BSE Comprehensive 

Final Rulemaking 

Environmental Assessment 

May 2013 

United States 

Department of 

Agriculture 

Marketing and 

Regulatory 

Programs 

Animal and 

Plant Health 

Inspection 

Service 
BSE Comprehensive Proposed 

Rulemaking 

Environmental Assessment 

May 2013 

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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TARGET Center at (202) 720–2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, 

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 ........................................................ 19 

III. Potential Environmental Impacts ............................................. 19 

 A. Public Health ...................................................................... 20 

 B. Physical Environment ......................................................... 41 

 C. Highly Uncertain or Unique or Unknown Risks ................... 61 

 D. Endangered or Threatened Species .................................. 62 

 E. Cumulative Impacts ............................................................ 63 

IV. Agencies or Persons Contacted ............................................. 71 

V. References .............................................................................. 72 

VI. Appendix 
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 OIE guidelines) 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 guidelines. 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 OIE 

guidelines 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 OIE guidelines; 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 recognized by the OIE. 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 restrict the importation of certain bovinederived products from regions listed in 9 CFR §§ 94.18(a)(1) and (a)(2). 

Prohibited materials from these regions include processed animal protein; 

tankage; offal; tallow other than tallow derivatives unless the 

Administrator determines the tallow cannot be used in feed, regardless of 

the animal species from which the material was derived; glands and 

unprocessed fat tissue derived from ruminants; processed fats and oils, and 

derivatives of processed animal protein, tankage, and offal, regardless of 

the animal species from which the material was derived; and derivatives of 

 

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 

glands from ruminants. Also, any of these materials are prohibited from a 

facility 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 requirements 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. Additionally, 

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). 

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). 

Except for tallow prohibited in 9 CFR §95.4(a)(1), 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 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 
6 

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. 

Of regions that meet the category “where BSE exists,” live bovines and 

bovine-derived products are not allowed to be imported from these 

regions; the only exception to the APHIS regulatory restrictions from 

these regions is the allowance of the importation of whole cuts of boneless 
7 

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 that meet the category that “presents an 

undue risk of introducing BSE into the United States.” 

Currently, 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 OIE BSE guidelines, which are based on 

current science and understanding of the risk of BSE transmission. 

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

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

 

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 airinjection 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 

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 guidelines. Provisions in the OIE guidelines 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. interpretations of the science and policies supporting the science 

where the U.S. currently differs. 

 

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 

Under this alternative, APHIS would completely embrace BSE risk 

classifications for regions that would be identical to those established by 

the OIE guidelines 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 according to BSE risk classification in the OIE 

guidelines. 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-to-ruminant 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 guidelines. 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 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 

 

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 

provisions for BSE in the OIE guidelines 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 guidelines: 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 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, unless the Administrator 

believes there is good reason not to classify the country as such. 

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 OIE guidelines include current science-based 

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

guidelines establish 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 
11 

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 guidelines. 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 BSE guidelines, 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 guidelines (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. The 

modifications are summarily listed in table 2. 

Table 2. Summary of Modifications Between OIE Requirements and U.S. 

Requirements Under this Alternative 

OIE Requirements U.S. Requirements 

Specified Risk Material (SRM) removal 

SRM definition:* 

 brain 

 spinal cord 

 skull 

 vertebral column 

 eyes 

 tonsils** 

 distal ileum** 

*Age requirements for SRM removal: 

 Controlled BSE risk = Older than 30 

months 

 Undetermined BSE risk = Older 

than 12 months 

**Must be removed from cattle of all ages. 

SRM removal 

SRM definition:* 

 brain 

 spinal cord 

 skull, 

 vertebral column** 

 dorsal root ganglia 

 trigeminal ganglia 

 eyes, 

 tonsils*** 

 distal ileum*** 

*Age requirements for SRM removal: 

 Controlled BSE risk = 30 months 

of age or older 

 Undetermined BSE risk = over 12 

months of age 

**Excludes wings of the sacrum, transverse 

processes of the thoracic and lumbar 

vertebrae, and vertebrae of the tail. 

***Must be removed from cattle of all ages. 

Continued
12 

Table 2, continued. 

OIE Requirements U.S. Requirements

Live animals allowed provided that they were 

born after the date of an effective 

implementation of the region’s feed ban. 

OIE does not determine the date of the 

region’s effective implementation of the 

ruminant-to-ruminant feed ban. 

Live animals: same as OIE requirements, 

except that APHIS would determine the 

date of the region’s effective 

implementation of a ruminant-to-ruminant 

feed ban and APHIS would prohibit live 

animals from undetermined BSE risk 

regions except in limited situations. 

Refers to cattle APHIS regulatory requirements refer to 

bovines (Bos taurus (domestic cattle), Bos 

indicus (zebu cattle), and Bison bison

(American bison). FSIS regulatory 

requirements refer to cattle. 

Tallow and tallow derivatives with a 

maximum level of insoluble impurities of 0.15 

percent by weight and derivatives from this 

tallow: 

 Unrestricted regardless of BSE risk 

status of cattle population. 

Tallow with more than 0.15 percent insoluble 

impurities by weight requires certification that 

it is: 

 Sourced from a negligible BSE risk 

country; or 

 If sourced from a controlled BSE 

risk country, derived from cattle that 

passed ante- and post-mortem 

inspections and does not contain 

SRMs. 

Tallow derivatives other than those made 

from tallow with a maximum level of 

insoluble impurities of 0.15 percent by weight 

requires certification that it is: 

 Sourced from a negligible BSE risk 

country; or 

 Sourced from a controlled BSE risk 

country and is derived from cattle 

that have passed ante- and postmortem inspections and does not 

contain SRMs; or 

 Produced by hydrolysis, 

saponification, or transesterification 

under high temperature and 

pressure conditions. 

