Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products, 15848-15913 [2012-6151]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Proposed Rules]
[Pages 15848-15913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6151]



[[Page 15847]]

Vol. 77

Friday,

No. 52

March 16, 2012

Part II





Department of Agriculture





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Animal and Plant Health Inspection Service





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9 CFR Parts 92, 93 et al.





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

Federal Register / Vol. 77 , No. 52 / Friday, March 16, 2012 / 
Proposed Rules

[[Page 15848]]


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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: Proposed rule.

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SUMMARY: We are proposing to amend 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 proposing to 
base importation conditions on the inherent risk of BSE infectivity in 
specified commodities, as well as on the BSE risk status of the region 
from which the commodities originate. We are proposing to establish 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 proposing for the importation 
of specified commodities are based on internationally accepted 
scientific literature and, except in a few instances, are consistent 
with guidelines set out in the OIE's Terrestrial Animal Health Code. We 
are also proposing to classify certain specified countries as to BSE 
risk and are proposing to remove BSE restrictions on the importation of 
cervids and camelids and products derived from such animals. We are 
proposing to make these amendments after conducting a thorough review 
of relevant scientific literature and a comprehensive evaluation of the 
issues and concluding that the proposed changes to the regulations 
would 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. In this document we are also affirming the 
position we took in removing the delay of applicability of certain 
provisions of the rule entitled ``Bovine Spongiform Encephalopathy; 
Minimal-Risk Regions and Importation of Commodities,'' published in the 
Federal Register on January 4, 2005 (70 FR 460-553). The delay of 
applicability was removed in a final rule entitled ``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).

DATES: We will consider all comments that we receive on or before May 
15, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2008-0010-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2008-0010, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2008-
0010 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.

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) 851-3364.
    For information regarding ruminant products and for other 
information regarding this proposed 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) 734-3277.

SUPPLEMENTARY INFORMATION: 

I. Overview

Background

    In order to guard against the introduction of animal diseases, the 
Animal and Plant Health Inspection Service (APHIS) 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 parts 92, 93, 94, 95, 96, and 98 of the U.S. Code of 
Federal Regulations (CFR) (referred to below as the regulations) govern 
the importation of certain animals, birds, poultry, meat, other animal 
products and byproducts, hay, and straw into the United States in order 
to prevent the introduction of various animal diseases, including 
bovine spongiform encephalopathy (BSE), a chronic degenerative disease 
that affects the central nervous system of cattle. In this document we 
are proposing to amend the import regulations related to BSE.

Nature of BSE

    BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). All TSEs affect the central nervous 
system of infected animals. However, the distribution of infectivity in 
the body of the animal and mode of transmission differ according to the 
species and the TSE agent. In addition to BSE, TSEs include, among 
other diseases, scrapie in sheep and goats, chronic wasting disease in 
deer and elk, and Creutzfeldt-Jakob disease in humans.
    The agent that causes BSE has yet to be fully characterized. The 
theory that is most accepted in the international scientific community 
is that the agent is an abnormal form of a normal protein known as 
cellular prion protein. The BSE agent does not evoke a traditional 
immune response or inflammatory reaction in host animals. BSE is 
confirmed by post-mortem examination of an animal's brain tissue, which 
may include detection of the abnormal form of the prion protein in the 
brain tissues. The pathogenic form of the protein is both less soluble 
and more resistant to degradation than the normal form. The BSE agent 
is resistant to heat and to normal sterilization processes.
    BSE is not a contagious disease, and therefore is not spread 
through casual contact between animals. Scientists believe that 
transmission is through ingestion of feed that has been contaminated 
with a sufficient amount of tissues or organs containing the BSE agent 
from an infected animal. This route of transmission can be prevented by 
excluding from ruminant feed tissues or organs that could potentially 
carry the BSE agent.
    Other characteristics of the BSE agent, as evidenced by 
epidemiology, transmission studies, and pathogenesis are discussed in 
detail in a final rule APHIS published in the Federal Register on 
September 18, 2007 (72 FR 53314-53379, Docket No. APHIS-2006-0041) and 
in the supporting scientific

[[Page 15849]]

documentation that was prepared for this proposed rule. (The supporting 
scientific documentation can be accessed at the APHIS Web site at 
https://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/RiskAssessment06-041-1%20.pdf).

Roles of Different Agencies

    APHIS, an animal health agency within USDA, promulgates its 
regulations regarding BSE under the authority of the Animal Health 
Protection Act (7 U.S.C. 8301 et seq.), which gives the Secretary broad 
discretion to regulate the importation of animals and animal products 
if necessary to protect the health of U.S. livestock.
    Because variant Creutzfeldt-Jakob Disease (vCJD) in humans has been 
linked to exposure to the BSE agent, APHIS collaborates with other 
Federal agencies with regulatory responsibility for assuring food 
safety and the protection of human health to implement a comprehensive 
coordinated U.S. response to BSE. Within USDA, protecting human health 
from the risks of BSE is carried out by the Food Safety and Inspection 
Service (FSIS), the agency charged with responsibility for 
administering the Federal Meat Inspection Act, which was enacted to 
ensure that meat and meat food products distributed in commerce are 
wholesome, not adulterated, and properly marked, labeled, and packaged. 
The USDA agencies carry out their programs in close coordination with 
the following Centers of the Food and Drug Administration (FDA) of the 
U.S. Department of Health and Human Services: The 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.

Rulemaking Regarding BSE

    The protective measures the Federal Government has taken have 
evolved over the years, as scientific understanding of the disease has 
increased. In 1989, APHIS prohibited the importation of live cattle and 
other ruminants and certain ruminant products, including most rendered 
protein products, into the United States from countries where BSE is 
known to exist, and codified this prohibition in the CFR on April 30, 
1991 (56 FR 19794-19796, Docket No. 90-252). The list of regions in 
which BSE is known to exist is set out in the current regulations in 
Sec.  94.18(a)(1).
    In June 1997, FDA prohibited the use of all mammalian protein--with 
the exception of pure pork and pure equine protein from single species 
processing plants and certain other materials--in animal feeds given to 
cattle and other ruminants, and established measures to protect against 
the contamination of ``allowable'' feed material with materials that 
could contain the BSE agent. We discuss this and other FDA actions 
regarding BSE in this document under the heading ``Evolution of U.S. 
Regulatory Response to BSE.''
    In rulemaking made effective December 12, 1997, and published in 
the Federal Register on January 6, 1998, APHIS added to the regulations 
a category of regions that pose an undue risk of introducing BSE into 
the United States. In the rulemaking document establishing that 
category (63 FR 406-408, Docket No. 97-127-1), we explained that our 
decision to add the category was based on developments that led us to 
believe that, at the time, the BSE agent might have been present but as 
yet undetected throughout Europe. We noted that the Netherlands, 
Belgium, and Luxembourg had recently reported their first case of BSE 
in native-born cattle. Additionally, we noted that Belgium and 
Luxembourg had reported that cattle diagnosed with BSE had 
inadvertently been processed into the animal food chain. We concluded 
that, because of the movement of ruminants and ruminant products within 
Europe, the possibility existed that this potentially contaminated 
animal feed might have been moved to other European countries.
    In our 1997 rulemaking, we applied the same import prohibitions and 
restrictions to regions of undue risk for BSE that were being applied 
to regions listed as those in which BSE is known to exist. The list of 
regions of undue risk for BSE is set out in the current regulations in 
Sec.  94.18(a)(2). Imports from any region not listed in either of 
those two categories were not subject to any BSE prohibitions or 
restrictions.
    In December 2000, APHIS expanded its prohibitions on imports of 
rendered ruminant protein products from BSE-restricted regions to 
include rendered protein products of any animal species because of 
concern that cattle feed supposedly free of ruminant protein may have 
been cross-contaminated with the BSE agent (66 FR 42595-42601, Docket 
No. 00-121-1). FDA also issued import alerts on animal feed ingredients 
for APHIS-listed countries.
    On November 4, 2003, APHIS published a proposed rule in the Federal 
Register (68 FR 62386-62405, Docket No. 03-080-1) in which we proposed 
to establish a category of regions that present a minimal risk of 
introducing BSE into the United States via live ruminants and ruminant 
products and byproducts, and to add Canada to this category. The 
proposal also set forth conditions for the importation of certain live 
ruminants and ruminant products and byproducts from BSE minimal-risk 
regions.
    In the November 2003 proposal, we set forth factors that would be 
taken into account in determining whether a country qualified as a BSE 
minimal-risk region. According to our proposed definition of a BSE 
minimal-risk region, such measures would include importation 
restrictions, surveillance, and a feed ban. With regard to a feed ban, 
we proposed that, to be recognized as a BSE minimal-risk region, a 
country must have in place a ban on the feeding of ruminant protein to 
ruminants that appears to be an effective barrier to the dissemination 
of the BSE infectious agent, with no evidence of significant 
noncompliance with the ban.
    On December 25, 2003, less than 2 weeks before the close of the 
comment period for the proposed rule, a case of BSE in a dairy cow of 
Canadian origin in Washington State was verified by an international 
reference laboratory. Subsequently, both FSIS and FDA implemented 
significant additional measures in the United States to protect human 
health. In addition, APHIS commenced an enhanced BSE surveillance 
program to determine the incidence of the disease in the United States.
    The measures taken by Federal agencies in January 2004 led to a 
change in APHIS' November 2003 proposed rule. Among the actions taken 
by FSIS to supplement its measures to prevent the BSE agent from 
entering the human food supply was to designate as specified risk 
materials (SRMs) certain tissues from cattle 30 months of age and 
older, and the tonsils and distal ileum of the small intestine of all 
cattle, and to prohibit their use as human food. FSIS also required all 
slaughtering and processing establishments to develop, implement, and 
maintain written procedures for the removal, segregation, and 
disposition of SRMs. FSIS did not restrict the age of cattle eligible 
for slaughter, because the removal of SRMs effectively mitigates the 
BSE risk to humans associated with cattle that pass

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both ante-mortem and post-mortem inspections (i.e., apparently healthy 
cattle). (We discuss below additional BSE-related regulatory actions 
taken by FSIS and FDA under the heading ``Evolution of U.S. Regulatory 
Response to BSE.'')
    The risk mitigation measures that FSIS implemented regarding 
slaughtered cattle had ramifications for the importation of bovine-
derived meat from other countries. Pursuant to the Federal Meat 
Inspection Act, countries that export meat to the United States must 
implement food safety requirements that are equivalent to those in 
place in the United States. To be eligible to export beef to the United 
States, a country must have in place a system to effectively keep SRMs 
out of the production chain and to prevent cross-contamination of beef 
with SRMs. FSIS determined the SRM requirements implemented by Canada 
in July 2003 to be equivalent to FSIS' requirements. Additionally, 
FDA's feed ban prohibits most mammalian protein, including ruminant 
protein, from entering the ruminant feed chain in the United States.
    On March 8, 2004, APHIS published a document in the Federal 
Register (69 FR 10633-10636, Docket No. 03-080-2) explaining the 
effects on our proposed rule of the detection of BSE in the State of 
Washington in a cow imported from Canada and of the additional measures 
taken by FSIS, APHIS, and FDA. That document explained why the 
detection of an imported BSE-infected cow did not alter the conclusions 
we had reached in our original risk assessment. It explained further 
that, in fact, the resulting additional measures put in place by FSIS 
provided a basis for removing from the proposed provisions an age 
restriction on cattle from which meat would be derived for export to 
the United States. Accordingly, we proposed to allow the importation of 
beef derived from cattle of any age. To give the public additional time 
to comment on the proposal in light of these developments, we reopened 
and extended the comment period for an additional 30 days.
    On January 4, 2005, APHIS published in the Federal Register (70 FR 
460-553, Docket No. 03-080-3) a final rule that established the 
criteria for BSE minimal-risk regions, listed Canada as a BSE minimal-
risk region, and specified importation requirements for live animals, 
and meat products and byproducts. The final rule allowed the 
importation of meat from bovines of any age, as we had proposed on 
March 8, 2004. The final rule was scheduled to become effective on 
March 7, 2005.\1\
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    \1\ On March 2, 2005, Judge Richard F. Cebull of the U.S. 
District Court for the District of Montana ordered that the 
implementation of APHIS' January 4, 2005, final rule be 
preliminarily enjoined. On July 14, 2005, the U.S. States Court of 
Appeals for the Ninth Circuit ordered that the preliminary 
injunction order be vacated and the case remanded to the District 
Court.
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    In January 2005, BSE was confirmed in two cows in Canada.
    On March 11, 2005, APHIS published a document in the Federal 
Register (70 FR 12112-12113, Docket No. 03-080-6) that, pursuant to an 
announcement by the Secretary of Agriculture on February 9, 2005, 
delayed the applicability of the provisions of the January 2005 final 
rule as they applied to the importation from Canada of certain 
commodities, including meat, meat food products, and meat byproducts 
other than liver when derived from bovines 30 months of age or older 
when slaughtered. We discuss the delay of applicability in more detail, 
below.
    On August 18, 2005, APHIS published in the Federal Register (70 FR 
48494-48500, Docket No. 05-004-1) a proposed rule to amend the 
regulations by allowing, under certain conditions, the importation of 
whole cuts of boneless beef from Japan.
    On November 28, 2005, APHIS published in the Federal Register an 
interim rule (70 FR 71213-71218, Docket No. 03-080-8) that amended 
certain provisions established by the January 2005 final rule. The 
interim rule broadened the list of who is authorized to break seals on 
conveyances and allows transloading under supervision of products 
transiting the United States.
    On December 14, 2005, APHIS published a final rule in the Federal 
Register (70 FR 73905-73919, Docket No. 05-004-2) that made final its 
August 2005 proposed rule regarding certain cuts of boneless beef from 
Japan. The risk assessment conducted for that rulemaking examined the 
evidence supporting the safety of this commodity. This evidence and 
APHIS' conclusions were consistent with those of the World Organization 
for Animal Health (OIE) for trade in meat derived from cattle from 
regions of controlled risk for BSE. (The risk document, ``Analysis of 
Bovine Spongiform Encephalopathy (BSE) Risk to the U.S. Cattle 
Population from Importation of Whole Cuts of Boneless Beef from 
Japan,'' can be accessed at https://www.regulations.gov/#!documentDetail;D=APHIS-2005-0073-0002). The OIE is the international 
standard-setting organization for guidelines related to animal health.
    On March 14, 2006, APHIS published in the Federal Register a 
technical amendment (71 FR 12994-12998, Docket No. 03-080-9) that 
clarified our intent with regard to certain provisions in the January 
2005 final rule and corrected several inconsistencies within the rule.
    On August 9, 2006, APHIS published in the Federal Register a 
proposed rule (71 FR 45439-45444, Docket No. APHIS-2006-0026) that 
proposed to amend the provisions established by the January 2005 final 
rule by removing several restrictions regarding the identification of 
animals and the processing of ruminant materials from BSE minimal-risk 
regions, and by relieving BSE-based restrictions on hide-derived 
gelatin from BSE minimal-risk regions. We solicited comments concerning 
our proposal for 60 days ending October 10, 2006. On November 9, 2006, 
we published a document in the Federal Register (71 FR 65758-65759, 
Docket No. APHIS-2006-0026) reopening and extended the comment period 
until November 24, 2006.
    On January 9, 2007, APHIS published a proposed rule in the Federal 
Register (72 FR 1101-1129, Docket No. APHIS-2006-0041) that proposed to 
establish conditions for the importation of the following commodities 
from BSE minimal-risk regions: Live bovines for any use born on or 
after a date determined by APHIS to be the date of effective 
enforcement of a ruminant-to-ruminant feed ban in the region of 
export;\2\ blood and blood products derived from bovines; and casings 
and part of the small intestine derived from bovines.
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    \2\ Requiring that live bovines exported to the United States 
from BSE minimal-risk regions be born after the date of effective 
enforcement of a ruminant-to-ruminant feed ban is consistent with 
the OIE standards for the exportation of live bovines from countries 
classified by the OIE as having either a negligible or a controlled 
BSE risk. We consider effective enforcement to have been achieved 
after completion of the initial (or practical) period of 
implementation of a feed ban and after sufficient time has elapsed 
to allow most feed products to cycle through the system. The 
practical implementation period, which begins when the regulations 
are initially put in place, can be determined by evaluating 
implementation guidance and policies, such as allowing grace periods 
for certain aspects of the industry. In addition, the time necessary 
for initial education of industry and training of inspectors must be 
considered. After the practical implementation period is defined, we 
then consider the time necessary subsequent to practical 
implementation to allow most feed products to cycle through the 
system, given the management practices in the country. Effective 
enforcement does not necessarily mean that 100 percent compliance 
with the feed ban requirements will be achieved.
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    On September 18, 2007, APHIS published in the Federal Register (72 
FR 53314-53379, Docket No. APHIS-2006-0041) a final rule that adopted 
the

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changes to the regulations we had proposed in January 2007. 
Additionally, the September 2007 final rule removed the partial delay 
of applicability of the January 2005 final rule with respect to meat 
and certain meat products and byproducts derived from cattle over 30 
months of age.
    On January 18, 2008, APHIS published in the Federal Register a 
final rule (73 FR 3379-3385, Docket No. APHIS-2006-0026) that made 
final the provisions of our August 9, 2006, proposed rule, with some 
changes.
    On July 3, 2008, Judge Lawrence L. Piersol of the U.S. District 
Court for the District of South Dakota, in response to a motion filed 
in that Court, ordered USDA to provide the public with notice and a 
further opportunity to comment on the provisions of our January 2005 
final rule regarding the importation of beef from bovines 30 months of 
age or older when slaughtered, to consider comments made by interested 
parties, and to revise the rule as USDA deems necessary.
    On September 18, 2008, APHIS published a request for comments in 
the Federal Register (73 FR 54083-54089), in which we provided the 
public with such notice and further opportunity to comment. We 
solicited comments for 60 days ending November 17, 2008.
    In this document, we discuss the issues raised by commenters in 
response to our September 2008 request for comments and provide our 
responses to those comments. Following that discussion, we describe and 
discuss changes we are proposing to make to the APHIS BSE regulations. 
However, in order to present our responses to the comments and the 
changes we are proposing in the context of the available scientific 
research and empirical data regarding the transmission of BSE, we 
consider it necessary to first discuss what is known regarding SRMs and 
the role of feed bans in reducing BSE risk.

Tissue Localization

    Some bovine tissues have demonstrated infectivity, whereas others 
have not. Most of the information on the development and distribution 
of tissue infectivity in BSE-infected cattle has been derived from 
experimental pathogenesis studies conducted in the United Kingdom and 
Germany (Wells, et al., 1994; 1996; 1998; 1999; 2005; EFSA 2007; 
Hoffman 2007; Hoffman 2011). In these studies, cattle were deliberately 
infected with BSE through oral exposure to the brain tissue of cattle 
with confirmed BSE. Subsets of the experimentally infected cattle were 
killed at regular intervals as the disease progressed. At each 
interval, the tissues of the infected cattle were examined for 
histopathological changes consistent with BSE and for abnormal prion 
proteins. Also, at each interval, a mouse assay was done--i.e., tissues 
of the BSE-infected cattle were injected intracerebrally and 
intraperitoneally into different types of mice (e.g., wild mice and 
mice genetically altered to be highly susceptible to BSE) to identify 
those tissues of cattle containing infectivity.
    The first United Kingdom pathogenesis studies involved 30 animals, 
each of which received a single dose of 100g of infected brain at 4 
months of age (Wells, et al., 1994; 1996; 1998; 1999; 2005). This dose 
is probably 10-100 times greater than that associated with field 
exposure via feed (DEFRA, 2006). The studies demonstrate that in cattle 
infected with BSE, the total amount of infectivity in the animal, as 
well as the distribution of infectivity in the animal's body, changes 
over time (Wells, et al., 1994; 1996; 1998; 1999; 2005). The highest 
levels of infectivity were detected in the brain and spinal cord at the 
end stages of disease. Some cattle exhibited clinical signs of BSE as 
early as 35 months after oral exposure to the BSE agent. By 37 months 
after oral exposure, all five animals that were still alive 
demonstrated clinical evidence of BSE. Infectivity was found in cattle 
with clinical signs of BSE in the brain, spinal cord, DRG,\3\ 
trigeminal ganglia, and the distal ileum of the small intestine.
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    \3\ DRG are clusters of nerve cells attached to the spinal cord 
that are contained within the bones of the vertebral column. ``DRG'' 
as used in this document has the same meaning as the term ``dorsal 
spinal nerve root ganglia.'' Trigeminal ganglia are clusters of 
nerve cells connected to the brain that lie close to the exterior of 
the skull.
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    BSE infectivity was demonstrated in the brain, spinal cord, and DRG 
as early as 32 months after oral exposure to the BSE agent in some 
cattle (Wells, et al., 1994; 1996; 1998; 1999; 2005). Infectivity was 
demonstrated in these tissues 3 months before animals began to develop 
clinical signs of the disease. Infectivity was demonstrated in the 
distal ileum of cattle 6 to 18 months after oral exposure to the BSE 
agent and again at 38 months and 40 months after oral exposure. A 
similar study (Espinosa, et al., 2007) examined the infectivity of 
tissues from these same animals by intracerebral inoculation of highly 
sensitive transgenic mice overexpressing bovine PrP (prion protein). 
This study's findings were similar to those of Wells, et al., described 
above. In addition, infectivity in the sciatic nerve was found at low 
levels only after 30 months from exposure. No detectable infectivity 
was found in the spleen, skeletal muscle, blood, or urine of 
asymptomatic cattle.
    As explained by the United Kingdom's Department for Environment, 
Food and Rural Affairs (DEFRA) and by the European Commission's 
Scientific Steering Committee, a second phase of the pathogenesis 
studies, which used a cattle bioassay as an endpoint, was conducted to 
ensure that low levels of infectivity that may not have been detected 
in the first phase using the mouse bioassay were not missed (DEFRA, 
2006; EC SSC 2002). This second phase of the study was completed in 
March 2007 (Gerald Wells, personal communication, 2008).
    In the cattle bioassay, tissues from the same cattle orally exposed 
to BSE in the earlier pathogenesis studies were injected directly into 
the brain of BSE-free cattle (DEFRA, 2006). This method is considered 
to be several hundred-fold more sensitive in detecting BSE infectivity 
than the mouse bioassay (DEFRA, 2006). Preliminary results from the 
cattle bioassay study demonstrate that, in addition to the materials 
that were found to contain infectivity when the mouse bioassay was 
used, the tonsils of calves 10 months after oral exposure to the BSE 
agent also contain infectivity. However, because only one of five 
animals injected with tonsil material from infected animals developed 
clinical BSE at 45 months post-inoculation, the level of infectivity in 
the tonsils appears to be very low.
    BSE infectivity has not been demonstrated in the muscle tissue of 
BSE-infected cattle examined in these studies through either the mouse 
bioassay or the cattle assays (Wells 1996; 2005; personal communication 
2008). All assays of the skeletal muscle pools were completed in March 
2007 (Wells, personal communication 2008).
    A larger pathogenesis study conducted in Germany involved calves 
that were orally challenged with macerated brainstems from BSE-positive 
cattle (EFSA 2007; Hoffman 2007). Every 4 months, randomly selected 
animals are euthanized and necropsied, and more than 150 tissue and 
bodily fluid samples are collected from each animal and analyzed by 
immunohistochemistry, pure-tone average Western blot, and transgenic 
mouse bioassay (TgbovXV). The initial results from the German BSE 
pathogenesis study demonstrate that BSE prions can reach the brain as 
soon as 24 months after a massive oral challenge (Hoffman 2007).
    In addition to these studies on experimentally infected cattle,

[[Page 15852]]

distribution of tissue infectivity has also been studied in cattle 
exposed to BSE under field conditions. In these animals, at the end 
stages of the incubation period with demonstrated clinical signs, BSE 
infectivity has been confirmed by mouse bioassay only in the brain, 
spinal cord, and retina of the eye (EC SSC 2001).
    In a 2005 study, mice genetically engineered to be highly 
susceptible to BSE and to overexpress the bovine prion protein were 
inoculated with tissues from an end-stage clinically affected BSE-
infected cow (Buschmann and Groschup, 2005). The sensitivity of these 
mice to infection is significantly greater than other mice panels used 
in bio-assays, and the sensitivity is even greater than that of cattle 
by approximately tenfold. Using these highly sensitive mice, this study 
demonstrated low levels of infectivity in the facial and sciatic nerves 
of the peripheral nervous system of the cow. While this study, and the 
2007 study by Espinosa, et al., produced interesting findings that can 
help further characterize the pathogenesis of BSE, they cannot be 
extrapolated into the context of the risk presented by natural (i.e., 
field) exposure pathways. The findings may be influenced by the 
overexpression of prion proteins in these genetically engineered mice. 
Any apparent levels of infectivity are low in these extremely sensitive 
mice and would be even lower in other species such as cattle. Moreover, 
the route of administration to the mice was both intraperitoneal and 
intracerebral, both of which are very efficient routes of infection as 
compared to oral consumption.
    Tissues that have demonstrated infectivity, and thus are likely to 
contain the infectious BSE agent in infected cattle, are brain, tonsil, 
spinal cord, eyes, trigeminal ganglia, DRG, and distal ileum. 
Approximately 90 percent of the infectivity is associated with the 
brain, spinal column, DRG, and trigeminal ganglia. The remaining 10 
percent is associated with the infectivity in the distal ileum. In BSE, 
as with other TSEs, the total amount of infectivity in an animal 
increases throughout the incubation period, reaching the highest load 
at the end of that period, very close to the death of the animal. 
Infectivity is considered to increase exponentially, reaching 4.5 logs 
less than a clinical case at 50 percent of the incubation period and 3 
logs less than a clinical case by 70 percent of the incubation period 
(Comer and Huntly, 2003).
    All of this research has contributed to the definition of which 
tissues should be considered SRMs. Both the types of tissues and the 
understanding of the progression of the infectivity throughout the 
incubation period contribute to the definition of SRMs. Affiliated 
tissues or structures such as skull or vertebral column are also 
considered risk materials because of the difficulty in separating out 
small tissues such as DRG from the vertebral column. The risks 
associated with tissue localization can be mitigated by excluding SRMs 
from the food or feed chain or by excluding them completely from 
importation. FSIS and FDA regulations regarding SRMs, which we discuss 
below under the heading ``Evolution of U.S. Regulatory Response to 
BSE,'' are based on this scientific knowledge and an understanding of 
the mitigative effects of exclusion of SRMs (FSIS, 2004; 2004a; 2004b; 
2005; 2007; FDA, 2004; 2005; 2007; 2008).
    The measures taken by FSIS included declaring SRMs to be inedible 
and requiring their removal from cattle at slaughter. As noted above, 
even if a BSE-infected cow 30 months or older that was presented for 
slaughter were not exhibiting clinical signs of the disease and passed 
ante-mortem and post-mortem inspections, the removal of SRMs from the 
cow would effectively mitigate the BSE risk to humans.
    Within USDA, APHIS and FSIS review and consider carefully, on an 
ongoing basis, all BSE research regarding the definition of SRMs, as do 
other countries that participate in the OIE. U.S. regulations regarding 
SRM removal are consistent with international guidelines.

Feed Bans

    As noted, scientists believe that the route of field transmission 
in animals is through ingestion of feed that has been contaminated with 
tissues or organs containing the BSE agent from an infected animal. 
This route of transmission can be prevented by excluding potentially 
contaminated materials from ruminant feed.
    Experience internationally in countries with BSE has demonstrated 
that feed bans are effective control measures and that the incidence of 
BSE worldwide continues to decline because of these measures (OIE, 
2010). In the United States, prohibitions on the use of ruminant 
protein in ruminant feed are imposed by FDA to mitigate the risk of BSE 
transmission.
    Because of the demonstrated efficacy of an effectively enforced 
feed ban in reducing the possibility of exposure of cattle to the BSE 
agent, the OIE provides guidelines for trade in live cattle from 
regions that have reported BSE if such regions have an effective feed 
ban in place, provided the cattle were born after the date when the 
feed ban was effectively enforced.
    By eliminating transmission, an effective feed ban reduces the 
possibility of the existence of infected animals in a given cattle 
population, which in turn reduces further the chances of healthy 
animals being exposed to the BSE agent via subsequent recycling of 
infectivity.

September 2008 Request for Comments

    As we discussed earlier in this document, the final rule that APHIS 
published in January 2005 to establish criteria for BSE minimal-risk 
regions, list Canada as a BSE minimal-risk region, and specify 
importation requirements for live animals, and meat products and 
byproducts was the outcome of a rulemaking process that APHIS initiated 
in 2003 to update its BSE regulations to reflect the latest scientific 
data and knowledge of the disease.
    As discussed above, in our November 2003 proposal, we set forth 
factors that would be taken into account in determining whether a 
country qualified as a BSE minimal-risk region. According to our 
proposed definition of a BSE minimal-risk region, such measures would 
include importation restrictions, surveillance, and a feed ban. With 
regard to a feed ban, we proposed that, to be recognized as a BSE 
minimal-risk region, a country must have in place a ban on the feeding 
of ruminant protein to ruminants that appears to be an effective 
barrier to the dissemination of the BSE infectious agent, with no 
evidence of significant noncompliance with the ban.
    We explained the role a feed ban plays in reducing BSE risk, 
stating that the primary source of BSE infection is feed contaminated 
with the infectious agent, that scientific evidence shows that feed 
contamination results from the incorporation of ingredients that 
contain abnormal ruminant protein derived from specific tissues from 
infected animals, and that bans prohibiting incorporation of ruminant 
protein into ruminant feed are imposed to mitigate risk (Wilesmith, et 
al., 1988; 1991; 1992).
    In subsequent rulemaking documents, we elaborated further on the 
role and effect of a feed ban. In our January 2007 proposed rule, which 
we described earlier in this document, we discussed data associated 
with a ruminant-to-ruminant feed ban in the United Kingdom and 
indicated that experience in the United Kingdom demonstrates that 
implementation of a ruminant-to-ruminant feed ban causes BSE

[[Page 15853]]

prevalence to decrease. We noted that as a result of reducing the 
recycling of infectivity in the United Kingdom, the annual incidence of 
BSE fell by 99.4 percent, from 36,680 animals in 1992 to 203 in 2005 
(DEFRA 2006a) and concluded that there is every reason to expect 
downward pressure on the prevalence of BSE in any country that 
implements a feed ban.
    The conditions for the importation of ruminant products and 
byproducts from BSE minimal-risk regions that we proposed in November 
2003 were proposed as changes to parts 94 and 95 of the regulations. 
The commodities addressed by the proposed changes to part 94 included 
meat and other edible products derived from ruminants. Part 95 
addressed the importation of byproducts derived from ruminants.

Changes Regarding the Importation of Meat From Bovines Proposed in 
November 2003

    As set forth in our November 2003 proposed rule, the provisions in 
part 94 for the importation of meat derived from bovines from BSE 
minimal-risk regions required that the following conditions be met:
     The meat is derived from bovines that were less than 30 
months of age when slaughtered and that are not known to have been fed 
ruminant protein, other than milk protein, during their lifetime;
     The bovines from which the meat is derived were 
slaughtered at a facility that either slaughters only bovines less than 
30 months of age or complies with a segregation process approved by the 
national veterinary authority of the region of origin and the APHIS 
Administrator as adequate to prevent contamination or commingling of 
the meat with products not eligible for importation into the United 
States;
     The intestines of the bovines were removed at slaughter; 
and
     The product qualifies as meat under the definition of meat 
in the FSIS regulations at 9 CFR 301.2.
    As noted, one of the conditions for the importation of bovine-
derived meat from BSE minimal-risk regions was that the bovines from 
which the meat is derived be less than 30 months of age when 
slaughtered. The relevance of the age of the animal to the risk of BSE, 
which we explained earlier in this document under the heading ``Tissue 
Localization,'' pertains to which tissues in a BSE-infected bovine have 
been demonstrated to contain BSE infectivity and the age at which a 
BSE-infected animal has been found to show infectivity in those 
tissues. In essence, as we stated in our November 2003 proposed rule, 
the proposed restriction on the age of the animals from which the 
commodity was derived was a measure to guard against the importation 
of, or contamination of meat through contact with, SRMs.
    As noted above, after a BSE-infected cow of Canadian origin was 
discovered in Washington State in December 2003, both FSIS and FDA 
implemented significant additional measures in the United States to 
protect human health. Among the measures taken by FSIS and FDA was to 
declare SRMs to be inedible and require their removal from cattle at 
slaughter. FSIS 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 DRG of cattle 30 months of age or older, 
and the tonsils and distal ileum of the small intestine of all cattle. 
To ensure effective removal of the distal ileum, FSIS also required all 
slaughtering and processing establishments to develop, implement, and 
maintain written procedures for the removal, segregation, and 
disposition of SRMs. Establishments were specifically required to 
implement procedures to address the potential contamination of edible 
materials with SRMs before, during, and after entry into the 
establishment. As noted above, FSIS did not restrict the age of cattle 
eligible for slaughter. Even if a BSE-infected cow 30 months or older 
that was presented for slaughter were not exhibiting clinical signs of 
the disease and passed ante-mortem and post-mortem inspections, the 
removal of SRMs from the cow would effectively mitigate the BSE risk to 
humans.
    As discussed above, pursuant to the Federal Meat Inspection Act, 
implementation in the United States of those mitigation measures by 
FSIS meant that any country seeking to export beef to the United States 
would have to have equivalent mitigation measures in place. FSIS 
determined the SRM requirements implemented by Canada in July 2003 to 
be equivalent to FSIS' requirements.
    As noted above, in March 2004, APHIS published a proposed rule and 
reopening of comment period in the Federal Register in which we 
explained why the detection of an imported BSE-infected cow did not 
alter the conclusions we had reached in the assessment of risk on which 
our November 2003 proposed rule was based. We explained further that, 
in fact, the resulting additional measures put in place by FSIS (i.e., 
declaring SRMs to be inedible and requiring their removal from cattle 
at slaughter) provided a basis for our removing from the provisions we 
had proposed in November 2003 the age restriction on cattle from which 
meat could be derived for export to the United States. In the March 
2004 proposed rule and reopening of comment period, we stated that we 
did not believe it was necessary to require that beef imported from BSE 
minimal-risk regions be derived only from cattle less than 30 months of 
age, provided measures equivalent to those established by FSIS in the 
United States to ensure that SRMs are removed when the animals are 
slaughtered are in place in the exporting country and that such other 
measures as are necessary are in place.
    As noted above, in January 2005 we published in the Federal 
Register a final rule that established the criteria for BSE minimal-
risk regions, listed Canada as a BSE minimal-risk region, and specified 
conditions for the importation from BSE minimal-risk regions for live 
animals and meat, meat byproducts, and meat food products. For the 
reasons we discussed in our March 8, 2004, Federal Register document, 
the final rule did not limit the importation of bovine-derived meat 
from Canada to that derived from cattle younger than 30 months of age. 
In the final rule, we set forth in part 94 the following conditions for 
the importation from BSE minimal-risk regions of meat, meat byproducts, 
and meat food products derived from bovines:
     The bovines from which the meat, meat byproduct, or meat 
food product is derived have been subject to a ruminant feed ban 
equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000;
     The meat, meat byproduct, or meat food product is derived 
from bovines for which an air-injected stunning process was not used at 
slaughter; and
     The SRMs and small intestine of the bovines were removed 
at slaughter.
    As noted above, in March 2005, APHIS published a document in the 
Federal Register that, pursuant to an announcement by the Secretary of 
Agriculture on February 9, 2005, delayed the applicability of the 
provisions of the January 2005 final rule as they applied to the 
importation from Canada of the following commodities when derived from 
bovines 30 months of age or older when slaughtered: (1) Meat, meat food 
products, and meat byproducts other than liver; (2) whole or half 
carcasses; (3) offal; (4) tallow composed of less than 0.15 percent 
insoluble impurities that is not otherwise eligible for importation 
under 9 CFR 95.4(a)(1)(i); and (5) gelatin

[[Page 15854]]

derived from bones of bovines that is not otherwise eligible for 
importation under 9 CFR 94.18(c).
    In his February 9, 2005, announcement, the Secretary stated that, 
because ongoing investigations into the January 2005 finds of BSE in 
Canada in animals over 30 months of age were not complete, he felt it 
prudent to delay the effective date for allowing imports of meat from 
bovines 30 months of age and over. He also indicated that the delay of 
applicability would address concerns that the January 2005 final rule 
allowed the importation of meat from bovines 30 months of age or older 
while continuing to prohibit the importation of live cattle 30 months 
of age or older for processing in the United States. The Secretary 
stated that the Department would consider and develop a plan--based on 
the latest scientific information and with the protection of public and 
animal health as the highest priority--to allow imports of live bovines 
30 months of age or older.
    As discussed earlier in this document, in January 2007 we published 
a proposed rule in the Federal Register to, among other things, 
establish conditions for the importation from BSE minimal-risk regions 
of live bovines for any use born on or after a date determined by APHIS 
to be the date of effective enforcement of a ruminant-to-ruminant feed 
ban in the region of export.
    As noted above, in September 2007, we published a final rule in the 
Federal Register that adopted the changes to the regulations we had 
proposed in January 2007. Additionally, the September 2007 final rule 
removed the partial delay of applicability of the January 2005 final 
rule with respect to meat and certain meat products and byproducts 
derived from cattle over 30 months of age that we addressed in our 
March 2005 notice. In our September 2007 final rule, we stated that, 
subsequent to implementation of the partial delay of applicability, 
``we [had] obtained additional information regarding all aspects of the 
issues that prompted the delay of applicability and [had] conducted 
additional analyses'' as indicated by the Secretary in February 2005 to 
allow imports of live bovines 30 months of age or older (72 FR 53316).
    As we concluded in our September 2007 final rule, the risk 
assessment for that final rule demonstrates the negligible BSE risk 
from the importation of additional classes of live bovines, including 
those 30 months of age or older.

