15848 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 

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. 

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 

http://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 http:// 

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 CreutzfeldtJakob 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 

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Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 15849 

documentation that was prepared for 

this proposed rule. (The supporting 

scientific documentation can be 

accessed at the APHIS Web site at 

http://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 § 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 nativeborn 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 § 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 BSErestricted 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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15850 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 

1On 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. 

2Requiring 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. 

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 minimalrisk 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

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 http://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 minimalrisk 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-toruminant 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. 

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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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. 

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 BSEinfected 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. 

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 BSEfree 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, 

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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-toruminant feed ban in the United 

Kingdom and indicated that experience 

in the United Kingdom demonstrates 

that implementation of a ruminant-toruminant feed ban causes BSE 

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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 antemortem 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 BSEinfected 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 bovinederived 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 minimalrisk 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 

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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 minimalrisk 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 

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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 airinjected 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 bovinederived 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 minimalrisk 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 

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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 

§ 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 bovinederived 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. 

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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. 

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: 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’’, 

http://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, MayJune 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

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. 

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. 

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6BSE 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. 

7The 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). 

8The commenter cites the Harvard Risk 

Assessment of Bovine Spongiform Encephalopathy 

Update, Phase IA, October 31, 2005, at 29 (AR 

17086). 

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). 

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

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. 

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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— 

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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 

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(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 reanalyzed 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 

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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 SRMrelated 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 orderof-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 cattlehuman 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 postmortem 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 

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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 §§ 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’ almostexclusive 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 PrpTSE 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. 

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9The 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: 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 PrPBSE (the abnormal 

form of the prion protein) in various 

tissues. However, demonstrating the 

presence of PrPBSE 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 PrPBSE 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 PrPBSE 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 PrPBSE

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 PrPBSE 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

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 

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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 BSEinfected 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. 

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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 

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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 

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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 minimalrisk 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 standardsetting 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 

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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 

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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 nonambulatory 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 BSEpositive 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 standardsetting 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 sciencebased standards govern international 

trade in animals and animal products. 

The OIE aims to achieve these through 

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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 

http://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 http: 

//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 

http://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 http:// 

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 

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10For example, ruminant-derived MBM and 

greaves, and products containing such, sourced 

from regions of controlled and undetermined risk 

would be prohibited. 

with regard to BSE set forth in APHIS’ 

regulations became: (1) Those in which 

BSE is known to exist (listed in 

§ 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 

§ 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 

§ 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 

§ 94.18(a), those regions listed in 

§ 94.18(a)(1) (regions in which BSE is 

known to exist) and in § 94.18(a)(2) 

(regions that present an undue risk of 

introducing BSE into the United States) 

are subject to the most restrictive BSErelated 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 § 94.18(a)(1) or 

§ 94.18(a)(2). Additionally, with certain 

exceptions, regions listed in either 

§ 94.18(a)(1) or § 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 § 94.18(a)(1) or 

§ 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 ruminantto-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 § 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

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 

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11Although 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. 

12The current regulations regarding BSE 

minimal-risk regions apply to bison as well as 

cattle. In current §§ 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 cattlespecific 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. 

13The current regulations regarding BSE 

minimal-risk regions apply to bison as well as 

cattle. In current §§ 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 cattlespecific evidence discussed in this proposed rule 

Continued 

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 § 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 bovinederived 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

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 

§ 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 BSEinfected brain (Martin, et al., 2007); 

however red deer challenged intragastrically with BSE-infected brain 

developed neither clinical signs of 

disease nor presence of PrPsc at postmortem examination. In addition, 

surveillance in the United Kingdom and 

European cervid population did not 

show any evidence of any TSEs 

(http://www.cdc.gov/Ncidod/eid/ 

vol12no02/pdfs/05–0970.pdf; http:// 

www.defra.gov.uk/animalh/bse/ 

othertses/index.html). 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

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are also applicable to bison. The provisions of this 

proposed rule would apply to bovines as defined 

in the current regulations, which include bison. 

As discussed above, commodities 

from regions not listed in any of the 

categories set forth in § 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 § 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 § 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 

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• 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 § 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 § 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 § 92.7 Article 11.5.22 of the 

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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 

http://www.oie.int/eng/normes/Mcode/

en_sommaire.htm. Additionally, § 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: 

http://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 (http://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 §§ 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. 

