58570 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 589 

[Docket No. 2002N–0273] (formerly Docket 

No. 02N–0273) 

RIN 0910–AF46 

Substances Prohibited From Use in 

Animal Food or Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the agency’s regulations to 

prohibit the use of certain cattle origin 

materials in the food or feed of all 

animals. These materials include the 

following: The brains and spinal cords 

from cattle 30 months of age and older, 

the brains and spinal cords from cattle 

of any age not inspected and passed for 

human consumption, the entire carcass 

of cattle not inspected and passed for 

human consumption if the brains and 

spinal cords have not been removed, 

tallow that is derived from the materials 

prohibited by this proposed rule that 

contains more than 0.15 percent 

insoluble impurities, and mechanically 

separated beef that is derived from the 

materials prohibited by this proposed 

rule. These measures will further 

strengthen existing safeguards designed 

to help prevent the spread of bovine 

spongiform encephalopathy (BSE) in 

U.S. cattle. 

DATES: Submit written or electronic 

comments by December 20, 2005. 

Submit written comments on the 

information collection provisions by 

November 7, 2005. 

ADDRESSES: You may submit comments, 

identified by [Docket No. 2002N–0273 

or RIN 0910–AF46], by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). or Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Burt 

Pritchett, Center for Veterinary 

Medicine (HFV–222), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6860, email: burt.pritchett@fda.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Bovine Spongiform 

Encephalopathy 

B. Current Animal Feed Safeguards in 

the United States 

C. Risk of BSE in North America 

D. Additional Measures Considered to 

Strengthen Animal Feed Safeguards 

1. Comments on November 6, 2002 

Advance Notice of Proposed 

Rulemaking (ANPRM) 

2. Actions in Response to Washington 

State Case 

3. Comments on July 14, 2004 

ANPRM 

II. Proposed Measures to Strengthen 

Animal Feed Safeguards 

A. FDA Response to Comments to the 

2004 ANPRM 

B. Additional Measures to Further 

Strengthen Feed Protection 

C. Basis for Proposing to Apply 

Additional Measures to All Animal 

Food and Feed 

D. Cattle Materials Proposed to be 

Prohibited From Use in All Animal 

Food and Feed 

E. Disposal of Cattle Materials 

Prohibited in Animal Feed 

III. Description of Proposed Rule and 

Legal Authority 

A. Definitions 

B. Proposed Requirements 

C. Proposed Recordkeeping and 

Access Requirements 

D. Conforming Changes to 21 CFR 

589.2000—Animal Proteins 

Prohibited in Ruminant Feed 

E. Legal Authority 

IV. Analysis of Economic Impacts 

A. Summary of Proposed Regulatory 

Impact Analysis 

B. Need for Regulation 

C. Benefits 

D. Costs 

E. Government Costs 

F. Sensitivity Analysis 

G. Regulatory Flexibility Analysis 

V. Paperwork Reduction Act 

VI. Environmental Impact 

VII. Federalism 

VIII. Comments 

IX. References 

I. Background 

A. Bovine Spongiform Encephalopathy 

BSE belongs to the family of diseases 

known as transmissible spongiform 

encephalopathies (TSEs). In addition to 

BSE, TSEs also include scrapie in sheep 

and goats, chronic wasting disease 

(CWD) in deer and elk, and CreutzfeldtJakob disease (CJD) in humans. The 

agent that causes BSE and other TSEs 

has yet to be fully characterized. The 

most widely accepted theory in the 

scientific community is that the agent is 

an abnormal form of a normal cellular 

prion protein. The abnormal form of the 

prion protein is less soluble and more 

resistant to heat degradation than the 

normal form. The abnormal prion does 

not evoke any demonstrated immune 

response or inflammatory reaction in 

host animals. BSE is diagnosed by 

postmortem microscopic examination of 

an animal’s brain tissue and by 

detection of the abnormal form of the 

prion protein in an animal’s brain 

tissue. There is currently no available 

test to detect the disease in a live 

animal. 

Since November 1986, there have 

been more than 180,000 confirmed cases 

of BSE in cattle worldwide. Over 95 

percent of all BSE cases have occurred 

in the United Kingdom, where the 

epidemic peaked in 1992/1993, with 

approximately 1,000 new cases reported 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58571 

per week. In addition to the United 

Kingdom, the disease has been 

confirmed in native-born cattle in 22 

European countries and in some 

nonEuropean countries, including 

Japan, Israel, Canada, and the United 

States. 

Epidemiological studies have 

characterized the outbreak of BSE in the 

United Kingdom as a prolonged 

epidemic arising at various locations, 

with all occurrences due to a common 

source, and have suggested that feed 

contaminated by a TSE agent was the 

cause of the disease outbreak (Ref. 1). 

The subsequent spread of BSE was 

associated with the feeding of meat-andbone-meal from rendered BSE-infected 

cattle to non-infected cattle (Ref. 1). It 

appears likely that the BSE agent was 

transmitted among cattle at an 

increasing rate by ruminant-to-ruminant 

feeding until the United Kingdom ban 

on such practices went into effect in 

1988 (Ref. 2). 

Agricultural officials in the United 

Kingdom have taken a series of actions 

to eliminate BSE. These actions include 

making BSE a reportable disease, 

banning mammalian meat-and-bone 

meal in feed for all food-producing 

animals, prohibiting the inclusion of 

animals more than 30 months of age in 

the animal and human food chains, and 

destroying all animals showing signs of 

BSE. As a result of these actions, most 

notably the feed bans, the rate of newly 

reported cases of BSE in the United 

Kingdom has decreased sharply and 

continues on a downward trend. 

In 1996, a newly recognized form of 

the human disease CJD, referred to as 

variant CJD (vCJD), was reported in the 

United Kingdom. Scientific and 

epidemiological studies have linked 

vCJD to exposure to the BSE agent, most 

likely through human consumption of 

beef products contaminated with the 

agent. To date, approximately 150 

probable and confirmed cases of vCJD 

have been reported in the United 

Kingdom, where there had likely been a 

high level of contamination of beef 

products. It is believed that in the 

United States, where measures to 

prevent the introduction and spread of 

BSE have been in place for some time, 

there is far less potential for human 

exposure to the BSE agent. The Centers 

for Disease Control and Prevention 

(CDC) leads a surveillance system for 

vCJD in the United States. To date, CDC, 

has not detected vCJD in any resident of 

the United States that had not lived in 

or traveled to the United Kingdom for 

extended periods of time. In 2002, a 

probable case of vCJD was reported in 

a Florida resident who had lived in the 

United Kingdom during the BSE 

epidemic. Epidemiological data indicate 

that the patient likely was exposed to 

the BSE agent before moving to the 

United States. 

B. Current Animal Feed Safeguards in 

the United States 

In the Federal Register of June 5, 1997 

(62 FR 30936) (the 1997 ruminant feed 

final rule), FDA published a final rule 

to provide that animal protein derived 

from mammalian tissues is prohibited 

for use in ruminant feed. Although BSE 

had not been identified in the United 

States at that time, the 1997 ruminant 

feed final rule was put in place to 

prevent the establishment and 

amplification of BSE in the United 

States through animal feed and thereby 

minimize risk to humans and animals. 

The 1997 ruminant feed final rule 

created a new § 589.2000 (21 CFR 

589.2000), Animal proteins prohibited 

in ruminant feed, and established a 

system of controls to ensure that 

ruminant feed did not contain animal 

protein derived from mammalian 

tissues. The 1997 ruminant feed final 

rule set out requirements for persons 

who manufacture, process, blend, or 

distribute certain animal protein 

products or ruminant feeds containing 

such products. 

