# BSE Comprehensive Proposed Rulemaking

Environmental Assessment May 2011 United States Department of Agriculture

Marketing and Regulatory Programs

A nimal and
Plant Health Inspection
Service

# BSE Comprehensive Proposed Rulemaking

Environmental Assessment May 2011

Agency Contact: Dr. Christopher C. Robinson Assistant Director, Import Products National Center for Import and Export Veterinary Services Animal and Plant Health Inspection Service U.S. Department of Agriculture
4700 River Rd. Unit 40 Riverdale, MD 20737

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## Table of Contents

I. In troducti on ............................................................................... 1

II. Proposed Action a nd Alternat ives ............................................. 3 A. Alternative: No Action (Maintain the Current APHIS BSE Import Regulations) .......................................... 3 B. Alternative: Align APH IS BSE Import Regulations with Internationally Acc epted BSE Guidelines, with
No Modifications ................................................................... 8 C. Align APHIS BSE Import Regulations with Internationally Accepted BSE Guidelines, with Modified Requirements (Pre ferred Alternative) ........... 10
D. Other Alternatives Cons idered but Dismissed from
Further Consi deration ........................................................ 16

III. Potential Enviro nmental Impacts ............................................. 17
A. Public Health ...................................................................... 17 B. Physical En vironment ......................................................... 39 C. Highly Uncertain or Unique or Unknown Risks ................... 50 D. Endangered or Th reatened Spec ies .................................. 50
E. Cumulative Impacts ............................................................ 52

IV. Agencies or Pers ons Contac ted ............................................. 58

V. Refer ences .............................................................................. 59

Appendix. Additional Info rmation for Chap ter 3. .......................... 641 

## I. Introduction

The United States Department of Ag riculture (USDA), Animal and Plant Health Inspection Service (APHIS) re gulates the importation of animals and animal products into the Unite d States to guard against the

introduction of animal diseases not cu rrently 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 rest rict 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 subj ect to compliance with the National Environmental Policy Act of 1969 (NEPA), 1 APHIS has prepared this environmental assessment (EA) to cons ider the environmental effects of a proposed action—a rulemaking that seeks to adopt a strategy as the means of dealing with particular animal he alth risks—and alternatives to that proposed action, consistent with NEPA regulations. 2 This EA evaluates the potential effects on the quali ty of the human environment 3 from a rulemaking to closely align APHIS import requirements with internationally accepted and science-ba sed 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 th e availability of this document to the public.

Purpose of and Need for the Proposed Action

The disease of concern that the prop osed action is based upon is bovine spongiform encephalopathy (BSE), a progr essive neurological disorder of cattle that research suggests is caused by a pathogenic form of a normally occurring protein known as a prion (B olton et al., 1982; Prusiner, 1994). BSE belongs to a family of diseas es known as transmissible spongiform encephalopathies (TSEs). The primar y host of BSE is cattle. More information about the agent that cau ses BSE and BSE characteristics is provided in chapter 3, unde r 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) pa rts 1500–1508; 7 CFR 1b; and 7 CFR part 372.

3 The “human environment” is interpreted comprehensiv ely to include the natural and physical environment and the relationship of people with th at 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 Sc ientific 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 pr oposing 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 requirem ents more closely with the World Organization for Animal Health’s (referred to as OIE, the Office International des Epizooties 5 ) recommended guidelines 6 (herein referred to as the OIE Code) for the trade of liv e bovine and bovine products between

countries based on their BSE risk st atus and where APHIS interpretation of scientific literature and existing re gulations and policie s is in agreement with the OIE Code. The changes to APHIS import requirements would be aligned more closely with OIE-r ecommended guidelines for managing

human and animal health risks asso ciated with the presence of bovine spongiform encephalopathy (BSE). APHIS’ proposed BSE import requirements would be based on OIE r ecommendations with the exception of some modifications, where necessar y, to reflect APHIS’ interpretation

of the scientific literature and curr ent U.S. policies and regulations.

The need for aligning APHIS’ BSE import regulations with the OIE Code includes updating and streamlining principles as follows:

 To ensure that APHIS import restri ctions 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 dis ease, 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 bovin es and bovine-derived products

when there is no scientific basis for trade restriction.

 To remove BSE-related restricti ons 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 OI E as the international organization for development of standards, guidelines, and recommendations with rega rd 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-st andard-setting/terrestrial-code/.3  To align APHIS BSE import tradi ng policy with internationally accepted standards, while maintaining APHIS responsiveness, authority, and responsibilities for protecting U.S. animal health.

 To streamline APHIS’ proce ss for recognizing a region’s 7 BSE risk status in order to improve th e efficiency and transparency in which APHIS can respond to requests from exporting regions for

evaluation of their animal dise ase 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 environm ental document to consider the environmental effects of a proposed ac tion and alternatives to that action consistent with NEPA procedures and regulations. 8 The proposed action being considered is the alignment of APHIS import regulations, as closely as possible (with modified requirements), with the OIE Code; this

alternative is discussed in secti on 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 be low) but is dismissed from further

consideration because it does not meet th e 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 mainta in restrictions and prohibitions under the current APHIS BSE import re gulations (9 CFR parts 93-96) for live ruminants and ruminant products from regions where BSE exists or that present an undue risk of introdu cing BSE into the United States.

Under APHIS BSE import regulations (9 CFR section (§) 94.18(a)), the three risk definitions (hereafter referr ed 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 pa rt 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 mi nimal 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, ed ible products other than meat, and live bovines from many regions currently categorized by the OIE for BSE. Edible products that are exceptions to this requirement include (1) gelatin, as long as it is not derived from bovi nes 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. Ge latin 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 pr ohibited, but they are restricted under APHIS’ regulations regarding rinde rpest and foot-and-mouth disease (FMD). Imports of bovine embr yos from regions where FMD or rinderpest exists are allo wed only if certain conditions are met, including

BSE-related conditions.

Current APHIS regulations prohibit or restrict the impor tation of certain products from regions listed in 9 CFR §§ 94.18(a)(1) and (a)(2). These materials include processed animal protein, derivatives of processed animal proteins; tankage; offal; proce ssed fats and oils, certain tallow (other than tallow derivatives), unless the Administrator determines that the tallow cannot be used in feed, rega rdless of the animal species from

which the material was derived. In addition glands and unprocessed fat tissue derived from ruminants;, and de rivatives of glands from ruminants are prohibited. Also, any of these materials are prohibited from a facility

9 Gelatin is imported for use in human food, human pharmaceutical products, photogr aphy, 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 Stat es Veterinary Permit for Im portation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit applicati on on VS form 16-3 and the application must state the intended use of the gelatin a nd the name and address of the consignee in the United

States.

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

the United States.

12 Other than gelatin allowed importa tion 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 rumina nt feed ban equivalent to FSIS requirements in 21 CFR § 589.2000.5 that processes and stores materials fro m ruminants that have been in any region listed in 9 CFR §§ 94.18(a)(1) a nd (a)(2). These require-ments are stated in 9 CFR §§ 95.4(a)(1)(i )-(iv) and §§ 95.4(a )(2)(i)-(iv).

The importation of hide-derived gelatin is allowed from a region listed in 9 CFR § 94.18(a)(3) provided that th e gelatin has not been commingled with materials ineligible for entry into the United States. Bone-derived gelatin from bovines is allowed impor tation from a region listed in 9 CFR § 94.18(a)(3) provided that the bovines from which it is derived are subject to a ruminant feed ban (in accordance with 21 CFR § 589.2000) and SRMs were removed and the gelatin has not been commingled with materials ineligible for entry into the United States. These requirements are stated in 9 CFR §§ 94.19(f)(1)-(2). In addition gelatin derived from ruimants that have been in any region listed in 94.18(a) may be imported for use in human food, human pharmaceutical products, photography or some other use th at will not result in the gelatin coming in contact with rumi nants in the United States.

Importation of bovine-derived offal is prohibited from regions listed in 9 CFR §§ 94.18(a)(1) and (a)(2) and is allowed for importation from regions listed in 9 CFR § 94.18(a)(3) as long as it contains no SRMs and is derived from bovines from which the SRMs were removed, the bovines were not subjected to an air-injected stunning process at slaughter, and the bovines are subject to a ruminant feed ban equivalent to requirements established by U.S. Health and Human Services’ Food and Drug Administration (FDA) (21 CFR § 58 9.2000). These requirements are stated in 9 CFR §§ 95.4(h)(1)-(4).

Importation of serum albumin, serocolost rum, amniotic liquids or extracts, and placental liquids derived from bovi nes 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 arti cle is for use as an ingredient in cosmetics, (2) the person importing has obtained an import permit from APHIS, and (3) the permit application st ates the intended use of the article

and name and address of the consi gnee 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 th e 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 requirement s are stated in 9 CFR § 95.4(f).

The importation of tallow is allowed if it is derived from bovines that have not been in a region listed in 9 CFR §§ 94.18(a)(1) and (a)(2), it is6 composed of less than 0.15 percent insoluble impurities, and it was not exposed to or commingled with any other animal origin material. Also, the tallow shipment must be accompanie d by a certificate stating that these requirements have been met and the certificate must be signed by the appropriate officials. The shipment mu st arrive at a port listed in 9 CFR § 94.19(g). These requirements ar e 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 stomach s) 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 re gulations, where the importation of live bovines and bovine-derived prod ucts 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, Wale s, Isle of Man), Northern Ireland, and the
Falklands.

For regions that meet the category “w here BSE exists,” importation of live bovines and bovine-derived products is not allowed. The only exception to the APHIS regulatory restrictions on th ese regions is the allowance of the7 importation of whole cuts of boneless beef from Japan according to certain conditions, 13 based on a prior APHIS risk evaluation and rulemaking process. No bovine-derived products are currently allowed from regions listed in 9 CFR 94.18 (a)(1) and (a)(2 ) except according to regulations.

Currently, 9 CFR 94.18(a)(3) recognizes regions for being minimal risk for BSE. The only region listed as presenting a “minimal risk of introducing BSE into the United States ” is Canada. Under current APHIS BSE import regulations, the United States allows the importation of live bovines and bovine-derived products from Canada according to certain

conditions 14 that must be met for each of the following commodities:

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

 Bovine casings (defined as stom achs; esophagi; urinary bladders; and small intestine, other than th e 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 AP HIS’ BSE import regulations from exporting live bovines and bovine-deriv ed products and that want to export these commodities under th e current APHIS BSE import regulations can request APHIS’ rec ognition as a minimal-risk region. However, meeting the minimal risk region requirements is overly restrictive for a region that othe rwise 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 preven ting 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 allo w the importation of live bovines or bovine-derived products is a laborious and lengthy task and would result in regions meeting requirements th at are more restrictive than requirements in place under the OI E Code, which is based on current science and understanding of th e risk of BSE transmission.

13 9 CFR § 94.27. Conditions include that the beef is deri ved from cattle that were born, raised, and slaughtered in Japan and is prepared in an establishment that is e ligible to have its products imported to the United States

under 21 U.S.C. 601 et seq . and 9 CFR § 327.2; the SRMs are removed; and air-injection stunning devices were not used on cattle from which the beef is derived prior to slaughter.

14 Conditions are provided in 9 CFR § 94.19.8 The importation of live bovines or b ovine-derived products from regions

that are not listed in the three BS E risk categories discussed above is unrestricted with regard to BS E; however, importation of these commodities from some regions may be restricted or prohibited because of other animal diseases. Mexico, Au stralia, and New Zealand are major exporters of either live cattle or bovine-derived products to the United States. These three regions and any othe r 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 wi thout BSE-related restrictions.

BSE Restrictions on Cervids and Camelids

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

cervids 15 and camelids 16 (also classified as ruminants, as are bovine species) and certain products thereof 17 from regions listed under 9 CFR §§ 94.18(a)(1) and (2) are prohibited. Live cervids and camelids and products thereof are allowed importati on 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 cu rrent BSE import requirements with regulations that would be entirely co nsistent with World Organization for Animal Health (referred to as OIE) gu idelines for BSE, established in the

2010 OIE Terrestrial Animal Health Code in Chapter 11.5. OIE BSE guidelines are developed by BSE expe rts based on current scientific understanding of the BSE agent, ep idemiology, infectivity distribution, and mitigations preventing BSE exposu re. OIE recommends a region’s

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

described in the Code. Provisions in the OIE Code include science-based conditions (requirements) for importation of live cattle and cattle-derived products according to the BSE risk category of the exporting region. Currently, a few minor differences exist between OIE requirements and U.S. requirements, including the definition of specified risk materials (SRMs) (the animal tissues that contai n 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 slaughte r. In aligning completely with the OIE requirements, APHIS would not be consistent with U.S.

15 .Species of the family Cervidae , such as deer, reindeer, moose, and elk.

16 Species of the family Camelidae , such as camels, llamas, alpacas, and vicunas.

17 With the exception of camel hair and deer skins, which have no BSE-related restriction

.9 interpretations of the science and pol icies supporting the science where the U.S. currently differs.

Under this alternative, APHIS w ould completely embrace BSE risk classifications for regions that would be identical to those established by the OIE Code as negligible BSE risk and controlled-BSE risk Countries that have not been recognized by the OIE will default as undetermined BSE risk. APHIS would also adopt th e OIE criteria under each of these

risk classifications.