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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 crosscontamination 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 

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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 

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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 ruminantderived 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 ruminantderived 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 

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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 § 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; 

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• Measures taken to control crosscontamination 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 OIErecommended 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 § 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 

§ 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 § 94.18(a). 

Under the current regulations, live 

bovines are eligible for importation from 

Canada if the conditions in § 93.436 and 

related sections are met. 

Some of the requirements that are 

included in current § 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 § 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 § 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 

§ 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 

§ 93.436 include specifics as to how 

those general requirements apply to 

Canada. For instance, the regulations in 

current § 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-toruminant 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 §§ 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 

§ 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. 

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14Mechanically 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 § 94.0 of this proposed rule. 

15Additionally, 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. 

16On 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. 

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 BSErelated 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; 

• 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. 

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. 

In §§ 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 

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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 § 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 

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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 

§ 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 § 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 antemortem 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 

§ 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 § 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 antemortem 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 § 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 § 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 antemortem and post-mortem inspections; 

• The bovines from which the 

commodities were derived were not 

subjected to a stunning process with a 

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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, § 95.6 contains 

provisions regarding BSE and the 

importation of offal derived from 

bovines. In § 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 HunterHarvested Bovines 

In the current regulations, § 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 § 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 § 94.22 of this 

proposed rule, we are including 

provisions for the importation of hunterharvested 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 noncaptive 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 

§ 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 

§ 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 

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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 postmortem 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 § 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 § 94.23(c) for gelatin and 

§ 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 

§ 94.23(d) for gelatin and § 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 °C (280.4 °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 

§ 94.23(f) for gelatin and § 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 http:// 

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 

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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 BSErelated 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 § 95.10 

to allow the importation of bovinederived 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 § 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 § 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 § 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 http:// 

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 

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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 antemortem 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 § 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 postmortem inspections and SRMs are 

excluded. Therefore, we are proposing 

in § 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 antemortem 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 § 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 http:// 

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 

§ 95.4 allow the importation of 

derivatives from bovine-derived tallow 

without restriction with regard to BSE. 

Under § 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 bovinederived 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 § 95.1 to 

define tallow derivative as FDA does. In 

§ 95.9, we are proposing to allow the 

importation from any region of tallow 

derivatives that meet our definition in 

§ 95.1. In § 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 bovinederived 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 § 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 

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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 http:// 

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 § 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 BSErelated restrictions in § 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-vivoderived 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 

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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 § 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-StrausslerScheinker) 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 hamsteradapted 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 crosscontamination 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 crosscontamination, 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 crosscontamination 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 § 95.12 to require 

mitigations to decrease the risk of crosscontamination. 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 

§ 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 

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ruminants. To guard against such a 

possibility, the current regulations in 

§ 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 § 94.18(a)) has not 

been commingled with ruminant 

materials that are prohibited entry into 

the United States. The regulations in 

§ 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 § 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 

§ 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 § 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 §§ 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 § 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 

§ 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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/.) 

We are proposing in § 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 § 95.5 to allow the 

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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 

§ 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, §§ 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 § 94.27 and 

§ 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 

§ 94.27 and § 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 § 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 § 95.29 (redesignated as 

§ 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 

§ 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 § 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 § 96.2(b) 

prohibits the importation of casings, 

except stomachs, from ruminants that 

originated in or were processed in any 

region listed in § 94.18(a) for BSE, 

unless specified conditions in 

§ 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 minimalrisk region listed in § 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 § 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 

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17The United States is also classified by the OIE 

as a region of controlled risk for BSE. 

casings derived from sheep from 

Canada. 

We are proposing to amend the 

current § 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 

§ 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 § 94.18 prohibit or restrict the 

importation of most products derived 

from ruminants from regions in which 

BSE exists (listed in current 

§ 94.18(a)(1)) or that pose an undue risk 

of BSE (listed in current § 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 

§ 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 § 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 § 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 §§ 94.24 

through 94.27. The provisions in part 95 

that are particular to ovines and 

caprines are set forth in §§ 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 § 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 § 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 § 96.3 to reflect the 

changes we are proposing to make in 

§ 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

The OIE recommendations regarding 

each of the above countries can be 

viewed at http://www.oie.int/en/animalhealth-in-the-world/official-diseasestatus/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 

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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 § 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 § 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 § 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 § 93.427. Current § 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 APHISproposed 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 

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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, 

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15896 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 

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. 

