products are expected to be minor. U.S. small entities are unlikely to 
be significantly affected. This rule contains no mandatory reporting, 
recordkeeping, or other compliance requirements for U.S. entities.

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.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this final rule. The environmental assessment 
provides a basis for the conclusion that the importation of live 
bovines and bovine products under the conditions specified in this rule 
will not have a significant impact on the quality of the human 
environment. Based on the finding of no significant impact, the 
Administrator of the Animal and Plant Health Inspection Service has 
determined that an environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were prepared in accordance with: (1) The National Environmental Policy 
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    The environmental assessment and finding of no significant impact 
may be viewed on the Regulations.gov Web site.\6\ Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, room 1141, South Building, 
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. 
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing 
to inspect copies are requested to call ahead on (202) 799-7039 to 
facilitate entry into the reading room. In addition, copies may be 
obtained by writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.
---------------------------------------------------------------------------

    \6\ Go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2008-0010. The environmental assessment and finding of no 
significant impact will appear in the resulting list of documents.
---------------------------------------------------------------------------

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping

[[Page 72993]]

requirements included in this final rule, which were filed under 0579-
0393, have been submitted for approval to the Office of Management and 
Budget (OMB). When OMB notifies us of its decision, if approval is 
denied, we will publish a document in the Federal Register providing 
notice of what action we plan to take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects

9 CFR Part 92

    Animal diseases, Imports, Incorporation by reference, Livestock, 
Poultry and poultry products, Region, Reporting and recordkeeping 
requirements.

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.

9 CFR Part 96

    Imports, Livestock, Reporting and recordkeeping requirements.

9 CFR Part 98

    Animal diseases, Imports.

    Accordingly, we are amending 9 CFR parts 92, 93, 94, 95, 96, and 98 
as follows:

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS

0
1. The authority citation for part 92 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. In Sec.  92.1, definitions of approved laboratory, bovine, exporting 
region, OIE, OIE Code, OIE Terrestrial Manual, processed animal 
protein, region of controlled risk for BSE, region of negligible risk 
for BSE, region of undetermined risk for BSE, specified risk materials 
(SRMs) from regions of controlled risk for BSE, and specified risk 
materials (SRMs) from regions of undetermined risk for BSE are added in 
alphabetical order to read as follows:


Sec.  92.1  Definitions.

* * * * *
    Approved laboratory. A properly equipped institution in the 
exporting region, approved by the official authority who is responsible 
for animal health matters in that region, that is staffed by 
technically competent personnel under the control of a specialist in 
veterinary diagnostic methods who is responsible for the results.
    Bovine. Bos taurus, Bos indicus, and Bison bison.
* * * * *
    Exporting region. A region from which shipments are sent to the 
United States.
* * * * *
    OIE. The World Organization for Animal Health.
    OIE Code. The Terrestrial Animal Health Code of the World 
Organization for Animal Health.
    OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines 
for Terrestrial Animals of the World Organization for Animal Health.
* * * * *
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
* * * * *
    Region of controlled risk for bovine spongiform encephalopathy 
(BSE).\1\ A region for which a risk assessment has been conducted 
sufficient to identify the historical and existing BSE risk factors in 
the region and that:
---------------------------------------------------------------------------

    \1\ A list of regions classified by APHIS as regions of 
controlled risk for BSEs is available at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
---------------------------------------------------------------------------

    (1) Has demonstrated that appropriate mitigations are being taken 
to manage all identified risks, but may not have been taken for the 
periods of time necessary to be classified as a region of negligible 
risk for BSE.
    (2) Is a region in which it can be demonstrated through an 
appropriate control and audit that neither meat-and-bone meal nor 
greaves derived from ruminants has been fed to ruminants.
    (3) Has demonstrated that Type A surveillance in accordance with 
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.  
92.7, or with equivalent guidelines recognized by the Administrator is 
in place and the relevant points target, in accordance with Table 1 of 
Article 11.5.22 of the OIE Code, or with equivalent guidelines 
recognized by the Administrator has been met. Type B surveillance in 
accordance with Article 11.5.22 of the OIE Code, or with equivalent 
guidelines recognized by the Administrator, is sufficient in place of 
Type A surveillance or its equivalent once the relevant points target 
for Type A surveillance or its equivalent has been met.
    (4) Meets one of the following conditions:
    (i) Has had no case of BSE in the region or every case has been 
demonstrated to have been imported and has been completely destroyed; 
or
    (ii) Has had at least one indigenous case, and all bovines 
described in either paragraph (4)(ii)(A) or (4)(ii)(B) of this 
definition, if still alive, are officially identified with unique 
individual identification that is traceable to the premises of origin 
of the animal, have their movements controlled, and, when slaughtered 
or at death, are completely destroyed:
    (A) All bovines that, during their first year of life, were reared 
with a bovine determined to be infected with BSE during its first year 
of life, and that investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period; or
    (B) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd as a BSE-infected bovine either within 12 
months before or 12 months after the birth of the infected animal.
    (5) Meets the conditions in one of or both paragraphs (5)(i) or 
(5)(ii) of this definition:
    (i) Has met the following conditions, but not for at least the past 
7 years:
    (A) Conducted an ongoing awareness program for veterinarians, 
farmers, and workers involved in transportation, marketing, and 
slaughter of bovines to encourage reporting of bovines showing

[[Page 72994]]

clinical signs that could be indicative of BSE;
    (B) Required notification and investigation of all bovines showing 
clinical signs consistent with BSE; and
    (C) Has carried out the examination, in accordance with 
internationally accepted diagnostic tests and procedures and in 
approved laboratories, of brain or other tissues collected as part of 
the surveillance and monitoring described in paragraphs (3) and 
(5)(i)(A) and (5)(i)(B) of this definition; or
    (ii) Has prohibited the feeding to ruminants in the region of meat-
and-bone meal and greaves derived from ruminants, but it cannot be 
demonstrated through an appropriate level of control and audit that the 
prohibited materials have not been fed to ruminants in the region for 
at least the past 8 years.
    Region of negligible risk for bovine spongiform encephalopathy 
(BSE).\2\ A region for which a risk assessment has been conducted 
sufficient to identify the historical and existing BSE risk factors in 
the region and that:
---------------------------------------------------------------------------

    \2\ A list of regions classified by APHIS as regions of 
negligible risk for BSEs is available at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
---------------------------------------------------------------------------

    (1) Has demonstrated that appropriate mitigations to manage all 
identified risks have been taken for each relevant period of time to 
meet each identified risk, as set forth in this definition.
    (2) Has demonstrated that Type B surveillance in accordance with 
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.  
92.7, or with equivalent guidelines recognized by the Administrator is 
in place and the relevant points target, in accordance with Table 1 of 
Article 11.5.22 of the OIE Code, or with equivalent guidelines 
recognized by the Administrator has been met.
    (3) Meets one of the following conditions:
    (i) Has had no case of BSE in the region or every case has been 
demonstrated to have been imported and has been completely destroyed; 
or
    (ii) Has had at least one indigenous case, but every indigenous 
case was born more than 11 years ago, and all bovines described in 
either paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still 
alive, are officially identified with unique individual identification 
that is traceable to the premises of origin of the animal, have their 
movements controlled, and, when slaughtered or at death, are completely 
destroyed:
    (A) All bovines that, during their first year of life, were reared 
with a bovine determined to be infected with BSE during its first year 
of life, and that investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period; or
    (B) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd as a BSE-infected bovine either within 12 
months before or 12 months after the birth of the infected animal.
    (4) Has, for at least the past 7 years:
    (i) Conducted an ongoing awareness program for veterinarians, 
farmers, and workers involved in transportation, marketing, and 
slaughter of bovines to encourage reporting of bovines showing clinical 
signs that could be indicative of BSE;
    (ii) Required notification and investigation of all bovines showing 
clinical signs consistent with BSE; and
    (iii) Carried out the examination, in accordance with 
internationally accepted diagnostic tests and procedures and in 
approved laboratories, of brain or other tissues collected as part of 
the required surveillance and monitoring described in paragraphs (2) 
and (4)(i) and (4)(ii) of this definition.
    (5) Has demonstrated through an appropriate level of control and 
audit that, for at least the past 8 years, neither meat-and-bone meal 
nor greaves derived from ruminants have been fed to ruminants in the 
region.
    Region of undetermined risk for bovine spongiform encephalopathy 
(BSE). Any region that is not classified as either a region of 
negligible risk for BSE or a region of controlled risk for BSE.
* * * * *
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
* * * * *

0
3. Subpart A, consisting of existing Sec. Sec.  92.2 through 92.4, is 
added under the following heading:

Subpart A--Procedures for Requesting Recognition of Regions Other 
Than for BSE

0
4. Subpart B, consisting of Sec. Sec.  92.5, 92.6, and 92.7, is added 
to read as follows:
Subpart B--Procedures for Requesting BSE Risk Status Classification 
With Regard to Bovines
Sec.
92.5 Determination of the BSE risk classification of a region.
92.6 Determination of the date of effective enforcement of a 
ruminant-to-ruminant feed ban.
92.7 Incorporation by reference.

Subpart B--Procedures for Requesting BSE Risk Status Classification 
With Regard to Bovines


Sec.  92.5  Determination of the BSE risk classification of a region.