Tallow from bovines allowed if: 

(1) Composed of a maximum level of 

insoluble impurities of 0.15 

percent; or 

(2) Originates from a negligible BSE 

risk region; or 

(3) Originates from a controlled BSE 

risk region and is derived from 

bovines that passed ante- and 

post-mortem inspections, and has 

not been prepared using SRMs as 

APHIS-defined for region of 

controlled BSE risk; and 

(4) Accompanied by certification that 

requirements have been met 

above in (1), (2), or (3); or 

(5) If it does not meet requirement (1) 

above, is accompanied by 

certification of the exporting 

region’s BSE risk classification; or 

(6) The Administrator determines it 

will not come into contact with U.S. 

ruminants and can be imported 

under conditions that prevent BSE 

introduction, and importer obtains 

appropriate import permit. 

Tallow derivatives from bovines allowed if: 

(1) From any region provided it meets 

the definition of tallow derivative in 

proposed APHIS regulations (§ 

95.1, consistent with FDA’s 

definition in 21 CFR 589.2001); or 

(2) Originates from tallow composed 

of a maximum level of insoluble 

impurities of 0.15 percent in 

weight; or 

(3) Originates from tallow from a 

negligible BSE risk region; or 

(4) Originates from tallow from a 

controlled BSE risk region and 

derived from bovines that passed 

ante- and post-mortem 

inspections, and does not contain 

SRMs as defined for controlled 

BSE risk regions; 

continued
13 

OIE Requirements U.S. Requirements

 (5) In all cases above, accompanied 

by certification that states 

requirements met or, if does not 

meet requirements (1) or (2) 

above, indicates the BSE risk 

classification of exporting region; 

or, 

The Administrator determines that tallow 

derivative will not come into contact with 

ruminants in the United States and can be 

imported under conditions that will prevent 

BSE introduction, and importer obtains 

appropriate import permit. 

Blood and blood products 

For all blood: 

 Collected in a manner that avoids 

contamination. 

For blood collected at slaughter, the 

slaughtered animal: 

 Passed ante-mortem inspection. 

 Was not subjected to a stunning 

process with a device injecting 

compressed air or gas into the 

cranial cavity or to a pithing 

process. 

Blood collected at slaughter and blood from 

products collected at slaughter: 

 Collected in a hygienic manner 

that prevents contamination of the 

blood with SRMs. 

 Passed ante-mortem inspection. 

 Was not subjected to a stunning 

process with a device injecting 

compressed air or gas into the 

cranial cavity or to a pithing 

process. 

 Accompanied by certification that 

requirements have been met. 

Blood collected from live donor bovines and 

from products derived from blood collected 

from live donor bovines: 

 Collected in a hygienic manner 

that prevents contamination of the 

blood with SRMs. 

 Donor animal was free of clinical 

signs of disease. 

 Accompanied by certification that 

requirements have been met. 

Meat and bone meal and greaves from 

ruminants: 

 Products originate from a 

country classified as 

negligible BSE risk. 

 Bovines from which the 

product originated were 

born after the date the 

feed ban was effectively 

enforced, if the exporting 

country has had an 

indigenous BSE case. 

Refers to processed animal protein 

From a region of negligible BSE risk that is 

derived from nonruminant animals: 

 Material is not otherwise prohibited 

under the provisions in APHIS 

regulations (§ 95.4) regarding 

materials derived from ovines or 

caprines. 

 Commodity is accompanied by 

specific certifications related to the 

bovines from which the commodity 

was derived (e.g., passing anteand post-mortem inspections) and 

that states the region of export is a 

region of negligible risk for BSE. 

Or, if indigenous case of BSE 

occurred in region, commodity is 

accompanied by certification that 

also includes that the commodity 

was derived from bovines subject 

to a ban on the feeding to 
14 

OIE Requirements U.S. Requirements

ruminants of processed animal 

protein derived from ruminants and 

certification includes that region of 

export is a region of negligible 

BSE risk. 

From a region of controlled BSE risk or 

undetermined BSE risk; 

 In addition to above requirements, 

if derived from nonruminants, 

except for blood and blood 

products listed in next bullet, may 

not be imported unless certain 

conditions are met, e.g., does not 

contain and was not contaminated 

with material derived from 

ruminants originating from 

controlled BSE risk or determined 

BSE risk. 

 Blood meal, blood plasma, and 

other blood products: 

o Material does not contain and 

was not commingled with 

ruminant blood or blood 

products prohibited importation 

into the United States. 

 Annual inspection of facility for 

compliance with provisions. 

From ruminant animals: 

 Allowed if from negligible BSE risk 

region and in which there has 

never been an indigenous BSE 

case. 

 If from negligible BSE risk region 

in which there has been an 

indigenous BSE case, 

commodities containing such 

products allowed if derived from 

ruminants that were subject to a 

ban on the feeding to ruminants of 

processed animal protein derived 

from ruminants. 

 Not allowed if derived from 

ruminants from controlled BSE risk 

or undetermined BSE risk regions. 

Cervids and camelids 

OIE BSE guidelines do not address cervids 

and camelids. 

Cervids and camelids 

No restrictions with regard to BSE from the 

importation of live cervids and camelids and 

their products from any region of the world. 

An alignment of APHIS’ regulations with the OIE BSE guidelines could 

result in a resumption or initiation of importation of live bovines20 or 

 

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. 
15 

bovine-derived product from regions currently restricted or prohibited by 

the regulations. The following table (table 3) shows regions that are 

currently restricted or prohibited from importing 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 3 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/). 

