BSE Comprehensive 

Proposed Rulemaking 

Environmental Assessment 

May 2011 

United States 

Department of 

Agriculture 

Marketing and 

Regulatory 

Programs 

Animal and 

Plant Health 

Inspection 

Service 
BSE Comprehensive Proposed 

Rulemaking 

Environmental Assessment 

May 2011 

Agency Contact: 

Dr. Christopher C. Robinson 

Assistant Director, Import Products 

National Center for Import and Export 

Veterinary Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

4700 River Rd. Unit 40 

Riverdale, MD 20737 

 __________________________________________________________ 

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Room 326–W, Whitten Building, 1400 Independence Avenue, SW, Washington, 

DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 
Table of Contents 

 I. Introduction ............................................................................... 1 

 II. Proposed Action and Alternatives ............................................. 3 

A. Alternative: No Action (Maintain the Current 

 APHIS BSE Import Regulations) .......................................... 3 

B. Alternative: Align APHIS BSE Import Regulations 

 with Internationally Accepted BSE Guidelines, with 

 No Modifications ................................................................... 8 

C. Align APHIS BSE Import Regulations with 

 Internationally Accepted BSE Guidelines, 

with Modified Requirements (Preferred Alternative) ........... 10 

D. Other Alternatives Considered but Dismissed from 

 Further Consideration ........................................................ 16 

III. Potential Environmental Impacts ............................................. 17 

 A. Public Health ...................................................................... 17 

 B. Physical Environment ......................................................... 39 

 C. Highly Uncertain or Unique or Unknown Risks ................... 50 

 D. Endangered or Threatened Species .................................. 50 

 E. Cumulative Impacts ............................................................ 52 

IV. Agencies or Persons Contacted ............................................. 58 

 V. References .............................................................................. 59 

Appendix. Additional Information for Chapter 3. .......................... 64 
1 

I. Introduction 

The United States Department of Agriculture (USDA), Animal and Plant 

Health Inspection Service (APHIS) regulates the importation of animals 

and animal products into the United States to guard against the 

introduction of animal diseases not currently present or prevalent in this 

country. APHIS regulations in 9 Code of Federal Regulations (CFR) parts 

92, 93, 94, 95, 96, and 98 prohibit or restrict the importation into the 

United States of specified animals and animal products to prevent the 

introduction of various animal diseases. 

As a Federal Government agency subject to compliance with the National 

Environmental Policy Act of 1969 (NEPA),1 APHIS has prepared this 

environmental assessment (EA) to consider the environmental effects of a 

proposed action—a rulemaking that seeks to adopt a strategy as the means 

of dealing with particular animal health risks—and alternatives to that 

proposed action, consistent with NEPA regulations.2 This EA evaluates 

the potential effects on the quality of the human environment3

 from a 

rulemaking to closely align APHIS import requirements with 

internationally accepted and science-based standards that are designed to 

manage animal health risks associated with the presence of a disease agent 

in bovines. APHIS’ NEPA regulations classify rulemakings that seek to 

remedy specific animal health risks as actions normally requiring 

preparation of EAs.4

 

In accordance with requirements under the APHIS NEPA regulations, this 

document is being made available for public review and comment. 

Written comments are welcome and should be sent to the agency 

contact(s) identified in the notice that announced the availability of this 

document to the public. 

Purpose of and Need for the Proposed Action 

The disease of concern that the proposed action is based upon is bovine 

spongiform encephalopathy (BSE), a progressive neurological disorder of 

cattle that research suggests is caused by a pathogenic form of a normally 

occurring protein known as a prion (Bolton et al., 1982; Prusiner, 1994). 

BSE belongs to a family of diseases known as transmissible spongiform 

encephalopathies (TSEs). The primary host of BSE is cattle. More 

information about the agent that causes BSE and BSE characteristics is 

provided in chapter 3, under the Public Health section of this EA, and in 

 

1

 42 United States Code (U.S.C.) 4321 et seq. 

2

 40 Code of Federal Regulations (CFR) parts 1500–1508; 7 CFR 1b; and 7 CFR part 372. 3

 The “human environment” is interpreted comprehensively to include the natural and physical environment and 

the relationship of people with that environment (40 CFR § 1508.14). 4

 7 CFR § 372.5(b)(1) 
2 

the appendix, Characteristics of the BSE Agent, of the “BSE 

Comprehensive Rule, Supporting Scientific Documentation, August 

2009,” (hereafter referred to as the “APHIS supporting scientific 

documentation”) prepared for the proposed rulemaking (USDA, APHIS, 

2009). 

Through the rulemaking, APHIS is proposing to revise regulatory BSE 

prohibitions and restrictions for importing live bovine and bovine 

products. The purpose of revisions to APHIS’ BSE import regulations is 

to align the agency’s import requirements more closely with the World 

Organization for Animal Health’s (referred to as OIE, the Office 

International des Epizooties5

) recommended guidelines6 (herein referred to 

as the OIE Code) for the trade of live bovine and bovine products between 

countries based on their BSE risk status and where APHIS interpretation 

of scientific literature and existing regulations and policies is in agreement 

with the OIE Code. The changes to APHIS import requirements would be 

aligned more closely with OIE-recommended guidelines for managing 

human and animal health risks associated with the presence of bovine 

spongiform encephalopathy (BSE). APHIS’ proposed BSE import 

requirements would be based on OIE recommendations with the exception 

of some modifications, where necessary, to reflect APHIS’ interpretation 

of the scientific literature and current U.S. policies and regulations. 

The need for aligning APHIS’ BSE import regulations with the OIE Code 

includes updating and streamlining principles as follows: 

 To ensure that APHIS import restrictions and prohibitions, initially 

established in regulations in 1991 with subsequent amendments, 

reflect the most current scientific understanding of BSE risk, based 

on the characteristics of the disease, including transmission and 

risk mitigations necessary to protect animal health, while 

maintaining consistency with U.S. policies for protecting public 

health and animal health from BSE exposure. 

 To allow importation of live bovines and bovine-derived products 

when there is no scientific basis for trade restriction. 

 To remove BSE-related restrictions for the importation of live 

cervids and camelids and products thereof when there is no 

scientific basis for trade restriction. 

 

5

 The World Trade Organization (WTO) recognizes the OIE as the international organization for development 

of standards, guidelines, and recommendations with regard to animal health and zoonoses (diseases that are 

transmissible from animals to humans). 

6

 As of May 2010, Chapter 11.5 of the Terrestrial Animal Health Code; available through the Internet at 

http://www.oie.int/en/international-standard-setting/terrestrial-code/. 
3 

 To align APHIS BSE import trading policy with internationally 

accepted standards, while maintaining APHIS responsiveness, 

authority, and responsibilities for protecting U.S. animal health. 

 To streamline APHIS’ process for recognizing a region’s7 BSE 

risk status in order to improve the efficiency and transparency in 

which APHIS can respond to requests from exporting regions for 

evaluation of their animal disease status, while continuing to 

protect U.S. animals from risk of BSE exposure from any potential 

BSE-infected commodities. 

II. Proposed Action and Alternatives 

APHIS is preparing this environmental document to consider the 

environmental effects of a proposed action and alternatives to that action 

consistent with NEPA procedures and regulations.8

 The proposed action 

being considered is the alignment of APHIS import regulations, as closely 

as possible (with modified requirements), with the OIE Code; this 

alternative is discussed in section C, below, and is the preferred 

alternative. Alternatives to the proposed action considered in this 

environmental assessment are (1) No Action, which would maintain the 

current APHIS BSE import prohibitions and restrictions and (2) alignment 

of APHIS import regulations with OIE BSE risk classifications, with no 

modifications, discussed in sections A and B below. Another alternative 

is briefly described (in section D below) but is dismissed from further 

consideration because it does not meet the full purpose of and need for the 

proposed action. 

A. Alternative: No Action (Maintain the Current 

APHIS BSE Import Regulations) 

The No Action alternative would maintain restrictions and prohibitions 

under the current APHIS BSE import regulations (9 CFR parts 93-96) for 

live ruminants and ruminant products from regions where BSE exists or 

that present an undue risk of introducing BSE into the United States. 

Under APHIS BSE import regulations (9 CFR section (§) 94.18(a)), the 

three risk definitions (hereafter referred to as “categories”) for regions 

where BSE has been found are as follows: 

 

7 APHIS regulations define a region as “any defined geographic land area identifiable by geological, political, 

or surveyed boundaries. A region may consist of “(1) a national entity (country), (2) part of a national entity, 

(3) parts of several national entities combined into an area, or (4) a group of national entities (countries) 

combined into a single area (9 CFR § 94.0, Definitions).

8

 40 CFR parts 1500–1508, 7 CFR part 1b, and 7 CFR part 372.
4 

§ 94.18(a)(1) regions in which BSE is known to exist, 

§ 94.18(a)(2) regions 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, and 

§ 94.18(a)(3) regions that present a minimal risk of introducing BSE into 

the United States via live ruminants and ruminant products 

and byproducts (includes live bovines and bovine-derived 

products). 

Because of BSE concerns in the past that were based on the more limited 

scientific understanding of the BSE disease at the time, the APHIS 

regulations (9 CFR §§ 94.18(a)(1), (2), and (3)) prohibit or restrict the 

importation of meat, meat products, edible products other than meat, and 

live bovines from many regions currently categorized by the OIE for BSE. 

Edible products that are exceptions to this requirement include (1) gelatin, 

as long as it is not derived from bovines that have been in any regions 

listed in 9 CFR § 94.18(a) or unless conditions listed in 9 CFR §§ 

94.18(c)(1),9

 (2),10 and (3)11 or conditions in 9 CFR § 94.19(f)12 have been 

met and (2) milk or milk products. Gelatin as defined above and milk or 

milk products are recognized as safe for trade, as are semen and hides and 

skins, regardless of the BSE status of the exporting region. Currently, 

imports of bovine embryos are not prohibited, but they are restricted under 

APHIS’ regulations regarding rinderpest and foot-and-mouth disease 

(FMD). Imports of bovine embryos from regions where FMD or 

rinderpest exists are allowed only if certain conditions are met, including 

BSE-related conditions. 

Current APHIS regulations prohibit or restrict the importation of certain 

products from regions listed in 9 CFR §§ 94.18(a)(1) and (a)(2). These 

materials include processed animal protein, derivatives of processed 

animal proteins; tankage; offal; processed fats and oils, certain tallow 

(other than tallow derivatives), unless the Administrator determines that 

the tallow cannot be used in feed, regardless of the animal species from 

which the material was derived. In addition glands and unprocessed fat 

tissue derived from ruminants;, and derivatives of glands from ruminants 

are prohibited. Also, any of these materials are prohibited from a facility 

 

9

 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. 10 The importer of the gelatin 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 and the 

application must state the intended use of the gelatin and the name and address of the consignee in the United 

States. 

11 The permit application must state the intended use of the gelatin and name and address of the consignee in 

the United States. 

12 Other than gelatin allowed importation under 9 CFR § 94.18(c), the gelatin is from a minimal risk region and 

is derived from the bones of bovines subject to a ruminant feed ban equivalent to FSIS requirements in 21 CFR 

§ 589.2000. 
5 

that processes and stores materials from ruminants that have been in any 

region listed in 9 CFR §§ 94.18(a)(1) and (a)(2). These require-ments are 

stated in 9 CFR §§ 95.4(a)(1)(i)-(iv) and §§ 95.4(a)(2)(i)-(iv). 

The importation of hide-derived gelatin is allowed from a region listed in 

9 CFR § 94.18(a)(3) provided that the gelatin has not been commingled 

with materials ineligible for entry into the United States. Bone-derived 

gelatin from bovines is allowed importation from a region listed in 9 CFR 

§ 94.18(a)(3) provided that the bovines from which it is derived are 

subject to a ruminant feed ban (in accordance with 21 CFR 

§ 589.2000) and SRMs were removed and the gelatin has not been 

commingled with materials ineligible for entry into the United States. 

These requirements are stated in 9 CFR §§ 94.19(f)(1)-(2). In addition 

gelatin derived from ruimants that have been in any region listed in 

94.18(a) may be 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. 

Importation of bovine-derived offal is prohibited from regions listed in 

9 CFR §§ 94.18(a)(1) and (a)(2) and is allowed for importation from 

regions listed in 9 CFR § 94.18(a)(3) as long as it contains no SRMs and is 

derived from bovines from which the SRMs were removed, the bovines 

were not subjected to an air-injected stunning process at slaughter, and the 

bovines are subject to a ruminant feed ban equivalent to requirements 

established by U.S. Health and Human Services’ Food and Drug 

Administration (FDA) (21 CFR § 589.2000). These requirements are 

stated in 9 CFR §§ 95.4(h)(1)-(4). 

Importation of serum albumin, serocolostrum, amniotic liquids or extracts, 

and placental liquids derived from bovines in any region listed in 9 CFR 

§§ 94.18(a)(1)-(3) and collagen and collagen products that meet any 

conditions listed in 9 CFR § 95.4(a)(1)-(3) is prohibited unless the 

following conditions are met: (1) the article is for use as an ingredient in 

cosmetics, (2) the person importing has obtained an import permit from 

APHIS, and (3) the permit application states the intended use of the article 

and name and address of the consignee in the United States. These 

requirements are stated in 9 CFR § 95.4(d)(1)-(3). 

Importation of insulin from bovines that is otherwise prohibited in 9 CFR 

§ 95.4(a) is allowed if it is for the personal medical use of the person 

importing the shipment and the person has applied for and obtained an 

import permit from APHIS, and provided that it is not prohibited under 

FDA regulations. These requirements are stated in 9 CFR § 95.4(f). 

The importation of tallow is allowed if it is derived from bovines that have 

not been in a region listed in 9 CFR §§ 94.18(a)(1) and (a)(2), it is 
6 

composed of less than 0.15 percent insoluble impurities, and it was not 

exposed to or commingled with any other animal origin material. Also, 

the tallow shipment must be accompanied by a certificate stating that these 

requirements have been met and the certificate must be signed by the 

appropriate officials. The shipment must arrive at a port listed in 9 CFR 

§ 94.19(g). These requirements are stated in 9 CFR § 95.4(g). 

Importation of bovine hides and skins is allowed according to restrictions 

unrelated to BSE, as stated in 9 CFR §§ 95.5 and 95.6. Importation of 

bovine-derived casings (except stomachs) that originated in or were 

processed in any region listed in 9 CFR §§ 94.18(a)(1) and (a)(2) is 

prohibited (9 CFR § 96.2). 

Table 1 provides the list of regions that meet one of the three APHIS BSE 

risk categories, in current APHIS regulations, where the importation of 

live bovines and bovine-derived products are either prohibited or 

restricted. 

Table 1. Regions in BSE Risk Categories Under Current APHIS Regulations 

Regions Where 

BSE Exists 

(9 CFR § 94.18(a)(1)) 

Regions That Present An 

Undue Risk of 

Introducing BSE into the 

United States 

(9 CFR § 94.18(a)(2)) 

Regions That Present 

A Minimal Risk of 

Introducing BSE into 

the United States 

(9 CFR § 94.18(a)(3)) 

Austria 

Belgium 

Czech Republic 

Denmark 

Finland 

France 

Germany 

Greece 

Republic of Ireland 

Israel 

Italy 

Japan 

Liechtenstein 

Luxembourg 

Oman 

The Netherlands 

Poland 

Portugal 

Slovakia 

Slovenia 

Spain 

Switzerland 

United Kingdom* 

Albania 

Andorra 

Bosnia-Herzegovina 

Bulgaria 

Croatia 

Federal Republic of 

Yugoslavia 

Hungary 

Former Yugoslav Republic of 

Macedonia 

Monaco 

Norway 

Romania 

San Marino 

Sweden 

Canada 

* Includes Great Britain (England, Scotland, Wales, Isle of Man), Northern Ireland, and the 

Falklands. 

For regions that meet the category “where BSE exists,” importation of live 

bovines and bovine-derived products is not allowed. The only exception to 

the APHIS regulatory restrictions on these regions is the allowance of the 
7 

importation of whole cuts of boneless beef from Japan according to certain 

conditions,13 based on a prior APHIS risk evaluation and rulemaking 

process. No bovine-derived products are currently allowed from regions 

listed in 9 CFR 94.18 (a)(1) and (a)(2) except according to regulations. 

Currently, 9 CFR 94.18(a)(3) recognizes regions for being minimal risk 

for BSE. The only region listed as presenting a “minimal risk of 

introducing BSE into the United States” is Canada. Under current APHIS 

BSE import regulations, the United States allows the importation of live 

bovines and bovine-derived products from Canada according to certain 

conditions14 that must be met for each of the following commodities: 

 Live bovines born on or after March 1, 1999. 

 Bovine casings (defined as stomachs; esophagi; urinary bladders; 

and small intestine, other than the distal ileum, that are used to 

encase processed meats in foods such as sausage). 

 Bovine blood and blood products. 

 Fresh/chilled or frozen beef from bovines. 

 Bovine meat, meat food, and meat byproducts. 

 Bovine offal. 

 Gelatin, both bone-derived and hide-derived. 

 Tallow that is composed of a maximum level of insoluble 

impurities of 0.15 percent in weight. 

Regions currently prohibited under APHIS’ BSE import regulations from 

exporting live bovines and bovine-derived products and that want to 

export these commodities under the current APHIS BSE import 

regulations can request APHIS’ recognition as a minimal-risk region. 

However, meeting the minimal risk region requirements is overly 

restrictive for a region that otherwise could export live bovines and 

bovine-derived products according to the internationally accepted OIE risk 

classifications that are based on the more current understanding about BSE 

transmission and safeguards preventing risk of BSE exposure. Few 

regions would be able to meet APHIS’ restrictive minimal-risk definition. 

Based upon the current APHIS BSE import regulations, undertaking 

necessary risk assessments to allow the importation of live bovines or 

bovine-derived products is a laborious and lengthy task and would result 

in regions meeting requirements that are more restrictive than 

requirements in place under the OIE Code, which is based on current 

science and understanding of the risk of BSE transmission. 

 

13 9 CFR § 94.27. Conditions include that the beef is derived from cattle that were born, raised, and slaughtered 

in Japan and is prepared in an establishment that is eligible to have its products imported to the United States 

under 21 U.S.C. 601 et seq. and 9 CFR § 327.2; the SRMs are removed; and air-injection stunning devices were 

not used on cattle from which the beef is derived prior to slaughter. 

14 Conditions are provided in 9 CFR § 94.19. 
8 

The importation of live bovines or bovine-derived products from regions 

that are not listed in the three BSE risk categories discussed above is 

unrestricted with regard to BSE; however, importation of these 

commodities from some regions may be restricted or prohibited because of 

other animal diseases. Mexico, Australia, and New Zealand are major 

exporters of either live cattle or bovine-derived products to the United 

States. These three regions and any other region that is not listed in any of 

the three BSE risk categories under APHIS import regulations (in 9 CFR 

§§ 94.18(a)(1), (2), or (3)) can export live bovines or bovine-derived 

products to the United States without BSE-related restrictions. 