This alternative would allow the importation of live bovines and bovinederived products 18 to the United States from regions according to certain requirements defined by BSE risk cla ssification in the OIE Code. Under this alternative, APHIS would accept OIE’s classification of a region’s

BSE risk status with no further eval uation or modifications. This would

eliminate the need for APHIS to c onduct its own risk assessment and evaluation for each region and publish proposed and final rules for each determination of a region’s risk cl assification. 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 e ffective date of its ruminant-toruminant feed ban, and APHIS would accept the exporting region’s certification that the exported cattle were born after the date of the region’s feed ban date without fu rther verificatio n 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 st atus 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 pu rpose for aligning APHIS BSE import regulations with guidelines based up on the most current science on BSE

and meet the need to enhance the efficiency with which APHIS could recognize a region’s BSE risk status. However, this alternative would require a change in policy differences between U.S. regulations for animal health and public health and provisions in the OIE Code. In carrying out its mission to protect animal health, APHIS works in concert with other U.S. Federal agencies, such as the FDA and the USDA’s Food Safety and Inspection Service (FSIS) that have direct authority over public health

18 APHIS regulations currently include bison and cattle (bot h classified as bovine an imals) and would continue to do so under revised APHIS regulations.

19 OIE’s evaluation does not include a de termination of the date of a region’s effectively enforced feed ban.10 issues when agency missions are in terrelated. APHIS supports the U.S. BSE policy requirements of other agen cies; therefore, changing U.S. BSE import requirements to be exactly the same as the provisions for BSE in

the OIE Code would not be a reasonabl e 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 pr ocess of acceptance and official recognition of a region’s BSE risk cla ssification status, this alternative also would not allow APHIS the opport unity to be transparent in its acceptance of a region’s risk classifica tion in that it would not afford an opportunity for the public to comm ent on APHIS’ consideration of region’s risk classification. AP HIS 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 alte rnative would not

allow APHIS to make decisions under its authority for safeguarding U.S. animal health or respond in an e fficient manner to trade requests from regions that do not have an OIE classification.



### C. Align APHIS BSE Im port Regulations with Internationally Accepted BSE Guidelines, with Modified Requirements (Preferred Alternative)

Under this alternative, APHIS w ould amend its current BSE import regulations to make the regulati ons consistent with BSE risk

classifications established in the OIE Code: negligible BSE risk, controlled BSE risk, and undetermined BSE risk, and align APHIS’ import requirements, as closely as possible, with the 2010 (Chapter 11.5) OIE guidelines in the OIE Terrestrial Animal Health Code . In doing so, APHIS would (1) adopt the categories a nd criteria for classification of the BSE risk status of exporting regions, a nd (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 ne gligible BSE risk or controlled BSE risk, APHIS would seek information to support concurre nce with the OIE

classification. If the information is not publicly availa ble, APHIS could request that a country supply the same information given to the OIE.

APHIS would announce its intent in the Federal Register, subject to public comment, to consider the country to ha ve the same BSE risk classification as that determined by the OIE.

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

note that APHIS’ current risk assessment criteria are identical to the OIE’s risk assessment requirements for determining a region’s BSE risk

classification. Provisions in the OIE Code include current science-based conditions (requirements) for the impor tation of live cattle and cattlederived products according to each le vel of BSE risk classification. The11 OIE Code establishes provisions for the BSE risk status of the cattle population in a country, zone, or comp artment (herein referred to as “region”). As described in OIE Code’s BSE Chapter 11.5, OIE requires information from an exporting region to support a risk assessment. OIE uses the information to complete (1) a release assessment, which evaluates the possibility of introducing BSE in to the exporting region through live animals, animal products, or meat and bone meal, and (2) an exposure assessment, which considers the likeli hood 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 asse ssment and other evaluation criteria

described in the OIE Code. The risk status classification for an exporting region would be based on a BSE regi on risk evaluation conducted either by the OIE or, when a region does not have an OIE risk classification, by

APHIS.

In aligning with the OIE Code, APHI S is proposing some modifications, where necessary, to reflect APHIS’ interpretation of the scientific literature and current USDA (FSIS) re gulations. Modifications between requirements in the OIE Code (discu ssed in the Scientific Supporting

Documentation related to the ru lemaking) and proposed APHIS BSE requirements, described in further deta il in the rulemaking text that this EA supports, are based upon APHIS’ inte rpretation of scientific literature and current USDA regula tions and policies.

An alignment of APHIS’ regulations w ith the OIE Code could result in a resumption or initiation of importation of live bovines 20 or bovine-derived product from regions currently restricted or prohibited by the regulations. The following table (table 2) shows regi ons that are currently restricted or prohibited from exporting these commoditie s to the United States and their

current OIE BSE risk cla ssification (see chapter 11.5 for description of BSE risk classifications). A re gion that has not received an OIE

classification defaults to the OIE risk status of undetermined BSE risk (table 2 is not a complete list of regions with OIE risk classifications; OIE’s BSE risk status recogniti on of countries can be found athttp://www.oie.int/en/animal-health-in-the-world/official-diseasestatus/bse/list-of-bse-risk-status/).

20 For purposes of this document, bovines include cattle and bison. The rulemaking related to this EA addresses the importation of live bovines. Compared to the amount of bovines produced in the United States, a small amount of bovines are imported to the United Stat es, and most of them are cattle; thus, when this document refers to the term “bovines,” it mostly pertains to cattle.12 Table 2. Regions with U.S. BSE Risk Categories and Their OIE BSE Risk
Classification

U.S. BSE Risk Category and Region OIE’s BSE Risk Status Recognition (as of May 2011)
Regions where BSE is considered to exist according to APHIS’ current regulations (9 CFR 94.18(a)(1):

Austria Controlled

Belgium Controlled Czech Republic Controlled Denmark Negligible Finland Negligible

France Controlled Germany Controlled

Greece Controlled

Ireland Controlled

Israel ** Italy Controlled Japan Controlled

Liechtenstein Controlled Luxembourg Controlled

Oman **

The Netherlands Controlled

Poland Controlled Portugal Controlled Slovak Republic Controlled

Slovenia Controlled Spain Controlled

Switzerland Controlled United Kingdom Controlled Regions that present an undue BSE risk according to APHIS’ current regulations (9 CFR 94.18(a)(2):

Albania **

Andorra ** Bosnia-Herzegovina ** Bulgaria **

Croatia ** Federal Republic of Yugoslavia ** Hungary Controlled Former Yugoslav Republic of Macedonia **

Monaco ** Norway Negligible

Romania **

San Marino ** Sweden Negligible BSE Minimal-risk regions according to APHIS’ current regulations (9 CFR 94.18(a)(3):

Canada Controlled

** Until a region receives approval of an OI E classification of negligible BSE risk or controlled BSE risk, the region defaults to t he OIE risk status of undetermined BSE risk.13 Live bovines and bovine-derived products 21 would be allowed importation into the United States from regions according to certain requirements

defined for each of the three BSE risk classifications in the OIE Code. As addressed in the APHIS supporting scientific documentation, the OIE

recommends that several cattle-de rived commodities can be traded regardless of the BSE status of the catt le population in the region of origin.

These commodities are not risk factors for BSE. Current APHIS regulations do not prohibit the import ation of milk and milk products, semen and in vivo derived embryos, or hides and skin; however, these commodities are included on the list for the purposes of completeness with

the list contained in the 2010 OIE Code.

List of Commodities Proposed for Importation Without Restriction

APHIS is proposing that the following bovine-derived commodities be allowed for importation without rest riction 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 deriva tives 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 subj ected, prior to slaughter, to a stunning process with a device inject ing 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 an imals that were not subjected, prior to slaughter, to a stunning process with a device injecting compressed air or gas into the cranial cavity or to a pithing process, and passed ante-mortem inspection; and that has been prepared in a manner to avoid contamination with SRMs.

Also addressed in the APHIS supporti ng 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 prev iously mentioned. In aligning with

21 APHIS regulations currently include bison and cattle (bot h classified as bovine an imals) 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 advan ced meat recovery (AMR) systems is defined as meat

and does not include MS beef.14 the OIE Code, APHIS is proposing th at the commodities allowed for importation with restrictions be ba sed on OIE recommendations. APHIS proposes to impose risk mitigations or other restrictions on certain commodities according to the BSE risk status of the exporting region.

List of Commodities Proposed for Importation With Restriction

The commodities recommended for re stricted trade are as follows:

 Live bovines from regions of neg ligible BSE risk or controlled BSE risk;

 Meat (other than deboned skelet al muscle meat from bovine

animals that meets certain condi tions described above), meat products, and meat byproducts;

 Gelatin and collagen prepared fr om bones, intended for food, animal feed, fertilizers, veteri nary biologics, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health pr oducts) or medical devices;

 Tallow, tallow derivatives, and dicalcium phosphat e (other than

tallow with a maximum level of insoluble impurities of 0.15 percent in weight and dicalcium pho sphate with no trace of protein or fat) intended for food, animal food, fertilizers, cosmetics, pharmaceuticals including biologics, or medical devices; and

 Processed animal protein.

If the OIE has classified a country as either negligible BSE risk or controlled BSE risk, APHIS would seek information to support

concurrence with the OIE classifi cation or request the information, including the same information given to the OIE, if it is not publicly

available. APHIS would announce its intent in the Federal Register, subject to public comment, to consid er the country to have the same BSE

risk classification as that determined by the OIE. APHIS also would make available the summary of the BSE OIE ad hoc group conclusions for review during the comment period. After the review of comments received, the Administrator would an nounce in the Federal Register the final determination regarding the co untry’s classification, along with a discussion of and response to pertin ent issues raised by commenters. When recognizing a country as either ne gligible risk or controlled risk for BSE, APHIS would include that country in a list of regi ons of negligible risk or controlled risk for BSE, as applicable. APHIS would make that list available to the public on the agency’s Web site.

If a region does not have an OIE ri sk classification a nd 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 for15 comment prior to finalizing a determination of the region’s BSE risk

classification. Classifica tion by APHIS as either negligible BSE risk or controlled BSE risk would be for a 1-y ear period. The risk classification criteria and process are further de scribed in the relevant rulemaking docket. Similar to OIE requirements for countries classified as either negligible BSE risk or controlled BS E risk by the OIE, regions evaluated by APHIS and classified as negligible BSE risk or controlled BSE risk would need to submit updated information to APHIS each year. If APHIS at any time determines that a regi on no longer meets th e criteria for the risk classification it had previously received, APHIS would amend its BSE risk status list of regions accordingly.

Although the OIE Code requires a region that requests to export live animals to have an effective feed ban, the OIE does not determine the date the feed ban was effectively enforced. In being transpar ent on a region’s date of effective feed ban enforcement, as an additional requirement, APHIS would require supporting document ation from negligible countries that reported indigenous cases and co ntrolled risk countries and would conduct an independent evaluation to ve rify the region’s date of effective

enforcement of a ruminant-to-rumina nt feed ban. Based upon review of the documentation, APHIS would determine the date of the region’s effectively enforced ruminant-to-ruminant feed ban. 23 APHIS would

make the determination of the date of the effective feed ban and supporting documentation available to the public for review and comment.

23 As APHIS has determined this date under its current re gulatory process for Canada as a minimal risk region, the date of Canada’s effectively en forced feed ban would remain the sa me under the proposed rulemaking when implemented.16 As of May 2011, regions that have an OIE BSE risk classification (adopted by the OIE International Committee) are as follows: 24

Complete List of Regions with OI E BSE Risk Status Classification, May 2011

Negligible BSE Risk Controlled BSE Risk

Argentina
Australia
Chile
Denmark
Finland
Iceland
India
New Zealand Norway
Panama Paraguay
Peru Singapore
Sweden Uruguay Austria Belgium
Brazil
Canada Chinese Taipei
Colombia Cyprus Czech Republic
Estonia
France Germany
Greece Hungary
Ireland Italy Japan Korea (Rep. Of)
Latvia
Liechtenstein
Lithuania Luxembourg
Malta
Mexico
The Netherlands
Poland Portugal Slovak Republic
Slovenia Spain
Switzerland United Kingdom
United States of America

Changes to BSE Restrictions with Regard to Cervids and
Camelids

Under this alternative (to align AP HIS import regulations more closely with OIE requirements), the importation of live cervids and camelids and products thereof would be allowe d from regions of any BSE risk

classification without BSE-re lated restrictions.



### D. Other Alternatives Considered but Dismissed from
Further Consideration

An alternative considered in the pa st was to amend the current APHIS regulations to modify an existing BS E risk category. This alternative would allow regions in the existi ng BSE risk categories under 9 CFR §§ 94.18(a)(1) and (2) to import low-risk beef and meat food according to

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

would have been less restrictive th an the current regulations, this

alternative still would be more restri ctive than the OIE Code in that it would continue to restrict other pot entially allowable commodities from some regions; the changes to the cu rrent regulation would not be allinclusive in allowing the importatio n of live bovines and other bovinederived products from regions according to conditions based on the

current science known about BSE. Th is alternative does not meet the

24 Information available on the Internet at http://www.oie.int/en/animal-health -in-the-world/official-diseasestatus/bse/list-of-bse-risk-status/.17 purpose and need for amending APHI S’ BSE import regulations as

discussed earlier in this document.