Table 3. 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 2012) 

Regions where BSE is considered to exist

according to APHIS’ current regulations 

(9 CFR 94.18(a)(1):

Austria Negligible 

Belgium Negligible 

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 Controlled 

Federal Republic of Yugoslavia ** 

Hungary Controlled 

Former Yugoslav Republic of Macedonia ** 

Monaco ** 

Norway Negligible 

 
16 

U.S. BSE Risk Category and Region 

OIE’s BSE Risk Status 

Recognition 

(as of May 2012) 

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. 

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 

guidelines. 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 BSE guidelines. 

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 

 

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. 
17 

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 

OIE guidelines, 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. 

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. 

Under the proposed action, APHIS would announce its intent in the 

Federal Register, subject to public comment, to consider a region to have 

the same BSE risk classification as determined by the OIE, unless the 

Administrator believes there is good reason not to classify the region 

based on OIE’s BSE risk classification of the region. 

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 

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 
18 

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 BSE guidelines require 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. 

As of May 2012, regions that have an OIE BSE risk classification 

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

List of Regions with OIE BSE Risk Status Classifications 

Negligible BSE Risk Controlled BSE Risk

Argentina

Australia 

Austria 

Belgium 

Brazil 

Chile 

Colombia 

Denmark 

Finland 

Iceland 

India 

New Zealand 

Norway 

Panama 

Paraguay 

Peru 

Singapore 

Sweden 

Uruguay

Canada 

Chinese Taipei 

Croatia 

Cyprus 

Czech Republic 

Estonia 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy 

Japan 

Korea (Rep. Of) 

Latvia 

Liechtenstein 

Lithuania 

Luxembourg 

Malta 

Mexico 

The Netherlands 

Nicaragua 

Poland 

Portugal 

Slovak Republic 

Slovenia 

Spain 

Switzerland 

United Kingdom 

United States of America

 

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. 

24 Information available on the Internet at http://www.oie.int/en/animal-health-in-the-world/officialdisease-status/bse/list-of-bse-risk-status/. 
19 

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 BSE guidelines. Although this 

alternative would have been less restrictive than the current regulations, 

this alternative still would be more restrictive than the OIE guidelines 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 

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 
20 

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. 

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 December 2012, data 

shows a total of 224 definite and probable cases of vCJD (European 

Creutzfeldt-Jakob Disease Surveillance Network, 2012). Of these, 173 

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, refer to 
21 

table 2) 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 

224 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 

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 

 

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. 

26 9 CFR parts 92–96 and 98 27 9 CFR § 94.18(a)(1) 
22 

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 

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 

 

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). 

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 
23 

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: 

 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. 

 

35 70 FR 53063, September 7, 2005 36 73 FR 22719, April 25, 2008 
24 

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 

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 

 

37 9 CFR Parts 92–96 and 98 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
25 

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 that 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. 

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 import 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 

import 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). 

 

42 70 FR 53043, September 7, 2005 

1. No Action 

(Maintain the 

Current 

APHIS BSE 

Import 

Regulations) 
26 

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. 

 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,” 

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 

 

43 9 CFR § 93, 94, 95 and 96 44 73 FR 3379, January 18, 2008 
27 

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 Impact (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 

camelids would continue as currently regulated without BSE-related 

prohibitions. 

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 guidelines) for BSE classification and 

import regulations. In aligning with the OIE guidelines, 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 OIE guidelines if this alternative is 

implemented. 

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

the process to revise OIE BSE guidelines. The United States supports the 

changes that have been made to OIE guidelines, 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 OIE guidelines also increases the efficiency and 

transparency with which APHIS can respond to import requests. 

The 2010 OIE guidelines 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 bovine-derived products into the United States. 

2. Align APHIS 

BSE Import 

Regulations 

with Internationally 

Accepted 

Guidelines, 

with Modified 

Requirements 
28 

Under existing OIE guidelines, 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 OIE 

guidelines. 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 

regardless of the BSE risk classification of the region exporting the 

commodity. These commodities are allowed for unrestricted trade under 

existing OIE guidelines. 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 guidelines 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 guidelines are 
29 

implemented 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 

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 existing OIE guidelines 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. 
30 

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 trade45 and determined 

where measures that differed from OIE guidelines 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 OIE guidelines that 

would remain if this alternative is implemented (previously summarized in 

table 2) are discussed below. The proposed modifications from OIE 

guidelines 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 OIE BSE guidelines refer 

to cattle and APHIS BSE import regulations refer to bovines, other areas 

of difference between OIE guidelines 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: 

 

45 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 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. 
31 

(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 

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

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

column are included in FSIS’ definition of 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 OIE guidelines, 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 regions46 because the removal of SRMs from 

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

 

46 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. 
32 

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% 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 

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 guidelines define 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 
33 

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

ruminants has been effectively enforced. The OIE guidelines further state 

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.47 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 

guidelines require 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 guidelines, 

with some 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 guidelines 

do 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 

 

47 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. 
34 

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. 

Under the proposed alternative discussed in this document, APHIS would 

align with current OIE guidelines concerning regulation of importation of 

tallow and tallow derivatives. Under OIE guidelines, 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. 