The 1997 ruminant feed final rule 

(§ 589.2000) prohibits the use of 

mammalian-derived proteins in 

ruminant feed, with the exception of 

certain proteins believed at that time not 

to pose a risk of BSE transmission. 

These exceptions to the definition of 

‘‘protein derived from mammalian 

tissues’’ included: Blood and blood 

products; gelatin; inspected meat 

products which have been cooked and 

offered for human food and further heat 

processed for feed (such as plate waste 

and used cellulosic food casings), 

referred to herein as ‘‘plate waste’’ milk 

products (milk and milk protein); and 

any product whose only mammalian 

protein consists entirely of porcine or 

equine protein. The 1997 ruminant feed 

final rule does not prohibit ruminant 

animals from being fed processed 

animal proteins derived from 

nonmammalian species (e.g., avian or 

aquatic animals). The 1997 ruminant 

feed final rule permits the manufacture 

of non-ruminant feed containing 

prohibited mammalian protein and 

ruminant feed on the same premises, 

provided that separate equipment is 

used in the production of ruminant feed 

or that documented adequate clean-out 

procedures are used between 

production batches. 

Following the discovery of a BSE 

positive cow in Washington State in 

December 2003, FDA provided guidance 

on the use of materials from BSE 

positive cattle. In Guidance for Industry, 

‘‘Use of Material from BSE Positive 

Cattle in Animal Feed,’’ published in 

the Federal Register in September 2004 

(69 FR 58448), FDA stated its view that 

under section 402(a)(5) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 342(a)(5)), animal feed and 

feed ingredients containing materials 

derived from a BSE-positive animal are 

considered adulterated and should be 

recalled or otherwise removed from the 

marketplace. 

C. Risk of BSE in North America 

In April 1998, the United States 

Department of Agriculture (USDA) 

contracted with the Harvard Center for 

Risk Analysis (HCRA) at Harvard 

University and the Center for 

Computational Epidemiology at 

Tuskegee University to conduct a 

comprehensive investigation of the BSE 

risk in the United States. The report, 

(Ref. 3) widely referred to as the 

Harvard Risk Assessment or the Harvard 

Study, is referred to in this document as 

the Harvard-Tuskegee Study. The study 

was completed in 2001 and released by 

USDA. Following a peer review of the 

Harvard-Tuskegee Study in 2002, the 

authors released a revised risk 

assessment in 2003 (Ref. 4). 

The Harvard-Tuskegee Study 

reviewed available scientific 

information related to BSE and other 

TSEs, assessed pathways by which BSE 

could potentially occur in the United 

States, and identified measures that 

could be taken to protect human and 

animal health in the United States. The 

assessment concluded that the United 

States is highly resistant to any 

proliferation of BSE, and that measures 

taken by the U.S. Government and 

industry make the United States robust 

against the spread of BSE. 

The Harvard-Tuskegee Study 

concluded that the most effective 

measures for reducing potential 

introduction and spread of BSE are as 

follows: (1) The ban placed by USDA’s 

Animal and Plant Health Inspection 

Service on the importation of live 

ruminants and ruminant meat-and-bone 

meal from the United Kingdom since 

1989 and all of Europe since 1997 and 

(2) the feed ban instituted in 1997 by 

FDA to prevent recycling of potentially 

infectious cattle tissue. The HarvardTuskegee Study further indicated that, if 

introduction of BSE had occurred via 

importation of live animals from the 

United Kingdom before 1989, mitigation 

measures already in place would have 

minimized exposure and begun to 

eliminate the disease from the cattle 

58572 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

population even assuming less than 

complete compliance with the feed ban. 

The Harvard-Tuskegee Study also 

identified pathways or practices that, if 

addressed, would further decrease the 

already low risk of spread BSE if it were 

introduced into the United States. These 

include the following: (1) Failing to 

comply with FDA’s ruminant feed 

regulations that prohibit the use of 

certain proteins in feed for cattle and 

other ruminants; and (2) rendering of 

animals that die on the farm (considered 

the highest risk cattle), and then 

incorporating (through illegal diversion 

or cross-contamination) the rendered 

product in ruminant feed. The HarvardTuskegee Study’s independent 

evaluation of the potential additional 

risk mitigation measures predicts that a 

prohibition against rendering of animals 

that die on the farm would reduce 

potential new cases of BSE in cattle 

following a hypothetical introduction of 

10 infected animals by 80 percent (from 

4.3 to 0.77 cases) as compared to the 

base case scenario, (i.e., present state of 

the U.S. cattle population, along with 

government regulations and prevailing 

agricultural practices, and an 

assumption of less than complete 

compliance with the feed ban) (Ref. 4). 

Further, the study evaluated the impact 

of a specified risk materials (SRMs) ban 

that would prohibit high risk materials 

such as the brain, spinal cord, vertebral 

column and animals that die on the 

farm, from inclusion in human and 

animal food. The analysis predicts that 

this measure would reduce potential 

new BSE cases in cattle following a 

hypothetical introduction of ten 

infected animals by 90 percent (from 4.3 

to 0.53 cases). 

In 2003, following the detection of 

BSE in a native-born cow in Canada, the 

HCRA evaluated the implications of a 

then-hypothetical introduction of BSE 

into the United States (Ref. 5), using the 

same simulation model developed for 

the initial Harvard-Tuskegee Study. The 

results of this assessment were 

consistent with the conclusions of the 

earlier study—namely, that the United 

States presents a very low risk of 

establishing or spreading BSE should it 

be introduced. 

On December 23, 2003, USDA 

announced that a dairy cow in 

Washington State had tested positive for 

BSE. The results were confirmed on 

December 25, 2003, by the Veterinary 

Laboratories Agency in Weybridge, 

England. Immediately after the 

diagnosis was confirmed, USDA, FDA, 

and other Federal and State agencies 

initiated an epidemiological 

investigation (Ref. 6), and began 

working together to trace any potentially 

infected cattle, trace potentially 

contaminated rendered product, 

increase BSE surveillance, and take 

additional measures to address risks to 

human and animal health. The 

epidemiological investigation and DNA 

test results confirmed that the infected 

cow was born and most likely became 

infected in Alberta, Canada, before 

Canada’s 1997 implementation of a ban 

on feeding mammalian protein to 

ruminants. 

On January 22 through 24, 2004, the 

Secretary of Agriculture convened an 

international panel of experts on BSE. 

The panel, referred to as the 

International Review Team (IRT), was 

asked to: (1) Assess the epidemiological 

investigation conducted in response to 

the BSE case in Washington State, (2) 

provide expert opinion about when the 

active phase of the investigation should 

be terminated, (3) consider the response 

actions of the United States to date, and 

(4) provide recommendations about 

actions that could be taken to provide 

additional meaningful human or animal 

health benefits in light of the North 

American experience. The IRT provided 

its report on February 4, 2004. 

In May 2004, USDA contracted with 

HCRA to update the BSE risk 

assessment model to reflect its January 

2004 rulemaking to prohibit SRMs and 

certain other cattle material in human 

food. HCRA was also asked to update 

the parameters in the model for 

compliance with FDA’s feed ban. HCRA 

was also asked to model the impact that 

the IRT recommendation would have on 

the BSE risk to humans and cattle. 