## III. Potential Environmental Impacts

The NEPA implementing regulations provi de criteria that Federal agencies should evaluate, if applicable, in environmental documents for proposed

actions. This section of the EA addre sses the applicable criteria related to potential impacts from the No Action a lternative and the proposed action. NEPA criteria that are applicable for consideration in this section of the document include potential effect s on public health, the physical environment, and federally listed enda ngered or threatened species, highly uncertain or unique or unknown risk s 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 responsib ilities under NEPA. APHIS’ mission, in part, is to protect the health of U.S. agri culture, but often its mission requires cooperation with other agencies that have authority over related matters, such as public health, because thos e matters fall under the authority of other Federal agencies. As the risk of BSE exposure could impact public health, APHIS cooperates with othe r 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 Di sease 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 dis ease of cattle. BSE belongs to a family of diseases known as transm issible spongiform encephalopathies (TSE). Research suggests that BSE is caused by an abnormal form of a normally occurring type of protein k nown as a prion (Bolton et al., 1982; Prusiner, 1994). The CDC defines a pr ion as “an abnormal, transmissible agent that is able to induce abnor mal folding of normal cellular prion proteins in the brain, leading to brai n damage and the characteristic signs and symptoms of the disease” (CDC, 2006). The abnormal BSE prion protein is less soluble and more re sistant to degradation than a normal prion protein. The abnormal prion prot ein is also extremely resistant to heat and to normal sterilization proce sses, making it difficult to inactivate with standard methods used to pr ocess human food and animal feed. Further, the BSE infectious agent do es not evoke any apparent immune response or inflammatory reaction.18 The public health concern associated with changing current regulations regarding importation of live bovines and bovine-derived products is the potential for human exposure to BSE-in fected materials. Exposure to the BSE infective agent has the potential to cause development of variant Creutzfeldt-Jakob disease in humans (v CJD), 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 th an in cattle (EC SSC, 2000). To put infectivity differences between humans and cattle in perspective, during the BSE epidemic in the Un ited Kingdom (UK), an estimated 1 million animals were infected. Worldwide, as of March 2011, data shows a total of 221 definite and pr obable cases of vCJD (National

Creutzfeldt-Jakob Disease Surveillance Unit, 2011). Of these, 172 cases have been reported by the UK and the remainder reported by other countries. In some cases reported to have occurred outside the UK, the actual exposure to the BSE agent was likely to have occurred in the UK. Human exposure to the BSE agent or BSE infectivity probably happened before mitigation measures, such as specified risk material (SRM) removal, were in place to prevent such exposures. The wide variation in these numbers—more than 1 million infected animals with high infectivity present prior to the introduction of control measures, and 221 vCJD cases—demonstrates the significant sp ecies barrier for BSE transmission

between cattle and humans.

The animal health concern associated with changing curren t 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 bovin es and bovine-derived products are allowed into the United States is pot ential exposure to the BSE infective agent. One mechanism for BSE infe ction 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 (inc luding 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, in cluding public health and associated animal health as it relates to public h ealth, could potentially be affected by

25 The U.S. feed ban final rule, enforced by FDA, b ecame effective on August 4, 1997. The regulations are found in 21 CFR § 589.2000.19 changing current restrictions on impor tation of bovines or bovine-derived materials by aligning more clos ely 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 thr ee agencies are designed to protect humans and animals from exposure to the BSE infective agent and subsequent establishm ent of the disease.

Current APHIS regulations 26 prohibit or restrict importation of live bovines from regions that are identifie d as falling under any one of three risk categories due to BSE. These risk categories include (1) regions in which BSE is known to exist, 27 (2) regions that present an undue risk of introducing BSE into the United States because their import regulations

are less restrictive than those that w ould be acceptable fo r import into the United States and/or because the regi ons have inadequate surveillance, 28
and (3) regions that present a minimal risk of introducing BSE into the

United States via live ruminants a nd ruminant products and by-products (including bovines and bovine-derived products). 29

FSIS has implemented regulations de signed to directly protect human health from BSE exposure in conjunction with APHIS regulations; FSIS’ regulations also indirectly protect an imal 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 rules 30 to prevent potential human exposure exposure to BSE through consumption of meat and meat food products. These regula tions 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 esta blishments that process the carcasses or parts of

26 9 CFR parts 92–96 and 98

27 9 CFR § 94.18(a)(1)

28 9 CFR § 94.18(a)(2)

29 9 CFR § 94.18(a)(3)

30 69 FR 1862–1874, January 12, 2004 (Prohibition of the Us e of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disa bled Cattle; Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems; Pr ohibition of the Use of Certain Stunning Devices to Immobilize Cattle at Slaughter); Bovine Spongiform Encephalopathy Surveillance Program; Interim Final Rules and Notice).20 cattle are required to develop, implemen t, and maintain procedures for the removal, segregation, and dispositio n of SRMs. The 2004 interim final rules also required the condemnation of non-ambulatory disabled cattle presented for slaughter. 31 FSIS prohibited the slau ghter 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 ru le that affirms and strengthens the interim measures to prevent po tential 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 rule 34 designating some materials from cattle as “prohibited cattle materials” with regard to

materials derived from cattle for use in human food and cosmetics. These prohibited materials, which included the entire small intestine, were banned from use in human food products, including dietary supplements and cosmetic products, and included the following:

 cattle material from nonambulatory cattle,

 cattle material from organs from cattle 30 months of age or older in which infectious prions are most likely to occur, and the tonsils

and the small intestine of cattle of all ages,

 cattle material from mechanic ally 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 dist al ileum to be used for human food products or cosmetics. This interim final rule was combined in a final regulation on cattle materials in anim al feed issued in April 2008. The April 2008 regulation 36 prohibits the use of certain cattle materials from animal feed, including pet food. Th e prohibited materials include:

31 Non-ambulatory disabled livestock, including cattle, are livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, thos e with broken appendages, se vered tendons or ligaments, nerve paralysis, fractured vertebral column or metabolic conditions (69 FR, January 12, 2004)

32 72 FR 38700, July 13, 2007

33 62 FR 30936, June 5, 1997

34 69 FR 42256, July 14, 2004

35 70 FR 53063, September 7, 2005

36 73 FR 22719, April 25, 200821  the entire carcass of BSE-positive cattle,

 the brains and spinal cords of ca ttle 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 derive d from the materials prohibited by this regulation, and

 tallow that is derived from th e materials prohibited by this regulation.

The regulation is an added measure to exclude high-risk materials from all animal feeds and to prevent any accide ntal 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 issu ance, but the compliance date was established to be 6 months later (O ctober 29, 2009) to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new requirements. When it became effective on April 27, 2009, this regulation became another overlapping safeguard in addition to those already in place.

Background: Bovine-derived Products

Mitigation measures are currently in place to protect both human andanimal health from exposure to the BSE infective agent from bovinederived products produced in the Un ited States or imported into the country. These mitigation measures ar e 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 produ cts are concentrated on preventing improper slaughter procedures or en suring 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 regulations 37 prohibit importation of ruminant-derived products (including bovine-derived products) from regions that are known to have BSE or that present an undue risk for BSE infection because of import

37 9 CFR Parts 92–96 and 9822 practices or inadequate surveillanc e 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 pr oduction of meat products intended for human consump tion, 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 potentia l exposure to the BSE infective agent focus on enforcement of the existing ruminant feed ban and regulations regarding the in spection 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 poten tial 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 prohibi tions were unnecessary because, based on UK history during the BSE epidem ic and the fact that there have been no diagnosed cases of BSE in cer vids, it would be highly unlikely

that BSE would be introduced in to the United States through the importation of cervids and camelids. The focus of the rulemaking was BSE and minimal risk regions, so th e removal of this prohibition only applied to BSE-related restrict ions and minimal risk regions.

38 9 CFR § 94.18(a)(1)

39 9 CFR § 94.18(a)(2)

40 9 CFR § 94.18(a)(3)

41 69 Federal Register 1892, January 12, 200423 Live Bovines and Bovine-derived Products

Under the No Action alternative for this environmental assessment, the current restrictions and prohibi tions under the APHIS BSE import regulations would continue to be effec tive. The regions that currently are allowed to export live bovines a nd 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 pr oducts 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 cl assified 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 a ccording to certain requirements in 9 CFR § 94.27. Under the No Action alte rnative, 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

2005 42 (hereafter referred to as MRR1) established the minimal risk category under APHIS BSE import regula tions and recognized Canada as a minimal risk region. This regulation allowed Canada to once again export to the United States live bovine s under the age of 30 months (after a temporary import halt on all live bovines from Canada by the United States because of the first BSE find in a Canadian animal in May 2003). A rulemaking was finalized after a subs equent 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 implem ented 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 stom achs; esophagi; urinary bladders; and small intestine, other than th e distal ileum, that are used to encase processed meats in foods such as sausage).

 Bovine blood and blood products.

42 70 FR 53043, September 7, 2005

43 9 CFR § 93, 94, 95 and 96

44 73 FR 3379, January 18, 2008 1. No Action (Maintain the
Current
APHIS BSE Import Regulations)24  Fresh/chilled or frozen beef from bovines.

 Bovine meat, meat food, and meat byproducts.

 Bovine offal.

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

 Tallow that is composed of a maximum level of insoluble impurities of 0.15 percent in weight.

The “Importation of Certain Commo dities from BSE Minimal-risk Regions (Canada), Final Environm ental Assessment, September 2007,” 45

hereinafter referred to as the M RR2 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 expos ure, 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) (U SDA, 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 a nd quantitative exposure assessments to evaluate the likelihood of exposi ng susceptible animals in the United

States from a release of BSE infectiv ity from imported live animals. The

risk assessment concluded that the ri sk of BSE becoming established in the United States as a result of implementation of the MRR2 rule and subsequent trade with Canada was negligible.

The MRR2 environmental assessment process concluded with a Finding of No Significant Impact 46 (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 cert ain conditions, the importation of live bovines born on or after March 1, 1999, bovine small intestines except for the distal ileum, and bovine blood an d blood products from Canada.

Live Cervids and Camelids

Under the prior rulemaking for MRR 1, BSE-related prohibitions on the importation of cervids and camelids were removed for minimal risk regions. Under the No Action alterna tive, the importation of cervids and

45 Available on the Internet at http://www.aphis.usda.gov/newsroom /hot_issues/bse/downloads/envi ronmental_assessment9-2007.doc

46 Available on the Internet at http://www.aphis.usda.gov/newsroom/ hot_issues/bse/downloads/environmen tal_assessment_fonsi9-2007.pdf25 camelids would continue as curren tly regulated without BSE-related prohibitions from minimal risk regions.

Live Bovines and Bovine-derived Products

Under this alternative, existing AP HIS import requirements to address BSE concerns would be changed so that the regulations are mostly consistent with guidelines from the World Organization for Animal Health (hereinafter referred to as the OIE Code) for BSE classification and import regulations. In aligning with the OI E Code, some requirements that would be incorporated into APHIS’ BSE im port regulations would be somewhat modified from the OIE requirement s in order to reflect APHIS’ interpretation of existing scientific literature and existing USDA regulations and policies, resulting in some differences between APHIS regulations and the OIE Code if th is alternative is implemented.

The United States is a Member Country of the OIE and has participated in the process to revise the OIE Code . The United States supports the changes that have been made to th e OIE Code, which is one reason for revising APHIS BSE import requirements to be more consistent with

international trade standards reco mmended by OIE. Aligning APHIS regulations with the OIE Code al so increases the efficiency and transparency with which APHIS can respond to import requests.

The 2010 OIE Code describe three BSE ri sk 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 reques ting to import live bovines or bovinederived products into the United States.

Under the existing OIE Code, a risk evaluation process is used to determine a region’s BSE classificati on. OIE evaluates the potential for BSE introduction into the exporting re gion as a result of live bovines or bovine-derived products. In addition, an exposure assessment is conducted to evaluate the risk of exposu re to the BSE infective agent if it is introduced via importation of live bovines or bovine-derived products. In the exposure assessment, the expo rting region’s practices concerning

animal feed ban enforcement and slaughter, processing and rendering practices are evaluated. Other inform ation such as epidemiological data, awareness and notification programs, and surveillance programs is also required in order to determine a regi on’s BSE classification under the OIE Code. The OIE risk evaluation proce ss for determining BSE classification

is identical to the APHIS risk as sessment process for a country’s importation of animals and animal products. If this alternative is implemen ted, some bovine-derived commodities imported into the United States would be allowed for unrestricted trade 2. Align APHIS BSE Import Regulations
with Internationally Accepted Guidelines,
with Modified
Re q uirements26 regardless of the BSE risk classi fication of the region exporting the commodity. These commodities are allowed for unrestricted trade under the existing OIE Code. The OIE unr estricted trade designation results

from OIE’s review of scientific li terature on BSE and the determination that certain products have essentiall y 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 literatu re concluded that some commodities may have a potential risk for tran smission of BSE, and that those

commodities should be allowed for tr ade under some restrictions to

minimize risk. Under this alterna tive, APHIS proposes to allow the commodities (the list of which is provided earlier in chapter II.C of this document) for restricted trade, provide d that risk mitigations and certain other restrictions dependent upon the OI E risk classification of the region importing the materials are followed.

APHIS’ restrictions for the commodities listed above would be broadly based on OIE recommendations. APHIS would, however, propose some differences from the OIE Code to reflect APHIS’ interpretation of scientific literature, to take into account existing USDA regulations and policies, and to harmonize with exis ting regulations from other U.S. Federal agencies responsible fo r management of BSE issues.