    All countries of the world are considered by APHIS to be in one of 
three BSE risk categories--negligible risk, controlled risk, or 
undetermined risk. These risk categories are defined in Sec.  92.1. Any 
region that is not classified by APHIS as presenting either negligible 
risk or controlled risk for BSE is considered to present an 
undetermined risk. The listing of those regions classified by APHIS as 
having either negligible risk or controlled risk can be accessed on the 
APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. The listing can also be obtained by 
writing to APHIS at National Import Export Services, 4700 River Road 
Unit 38, Riverdale, MD 20737. APHIS may classify a region for BSE 
according to either paragraph (a) or paragraph (b) of this section.
    (a) BSE risk classification based on OIE classification. If the OIE 
has classified a country as either BSE negligible risk or BSE 
controlled risk, APHIS will seek information to support concurrence 
with the OIE classification. This information could be publicly 
available information, or APHIS could request that countries supply the 
same information given to the OIE. APHIS will announce in the Federal 
Register, subject to public comment, each intent to concur with an OIE 
classification. APHIS will also post the summary of the BSE OIE ad hoc 
group conclusions for review during the comment period.

[[Page 72995]]

The summaries would be available for review on the APHIS Web site at  
http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. 
Following review of any comments received, the Administrator will 
announce his or her final determination regarding classification of the 
country in the Federal Register, along with a discussion of and 
response to pertinent issues raised by commenters. If APHIS recognizes 
a country as either negligible risk or controlled risk for BSE, the 
Agency will include that country in a list of regions of negligible 
risk or controlled risk for BSE, as applicable, that APHIS will make 
available to the public on the Agency's Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
    (b) Regions seeking classification as negligible or controlled risk 
that have not been classified by the OIE. A region that has not 
received classification by OIE as either negligible risk or controlled 
risk for BSE and that wishes to be classified by APHIS as negligible 
risk or controlled risk must submit to the Administrator a request for 
classification, along with documentation sufficient to allow APHIS to 
conduct an evaluation of whether the region meets the criteria for 
classification. A list of the documentation required can be accessed on 
the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. If, following evaluation of the information 
submitted, the Administrator determines that the region meets the 
criteria for classification as negligible risk or controlled risk, 
APHIS will announce that determination in the Federal Register and will 
make available to the public on the APHIS Web site the evaluation 
conducted by APHIS, as well as the information provided by the 
requesting region. APHIS will accept public comment on its intent. 
Following review of any comments received, the Administrator will 
announce his or her final determination regarding classification of the 
region in the Federal Register, along with a discussion of and response 
to pertinent issues raised by commenters.
    (c) Retention of classification as either negligible risk or 
controlled risk. (1) As required by the OIE for countries classified as 
either negligible risk or controlled risk by the OIE, regions evaluated 
by APHIS and classified as negligible or controlled risk would need to 
submit updated information to APHIS each year. The required information 
includes documentation of the following:
    (i) Relevant changes in BSE legislation, compared to the previous 
year;
    (ii) The importation into the region during the year of cattle, 
processed animal protein, and products containing processed animal 
protein;
    (iii) Audit findings in rendering plants and feed mills that 
process ruminant material or material from mixed species that contains 
ruminant material, related to the prohibition of the feeding to 
ruminants of processed animal protein;
    (iv) Audit findings in rendering plants and feed mills that process 
nonruminant material, related to the prohibition of the feeding to 
ruminants of processed animal protein;
    (v) Infractions at the types of facilities listed above;
    (vi) If and why, in light of the audit findings, there has been no 
significant exposure of cattle to the BSE agent through consumption of 
processed animal protein of bovine origin;
    (vii) Surveillance efforts;
    (viii) All clinical BSE suspects; and
    (ix) Any new cases of BSE.
    (2) If APHIS at any time determines that a region no longer meets 
the criteria for the risk classification it had previously received, 
APHIS will remove the region from its list of regions so classified. If 
the OIE determines the region no longer meets the criteria for the risk 
classification it had previously received, APHIS may concur with the 
OIE determination or may request updated information from the region 
and determine whether to concur with the OIE decision APHIS will 
announce its intent in the Federal Register and accept public comment 
regarding that intent. Following review of any comments received, the 
Administrator will announce in the Federal Register his or her final 
determination regarding classification of the region, along with a 
discussion of and response to pertinent issues raised by commenters.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  92.6  Determination of the date of effective enforcement of a 
ruminant-to-ruminant feed ban.

    (a) In order for APHIS to determine the eligibility of live bovines 
for importation from a region classified as BSE negligible risk or BSE 
controlled risk, APHIS must determine the date from which a ban on the 
feeding of ruminant material to ruminants has been effectively enforced 
in the region. APHIS will base its determination of the date of 
effective enforcement on the information included in the dossier the 
region submitted when it requested to be classified regarding BSE risk. 
The information APHIS will consider will include, but not be limited 
to:
    (1) Policies and infrastructure for feed ban enforcement, including 
an awareness program for producers and farmers;
    (2) Livestock husbandry practices;
    (3) Disposition of processed animal protein produced from domestic 
bovines, including the feeding of such material to any animal species;
    (4) Measures taken to control cross-contamination and mislabeling 
of feed; and
    (5) Monitoring and enforcement of the ruminant-to-ruminant feed 
ban, including audit findings in rendering plants and feed mills that 
process ruminant material.
    (b) After conducting its evaluation, APHIS will announce in the 
Federal Register for public comment the date APHIS considers to be the 
date of effective enforcement of a ruminant-to-ruminant feed ban in the 
requesting region, and will make available to the public the evaluation 
conducted by APHIS, as well as the supporting documentation. Following 
review of any comments received, the Administrator will announce his or 
her final determination in the Federal Register, along with a 
discussion of and response to pertinent issues raised by commenters.


Sec.  92.7  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, USDA must publish notice of change in the 
Federal Register and the material must be available to the public. All 
approved material is available for inspection at the Animal and Plant 
Health Inspection Service (APHIS), and is available from the sources 
listed below. For information about the availability of this material 
at APHIS, call 301-851-3300 or write to National Import Export 
Services, 4700 River Road Unit 38, Riverdale, MD 20737. It is also 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202[hyphen]741[hyphen]6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) World Organization for Animal Health (OIE), 12, rue de Prony 
75017 Paris, France, or email oie@oie.int, http://www.oie.int/eng/normes/Mcode/en_sommaire.htm.

[[Page 72996]]

    (1) Terrestrial Animal Health Code, Chapter 11.5-Bovine Spongiform 
Encephalopathy, Article 11.5.22 (Surveillance activities), 22nd 
Edition, 2013.
    (2) [Reserved]

(Approved by the Office of Management and Budget under control 
number 0579-0393)

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
5. 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
6. Section 93.400 is amended by adding definitions of exporting region 
and processed animal protein in alphabetical order and revising the 
definition of recognized slaughtering establishment to read as follows:


Sec.  93.400  Definitions.

* * * * *
    Exporting region. A region from which shipments are sent to the 
United States.
* * * * *
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
* * * * *
    Recognized slaughtering establishment. Any slaughtering 
establishment operating under the provisions of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection 
act.\2\
* * * * *

    \2\ See footnote 1.

Sec.  93.401  [Amended]

0
7. In Sec.  93.401, paragraph (a), the second sentence is amended by 
adding the word ``non-bovine'' before the word ``ruminant'' and by 
removing the citation ``Sec.  94.18(a)(1) or (a)(2)'' and adding the 
citation ``Sec.  94.24(a)'' in its place.


Sec.  93.405  [Amended]

0
8. Section 93.405 is amended as follows:
0
a. In paragraph (a)(4), by removing the words ``bovines, sheep, or 
goats from regions listed as BSE minimal-risk regions in Sec.  
94.18(a)(3) of this subchapter'' and adding the words ``sheep or goats 
from Canada'' in their place and by removing the words ``and 
93.436(a)(3) and (b)(4)''; and
0
b. In the OMB citation at the end of the section, by removing the words 
``numbers 0579-0040, 0579-0165, and 0579-0234'' and adding the words 
``numbers 0579-0040, 0579-0165, 0579-0234, and 0579-0393'' in their 
place.

0
9. Section 93.418 is amended as follows:
0
a. By revising the section heading;
0
b. By adding paragraph (d); and
0
c. By adding an OMB citation to the end of the section.
    The revision and additions read as follows:


Sec.  93.418  Cattle and other bovines from Canada.

* * * * *
    (d) In addition to meeting the requirements of paragraphs (a) 
through (c) of this section, bovines may be imported from Canada only 
under the following conditions:
    (1) The bovines are imported for immediate slaughter under Sec.  
93.420; or
    (2) The bovines are imported for other than immediate slaughter 
under the following conditions:
    (i) The bovines were born after March 1, 1999, the date determined 
by APHIS to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in Canada;
    (ii) The bovines are imported only through a port of entry listed 
in Sec.  93.403(b) or as provided for in Sec.  93.403(f);
    (iii) The bovines were officially identified prior to arriving at 
the port of entry in the United States with unique individual 
identification that is traceable to each bovine's premises of origin. 
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
    (iv) The bovines are permanently and humanely identified using one 
of the following additional methods:
    (A) A ``C[squ]N'' mark properly applied with a freeze brand, hot 
iron, or other method, and easily visible on the live animal and on the 
carcass before skinning. Such a mark must be not less than 2 inches nor 
more than 3 inches high, and must be applied to each animal's right 
hip, high on the tail-head (over the junction of the sacral and first 
coccygeal vertebrae); or
    (B) A tattoo with the letters ``CN'' applied to the inside of one 
ear of the animal; or
    (C) Other means of permanent identification upon request if deemed 
adequate by the Administrator to humanely identify the animal in a 
distinct and legible way as having been imported from Canada.
    (3) The bovines are accompanied by a certificate issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of paragraph (d)(2) of 
this section, as applicable, have been met.