BSE Restrictions on Cervids and Camelids 

Under the current APHIS BSE import regulations, the importation of live 

cervids15 and camelids16 (also classified as ruminants, as are bovine 

species) and certain products thereof17 from regions listed under 9 CFR §§ 

94.18(a)(1) and (2) are prohibited. Live cervids and camelids and 

products thereof are allowed importation with no BSE-related restrictions 

from a region listed in 9 CFR § 94.18(a)(3) (as provided in 9 CFR §§ 

93.408(e) and (f)). 

B. Alternative: Align APHIS BSE Import Regulations 

 with Internationally Accepted BSE Guidelines, with 

 No Modifications 

This alternative would replace the current BSE import requirements with 

regulations that would be entirely consistent with World Organization for 

Animal Health (referred to as OIE) guidelines for BSE, established in the 

2010 OIE Terrestrial Animal Health Code in Chapter 11.5. OIE BSE 

guidelines are developed by BSE experts based on current scientific 

understanding of the BSE agent, epidemiology, infectivity distribution, 

and mitigations preventing BSE exposure. OIE recommends a region’s 

risk status on the basis of a risk assessment and other evaluation criteria 

described in the Code. Provisions in the OIE Code include science-based 

conditions (requirements) for importation of live cattle and cattle-derived 

products according to the BSE risk category of the exporting region. 

Currently, a few minor differences exist between OIE requirements and 

U.S. requirements, including the definition of specified risk materials 

(SRMs) (the animal tissues that contain detectable levels of the BSE agent, 

discussed further later in this document) and the age at which these SRMs 

must be removed from cattle at slaughter. In aligning completely with the 

OIE requirements, APHIS would not be consistent with U.S. 

 

15.Species of the family Cervidae, such as deer, reindeer, moose, and elk. 16 Species of the family Camelidae, such as camels, llamas, alpacas, and vicunas. 17 With the exception of camel hair and deer skins, which have no BSE-related restriction. 
9 

interpretations of the science and policies supporting the science where the 

U.S. currently differs. 

Under this alternative, APHIS would completely embrace BSE risk 

classifications for regions that would be identical to those established by 

the OIE Code as negligible BSE risk and controlled-BSE risk Countries 

that have not been recognized by the OIE will default as undetermined 

BSE risk. APHIS would also adopt the OIE criteria under each of these 

risk classifications. 

This alternative would allow the importation of live bovines and bovinederived products18 to the United States from regions according to certain 

requirements defined by BSE risk classification in the OIE Code. Under 

this alternative, APHIS would accept OIE’s classification of a region’s 

BSE risk status with no further evaluation or modifications. This would 

eliminate the need for APHIS to conduct its own risk assessment and 

evaluation for each region and publish proposed and final rules for each 

determination of a region’s risk classification. APHIS would not conduct 

an independent evaluation of a region’s feed ban to determine a date of 

effective enforcement for the purposes of exporting live cattle. The 

exporting region would determine the effective date of its ruminant-toruminant feed ban, and APHIS would accept the exporting region’s 

certification that the exported cattle were born after the date of the 

region’s feed ban date without further verification of the date.19

APHIS would concur with the OIE’s list of regions recognized as 

negligible BSE risk or controlled BSE risk. (A summary of OIE’s 

procedure for recognition of a region’s disease status can be found through 

the Internet at OIE’s Web site found at http://www.oie.int/animal-healthin-the-world/official-disease-status/official-recognition-policy-andprocedures/.) 

Dismissing as a Reasonable Alternative 

This alternative would serve the purpose for aligning APHIS BSE import 

regulations with guidelines based upon the most current science on BSE 

and meet the need to enhance the efficiency with which APHIS could 

recognize a region’s BSE risk status. However, this alternative would 

require a change in policy differences between U.S. regulations for animal 

health and public health and provisions in the OIE Code. In carrying out 

its mission to protect animal health, APHIS works in concert with other 

U.S. Federal agencies, such as the FDA and the USDA’s Food Safety and 

Inspection Service (FSIS) that have direct authority over public health 

 

18 APHIS regulations currently include bison and cattle (both classified as bovine animals) and would continue 

to do so under revised APHIS regulations. 

19 OIE’s evaluation does not include a determination of the date of a region’s effectively enforced feed ban. 
10 

issues when agency missions are interrelated. APHIS supports the U.S. 

BSE policy requirements of other agencies; therefore, changing U.S. BSE 

import requirements to be exactly the same as the provisions for BSE in 

the OIE Code would not be a reasonable alternative to completely address 

the need for the proposed action, as described in chapter 1 of this 

document. Although the United States is a voting member with the OIE 

and participates in the OIE’s process of acceptance and official 

recognition of a region’s BSE risk classification status, this alternative 

also would not allow APHIS the opportunity to be transparent in its 

acceptance of a region’s risk classification in that it would not afford an 

opportunity for the public to comment on APHIS’ consideration of 

region’s risk classification. APHIS also would be giving up its 

independent authority to conduct any evaluation of a region that does not 

have an OIE classification and that would want to export live bovines or 

bovine-derived products to the United States. This alternative would not 

allow APHIS to make decisions under its authority for safeguarding U.S. 

animal health or respond in an efficient manner to trade requests from 

regions that do not have an OIE classification. 

C. Align APHIS BSE Import Regulations with 

Internationally Accepted BSE Guidelines, with 

Modified Requirements (Preferred Alternative) 

Under this alternative, APHIS would amend its current BSE import 

regulations to make the regulations consistent with BSE risk 

classifications established in the OIE Code: negligible BSE risk, 

controlled BSE risk, and undetermined BSE risk, and align APHIS’ import 

requirements, as closely as possible, with the 2010 (Chapter 11.5) OIE 

guidelines in the OIE Terrestrial Animal Health Code. In doing so, 

APHIS would (1) adopt the categories and criteria for classification of the 

BSE risk status of exporting regions, and (2) use this status to determine 

import policies as defined in the OIE’s Code Chapter on BSE. If the OIE 

has classified a country as either negligible BSE risk or controlled BSE 

risk, APHIS would seek information to support concurrence with the OIE 

classification. If the information is not publicly available, APHIS could 

request that a country supply the same information given to the OIE. 

APHIS would announce its intent in the Federal Register, subject to public 

comment, to consider the country to have the same BSE risk classification 

as that determined by the OIE. 

In proposing to align with the OIE BSE risk classifications of regions, we 

note that APHIS’ current risk assessment criteria are identical to the OIE’s 

risk assessment requirements for determining a region’s BSE risk 

classification. Provisions in the OIE Code include current science-based 

conditions (requirements) for the importation of live cattle and cattlederived products according to each level of BSE risk classification. The 
11 

OIE Code establishes provisions for the BSE risk status of the cattle 

population in a country, zone, or compartment (herein referred to as 

“region”). As described in OIE Code’s BSE Chapter 11.5, OIE requires 

information from an exporting region to support a risk assessment. OIE 

uses the information to complete (1) a release assessment, which evaluates 

the possibility of introducing BSE into the exporting region through live 

animals, animal products, or meat and bone meal, and (2) an exposure 

assessment, which considers the likelihood that cattle within the exporting 

region could have been exposed to the BSE agent. Article 11.5.2 also 

describes additional information necessary to determine the risk status of a 

region, including the epidemiological BSE situation in the region, the 

presence of an awareness program and notification requirements for BSE, 

and adequacy of surveillance for BSE. OIE recommends a region’s risk 

status on the basis of a risk assessment and other evaluation criteria 

described in the OIE Code. The risk status classification for an exporting 

region would be based on a BSE region risk evaluation conducted either 

by the OIE or, when a region does not have an OIE risk classification, by 

APHIS. 

In aligning with the OIE Code, APHIS is proposing some modifications, 

where necessary, to reflect APHIS’ interpretation of the scientific 

literature and current USDA (FSIS) regulations. Modifications between 

requirements in the OIE Code (discussed in the Scientific Supporting 

Documentation related to the rulemaking) and proposed APHIS BSE 

requirements, described in further detail in the rulemaking text that this 

EA supports, are based upon APHIS’ interpretation of scientific literature 

and current USDA regulations and policies. 

An alignment of APHIS’ regulations with the OIE Code could result in a 

resumption or initiation of importation of live bovines20 or bovine-derived 

product from regions currently restricted or prohibited by the regulations. 

The following table (table 2) shows regions that are currently restricted or 

prohibited from exporting these commodities to the United States and their 

current OIE BSE risk classification (see chapter 11.5 for description of 

BSE risk classifications). A region that has not received an OIE 

classification defaults to the OIE risk status of undetermined BSE risk 

(table 2 is not a complete list of regions with OIE risk classifications; 

OIE’s BSE risk status recognition of countries can be found at 

http://www.oie.int/en/animal-health-in-the-world/official-diseasestatus/bse/list-of-bse-risk-status/). 

 

20 For purposes of this document, bovines include cattle and bison. The rulemaking related to this EA 

addresses the importation of live bovines. Compared to the amount of bovines produced in the United States, a 

small amount of bovines are imported to the United States, and most of them are cattle; thus, when this 

document refers to the term “bovines,” it mostly pertains to cattle. 
12 

Table 2. Regions with U.S. BSE Risk Categories and Their OIE BSE Risk 

Classification 

U.S. BSE Risk Category and Region 

OIE’s BSE Risk Status 

Recognition 

(as of May 2011) 

Regions where BSE is considered to exist

according to APHIS’ current regulations 

(9 CFR 94.18(a)(1):

Austria 

Controlled 

Belgium Controlled 

Czech Republic Controlled 

Denmark Negligible 

Finland Negligible 

France Controlled 

Germany Controlled 

Greece Controlled 

Ireland Controlled 

Israel ** 

Italy Controlled 

Japan Controlled 

Liechtenstein Controlled 

Luxembourg Controlled 

Oman ** 

The Netherlands Controlled 

Poland Controlled 

Portugal Controlled 

Slovak Republic Controlled 

Slovenia Controlled 

Spain Controlled 

Switzerland Controlled 

United Kingdom Controlled 

Regions that present an undue BSE risk

according to APHIS’ current regulations 

(9 CFR 94.18(a)(2): 

Albania ** 

Andorra ** 

Bosnia-Herzegovina ** 

Bulgaria ** 

Croatia ** 

Federal Republic of Yugoslavia ** 

Hungary Controlled 

Former Yugoslav Republic of Macedonia ** 

Monaco ** 

Norway Negligible 

Romania ** 

San Marino ** 

Sweden Negligible 

BSE Minimal-risk regions according to 

APHIS’ current regulations 

(9 CFR 94.18(a)(3): 

Canada Controlled 

** Until a region receives approval of an OIE classification of negligible BSE risk or 

controlled BSE risk, the region defaults to the OIE risk status of undetermined BSE risk. 
13 

Live bovines and bovine-derived products21 would be allowed importation 

into the United States from regions according to certain requirements 

defined for each of the three BSE risk classifications in the OIE Code. As 

addressed in the APHIS supporting scientific documentation, the OIE 

recommends that several cattle-derived commodities can be traded 

regardless of the BSE status of the cattle population in the region of origin. 

These commodities are not risk factors for BSE. Current APHIS 

regulations do not prohibit the importation of milk and milk products, 

semen and in vivo derived embryos, or hides and skin; however, these 

commodities are included on the list for the purposes of completeness with 

the list contained in the 2010 OIE Code. 

List of Commodities Proposed for Importation Without Restriction 

APHIS is proposing that the following bovine-derived commodities be 

allowed for importation without restriction regardless of the exporting 

region’s BSE risk classification: 

 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 derivatives made from this tallow; 

 Dicalcium phosphate with no trace of protein or fat; 

 Deboned skeletal muscle meat (excluding mechanically separated 

meat),22 from bovines, as long as the animals from which the meat 

is derived passed ante- and post-mortem inspection, SRMs were 

removed, the animals were not subjected, prior to slaughter, to a 

stunning process with a device injecting compressed air or gas into 

the cranial cavity or to a pithing process, and which has been 

prepared in a manner to avoid contamination with SRMs; and 

 Blood and blood by-products from animals that were not subjected, 

prior to slaughter, to a stunning process with a device injecting 

compressed air or gas into the cranial cavity or to a pithing 

process, and passed ante-mortem inspection; and that has been 

prepared in a manner to avoid contamination with SRMs.

Also addressed in the APHIS supporting scientific documentation (USDA, 

APHIS, 2009), the OIE recommends different conditions or risk 

mitigations for trade in designated commodities from regions based on the 

three OIE BSE risk classifications previously mentioned. In aligning with 

 

21 APHIS regulations currently include bison and cattle (both classified as bovine animals) and would continue 

to do so under revised APHIS regulations. 

22 Mechanically separated (MS) beef is prohibited from being produced for human food according to FSIS 

regulations (9 CFR § 318.24). Meat produced using advanced meat recovery (AMR) systems is defined as meat 

and does not include MS beef. 
14 

the OIE Code, APHIS is proposing that the commodities allowed for 

importation with restrictions be based on OIE recommendations. APHIS 

proposes to impose risk mitigations or other restrictions on certain 

commodities according to the BSE risk status of the exporting region. 

 

List of Commodities Proposed for Importation With Restriction 

The commodities recommended for restricted trade are as follows: 

 Live bovines from regions of negligible BSE risk or controlled 

BSE risk; 

 Meat (other than deboned skeletal muscle meat from bovine 

animals that meets certain conditions described above), meat 

products, and meat byproducts; 

 Gelatin and collagen prepared from bones, intended for food, 

animal feed, fertilizers, veterinary biologics, or as unprocessed 

material for the preparation of cosmetics, drugs (including 

pharmaceuticals and natural health products) or medical devices; 

 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) intended for food, animal food, fertilizers, cosmetics, 

pharmaceuticals including biologics, or medical devices; and 

 Processed animal protein. 

 If the OIE has classified a country as either negligible BSE risk or 

controlled BSE risk, APHIS would seek information to support 

concurrence with the OIE classification or request the information, 

including the same information given to the OIE, if it is not publicly 

available. APHIS would announce its intent in the Federal Register, 

subject to public comment, to consider the country to have the same BSE 

risk classification as that determined by the OIE. APHIS also would make 

available the summary of the BSE OIE ad hoc group conclusions for 

review during the comment period. After the review of comments 

received, the Administrator would announce in the Federal Register the 

final determination regarding the country’s classification, along with a 

discussion of and response to pertinent issues raised by commenters. 

When recognizing a country as either negligible risk or controlled risk for 

BSE, APHIS would include that country in a list of regions of negligible 

risk or controlled risk for BSE, as applicable. APHIS would make that list 

available to the public on the agency’s Web site. 

If a region does not have an OIE risk classification and requests APHIS’ 

evaluation of its risk status in order to export certain commodities 

according to the requirements in APHIS’ proposed regulations, APHIS 

would prepare an evaluation and make it available to the public for 
15 

comment prior to finalizing a determination of the region’s BSE risk 

classification. Classification by APHIS as either negligible BSE risk or 

controlled BSE risk would be for a 1-year period. The risk classification 

criteria and process are further described in the relevant rulemaking 

docket. Similar to OIE requirements for countries classified as either 

negligible BSE risk or controlled BSE risk by the OIE, regions evaluated 

by APHIS and classified as negligible BSE risk or controlled BSE risk 

would need to submit updated information to APHIS each year. If APHIS 

at any time determines that a region no longer meets the criteria for the 

risk classification it had previously received, APHIS would amend its BSE 

risk status list of regions accordingly. 

Although the OIE Code requires a region that requests to export live 

animals to have an effective feed ban, the OIE does not determine the date 

the feed ban was effectively enforced. In being transparent on a region’s 

date of effective feed ban enforcement, as an additional requirement, 

APHIS would require supporting documentation from negligible countries 

that reported indigenous cases and controlled risk countries and would 

conduct an independent evaluation to verify the region’s date of effective 

enforcement of a ruminant-to-ruminant feed ban. Based upon review of 

the documentation, APHIS would determine the date of the region’s 

effectively enforced ruminant-to-ruminant feed ban.23 APHIS would 

make the determination of the date of the effective feed ban and 

supporting documentation available to the public for review and comment. 

 

23 As APHIS has determined this date under its current regulatory process for Canada as a minimal risk region, 

the date of Canada’s effectively enforced feed ban would remain the same under the proposed rulemaking when 

implemented. 
16 

As of May 2011, regions that have an OIE BSE risk classification 

(adopted by the OIE International Committee) are as follows:24 

Complete List of Regions with OIE BSE Risk Status Classification, 

May 2011 

Negligible BSE Risk Controlled BSE Risk

Argentina

Australia 

Chile 

Denmark 

Finland 

Iceland 

India 

New Zealand 

Norway 

Panama 

Paraguay 

Peru 

Singapore 

Sweden 

Uruguay

Austria 

Belgium 

Brazil 

Canada 

Chinese Taipei 

Colombia 

Cyprus 

Czech Republic 

Estonia 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy 

Japan 

Korea (Rep. Of) 

Latvia 

Liechtenstein 

Lithuania 

Luxembourg 

Malta 

Mexico 

The Netherlands 

Poland 

Portugal 

Slovak Republic 

Slovenia 

Spain 

Switzerland 

United Kingdom 

United States of America

Changes to BSE Restrictions with Regard to Cervids and 

Camelids 

Under this alternative (to align APHIS import regulations more closely 

with OIE requirements), the importation of live cervids and camelids and 

products thereof would be allowed from regions of any BSE risk 

classification without BSE-related restrictions. 

D. Other Alternatives Considered but Dismissed from 

Further Consideration 

An alternative considered in the past was to amend the current APHIS 

regulations to modify an existing BSE risk category. This alternative 

would allow regions in the existing BSE risk categories under 9 CFR 

§§ 94.18(a)(1) and (2) to import low-risk beef and meat food according to 

OIE-recommended criteria in the OIE Code. Although this alternative 

would have been less restrictive than the current regulations, this 

alternative still would be more restrictive than the OIE Code in that it 

would continue to restrict other potentially allowable commodities from 

some regions; the changes to the current regulation would not be allinclusive in allowing the importation of live bovines and other bovinederived products from regions according to conditions based on the 

current science known about BSE. This alternative does not meet the 

 

24 Information available on the Internet at http://www.oie.int/en/animal-health-in-the-world/official-diseasestatus/bse/list-of-bse-risk-status/. 
17 

purpose and need for amending APHIS’ BSE import regulations as 

discussed earlier in this document. 

III. Potential Environmental Impacts

The NEPA implementing regulations provide criteria that Federal agencies 

should evaluate, if applicable, in environmental documents for proposed 

actions. This section of the EA addresses the applicable criteria related to 

potential impacts from the No Action alternative and the proposed action. 