Historically, virtually all live bovines imported into the United States are from Canada and Mexico (see Regulatory Impact Analysis in USDA, APHIS, 2011). APHIS estimates that if the OIE Code isimplemented under APHIS regulations with some m odifications, there will not be any significant increases in im ports of live bovines. Due to the logistics of importing live bovines from regions ot her than Canada and Mexico and complementarity of their cattle and beef sectors (USDA, ERS, 2009a), imports of live bovines from other count ries are not likely. In a previous risk assessment (USDA, APHIS, 2007b) , the likelihood of release of the BSE infective agent that could poten tially 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 impact s 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 w ith some restrictions, which are in place to prevent exposure to the BSE infective agent. Live bovines imported from regions classified as ne gligible risk for BSE or controlled27 risk for BSE would be permitted to en ter the United States according to the same provisions outlined by OI E. However, importation of live bovines from regions that are classi fied as undetermined risk for BSE according to the existing OIE Code would be prohibited, except under certain specific conditions.

APHIS proposes not to allow live bovi nes 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 st ructure, surveillance and import controls and a documented feed ban) have by definition not been met; and (2) A separate identification and tracki ng 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 slaughte red 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 cond itions, and on a case-by-case basis. These limited exceptions to the prohi bition would be determined by the APHIS Administrator and would requi re conditions to ensure the prevention of BSE introduction into the United States.

For bovine-derived products, previous APHIS risk assessments (USDA, APHIS, 2004b, and USDA, APHIS, 2007b) and the APHIS supporting scientific documentation (USDA, APHIS, 2009) associated with the proposed regulations inves tigated the potential imp acts 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 sa feguards in place for the lifecycle of bovines, including a ruminant-to-rumina nt feed ban, removal, segregation and disposition of SRMs, and slaughter and processing practices. If this alternative is implemented, APHIS w ill 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 th at 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 produc ts for restricted trade 47 and determined

47 Live bovines; meat (other than deboned skeletal mu scle), meat products, and meat byproducts; gelatin and collagen prepared from bones, intended for food, animal food, fer tilizers, veterinary biologics, or as28 where measures that differed from the OIE Code are recommended to

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

APHIS’ assessments are include d in the supporti ng scientific documentation (USDA, APHIS, 2009).

The differences between APHIS regulat ions and the OIE Code that would remain if this alternative is implemented are discussed below. The proposed modifications from the OI E Code would ensure that APHIS regulations are consistent with the most current scientific understanding of aspects of BSE risk, including transmission and risk mitigations that are necessary to protect human and an imal health. Besides the minor

difference that the OIE Code refe rs to cattle and APHIS BSE import regulations refer to bovines, other areas of difference between the OIE Code and proposed APHIS regulations include the definition of SRMs, the age of the bovine animal from which SRMs are required to be removed, and the requirement for proving the effec tive 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 agen t. The OIE list of tissues includes: (1) tonsils and distal ileum from cattle of all ages, (2) brains, eyes, spinal cord, skull, and vertebral column fr om animals over 30 months of age from controlled BSE risk regions, and (3) brains, eyes, spinal cord, skull

and vertebral column from animal s 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 co lumn (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 tonsil s 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 m onths of age or older as SRM. Although the skull and vertebral column of cattle infected with BSE have not demonstrated infectivity, the skull contains the eyes, trigeminal

unprocessed material for the preparat ion of cosmetics, drugs (including pharmaceuticals and natural health products) or medical devices; tallow, and tallow deriva tives 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 me dical devices, animal food, fertilizers, cosmetics, pharmaceuticals including biologics, or medi cal devices; and meat and bone meal.29 ganglia, and brain, and the vertebral column contains DRG and spinal cord. Thus, because they contain hi gh-risk tissues, skull and vertebral

column are included in FSIS’ definition of SRM. Unlike other parts of the vertebral column, the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and th e wings of the sacrum do not contain spinal cord or DRG. Therefore, FSI S 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 BS E instead of OIE SRM definitions.

Under the OIE Code, SRMs must be removed from cattle over the age of 30 months originating from regions iden tified as controlled BSE risk. For regions identified as undetermined BSE risk, SRMs must be removed from animals over the age of 12 mont hs. As discussed above, APHIS is proposing under this alternative to prohibit the importation of live bovines from undetermined BSE risk regions 48 because the removal of SRMs from bovines over the age of 12 months im ported live and slaughtered in the United States would require establis hing 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 othe r tissues are designated as SRMs for cattle at 30 months of age and olde r. The U.S. decision was based on scientific data and experiences in th e 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 mont hs 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 mont hs of age for use in human food has the largest impact on human exposure, reducing potential human exposure by more than 99 percent on average (Cohen and Gray, 2005).

FSIS’ definition for SRMs, as supporte d by the scientific data, experience and analysis described above, is accept ed internationally in BSE standards

48 Except in limited situations, such as movement to z oos and exhibitions, and under specified conditions on a case-by-case basis if the APHIS Administrator determin es that the bovines can be imported under conditions that prevent the introduction of BSE into the United States.30 set by various countries and is consis tent 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 require ments listed in the FSIS regulations at 9 CFR 310.22(a). For bovine-deriv ed products from regions of undetermined BSE risk, APHIS woul d require that SRMs be removed according to the same requirements list ed in the FSIS regulations at 9 CFR 310.22(a), except that that the follow ing bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: brai n, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (exclu ding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

b. Proof of Effective Date of Enforcement of Feed Ban

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

cannot demonstrate or are unable to m eet the requirements of negligible

BSE risk or controlled BS E risk status. In order to export live bovines, a region with negligible BSE risk stat us would be required to have an effectively enforced feed ban (verif ied through audit and compliance) in place for at least 8 years and for contro lled risk countries for less than 8 years. The region also would be required to certify th at bovines from negligible risk countries (which reported an indigenous case) and

controlled risk countries selected for export were born after the date from which the ban on feeding of ruminant meat-and-bone meal and greaves to ruminants has been effectively enforce d. The OIE Code further states that cattle from a region of undetermined BSE risk can be exported if they were born at least 2 years after the da te from which the ban on the feeding of meat-and-bone meal and greaves derived from ruminants was effectively enforced. APHIS consider s that cattle intended for particular uses that will not lead to possi ble transmission of the agent do not

constitute a risk for livestock exposure.

The OIE recommends that regardle ss of the region’s BSE risk classification, all region s can export live cattle. 49 For regions of negligible BSE risk that experienced an indigen ous BSE case and for controlled risk countries, the exporting region must cer tify 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 b een effectively enforced. The OIE Code requires that a region of undetermined BSE risk must certify that the bovines selected for export were born 2 years after the date the ban was effectively enforced. APHIS proposes to adopt the OIE Code, with some

49 In carrying out its evaluation process, the OIE refers to risk factors as they involve “cattle.” Therefore, when discussing the OIE process in this pr oposed rule, we use the term “cattle.” However, the provisions of the proposed rule would apply to bovines as defined in the current regulations, which include bison.31 modifications for a region of undeterm ined BSE risk incl uding that APHIS will prohibit the importation of live bovines from a region of undetermined BSE risk, except for speci fic uses on a case-by-case basis and under conditions determined by the APHIS Administrator to be adequate to prevent the spread of BS E. Also, because the OIE Code does not require the identification of a specif ic date of the effective feed ban in any region, the establishment of a sp ecific date would be necessary and, therefore, APHIS would request and ev aluate 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 policie s and infrastructure for feed ban enforcement, including an awareness program for producers and farmers;

2. Documentation describing livesto ck and husbandry practices;

3. Documentation describing the di sposition of processed animal protein produced from domestic bovines, including the feeding of any animal species;

4. Documentation on the measures taken to control crosscontamination and mislabeling of feed intended for bovines with processed animal protein. This documentation must indicate the measures taken to prevent cross- contamination and mislabeling of feed intended for bovines with processed animal protein;

5. Documentation describing monitori ng and enforcement of the ban on the feeding of ruminant MB M 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 pr event 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 re striction that the tallow cannot be

used in animal feed. Pr otein-free tallow from a mi nimal risk region can be imported into the United States for any use under current APHIS regulations.32 Under the proposed alternative discu ssed in this document, APHIS would align with current the OIE Code c oncerning regulation of importation of tallow and tallow derivatives. Under the OIE Code, definitions for two types of tallow are relevant to APHIS regulations: (1) tallow and derivatives made from this tallow and (2) tallow with a maximum level of insoluble impurities of 0.15 percent by weight and derivatives made from

this tallow. The considerations a nd conclusions regarding each of these

two definitions are discusse d in more detail below.

The OIE Code does not sp ecifically define the term “tallow derivative.” However, FDA defines “tallow derivative” as:

 "... [A]ny chemical obtained through initial hydrolysis, saponification, or tran sesterification of tallow; chemical

conversion of material obtained by hydrolysis, saponification, or transesterification may be applie d to obtain the desired product." 50

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

would meet the OIE Code under whic h tallow derivatives from any country could be traded. APHIS proposes to follow the FDA definition of

“tallow derivative” in the discussi ons concerning proposed regulations

below.

(1) Tallow and Tallow Derivatives Other Than Tallow with a Maximum Level of Insoluble Impuri ties of 0.15 Percent by Weight
and Derivatives: Tallow and tallow derivative s, as described in this section, contain insoluble impurities of more than 0.15 percent in weight. The conditions for importation of tallow as defined in this section depend on the risk category of the exporting re gion (OIE, 2010). For tallow that is intended for use in food, feed, fertil izers, cosmetics, pharmaceuticals or medical devices, the OIE Code requi re an international veterinary certificate confirming that the foll owing 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 ove r 30 months of age at slaughter.

For tallow as defined in this sect ion, if the proposed alternative is implemented, APHIS would adopt OI E recommendations for conditions required before receiving the commod ity. These conditions are either:

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

50 21 CFR 589.200133  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 ar e discussed in more detail in the proposed rulemaking text that this EA supports.

For derivatives from bovine-derived tallow other than tallow with a maximum level of insoluble impurities of 0.15 percent in weight, the OIE Code recommends that trade be allowed under any of the following

conditions:

 It originates from a country of negligible risk for BSE;

 It originates from a country of c ontrolled 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 ri sk for BSE or a country of undetermined risk for BSE and was produced by hydrolysis, saponification, or transe sterification. Those processes create conditions of high enough temperature and pressure to inactivate the BSE agent.

Under the proposed alternative, APHIS would allow importation of tallow

derivatives sourced from other than tallow with a maximum level of insoluble impurities of 0.15 percent by weight according to the OIE Code when accompanied by certification that the above conditions have been met or on a case-by-case basis as determined by the Administrator.

(2) Tallow with a Maximum Level of Insoluble Impurities of 0.15 Percent by Weight and Derivatives: For tallow with a maximum level of insoluble impurities of 0.15 percent by weight, the OIE Code does not require any mitigation or conditions for import, regardless of the BSE classification of the importing regio n, provided that the tallow and any

derivatives from it contain a maximum level of insoluble impurities of 0.15 percent in weight. The OIE Code regarding tallow derived from

bovines is based on the conclusion that tallow with a maximum level of insoluble impurities of 0.15 percent in weight and derivatives made from

this are not a risk factor in the tr ansmission 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 from34 this tallow as discussed in this se ction, if the proposed alternative is implemented, APHIS would follow the OIE Code for importation; thus, imported tallow containing a maximum level of insoluble impurities of 0.15 percent in weight will be unrestricted.

Current APHIS regulations do not include any restrictions or conditions on receipt of imports of ta llow 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 wi thout restriction due to BSE.

d. Regulation of Bl ood and Blood Products

Under the proposed alternative, regulation of bovine blood and blood products would differ from both exis ting APHIS regulations and the OIE Code. Existing FDA regulations 51 prohibit the use of most mammalian proteins in ruminant feed excep t for some products for which the

likelihood of transmission of BSE is very low. Blood and blood products are included in the list of products for which there is an exception to the existing FDA regulations.

Currently, the OIE Code recommends that blood and blood products be eligible for trade from any region pr ovided that the products meet the following conditions:

 The blood and blood products must be derived from bovines that were not subjected to air-inject ed stunning or pithing prior to slaughter and are collected in a ma nner that avoids contamination.

Studies have never demonstrated BS E in bovine blood or blood products, but APHIS recognizes that the possib ility of cross-contamination with

infected SRM material exists. For this reason, APHIS proposes to adopt the OIE Code concerning regulati on of blood and blood products with

some modifications to decrease th is risk of cross-contamination.

Under the proposed alternative, APHI S would allow the importation of bovine blood and blood products provid ed that the products meet the following conditions:

 Blood must be collected under hygien ic conditions that prevents

contamination of the blood with SRMs

 For blood collected at slaughter and products derived from blood collected at slaughter, slaughtered animals must meet the following requirements:

o Animals must have passed ante-mortem inspection

51 21 CFR 589.200035 o Animals must not have been subjected to a stunning process with a device injecti ng compressed air or gas into the cranial cavity, or to a pith ing process prior to slaughter

 For blood collected from live bovin es 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 accompanie d 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 ot her 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 ar e prohibited from importation

into the United States.

 Additionally, APHIS would requir e that each shipment of blood and blood products to the United States must be accompanied by certification that the applicable requirements have been met.

e. Regulation of Pro cessed 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 pr otein.” In part 95 of current APHIS regulations, “processed animal protei n” is defined as “meat meal, bone meal, MBM, blood meal, dried plasma and other blood products, hydrolyzed proteins, hoof meal, hor n meal, poultry meal, feather meal, fish meal, and any other similar produc ts.” Like MBM, each of the other products defined as processed animal protein is a rendered product, except for blood and blood products. (Pr oposed regulations concerning blood and blood products are discussed above.)