OIE guidelines do 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." 48 

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

would meet the OIE guidelines 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 

 

48 21 CFR 589.2001 
35 

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, OIE guidelines 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 

 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, OIE 

guidelines recommend 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. 
36 

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 

guidelines 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, OIE guidelines do 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. OIE guidelines regarding tallow derived from 

bovines are based on the conclusion that tallow with a maximum level of 

insoluble impurities of 0.15 percent in weight and derivatives made from 

this are not a risk factor in the transmission of the BSE agent. APHIS 

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

insoluble impurities of 0.15 percent in weight and derivates made from 

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

implemented, APHIS would follow the OIE guidelines 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 OIE 

guidelines. Existing FDA regulations49 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. 

Current OIE guidelines recommend that blood and blood products be 

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

following conditions: 

 

49 21 CFR 589.2000
37 

 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 

OIE guidelines 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 

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. 
38 

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 animal protein 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 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 OIE guidelines 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 processed animal protein derived from ruminants: 
39 

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. 

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. 
40 

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 

regions that would be allowed to import 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 
41 

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://wwwnc.cdc.gov/eid/article/12/2/05-0970_article.htm, 

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. OIE guidelines for BSE 

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

products. 

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.50 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 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. 

The discussion that follows 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. 

 

50 40 CFR § 1508.8 

1. Transport of 

 Commodities 
42 

Live cervids, specifically deer and elk, and live camelids are imported into 

the United States from Canada. Imported cervid products include deer 

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 must transit 

through approved U.S. ports. 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 51 and 16 approved ports of entry at 

the U.S./Mexico border,52 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. 

Efforts Regulating Pollutants of the Physical Environment From 

Commercial Trucks 

Since the Clean Air Act of 1970, emissions standards for cars and trucks, 

forcing improved engine technology and reformulated gasolines, have 

greatly reduced the amount of air pollution. Environmental quality issues 

 

51 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)). 

52 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)). 
43 

related to commercial truck transport continue to be studied and addressed 

at Federal, State, and local levels. For example, the U.S. Environmental 

Protection Agency (EPA) is addressing the increase in emissions from the 

growth in transport freight within the United States. EPA developed a 

strategy to reduce diesel emissions by requiring new diesel engine 

standards beginning in 2004 vehicle models and initiating a program 

requiring U.S. refiners to provide cleaner diesel fuels. Similar to the 

United States, Canadian environmental protection laws include vehicle 

emissions requirements that are designed to prevent harmful air emissions 

from vehicles, including commercial trucks. Truck transport activities are 

subject to comprehensive environmental regulation in both the United 

States and Canada. 

Although Mexico’s diesel engine standards were aligned with the U.S. 

EPA standards for 1994 to 2003, the United States revised its emission 

standards to require a 50 percent reduction in NOx for 2004 to 2007 

models and a 90 percent reduction in NOx and PM from 2007 and 

subsequent model year engines. The 2007 engine standards also require 

the use of ultra-low sulfur diesel fuel (15 parts per million (ppm) sulfur), 

which is not required in Mexico. It has been estimated that approximately 

two-thirds of Mexico’s national truck fleet is comprised of trucks 

manufactured before 1993 and that, therefore, the majority of trucks from 

Mexico may be operating without the benefit of newer, more efficient 

engines (IEI and R&AEC, Ltd., 2007)). Historically, commercial trucks 

crossing from Mexico into the United States have been limited to 

operation within a 20-mile commercial zone (IEI and R&AEC, Ltd., 

2007). It has been the practice that cattle transported from Mexico are offloaded from trucks at the ports of entry, fed and watered, inspected by 

veterinarians, and treated for cattle ticks when needed, all of which occurs 

during a 24–48 hour period. The cattle are then moved across the 

international border on foot, and then loaded onto trailers on the U.S. side 

of the border to be taken to their U.S. destinations (Skaggs et al., 2004). 

Although this procedure remains in place for some ports of entry where 

cattle are inspected at the U.S./Mexico border, more recently this 

procedure has changed for at least three U.S./Mexico border ports of entry 

due to security reasons for inspection personnel, resulting in cattle being 

transported directly to and off-loaded for inspection on the U.S. side of the 

border. Commercial trucks from Mexico continue to be restricted within a 

20-25 mile zone in the United States. 

With regard to emissions from commercial trucks and other sources along 

the U.S./Mexico border areas, EPA continues efforts in accordance with 

its mission for protecting the environment and public health. A 

partnership among Federal, State, and local governments in the United 

States and Mexico’s government and with U.S. border tribes resulted in 

the Border 2012 program. The mission of the program is “to protect the 
44 

environment and public health in the U.S.-Mexico border region, 

consistent with principles of sustainable development” (EPA, 2010a). The 

Nogales project is part of two decades of cooperation between the United 

States and Mexico to reduce air pollution along the border through both 

the binational Border 2012 and another program called Border XXI (EPA, 

2008). Other efforts have included the reducucton of diesel emissions 

pollution associated with commercial truck transports along U.S./Mexico 

travel corridors. Some of these efforts, funded in large part by the U.S. 

EPA, included the San Diego-Tijuana Diesel Emissions Reduction Project, 

the Blue Skyways Collaborative, and the West Coast Collaborative. 

Efforts Regulating Pollutants of the Physical Environment from Ship 

Vessels and Locomotives 

Diesel engines are used to operate ship vessels and some locomotive 

trains53 and add to the harmful emissions (mentioned earlier) produced by 

other diesel-operated transport modes. It is reported that the large cargo 

ships, carrying the world’s cars, clothing, toys, and other consumer goods, 

burn a diesel fuel that is 1,800 times dirtier than the norm for heavy-duty 

U.S. trucks. EPA, after court challenges by environmental groups, agreed 

to regulate ship emissions. EPA is working with the United Nations’ 

International Maritime Organization (IMO), the world’s top maritime 

body responsible for regulating the industry, on new emission standards 

for diesel engines on board large ocean-going vessels to reduce air 

pollutant emissions and CO2, the main contributor to greenhouse gases. 