II. Issues Raised in Response to Request for Comments

    The September 2007 final rule, which included the removal of the 
partial delay of applicability of the provisions of the January 2005 
rule relating to meat derived from cattle 30 months of age or older, 
became effective on November 19, 2007.
    As noted above, on September 18, 2008, we published in the Federal 
Register a document that provided the public with notice and further 
opportunity to comment on the provisions of our January 2005 final rule 
regarding the importation from BSE minimal-risk regions of beef from 
bovines 30 months of age or older when slaughtered, for which the delay 
of applicability was removed in our September 2007 final rule. We 
solicited comments for 60 days ending November 17, 2008.
    We received 12 comments by that date, including one submission that 
included a compilation of comments from a large number of individuals. 
The comments were from individual private citizens; associations of 
producers of livestock and other agricultural commodities, both in the 
United States and Canada; associations of meat processors; a consumer 
organization; and the Government of Canada. We carefully considered all 
comments received and we discuss in the following section the issues 
raised by the commenters and our response to those issues.

Comments in Support of the Removal of the Delay of Applicability

    Five of the comments expressed support for the removal of the delay 
of applicability of provisions of our January 2005 final rule.
    The remainder of the commenters opposed the removal of delay of 
applicability. Of those commenters, several provided no information to 
support their opposition. Others expressed general concern that 
allowing the importation of bovines and commodities derived from 
bovines from BSE minimal-risk regions would create an unacceptable 
disease risk. We discuss in the following section specific issues 
raised by commenters who opposed the removal of delay of applicability.

Meat Derived From Bovines Less Than 30 Months of Age

    As noted above, one of the import conditions in the November 2003 
proposed rule was that meat imported from bovines slaughtered in BSE 
minimal-risk regions be derived from bovines less than 30 months of age 
when slaughtered. Also as noted, in March 2004 we published a proposed 
rule and a reopening of the comment period for the November 2003 
proposed rule. We explained in that document that we believed BSE risk 
mitigation measures implemented by FSIS subsequent to our November 2003 
proposed rule provided a basis for removing from the proposed 
provisions the requirement that beef imported from BSE minimal-risk 
regions be derived only from cattle less than 30 months of age, with 
the provision that equivalent measures are in place to ensure that SRMs 
are removed when the animals are slaughtered and that such other 
measures as are necessary are in place.
    Issue: In our September 2008 request for comments, we included a 
chronology of the relevant rulemaking documents that had preceded the 
request for comments and referenced our March 2004 proposed rule and 
reopening of the comment period for the November 2003 proposed rule. 
One commenter stated that, in our September 2008 document, we 
mischaracterized our March 2004 proposed rule and reopening of the 
comment period as proposing to allow the importation from BSE minimal-
risk regions of beef derived from cattle of any age. The commenter 
stated that the March 2004 proposed rule and reopening of the comment 
period 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.
    Response: When we stated in our September 2008 request for comments 
that our March 2004 proposed rule and reopening of the comment period 
proposed to allow the importation of beef derived from cattle of any 
age, our intent was to explain that, under the provisions of the March 
2004 proposed rule and reopening of the comment period, the fact that 
bovines from which meat and meat products intended for importation into 
the United States from a BSE minimal-risk region were 30 months of age 
or older when slaughtered would not in itself preclude the commodities 
from being imported. 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

[[Page 15855]]

consistent with that which we used in the risk analysis for our January 
2005 final rule (APHIS, 2004).
    Issue: One commenter noted that the risk assessment APHIS conducted 
for its January 2005 final rule identified as a requirement for the 
importation of bovine-derived meat and meat products from a BSE 
minimal-risk country that veterinary officials in the exporting country 
certify that the animals from which the meat and meat products were 
derived were subject to a feed ban considered equivalent to that in 
place in the United States. The commenter also noted that APHIS' 
November 2003 proposed rule included a requirement that bovine-derived 
meat imported from a BSE minimal-risk region be derived from bovines 
that were not known to have been fed ruminant protein, other than milk 
protein, during their lifetime.
    The commenter noted, further, that, in APHIS' September 2008 
request for comments, we stated that, with respect to the importation 
of meat, the 30-month age restriction contained in our November 2003 
proposed rule was a measure to guard against the importation of, or 
contamination of meat through contact with, tissues other than meat 
that have the potential of containing high levels of BSE infectivity. 
According to the commenter, that wording mischaracterized APHIS' 
rationale in the November 2003 proposed rule regarding the 30-month age 
restriction on bovines from which meat and meat products were derived. 
The commenter stated that APHIS' true intention regarding the 30-month 
age restriction was to prevent the importation of products derived from 
Canadian cattle that had been exposed to BSE infectivity.
    The commenter cited text from the risk assessment conducted for 
APHIS' 2005 final rule that stated that the risk of introducing BSE 
infectivity can be reduced by requiring that animals presented for 
export and animals from which meat or meat products intended for export 
were derived were subject to a ruminant feed ban. Additionally, the 
commenter cited text from (1) APHIS' November 2003 proposed rule that 
stated that animals, and the products derived from those animals, will 
present a lower risk if the animals were born after the implementation 
of an effective feed ban and (2) from the risk assessment APHIS 
conducted for its January 2005 final rule that stated that, in 
addition, Canadian cattle less than 30 months of age would have been 
born and raised during a time when the Canadian feed ban had been in 
place for more than 5 years, and, based on evidence of a high level of 
compliance with the feed ban, are unlikely to have been exposed to the 
BSE agent.
    The commenter discussed APHIS' provisions regarding two specific 
products derived from bovines--tongues and liver--to support the 
commenter's contention that APHIS' true intent regarding the 30-month 
age restriction on bovines from which meat and meat products are 
derived was to prevent the importation of products derived from 
Canadian cattle that had been exposed to BSE infectivity, rather than 
to guard against the importation of, or contamination of meat through 
contact with, tissues other than meat that have the potential of 
containing high levels of BSE infectivity.
    With regard to tongues, the commenter stated that APHIS' November 
2003 proposed rule would have allowed the importation of bovine 
tongues, even tongues derived from cattle 30 months of age or older, 
despite the fact that APHIS acknowledged that tongues are connected to 
and bear the risk of contamination by tonsils, which the commenter 
stated have the potential of containing high levels of BSE infectivity. 
The commenter stated that, to mitigate this risk, APHIS proposed to 
require that tongues be derived from cattle from which the tonsils were 
removed at slaughter and that were born after the implementation of an 
effective feed ban and were not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    The commenter pointed to a similar situation regarding bovine-
derived liver from BSE minimal-risk regions. The commenter stated that 
APHIS' November 2003 proposed rule would have allowed the importation 
of liver that was not subject to the 30-month age restriction, even 
though, according to APHIS, it was susceptible to contamination by 
brain emboli, tissues that have the potential of containing high levels 
of BSE infectivity. The commenter noted that, in APHIS' November 2003 
proposed rule, the only mitigation of the potential for the 
contamination of liver by the BSE agent was the requirement that the 
liver not be derived from cattle for which an air-injected stunning 
process was used at slaughter. The commenter noted that in APHIS' 
January 2005 final rule, however, the importation of liver from BSE 
minimal-risk regions was governed by the same conditions as those set 
forth for other types of meat from bovines, including the requirement 
that liver be derived from bovines that were subject to a ruminant feed 
ban.
    Response: We consider the commenter's assertion to be inconsistent 
with APHIS' stated intent in its rulemaking documents and supporting 
risk analyses, with the regulatory provisions of previous rulemaking 
documents, and with internationally accepted scientific literature.
    In presenting the issues noted above, the commenter seems to be 
incorrectly concluding that two separate risk mitigation measures we 
included in our November 2003 proposed rule--(1) a prohibition on the 
importation from BSE minimal-risk regions of bovine-derived meat and 
meat products from animals that were 30 months of age or older when 
slaughtered, and (2) a requirement that the animals from which the 
commodities were derived were subject to a ruminant feed ban--were 
intended to mitigate BSE risk in the same way, i.e., by preventing the 
importation of products derived from Canadian cattle that had been 
exposed to BSE infectivity.
    The commenter's characterization of APHIS' rationale for the 30-
month age restriction is inconsistent with the explanation we provided 
in our November 2003 proposed rule. In the November 2003 proposed rule, 
we explained in detail the likelihood that specific tissues in a BSE-
infected bovine of a certain age will contain the disease agent and how 
that likelihood influences the risk of BSE transmission from an 
infected animal. We stated in the proposed rule that ``levels of 
infectious agent in certain tissues vary with the age of an animal, so 
the age of the animal influences risk'' (68 FR 62390), then discussed 
in detail the research findings supporting that statement. We concluded 
our discussion of the influence of the age of the animal on BSE risk by 
stating that ``because BSE infectivity has not been found in most 
bovine tissues until at least 32 months post-exposure, we believe that 
by requiring that bovines imported into the United States from BSE 
minimal-risk regions be less than 30 months of age, the risk of the BSE 
agent being present at infectious levels in most tissues in the animal 
is minimized.'' (62 FR 62391)
    As we discuss earlier in this document, in our March 2004 proposed 
rule and reopening of the comment period, we explained that, in light 
of the SRM removal requirements implemented in the United States by 
FSIS following the diagnosis of BSE in Washington State in December 
2003 in a cow imported from Canada, we did not believe it would be 
necessary to require that beef imported from BSE minimal-risk regions 
be derived only from cattle less than 30 months of age, provided 
equivalent measures are in place to ensure that SRMs are removed

[[Page 15856]]

when the animals are slaughtered, and that such other measures as are 
necessary are in place. In our September 2007 final rule, we emphasized 
that the removal and disposal of SRMs is the key factor in the food 
safety of products from bovines used for human consumption.
    The ``other measures'' regarding the importation of bovine-derived 
meat, meat byproducts, and meat food products and meat products from 
BSE minimal-risk regions set forth in our January 2005 final rule were 
that (1) the commodity be derived from bovines that have been subject 
to a ruminant feed ban equivalent to the requirements established by 
FDA in the United States and (2) the commodity be derived from bovines 
for which an air-injected stunning process was not used at slaughter.
    As the commenter noted, effective enforcement of a ruminant-to-
ruminant feed ban reduces the risk that an animal will be exposed to 
the BSE agent. However, the removal of SRMs from bovines is an 
effective means of mitigating the risk of BSE transmission to humans 
from meat, meat products, and meat byproducts derived even from an 
exposed animal. In comparison, the BSE regulations for live bovines 
imported from a BSE minimal-risk region require that the animals were 
born after the date of effective enforcement of a ruminant-to-ruminant 
feed ban to reduce the likelihood that a BSE-infected live animal is 
imported into the United States.
    Requiring that SRMs be removed from bovines from which meat and 
meat products are derived, as is required in both the United States and 
Canada, ensures that tissues containing BSE infectivity are removed 
even from a BSE-infected animal that might be presented for slaughter 
showing no visible signs of BSE. We note that the OIE Code for trade in 
fresh meat and meat products from cattle from countries of controlled 
BSE risk (both Canada and the United States are classified as countries 
of controlled BSE risk by the OIE) recognizes the negligible risk 
presented by such products as long as SRMs are removed. Therefore, the 
Code does not recommend that the date of birth of the animal from which 
the commodity was derived be a condition for such trade, or that the 
commodity be accompanied by certification that the animal was subject 
to a feed ban.
    APHIS' confidence in the effectiveness of SRM removal in reducing 
BSE risk was demonstrated in a final rule that APHIS published in 
December 2005 to allow the importation, under certain conditions, of 
boneless beef from Japan. Although that rulemaking differs from the 
rulemaking APHIS conducted regarding BSE minimal-risk regions in the 
sense that the only commodity addressed in the Japan rulemaking was 
boneless beef--whereas a more extensive list of commodities was made 
eligible for importation into the United States from BSE minimal-risk 
regions--it is significant to note that the conditions in Sec.  94.27 
of the regulations for the importation of boneless beef from Japan do 
not include the requirement that the bovines from which the beef was 
derived were subject to a feed ban. The requirements for the 
importation of boneless beef from Japan are that it be prepared in an 
establishment eligible to have its products imported into the United 
States under the Federal Meat Inspection Act and the FSIS regulations 
in 9 CFR 327.2, that it meet all other applicable requirements of the 
Federal Meat Inspection Act and regulations thereunder (9 CFR chapter 
III), including the requirements for the removal of SRMs and the 
prohibition on the use of air-injection stunning devices prior to 
slaughter on cattle from which the beef is derived, and that it be 
derived from cattle that were not subjected to a pithing process at 
slaughter.
    Although a ruminant-to-ruminant feed ban reduces the possibility of 
exposure of bovines to the BSE agent and is an important measure in 
mitigating the risk that BSE will be transmitted in a region, it serves 
a different role in BSE mitigation than does SRM removal.
    Issue: One commenter stated that APHIS, in its September 2008 
request for comments, explained that the conclusion reached in the risk 
assessment for the September 2007 final rule regarding the negligible 
BSE risk from the importation of cattle from Canada, even those 30 
months of age older, gave further support to the conclusion of the risk 
analysis conducted for APHIS' 2005 final rule that the importation of 
meat and meat products derived from bovines from BSE minimal-risk 
regions posed a low BSE risk, provided certain conditions were met.
    The commenter stated that both the risk assessment for APHIS' 2007 
final rule regarding the importation of live older bovines and the risk 
assessment for APHIS' 2005 final rule were predicated on a bovine's 
being subject to a feed ban during its entire lifetime and that neither 
the January 2005 final rule nor the risk analysis that accompanied that 
rule addressed the risk of BSE contamination in meat or meat products 
derived from cattle that were born prior to the date of effective 
enforcement of Canada's feed ban. Therefore, stated the commenter, 
APHIS had no basis to lift its restriction on the importation of beef 
from Canadian cattle that were over 30 months of age when slaughtered.
    The commenter stated further that APHIS, in its September 2007 
final rule, deleted from the regulations without explanation the 
requirement that bovine-derived meat and meat products imported from a 
BSE minimal-risk region be derived from an animal that had been subject 
to a feed ban.
    Response: The commenter is incorrect in stating that the September 
2007 final rule removed the requirement that bovine-derived meat and 
meat products, and certain byproducts, imported from a BSE minimal-risk 
region be derived from animals that had been subject to a feed ban.
    With regard to the commenter's discussion of the wording we used in 
our September 2008 request for comments in referring to our risk 
assessments, although we acknowledge that the wording we used in that 
document could be interpreted in several ways, our intent was to 
compare the likelihood of BSE introduction into the United States 
through the importation of live bovines from Canada with the likelihood 
of BSE introduction through the importation of bovine-derived meat and 
meat products from Canada. In making such a comparison, we referred to 
the risk assessments for our January 2005 and September 2007 final 
rules, in which we explained in detail the role of SRMs in BSE 
transmission and the effectiveness of reducing the likelihood of BSE 
transmission through the removal of SRMs at slaughter. Our point was 
that, if, as we concluded in our September 2007 final rule, the risk of 
BSE exposure in the United States from the importation of live 
bovines--with SRMs intact--from Canada is negligible, then the 
importation of bovine-derived meat and meat products from Canada would 
present even less of a risk, because the SRMs from the bovines from 
which the meat and meat products were derived would have been left 
behind in Canada.

Effectiveness of Canadian Inspection System

    As discussed above, one of the required risk mitigation measures 
for bovine-derived meat and meat products imported from Canada is that 
the SRMs of the bovines from which the commodities are derived were 
removed at slaughter.

[[Page 15857]]

    Issue: Several commenters expressed concern about the ability of 
Canadian food inspectors to ensure that meat products are free from 
SRMs. One commenter stated that, in a 2007 audit of Canadian food 
establishments eligible to export to the United States, FSIS reported 
the following: ``Inspection system controls at all levels were not 
fully developed and implemented. There were many instances of 
deficiencies both in the documentation reviews and in the operations 
audits that should have been addressed prior to the FSIS audit. Some 
inspection personnel were not well-trained in the performance of their 
inspection tasks.'' (The commenter cited ``Food Safety and Inspection 
Service, United States Department of Agriculture, ``Final Report of an 
Audit Carried Out in Canada Covering Canada's Meat, Poultry, and Egg 
Products Inspection System, May 1 through June 6, 2007'', https://
www.fsis.usda.gov/OPPDE/FAR/Canada/Canada2007.pdf.'')
    Response: In addressing this issue, FSIS has stated that, with 
respect to the FSIS audit of Canada in 2007, FSIS specifically assessed 
controls for SRM removal in Canada and identified no related 
deficiencies. With regard to the other deficiencies identified in the 
2007 audit, FSIS stated that none caused FSIS to question whether the 
Canadian inspection system was adequate with regard to SRM control. 
FSIS has included a review of controls for SRM removal in its audits 
since 2005. In each review--including audits conducted in February 
2005, April-May 2006, May-June 2007, and May-June 2008--no deficiencies 
were noted in relation to SRM removal and other BSE-related 
requirements.
    Issue: One commenter stated that the Canadian Food Inspection 
Agency (CFIA) is considering weakening government food inspection and 
turning the inspection process over to industry and that further 
deregulation of meat inspection in Canada would endanger U.S. public 
health.
    Response: In addressing this issue, FSIS has informed APHIS that 
FSIS has been in contact with CFIA, including follow-up discussions 
about possible changes to the inspection system in Canada. FSIS is not 
aware of any substantive planned changes at this time. Any changes 
affecting meat, poultry, or processed egg product destined for the 
United States would require discussion related to equivalency to the 
U.S. inspection system.
    Issue: One commenter stated that, although APHIS' September 2008 
request for comments indicated that FSIS has determined that Canada has 
implemented food safety requirements that are equivalent to those in 
the United States, including Canada's July 2003 requirements regarding 
SRMs, there is a disparity between what FSIS is supposed to require of 
foreign plants that ship products to the United States and what is 
actually practiced.
    Response: In 2005, FSIS conducted an enforcement audit to evaluate 
Canada's implementation of SRM controls for products destined for the 
United States. FSIS concluded that SRM controls had been effectively 
implemented, in accordance with FSIS regulatory requirements, in 
Canadian establishments certified to export beef to the United States. 
The audit led to no delistments of eligible establishments, nor to any 
notices of intent to delist eligible establishments.\4\
---------------------------------------------------------------------------

    \4\ Delistment of an establishment removes it from the list of 
establishments authorized to export meat and meat products to the 
United States. A notice of intent to delist is issued to an 
establishment that conducts marginally acceptable practices, and 
puts it on notice that it will be delisted unless specified 
improvements are made.
---------------------------------------------------------------------------

    Issue: One commenter cited a December 2005 report by the USDA's 
Office of Inspector General (OIG) that stated, in part:

    In July 2003, FSIS found that Canadian inspection officials were 
not enforcing pathogen reduction and HACCP system regulations. These 
same types of concerns were identified again in June 2005, almost 2 
years later. However, as of September 2005, FSIS has not made a 
determination whether the identified concerns are serious enough to 
limit the import of Canadian products. As a result, FSIS has allowed 
the importation of almost 700 million pounds of meat and poultry 
from plants that did not receive daily inspection, a requirement for 
all U.S. meat and poultry plants. Additionally, FSIS allowed the 
import of over 261 million pounds of ready-to-eat meat and poultry 
that had not been subjected to finished product testing for Listeria 
monocytogenes, as is required of U.S. plants. (The commenter cited 
``Audit Report Food Safety and Inspection Service Assessment of the 
Equivalence of the Canadian Inspection System, U.S. Department of 
Agriculture, Office of Inspector General, Northeast Region, Report 
No. 24601-05-Hy, December 2005, at 4.'')

    The commenter stated that, according to the OIG, FSIS does not have 
protocols or guidelines for evaluating deficiencies in a country's 
inspection system that could jeopardize a country's overall equivalence 
determination and that FSIS did not institute compensating controls to 
ensure that public health was not compromised while deficiencies were 
present.
    Response: As noted in the OIG report, FSIS addressed audit 
deficiencies with CFIA officials during and immediately following the 
2003 and 2005 audits. For those deficiencies that had potential impact 
on public health, FSIS auditors required the establishments to take 
immediate corrective actions. In some instances, FSIS also required 
enforcement action to be taken by Canadian authorities. These 
enforcement actions included immediate delistment of the establishment 
or the issuance of a warning letter requiring specific corrective 
actions within 30 days. FSIS' analysis of the audit reviews have 
identified and resolved all potential public health concerns.
    Issue: One commenter stated that, in a follow-up report issued by 
the OIG in August 2008, the OIG reported that FSIS could not 
demonstrate that the number of intensified inspections for physical and 
laboratory failures provided the appropriate level of protection to 
ensure the safety and wholesomeness of imported products.
    Response: In response to Recommendation 8 of OIG audit 
24601-08-Hy, FSIS agreed with OIG's findings and stated that FSIS would 
determine the appropriate number of intensified inspections needed 
following physical and laboratory failures to ensure the safety and 
wholesomeness of imported products.\5\ After further analysis of 
available data, FSIS determined that the current number of intensified 
inspections for laboratory and physical failures is sufficient and 
appropriately established. Thus, according to FSIS, further revisions 
to the FSIS procedures for intensified inspections are unnecessary.
---------------------------------------------------------------------------

    \5\ Intensified inspections are triggered after a product fails 
to pass reinspections for physical and laboratory testing. If the 
level of inspection is increased, FSIS management officials have 
decided to perform reinspection activities above the normal level of 
inspection for a lot, based on problems associated with the specific 
product, foreign establishment, or country.
---------------------------------------------------------------------------

    Issue: One commenter stated that the OIG found that FSIS could not 
demonstrate that it performed an adequate sampling of foreign 
establishments to validate that the country's inspection system is 
equivalent to that in the United States. The commenter stated, further, 
that the OIG found that FSIS did not visit the minimum number of 
establishments necessary to validate that inspection systems were 
equivalent to that in the United States in three of the four countries 
it reviewed and questioned whether FSIS had sufficient data to conclude 
that these countries' inspection systems were equivalent to the U.S. 
system.

[[Page 15858]]

    Response: In response to Recommendation 2 of OIG audit 
24601-08-Hy, FSIS has developed and implemented a process to document 
the reasons for the number of establishments selected for an on-site 
country audit as part of the agenda for the pre-audit conference 
between FSIS and the foreign country. In addition, FSIS has implemented 
a statistically based sampling plan using a country's recent history of 
overall compliance with FSIS requirements, as well as information 
provided by the country on a continuous basis, in determining that the 
foreign country's inspection system is performing adequately.

Efficacy of SRM Removal in Mitigating the Risk of BSE

    Issue: One commenter stated that the risk modeling the commenter 
said APHIS relies on to support its claim that SRM removal alone is 
sufficient to mitigate the potential BSE risk to humans shows 
otherwise. The commenter stated that the risk modeling shows that there 
are two significant factors that contribute to the reduction in 
potential BSE risk to humans: (1) The amount of BSE infectivity in 
circulation (based on the number of BSE-infected cattle), and (2) 
compliance with SRM removal requirements. The commenter stated that the 
influence of the amount of BSE infectivity is demonstrated by the fact 
that when the 2005 risk model was updated to include the presence of 
BSE-contaminated poultry litter, resulting in more BSE-infected cattle, 
the effectiveness of SRM removal in reducing potential BSE risk to 
humans was decreased by nearly half (from 20 oral ID50s to 
11oral ID50s) \6\ even with perfect compliance with SRM 
removal requirements.\7\ (BSE infectivity is expressed in terms of 
cattle oral ID50s. A cattle oral ID50 is defined 
as the amount of infectivity required to cause infection in 50 percent 
of an exposed cattle population).
---------------------------------------------------------------------------

    \6\ BSE infectivity is expressed in terms of cattle oral 
ID50s. A cattle oral ID50 is defined as the 
amount of infectivity required to cause infection in 50 percent of 
an exposed cattle population.
    \7\ The commenter cites Harvard Risk Assessment of Bovine 
Spongiform Encephalopathy Update, Phase IA, Supplemental Simulation 
Results, December 26, 2006, Appendix 2A, Section 2.1.2c, line 15 (AR 
17464); see also Harvard Risk Assessment of Bovine Spongiform 
Encephalopathy Update, Phase IA, October 31, 2005, Appendix 2A, 
Section 2.1.2, line 15 (AR 17109).
---------------------------------------------------------------------------

    The commenter stated that the authors of the risk models further 
substantiated that the amount of circulating infectivity impacts human 
health even with perfect compliance by explaining why the potential 
risk to humans was reduced following a simulation that prohibited SRMs 
from being used in both human food and animal feed. The commenter 
quoted the authors of the risk model as stating:

    Removing infectious tissues from both human food and animal 
feed, assuming that the ban effectively covers dead stock, and 
assuming perfect compliance, together have a substantial impact on 
both the potential human exposure and the spread of BSE * * *. 
Potential human exposure decreases both because there are fewer BSE 
cases and because the measures remove infectious tissues from the 
human food supply. Average human exposure decreases by more than 99 
percent from 3,800 cattle oral ID50s to 10 oral 
ID50s.'' \8\
---------------------------------------------------------------------------

    \8\ The commenter cites the Harvard Risk Assessment of Bovine 
Spongiform Encephalopathy Update, Phase IA, October 31, 2005, at 29 
(AR 17086).

    Response: The commenter appears to be attempting to use various 
model results to suggest that the SRM restrictions simulated in the 
models are not sufficient to mitigate the public health risk when there 
are higher numbers of infected animals present. However, the model 
results themselves do not support this conclusion. To discuss the 
commenter's statements in meaningful context, it is necessary to first 
provide a history of the models and model runs referred to.
    In 2001, Harvard University provided USDA with the results of an 
extensive model that simulated the results of introducing BSE-infected 
cattle into the United States. This model has since been used and 
updated by both FSIS and APHIS at various times. These uses and updates 
include the following that are of significance and/or referenced in 
this docket:
     2004--FSIS used model runs as part of their ``Preliminary 
Analysis of Interim Final Rules and an Interpretive Rule to Prevent the 
BSE Agent from Entering the U.S. Food Supply.''
     October 2005--FSIS asked Harvard to update the model and 
run several simulations, and these were published for public comment 
``Harvard Risk Assessment of BSE Update; Phase IA, October 31, 2005.''
     December 2006--FSIS/Harvard incorporated changes based on 
public comment from the October 2005 simulations. This was made public, 
along with the responses to the public comments as ``Harvard Risk 
Assessment of BSE Update; Phase IA; Supplemental Simulation Results, 
December 26, 2006.''
     September 2007--APHIS used the model, with amendments, as 
part of the risk assessment supporting its September 2007 final rule. 
The quantitative model was used to support the exposure assessment of 
the risk assessment.
    In each of these instances, the assumptions used, the scenarios 
examined, and even the model itself differed from those in the others. 
It is therefore challenging to compare results from different instances 
of using the model without understanding the changes in the assumptions 
and the simulations. In the following paragraphs, we summarize these 
different model runs in chronological order and provide selected 
results from each, to help clarify the interpretation of the results.
    2004: In this instance, FSIS used a modified version of the 2001 
Harvard BSE risk assessment model (as revised by Harvard in response to 
peer review comments). The baseline estimate assumed that five BSE-
infected animals were imported into the United States in 2003. The 
model then simulated the spread of BSE infectivity until 2020. The 
analysis assumed that measures implemented in the United States to 
prevent the spread of BSE--e.g., the FDA feed ban--were in place at the 
time that infectivity was introduced. FSIS simulated the introduction 
of public health risk mitigation options--i.e., restrictions on SRMs 
and advanced meat recovery (AMR)--and assumed that these were 
implemented in 2004, 1 year after the infectivity was introduced. 
Therefore, because of these assumptions, the simulated mitigation 
options could never remove all of the infectivity that could be 
available for human consumption over the model simulation timeframe. In 
other words, BSE infectivity could enter the human food supply for 1 
year before FSIS mitigations took effect. In the baseline analysis, 
with five infected animals introduced into the United States, over the 
17-year simulation a mean of slightly less than two additional animals 
were affected. The baseline level of potential human exposure for the 
introduction of 5 infected animals--with no SRM risk mitigation options 
in place during the 17-year simulation--was an average of 22 cattle 
oral ID50s over the 17-year timeframe. With the introduction 
of SRM and AMR requirements (essentially the same requirements as those 
established by the FSIS regulations), the potential human exposure was 
an average of 7.5 cattle oral ID50s over the 17-year 
simulation. This was an 80 percent reduction in this simulation. Again, 
it is important to note that the public health assumptions used in 
these simulations could never remove more than 90 percent of the 
potential human exposure from the simulation.

[[Page 15859]]

    In 2005 and 2006, FSIS again used the model to simulate a variety 
of risk mitigation options. The original simulations were published in 
October 2005 and public comment on the model and the assumptions used 
was invited. In response to the public comments received, some changes 
were made to the model and the assumptions, and the final results were 
published in December 2006. The base case in each of these simulations 
represented the circumstances in the United States prior to December 
2003--i.e., with an FDA feed ban in place prior to the introduction of 
infected animals. In each scenario, 500 infected animals were 
introduced at one time and the model ran a total of 50,000 simulation 
runs for each scenario. The scenarios considered included various food 
safety measures, animal health measures (changes to the feed ban), and 
combinations of both.
    The October 2005 model included the following results. The results 
of the base case simulation--500 infected animals and a simulation 
timeframe of 20 years--indicated a mean of 680 total infected animals 
over the 20 years (500 imported animals and 180 domestic animals) and a 
mean of 3,800 cattle oral ID50s potentially available for 
human consumption. In comparison, the scenario that modeled a 
comprehensive ban from human food of SRMs from cattle 30 months of age 
or older (which we refer to below as ``30-month SRM restrictions'') 
yielded similar results for the number of infected animals, but with a 
mean of only 11 cattle oral ID50s potentially available for 
human consumption over the entire 20-year timeframe. The authors noted 
that they found that the food safety measures enacted by USDA all 
reduce potential human exposure to BSE infectivity but have little 
effect on spread of BSE in the cattle population. They also 
specifically noted that the results of the food safety measures enacted 
were relative reductions to what is already a small risk in absolute 
terms, especially in light of the fact that these simulations reflect 
the assumed introduction of 500 infected cattle into the United States. 
One other scenario modeled in this report was a removal of SRMs of 
animals 12 months and older (which we refer to below as a ``12-month 
SRM restrictions'') from both the human and the animal food chain. This 
scenario decreased the number of infected animals to a mean of 540 
total infected animals over the 20 years (including both imports and 
domestic cases) and indicated a mean of 9.8 cattle oral 
ID50s potentially available for human consumption. The 
authors conclude that this scenario indicates potential human exposure 
decreases both because there are fewer BSE cases and because the 
measures remove infectious tissues from the human food supply, although 
the amount of infectivity potentially available for human consumption 
(9.8 oral ID50s) was not significantly different from the 
simulation that modeled SRM removal (30 months of age and older) from 
only the human food supply. In other words, the number of BSE cases 
(680 total in the simulation with SRM removal from only human food as 
compared to 540 total in the simulation with SRM removal from both 
human and animal food chain) did not appear to significantly impact the 
potential human exposure.
    The December 2006 model provided similar results in many ways. This 
report included a change to explicitly model contamination of cattle 
feed as a result of the recycling of poultry litter. The base case 
again simulated 500 infected animals introduced, with 50,000 simulation 
runs of 20-year timeframes. The base case results indicated a mean of 
700 total infected animals over the 20 years (500 imported animals and 
200 domestic animals), with a mean of 6,600 cattle oral 
ID50s potentially available for human consumption. Modeling 
a requirement for removal from the human food supply of SRMs from 
cattle 30 months of age or older, with 100 percent compliance, 
indicated a mean of 20 oral ID50s potentially available for 
human consumption over the 20-year time period. This same requirement, 
with an assumption of 99 percent compliance, indicated a mean of 83 
oral ID50s potentially available for human consumption.
    APHIS used a modified version of the Harvard model as part of the 
risk assessment that supported the September 2007 final rule. 
Specifically, we used the quantitative model in our exposure assessment 
to consider less likely scenarios. The model simulated BSE release and 
exposure in the United States over 20 years, with the introduction of 
infected animals from Canada at a constant rate over the entire period. 
We assumed that the existing FDA feed ban requirements were in place 
throughout the 20 years, and that FSIS and FDA restrictions on SRMs in 
human food were the same as implemented in 2004. The base case scenario 
results indicated that the importation of approximately 19 infected 
animals leads to approximately 2 U.S. cases as secondary spread, for a 
total of 21 infected animals over the 20-year period. The base case 
indicated a mean of 45 cattle oral ID50s potentially 
available for human consumption.
    As noted above, the model results themselves do not support what 
seems to be the commenter's conclusion that the SRM restrictions 
simulated are not sufficient to mitigate the public health risk when 
there are higher numbers of infected animals present. Specifically, in 
the October 2005 model, both the base case and the 30-month SRM 
restrictions from human food indicated the same number of total 
infected animals--680 infected animals over the 20-year timeframe. Yet, 
the simulation modeling the 30-month SRM restrictions from human food 
reduced the mean amount of cattle oral ID50s available for 
human consumption from 3,800 to 11. In the scenario where 12-month SRM 
restrictions were applied in both human and animal food, although the 
number of total BSE cases changed (540 total infected animals), the 
amount of oral ID50s potentially available for human 
consumption (9.8 oral ID50s) stayed essentially the same as 
those in the 30-month SRM restriction scenario (11 oral 
ID50s). It should be noted that the assumptions used in the 
APHIS base case exposure assessment provided a total of only 21 
infected animals over a 20 year time period--significantly less than 
the approximately 700 total infected animals in the FSIS simulations.
    It is important to place some context around the results of the 
amount of infectivity potentially available for human consumption. The 
significance of cattle oral ID50s to human exposure and 
susceptibility is not known; however, various studies suggest that the 
infectious agent may be 10 to 10,000 times less pathogenic in humans 
than in cattle because of a species barrier (EC SSC, 2000). Thus, if 
the cattle-human species barrier were 100, it would mean that 100 times 
more infective material would be required in order to have a similar 
probability of infecting a human as a bovine. Comer and Huntly (2003) 
estimated, after an evaluation of available literature, that 54,000,000 
(54 million) bovine oral ID50s were available for human 
consumption in Great Britain from 1980 to 2003. This extremely large 
amount of available infectivity has resulted in 168 cases of vCJD 
identified or suspected in the United Kingdom through March 2009, plus 
a few additional cases identified in other countries but attributed to 
exposure in the United Kingdom. When compared to the United Kingdom's 
BSE experience and the associated estimate of available bovine oral 
ID50s, the mean values of 11 potentially available cattle 
oral ID50s--