Current OIE guidance acknowledges the re latively greater BSE risk posed by processed ruminant protein (meat and bone meal and greaves derived from ruminants) compared to other animal products. Countries seeking

BSE risk classification must inform the OIE whether MBM, greaves, or feedstuffs containing either, have been imported into that country within the past 8 years, and, if so, from wh at country and in what quantities. While APHIS has not yet done an assessm ent of the BSE ri sk of processed36 animal protein products, APHIS believe s it is necessary to take into account the risk that the other produ cts could become commingled with MBM, which, if derived from inf ected ruminants, may contain the infectious BSE agent.

Under the proposed alternative, regul ation of processed animal protein

would differ from the OIE Code in order to incorporate measures to mitigate APHIS’ concern about the BS E risk associated with potential commingling of processed animal prot ein with other potentially infected commodity types.

Importation of processed animal prot eins derived from ruminants would be prohibited unless the products meet the following conditions:

 The region exporting processed rumi nant animal protein products must be a region with negligible ri sk status for BSE, or the product must be derived from ruminants born and raised in a region of negligible risk for BSE. Pro cessed ruminant animal protein products from a region of controll ed risk for BSE or a region of undetermined risk would not be eligible for importation into the

United States.

 If either of the following condi tions apply, the product must be

derived from ruminants that were subject to a ban on the feeding of ruminants with meat and bone meal and greaves derived from

ruminants:

o The product is exported to the United States from a region of negligible risk for BSE in which there has been at least one indigenous case of BSE; or

o The product is derived from ru minants 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 applic able requirements discussed above

have been met.37 For processed animal proteins derived from animals other than ruminants, importation would be prohibited unle ss the products meet the following

conditions:

 From a region of negligible BSE risk:

o Material is not otherwise prohi bited 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 St ates 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 doe s 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 a nd was not commingled with

ruminant blood or blood products prohibited from importation into the United States.

 Annual inspection of facility for compliance with provisions must

be conducted.

f. Harmonization with Existi ng 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 bovine s 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 carcasse s 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 im ported bovines or bovine-derived products from regions outside of th e United States, including any new38 regions that would be allowed to export live bovines or bovine-derived products, would continue to be subjec t to applicable existing FSIS and/or FDA regulations. If this alternativ e is implemented, restrictions on the

trade of live bovines for each of the OI E 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 regi on 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 rumina nts, natural transmission of BSE has not been reported in cervids and cam elids (i.e., llamas, alpacas, guanacos, and vicuñas). One ongoing study shows that red deer ( cervus elaphus) developed clinical signs similar to ch ronic wasting disease on intracerebral

inoculation of BSE infect ed brain (Martin et al., 2007); however, red deer challenged intra-gastrically with BS E infected brain developed neither clinical signs of diseas e nor presence of the a bnormal type of the prion protein at post mortem examinati on. Since intra-gastric inoculation resembles closely natural transmi ssion, the absence of positive results indicates that the species are not likely to be susceptible to BSE. In addition, surveillance in the UK and European cervid population did not show any evidence of any TSEs (http://www.cdc.gov/Ncidod/ eid/vol12no02/pdfs/05-0970.pdf, http://archive.defra.gov.uk/foodfarm/fa rmanimal/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 restri ctions for all live cervids, camelids, and their products from any region of the world. The OIE Code for BSE does not address any restric tions with regard to cerv ids, camelids, or their products.39 

### B. Physical Environment

This section considers the extent of impacts on the physical environment that are unrelated to BSE exposure but that result from actions associated

with the No Action alternative and the proposed action. As defined under NEPA, direct impacts are caused by the action and occur at the same time; indirect impacts are caused by the ac tion and occur later in time or are farther removed in distance, but are still reasonably foreseeable. 52

The actions that could result in potential impacts on the physical environment by either the No Action a lternative 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 a lternative (the baseline) and the proposed action could affect the qualit y of the human environment would depend upon the amount of imported commodities from the (1) transport of imported commodities, (2) the hol ding of imported live bovines in feedlots, and (3) the disposal of SRMs removed from imported slaughtered bovines. Laws, such as the Clean Water Act and Clean Air Act, serve to protect the quality of the human environment from the potential effects related to vehicle, railroad, and ship transport; animal feedlots; and disposal of animal tissues and waste. These laws are enforced by State and Federal agencies , including the U.S. Environmental Protection Agency.

The discussion that follows provides the baseline (the current situation— No Action alternative) of the amount of imported animals and animal products under the current regulation s, the amount of live bovines that contribute to feedlot impacts, and will explain the extent to which these

activities under the al ternative (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 virt ually all of the live cattle imported

into the United States. Bovine-d erived products are imported from Canada, Mexico, Australia, New Ze aland, Uruguay, and several other

countries. Live bovines and bovine-deriv ed products from either Canada or Mexico are mostly transporte d by commercial trucks, with the possibility that a small percentage of bovine-derived products are transported by rail car from Canada.

Live cervids, specifically deer and el k, and live camelids are imported into

the United States from Canada. Im ported cervid products include deer

52 40 CFR § 1508.8 1. Transport of
Commodities40 meat and deer and elk semen, with Ne w Zealand as the major exporter of

most deer meat and Canada as the ma jor exporter of cervid semen to the

United States. Deer skin and camel hair are the only other identified cervid and camelid products, respectivel y, imported to the United States.

Because live bovines, cervids, and camelids imported are most likely transported by commercial trucks, e nvironmental 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 e ngines, they contribute to emissions of the following air pollutants: carbon mon oxide (CO), nitrogen oxides (NO X ) sulfur dioxide (SO 2 ), volatile organic compounds (VOC), and particulate matter (PM). In addition, diesel exha ust contains 40 specific hazardous air pollutants, such as formalde hyde (IEI and R&AEC, Ltd., 2007). Burning

of diesel fuel also results in emissions of carbon dioxide (CO 2 ), the most prevalent greenhouse gas. Greenhouse ga ses prevent ultrav iolet rays from leaving the earth’s atmosphere, re sulting in a “greenhouse” or warming effect, which is a major part of global climate change.

In order to be imported, live bovines and other live ruminants can enter the United States through any of 20 approve d ports of entry authorized for importation of ruminants at the U.S./Canada border 53 and 16 approved ports of entry at the U.S./Mexico border, 54 and also could enter through any of the following approved air and ocean ports: Los Angeles, California; Miami, Florida; and Newburgh, New York.

Most ruminant-derived products from countries that do not share a land

border with the United States are tr ansported by ship vessel and then transported to their final destinations by truck. Ruminant-derived products can be imported into the United States through more than 225 international and sea ports of entry where Customs and Border Protection Agricultural Specialists are present.



### a. No Action—Maintain the Current APHIS BSE Import Regulations

For this alternative, No Action—mai ntain the current APHIS BSE import regulations, imports of live bovine s and bovine-derived products are considered to address potential impact s on the physical environment. The totals of imported commodities al lowed under the current APHIS import

53 U.S./Canada border approved ports of entry: Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, and Sault Ste. Marie, MI; Baudette, MN; Opheim, Raym ond, and Sweetgrass, MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, VT; and Oroville and Sumas, WA (9 CFR 93.403(b)).

54 U.S./Mexico border approved ports of entry: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; Calexico and San Ysidro, California; Antelope We lls, Columbus, and Santa Teresa, New Mexico; and Brownsville, Del Rio, Eagle Pass, Hidalgo, La redo, and Presidio, Texas (9 CFR 93.403(c)).41 regulations to portray the current situ ation and the potenti al contribution to impacts on the physical environment. Other than for BSE, APHIS also restricts the importation of live bovi nes and bovine-derived products for other animal diseases, such as foot-and-mouth disease. These commodities are allowed importation provided they meet other requirements that are designed to prevent the introduction of animal diseases that could impact the U.S. animal populations.

(1) Transport of Imported Live Bovines Contributing to Environmental Impacts

As mentioned previously, Canada and Mexico provide virtually all the live bovines imported into the United States. On average, each country provides about 1 million live cattle to the United States annually. Importing live cattle from countries other than Canada and Mexico is impracticable. Factors, such as lack of ample quarantin e facilities to hold cattle upon arrival and the di stance and costs associat ed 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 relate d to their value in improved genetics. The advent of improved technology fo r successfully importing semen and embryos has negated much of the need for importing the animals themselves for breeding purposes.

(a) From Canada

Using 2008 and 2009 import information, the average number of cattle imported annually from Canada during these 2 years was approximately 1.35 million (USDA, ERS, 2011a; see table A-1 in appendix). During this 2-year period, the U.S. cattle inventory average was 95 million cattle (USDA, ERS, 2010). Thus, the number of cattle imported from Canada contributed to about 1.4 percent of the total U.S. cattle population.

Deriving data from a U.S. Department of Transportation (U.S. DOT) database, the average annual number of all commercial truck crossings

from Canada into the United States for 2008 and 2009 for the 20 approved U.S./Canada land ports of entry for ca ttle 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 Ca nada, the transport of bovines would have required the need for approximately 27,118 trucks. 56 The average estimated number of truck transpor ts (27,118) for imported bovines from Canada is about 0.6 percent (or, abou t 1⁄2 of 1 percent) of the average annual commercial truck crossings (4.57 million) per year (2008 and

55 Truck crossings at 20 approved U.S./Canada land por ts of entry for bovine imports during 2008 and 2009, respectively: 4,955,503, and 4,176,933 (2-year average: 4,566,218).

56 32,368 + 21,868 = 54,236; 54,236 ÷ 2 = 27,118.42 2009) from Canada to the United Stat es through the approved U.S/Canada ports of entry for cattle—an insignif icant number when compared to the

total annual truck crossi ngs at these locations. 57

When comparing to a higher baseline, the overall truck transport total for all U.S./Canada ports of entry, ex cluding 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 crossing s through all U.S./Canada ports of entry for 2008 and 2009, 27,118 truck transpor ts 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 bord er. As well, other transport modes (including cars, buses, and small trucks (which are not included in these figures for cross-border transport of cattle) contribute to pollutant emissions and greenhouse gases at the U.S./Canada border.

(b) From Mexico

Using 2008 and 2009 data, the average num ber of cattle imported annually from Mexico was approximately 0.82 million (USDA, ERS, 2010; see table A-2 in appendix). During th is 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 data base, 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 cattle 58
is nearly 3 million (2,994,589) (U.S. DOT, 2011a). Based on the average of 2008 and 2009 data on cattle impor ted to the United States from
Mexico from 2008 and 2009 and an av erage of 50 cattle per truckload, 59
the transport of cattle would have required the need for approximately 16,435 trucks. The average estimated nu mber 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 commerci al truck crossings (3 million) per year from Mexico to the United States only through the approved U.S./Mexico ports of entry for cattle.

When comparing to a higher baseline, the average truck transport total for all U.S./Mexico ports of entry for 2008 and 2009 was about 4.58 million

57 27,118 ÷ 4,566,218 = 0.6 percent

58 U.S./Mexico border approved ports of entry: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; Calexico and San Ysidro, California; Antelope We lls, Columbus, and Santa Teresa, New Mexico; and Brownsville, Del Rio, Eagle Pass, Hidalgo, La redo, and Presidio, Texas (9 CFR 93.403(c)).

59 This is a conservative estimate; virtually all cattle from Mexico are young feeder cattle, which could allow more cattle per livestock hauling trailer.43 (4,578,856) (U.S. DOT, 2011a). When comparing the average number of annual truck transports for cattle imported through the 16 approved U.S./Mexico border ports (16,435) to th e number of annual truck crossings through all U.S./Mexico ports of entry for 2008-2009, 16,435 truck transports for cattle represents ap proximately 0.4 percent of the overall average annual total truck crossi ngs 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 pe rcentage of air pollutants and greenhouse gas emissions toward the amounts contributed from the annual number of truck transports at the U. S./Mexico border. These data do not include other transport modes, such as buses and cars that also contribute to pollutant emissions and greenhouse gas emissions at the U.S./Mexico

border.

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

For 2008 and 2009, an average total of approximately 871,331 metric tons (MT) of bovine-derived products fo r human consumption were imported (see appendix, table A-3). Because of the geographic locations, distance, and weight of products, the majority of these types of products from other than Canada and Mexico are transp orted by ship vessel. Because of geographic proximity, it is assumed th at 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 relate d 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; fr ozen, fresh, or chilled carcasses and half-carcasses; and other bovine m eat and edible bovine offal.

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

about 850 million metric tons (MT) (U.S. DOT, 2011b). 60 The average amount of imported bovine-derived products for 2008 and 2009 is about 871,331 MT. The amount of imported bovi ne-derived products that most likely are transported by ship vesse l (excluding the amount of these products from Canada and Mexico (315,435 MT 61 )) is about 555,896 MT,

60 Excluding postal and military shipments

61 294,901 + 20,534 = 315,435 MT44 or 0.7 percent 62 — 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-der ived products from Canada are transported by commercial trucks, the amount of bovi ne-derived products from Canada (about 294,901 MT 63 ) would require about 14,776 commercial truck transports. Assuming that all bovine-d erived products from Mexico are transported by commercial trucks, th e amount of bovine-derived products from Mexico (about 20,534 MT 64 ) would require about 1,029 commercial truck transports.