NEPA criteria that are applicable for consideration in this section of the 

document include potential effects on public health, the physical 

environment, and federally listed endangered or threatened species, highly 

uncertain or unique or unknown risks on the human environment, and 

cumulative impacts. 

When applicable to a Federal agency’s proposed action, public health is 

among numerous considerations that an agency must address when 

carrying out its responsibilities under NEPA. APHIS’ mission, in part, is 

to protect the health of U.S. agriculture, but often its mission requires 

cooperation with other agencies that have authority over related matters, 

such as public health, because those matters fall under the authority of 

other Federal agencies. As the risk of BSE exposure could impact public 

health, APHIS cooperates with other Federal agencies; FSIS and FDA 

have authority over BSE-related public health matters. APHIS has 

communicated with these agencies and the U.S. Department of Health and 

Human Services’ Centers for Disease Control (CDC) about the 

development of the proposed rulemaking for which this environmental 

assessment has been prepared. 

A. Public Health 

BSE is a progressive neurological disease of cattle. BSE belongs to a 

family of diseases known as transmissible spongiform encephalopathies 

(TSE). Research suggests that BSE is caused by an abnormal form of a 

normally occurring type of protein known as a prion (Bolton et al., 1982; 

Prusiner, 1994). The CDC defines a prion as “an abnormal, transmissible 

agent that is able to induce abnormal folding of normal cellular prion 

proteins in the brain, leading to brain damage and the characteristic signs 

and symptoms of the disease” (CDC, 2006). The abnormal BSE prion 

protein is less soluble and more resistant to degradation than a normal 

prion protein. The abnormal prion protein is also extremely resistant to 

heat and to normal sterilization processes, making it difficult to inactivate 

with standard methods used to process human food and animal feed. 

Further, the BSE infectious agent does not evoke any apparent immune 

response or inflammatory reaction. 
18 

The public health concern associated with changing current regulations 

regarding importation of live bovines and bovine-derived products is the 

potential for human exposure to BSE-infected materials. Exposure to the 

BSE infective agent has the potential to cause development of variant 

Creutzfeldt-Jakob disease in humans (vCJD), a rare, degenerative, fatal 

brain disorder in humans. It is believed that the persons who have 

developed vCJD most likely became infected through their consumption 

of cattle products contaminated with the agent of BSE (CDC, 2010). Such 

human exposure could occur through the consumption of bovine-derived 

products such as meat or meat products contaminated with BSE-infected 

tissues. Various studies suggest that the infectious agent may be 10 to 

10,000 times less pathogenic in humans than in cattle (EC SSC, 2000). To 

put infectivity differences between humans and cattle in perspective, 

during the BSE epidemic in the United Kingdom (UK), an estimated 

1 million animals were infected. Worldwide, as of March 2011, data 

shows a total of 221 definite and probable cases of vCJD (National 

Creutzfeldt-Jakob Disease Surveillance Unit, 2011). Of these, 172 cases 

have been reported by the UK and the remainder reported by other 

countries. In some cases reported to have occurred outside the UK, the 

actual exposure to the BSE agent was likely to have occurred in the UK. 

Human exposure to the BSE agent or BSE infectivity probably happened 

before mitigation measures, such as specified risk material (SRM) 

removal, were in place to prevent such exposures. The wide variation in 

these numbers—more than 1 million infected animals with high infectivity 

present prior to the introduction of control measures, and 221 vCJD 

cases—demonstrates the significant species barrier for BSE transmission 

between cattle and humans. 

The animal health concern associated with changing current regulations is 

related to human health concerns, so it is included in this section. As is 

the case with humans, the major animal health concern that would exist if 

regulations are changed and live bovines and bovine-derived products are 

allowed into the United States is potential exposure to the BSE infective 

agent. One mechanism for BSE infection in cattle was identified as 

consumption of feed contaminated with the BSE infective agent. To 

prevent transmission of BSE by this route, many countries including the 

United States implemented ruminant feed bans. These feed bans prohibit 

the feeding of ruminant proteins to ruminants (including ruminant-toruminant feeds).25 

For the purpose of this environmental assessment, the main concern 

regarding potential BSE exposure is how the human and/or animal 

environment in the United States, including public health and associated 

animal health as it relates to public health, could potentially be affected by 

 

25 The U.S. feed ban final rule, enforced by FDA, became effective on August 4, 1997. The regulations are 

found in 21 CFR § 589.2000. 
19 

changing current restrictions on importation of bovines or bovine-derived 

materials by aligning more closely with OIE recommendations. 

Background: Live Bovines 

Mitigation measures are currently in place in the United States through 

several Federal agencies’ regulations to protect both human and animal 

health from potential transmission and exposure to the BSE infective 

agent. APHIS BSE import regulations are designed to protect animal 

health from potential transmission and exposure to the BSE infective 

agent. Other U.S. Federal agencies, such as FSIS and FDA, have also 

implemented regulations to protect human and/or animal health. In 

combination, regulations from all three agencies are designed to protect 

humans and animals from exposure to the BSE infective agent and 

subsequent establishment of the disease. 

Current APHIS regulations26 prohibit or restrict importation of live 

bovines from regions that are identified as falling under any one of three 

risk categories due to BSE. These risk categories include (1) regions in 

which BSE is known to exist,27 (2) regions that present an undue risk of 

introducing BSE into the United States because their import regulations 

are less restrictive than those that would be acceptable for import into the 

United States and/or because the regions have inadequate surveillance,28

and (3) regions that present a minimal risk of introducing BSE into the 

United States via live ruminants and ruminant products and by-products 

(including bovines and bovine-derived products).29

FSIS has implemented regulations designed to directly protect human 

health from BSE exposure in conjunction with APHIS regulations; FSIS’ 

regulations also indirectly protect animal health through the identification 

of SRMs prohibited from use in animal feed under regulations 

implemented by FDA. 

On January 12, 2004, FSIS issued three interim final rules30 to prevent 

potential human exposure exposure to BSE through consumption of meat 

and meat food products. These regulations designated materials from 

cattle as SRMs, declared that SRMs are inedible, and prohibited their use 

in human food. Under these interim final rules, establishments that 

slaughter cattle and establishments that process the carcasses or parts of 

 

26 9 CFR parts 92–96 and 98 

27 9 CFR § 94.18(a)(1) 

28 9 CFR § 94.18(a)(2) 

29 9 CFR § 94.18(a)(3) 

30 69 FR 1862–1874, January 12, 2004 (Prohibition of the Use of Specified Risk Materials for Human Food and 

Requirements for the Disposition of Non-Ambulatory Disabled Cattle; Meat Produced by Advanced Meat/Bone 

Separation Machinery and Meat Recovery Systems; Prohibition of the Use of Certain Stunning Devices to 

Immobilize Cattle at Slaughter); Bovine Spongiform Encephalopathy Surveillance Program; Interim Final 

Rules and Notice). 
20 

cattle are required to develop, implement, and maintain procedures for the 

removal, segregation, and disposition of SRMs. The 2004 interim final 

rules also required the condemnation of non-ambulatory disabled cattle 

presented for slaughter. 31 FSIS prohibited the slaughter of these animals 

because of FSIS’ determination that they present a sufficient risk of 

exposing humans to the BSE agent to render them unfit for use as human 

food. 

On July 13, 2007, FSIS published a final rule that affirms and strengthens 

the interim measures to prevent potential human exposure to the BSE 

agent that it issued in 2004.32 The July 2007 final rule became effective 

on October 1, 2007. 

FDA has also implemented regulations to protect humans and animals 

from exposure to the BSE infective agent in food. On June 5, 1997, 

FDA’s ruminant feed ban prohibiting the feeding of ruminant protein 

material to ruminants was published; its effective date was August 4, 

1997.33 On July 14, 2004, FDA issued an interim final rule34 designating 

some materials from cattle as “prohibited cattle materials” with regard to 

materials derived from cattle for use in human food and cosmetics. These 

prohibited materials, which included the entire small intestine, were 

banned from use in human food products, including dietary supplements 

and cosmetic products, and included the following: 

 cattle material from nonambulatory cattle, 

 cattle material from organs from cattle 30 months of age or older in 

which infectious prions are most likely to occur, and the tonsils 

and the small intestine of cattle of all ages, 

 cattle material from mechanically separated beef, and 

 cattle material from cattle that are not inspected and passed for 

human consumption. 

FDA amended the interim final rule in 2005,35 designating only the distal 

ileum of the small intestine of cattle as an SRM, allowing other portions of 

the small intestine other than the distal ileum to be used for human food 

products or cosmetics. This interim final rule was combined in a final 

regulation on cattle materials in animal feed issued in April 2008. The 

April 2008 regulation36 prohibits the use of certain cattle materials from 

animal feed, including pet food. The prohibited materials include: 

 

31 Non-ambulatory disabled livestock, including cattle, are livestock that cannot rise from a recumbent position 

or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, 

nerve paralysis, fractured vertebral column or metabolic conditions (69 FR, January 12, 2004) 32 72 FR 38700, July 13, 2007 33 62 FR 30936, June 5, 1997 34 69 FR 42256, July 14, 2004 35 70 FR 53063, September 7, 2005 36 73 FR 22719, April 25, 2008 
21 

 the entire carcass of BSE-positive cattle, 

 the brains and spinal cords of 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 and older from which the 

brains and spinal cords were not effectively removed or otherwise 

effectively excluded from animal feed, 

 mechanically separated beef derived from the materials prohibited 

by this regulation, and 

 tallow that is derived from the materials prohibited by this 

regulation. 

The regulation is an added measure to exclude high-risk materials from all 

animal feeds and to prevent any accidental feeding of such ingredients to 

cattle. The regulation further serves to protect animals and consumers 

from the already low risk of BSE exposure. The regulation became 

effective 12 months from its issuance, but the compliance date was 

established to be 6 months later (October 29, 2009) to allow the livestock, 

meat, rendering, and feed industries time to adapt their practices to comply 

with the new requirements. When it became effective on April 27, 2009, 

this regulation became another overlapping safeguard in addition to those 

already in place. 

Background: Bovine-derived Products

Mitigation measures are currently in place to protect both human and 

animal health from exposure to the BSE infective agent from bovinederived products produced in the United States or imported into the 

country. These mitigation measures are enforced through regulations from 

several different Federal agencies. Transmission of the BSE agent to 

humans is thought to be the result of consumption of cattle products 

contaminated with the BSE agent. Therefore, mitigation measures 

associated with bovine-derived products are concentrated on preventing 

improper slaughter procedures or ensuring that bovine-derived products 

imported into the United States are produced according to appropriate 

slaughter and processing procedures. As is the case with live cattle, the 

FSIS and FDA regulations are designed to protect human health with 

regard to cattle-derived products. FSIS’ regulations have an indirect effect 

on protection of animal health as discussed above. These mitigation 

measures are discussed in more detail below. 

 

APHIS regulations37 prohibit importation of ruminant-derived products 

(including bovine-derived products) from regions that are known to have 

BSE or that present an undue risk for BSE infection because of import 

 

37 9 CFR Parts 92–96 and 98 
22 

practices or inadequate surveillance procedures. Other U.S. agency 

regulations, such as those under the authority of FSIS (see paragraphs 

below), also regulate slaughter or processing practices. The existing 

regulations from U.S. agencies serve to restrict importation of meat, meat 

products, and edible products other than meat from regions that are 

identified as falling under any one of the same three risk classifications 

discussed above due to BSE.38 39 40

FSIS has authority in the United States to regulate the production of meat 

products intended for human consumption, including meat products from 

cattle. FSIS’s authority extends to inspection of cattle slaughter and 

processing facilities and inspection of animals in these facilities, and, in 

some facilities, collection of samples from high-risk cattle to assist APHIS 

with BSE surveillance activities.41 In 2004, FSIS published three interim 

final rules to further strengthen BSE animal health safeguarding measures 

for cattle in the United States. FSIS finalized measures related to SRMs 

and non-ambulatory cattle in July 2007, as discussed above in the 

background section on live bovines. 

FDA regulations that are designed to prevent potential exposure to the 

BSE infective agent focus on enforcement of the existing ruminant feed 

ban and regulations regarding the inspection of establishments producing 

animal feed. As discussed above in the background section on live 

bovines, FDA has specified “prohibited cattle materials” that cannot enter 

the human food supply to minimize potential exposure to materials that 

could contain the BSE infective agent. 

Background: Live Cervids and Camelids 

In the minimial risk regions rulemaking implemented in 2005 (referred to 

as MRR1), APHIS removed the BSE-related prohibition for the 

importation of cervids and camelids from a BSE minimal-risk region. 

APHIS determined that such prohibitions were unnecessary because, 

based on UK history during the BSE epidemic and the fact that there have 

been no diagnosed cases of BSE in cervids, it would be highly unlikely 

that BSE would be introduced into the United States through the 

importation of cervids and camelids. The focus of the rulemaking was 

BSE and minimal risk regions, so the removal of this prohibition only 

applied to BSE-related restrictions and minimal risk regions. 

 

38 9 CFR § 94.18(a)(1) 

39 9 CFR § 94.18(a)(2) 

40 9 CFR § 94.18(a)(3) 

41 69 Federal Register 1892, January 12, 2004
23 

Live Bovines and Bovine-derived Products 

Under the No Action alternative for this environmental assessment, the 

current restrictions and prohibitions under the APHIS BSE import 

regulations would continue to be effective. The regions that currently are 

allowed to export live bovines and bovine-derived products with 

restrictions and those that are unrestricted (not listed in any of the three 

APHIS BSE risk categories in 9 CFR § 94.18(a)(1), (2), and (3)) would be 

able to continue trade in these products with the United States without 

having to meet any new requirements. Regions listed in the risk 

categories under the APHIS BSE import regulations and that are allowed 

to import bovine-derived products and/or live bovines include Japan and 

Canada. After a prior APHIS risk evaluation and rulemaking process, 

Japan is the only region classified as a region “where BSE exists” that is 

allowed, under current APHIS regulations, to import certain cuts of fresh 

boneless beef into the United States according to certain requirements in 

9 CFR § 94.27. Under the No Action alternative, this would continue. 

Canada is the only region meeting the definition of a minimal risk region. 

A risk assessment process and rulemaking implemented in September 

200542 (hereafter referred to as MRR1) established the minimal risk 

category under APHIS BSE import regulations and recognized Canada as 

a minimal risk region. This regulation allowed Canada to once again 

export to the United States live bovines under the age of 30 months (after 

a temporary import halt on all live bovines from Canada by the United 

States because of the first BSE find in a Canadian animal in May 2003). 

A rulemaking was finalized after a subsequent risk assessment to allow the 

importation of live bovines born on or after March 1, 1999, and certain 

bovine-derived commodities from Canada. The final rulemaking was 

announced in a Federal Register (FR) notice on September 18, 2007,43 and 

was implemented as a final regulation (hereinafter referred to as MRR2) 

on November 19, 2007. To date, Canada is the only region that has been 

recognized as a minimal risk region under the APHIS regulations. Under 

the No Action alternative, as detailed in the MRR1 and MRR2 final rules 

and a followup rule to MRR2 implemented in January 2008 that clarified 

some aspects of the previous two rules,44 Canada would continue to be 

allowed to import the following commodities into the United States: 

 Live bovines born on or after March 1, 1999. 

 Bovine casings (defined as stomachs; esophagi; urinary bladders; 

and small intestine, other than the distal ileum, that are used to 

encase processed meats in foods such as sausage). 

 Bovine blood and blood products. 

 

42 70 FR 53043, September 7, 2005 

43 9 CFR § 93, 94, 95 and 96 

44 73 FR 3379, January 18, 2008 

1. No Action 

(Maintain the 

Current 

APHIS BSE 

Import 

Regulations) 
24 

 Fresh/chilled or frozen beef from bovines. 

 Bovine meat, meat food, and meat byproducts. 

 Bovine offal. 

 Gelatin, both bone-derived and hide-derived. 

 Tallow that is composed of a maximum level of insoluble 

impurities of 0.15 percent in weight. 

The “Importation of Certain Commodities from BSE Minimal-risk 

Regions (Canada), Final Environmental Assessment, September 2007,”45

hereinafter referred to as the MRR2 EA (USDA, APHIS, 2007a), 

considered the potential impacts of BSE exposure that could result from 

implementation of the MRR2 rule. The MRR2 EA addressed the potential 

risk of human health impacts and the mitigation measures that have been 

implemented to prevent BSE exposure, including the ruminant-toruminant feed ban and other safeguard measures, such as removal of 

SRMs at the time of slaughter. In addition to other supporting 

environmental assessments and risk documents for the prior MRR rule 

(establishing a minimal risk category and conditions to allow the 

importation of bovines under 30 months of age and certain other 

ruminants and products thereof) (USDA, APHIS, 2003; USDA, APHIS, 

2004a; and USDA, APHIS, 2004b), the EA referred to the risk assessment 

prepared to support the MRR2 rule (USDA, APHIS, 2007b). The MRR2 

risk assessment included qualitative and quantitative exposure assessments 

to evaluate the likelihood of exposing susceptible animals in the United 

States from a release of BSE infectivity from imported live animals. The 

risk assessment concluded that the risk of BSE becoming established in 

the United States as a result of implementation of the MRR2 rule and 

subsequent trade with Canada was negligible. 

The MRR2 environmental assessment process concluded with a Finding 

of No Significant Impact46 (FONSI), determining that implementation of 

the proposed rule should not have significant impacts on the human 

environment. The FONSI concluded that implementation of the proposed 

rule would safely allow, under certain conditions, the importation of live 

bovines born on or after March 1, 1999, bovine small intestines except for 

the distal ileum, and bovine blood and blood products from Canada. 

Live Cervids and Camelids 

Under the prior rulemaking for MRR1, BSE-related prohibitions on the 

importation of cervids and camelids were removed for minimal risk 

regions. Under the No Action alternative, the importation of cervids and 

 

45 Available on the Internet at 

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/environmental_assessment9-2007.doc 46 Available on the Internet at 

http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/environmental_assessment_fonsi9-2007.pdf 
25 

camelids would continue as currently regulated without BSE-related 

prohibitions from minimal risk regions. 

Live Bovines and Bovine-derived Products 

Under this alternative, existing APHIS import requirements to address 

BSE concerns would be changed so that the regulations are mostly 

consistent with guidelines from the World Organization for Animal Health 

(hereinafter referred to as the OIE Code) for BSE classification and import 

regulations. In aligning with the OIE Code, some requirements that would 

be incorporated into APHIS’ BSE import regulations would be somewhat 

modified from the OIE requirements in order to reflect APHIS’ 

interpretation of existing scientific literature and existing USDA 

regulations and policies, resulting in some differences between APHIS 

regulations and the OIE Code if this alternative is implemented. 