EPA announced that the agency is establishing new standards to reduce 

soot and PM by 90 percent and NOx by 80 percent from marine and 

locomotive diesel engines. Phasing in of these revised standards for PM 

and NOx will begin in 2014 for marine diesel engines and 2015 for 

locomotive engines (EPA, 2011a). 

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 from all 

countries (no matter which current APHIS risk category they meet) are 

factored into the discussion of potential impacts on the physical 

environment to compare with the proposed action. Data related to the 

volume of imported commodities allowed under the current APHIS import 

regulations is used to show the extent of 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 bovinederived products for other animal diseases, such as foot-and-mouth 

 

53 Some locomotives are powered by electricity or steam. 
45 

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. 

Data on the volume of imported live bovines, cervids, and camelids and 

their products is provided in this section to allow for a comparison of the 

extent of impacts on the physical environment between the No Action 

alternative and the proposed action. Later in this section, that data is used 

to show the extent to which transport of commodities under the No Action 

alternative and the proposed action potentially could contribute to impacts 

on the physical environment when compared to a baseline of related 

activities. 

(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. 

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. 
46 

(a) From Canada 

As mentioned above, live bovines from Canada must be transported 

through one of 20 approved U.S. ports of entry at the U.S./Canada border. 

After a temporary halt in the import of live bovines from Canada because 

of a reported BSE case in December 2003, the United States resumed 

importation of live bovines from Canada that were under 30 months of age 

in 2004. On November 19, 2007, resulting from the MRR2 rulemaking 

previously mentioned, the United States resumed importation of live 

bovines 30 months of age and older from Canada, provided they were 

born on or after March 1, 1999. The following table provides the numbers 

of live bovines imported from Canada during 2008 and 2009, reflecting 

the intial 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.54

Table 4a. 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-products/livestock-meat-international-trade-data.aspx. 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 

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). 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. 

 

54 A complete year of truck transport data is 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, the use 

of data in the remainder of this document will use 2008 and 2009 data to arrive at a 2-year average of 

recent data. 
47 

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 

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 making 

comparison 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 

It has been the practice that cattle imported to the United States from 

Mexico are transported to any of 16 approved ports of entry on the 

Mexican side of the border, off-loaded from trucks, fed and watered, 

inspected by veterinarians, treated for cattle fever ticks when required, 

moved across the U.S. border on foot, and reloaded onto trucks on the 

U.S. side of the border for transport to their U.S. destinations. 

Table 4b. 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

 

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. 

57 27,118 ÷ 4,566,218 = 0. 6 percent
48 

Using 2008 and 2009 data, the average number of cattle imported annually 

from Mexico was approximately 0.82 million (USDA, ERS, 2010). 

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 making comparison at a 

higher baseline, the averagetruck transport total for all U.S./Mexico ports 

of entry for 2008 and 2009 was about 4.58 million (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. As well, other 

transport modes, including buses, cars, and ships (which are not included 

in these figures for cross-border transport of cattle), contribute to pollutant 

emissions and greenhouse gas emissions at the U.S./Mexico border. 

 

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. 
49 

(2) Transport of Imported Bovine-derived Products Contributing to 

Environmental Impacts 

Most beef imported by the United States is lower value, grass-fed beef 

destined for processing, primarily as ground beef (USDA, ERS, 2008a). 

The major suppliers of U.S. beef imports have been Australia, Canada, 

and New Zealand. Most beef from Australia and New Zealand goes into 

processed products, such as ground beef. The United States also imports 

cooked beef from Argentina and Brazil (imports from these countries are 

restricted to cooked products because of disease restrictions, such as footand-mouth disease, to ensure protection of U.S. animal health). In 2004 

and 2005, imports from Uruguay increased and then decreased in 2006 

when Uruguay began selling to other countries formerly supplied by 

Argentina and Brazil, whose beef exports were reduced because of 

livestock disease problems and internal political and economic issues. 

For 2008 and 2009, an average total of approximately 871,331 metric tons 

(MT) of bovine-derived products for human consumption were imported 

(see table 5) (information source: USDA, FAS, 2011). 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. 

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 the 

following table: 
50 

Table 5. 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)60

2009 imported

bovine-derived 

products 

(MT)61

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

The average total of all U.S. waterborne imports for 2008 and 2009 is 

about 850 million metric tons (MT) (U.S. DOT, 2011b).62 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 MT63)) is about 555,896 MT, 

or 0. 7 percent64— 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 MT65) 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 MT66) would require about 1,029 commercial 

truck transports. 

 

60 One metric ton is equivalent to about 2,204 pounds 61 One metric ton is equivalent to about 2,204 pounds 62 Excluding postal and military shipments 63 294,901 + 20,534 = 315,435 MT 64 555,896 ÷ 850,000,000 = about 0.7 percent. 65 294,901 × 2,204.62 lb/MT = ~650,144,643 lb.; 650,144,643 lb. ÷ 44,000 lb/truckload = 14,776 

commercial trucks 

66 20,534 × 2,204.62 lb/MT = 45,269,667 lb., 45,269,667 ÷ 44,000 lb/truckload = 1,029 commercial 

trucks 
51 

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. The 

truck transports for moving both live bovines and bovine-derived 

commodities into the United States are shown in the table below. 