The remainder of transported bovine- derived products from countries

other than Canada and Mexico is about 555,896 MT and would require a minimum of 27,853 commercial transport trucks, assuming that each truckload would be dedicated solely to these commodities and movement

to the final destinations. 65 Realistically, bovine-derived products would likely be shipped in smaller amounts th an a full truckload and, especially

from countries other than Canada and Mexico, could be imported through any of 225 ports of entry.

Transport of Imported Commodities

Commercial trucks are used for liv e bovines and bovine-derived products, transporting the commodities from Canada or Mexico into the United States, and trucks are used fo r transporting these commodities to their various destinations once they a rrive within the United States. Table A-4 of the appendix provides the estimated 2008 and 2009 annual number of truck transports for moving both live bovines and bovine-derived

commodities into the United States.

The estimated number of truck tran sports for imported live bovines and bovine-derived products from Canada (41,894) represents about

0.9 66 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 truc k crossings when compared to the total annual truck crossings at these locations.

When making comparison to a high er baseline, the 2008-2009 average truck transport total for all U.S./Canada ports of entry, excluding Alaska, for 2008 and 2009 was 5.45 million (U.S. DOT, 2011a). When comparing

62 555,896 ÷ 850,000,000 = about 0.7 percent.

63 294,901 × 2,204.62 lb/MT = ~650,145,415 lb.; 650,145,415 lb. ÷ 44,000 lb/truckload = 14,776 commercial

trucks

64 20,534 × 2,204.62 lb/MT = 45,269,667 lb., 45,269,667 ÷ 44,000 lb/truckload = 1,029 commercial trucks

65 555,896 x 2,204.62 lb/MT = 1,225,540,897 lb; 1,225,540,897 ÷ 44,000 lb/truckload = 27,853 commercial

trucks.

66 41,894 ÷ 4,566,218 = 0.9 percent45 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 crossi ngs through all U.S./Canada ports of entry for 2008 and 2009, 41,894 truck tr ansports represents about 0.8 67
percent of the overall average annua l total truck crossings at the U.S./Canada border. Other transpor t modes (including cars, buses, and small trucks) are not included in the ove rall 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 0.6 68 percent (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 crossing s when compared to the total annual truck crossings at these locations. When making comparison at a higher baseline, the overall truck transport total for all U.S./Mexico ports of entry for 2008 and 2009 were 4.58 million (U.S. DOT, 2011a).

When comparing the average number of annual truck transports for cattle imported through the 16 approved U.S./Mexico border ports for 2008 and 2009 (17,464) to the average number of annual truck crossings through all U.S./Mexico ports of entry for 2008 and 2009, 17,464 truck transports for cattle represents approximately 0.4 69 percent of the overall average annual total truck crossings at the U.S./Mex ico border. Other transport modes (including cars, buses, and small truc ks) are not included in the overall total vehicle crossings at the U.S./Mexico border.

When combining the estimated number of truck transports for imported bovines and bovine-derived products fr om Canada and Mexico to the

additional amount of bovine-derived products from other countries, the amount of truck transports is a bout 87,211—still an uns ubstantial amount when considering the an nual totals of truck crossings through both the Canada and Mexico border ports.

67 41,894 ÷ 5,447,876.5 = about 0.8 percent

68 17,464 ÷ 2,994,589 = about 0.6 percent

69 17,464 ÷ 4,578,856 = about 0.4 percent46 (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) an d live camelids (alpacas, camels, and/or llamas) were imported to the United States, all from Canada. Table A-5 (see appendix) summarizes these imports and provides an estimate of the number of transport ve hicles that would have likely been required to transport the animals.

Live Cervids and Camelids

It is estimated (based on an annual av erage) that 1,097 transport vehicles (horse or cattle trailer) would have be en needed to transport the amount of live cervids and camelids imported from Canada during 2008 and 2009 (see appendix, table A-5).

Cervid and Camelid Products

With regard to cervid products, during 2008, 393 shipments of cervid semen were imported from Canada. During 2009, 1,264 cervid semen shipments and 311 cervid embryos were imported from Canada. These products are generally shipped in small containers and are mostly transported by private vehicle or transported by airplane or ground transportation fast delivery services.

During 2008, importation of deer meat into the United States totaled approximately 912 MT from 3 countri es. During 2009, importation of

deer meat into the United States totaled approximately 913 MT from 3 countries. In both years, the ma jority (approximately 910 MT) of imported deer meat was from New Z ealand (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 MTand for 2009 was about 750 million MT (U.S. DOT, 2011b). For BSErestricted commodities, the amount of imported cervid-derived products shipped during the years of 2008 and 2009 most likely were transported by ship vessel and comprise a fraction of 1 percent of the reported U.S.

annual volume of U.S. waterborne imports for either 2008 or 2009.47 b. Proposed Action—Align AP HIS Regulations with OIE Guidelines, with Modi fied Requirements

Under the proposed rulemaking, live bovines and bovine-derived products from any region could be imported in to 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 co mpleted. However, few live bovines are exported to the United States from re gions other than Canada and Mexico; the livestock market in the United States is efficient and well-established, and exporters in geographically dist ant countries are at a competitive disadvantage in that market, espe cially given the added cost of transporting animals to the United States. The proposed rulemaking is not likely to offset that disadvantage. Canada and Mexico historically have been the main source of live bovines imported to the United States. The proposed rulemaking should have minimal impact on U.S. importation of live bovines and bovine-derived prod ucts from Canada and Mexico (USDA, APHIS, 2011). The anticipat ed annual volume of live bovines and bovine-derived products that coul d be imported to the United States based on the provisions in the proposed rulemaking is not expected to change appreciably from the amounts shown in tables A-1, A-2, and A-3 (in the appendix).

The proposed rulemaking is expected to have minimal impact on U.S. imports of live cervids and camelids and minimal impact on U.S. imports of cervid and camelid products (USDA, APHIS, 2011) and, therefore, would not affect the amount of cervid and camelid imports discussed in

the No Action alternat ive 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 Stat es. Movement of these commodities would occur by various transport modes, including truck, ship, and train or

a combination of these modes.

Feedlot operations are regulated by environmental protection laws and regulations, such as the Clean Wate r Act and Clean Air Act, under the authority of the U.S. EPA and State and local agencies. USDA’s ERS reports that cattle feeding is concentrat ed 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 animal s are fed in concentrated animal feeding operations for several months fo r further growth and then sent for slaughter. 2. Holding Imported
Bovines in
Feedlots48 The types of environmental impacts a ssociated with holding livestock in

feedlots include air and water pollutant discharges and emissions, such as nutrients, organic matter, pathoge ns, and odorous/vol atile 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 oper ations can contribut e to water quality degradation. Many of these opera tions 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). Nitrat e contamination is more prevalent in ground waters than in surface wate rs (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 conver sion of otherwise unusable plant

materials into nutritious food and fiber is a positive aspect of the digestive systems of ruminant animals, such as cattle, the digest ive 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 wa ste management (EPA, 2011).

a. No Action Alternative

For the years 2008 and 2009, an average of 26 million cattle was marketed from U.S. feedlots (USDA, NASS, 2009; USDA, NASS, 2010). 70 Cattle are moved into feedlots at various times of the year and are fed in feedlots for several months. Thus, cattle that ar e moved into feedlots in the latter months of a reporting year may be av ailable for marketing in the next year. As well, bovines are imported from Canada and Mexico throughout the year and there is no available br eakdown from statistic al reports on the

number of marketed cattle that were im ported; they are part of the overall

U.S. total marketed.

As estimated for 2008 and 2009 (see appendix, table A-6), bovines imported from Canada and Mexico represented about 4 percent 71 72 of the

70 About 26,449,000 for 2008 and 25,604,000 for 2009.

71 185,574 + 705,661 = 891,235, representing 3 percent of 26,449,000. (The total of 185,574 is based upon an assumption that cattle imported from Canada (in 2008) and designated as ot her than for breeding, dairy, or immediate slaughter purposes are feeder cattle.)49 total U.S. cattle in feedlots marketed during that period and likely contributed toward a relative portion of overall environmental impacts in feedlots that are regulated by Fe deral, State, and local laws.

b. Proposed Action

According to the related regulatory imp act analysis, the effect of this proposed rule on imports into the United States would be minimal at most; therefore, the number of bovines impor ted into feedlots for feeding and then slaughter would not apprec iably differ from the No Action

alternative.

The processing of bovines for slaught er generates SRMs that would be disposed of at slaughter. As discus sed 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 ar e considered at particular risk of containing infectious levels of th e BSE agent in BSE-infected cattle

.

Although differences are noted in SRM weight from two sources (see appendix, table A-7), for purposes of th is EA the SRM calculations use the most conservative weights from the combination of both sources. For cattle under 30 months of age, SRMs incl ude the distal ileum and tonsils, totaling approximately 3 pounds per animal. For cattle 30 months of age and older, SRMs include the brain, spin al cord, eyes, skull, trigeminal ganglia, distal ileum, tonsils, and ve rtebral column, totaling approximately 57 pounds (USDHHS, FDA, 2005; USDA, FSIS, 2007).

a. No Action Alternative

Under the No Action alternative, whic h 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 ca ttle must be removed at slaughter, including from those that are impor ted. (Under APHIS regulations, SRMs are also required to be removed, but reference in the regulations is to removal from bovines instead of speci fically to cattle.) The revised APHIS BSE import regulations became effective on November 19, 2007.

72 75,063 + 940,789 = 1,015,852; representing 4 percent of a nnual slaughter of 25,604,000, (The total of 75,063 is based upon an assumption that cattle imported from Canada (in 2009) and designa ted as other than for breeding, dairy, or immediate sla ughter purposes are feeder cattle.) 3. SRMs
Generated50 To account for SRMs generated annually from imported live bovines under the No Action alternative, this analysis includes imported live

bovines that are unrestricted fo r BSE under existing APHIS import regulations. Import data for liv e bovines from 2008 and 2009 are averaged to arrive at the total of SRMs generated annually from imported bovines (see appendix, tables A-8 and A-9). For 2008, SRMs generated from imported cattle (both Canada and Mexico) are estimated to be about 20.1 million pounds and for 2009 to be about 19.5 million pounds.

b. Proposed Rulemaking

Under the proposed rulemaking, imported live bovines from the countries

of Canada and Mexico would continue . As determined in the related regulatory impact analysis, the amo unt of live bovines imported from Canada are not expected to be aff ected and, at most, impacts on the number of types of bovines currently eligible for importation from Mexico would be minimal based on changes proposed for the APHIS BSE import regulations (USDA, APHIS, 2011). Because the proposed changes to APHIS’ BSE import regulations would not cause a substantial change in the number of imported live bovines from Canada, Mexico, or other countries, a substantial difference in the amount of SRMs that would be removed at slaughter and disposed from imported live bovines is not expected.



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

The OIE Code that APHIS regulations will closely align with is based on

an international sc ientific consensus about the BSE agent, the mechanisms for its spread, and the tissues that ar e most likely to harbor the infective agent. Scientific research, backed by practical experien ce, has resulted in

a defined series of measures that c ountries 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), comb ined with the requirements in existing regulations for SRM removal and the ruminant feed ban enforced by FSIS and FDA respectively, are desi gned 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 Federa l agencies to ensure that their actions are not likely to jeopardize the continued ex istence of endangered or threatened species or result in the destruction or adverse modification of critical habitat. Therefore, the following s ection discusses the effect of the51 proposed action and No Action alternativ es on federally listed threatened and endangered species in the United States.

Transmissible spongiform encephalopath ies (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 rumina nt species were considered as potentially at risk from the ingestion of contaminated feed (see table 3).

Table 3. Endangered Wild Ruminant Species in the United States Potentially At Risk From Transmissible Spongiform Encephalopathies.

Common Name Scientific Name Listing Status

Woodland caribou Rangifer tarandus caribou Endangered

Columbian white-tailed deer Odocoileus virginianus
leuceurus Endangered

Key deer Odocoileus virginianus clavium Endangered Sonoran pronghorn Antilocapra americana
sonoriensis Endangered

Peninsular bighorn sheep Ovis canadensis nelsonii Endangered with
critical habitat Sierra Nevada bighorn sheep Ovis canadensis sierrae Endangered with
critical habitat

Also, for the proposed action and No Action alternatives, eight federally

listed cats were considered for risk of infection from BSE because of the possibility that they could feed on BSE-infected bovi ne carcasses (see table 4).

Table 4. Federally Listed Cats Known to Feed on Bovine Carcasses.

Common Name Scientific Name Listing Status

Canada lynx Lynx canadensis Threatened
Eastern puma (=cougar) Puma (=Felis) concolor cougar Endangered

Endangered Endangered

Endangered Endangered Endangered Florida panther Puma (=Felis) concolor coryi Gulf Coast jaguarundi Herpailurus (=Felis) yagouaroundi
cacomitli Jaguar Panthera onca

Ocelot Leopardus (=Felis) pardalis Sinaloan jaguarundi Herpailurus (=Felis) yagouaroundi
tolteca Puma (=mountain lion) Puma (=Felis) concolor (all subsp. except coryi) Similarity of appearance to a
threatened taxon52 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, AP HIS, 2005; and USDA, APHIS, 2007a). In those environmental anal yses, 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 designate d critical habitat.