In December 2004, Canada announced 

that a third North American cow tested 

positive for BSE. An ongoing 

epidemiologic investigation found that 

this animal, an 8-year-old, 

nonambulatory dairy cow, originated in 

Alberta, Canada and was born before the 

Canadian feed ban went into effect in 

August 1997. Shortly thereafter, in 

January 2005, another cow in Alberta 

was found to be positive for BSE. This 

case involved a beef cow born in March 

1998, 6 months after the Canadian feed 

ban went into effect. Based on 

preliminary information, Canada 

believes that the most likely source of 

infection in this animal was feed 

produced before implementation of 

Canada’s feed ban (Ref. 7). 

In June 2005, USDA announced that 

a 12-year-old beef cow, born and raised 

in Texas, was confirmed BSE positive. 

The BSE-positive cow most likely 

became infected before FDA’s 

implementation of the 1997 ruminant 

feed final rule. It was determined that 

no part of the animal entered the human 

food or animal feed chains. 

D. Additional Measures Considered to 

Strengthen Animal Feed Safeguards 

1. Comments on November 6, 2002, 

Advance Notice of Proposed 

Rulemaking (ANPRM) 

In the Federal Register of October 5, 

2001 (66 FR 50929), FDA announced its 

plan for an October 30, 2001 public 

hearing in Kansas City, MO, to solicit 

comments from the public on the 1997 

ruminant feed regulation. Recognizing 

that new information had emerged since 

publication of the feed rule in 1997, 

FDA requested comments on whether 

changes to the rule or other additional 

measures were necessary (Ref. 8). 

Information obtained from the public 

hearing and from the Harvard-Tuskegee 

Study was used in the publication of an 

ANPRM (2002 ANPRM) in the Federal 

Register of November 6, 2002 (67 FR 

67572). This ANPRM sought comment 

from affected industries and the public 

on possible ways to strengthen the 1997 

ruminant feed regulation. The ANPRM 

specifically asked for comments on a 

number of questions related to the 

following five aspects of the BSE feed 

regulation: (1) Excluding brain and 

spinal cord from rendered animal 

products, (2) prohibiting the use of 

poultry litter in cattle feed, (3) assessing 

the improper use of pet food as a feed 

for ruminants, (4) preventing crosscontamination, and (5) eliminating the 

plate waste exemption. 

The predominant view of those who 

submitted comments in response to the 

ANPRM was that the BSE risk in the 

United States was low enough that no 

new feed controls were needed. Most 

said that the current feed ban provided 

more than adequate protection against 

BSE, that there was no scientific 

justification for additional regulations, 

that compliance with the 1997 ruminant 

feed final rule was extremely high, and 

that over 19,900 USDA surveillance 

samples in 2002 alone failed to detect 

BSE in U.S. cattle. They also cited the 

Harvard-Tuskegee Study conclusion 

that existing control measures made the 

risk to U.S. cattle and to U.S. consumers 

from BSE very low. 

In the 2002 ANPRM, FDA said that 

the Harvard-Tuskegee Study identified 

the removal of high-risk bovine tissues, 

such as brain, spinal cord, intestine, and 

eyes, from human food and from 

rendered material for all animal feed as 

a way to reduce the potential exposure 

of cattle and humans to the BSE agent. 

The 2002 ANPRM then asked for 

comments on the following three 

questions related to SRMs: (1) Should 

high risk materials be excluded from 

rendered products?; (2) how feasible 

would it be for the rendering industry 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58573 

to implement such an exclusion?; and 

(3) what will be the adverse and positive 

economic, environmental, and health 

impacts from an exclusion? 

Comments in support of an SRM ban 

included one comment from USDA 

citing conclusions from the HarvardTuskegee Study that this action would 

significantly reduce the amount of 

infectivity in the animal feed chain, and 

would reduce risks resulting from 

‘‘leaks’’ in the feed ban. Other 

comments stressed the infectivity of 

these tissues, and the recommendation 

by the World Health Organization 

(WHO) that countries exclude these 

tissues from the animal and human food 

chain (Ref. 9). 

Comments opposing an SRM ban said 

that the measure would be redundant 

because the 1997 ruminant feed final 

rule already prohibits this high-risk 

material in ruminant feed. Therefore, 

the ban would only be beneficial if BSE 

were present in the United States and 

there were significant non-compliance 

with the feed ban. The comments also 

cited the conclusions of the HarvardTuskegee Study that the risks of BSE in 

the United States are low. One comment 

said that restrictions on SRMs in animal 

feed should be decoupled from 

restrictions for human food because of 

the substantial reduction in infectivity 

obtained during rendering. Another 

comment said that an SRM ban would 

give only the perception of a risk 

reduction, not a real reduction, and that 

it would send the message to our trading 

partners that our BSE risks are such that 

more controls are needed. Australia 

asked that, if an SRM ban is 

implemented, the ban not apply to 

Australia because of its widely 

recognized status as a low-risk BSE 

country. 

Numerous comments addressed the 

feasibility and the adverse economic 

impacts of an SRM ban. One comment 

pointed out that it is not feasible to 

remove central nervous system (CNS) 

tissue from decomposing carcasses. 

Comments from a trade association said 

that an SRM ban would require costly 

restructuring of facilities that would 

force many small rendering plants out of 

business, depriving some parts of the 

country access to rendering as a means 

of animal disposal. A June 2002 Sparks 

Report estimated disposal costs of an 

SRM ban to be $54 million, based on the 

assumption that the ban would apply to 

all cattle because of the difficulty of 

determining the age of cattle at slaughter 

(Ref. 10). According to an earlier 1996 

Sparks Report, the cost of disposal of 1.7 

billion pounds of CNS tissue and dead 

stock would exceed $400 million. 

Another estimate for disposal was $50 

million for the beef industry alone. One 

comment said that feed costs account 

for 70 percent of poultry production 

cost, and that renderers would pass on 

the costs of excluding brains and spinal 

cords to the poultry industry. 

Several comments mentioned the 

environmental impact of an SRM ban. 

One comment stated that a total ban on 

SRMs in rendered animal products 

would create a waste stream with no 

economic value. Another comment said 

that a ban on SRMs would encourage 

improper disposal of dead stock because 

there are no federal regulations on 

disposal of dead animals. 

2. Actions in Response to Washington 

State Case 

In response to the BSE case identified 

in Washington State, USDA published 

an interim final rule in the Federal 

Register of January 12, 2004 (69 FR 

1861), excluding high-risk tissues from 

human food. The interim final rule 

prohibited the use of SRMs and certain 

other cattle material in USDA-regulated 

human food. USDA defined SRMs as 

brain, skull, eyes, trigeminal ganglia, 

spinal cord, vertebral column 

(excluding the vertebra 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 and older, and 

the tonsils and distal ileum of the small 

intestine of cattle of all ages. To ensure 

effective removal of the distal ileum, 

USDA requires that the entire small 

intestine be removed and disposed of as 

inedible product. In its January 12, 

2004, interim final rule, USDA took the 

additional step of making cattle that are 

unable to rise from a recumbent 

position, referred to in this document as 

nonambulatory disabled cattle, 

ineligible to be slaughtered for human 

consumption. 

On January 26, 2004, FDA announced 

its intention to implement additional 

measures to strengthen existing BSE 

safeguards for FDA-regulated products. 