[[Page 15860]]

or even 20 oral ID50s or 83 oral ID50s--over a 
20-year period are miniscule.
    Issue: One commenter stated that the prevalence of BSE in Canada is 
significantly higher than BSE prevalence in the United States and that 
APHIS has no basis to claim that measures implemented in the United 
States to mitigate the prevalence of BSE in this country are sufficient 
to mitigate a much higher prevalence in Canada. The commenter 
referenced a statement by the Centers for Disease Control (CDC) that 
the prevalence of BSE in Canada has been 90 percent likely to be 
between 18-fold and 48-fold higher than the previously published best 
estimate of the prevalence of BSE in the United States. The commenter 
stated that CDC notes that, nonetheless, a BSE prevalence in Canada 23-
fold higher than that in the United States continues to be used in the 
Harvard Risk Assessments' ``worst case'' analysis when evaluating the 
risk of imported Canadian cattle's causing BSE to spread among U.S. 
animals.
    Response: In comparing the estimate of the prevalence of BSE in the 
United States with the estimated prevalence of BSE in Canada, it should 
be noted that the estimated number of BSE-infected animals per million 
is very low in either case--0.167 cases per million in the United 
States and 3 to 8 cases per million in Canada.
    The commenter states that prevalence of disease has a significant 
impact on the effectiveness of mitigation measures, but provides no 
evidence to support this claim. Evidence in countries with significant 
outbreaks of BSE indicates that the animal health and public health 
mitigation measures are effective, even in the face of significantly 
higher prevalence levels. The primary animal health mitigation measure 
is a feed ban to prevent the inclusion of potentially infective tissues 
from being fed to cattle. This measure has demonstrably worked in the 
United Kingdom, a country with a significantly higher prevalence level 
relative to other countries. The number of BSE cases identified in 
birth year cohorts (all cattle born in a given year) in the United 
Kingdom has continued to decline since peaking in 1987. The United 
Kingdom established its initial feed ban requirement in 1988. This 
continuous decline clearly demonstrates the effectiveness of a feed ban 
as an animal health mitigative measure in the face of an outbreak with 
high prevalence. Similarly, on the public health side, SRM restrictions 
are an effective public health measure, even in a high prevalence 
situation. Experience in the United Kingdom and elsewhere in Europe 
demonstrates this effectiveness. The models used by FSIS that are 
discussed above continue to indicate the effectiveness of this measure, 
even when simulating relatively high numbers of infected animals 
present in the system. Given all of these points, APHIS has no reason 
to believe that the effectiveness of these mitigation measures is 
impacted by differences in prevalence levels.
    Issue: One commenter stated that it is important to note that 
APHIS' estimate of the prevalence of BSE in Canada is based on the 
detection of 11 cases of BSE, and that since that estimate was made, 
additional cases of BSE in Canadian cattle have been diagnosed. The 
commenter stated that APHIS should not rely on outdated prevalence 
estimates to evaluate Canada's BSE risk.
    Response: In conducting our assessment of the risk of importing 
live bovines from Canada under the provisions of the 2007 final rule, 
we took into account, among other factors, the estimated prevalence of 
BSE in Canada. In discussing our estimate of BSE prevalence in Canada 
in that final rule, we explained that the number of BSE cases detected 
through surveillance understates the disease prevalence because exposed 
animals may be incubating disease and carrying infectious material in 
their tissues without presenting clinical symptoms. We noted, 
additionally, that surveillance will miss a proportion of detectable 
cases. Therefore, as we explained in our 2007 final rule, we applied 
statistical methods to the available epidemiologic and surveillance 
data to estimate, with attendant uncertainty, the prevalence of BSE in 
Canada. Even taking into account this attendant uncertainty, our 
qualitative and quantitative assessments of release of BSE into the 
United States via the import of live bovines from Canada demonstrate an 
extremely low likelihood of release, and that, because of the 
comprehensive mitigations already in place in the U.S., the likelihood 
of establishment is negligible.
    Issue: One commenter noted that the epidemiological investigation 
conducted by Canada regarding an animal born in 2003 indicated that the 
most likely source of infection was consumption of commercial cattle 
feed produced in Canada. The commenter concluded that such information 
demonstrates that what the commenter termed ``Canada's widespread BSE 
exposure'' occurred because the August 1997 feed ban in Canada failed 
to address the cross-contamination of cattle feed with feed produced 
for other animals.
    The commenter stated that APHIS' statement that its 2005 evaluation 
of the feed ban in Canada revealed that overall compliance with the 
feed ban is good and that the feed ban was reducing the risk of 
transmission of BSE in the Canadian cattle population has been 
disproven by subsequent outbreaks of BSE in cattle that were born years 
after the implementation of Canada's feed ban. The commenter stated 
further that the CDC has reported that occurrence of BSE in Canada has 
risen in recent years.
    The commenter stated that there is no evidence that the prevalence 
of BSE in Canada is decreasing at this time. The commenter noted that 
most of the animals diagnosed with BSE in Canada were born after Canada 
implemented its 1997 feed ban and that over half of those cases were 
born after March 1, 1999, the date that APHIS determined to be the date 
of effective enforcement of the feed ban in Canada. The commenter also 
noted that more animals determined to be infected with BSE--two--were 
born in 2000 than in any other year. Other commenters also expressed 
opposition to the removal of the delay of applicability of the 
provisions described above because of the diagnosis of BSE in a number 
of Canadian-born cows since the diagnosis of BSE in a Canadian-born cow 
in May 2003. Some commenters expressed particular concern regarding the 
discovery of BSE in Canadian cattle within the past several years. One 
commenter stated that Canada's feed ban was not made whole until July 
2007, when Canada took steps to ban ruminant protein from all animal 
feed and fertilizer. The commenter concluded that USDA should withdraw 
the September 2007 final rule and initiate a rulemaking to determine if 
Canada's feed ban is likely to have become effectively enforced after 
July 2007.
    Response: We disagree with the commenters' conclusions. The 
commenters suggest that, in order for the Canadian feed ban to be 
considered effective, BSE surveillance data would have to demonstrate 
that the likelihood of BSE transmission in that country has been 
eliminated. However, as noted in the risk assessment for our September 
2007 final rule, Canadian BSE surveillance data do not provide a 
statistical basis for distinguishing BSE prevalence among birth year 
cohorts (APHIS, 2007); the overall prevalence is so low that 
distinguishing any difference is nearly impossible. In other words, the 
data cannot distinguish any significant difference in prevalence among 
animals born in different years, which would have been one way to 
demonstrate the effect of a feed ban

[[Page 15861]]

(e.g., if the feed ban were implemented at the beginning of 1997, 
surveillance data showing a higher BSE prevalence in animals born in 
1996 than in animals born in 1997 would support the effectiveness of 
the feed ban). However, in the absence of a feed ban that reduced 
exposure to BSE, we would expect the prevalence of the disease to 
increase over time. We have no evidence that such an increase has 
occurred but we do have data that the feed ban is being enforced.
    Furthermore, as we discussed in the risk assessment for our 
September 2007 final rule, detection of BSE in an animal born after the 
date a feed ban was implemented does not indicate an overall failure of 
the measures in place to stem transmission of the disease in that 
country. Most other countries that have experienced cases of BSE have 
reported similar cases. Human error is expected, which is why the feed 
ban is comprised of a number of interrelated measures that have a 
cumulative effect. Our risk assessment does not assume 100 percent 
compliance with all measures all of the time. We discussed factors 
related to the feed ban in Canada since before its implementation in 
1997. We considered activities related to inspection and compliance 
with the feed ban, the rendering industry, the risk of cross-
contamination, education activities and industry awareness, and on-farm 
practices that might contribute to the efficacy of the feed ban. In 
addition, we highlighted the fact that since the implementation of the 
feed ban on August 4, 1997, Canada has continued to revise and 
strengthen its processes and procedures to further enhance the 
effectiveness of the feed ban.
    With regard to the commenter's recommendation that a date in July 
2007 be considered as the date of effective enforcement of a feed ban 
in Canada, as we discussed in our September 2007 final rule, we 
consider the July 2007 expansion of the Canadian feed ban to be an 
enhancement of an already effective ban. In July 2007, Canada modified 
its feed ban to remove SRMs from all animal feeds, pet food, and 
fertilizer. CFIA, in explaining its rationale for the enhanced ban, 
emphasizes that although surveillance results and investigations of BSE 
cases indicate that the feed ban in Canada has effectively reduced the 
spread of BSE since being implemented in 1997, even compliance with the 
ban's requirements left limited opportunities for contamination during 
manufacture, transportation, and storage that CFIA considered worth 
eliminating. In addition, the accidental misuse of feed on farms with 
multiple species could not be discounted. With the enhanced ban, CFIA 
projects that the eradication of BSE in Canada will be accelerated. 
Following such a regulatory path does not indicate that the feed ban in 
Canada prior to July 2007 was not effective or effectively enforced.
    Issue: One commenter stated that APHIS, in its September 2007 final 
rule, established that SRM removal requirements are approximately 19 
percent less effective in preventing human exposure to the BSE agent 
when those requirements are applied to cattle born before effective BSE 
mitigation measures were in place, such as in cattle born before the 
Canadian feed ban became effective.
    The commenter discussed analyses that were conducted by FSIS to 
estimate the likely reduction of potential human exposure to BSE given 
the SRM removal requirements established by that Agency. The commenter 
stated that, in its 2004 evaluation, FSIS estimated that the SRM 
removal policy adopted by that Agency could reduce potential human 
exposure to BSE by 80 percent, based on the assumption that five BSE-
infected animals had been introduced into the United States 12 months 
before FSIS implemented its BSE mitigation measures, including SRM 
removal. In 2005, stated the commenter, FSIS re-analyzed the likely 
reduction in potential human exposure, this time assuming that U.S. 
risk mitigation measures were implemented before the introduction of 
BSE-infected cattle in the United States. Using that assumption, said 
the commenter, FSIS indicated that the mitigation measures implemented 
by FSIS in 2004 would reduce potential human exposure by more than 99 
percent on average. APHIS discussed the results of this re-analysis in 
its September 2007 final rule, stating:

    ``Since all scenarios [evaluated by FSIS] included at least some 
time in which the mitigations were not implemented, under the 
simulations, a certain amount of potential infectivity was allowed 
into inappropriate channels, such as human food. Because none of 
these scenarios incorporated the more realistic assumption that the 
mitigations were implemented (even imperfectly) throughout the 
simulation period, it is inappropriate to use this analysis as a 
citation for the level of public health protection provided by risk 
mitigation measures in place in the United States.
    A more appropriate analysis for understanding the role of SRM 
removal in potential human exposure to BSE infectivity would be the 
FSIS update of the same Harvard simulation model that was available 
for public comment in 2006 * * *. This updated model used the ``base 
case'' as the circumstances in the United States prior to December 
2003, and simulated the response of the U.S. system for 20 years 
following the import of BSE-infected cattle. FSIS' updated model 
estimated the impact of various risk management measures, including 
measures that were adopted, considered, or proposed by various 
agencies and groups. These simulations, where the risk mitigation 
was applied during the entire simulation, as opposed to the 
simulation in the [2004] analysis * * * (in which it was not), 
indicated that removing SRMs, as currently defined by FSIS, reduced 
potential human exposure by more than 99 percent, on average. This 
report also stated that ``[i]t is worth noting that these measures 
reduce what is already a small exposure in absolute terms.'' (72 FR 
53335-53336)

    The commenter stated that the latter FSIS analysis is irrelevant to 
the issue of risk related to the importation of beef from Canada 
derived from cattle 30 months of age or older, because Canada is known 
to have had at least three generations of BSE infectivity in its native 
cattle herd prior to the time that Canada implemented its BSE 
mitigation measures, including SRM removal.
    Response: The commenter states that APHIS established that SRM 
removal requirements are approximately 19 percent less effective in 
preventing human exposure to the BSE agent when those requirements are 
applied to cattle born before effective BSE mitigation measures were in 
place, such as in cattle born before the Canadian feed ban became 
effective. However, APHIS did not establish or suggest such a 
conclusion. In our September 2007 final rule, we responded to a 
commenter who raised the issue of the FSIS 2004 model, where the 
potential human exposure was reduced by only 80 percent. APHIS 
explained that this specific use of the model was not appropriate in 
completely evaluating the role of SRM removal in potential human 
exposure and noted that the FSIS 2005/2006 simulations provided a 
better analysis for understanding potential human exposure. APHIS noted 
that the FSIS 2004 model included ``* * * at least some time in which 
the mitigations were not implemented * * *'' (72 FR 53336). The 
commenter appears to have interpreted this to include all mitigations, 
including animal health mitigations such as the feed ban. This is 
inaccurate, as the FSIS 2004 model assumed that the feed ban 
requirements were in place throughout the 17-year time period of the 
simulations.
    The commenter suggests that use of the FSIS 2005 model is 
inappropriate in an evaluation of the risk of imported beef from 
Canada, because Canada had infectivity in its cattle herd for at least 
three generations prior to implementing SRM restrictions. The commenter 
is

[[Page 15862]]

correct that the timeframe of implementing SRM restrictions is 
important for public health considerations. However, the commenter's 
conclusion that the presence of infectivity in animals prior to the 
implementation of SRM restrictions affects the effectiveness of those 
SRM restrictions is inaccurate. Requirements to prevent the inclusion 
of SRMs in the human food supply provide an immediate public health 
impact, regardless of the length of time infectivity may have been 
present in animals. These restrictions prevent infectious tissues from 
any animal--born before or after a feed ban--from entering the human 
food supply. As demonstrated in the FSIS 2005 and 2006 models, they 
provide significant public health protection, even over a 20-year 
timeframe.
    Issue: The commenter stated that APHIS has provided no basis for an 
assertion that the rate of compliance with SRM removal requirements for 
Canadian cattle slaughtered in either the United States or Canada is 
adequate to protect human health. The commenter stated that the 
influence of the extent of compliance with SRM removal requirements is 
demonstrated by that fact that, all else being equal, when compliance 
with SRM removal requirements drops by only 1 percent, the potential 
risk to human health is more than quadrupled (increasing from 20 oral 
ID50s to 83 oral ID50s).
    Response: We disagree that APHIS has not provided a basis for its 
conclusion that SRM removal in the United States or Canada constitutes 
an effective safeguard of human health with regard to BSE. In our 
September 2007 final rule, we established conditions for the 
importation into the United States of live bovines born on or after the 
date of effective enforcement of a ruminant-to-ruminant feed ban in a 
BSE minimal-risk region, as well as conditions for the importation of 
other bovine-derived commodities. As part of that rulemaking, we 
conducted an assessment of the potential BSE risk of implementing the 
provisions of the final rule. The exposure model used for the risk 
assessment assumed that SRMs are effectively removed 99 percent of the 
time in the United States. This assumption was based on FSIS summaries 
of Noncompliance Records performed from January 2004 to May 2005 in 
about 6,000 federally inspected meat and poultry establishments. Based 
on these records, FSIS estimated that noncompliance with respect to 
SRM-related regulations had a frequency of less than 1 percent.
    In our September 2007 final rule, we explored the possible impact 
of assuming an arbitrary decrease (compared to the results of our 
exposure model) in SRM removal compliance in the United States on the 
availability of infectivity for human consumption. The model was for 
the United States, not Canada, but based on similarities in 
slaughterhouse practices in the United States and Canada, we can make a 
broad general assumption that the results in Canada would be the same 
as those in the United States. As discussed earlier in this document, 
in a 2007 audit in Canada, FSIS specifically assessed controls for SRM 
removal in Canada and identified no related deficiencies.
    In our September 2007 final rule, we discussed the significance of 
an order-of-magnitude increase in available infectivity compared to our 
model's findings. First, we considered the results of that model, which 
uses the unlikely assumption that prevalence in Canada (and thus the 
proportion of infected animals imported from Canada) remains constant 
over the next 20 years. In the model's scenario, the total amount of 
infectivity potentially available for human consumption over the 20 
years of the analysis is 45 cattle oral ID50s.
    As discussed above, if the cattle-human species barrier were 100, 
it would mean that 100 times more infective material would be required 
in order to have a similar probability of infecting a human as a 
bovine. As noted, the extremely large amount of infectivity available 
for human consumption in Great Britain from 1980 to 2003--estimated by 
Comer and Huntly (2003) as 54 million bovine oral ID50s--
resulted in 168 cases of vCJD identified in the United Kingdom through 
March 2009, plus a few additional cases identified in other countries 
but attributed to exposure in the United Kingdom. As discussed above, 
when compared to the United Kingdom's BSE experience and the associated 
estimate of available bovine oral ID50s, the expected or 
average value of 45 cattle oral ID50s indicates that only a 
miniscule amount of the BSE infective agent could possibly be available 
for potential human exposure in the United States over a 20-year 
period. (The potential for human exposure under this scenario is 
estimated at 1,200,000 times less in the United States than what the 
United Kingdom experienced during its BSE epidemic.) Even if compliance 
with the SRM ban were not as high as the 99 percent estimated in our 
exposure model, and we were to assume that the infectivity available 
for human consumption were increased by an order of magnitude (10x), it 
would still be far less than that estimated to have circulated in the 
United Kingdom and, we conclude, not be of significance to human 
health.
    Issue: One commenter noted that APHIS stated in its September 2007 
final rule that effective enforcement of a ruminant-to-ruminant feed 
ban does not necessarily mean 100 percent compliance with the feed ban 
will be achieved. The commenter stated that, although APHIS concludes 
that removal of SRMs effectively mitigates the BSE risk to humans 
associated with cattle that pass both ante-mortem and post-mortem 
inspections, FSIS states that this conclusion regarding the 
effectiveness of SRM removal is valid only if compliance is perfect. 
The commenter stated that it is arbitrary and capricious for APHIS to 
conclude that a feed ban is effective and effectively enforced even 
without perfect compliance, while at the same time concluding that SRM 
removal requirements provide effective mitigation to human health, even 
though such a level of protection is predicated on perfect compliance.
    Response: We disagree with the commenter's logic. There are 
multiple mitigation measures that contribute to reduction of BSE risk. 
Each has its own degree of importance in a systemic reduction in risk. 
As we discuss above, enforcement of an effective feed ban in a region 
has the effect of reducing the amount of circulating BSE infectivity in 
that region. This makes it less likely that any one animal in that 
region will be infected with BSE. SRM removal is a method of removing 
and disposing of tissues that present a high likelihood of containing 
BSE infectivity if an animal were infected. In effect, countries such 
as the United States, Canada, and other countries worldwide that 
require SRM removal are making the assumption that any one animal 
presented for slaughter could be infected with BSE, even though the 
presence of an effective feed ban in that country reduces the 
likelihood of that to a minimal level.
    With regard to the text from the FSIS document regarding perfect 
compliance, it is important to review the wording cited by the 
commenter in context. In the FSIS interim rule referred to by the 
commenter, FSIS refers to the December 2006 model we describe above, 
and states the following:

    However, although both the number of BSE cases and the level of 
human exposure increased in the post-public comment runs, 
conclusions with regard to prohibiting the use of SRMs for human 
food remain the same. More specifically, even with the revised base 
case, the post-public comment

[[Page 15863]]

runs show that excluding the materials designated as SRMs in this 
final rule almost completely eliminates potential human exposure to 
the BSE agent if compliance is perfect. Similarly, the post-public 
comment runs found that neither lowering the age classification for 
SRMs from cattle 30 months of age and older to 12 months of age and 
older, nor from 30 months of age and older to 24 months of age and 
older, provides additional benefits in reducing the level of 
potential human exposure to the BSE agent. Thus, the results of the 
2005 model, regardless of the base case used, have not led the 
Agency to change its conclusion that the measures adopted in this 
final rule are prudent for preventing potential human exposure to 
the BSE agent. (72 FR 38726)

    In addition, in the same rule, FSIS refers to the October 2005 
model we described above, and states the following: ``The pre-public 
comment runs found that removing SRMs from cattle 30 months of age and 
older almost completely eliminates potential human exposure, reducing 
it to 11 cattle oral ID50s * * *. It is worth noting that 
these are relative reductions to what is already a small risk in 
absolute terms, especially in light of the fact that these simulations 
reflect the assumed introduction of 500 infected cattle into the U.S.'' 
(72 FR 38725)
    FSIS considered all of the information from the modeling 
simulations, including those runs where compliance was assumed to be 
less than 100 percent. Evaluating all of these results and statements 
together demonstrates the overall conclusion that SRM removal 
effectively mitigates the BSE risk to humans.
    We also note that APHIS did not assume 100 percent compliance with 
SRM removal in the exposure assessment of our risk assessment. As noted 
elsewhere, we assumed a 99 percent compliance rate, acknowledging that 
no regulatory effort can ever ensure 100 percent compliance.

Specified Risk Materials

    One of the requirements for the importation of meat, meat 
byproducts, and meat food products derived from bovines in BSE minimal-
risk regions is that the SRMs of the bovines were removed at slaughter. 
In Sec. Sec.  94.0 and 95.1 of the regulations, SRMs are defined as 
``[t]hose bovine parts considered to be at particular risk of 
containing the bovine spongiform encephalopathy (BSE) agent in infected 
animals, as listed in the FSIS regulations at 9 CFR 310.22(a).'' With 
some limited exceptions, the FSIS regulations list the following 
tissues as SRMs: (1) The 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 DRG from cattle 30 months of age and older, 
and (2) the distal ileum of the small intestine and the tonsils from 
all cattle. If the small intestine is to be used for human food, the 
distal ileum must be removed by a procedure that removes at least 80 
inches of the uncoiled and trimmed small intestine as measured from the 
ceco-colic junction and progressing proximally towards the jejunum, or 
must be otherwise removed by a procedure that the establishment 
demonstrates is effective in ensuring complete removal of the distal 
ileum.
    Issue: One commenter stated that central to APHIS' September 2008 
request for comments is the Agency's assumption that SRM removal will 
effectively protect consumers from exposure to BSE. The commenter 
stated that such an assumption is called into question by numerous 
studies demonstrating the limitations on mitigating the risk of BSE 
exposure via SRM removal. The commenter stated that the CDC has 
acknowledged that the risk of humans developing vCJD from eating muscle 
meat from cattle potentially infected with BSE cannot be precisely 
determined. The commenter stated that APHIS should have, but has not, 
explained why this uncertainty does not undermine what the commenter 
termed APHIS' almost-exclusive reliance on SRM removal requirements to 
protect American public health from potentially hazardous Canadian 
imports.
    The commenter stated that the current inability to detect BSE 
prions in certain tissues does not mean that there is insufficient 
infectivity to be a hazard and that, while BSE prions have been found 
only in a solitary bovine muscle of a single cow, that likely is a 
function of the current limited analytical sensitivity of the test. The 
commenter stated that all the other information points to the 
likelihood that prions are present in such tissues.
    The commenter stated that APHIS ignores the significance of 
recently detected BSE variations and dismisses the relevance of new 
studies that have detected BSE infectivity in new tissues. The 
commenter stated that in its September 2008 request for comments, APHIS 
stated that the new findings could be the result of more sensitive 
tests and of detection tools that may over-express the BSE agent. The 
commenter stated that APHIS incorrectly argued in its September 2008 
request for comments that, because demonstrating the presence of PrP 
does not necessarily indicate the presence of BSE infectivity, studies 
that have detected abnormal PrP in the facial and sciatic nerves do not 
warrant new mitigation measures. The commenter stated that the World 
Health Organization (WHO) has found both the presence of Prp\TSE\ and 
BSE infectivity in the peripheral nerves of cattle. The commenter 
stated that the WHO has identified two classifications of BSE tissue 
infectivity, ``high infectivity'' and ``lower infectivity,'' and that 
the WHO includes peripheral nerves (e.g. sciatic and facial nerves) in 
the category of lower infectivity.
    The commenter stated that, in its request for comments, APHIS 
specifically cited research that detected BSE infectivity in the 
sciatic nerve of cattle, but only after 30 months after exposure. 
Despite this, stated the commenter, APHIS does not require mitigation 
measures regarding the sciatic nerve in cattle 30 months of age or 
older. The commenter stated that facial and sciatic nerves are the only 
bovine tissues scientifically determined by multiple studies to harbor 
BSE infectivity for which APHIS requires no risk mitigations, not even 
the mitigation of requiring that beef imported from Canada be derived 
only from cattle that were subject to a feed ban during their 
lifetimes. The commenter stated that this policy is inconsistent with 
APHIS' consideration of tonsils in cattle of any age as an SRM tissue, 
even though APHIS cites only one study that found what appears to be a 
very low level of infectivity in the tonsils of BSE-infected cattle.
    The commenter disagreed with this policy, stating that (1) BSE 
infectivity is known to exist in non-SRM tissues; (2) BSE infectivity 
is known to have been circulating in Canadian cattle for years, leading 
up to and including 2003; and (3) APHIS does not know the minimum 
dosage necessary to cause BSE infectivity in either humans or cattle. 
The commenter cited 2006 WHO guidelines as stating: ``It remains 
unknown whether tissues containing such very small amounts of 
infectious material [detected by novel techniques] would transmit 
infection to humans.'' (The commenter cites WHO Guidelines on Tissue 
Infectivity Distribution in Transmissible Spongiform Encephalopathies, 
World Health Organization, 2006, at 10.) Based on this uncertainty, 
stated the commenter, APHIS should take precautionary steps to avoid 
human exposure to meat and meat products from Canadian cattle that pose 
the highest risk of infection-- cattle 30 months of age or older-- 
particularly those born before the Canadian feed ban was effective.

[[Page 15864]]

    Response: A similar issue was raised by the commenter in response 
to our January 2007 proposed rule. We are aware of the studies cited by 
the commenter and do not agree that they question the efficacy of SRM 
removal. In our September 2007 final rule, we acknowledged that studies 
using new methods that provide increased sensitivity will probably 
demonstrate the presence of PrP\BSE\ (the abnormal form of the prion 
protein) in various tissues. However, demonstrating the presence of 
PrP\BSE\ does not necessarily indicate the presence of BSE infectivity, 
especially if no infectivity is demonstrated via the most sensitive 
method available: Cattle-to-cattle exposure via intracerebral 
transmission. Therefore, one cannot automatically assume that a finding 
of PrP\BSE\ in a tissue means the tissue should be defined as an SRM. 
The OIE made this particular point in the Terrestrial Animal Health 
Standards Commission Report, October 2006--Supporting Document for 
Chapter 2.3.13. Of the Terrestrial Animal Health Code on Bovine 
Spongiform Encephalopathy, as follows:

    The availability of experimental infectivity data has 
significantly increased in recent years. During the same interval, 
extremely sensitive tests have been developed, including those 
employing highly sensitive transgenic mice strains and potentially 
more sensitive laboratory PrP detection methods. With the 
development of such highly sensitive methods, the probability of 
detection of PrP\BSE\ in tissues that are not currently listed as 
infectious is increasing. However, such findings need to be 
considered in context, and their relevance to establishing risk to 
consumers evaluated carefully when the quantity of PrP\BSE\ detected 
is potentially below the limit of detection of intracerebral (i.c.) 
cattle to cattle bioassay. By April 2007, 165 variant Creutzfeldt-
Jakob Disease (vCJD) cases had been detected in the United Kingdom, 
a country where most probably the majority of the population was 
exposed to the BSE-agent. The latest models of the vCJD epidemic 
estimate that the potential scale of the clinical epidemic arising 
from food-borne exposure is unlikely to exceed 400 future cases in 
the United Kingdom (Clarke and Ghani, 2005). The relatively low 
number of predicted vCJD cases in relation to the massive exposure 
to the BSE agent is suggested to be due mainly to a significant 
species barrier between cattle and humans (Comer and Huntley, 2004; 
Bishop et al., 2006).

    APHIS is familiar with the results of the study (Buschmann, 2005) 
in which tissues from a BSE-diseased cow were inoculated into 
genetically engineered (transgenic) mice that are highly susceptible to 
BSE and that overexpress the bovine prion protein. Using this extremely 
sensitive mouse assay, the study demonstrated low levels of infectivity 
in the peripheral nervous system (e.g., facial and sciatic nerves) of 
the infected cow. APHIS discussed these findings in the risk assessment 
it made available with its September 2007 final rule and concluded that 
``[g]iven all these factors there is not sufficient information to 
alter our understanding of the epidemiologically significant 
distribution of BSE infectivity in cattle.'' (APHIS, 2007). APHIS also 
acknowledges the results of Japanese studies in which PrP\BSE\ has been 
reported in the peripheral nerves of a case of BSE (Iwamaru et al., 
2005) and in some peripheral nerves of cattle slaughtered at abattoirs 
in Japan (Iwata et al., 2006) by Western blot analyses. APHIS has also 
reviewed the German study in which infectivity was detected in the 
brainstem of an animal at 24 months post-infection (Hoffman, 2007). We 
have carefully considered all of these findings. USDA reviews and takes 
into consideration all BSE research for the definitions of SRMs, as do 
Canada and other countries internationally. As noted in the quote 
above, international policies regarding SRM removal have not changed 
based on the results of the studies discussed. Both the U.S. and 
Canadian policies regarding SRM removal are consistent with 
international standards.
    Finally, we consider the quote the commenter provides from the WHO 
2006 report to be of little use when presented out of context. In the 
report referenced by the commenter, the WHO was discussing in a 
hypothetical fashion the possibility of advances in techniques to 
detect PrPTSE not limited to PrPBSE. The WHO 
statement reads as follows:

    Several new methods attempting to detect PrPTSE using 
novel techniques * * * if successfully developed, might eventually 
offer sufficient sensitivity to demonstrate amounts of agent below 
the level of detection of currently validated tests. It has been 
speculated that such methods might find small amounts of agent in 
some tissues currently thought to be free of infectivity. It remains 
unknown whether tissues containing such very small amounts of 
infectious material would transmit infection to humans. (WHO, 2006)

    Issue: One commenter stated that APHIS' assumption that removal of 
the tonsils removes the potential for BSE transmission is unjustified 
given that APHIS has not evaluated the potential for contamination of 
tongue with tonsil tissue. The commenter stated that, although APHIS 
claims the possibility of such contamination is eliminated by current 
slaughter techniques, scientists who examined over 250 bovine tongues 
intended for human consumption found tonsillar tissue in the vast 
majority; in some cases, even after the most rigorous trimming of the 
root of the tongue.\9\
---------------------------------------------------------------------------

    \9\ The commenter cites Wells, G., Spiropoulos, J., Hawkins, S., 
and Ryder, S., Pathogenesis of Experimental Bovine Spongiform 
Encephalopathy; Preclinical Infectivity in Tonsil and Observations 
on the Distribution of Lingual Tonsil in Slaughtered Cattle, 
Veterinary Record (2005) 156, 401-407.
---------------------------------------------------------------------------

    Response: We are making no changes based on the comment. As we 
discussed in our September 2007 final rule, Wells et al. (2005) state 
the following:

    However, the trace level of infectivity so far detected in 
tonsillar tissue and the localization of the lingual tonsillar 
lymphoid tissue, together with the current SRM legislation for the 
removal of tonsil from cattle carcasses and the low and diminishing 
prevalence of BSE in the UK suggest that the risk of human exposure 
to infected tonsil is now remote. It seems likely that under these 
circumstances any additional trimming of the tongue would result in 
an immeasurable reduction in the risk * * *
    In other words, the study cited by the commenter does not present a 
strong case for additional risk measures, and, in fact, points to the 
opposite conclusion.
    Moreover, even before the SRM requirements were implemented in 
January 2004, FSIS did not consider tonsil to be edible tissue--it was 
previously required to be removed. As noted in FSIS Notice 50-04:

    In the preamble to 9 CFR 310.22, FSIS stated that tonsils of all 
livestock species, including cattle, were already required to be 
removed and were prohibited for use as ingredients in meat food 
products under 9 CFR 318.6(b)(6). The accepted practice for removing 
the tonsils from livestock has been to remove all visible tonsils. 
In cattle, this includes separation of the palatine tonsils and 
lingual tonsils from the tongue (in establishments that harvest the 
tongue for human food) by a transverse cut caudal (just behind) the 
last vallate papillae * * * FSIS expected that establishments would 
continue to remove tonsils from cattle in accordance with the 
procedures that they had implemented to comply with 9 CFR 
318.6(b)(6) * * * Establishments that slaughter cattle should have 
been following these practices before tonsils were designated as 
SRMs. (FSIS, 2004c).

    APHIS' quantitative exposure model conducted for the September 2007 
final rule included an update that acknowledged the potential 
infectivity in tonsils and clearly added these as an SRM, with the 
acknowledgment that they could still be potentially available for human 
consumption. In fact, the output tables from the model runs show the 
potential oral ID50s derived from tonsils and available for 
human consumption over the 20-year period of

[[Page 15865]]

the analysis. These values are obviously very low, ranging from 0.026 
oral ID50s in the base case scenario to 0.16 oral 
ID50s in sensitivity analysis 6 (in which all uncertain 
parameters were simultaneously set to their corresponding pessimistic 
level). Such very small values are not surprising given the low 
likelihood of infectivity in the tissue itself. Moreover, although our 
model predicts a vanishingly low level of possible human exposure via 
tonsils, we have not stated that the risk is ``eliminated,'' as was 
suggested in the comment.
    Issue: One commenter stated that it is not yet possible to 
demonstrate how effective SRM removal is in mitigating the risk of BSE, 
because SRM removal requirements have not been in place long enough for 
an effect to be evident, particularly in light of the lengthy 
incubation periods assumed for vCJD in humans. The commenter stated 
that any human who consumed beef from a BSE-infected animal slaughtered 
after SRM removal requirements were implemented would not be expected 
to show signs of vCJD for about 17 years. The commenter stated that, if 
there has been a reduction in the number of cases of vCJD infection--
which the commenter said is unclear--it is much more likely that that 
the reduction resulted from decreases in the number of infected cattle 
in the past decade due to feed bans, rather than to what the commenter 
termed the much more recent implementation of SRM removal.
    Response: The commenter raised a similar issue in response to our 
January 2007 proposed rule. In response to the comment, we acknowledged 
in our September 2007 final rule that there has been no specific 
controlled study that clearly and unequivocally demonstrates the 
effectiveness of SRM restrictions on protecting public health. However, 
the absence of such a study does not negate the fact that substantial 
epidemiological and case evidence clearly indicate the success of such 
control measures. As we stated in our September 2007 final rule, it is 
widely and generally accepted internationally, including by such 
international bodies as the WHO and the OIE, that the primary public 
health protective measure regarding BSE is the removal of SRMs from the 
human food supply (WHO, 2002).
    The OIE Scientific Revue notes the following: ``Excluding SRM from 
the human food chain effectively minimizes the risk of human exposure 
and is the most important measure taken to protect consumers. Failure 
to remove SRMs would probably expose a large number of consumers to an 
unnecessary risk.'' (Heim and Kihm, 2003). This point is also widely 
acknowledged in scientific literature. For example, Bradley and 
Liberski (2004) conclude that ``risks to humans from infected cattle 
are now remote so long as the [bans on the use of SRMs in human food] 
are rigorously enforced.'' Fox and Peterson (2004) conclude that 
``[a]doption of the human [specified bovine offal] ban in the United 
Kingdom in 1989 is probably the only example in the BSE story of a 
government going beyond expert opinion in taking a precautionary 
measure. It turned out to be the correct decision, and likely saved 
thousands of people from exposure to the disease.''
    Simulation models and analysis conducted in the United Kingdom 
support the assumption that primary exposure sources for people were 
SRMs in the food supply prior to imposed restrictions. These models 
have been updated and revised repeatedly since the original 
identification of vCJD and the link to BSE in cattle (Ghani et al., 
1998, 2000, 2001, 2003). They incorporate assumptions for all the 
parameters that could influence the course of vCJD in the United 
Kingdom--including assumptions about primary exposure from dietary 
sources, calculations about how many infected cattle may have been 
slaughtered at different points in time, what tissues from those 
animals were available for consumption, and what restrictions were 
imposed on the tissues and types of products available for consumption. 
The models are updated routinely to incorporate new information about 
vCJD cases as they are reported.
    These models have been used to predict the course of the vCJD 
epidemic in the United Kingdom. Initially, the projections were fairly 
high with considerable uncertainty. As more information is incorporated 
into the models, these projections continue to decline and the 
uncertainty levels also decrease. The number of clinical cases of vCJD 
in the United Kingdom has continued to decline since an apparent peak 
in 2000 (Andrews, 2007). This decline is consistent with projections 
made from the models, thus validating some of the assumptions used in 
the models. As an example, Cooper and Bird (2003) assume that the 
primary sources of exposure are the consumption of meat products--
including mechanically separated meat and head meat-that were most 
likely contaminated with SRMs such as spinal cord, DRG, and brain. 
Restrictions on the inclusion of spinal cord and brain, among other 
tissues, were initially imposed in the United Kingdom in 1989. 
Restrictions on the production of mechanically separated meat, which 
included a significant level of infectivity from DRG, were imposed in 
the United Kingdom in 1995. Cooper and Bird (2003) concluded that 
``[t]here is remarkable similarity between the age distribution and 
gender of simulated and observed vCJD patients, which supports (but 
does not prove) our assumption about the primary sources of exposure to 
BSE.''
    The commenter noted the ``exceedingly long incubation periods 
assumed for humans.'' More recent updates of the models described 
previously have included estimates of the mean incubation period for 
vCJD (Ghani et al., 2003), estimating the mean incubation period at 
12.6 years when using the accumulated case data from confirmed vCJD 
cases. When additional information was added from results of a 
screening study performed on appendix and tonsil tissues, the mean 
incubation period was 16.7 years when fitted to this data. From this 
evidence, we can conclude that even the longer mean incubation period 
of 16.7 years would allow sufficient time to demonstrate the effect of 
SRM restrictions on the outbreak, since the initial SRM restrictions 
were imposed in 1989. We note that all vCJD cases that have been 
genotyped to date, with one exception, have been of the homozygous 
methionine (MM) genotype at codon 129 of the human prion protein gene. 
In describing the methodology used for their 2003 update of projections 
of future vJCD cases in the United Kingdom, Ghani et al. indicated that 
approximately 40 percent of the Caucasian population is homozygous 
methionine, with approximately 10 percent valine homozygous, and the 
remaining 50 percent heterozygous. While the effect of genotype on vCJD 
is still unknown, we can evaluate scenarios in the MM genotype as an 
example of epidemic progression, because this genotype may be the most 
susceptible and/or have shorter incubation periods than other 
genotypes.
    Issue: One commenter stated that, in its September 2008 request for 
comments, APHIS misguidedly relied on OIE recommendations to justify 
its decision not to strengthen SRM removal requirements and to allow 
the importation from Canada of live cattle 30 months of age or older. 
The commenter stated that APHIS should base its assessment of the 
effectiveness of BSE mitigation measures on empirical data from 
countries that have imposed BSE restrictions, rather than on 
empirically unproven standards such as those recommended by the OIE.