The United States is a Member Country of the OIE and has participated in 

the process to revise the OIE Code. The United States supports the 

changes that have been made to the OIE Code, which is one reason for 

revising APHIS BSE import requirements to be more consistent with 

international trade standards recommended by OIE. Aligning APHIS 

regulations with the OIE Code also increases the efficiency and 

transparency with which APHIS can respond to import requests. 

The 2010 OIE Code describe three BSE risk classifications for regions: 

negligible risk, controlled risk, and undetermined risk for BSE. Under this 

alternative, APHIS BSE regulations would adopt the same three BSE 

classifications for any regions requesting to import live bovines or bovinederived products into the United States. 

Under the existing OIE Code, a risk evaluation process is used to 

determine a region’s BSE classification. OIE evaluates the potential for 

BSE introduction into the exporting region as a result of live bovines or 

bovine-derived products. In addition, an exposure assessment is 

conducted to evaluate the risk of exposure to the BSE infective agent if it 

is introduced via importation of live bovines or bovine-derived products. 

In the exposure assessment, the exporting region’s practices concerning 

animal feed ban enforcement and slaughter, processing and rendering 

practices are evaluated. Other information such as epidemiological data, 

awareness and notification programs, and surveillance programs is also 

required in order to determine a region’s BSE classification under the OIE 

Code. The OIE risk evaluation process for determining BSE classification 

is identical to the APHIS risk assessment process for a country’s 

importation of animals and animal products. 

If this alternative is implemented, some bovine-derived commodities 

imported into the United States would be allowed for unrestricted trade 

2. Align APHIS 

BSE Import 

Regulations 

with Internationally 

Accepted 

Guidelines, 

with Modified 

Requirements 
26 

regardless of the BSE risk classification of the region exporting the 

commodity. These commodities are allowed for unrestricted trade under 

the existing OIE Code. The OIE unrestricted trade designation results 

from OIE’s review of scientific literature on BSE and the determination 

that certain products have essentially no risk of transmitting BSE. Under 

this alternative, APHIS would allow certain commodities without 

restrictions; a list of the commodities is provided earlier in this document 

(chapter II.C). 

OIE’s review of scientific literature concluded that some commodities 

may have a potential risk for transmission of BSE, and that those 

commodities should be allowed for trade under some restrictions to 

minimize risk. Under this alternative, APHIS proposes to allow the 

commodities (the list of which is provided earlier in chapter II.C of this 

document) for restricted trade, provided that risk mitigations and certain 

other restrictions dependent upon the OIE risk classification of the region 

importing the materials are followed. 

APHIS’ restrictions for the commodities listed above would be broadly 

based on OIE recommendations. APHIS would, however, propose some 

differences from the OIE Code to reflect APHIS’ interpretation of 

scientific literature, to take into account existing USDA regulations and 

policies, and to harmonize with existing regulations from other U.S. 

Federal agencies responsible for management of BSE issues. 

Historically, virtually all live bovines imported into the United States are 

from Canada and Mexico (see Regulatory Impact Analysis in USDA, 

APHIS, 2011). APHIS estimates that if the OIE Code isimplemented 

under APHIS regulations with some modifications, there will not be any 

significant increases in imports of live bovines. Due to the logistics of 

importing live bovines from regions other than Canada and Mexico and 

complementarity of their cattle and beef sectors (USDA, ERS, 2009a), 

imports of live bovines from other countries are not likely. In a previous 

risk assessment (USDA, APHIS, 2007b), the likelihood of release of the 

BSE infective agent that could potentially result from imports of live 

bovines was assessed in both qualitative and quantitative analyses. The 

risk assessments concluded that the prevalence of BSE will continue to 

decrease as mitigation measures such as the ruminant feed ban and SRM 

segregation continue to be applied. The associated risk of establishment 

of the BSE infective agent and impacts to animal and human health were 

determined to be negligible. 

As noted above, live bovines would be approved for import into the 

United States under this alternative with some restrictions, which are in 

place to prevent exposure to the BSE infective agent. Live bovines 

imported from regions classified as negligible risk for BSE or controlled 
27 

risk for BSE would be permitted to enter the United States according to 

the same provisions outlined by OIE. However, importation of live 

bovines from regions that are classified as undetermined risk for BSE 

according to the existing OIE Code would be prohibited, except under 

certain specific conditions. 

APHIS proposes not to allow live bovines from undetermined BSE risk 

regions for two reasons: 

(1) If a country is classified as undetermined for BSE risk, OIE 

conditions that are in place to minimize the potential for exposure 

to BSE (such as a veterinary structure, surveillance and import 

controls and a documented feed ban) have by definition not been 

met; and 

(2) A separate identification and tracking process would be required in 

the United States in order to ensure that, according to the 

provisions of the OIE for animals from undetermined BSE risk 

regions, SRMs have been removed from animals 12 months of age 

and older that are slaughtered in the United States. 

If this alternative is implemented, importation of live bovines from a 

region of undetermined risk for BSE would be prohibited, except in very 

limited situations, under specified conditions, and on a case-by-case basis. 

These limited exceptions to the prohibition would be determined by the 

APHIS Administrator and would require conditions to ensure the 

prevention of BSE introduction into the United States. 

For bovine-derived products, previous APHIS risk assessments (USDA, 

APHIS, 2004b, and USDA, APHIS, 2007b) and the APHIS supporting 

scientific documentation (USDA, APHIS, 2009) associated with the 

proposed regulations investigated the potential impacts to animal health 

resulting from the importation of bovine-derived materials. The risk of 

BSE exposure from bovine-derived products was determined to be 

negligible because of the multiple safeguards in place for the lifecycle of 

bovines, including a ruminant-to-ruminant feed ban, removal, segregation 

and disposition of SRMs, and slaughter and processing practices. If this 

alternative is implemented, APHIS will adopt OIE criteria, with a few 

modifications, used to determine a BSE risk classification for a region 

requesting to import bovine-derived products into the United States. 

The primary public health risk that could potentially result from 

implementation of this alternative is the potential for exposure to BSEinfected live animals or animal products because of the proposed change 

in import regulations. APHIS qualitatively assessed the safety of live 

bovines and certain bovine products for restricted trade47 and determined 

 

47 Live bovines; meat (other than deboned skeletal muscle), meat products, and meat byproducts; gelatin and 

collagen prepared from bones, intended for food, animal food, fertilizers, veterinary biologics, or as 
28 

where measures that differed from the OIE Code are recommended to 

maintain or further minimize risk of exposure to the BSE infective agent. 

APHIS’ assessments are included in the supporting scientific 

documentation (USDA, APHIS, 2009). 

The differences between APHIS regulations and the OIE Code that would 

remain if this alternative is implemented are discussed below. The 

proposed modifications from the OIE Code would ensure that APHIS 

regulations are consistent with the most current scientific understanding of 

aspects of BSE risk, including transmission and risk mitigations that are 

necessary to protect human and animal health. Besides the minor 

difference that the OIE Code refers to cattle and APHIS BSE import 

regulations refer to bovines, other areas of difference between the OIE 

Code and proposed APHIS regulations include the definition of SRMs, the 

age of the bovine animal from which SRMs are required to be removed, 

and the requirement for proving the effective date of enforcement of a feed 

ban in a region requesting to import live animals into the United States. 

a. Definition of SRMs 

The OIE designates certain tissues as SRMs. These materials pose the 

greatest risk of containing the BSE agent. The OIE list of tissues includes: 

(1) tonsils and distal ileum from cattle of all ages, (2) brains, eyes, spinal 

cord, skull, and vertebral column from animals over 30 months of age 

from controlled BSE risk regions, and (3) brains, eyes, spinal cord, skull 

and vertebral column from animals over 12 months of age from 

undetermined BSE risk regions. The OIE considers affiliated tissues or 

structures such as skull or vertebral column as risk materials because of 

the difficulty in separating them from potentially infectious tissues (OIE, 

2010). 

In the United States, FSIS imposed regulations to protect human health. 

FSIS regulations in 2004 established as SRM 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 dorsal root ganglia (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. 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 SRM. 

Although the skull and vertebral column of cattle infected with BSE have 

not demonstrated infectivity, the skull contains the eyes, trigeminal 

 

unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health 

products) or medical devices; tallow, and tallow derivatives other than tallow with a maximum level of 

insoluble impurities of 0.15% in weight and dicalcium phosphate, intended for food, animal food, fertilizers, 

cosmetics, pharmaceuticals including biologics, or medical devices, animal food, fertilizers, cosmetics, 

pharmaceuticals including biologics, or medical devices; and meat and bone meal. 
29 

ganglia, and brain, and the vertebral column contains DRG and spinal 

cord. Thus, because they contain high-risk tissues, skull and vertebral 

column are included in FSIS’ definition of SRM. 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 excluded these parts of the vertebral 

column from the materials designated as SRM. Head meat, cheek meat, 

and tongue may continue to be used for human food, provided they are not 

contaminated with SRM. FSIS affirmed and strengthened the 2004 SRM 

interim measures in July 2007. APHIS will continue to support the FSIS 

definitions of SRMs if this alternative is implemented. Therefore, for 

consistency and to remain harmonized with other existing U.S. Federal 

agency regulations, APHIS will use the FSIS definition for SRMs for 

regions of controlled risk for BSE instead of OIE SRM definitions. 

Under the OIE Code, SRMs must be removed from cattle over the age of 

30 months originating from regions identified as controlled BSE risk. For 

regions identified as undetermined BSE risk, SRMs must be removed 

from animals over the age of 12 months. As discussed above, APHIS is 

proposing under this alternative to prohibit the importation of live bovines 

from undetermined BSE risk regions48 because the removal of SRMs from 

bovines over the age of 12 months imported live and slaughtered in the 

United States would require establishing a separate identification and 

tracking system for these animals. 

Although the United States has designated the distal ileum and tonsils of 

cattle of all ages as SRMs, the other tissues are designated as SRMs for 

cattle at 30 months of age and older. The U.S. decision was based on 

scientific data and experiences in the UK and elsewhere in Europe as well 

as the use of a simulation model developed by the Harvard Center for Risk 

Analysis. An extensive analysis of Harvard’s simulation model estimates 

the impact of food safety measures put into place by FSIS. Among the 

measures evaluated were a ban on the use of nonambulatory cattle for 

human food, prohibition of the use of advanced meat recovery (AMR) in 

the processing of animals over 30 months of age, and SRM removal from 

cattle at different age cutoffs, i.e., 12 months and older versus 30 months 

and older. The analysis found that of the measures put into place by FSIS, 

a ban on SRMs from animals over 30 months of age for use in human food 

has the largest impact on human exposure, reducing potential human 

exposure by more than 99 percent on average (Cohen and Gray, 2005). 

FSIS’ definition for SRMs, as supported by the scientific data, experience 

and analysis described above, is accepted internationally in BSE standards 

 

48 Except in limited situations, such as movement to zoos and exhibitions, and under specified conditions on a 

case-by-case basis if the APHIS Administrator determines that the bovines can be imported under conditions 

that prevent the introduction of BSE into the United States. 
30 

set by various countries and is consistent with OIE recommendations for a 

region of controlled BSE risk. For bovine-derived products from regions 

of controlled BSE risk, APHIS would require that SRMs be removed from 

bovines according to the same requirements listed in the FSIS regulations 

at 9 CFR 310.22(a). For bovine-derived products from regions of 

undetermined BSE risk, APHIS would require that SRMs be removed 

according to the same requirements listed in the FSIS regulations at 9 CFR 

310.22(a), except that 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.

b. Proof of Effective Date of Enforcement of Feed Ban 

The OIE Code defines regions of undetermined BSE risk as those that 

cannot demonstrate or are unable to meet the requirements of negligible 

BSE risk or controlled BSE risk status. In order to export live bovines, a 

region with negligible BSE risk status would be required to have an 

effectively enforced feed ban (verified through audit and compliance) in 

place for at least 8 years and for controlled risk countries for less than 

8 years. The region also would be required to certify that bovines from 

negligible risk countries (which reported an indigenous case) and 

controlled risk countries selected for export were born after the date from 

which the ban on feeding of ruminant meat-and-bone meal and greaves to 

ruminants has been effectively enforced. The OIE Code further states that 

cattle from a region of undetermined BSE risk can be exported if they 

were born at least 2 years after the date from which the ban on the feeding 

of meat-and-bone meal and greaves derived from ruminants was 

effectively enforced. APHIS considers that cattle intended for particular 

uses that will not lead to possible transmission of the agent do not 

constitute a risk for livestock exposure. 

The OIE recommends that regardless of the region’s BSE risk 

classification, all regions can export live cattle.49 For regions of negligible 

BSE risk that experienced an indigenous BSE case and for controlled risk 

countries, the exporting region must certify that the bovines selected for 

export were born after the date from which the ban on feeding of ruminant 

MBM and greaves to ruminants has been effectively enforced. The OIE 

Code requires that a region of undetermined BSE risk must certify that the 

bovines selected for export were born 2 years after the date the ban was 

effectively enforced. APHIS proposes to adopt the OIE Code, with some 

 

49 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, the provisions of the 

proposed rule would apply to bovines as defined in the current regulations, which include bison. 
31 

modifications for a region of undetermined BSE risk including that APHIS 

will prohibit the importation of live bovines from a region of 

undetermined BSE risk, except for specific uses on a case-by-case basis 

and under conditions determined by the APHIS Administrator to be 

adequate to prevent the spread of BSE. Also, because the OIE Code does 

not require the identification of a specific date of the effective feed ban in 

any region, the establishment of a specific date would be necessary and, 

therefore, APHIS would request and evaluate information to determine the 

date of the effective enforcement of a ruminant-to-ruminant feed ban prior 

to allowing importation of live bovines from a region of controlled BSE 

risk. APHIS also may conduct a site visit to the requesting country to 

complement and verify the information provided. The information that 

APHIS would request in order to make this determination would include, 

but not necessarily be limited to: 

1. Documentation describing the policies and infrastructure for feed 

ban enforcement, including an awareness program for producers 

and farmers; 

2. Documentation describing livestock and husbandry practices; 

3. Documentation describing the disposition of processed animal 

protein produced from domestic bovines, including the feeding of 

any animal species; 

4. Documentation on the measures taken to control crosscontamination and mislabeling of feed intended for bovines with 

processed animal protein. This documentation must indicate the 

measures taken to prevent cross-contamination and mislabeling of 

feed intended for bovines with processed animal protein; 

5. Documentation describing monitoring and enforcement of the ban 

on the feeding of ruminant MBM and greaves to ruminants, 

including audit findings in rendering plants and feed mills that 

process ruminant material. 

c. Regulation of Tallow and Tallow Derivatives 

Under the proposed action alternative, regulation of tallow and tallow 

derivatives would change from the current APHIS requirements for these 

products. APHIS has recognized for some time that tallow is a potential 

BSE risk if mitigation measures to prevent the inclusion of BSE infective 

material are not used. Therefore, under the current APHIS regulations, 

tallow is allowed to enter the United States with specific risk mitigation 

measures. These measures include a restriction that the tallow cannot be 

used in animal feed. Protein-free tallow from a minimal risk region can be 

imported into the United States for any use under current APHIS 

regulations. 
32 

Under the proposed alternative discussed in this document, APHIS would 

align with current the OIE Code concerning regulation of importation of 

tallow and tallow derivatives. Under the OIE Code, definitions for two 

types of tallow are relevant to APHIS regulations: (1) tallow and 

derivatives made from this tallow and (2) tallow with a maximum level of 

insoluble impurities of 0.15 percent by weight and derivatives made from 

this tallow. The considerations and conclusions regarding each of these 

two definitions are discussed in more detail below. 

The OIE Code does not specifically define the term “tallow derivative.” 

However, FDA defines “tallow derivative” as: 

 "... [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." 50 

According to the FDA definition, all bovine-derived tallow derivatives 

would meet the OIE Code under which tallow derivatives from any 

country could be traded. APHIS proposes to follow the FDA definition of 

“tallow derivative” in the discussions concerning proposed regulations 

below. 

(1) Tallow and Tallow Derivatives Other Than Tallow with a 

Maximum Level of Insoluble Impurities of 0.15 Percent by Weight 

and Derivatives: Tallow and tallow derivatives, as described in this 

section, contain insoluble impurities of more than 0.15 percent in weight. 

The conditions for importation of tallow as defined in this section depend 

on the risk category of the exporting region (OIE, 2010). For tallow that is 

intended for use in food, feed, fertilizers, cosmetics, pharmaceuticals or 

medical devices, the OIE Code require an international veterinary 

certificate confirming that the following conditions have been met: 

 the commodities came from a region categorized as negligible BSE 

risk; or 

 the commodities originate from a region categorized as controlled 

BSE risk, are derived from cattle that have passed ante-mortem 

and post-mortem inspections, and have not been prepared using 

tonsil, distal ileum, and the brain, eyes, spinal column, or vertebral 

column from animals that were over 30 months of age at slaughter. 

For tallow as defined in this section, if the proposed alternative is 

implemented, APHIS would adopt OIE recommendations for conditions 

required before receiving the commodity. These conditions are either: 

 It is sourced from a region of negligible risk for BSE; or 

 

50 21 CFR 589.2001 
33 

 If it is sourced from a region of controlled risk for BSE, it was 

derived from bovines that have passed ante- and post-mortem 

inspections and has not been prepared using SRMs. 

 It is accompanied by certification of the BSE risk classification of 

the exporting region and that the applicable conditions, above, 

have been met. 

Under the proposed alternative, 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 determined by the Administrator. The 

conditions of this case-by-case basis are discussed in more detail in the 

proposed rulemaking text that this EA supports. 

For 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 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- 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. 

Under the proposed alternative, APHIS would allow importation of tallow 

derivatives sourced from other than tallow with a maximum level of 

insoluble impurities of 0.15 percent by weight according to the OIE Code 

when accompanied by certification that the above conditions have been 

met or on a case-by-case basis as determined by the Administrator. 

(2) Tallow with a Maximum Level of Insoluble Impurities of 0.15 

Percent by Weight and Derivatives: For tallow with a maximum level 

of insoluble impurities of 0.15 percent by weight, the OIE Code does not 

require any mitigation or conditions for import, regardless of the BSE 

classification of the importing region, provided that the tallow and any 

derivatives from it contain a maximum level of insoluble impurities of 

0.15 percent in weight. The OIE Code regarding tallow derived from 

bovines is 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 

agrees with this conclusion and, for tallow with a maximum level of 

insoluble impurities of 0.15 percent in weight and derivates made from 
34 

this tallow as discussed in this section, if the proposed alternative is 

implemented, APHIS would follow the OIE Code for importation; thus, 

imported tallow containing a maximum level of insoluble impurities of 

0.15 percent in weight will be unrestricted. 