These measures included the issuance 

of an interim final rule to implement 

additional measures related to animal 

feed. The interim final rule would have 

implemented four specific measures 

related to animal feeds. These measures 

included the elimination of the 

exemptions for blood and blood 

products and ‘‘plate waste’’ from the 

1997 ruminant feed rule, a prohibition 

on the use of poultry litter in ruminant 

feed, and a requirement for dedicated 

equipment and facilities to prevent 

cross-contamination. 

However, on February 4, 2004, IRT 

released its report on measures related 

to BSE in the United States. The report 

recommendations included a somewhat 

different set of measures for reducing 

the risks associated with animal feed 

than the measures FDA had announced 

that it intended to implement through 

an interim final rule. Although FDA 

believed its previously announced 

measures would serve to reduce the 

already small risk of BSE spread 

through animal feed, the broader 

measures recommended by the IRT, if 

implemented, could make some of the 

previously announced measures 

unnecessary. FDA believed that 

additional information was needed to 

determine the best course of action in 

light of the IRT recommendations and 

decided to publish an ANPRM, which 

requested comments on the 

recommendations of the IRT, as well as 

on other measures under consideration 

to protect the animal feed supply. 

Consistent with measures 

implemented by USDA to exclude highrisk cattle tissues from human food (69 

FR 1861), FDA published an interim 

final rule on July 14, 2004 (69 FR 

42255), prohibiting a similar list of risk 

materials from FDA-regulated human 

food, including dietary supplements, 

and cosmetics. 

3. Comments on July 14, 2004, ANPRM 

In the Federal Register of July 14, 

2004 (69 FR 42287), FDA published an 

ANPRM (2004 ANPRM) jointly with 

USDA in which FDA announced its 

tentative conclusion that it should 

propose banning SRMs in all animal 

feed. In this ANPRM, FDA asked for 

comment on this measure and also on 

the IRT’s recommendations to require 

dedicated equipment or facilities for 

feed manufacture and transport, and its 

recommendation to prohibit the use of 

all mammalian and poultry protein in 

ruminant feed. Finally, FDA also asked 

for comment on the set of measures that 

the agency had announced in January 

2004. Comments submitted in response 

to the 2004 ANPRM that relate to SRMs 

are summarized in sections I.D.3a 

through I.D.3f by general topic area. 

a. Need for SRM ban. As with the 

comments received in response to the 

2002 ANPRM, many comments 

questioned the need for an SRM ban at 

the time of the 2004 ANPRM. Several 

comments argued that the comparison 

made by the IRT between the BSE 

situations in Europe and the United 

States is inappropriate. One reason 

given for the invalid comparison was 

that there were an estimated 3 to 4 

million undiagnosed BSE cases in the 

United Kingdom, compared to two 

diagnosed cases in North America in 

cattle born before feed restrictions were 

implemented. Another comment said 

58574 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

that the United States did, in fact, learn 

from the European experience and 

implemented controls early so that 

potential animal exposure to the BSE 

agent in the United States remains 

exceedingly small compared to the 

massive exposure in the United 

Kingdom. One comment submitted by 

the agriculture department of a state 

with a large agriculture industry said 

that its findings from 600 inspections do 

not support the premise of the IRT’s 

recommendation that an SRM ban is 

needed to address problems of crosscontamination and on-farm misfeeding. 

The state indicated that, in these 

inspections, it did not observe any 

prohibited materials or feed containing 

prohibited materials on farms where 

ruminant feeds were being mixed. 

Other comments said that the 

reduction in risk obtained through an 

SRM ban would be minimal, mostly 

citing the effectiveness of the current 

firewalls in reducing BSE infectivity in 

the cattle population. One comment 

said that the Harvard-Tuskegee Study 

conclusion that an SRM ban will reduce 

potential cattle exposure to BSE 

infectivity by 88 percent sounds more 

impressive than it really is. Reducing a 

very small risk by 88 percent does not 

necessarily provide significant risk 

reduction. 

Finally, many comments questioned 

FDA’s decision to ban SRMs from 

animal feed before the results of USDA’s 

enhanced BSE surveillance program are 

known. USDA’s one-time effort to test as 

many high-risk cattle as possible was 

started on June 1, 2004, and was 

expected to be completed by the end of 

2005. One comment pointed out that the 

IRT’s recommendations for defining 

SRMs are predicated on the outcome of 

this aggressive surveillance program. 

In support of FDA’s tentative 

conclusion that it should propose to ban 

SRMs from all animal feed, many 

comments cited the conclusion of the 

Harvard-Tuskegee Study that an SRM 

ban will provide additional risk 

reduction, and also cited the 

recommendation of the IRT that SRMs 

should be excluded from all animal 

feed, including pet food. One comment 

said that an SRM ban would restore 

confidence in U.S. beef exports. 

b. Definition of SRMs. SRMs are 

typically defined as the tissues in which 

BSE infectivity has been demonstrated 

in experimentally or naturally infected 

animals. SRMs are further defined by 

the OIE Terrestrial Animal Health Code 

based on the age of the animal and the 

BSE risk status of a country. In the 2004 

ANPRM, FDA asked how SRMs should 

be defined for animal feed, specifically, 

if the SRM list should be the same list 

as for human food. FDA also asked what 

information is available to support 

having two different lists. 

Comments from one organization 

included data from the HarvardTuskegee Report on the relative 

infectivity of specific tissues. These data 

were based on pathogenesis studies 

carried out in the United Kingdom and 

showed the fraction of total infectivity 

of each tissue to be: Brain 64.1 percent; 

spinal cord 25.6 percent; dorsal root 

ganglia 3.8 percent; trigeminal ganglia 

2.6 percent; distal ileum 3.3 percent; 

tonsil <0.1 percent; and eyes <0.1 

percent. The comment used the data to 

make the point that 90 percent of 

infectivity could be removed by 

excluding only the brain and spinal 

cord. A different comment citing the 

same data pointed out that the 

infectivity distribution represents more 

than a worst case scenario because, in 

the pathogenesis study, the BSE dose 

administered orally to calves was 

substantially greater than would 

reasonably be expected under field 

conditions. This second comment went 

on to point out that FDA’s interim final 

rule on food and cosmetics said that in 

cattle infected under field conditions, 

BSE infectivity had been demonstrated 

only in the brain, spinal cord, and retina 

of the eye at the end stages of the 

disease. 

Many comments recommended that 

the human food list of SRMs be used to 

define which SRMs should be excluded 

from animal feed. Several comments 

recommended expanding the list 

beyond the human food list by applying 

it to tissues from cattle 12 months of age 

or older, or to tissues from all cattle. 

Others advocated eliminating bovine or 

animal protein from ruminant feed 

altogether. Reasons given by the 

comments for these recommendations 

were the large risk reduction that could 

be achieved and the desirability of being 

consistent with the requirements for 

human food. 

Those who submitted comments in 

support of a more limited SRM list 

mostly did so to minimize the volume 

of material that would require nonfeed 

disposal. The comments stated that 

reducing this volume of material that 

would require nonfeed disposal would 

lessen the adverse impact of an SRM 

ban on the livestock, meat, and animal 

feed industries. One company used the 

Harvard model to simulate three 

different SRM scenarios and then 

submitted data showing that limiting 

the SRM list to brain and spinal cord 

(while also prohibiting use of dead stock 

and downers over 30 months of age), 

eliminating vacuum rendering, and 

keeping the existing feed ban in place, 

achieved a risk reduction equivalent to 

that obtained by banning the full human 

list of SRMs. 