(Approved by the Office of Management and Budget under control 
number 0579-0393)



0
10. Section Sec.  93.420 is revised to read as follows:


Sec.  93.420  Ruminants from Canada for immediate slaughter other than 
sheep and goats.

    (a) General requirements. The requirements for the importation of 
sheep and goats from Canada for immediate slaughter are contained in 
Sec.  93.419. There are no BSE-related restrictions on the importation 
of cervids or camelids from Canada. All other ruminants imported from 
Canada for immediate slaughter, in addition to meeting all other 
applicable requirements of this part, may be imported only under the 
following conditions:
    (1) The ruminants must be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) and be 
inspected at the port of entry and otherwise handled in accordance with 
Sec.  93.408.
    (2) The ruminants must be moved directly from the port of entry to 
a recognized slaughtering establishment in conveyances that are sealed 
with seals of the U.S. Government at the port of entry. The seals may 
be broken only at the recognized slaughtering establishment by an 
authorized USDA representative.
    (3) The ruminants must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33, which 
must include the location of the recognized slaughtering establishment.
    (b) Bovines. In addition to meeting the requirements of paragraph 
(a) of this section, bovines may be imported from Canada for immediate 
slaughter only under the following conditions:
    (1) The bovines must have been born after March 1, 1999, the date 
determined by APHIS to be the date of effective enforcement of a 
ruminant-to-ruminant feed ban in Canada;

[[Page 72997]]

    (2) Before the animal's arrival at the port of entry into the 
United States, each bovine imported into the United States from Canada 
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; and
    (3) The bovines must be accompanied by a certificate issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of paragraphs (b)(1) and 
(b)(2) of this section have been met.

(Approved by the Office of Management and Budget under control 
numbers 0579-0234 and 0579-0393)


0
11. In Sec.  93.423, paragraph (e) is added to read as follows:


Sec.  93.423  Ruminants from Central America and the West Indies.

* * * * *
    (e) In addition to meeting all other applicable requirements of 
this part, bovines from Central America and the West Indies may be 
imported only in accordance with Sec.  93.436.
* * * * *

0
12. Section 93.427 is amended as follows:
0
a. By revising the section heading;
0
b. By adding paragraph (e); and
0
c. By adding an OMB citation at the end of the section.
    The revision and additions read as follows:


Sec.  93.427  Cattle and other bovines from Mexico.

* * * * *
    (e) BSE. In addition to meeting the requirements of paragraphs (a) 
through (d) of this section and all other applicable requirements of 
this part, bovines may be imported from Mexico only under the following 
conditions:
    (1) The bovines were born after November 30, 2007, the date 
determined by APHIS to be the date of effective enforcement of a 
ruminant-to-ruminant feed ban in Mexico.
    (2) The bovines were officially identified prior to arriving at the 
port of entry in the United States with unique individual 
identification that is traceable to each bovine's premises of origin. 
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.
    (3) The bovines, if sexually intact, are permanently and humanely 
identified using one of the following additional methods:
    (i) An ``MX'' mark properly applied with a freeze brand, hot iron, 
or other method, and easily visible on the live animal and on the 
carcass before skinning. Such a mark must be not less than 2 inches nor 
more than 3 inches high, and must be applied to each animal's right 
hip, high on the tail-head (over the junction of the sacral and first 
coccygeal vertebrae); or
    (ii) A tattoo with the letters ``MX'' applied to the inside of one 
ear of the animal; or
    (iii) Other means of permanent identification upon request if 
deemed adequate by the Administrator to humanely identify the animal in 
a distinct and legible way as having been imported from Mexico.
    (4) The bovines are accompanied by a certificate issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of paragraphs (e)(1) 
through (e)(3) of this section have been met.

(Approved by the Office of Management and Budget under control 
number 0579-0393)


0
13. In Sec.  93.432, the section heading is revised and paragraph (e) 
is added to read as follows:


Sec.  93.432  Cattle and other bovines from the Republic of Ireland.

* * * * *
    (e) In addition to meeting all other applicable requirements of 
this part, bovines from the Republic of Ireland may be imported only in 
accordance with Sec.  93.436.

0
14. Section Sec.  93.436 is revised to read as follows:


Sec.  93.436  Bovines from regions of negligible risk, controlled risk, 
and undetermined risk for BSE.

    The importation of bovines is prohibited, unless the conditions of 
this section and any other applicable conditions of this part are met. 
Once the bovines are imported, if they do not meet the conditions of 
this section, they must be disposed of as the Administrator may direct.
    (a) Bovines from a region of negligible risk for BSE in which there 
has been no indigenous case of BSE. Bovines from a region of negligible 
risk for BSE, as defined in Sec.  92.1 of this subchapter, in which 
there has been no indigenous case of BSE, may be imported only if the 
bovines are accompanied by an original certificate issued by a full-
time salaried veterinary officer of the national government of the 
exporting region, or issued by a veterinarian designated or accredited 
by the national government of the exporting region and endorsed by a 
full-time salaried veterinary officer of the national government of the 
exporting region, representing that the veterinarian issuing the 
certificate was authorized to do so, and the certificate attests that 
the exporting region of the bovines is classified by APHIS as a 
negligible-risk region for BSE in which there has been no indigenous 
case of BSE.
    (b) Bovines from a region of negligible risk for BSE in which there 
has been an indigenous case of BSE and bovines from a region of 
controlled risk for BSE. Bovines from a region of negligible risk for 
BSE, as defined in Sec.  92.1 of this subchapter, in which there has 
been an indigenous case of BSE, and bovines from a region of controlled 
risk for BSE, as defined in Sec.  92.1 of this subchapter, may be 
imported only under the following conditions:
    (1) Prior to importation into the United States, each bovine is 
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.
    (2) The bovines are permanently and humanely identified before 
arrival at the port of entry with a distinct and legible mark 
identifying the exporting country. Acceptable means of permanent 
identification include the following:
    (i) A mark properly applied with a freeze brand, hot iron, or other 
method, and easily visible on the live animal and on the carcass before 
skinning. Such a mark must be not less than 2 inches nor more than 3 
inches high, and must be applied to each animal's right hip, high on 
the tail-head (over the junction of the sacral and first coccygeal 
vertebrae);
    (ii) A tattoo with letters identifying the exporting country must 
be applied to the inside of one ear of the animal; or
    (iii) Other means of permanent identification upon request if 
deemed adequate by the Administrator to humanely identify the animal in 
a distinct and legible way as having been imported from a region of 
negligible risk for BSE in which there has been an indigenous case of 
BSE or from a region of controlled risk for BSE.
    (3) The bovines were born after the date from which the ban on the 
feeding of ruminants meat-and-bone meal or

[[Page 72998]]

greaves derived from ruminants has been effectively enforced.
    (4) The bovines are accompanied by an original certificate issued 
by a full-time salaried veterinary officer of the national government 
of the exporting region, or issued by a veterinarian designated or 
accredited by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so, and the certificate 
attests to the BSE risk classification of the exporting region and that 
the conditions of paragraphs (b)(1) through (b)(3) of this section have 
been met.
    (5) If there has been an indigenous case of BSE in the exporting 
region, the following restrictions apply:
    (i) Bovines that, during their first year of life, were reared with 
a bovine determined to be infected with BSE during its first year of 
life, and that an investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period are not 
eligible for importation into the United States; and
    (ii) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd as a BSE-infected bovine either within 12 
months before or 12 months after the birth of the infected animal are 
not eligible for importation into the United States.
    (c) Bovines from a region of undetermined risk for BSE. Importation 
of bovines from a region of undetermined risk for BSE, as defined in 
Sec.  92.1 of this subchapter, is prohibited; Except that: The 
Administrator may allow such imports on a case-by-case basis if the 
live bovines are imported for specific uses, including, but not limited 
to, show or exhibition, and under conditions determined by the 
Administrator to be adequate to prevent the spread of BSE.

(Approved by the Office of Management and Budget under control 
number 0579-0234)

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, 
HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM 
ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

0
15. 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
16. Section 94.0 is amended by removing the definitions of cervid and 
specified risk materials (SRMs) and adding definitions of exporting 
region, mechanically separated meat, processed animal protein, 
specified risk materials (SRMs) from regions of controlled risk for 
BSE, and specified risk materials (SRMs) from regions of undetermined 
risk for BSE in alphabetical order to read as follows:


Sec.  94.0  Definitions.

* * * * *
    Exporting region. A region from which shipments are sent to the 
United States.
* * * * *
    Mechanically separated meat. A finely comminuted product resulting 
from the mechanical separation and removal of most of the bone from 
attached skeletal muscle of bovine carcasses that meets the FSIS 
specifications contained in 9 CFR 319.5.
* * * * *
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
* * * * *
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
* * * * *


Sec.  94.1  [Amended]

0
17. In Sec.  94.1, paragraphs (b)(4) and (d) are amended by removing 
the citation ``Sec.  94.22'' both times it appears and adding the 
citation ``Sec.  94.29'' in their place.


Sec.  94.9  [Amended]

0
18. In Sec.  94.9, paragraph (c) is amended by removing the citation 
``Sec.  94.24'' and adding the citation ``Sec.  94.31'' in its place.


Sec.  94.10  [Amended]

0
19. In Sec.  94.10, paragraph (c) is amended by removing the citation 
``Sec.  94.24'' and adding the citation ``Sec.  94.31'' in its place.

0
20. Section 94.18 is revised to read as follows:


Sec.  94.18  Bovine spongiform encephalopathy; importation of edible 
products derived from bovines.