References 

Andrews, N.J. (2007). Incidence of Variant 

Creutzfeldt-Jakob Disease Deaths in the 

UK, January 1994–December 2006. 

National Creutzfeldt-Jakob Disease 

Surveillance Unit, University of 

Edinburgh. (www.cjd.ed.ac.uk/ 

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Anil, M. H., S. Love, S. Williams, A. Shand, 

J. L. McKinstry, C. R. Helps, A. WatermanPearson, J. Seghatchian, and D. A. Harbour. 

(1999). Potential contamination of beef 

carcasses with brain tissue at slaughter. 

Vet. Rec. 145:460–462. 

Animal and Plant Health Inspection Service 

(APHIS). (2004). Analysis of risk—update 

for the Final Rule: bovine spongiform 

encephalopathy; minimal risk regions and 

importation of commodities, page 15. 

December. (http://www.aphis.usda.gov/ 

newsroom/hot_issues/bse/background) 

Animal and Plant Health Inspection Service 

(APHIS). (2007). Revised assessment of 

Bovine Spongiform Encephalopathy (BSE) 

risks associated with the importation of 

certain commodities from BSE minimal 

risk regions (Canada). (http:// 

www.aphis.usda.gov/newsroom/ 

hot_issues/bse/index.shtml) 

Barlow, R.M. and D.J. Middleton. (1990). 

Dietary transmission of bovine spongiform 

encephalopathy to mice. Vet. Rec. 126: 

111–112. 

Bishop, M., P. Hart, et al. (2006). Predicting 

susceptibility and incubation time of 

human-to-human transmission of vCJD. 

Lancet Neurology 5. pp. 393–398. 

Bosque, P.J., C. Ryou, G. Telling, D. Peretz, 

G. Legname, S.J. DeArmond, and S.B. 

Prusiner. (2002). Prions in skeletal muscle. 

Proc. Natl. Acad. Sci. 99: 3812–3817. 

Bradley, R. (1990). Editorial: Bovine 

Spongiform Encephalopathy: The Need for 

Knowledge, Balance, Patience, and Action. 

J. Pathology. 160: 283–285. 

Bradley, R. (1996). The research programme 

on transmissible spongiform 

encephalopathies in Britain with special 

reference to bovine spongiform 

encephalopathy. Dev. Biol. Scand. 80: 157– 

170. 

Bradley, R. and P. Liberski. (2004). Bovine 

Spongiform Encephalopathy (BSE): The 

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Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 15899 

1A list of regions classified by APHIS as regions 

of controlled risk for BSE is available at [ADDRESS 

TO BE ADDED IN FINAL RULE] 

(http://www.oie.int/eng/info/en_

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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 § 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: 

§ 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) 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-andbone 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 § 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 

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2A list of regions classified by APHIS as regions 

of negligible risk for BSE is available at [ADDRESS 

TO BE ADDED IN FINAL RULE]. 

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: 

(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 § 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 

§ 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, 

§§ 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 

§ 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 

§ 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 

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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. 

§ 92.6 Determination of the date of 

effective enforcement of a ruminant-toruminant 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 crosscontamination 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-toruminant 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. 

§ 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 

http://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: http://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: 

§ 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 

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2See footnote 1. 

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

* * * * * 

§ 93.401 [Amended] 

7. In § 93.401, paragraph (a), the 

second sentence is amended by adding 

the word ‘‘non-bovine’’ before the word 

‘‘ruminant’’ and by removing the 

citation ‘‘§ 94.18(a)(1) or (a)(2)’’ and 

adding the citation ‘‘§ 94.24(a)’’ in its 

place. 

§ 93.405 [Amended] 

8. In § 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 § 93.436(a)(3) and 

(b)(4)’’. 

9. In § 93.418, the section heading is 

revised and a new paragraph (d) is 

added to read as follows: 

§ 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 § 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 

§ 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∧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 

§ 93.405 that states, in addition to the 

statements required by § 93.405, that the 

conditions of paragraph (d)(2) of this 

section, as applicable, have been met. 