The following are other suggestions 

provided in comments submitted in 

response to the 2004 ANPRM for 

reducing the volume of SRM material 

needing alternative disposal: (1) Allow 

the use of SRMs from animals that test 

negative for BSE, (2) designate only the 

head as an SRM which reduces by 64 

percent the potential BSE infectivity in 

feed, (3) allow the use of intestines from 

veal calves whose carefully controlled 

diets consist of low-risk formulas, and 

(4) allow mechanically separated beef 

from pet food plants to be used if SRMs 

are removed before meat is 

mechanically separated from bones. 

c. Cattle not inspected and passed for 

human consumption. The term ‘‘cattle 

not inspected and passed for human 

consumption’’ is used in this document 

to mean cattle that were not inspected 

and passed for human consumption by 

the appropriate regulatory authority. For 

the purposes of this document, this term 

also includes nonambulatory disabled 

cattle, i.e., cattle that could not rise from 

a recumbent position or that could not 

walk, including, but not limited to, 

those with broken appendages, severed 

tendons or ligaments, nerve paralysis, 

fractured vertebral column, or metabolic 

conditions. This proposed definition is 

consistent with the use of the terms 

‘‘inspected and passed and 

nonambulatory disabled cattle’’ as 

defined in USDA’s interim final rule on 

human food (69 FR 1862) and FDA’s 

interim final rule on human food and 

cosmetics (69 FR 42255). For the 

purposes of this proposed rule, 

nonambulatory disabled cattle are 

included in the definition of cattle not 

inspected and passed, since 

nonambulatory disabled cattle cannot be 

passed for human consumption. 

A number of questions were included 

in the 2004 ANPRM regarding the use 

of materials from cattle not inspected 

and passed for human consumption as 

previously defined. Comments received 

discussed both the advantages and 

disadvantages of excluding these 

animals from being rendered for use in 

animal feed. 

Advantages mentioned included the 

additional risk reduction that would be 

provided by the measure. A number of 

comments cited the Harvard-Tuskegee 

Study, which showed that removing 

dead stock from the feed chain would 

reduce potential exposure of cattle to 

the BSE agent by 88 percent. However, 

other comments noted that such a ban 

would result in dead stock being 

disposed of on the farm, impacting 

USDA’s surveillance program and 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58575 

increasing environmental problems due 

to improper disposal of animal 

carcasses. Concerns were also expressed 

about lack of infrastructure for non-feed 

disposal of dead stock, and the serious 

economic impact of diverting these 

animals to alternative disposal. 

In response to the question in the 

2004 ANPRM about effective removal of 

SRMs from dead stock and 

nonambulatory disabled cattle, several 

comments stated that such removal 

would not be economically or 

technically feasible. Other comments 

stated that SRM material could be 

effectively removed because there is no 

substantial difference between the 

processing of dead and nonambulatory 

animals at rendering facilities and the 

processing of healthy cattle at slaughter 

plants. One other comment mentioned 

instances where some USDA-inspected 

deboning facilities already remove 

SRMs from dead cattle at the request of 

pet food manufacturers. This comment 

also said that, based on their experience, 

SRMs can be removed from dead cattle 

in all but the hottest months of the year 

when the rate of decomposition 

increases. Another comment said that 

removing SRMs from dead stock may 

increase exposure of plant employees to 

pathogens and zoonotic diseases. 

One comment noted that the 

European experience has shown that 

cattle at highest risk for BSE are dead 

cattle, downer cattle, and ante-mortem 

condemned cattle over 30 months of 

age. This comment said that, while it is 

possible to remove the meat from these 

carcasses for use in pet food, they are 

not aware of any way of verifying the 

removal of SRMs from dead and 

nonambulatory cattle (short of active 

government oversight) that would allow 

this material to be rendered for use in 

feeds for non-ruminant animals. 

Another comment suggested that as an 

option for reducing the amount of 

material for disposal, dead stock under 

30 months of age be allowed to be 

rendered for feed use. This comment 

also said that USDA could test dead 

stock over 30 months of age, allowing 

material from negative animals to be 

used in feed. 

d. Small intestine. The 2004 ANPRM 

also requested information to evaluate 

the IRT recommendation that the entire 

intestine from cattle of all ages should 

be excluded from the human and animal 

food chains. With publication of its 

interim final rule on January 12, 2004, 

USDA required that the entire small 

intestine be disposed of as inedible. 

Likewise, FDA prohibited the use of the 

entire small intestine in FDA-regulated 

human food and cosmetics, even though 

the agency only considers the distal 

ileum portion of the small intestine to 

be a specified risk material (69 FR 

42259). 

However, based on comments 

received in response to the FDA interim 

final rule on human food and cosmetics, 

FDA concluded that processors have the 

technology to effectively remove the 

distal ileum portion from the rest of the 

small intestine. Thus, FDA amended the 

human food and cosmetics interim final 

rule to state that the small intestine is 

not considered prohibited cattle 

material if the distal ileum is removed 

by a procedure that removes at least 80 

inches of the uncoiled and trimmed 

small intestine as measured from the 

caeco-colic junction and progressing 

proximally towards the jejunum or by a 

procedure that the establishment can 

demonstrate is equally effective in 

ensuring complete removal of the distal 

ileum (70 FR 53063, September 7, 2005). 

This amendment is consistent with 

USDA requirements (70 FR 53043, 

September 7, 2005). 

Many comments in response to the 

2004 ANPRM stated that inclusion of 

the entire small intestine from cattle less 

than 30 months of age in the list of 

prohibited material would double the 

volume of SRMs from slaughter 

requiring alternative disposal while 

only marginally decreasing infectivity. 

Several comments stated that only the 

distal ileum should be included in the 

list of SRMs and noted that it is easily 

identified for separation at slaughter. 

One comment questioned the need to 

designate the intestinal tract as SRM, 

pointing out that the distal ileum 

accounts for only 5 percent of 

infectivity, which is reduced by two 

logs during rendering. Another 

comment said that it was unnecessary to 

designate any portion of the intestinal 

tract of cattle less than 30 months of age 

as SRM because these animals were 

born 4 1/2 years after the feed ban was 

implemented, and are therefore low risk 

animals. Several comments said that, if 

packers can demonstrate a satisfactory 

technique, they should be allowed to 

remove only the distal ileum rather than 

the entire small intestine. 

One comment expressing concern 

about the BSE risk associated with 

bovine intestines said that research in 

the United Kingdom found positive 

immunostaining for the resistant form of 

the prion protein along the length of the 

intestine, which provides evidence that 

the entire intestine should be 

considered SRM. 

e. Infrastructure for alternative 

disposal. We received a number of 

comments addressing the issue of 

disposal infrastructure. One comment 

noted that the IRT recognized that an 

infrastructure was not in place to 

dispose of SRM material and that the 

IRT had suggested that a staged 

implementation may be necessary to 

allow this infrastructure to develop. One 

comment said that before an SRM ban 

is implemented a comprehensive plan 

for disposal of this material needs to be 

developed. Another comment noted that 

in Texas, SRMs are considered special 

waste, and that no landfill in the state 

is capable of accommodating a large 

volume of this material. Additional 

comments indicated that this concern 

was also true for other states, including 

Nebraska and Utah. 