[[Page 15866]]

    The commenter stated that Japan allows the importation of beef only 
from cattle 20 months of age or younger and that the European Union 
limits imports of beef to that derived from cattle under 30 months of 
age.
    The commenter stated that all countries in which BSE has been 
diagnosed, except for Canada, remove the brain, spinal column, etc., at 
slaughter from all bovines 12 months and over, rather than just from 
all bovines 30 months of age or older, as is required by APHIS for the 
importation of meat, meat byproducts, and meat food products from BSE 
minimal-risk regions. The commenter noted that Japan requires the 
removal of SRMs from cattle of any age. Therefore, stated the 
commenter, the experience with SRM removal in those countries is 
inapplicable for predicting risk in the United States and APHIS lacks a 
basis for stating that the SRM removal it requires has been 
demonstrated to be highly effective.
    Response: We disagree with the commenter in several ways. First, 
contrary to the commenter's statement, the European Union has 
determined that its policies regarding the importation of beef are 
consistent with the OIE Code. Second, the commenter failed to list the 
United States as a country in which BSE has been diagnosed in a native 
animal that requires removal of the brain, spinal column, etc., at 
slaughter from bovines 30 months of age or older. Finally, the 
commenter's recommendations are inconsistent with scientific findings 
regarding BSE transmission generally accepted internationally.
    As we noted in our September 2007 final rule, in the past few 
years, significant consideration has been given to the age limits on 
SRMs and their appropriateness. Additional information obtained from 
new research findings has contributed to these evaluations. Scientists 
in Europe have specifically examined these findings as part of their 
consideration of the age limit in cattle for the removal of SRMs (EFSA 
Journal, 2005; 2007). In each of these opinions, they conclude that any 
likely detectable infectivity in the central nervous system (CNS)--
including the SRMs in question--appears at about 75 percent of the 
incubation time. These opinions also note that the experimental low-
dose scenarios are more likely to resemble the actual field exposure. 
The low-dose research scenarios are those in which calves were exposed 
orally to 1 gram of highly infective brain tissue, rather than the 100 
grams used in the high-dose scenario. Experimental attack rate studies 
indicate that the incubation period for the low-dose scenario has a 
mean of 60 months, with a range of 45 to 73 months (Wells et al., 
2007). Using the low end of this range of incubation period, and 
assuming that infectivity is present in the CNS at 75 percent of the 
incubation period, they predict that infectivity would be sub-
detectable or still absent in CNS in cattle aged 33 months.
    In the United Kingdom, even including cases from the height of the 
BSE epidemic there, which are believed to have had shorter incubation 
periods than more recent cases, the peak age at onset of clinical signs 
was 5 to 6 years. This age of clinical onset is consistent with an 
assumption that the average incubation period in the United Kingdom has 
been about 60 months. The average age of animals identified with 
disease in the European Union is higher than this-the average was 86 
months in 2001 and has increased since then. This evidence indicates 
that considering certain tissues in bovines 30 months of age or older 
to be SRMs, and removing and disposing of those tissues, would 
eliminate the majority of infectivity present, and removing and 
disposing of these same tissues from bovines between 12 and 30 months 
of age would not provide any significant additional protection.
    This same point is illustrated in various models. Comer and Huntly 
(2003) modeled the potential human exposure available in the United 
Kingdom from 1980 through 2002. They concluded that an estimated total 
of 54 million bovine oral ID50 units could have been 
consumed in that timeframe. This period included both the beginning of 
the epidemic in cattle, before the disease was recognized and public 
health control measures were established, and later in the epidemic 
when control measures were developed and instituted. Comer and Huntly 
also concluded that 99.4 percent of this estimated exposure was from 
animals older than 30 months of age. Therefore, SRM restrictions from 
animals greater than 30 months would reduce the vast majority of 
potential exposure.
    Also, as discussed above in this document, in 2006, FSIS/Harvard 
incorporated changes based on public comment on an October 2005 
simulation that used a modified version of the 2001 Harvard BSE risk 
assessment model. This was made available to the public, along with the 
responses to the public comments, as ``Harvard Risk Assessment of BSE 
Update; Phase IA; Supplemental Simulation Results, December 26, 2006.'' 
The base case simulated 500 infected animals introduced, with 50,000 
simulation runs of 20-year timeframes. The base case results, which 
assumed no removal of SRMs, indicated a mean of 700 total infected 
animals over the 20 years (500 imports and 200 domestic), with a mean 
of 6,600 cattle oral ID50s potentially available for human 
consumption. In comparison, modeling a requirement for removal from the 
human food supply of SRMs from cattle 30 months of age or older, 
assuming 100 percent compliance, indicated a mean of 20 oral 
ID50s potentially available for human consumption over the 
20-year time period. The update also modeled requirements for removal 
from the human food supply of SRMs from cattle 12 months of age and 
older and 24 months of age and older. There was no significant 
difference between the results of those models and that which modeled a 
requirement for removal from the human food supply of SRMs from cattle 
30 months of age and older--viz., 17 oral ID50s each when 
SRM removal from cattle 12 months of age and older and 24 months of age 
and older were modeled, compared to 20 oral ID50s when 
removal of SRMs from cattle 30 months of age was modeled.
    In summary, we agree with the conclusion that has been widely 
reached and that has generally been accepted internationally, that the 
primary public health protective measure regarding BSE is the removal 
of SRMs from the human food supply, and we concur that the OIE 
recommendations address those tissues that have been shown to contain 
BSE infectivity.
    Issue: Several commenters stated that our September 2007 final rule 
should be withdrawn because the USDA's OIG reported in 2008 that APHIS' 
import controls are not sufficient to prevent, detect, or address the 
entry of animals that do not meet import requirements. The commenters 
expressed concern about APHIS' ability to prevent the introduction of a 
BSE-infected animal from Canada and concluded that the OIG report 
demonstrates that APHIS is incapable of adequately enforcing import 
restrictions necessary to protect the health of U.S. cattle and U.S. 
consumers.
    One commenter stated that the OIG report dealt with, among other 
things, APHIS' enforcement of requirements in its January 2005 final 
rule during the period between August 2006 and July 2007. The commenter 
stated that the report concluded that APHIS' import procedures were not 
sufficient to prevent unauthorized shipments of live animals into the 
United States. The commenter stated, further, that according to the OIG 
report, the

[[Page 15867]]

problems that the OIG found regarding compliance with APHIS' January 
2005 final rule raise concerns with APHIS' controls over live animal 
imports and whether the controls are adequate to ensure compliance with 
import restrictions contained in APHIS' September 2007 final rule. The 
commenter stated that the OIG audit also referenced other findings 
regarding APHIS enforcement of its regulations.
    The commenter stated that the OIG report contradicts APHIS' 
statement in its September 2007 final rule that there were only 
individual instances of errors or violations regarding the provisions 
of APHIS' January 2005 final rule. The commenter stated that OIG found 
the errors and violations to be pervasive and stated that the OIG 
report concluded that problems associated with inaccurate health, age, 
identification, and pregnancy status on Canadian cattle certificates 
that were used to import more than 7,000 cattle were not isolated 
occurrences because they involved at least 52 different Canadian 
veterinarians and 40 CFIA officials. The commenter stated that APHIS 
was aware, while preparing its September 2007 final rule, that OIG was 
auditing its import controls and finding what the commenter termed 
serious violations of APHIS' enforcement of the January 2005 final 
rule.
    Response: We agree that the OIG audit referenced by the commenter 
identified several areas where APHIS could improve its management 
controls and documentation regarding import procedures. Our response to 
the audit agrees with many of the recommendations and identifies 
actions to address them. In many instances, these actions will assist 
APHIS in documenting issues to provide sufficient information for an 
analysis to determine the true significance of the reported issues. The 
report itself acknowledges that OIG had ``difficulty assessing the 
significance of import noncompliance * * *.'' (Audit Report, USDA's 
Controls Over the Importation and Movement of Live Animals, Department 
of Agriculture, Office of Inspector General, Midwest Region, Report No. 
50601-0012-Ch, March 2008). The commenter stated that OIG found errors 
in certificates to be pervasive, yet the report does not reach this 
conclusion. OIG identified a total of 211 cattle that were imported 
with inaccuracies on the health certificate--86 animals inaccurately 
certified for pregnancy status, 105 animals allegedly inaccurately 
certified for age, and 21 with inaccurate identification. These 
inaccuracies are out of a total of 1.1 million animals imported in that 
year. While we agree with the recommendations in the report and are 
taking actions to improve our processes, we disagree with the 
commenter's conclusion that this level of inaccuracies is pervasive and 
that this demonstrates that APHIS is incapable of enforcing its import 
regulations.
    Issue: One commenter stated that, in its September 2007 final rule, 
APHIS relied on disproven findings to support its decision to remove 
the delay of applicability of those provisions of its January 2005 
final rule governing the importation of meat and meat byproducts from 
BSE minimal-risk regions. The commenter stated that, as justification 
for its decision to lift the ban on the importation of such commodities 
from Canada, APHIS asserted that its 2005 evaluation of the 
epidemiology of BSE cases identified at that time suggested that 
Canada's BSE outbreak was only a local exposure, based on the 
relatively small geographical location, temporal association, and the 
clustering of cases. The commenter stated that this conclusion has been 
disproven by subsequent outbreaks of BSE that occurred prior to APHIS' 
publication of its September 2007 final rule.
    Response: The commenter is incorrect that, in its September 2007 
final rule, APHIS cited the results of the 2005 evaluation of the 
epidemiology of BSE cases identified in Canada as justification for 
lifting the delay of applicability of certain provisions of its January 
2005 final rule. In its September 2007 final rule, APHIS explained its 
rationale for the lifting of the delay of applicability as follows:

    Since the date of the partial delay of applicability of our 
January 2005 final rule, we have obtained additional information 
regarding all aspects of the issues that prompted the delay of 
applicability and have conducted additional analyses in line with 
the plan as described. The risk assessment for this final rule 
demonstrates the negligible BSE risk from the importation of 
additional classes of live cattle, including those 30 months of age 
or older. This includes acknowledging the potential risk pathway 
that could be available if the SRMs from infected imported cattle 
entered the ruminant feed supply in contravention of current feed 
regulations. The negligible risk from the importation of live older 
cattle therefore gives further support to the conclusion of the risk 
analysis conducted for our January 2005 final rule regarding meat 
and meat products derived from bovines of any age in BSE minimal-
risk regions. Specifically, the risk is even lower for the 
importation of meat and meat products, as the SRMs will be removed 
in accordance with the regulations, than for live bovines. (72 FR 
53316)

    APHIS' description of the 2005 epidemiological investigation 
referred to by the commenter appeared in its September 2008 request for 
comments on the removal of the delay of applicability, and was 
included, for the sake of completeness, in a chronological list of 
events that occurred since APHIS' November 2003 proposal to establish 
the category of BSE minimal-risk regions. In the September 2008 request 
for comments, APHIS did not point to the 2005 epidemiological 
investigation as the rationale for removing the delay of applicability.
    Issue: One commenter stated that, in its September 2007 final rule, 
APHIS projected that 75,000 cull cattle 30 months of age and older 
would be imported from Canada. However, stated the commenter, USDA data 
showed that by November 8, 2008, the United States had imported 
approximately 167,224 cull cattle 30 months of age or older from 
Canada. The commenter stated that APHIS has explained that projected 
imports are a key component of the likelihood of BSE infectivity. Thus, 
stated the commenter, APHIS' estimate that the implementation of the 
September 2007 final rule could lead to the introduction of between 19 
and 105 BSE-infected cattle into the United States--which could, in 
turn, produce BSE infections in 2 to 75 U.S.-born cattle, lasting over 
a 20-year period--understates the actual level of BSE infectivity that 
has likely entered the United States in 2008.
    Response: The commenter is correct that, in analyzing the potential 
economic effects of its September 2007 final rule, APHIS projected that 
75,000 cull cattle 30 months of age and older would be imported into 
the United States from Canada in 2008. That number was a decrease from 
the 657,000 head that APHIS had originally projected in its January 
2007 proposed rule, and took into account information supplied by 
commenters on the proposed rule. However, the risk analysis for the 
September 2007 final rule continued to use a projected importation of 
657,000 head. Therefore, the number of cull cattle actually imported 
under the provisions of the final rule was less than that assumed in 
the risk analysis.
    Issue: One commenter stated that APHIS' promulgation of its 
September 2007 final rule violates the Agency's Congressional mandate 
to take the action necessary to prevent the introduction into or 
dissemination within the United States and to take the steps necessary 
to detect, control, and eradicate animal disease. The commenter stated 
that APHIS acknowledged that the September 2007 final rule could result 
in the importation

[[Page 15868]]

of some BSE-infected cattle from Canada. For this reason, stated the 
commenter, APHIS should withdraw its September 2007 final rule.
    Response: We disagree that the Secretary acted outside his broad 
authority under the Animal Health Protection Act (AHPA) (7 U.S.C. 8301 
et seq.) in promulgating the September 2007 final rule. The applicable 
section of the AHPA provides that ``the Secretary may prohibit or 
restrict * * * the importation or entry of any animal, article, or 
means of conveyance * * * if the Secretary determines that the 
prohibition or restriction is necessary to prevent the introduction 
into or dissemination within the United States of any pest or disease 
of livestock'' (7 U.S.C. 8303 (a)(1)). The United States Court of 
Appeals for the Ninth Circuit held that this section confers ``wide 
discretion'' on the Secretary in dealing with imports and ``does not 
impose any requirement on USDA that all of its actions carry no 
associated increased risk of disease'' (R-CALF v. USDA, 415 F.3d 1078, 
1094). The court found that open borders are a default under the AHPA 
and that the Secretary can close them only when he has determined that 
it is necessary. The court noted that the statute's use of the word 
``may'' suggests that the Secretary has broad discretion to decide 
whether to close the borders at all (id. at 1094-1095). We do not 
believe that the September 2007 final rule violates our statutory 
mandate and we deny the commenter's request to withdraw the rule on 
this basis.
    Issue: One commenter stated that the United States should prohibit 
the importation of beef or cattle from any country known to have BSE. 
Another commenter stated that beef and cattle trade with Canada should 
not be expanded until, among other actions pertaining just to live 
animals, Canada can verify 100 percent compliance with its ruminant 
feed ban and that its cattle herd and beef products are BSE-free.
    Response: The actions recommended by the commenter are not 
supported by scientific evidence or empirical data, nor are they 
consistent with internationally accepted animal health standards. Such 
action, if taken in turn by U.S. trading partners with regard to U.S. 
beef and cattle, would eliminate the export of beef and cattle from the 
United States.
    In a series of documents published from November 2003 through 
September 2008, which we discuss above in this document, APHIS provides 
the scientific rationale for classifying Canada as a BSE minimal-risk 
region and allowing the importation of certain ruminants and ruminant 
products from Canada under specified conditions.
    The regulatory conditions for the importation into the United 
States of beef and cattle from a BSE minimal-risk region such as Canada 
are consistent with the OIE Code for trade in beef and live animals 
from a country recognized by the OIE as having controlled risk for BSE. 
Both Canada and the United States are recognized as BSE controlled risk 
countries.
    The OIE, of which the United States is a Member country, is the 
internationally recognized standard-setting body that develops science-
based recommendations for the safe trade of animals and animal 
products. The World Trade Organization has recognized 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.
    The OIE facilitates intergovernmental cooperation to prevent the 
spread of contagious diseases in animals by sharing scientific research 
among its members. The major functions of the OIE are to collect and 
disseminate information on the distribution and occurrence of animal 
diseases and to ensure that science-based standards govern 
international trade in animals and animal products. The OIE carries out 
its function through the development and revision of international 
standards for diagnostic tests, vaccines, and the safe international 
trade of animals and animal products.
    The OIE develops risk-based standards, which, if agreed upon by 
Member countries through consensus, are published in the OIE 
Terrestrial Animal Health Code (Code). However, each OIE Member country 
is obligated to review and comment on proposed OIE standards, and make 
decisions regarding the adoption of those standards, strictly on their 
scientific merits.
    As an OIE Member country, the United States reviews and, where 
appropriate, comments on all draft OIE chapters and revisions. As part 
of the U.S. 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.
    In addition, each year, prior to formulating its comments for the 
OIE annual meeting, APHIS makes available on its Web site those 
potential changes to the Code that the OIE has submitted to Member 
countries for comment, and accepts information and recommendations from 
the public regarding those proposed changes. Through its OIE Reference 
Laboratories and Collaborating Centers, APHIS also provides OIE Member 
countries with technical assistance and expert advice on disease 
surveillance and control and risk analysis, as well as diagnostic 
assistance, evaluation, and consultation.
    Over the years, the OIE Member countries, including the United 
States, have agreed by consensus to amend the OIE Code based on 
increased scientific evidence regarding the disease. The OIE Code 
reflects the current understanding that, depending on multiple factors, 
there can be gradations in the risk of the BSE agent being moved from 
one country to another, and gradations in the risk of BSE transmission 
and amplification within any particular country. As a member of the 
OIE, 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.
    Issue: One commenter stated that beef and cattle trade with Canada 
should not be expanded until U.S. international beef export markets are 
firmly established. The commenter also urged that, if the restrictions 
on importations from Canada are removed, American cattle producers be 
compensated for economic disadvantages that might arise from such 
importations. Another commenter stated that U.S. exports are suffering 
because the United States requirements for imports from Canada are 
consistent with OIE standards but less stringent than the requirements 
imposed by other countries for the importation into those countries of 
beef from the United States.
    Another commenter stated that, as noted above, in its September 
2007 final rule, APHIS projected that 75,000 cull cattle 30 months of 
age older would be imported from Canada. However, stated the commenter, 
USDA data showed that by November 8, 2008, the United States had 
imported approximately 167,224 cull cattle 30 months of age or older 
from Canada. The commenter stated that although APHIS had projected 
revenue losses of over $66 million for U.S. cattle producers due to the 
importation from Canada of cattle 30 months of age or older, the larger 
number of such cattle actually imported will make those losses 
significantly higher.
    Response: As we stated in our September 2007 final rule, APHIS does

[[Page 15869]]

not have the statutory authority to restrict trade based purely on its 
potential economic impact, market access effects, or quantity of 
products expected to be imported. Under the AHPA, the Secretary of 
Agriculture may prohibit or restrict the importation or entry of any 
animal or article when the Secretary determines it is necessary to 
prevent the introduction or dissemination of a pest or disease of 
livestock. This authority has been delegated to APHIS.
    We note that neither our January 2005 final rule nor our September 
2007 final rule made any commodities eligible for importation from 
Canada that were not already allowed importation prior to May 2003, 
when a BSE-infected cow was diagnosed in Canada. One difference between 
the current situation and pre-May 2003, however, is that certain of the 
commodities that are now eligible for importation are subject to risk-
mitigating importation conditions appropriate to the fact that BSE has 
been detected in Canada and that we consider that country a minimal-
risk region for BSE. Both Canada and the United States have been 
classified as controlled-risk countries for BSE under the OIE Code. 
Nonetheless, there are some commodities (e.g., cattle born before March 
1, 1999) that continue to be ineligible for importation into the United 
States. Even taking into account such restrictions, however, the 
current regulations represent to a great extent a return to trade 
patterns that existed between the United States and Canada for many 
years previously.
    Issue: One commenter stated that during the period 2004-2007 the 
United States lost a total of $11 billion in the sale of U.S. beef 
abroad, including $5.7 billion in lost sales to Japan and $3.7 billion 
in lost sales to Korea. The commenter stated that restrictions on the 
importation of U.S. beef by other countries shows that those countries 
view OIE BSE risk mitigation standards--which the commenter stated the 
United States applies to imports of Canadian cattle and beef--as 
inadequate to protect their consumers from exposure to BSE.
    Response: The reduction in export sales that the commenter cites 
occurred during a 3-year period that began following the diagnosis of 
BSE in a cow of Canadian origin in Washington State in December 2003, 
prior to the publication of APHIS' final rule recognizing the category 
of BSE minimal-risk regions. As we stated in our September 2007 final 
rule, U.S. Government agencies are actively negotiating with trading 
partners to reestablish our export markets. After the December 2003 
detection of an imported BSE-infected cow in Washington State, many of 
the 114 nations that imported U.S. beef banned our beef and live 
animals, despite the apparent lack of scientific basis for such 
measures. The efforts of multiple U.S. Government agencies have 
succeeded in removing bans in over half of those markets, including our 
largest export market, Japan. U.S. Government agencies continue to work 
to reopen or further open markets where restrictions remain.
    Issue: One commenter stated that beef and cattle trade with Canada 
should not be expanded until mandatory country of origin labeling 
(COOL) is fully implemented and enforced.
    Response: On May 13, 2002, President Bush signed into law the Farm 
Security and Rural Investment Act of 2002, more commonly known as the 
2002 Farm Bill. One of its many initiatives requires country of origin 
labeling (COOL) for beef, lamb, pork, fish, perishable agricultural 
commodities and peanuts. The COOL program became fully effective as of 
March 16, 2009. However, as USDA's Agricultural Marketing Service noted 
in its October 30, 2004 proposal in discussing Section 10816 of Public 
Law 107-171 (7 U.S.C. 1638-1638d), the ``intent of the law is to 
provide consumers with additional information on which to base their 
purchasing decisions. It is not a food safety or animal health measure. 
COOL is a retail labeling program and as such does not address food 
safety or animal health concerns.''

Affirmation of Position Regarding Removal of Delay of Applicability

    After closely considering the issues raised by commenters in 
response to our September 2008 request for comments, for the reasons 
given in our September 2007 final rule and in this document we are 
affirming the position we took in removing the delay of applicability 
of certain provisions of our January 2005 final rule.

III. Proposed Changes

    Although APHIS has amended its BSE regulations in recent years 
consistent with increased scientific understanding of the disease, we 
believe that the regulations contain certain provisions that are not 
yet fully consistent with the latest scientific literature. Therefore, 
in this document we are proposing to establish conditions for the 
importation of live bovines and products derived from bovines that we 
believe are more reflective of current scientific understanding of BSE.
    We are proposing to base importation conditions on the inherent 
risk of BSE infectivity in specified commodities, as well as on the BSE 
risk status of the region from which the commodities originate. We are 
proposing to establish a system for classifying regions as to BSE risk 
that is consistent with the system employed by the OIE. The conditions 
we are proposing for the importation of specified commodities are based 
on internationally accepted scientific literature and, except in a few 
instances, are consistent with the OIE Code. We are also proposing to 
classify certain specified countries as to BSE risk and are proposing 
to remove BSE restrictions on the importation of cervids and camelids 
and products derived from such animals. We are proposing to make these 
amendments after conducting a thorough review of relevant scientific 
literature and a comprehensive evaluation of the issues and concluding 
that the proposed changes to the regulations would 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.

Evolution of U.S. Regulatory Response to BSE

    As discussed earlier in this document, the Federal Government 
conducts a coordinated response to protect humans and livestock from 
BSE. The protective measures APHIS has taken have evolved over the 
years, as scientific understanding of the disease has increased. From 
1997 until 2005, the only two categories of regions listed in the CFR 
with regard to BSE were regions in which BSE is known to exist and 
regions of undue risk for BSE. The regulations prohibit the importation 
from such regions of live cattle and other ruminants and certain 
ruminant products, including most rendered protein products. Imports 
from any region not listed in either of those two categories are not 
subject to any BSE prohibitions or restrictions. While this approach 
has been successful in protecting against the risk of BSE, advances in 
scientific understanding of the disease now allow the United States to 
take a more focused approach.
    In terms of method of transmission, BSE differs from most other 
livestock diseases. Oral ingestion of feed contaminated with the BSE 
agent is the only documented route of field transmission of the 
disease. This understanding of the disease made it increasingly evident 
that preventing material potentially infected with the BSE agent from 
being fed to ruminants is a key to preventing introduction and 
amplification of the disease within a

[[Page 15870]]

livestock population. Scientific research also found that some bovine 
tissues have demonstrated infectivity, whereas others have not, and 
that levels of infectious agent in certain tissues vary with the age of 
an animal.
    This scientific evidence regarding the most likely method of 
transmission of BSE was the basis for measures taken by Federal 
agencies to protect the U.S. human and livestock populations from BSE. 
As noted above under the heading ``Rulemaking Regarding BSE,'' in June 
1997 FDA prohibited the use of all mammalian protein, with the 
exception of pure pork and pure equine protein from single species 
processing plants, in animal feeds given to cattle and other ruminants, 
and established measures to protect against the contamination of 
``allowable'' feed material with materials that could contain the BSE 
agent (62 FR 30936; codified at 21 CFR 589.2000). The rule also allows 
exceptions for certain products believed to present a low risk of 
transmitting BSE: blood and blood products; gelatin; inspected meat 
products that have been cooked and offered for human food and further 
heat processed for feed (such as plate waste and used cellulosic food 
casings, referred to below as ``plate waste''); and milk products (milk 
and milk protein).
    FSIS, in a series of three interim final rules published in the 
Federal Register on January 12, 2004, established provisions to 
supplement its measures to prevent the BSE agent from entering the 
human food supply. As discussed above, in one of the interim final 
rules (FSIS Docket No. 03-025IF; 69 FR 1861-1874), FSIS, among other 
actions, designated 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 DRG of cattle 30 months of age and older, and the 
tonsils and distal ileum of the small intestine of all cattle as SRMs, 
and prohibited their use as human food. To ensure effective removal of 
the distal ileum, the SRM rule required establishments to remove the 
entire small intestine and dispose of it as inedible. FSIS also 
required all slaughtering and processing establishments to develop, 
implement, and maintain written procedures for the removal, 
segregation, and disposition of SRMs. Establishments were specifically 
required to implement procedures to address the potential contamination 
of edible materials with SRMs before, during, and after entry into the 
establishment. FSIS did not restrict the age of cattle eligible for 
slaughter, because the removal of SRMs effectively mitigates the BSE 
risk to humans associated with cattle that pass both ante-mortem and 
post-mortem inspections (i.e., apparently healthy cattle). The rule 
also declared mechanically separated beef (MS beef)) to be inedible and 
prohibited its use for human food, and prohibited all non-ambulatory 
disabled cattle for use as human food.
    The second interim final rule (FSIS Docket No. 03-038IF; 69 FR 
1874-1885) prohibited products produced by advanced meat recovery 
systems from being labeled as ``meat'' if, among other things, they 
contain central nervous system (CNS) tissue.
    The third interim final rule (FSIS Docket No. 01-0331IF; 69 FR 
1885-1891) prohibited the use of penetrative captive bolt stunning 
devices that deliberately inject air into the cranial cavity of cattle 
because they may force large fragments of CNS tissue into the 
circulatory system of stunned cattle where they may become lodged in 
edible tissues.
    On July 14, 2004, FDA published in the Federal Register an interim 
final rule (69 FR 42255-42274, Docket No. 2004N-0081), consistent with 
the January 2004 FSIS rulemaking, that prohibited the use of certain 
cattle material in human food, including dietary supplements, and 
cosmetics.
    On September 7, 2005, FSIS published in the Federal Register an 
interim final rule (70 FR 53043-53050, Docket No. 03-025IFA) that 
allowed for use as human food, under certain conditions, beef small 
intestine, excluding the distal ileum, derived from cattle slaughtered 
in official U.S. establishments or in certified foreign establishments 
in countries listed by FSIS in 9 CFR 327.2(b) as eligible to export 
meat products to the United States.
    Also on September 7, 2005, FDA published an interim final rule (70 
FR 53063-53069, Docket No. 2004N-0081) and request for comments in 
which it provided that small intestine is not considered a prohibited 
cattle material if the distal ileum is removed by a qualifying 
procedure. FSIS imposed a similar requirement in its interim rule.
    On July 13, 2007, FSIS published an interim final rule (72 FR 
38199-38730, Docket No. 03-025F) that affirmed its January 2004 interim 
final rules with some changes.
    In its September 2007 final rule (discussed above under the heading 
``Rulemaking Regarding BSE,'') APHIS, among other things, made its BSE 
regulations consistent with the FSIS and FDA changes regarding the 
small intestine.
    On April 25, 2008, FDA published a final rule (73 FR 22718-22758, 
Docket No. 2002N-0273) to prohibit the following in the food or feed of 
all animals: The entire carcass of BSE-positive cattle; the brains and 
spinal cord from cattle 30 months of age and older; the entire carcass 
of cattle not inspected and passed for human consumption that are 30 
months of age or older from which brains and spinal cords were not 
removed; tallow that is derived from BSE-positive cattle; tallow that 
is derived from other materials prohibited by the April 2008 final rule 
that contains more than 0.15 percent insoluble impurities; and 
mechanically separated beef that is derived from the materials 
prohibited by the April 2008 final rule.

International Standards

    The science upon which U.S. Federal agencies have based their 
rulemaking has also been the basis for internationally accepted BSE-
related standards governing the trade of ruminants and ruminant 
products. Much of the information that follows regarding the OIE and 
the United States' role in international standard setting is set out 
above in our response to a comment from the public on our September 
2008 request for comments. We repeat it here because of its relevance 
to the changes we are proposing in this document. As noted above, the 
OIE, of which the United States is a Member country, is the 
internationally recognized standard-setting body that develops science-
based recommendations for the safe trade of animals and animal 
products. The OIE is currently composed of 174 Member nations, each of 
which is represented by a delegate who, in most cases, is the chief 
veterinary officer of that country. The World Trade Organization has 
recognized the OIE as the international forum for setting animal health 
standards, reporting global animal disease events, and presenting 
guidelines and recommendations on sanitary measures related to animal 
health.
    As noted above, the OIE facilitates intergovernmental cooperation 
to prevent the spread of contagious diseases in animals by sharing 
scientific research among its members. The major functions of the OIE 
are to collect and disseminate information on the distribution and 
occurrence of animal diseases and to ensure that science-based 
standards govern international trade in animals and animal products. 
The OIE aims to achieve these through

[[Page 15871]]

the development and revision of international standards for diagnostic 
tests, vaccines, and the safe international trade of animals and animal 
products.
    The OIE develops risk-based standards, which, if agreed upon by 
Member countries through consensus, are published in the OIE 
Terrestrial Animal Health Code (Code). The OIE Code chapters are 
drafted (or revised) by either the Terrestrial Animal Health Standards 
Commission or by ad hoc groups composed of technical experts nominated 
by the Director General of the OIE by virtue of their subject-area 
expertise. Once a new chapter is drafted or an existing one is revised, 
the chapter is distributed to Member countries for review and comment.
    Generally, if a country has concerns with a particular draft 
standard, and supports those concerns with sound technical information, 
the pertinent OIE Code Commission will revise that standard 
accordingly, circulate the revised standard to OIE Member countries for 
comment, and present the revised draft for adoption at the General 
Session in May. In the event that a country's concerns regarding a 
draft standard are not taken into account, that country may refuse to 
support the standard when it comes up for adoption at the General 
Session. However, each Member country is obligated to review and 
comment on proposed standards, and make decisions regarding the 
adoption of those standards, strictly on their scientific merits.
    Through APHIS, the United States plays on ongoing role in the 
development and revision of the OIE Code. The science upon which APHIS 
has based its regulations has also been the basis for APHIS' 
recommendations regarding and response to BSE-related changes in the 
OIE Code. APHIS maintains a data base of disease and subject matter 
experts to review specific Code chapters; monitors and evaluates 
reports and scientific data produced by the OIE; and conducts meetings 
with staff members, pertinent industry groups, and subject matter 
experts to review and develop positions for the safe movement of animal 
and animal products.
    As an OIE Member country, the United States reviews and, where 
appropriate, comments on all draft OIE chapters and revisions. As part 
of the U.S. 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.
    In addition, each year, prior to formulating its comments for the 
OIE annual meeting, APHIS makes available on its Web site those 
potential changes to the Code that the OIE has submitted to Member 
countries for comment, and accepts information and recommendations from 
the public regarding those proposed changes. (The proposed changes can 
be accessed at https://www.aphis.usda.gov/import_export/animals/oie/). 
Through its OIE Reference Laboratories and Collaborating Centers, APHIS 
also provides OIE Member countries with technical assistance and expert 
advice on risk analysis and disease surveillance and control, as well 
as diagnostic assistance, evaluation, and consultation.
    Over the years, the OIE Member countries, including the United 
States, have agreed by consensus to amend the OIE Code based on 
increased scientific evidence regarding the disease. The OIE Code 
reflects the current understanding that, depending on multiple factors, 
there can be gradations in the risk of the BSE agent being moved from 
one country to another, and gradations in the risk of BSE transmission 
and amplification within any particular country. As a member of the 
OIE, 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.
    This recognition of varying levels of BSE risk is the underpinning 
for OIE's system of classifying countries according to different levels 
of BSE risk. Currently, the OIE categorizes countries as either 
negligible risk, controlled risk, or undetermined risk for BSE. For 
live cattle and for many products derived from cattle, the trade 
conditions recommended by the OIE Code are based on the BSE risk 
classification of the exporting country.

