Federal Register, Volume 78 Issue 233 (Wednesday, December 4, 2013)

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Rules and Regulations]
[Pages 72980-73008]
From the Federal Register Online via the Government Publishing 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

[[Page 72980]]

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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

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,

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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 [email protected], 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