    (a) The importation of meat, meat products, and other edible 
products derived from bovines is prohibited with regard to BSE, except 
as provided in this section and in Sec. Sec.  94.19, 94.20, 94.21, 
94.22, 94.23, and 94.27.
    (b) The following commodities derived from bovines may be imported 
into the United States without restriction regarding BSE, provided that 
all other applicable requirements of this part are met:
    (1) Milk and milk products;
    (2) Boneless skeletal muscle meat (excluding mechanically separated 
meat) that:
    (i) Is derived from bovines that were not, prior to slaughter, 
subjected to a pithing process or to stunning with a device injecting 
compressed air or gas into the cranial cavity, and that passed ante-
mortem and post-mortem inspection;
    (ii) Has been prepared in a manner to prevent contamination with 
SRMs; and
    (iii) Is accompanied to the United States by an original 
certificate stating that the conditions of paragraphs (b)(2)(i) and 
(b)(2)(ii) of this section have been met. The certificate must be 
issued and signed by a full-time salaried veterinary officer of the 
national government of the exporting region or signed by a person 
authorized to issue such certificates by the veterinary services of the 
national government of the exporting region.

(Approved by the Office of Management and Budget under control 
number 0579-0015)


[[Page 72999]]



0
21. Section 94.19 is revised to read as follows:


Sec.  94.19  Importation of meat, meat byproducts, and meat food 
products derived from bovines from regions of negligible risk for BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS 
in 9 CFR 301.2-except that those terms as applied to bison shall have a 
meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.  94.18(b)(2)--may be imported from a region of negligible risk 
for BSE, as defined in Sec.  92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were exported from a region of negligible risk 
for BSE.
    (b) If BSE has been diagnosed in one or more indigenous bovines in 
the region of negligible risk, the commodities were derived from 
bovines subject to a ban on the feeding to ruminants of meat-and-bone 
meal or greaves derived from ruminants.
    (c) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (d) The commodities are accompanied by an original certificate 
stating that the exporting region is classified by APHIS as a region of 
negligible risk for BSE and that the conditions of paragraphs (a) 
through (c) of this section, as applicable, have been met. The 
certificate must be issued and signed by a full-time salaried 
veterinary officer of the national government of the exporting region, 
or signed by a person authorized to issue such certificates by the 
veterinary services of the national government of the exporting region.

    Note: To be eligible to export meat, meat byproducts, and meat 
food products under the conditions of this section for human 
consumption, a region must also be one that has demonstrated to FSIS 
in accordance with 9 CFR 310.22 that its BSE risk status can 
reasonably be expected to provide the same level of protection from 
human exposure to the BSE agent as does prohibiting specified risk 
materials for use as human food in the United States.


(Approved by the Office of Management and Budget under control 
number 0579-0393)


0
22. Section 94.20 is revised to read as follows:


Sec.  94.20  Importation of meat, meat byproducts, and meat food 
products derived from bovines from regions of controlled risk for BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS 
in 9 CFR 301.2--except that those terms as applied to bison shall have 
a meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.  94.18(b)(2)--may be imported from a region of controlled risk 
for BSE, as defined in Sec.  92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were exported from a region of controlled risk 
for BSE.
    (b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (c) The commodities were derived from bovines that were not 
subjected to a stunning process, prior to slaughter, with a device 
injecting compressed air or gas into the cranial cavity, or to a 
pithing process.
    (d) The commodities were produced and handled in a manner that 
ensured that such commodities do not contain and are not contaminated 
with either of the following:
    (1) SRMs from regions of controlled risk for BSE; or
    (2) Mechanically separated meat from the skull and vertebral column 
from bovines 30 months of age or older.
    (e) The commodities are accompanied by an original certificate 
stating that the exporting region is classified by APHIS as a region of 
controlled risk for BSE, and that the conditions of this section have 
been met. The certificate must be issued and signed by a full-time 
salaried veterinary officer of the national government of the exporting 
region, or signed by a person authorized to issue such certificates by 
the veterinary services of the national government of the exporting 
region.

(Approved by the Office of Management and Budget under control 
numbers 0579-0015 and 0579-0393)


0
23. Section 94.21 is added to read as follows:


Sec.  94.21  Importation of meat, meat byproducts, and meat food 
products derived from bovines from regions of undetermined risk for 
BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS 
in 9 CFR 301.2-except that those terms as applied to bison shall have a 
meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.  94.18(b)(2)--may be imported from regions of undetermined risk 
for BSE, as defined in Sec.  92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were derived from bovines that have never been 
fed meat-and-bone meal or greaves derived from ruminants.
    (b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (c) The commodities were derived from bovines that were not 
subjected to a stunning process, prior to slaughter, with a device 
injecting compressed air or gas into the cranial cavity, or to a 
pithing process.
    (d) The commodities were produced and handled in a manner that 
ensured that such commodities do not contain and are not contaminated 
with any of the following:
    (1) SRMs from regions of undetermined risk for BSE; or
    (2) Mechanically separated meat from the skull and vertebral column 
from bovines over 12 months of age.
    (e) The commodities are accompanied by an original certificate 
stating that the exporting region is a region of undetermined risk for 
BSE and that the conditions of this section have been met. The 
certificate must be issued and signed by a full-time salaried 
veterinary officer of the national government of the exporting region, 
or signed by a person authorized to issue such certificates by the 
veterinary services of the national government of the exporting region.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  94.27  [Removed]

0
24. Section 94.27 is removed.


Sec. Sec.  94.22 through 94.26  [Redesignated Sec. Sec.  94.29 through 
94.33]

0
25. Sections 94.22 through 94.26 are redesignated as Sec. Sec.  94.29 
through 94.33, respectively.

0
26. New Sec. Sec.  94.22 through 94.27 are added to read as follows:

Sec.
* * * * *
94.22 Meat or dressed carcasses of hunter-harvested bovines.
94.23 Importation of gelatin derived from bovines.
94.24 Restrictions on importation of meat and edible products from 
ovines and caprines due to bovine spongiform encephalopathy.
94.25 Restrictions on the importation from Canada of meat and edible 
products from ovines and caprines other than gelatin.
94.26 Gelatin derived from horses or swine or from ovines or 
caprines that have not been in a region restricted because of BSE.
94.27 Transit shipment of articles.
* * * * *


Sec.  94.22  Meat or dressed carcasses of hunter-harvested bovines.

    The meat or dressed carcass (eviscerated and the head is removed) 
is

[[Page 73000]]

derived from a wild bovine that has been legally harvested in the wild, 
as verified by proof such as a hunting license, tag, or the equivalent 
that the hunter must show to the authorized inspector.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  94.23  Importation of gelatin derived from bovines.

    (a) The importation of gelatin derived from bovines is prohibited 
because of BSE, unless:
    (1) The gelatin meets the requirements of either paragraph (b), 
(c), or (d), as well as the requirements of paragraph (e) of this 
section and all other applicable requirements of this part; or
    (2) The gelatin is authorized importation under paragraph (f) of 
this section and meets all other applicable requirements of this part.
    (b) The gelatin is derived from hides and skins, provided the 
gelatin has not been commingled with materials ineligible for entry 
into the United States.
    (c) The gelatin is derived from the bones of bovines and originates 
in a region of negligible risk for BSE.
    (d) The gelatin is derived from the bones of bovines, originates in 
a region of controlled risk or undetermined risk for BSE, and meets the 
requirements of paragraphs (d)(1) through (d)(4) of this section:
    (1) The bones from which the gelatin was derived were derived from 
bovines that passed ante-mortem and post-mortem inspection.
    (2) The bones from which the gelatin was derived did not include 
the skulls of bovines or the vertebral column of bovines 30 months of 
age or older.
    (3) The bones were subjected to a process that includes all of the 
following steps, or to a process at least as effective in reducing BSE 
infectivity:
    (i) Degreasing;
    (ii) Acid demineralization;
    (iii) Acid or alkaline treatment;
    (iv) Filtration; and
    (v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a 
minimum of 4 seconds; and
    (4) The gelatin has not been commingled with materials ineligible 
for entry into the United States.
    (e) The gelatin is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (b), (c), or 
(d) of this section, as applicable, have been met and, for gelatin 
other than that described in paragraph (b) of this section, must 
indicate the BSE risk classification of the exporting region.
    (f) The Administrator determines that the gelatin will not come 
into contact with ruminants in the United States and can be imported 
under conditions that will prevent the introduction of BSE into the 
United States, and the person importing the gelatin has obtained a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the gelatin and name and address 
of the consignee in the United States.


Sec.  94.24  Restrictions on importation of meat and edible products 
from ovines and caprines due to bovine spongiform encephalopathy.

    (a) Except as provided in paragraph (b) of this section and in 
Sec.  94.25, the importation of meat, meat products, and edible 
products other than meat (excluding milk and milk products) from ovines 
and caprines that have been in any of the following regions is 
prohibited: Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, 
Bulgaria, Canada, Croatia, the Czech Republic, Denmark, the Federal 
Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, the 
Republic of Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, 
the Former Yugoslav Republic of Macedonia, Monaco, Norway, Oman, the 
Netherlands, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, 
Spain, Sweden, Switzerland, and the United Kingdom.
    (b) The importation of gelatin derived from ovines or caprines that 
have been in any region listed in paragraph (a) of this section is 
prohibited unless the following conditions have been met:
    (1) The gelatin is imported for use in human food, human 
pharmaceutical products, photography, or some other use that will not 
result in the gelatin coming in contact with ruminants in the United 
States.
    (2) The person importing the gelatin obtains a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors by filing a permit application on 
VS Form 16-3. To apply for a permit, file a permit application on VS 
Form 16-3 (available from APHIS, Veterinary Services, National Center 
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended 
use of the gelatin and name and address of the consignee in the United 
States.