10. Section § 93.420 is revised to read 

as follows: 

§ 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 

§ 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 

§ 93.403(b) or as provided for in 

§ 93.403(f) and be inspected at the port 

of entry and otherwise handled in 

accordance with § 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 § 93.405 that states, in addition to 

the statements required by § 93.405, that 

the conditions of paragraphs (b)(1) and 

(b)(2) of this section have been met. 

11. In § 93.423, a new paragraph (e) is 

added to read as follows: 

§ 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 § 93.436. 

* * * * * 

12. In § 93.427, the section heading is 

revised and a new paragraph (e) is 

added to read as follows: 

§ 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 

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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 

§ 93.405 that states, in addition to the 

statements required by § 93.405, that the 

conditions of paragraph (e)(1) through 

(e)(3) of this section have been met. 

13. In § 93.432, the section heading is 

revised and a new paragraph (e) is 

added to read as follows: 

§ 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 § 93.436. 

14. Section § 93.436 is revised to read 

as follows: 

§ 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 § 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 § 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 § 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 fulltime 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 § 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-ANDMOUTH 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 

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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: 

§ 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. 

* * * * * 

§ 94.1 [Amended] 

17. In § 94.1, paragraphs (b)(4) and (d) 

are amended by removing the citation 

‘‘§ 94.22’’ both times it appears and 

adding the citation ‘‘§ 94.28’’ in their 

place. 

§ 94.9 [Amended] 

18. In § 94.9, paragraph (c) is 

amended by removing the citation 

‘‘§ 94.24’’ and adding the citation 

‘‘§ 94.30’’ in its place. 

§ 94.10 [Amended] 

19. In § 94.10, paragraph (c) is 

amended by removing the citation 

‘‘§ 94.24’’ and adding the citation 

‘‘§ 94.30’’ in its place. 

20. Section 94.18 is revised to read as 

follows: 

§ 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 §§ 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: 

§ 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 § 94.18(b)(2)—may be 

imported from a region of negligible risk 

for BSE, as defined in § 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: 

§ 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 § 94.18(b)(2)—may be 

imported from a region of controlled 

risk for BSE, as defined in § 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 § 94.19(a) 

through (c), as applicable, or a region of 

controlled risk for BSE. 

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(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 § 94.21 is added to read as 

follows: 

§ 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 § 94.18(b)(2)—may be 

imported from regions of undetermined 

risk for BSE, as defined in § 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. 

§ 94.27 [Removed] 

24. Section 94.27 is removed. 

§§ 94.22 through 94.26 [Redesignated] 

25. Sections 94.22 through 94.26 are 

redesignated as §§ 94.28 through 94.32, 

respectively. 

26. New §§ 94.22 through 94.27 are 

added to read as follows: 

§ 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. 

§ 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 postmortem 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 °C (280.4 °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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the gelatin and name and address of the 

consignee in the United States. 

§ 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 § 94.25, the 

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importation of meat, meat products, and 

edible products other than meat 

(excluding milk and milk products) 

from ovines and caprines that have been 

in any of the following regions is 

prohibited: Albania, Andorra, Austria, 

Belgium, Bosnia-Herzegovina, Bulgaria, 

Canada, Croatia, the Czech Republic, 

Denmark, the Federal Republic of 

Yugoslavia, Finland, France, Germany, 

Greece, Hungary, the Republic of 

Ireland, Israel, Italy, Japan, 

Liechtenstein, Luxembourg, the Former 

Yugoslav Republic of Macedonia, 

Monaco, Norway, Oman, the 

Netherlands, Poland, Portugal, Romania, 

San Marino, Slovakia, Slovenia, Spain, 

Sweden, Switzerland, and the United 

Kingdom. 

(b) The importation of gelatin derived 

from ovines or caprines that have been 

in any region listed in paragraph (a) of 

this section is prohibited unless the 

following conditions have been met: 

(1) The gelatin is imported for use in 

human food, human pharmaceutical 

products, photography, or some other 

use that will not result in the gelatin 

coming in contact with ruminants in the 

United States. 

(2) The person importing the gelatin 

obtains a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3. To 

apply for a permit, file a permit 

application on VS Form 16–3 (available 

from APHIS, Veterinary Services, 

National Center for Import and Export, 

4700 River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the gelatin and name and address of the 

consignee in the United States. 

§ 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. 