Two organizations submitted 

slaughter and cattle mortality data to 

emphasize the amount of waste that 

would be generated by regulations that 

would exclude this material from being 

rendered for use in animal feed. One of 

these organizations said that it is deeply 

concerned that FDA fails to recognize 

that a suitable disposal infrastructure 

does not exist to deal with the very large 

quantities of SRMs that would be 

generated on a daily basis. Its estimate 

for the volume of waste generated from 

slaughter and cattle mortalities was 2 

billion pounds per year. The other 

organization submitted similar 

comments saying that the U.S. system is 

currently unprepared to manage the 

waste disposal challenges certain to 

arise if significant quantities of livestock 

mortalities and slaughter byproducts 

require disposal by means other than 

rendering. The comments further stated 

that the disposal and environmental 

challenges resulting from the ban would 

be faced immediately, but the solutions 

to these challenges would arise only 

after significant time and financial 

investment across the livestock sector. 

The comments also said that there is an 

absence of direct regulatory control over 

alternative methods of disposing of the 

enormous quantities of this unpleasant 

material. 

Another comment suggested that 

renderers should be allowed to dedicate 

lines to SRM material and SRM-free 

material within a single facility. 

Equipment for receiving, grinding, 

cooking, processing, and conveying 

could be dedicated lines, while the 

facility itself, including the utilities, 

odor control, and wastewater treatment 

systems be shared. Further, another 

comment suggested FDA work with the 

rendering industry to develop cleanout 

procedures that would allow a plant to 

process both SRMs and SRM-free 

material. These procedures would be 

helpful to allow for seasonal deer 

rendering, for cleaning up after 

accidental cross-contamination, and for 

58576 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

converting a facility back to SRM-free 

rendering. 

One comment addressed the use of 

rendered SRM material as an alternative 

fuel source for cement kilns, indicating 

that ruminant meat and bone meal and 

fat are being used as a fuel source in 

Europe and Japan. According to the 

comment, these materials burn 

efficiently, and the heat from the kiln 

leaves virtually no organic residue. 

f. Verification of SRM removal and 

SRM marking. One comment stated that, 

in the absence of a practical test for 

verification of SRM removal, the 

documentation required by HACCP 

plans should be sufficient to show that 

SRMs at slaughter are excluded from 

animal feed channels. Thus, inspections 

of records could be used to verify SRM 

removal. Also, the comment stated that 

FDA can verify SRM removal by shifting 

resources from inspections of thousands 

of feed mills and farms to the much 

smaller number of slaughter plants and 

renderers. 

One comment stated that rendering 

plants are capable of keeping raw 

materials from various sources 

separated and capable of using 

production, inventory, and shipping 

records to document the movement of 

both SRM and SRM-free materials. Such 

management practices can be verified by 

inspection, much like those conducted 

at USDA-inspected cattle slaughter 

facilities. The comment went on to say 

that, if a rendering plant is dedicated to 

rendering only SRMs, such a plant will 

have to be inspected to determine how 

it disposes of SRMs. 

Two comments suggested that raw or 

SRM-derived rendered materials can be 

effectively marked using automatic 

dosage pumps to dispense markers like 

glyceroltriheptanoate (GTH). GTH is a 

C7 synthetic fatty acid not found in 

nature. A gas chromatography (GC) 

method for its detection is available. 

Charcoal was mentioned as another 

potential marker for use in rendered 

products. 

II. Proposed Measures to Strengthen 

Animal Feed Safeguards 

A. FDA Response to Comments to the 

2004 ANPRM 

FDA agrees with the numerous 

comments saying that it is important to 

keep the BSE risk in the United States 

in proper perspective. FDA 

acknowledges that the risk is likely low, 

and acknowledges that it is 

inappropriate to compare the BSE 

situation in the United States to the 

situation in Europe. However, FDA 

disagrees with comments concluding 

that for these reasons no additional 

measures are needed. Even though 

strong control measures have been put 

in place and compliance with the 

current BSE feed regulation is high by 

renderers, protein blenders and feed 

mills, the Agency is concerned, as 

discussed further below, about such 

issues as the presence of high risk 

material in the non-ruminant feed 

supply and cross-contamination of 

ruminant feed during the rendering or 

feed manufacturing process. For 

example, without fully dedicated 

equipment, it may not be possible to 

verify that there is zero carryover of feed 

or feed ingredients in equipment, even 

where a firm’s cleanout procedures have 

been judged to be adequate. In addition, 

resource constraints limit FDA’s ability 

to assure full compliance by all 

segments of the industry that are subject 

to the current BSE feed regulation. For 

example, resources are not available to 

the FDA and its state counterparts to 

fully verify compliance on over 1 

million farms where cattle are being fed. 

FDA does not agree with comments 

that the agency should wait until USDA 

completes its enhanced BSE 

surveillance program before deciding if 

additional feed controls are needed. As 

stated in the July 2004 ANPRM, FDA 

had tentatively decided based on clear 

evidence that the BSE agent had been 

introduced into the North American 

animal feed supply, and based on the 

recommendation of the IRT, that SRMs 

should be removed from all animal feed. 

Results from the enhanced surveillance 

that was being conducted concurrent 

with our rulemaking process indicated 

that BSE had been introduced into the 

United States, but was present at a very 

low level. These results reinforced 

FDA’s decision that the measures being 

proposed are appropriate. 

With respect to the definition of 

SRMs, FDA agrees that prohibiting the 

full list of SRMs would achieve greater 

risk reduction than prohibiting a partial 

list, but also agrees with comments 

saying that the infrastructure does not 

currently exist to handle the volume of 

material that would require non-feed 

disposal if the full list of SRMs were 

diverted from animal feed use. 

Therefore, FDA agrees that focusing on 

brain and spinal cord is an effective 

approach for achieving additional 

animal and public health protection 

while minimizing the economic, 

environmental, and public health 

concerns associated with disposal of the 

full list of SRMs. FDA, however, seeks 

comments on whether a full SRM ban is 

warranted. 

Comments were mixed on the 

feasibility of removing SRMs from dead 

stock. FDA therefore concluded that 

some firms would elect to remove SRMs 

and render the remainder of the carcass, 

and that this could lessen difficulties 

associated with alternative disposal. 

FDA does not agree that allowing testnegative animals to be rendered for 

animal feed use is appropriate. Unlike 

Europe, rapid screening tests in the 

United States have been used only for 

surveillance purposes. These tests have 

not been used as food or feed safety tests 

because currently available tests can 

detect BSE only in the late stages of 

disease. Finally, although FDA agrees 

that vacuum rendering is less effective 

at inactivating TSEs than atmospheric 

rendering, the Agency disagrees that 

vacuum rendering should be prohibited. 

Modeling results submitted with the 

comment showed that such a 

prohibition would result in an 

additional one percent reduction in risk. 

In light of other measures being 

proposed and the fact that few plants 

use vacuum rendering, FDA does not 

believe that prohibiting this rendering 

process would appreciably improve 

animal or public health protection. 

B. Additional Measures to Further 

Strengthen Feed Protection 

The United States and Canadian feed 

regulations implemented in 1997 were 

necessary because of uncertainty about 

whether BSE infectivity had already 

been introduced into North America 

before new import restrictions on live 

cattle and meat and bone meal from 

Europe were put in place. It is now clear 

from the five North American BSE cases 

that the BSE agent was introduced into 

the North American animal feed supply 

at some point in time. While FDA 

continues to believe that compliance 

with the feed regulation has provided 

strong protection against the spread of 

BSE, the agency believes that the recent 

cases are an indication that additional 

animal feed protections are needed to 

remove residual infectivity that may be 

present in the animal feed supply. FDA 

also believes that of all the options 

considered since publication of the 2002 

ANPRM, excluding the highest risk 

tissues from all animal feed is the best 

approach to address the risks of BSE in 

the United States. In the 2004 ANPRM, 

FDA announced its tentative conclusion 

that it should propose a prohibition on 

the use of SRMs in all animal feed. 