Sec.  94.25  Restrictions on the importation from Canada of meat and 
edible products from ovines and caprines other than gelatin.

    The commodities listed in paragraphs (a) and (b) of this section 
may be imported from Canada if the conditions of this section are met.
    (a) Meat, carcasses, meat byproducts, and meat food products from 
ovines or caprines. (1) The meat, carcass, meat byproduct, or meat food 
product, as defined by FSIS in 9 CFR 301.2, is derived from ovines or 
caprines that are 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 the ovines or caprines:
    (i) Were less than 12 months of age when slaughtered;
    (ii) Were slaughtered at a facility that either slaughters only 
ovines or 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;
    (iii) Did not test positive for and were not suspect for a 
transmissible spongiform encephalopathy;
    (iv) Never resided in a flock or herd that has been diagnosed with 
BSE; and
    (v) Were not subject to any movement restrictions within Canada as 
a result of exposure to a transmissible spongiform encephalopathy.
    (2) The commodities are accompanied by an original certificate of 
such compliance issued by a full-time salaried veterinary officer of 
Canada, or issued by a veterinarian designated by the Canadian 
government and endorsed by a full-time salaried veterinary officer of 
the Government of Canada, representing that the veterinarian issuing 
the certificate was authorized to do so; and if all other applicable 
requirements of this part are met.

[[Page 73001]]

    (b) Meat or dressed carcasses of hunter-harvested ovines or 
caprines. (1) The meat or dressed carcass (eviscerated and the head is 
removed) is derived from a wild ovine or caprine that has been legally 
harvested in the wild, as verified by proof such as a hunting license, 
tag, or the equivalent that the hunter must show to the United States 
Customs and Border Protection official; and
    (2) The animal from which the meat is derived was harvested within 
a jurisdiction specified by the Administrator for which the game and 
wildlife service of the jurisdiction has informed the Administrator 
either that the jurisdiction conducts no type of game feeding program, 
or has complied with, and continues to comply with, a ruminant feed ban 
equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000.
    (c) Ports. All products to be brought into the United States under 
this section must, if arriving at a land border port, arrive at one of 
the following ports: Eastport, ID; Houlton, ME; Detroit (Ambassador 
Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; 
Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace 
Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and 
Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), 
Lynden, Oroville, and Sumas (Cargo), WA.


Sec.  94.26  Gelatin derived from horses or swine or from ovines or 
caprines that have not been in a region restricted because of BSE.

    Gelatin derived from horses or swine, or from ovines or caprines 
that have not been in any region listed in Sec.  94.24(a) must be 
accompanied at the time of importation into the United States by an 
official certificate issued by a veterinarian employed by the national 
government of the region of origin. The official certificate must state 
the species of animal from which the gelatin is derived and, if the 
gelatin is derived from ovines or caprines, certify that the gelatin is 
not derived from ovines or caprines that have been in any region listed 
in Sec.  94.24(a).


Sec.  94.27  Transit shipment of articles.

    Meat, meat products, and other edible products derived from 
bovines, ovines, or caprines that are otherwise prohibited importation 
into the United States in accordance with Sec.  94.18 through Sec.  
94.26 may transit air and ocean ports in the United States for 
immediate export if the conditions of paragraphs (a) through (c) this 
section are met. Meat, meat products, and other edible products derived 
from bovines, ovines, or caprines are eligible to transit the United 
States by overland transportation if the requirements of paragraphs (a) 
through (d) of this section are met:
    (a) The articles must be sealed in leakproof containers bearing 
serial numbers during transit. Each container must remain sealed during 
the entire time that it is in the United States.
    (b) The person moving the articles must notify, in writing, the 
inspector at both the place in the United States where the articles 
will arrive and the port of export before such transit. The 
notification must include the:
    (1) Times and dates of arrival in the United States;
    (2) Times and dates of exportation from the United States;
    (3) Mode of transportation; and
    (4) Serial numbers of the sealed containers.
    (c) The articles must transit the United States in Customs bond.
    (d) The commodities must be eligible to enter the United States in 
accordance with the provisions of this part and must be accompanied by 
the certification required by that section. Additionally, the following 
conditions must be met:
    (1) The shipment must be exported from the United States within 7 
days of its entry; and
    (2) The commodities may not be transloaded while in the United 
States, except for direct transloading under the supervision of an 
authorized inspector, who must break the seals of the national 
government of the region of origin on the means of conveyance that 
carried the commodities into the United States and seal the means of 
conveyance that will carry the commodities out of the United States 
with seals of the U.S. Government.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  94.28  [Amended]

0
27. In Sec.  94.28, paragraph (c) is amended by removing the citation 
``Sec.  94.28(b)(5)'' and adding ``paragraph (b)(5) of this section'' 
in its place.

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

0
28. 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
29. Section 95.1 is amended by removing the definition of specified 
risk materials (SRMs), by revising the definition of offal, and by 
adding definitions of exporting region, specified risk materials (SRMs) 
from regions of controlled risk for BSE, specified risk materials 
(SRMs) from regions of undetermined risk for BSE, and tallow derivative 
in alphabetical order to read as follows:


Sec.  95.1  Definitions.

* * * * *
    Exporting region. A region from which shipments are sent to the 
United States.
* * * * *
    Offal. The inedible parts of a butchered animal.
* * * * *
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
* * * * *
    Tallow derivative. Any chemical obtained through initial 
hydrolysis, saponification, or transesterification of tallow; chemical 
conversion of material obtained by hydrolysis, saponification, or 
transesterification may be applied to obtain the desired product.
* * * * *

0
30. Section 95.4 is revised to read as follows:


Sec.  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) Except as provided in paragraphs (c), (d), (e), (f), or (g) of 
this section or in Sec.  95.15, any of the materials listed in 
paragraph (b) of this section derived from animals, or products 
containing

[[Page 73002]]

such materials, are prohibited importation into the United States if 
paragraph (a)(1), (a)(2), or (a)(3) of this section applies:
    (1) The animals have been in any region listed in paragraph (a)(4) 
of this section;
    (2) The materials have been stored, rendered, or otherwise 
processed in a region listed in paragraph (a)(4) of this section; or
    (3) The materials have otherwise been associated with a facility in 
a region listed in paragraph (a)(4) of this section.
    (4) Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, 
Bulgaria, Canada, Croatia, the Czech Republic, Denmark, the Federal 
Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, the 
Republic of Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, 
the Former Yugoslav Republic of Macedonia, Monaco, Norway, Oman, the 
Netherlands, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, 
Spain, Sweden, Switzerland, and the United Kingdom.
    (b) Restricted materials: (1) 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;
    (2) Glands, unprocessed fat tissue, and blood and blood products;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal; or
    (4) Derivatives of glands and blood and blood products.
    (c) The import prohibition in paragraph (a) of this section does 
not apply if the following conditions are met prior to importation:
    (1) The material is derived from one of the following:
    (i) A nonruminant species and the material is not ineligible for 
importation under Sec.  95.13 or Sec.  95.14;
    (ii) Cervids or camelids;
    (iii) Bovines, and the material is not ineligible for importation 
under the conditions of Sec.  95.5, Sec.  95.6, Sec.  95.7, Sec.  95.8, 
Sec.  95.9, Sec.  95.10, or Sec.  95.12; or
    (iv) Ovines or caprines that have never been in any region listed 
in paragraph (a)(4) of this section.
    (2) In any region other than Canada that is listed in paragraph 
(a)(4) of this section, 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 ovines or caprines 
that have been in any region that is listed in paragraph (a)(4) of this 
section.
    (3) In Canada, 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 ovines and caprines that have been in 
any region other than Canada that is listed in paragraph (a)(4) of this 
section.
    (4) The facility demonstrates to APHIS that the materials intended 
for exportation to the United States were transported to and from the 
facility in a manner that would prevent cross-contamination by or 
commingling with prohibited materials.
    (5) If the facility processes or handles any material derived from 
mammals, inspection of the facility for compliance with the provisions 
of this section is conducted at least annually by a representative of 
the government agency responsible for animal health in the region, 
unless the region chooses to have such inspection conducted by APHIS. 
If APHIS conducts the inspections required by this section, the 
facility has entered into a cooperative service agreement executed by 
the operator of the facility and APHIS. In accordance with the 
cooperative service agreement, the facility must be current in paying 
all costs for a veterinarian of APHIS to inspect the facility (it is 
anticipated that such inspections will occur approximately once per 
year), including travel, salary, subsistence, administrative overhead, 
and other incidental expenses (including excess baggage provisions up 
to 150 pounds). In addition, the facility must have on deposit with 
APHIS an unobligated amount equal to the cost for APHIS personnel to 
conduct one inspection. As funds from that amount are obligated, a bill 
for costs incurred based on official accounting records will be issued 
to restore the deposit to the original level, revised as necessary to 
allow for inflation or other changes in estimated costs. To be current, 
bills must be paid within 14 days of receipt.
    (6) The facility allows periodic APHIS inspection of its 
facilities, records, and operations.
    (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 exporting 
region certifying that the conditions of paragraphs (c)(1) through 
(c)(5) of this section have been met.
    (8) The person importing the shipment has applied for and obtained 
from APHIS a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors by 
filing a permit application on VS Form 16-3. (VS Form 16-3 may be 
obtained from APHIS, Veterinary Services, National Center for Import 
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/animal_health/permits/.)
    (d) Except as provided in paragraph (e) of this section and in 
Sec.  95.15, serum from ovines or caprines that have been in any region 
listed in paragraph (a)(4) of this section is prohibited importation 
into the United States, except for scientific, educational, or research 
purposes if the Administrator determines that the importation can be 
made under conditions that will prevent the introduction of BSE into 
the United States. Such serum must be accompanied by a permit issued by 
APHIS in accordance with Sec.  104.4 of this chapter and must be moved 
and handled as specified on the permit.
    (e) The importation of serum albumin, serocolostrum, amniotic 
liquids or extracts, and placental liquids derived from ovines or 
caprines that have been in any region listed in paragraph (a)(4) of 
this section, and collagen and collagen products that are derived from 
ovines or caprines and that would otherwise be prohibited under 
paragraphs (a) and (b) of this section, is prohibited unless the 
following conditions have been met:
    (1) The article is imported for use as an ingredient in cosmetics;
    (2) The person importing the article has obtained a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors by filing a permit application on 
VS Form 16-3 (VS Form 16-3 may be obtained from APHIS, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/.); and
    (3) The permit application states the intended use of the article 
and the name and address of the consignee in the United States.
    (f) Insulin otherwise prohibited under paragraphs (a) and (b) of 
this section may be imported if the insulin is for the personal medical 
use of the person importing it and if the person importing the shipment 
has applied for and obtained from APHIS a United States Veterinary 
Permit for Importation and Transportation of Controlled Materials and 
Organisms and Vectors. To apply for a permit, file a permit application 
on VS Form 16-3 (available from APHIS, Veterinary Services, National 
Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD 
20737-1231, or electronically at http://www.aphis.usda.gov/animal--
health/