APHIS’ proposal to align its regulations with the OIE Code, with modified requirements, would continue to protect U.S. cattle from exposure to BSEinfected imports (USDA, APHIS, 2009) . This would result in protection of federally listed ruminants and cats from exposure to BSE via

contaminated feed or infected bovin e carcasses. Therefore, APHIS has determined that implementation of the proposed action would have no effect on federally listed ruminants or cats or their de signated 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 futu re actions. Actions resulting in a cumulative impact may or may not be generated by the same agency. Cumulative impacts can result from individually minor but collectively significant actions taking place over a period of time. 73

BSE-infected bovines and bovine-derived materials can potentially impact the human environment, including pub lic health, if SRMs with infectious levels of the BSE agent enter the f ood chain. Existing regulations in the United States containing mitigation m easures to prevent the BSE agent from entering the food chain are discu ssed previously in this document. Mitigation measures contained in the OIE guidance that APHIS is proposing to adopt (with some m odifications) under the preferred alternative are also discussed previously in this document. The cumulative impacts of the current APHIS regulations, the proposed action (changing APHIS import regulations so that they are mostly consistent with the OIE Code for importation of live bovines and importation of bovine-derived products), and any futu re proposed actions should not have a significant impact on the human environment in the United States.

73 40 CFR § 1508.7 1. Public Health53 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 regula tions. 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 St ates. Because of the interlocking, overlapping, harmonized nature of the proposed revised APHIS regulations with regulations from othe r 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 guidan ce, 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 BS E 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 segr egating these SRMs, in combination with established regulations for removing and segregating SRMs from U.S. bovines, would not increase pub lic health risks from BSE exposure, assuming that U.S. facilities adhere to existing regulations enforced by

FSIS and FDA.

Other U.S. Federal Agency Regulations

Current APHIS regulations and regula tions under the proposed alternative discussed in this document are designe d, 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 ch ange if APHIS implements new regulations as proposed in this docu ment. The FDA and FSIS regulations

are discussed in more detail in the Pub lic 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 tissu es that constitute SRMs and SRM removal, segregation and disposition, all of which are

intended to ensure that SRMs do not enter the human food chain54 and that they do not contaminate edible meat, cosmetic, medical, or other products intended for human consumption.

 FSIS regulations on the disposi tion of nonambulatory cattle. Under FSIS regulations, nonambulat ory cattle must be condemned and are prohibited from being used in any edible products intended for human consumption. Carcasse s of nonambulatory cattle must be disposed of by tanking (a n inedible rendering process), incineration, or denaturing by materials approved by the

Administrator of FSIS.

 FSIS regulations prohibiting inco rporation of mechanically separated meat in food intended for human consumption.

 FSIS regulations prohibiting the us e of certain stunning devices and pithing during slaughter.

In April 2008, FDA issued a final regulation 74 that prohibits the use of certain cattle materials from animal feed, including pet food. The prohibited materials include (1) the en tire carcass of BSE-positive cattle, (2) the brains and spinal cords of cattl e 30 months of age and older, (3) the entire carcass of cattle not inspec ted and passed for human consumption that are 30 months of age and older fr om which the brains and spinal cords were not effectively removed or ot herwise effectively excluded from animal feed, (4) mechanically separa ted beef derived from the materials prohibited by this regulation, and (5) tallow that is derived from the materials prohibited by this regulati on. The regulation is an added measure to exclude high-risk materi als from all animal feeds and to prevent any accidental feeding of su ch ingredients to cattle. The regulation further serves to prot ect animals and consumers from the already low risk of BSE exposure. The regulation became effective October 29, 2009, allowing the livest ock, meat, rendering, and feed industries time to adapt their pr actices to comply with the new requirements. 75 When implemented, this regulation will become another overlapping safeguard in addition to the safeguards listed above.

a. Transport of Commodities

Commercial trucks are one segment of the transport indus try. Including

an increase in trade with Canada a nd 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 ai r 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 industr y groups, are underway to reduce air pollutants and greenhouse gases from other transport modes, including

74 73 FR 22720, April 25, 2008

75 21 CFR 589.2001, April 27, 2009 2. Physical
Environment55 ship vessels and locomotives. As transport is a necessary action for imported and exported commodities, th e efforts to reduce impacts on the physical environment from the variou s transport modes are important for protecting environmental quality now and in the future. Provided that the amounts of imported live bovines an d bovine-derived products do not increase substantially in future years, it is possible that the contribution of emissions from the transport of these commodities could be reduced because of the U.S. regulatory effort s that are intended to reduce the amounts of diesel engine emissions from commercial trucks, marine vessels, and locomotives.

As discussed in the regula tory impact analysis prepared for the proposed rulemaking (USDA, APHIS, 2011), th e proposed regulatory changes to closely align the APHIS BSE import regulations with the OIE Code should have, at most, minimal impact on the imports of live bovines or bovine-derived products into the United States from Canada and Mexico (USDA, APHIS, 2011). The regulatory changes also are unlikely to have an appreciable impact on U.S. imports of cattle and bison from countries other than Canada and Mexico (US DA, 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 commoditi es associated with the proposed rulemaking, the baseline of transpor t activities associ ated with the importation of these commodities is not expected to change appreciably. Therefore, impacts on the physical envir onment, e.g., additional transports of products, from the proposed regulat ory changes are not expected to change appreciably from the curren t baseline of impacts on the physical

environment.

Environmental impacts related to the transport modes would continue to be regulated under Federal laws, such as the Clean Air Act and Clean Water Act, that serve to protect the quality of the human environment. Changes to the APHIS BSE import regul ations are not expected to result in an appreciable change in the baseline of current impacts on the environment from the importati on of these commodities.

b. SRMs Generated

For purposes of cumulative impacts under this analysis, the amount of SRMs that would be generated under th e 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 cattle 76
slaughter is about 34 million head (USDA, ERS, 2010). For 2008 and

76 Includes calves.56 2009, the average number of cattle processed through commercial slaughter that were under 30 months of age is estimated to be 27 million, and the average number of cattle 30 months of age and older processed through commercial slaughter is estimated to be 6.25 million (USDA, ERS, 2010). 77 The annual U.S. slaughter of cattle results in the generation of approximately 440 million pounds of SRMs (see appendix, table A-10).

BSE-infected bovines may affect the human environment, which includes the natural or physical environment, if these animals were to become a part of the supply of animals processed at slaughter. However, safeguards in place at slaughter, required accord ing to U.S. regulatory requirements, such as visual inspection of animals presented for slaughter, the prohibition of certain slaughter practic es, and the removal and disposition of SRMs at slaughter, are designed to prevent potential exposure from any possible BSE infectivity in processed animals.

With regard to the importation of live bovines and bovine-derived products, two of the most important risk mitigation measures are the

control of SRMs and feed bans. Most of the the OIE Code rests on these two significant mitigation measures. Additional risk mitigation measures include the application of certain pr oduction processes that inactivate the BSE agent. The use of these mitigation measures as outlined in the OIE Code substantially reduces the risk th at the BSE agent might be present in the animals or products presented fo r trade. The importance of risk mitigation measures, including SRM removal and proper disposal, an

effective ruminant-to-ruminant feed ban, and production processes for

certain bovine-derived commodities (such as gelatin production), are

discussed in further detail in the scientific supporting documentation and the related rulemaking docket.

Under the proposal, the risk mitigation measures included in the OIE Code would be applied both in the country of origin (to minimize the risk that the BSE agent would be present in an imported animal or product) and in the United States (to minimize the risk that BSE would be established in the United States if it was present in an imported animal or product). APHIS modifications to these guidelines, such as, SRM removal for bovine-derived commodities in accordance with FSIS regulations and no

live bovines from undetermined BSE ri sk countries, to reflect APHIS’ interpretation of the scientific literature and current USDA regulations and policies would further support requirem ents that prevent the introduction or transmission of the BSE agent via imported commodities, further support safeguarding efforts to prevent the introduction and spread of the BSE agent. The combined OIE requirements and additional APHIS requirements are intended to prevent the introduction and spread of the

77 Based on an assumption that all cull cattle (cows and bu lls for slaughter) were at least 30 months of age and all others (steers and heifers) were under 30 months of age.57 BSE agent from imported commodities regardless of a country’s BSE prevalence.

SRM removal occurs at slaughter for all bovines, whether they are U.S.- produced or imported. FSIS 78 requires SRMs to be rendered as “unfit for human food” within the meaning of section 1(m)(3) of the adulteration provisions of the Federal Meat Inspection Act. 79 To date, there is no evidence to suggest that the amount of SRMs removed from imported live

bovines under the current APHIS BS E import regulations has caused adverse impacts on the quality of the human environment. Based on

available information related to eco nomics and practicability, the amount of imported live bovines is not expect ed to change because of proposed changes to the APHIS BSE import regulat ions. Relative to the amount of imported live bovines, a change in th e 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 requireme nts and requirements under the proposed rulemaking for the importati on of live bovines would serve as overlapping safeguards. SRM removal and disposal practices according to FSIS regulations would not increase im pacts on the human environment.

In comparing the amount of SRMs removed in U.S. cattle slaughter annually (2008 and 2009) to the SRMs generated from imported cattle annually, SRMs generated from cattle imported from Canada and from Mexico (an average of 19.5 million pounds) represent less than 1 percent of the total SRMs generated from annual U.S. cattle slaughter.

The proposed action would continue to allow imported live bovines from

Canada and Mexico with no relativ e change in the amount imported. Therefore, the amount of SRMs gene rated 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. cattl e in feedlots and contributed toward a relative portion of environmental impacts in cattle feedlots that are regulated by Federal, State, and lo cal laws. Other livestock production, such as swine, that are not a part of this proposed action, contribute to environmental impacts from feedlots also. As discussed earlier in this

78 In accordance with 9 CFR part 314

79 21 U.S.C. 601(m)(3) 3. Holding Imported
Bovines in
Feedlots58 document, various Federal, State, an d local laws regulate the pollutants and emissions caused by animal production. While methane gas emissions are not regulated, various studies and EPA efforts are underway

to determine how to reduce their impact on the environment.

The proposed action would continue to allow the importation of live

bovines from Canada and Mexico w ith 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 envi ronmental impacts contributed by imported live bovines under the proposed action would have an additive impact on the baseline of impacts from feedlot produc tion on the natural and physical environment or that the impacts would be unmanageable under existing U.S. regulations (Federal, State, and local) that are intended to protect U.S. environmental quality.



## IV. Agencies or Persons Contacted

U.S. Department of Agriculture Animal and Plant Health Inspection Service Policy and Program Development, Environmental and Risk Analysis

Services Riverdale, MD

U.S. Department of Agriculture Animal and Plant Health Inspection Service Policy and Program Development, Policy Analysis and Development Riverdale, MD

U.S. Department of Agriculture

Economic Research Service Washington, DC

U.S. Department of Agriculture National Agricultural Statistics Service Washington, DC

U.S. Department of Agriculture Food Safety and Inspection Service Washington, DC

U.S. Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition Washington, DC59 

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### Appendix. Additional Information for Chapter 3.

A. Transport of Imported Li ve Bovines, Bovine-derived Commodities, and Cervids and Camelids

Live Bovines

While livestock are transported in ma ny 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, in cluding 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 we ighed 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 truc k sizes and capacities, thus the number of truck transports is sl ightly overestimated.

Table A-1 provides the numbers of live bovines imported from Canada during 2008 and 2009, reflecting the initial two years of import data for live bovines from Canada, since the resumption of trade in bovines born on or after March 1, 1999, and the estim ated number of commercial truck transports that would have b een required for their import. 80

80 As of the time of collecting data , a complete year of truck transport data was not yet available for calendar year 2010; therefore, import data from 2008 and 2009 for liv e bovines are used to correspond with the two most recent complete calendar years of data for truck crossi ngs at the Canada and Mexico U.S. border crossing,
which are for 2008 and 2009 as of the date of this environm ental analysis. To be consistent throughout, this EA

uses 2008 and 2009 data to arrive at a 2-year average of recent data.65 Table A-1. 2008 and 2009 Live Bovine Imports from Canada and Estimated Truck Transports Required Bovine imports 1 Estimated no. of truck transports required

2008 Cattle 1,581,303 31,626 Bison 29,670 742

2008 Total 1,610,973 32,368

2009 Cattle 1,061,005 21,221 Bison 25,850 647

2009 Total 1,086,855 21,868 2-year Average 1,348,914 27,118

1 Source for cattle imports: Livestock and meat trade data. Available on the Internet at http://www.ers.usda.gov/data/meattrade . Source for bison imports: Fore ign Agricultural Service, U.S. Trade Internet System. U.S. Trade Imports – HS Code 0102904010. Available on Internet via http://www.fas.usda.gov/gats/default.aspx

Table A-2 provides the numbers of live bovines imported from Mexico during 2008 and 2009, and the estimated number of commercial truck transports that would have b een required for their import.