The decision to propose banning 

SRMs from all animal feed led to the 

following questions: (1) Which material 

to exclude, (2) what alternative disposal 

methods could be used, (3) what the 

economic and environmental impacts of 

diverting material to alternative disposal 

would be, and (4) how an SRM ban 

could be enforced. As the IRT reported, 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58577 

exclusion of large volumes of raw 

material is a massive burden for all 

countries affected by BSE. FDA received 

valuable information pertaining to these 

issues in comments submitted in 

response to the 2004 ANPRM. 

In reaching a decision about what 

specific additional measures should be 

proposed at this time, FDA considered 

the magnitude of the BSE risk in the 

United States. While the recent North 

American cases clearly show the BSE 

agent was introduced, the USDA 

enhanced BSE surveillance program 

indicates that the prevalence of the 

disease in the United States is very low. 

As of July 2005, USDA has tested over 

418,000 high-risk cattle under its 

enhanced BSE surveillance program 

(Ref. 11), and has found one positive 

animal in addition to the cow identified 

in Washington State in December 2003. 

Therefore, FDA believes that the 

additional measures being proposed are 

appropriate at this time. The agency 

proposes to prohibit from use in all 

animal feed the brains and spinal cords 

from cattle 30 months of age and older, 

the brains and spinal cords from all 

cattle not inspected and passed for 

human consumption, and the entire 

carcass of cattle not inspected and 

passed for human consumption from 

which brains and spinal cords were not 

removed. The agency also proposes to 

prohibit from use in all animal feed 

mechanically separated beef and tallow 

that are derived from materials 

prohibited by the rule. However, the 

rule proposes to exempt tallow from this 

requirement if it contains no more than 

0.15 percent insoluble impurities. 

C. Basis for Proposing to Apply 

Additional Measures to All Animal 

Food and Feed 

The current U.S. ruminant feed 

regulation prohibits the use of certain 

mammalian-origin proteins in ruminant 

feed, but allows the use of these 

materials in feed for non-ruminant 

species. FDA believes that the presence 

of high-risk materials in the nonruminant feed supply presents a 

potential risk of BSE to cattle in the 

United States. European experience 

showed that, in countries with high 

levels of circulating BSE infectivity, 

controls on only ruminant feed were not 

sufficient to prevent further 

transmission of BSE. Until SRMs were 

removed from all animal feed, a 

significant number of new cases 

continued to be found in cattle born in 

the United Kingdom after 

implementation of a ruminant-toruminant feed ban (Ref. 12). These new 

cases were attributed to either crosscontamination during feed manufacture 

and transport, or to intentional or 

unintentional misfeeding on the farm. 

The 1997 ruminant feed regulation 

requires feed manufacturers and 

distributors that handle both ruminant 

feed and feed ingredients and materials 

prohibited in ruminant feed to control 

cross-contamination by either: (1) 

Maintaining separate equipment or 

facilities or (2) using adequate clean-out 

procedures or other means adequate to 

prevent carry-over of prohibited 

material into feed for ruminant animals. 

FDA has been concerned about the 

adequacy of such clean-out procedures 

and sought public comment on this 

issue in the 2002 ANPRM. Although 

many firms using the clean-out option 

have written procedures in place, 

evaluating their adequacy is difficult 

because of wide variation in equipment 

and practices used by the feed industry, 

and because there is currently no 

definitive test method to detect 

prohibited proteins. 

Further increasing FDA’s concerns 

about cross-contamination are 

preliminary data from an unpublished 

study showing that the minimum 

infectious dose for BSE may be lower 

than previously thought. Interim results 

at approximately 5 years post exposure 

of an oral challenge experiment have 

demonstrated transmission of BSE to 1 

out of 15 animals that received 0.01 

gram of brain tissue from a BSE-infected 

animal (Ref. 13). The lowest dose 

previously tested was 1.0 gram of brain 

tissue which showed transmission of 

BSE in 7 out of 10 animals in the trial 

group. This finding of a lower minimum 

infectious dose for BSE would suggest 

that the risk from cross-contamination is 

greater than previously thought. We 

seek comment on this interpretation of 

theses interim results. 

Instances of cattle being exposed to 

prohibited material through 

noncompliance with the 1997 feed bans 

have been identified in both Canada and 

the United States. The investigation by 

the Canadian Food Inspection Agency of 

the BSE case identified in May 2003 

found several instances where cattle 

might have had access to non-ruminant 

feed containing prohibited material. In 

the United States, FDA inspections have 

identified situations where cattle could 

have been exposed to material 

prohibited in ruminant feed as a result 

of ruminant feed being contaminated 

with non-ruminant feed, or nonruminant feed not being properly 

labeled. 

In fiscal year 2004 and the first half 

of fiscal year 2005, federal and state 

inspections identified 41 instances (0.4 

percent of inspections) of crosscontamination or commingling 

problems in firms that handle animal 

feeds containing prohibited mammalian 

protein (Ref. 14). During this same 

period, inspections identified 165 

instances (1.7 percent of inspections) in 

which non-ruminant feeds containing 

prohibited material were not properly 

labeled with the caution statement ‘‘Do 

Not Feed to Cattle or Other Ruminants’’. 

Firms receiving mislabeled feed would 

not be aware of the need to take steps 

to prevent cross-contamination of 

ruminant feed with such products. 

Furthermore, inspections during this 

period identified 604 instances (6.3 

percent of inspections) in which firms 

handling animal feeds containing 

prohibited mammalian protein did not 

meet the recordkeeping requirements. 

These instances involved a variety of 

recordkeeping deficiencies, including 

not maintaining sales records for feeds 

received or distributed, not establishing 

written protocols for avoiding 

commingling, and not fully 

documenting clean-out measures 

utilized. Such deficiencies are typically 

corrected by the involved firms without 

further action by the agency. However, 

the occurrence of these deficiencies 

nonetheless supports the need for 

additional measures to address concerns 

about the presence of high-risk materials 

in the non-ruminant feed supply. 

Without sales records, it is difficult to 

verify the source of feed or feed 

ingredients or to track distributed feeds 

when conducting recalls in response to 

known instances of product 

contamination. Without appropriate 

documentation of procedures related to 

commingling or cross-contamination, it 

is difficult to verify that workers are 

informed of such procedures or that the 

procedures are adequate. 

FDA has issued warning and untitled 

letters to firms addressing 

noncompliance with the current 

ruminant feed ban regulation and a feed 

manufacturer has been permanently 

enjoined in connection with 

noncompliance with the current feed 

ban regulation. 