[[Page 73003]]

permits/). The application for such a permit must state the intended 
use of the insulin and the name and address of the consignee in the 
United States.

    Note to paragraph (f): Insulin that is not prohibited from 
importation under this paragraph may be prohibited from importation 
under other Federal laws, including the Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 321 et seq.

    (g) Offal that is otherwise prohibited under paragraphs (a) and (b) 
of this section because it is derived from ovines or caprines that have 
been in a region listed in paragraph (a)(4) of this section may be 
imported into the United States if the offal is derived from ovines or 
caprines from Canada that have not been in a region listed in paragraph 
(a)(4) of this section other than Canada, and the following conditions 
are met:
    (1) The offal:
    (i) Is derived from ovines or caprines that were less than 12 
months of age when slaughtered and that are 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;
    (ii) Is not derived from ovines or caprines that have tested 
positive for or are suspect for a transmissible spongiform 
encephalopathy;
    (iii) Is not derived from animals that have resided in a flock or 
herd that has been diagnosed with BSE; and
    (iv) Is derived from ovines or caprines whose movement was not 
restricted in the BSE minimal-risk region as a result of exposure to a 
transmissible spongiform encephalopathy.
    (2) Each shipment to the United States is accompanied by an 
original certificate signed by a full-time salaried veterinary officer 
of the national government of the exporting region, or issued by a 
veterinarian designated by the exporting region and endorsed by a full-
time salaried veterinary officer of the national government of the 
exporting region, representing that the veterinarian issuing the 
certificate was authorized to do so. The certificate must state that 
the requirements of paragraph (g)(1) of this section have been met; and
    (3) The shipment, if arriving at a U.S. land border port, arrives 
at a port listed in Sec.  94.25(c) of this subchapter.

(Approved by the Office of Management and Budget under control 
numbers 0579-0015, 0579-0234, and 0579-0393)

Sec. Sec.  95.5 through 95.30  [Redesignated as Sec. Sec.  95.16 
through 95.41]

0
31. Sections 95.5 through 95.30 are redesignated as Sec. Sec.  95.16 
through 95.41, respectively.
0
32. New Sec. Sec.  95.5 through 95.15 are added to read as follows:
Sec.
* * * * *
95.5 Processed animal protein derived from ruminants.
95.6 Offal derived from bovines.
95.7 Collagen derived from bovines.
95.8 Tallow derived from bovines.
95.9 Derivatives of tallow derived from bovines.
95.10 Dicalcium phosphate derived from bovines.
95.11 Specified risk materials.
95.12 Blood and blood products derived from bovines.
95.13 Importation from regions of negligible risk for BSE of 
processed animal protein derived from animals other than ruminants.
95.14 Importation from regions of controlled risk or undetermined 
risk for BSE of processed animal protein derived from animals other 
than ruminants.
95.15 Transit shipment of articles.
* * * * *


Sec.  95.5  Processed animal protein derived from ruminants.

    The importation of ruminant-derived processed animal protein, or 
any commodities containing such products, is prohibited unless the 
conditions of this section are met:
    (a) The exporting region is a region of negligible risk for BSE; 
and
    (1) The product has not been commingled or contaminated with 
ruminant meat-and-bone meal or greaves from a region of controlled or 
undetermined risk for BSE; and
    (2) The product must be derived from ruminants that were subject to 
a ban on the feeding of ruminants with meat-and-bone meal or greaves 
derived from ruminants if it is either:
    (i) Exported from a region of negligible risk for BSE in which 
there has been at least one indigenous case of BSE; or
    (ii) Derived from ruminants that were in a region of negligible 
risk for BSE in which there has been at least one indigenous case of 
BSE.
    (b) The exporting region is a region of controlled or undetermined 
risk, the product is ruminant-derived processed animal protein other 
than ruminant meat-and-bone meal or greaves, and it has been 
demonstrated that the product has not been commingled or contaminated 
with ruminant meat-and-bone meal or greaves from a controlled or 
undetermined risk region.
    (c) Each shipment to the United States is accompanied by an 
original certificate signed by a full-time salaried veterinary officer 
of the national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state the exporting region and that the requirements 
of this section, as applicable, have been met.
    (d) The person importing the processed animal protein obtains a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors by filing a permit 
application on VS Form 16-3. To apply for a permit, file a permit 
application on VS Form 16-3 (available from APHIS, Veterinary Services, 
National Center for Import and Export, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the processed animal protein and 
name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.6  Offal derived from bovines.

    Offal derived from bovines is prohibited importation into the 
United States unless it meets the requirements for the importation of 
meat, meat products, and meat byproducts in either Sec.  94.19, Sec.  
94.20, or Sec.  94.21, with the exception of the requirements in Sec.  
94.19(c), Sec.  94.20(b), and Sec.  94.21(b), respectively. The person 
importing the offal must obtain a United States Veterinary Permit for 
Importation and Transportation of Controlled Materials and Organisms 
and Vectors by filing a permit application on VS Form 16-3. To apply 
for a permit, file a permit application on VS Form 16-3 (available from 
APHIS, Veterinary Services, National Center for Import and Export, 4700 
River Road Unit 38, Riverdale, MD 20737-1231, or electronically at 
http://www.aphis.usda.gov/animal_health/permits/). The application for 
such a permit must state the intended use of the offal and name and 
address of the consignee in the United States.


Sec.  95.7  Collagen derived from bovines.

    (a) The importation of collagen derived from bovines is prohibited 
because of BSE unless:
    (1) The collagen meets the requirements of either paragraph (b), 
(c), or (d), as well as the requirements of paragraph (e) of this 
section and all other applicable requirements of this part; or
    (2) The collagen is authorized importation under paragraph (f) of 
this

[[Page 73004]]

section and meets all other applicable requirements of this part:
    (b) The collagen is derived from hides and skins, provided the 
collagen has not been commingled with materials ineligible for entry 
into the United States.
    (c) The collagen is derived from the bones of bovines that 
originated from a region of negligible risk for BSE.
    (d) The collagen is derived from the bones of bovines that 
originated from a region of controlled or undetermined risk for BSE and 
meets the requirements of paragraphs (d)(1) through (d)(4) of this 
section:
    (1) The bones from which the collagen was derived were derived from 
bovines that passed ante-mortem and post-mortem inspection;
    (2) The bones from which the collagen was derived did not include 
the skulls of bovines or the vertebral column of bovines 30 months of 
age or older;
    (3) The bones were subjected to a process that includes all of the 
following steps, or to a process at least as effective in reducing BSE 
infectivity:
    (i) Degreasing;
    (ii) Acid demineralization;
    (iii) Acid or alkaline treatment;
    (iv) Filtration; and
    (v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a 
minimum of 4 seconds; and
    (4) The collagen has not been commingled with materials ineligible 
for entry into the United States.
    (e) The collagen is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (b), (c), or 
(d) of this section, as applicable, have been met and, for collagen 
other than that described in paragraph (b) of this section, must 
indicate the BSE risk classification of the exporting region.
    (f) The Administrator determines that the collagen will not come 
into contact with ruminants in the United States and can be imported 
under conditions that will prevent the introduction of BSE into the 
United States, and the person importing the collagen has obtained a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the collagen and the name and 
address of the consignee in the United States.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.8  Tallow derived from bovines.

    (a) The importation of bovine-derived tallow is prohibited unless:
    (1) The requirements of either paragraph (b), (c), or (d), as well 
as the requirements of paragraph (e) of this section are met; or
    (2) The requirements of paragraph (f) of this section are met.
    (b) The tallow is composed of a maximum level of insoluble 
impurities of 0.15 percent in weight; or
    (c) The tallow originates from a region of negligible risk for BSE; 
or
    (d) The tallow originates from a region of controlled risk for BSE, 
is derived from bovines that have passed ante-mortem and post-mortem 
inspections, and has not been prepared using SRMs as defined for 
regions of controlled risk for BSE in Sec.  92.1 of this subchapter.
    (e) The tallow is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (b), (c), or 
(d) of this section, as applicable, have been met and, for tallow other 
than that described in paragraph (b) of this section, must indicate the 
BSE risk classification of the exporting region.
    (f) The Administrator determines that the tallow will not come into 
contact with ruminants in the United States and can be imported under 
conditions that will prevent the introduction of BSE into the United 
States, and the person importing the tallow has obtained a United 
States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the tallow and the name and 
address of the consignee in the United States.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.9  Derivatives of tallow derived from bovines.