Changes to APHIS' Regulations Regarding BSE

    In recent years, APHIS has amended its regulations consistent with 
scientific evidence and BSE risk management that allow the United 
States to take a more focused approach to categorizing regions and 
establishing import prohibitions and restrictions with regard to BSE. 
As discussed above, in January 2005, APHIS amended its regulations to 
recognize a category of regions that present a minimal risk of 
introducing BSE into the United States, even though BSE may have been 
diagnosed in the region. In evaluating the BSE risk from a region to 
determine whether to classify it as a minimal-risk region, APHIS 
considers a combination of factors, focusing on overall effectiveness 
of control mechanisms in place (e.g., surveillance, import controls, 
and a ban on the feeding of ruminant protein to ruminants). In its 2005 
rule, APHIS also established conditions for the importation of certain 
live ruminants and ruminant products and byproducts from such regions 
and recognized Canada as a BSE minimal-risk region. We based our 
recognition of Canada as a BSE minimal-risk region on an analysis we 
conducted of the conditions considered for such a designation and the 
information available to us regarding how Canada meets those 
conditions. (The risk document, ``Analysis of Risk--Update for the 
Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and 
Importation of Commodities.'' which also identified measures necessary 
to mitigate any BSE risk that specific commodities imported from Canada 
might present to the United States, can be accessed at https://www.aphis.usda.gov/peer_review/downloads/risk_assessment_final9-2007.pdf)
    As noted above, in December 2005, APHIS amended its regulations to 
allow the importation of certain cuts of boneless beef from Japan. The 
risk assessment conducted for that rulemaking examined the evidence 
supporting the safety of this commodity. This evidence and APHIS' 
conclusions were consistent with OIE for trade in meat derived from 
cattle from regions of controlled risk for BSE. (The risk document, 
``Analysis of Bovine Spongiform Encephalopathy (BSE) Risk to the U.S. 
Cattle Population from Importation of Whole Cuts of Boneless Beef from 
Japan,'' can be accessed at https://www.regulations.gov/#!documentDetail;D=APHIS-2005-0073-0002).
    As discussed above, in September 2007, APHIS again amended the BSE 
regulations to allow the importation of additional commodities from BSE 
minimal-risk regions. As part of this rulemaking, APHIS conducted a 
risk assessment that was peer reviewed by recognized experts in the 
field. (The risk assessment, peer review, and APHIS responses to peer 
review comments can be accessed at https://www.aphis.usda.gov/peer_review/downloads/risk_assessment_%20final9-2007.pdf).

BSE Categories in Current APHIS Regulations

    With the 2005 addition to the regulations of the BSE minimal-risk 
category, the three categories of regions

[[Page 15872]]

with regard to BSE set forth in APHIS' regulations became: (1) Those in 
which BSE is known to exist (listed in Sec.  94.18(a)(1) of the 
regulations); (2) those that present an undue risk of introducing BSE 
into the United States because their import requirements are less 
restrictive than those that would be acceptable for import into the 
United States and/or because the regions have inadequate surveillance 
(listed in Sec.  94.18(a)(2) of the regulations); and (3) those that 
present a minimal risk of introducing BSE into the United States via 
live ruminants and ruminant products and byproducts (listed in Sec.  
94.18(a)(3) of the regulations). These are the categories set forth in 
the current regulations.
    How APHIS categorizes a region with regard to BSE risk determines 
which ruminants and products derived from ruminants from that region 
are eligible for importation into the United States. Of the three 
categories listed in Sec.  94.18(a), those regions listed in Sec.  
94.18(a)(1) (regions in which BSE is known to exist) and in Sec.  
94.18(a)(2) (regions that present an undue risk of introducing BSE into 
the United States) are subject to the most restrictive BSE-related 
regulatory provisions. The prohibitions and restrictions on the 
importation of live ruminants and commodities derived from ruminants 
are the same for regions in either of those categories.
    The importation of live ruminants of any kind is prohibited from 
regions listed in either Sec.  94.18(a)(1) or Sec.  94.18(a)(2). 
Additionally, with certain exceptions, regions listed in either Sec.  
94.18(a)(1) or Sec.  94.18(a)(2) are not eligible to import into the 
United States the following commodities derived from ruminants that 
have been in the regions: Meat; meat products; and edible products 
other than meat. Also, with certain limited exceptions, the following 
commodities are prohibited importation into the United States if they 
are derived from ruminants that have been in any region listed in Sec.  
94.18(a)(1) or Sec.  94.18(a)(2), or if the commodities themselves have 
been in such regions (and, in some cases, if they are derived from 
nonruminant species that might have been commingled with products 
derived from ruminants): Processed animal protein; tankage; offal; 
tallow other than tallow derivatives (unless, in the opinion of the 
Administrator, the tallow cannot be used in feed); glands and 
unprocessed fat tissue; processed fats and oils; derivatives of 
processed animal protein, tankage, and offal; derivatives of glands; 
casings, other than stomachs; and serum and related materials.
    Under the regulations regarding BSE minimal-risk regions, specified 
live ruminants and products derived from ruminants are eligible for 
importation from such regions, provided certain conditions are met. 
Factors governing the eligibility of and conditions for importation of 
such commodities from BSE minimal-risk regions include the following: 
The species of animal intended for importation or from which products 
were derived; whether an animal intended for importation has been 
properly identified; whether the animal had been subject to a ruminant-
to-ruminant feed ban; and, in the case of products derived from 
bovines, whether specified BSE risk materials were removed from the 
animal at slaughter.
    APHIS does not restrict the importation into the United States of 
ruminants and ruminant products from any region that is not listed in 
one of the three categories included in Sec.  94.18(a) (regions in 
which BSE is known exists, regions of undue risk for BSE, and regions 
of minimal risk for BSE), but their importation might be prohibited or 
restricted due to other animal diseases.

Proposed Changes

    Refining science-based regulations for safe trade in bovines and 
meat and other products derived from bovines has been and continues to 
be a high priority for APHIS. As noted above, although APHIS' 
regulatory changes in recent years with regard to BSE have been 
consistent with increased scientific understanding of the disease, we 
believe that further refinement of the regulations is in order given 
the latest scientific literature regarding BSE. In this document, we 
are proposing to amend the regulations to establish importation 
requirements based on our current scientific understanding of the risk 
of BSE. In many instances these changes, while still protecting 
livestock in the United States from BSE, would allow the importation 
into the United States of additional commodities. In a few cases, this 
proposal would make BSE-related import conditions more restrictive.\10\
---------------------------------------------------------------------------

    \10\ For example, ruminant-derived MBM and greaves, and products 
containing such, sourced from regions of controlled and undetermined 
risk would be prohibited.
---------------------------------------------------------------------------

OIE Code

    APHIS is closely familiar with the development of the OIE Code and 
considers it to be based on sound science. The scientific literature 
upon which we are basing our proposed regulations includes literature 
that has been considered by OIE subject matter experts and Member 
countries in developing and updating the OIE Code, as well as other 
scientific literature reviewed by APHIS. One result of implementing 
these science-based changes would be to make the APHIS regulations more 
consistent with the 2010 OIE Code. In those few instances where our 
proposed provisions differ from the guidelines in the 2010 OIE Code, we 
provide a science-based rationale for those differences, either in this 
document or in the supporting scientific documentation.
    The OIE Code reflects the scientific understanding of the nature of 
BSE and appropriate risk mitigation measures. Two of the most important 
risk mitigation measures are the control of SRMs and feed bans. Most of 
the OIE guidelines rest on these two significant mitigation measures. 
An additional risk mitigation measure can be the application of certain 
production processes that can achieve a level of inactivation of the 
BSE agent. In some instances, industrial production methods--such as 
those for gelatin production--are sufficient to provide varying levels 
of inactivation of the BSE agent. These are described in more detail in 
this document in the relevant sections for these products. The use of 
these mitigation measures as outlined in the OIE Code significantly 
reduces the risk that the BSE agent might be present in the animals or 
products presented for trade.
    The same mitigation measures are applied domestically, thus 
minimizing the risk that BSE will become established in the United 
States if the BSE agent is present in an imported animal or product. 
Using the importation of live cattle as an example, we can consider the 
risk pathway for transmission of BSE. Several steps must take place for 
BSE to be transmitted to cattle in the United States from a bovine 
imported live from another country. A BSE-infected bovine must be 
imported into the United States; the infected bovine must die or be 
slaughtered; tissues from that animal that contain sufficient levels of 
the infectious agent must be sent to a rendering facility; the 
infectivity present in these tissues must survive inactivation in the 
rendering process; the resulting processed animal protein containing 
the abnormal prion protein must be incorporated into feed; and this 
feed must be fed to cattle at a level adequate to infect the cattle. 
(The amount of infectious material required in feed for cattle to 
become infected is dependent on the age of the cattle; younger cattle 
are more susceptible to BSE and require less BSE-contaminated feed to 
become infected.) The nature

[[Page 15873]]

and likelihood of these pathways depend in large part on mitigations--
such as SRM controls and a feed ban--acting in series and in parallel 
that reduce the likelihood that BSE will be established in the United 
States.
    The combined OIE requirements and additional APHIS requirements 
would serve to prevent the introduction and spread of the BSE agent 
from imported commodities regardless of a country's BSE prevalence.

Classification of Regions as to BSE Risk

    One of the structural changes this proposed rule would make to the 
current BSE regulations would be to change the current Sec.  94.18(a) 
categories of regions in which BSE is known to exist, regions of undue 
risk for BSE, and BSE minimal-risk regions to the system used by the 
OIE of classifying areas as being either of negligible risk, controlled 
risk, or undetermined risk for BSE.\11\ Whether a live bovine or a 
bovine-derived product would be eligible for importation into the 
United States, and under what conditions, would in many cases be 
determined by the BSE category of the region from which the animal or 
product originates.\12\
---------------------------------------------------------------------------

    \11\ Although the OIE Code refers to categorization of 
``countries, zones, or compartments,'' the only areas that have been 
classified by OIE with regard to BSE risk to date have been entire 
countries. In discussing animal diseases in its regulations, APHIS 
uses the term ``region'' to refer to foreign areas. Under the APHIS 
regulations, a region can consist of any of the following: (1) A 
national entity (country); (2) part of a national entity (zone, 
county, department, municipality, parish, Province, State, etc.); 
(3) parts of several national entities combined into an area; or (4) 
a group of national entities combined into a single area. In our 
proposed rule, we would continue to use the term ``region'' in order 
to be consistent with our current animal import regulations, and 
will refer to the geographic and political entities considered by 
the OIE as ``regions.'' However, when considering BSE risk 
classification, we do not anticipate dealing with any entities other 
than individual countries in their entirety. Considering the BSE 
risk status of entire individual countries would be consistent with 
past APHIS practice, as well as OIE practice.
    \12\ The current regulations regarding BSE minimal-risk regions 
apply to bison as well as cattle. In current Sec. Sec.  93.400, 
94.0, and 95.1 of the regulations, bovine is defined as Bos taurus, 
Bos indicus, and Bison bison. Although the research and other data 
cited in this proposed rule refer to bovines other than bison (i.e., 
to ``cattle''), there is no evidence to indicate that the BSE 
susceptibility of bison differs from that of cattle. We therefore 
assume that our conclusions based on cattle-specific evidence 
discussed in this proposed rule are also applicable to bison. The 
provisions of this proposed rule would apply to bovines as defined 
in the current regulations, which include bison.
---------------------------------------------------------------------------

BSE Classification of Regions

    We are proposing to base APHIS' classification of the BSE risk 
status of a region on the results of an evaluation of BSE risk posed by 
that region. Under this proposed rule, that evaluation could have been 
conducted either by APHIS or by the OIE. The process the OIE uses in 
conducting such an evaluation and the information it considers are 
equivalent to the process and information APHIS considers necessary to 
arrive at an appropriate determination of BSE risk. The process and 
information considered are discussed at greater length, below, under 
the heading ``Process for Determining BSE Risk Classification.''

Scope of This Proposed Rule

    The current APHIS regulations regarding BSE encompass all ruminants 
and products from all ruminants. Under the current regulations in 9 CFR 
parts 93, 94, and 98, ruminants are defined as ``all animals that chew 
the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, 
camels, llamas and giraffes.'' Included among ruminants are bovines 
(e.g., cattle), ovines (e.g. sheep), caprines (e.g., goats), cervids 
(e.g., deer and elk), and camelids (e.g., llamas and alpacas). Bovines 
are defined in the regulations as bos taurus, bos indicus, and bison 
bison--cattle and bison. In the following paragraphs, we discuss how 
this proposed rule applies to each of these groups of ruminants.
Cervids and Camelids
    In prohibiting the importation of all ruminants from regions listed 
in Sec.  94.18(a)(1) and (a)(2), the current regulations prohibit the 
importation from such regions of cervids and camelids, and products 
derived from such animals, from such regions. However, live cervids and 
camelids and products derived from cervids and camelids are eligible 
for importation from BSE minimal-risk regions without restriction 
regarding BSE.
    In this document, we are proposing to remove all restrictions with 
regard to BSE from the importation of live cervids and camelids and 
their products from any region of the world. Although BSE has been 
shown to be naturally and experimentally transmitted to a wide range of 
ruminants, natural transmission of BSE has not been reported in cervids 
or camelids. One ongoing study shows that red deer (cervus elaphus) 
developed clinical signs similar to chronic wasting disease upon 
intracerebral inoculation of BSE-infected brain (Martin, et al., 2007); 
however red deer challenged intra-gastrically with BSE-infected brain 
developed neither clinical signs of disease nor presence of PrPsc at 
post-mortem examination. In addition, surveillance in the United 
Kingdom and European cervid population did not show any evidence of any 
TSEs (https://www.cdc.gov/Ncidod/eid/vol12no02/pdfs/05-0970.pdf; https://www.defra.gov.uk/animalh/bse/othertses/). Therefore, APHIS 
considers the BSE risk from removing import restrictions on cervids and 
camelids and their products to be very low. The OIE Code with respect 
to BSE does not address trade in cervids or camelids.
Ovines and Caprines
    In this proposal, we continue to apply the current import 
prohibitions and restrictions regarding ovines and caprines (e.g., 
sheep and goats) and their products. 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 such 
animals. Upon completion of such a proposal, we will publish it in the 
Federal Register for public comment.
    Because this proposed rule contains no substantive changes to the 
import regulations regarding ovines and caprines, any comments we 
receive in response to this proposed rule that pertain to ovines and 
caprines will not be addressed in this rulemaking, but will be 
considered as we develop our proposed rule regarding the importation of 
ovines and caprines and products from such animals.
    Although we are not proposing at this time to make any substantive 
changes to the regulations regarding the importation of ovines and 
caprines and products derived from such animals with regard to BSE, we 
are proposing certain formatting and wording changes to those 
regulations. We discuss these proposed changes below under the heading 
``Provisions Regarding Ovines and Caprines.''
Bovines
    As noted above, we are proposing to amend our import regulations 
with regard to bovines and BSE in a way that would result in our 
regulations being more consistent with the current scientific 
understanding of BSE, which is also reflected in the recommendations 
regarding trade in cattle and cattle products set forth in Chapter 11.5 
of the OIE Code.\13\
---------------------------------------------------------------------------

    \13\ The current regulations regarding BSE minimal-risk regions 
apply to bison as well as cattle. In current Sec. Sec.  93.400, 
94.0, and 95.1 of the regulations, bovine is defined as Bos taurus, 
Bos indicus, and Bison bison. Although the research and other data 
cited in this proposed rule refer to bovines other than bison (i.e., 
to ``cattle''), there is no evidence to indicate that the BSE 
susceptibility of bison differs from that of cattle. We therefore 
assume that our conclusions based on cattle-specific evidence 
discussed in this proposed rule are also applicable to bison. The 
provisions of this proposed rule would apply to bovines as defined 
in the current regulations, which include bison.

---------------------------------------------------------------------------

[[Page 15874]]

    As discussed above, commodities from regions not listed in any of 
the categories set forth in Sec.  94.18(a) (regions in which BSE is 
known to exist, regions of undue risk for BSE, and regions of minimal 
risk for BSE) are currently not subject to import restrictions because 
of BSE. Imports from BSE-affected regions and those that present an 
undue risk are governed by the same set of restrictions, which prohibit 
the importation of live ruminants and most products derived from 
ruminants. Imports from BSE minimal-risk regions are governed by their 
own set of restrictions, which allow for the importation of more 
commodities than do the regulations regarding BSE-affected regions and 
those that present an undue risk.
    As noted above, the 2010 OIE Code chapter regarding BSE provides 
for three possible BSE risk classifications: Negligible risk, 
controlled risk, and undetermined risk. APHIS has thoroughly reviewed 
the peer-reviewed scientific literature on BSE that the OIE uses to 
support its guidelines for risk evaluations (discussed in ``Supporting 
document for Chapter 2.3.13 of the Terrestrial Animal Health Code on 
Bovine Spongiform Encephalopathy'' (OIE TAHSC, 2006)) and, with certain 
limited exceptions, agrees with the OIE's recommendations and 
guidelines. We discuss below the factors the OIE takes into account in 
making its classifications.
    Under the OIE Code for live cattle and many products derived from 
cattle, many of the recommended measures to mitigate any BSE risk from 
the trade of such commodities depend on the risk classification of an 
exporting region. The OIE takes many factors into account in 
determining whether the BSE risk in a particular country is negligible, 
controlled, or undetermined. These factors include: The history of BSE 
in the country; whether BSE-infected animals in the country were 
imported or were indigenous; if indigenous, how long ago an infected 
animal was born; identification and destruction of infected animals and 
potentially exposed animals; the level of surveillance for BSE carried 
out in the country and the length of time the surveillance has been 
carried out; whether, and for how long, appropriate awareness and 
notification programs and laboratory diagnostic procedures have been in 
place; whether, and for how long, a ban on the feeding of ruminant 
materials to other ruminants has been effectively enforced. These are 
the same factors that APHIS took into account when determining that 
Canada qualified as a BSE minimal-risk region.
    In this proposal, we are proposing to amend our BSE regulations to 
structure classification of regions for BSE risk in the same way as 
does the OIE. Such classification is based on an overall evaluation of 
the BSE risk of a region, including a risk assessment. Because the data 
and process for a BSE risk evaluation that APHIS would conduct are 
equivalent to those employed by the OIE in making its own evaluations, 
we are proposing that APHIS' classification of the BSE risk status of 
an exporting region could be based on either an evaluation of the BSE 
risk of a country that is conducted by the OIE, or, for regions not yet 
classified by OIE, on an evaluation conducted by APHIS following a 
request.

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

    We are proposing to add definitions of a region of negligible risk 
for BSE, a region of controlled risk for BSE, and a region of 
undetermined risk for BSE to the regulations in Sec.  92.1. The 
definitions we are proposing to add are substantively the same as those 
used by the OIE in its Code. However, stylistically, our proposed 
definitions are, in some places, worded differently from the wording 
used in the OIE Code.
Regions of Negligible Risk for BSE
    There are multiple criteria that must be met for a region to 
qualify as a region of negligible risk for BSE. Our proposed definition 
of a region of negligible risk for BSE appears in Sec.  92.1 and 
includes the following conditions. We are proposing that a region of 
negligible risk for BSE is one for which a risk assessment has been 
conducted that is sufficient to identify the historical and existing 
BSE risk factors in the region and that:
     Has demonstrated that appropriate BSE risk mitigation 
measures have been taken for at least as long as indicated in this 
definition;
     Has demonstrated that Type B surveillance in accordance 
with Article 11.5.22 of the OIE Code, 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 (OIE guidelines for surveillance are discussed below under the 
heading ``Epidemiological situation concerning BSE in the country.'')
     Has, for at least the past 7 years:
    1. Conducted an ongoing awareness program for veterinarians, 
farmers, and workers involved in the transportation, marketing and 
slaughter of bovines to encourage reporting of all bovines showing 
clinical or behavioral signs that could be indicative of BSE.
    2. Required notification and investigation of all bovines showing 
clinical signs consistent with BSE; and
    3. 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 system;
     Has demonstrated through an appropriate level of control 
and audit that, for at least the past 8 years, neither meat-and-bone 
meal (MBM) nor greaves derived from ruminants have been fed to 
ruminants. In the OIE Code, the 8-year requirement regarding a feed ban 
applies to MBM and greaves derived from ruminants. Even though the OIE 
recommends that regions that are considered controlled risk or 
undetermined risk should not trade in MBM and greaves derived from 
ruminants, or in any commodities containing such, APHIS is proposing 
that the recommendation apply to processed animal protein derived from 
ruminants or commodities containing processed animal protein derived 
from ruminants. In part 95 of the current regulations, processed animal 
protein is defined as ``meat meal, bone meal, MBM, blood meal, dried 
plasma and other blood products, hydrolyzed proteins, hoof meal, horn 
meal, poultry meal, feather meal, fish meal, and any other similar 
products.'' Like MBM, each of the other products in the definition is a 
rendered product, and, except for blood and blood products, we have not 
yet done an assessment of the BSE risk of the products. Additionally, 
we believe it is necessary to take into account the risk that the other 
products could become commingled with MBM, which, if derived from 
infected ruminants, may contain the infectious agent. APHIS would allow 
the importation of those processed animal proteins derived from 
ruminants or commodities containing such after an assessment of the 
risk has determined that these products are not commingled or 
contaminated with ruminant MBM or greaves.
    In addition to meeting the criteria listed above, for a region to 
qualify as a region of negligible risk for BSE, one of the following 
conditions must apply; either:
     There has been no case of BSE in the region; or

[[Page 15875]]

     There have been one or more cases, but each case has been 
demonstrated to have been imported and has been completely destroyed; 
or
     There has been at least one indigenous case, but every 
indigenous case was born more than 11 years ago. If there has been one 
or more indigenous cases, all bovines included in either of the 
following two categories must, if still alive, be 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, be completely destroyed:
    1. 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 feed that 
potentially contained SRM material as the infected animal during that 
period; or
    2. 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.
Regions of Controlled Risk for BSE
    If a region does not qualify as a region of negligible risk for 
BSE, we are proposing that it could be classified as a region of 
controlled risk for BSE if specified conditions are met, as set forth 
in Sec.  92.1 of this proposed rule and described below. We are 
proposing that a region of controlled risk for BSE is one for which a 
risk assessment has been conducted sufficient to identify the 
historical and existing BSE risk factors in the region and that:
     Has demonstrated that appropriate mitigations are being 
taken to manage all identified risks, but has not taken every 
mitigation measure for the length of time that would be necessary to 
qualify as a region of negligible risk for BSE;
     Has demonstrated that Type A surveillance in accordance 
with Article 11.5.22 of the OIE Code, 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 equivalent guidelines recognized by the Administrator has been met. 
Type B surveillance, or equivalent surveillance recognized by the 
Administrator, is sufficient in place of Type A surveillance once the 
relevant points target for Type A surveillance has been met;
     Meets the conditions of one of the two following sets of 
conditions:
    Conditions Set 1. There has been no case of BSE in the region, or, 
if there have been one or more cases of BSE, every case has been 
demonstrated to have been imported and has been destroyed. In addition, 
both of the following conditions apply:
     The following conditions have been met and continue to be 
met:
    a. The region has conducted an ongoing awareness program for 
veterinarians, farmers, and workers involved in transportation, 
marketing and slaughter of bovines to encourage reporting of all 
bovines showing clinical signs that could be indicative of BSE;
    b. The region has required notification and investigation of all 
bovines showing clinical signs consistent with BSE; and
    c. The region 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 required surveillance and monitoring system;

and:

     The feeding to ruminants of MBM and greaves derived from 
ruminants is prohibited in the region.
    However, the requirements described above regarding awareness, 
notification, and examination have not been met for at least the past 7 
years and/or it cannot be demonstrated that controls over the feeding 
of ruminant protein to ruminants have been in place for at least the 
past 8 years.
    Conditions Set 2. There has been an indigenous case of BSE, and 
either or both of the following applies; either:
     The following conditions have been met and continue to be 
met, but not for at least the past 7 years:
    a. The region has conducted an ongoing awareness program for 
veterinarians, farmers, and workers involved in transportation, 
marketing and slaughter of bovines to encourage reporting of all 
bovines showing clinical signs that could be indicative of BSE;
    b. The region has required notification and investigation of all 
bovines showing clinical signs consistent with BSE;
    c. The region 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 required surveillance and monitoring system;

or:

     The feeding to ruminants of MBM or greaves derived from 
ruminants is prohibited in the region, but it cannot be demonstrated 
through an appropriate level of control and audit that the prohibited 
material has not been fed to ruminants for at least the past 8 years.
     Additionally, in either of the situations described in 
this second set of conditions, for a region to qualify as a region of 
controlled risk for BSE, the following condition must be met: If alive 
in the region, bovines that are included in either of the following 
categories 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 feed that 
potentially contained SRM material 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 the BSE-infected bovine either within 
12 months before or 12 months after the birth of the infected animal.
Regions of Undetermined Risk for BSE
    A region of undetermined risk for BSE is defined by the OIE, and 
would be defined by APHIS in Sec.  92.1, as a region that does not meet 
the criteria for being classified as either a region of negligible risk 
for BSE or a region of controlled risk for BSE.
Incorporation by Reference of OIE Code Standards for BSE Surveillance
    The proposed definitions of region of negligible risk for BSE and 
region of controlled risk for BSE include the criteria that the region 
has demonstrated that specified surveillance in accordance with Article 
11.5.22 of the OIE Code, or with equivalent guidelines recognized by 
the Administrator, is in place and that the relevant points target, in 
accordance with Table 1 of Article 11.5.22 of the OIE Code or 
equivalent guidelines recognized by the Administrator has been met.
    As discussed above, the OIE, of which the United States is a member 
country, is the internationally recognized standard-setting body that 
develops science-based recommendations for the safe trade of animals 
and animal products. We are proposing to incorporate into the 
regulations by reference at Sec.  92.7 Article 11.5.22 of the

[[Page 15876]]

OIE Code. The OIE surveillance standards are discussed in more detail, 
below, under the heading ``Epidemiological situation concerning BSE in 
the country.'' Section 92.7 would also state that the incorporation by 
reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and that the OIE 
maintains a copy of its standards on its internet homepage at https://www.oie.int/eng/normes/Mcode/en_sommaire.htm. Additionally, Sec.  92.7 
would state that copies of the OIE standards are available for 
inspection at the National Archives and Records Administration (NARA) 
and that information on the availability of this material at NARA can 
be obtained by calling 202-741-6030 or by going to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Process for Determining BSE Risk Classification

    In the following paragraphs, we discuss the process followed by the 
OIE in conducting its evaluation of a country for BSE risk. As noted 
above, APHIS recognizes the scientific validity of the process used by 
the OIE and employed an equivalent process in classifying Canada as a 
BSE minimal-risk region and, in subsequent rulemaking, allowing 
additional imports of live bovines and bovine products from Canada.
    In carrying out its evaluation process, the OIE refers to risk 
factors as they involve ``cattle.'' Therefore, when discussing the OIE 
process in this proposed rule, we use the term ``cattle.'' However, as 
we note above in this document, the provisions of this proposed rule 
would apply to bovines as defined in the current regulations, which 
include bison.
    As described in the questionnaire for BSE status recognition 
(https://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/A_BSE quest.pdf) that is based on Articles 11.5.3 and 11.5.4 
of the OIE Code, countries requesting classification from the OIE as a 
country of negligible risk for BSE or a country of controlled risk for 
BSE must submit a dossier containing BSE historical data to support a 
risk assessment and overall evaluation. The information in the dossier 
is evaluated by BSE experts who are leading specialists regarding the 
disease.
    In the following paragraphs we discuss the OIE procedure for 
recommending the BSE classification of a country and the rationale 
behind the considerations taken. As noted above, APHIS considers the 
approach taken by the OIE to be based on the current scientific 
understanding of BSE. In its own evaluations of the BSE risk in other 
countries, APHIS has taken, and will continue to take, an equivalent 
approach.
    For purposes of discussion of the classification process, we will 
follow the OIE terminology in discussing the country being evaluated 
for BSE risk as the exporting country or exporting region. In proposed 
Sec. Sec.  92.1, 93.400, 94.0, and 95.1, we define exporting region as 
a region from which shipments are sent to the United States.
    The risk classification of an exporting country may be influenced 
by commodities the country has imported from another country. For 
purposes of discussion, we will follow the OIE terminology and refer to 
a country that sends commodities to the ``exporting country'' as a 
``country of origin.''

Components of a Risk Assessment

    A risk assessment is the primary tool used by the OIE in 
determining whether to recognize a country as either a country of 
negligible risk for BSE or a country of controlled risk for BSE, and 
would be the primary tool used by APHIS in making such a determination. 
An assessment of BSE risk includes at least two components: A release 
assessment and an exposure assessment. A release assessment assesses 
the likelihood that BSE has been introduced into the exporting country 
through live animals, processed animal protein, or other animal 
products. An exposure assessment assesses the likelihood that cattle 
within the exporting country could have been exposed to the BSE agent.
    Under the OIE Code, in addition to the information necessary to 
allow OIE to conduct a risk assessment, a country requesting OIE 
classification as a country of negligible risk or controlled risk for 
BSE must also submit information regarding the country's BSE awareness 
program, its notification requirements for BSE, its diagnostic 
capabilities, and its BSE surveillance program. This type of 
information was also considered by APHIS in conducting its evaluation 
of the BSE disease risk of Canada.

Release Assessment Component of a Risk Assessment

    As noted above, a release assessment assesses the likelihood of 
release of the BSE agent into a country through the importation of 
potentially infected live cattle, processed animal protein, or other 
products of animal origin potentially infected with BSE. In the 
following paragraphs, we discuss the significance of these commodities 
with regard to BSE risk.
Potentially Infected Live Cattle
    An assessment of the risk of the release of the BSE agent in the 
exporting country includes consideration of whether potentially 
infected live cattle were imported into that country. The risk of the 
release of the BSE agent in the exporting country is dependent on:
     The BSE status of the country of origin of the potentially 
infected live cattle;
     The feeding and management of the cattle in the country of 
origin;
     Whether the cattle are dairy or beef breeds, if there are 
differences in exposure due to feeding practices in the country of 
origin;
     The date at which imports occurred, relative to the BSE 
mitigation in the country of origin; and
     The volume of potentially contaminated imports.
Products of Animal Origin That Could Pose a BSE Risk
    A release assessment also considers the importation of animal 
products that could pose a BSE risk. As with importation of potentially 
infected live cattle, there are various factors that can affect the 
potential risk presented by products of animal origin.
     The risk of the release of the BSE agent in the exporting 
country due to the importation of animal products is dependent on:
     Whether products from cattle contain tissues of the type 
known to contain BSE infectivity (i.e., SRMs);
     The country of origin of the products and the BSE status 
of that country;
     The feeding and management of the animals in the country 
of origin;
     Whether the cattle from which the products are derived in 
the country of origin are dairy or beef breeds, if there are 
differences in exposure due to feeding practices in the country of 
origin; and
     The age at which the cattle from which the products were 
derived were slaughtered in the country of origin.
    For both live animals and animal products, some of the risk factors 
identified can be mitigated through import requirements. These are 
evaluated as part of the OIE process. For example, if a country 
prohibited the importation of any cattle products containing or derived 
from SRMs, the risk would be mitigated. Therefore, imports meeting 
those conditions would not necessarily result in an elevated risk as 
noted in the risk assessment.

[[Page 15877]]

    For most animal products, the OIE evaluates the information 
described above regarding products of animal origin that have been 
imported during the previous 7 years into the potential exporting 
country (i.e., the country seeking a BSE risk classification from the 
OIE).
    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 if originating from low-risk countries.
    Because of the relatively greater BSE risk posed by processed 
ruminant protein compared to other animal products, the required 
reporting period for MBM and greaves is greater than for other animal 
products, and countries seeking BSE risk classification must inform the 
OIE whether MBM, greaves, or feedstuffs containing either, have been 
imported into that country within the past 8 years, and, if so, from 
what country and in what quantities. (In the OIE Code, MBM is defined 
as ``the solid protein products obtained when animal tissues are 
rendered, including any intermediate protein product other than 
peptides of a molecular weight less than 10,000 daltons and amino 
acids.'' Greaves are the protein-containing residue obtained after the 
partial separation of fat and water during the rendering process.) 
Eight years are associated with the incubation period of BSE, and 
represent a time period longer than the one representing the 95th 
percentile of the normal distribution of the age of clinical BSE cases 
detected at the peak of the United Kingdom and Swiss epidemic--i.e., 95 
percent of clinical cases of BSE would be expected to be detected in 
some period of time less than 8 years after exposure to MBM or greaves 
contaminated with the BSE agent.

Exposure Assessment of the Exporting Country

    The exposure assessment assesses the likelihood of exposure to the 
BSE agent of cattle in the exporting country, given the release of the 
BSE agent into the country. The exposure assessment evaluates the 
entire risk pathway for the transmission of BSE in the country. This 
includes all aspects of the cattle feed production and management 
systems.
    Evidence indicates that field transmission of BSE requires that 
cattle ingest feed that has been contaminated with tissues or organs 
containing the BSE agent from an infected animal. Several steps in the 
risk pathway must take place consecutively for this to happen. An 
infected animal, carrying significant amounts of the infectious agent, 
must die or be slaughtered; tissues from that animal that contain the 
infectious agent must be sent to a rendering facility; the infectivity 
present in these tissues must survive inactivation in the rendering 
process; the resulting protein must be incorporated into feed, and this 
feed must be fed to at least one bovine at an adequate level.
    The exposure assessment conducted by the OIE carefully evaluates 
all of these steps in the pathway as they consider the potential for 
the exposure of cattle to the BSE agent through consumption of MBM or 
greaves of bovine origin. This incorporates an evaluation of the 
implementation and enforcement of feed bans, including measures to 
prevent cross-contamination of animal feed. It includes all aspects of 
the potential for recycling and amplification of the BSE agent--whether 
the origin and use of bovine carcasses (including fallen stock), 
byproducts, and slaughterhouse waste presented a risk of recycling or 
amplification of the BSE agent; the parameters of the rendering 
processes; and the methods of producing feed for cattle and other 
animals. The OIE evaluates information addressing each of the factors 
listed above.
    The rendering industry is crucial in reducing the risk of 
transmitting BSE infectivity, not only because of its role in 
inactivation of the BSE agent, but also because it serves as a critical 
control point for the redirection of ruminant protein away from cattle 
feeds. The OIE evaluates all aspects of the rendering industry. These 
include what types of tissues and/or carcasses are used as inputs in 
the rendering process. If SRMs are excluded from the input tissues or 
carcasses, this reduces the risk. It also includes the parameters of 
the rendering processes. Certain rendering processes can inactivate a 
proportion of the BSE agent present. If a fraction of the BSE 
infectivity were to escape in activation at the rendering facility, it 
would need to bypass controls imposed to prevent cross-contamination 
and ensure proper labeling of rendered materials (at the renderer) and 
feeds produced using prohibited MBM (at the feed mill).
    The OIE also evaluates any feed ban or feed controls that are in 
place in the country. As noted above, it is widely accepted that BSE is 
caused by the consumption of processed animal protein of ruminant 
origin carrying and/or contaminated with the BSE agent. For potential 
exporting countries requesting a classification of BSE risk, the OIE 
evaluates information on whether MBM or greaves of ruminant origin have 
been fed to cattle in the country within the previous 8 years, 
including information regarding the implementation and enforcement of a 
feed ban and measures to prevent cross-contamination of animal feed. 
This evaluation includes consideration of the regulations imposing a 
feed ban, the veterinary infrastructure used to enforce and audit all 
aspects of the feed ban, and results of all audits or enforcement 
activities.
    The overall risk of BSE in the cattle population of a country is 
proportional to the level of known or potential exposure to BSE 
infectivity and the potential for recycling and amplification of the 
infectivity through livestock feeding practices. For a risk assessment 
to conclude that the cattle population of a country is of negligible or 
controlled risk for BSE, it must have been demonstrated that 
appropriate measures have been taken for a set period of time to manage 
any risks identified. The risk assessment evaluates information, within 
the context of the risk described above, regarding all aspects of the 
feeding practices over the previous 8 years in the country.