§ 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 § 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 § 94.24(a). 

§ 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 § 94.18 

through § 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 http:// 

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 

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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 §§ 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: 

§ 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: 

§ 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 § 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 § 95.13 or § 95.14; 

(ii) Cervids or camelids; 

(iii) Bovines, and the material is not 

ineligible for importation under the 

conditions of § 95.5, § 95.6, § 95.7, 

§ 95.8, § 95.9, § 95.10, or § 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 crosscontamination 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 

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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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/.) 

(d) Except as provided in paragraph 

(e) of this section and in § 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 § 104.4 of 

this chapter and must be moved and 

handled as specified on the permit. 

(e) The importation of serum albumin, 

serocolostrum, amniotic liquids or 

extracts, and placental liquids derived 

from ovines or caprines that have been 

in any region listed in paragraph (a)(4) 

of this section, and collagen and 

collagen products that are derived from 

ovines or caprines and that would 

otherwise be prohibited under 

paragraphs (a) and (b) of this section, is 

prohibited unless the following 

conditions have been met: 

(1) The article is imported for use as 

an ingredient in cosmetics; 

(2) The person importing the article 

has obtained a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3 

(VS Form 16–3 may be obtained from 

APHIS, Veterinary Services, National 

Center for Import and Export, 4700 

River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/ 

permits/); and 

(3) The permit application states the 

intended use of the article and the name 

and address of the consignee in the 

United States. 

(f) Insulin otherwise prohibited under 

paragraphs (a) and (b) of this section 

may be imported if the insulin is for the 

personal medical use of the person 

importing it and if the person importing 

the shipment has applied for and 

obtained from APHIS a United States 

Veterinary Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http:// 

www.aphis.usda.gov/animal_health/ 

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 § 94.25(d) of this subchapter. 

§§ 95.5 through 95.30 [Redesignated] 

30. Sections 95.5 through 95.30 are 

redesignated as §§ 95.16 through 95.41, 

respectively, 

31. Sections 95.5 through 95.15 are 

added to read as follows: 

§ 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-andbone 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 

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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. 

§ 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 

§ 94.19, § 94.20, or § 94.21, with the 

exception of the requirements in 

§ 94.19(c), § 94.20(b), and § 94.21(b), 

respectively. 

§ 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 postmortem 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 °C (280.4 °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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the collagen and the name and address 

of the consignee in the United States. 

§ 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 antemortem and post-mortem inspections, 

and has not been prepared using SRMs 

as defined for regions of controlled risk 

for BSE in § 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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the tallow and the name and address of 

the consignee in the United States. 

§ 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 § 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 postmortem inspections, and does not 

contain SRMs as defined for regions of 

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controlled risk for BSE in § 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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the tallow derivative and the name and 

address of the consignee in the United 

States. 

§ 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 postmortem inspections, and does not 

contain SRMs as defined for regions of 

controlled risk for BSE in § 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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the dicalcium phosphate and the name 

and address of the consignee in the 

United States. 

§ 95.11 Specified risk materials. 

Notwithstanding any other provisions 

of this part, the importation of specified 

risk materials from controlled-risk 

regions or undetermined-risk regions for 

BSE, and any commodities containing 

such materials, is prohibited, unless the 

Administrator determines that the 

materials or other commodities will not 

come into contact with ruminants in the 

United States and can be imported 

under conditions that will prevent the 

introduction of BSE into the United 

States, and the person importing the 

materials or other commodities has 

obtained a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http:// 

www.aphis.usda.gov/animal_health/ 

permits/). The application for such a 

permit must state the intended use of 

the materials and other commodities 

and the name and address of the 

consignee in the United States. 

§ 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. 

§ 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 § 95.4; 

(b) The processed animal protein 

imported into the United States in 

accordance with this section is 

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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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). 

§ 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 § 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 http:// 

www.aphis.usda.gov/animal_health/ 

permits/). 

§ 95.15 Transit shipment of articles. 

Articles that are otherwise prohibited 

importation into the United States in 

accordance with §§ 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 http:// 

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 §§ 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 

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15912 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 

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. 

§ 95.17 [Amended] 

32. In newly redesignated § 95.17, the 

introductory text is amended by 

removing the citation ‘‘§ 95.5’’ and 

adding the citation ‘‘§ 95.16’’ in its 

place. 