    (a) The importation of derivatives of tallow from bovines is 
prohibited unless the commodity meets the conditions of either 
paragraph (b), (c), (d), or (e) of this section as well as paragraph 
(f) of this section, or, alternatively, meets the conditions of 
paragraph (g) of this section.
    (b) The commodity meets the definition of tallow derivative in 
Sec.  95.1.
    (c) The derivative is from tallow composed of a maximum level of 
insoluble impurities of 0.15 percent in weight.
    (d) The derivative is from tallow that originates from a region of 
negligible risk for BSE.
    (e) The derivative is from tallow that originates from a region of 
controlled risk for BSE, is derived from bovines that have passed ante-
mortem and post-mortem inspections, and does not contain SRMs as 
defined for regions of controlled risk for BSE in Sec.  92.1 of this 
subchapter.
    (f) The tallow derivative is accompanied to the United States by an 
original certificate signed by a full-time salaried veterinary officer 
of the national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (b), (c), 
(d), or (e) of this section, as applicable, have been met and, for 
tallow derivatives other than those described in paragraph (b) or (c) 
of this section, must indicate the BSE risk classification of the 
exporting region.
    (g) The Administrator determines that the tallow derivative will 
not come into contact with ruminants in the United States and can be 
imported under conditions that will prevent the introduction of BSE 
into the United States, and the person importing the tallow derivative 
has obtained a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 
(available from APHIS, Veterinary Services,

[[Page 73005]]

National Center for Import and Export, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the tallow derivative and the 
name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.10  Dicalcium phosphate derived from bovines.

    (a) The importation of dicalcium phosphate derived from bovines is 
prohibited unless:
    (1) The requirements of either paragraph (b), (c), or (d) and the 
requirements of paragraph (e) of this section are met; or
    (2) The requirements of paragraph (f) of this section are met.
    (b) The dicalcium phosphate contains no trace of protein or fat; or
    (c) The dicalcium phosphate originates from a region of negligible 
risk for BSE; or
    (d) The dicalcium phosphate originates from a region of controlled 
risk for BSE, is derived from bovines that have passed ante-mortem and 
post-mortem inspections, and does not contain SRMs as defined for 
regions of controlled risk for BSE in Sec.  92.1 of this subchapter.
    (e) The dicalcium phosphate is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must indicate the BSE risk classification of the exporting 
region and state that the requirements of paragraph (b) (c), or (d) of 
this section, as applicable, have been met.
    (f) The Administrator determines that the dicalcium phosphate will 
not come into contact with ruminants in the United States and can be 
imported under conditions that will prevent the introduction of BSE 
into the United States, and the person importing the dicalcium 
phosphate has obtained a United States Veterinary Permit for 
Importation and Transportation of Controlled Materials and Organisms 
and Vectors. To apply for a permit, file a permit application on VS 
Form 16-3 (available from APHIS, Veterinary Services, National Center 
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended 
use of the dicalcium phosphate and the name and address of the 
consignee in the United States.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.11  Specified risk materials.

    Notwithstanding any other provisions of this part, the importation 
of specified risk materials from controlled-risk regions or 
undetermined-risk regions for BSE, and any commodities containing such 
materials, is prohibited, unless the Administrator determines that the 
materials or other commodities will not come into contact with 
ruminants in the United States and can be imported under conditions 
that will prevent the introduction of BSE into the United States, and 
the person importing the materials or other commodities has obtained a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the materials and other 
commodities and the name and address of the consignee in the United 
States.


Sec.  95.12  Blood and blood products derived from bovines.

    The importation of bovine blood and products derived from bovine 
blood is prohibited unless the following conditions and the conditions 
of all other applicable parts of this chapter are met:
    (a) For blood collected at slaughter and for products derived from 
blood collected at slaughter:
    (1) The blood was collected in a hygienic manner, as determined by 
the Administrator, that prevents contamination of the blood with SRMs; 
and
    (2) The slaughtered animal passed ante-mortem inspection and was 
not subjected to a pithing process or to a stunning process with a 
device injecting compressed air or gas into the cranial cavity.
    (b) For blood collected from live donor bovines and for products 
derived from blood collected from live donor bovines:
    (1) The blood was collected in a hygienic manner, as determined by 
the Administrator, that prevents contamination of the blood with SRMs; 
and
    (2) The donor animal was free of clinical signs of disease.
    (c) The blood and blood products are accompanied to the United 
States by an original certificate that states that the conditions of 
this section have been met. The certificate must be issued by a full-
time salaried veterinary officer of the national government of the 
exporting region, or issued by a veterinarian designated by the 
national government of the exporting region and endorsed by a full-time 
salaried veterinary officer of the exporting region, representing that 
the veterinarian issuing the certificate was authorized to do so.

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.13  Importation from regions of negligible risk for BSE of 
processed animal protein derived from animals other than ruminants.

    The importation from regions of negligible risk for BSE of 
processed animal protein derived from animals other than ruminants is 
prohibited importation into the United States unless the following 
conditions are met:
    (a) The processed animal protein is not prohibited importation 
under Sec.  95.4;
    (b) The processed animal protein imported into the United States in 
accordance with this section is accompanied by an original certificate 
signed by a full-time salaried veterinary officer of the national 
government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so, that indicates that 
the material is derived from animals other than ruminants.
    (c) The person importing the shipment has applied for and obtained 
from APHIS a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 
(available from APHIS, Veterinary Services, National Center for Import 
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/animal_health/permits/).

[[Page 73006]]


(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.14  Importation from regions of controlled risk or 
undetermined risk for BSE of processed animal protein derived from 
animals other than ruminants.

    The importation from regions of controlled risk or undetermined 
risk for BSE of processed animal protein derived from animals other 
than ruminants is prohibited importation into the United States unless 
the following conditions are met:
    (a) The processed animal protein is not prohibited importation 
under Sec.  95.4;
    (b) Except as provided in paragraph (c) of this section, the 
processed animal protein does not contain and was not commingled with 
material derived from ruminants originating in a BSE controlled- or 
undetermined-risk region;
    (c) For blood meal, blood plasma, and other blood products, the 
material does not contain and was not commingled with ruminant blood or 
blood products prohibited importation into the United States under this 
part.
    (d) Inspection of the facility for compliance with the provisions 
of this section is conducted at least annually by a competent authority 
of the government agency responsible for animal health in the region, 
unless the region chooses to have such inspections conducted by APHIS. 
The inspections must verify either that:
    (1) All steps of processing and storing the material are carried 
out in a facility that has not been used for the processing or storage 
of materials derived from ruminants originating in a BSE controlled- or 
undetermined-risk region; or
    (2) The material is produced in a manner that prevents 
contamination of the processed animal protein with materials prohibited 
importation into the United States.
    (e) If APHIS conducts the inspections required by paragraph (d) of 
this section, the facility has entered into a cooperative service 
agreement executed by the operator of the facility and APHIS. In 
accordance with the cooperative service agreement, the facility must be 
current in paying all costs for a veterinarian of APHIS to inspect the 
facility (it is anticipated that such inspections will occur 
approximately once per year), including travel, salary, subsistence, 
administrative overhead, and other incidental expenses (including 
excess baggage provisions up to 150 pounds). In addition, the facility 
must have on deposit with APHIS an unobligated amount equal to the cost 
for APHIS personnel to conduct one inspection. As funds from that 
amount are obligated, a bill for costs incurred based on official 
accounting records will be issued to restore the deposit to the 
original level, revised as necessary to allow for inflation or other 
changes in estimated costs. To be current, bills must be paid within 14 
days of receipt.
    (f) The facility allows periodic APHIS inspection of its 
facilities, records, and operations.
    (g) The processed animal protein imported into the United States in 
accordance with this section is accompanied by an original certificate 
signed by a full-time, salaried veterinary officer of the national 
government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time, salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so, that states that the 
processed animal protein is not of ruminant origin and that conditions 
of this section have been met.
    (h) The person importing the shipment has applied for and obtained 
from APHIS a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 
(available from APHIS, Veterinary Services, National Center for Import 
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/animal_health/permits/).

(Approved by the Office of Management and Budget under control 
number 0579-0393)

Sec.  95.15  Transit shipment of articles.

    Articles that are otherwise prohibited importation into the United 
States in accordance with Sec. Sec.  95.4 through 95.14 may transit air 
and ocean ports in the United States for immediate export if the 
conditions of paragraphs (a) through (c) of this section are met. 
Articles are eligible to transit the United States by overland 
transportation if the requirements of paragraphs (a) through (e) of 
this section are met.
    (a) The articles must be sealed in leakproof containers bearing 
serial numbers during transit. Each container must remain sealed during 
the entire time that it is in the United States.
    (b) Before such transit, the person moving the articles must 
notify, in writing, the inspector at both the place in the United 
States where the articles will arrive and the port of export. The 
notification must include the:
    (1) Times and dates of arrival in the United States;
    (2) Times and dates of exportation from the United States; and
    (3) Serial numbers of the sealed containers.
    (c) The articles must transit the United States under Customs bond.
    (d) The person moving the articles must obtain a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors. To apply for a permit, file a 
permit application on VS Form 16-3 (available from APHIS, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/).
    (e) The commodities must be eligible to enter the United States in 
accordance with Sec. Sec.  95.4 through 95.14 and must be accompanied 
by the certification required by that section. Additionally, the 
following conditions must be met:
    (1) The shipment must be exported from the United States within 7 
days of its entry;
    (2) The commodities may not be transloaded while in the United 
States, except for direct transloading under the supervision of an 
authorized inspector, who must break the seals of the national 
government of the exporting region on the means of conveyance that 
carried the commodities into the United States and seal the means of 
conveyance that will carry the commodities out of the United States 
with seals of the U.S. Government; and
    (3) A copy of the import permit required under paragraph (d) of 
this section must be presented to the inspector at the port of arrival 
and the port of export in the United States.