Current APHIS regulations do not include any restrictions or conditions on 

receipt of imports of tallow derivatives. Under the proposed alternative, 

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. 

d. Regulation of Blood and Blood Products 

Under the proposed alternative, regulation of bovine blood and blood 

products would differ from both existing APHIS regulations and the OIE 

Code. Existing FDA regulations51 prohibit the use of most mammalian 

proteins in ruminant feed except for some products for which the 

likelihood of transmission of BSE is very low. Blood and blood products 

are included in the list of products for which there is an exception to the 

existing FDA regulations. 

Currently, the OIE Code recommends that blood and blood products be 

eligible for trade from any region provided that the products meet the 

following conditions: 

 The blood and blood products must be derived from bovines that 

were not subjected to air-injected stunning or pithing prior to 

slaughter and are collected in a manner that avoids contamination. 

Studies have never demonstrated BSE in bovine blood or blood products, 

but APHIS recognizes that the possibility of cross-contamination with 

infected SRM material exists. For this reason, APHIS proposes to adopt 

the OIE Code concerning regulation of blood and blood products with 

some modifications to decrease this risk of cross-contamination. 

Under the proposed alternative, APHIS would allow the importation of 

bovine blood and blood products provided that the products meet the 

following conditions: 

 Blood must be collected under hygienic conditions that prevents 

contamination of the blood with SRMs 

 For blood collected at slaughter and products derived from blood 

collected at slaughter, slaughtered animals must meet the following 

requirements: 

o Animals must have passed ante-mortem inspection 

 

51 21 CFR 589.2000 
35 

o Animals must not have been subjected to a stunning 

process with a device injecting compressed air or gas into 

the cranial cavity, or to a pithing process prior to slaughter 

 For blood collected from live bovines and products collected from 

live bovines, the following requirements must be met: 

o Donor animals must be free of clinical signs of disease 

 For all types of blood and blood products, shipments into the 

United States must be accompanied by certification that the above 

applicable requirements have been met. 

Specific additional requirements for blood meal, blood plasma and other 

blood products derived from animals other than ruminants from regions 

with controlled or undetermined risk status for BSE are also included in 

the proposed regulations. These additional requirements further decrease 

the possibility of cross-contamination with materials that are potentially 

infected with BSE. For blood and blood products derived from animals 

other than ruminants, the following requirements must be met: 

 Material must not contain or have been commingled with ruminant 

blood or blood products which are prohibited from importation 

into the United States. 

 Additionally, APHIS 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. 

e. Regulation of Processed Animal Protein 

OIE includes guidelines for importation of products referred to as meatand-bone meal (MBM) and greaves. For the purposes of the proposed 

rule, where the OIE refers to “meat-and-bone meal and greaves,” APHIS 

refers instead to “processed animal protein.” In part 95 of current APHIS 

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 defined as processed animal protein is a rendered product, except 

for blood and blood products. (Proposed regulations concerning blood 

and blood products are discussed above.) 

Current OIE guidance acknowledges the relatively greater BSE risk posed 

by processed ruminant protein (meat and bone meal and greaves derived 

from ruminants) compared to other animal products. 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. 

While APHIS has not yet done an assessment of the BSE risk of processed 
36 

animal protein products, APHIS believes 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 BSE agent. 

Under the proposed alternative, regulation of processed animal protein 

would differ from the OIE Code in order to incorporate measures to 

mitigate APHIS’ concern about the BSE risk associated with potential 

commingling of processed animal protein with other potentially infected 

commodity types. 

Importation of processed animal proteins derived from ruminants would 

be prohibited unless the products meet the following conditions: 

 The region exporting processed ruminant animal protein products 

must be a region with negligible risk status for BSE, or the product 

must be derived from ruminants born and raised in a region of 

negligible risk for BSE. Processed ruminant animal protein 

products from a region of controlled risk for BSE or a region of 

undetermined risk would not be eligible for importation into the 

United States. 

 If either of the following conditions apply, the product must be 

derived from ruminants that were subject to a ban on the feeding of 

ruminants with meat and bone meal and greaves derived from 

ruminants: 

o 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 

o The product is derived from ruminants that were born or 

raised in a region of negligible risk for BSE in which there 

has been at least one indigenous case of BSE. 

 Each shipment of processed animal proteins derived from 

ruminants to the United States must be accompanied by a 

certificate stating that the exporting region is a region of negligible 

risk for BSE and that all applicable requirements discussed above 

have been met. 
37 

For processed animal proteins derived from animals other than ruminants, 

importation would be prohibited unless the products meet the following 

conditions: 

 From a region of negligible BSE risk: 

o Material is not otherwise prohibited under the provisions in 

APHIS regulations (§ 95.4) regarding materials derived 

from ovines or caprines. 

o Each shipment must be accompanied by specific 

certifications and must indicate BSE risk classification of 

the exporting region. 

o 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 (VS Form 16-3). 

 From a region of controlled BSE risk or undetermined BSE risk; 

o In addition to above requirements, except for blood and 

blood products listed in next bullet, products may not be 

imported unless the product does not contain and was not 

contaminated with material derived from ruminants 

originating from controlled BSE risk or determined BSE 

risk. 

 For blood meal, blood plasma, and other blood products: 

o Material does not contain and was not commingled with 

ruminant blood or blood products prohibited from 

importation into the United States. 

 Annual inspection of facility for compliance with provisions must 

be conducted. 

f. Harmonization with Existing U.S. Regulations by Other 

Federal Agencies 

Existing regulations implemented by FSIS and FDA regarding protection 

of the food supply and slaughter and processing procedures in the United 

States would remain the same if this alternative is implemented. The FSIS 

and FDA regulations would not be impacted by the proposed changes in 

APHIS import regulations. Under the APHIS regulations proposed in this 

document, importation of live bovines from undetermined BSE risk 

regions would be prohibited except under certain specific conditions and 

by a decision from the Administrator. Current FSIS regulations require 

that SRMs be removed from the carcasses of cattle that are 30 months of 

age and older at the time of slaughter and the removal of tonsils and the 

distal ileum from cattle of all ages. APHIS has briefed FSIS on the 

proposed regulations and will cooperate with FSIS to address issues of 

enforcement. The processing of imported bovines or bovine-derived 

products from regions outside of the United States, including any new 
38 

regions that would be allowed to export live bovines or bovine-derived 

products, would continue to be subject to applicable existing FSIS and/or 

FDA regulations. If this alternative is implemented, restrictions on the 

trade of live bovines for each of the OIE BSE risk classifications serve as 

additional mitigation measures. These restrictions include: 

a. For negligible BSE risk—animals are identified by a permanent 

identification system in such a way that demonstrates that they were 

not exposed to BSE cases or their cohorts, and they were born after 

the date of the ban on using MBM and greaves of ruminant origin 

was effectively enforced. 

b. For controlled BSE risk—the region complies with the conditions 

under Article 11.5.4; animals are identified by a permanent 

identification system in such a way that demonstrates that they were 

not exposed to BSE cases or their cohorts, and they were born after 

the date of the ban on using MBM and greaves of ruminant origin 

was effectively enforced. 

g. Live Cervids and Camelids and Products

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 and camelids (i.e., llamas, alpacas, guanacos, 

and vicuñas). One ongoing study shows that red deer (cervus elaphus)

developed clinical signs similar to chronic wasting disease on intracerebral 

inoculation of BSE infected brain (Martin et al., 2007); however, red deer 

challenged intra-gastrically with BSE infected brain developed neither 

clinical signs of disease nor presence of the abnormal type of the prion 

protein at post mortem examination. Since intra-gastric inoculation 

resembles closely natural transmission, the absence of positive results 

indicates that the species are not likely to be susceptible to BSE. In 

addition, surveillance in the UK and European cervid population did not 

show any evidence of any TSEs 

(http://www.cdc.gov/Ncidod/eid/vol12no02/pdfs/05-0970.pdf, 

http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/bse/docum

ents/comms_strat.pdf). Therefore, APHIS considers the BSE risk from 

removing import restrictions for cervids or camelids and their products to 

be very low. Under the proposed rulemaking requirements, APHIS 

proposes to remove BSE-related restrictions for all live cervids, camelids, 

and their products from any region of the world. The OIE Code for BSE 

does not address any restrictions with regard to cervids, camelids, or their 

products. 
39 

B. Physical Environment 

This section considers the extent of impacts on the physical environment 

that are unrelated to BSE exposure but that result from actions associated 

with the No Action alternative and the proposed action. As defined under 

NEPA, direct impacts are caused by the action and occur at the same time; 

indirect impacts are caused by the action and occur later in time or are 

farther removed in distance, but are still reasonably foreseeable.52 

The actions that could result in potential impacts on the physical 

environment by either the No Action alternative or the proposed action are 

(1) the transport of commodities that would be allowed to be imported, 

(2) the holding of imported live bovines in feedlots, and (3) and disposal 

of SRMs that result from slaughter of imported bovines. The degree to 

which impacts under the No Action alternative (the baseline) and the 

proposed action could affect the quality of the human environment would 

depend upon the amount of imported commodities from the (1) transport 

of imported commodities, (2) the holding of imported live bovines in 

feedlots, and (3) the disposal of SRMs removed from imported 

slaughtered bovines. Laws, such as the Clean Water Act and Clean Air 

Act, serve to protect the quality of the human environment from the 

potential effects related to vehicle, railroad, and ship transport; animal 

feedlots; and disposal of animal tissues and waste. These laws are 

enforced by State and Federal agencies, including the U.S. Environmental 

Protection Agency. 

The discussion that follows provides the baseline (the current situation—

No Action alternative) of the amount of imported animals and animal 

products under the current regulations, the amount of live bovines that 

contribute to feedlot impacts, and will explain the extent to which these 

activities under the alternative (No Action) and the proposed action 

contribute or could contribute to impacts on the environment when 

comparing the actions to a baseline of related actions. 

Canada and Mexico have provided virtually all of the live cattle imported 

into the United States. Bovine-derived products are imported from 

Canada, Mexico, Australia, New Zealand, Uruguay, and several other 

countries. Live bovines and bovine-derived products from either Canada 

or Mexico are mostly transported by commercial trucks, with the 

possibility that a small percentage of bovine-derived products are 

transported by rail car from Canada. 

Live cervids, specifically deer and elk, and live camelids are imported into 

the United States from Canada. Imported cervid products include deer 

 

52 40 CFR § 1508.8 

1. Transport of 

 Commodities 
40 

meat and deer and elk semen, with New Zealand as the major exporter of 

most deer meat and Canada as the major exporter of cervid semen to the 

United States. Deer skin and camel hair are the only other identified 

cervid and camelid products, respectively, imported to the United States. 

Because live bovines, cervids, and camelids imported are most likely 

transported by commercial trucks, environmental impacts from their 

transport would mostly be related to diesel engine pollutants and 

greenhouse gas emissions. Although diesel engines are more fuel efficient 

than gasoline-powered engines, they contribute to emissions of the 

following air pollutants: carbon monoxide (CO), nitrogen oxides (NOX) 

sulfur dioxide (SO2), volatile organic compounds (VOC), and particulate 

matter (PM). In addition, diesel exhaust contains 40 specific hazardous air 

pollutants, such as formaldehyde (IEI and R&AEC, Ltd., 2007). Burning 

of diesel fuel also results in emissions of carbon dioxide (CO2), the most 

prevalent greenhouse gas. Greenhouse gases prevent ultraviolet rays from 

leaving the earth’s atmosphere, resulting in a “greenhouse” or warming 

effect, which is a major part of global climate change. 

 

In order to be imported, live bovines and other live ruminants can enter the 

United States through any of 20 approved ports of entry authorized for 

importation of ruminants at the U.S./Canada border 53 and 16 approved 

ports of entry at the U.S./Mexico border,54 and also could enter through 

any of the following approved air and ocean ports: Los Angeles, 

California; Miami, Florida; and Newburgh, New York. 

Most ruminant-derived products from countries that do not share a land 

border with the United States are transported by ship vessel and then 

transported to their final destinations by truck. Ruminant-derived products 

can be imported into the United States through more than 225 

international and sea ports of entry where Customs and Border Protection 

Agricultural Specialists are present. 

a. No Action—Maintain the Current APHIS BSE Import 

Regulations 

For this alternative, No Action—maintain the current APHIS BSE import 

regulations, imports of live bovines and bovine-derived products are 

considered to address potential impacts on the physical environment. The 

totals of imported commodities allowed under the current APHIS import 

 

53 U.S./Canada border approved ports of entry: Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, 

and Sault Ste. Marie, MI; Baudette, MN; Opheim, Raymond, and Sweetgrass, MT; Alexandria Bay, Buffalo, 

and Champlain, NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, VT; and Oroville 

and Sumas, WA (9 CFR 93.403(b)). 

54 U.S./Mexico border approved ports of entry: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; 

Calexico and San Ysidro, California; Antelope Wells, Columbus, and Santa Teresa, New Mexico; and 

Brownsville, Del Rio, Eagle Pass, Hidalgo, Laredo, and Presidio, Texas (9 CFR 93.403(c)). 
41 

regulations to portray the current situation and the potential contribution to 

impacts on the physical environment. Other than for BSE, APHIS also 

restricts the importation of live bovines and bovine-derived products for 

other animal diseases, such as foot-and-mouth disease. These 

commodities are allowed importation provided they meet other 

requirements that are designed to prevent the introduction of animal 

diseases that could impact the U.S. animal populations. 

(1) Transport of Imported Live Bovines Contributing to 

Environmental Impacts 

As mentioned previously, Canada and Mexico provide virtually all the live 

bovines imported into the United States. On average, each country 

provides about 1 million live cattle to the United States annually. 

Importing live cattle from countries other than Canada and Mexico is 

impracticable. Factors, such as lack of ample quarantine facilities to hold 

cattle upon arrival and the distance and costs associated with transporting 

cattle from countries farther away from U.S. borders, make it 

economically unfeasible to export live animals from far distances. Few 

live cattle are exported from countries other than Canada and Mexico and 

when they are, it is for reasons related to their value in improved genetics. 

The advent of improved technology for successfully importing semen and 

embryos has negated much of the need for importing the animals 

themselves for breeding purposes. 

(a) From Canada 

Using 2008 and 2009 import information, the average number of cattle 

imported annually from Canada during these 2 years was approximately 

1.35 million (USDA, ERS, 2011a; see table A-1 in appendix). During this 

2-year period, the U.S. cattle inventory average was 95 million cattle 

(USDA, ERS, 2010). Thus, the number of cattle imported from Canada 

contributed to about 1.4 percent of the total U.S. cattle population. 

Deriving data from a U.S. Department of Transportation (U.S. DOT) 

database, the average annual number of all commercial truck crossings 

from Canada into the United States for 2008 and 2009 for the 20 approved 

U.S./Canada land ports of entry for cattle is about 4.57 million (U.S. DOT, 

2011a).55 Based on the average of 2008 and 2009 data on bovines 

imported to the United States from Canada, the transport of bovines would 

have required the need for approximately 27,118 trucks.56 The average 

estimated number of truck transports (27,118) for imported bovines from 

Canada is about 0.6 percent (or, about 1⁄2 of 1 percent) of the average 

annual commercial truck crossings (4.57 million) per year (2008 and 

 

55 Truck crossings at 20 approved U.S./Canada land ports of entry for bovine imports during 2008 and 2009, 

respectively: 4,955,503, and 4,176,933 (2-year average: 4,566,218). 

56 32,368 + 21,868 = 54,236; 54,236 ÷ 2 = 27,118. 
42 

2009) from Canada to the United States through the approved U.S/Canada 

ports of entry for cattle—an insignificant number when compared to the 

total annual truck crossings at these locations.57 

When comparing to a higher baseline, the overall truck transport total for 

all U.S./Canada ports of entry, excluding Alaska, for 2008 and 2009 was 

5.45 million (5,447,876.5) (U.S. DOT, 2011a). When comparing the 

average number of annual commercial truck transports (27,118) for cattle 

imported through the 20 approved U.S./Canada border ports to the number 

of annual commercial truck crossings through all U.S./Canada ports of 

entry for 2008 and 2009, 27,118 truck transports for cattle equates to about 

0. 5 percent (about 1⁄2 of 1 percent) of the overall average annual total 

truck crossings at the U.S./Canada border. As well, other transport modes 

(including cars, buses, and small trucks (which are not included in these 

figures for cross-border transport of cattle) contribute to pollutant 

emissions and greenhouse gases at the U.S./Canada border. 

(b) From Mexico 

Using 2008 and 2009 data, the average number of cattle imported annually 

from Mexico was approximately 0.82 million (USDA, ERS, 2010; see 

table A-2 in appendix). During this same period, the U.S. cattle 

population average was 95 million cattle (USDA, ERS, 2010). Thus, the 

number of cattle imported from Mexico contributed to less than 1 percent 

of the total U.S. cattle population. 

Deriving data from a U.S. DOT database, the average annual number of 

all commercial trucks crossing from Mexico into the United States for 

2008 and 2009 for the 16 approved U.S./Mexico ports of entry for cattle58

is nearly 3 million (2,994,589) (U.S. DOT, 2011a). Based on the average 

of 2008 and 2009 data on cattle imported to the United States from 

Mexico from 2008 and 2009 and an average of 50 cattle per truckload,59

the transport of cattle would have required the need for approximately 

16,435 trucks. The average estimated number of truck transports (16,435) 

for imported cattle from Mexico is about 0.5 percent (or about 1⁄2 of 

1 percent) of the total annual commercial truck crossings (3 million) per 

year from Mexico to the United States only through the approved 

U.S./Mexico ports of entry for cattle. 

When comparing to a higher baseline, the average truck transport total for 

all U.S./Mexico ports of entry for 2008 and 2009 was about 4.58 million 

 

57 27,118 ÷ 4,566,218 = 0.6 percent

58 U.S./Mexico border approved ports of entry: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; 

Calexico and San Ysidro, California; Antelope Wells, Columbus, and Santa Teresa, New Mexico; and 

Brownsville, Del Rio, Eagle Pass, Hidalgo, Laredo, and Presidio, Texas (9 CFR 93.403(c)). 59 This is a conservative estimate; virtually all cattle from Mexico are young feeder cattle, which could allow 

more cattle per livestock hauling trailer. 
43 

(4,578,856) (U.S. DOT, 2011a). When comparing the average number of 

annual truck transports for cattle imported through the 16 approved 

U.S./Mexico border ports (16,435) to the number of annual truck crossings 

through all U.S./Mexico ports of entry for 2008-2009, 16,435 truck 

transports for cattle represents approximately 0.4 percent of the overall 

average annual total truck crossings at the U.S./Mexico border. 