Table A-2. 2008 and 2009 Live Cattle Imports from Mexico and Estimated Number of Truck Transports Required

Cattle Imports Estimated no. of truck transports required
2008 702,661 14,053 2009 940,869 18,817

2-year Average 821,765 16,435

Bovine-derived Products

Of the countries from which the United States currently allows imports of bovine-derived products (this include s countries or regions with and without restrictions with regard to BSE), the volume and average volume of bovine-derived products for 2008 a nd 2009 are provided in table A-3.66 Table A-3. Volume (20008 and 2009) of Bovine-derived Products Imported to the United States (in Metric Tons (MT))

Region of Origin 2008 imported
bovine-derived products

(MT) 81 2009 imported
bovine-derived products

(MT) 82 2008-2009

average (MT, rounded)

A rgentina 13,497.7 10,622.1 12,060
A ustralia 233,332. 5 270,951.2 252,142 Brazil 53,475.8 49,270.0 51,373 Canada 296,083.6 293,719.3 294,901
Chile 807.4 753.6 781 Costa Rica 6,386. 5 7,712.5 7,050 Honduras 2,202.3 1579.3 1,890 Japan 149 140.8 145 Mexico 15,628.4 25,439.9 20,534 New Zealand 175,783.3 172,457.0 174,120 Nicaragua 33,475.2 30,092.1 31,784
Pacific Islands 0.0 0.9 1.0 Uruguay 23,882.1 25,217.4 24,550 Total 854,706.6 887,956.1 871,331
Information source: USDA, FAS, 2011.

Table A-4 provides the total estim ated/averaged commercial truck transports for imported live bovine s and bovine-derived products for 2008 and 2009 (for Canada and Mexico).

Table A-4. Estimated Average Number of Commercial Truck Transports for Imported Live Bovines and Bovine-derived Products from Canada and Mexico, 2008-2009.

Region of Origin Truck Transports for
Live Bovines Truck Transports
for Bovinederived Products Total Truck Transports for Live
Bovines and Bovinederived Products at
the U.S. Northern and

Southern Borders Canada 27,118 14,776 41,894 Mexico 16,435 1,029 17,464 Total 43,553 15,804 59,358

Live Cervids and Camelids

Imported deer, weighing about 97-300 pounds each, are generally transported in a horse or cattle trailer (which vary in size) and in loads of about 30 head each. Imported elk generally range in weight from about 600-900 pounds each and are usually transp orted in a load of 1-3 heads per horse or cattle trailer; the estimat e of transport vehicles in the table below is based on an average of 2 animals per shipment. Imported alpacas, camels, and llamas genera lly range in weight from 100-400

81 One metric ton is equivalent to about 2,204 pounds.

82 One metric ton is equivalent to about 2,204 pounds.67 pounds each and are typically transported in loads of 2-18 heads in a horse or cattle trailer; the estimate of tran sport vehicles in the table below is based on an average of 10 animals per shipment. These imports have originated from Canada.

Table A-5. Imported Live Cervids and Camelids, 2008-2009, and Estimated No. Transport Vehicles

Imports 2008 2009 Total Estimated No. of Transport
Vehicles
Cervids
Deer 27 459 486 162 Elk 487 1,277 1,764 882
Camelids 330 232 562 53 Total No. of Transport Vehicles 1,097

B. Cattle in Feedlots

The following is a general estimation of imported cattle marketed in 2008
and 2009 and does not account for animals imported in the latter part of a year being marketed in the subsequent year.

Table A-6. Estimate of Imported Bovines in Feedlots During 2008 and 2009 Compared to Overall Total of U.S. Cattle Marketed from Feedlots
in 2008 and 2009

Region of Origin Estimated No.
Head of Cattle Imported and
Placed in Feedlots
in 2008 a Estimated No. Head of Cattle Imported and
Placed in Feedlots in
2009 a

Canada 185,574 a 75,063 a

Mexico 705,661 940,789 b

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 feedlot s 3 percent 4 percent

a Assuming that all cattle not classified as imported for purposes of breeding, dairy, or for immediate slaughter are feeder cattle.
b Total 2009 MX imports minus 40 imported for breeding purposes.

C. Specified Risk Materials (SRMS) Generated

The following table provides information about the weight of SRMs generated during slaughter, according to the defi nition of SRMs regulated under FDA and FSIS regulations. We not e that these calculations vary because SRMS calculated in the FDA document (an environmental assessment) were based on regulatory amendments to prohibit SRMs from

use in animal food or feed and in the FSIS document (an economic analysis) were based on regulatory am endments to prohibit SRMs for use68 in human food. APHIS used a conserva tive calculation in arriving at the amount of SRMs generated from liv e bovines at slaughter—3.1 pounds of SRM for cattle under 30 months of ag e and 57 pounds for cattle 30 months of age and older, which considers a larger amount of SRMs removed as

did the FDA document.

Table A-7. Weight (in pounds) of Speci fied Risk Materials (SRMs) for Cattle 30 Months of Age and Older

SRMs Weight in lb. (USDHHS, FDA, 2005) Weight in lb. (USDA, FSIS, 2007)

Brain 1.0 0.936 Spinal cord 0.374 0.4 Eyes 0.22 *included w/skull weight Skull + trigeminal ganglia 15.2 16.2

Distal ileum 3.5 0.5

Tonsils 0.3 2.5

Vertebral column 36.5 Not included* Total pounds 57.094 20.536

* In an economic analysis

, FSIS did not include the weight of the vertebral column in its table of “Estimated Most-likely weight of SRMs per Head at Slaughter Establishments” (USDA, FSIS, 2007) (because of the potential use of the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum fr om cattle 30 months of age and older in products for human consumption provided that the vertebral co lumn portion that contains DRG (dorsal root ganglia) is excluded).

According to calculations for SRM regulation by FDA, “cattle not over 30 months of age” (in other words, cattle 30 months of age and under) generate approximately 28.3 pounds of SRMs while cattle over 30 months of age generate approximately 88.5 83 pounds of SRMs (USDHHS, FDA, 2005). For these calculations FDA incl uded the entire small intestines. However, BSE infectivity has not been confirmed in any portion of the

intestinal tract of cattle other than the distal ileum. FSIS regulations permit beef small intestines, excluding the distal ileum, to be used for

human food. 84 The FDA regulations permit the manufacture and use of beef casings derived from beef small intestines, excluding the distal ileum,

for human food and cosmetics. 85 Therefore, for APHIS’ purposes, it is inappropriate to consider the entire small intestines when calculating the weight of SRMs generated during slaughter.

For cattle 30 months of age and younger, the entire sma ll intestine (with distal ileum) weighs about 28 pounds. For cattle over 30 months of age, the entire small intestine (with dist al ileum) weighs about 35 pounds. According to industry sources, the distal ileum comprises roughly 10

83 The following tissues are designated as SRMs: the brai n, skull, eyes, trigemin al ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the distal ileum and tonsils of all cattle (9 CFR § 310.22(a)).

84 70 FR 53043, September 7, 2005.

85 70 FR 53063, September 7, 2005.69 percent 86 of the small intestine by we ight (USDA, FSIS, 2005). By multiplying FDA’s estimate for the weight of the small intestines 87 (which includes the distal ileum) by 10 perc ent, cattle under 30 months would generate approximately 2.8 pounds of distal ileum, while cattle over 30 months would generate approxima tely 3.5 pounds of distal ileum. Using these weights for the distal ileum instead of the weight of the entire small intestine, cattle under 30 months of age would generate approximately 3.1 pounds of SRMs 88 while cattle over 30 months of age would generate approximately 57 pounds of SRMs. 89 FDA estimates that cattle 30 months of age would gene rate the same amount of SRMs as cattle under 30 months of age. However, as per the definition of SRMs in 9 CFR § 310.22(a) (see footnote 83 belo w), cattle 30 months of age would generate an equal amount of SRMs as cattle over 30 months of age.

The following tables (A-8 and A-9) provide a breakdown of the total numbers of live bovines, according to age groups, that are imported from Canada and Mexico annually for sl aughter (both feeding and immediate slaughter) and the estimated weight of total SRM materials that must be removed at slaughter from these animals. It is noted that bovines that are imported for breeding or dairy purpose s are not includes in these tables.

Table A-8. Estimated SRMs Generated from Imported Live Bovines Under the No Action Alternative (for 2008)

Origin of Imported
Live
Bovines Imported
bovines 30
months of

age and

older SRMs generated

(in lbs.)

from
bovines 30
months of

age and

older Imported
bovines
under 30
months of age (except for dairy or breeding) SRMs generated

(in lbs.)

from
bovines
under 30
months of

age Total
estimated weight (in

lbs.) of
SRMs
removed at slaughter
Canada
- Cattle 234,615 a 13,373,055 1,301,910 b 4,035,921 17.4 million
- Bison 7,418 a 422,826 22,252 68,981 0.5 million Mexico n/a n/a 702,661 c 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 fo r bulls and cows for immediate slaughter during 2008 (234,615) and an estimate that 25 percent of bison imported during 2008 are 30 months of age or older (overall import numbers obtained through USDA, ERS, 2010 and USDA, FAS, 2011).

b Total of 1,581,303 cattle (USDA, ERS, 2011) subtracting 234,615 imported cull cattle and 44,778 breeding or dairy purpose cattle (USDA, FAS, 2011).

c Import information for 2008 from “Annual and cumulative year-to-date U.S. trade (head)” table (USDA, ERS, 2011).

86 The weight of the distal ileum is highly variable from on e animal to the next. Howe ver, the estimate that the distal ileum comprises 10 percent of the entire small inte stine is a conservative esti mate (USDA, FSIS, personal communication, 2005).

87 28.0 pounds in cattle under 30 months a nd 35.0 pounds in cattle over 30 months.

88 2.8 pounds of distal ileum + 0.3 pounds of to nsils (USDHHS, FDA, 2005) = 3.1 pounds of SRMs.

89 3.5 pounds of distal ileum + 0.3 pounds of tons ils (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 ga nglia) (USDHHS, FDA, 2005) + 36.5 pounds of vertebral column (USDHHS, FDA, 2005) = 57.0 pounds of SRMs.70 Table A-9. Estimated SRMs Generated from Imported Live Bovines Under the No Action Alternative (for 2009)

Origin of Imported
Live
Bovines Imported
bovines
30 months of age and
older SRMs generated

(in lbs.)

from
bovines
30 months of age and
older Imported
bovines
under 30
months of age (except for dairy or breeding) SRMs generated

(in lbs.)

from
bovines
under 30
months of

age Total
estimated

weight (pounds) of
SRMs
removed at slaughter
Canada
- Cattle 239,671 a 13,661,247 812,108 b 2,517,535 16.2 million
- Bison 6,462 a 368,334 19,388 60,103 0.4 million
Mexico n/a n/a 940,829 c 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 fo r 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) subs tracting 239,647 imported cull cattle (USDA, FAS, 2011) and 9,226 breeding or dairy purpose cattle (USDA, FAS, 2011).

c Import information for 2009 from “Annual and cumulative year-to-date U.S. trade (head) table (USDA, ERS, 2011).

The amount of SRMs generated includes bovines imported for purposes such as feeding or immediate slaugh ter. The amount for SRMs generated does not include bovines that are impor ted 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. sl aughter animals. A conservative assumption is made that all cows and bulls imported from Canada for immediate slaughter are in the catego ry of 30 months of age or older, although this is not always necessarily the case. In determining a conservative but realistic assumpti on 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 olde r (because of the difference in the

amount of SRMs that must be removed at slaughter), this document relied on data from an FAS import databa se that groups cattle by their import purpose to help determine those that would most likely be considered as cattle that are 30 months of age and ol der. These data include groups that

are cows and bulls for immediate sla ughter. The imported cattle in this age group from Canada during 2008 total 234,615 and during 2009 total 239,671, as reflected in tables A- 8 and A-9 of the appendix.

Data on the number of imported bi son by age groups is not readily

available. In order to determine th e age grouping of bison imported from Canada during 2008, this document base s 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 olde r) from data obtained for 2008 through71 APHIS’ Veterinary Services Im port Tracking System Database. 90 Based on 2008 data, approximately 25 percent of the imported bison were 30 months of age or older; this percentage is applie d the same for 2009 data.

Cattle are imported from Mexico, a re gion that is not subject to BSE restrictions under current APHIS impor t regulations. Cattle imported from Mexico mostly are young cattle destined for pasture, backgrounding, finishing, and slaughter within the Un ited States (Skaggs et al., 2004); for purposes of SRM removal, these animals fall in the “under 30 months of age” category.

SRM removal occurs at slaughter for all bovines, whether they are U.S.- produced or imported. FSIS 91 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 Inspec tion Act. The annual U.S. slaughter of cattle results in the generation of approximately 440 million pounds of SRMs (see table A-10, below).

Table A-10. Estimated Average Annual Amount of SRMs Generated at Slaughter in the United States (for 2008 and 2009) 92

Origin of SRMs SRMs from
Bovines 30 Months of Age

and Older (in million lbs.) SRMs from
Bovines Under
30 Months of Age (in million lbs.) Total SRMs
Generated (in million lbs.)

Bovines imported from Canada (based on average from 2008
& 2009 data from tables A-8 and A-9) 14 3 17

Cattle imported from Mexico (based on 2008
& 2009 data from tables A8 and A-9) n/a 2.5 2.5

U.S. cattle average
from annual commercial slaughter 356 a 84 b 440

a Average for cull beef & dairy cull cattle slaughter for 2008 (6.3 million) and for 2009 (6.2 million) = 6.25 million × 57 lb. (annual slaughter numbers obtained from USDA, ERS, 2010).

b Average steers & heifers slaughter for 2008 (27. 5 million) and 2009 (26.5 million) = 27million × 3.1 lb. (annual slaughter totals obtained from USDA, ERS, 2010).

90 Personal communication with Dr. Peter Merrill, Assi stant Director, Live Animal Imports, National Center for Import and Export, Veterinary Services, APHIS.

91 In accordance with 9 CFR part 314

92 Totals are rounded.