§ 95.18 [Amended] 

33. In newly redesignated § 95.18, the 

introductory text is amended by 

removing the citation ‘‘§ 95.8’’ and 

adding the citation ‘‘§ 95.19’’ in its 

place, and footnote 1 to paragraph (c) is 

amended by removing the citation 

‘‘§ 95.5’’ and adding the citation 

‘‘§ 95.16’’ in its place. 

§ 95.19 [Amended] 

34. In newly redesignated § 95.19, the 

introductory text is amended by 

removing the citation ‘‘§ 95.7’’ and 

adding the citation ‘‘§ 95.18’’ in its 

place. 

§ 95.20 [Amended] 

35. In newly redesignated § 95.20, the 

introductory text is amended by 

removing the citation ‘‘§ 95.10’’ and 

adding the citation ‘‘§ 95.21’’ in its 

place, and footnote 1 to paragraph (c) is 

amended by removing the citation 

‘‘§ 95.5’’ and adding the citation 

‘‘§ 95.16’’ in its place. 

§ 95.21 [Amended] 

36. In newly redesignated § 95.21, the 

introductory text is amended by 

removing the citation ‘‘§ 95.9’’ and 

adding the citation ‘‘§ 95.20’’ in its 

place. 

§ 95.23 [Amended] 

37. In newly redesignated § 95.23, the 

introductory text is amended by 

removing the citation to ‘‘§ 95.11’’ and 

adding the citation ‘‘§ 95.22’’ in its 

place. 

§ 95.25 [Amended] 

38. In newly redesignated § 95.25, the 

introductory text is amended by 

removing the citation ‘‘§ 95.16’’ and 

adding the citation ‘‘§ 95.27’’ in its 

place. 

§ 95.26 [Amended] 

39. Newly redesignated § 95.26 is 

amended by removing the citation 

‘‘§ 95.16’’ and adding the citation 

‘‘§ 95.27’’ in its place. 

§ 95.27 [Amended] 

40. In newly redesignated § 95.27, the 

introductory text is amended by 

removing the citation ‘‘§ 95.15’’ and 

adding the citation ‘‘§ 95.26’’ in its 

place. 

§ 95.29 [Amended] 

41. Newly redesignated § 95.29 is 

amended by removing the citation 

‘‘§ 95.17’’ and adding the citation 

‘‘§ 95.28’’ in its place. 

§ 95.32 [Amended] 

42. Newly redesignated § 95.32 is 

amended by removing the citation 

‘‘§ 95.28’’ and adding the citation 

‘‘§ 95.39’’ in its place, and by removing 

the citation ‘‘§ 95.22’’ and adding the 

citation ‘‘§ 95.33’’ in its place. 

§ 95.33 [Amended] 

43. Newly redesignated § 95.33 is 

amended by removing the citation 

‘‘§ 95.28’’ and adding the citation 

‘‘§ 95.39’’ in its place, and by removing 

the citation ‘‘§ 95.21’’ and adding the 

citation ‘‘§ 95.32’’ in its place. 

§ 95.36 [Amended] 

44. In newly redesignated § 95.36, 

paragraphs (a) and (b) are amended by 

removing the citation ‘‘§ 95.26’’ both 

times it appears and adding the citation 

‘‘§ 95.37’’ in their place. 

45. Newly redesignated § 95.40 is 

revised to read as follows: 

§ 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 § 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 § 95.4(a)(4), with the 

regions listed in § 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 

§ 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 § 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 § 96.2, paragraph (b) is revised 

and paragraph (c) is added to read as 

follows: 

§ 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 

§ 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 § 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 

§ 96.3; and 

(iv) Is presented to an authorized 

inspector at the port of entry. 

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Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Proposed Rules 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 § 92.1 of this 

subchapter, the certificate required 

under § 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 § 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 § 96.3 and paragraphs 

(b)(2)(i) through (b)(3)(iv) of this section. 

* * * * * 

48. In § 96.3, paragraph (d) is revised 

to read as follows: 

§ 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 § 96.2(b) and 

the certificate accompanying bovine 

casings must state that the casings meet 

the requirements of either § 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: 

§ 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 § 98.15, the introductory text of 

paragraph (a) is revised to read as 

follows: 

§ 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 

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