The transport of cattle from Mexico comprises a small percentage 

(0.4 percent) of the total annual truck crossings at the U.S./Mexico border; 

therefore, the number of truck transports for imported cattle from Mexico 

is minimal compared to overall truck transports at the U.S/Mexico border 

and likewise contribute a small percentage of air pollutants and 

greenhouse gas emissions toward the amounts contributed from the annual 

number of truck transports at the U.S./Mexico border. These data do not 

include other transport modes, such as buses and cars that also contribute 

to pollutant emissions and greenhouse gas emissions at the U.S./Mexico 

border. 

(2) Transport of Imported Bovine-derived Products Contributing to 

Environmental Impacts 

For 2008 and 2009, an average total of approximately 871,331 metric tons 

(MT) of bovine-derived products for human consumption were imported 

(see appendix, table A-3). Because of the geographic locations, distance, 

and weight of products, the majority of these types of products from other 

than Canada and Mexico are transported by ship vessel. Because of 

geographic proximity, it is assumed that the majority of these products 

from Canada and Mexico are transported by commercial trucks, and a 

small amount of these products from Canada may be transported by rail 

car. Air transport is generally not used for bovine-derived products 

because of the weight and costs related to their transport. The types of 

bovine-derived products include beef sausages; salted, dried, or smoked 

meat; frozen, fresh, or chilled boneless cuts of meat; frozen, fresh, or 

chilled cuts of meat with bone-in; frozen, fresh, or chilled carcasses and 

half-carcasses; and other bovine meat and edible bovine offal. 

The average total of all U.S. waterborne imports for 2008 and 2009 is 

about 850 million metric tons (MT) (U.S. DOT, 2011b).60 The average 

amount of imported bovine-derived products for 2008 and 2009 is about 

871,331 MT. The amount of imported bovine-derived products that most 

likely are transported by ship vessel (excluding the amount of these 

products from Canada and Mexico (315,435 MT61)) is about 555,896 MT, 

 

60 Excluding postal and military shipments 

61 294,901 + 20,534 = 315,435 MT 
44 

or 0.7 percent62— slightly more than 1⁄2 of 1 percent of the reported U.S. 

annual volume of U.S. waterborne imports for 2008 and 2009. 

 

Assuming that all bovine-derived products from Canada are transported by 

commercial trucks, the amount of bovine-derived products from Canada 

(about 294,901 MT63) would require about 14,776 commercial truck 

transports. Assuming that all bovine-derived products from Mexico are 

transported by commercial trucks, the amount of bovine-derived products 

from Mexico (about 20,534 MT64) would require about 1,029 commercial 

truck transports. 

The remainder of transported bovine-derived products from countries 

other than Canada and Mexico is about 555,896 MT and would require a 

minimum of 27,853 commercial transport trucks, assuming that each 

truckload would be dedicated solely to these commodities and movement 

to the final destinations.65 Realistically, bovine-derived products would 

likely be shipped in smaller amounts than a full truckload and, especially 

from countries other than Canada and Mexico, could be imported through 

any of 225 ports of entry. 

Transport of Imported Commodities 

Commercial trucks are used for live bovines and bovine-derived products, 

transporting the commodities from Canada or Mexico into the 

United States, and trucks are used for transporting these commodities to 

their various destinations once they arrive within the United States. Table 

A-4 of the appendix provides the estimated 2008 and 2009 annual number 

of truck transports for moving both live bovines and bovine-derived 

commodities into the United States. 

The estimated number of truck transports for imported live bovines 

and bovine-derived products from Canada (41,894) represents about 

0.966 percent (less than 1 percent) of the 2008-2009 average number of 

commercial truck crossings (4.56 million) per year from Canada to the 

United States through the 20 approved U.S/Canada ports of entry for 

cattle—an insignificant number of truck crossings when compared to the 

total annual truck crossings at these locations. 

When making comparison to a higher baseline, the 2008-2009 average 

truck transport total for all U.S./Canada ports of entry, excluding Alaska, 

for 2008 and 2009 was 5.45 million (U.S. DOT, 2011a). When comparing 

 

62 555,896 ÷ 850,000,000 = about 0.7 percent. 

63 294,901 × 2,204.62 lb/MT = ~650,145,415 lb.; 650,145,415 lb. ÷ 44,000 lb/truckload = 14,776 commercial 

trucks 

64 20,534 × 2,204.62 lb/MT = 45,269,667 lb., 45,269,667 ÷ 44,000 lb/truckload = 1,029 commercial trucks 

65 555,896 x 2,204.62 lb/MT = 1,225,540,897 lb; 1,225,540,897 ÷ 44,000 lb/truckload = 27,853 commercial 

trucks. 

66 41,894 ÷ 4,566,218 = 0.9 percent
45 

the average number of annual truck transports (41,894) for live bovines 

and bovine-derived products imported through U.S./Canada border ports 

to the number of annual truck crossings through all U.S./Canada ports of 

entry for 2008 and 2009, 41,894 truck transports represents about 0.867

percent of the overall average annual total truck crossings at the 

U.S./Canada border. Other transport modes (including cars, buses, and 

small trucks) are not included in the overall total vehicle crossings at the 

U.S./Canada border. 

The estimated average number of truck transports for imported cattle and 

bovine-derived products from Mexico (17,464) is about 0.668percent (or, 

slightly less than 1 percent) of the total average number of commercial 

truck crossings (3 million) per year from Mexico to the United States only 

through the 16 approved U.S./Mexico ports of entry for cattle—an 

insignificant number of truck crossings when compared to the total annual 

truck crossings at these locations. When making comparison at a higher 

baseline, the overall truck transport total for all U.S./Mexico ports of entry 

for 2008 and 2009 were 4.58 million (U.S. DOT, 2011a). 

When comparing the average number of annual truck transports for cattle 

imported through the 16 approved U.S./Mexico border ports for 2008 and 

2009 (17,464) to the average number of annual truck crossings through all 

U.S./Mexico ports of entry for 2008 and 2009, 17,464 truck transports for 

cattle represents approximately 0.469 percent of the overall average annual 

total truck crossings at the U.S./Mexico border. Other transport modes 

(including cars, buses, and small trucks) are not included in the overall 

total vehicle crossings at the U.S./Mexico border. 

When combining the estimated number of truck transports for imported 

bovines and bovine-derived products from Canada and Mexico to the 

additional amount of bovine-derived products from other countries, the 

amount of truck transports is about 87,211—still an unsubstantial amount 

when considering the annual totals of truck crossings through both the 

Canada and Mexico border ports. 

 

67 41,894 ÷ 5,447,876.5 = about 0.8 percent 68 17,464 ÷ 2,994,589 = about 0.6 percent 69 17,464 ÷ 4,578,856 = about 0.4 percent
46 

(3) Transport of Live Cervids and Camelids and Related Products 

Contributing to Environmental Impacts 

Live cervids and camelids and products thereof are allowed from regions 

that are not restricted because of BSE and from regions listed in 

94.18(a)(3) as a minimal risk region (namely, Canada). During 2008 and 

2009, live cervids (deer and elk) and live camelids (alpacas, camels, 

and/or llamas) were imported to the United States, all from Canada. 

Table A-5 (see appendix) summarizes these imports and provides an 

estimate of the number of transport vehicles that would have likely been 

required to transport the animals. 

Live Cervids and Camelids 

It is estimated (based on an annual average) that 1,097 transport vehicles 

(horse or cattle trailer) would have been needed to transport the amount of 

live cervids and camelids imported from Canada during 2008 and 2009 

(see appendix, table A-5). 

Cervid and Camelid Products 

With regard to cervid products, during 2008, 393 shipments of cervid 

semen were imported from Canada. During 2009, 1,264 cervid semen 

shipments and 311 cervid embryos were imported from Canada. These 

products are generally shipped in small containers and are mostly 

transported by private vehicle or transported by airplane or ground 

transportation fast delivery services. 

During 2008, importation of deer meat into the United States totaled 

approximately 912 MT from 3 countries. During 2009, importation of 

deer meat into the United States totaled approximately 913 MT from 3 

countries. In both years, the majority (approximately 910 MT) of 

imported deer meat was from New Zealand (USDA, FAS, 2011) and was 

most likely imported by ship vessel. 

Other than camel hair imported in 2008, no other camelid products were 

imported for 2008 or 2009. 

The total of U.S. waterborne imports for 2008 was about 950 million MT 

and for 2009 was about 750 million MT (U.S. DOT, 2011b). For BSErestricted commodities, the amount of imported cervid-derived products 

shipped during the years of 2008 and 2009 most likely were transported by 

ship vessel and comprise a fraction of 1 percent of the reported U.S. 

annual volume of U.S. waterborne imports for either 2008 or 2009. 
47 

b. Proposed Action—Align APHIS Regulations with OIE 

Guidelines, with Modified Requirements 

Under the proposed rulemaking, live bovines and bovine-derived products 

from any region could be imported into the United States, provided that 

the region meets the requirements for its risk classification status 

described in the proposed rulemaking. For importation of live bovines, an 

APHIS evaluation and determination of a region’s date of an effective 

feed ban also would have to be completed. However, few live bovines are 

exported to the United States from regions other than Canada and Mexico; 

the livestock market in the United States is efficient and well-established, 

and exporters in geographically distant countries are at a competitive 

disadvantage in that market, especially given the added cost of 

transporting animals to the United States. The proposed rulemaking is not 

likely to offset that disadvantage. Canada and Mexico historically have 

been the main source of live bovines imported to the United States. The 

proposed rulemaking should have minimal impact on U.S. importation of 

live bovines and bovine-derived products from Canada and Mexico 

(USDA, APHIS, 2011). The anticipated annual volume of live bovines 

and bovine-derived products that could be imported to the United States 

based on the provisions in the proposed rulemaking is not expected to 

change appreciably from the amounts shown in tables A-1, A-2, and A-3 

(in the appendix). 

 

The proposed rulemaking is expected to have minimal impact on U.S. 

imports of live cervids and camelids and minimal impact on U.S. imports 

of cervid and camelid products (USDA, APHIS, 2011) and, therefore, 

would not affect the amount of cervid and camelid imports discussed in 

the No Action alternative section above. 

Under the proposed rulemaking, imported live bovines, cervids, camelids, 

and products thereof would continue to result in the need for transport of 

these commodities to the United States. Movement of these commodities 

would occur by various transport modes, including truck, ship, and train or 

a combination of these modes. 

 

Feedlot operations are regulated by environmental protection laws and 

regulations, such as the Clean Water Act and Clean Air Act, under the 

authority of the U.S. EPA and State and local agencies. USDA’s ERS 

reports that cattle feeding is concentrated in the Great Plains but is also 

important in parts of the Corn Belt, Southwest, and Pacific Northwest 

(USDA, ERS, 2009b). While the United States is the largest producer of 

beef in the world, young bovine animals are imported to add to the need 

for production animals. Production animals are fed in concentrated animal 

feeding operations for several months for further growth and then sent for 

slaughter. 

2. Holding 

Imported 

Bovines in 

Feedlots 
48 

The types of environmental impacts associated with holding livestock in 

feedlots include air and water pollutant discharges and emissions, such as 

nutrients, organic matter, pathogens, and odorous/volatile compounds, 

such as ammonia. Pollutants from animal feeding operations can impact 

surface water, groundwater, air, and soil (EPA, 2009a). Waste disposal 

practices used by animal feeding operations can contribute to water quality 

degradation. Many of these operations collect manure from animal 

confinement areas in solid or liquid form and apply it to farmland as a 

nutrient for crops or simply as a disposal method (EPA, 2009b). In 

groundwater, pathogens and nitrates from manure can impact public health 

via drinking water (EPA, 2009a). Nitrate contamination is more prevalent 

in ground waters than in surface waters (EPA, 2009a). In addition to 

adverse impacts, animal manure can provide environmental benefits; if 

applied under proper conditions, animal manure is a valuable fertilizer and 

soil conditioner. 

Animal production is also one of the human-related contributors to 

methane emissions. While conversion of otherwise unusable plant 

materials into nutritious food and fiber is a positive aspect of the digestive 

systems of ruminant animals, such as cattle, the digestive system of a 

ruminant animal also produces methane (EPA, 2007). The U.S. EPA 

reports that in the United States, based on a cattle population of about 

100 million, about 5.5 million metric tons of methane is released into the 

air each year, accounting for 20 percent of U.S. methane emissions. 

Methane, a greenhouse gas believed to contribute to global warming, is 

emitted from various human-related and natural sources. Other humanrelated sources of methane emissions include fossil fuel production, rice 

cultivation, biomass burning, and waste management (EPA, 2011). 

a. No Action Alternative 

For the years 2008 and 2009, an average of 26 million cattle was marketed 

from U.S. feedlots (USDA, NASS, 2009; USDA, NASS, 2010).70 Cattle 

are moved into feedlots at various times of the year and are fed in feedlots 

for several months. Thus, cattle that are moved into feedlots in the latter 

months of a reporting year may be available for marketing in the next 

year. As well, bovines are imported from Canada and Mexico throughout 

the year and there is no available breakdown from statistical reports on the 

number of marketed cattle that were imported; they are part of the overall 

U.S. total marketed. 

As estimated for 2008 and 2009 (see appendix, table A-6), bovines 

imported from Canada and Mexico represented about 4 percent71 72 of the 

 

70 About 26,449,000 for 2008 and 25,604,000 for 2009. 71 185,574 + 705,661 = 891,235, representing 3 percent of 26,449,000. (The total of 185,574 is based upon an 

assumption that cattle imported from Canada (in 2008) and designated as other than for breeding, dairy, or 

immediate slaughter purposes are feeder cattle.) 
49 

total U.S. cattle in feedlots marketed during that period and likely 

contributed toward a relative portion of overall environmental impacts in 

feedlots that are regulated by Federal, State, and local laws. 

b. Proposed Action 

According to the related regulatory impact analysis, the effect of this 

proposed rule on imports into the United States would be minimal at most; 

therefore, the number of bovines imported into feedlots for feeding and 

then slaughter would not appreciably differ from the No Action 

alternative. 

The processing of bovines for slaughter generates SRMs that would be 

disposed of at slaughter. As discussed earlier in this document, SRMs are 

the tissues that are required, according to U.S. regulations, to be removed 

from bovines because, in the case of an animal that has had exposure to 

the BSE infective agent, these tissues are considered at particular risk of 

containing infectious levels of the BSE agent in BSE-infected cattle. 

Although differences are noted in SRM weight from two sources (see 

appendix, table A-7), for purposes of this EA the SRM calculations use the 

most conservative weights from the combination of both sources. For 

cattle under 30 months of age, SRMs include the distal ileum and tonsils, 

totaling approximately 3 pounds per animal. For cattle 30 months of age 

and older, SRMs include the brain, spinal cord, eyes, skull, trigeminal 

ganglia, distal ileum, tonsils, and vertebral column, totaling approximately 

57 pounds (USDHHS, FDA, 2005; USDA, FSIS, 2007). 

a. No Action Alternative 

Under the No Action alternative, which represents the current situation 

with regard to importation of live bovines and bovine-derived products, 

live cattle and bison are imported from Canada, a BSE minimal-risk 

region (9 CFR 94.18(a)(3)), and cattle are imported from Mexico, a region 

whose importation of bovines and bovine-derived products is not 

restricted under any of the APHIS BSE risk classifications (defined in 

9 CFR §§ 94.18(a)(1), (2), and (3)). As mentioned previously, FSIS 

regulations require that SRMs from cattle must be removed at slaughter, 

including from those that are imported. (Under APHIS regulations, SRMs 

are also required to be removed, but reference in the regulations is to 

removal from bovines instead of specifically to cattle.) The revised 

APHIS BSE import regulations became effective on November 19, 2007. 

 

72 75,063 + 940,789 = 1,015,852; representing 4 percent of annual slaughter of 25,604,000, (The total of 75,063 

is based upon an assumption that cattle imported from Canada (in 2009) and designated as other than for 

breeding, dairy, or immediate slaughter purposes are feeder cattle.) 

3. SRMs 

Generated 
50 

To account for SRMs generated annually from imported live bovines 

under the No Action alternative, this analysis includes imported live 

bovines that are unrestricted for BSE under existing APHIS import 

regulations. Import data for live bovines from 2008 and 2009 are 

averaged to arrive at the total of SRMs generated annually from imported 

bovines (see appendix, tables A-8 and A-9). For 2008, SRMs generated 

from imported cattle (both Canada and Mexico) are estimated to be about 

20.1 million pounds and for 2009 to be about 19.5 million pounds. 

b. Proposed Rulemaking 

Under the proposed rulemaking, imported live bovines from the countries 

of Canada and Mexico would continue. As determined in the related 

regulatory impact analysis, the amount of live bovines imported from 

Canada are not expected to be affected and, at most, impacts on the 

number of types of bovines currently eligible for importation from Mexico 

would be minimal based on changes proposed for the APHIS BSE import 

regulations (USDA, APHIS, 2011). Because the proposed changes to 

APHIS’ BSE import regulations would not cause a substantial change in 

the number of imported live bovines from Canada, Mexico, or other 

countries, a substantial difference in the amount of SRMs that would be 

removed at slaughter and disposed from imported live bovines is not 

expected. 

C. Highly Uncertain or Unique or Unknown Risks 

The OIE Code that APHIS regulations will closely align with is based on 

an international scientific consensus about the BSE agent, the mechanisms 

for its spread, and the tissues that are most likely to harbor the infective 

agent. Scientific research, backed by practical experience, has resulted in 

a defined series of measures that countries can use to keep the BSE agent 

out of the food and feed chain and thus ensure the safety of public health 

and, indirectly, animal health. The revised requirements and conditions in 

the APHIS rulemaking for which this EA is prepared (based on the most 

current science known about BSE), combined with the requirements in 

existing regulations for SRM removal and the ruminant feed ban enforced 

by FSIS and FDA respectively, are designed to protect public health and 

animal health from the possibility of exposure to the BSE agent. 

D. Endangered or Threatened Species 

Section 7 of the Endangered Species Act (ESA) and ESA’s implementing 

regulations require Federal agencies to ensure that their actions are not 

likely to jeopardize the continued existence of endangered or threatened 

species or result in the destruction or adverse modification of critical 

habitat. Therefore, the following section discusses the effect of the 
51 

proposed action and No Action alternatives on federally listed threatened 

and endangered species in the United States. 

Transmissible spongiform encephalopathies (TSE’s) have been reported in 

European zoos in wild ruminants, cats, and monkeys (Cunningham et al., 

2004) and most are believed to have resulted from consumption of 

contaminated feed. Thus, for the proposed action and the No Action 

alternative, six endangered ruminant species were considered as 

potentially at risk from the ingestion of contaminated feed (see table 3). 

Table 3. Endangered Wild Ruminant Species in the United States 

 Potentially At Risk From Transmissible Spongiform 

 Encephalopathies. 