Additional Factors To Be Considered in the Determination of BSE Risk 
Status

Epidemiological Situation Concerning BSE in the Country
    Surveillance programs generate a picture of the epidemiological 
situation of BSE in a country. The more targeted the surveillance 
activities, the greater the power of the information. Surveillance 
targeted at high-risk populations for BSE provides more powerful 
information than generic animal disease surveillance for the entire 
cattle population.
    Depending on the characteristics of the country, the goal of BSE 
surveillance could be to:
     Detect cases at a predetermined design prevalence;
     Monitor the evolution of the disease (i.e., introduction 
and/or spread);
     Monitor the effectiveness of a feed ban and/or other risk 
mitigation measures; or
     Provide supporting evidence for claimed BSE status or for 
maintaining status or advancing to a higher BSE status.
    Targeted sampling for BSE surveillance focuses on two factors that

[[Page 15878]]

have been shown to be relevant to determining the risk for BSE: 
Clinical presentation and age. For the purpose of disease detection, it 
is most efficient to collect as many samples as possible from the 
surveillance stream that has the greatest likelihood of finding the 
disease--cattle displaying clinical signs consistent with BSE. This is 
referred to as targeted surveillance.
    The OIE Code provides guidelines for surveillance programs based on 
a weighted point system (Article 11.5.22). This system reflects 
international scientific consensus that the best BSE surveillance 
programs focus on obtaining quality samples from targeted 
subpopulations, rather than looking at the entire adult cattle 
population.
    OIE has identified the following four subpopulations of cattle for 
surveillance purposes:
    1. Clinical suspects: Cattle over 30 months of age that display 
behavioral or clinical signs consistent with BSE.
    2. Casualty slaughter: Cattle over 30 months of age that are 
nonambulatory, recumbent, unable to rise or to walk without assistance, 
sent for emergency slaughter, or condemned at ante-mortem inspection.
    3. Fallen stock: Cattle over 30 months that are found dead on-farm 
or during transport to or at an abattoir.
    4. Healthy slaughter: Cattle over 36 months that exhibit no 
clinical signs consistent with BSE or other diseases.
    The number of points a sample receives correlates directly to an 
animal's clinical presentation at the time of sampling. The highest 
point values are assigned to those samples from the subpopulation of 
animals with classic clinical signs of the disease. The lowest point 
values correspond to animals from the subpopulation of clinically 
normal animals tested at routine slaughter. This weighted approach 
allows countries the flexibility to sample readily available 
surveillance streams, while taking into account the differences in the 
statistical value of samples from different streams. As a result, 
countries have the option of using varying approaches that can provide 
equal levels of assurance in defining the level of disease.
Type A Surveillance
    Type A surveillance is recommended for countries that would like to 
meet the controlled-risk status. The OIE BSE surveillance guidelines 
recommend a target number of surveillance points for Type A 
surveillance based on the size of a country's cattle population. For 
instance, a country with an adult cattle population of 800,000 to 1 
million should collect samples whose total point value equals 240,000 
points. These points are accrued over 7 consecutive years, and are 
weighted according to the surveillance stream and age of the animal 
sampled.
Type B Surveillance
    Type B surveillance may be carried out by countries of negligible 
BSE risk status to confirm the conclusions of the risk assessment 
(e.g., by demonstrating the effectiveness of the measures mitigating 
any risk factors identified, through surveillance targeted to maximize 
the likelihood of identifying failures of such measures).
    Type B surveillance may also be carried out by countries of 
controlled BSE risk status (OIE Code, Article 11.5.4) following the 
achievement of the relevant points target using Type A surveillance, to 
maintain confidence in the knowledge gained through Type A 
surveillance. As with Type A surveillance, the recommended number of 
points for Type B surveillance is based on the size of a country's 
cattle population. For instance, a country with a cattle population of 
800,000 to 1 million should collect samples whose total point value 
equals 120,000.
Presence of a BSE Awareness Program
    The OIE will evaluate information about the existence of any 
awareness programs; the target audience; the curriculum; how long the 
program has been in place; and any contingency and/or preparedness 
plans that address BSE.
Compulsory Notification and Investigation
    Proper management of the disease requires that there be incentives 
and/or obligations to report and investigate suspect BSE cases. 
Therefore, the OIE will evaluate information about any guidance given 
to veterinarians, producers, workers at auctions, slaughterhouses, 
etc., with regard to the criteria that would initiate the investigation 
of an animal as a BSE suspect; whether these criteria have changed over 
time; the date and content of the legal act making notification of BSE 
suspects compulsory; and any measures in place to stimulate 
notification, such as compensation payments or penalties for not 
reporting a suspect.
Sample Testing
    For a country's BSE surveillance system to be recognized by the 
OIE, samples must be tested in accordance with the OIE's Manual of 
Diagnostic Tests and Vaccines for Terrestrial Animals. The OIE 
evaluates whether countries seeking BSE classification uses diagnostic 
procedures and methods that are consistent with those described in 
OIE's disease diagnostic manual and whether these diagnostic procedures 
and methods have been applied throughout the entire surveillance 
period.
BSE History of the Country
    It is important to note that in order to retain classification by 
OIE as a country of negligible risk or controlled risk for BSE, a 
country must continue to observe OIE's guidelines and report any 
significant events that might change that status. The OIE reserves the 
right to revoke the given disease status of any country that fails to 
comply with this process. In order to retain classification, Member 
countries are obligated to notify the OIE in writing that the 
epidemiological situation with respect to each of the diseases for 
which the OIE has classified the country has remained unchanged in 
order to retain classification. APHIS also believes that it is 
essential to have periodically updated information from a country that 
APHIS recognizes as either negligible risk or controlled risk for BSE, 
and are including a requirement for such updated information in this 
proposed rule, as discussed below under the heading ``Requirement for 
Updated Information.''

The Process for APHIS Recognition of the BSE Risk Classification of a 
Region

    Under this proposed rule, each country of the world will be 
considered by APHIS to be in the BSE undetermined risk category, unless 
APHIS has recognized that country as either a region of negligible risk 
for BSE or a region of controlled risk for BSE.
    APHIS recognition of a region as a region of negligible risk or 
controlled risk for BSE could be achieved in one of two ways.
     If the OIE has classified a country as either BSE 
negligible risk or BSE controlled risk, APHIS would 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 would 
announce in the Federal Register, subject to public comment, our intent 
to concur with an OIE classification. APHIS would also post the summary 
of the BSE OIE ad hoc group conclusions for review during the comment 
period. The summaries would be available for review on the APHIS Web 
site. Following review of any comments received, the Administrator 
would announce his or her final

[[Page 15879]]

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 would include 
that country in a list of regions of negligible risk or controlled risk 
for BSE, as applicable, that APHIS would make available to the public 
on the Agency's Web site.
     A region that has not received categorization by OIE as 
either negligible risk or controlled risk for BSE and that wishes to be 
recognized by USDA as negligible risk or controlled risk could submit 
to the Administrator a request for such classification, along with 
documentation sufficient to allow the USDA to conduct an evaluation of 
whether the region meets the criteria for such classification. If, 
following such evaluation, the Administrator determines that the region 
meets the criteria for negligible or controlled risk, APHIS would 
announce that determination in the Federal Register and would make 
available to the public the evaluation conducted by APHIS, as well as 
the information provided by the requesting region. APHIS would accept 
public comment on its intent. Following review of any comments 
received, the Administrator would 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.

Requirement for Updated Information

    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:
     Relevant changes in BSE legislation, compared to the 
previous year;
     The importation into the region during the year of cattle, 
processed animal protein and products containing such material;
     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 of MBM or 
greaves to ruminants;
     Audit findings in rendering plants and feed mills that 
process nonruminant material, related to the prohibition of the feeding 
to ruminants of ruminant-derived MBM and greaves;
     Infractions at the types of facilities listed above;
     If and why, in light of the audit findings, there has been 
no significant exposure of cattle to the BSE agent through consumption 
of ruminant-derived MBM and greaves;
     Surveillance efforts;
     All clinical BSE suspects;
     Any new cases of BSE.
    If APHIS at any time determines that a region no longer meets the 
criteria for the risk classification it had previously received, APHIS 
would remove it 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.

Conditions for Importation of Commodities

    The BSE-related importation conditions we are proposing for live 
bovines and products derived from bovines are based on internationally 
accepted data and research. These same data and research are used by 
the OIE in formulating its recommendations regarding trade in cattle 
and products derived from cattle with regard to BSE, and include 
experimental data, epidemiological data, information about risk 
mitigation strategies regarding processing, and data from risk 
assessment studies.
    In the following section, we discuss the pertinent scientific 
information regarding each type of commodity considered for importation 
and explain APHIS' conclusions regarding mitigation measures, if any, 
that we consider necessary to safely allow for the importation of that 
type of commodity, taking into account the BSE risk classification of 
the region of export. In most cases, the conclusions we have reached 
are consistent with those reached by the OIE. In those few cases where 
our conclusions regarding mitigation measures differ from that of the 
OIE, we note the differences and explain our rationale for differing 
with the OIE Code. If the information we considered is based on 
research or other data concerning cattle and products from cattle, we 
discuss the information as it applies to cattle. However, for the 
reason we stated above in footnote 3 of this document, where we propose 
to modify our regulations based on that information, we propose to 
apply the amendments to bovines, rather than just to cattle. In the 
sections that follow, we discuss the OIE recommendations regarding 
trade of specific types of bovine commodities.

Live Bovines

    The OIE Code recommends that trade in live cattle be allowed from 
regions of negligible, controlled, and undetermined risk for BSE under 
the following conditions.
    From regions of negligible risk and regions of controlled risk for 
BSE: The bovines are accompanied by an international veterinary 
certificate attesting to the BSE risk classification of the region of 
export. Additionally, for exports of live cattle from regions of 
negligible risk for BSE that have had an indigenous case of BSE and 
from regions of controlled risk for BSE, the following conditions must 
be met and attested to on the certificate: The cattle intended for 
export were born after the date a ban on the feeding of MBM and greaves 
of ruminant origin to ruminants was effectively enforced, and are 
identified with a permanent identification system that enables them to 
be identified if they are birth or feed cohorts of an infected animal.
    From regions of undetermined risk for BSE: The bovines were born at 
least 2 years after a ban on the feeding of MBM and greaves of ruminant 
origin to ruminants was effectively enforced, and are identified by a 
permanent identification system in such a way that enables them to be 
identified if they are birth or feed cohorts of an infected animal. In 
addition, the region must demonstrate that, if alive in the region, 
bovines that are included in either of the following two categories are 
officially identified with unique individual identification that is 
traceable to the premises of origin of the animal, their movements are 
controlled, and, when slaughtered or at death, they are completely 
destroyed:
    1. 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 feed that 
potentially contained SRM material as the infected animal during that 
period;
    2. 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

[[Page 15880]]

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.

APHIS' Proposed Provisions Regarding the Importation of Live Bovines 
With Regard to BSE Risk

    In this proposed rule, we concur with the conclusions reached by 
the OIE regarding import conditions for cattle from regions of 
negligible risk and controlled risk with regard to BSE, but differ from 
the OIE Code regarding the importation of bovines from regions of 
undetermined BSE risk. We discuss our proposed provisions regarding 
importations from undetermined risk regions, below. With regard to 
importations of live bovines from regions of negligible or controlled 
risk for BSE, we are proposing in Sec.  93.436(a) and (b) that bovines 
may be imported under the following conditions:
     The bovines are accompanied by an original certificate 
that indicates the APHIS BSE risk classification of the region of 
export and states that the following conditions, where applicable, have 
been met.
     From regions of negligible risk for BSE that have had an 
indigenous case of BSE and from regions of controlled risk for BSE, 
before the animals' arrival at the port of entry into the United 
States, each bovine imported into the United States is officially 
identified with unique individual identification that is traceable to 
the premises of origin of the animal. We consider this requirement 
necessary for us to determine the likelihood of exposure to potentially 
contaminated materials. We would provide that no person may alter, 
deface, remove, or otherwise tamper with the official identification 
while the animal is in the United States or moving into or through the 
United States, except that the identification may be removed at 
slaughter.
     From regions of negligible risk for BSE that have had an 
indigenous case of BSE and from regions of controlled risk for BSE, 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:
    1. 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);
    2. A tattoo with letters identifying the exporting country must be 
applied to the inside of one ear of the animal;
    3. 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 the BSE minimal-
risk exporting region.
     From regions of negligible risk for BSE that have had an 
indigenous case of BSE and from regions of controlled risk for BSE, the 
bovines were born after the date from which the ban on the feeding of 
ruminants with processed ruminant proteins has been effectively 
enforced.
    Additionally, if there has been an indigenous case of BSE in the 
region, the following restrictions would apply:
     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 feed that 
potentially contained SRM material as the infected animal during that 
period would not be eligible for importation to the United States; and
     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, no 
bovine 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 would 
be eligible for importation into the United States.

Date of Effective Enforcement of a Feed Ban

    As noted, for the importation of cattle from certain risk 
classifications of countries, one of the OIE-recommended mitigations is 
that the animals were born after the date a feed ban was effectively 
enforced. The primary source of BSE infection, and the only documented 
route of field transmission of the disease, is commercial feed 
contaminated with ruminant protein derived from infected animals 
(Wilesmith, et al., 1988; 1991; 1992; Prince, et al., 2003). Bans that 
prohibit incorporation of mammalian or ruminant protein into ruminant 
feed have been shown to be effective in mitigating the risk of BSE 
transmission and are an integral factor in evaluating the BSE risk of a 
region. The experience regarding BSE in the United Kingdom, which was 
discussed in detail in the risk assessment we conducted for our 
September 2007 final rule, demonstrated the effectiveness of a 
ruminant-to-ruminant feed ban in reducing the prevalence of BSE (APHIS, 
2007).
    Although, in evaluating a country for BSE risk classification, the 
OIE examines whether the country has an effectively enforced ban on the 
feeding of ruminant-derived processed animal protein to other 
ruminants, and although some of the trade conditions recommended by the 
OIE with regard to BSE are dependent on when a country achieved 
effective enforcement of such a feed ban, the OIE does not provide 
specific recommendations for determining the date of effective 
enforcement of a feed ban. For a country that wishes to export live 
bovines to the United States and that is classified by APHIS as 
controlled risk for BSE or as negligible risk for BSE and the country 
has reported an indigenous case of BSE, APHIS would need to determine 
the date a feed ban was effectively enforced in the country.
    It is important to note that the existence of an effectively 
enforced feed ban does not mean there will be no instances of 
contravention of the feed ban, either accidentally or intentionally, 
just as isolated transgressions of U.S. laws do not necessarily 
constitute ineffective enforcement of those laws. Nor does it mean that 
BSE will never be detected in a bovine born after the date from which a 
feed ban is considered to have been effectively enforced. Human error 
is expected, and no regulatory effort can ensure 100 percent 
compliance, which is why a feed ban is comprised of a number of 
interrelated measures that have a cumulative effect.
    In our September 2007 final rule to allow additional live bovines 
and certain bovine products from BSE minimal-risk regions (72 FR 53314-
53379, Docket No. APHIS-2006-0041), we explained the considerations and 
process used by APHIS to determine the date of effective enforcement of 
a ruminant-to-ruminant feed ban in Canada. In this proposal, we are 
proposing to base our determination of the date of effective 
enforcement of a ruminant-to-ruminant feed on similar considerations. 
The information would include, but not necessarily be limited to:
     Policies and infrastructure for feed ban enforcement, 
including an awareness program for producers and farmers;
     Livestock and husbandry practices;
     Disposition of processed animal protein produced from 
domestic bovines, including the feeding of any animal species;

[[Page 15881]]

     Measures taken to control cross-contamination and 
mislabeling of feed intended for bovines with processed animal protein;
     Monitoring and enforcement of the ruminant feed ban, 
including audit findings in rendering plants and feed mills that 
process ruminant material.
    Additionally, in determining the date of effective enforcement of a 
country's feed ban, APHIS may conduct a site visit to the requesting 
country to complement and verify the information provided by the 
country.
    After receiving and evaluating the necessary information, APHIS 
would publish 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 would make available to 
the public the evaluation conducted by APHIS, as well as the supporting 
documentation. Following review of any comments received, the 
Administrator would announce his or her final determination in the 
Federal Register, along with a discussion of and response to pertinent 
issues raised by commenters.

Live Bovines From Regions of Undetermined Risk for BSE

    With regard to the importation of live bovines, we propose allowing 
the importation of live bovines from regions of undetermined risk for 
BSE only in very limited situations.
    We believe that the nature of a region that is classified as 
undetermined with regard to BSE risk is such that making a general 
determination in this regulation that the conditions recommended by the 
OIE have been met could not be made with a sufficient degree of 
confidence. When it comes to the overall BSE risk of an exporting 
region, factors in addition to a feed ban--such as veterinary 
infrastructure, surveillance, and import controls--play a role. Such 
factors are taken into consideration when determining whether to 
classify a region as negligible or controlled risk for BSE. If enough 
evidence has been evaluated to conclude that a region of undetermined 
risk for BSE has in place an effectively enforced feed ban--upon which 
importation of live bovines would be dependent--and that the region can 
demonstrate that the other conditions have been met, APHIS believes the 
region would qualify as at least controlled risk. We believe that the 
fact that a region is in the BSE undetermined-risk category argues 
against a generalized determination by way of this proposed rule that 
the OIE-recommended conditions have been met.
    For the reasons discussed above, we are proposing to allow the 
importation of live bovines from regions of undetermined risk for BSE 
only in very limited situations. In Sec.  93.436(c) of this proposed 
rule, we provide that, with regard to BSE, live bovines may be imported 
from regions of undetermined risk for BSE for specific limited uses, 
such as movement to exhibitions and zoos, under specified conditions on 
a case-by-case basis, if the Administrator determines that the bovines 
can be imported under conditions that will prevent the introduction of 
BSE into the United States. Instructions for applying for a permit for 
the importation of live ruminants are included in current Sec.  93.404.

Provisions Regarding the Importation of Live Bovines From Canada

    Canada is classified by the OIE as a region of controlled risk for 
BSE and, under our proposal, live bovines from Canada would be subject 
to all of the import requirements we are proposing for regions of 
controlled risk for BSE. However, Canada is currently singular in the 
APHIS BSE regulations in that it is the only region recognized by APHIS 
as a BSE minimal-risk region. As a BSE minimal-risk region, Canada is 
eligible to import live bovines into the United States that are 
prohibited importation from other regions listed in Sec.  94.18(a). 
Under the current regulations, live bovines are eligible for 
importation from Canada if the conditions in Sec.  93.436 and related 
sections are met.
    Some of the requirements that are included in current Sec.  93.436 
would continue to apply to imports from Canada, in some cases for 
reasons other than BSE risk, but would not apply as a general rule to 
every region of controlled risk for BSE. These include the requirement 
in current Sec.  93.436(a)(4) that bovines from Canada intended for 
immediate slaughter be moved from the port of entry to a slaughtering 
establishment in a sealed means of conveyance, which we are proposing 
to include in Sec.  93.420 of this proposal for the importation of all 
ruminants imported from Canada for immediate slaughter. This provision 
exists as a safeguard against diseases other than BSE.
    Certain of the requirements in current Sec.  93.436 for the 
importation of live bovines from Canada are substantively the same as 
the requirements we are proposing for the importation of live bovines 
from any region of controlled risk for BSE--such as the requirement 
that live bovines intended for importation be permanently identified--
by branding, tattooing, or some other method--as to country of export, 
and the requirement that the bovines were born on or after the date of 
effective enforcement of a ruminant-to-ruminant feed ban in the region 
of origin. However, the provisions in current Sec.  93.436 include 
specifics as to how those general requirements apply to Canada. For 
instance, the regulations in current Sec.  93.436 specify the lettering 
that must be used for a brand or tattoo to identify the bovines as 
being of Canadian origin and specify that APHIS recognizes March 1, 
1999, as the date of effective enforcement of a ruminant-to-ruminant 
feed ban in Canada.
    Because this proposed rule would retain these specifics, we are 
proposing to set forth the importation requirements for live bovines 
from Canada in sections of the CFR that would be dedicated to imports 
from Canada, specifically Sec. Sec.  93.418 and 93.420.

Commodities Recommended for Unrestricted Trade With Regard to BSE

    A review of scientific literature (discussed in the ``Supporting 
document for Chapter 2.3.13 of the Terrestrial Animal Health Code on 
Bovine Spongiform Encephalopathy'' (OIE TAHSC, 2006)) (the contents of 
Chapter 2.3.13 have been updated and currently appear in Chapter 11.5) 
has led the OIE to recognize certain products as safe for trade with 
regard to BSE, regardless of the BSE status of the exporting region.
    Bovine-derived commodities that the OIE recommends be allowed to be 
traded without any restrictions for BSE include:
     Milk and milk products;
     Semen and in vivo derived embryos;
     Hides and skins;
     Gelatin and collagen from hides and skins;
     Tallow with a maximum level of insoluble impurities of 
0.15 percent in weight; and
     Dicalcium phosphate with no trace of protein or fat.
    APHIS has reached the same conclusions. Some of the commodities 
listed above are already eligible for importation without BSE-related 
restrictions from regions listed in Sec.  94.18(a) of the regulations. 
These are milk and milk products, semen, and hides and skins. For these 
commodities, we are proposing no changes to their importation status 
with regard to BSE. The rationale for allowing their importation has 
been discussed in previous rulemaking and is not addressed in this 
document.

[[Page 15882]]

    The remaining commodities listed above--those that are not 
currently eligible for unrestricted importation into the United States 
with regard to BSE--would become so under the provisions of this 
proposed rule.

Commodities Recommended for Trade Under the Same Conditions, Regardless 
of the Risk Classification of the Exporting Region

    The OIE recommends that several other types of bovine commodities 
be eligible for trade without ``any BSE-related conditions, regardless 
of the BSE risk status of the cattle population of the exporting 
country, zone, or compartment'' (OIE Code Article 11.5.1). Although the 
OIE Code refers to an absence of ``BSE-related conditions'' for these 
commodities, the OIE recommendations do include qualifying conditions 
regarding the processing of such commodities, in order to guard against 
the contamination of the commodities by other materials that might 
contain BSE infectivity. These commodities are:
     Boneless skeletal muscle meat (excluding mechanically 
separated meat \14\) from cattle, provided (1) the cattle were not 
subjected to air injected stunning before slaughter or to pithing, (2) 
the cattle passed ante-mortem and post-mortem inspections, and (3) the 
product has been prepared in a manner that avoids contamination with 
SRMs;
---------------------------------------------------------------------------

    \14\ Mechanically separated meat is 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. A definition of 
mechanically separated meat is included in Sec.  94.0 of this 
proposed rule.
---------------------------------------------------------------------------

     Blood and blood byproducts from cattle that were not 
subjected, prior to slaughter, to air-injected stunning or to pithing.
    We are proposing to allow the importation of these commodities \15\ 
from any region under the same conditions recommended by the OIE, with 
one exception. With regard to blood and blood products, we are 
proposing some additional requirements regarding the collection of 
blood and blood products to guard against contamination. We reference 
the scientific rationale for allowing such importation in a discussion 
of each type of commodity, below, and explain as well our rationale for 
proposing several risk mitigation measures slightly different from 
those recommended by the OIE.
---------------------------------------------------------------------------

    \15\ Additionally, 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.
---------------------------------------------------------------------------

Specified Risk Materials

    For some commodities, a condition for importation under this 
proposed rule is that the commodity not contain or be potentially 
contaminated with SRMs. Under this proposed rule, tissues from bovines 
from regions of negligible risk for BSE are not considered SRMs and 
what is considered an SRM in a region of controlled risk differs 
somewhat from what is considered an SRM in a region of undetermined 
risk.
Regions of Negligible Risk for BSE
    By definition, in a region that has been evaluated and has been 
determined to be a region of negligible animal health risk, there is a 
negligible risk of circulating BSE infectivity. Consequently, we do not 
believe it is necessary to consider any tissues from bovines from a 
region of negligible risk for BSE to be SRMs. This conclusion is 
consistent with internationally accepted BSE-related standards. It is 
also consistent with the approach taken by FSIS in an affirmation of 
interim final rules with amendments published on July 13, 2007 (72 FR 
38199-38730, Docket No. 03-025F).
    In that document, FSIS amended its September 7, 2005 interim final 
rule to exclude from the FSIS definition of SRMs materials from cattle 
from foreign countries that can demonstrate that their BSE risk status 
can reasonably be expected to provide the same level of protection from 
human exposure to the BSE agent as does prohibiting SRMs for use as 
human food in the United States. In its document, FSIS stated that an 
``evaluation of a country's BSE risk status would consider whether 
appropriate measures are in place to manage identified risks. This 
would include consideration of import policies and import history to 
determine the likelihood of the introduction of BSE into the country. 
It could also include (among other things) consideration of any of the 
following: Effective surveillance efforts; measures to identify and 
effectively control pathways for the amplification of BSE; appropriate 
awareness programs; effective epidemiological investigations as 
necessary, with appropriate tracing, control and destruction of risk 
animals; continuing risk considerations with corresponding revisions of 
existing mitigations; appropriate public health control measures 
commensurate with risk; and the infrastructure sufficient to define and 
implement any of the above.'' (72 FR 38718) FSIS stated further that 
evaluation of a country's measures would be conducted by FSIS officials 
with technical program expertise along with, where appropriate, 
technical experts from other agencies, such as APHIS and FDA, with FSIS 
making the final determination.
Regions of Controlled Risk and Negligible Risk
    As noted above, in January 2004, FSIS regulations established as 
SRMs the skull, brain, spinal cord, trigeminal ganglia, eyes, vertebral 
column (excluding the vertebrae of the tail, the transverse processes 
of the thoracic and lumbar vertebrae, and the wings of the sacrum), and 
DRG of cattle 30 months of age or older, as well as the tonsils and 
distal ileum of the small intestine of cattle of all ages.\16\ FSIS 
designates potentially infective materials, as well as certain 
materials that are closely associated with potentially infective 
materials, from cattle 30 months of age or older as SRMs. Although the 
skull and vertebral column of cattle infected with BSE have not 
demonstrated infectivity, the skull contains the eyes, trigeminal 
ganglia, and brain, and the vertebral column contains DRG and spinal 
cord. Thus, because they contain high-risk tissues, skulls and 
vertebral column are included in FSIS' definition of SRMs. Unlike other 
parts of the vertebral column, the vertebrae of the tail, the 
transverse processes of the thoracic and lumbar vertebrae, and the 
wings of the sacrum do not contain spinal cord or DRG. Therefore, FSIS 
excludes these parts of the vertebral column from the materials 
designated as SRMs. Under FSIS regulations, head meat, cheek meat, and 
tongue may be used for human food, provided they are not contaminated 
with SRMs.
---------------------------------------------------------------------------

    \16\ On July 13, 2007, FSIS published an affirmation with 
amendments (72 FR 38700, Docket No. 03-025F) of its January 2004 
interim final rule. Among the amendments included in July 2007 was a 
provision that excludes from the definition of SRMs materials from 
cattle from countries that can demonstrate that their BSE risk 
status can reasonably be 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.
---------------------------------------------------------------------------

    In Sec. Sec.  92.1, 94.0, and 95.1 of this proposed rule, APHIS 
defines SRMs from regions of controlled risk for BSE and undetermined-
risk regions as the same tissues considered by FSIS to be SRMs, with 
one exception. For regions of undetermined risk for BSE, APHIS is 
consistent with OIE in considering the tissues that FSIS considers to 
be SRMs in animals 30 months of age or older to be SRMs if the tissues 
come from animals over 12 months of age. Research demonstrates that the 
incubation period

[[Page 15883]]

for BSE is apparently linked to the infectious dose received, i.e., the 
larger an infectious dose received, the shorter the incubation period 
(EC SSC, 2002). While some cases have been found in animals less than 
30 months of age, these have been relatively few and have occurred 
primarily in countries with significant levels of circulating 
infectivity. Specifically, BSE was found in animals less than 30 months 
of age in the United Kingdom in the late 1980s to early 1990s, when the 
incidence of BSE was extremely high (the youngest case, detected in 
1989, was 21 months). The exceptional detection of BSE in young animals 
during the peak of the BSE epidemic in the United Kingdom supports a 
cautious approach in defining SRMs for regions of undetermined risk for 
BSE. Theoretically, in such regions, high levels of circulating 
infectivity could exist if the region is not implementing BSE risk 
management measures.
    Because BSE infectivity is detectable in central nervous system 
tissue at three-quarters of the incubation period, the 12-month 
provision would ensure the removal of tissues potentially containing 
infectivity from even the single youngest animal observed since the 
start of BSE surveillance in the United Kingdom.

Other Bovine Commodities

    According to the OIE recommendations, certain bovine commodities 
may or may not be eligible for importation, depending on the BSE risk 
classification of the country that would be exporting the commodity and 
on whether specified conditions have been met to mitigate BSE risk 
based on the country's risk classification.
    These commodities include:
     Meat that does not meet the conditions, described above, 
for boneless skeletal muscle meat;
     Gelatin and collagen prepared from bones;
     Tallow, tallow derivatives, and dicalcium phosphate (other 
than tallow with a maximum level of insoluble impurities of 0.15 
percent in weight and dicalcium phosphate with no trace of protein or 
fat); and
     MBM and greaves.
    Although APHIS' proposed provisions regarding these commodities are 
broadly based on OIE recommendations, we are also proposing some 
modifications to those guidelines, where necessary, to reflect APHIS' 
interpretation of the scientific literature and current USDA 
regulations and policies.
    In the sections that follow, we discuss the science that supports 
the OIE recommendations and the import conditions we are proposing, and 
present the rationale for the few instances where our proposed 
provisions differ from OIE recommendations.

Meat, Meat Byproducts, and Meat Food Products

    In our discussion, where we refer to meat, meat byproducts, and 
meat food products, we consider those commodities to be as defined in 
the FSIS regulations in 9 CFR 301.2.
    As noted earlier in this document, BSE infectivity has not been 
demonstrated in the muscle tissue of BSE-infected cattle examined in 
either mouse bioassay studies (in which different bovine tissues are 
inoculated into mice to determine which tissues carried infectivity) or 
in cattle assays in the United Kingdom pathogenesis study (Wells, et 
al., 1996; 2005; Wells, personal communications, 2008). Some reports 
have identified the presence of prions in muscle tissue from rodents, 
humans, and small ruminants infected with TSEs other than BSE (Bosque 
et al., 2002). Those findings are consistent with differences in the 
transmission, host range, genetic susceptibility, infectivity 
distribution, and epidemiology found in different TSEs that affect 
animals and humans. In the transgenic mice over-expressing the bovine 
PrP gene (Tg bov XV), infectivity was detected in one muscle 
(semitendinosus) from a single clinical case of BSE in Germany 
(Buschmann and Groschup, 2005). The sensitivity of these mice to 
infection is significantly greater than that of the mice used for the 
United Kingdom pathogenesis study (10,000-fold) and even greater than 
that of cattle (approximately tenfold).
    From studies of the pathogenesis of experimental BSE in cattle, no 
infectivity has been found in assays of skeletal muscle pools (triceps, 
masseter, sternocephalicus and longissimus dorsi) completed in wild-
type mice bioassay and in cattle bioassay (masseter, semitendinosus and 
longissimus dorsi) from selected kill time points of the oral exposure 
study (Wells et al., 1996 and 2005). All assays of the skeletal muscle 
pools were completed in March 2007 (Wells, personal communication, 
2008).
    Recent studies using tissues from asymptomatic cattle challenged 
orally with BSE and culled at 20, 24, 27, 30, and 33 months, and 
inoculated intracerebrally into BoPrP-Tg110 mice, have failed to detect 
infectivity in muscle (Espinosa et al., 2007).
    The United Kingdom's Spongiform Encephalopathy Advisory Committee 
(SEAC, 2001) and the European Commission's (EC) Scientific Steering 
Committee (SSC) evaluated the implications of the findings of the 
presence of infectivity in muscle for other TSEs in different species 
in relation to human food safety. EC SSC concluded that there was no 
reason to revise its opinions regarding the safety of meat, given the 
consistent negative results in BSE infectivity experiments (EC SSC, 
2002a). SEAC concluded that the findings could not be directly applied 
to BSE in cattle and did not change the assessment of the risk to 
humans of consumption of beef. Updated opinions from the EC SSC are 
consistent with its original reports.
    Skeletal muscle meat in and of itself is regarded as safe with 
regard to BSE, regardless of the BSE risk category of the region of 
export and origin. Any blood that might be associated with the meat is 
also, in and of itself, regarded as safe with regard to BSE, as 
discussed below under the heading ``Blood and Blood Products.''
    However, it is possible that, in regions in which there is some 
circulating BSE infectivity, such meat could become contaminated with 
the BSE agent unless certain measures are taken to preclude such 
contamination. In this proposed rule, although we are proposing to 
allow the importation of boneless skeletal muscle meat from any BSE 
category of region, such importation would be contingent on the 
necessary safeguards against contamination having been met in the 
region of export.
    One of these safeguards is that the bovines from which the meat was 
derived 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 (EFSA Journal, 2004; TAFS, 2004). Several 
studies have shown that penetrative captive bolt stunners that 
incorporate air-injection can force visible pieces of brain and other 
central nervous system tissue into the circulatory system of stunned 
cattle (Anil, et al., 1999; Schmidt, et al., 1999). In addition, the 
pithing process could cause dissemination of central nervous tissue 
throughout the body.
    Another safeguard is the removal of SRMs. Handling of SRMs in ways 
that prevent contamination of the carcass is an important mitigation in 
preventing contamination of edible meat with BSE infectivity (EFSA 
Journal, 2005).
    Therefore, with regard to BSE, we are proposing in Sec.  
94.18(b)(2) to allow the importation of boneless skeletal muscle meat 
from bovines, regardless of the BSE risk status of the region of 
export, provided that (1) the cattle were not subjected to air injected 
stunning before slaughter or to pithing, (2) the cattle

[[Page 15884]]

passed ante-mortem and post-mortem inspections, and (3) the meat has 
been prepared in a manner that avoids contamination with SRM tissues.
    Additionally, the shipment of such meat to the United States would 
have to be accompanied by an original certificate stating that the 
above conditions have been met. The certificate must be issued by a 
full-time salaried veterinary officer of the national government of the 
region of export, or be issued by a veterinarian designated by the 
national government of the region of export and endorsed by a full-time 
salaried veterinary officer of the region of export, representing that 
the veterinarian issuing the certificate was authorized to do so. Our 
listing of who would be eligible to issue a certificate differs 
slightly from the list in Sec.  94.19 of the current regulations 
regarding the importation of meat and other edible products from BSE 
minimal-risk regions, in that we would not include veterinarians 
accredited by the national government of the region of origin. We are 
not including such individuals to avoid any situations where a 
veterinarian employed by an exporter might issue a certificate for that 
exporter's shipment.