Table 6. Estimated Average Number of Commercial Truck Transports for 

Imported Live Bovines and Bovine-derived Products 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 

The estimated number of truck transports for imported live bovines 

and bovine-derived products from Canada (41,894) represents about 

0.967 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 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 0.868 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 0.669percent (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 

 

67 41,894 ÷ 4,566,218 = 0.9 percent 68 41,894 ÷ 5,447,876.5 = about 0.8 percent 69 17,464 ÷ 2,994,589 = about 0.6 percent
52 

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 0.470 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. 

(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. The 

following table summarizes these imports and provides an estimate of the 

number of transport vehicles that would have likely been required to 

transport the animals. 

Table 6a. 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 

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 

above is based on an average of 2 animals per shipment. Imported 

alpacas, camels, and llamas generally range in weight from 100-400 

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 above is 

based on an average of 10 animals per shipment. 

 

70 17,464 ÷ 4,578,856 = about 0.4 percent
53 

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. 

b. Proposed Action—Align APHIS Regulations with OIE 

Guidelines, with Modified Requirements 

For the proposed action, imports of live bovines and bovine-derived 

products would be allowed from countries in any OIE-evaluated or 

APHIS-evaluated risk classification according to certain requirements 

under each risk classification. 

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 
54 

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 table 6, provided in the No 

Action alternative section above. 

 

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. 

 

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. 

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 

2. Holding 

Imported 

Bovines in 

Feedlots 
55 

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, 2011b). 

Efforts Regulating Pollutants of the Physical Environment from Livestock 

Impacts 

Potential impacts on air and water quality associated with livestock, 

including concentrated animal feed operations (CAFOs) are addressed 

under Federal, State, and local environmental statutes, regulations, and 

guidelines in the United States. Some Federal regulatory efforts related to 

controlling pollutants resulting from livestock and slaughter operations are 

discussed below. 

Since 1974, EPA has promulgated effluent guidelines for more than 

50 industrial categories. Effluent guidelines are national regulations that 

control the discharge of pollutants from industrial facilities to surface 

waters (EPA, 2004). These regulations include the National Pollutant 

Discharge Elimination System Permit regulations and Effluent Limitation 

Guidelines and Standards for CAFOs under the Clean Water Act, as well 

as State environmental regulations for proper management of waste water 

and manure from animal feedlot operations. EPA also has established 

requirements for CAFOs with regard to nitrate contamination of 

underground sources of drinking water, under the Safe Drinking Water 

Act. In February 2004, EPA established new waste water discharge 

standards for the meat and poultry products industry, including slaughter 

establishments that slaughter more than 50 million pounds of meat per 

year and, further, meat processors that generate more than 50 million 

pounds per year of finished products (such as bacon or sausage). State and 

Federal regulations in the United States are designed to encourage sound 

management practices for animal feeding operations and discourage 

polluting activities. 

Additionally, USDA’s Environmental Quality Incentive Program (EQIP), 

administered by the Natural Resources Conservation Service, can help 

CAFOs meet manure application standards proposed by EPA (USDA, 

ERS, 2003). This program provides technical and financial assistance in 

developing nutrient management plans, cost-share payments for waste 

management structures, and incentive payments to assist crop and 

livestock producers with environmental and conservation improvements 
56 

on the farm. EQIP also provides financial help to transport manure to offfarm locations (USDA, ERS, 2003). 

In addition to State laws and regulations for air emissions, a variety of 

provisions under the Clean Air Act address air emissions relating to 

animal feedlot activities. In January 2005, EPA announced an air quality 

compliance agreement to address emissions from certain animal feeding 

operations. This agreement is part of a national farm air emissions study, 

which is a part of EPA’s ongoing effort to minimize air emissions from 

animal feeding operations and to ensure that those operations comply with 

applicable provisions under the Clean Air Act, the Comprehensive 

Environmental Response, Compensation and Liability Act, and the 

Environmental Planning and Community Right-to-Know Act. The 

agreement will help in gathering scientific data that EPA needs to make 

informed regulatory and policy determinations and will establish an 

industry-funded emissions monitoring program that will help provide 

information, leading to better tools to help the farm industry, USDA, and 

EPA determine the compliance status of animal feeding operations (EPA, 

2006). The Federal environmental laws and their regulations, combined 

with State and local laws and regulations, are intended to protect the 

quality of the human environment in the United States. 

For now in the United States, there are no regulatory restrictions on cattle 

production, including in feedlots, specific to methane emissions. 

Scientists are researching ways to reduce methane production; studies are 

underway in Canada and Sweden to measure greenhouse gases released 

from cows (CTV News, 2008). EPA reports that many different 

management practices can improve a livestock operation’s production 

efficiency and reduce greenhouse gases. In this regard, EPA also reports 

that some of the most effective practices include improving grazing 

management; soil testing, followed by the addition of proper soil 

amendments and fertilizers; supplementing cattle diets with needed 

nutrients; providing appropriate water sources and protecting water 

quality; and improving genetic and reproductive efficiency (EPA, 2007). 

Livestock production systems, such as manure management systems, also 

produce other greenhouse gas emissions such as NOx and CO2 (EPA, 

2006). EPA has established a voluntary program, known as the AgSTAR 

Program, to reduce methane emissions in the livestock industry. This 

program encourages the use of anaerobic digestion technologies that 

recover and combust methane for odor control or as an on-farm energy 

resource (EPA, 2010b). 

The following paragraphs discuss the number of imported live bovines 

that are sent to feedlots for further growth before they are slaughtered and 

the baseline of U.S. cattle in feedlots. 
57 

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)71. 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. 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 7. 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.