Common Name Scientific Name Listing Status

Woodland caribou Rangifer tarandus caribou Endangered

Columbian white-tailed deer Odocoileus virginianus 

leuceurus

Endangered

Key deer Odocoileus virginianus clavium Endangered

Sonoran pronghorn Antilocapra americana 

sonoriensis

Endangered

Peninsular bighorn sheep Ovis canadensis nelsonii Endangered with 

critical habitat

Sierra Nevada bighorn 

sheep

Ovis canadensis sierrae Endangered with 

critical habitat

Also, for the proposed action and No Action alternatives, eight federally 

listed cats were considered for risk of infection from BSE because of the 

possibility that they could feed on BSE-infected bovine carcasses (see 

table 4).

Table 4. Federally Listed Cats Known to Feed on Bovine Carcasses. 

Common Name Scientific Name Listing Status

Canada lynx Lynx canadensis Threatened 

Eastern puma 

(=cougar)

Puma (=Felis) concolor cougar Endangered 

Endangered 

Endangered 

Endangered 

Endangered 

Endangered

Florida panther Puma (=Felis) concolor coryi

Gulf Coast jaguarundi Herpailurus (=Felis) yagouaroundi 

cacomitli

Jaguar Panthera onca

Ocelot Leopardus (=Felis) pardalis

Sinaloan jaguarundi Herpailurus (=Felis) yagouaroundi 

tolteca

Puma (=mountain lion) Puma (=Felis) concolor (all subsp. 

except coryi) 

Similarity of 

appearance to a 

threatened taxon 
52 

Effects of the No Action alternative on endangered and threatened species 

were analyzed in the environmental assessments prepared for each of the 

rulemakings that comprise the current APHIS BSE import requirements 

(USDA, APHIS, 2004a; USDA, APHIS, 2005; and USDA, APHIS, 

2007a). In those environmental analyses, APHIS determined that the 

importation of certain live ruminants, ruminant products, and by-products 

from Canada and the importation of whole cuts of boneless beef from 

Japan under certain conditions (the No Action alternative in this 

environmental analysis) would have no effect on federally listed ruminants 

or cats or their designated critical habitat. 

APHIS’ proposal to align its regulations with the OIE Code, with modified 

requirements, would continue to protect U.S. cattle from exposure to BSEinfected imports (USDA, APHIS, 2009). This would result in protection 

of federally listed ruminants and cats from exposure to BSE via 

contaminated feed or infected bovine carcasses. Therefore, APHIS has 

determined that implementation of the proposed action would have no 

effect on federally listed ruminants or cats or their designated critical 

habitat. 

E. Cumulative Impacts 

Under NEPA, Federal agencies are required to analyze the potential 

cumulative impacts of a proposed action. The Council on Environmental 

Quality (CEQ) defines cumulative impacts as impacts on the environment 

that result from incremental impact of an action when added to other past, 

present and reasonably foreseeable future actions. Actions resulting in a 

cumulative impact may or may not be generated by the same agency. 

Cumulative impacts can result from individually minor but collectively 

significant actions taking place over a period of time.73

BSE-infected bovines and bovine-derived materials can potentially impact 

the human environment, including public health, if SRMs with infectious 

levels of the BSE agent enter the food chain. Existing regulations in the 

United States containing mitigation measures to prevent the BSE agent 

from entering the food chain are discussed previously in this document. 

Mitigation measures contained in the OIE guidance that APHIS is 

proposing to adopt (with some modifications) under the preferred 

alternative are also discussed previously in this document. The 

cumulative impacts of the current APHIS regulations, the proposed action 

(changing APHIS import regulations so that they are mostly consistent 

with the OIE Code for importation of live bovines and importation of 

bovine-derived products), and any future proposed actions should not have 

a significant impact on the human environment in the United States. 

 

73 40 CFR § 1508.7 

1. Public Health
53 

To prevent the introduction and spread of the BSE agent, there are 

multiple required mitigation measures implemented by APHIS and other 

Federal agencies under current regulations. Under the proposed action 

discussed in this document, there are also multiple mitigation and 

safeguarding measures in place to prevent the introduction and spread of 

the BSE agent. A significant breakdown across multiple Federal agencies 

under the current regulations or a substantial failure of the OIE 

requirements that APHIS proposes to accept with some modifications 

described in the proposed action in this document would have to take 

place in order to cause the BSE agent to be released into human and 

animal food supplies in the United States. Because of the interlocking, 

overlapping, harmonized nature of the proposed revised APHIS 

regulations with regulations from other agencies in the United States, there 

is no evidence to conclude that such a significant system failure would 

take place. In cases where, under the proposed alternative, APHIS is 

proposing to deviate from OIE guidance, the deviations will result in 

additional levels of mitigation and safeguarding to prevent the 

introduction and spread of the BSE agent, even further decreasing any 

possibility of a system failure in BSE regulations. In the unlikely event 

that live bovines or bovine-derived products containing SRMs that are 

infected with BSE are imported into the United States, any potential 

cumulative risk of removing and segregating these SRMs, in combination 

with established regulations for removing and segregating SRMs from 

U.S. bovines, would not increase public health risks from BSE exposure, 

assuming that U.S. facilities adhere to existing regulations enforced by 

FSIS and FDA. 

Other U.S. Federal Agency Regulations 

Current APHIS regulations and regulations under the proposed alternative 

discussed in this document are designed, in part, to be harmonized with 

existing FDA and FSIS regulations. FDA and FSIS contribute to the 

overlapping safeguards currently in place to ensure that public health in 

the United States is protected from the BSE infective agent, and these 

overlapping safeguards would not change if APHIS implements new 

regulations as proposed in this document. The FDA and FSIS regulations 

are discussed in more detail in the Public Health section of this document. 

In summary, the overlapping, harmonized safeguards from both agencies 

include: 

 FDA’s ruminant-to-ruminant feed ban regulation. 

 FDA and FSIS regulations on tissues that constitute SRMs and 

SRM removal, segregation and disposition, all of which are 

intended to ensure that SRMs do not enter the human food chain 
54 

and that they do not contaminate edible meat, cosmetic, medical, 

or other products intended for human consumption. 

 FSIS regulations on the disposition of nonambulatory cattle. 

Under FSIS regulations, nonambulatory cattle must be condemned 

and are prohibited from being used in any edible products intended 

for human consumption. Carcasses of nonambulatory cattle must 

be disposed of by tanking (an inedible rendering process), 

incineration, or denaturing by materials approved by the 

Administrator of FSIS. 

 FSIS regulations prohibiting incorporation of mechanically 

separated meat in food intended for human consumption. 

 FSIS regulations prohibiting the use of certain stunning devices 

and pithing during slaughter. 

In April 2008, FDA issued a final regulation74 that prohibits the use of 

certain cattle materials from animal feed, including pet food. The 

prohibited materials include (1) the entire carcass of BSE-positive cattle, 

(2) the brains and spinal cords of cattle 30 months of age and older, (3) the 

entire carcass of cattle not inspected and passed for human consumption 

that are 30 months of age and older from which the brains and spinal cords 

were not effectively removed or otherwise effectively excluded from 

animal feed, (4) mechanically separated beef derived from the materials 

prohibited by this regulation, and (5) tallow that is derived from the 

materials prohibited by this regulation. The regulation is an added 

measure to exclude high-risk materials from all animal feeds and to 

prevent any accidental feeding of such ingredients to cattle. The 

regulation further serves to protect animals and consumers from the 

already low risk of BSE exposure. The regulation became effective 

October 29, 2009, allowing the livestock, meat, rendering, and feed 

industries time to adapt their practices to comply with the new 

requirements.75 When implemented, this regulation will become another 

overlapping safeguard in addition to the safeguards listed above. 

a. Transport of Commodities 

Commercial trucks are one segment of the transport industry. Including 

an increase in trade with Canada and Mexico over the last two decades, 

commercial trucks accounted for about 8 percent of highway vehicle miles 

traveled (IEI and R&AEC, Ltd., 2007). EPA has implemented numerous 

efforts associated with improving air quality for compliance with the 

Clean Air Act to reduce air pollutants, including those that contribute to 

greenhouse gases, from commercial trucks. Additional efforts by EPA, in 

coordination with transport industry groups, are underway to reduce air 

pollutants and greenhouse gases from other transport modes, including 

 

74 73 FR 22720, April 25, 2008 

75 21 CFR 589.2001, April 27, 2009

2. Physical 

 Environment 
55 

ship vessels and locomotives. As transport is a necessary action for 

imported and exported commodities, the efforts to reduce impacts on the 

physical environment from the various transport modes are important for 

protecting environmental quality now and in the future. Provided that the 

amounts of imported live bovines and bovine-derived products do not 

increase substantially in future years, it is possible that the contribution of 

emissions from the transport of these commodities could be reduced 

because of the U.S. regulatory efforts that are intended to reduce the 

amounts of diesel engine emissions from commercial trucks, marine 

vessels, and locomotives. 

As discussed in the regulatory impact analysis prepared for the proposed 

rulemaking (USDA, APHIS, 2011), the proposed regulatory changes to 

closely align the APHIS BSE import regulations with the OIE Code 

should have, at most, minimal impact on the imports of live bovines or 

bovine-derived products into the United States from Canada and Mexico 

(USDA, APHIS, 2011). The regulatory changes also are unlikely to have 

an appreciable impact on U.S. imports of cattle and bison from countries 

other than Canada and Mexico (USDA, APHIS, 2011). With regard to 

imported live cervids and camelids, the proposed regulatory changes are 

expected to have little or no impact on the amount of imported live cervids 

and camelids and are likely to be minimal, at most, for imported cervid 

and camelid products (USDA, APHIS, 2011). Relevant to the anticipated 

minimal changes in imported commodities associated with the proposed 

rulemaking, the baseline of transport activities associated with the 

importation of these commodities is not expected to change appreciably. 

Therefore, impacts on the physical environment, e.g., additional transports 

of products, from the proposed regulatory changes are not expected to 

change appreciably from the current baseline of impacts on the physical 

environment. 

Environmental impacts related to the transport modes would continue to 

be regulated under Federal laws, such as the Clean Air Act and Clean 

Water Act, that serve to protect the quality of the human environment. 

Changes to the APHIS BSE import regulations are not expected to result 

in an appreciable change in the baseline of current impacts on the 

environment from the importation of these commodities. 

b. SRMs Generated 

For purposes of cumulative impacts under this analysis, the amount of 

SRMs that would be generated under the proposed action is compared to a 

baseline of SRMs generated from U.S. commercial cattle slaughter. For 

the years 2008 and 2009, the average annual U.S. commercial cattle76

slaughter is about 34 million head (USDA, ERS, 2010). For 2008 and 

 

76 Includes calves. 
56 

2009, the average number of cattle processed through commercial 

slaughter that were under 30 months of age is estimated to be 27 million, 

and the average number of cattle 30 months of age and older processed 

through commercial slaughter is estimated to be 6.25 million (USDA, 

ERS, 2010).77 The annual U.S. slaughter of cattle results in the generation 

of approximately 440 million pounds of SRMs (see appendix, table A-10). 

BSE-infected bovines may affect the human environment, which includes 

the natural or physical environment, if these animals were to become a 

part of the supply of animals processed at slaughter. However, safeguards 

in place at slaughter, required according to U.S. regulatory requirements, 

such as visual inspection of animals presented for slaughter, the 

prohibition of certain slaughter practices, and the removal and disposition 

of SRMs at slaughter, are designed to prevent potential exposure from any 

possible BSE infectivity in processed animals. 

With regard to the importation of live bovines and bovine-derived 

products, two of the most important risk mitigation measures are the 

control of SRMs and feed bans. Most of the the OIE Code rests on these 

two significant mitigation measures. Additional risk mitigation measures 

include the application of certain production processes that inactivate the 

BSE agent. The use of these mitigation measures as outlined in the OIE 

Code substantially reduces the risk that the BSE agent might be present in 

the animals or products presented for trade. The importance of risk 

mitigation measures, including SRM removal and proper disposal, an 

effective ruminant-to-ruminant feed ban, and production processes for 

certain bovine-derived commodities (such as gelatin production), are 

discussed in further detail in the scientific supporting documentation and 

the related rulemaking docket. 

Under the proposal, the risk mitigation measures included in the OIE Code 

would be applied both in the country of origin (to minimize the risk that 

the BSE agent would be present in an imported animal or product) and in 

the United States (to minimize the risk that BSE would be established in 

the United States if it was present in an imported animal or product). 

APHIS modifications to these guidelines, such as, SRM removal for 

bovine-derived commodities in accordance with FSIS regulations and no 

live bovines from undetermined BSE risk countries, to reflect APHIS’ 

interpretation of the scientific literature and current USDA regulations and 

policies would further support requirements that prevent the introduction 

or transmission of the BSE agent via imported commodities, further 

support safeguarding efforts to prevent the introduction and spread of the 

BSE agent. The combined OIE requirements and additional APHIS 

requirements are intended to prevent the introduction and spread of the 

 

77 Based on an assumption that all cull cattle (cows and bulls for slaughter) were at least 30 months of age and 

all others (steers and heifers) were under 30 months of age.
57 

BSE agent from imported commodities regardless of a country’s BSE 

prevalence. 

SRM removal occurs at slaughter for all bovines, whether they are U.S.-

produced or imported. FSIS78 requires SRMs to be rendered as “unfit for 

human food” within the meaning of section 1(m)(3) of the adulteration 

provisions of the Federal Meat Inspection Act.79 To date, there is no 

evidence to suggest that the amount of SRMs removed from imported live 

bovines under the current APHIS BSE import regulations has caused 

adverse impacts on the quality of the human environment. Based on 

available information related to economics and practicability, the amount 

of imported live bovines is not expected to change because of proposed 

changes to the APHIS BSE import regulations. Relative to the amount of 

imported live bovines, a change in the amount of SRMs generated is not 

expected. Most importantly, U.S. regulatory requirements related to 

slaughter processes and SRM removal and disposition would remain 

unchanged. FSIS and FDA requirements and requirements under the 

proposed rulemaking for the importation of live bovines would serve as 

overlapping safeguards. SRM removal and disposal practices according to 

FSIS regulations would not increase impacts on the human environment. 

In comparing the amount of SRMs removed in U.S. cattle slaughter 

annually (2008 and 2009) to the SRMs generated from imported cattle 

annually, SRMs generated from cattle imported from Canada and from 

Mexico (an average of 19.5 million pounds) represent less than 1 percent 

of the total SRMs generated from annual U.S. cattle slaughter. 

The proposed action would continue to allow imported live bovines from 

Canada and Mexico with no relative change in the amount imported. 

Therefore, the amount of SRMs generated from imported live bovines is 

not expected to change appreciably from the current baseline of SRMs 

generated and disposed through U.S. slaughter of bovines. There is no 

evidence to indicate that the quantity of SRMs generated from imported 

live bovines and their disposal under the proposed action would have an 

additive impact on the natural and physical environment or that the 

quantity of SRMs generated from imported live bovines could not be 

appropriately managed by U.S. facilities. 

As discussed earlier in this document, imported cattle have represented a 

small amount of the total of U.S. cattle in feedlots and contributed toward 

a relative portion of environmental impacts in cattle feedlots that are 

regulated by Federal, State, and local laws. Other livestock production, 

such as swine, that are not a part of this proposed action, contribute to 

environmental impacts from feedlots also. As discussed earlier in this 

 

78 In accordance with 9 CFR part 314 79 21 U.S.C. 601(m)(3) 

3. Holding 

 Imported 

 Bovines in 

 Feedlots 
58 

document, various Federal, State, and local laws regulate the pollutants 

and emissions caused by animal production. While methane gas 

emissions are not regulated, various studies and EPA efforts are underway 

to determine how to reduce their impact on the environment. 

The proposed action would continue to allow the importation of live 

bovines from Canada and Mexico with minimal change in the amount 

imported. Therefore, the amount of environmental impacts from imported 

bovines in feedlots is not expected to change appreciably. There is no 

evidence to indicate that the environmental impacts contributed by 

imported live bovines under the proposed action would have an additive 

impact on the baseline of impacts from feedlot production on the natural 

and physical environment or that the impacts would be unmanageable 

under existing U.S. regulations (Federal, State, and local) that are intended 

to protect U.S. environmental quality. 

IV. Agencies or Persons Contacted 

U.S. Department of Agriculture 

Animal and Plant Health Inspection Service 

Policy and Program Development, Environmental and Risk Analysis 

Services 

Riverdale, MD 

U.S. Department of Agriculture 

Animal and Plant Health Inspection Service 

Policy and Program Development, Policy Analysis and Development 

Riverdale, MD 

U.S. Department of Agriculture 

Economic Research Service 

Washington, DC 

U.S. Department of Agriculture 

National Agricultural Statistics Service 

Washington, DC 

U.S. Department of Agriculture 

Food Safety and Inspection Service 

Washington, DC 

U.S. Health and Human Services 

Food and Drug Administration 

Center for Food Safety and Applied Nutrition 

Washington, DC 
59 

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http://www.bts.gov/programs/international/border_crossing_entry_data. 

Accessed April 2011. 

U.S. Department of Transportation, 2011b. Trade statistics: U.S. 

waterborne foreign trade by U.S. custom ports. U.S. waterborne foreign 

import by U.S. custom ports. Available: 

http://www.marad.dot.gov/documents/U.S._Waterborne_Foreign_Trade_b

y_Trading_Partners.xls 

USDHHS, FDACSee U.S. Department of Health and Human Services, 

Food and Drug Administration. 

U.S. Environmental Protection Agency, 2007. Ruminant livestock. 

Frequent questions. Last updated 3/21/07. Available: 

http://www.epa.gov/methane/rlep/faq.html. Accessed 3/24/08 and 

5/02/11. 

U.S. Environmental Protection Agency, 2009a. Potential environmental 

impacts of animal feeding operations. Updated 9/10/09. Available: 

http://www.epa.gov/agriculture/ag101/impacts.html. 

U.S. Environmental Protection Agency, 2009b. Ag 101. Beef production. 

Manure management. Updated 9/10/09. Available: 

http://www.epa.gov/agriculture/ag101/beef.html. Accessed 4/1/08 and 

5/02/11. 

U.S. Environmental Protection Agency, 2011. Methane. Sources and 

emissions. Updated 4/18/11. Available: 

http://www.epa.gov/methane/sources.html. Accessed 3/24/08 and 

4/29/11. 

World Organization for Animal Health (OIE), 2010. Terrestrial Animal 

Health Code (2010), Chapter 11.5: Bovine spongiform encephalophathy. 

Available: 

http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.11.5.htm. 

Accessed April 2011. 
64 

Appendix. Additional Information for Chapter 3. 