Meat Other Than Boneless Skeletal Muscle Meat, Meat Food Products, and 
Meat Byproducts Derived From Bovines

    For meat other than the boneless skeletal meat described above, 
meat food products, and meat byproducts, the conditions for importation 
would depend on the BSE risk classification of the region of export. 
These conditions are discussed in the following paragraphs.
Regions of Negligible Risk for BSE
    With regard to regions of negligible risk for BSE, we are proposing 
in Sec.  94.19 the conditions under which bovine meat that is not 
boneless skeletal meat, meat food products, and meat byproducts would 
be eligible for importation. These conditions are as follows; either:
    1. The commodity is accompanied by certification that the region of 
export is a region of negligible risk for BSE in which there has not 
been an indigenous case of BSE, and that the commodity is derived from 
bovines that passed ante-mortem and post-mortem inspection; or
    2. If there has been an indigenous case of BSE in the region of 
negligible risk, the commodity is accompanied by certification that the 
region of export is a region of negligible risk for BSE and that the 
commodity was derived from bovines that passed ante-mortem and post-
mortem inspection and were subject to a ban on the feeding to ruminants 
of processed animal protein derived from ruminants.
    Our proposed conditions for the importation of such commodities 
from negligible risk regions that have had an indigenous case of BSE 
are modified somewhat from those recommended by the OIE. The OIE 
recommends that such commodities be sourced from animals born after the 
date a ban on feeding ruminant MBM and greaves to ruminants had been 
effectively enforced. The OIE also recommends this condition for the 
importation of MBM and greaves derived from ruminants from such 
regions. There is a wide range of bovine products that could fall under 
these categories, including products that may have gone through 
multiple processing steps after slaughter. APHIS recognizes the 
difficulty in providing specific certification about the age of the 
animal from which the products were derived, given these steps. This 
difficulty, in combination with the overall low risk of such products 
from a negligible risk region, is why we propose to modify the OIE 
guidelines somewhat. We feel that because the criteria for this 
particular risk categorization calls for any indigenous case to be born 
more than 11 years ago and requires demonstration through an 
appropriate level of control and audit that for at least 8 years 
processed animal protein from ruminants has not been used in the 
feeding of ruminants (these criteria are discussed above under the 
heading ``Regions of Negligible Risk for BSE''), it is highly unlikely 
that such products could contain or be contaminated with the BSE agent. 
Taking these factors into consideration, APHIS concludes that the 
commodities under consideration pose an extremely low risk for BSE, as 
low as to be considered insignificant.
    As noted above, in July 2007 FSIS amended its regulations to 
exclude from the FSIS definition of SRMs materials from cattle from 
foreign countries that can demonstrate that their BSE risk status can 
reasonably be expected to provide the same level of protection from 
human exposure to the BSE agent as does prohibiting SRMs for use as 
human food in the United States. Our proposed provisions regarding the 
importation of meat, meat byproducts, and meat food products from 
regions of negligible risk for BSE are consistent with the FSIS 
provisions. In this proposed rule we would add a note to Sec.  94.19 to 
indicate that, to be eligible to export bovine meat, meat byproducts, 
and meat food products to the United States under the provisions of 
that section, a region recognized by APHIS as a one of negligible risk 
for BSE would also need to be one that has demonstrated to FSIS 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.
Regions of Controlled Risk for BSE
    We are proposing in Sec.  94.20 that, in addition to boneless 
skeletal muscle meat that meets the requirements listed above, bovine 
meat, meat byproducts, and meat food products would be eligible for 
importation from regions of controlled risk for BSE if the following 
requirements are met:
     The bovines from which the commodities were derived passed 
ante-mortem and post-mortem inspections;
     The bovines from which the commodities were derived were 
not subjected to a stunning process with a device injecting compressed 
air into the cranial cavity or to a pithing process;
     The commodity does not contain mechanically separated meat 
from the skull and vertebral column of bovines 30 months of age or 
older;
     The commodity was produced in a manner that ensures that 
it does not contain and is not contaminated with SRMs, as defined in 
Sec.  94.0 of this proposed rule for regions of controlled risk for 
BSE;
     The shipment is accompanied by an original certificate 
stating that the above conditions have been met. The certificate must 
be issued by a full-time salaried veterinary officer of the national 
government of the region of export, or be issued by a veterinarian 
designated by the national government of the region of export and 
endorsed by a full-time salaried veterinary officer of the region of 
export, representing that the veterinarian issuing the certificate was 
authorized to do so.
Regions of Undetermined Risk for BSE
    We are proposing in Sec.  94.21 that, in addition to boneless 
skeletal muscle meat that meets the requirements listed above, bovine 
meat, meat byproducts, and meat food products would be eligible for 
importation from regions of undetermined risk for BSE if the following 
requirements are met:
     The bovines from which the commodities were derived have 
never been fed processed animal protein derived from ruminants;
     The bovines from which the commodities were derived passed 
ante-mortem and post-mortem inspections;
     The bovines from which the commodities were derived were 
not subjected to a stunning process with a

[[Page 15885]]

device injecting compressed air into the cranial cavity or to a pithing 
process; and
     The commodities were produced in a manner that ensures 
that such products do not contain and are not contaminated with: (1) 
Mechanically separated meat from the skull and vertebral column of 
bovines over 12 months of age; or (2) SRMs as defined for regions of 
undetermined risk for BSE.
     The shipment is accompanied by an original certificate 
stating that the above conditions have been met. The certificate must 
be issued by a full-time salaried veterinary officer of the national 
government of the region of export, or be issued by a veterinarian 
designated by the national government of the region of export and 
endorsed by a full-time salaried veterinary officer of the region of 
export, representing that the veterinarian issuing the certificate was 
authorized to do so.

Offal

    In this proposed rule, Sec.  95.6 contains provisions regarding BSE 
and the importation of offal derived from bovines. In Sec.  95.1 of the 
current regulations, offal is defined as the inedible parts of a 
butchered animal that are removed in dressing, consisting largely of 
the viscera and trimmings, which may include, but are not limited to, 
brains, thymus, pancreas, liver, heart, or kidneys. We are proposing to 
apply the same import requirements to bovine-derived offal as those 
described above for bovine-derived meat, meat byproducts, and meat food 
products, with one exception. The proposed provisions for the 
importation of bovine-derived meat, meat byproducts, and meat food 
products include the requirement that the bovines from which the 
commodities were derived passed ante-mortem and post-mortem 
inspections. That requirement is a safeguard for commodities intended 
for human consumption. Because offal is, by definition, inedible, there 
is no need to require that the offal was derived from bovines that 
passed ante-mortem and post-mortem inspections.

Meat or Dressed Carcasses of Hunter-Harvested Bovines

    In the current regulations, Sec.  94.19(e) contains provisions for 
the importation into the United States of meat or carcasses of hunter-
harvested wild sheep, goats, or other ruminants other than cervids from 
BSE minimal-risk regions (the importation of cervid meat from BSE 
minimal-risk regions is unrestricted with regard to BSE). For hunter-
harvested meat or carcasses to be eligible for importation with regard 
to BSE, the following conditions must be met:
     The meat or dressed carcass is derived from an animal 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
     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 FDA at 21 CFR 589.2000.
    Consistent with the approach we are taking in this document not to 
propose any changes at this time to BSE regulations related to ovines 
or caprines, in Sec.  94.25(c) of this proposed rule, we are retaining 
the conditions described above as they apply to hunter-harvested wild 
ovines or caprines from BSE minimal-risk regions. In Sec.  94.22 of 
this proposed rule, we are including provisions for the importation of 
hunter-harvested wild bovines from any region. Under those provisions, 
the meat or carcass of a hunter-harvested wild bovine would be eligible 
for importation into the United States if it is 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 United States Customs and Border Protection official. 
Additionally, the carcass of a hunter-harvested wild bovine would have 
to be dressed (eviscerated and the head and spinal cord removed). We 
are not including a requirement comparable to that described above for 
ovines and caprines regarding the feeding of the wild bovines. BSE has 
been detected in wild bovines kept in captivity but not in non-captive 
wild bovines, and APHIS considers it very unlikely that wild bovines 
could be exposed to processed animal protein.

Gelatin and Collagen

    Gelatin is a highly purified protein manufactured from hides, skin, 
and/or bones of animals using various refining processes in which each 
step is able to significantly inactivate BSE infectivity. A similar 
process, with similar inactivation results, is used in the production 
of collagen.
Derived From Hides or Skins
    Bovine hides have not demonstrated BSE infectivity, even in 
infected animals. The safety of bovine hides with regard to BSE is 
recognized internationally. The OIE Code recommends that gelatin 
derived exclusively from the hides of bovines not be subject to trade 
restrictions. The European Commission Scientific Steering Committee's 
Updated Opinion on the Safety With Regard to TSE Risk of Gelatine 
Derived From Ruminant Bones or Hides (adopted by the Scientific 
Steering Committee at its December 5-6, 2002, meeting) states in 
section B(c): ``When ruminant hides are used for the production of 
gelatine, they are usually obtained from bovines. On the basis of 
current knowledge, it can be considered that the parts of the bovine 
hides used for the production of gelatine do not present a risk with 
regard to TSE's [transmissible spongiform encephalopathies, which 
include BSE], provided contamination with potentially infected 
materials is avoided.''
    Therefore, we believe there is no scientific basis for prohibiting 
the importation of gelatin derived from the hides of bovines and are 
proposing in Sec.  94.23(b) to allow the importation of gelatin derived 
from the hides or skins of bovines, regardless of the BSE risk 
classification of the region of origin, provided the gelatin has not 
been commingled with materials ineligible for entry into the United 
States. In Sec.  95.7(b), we are proposing equivalent provisions for 
the importation of collagen derived from bovine hides or skins.
Derived From Bones
    The different steps of the refining process in producing gelatin 
from bones, as well as the resulting infectivity reduction, are 
described below.
    1. Degreasing: Before bone can be used to manufacture gelatin, fat 
must be removed. This is done by crushing the bones, washing, and 
degreasing the chips with hot water to remove fat residues. Studies 
evaluating the efficiency of the degreasing process in decreasing the 
amount of nervous tissues present in bones have shown that, during the 
degreasing step, 98-99 percent of the proteins of nervous origin are 
eliminated (Mantze, et al., 1996).
    2. Acid treatment: The treatment consists of immersing the 
degreased chip bone into hydrochloric acid (approximately 4 percent, < 
pH 1.5) for a period of at least 2 days. This acid treatment changes 
the structure of the

[[Page 15886]]

collagen protein and reduces the infectivity that might be present 
(Grobben, et al., 2004).
    3. Alkaline treatment: The materials are soaked in a saturated lime 
solution (pH 12.5) for a period of 20 to 50 days. The alkaline 
treatment changes the internal structure of the BSE protein, if 
present. The combination of time, temperature, and concentration of the 
alkaline treatments reduces the levels of BSE infectivity in the event 
they were present in the raw materials (Grobben, et al., 2004).
    4. Further acid treatments: In the event gelatin is produced from 
ossein by an acid process, the ossein is immersed for 12 to 24 hours in 
acid (pH 2-3.5).
    5. Gelatin extraction: Once all the procedures are performed, 
gelatin is extracted by a series of hot water steps. These include 
purification by filtration and sterilization, both of which further 
remove suspended materials and thus further reduce the level of any 
remaining BSE infectivity, if present, which is unlikely at this stage 
in the production.
    Research studies mimicking the manufacturing process described 
above were unable to show detectable levels of infectivity in the mouse 
bioassay. The results are consistent with TSE infectivity reduction 
capacity exceeding a factor of 30.000 (4.5 logs, although results from 
most recent research indicate clearance factors exceeding 4.8 logs) (EC 
SSC adopted at the 12-13 September 2002 meeting). These studies have 
demonstrated that the common process of manufacturing bovine gelatin 
provides significant assurance of gelatin safety.
    Experimental studies have confirmed that the chemical processes 
used in the manufacture of gelatin derived from bones are sufficient to 
inactivate BSE infectivity that might have been present in the raw 
material (EC SSC, 1998). These experimental studies were designed to 
ensure that they accurately represented the ``lowest common 
denominator'' of current manufacture practices.
    A quantitative risk assessment (EFSA Journal, 2006) of the residual 
risk in bone-derived gelatin, obtained from bones fit for human 
consumption calculated different scenarios resulting in different risk 
levels. The study did not take into consideration the sourcing of 
bones. Results of the risk assessment indicate that the relevant 
exposures are very small compared to the historical exposure of the 
human population in the United Kingdom (1980-2001) due to meat and meat 
products in its diet. The removal of skull and vertebral column from 
the source materials results in only a very small risk reduction. 
However, the input parameters to the supporting risk assessment model 
sourced animals only from the healthy slaughter subpopulation and did 
not address the scenario where material was sourced from cattle not 
subject to ante- and post-mortem inspection.
    Although this evidence points to the conclusion that gelatin 
derived from bones that is produced using common manufacturing 
processes could be considered safe regardless of the region from which 
the bones originate, we believe that the limited parameters of the 
input data in the European Food Safety Authority (EFSA) assessment make 
it advisable to propose additional risk mitigations based on the BSE 
risk classification of the region of origin. Therefore, we are 
proposing in Sec.  94.23 to allow the importation of gelatin derived 
from the bones of bovines under the following conditions:
    Region of negligible risk: We are proposing in Sec.  94.23(c) for 
gelatin and Sec.  95.7(c) for collagen that gelatin and collagen 
derived from the bones of bovines would be eligible for importation 
from a region of negligible risk for BSE, provided that the bovines 
from which the gelatin was derived passed ante-mortem and post-mortem 
inspection, and provided the shipment is accompanied by certification 
as to the BSE risk classification of the region from which the gelatin 
or collagen originates and that the conditions for import have been 
met.
    Region of controlled risk or undetermined risk: We are proposing in 
Sec.  94.23(d) for gelatin and Sec.  95.7(d) for collagen that gelatin 
and collagen derived from the bones of bovines would be eligible for 
importation from a region of controlled risk or undetermined risk for 
BSE provided that: (1) The bovines from which the gelatin was derived 
passed ante-mortem and post-mortem inspection; (2) skulls from bovines 
of any age have been excluded from the processing (due to the fact that 
skull might still have pieces of brain attached), as has the vertebral 
column from bovines 30 months of age or older; (3) and the bones are 
subjected to a process that includes all of the following steps, or to 
a process at least as effective in reducing BSE infectivity:
    1. Degreasing;
    2. Acid demineralization;
    3. Acid or alkaline treatment;
    4. Filtration; and
    5. Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a 
minimum of 4 seconds.
    Shipments of gelatin and collagen imported into the United States 
under the above conditions would need to 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.
    We are proposing, additionally, in Sec.  94.23(f) for gelatin and 
Sec.  95.7(f) for collagen, to allow the importation of gelatin and 
collagen under conditions other than those described above 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. A United States Veterinary 
Permit for Importation and Transportation of Controlled Materials and 
Organisms and Vectors would need to be obtained. Application for a 
permit would need to 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 https://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the material and the name and 
address of the consignee in the United States.

Dicalcium Phosphate

    Considerable mineral content is recovered from the hydrochloric 
acid treatment of bone chip used in the production of gelatin. As 
stated earlier, before bones can be used in the manufacture of gelatin, 
fat and other impurities must be removed by a process called 
``degreasing.'' The bones are crushed to a small size and then washed 
and degreased in a process that removes any residues of fat, marrow, or 
other soft tissues. Before degreased bone chip material can be used to 
produce gelatin, minerals--including calcium and phosphate--must be 
removed. To remove minerals, the bone chip is soaked in hydrochloric 
acid (approximately 4 percent, < pH 1.5) for a period of at least 2 
days. The recovered minerals are further purified, followed by 
precipitation and drying. The resultant product is dicalcium phosphate.
    In 2003, the EC SSC stated that the residual risk in dicalcium 
phosphate derived from bovine bones was negligible when the raw 
material for the production of bovine bone dicalcium phosphate is 
obtained from a country of any risk categorization if (1) the dicalcium 
phosphate is derived from appropriate tissues (i.e., from animals fit 
for human consumption, with SRMs--including skull and vertebrae--
excluded, and cross-contamination with these bones avoided) and (2) 
submitted

[[Page 15887]]

to a production process that has a proven TSE infectivity reduction 
capacity (EC SSC, 2003).
    The same processing steps applied for the pretreatment of bones 
used to produce bone-derived gelatin are followed for pretreatment of 
bones for the production of dicalcium phosphate. Accordingly, studies 
that demonstrate the safety of gelatin resulting from the pretreatment 
of bone during degreasing and acid demineralization (Grobben, et al., 
2004; Manzke, et al., 1996) also indicate that a very safe dicalcium 
phosphate is yielded as a byproduct of the gelatin manufacturing 
process. Further, a significant reduction of TSE infectivity under 
experimental conditions has been demonstrated for dicalcium phosphate 
by a recent validation study in which dicalcium phosphate was prepared 
from bone artificially contaminated with TSEs and assayed for the 
presence of infectivity (Grobben, et al., 2006).
    In addition, according to the EC SSC (EC SSC, 2003) a 2003 
validation study by Groben, et al., shows that the acid process after 
degreasing and demineralization (as described above under the heading 
``Gelatin'') together result in a reduction of infectivity of 2.6 log 
10. The production process as a whole reduces the infectivity further 
up to 3.8 to 3.9 log 10.
    Research indicates that dicalcium phosphate is not a risk factor 
for the transmission of the BSE agent when the dicalcium phosphate 
contains no traces of protein or fat. However, there is evidence that 
dicalcium phosphate produced from bones under normal manufacturing 
processes can contain a small residual proteinaceous fraction. Although 
the scientific evidence points to a significant reduction in 
infectivity during processing of dicalcium phosphate, there is a 
potential that it will present higher risk when it contains traces of 
protein or fat.
    The OIE Code recommends no BSE-related restrictions for dicalcium 
phosphate that contains no trace of protein or fat. However, the OIE 
Code does recommend that dicalcium phosphate that is not free of 
protein or fat should originate only from negligible or controlled risk 
regions (OIE Code, 2010, Article 11.5.17), and that, if the material 
originates from a region of controlled risk for BSE, additional risk 
mitigation measures be applied. These additional measures are that the 
dicalcium phosphate is derived from cattle that have passed ante-mortem 
and post-mortem inspections and that the SRMs from cattle 30 months of 
age or older at the time of slaughter have been excluded (OIE Code, 
2010, Article 11.5.17).
    Based on our review of the science regarding dicalcium phosphate, 
we concur with the OIE's recommendations regarding trade of dicalcium 
phosphate. Therefore, we are proposing in Sec.  95.10 to allow the 
importation of bovine-derived dicalcium phosphate that contains no 
trace of protein or fat from any region, regardless of the region's BSE 
risk classification. We are proposing to provide in Sec.  95.10(b) to 
allow the importation from a region of negligible risk for BSE of 
bovine-derived dicalcium phosphate other than that with no trace of 
protein or fat if the dicalcium phosphate is accompanied by 
certification of the BSE classification of the exporting region. We are 
proposing to provide in Sec.  95.10(c) to allow the importation from a 
region of controlled risk for BSE of bovine-derived dicalcium phosphate 
other than that with no trace of protein or fat if the dicalcium 
phosphate is accompanied by certification that it is derived from 
bovines that have passed ante-mortem and post-mortem inspection and was 
produced in a manner that ensures that it does not contain and is not 
contaminated with SRMs.
    Bovine-derived dicalcium phosphate other than that with no trace of 
protein or fat would not be eligible for importation from a region of 
undetermined risk for BSE, except on a case-by-case basis as provided 
in the next paragraph.
    We are proposing in Sec.  95.10(e) to allow the importation of 
dicalcium phosphate that is not protein free under conditions other 
than those described above if the Administrator determines that the 
derivatives 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. A United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors must be obtained. 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 
https://www.aphis.usda.gov/animal_health/permits/). The application for 
such a permit must state the intended use of the material and the name 
and address of the consignee in the United States.

Tallow

    Several studies have evaluated TSE infectivity in tallow that was 
spiked with infected brain material and then subjected to rendering. In 
two rendering studies, one with BSE (Taylor et al., 1995) and the other 
with scrapie (Taylor, et al., 1997), no detectable infectivity from 
either agent was demonstrated from any of the tallow samples when 
assayed in mice. The BSE rendering study did not demonstrate any 
infectivity in crude unfiltered tallow, although the same rendering 
procedure produced MBM with almost the same infectivity levels as the 
untreated raw material. These studies suggest that during the 
manufacturing process of tallow, both BSE and scrapie agents do not 
preferentially separate with tallow during rendering but tend to remain 
with the MBM fraction.
    A review of inactivation of TSE agents during rendering (Taylor and 
Woodgate 2003) suggests that tallow is generally not considered to be 
related to risk of BSE infection for two main reasons: (1) That the 
BSE-spiked rendering studies confirmed the lack of detectable 
infectivity of tallow through mice bioassay; and (2) because 
epidemiological studies were not able to link the distribution and use 
of tallow in cattle feed to the incidence of BSE in the United Kingdom.
    Some countries (e.g., Denmark and Japan) have implicated tallow in 
milk replacers as a potential source of BSE infection. A 2003 
epidemiological report on BSE in Japan hypothesized tallow in calf milk 
replacer as one possible source and route of infection. However, 
statistical analysis of the data did not support the conclusion of any 
correlation between the use of milk replacer and BSE incidence (BSE 
Epidemiological Study Group report, 2003).
    A quantitative risk assessment of BSE transmission through tallow-
based milk replacer (Paisley and Hostrup-Pedersen, 2004) modeled the 
effects of level of impurities (0.02, 0.15, and 0.5 percent), inclusion 
of SRMs, and other inputs on the probability of occurrence of BSE 
cases. Although the results were associated with a high level of 
uncertainty, the study found that, under certain scenarios, tallow-
based milk replacer could be associated with transmission of BSE to 
calves. The simulations demonstrated the importance of SRM exclusion in 
limiting the probability of BSE infection, particularly from tallow 
with high impurity levels (0.5 percent). Uncertainty in the results 
stemmed from infectivity in central nervous system tissue and from the 
level of impurities in tallow.
    A quantitative risk assessment on the residual BSE risk posed by 
tallow (EFSA

[[Page 15888]]

Journal, 2005a) concluded that tallow was not a risk factor in 
transmitting the BSE agent, if the tallow was derived from cattle that 
have passed ante-mortem and post-mortem inspection. Likewise, while the 
level of soluble impurities did not significantly affect the risk of 
exposure, the assessment concluded that the source of raw material 
warranted further consideration. In addition, removal of SRMs 
corresponded to a 2 log reduction in potential BSE infectivity. The 
EFSA Scientific Panel concluded that, for the scenarios evaluated in 
the quantitative risk assessment, the exposure levels for tallow were 
minimal, thereby posing no risk of transmission.
    The OIE guidelines regarding tallow derived from bovines, and the 
current APHIS regulations regarding the importation of tallow from BSE 
minimal-risk regions are based on the conclusion that tallow with a 
maximum level of insoluble impurities of 0.15 percent in weight and 
derivatives made from this are not a risk factor in the transmission of 
the BSE agent. APHIS concludes that such tallow and derivatives made 
from this tallow can be imported without BSE restrictions, regardless 
of the BSE risk classification of the region of origin. We are 
proposing in Sec.  95.8(b) to allow such importation of tallow with a 
maximum level of insoluble impurities of 0.15 percent in weight.
    In addition, the evidence suggests that tallow other than tallow 
with a maximum level of insoluble impurities of 0.15 percent in weight 
is not a risk factor provided it is sourced from cattle that have 
passed ante-mortem and post-mortem inspections and SRMs are excluded. 
Therefore, we are proposing in Sec.  95.8 that tallow other than tallow 
with a maximum level of insoluble impurities of 0.15 percent in weight 
would be eligible for importation under the following conditions. 
Either:
     It is sourced from a region of negligible risk for BSE; or
     If it is sourced from a region of controlled risk for BSE, 
it was derived from bovines that have passed ante-mortem and post-
mortem inspections and has not been prepared using SRMs.
    Additionally, to be eligible for importation, bovine-derived tallow 
other than tallow with a maximum level of insoluble impurities of 0.15 
percent in weight would need to be accompanied by certification of the 
BSE risk classification of the exporting region and that the applicable 
conditions, above, have been met.
    Tallow other than tallow with a maximum level of insoluble 
impurities of 0.15 percent in weight would not be eligible for 
importation from a region of undetermined risk for BSE, except on a 
case-by-case basis as provided in the next paragraph.
    We are proposing in Sec.  95.8(f) to allow the importation of 
tallow other than tallow with a maximum level of insoluble impurities 
of 0.15 percent in weight under conditions other than those described 
above if the Administrator determines that the tallow 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. A United States Veterinary 
Permit for Importation and Transportation of Controlled Materials and 
Organisms and Vectors must be obtained. 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 https://www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the material and the name and 
address of the consignee in the United States.

Tallow Derivatives Other Than Those Made From Tallow With a Maximum 
Level of Insoluble Impurities of 0.15 Percent in Weight

    In addition to tallow itself, derivatives of tallow are a 
commercially traded commodity. Several studies have evaluated the 
effects of various time, temperature, and pressure processes on prion 
inactivation. The BSE-spiked tallow study (Taylor, et al., 1995) showed 
that, while infectivity does not persist in tallow during rendering, 
the level of infectivity of BSE subjected to a poorly inactivated 
rendering process remained at almost the same level as the untreated 
material.
    The current APHIS regulations in Sec.  95.4 allow the importation 
of derivatives from bovine-derived tallow without restriction with 
regard to BSE. Under Sec.  95.9(b) of this proposal, derivatives from 
bovine-derived tallow with a maximum level of insoluble impurities of 
0.15 percent in weight would continue to be eligible for importation 
into the United States without restriction due to BSE.
    With regard to derivatives from bovine-derived tallow other than 
tallow with a maximum level of insoluble impurities of 0.15 percent in 
weight, the OIE Code recommends that trade be allowed in such a 
commodity under any of the following conditions:
     It originates from a country of negligible risk for BSE;
     It originates from a country of controlled risk for BSE, 
is derived from bovines that have passed ante-mortem and post-mortem 
inspections, and does not contain SRMs; or
     It originates from either a country of controlled risk for 
BSE or a country of undetermined risk for BSE and was produced by 
hydrolysis, saponification, or transesterification. Those processes 
create conditions of high enough temperature and pressure to inactivate 
the BSE agent.
    The OIE Code does not define tallow derivative. However, in 21 CFR 
589.2001, the FDA defines tallow derivative as follows: ``* * * [A]ny 
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.'' According to the FDA definition, all 
bovine-derived tallow derivatives would meet the guideline in the OIE 
Code under which tallow derivatives from any country could be traded. 
In this document, we are proposing in Sec.  95.1 to define tallow 
derivative as FDA does. In Sec.  95.9, we are proposing to allow the 
importation from any region of tallow derivatives that meet our 
definition in Sec.  95.1. In Sec.  95.9 of this proposal, we are also 
providing that if an importer wishes to import a commodity the importer 
considers to be a tallow derivative, but that does not meet our 
proposed definition of tallow derivative, and the commodity was not 
derived from tallow with a maximum level of insoluble impurities of 
0.15 percent in weight, it must meet one of the following conditions to 
be eligible for importation:
     It originates from a country of negligible risk for BSE;
     It originates from a country of controlled risk for BSE, 
is derived from bovines that have passed ante-mortem and post-mortem 
inspections, and does not contain SRMs.
    Additionally, to be eligible for importation, derivatives from 
bovine-derived tallow other than tallow with a maximum level of 
insoluble impurities of 0.15 percent in weight would need to be 
accompanied by certification that the applicable conditions, above, 
have been met.
    We are proposing in Sec.  95.9(g) to allow the importation of 
derivatives of tallow other than tallow with a maximum level of 
insoluble impurities of 0.15 percent in weight under conditions other 
than those described above if the Administrator determines that the 
derivatives will not come into contact

[[Page 15889]]

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. A United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors must 
be obtained. 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 https://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended 
use of the material and the name and address of the consignee in the 
United States.

In-Vivo-Derived Embryos

    The current regulations in part 98 include BSE-related restrictions 
on the importation of embryos from ruminants. The regulations in Sec.  
98.15(a) provide that ruminant embryos may be imported into the United 
States from regions in which foot-and-mouth disease or rinderpest 
exists only if certain conditions apply with regard to BSE and other 
diseases. Among the conditions related to BSE are the following:
     During the year before embryo collection, no case of BSE 
occurred in or within 5 kilometers of the embryo collection unit;
     During the year before embryo collection, no case of BSE 
occurred in any herd in which the donor dam was present;
     Not less than 30 days nor more than 120 days after embryo 
collection, the donor dam was examined by an official veterinarian and 
was found free of clinical evidence of BSE;
     Between the time the embryos were collected and all 
required examinations and tests were conducted, no animals in the 
embryo collection unit with the donor dam, or in the donor dam's herd 
of origin, exhibited any clinical evidence of BSE.
    We are proposing to remove the BSE-related restrictions in Sec.  
98.15(a) on the importation of embryos derived from bovines, cervids, 
or camelids. This change would be consistent with the OIE Code 
regarding trade in in-vivo-derived embryos derived from bovines, and 
would be consistent with our proposal, discussed above under the 
heading ``Cervids and Camelids,'' to remove BSE-related import 
restrictions on cervids and camelids.
    No detectable infectivity has been found in susceptible mice fed 
placenta from confirmed cases of BSE (Middleton and Barlow, 1993; 
Barlow and Middleton, 1990; Bradley, 1990), nor in placenta, placental 
fluids, or ovary or uterine caruncle following mouse inoculation 
(Fraser and Foster, 1994; MAFF, 1997; EC SSC, 2000). Male reproductive 
tissues (e.g., testis, epididymis, prostate, semen, seminal vesicle) 
inoculated into mice showed no infectivity (Fraser and Foster, 1994; 
MAFF, 1999). In addition, infectivity was not detected in the fetal 
membranes and placenta of cattle with clinical BSE after cattle were 
dosed oro-nasally with a pooled tissue homogenate from BSE cattle. 
Animals were killed at 24 and 84 months post infection with no evidence 
of disease (Bradley, 1996; EC SSC, 2000).
    A different study examined the potential for washed embryos to 
transmit BSE (Wrathall et al., 2002). In this study, semen from 13 
bulls, 8 with clinical BSE, was used for artificial insemination (AI) 
of 167 clinically affected cows in the terminal stages of BSE. The 
resulting embryos were treated according to the recommendation of the 
International Embryo Transfer Society. The embryos were always 
transferred singly, but repeat transfers were done if returns to estrus 
occurred within the particular transfer session. Five hundred eighty-
seven viable embryos were transferred into 347 recipient heifers 
imported from New Zealand. A total of 266 live offspring were born, of 
which 54.1 percent had a BSE-positive sire as well as a BSE-positive 
dam. The recipient heifers were monitored for clinical signs of BSE for 
7 years after transfer, and the offspring were also monitored for 7 
years after birth. Twenty-seven heifers and 20 offspring died during 
monitoring, but none showed signs of BSE. The brains of these animals, 
in addition to the brains of animals killed, as scheduled, after 7 
years were examined for BSE by histopathology, PrP 
immunohistochemistry, and by electron microscopy for scrapie-associated 
fibrils. All results were negative. In addition to the embryos 
transferred into recipient heifers, 1,020 nonviable embryos were 
sonicated and inoculated intracerebrally into susceptible mice (20 
embryos per mouse) that were monitored for up to 700 days post 
inoculation; their brains were then examined for spongiform lesions. 
All results were negative. Additionally, uterine flush fluid samples 
from 41 cows were tested for BSE infectivity by intracerebral and 
intraperitoneal inoculation of 946 mice. One of these mice had some 
vacuolar pathology, but its relevance proved difficult to determine, 
since the putative incubation period was inconsistent with the survival 
of remaining mice in the group. All other mice with injections of flush 
fluids from the same cow were negative when finally killed and 
examined. Results of the study indicate that embryos are unlikely to 
carry BSE, and do not transmit the disease to recipients and their 
embryo transfer offspring, even when they are collected from donor cows 
at the end-stage, when the risk of maternal transmission (if it were to 
exist) would potentially be the highest.
    In a cohort study, 316 offspring of BSE confirmed cows (cases) and 
316 offspring from cows over 6 years old and without BSE from the same 
farm and age cohort (controls) have been observed under controlled 
conditions over a 7-year period. The purpose of the study was to 
determine whether maternal transmission occurs, and, if so, at what 
level of incidence. There was a statistically significant risk 
difference between the two cohorts examined (i.e., calves born to dams 
with BSE and calves born to healthy dams more than 6 years old). This 
difference was 9.7 percent, with a relative risk of 3.2 for offspring 
of cows that developed clinical BSE. This enhanced risk for the 
offspring of BSE dams appeared to decline the later the offspring were 
born after the 1988 feed ban was in place, but increased the closer 
that parturition was to the onset of clinical disease in the dam. The 
results cannot distinguish between a genetic component and true 
maternal transmission for which there is no other evidence. Instead, a 
combination of a genetic cause (i.e., increased susceptibility to feed 
exposure that could have occurred in any cattle in the study) and 
genuine transmission fits the computer model of the epidemic best 
(Donnelly, et al., 1997). Later studies by Donnelly, et al. (2002) 
significantly reduced the estimated risk to offspring, although they 
recognized that the introduction of culling of offspring of confirmed 
cases made estimation of the risk impossible other than by back-
calculation methods. The route for the hypothetical maternal 
transmission of BSE has not been established. Based on the modeling 
study, given that less than 1 percent of the offspring of affected 
cattle in the United Kingdom epidemic may succumb to this means of 
exposure, it is likely to be difficult to determine the route. More 
recent work on cases born after the 1996 feed ban fails to demonstrate 
evidence of maternal transmission (Hill, 2005). Thus, although maternal 
transmission may be possible, more recent epidemiologic

[[Page 15890]]

evidence suggests that maternal transmission of BSE is unlikely to 
occur at any appreciable level, if at all.
    For the reasons discussed above, we do not believe it is necessary 
to retain the BSE-related restrictions in Sec.  98.15(a) on the 
importation of embryos derived from bovines, cervids, or camelids.

Blood and Blood Products

    Blood and blood products can be divided into two main groups: (1) 
Whole blood and cellular derivatives such as red cell concentrate, 
platelets, and other cellular elements; and (2) plasma-derived products 
including serum (including fetal bovine serum (FBS), clotting factors, 
immunoglobulins, and albumin (Farshid, et al., 2005)). Plasma is the 
cell-free portion of the blood. Serum is plasma with fibrinogen and 
clotting factors removed.
Transmission Studies
    BSE infectivity has not been demonstrated in cattle blood or any 
tested derivatives (EC SSC, 2002). This conclusion derives from studies 
in which tissues from infected cattle were injected intracerebrally and 
intraperitoneally into mice (the ``mouse bioassay''), or 
intracerebrally into cattle (the ``cattle bioassay''). Mouse bioassays 
were performed using buffy coat (the white cell fraction of centrifuged 
whole blood), clotted blood, fetal calf blood, and serum from confirmed 
clinical cases (Kimberlin, 1996 cited in EC SSC, 2002). Wild-type mouse 
and cattle bioassays were performed on buffy coat from cattle 
experimentally exposed orally to the BSE agent. In all cases, no 
evidence of infectivity was detected. However, brain damage caused by 
certain stunning techniques can produce central nervous system tissue 
emboli in venous blood draining the head (EFSA Journal, 2004). A recent 
study (Espinosa, et al., 2007), utilizing material derived from the 
second United Kingdom Veterinary Laboratories Agency pathogenesis study 
(cattle challenged orally with BSE and culled 20, 24, 27, and 30 months 
post exposure), revealed no detectable blood infectivity by assay in 
transgenic BoPrP-Tg110 mice.
    Investigators have demonstrated that BSE can be transmitted to 
sheep by transfusion of whole blood from sheep experimentally infected 
with BSE (Houston, et al., 2000; Hunter, et al., 2002). In these 
studies, a transfusion of 400 ml of whole blood, taken from clinically 
normal infected sheep, caused disease in 2 of 24 recipients. Blood or 
buffy coat taken from clinically ill animals, however, did not cause 
disease in the four recipients. These same investigators also examined 
scrapie in sheep. A total of 4 sheep out of 21 transfused with blood 
from sheep naturally infected with scrapie developed disease. The 
transfusion of buffy coat derived from a clinically ill animal caused 
disease in the recipient. The EC SSC examined these studies and their 
implications. They concluded that the finding of infectivity in the 
blood of sheep could not be extrapolated to BSE in cattle (EC SSC, 
2002b).
    Brown, et al. (1999), using a human strain of TSE (Gerstmann-
Straussler-Scheinker) in mice inoculated intracerebrally, concluded 
that infectivity was present in the buffy coat (platelets, white cells) 
during the preclinical phase of TSE, but absent or in only trace 
amounts in the plasma or plasma fractions. Following the onset of 
clinical signs, increased infectivity of both buffy coat and plasma was 
found, but still at very low levels compared to levels in the central 
nervous system. As cited in a review of the relevant literature (Comer, 
2004, p. II.18), most studies using a rodent model and adapted strains 
of scrapie or CJD demonstrated that the fractions containing white 
blood cells have the highest levels of infectivity.
    In contrast to investigations of the natural distribution of 
infectivity in rodent blood fractions, one ``spiking'' study added high 
levels of hamster-adapted scrapie infectivity from brain homogenate to 
normal human blood. Following fractionation by centrifugation into red 
cells, white cells/platelets, and plasma components, titrations 
indicated that the majority of infectivity was in the red cell 
component (Brown, et al., 1998). These results, although not as 
relevant to understanding the natural distribution of TSEs in blood, 
may potentially apply to the distribution following cross-contamination 
at blood collection. Therefore, if contrary to current research, or if 
the proposed mitigations are not properly implemented, BSE infectivity 
is present in bovine blood, either naturally or via cross-
contamination, it would likely be highest in the cellular components. 
These fractions, both red and white cells, are excluded when harvesting 
FBS and bovine serum albumin used in the preparation of vaccines and 
drugs.
    Further decrease in TSE infectivity occurs with fractionation of 
plasma proteins. Fractionation is the process whereby specific 
proteins, such as albumin, are separated out from other components of 
the plasma. Infectivity in various fractions has been examined. For 
example, using data from several cited studies, Comer (2004) estimated 
that human albumin contains 3.1x10-5 vCJD ID50/gram. 
Compared to Comer's estimates of infectivity in whole blood (2 iv vCJD 
ID50/gram), this figure represents a dramatic decrease.
    Although BSE has never been detected in any bovine blood, blood 
product, or fetal blood, APHIS recognizes the possibility of cross-
contamination with SRMs at the time of collection, particularly in a 
slaughter environment. Certain slaughterhouse stunning practices-
specifically the use of devices that inject compressed air or gas into 
the cranial cavity or pithing processes--may introduce macro-emboli of 
tissue from the central nervous system into the circulatory system 
(Anil et al., 1999; Schmidt, et al., 1999). In addition, collection of 
blood in an open manner may allow other tissues to contaminate the 
blood.
    In order to prevent contamination due to such potential sources of 
infectivity, we are proposing in Sec.  95.12 to require mitigations to 
decrease the risk of cross-contamination. For all blood and for 
products derived from blood, a condition of importation eligibility 
would be that the blood was collected in a hygienic manner, as 
determined by the Administrator, that prevents contamination of the 
blood with SRMs. For blood collected at slaughter and for products 
derived from such blood, we would require that the slaughtered animal: 
(1) Pass ante-mortem inspection; and (2) not be subjected to a stunning 
process with a device injecting compressed air or gas into the cranial 
cavity, or to a pithing process. For blood collected from live donor 
bovines and for products derived from such blood, we would require that 
the donor animal be free of clinical signs of disease. Although this 
requirement regarding the disease status of live donor animals, which 
is set forth in the Sec.  95.4(e) of the current regulations, is not 
included in the OIE Code, we are including it here as an additional 
precaution against BSE contamination of the blood collected.
    Additionally, we would require that each shipment of blood and 
blood products to the United States must be accompanied by 
certification that the applicable requirements have been met.