As estimated for 2008 and 2009, bovines imported from Canada and 

Mexico represented about 4 percent72 73 of the 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 economic analysis, no net change in the number of 

imported live bovines from Canada is expected from the proposed 

rulemaking; therefore, the number of bovines imported into feedlots for 

 

71 About 26,449,000 for 2008 and 25,604,000 for 2009. 72 185,574 + 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.) 73 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.) 
58 

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. 

In order to calculate how many pounds of SRMs would be generated at 

slaughter, one must know how many pounds of SRMs are generated by 

each animal. According to 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 88.574 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.75 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.76 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 percent77 of the small intestine by weight (USDA, FSIS, 2005b). By 

multiplying FDA’s estimate for the weight of the small intestines78 (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 

 

74 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)).

75 70 FR 53043, September 7, 2005.

76 70 FR 53063, September 7, 2005. 77 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.

78 28.0 pounds in cattle under 30 months and 35.0 pounds in cattle over 30 months. 

3. SRMs 

Generated 
59 

approximately 3.1 pounds of SRMs79 while cattle over 30 months of age 

would generate approximately 57 pounds of SRMs.80 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 number78), cattle 30 months of age 

would generate an equal amount of SRMs as cattle over 30 months of age. 

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. 

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 in table 11. 

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 

 

79 2.8 pounds of distal ileum + 0.3 pounds of tonsils (USDHHS, FDA, 2005) = 3.1 pounds of SRMs. 

80 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. 
60 

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 8a and 8b. 

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 

APHIS’ Veterinary Services Import Tracking System Database.81 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. 

As discussed earlier, 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. 

The following tables 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. Again, it is noted that bovines that are 

imported for breeding or dairy purposes are not includes in these tables. 

Table 8a. 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). 

 

81 Personal communication with Dr. Peter Merrill, Assistant Director, Live Animal Imports, National 

Center for Import and Export, Veterinary Services, APHIS. 
61 

c

 Import information for 2008 from “Annual and cumulative year-to-date U.S. trade (head)” table 

(USDA, ERS, 2011).

 

Table 8b. 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).

b. Proposed Rulemaking 

Under the proposed rulemaking, imported live bovines from the countries 

of Canada and Mexico would continue. As determined in the economic 

analysis, the amount of live bovines from Canada and Mexico are not 

expected to increase or decrease based on changes proposed for the 

APHIS BSE import regulations. 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 BSE guidelines that APHIS regulations will closely align with 

are 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 
62 

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 

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 9). 

Table 9. 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 10).
63 

Table 10. Federally Listed Cats Known to Feed on Bovine Carcasses. 

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 guidelines, with 

modified requirements, would continue to protect U.S. cattle from 

exposure to BSE-infected imports (USDA, APHIS, 2011a). 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. 

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 
64 

Cumulative impacts can result from individually minor but collectively 

significant actions taking place over a period of time.82

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 OIE guidelines 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. 

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. 

 

82 40 CFR § 1508.7 

1. Public Health
65 

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 

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 regulation83 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 

 

83 73 FR 22720, April 25, 2008 
66 

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.84 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 

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 combined U.S. efforts that are intended to reduce the 

amounts of diesel engine emissions from commercial trucks, marine 

vessels, and locomotives. 

As discussed in the economic analysis document prepared for the 

proposed rulemaking, the proposed regulatory changes to closely align the 

APHIS BSE import regulations with OIE BSE guidelines 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 from the proposed 

 

84 21 CFR 589.2001, April 27, 2009

2. Physical 

 Environment 
67 

regulatory changes are not expected to change the current baseline of 

impacts on the physical environment. 

Environmental impacts related to the transport modes would continue to 

be regulated under Federal laws that are in place 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 

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 OIE guidelines rest 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 

guidelines significantly 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 

guidelines 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 
68 

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 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. FSIS85 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.86 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. 

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 cattle87

slaughter is about 34 million head (USDA, ERS, 2010). For 2008 and 

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).88 The annual U.S. slaughter of cattle results in the generation 

of approximately 440 million pounds of SRMs (see table 11). 

 

85 In accordance with 9 CFR part 314 86 21 U.S.C. 601(m)(3) 87 Includes calves 88 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.
69 

Table 11. Estimated Average Annual Amount of SRMs Generated at 

Slaughter in the United States (for 2008 and 2009)89 

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 8a & 8b) 14 3 17 

Cattle imported from 

Mexico (based on 

2008 & 2009 data 

from tables 8a & 8b) 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). 

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 

document, various Federal, State, and local laws regulate the pollutants 

and emissions caused by animal production. While methane gas 

 

89 Totals are rounded. 

3. Holding 

 Imported 

 Bovines in 

 Feedlots 
70 

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. 
71 

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 
72 

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78 

Appendix1 

EA Comments and Responses 

May 2013 

1. Comment: The EA was deficient and inadequate; APHIS must prepare 

an EIS 

Response: The Environmental Assessment (EA) prepared by 

APHIS discusses a proposed change in BSE regulations for the 

United States to more closely align its regulations with OIE 

standards. When analyzed according to the context and intensity 

factors that determine significance under NEPA (Sec. 1508.27; 43 

FR 56003, Nov. 29, 1978; 44 FR 874, Jan. 3, 1979), APHIS 

believes that the issues discussed in the EA do not meet the level 

of significance that would be required to prepare an EIS. 