Sec.  95.16  [Amended]

0
33. In newly redesignated Sec.  95.16, footnote 1 is amended by 
removing the citation ``Sec.  95.30'' and adding ``Sec.  95.41'' in its 
place.


Sec.  95.17  [Amended]

0
34. In newly redesignated Sec.  95.17, the introductory text is amended 
by removing the citation ``Sec.  95.5'' and adding the citation ``Sec.  
95.16'' in its place.


Sec.  95.18  [Amended]

0
35. In newly redesignated Sec.  95.18, the introductory text is amended 
by removing the citation ``Sec.  95.8'' and adding the citation ``Sec.  
95.19'' in its place, and footnote 3 to paragraph (c) is amended by 
removing the citation

[[Page 73007]]

``Sec.  95.5'' and adding the citation ``Sec.  95.16'' in its place.


Sec.  95.19  [Amended]

0
36. In newly redesignated Sec.  95.19, the introductory text is amended 
by removing the citation ``Sec.  95.7'' and adding the citation ``Sec.  
95.18'' in its place.


Sec.  95.20  [Amended]

0
37. In newly redesignated Sec.  95.20, the introductory text is amended 
by removing the citation ``Sec.  95.10'' and adding the citation 
``Sec.  95.21'' in its place, and footnote 4 to paragraph (c) is 
amended by removing the citation ``Sec.  95.5'' and adding the citation 
``Sec.  95.16'' in its place.


Sec.  95.21  [Amended]

0
38. In newly redesignated Sec.  95.21, the introductory text is amended 
by removing the citation ``Sec.  95.9'' and adding the citation ``Sec.  
95.20'' in its place.


Sec.  95.23  [Amended]

0
39. In newly redesignated Sec.  95.23, the introductory text is amended 
by removing the citation to ``Sec.  95.11'' and adding the citation 
``Sec.  95.22'' in its place.


Sec.  95.25  [Amended]

0
40. In newly redesignated Sec.  95.25, the introductory text is amended 
by removing the citation ``Sec.  95.16'' and adding the citation 
``Sec.  95.27'' in its place.


Sec.  95.26  [Amended]

0
41. Newly redesignated Sec.  95.26 is amended by removing the citation 
``Sec.  95.16'' and adding the citation ``Sec.  95.27'' in its place.


Sec.  95.27  [Amended]

0
42. In newly redesignated Sec.  95.27, the introductory text is amended 
by removing the citation ``Sec.  95.15'' and adding the citation 
``Sec.  95.26'' in its place.


Sec.  95.28  [Amended]

0
43. In newly redesignated Sec.  95.28, the introductory text is amended 
by removing the citation ``Sec.  95.18'' and adding the citation 
``Sec.  95.29'' in its place.


Sec.  95.29  [Amended]

0
44. Newly redesignated Sec.  95.29 is amended by removing the citation 
``Sec.  95.17'' and adding the citation ``Sec.  95.28'' in its place.


Sec.  95.32  [Amended]

0
45. Newly redesignated Sec.  95.32 is amended by removing the citation 
``Sec.  95.28'' and adding the citation ``Sec.  95.39'' in its place, 
and by removing the citation ``Sec.  95.22'' and adding the citation 
``Sec.  95.33'' in its place.


Sec.  95.33  [Amended]

0
46. Newly redesignated Sec.  95.33 is amended by removing the citation 
``Sec.  95.28'' and adding the citation ``Sec.  95.39'' in its place, 
and by removing the citation ``Sec.  95.21'' and adding the citation 
``Sec.  95.32'' in its place.


Sec.  95.36  [Amended]

0
47. In newly redesignated Sec.  95.36, paragraphs (a) and (b) are 
amended by removing the citation ``Sec.  95.26'' both times it appears 
and adding the citation ``Sec.  95.37'' in their place.

0
48. Newly redesignated Sec.  95.40 is revised to read as follows:


Sec.  95.40  Certification for certain materials.

    (a) In addition to meeting any other certification or permit 
requirements of this chapter, the following articles, if derived from 
ovines or caprines, may be imported into the United States from any 
region not listed in Sec.  95.4(a)(4) only if they are accompanied by a 
certificate, as described in paragraph (b) of this section:
    (1) 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;
    (2) Glands and unprocessed fat tissue;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal;
    (4) Derivatives of glands; and
    (5) Any product containing any of the materials listed in 
paragraphs (a)(1) through (a)(4) of this section.
    (b) The certificate required by paragraph (a) of this section must 
be an original official certificate, signed by a full-time, salaried 
veterinarian of the agency responsible for animal health in the 
exporting region, that states the following:
    (1) The animal species from which the material was derived;
    (2) The region in which any facility where the material was 
processed is located;
    (3) That the material was derived only from animals that have never 
been in any region listed in Sec.  95.4(a)(4), with the regions listed 
in Sec.  95.4(a)(4) specifically named;
    (4) That the material did not originate in, and was never stored, 
rendered, or processed in, or otherwise associated with, a facility in 
a region listed in Sec.  95.4(a)(4); and
    (5) The material was never associated with any of the materials 
listed in paragraph (a) of this section that have been in a region 
listed in Sec.  95.4(a)(4).
    (c) The certification required by paragraph (a) of this section 
must clearly correspond to the shipment by means of an invoice number, 
shipping marks, lot number, or other method of identification.

(Approved by the Office of Management and Budget under control 
number 0579-0234)

PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS 
OFFERED FOR ENTRY INTO THE UNITED STATES

0
49. The authority citation for part 96 continues to read as follows:

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


0
50. In Sec.  96.2, paragraph (b) is revised and paragraph (c) is added 
to read as follows:


Sec.  96.2  Prohibition of casings due to African swine fever and 
bovine spongiform encephalopathy.

* * * * *
    (b) Casings from ovines or caprines. The importation of casings, 
except stomachs, derived from ovines or caprines that originated in or 
were processed in any region listed in Sec.  95.4(a)(4) are prohibited, 
unless the following conditions are met:
    (1) The casings are derived from sheep that were slaughtered in 
Canada at less than 12 months of age and that were from a flock 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
    (2) The casings are accompanied by an original certificate that 
meets the requirements of Sec.  96.3 and:
    (i) States that the casings meet the conditions of this section;
    (ii) Is written in English;
    (iii) Is signed by an individual eligible to issue the certificate 
required under Sec.  96.3; and
    (iv) Is presented to an authorized inspector at the port of entry.
    (c) Casings from bovines. The importation of casings derived from 
bovines is prohibited, unless the following conditions are met:
    (1) If the casings are derived from bovines from a region of 
negligible risk for BSE, as defined in Sec.  92.1 of this subchapter, 
the certificate required under Sec.  96.3 indicates the APHIS BSE risk 
classification of the region in which the bovines were slaughtered and 
the casings were collected.

[[Page 73008]]

    (2) If the casings are derived from bovines from a region of 
controlled risk for BSE or a region of undetermined risk for BSE, as 
defined in Sec.  92.1 of this subchapter, the casings are not derived 
from the small intestine or, if the casings are derived from the small 
intestine, the casings are derived from that part of the small 
intestine that is eligible for use as human food in accordance with the 
requirements established by the Food Safety and Inspection Service at 9 
CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
    (3) The casings are accompanied by an original certificate that 
meets the requirements of Sec.  96.3 and paragraphs (b)(2)(i) through 
(b)(3)(iv) of this section.
* * * * *

0
51. In Sec.  96.3, paragraph (d) is revised to read as follows:


Sec.  96.3  Certificate for animal casings.

* * * * *
    (d) In addition to meeting the requirements of this section, the 
certificate accompanying sheep casings from Canada must state that the 
casings meet the requirements of Sec.  96.2(b) and the certificate 
accompanying bovine casings must state that the casings meet the 
requirements of either Sec.  96.2(c)(1) or (c)(2) as applicable.
* * * * *

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

0
52. The authority citation for part 98 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
53. Section 98.11 is amended by adding definitions of camelid and 
cervid, in alphabetical order, to read as follows:


Sec.  98.11  Definitions.

* * * * *
    Camelid. All species of the family Camelidae, including camels, 
guanacos, llamas, alpacas, and vicunas.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species.
* * * * *

0
54. In Sec.  98.15, the introductory text of paragraph (a) is revised 
to read as follows:


Sec.  98.15  Health requirements.

* * * * *
    (a) The donor dam is determined to be free of communicable diseases 
based on tests, examinations, and other requirements, as follows, 
except that, with regard to bovine spongiform encephalopathy, the 
following does not apply to bovines, cervids, or camelids.
* * * * *

    Done in Washington, DC, this 19th day of November 2013.
Max T. Holtzman,
Acting Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2013-28228 Filed 12-3-13; 8:45 am]
BILLING CODE 3410-34-P