A. Transport of Imported Live Bovines, Bovine-derived 

Commodities, and Cervids and Camelids 

Live Bovines 

While livestock are transported in many types of vehicles, for purposes of 

this analysis, we will consider that the cattle from Canada and Mexico 

would most likely be transported by a semi-trailer, generally used in the 

commercial industry for livestock. This type of vehicle is 40 feet long by 

8.5 feet wide and has multiple decks. The legal haul weight of 80,000 

pounds for this transport vehicle, including the weight of the truck and 

trailer (35,000 pounds) could carry 45,000 pounds in livestock (Cobb, 

undated). As an example of how many cattle this type of vehicle could 

carry, if all cattle in a load weighed 400 pounds each, at the most, about 

112 cattle per truckload (45,000 pounds ÷ 400 pounds = 112.5) could be 

transported. Trucks vary in size and capacity, and cattle weight varies 

from animal to animal, so the number per truckload will vary. This 

analysis estimates the number of bovines per truckload using a 

conservative number of 50 cattle or 40 bison per truckload to account for 

variations in animal weight and truck sizes and capacities, thus the number 

of truck transports is slightly overestimated. 

Table A-1 provides the numbers of live bovines imported from Canada 

during 2008 and 2009, reflecting the initial two years of import data for 

live bovines from Canada, since the resumption of trade in bovines born 

on or after March 1, 1999, and the estimated number of commercial truck 

transports that would have been required for their import.80

 

80 As of the time of collecting data, a complete year of truck transport data was not yet available for calendar 

year 2010; therefore, import data from 2008 and 2009 for live bovines are used to correspond with the two most 

recent complete calendar years of data for truck crossings at the Canada and Mexico U.S. border crossing, 

which are for 2008 and 2009 as of the date of this environmental analysis. To be consistent throughout, this EA 

uses 2008 and 2009 data to arrive at a 2-year average of recent data. 
65 

Table A-1. 2008 and 2009 Live Bovine Imports from Canada 

 and Estimated Truck Transports Required 

Bovine imports1

 Estimated no. of truck 

transports required 

2008 

Cattle 1,581,303 31,626

Bison 29,670 742

2008 Total 1,610,973 32,368

2009 

Cattle 1,061,005 21,221

Bison 25,850 647

2009 Total 1,086,855 21,868

2-year Average 1,348,914 27,118 1 Source for cattle imports: Livestock and meat trade data. Available on the Internet at 

http://www.ers.usda.gov/data/meattrade. Source for bison imports: Foreign Agricultural Service, U.S. 

Trade Internet System. U.S. Trade Imports – HS Code 0102904010. Available on Internet via 

http://www.fas.usda.gov/gats/default.aspx 

Table A-2 provides the numbers of live bovines imported from Mexico 

during 2008 and 2009, and the estimated number of commercial truck 

transports that would have been required for their import. 

Table A-2. 2008 and 2009 Live Cattle Imports from Mexico 

 and Estimated Number of Truck Transports Required 

Cattle Imports 

Estimated no. of truck 

transports required 

2008 702,661 14,053

2009 940,869 18,817

2-year Average 821,765 16,435

Bovine-derived Products 

Of the countries from which the United States currently allows imports of 

bovine-derived products (this includes countries or regions with and 

without restrictions with regard to BSE), the volume and average volume 

of bovine-derived products for 2008 and 2009 are provided in table A-3. 
66 

Table A-3. Volume (20008 and 2009) of Bovine-derived Products 

 Imported to the United States (in Metric Tons (MT)) 

Region of Origin

2008 imported 

bovine-derived 

products 

(MT)81

2009 imported

bovine-derived 

products 

(MT)82

2008-2009 

average 

(MT, rounded)

Argentina 13,497.7 10,622.1 12,060

Australia 233,332.5 270,951.2 252,142

Brazil 53,475.8 49,270.0 51,373

Canada 296,083.6 293,719.3 294,901

Chile 807.4 753.6 781

Costa Rica 6,386.5 7,712.5 7,050

Honduras 2,202.3 1579.3 1,890

Japan 149 140.8 145

Mexico 15,628.4 25,439.9 20,534

New Zealand 175,783.3 172,457.0 174,120

Nicaragua 33,475.2 30,092.1 31,784

Pacific Islands 0.0 0.9 1.0

Uruguay 23,882.1 25,217.4 24,550

Total 854,706.6 887,956.1 871,331

 Information source: USDA, FAS, 2011. 

Table A-4 provides the total estimated/averaged commercial truck 

transports for imported live bovines and bovine-derived products for 2008 

and 2009 (for Canada and Mexico). 

Table A-4. Estimated Average Number of Commercial Truck Transports for 

Imported Live Bovines and Bovine-derived Products from 

Canada and Mexico, 2008-2009. 

Region 

of Origin 

Truck Transports for 

Live Bovines 

Truck Transports 

for Bovinederived Products 

Total Truck 

Transports for Live 

Bovines and Bovinederived Products at 

the U.S. Northern and 

Southern Borders 

Canada 27,118 14,776 41,894 

Mexico 16,435 1,029 17,464 

Total 43,553 15,804 59,358 

Live Cervids and Camelids 

Imported deer, weighing about 97-300 pounds each, are generally 

transported in a horse or cattle trailer (which vary in size) and in loads of 

about 30 head each. Imported elk generally range in weight from about 

600-900 pounds each and are usually transported in a load of 1-3 heads 

per horse or cattle trailer; the estimate of transport vehicles in the table 

below is based on an average of 2 animals per shipment. Imported 

alpacas, camels, and llamas generally range in weight from 100-400 

 

81 One metric ton is equivalent to about 2,204 pounds. 

82 One metric ton is equivalent to about 2,204 pounds. 
67 

pounds each and are typically transported in loads of 2-18 heads in a horse 

or cattle trailer; the estimate of transport vehicles in the table below is 

based on an average of 10 animals per shipment. These imports have 

originated from Canada. 

Table A-5. Imported Live Cervids and Camelids, 2008-2009, and Estimated 

No. Transport Vehicles 

Imports 2008 2009 Total 

Estimated No. of 

Transport 

Vehicles 

Cervids 

 Deer 27 459 486 162 

 Elk 487 1,277 1,764 882 

Camelids 330 232 562 53 

Total No. of Transport Vehicles 1,097 

B. Cattle in Feedlots 

The following is a general estimation of imported cattle marketed in 2008 

and 2009 and does not account for animals imported in the latter part of a 

year being marketed in the subsequent year. 

 

Table A-6. Estimate of Imported Bovines in Feedlots During 2008 and 2009 

Compared to Overall Total of U.S. Cattle Marketed from Feedlots 

in 2008 and 2009

Region of Origin 

Estimated No. 

Head of Cattle 

Imported and 

Placed in Feedlots 

in 2008 a

Estimated No. Head of 

Cattle Imported and 

Placed in Feedlots in 

2009 a

Canada 185,574a 75,063 a

Mexico 705,661 940,789b

Total U.S. Cattle Marketed from 

Feedlots 26,449,000 25,604,000 

Percentage of imported cattle to 

feedlots compared to U.S. total 

slaughtered from feedlots 3 percent 4 percent a Assuming that all cattle not classified as imported for purposes of breeding, dairy, or for immediate 

slaughter are feeder cattle. 

b Total 2009 MX imports minus 40 imported for breeding purposes.

C. Specified Risk Materials (SRMS) Generated 

The following table provides information about the weight of SRMs 

generated during slaughter, according to the definition of SRMs regulated 

under FDA and FSIS regulations. We note that these calculations vary 

because SRMS calculated in the FDA document (an environmental 

assessment) were based on regulatory amendments to prohibit SRMs from 

use in animal food or feed and in the FSIS document (an economic 

analysis) were based on regulatory amendments to prohibit SRMs for use 
68 

in human food. APHIS used a conservative calculation in arriving at the 

amount of SRMs generated from live bovines at slaughter—3.1 pounds of 

SRM for cattle under 30 months of age and 57 pounds for cattle 30 months 

of age and older, which considers a larger amount of SRMs removed as 

did the FDA document. 

Table A-7. Weight (in pounds) of Specified Risk Materials (SRMs) for Cattle 

 30 Months of Age and Older 

SRMs 

Weight in lb.

(USDHHS, FDA, 2005) 

Weight in lb.

(USDA, FSIS, 2007) 

Brain 1.0 0.936 

Spinal cord 0.374 0.4 

Eyes 0.22 *included w/skull weight 

Skull + trigeminal ganglia 15.2 16.2 

Distal ileum 3.5 0.5 

Tonsils 0.3 2.5 

Vertebral column 36.5 Not included* 

Total pounds 57.094 20.536

* In an economic analysis, FSIS did not include the weight of the vertebral column in its table of 

“Estimated Most-likely weight of SRMs per Head at Slaughter Establishments” (USDA, FSIS, 2007) 

(because of the potential use of the vertebrae of the tail, the transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the sacrum from cattle 30 months of age and older in products for 

human consumption provided that the vertebral column portion that contains DRG (dorsal root 

ganglia) is excluded). 

According to calculations for SRM regulation by FDA, “cattle not over 

30 months of age” (in other words, cattle 30 months of age and under) 

generate approximately 28.3 pounds of SRMs while cattle over 30 months 

of age generate approximately 88.583 pounds of SRMs (USDHHS, FDA, 

2005). For these calculations FDA included the entire small intestines. 

However, BSE infectivity has not been confirmed in any portion of the 

intestinal tract of cattle other than the distal ileum. FSIS regulations 

permit beef small intestines, excluding the distal ileum, to be used for 

human food.84 The FDA regulations permit the manufacture and use of 

beef casings derived from beef small intestines, excluding the distal ileum, 

for human food and cosmetics.85 Therefore, for APHIS’ purposes, it is 

inappropriate to consider the entire small intestines when calculating the 

weight of SRMs generated during slaughter. 

For cattle 30 months of age and younger, the entire small intestine (with 

distal ileum) weighs about 28 pounds. For cattle over 30 months of age, 

the entire small intestine (with distal ileum) weighs about 35 pounds. 

According to industry sources, the distal ileum comprises roughly 10 

 

83 The following tissues are designated as SRMs: 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 dorsal root ganglia of cattle 30 months of age and older, and the 

distal ileum and tonsils of all cattle (9 CFR § 310.22(a)).

84 70 FR 53043, September 7, 2005. 85 70 FR 53063, September 7, 2005.
69 

percent86 of the small intestine by weight (USDA, FSIS, 2005). By 

multiplying FDA’s estimate for the weight of the small intestines87 (which 

includes the distal ileum) by 10 percent, cattle under 30 months would 

generate approximately 2.8 pounds of distal ileum, while cattle over 

30 months would generate approximately 3.5 pounds of distal ileum. 

Using these weights for the distal ileum instead of the weight of the entire 

small intestine, cattle under 30 months of age would generate 

approximately 3.1 pounds of SRMs88 while cattle over 30 months of age 

would generate approximately 57 pounds of SRMs.89 FDA estimates that 

cattle 30 months of age would generate the same amount of SRMs as 

cattle under 30 months of age. However, as per the definition of SRMs in 

9 CFR § 310.22(a) (see footnote 83 below), cattle 30 months of age would 

generate an equal amount of SRMs as cattle over 30 months of age. 

The following tables (A-8 and A-9) provide a breakdown of the total 

numbers of live bovines, according to age groups, that are imported from 

Canada and Mexico annually for slaughter (both feeding and immediate 

slaughter) and the estimated weight of total SRM materials that must be 

removed at slaughter from these animals. It is noted that bovines that are 

imported for breeding or dairy purposes are not includes in these tables. 

Table A-8. Estimated SRMs Generated from Imported Live Bovines Under 

 the No Action Alternative (for 2008) 

Origin of 

Imported 

Live 

Bovines 

Imported 

bovines 30 

months of 

age and 

older 

SRMs 

generated 

(in lbs.) 

from 

bovines 30 

months of 

age and 

older

Imported 

bovines 

under 30 

months of 

age (except 

for dairy or 

breeding) 

SRMs 

generated 

(in lbs.) 

from 

bovines 

under 30 

months of 

age 

Total 

estimated 

weight (in 

lbs.) of 

SRMs 

removed at 

slaughter 

Canada 

 - Cattle 234,615a 13,373,055 1,301,910 b

 4,035,921 17.4 million 

 - Bison 7,418a 422,826 22,252 68,981 0.5 million 

Mexico n/a n/a 702,661c 2,178,249 2.2 million 

SRM 

Total 13,795,881 6,283,151 20.1 million a

 Based on assumption from cattle import data for bulls and cows for immediate slaughter during 

2008 (234,615) and an estimate that 25 percent of bison imported during 2008 are 30 months of age 

or older (overall import numbers obtained through USDA, ERS, 2010 and USDA, FAS, 2011). 

b Total of 1,581,303 cattle (USDA, ERS, 2011) subtracting 234,615 imported cull cattle and 44,778 

breeding or dairy purpose cattle (USDA, FAS, 2011). 

c

 Import information for 2008 from “Annual and cumulative year-to-date U.S. trade (head)” table 

(USDA, ERS, 2011).

 

86 The weight of the distal ileum is highly variable from one animal to the next. However, the estimate that the 

distal ileum comprises 10 percent of the entire small intestine is a conservative estimate (USDA, FSIS, personal 

communication, 2005).

87 28.0 pounds in cattle under 30 months and 35.0 pounds in cattle over 30 months. 88 2.8 pounds of distal ileum + 0.3 pounds of tonsils (USDHHS, FDA, 2005) = 3.1 pounds of SRMs. 

89 3.5 pounds of distal ileum + 0.3 pounds of tonsils (USDHHS, FDA, 2005) + 0.936 pounds of brain 

(USDHHS, FDA, 2005) + 0.374 pounds of spinal cord (USDHHS, FDA, 2005) + 0.22 pounds of eyes 

(USDHHS, FDA, 2005) +15.2 pounds of skull (including trigeminal ganglia) (USDHHS, FDA, 2005) + 36.5 

pounds of vertebral column (USDHHS, FDA, 2005) = 57.0 pounds of SRMs. 
70 

Table A-9. Estimated SRMs Generated from Imported Live Bovines Under 

 the No Action Alternative (for 2009) 

Origin of 

Imported 

Live 

Bovines 

Imported 

bovines 

30 months 

of age and 

older 

SRMs 

generated 

(in lbs.) 

from 

bovines 

30 months 

of age and 

older

Imported 

bovines 

under 30 

months of 

age (except 

for dairy or 

breeding) 

SRMs 

generated 

(in lbs.) 

from 

bovines 

under 30 

months of 

age 

Total 

estimated 

weight 

(pounds) of 

SRMs 

removed at 

slaughter 

Canada 

 - Cattle 239,671a 13,661,247 812,108b 2,517,535 16.2 million 

 - Bison 6,462a 368,334 19,388 60,103 0.4 million 

Mexico n/a n/a 940,829c 2,916,570 2.9 million 

SRM 

Total 

 

14,029,581 

 

6,035,133 19.5 million a

 Based on assumption from cattle import data for bulls and cows for immediate slaughter during 

2009 (239,671) and an estimate that 25 percent of bison imported during 2009 are 30 months of age 

or older (overall import numbers obtained through information available via the Internet; see USDA, 

ERS, 2011 and USDA, FAS, 2011. 

b Total of 1,061,005 cattle (USDA, ERS, 2011) substracting 239,647 imported cull cattle (USDA, FAS, 

2011) and 9,226 breeding or dairy purpose cattle (USDA, FAS, 2011). 

c

 Import information for 2009 from “Annual and cumulative year-to-date U.S. trade (head) table 

(USDA, ERS, 2011).

The amount of SRMs generated includes bovines imported for purposes 

such as feeding or immediate slaughter. The amount for SRMs generated 

does not include bovines that are imported for breeding or dairy purposes 

because these animals are merged into U.S. herds and later are counted in 

the overall annual totals for U.S. slaughter animals. A conservative 

assumption is made that all cows and bulls imported from Canada for 

immediate slaughter are in the category of 30 months of age or older, 

although this is not always necessarily the case. In determining a 

conservative but realistic assumption on the amount of cattle imported 

from Canada according to those that are under 30 months of age and those 

that are 30 months of age and older (because of the difference in the 

amount of SRMs that must be removed at slaughter), this document relied 

on data from an FAS import database that groups cattle by their import 

purpose to help determine those that would most likely be considered as 

cattle that are 30 months of age and older. These data include groups that 

are cows and bulls for immediate slaughter. The imported cattle in this 

age group from Canada during 2008 total 234,615 and during 2009 total 

239,671, as reflected in tables A-8 and A-9 of the appendix. 

Data on the number of imported bison by age groups is not readily 

available. In order to determine the age grouping of bison imported from 

Canada during 2008, this document bases its estimate of SRMs generated 

from bison by the two age groupings (i.e., those under 30 months of age 

and those 30 months of age or older) from data obtained for 2008 through 
71 

APHIS’ Veterinary Services Import Tracking System Database.90 Based 

on 2008 data, approximately 25 percent of the imported bison were 30 

months of age or older; this percentage is applied the same for 2009 data. 

 

Cattle are imported from Mexico, a region that is not subject to BSE 

restrictions under current APHIS import regulations. Cattle imported from 

Mexico mostly are young cattle destined for pasture, backgrounding, 

finishing, and slaughter within the United States (Skaggs et al., 2004); for 

purposes of SRM removal, these animals fall in the “under 30 months of 

age” category. 

SRM removal occurs at slaughter for all bovines, whether they are U.S.-

produced or imported. FSIS91 requires SRMs to be rendered as “unfit for 

human food” within the meaning of section 1(m)(3) of the adulteration 

provisions of the Federal Meat Inspection Act. The annual U.S. slaughter 

of cattle results in the generation of approximately 440 million pounds of 

SRMs (see table A-10, below). 

Table A-10. Estimated Average Annual Amount of SRMs Generated at 

 Slaughter in the United States (for 2008 and 2009)92 

Origin of SRMs 

SRMs from 

Bovines 30 

Months of Age 

and Older 

(in million lbs.) 

SRMs from 

Bovines Under 

30 Months of 

Age 

(in million lbs.) 

Total SRMs 

Generated 

(in million 

lbs.) 

Bovines imported 

from Canada (based 

on average from 2008 

& 2009 data from 

tables A-8 and A-9) 14 3 17 

Cattle imported from 

Mexico (based on 2008 

& 2009 data from tables 

A8 and A-9) n/a 2.5 2.5 

U.S. cattle average 

from annual 

commercial slaughter 356a 84b 440 

a Average for cull beef & dairy cull cattle slaughter for 2008 (6.3 million) and for 2009 (6.2 million) = 

6.25 million × 57 lb. (annual slaughter numbers obtained from USDA, ERS, 2010). 

b Average steers & heifers slaughter for 2008 (27.5 million) and 2009 (26.5 million) = 27million × 

3.1 lb. (annual slaughter totals obtained from USDA, ERS, 2010). 

 

90 Personal communication with Dr. Peter Merrill, Assistant Director, Live Animal Imports, National Center 

for Import and Export, Veterinary Services, APHIS. 

91 In accordance with 9 CFR part 314 92 Totals are rounded.