2. Comment: Blind acceptance of OIE standards without meaningful 

consideration of alternatives 

Response: The proposed action discussed in the EA would be to 

accept the OIE standards with modifications of some standards as 

necessary to address issues that reflect APHIS’ interpretation of 

scientific literature and existing regulations and policies. The 

Introduction and Proposed Action and Alternatives sections of the 

EA discuss in more detail the reasoning behind the need for 

regulatory changes and the alternatives for regulatory changes that 

were considered and dismissed, including the alternative that did 

not involve OIE standards (see II. Proposed Action and 

Alternatives; D. Other Alternatives Considered by Dismissed from 

Further Consideration). 

3. Comment: The EA fails to conduct a cumulative impacts analysis 

Response: A cumulative impacts analysis was included in the EA. 

The cumulative impacts associated with the actions discussed in 

the EA are included in Section E: Cumulative Impacts in the EA 

document. The impacts discussed and analyzed include public 

health, the physical environment, including transport of 

commodities, generation of specialized risk material (SRM), and 

holding imported bovines in feedlots. As discussed in the 

document, the conclusions from the analysis of the cumulative 

impacts of these issues do not indicate any evidence that the 

proposed action would have additive impact on the natural and 

physical environment. 
79 

4. Comment: Failure to consult with FWS and NMFS on effects on 

endangered and threatened species; failure to follow ESA procedures 

Response: Section D: Endangered or Threatened Species in the 

EA document discusses the effects of both the No Action and the 

proposed alternatives in the EA. The effects of the No Action 

alternative (i.e., maintain the current APHIS BSE import 

regulations) were analyzed in several previous EA documents (see 

EA for citation of specific previous EA documents). In those 

previous EA’s, the conclusion was that the regulations had no effect 

on federally listed ruminants, cats, or their designated critical 

habitats. The proposed alternative in this EA would align U.S. 

regulations with OIE guidelines. If implemented, the proposed 

alternative, as concluded in the EA, “would have no effect on 

federally listed ruminants or cats or their designated critical habitat.” 

5. Comment: Certain practices in abattoirs do not mitigate the risk of BSE; 

splashes of water and bone dust may spread the disease. 

Response: Regulation of practices in slaughter and processing 

facilities are implemented by several U.S. Federal agencies, 

including FSIS and FDA. The proposed action in the EA (change in 

APHIS import regulations) would not impact existing measures in 

slaughter and processing facilities. APHIS continues to brief other 

relevant agencies on its proposed changes in its regulations and 

has committed to cooperating with these agencies to address any 

relevant enforcement issues. 

6. Comment: EA does not address the following: 

 The potential for farm workers, people who work with meat, and 

people using fertilizers to become ill. 

 Risk of BSE in human pharmaceuticals and medical products, 

organ transplants and skin grafts, contaminated medical 

instruments, or cosmetics 

 The difficulty of testing for BSE 

 The risk of transmission of CWD to cattle. 

Response: The EA includes an analysis of the potential 

environmental impacts of the preferred alternative, including a 

discussion of the human health risks. As discussed in section III. 

Potential Environmental Impacts, A. Public Health, “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 
80 

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.” 

The EA includes an analysis of the potential environmental impacts 

of the preferred alternative, including discussion of impacts 

regarding tallow and tallow derivatives, bovine blood and blood 

products, and processed animal proteins (see III. Potential 

Environmental Impacts, A. Public Health). Regulation of 

pharmaceuticals, medical products, organ transplants, skin grafts, 

medical instruments and cosmetics are the responsibility of several 

U.S. agencies. APHIS continues to brief other relevant agencies on 

its proposed changes in its regulations and has committed to 

cooperating with these agencies to address any relevant 

enforcement issues. 

The EA prepared by APHIS discusses a proposed change in BSE 

regulations for the United States to more closely align its 

regulations with OIE standards. Comments regarding the difficulty 

of testing for BSE and the risk of transmission of Chronic Wasting 

Disease (CWD) to cattle are outside the scope of this EA. 

7. Comment: EA makes no mention of Zurich study showing that BSE 

prions can be transmitted by air. 

Response: This study (Haybaeck J, Heikenwalder M, Klevenz B, 

Schwarz P, Margalith I, et al. (2011) Aerosols Transmit Prions to 

Immunocompetent and Immunodeficient Mice. PLoS Pathog 7(1): 

e1001257. doi:10.1371/journal.ppat.1001257) reports that under 

laboratory conditions, cellular prion proteins characteristic of 

transmissible spongiform encephalopathies (TSEs) may be able to 

be to be spread in aerosol form to mice by testing with scrapie 

proteins. Test animals developed scrapie after exposure to 

aerosolized scrapie proteins. While BSE is another type of TSE 

disease, the study did not test the potential infectivity of BSE and 

notes that “...the mechanisms of intranasal and aerosolic prion 

infection are not fully understood...”. APHIS and other U.S. 

Federal regulatory agencies responsible for BSE-related 

regulations and public health matters continue to monitor ongoing 

research that could potentially impact existing or future regulatory 

policies to incorporate new scientific developments that relate to 

this issue. 

8. Comment: EA fails to recognize that what we do not know about BSE is 

greater than what we know. 
81 

Response: No response necessary, comment is general and 

outside the scope of the issues discussed in the EA. 

9. Comment: EA claims that the proposed rule is not expect to result in an 

appreciable change in greenhouse gas emissions. The EA should 

address whether feed options, such as grass feeding, could have an 

impact on greenhouse gases, and should compare impact of smaller 

producers to larger facilities. 

Response: A qualitative assessment of the reductions in 

greenhouse gasses that are possible in animal feeding operations 

is discussed in the EA (See III. Potential Environmental Impacts; B. 

Physical Environment). A discussion of the different types of 

feeding practices for bovines and the relative impacts to 

greenhouse gasses is outside of the scope of the proposed 

regulation change and the EA.