Restrictions on Processed Animal Protein Derived From Nonruminants

    Although materials derived from nonruminants do not pose a BSE risk 
in and of themselves, the importation of such materials into the United 
States could pose a BSE risk if the nonruminant materials are 
commingled with materials from BSE-infected

[[Page 15891]]

ruminants. To guard against such a possibility, the current regulations 
in Sec.  95.4 restrict the importation of certain animal materials, 
regardless of the species from which it is derived, unless it can be 
demonstrated that the nonruminant material (or ruminant material if the 
ruminants are from a country not listed in Sec.  94.18(a)) has not been 
commingled with ruminant materials that are prohibited entry into the 
United States. The regulations in Sec.  95.4(c)(4) also contain 
provisions under which a facility that wishes to export such material 
to the United States from a region listed in Sec.  94.18(a), and that 
process or handle any material derived from mammals, must allow for 
periodic APHIS inspection of its facilities, records, and operations to 
ensure there is no commingling. Facilities in regions listed in Sec.  
94.18(a)(1) or (a)(2) that wish to export such material to the United 
States are required to enter into a cooperative service agreement with 
APHIS to provide for the payment of the costs of APHIS inspections.
    This proposed rule would continue to include safeguards against the 
commingling of nonruminant materials with materials that could contain 
BSE infectivity. The non-commingling provisions in proposed Sec.  
95.4(c) regarding materials derived from ovines and caprines would 
continue to apply to a variety of materials--e.g., processed animal 
protein, tankage, offal, tallow other than tallow derivatives, 
processed fats and oils, and derivatives of processed animal protein, 
tankage, and offal, pending any future rulemaking regarding ovines and 
caprines. However, in proposed Sec. Sec.  95.13 and 95.14, which 
address potential BSE contamination of nonruminant-derived materials 
due to commingling with materials derived from bovines, the provisions 
would apply only to processed animal protein, based on the scientific 
evidence discussed above regarding the role of such material in BSE 
transmission.
    We are proposing in Sec.  95.13 that processed animal protein from 
a region of negligible risk for BSE that is derived from animals other 
than ruminants may not be imported into the United States unless the 
following conditions are met:
     The material is not otherwise prohibited under the 
provisions in Sec.  95.4 regarding materials derived from ovines or 
caprines;
     The shipment of materials into 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 indicate the BSE risk 
classification of the region of export;
     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 https://www.aphis.usda.gov/animal_health/permits/.)
    We are proposing in Sec.  95.14 that processed animal protein from 
a region of controlled risk or undetermined risk for BSE that is 
derived from animals other than ruminants may not be imported into the 
United States unless, in addition to the requirements for importation 
listed above for importation from a region of negligible risk for BSE, 
the following conditions are met:
     Except as provided in the next bulleted condition for 
blood and blood products, the processed animal protein does not contain 
and was not commingled with material derived from ruminants originating 
in a region of controlled risk or undetermined risk for BSE.
     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. 
Because, as noted above, BSE infectivity has not been demonstrated in 
cattle blood or any tested derivatives (EC SSC, 2002), we do not 
believe it is necessary to require that processed animal protein 
derived from nonruminants not contain or be commingled with blood and 
blood products derived from any ruminant from a BSE controlled- or 
undetermined-risk region. However, because of the possibility that 
blood derived from bovines could be contaminated with the BSE agent if 
collected in a manner that does not ensure that it is not contaminated 
with tissues containing the BSE agent, we consider it necessary to 
prohibit the contamination or commingling of nonruminant processed 
animal protein from controlled- or undetermined-risk regions with blood 
or blood product that does not meet all the conditions (e.g., 
collection in a hygienic manner) necessary to make it eligible for 
importation into the United States.
     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.
     If APHIS conducts the required inspection, 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.

Processed Animal Protein Derived From Ruminants

    Epidemiological evidence indicates the consumption by a susceptible 
animal of processed animal protein of ruminant origin contaminated by 
the BSE agent is the route by which BSE is transmitted. A region 
recognized by APHIS as a region of negligible risk for BSE and in which 
there has never been an indigenous case of BSE would have a negligible 
likelihood of circulating BSE infectivity and, therefore, pose a 
negligible risk that a BSE-infected animal would be incorporated into 
rendered protein. Therefore, we are proposing in Sec.  95.5 to allow 
the

[[Page 15892]]

importation of processed animal protein derived from ruminants from 
such a region.
    In the case of a region of negligible risk for BSE that has had an 
indigenous case of the disease, we would require in Sec.  95.5 that the 
product be derived from ruminants that were subject to a ruminant-to-
ruminant feed ban.
    Under this proposal, processed animal protein derived from 
ruminants would not be eligible for importation into the United States 
from a region of controlled risk for BSE or a region of undetermined 
risk. Because the primary source of BSE exposure has been shown to be 
processed animal protein derived from ruminants contaminated with the 
BSE agent, and because processed animal protein could potentially carry 
or be contaminated with the BSE agent, we are proposing to prohibit the 
importation of processed animal protein from regions of controlled risk 
for BSE unless it can be demonstrated that such product has not been 
commingled or contaminated with ruminant MBM or greaves. We would 
prohibit the importation of processed animal protein derived from 
ruminants from regions of undetermined risk for BSE because of the 
possibility that such a region may not have adequate infrastructure and 
the capability to implement BSE-related risk mitigations, including an 
effectively enforced feed ban.

Transiting Provisions

    In the current regulations, Sec. Sec.  94.18(d) and 95.4(h) provide 
that articles that are otherwise prohibited importation into the United 
States under the BSE regulations may transit air and ocean ports in the 
United States for immediate export, provided certain conditions are 
met. The requirements are that:
     The person moving the articles has obtained an import 
permit from APHIS;
     The articles are sealed in leakproof containers bearing 
serial numbers during transit, and each container remains sealed during 
the entire time that it is in the United States;
     The person moving the articles notifies, 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 import permit number; the times and dates 
of arrival in the United States; the times and dates of exportation 
from the United States; the mode of transportation; and the serial 
numbers of the sealed containers; and
     The articles transit the United States in Customs bond.
    We are proposing in Sec.  94.27 and Sec.  95.15 to continue to 
allow such transiting of articles otherwise prohibited importation by 
the BSE regulations.
    Sections 94.18(d) and 95.4(h) of the current regulations also allow 
the overland transit through the United States of articles from BSE 
minimal-risk regions, provided the requirements listed above are met, 
and the following additional requirements are met:
     The articles are eligible to enter the United States in 
accordance with the BSE provisions in part 94 or part 95, as 
applicable;
     The shipment is exported from the United States within 7 
days of its entry;
     The commodities are not transloaded while in the United 
States, except for direct transloading under the supervision of an 
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
     A copy of the required import permit is presented to the 
inspector at the port of arrival and the port of export in the United 
States.
    In this document, we are proposing in Sec.  94.27 and Sec.  95.15 
to allow the overland transit of products governed by the BSE 
regulations, provided the same conditions for overland transit as those 
listed above are met.

Certification of Certain Materials

    Section 95.29 of the current regulations requires certification 
regarding the source, processing, and storage of certain specified 
animal materials imported from regions other than those listed in Sec.  
94.18(a), which lists regions from which the importation of ruminants 
and ruminant products are restricted because of BSE. The materials for 
which certification is required are the following:
     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, regardless of the animal species 
from which the material is derived;
     Glands and unprocessed fat tissue from ruminants;
     Processed fats and oils, and derivatives of processed 
animal protein, tankage, and offal, regardless of the animal species 
from which the material is derived;
     Derivatives of glands from ruminants; and
     Any product containing any of the listed materials.
    We are proposing to amend the provisions of Sec.  95.29 
(redesignated as Sec.  95.40 in this proposed rule) to make them apply 
only to materials derived from ovines or caprines. As discussed above, 
we are not at this time proposing to make any substantive changes to 
the BSE regulations governing ovines or caprines or products from such 
animals. The purpose of the provisions in current Sec.  95.29 as they 
apply to materials from nonruminant animals and to ruminants other than 
ovines and caprines--to ensure that materials eligible for entry into 
the United States have not been commingled with materials ineligible 
for entry because of their BSE risk--would be met by the provisions we 
are proposing to set forth in new Sec.  95.13, which we discuss above 
under the heading ``Restrictions on Processed Animal Protein Derived 
from Nonruminants.''

Importation of Casings

    Part 96 of the current regulations includes provisions regarding 
the importation of animal casings into the United States. Current Sec.  
96.2(b) prohibits the importation of casings, except stomachs, from 
ruminants that originated in or were processed in any region listed in 
Sec.  94.18(a) for BSE, unless specified conditions in Sec.  96.2(b)(1) 
or (b)(2) are met. These provisions are as follows:
     The casings are derived from sheep that were slaughtered 
in a BSE minimal-risk region listed in Sec.  94.18(a)(3) (currently 
only 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 FDA at 21 CFR 589.2000; or
     The casings are derived from bovines that were slaughtered 
in a BSE minimal-risk region, provided, 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 FSIS at 9 CFR 310.22 and the FDA 
at 21 CFR 189.5.
    Casings that are imported in accordance under either of the above 
scenarios must also be accompanied by certification that the applicable 
conditions have been met.
    In this document, we are proposing to amend Sec.  96.2(b) to 
specify that the prohibitions in that paragraph that currently apply to 
casings from all ruminants would apply only to casings derived from 
ovines or caprines. We are proposing no changes to the current 
provisions governing the importation of

[[Page 15893]]

casings derived from sheep from Canada.
    We are proposing to amend the current Sec.  96.2 provisions 
regarding casings derived from bovines to allow for the importation of 
casing derived from bovines provided the following conditions are met:
     If the casings are derived from bovines from a region of 
negligible risk for BSE, the certification required under Sec.  96.3 
indicates the APHIS BSE risk classification of the region in which the 
bovines were slaughtered and the casing processed.
     If the casings are derived from bovines from a region of 
controlled risk for BSE or a region of undetermined risk for BSE, 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 FSIS at 9 CFR 310.22 
and FDA at 21 CFR 189.5.
     The casings are accompanied by a certification that the 
required conditions have been met.

Provisions Regarding Ovines and Caprines

    In this proposal, we retain the current import prohibitions and 
restrictions regarding ovines and caprines (e.g., sheep and goats) and 
their products. However, we are proposing to make formatting and 
wording changes to the regulations regarding such animals, for several 
reasons.
    In many cases, the current import regulations regarding BSE apply 
to all ruminants or to several types of ruminants. For instance, the 
regulations in current Sec.  94.18 prohibit or restrict the importation 
of most products derived from ruminants from regions in which BSE 
exists (listed in current Sec.  94.18(a)(1)) or that pose an undue risk 
of BSE (listed in current Sec.  94.18(a)(2)), whether the ruminant from 
which the product is derived is a bovine, ovine, caprine, cervid, or 
camelid. Similar blanket prohibitions or restrictions are set forth in 
current part 93 with regard to live ruminants, in current part 95 with 
regard to products derived from ruminants other than meat and other 
edible products, and in current part 96, with regard to casings.
    The current regulations apply no BSE prohibitions or restrictions 
to live cervids and camelids from BSE minimal-risk regions (listed in 
current Sec.  94.18(a)(3)) or to products derived from such animals. 
The importation from BSE minimal-risk regions of live bovines, sheep, 
and goats--and products derived from such animals--is allowed under 
specified conditions.
    Because, in this proposed rule, we would retain the current 
importation provisions with regard to BSE as they apply to ovines and 
caprines--but not as they apply to bovines, cervids, and camelids--it 
is necessary to revise the current regulations to make them particular 
to ovines and caprines, pending any future rulemaking regarding such 
animals. Among the revisions we are proposing to the regulations 
regarding ovines and caprines is the removal of the terminology 
currently used in Sec.  94.18(a) to refer to the BSE risk status of a 
region (i.e., regions in which BSE exists, regions of undue risk for 
BSE, and regions of minimal-risk for BSE). In order to avoid confusion 
as to our intent regarding our proposed BSE risk classification system 
with regard to bovines (i.e., BSE negligible-, controlled-, and 
undetermined-risk regions), when we refer to regions that are listed in 
current Sec.  94.18(a) with regard to ovines and caprines, we simply 
list the names of those regions.
    In this proposed rule, the provisions in part 94 that are 
particular to ovines and caprines are set forth in Sec. Sec.  94.24 
through 94.27. The provisions in part 95 that are particular to ovines 
and caprines are set forth in Sec. Sec.  95.4, 95.15, and 95.40. In 
parts 93 and 96, the BSE import provisions related to ovines and 
caprines and their products are set forth in the same regulatory 
sections as in the current regulations.

Definitions

    In addition to the definitions we are proposing to add to the 
regulations that we discuss elsewhere in this document, we are 
proposing to add to Sec.  92.1 definitions of approved laboratory, OIE, 
OIE Code, and OIE Terrestrial Manual. Additionally, we are proposing to 
amend the definition of recognized slaughtering establishment in Sec.  
93.400 to mean a 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. This proposed definition is the same as 
that currently contained in 9 CFR 78.1.

Miscellaneous Nonsubstantive Changes

    We are also proposing to make nonsubstantive editorial and 
formatting changes to parts 92, 93, 94, 95, and 96, in order to make 
the text in those parts consistent with the changes that we discuss 
above in this document. These nonsubstantive changes include 
redesignation and reformatting of regulatory sections and amendment of 
cross-references where necessary.
    We are also proposing nonsubstantive editorial changes to Sec.  
96.3 to reflect the changes we are proposing to make in Sec.  96.2.

APHIS Classification of BSE Risk Status of Countries That Have Received 
Classification by the OIE

    As we discussed above in this document under the heading ``The 
Process for APHIS Recognition of the BSE Risk Classification of a 
Region,'' if the OIE has classified a country as either BSE negligible 
risk or BSE controlled risk, APHIS would give notice to the public that 
the Agency considers such classification by the OIE to be a basis for 
APHIS' recognition of the country as having the BSE risk classification 
determined by the OIE, subject to public comment regarding that intent.
    In accordance with that proposed process we are giving notice in 
this document that APHIS gives preliminary concurrence to the OIE risk 
classifications of the following countries:
     Regions of negligible risk for BSE: Argentina, Australia, 
Chile, Denmark, Finland, Iceland, New Zealand, Norway, Panama, 
Paraguay, Peru, Sweden, and Uruguay.
     Regions of controlled risk for BSE: Austria, Belgium, 
Brazil, Canada, Colombia, Cyprus, Czech Republic, Estonia, France, 
Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Liechtenstein, 
Lithuania, Luxembourg, Malta, Mexico, the Netherlands, Poland, 
Portugal, Republic of Korea, Slovak Republic, Slovenia, Spain, 
Switzerland, and the United Kingdom.\17\
---------------------------------------------------------------------------

    \17\ The United States is also classified by the OIE as a region 
of controlled risk for BSE.
---------------------------------------------------------------------------

    The OIE recommendations regarding each of the above countries can 
be viewed at https://www.oie.int/en/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/.

Date of Effective Enforcement of Feed Ban in Mexico

    As noted above, we are proposing to recognize Mexico as a country 
of controlled risk for BSE. Also as discussed above, for a country 
classified by APHIS as negligible-risk or controlled-risk for BSE that 
wishes to export live bovines to the United States, APHIS would need to 
determine the date a feed ban was effectively enforced in the country. 
Consequently, we have conducted an evaluation to determine the date of 
effective enforcement of a feed ban in Mexico. Based on that 
evaluation, we consider the date of

[[Page 15894]]

effective enforcement of a feed ban in Mexico to be November 30, 2007. 
Copies of our evaluation, as well as the supporting documentation, are 
available by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).

Public Comment Regarding BSE Classification of Countries and Date of 
Effective Enforcement of Feed Ban in Mexico

    We will accept public comment on our preliminary BSE risk 
classification of the countries listed above, as well as on our 
preliminary determination of the date of effective enforcement of a 
feed ban in Mexico, for the length of the comment period for this 
proposed rule document. Any final classification of countries regarding 
BSE risk would depend both on whether the classification system and 
procedures we are proposing in this document are made final and on 
comments received from the public regarding such classifications. 
Following review of any comments received, we will inform the public in 
the Federal Register of the Administrator's final determination 
regarding classification of the countries listed above and the date of 
effective enforcement of a feed ban in Mexico, along with a discussion 
of and response to pertinent issues raised by commenters.

Provisions Regarding the Importation of Live Bovines From Mexico

    As we discuss earlier in this document with regard to the 
importation of live bovines from Canada, the provisions we are 
proposing in Sec.  93.436 for the importation of live bovines from a 
region of controlled risk are generic to any such region. For instance, 
the provisions in Sec.  93.436 require that live bovines imported from 
a controlled risk region for BSE must have been born after the date 
from which the ban on the feeding of ruminants with MBM and greaves 
derived from ruminants has been effectively enforced. Also, the 
provisions in Sec.  93.436 require that live bovines intended for 
importation be permanently identified--by branding, tattooing, or some 
other method--as to the country of export. As noted above, in this 
document we are proposing to recognize November 30, 2007, as the date 
of effective enforcement of a feed ban in Mexico. Further, in this 
document, we are proposing to specify that the letters ``MX'' be used 
to identify sexually intact bovines as being of Mexican origin. (The 
regulations already require that cattle from Mexico that are other than 
sexually intact be identified as to country of origin, for diseases 
other than BSE.) To make this specific information more easily 
accessible in the regulations, we are proposing to set forth the 
provisions regarding the importation of live bovines from Mexico with 
regard to BSE in a new paragraph (f) in Sec.  93.427. Current Sec.  
93.427 contains requirements governing the importation of cattle from 
Mexico with regard to fever ticks, brucellosis, and tuberculosis.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed 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 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 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The proposed rule would make our bovine and bovine product import 
restrictions related to bovine spongiform encephalopathy (BSE) more 
reflective of current scientific thinking while continuing to guard 
against the introduction of BSE. The proposed process for classifying 
regions with respect to BSE risk would be based on the comprehensive 
review of relevant, internationally accepted scientific literature and 
would be consistent with the process employed by the World Organization 
for Animal Health (OIE). The proposed rule would also remove BSE-
related restrictions on the importation of live cervids and camelids 
and their products.
    While benefits of the proposed rule are expected to exceed its 
costs, effects on U.S. imports are expected to be minimal. Potential 
impacts of the proposed rule on U.S. export markets, by influencing 
trading partners' import policies, are not considered in this analysis.

Live Bovines (Cattle and Bison)

    Canada and Mexico are the sources of nearly all U.S. bovine 
imports. In the past 15 years, they have accounted for 99.9 percent of 
all cattle and bison imported into the United States. APHIS is 
proposing to classify Canada and Mexico as countries of controlled risk 
for BSE (their classification by the OIE).
    Imports from Canada are likely to be unaffected by this proposed 
rule because the proposed requirements would 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. Imports from Mexico also 
are likely to be largely unaffected, since nearly all cattle imported 
from Mexico (98 to 99 percent) are estimated to be less than 24 months 
of age and APHIS is proposing in this rule to establish 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 93 percent of all U.S. bovine product import 
volume (and 92 percent of the import value) over the five-year period, 
2006-2010. Imports from each of the six countries should continue 
essentially unchanged and without interruption under the proposed rule, 
because the protocols in place in these countries are already in full 
compliance with the proposed criteria. Argentina, Australia, New 
Zealand, and Uruguay are APHIS-proposed negligible risk regions for BSE 
that have never reported a case of BSE. Canada and Brazil, as proposed 
controlled risk regions for BSE, already satisfy FSIS inspection 
requirements and prohibitions on certain animal stunning or pithing and 
mechanically separated meat.
    Imports from the 36 (primarily European) countries listed in 9 CFR 
94.18 as prohibited from shipping bovine products to the United States 
likely would be insignificant under the proposed rule. 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

[[Page 15895]]

imports from the 36 countries account for more than 0.6 percent of 
imports of these products. Nor does the current trade climate suggest a 
significant volume of imports from the 36 countries in the future, at 
least in the near term. U.S. imports of beef and other bovine products 
have been in decline, a situation that makes it increasingly difficult 
for foreign exporters to compete in the U.S. market. Second, while 
bovine product exports by the European Union (EU-27) more than doubled 
in nominal value in five years, from $0.43 billion in 2006 to $1.01 
billion in 2010, the value of bovine product imports by EU-27 member 
countries in 2010 ($2.1 billion) was twice the value of their bovine 
product exports. 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 five years, 2006-2010, annual imports 
from such countries as a group averaged 6 to 7 percent of all U.S. 
bovine product imports by volume (7 to 8 percent by value), with 
virtually all of the products coming from Mexico, Nicaragua, and Costa 
Rica. Imports from Mexico already meet the proposed 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 proposing to recognize 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 proposed 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 
would likely have little or no impact. 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. Moreover, U.S. imports of meat and edible 
offal of deer have declined since 2005, a situation that makes it 
increasingly difficult for foreign exporters to compete in the U.S. 
market. The volume of U.S. imports of camelid products is very small. 
Their annual value averaged less than $50,000 over the five-year 
period, 2006-2010, 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 proposed rule would have 
little impact on consumer choice or import volumes. Likewise, we 
anticipate little or no impact for U.S. businesses because of changes 
in import volumes.
    Although the impact of this proposed rule on U.S. consumers and 
producers is expected to be minimal, the benefits of the rule are 
expected to outweigh 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 
fully supported by scientific evidence. Additionally, maintaining the 
status quo would not provide an opportunity to recognize 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 without allowing for modification deemed 
necessary by APHIS, 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.
    Small entities are prevalent in industries potentially affected by 
the proposed rule, but as described, we expect at most a minimal 
economic impact for U.S. businesses. We invite public comment on the 
rule's potential economic impact, including comment on the potential 
impact on small entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

National Environmental Policy Act

    Our affirmation of the position we took in removing the delay of 
applicability of certain provisions of our January 2005 final rule 
leaves those regulations unchanged. Therefore, we are also affirming 
the overall conclusions we reached in the environmental assessments we 
conducted for our January 2005 and September 2007 final rules.
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
proposed revision of the conditions for the importation of live bovines 
and products derived from bovines with regard to BSE set forth in this 
proposed rule, we have prepared an environmental assessment. The 
environmental assessment was 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 may be viewed on the Regulations.gov 
Web site or in our reading room. Instructions for accessing 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule. In addition, copies may be obtained by calling 
or writing to the individuals listed under FOR FURTHER INFORMATION 
CONTACT.

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 requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2008-0010. Please send a copy of your comments to: (1) Docket No. 
APHIS-2008-0010, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer,

[[Page 15896]]

OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., 
Washington, DC 20250. A comment to OMB is best assured of having its 
full effect if OMB receives it within 30 days of publication of this 
proposed rule.
    APHIS is proposing to revise the conditions for the importation of 
live bovines and products derived from bovines with regard to BSE, and 
is proposing to establish a system and process for classifying regions 
as to BSE risk that is consistent with the system and process employed 
by the OIE. For the most part, the changes made by this rule would 
expand the number and types of commodities eligible for entry into the 
United States with regard to BSE. However, in many cases, the 
commodities would be eligible for entry into the United States only if 
specified conditions have been met, and the commodities are accompanied 
by certification that the required conditions have been met. In some 
cases, the person seeking to import a commodity would need to apply for 
an import permit from APHIS.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average .3960737 hours per response.
    Respondents: U.S. importers of regulated animal products; full-time 
salaried veterinary officials of exporting regions; and foreign 
exporters of edible and inedible products derived from bovines.
    Estimated annual number of respondents: 784.
    Estimated annual number of responses per respondent: 41.4528.
    Estimated annual number of responses: 32,499.
    Estimated total annual burden on respondents: 12,872 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

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 proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

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Food and Drug Administration (FDA). (2005). Federal Register Volume 
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List of Subjects

9 CFR Part 92

    Animal diseases, Imports, 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 proposing to amend 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

    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.

    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 BSE is available at [ADDRESS TO BE ADDED IN 
FINAL RULE]
---------------------------------------------------------------------------

    (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 feed that 
potentially contained SRM material 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 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 (2) 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-

[[Page 15900]]

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 BSE is available at [ADDRESS TO BE ADDED IN 
FINAL RULE].
---------------------------------------------------------------------------

    (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 feed that 
potentially contained SRM material 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.
* * * * *
    3. A subpart heading is added after Sec.  92.1 to read as follows:

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

    4. A new Subpart B--Procedures for Requesting BSE Risk Status 
Classification With Regard to Bovines, 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 OIE Code standards for surveillance for BSE.

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 of 
this part. 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 [ADDRESS TO BE ADDED IN FINAL RULE]. 
The listing can also be obtained by writing to APHIS at [ADDRESS TO BE 
ADDED IN FINAL RULE]. 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. The summaries 
would be available for review on the APHIS Web site at [ADDRESS TO BE 
ADDED IN FINAL RULE]. 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

[[Page 15901]]

BSE, as applicable, that APHIS will make available to the public on the 
Agency's Web site at [ADDRESS TO BE ADDED IN FINAL RULE].
    (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 
such classification, along with documentation sufficient to allow APHIS 
to conduct an evaluation of whether the region meets the criteria for 
the classification. A list of the documentation required can be 
accessed on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE]. 
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.
    (d) 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 derived from ruminants;
    (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;
    (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.


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  OIE Code standards for surveillance for BSE.

    Article 11.6.22 of the OIE Code, effective 2009, are incorporated 
by reference. This incorporation by reference was approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. The OIE maintains a copy of these standards on its 
Internet homepage at https://www.oie.int/eng/normes/Mcode/en_sommaire.htm. Copies are available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

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

    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.

    6. Section 93.400 is amended by revising the definition of 
recognized slaughtering establishment and adding definitions of 
exporting region and processed animal protein, in alphabetical order, 
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

[[Page 15902]]

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]

    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]

    8. In Sec.  93.405, paragraph (a)(4) is amended by removing the 
words ``bovines, sheep, or goats from regions listed as BSE minimal-
risk regions in 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 Sec.  93.436(a)(3) and (b)(4)''.
    9. In Sec.  93.418, the section heading is revised and a new 
paragraph (d) is added to 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 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[caret]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 ``CAN'' 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.
    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.
    (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;
    (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.
    11. In Sec.  93.423, a new 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.
* * * * *
    12. In Sec.  93.427, the section heading is revised and a new 
paragraph (e) is added to 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

[[Page 15903]]

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 paragraph (e)(1) 
through (e)(3) of this section have been met.
    13. In Sec.  93.432, the section heading is revised and a new 
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.
    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 chapter, 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 cocygeal 
vertebrae);
    (ii) A tattoo with letters identifying the exporting country must 
be applied to the inside of one ear of the animal;
    (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 the BSE 
minimal-risk exporting region.
    (3) The bovines were born after the date from which the ban on the 
feeding of ruminants meat-and-bone meal or 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 feed that 
potentially contained SRM material 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.

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

    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.

    16. Section 94.0 is amended by removing the definitions of cervid 
and

[[Page 15904]]

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]

    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.  94.28'' in their place.


Sec.  94.9  [Amended]

    18. In Sec.  94.9, paragraph (c) is amended by removing the 
citation ``Sec.  94.24'' and adding the citation ``Sec.  94.30'' in its 
place.


Sec.  94.10  [Amended]

    19. In Sec.  94.10, paragraph (c) is amended by removing the 
citation ``Sec.  94.24'' and adding the citation ``Sec.  94.30'' in its 
place.
    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 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.
    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 derived from bovines that were born and 
raised in 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 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.

    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.

    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 derived from bovines that were born and 
raised in either a region of negligible risk for BSE that complies with 
Sec.  94.19(a) through (c), as applicable, or a region of controlled 
risk for BSE.

[[Page 15905]]

    (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 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.
    23. A new Sec.  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 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.


Sec.  94.27  [Removed]

    24. Section 94.27 is removed.


Sec. Sec.  94.22 through 94.26  [Redesignated]

    25. Sections 94.22 through 94.26 are redesignated as Sec. Sec.  
94.28 through 94.32, respectively.
    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.

    (1) The meat or dressed carcass (eviscerated and the head is 
removed) is 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 United States Customs 
and Border Protection official.


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 that indicates the BSE risk classification of the exporting 
region and 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.
    (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 https://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

[[Page 15906]]

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 https://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) 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:
    (2) Were less than 12 months of age when slaughtered;
    (3) 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;
    (4) Did not test positive for and were not suspect for a 
transmissible spongiform encephalopathy;
    (5) Never resided in a flock or herd that has been diagnosed with 
BSE; and
    (6) Were not subject to any movement restrictions within Canada as 
a result of exposure to a transmissible spongiform encephalopathy.
    (b) The commodities listed in paragraph (a) of this section 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.
    (c) 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.
    (d) 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 (d) 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 (e) of this section are met:
    (a) The person moving the articles 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 https://www.aphis.usda.gov/animal_health/permits/).
    (b) 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.
    (c) 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:
    (i) United States Veterinary Permit for Importation and 
Transportation of

[[Page 15907]]

Controlled Materials and Organisms and Vectors permit number;
    (ii) Times and dates of arrival in the United States;
    (iii) Times and dates of exportation from the United States;
    (iv) Mode of transportation; and
    (v) Serial numbers of the sealed containers.
    (d) The articles must transit the United States in Customs bond.
    (e) The commodities must be eligible to enter the United States in 
accordance with Sec. Sec.  94.18 through 94.26 and must be accompanied 
by the certification required by that section. Additionally, the 
following conditions must be met:
    (i) The shipment must be exported from the United States within 7 
days of its entry;
    (ii) 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;
    (iii) A copy of the import permit required under paragraph (a) of 
this section must be presented to the inspector at the port of arrival 
and the port of export in the United States.

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

    27. 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.

    28. Section 95.1 is amended by removing the definition of specified 
risk materials (SRMs), and 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.
* * * * *
    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.
* * * * *
    29. Section 95.4 is revised to read as follows:


Sec.  95.4  Restrictions due to bovine spongiform encephalopathy 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 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

[[Page 15908]]

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 (d)(1) through 
(d)(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 https://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 https://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 https://www.aphis.usda.gov/animal_health/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(d) of this subchapter.


Sec. Sec.  95.5 through 95.30  [Redesignated]

    30. Sections 95.5 through 95.30 are redesignated as Sec. Sec.  
95.16 through 95.41, respectively,
    31. Sections 95.5 through 95.15 are added to read as follows:


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 paragraph (a) and (b) of this section are met:
    (a) The exporting region is a region of negligible risk for BSE, or 
the product is derived from ruminants born and raised in a region of 
negligible risk for BSE, or it has been demonstrated that the product 
has not been commingled or contaminated with ruminant meat-and-bone 
meal or greaves. Additionally, if either paragraph (a)(1) or (a)(2) of 
this section applies, 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:
    (1) The product is exported to the United States from a region of 
negligible risk for BSE in which there has been at least one indigenous 
case of BSE; or
    (2) The product is derived from ruminants that were born or raised 
in a region of negligible risk for BSE in

[[Page 15909]]

which there has been at least one indigenous case of BSE.
    (b) 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 that the exporting region is a region of 
negligible risk for BSE and that the requirements of paragraph (a) of 
this section, as applicable, have been met.


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.


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 (f) of this 
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 that indicates the BSE risk classification of the exporting 
region and 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.
    (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 https://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.


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 part.
    (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 https://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.


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

[[Page 15910]]

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, National Center for Import 
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at https://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.


Sec.  95.10  Dicalcium phosphate derived from bovines.

    (a) The importation of dicalcium phosphate derived from bovines 
(other than dicalcium phosphate with no trace of protein or fat) is 
prohibited unless:
    (1) The requirements of either paragraph (b) or (c), and the 
requirements of paragraph (d) of this section are met; or
    (2) The requirements of paragraph (e) of this section are met.
    (b) The dicalcium phosphate originates from a region of negligible 
risk for BSE; or
    (c) 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.
    (d) 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) or (c) of this 
section, as applicable, have been met.
    (e) 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 https://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.


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 https://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.


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

[[Page 15911]]

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 originates from a 
region classified by APHIS as a region of negligible risk for BSE.
    (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 https://www.aphis.usda.gov/animal_health/permits/).


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 indicates the 
APHIS BSE risk classification of the exporting region and states that 
the 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 https://www.aphis.usda.gov/animal_health/permits/).


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 (d) 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 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 https://www.aphis.usda.gov/animal_health/permits/).
    (b) 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.
    (c) 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:
    (i) United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors permit 
number;
    (ii) Times and dates of arrival in the United States;
    (iii) Times and dates of exportation from the United States;
    (iv) Mode of transportation; and
    (v) Serial numbers of the sealed containers.
    (d) The articles must transit the United States under Customs bond.
    (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:
    (i) The shipment must be exported from the United States within 7 
days of its entry;
    (ii) 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

[[Page 15912]]

and seal the means of conveyance that will carry the commodities out of 
the United States with seals of the U.S. Government; and
    (iii) A copy of the import permit required under paragraph (a) of 
this section must be presented to the inspector at the port of arrival 
and the port of export in the United States.


Sec.  95.17  [Amended]

    32. 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]

    33. 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 1 to paragraph (c) is 
amended by removing the citation ``Sec.  95.5'' and adding the citation 
``Sec.  95.16'' in its place.


Sec.  95.19  [Amended]

    34. 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]

    35. 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 1 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]

    36. 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]

    37. 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]

    38. 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]

    39. 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]

    40. 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.  95.29  [Amended]

    41. 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]

    42. 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]

    43. 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]

    44. 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.
    45. 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 0579-0183)

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

    46. 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.

    47. 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.

[[Page 15913]]

    (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 of this part indicates the 
APHIS BSE risk classification of the region in which the bovines were 
slaughtered and the casings were collected.
    (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.
* * * * *
    48. 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

    49. 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.

    50. 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.
* * * * *
    51. 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 8th day of March 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-6151 Filed 3-15-12; 8:45 am]
BILLING CODE 3410-34-P