FDA is also concerned about 

intentional and unintentional 

misfeeding of non-ruminant feed to 

ruminants on the farm. Financial 

incentives for intentional misfeeding 

could occur any time inexpensive 

sources of prohibited protein are locally 

available to the feeder. The use of 

salvaged pet food that contains 

ruminant meat and bone meal is an 

example. There may be other incentives 

to intentionally feed non-ruminant feed 

to cattle. For example, the Florida 

Department of Agriculture and 

Consumer Services issued a statement 

cautioning against the misuse of pet 

58578 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

1A more recent report (Comer and Huntly, 2004, 

Journal of Risk Research, 7, (5) 523-543) attributes 

84.3 percent of infectivity to brain and spinal cord 

and 9.6 percent to distal ileum. We chose not to use 

the data from this more recent report because its 

author (personal communications) explained that 

the newer data suggesting that the level of 

infectivity in the distal ileum at 6 to 18 months of 

age is higher than earlier estimates also suggest that 

it is lower than earlier estimates at 32 months of 

age. 

food as feed for show cattle as a way to 

increase the shine in the cattle coat (Ref. 

15). Unintentional feeding could occur 

on the farm from feeding ruminants and 

non-ruminant in close proximity to each 

other. If intentional or unintentional 

uses occur, this proposed rule would 

protect cattle by removing the highest 

risk material from the non-ruminant 

feed being used in cattle feed. Assuring 

that misfeeding does not occur on the 

farm is particularly difficult due to the 

large number of cattle feeding 

operations in the United States, and 

FDA’s extremely limited resources to 

inspect these operations, which number 

over 1 million. 

Therefore, although overall 

compliance with the 1997 ruminant 

feed rule has been high for renderers, 

protein blenders, and feed mills, 

removal of the highest risk tissues from 

animal feed channels should serve to 

address noncompliance with the rule 

that could result in cattle exposure to 

prohibited material through crosscontamination, mislabeling, or 

intentional or unintentional misfeeding. 

D. Cattle Materials Proposed to be 

Prohibited From Use in All Animal Food 

and Feed 

1. Brain and Spinal Cord From Cattle 30 

months of Age and Older 

The USDA interim final rule 

published on January 12, 2004, provides 

a full description of the scientific 

rationale for identifying the list of 

tissues and selection of the 30-month 

age criterion used in its definition of 

SRMs. FDA has adopted an identical 

definition of SRMs in its interim final 

rule regarding FDA-regulated human 

food and cosmetics. In the preamble of 

its July 14, 2004 interim final rule 

regarding human food, including dietary 

supplements, and cosmetics, FDA 

includes a detailed discussion of its 

rationale for the SRM definition. As 

discussed in the preamble to the USDA 

and FDA interim final rules, infectivity 

is not present in most tissues that harbor 

BSE infectivity until more than 30 

months after the animal was exposed to 

the agent. Although the epidemiological 

and experimental data indicate that BSE 

can develop in animals less than 30 

months of age, the evidence available to 

date indicates that this was a very rare 

occurrence, and was associated with 

high levels of circulating infectivity at 

the peak of the BSE epidemic in the 

United Kingdom. The agency continues 

to believe that the rationale for the 30- 

month age criterion described 

previously for human food and 

cosmetics is appropriate and proposes 

that it be applied to animal feed as well. 

In response to a question posed in the 

2004 ANPRM as to which tissues should 

be defined as SRMs for animal feed, 

FDA received suggestions ranging from 

defining all animal protein as SRMs to 

limiting the SRM definition to the head 

only. FDA considered prohibiting from 

animal feed the same materials defined 

as SRMs that are currently prohibited 

from use in food for humans, but 

decided that proposing to require the 

removal of brain and spinal cord is the 

most appropriate approach at this time. 

In reaching the decision to propose to 

exclude only the brain and spinal cord 

from animal feed, FDA considered 

information regarding the tissue 

distribution of BSE infectivity. Under 

field conditions, BSE infectivity has 

been found in the brain, spinal cord, 

and retina of the eye in animals with 

clinical disease (Ref. 16). The Scientific 

Steering Committee (SSC) of the 

European Union (Ref. 17) has also 

reported on the proportion of total 

infectivity in various tissues.1

According to the report, in an animal 

with clinical BSE, approximately 64 

percent of the infectivity is in the brain, 

26 percent is in the spinal cord, 4 

percent is in the dorsal root ganglia, 2.5 

percent is in the trigeminal ganglia, and 

3 percent is in the distal ileum. The eyes 

are estimated to contain less than 1 

percent of the infectivity. Although 

available data are limited on the 

distribution of tissue infectivity, data 

from both naturally infected and 

experimentally infected cattle support 

the finding that the brain and spinal 

cord are the tissues with the highest 

level of infectivity. 

Because available data indicate that 

the brain and spinal cord contain about 

90 percent of BSE infectivity (Ref. 17), 

FDA believes that the most appropriate 

course of action is to concentrate efforts 

on excluding these highest risk tissues 

from animal feed. In deciding to 

propose to prohibit brain and spinal 

cord only, rather than the same list of 

materials previously defined as SRMs, 

FDA also considered the following: (1) 

Surveillance data indicate the current 

risk of BSE to U.S. cattle is very low, (2) 

the existing ruminant feed regulation 

provides strong protection against BSE, 

and (3) the new measures considered in 

this proposed rule represent a secondary 

level of protection to address failures in 

compliance that may occur with the 

existing ruminant feed rule. FDA 

believes that the existing ruminant feed 

rule provides the primary line of 

defense by prohibiting the use in 

ruminant feed of all material with 

potential BSE infectivity. The measures 

proposed by this rule will effectively 

reinforce existing ruminant feed 

protection measures by removing the 

tissues with the highest infectivity from 

all animal feed. As a result, these 

measures greatly minimize BSE risks if 

cross-contamination of ruminant feed 

with non-ruminant feed, or diversion of 

non-ruminant feeds to ruminants, were 

to occur. 

2. Cattle Not Inspected and Passed for 

Human Consumption 

As noted earlier in this document, the 

term ‘‘cattle not inspected and passed 

for human consumption’’ includes cattle 

not inspected and passed for human 

consumption by the appropriate 

regulatory authority as well as 

nonambulatory disabled cattle. 

European surveillance data indicate 

that cattle found dead or culled onsite, 

where the carcass was submitted to 

rendering (fallen stock), and cattle with 

health-related problems unfit for routine 

slaughter (emergency slaughter) have a 

greater incidence of BSE than healthy 

slaughter cattle. Surveillance data in the 

European Union in 2002 showed that 

there were 27.95 positive animals per 

10,000 emergency slaughter bovine 

animals tested and 6.15 positive animals 

per 10,000 fallen stock bovine animals 

tested compared to 0.31 positive 

animals per 10,000 healthy slaughter 

animals tested (Ref. 18). In Switzerland, 

the odds of finding a BSE case in fallen 

stock and emergency slaughter cattle 

were found to be 49 and 58 times 

higher, respectively, compared to the 

odds of finding a BSE case through 

passive surveillance (Ref. 19). These 

findings suggest that cattle not 

inspected and passed for human 

consumption are more likely to test 

positive for BSE than healthy cattle that 

have been inspected and passed for 

human consumption. 

Because cattle not inspected and 

passed for human consumption are 

included in the population of cattle at 

highest risk for BSE (Refs. 18 and 19), 

and processes are currently not 

established in the rendering industry for 

verifying the age of such cattle through 

inspection, the agency is proposing to 

define brains and spinal cords from all 

cattle not inspected and passed for 

human consumption, regardless of age, 

to be cattle materials prohibited in 

animal feed. As noted previously, the 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58579 

term cattle not inspected and passed for 

human consumption is defined in this 

proposed rule to include nonambulatory 

disabled cattle as defined by FDA in its 

interim final rule on human food and 

cosmetics and USDA in its interim final 

rule on human food. If the brains and 

spinal cords are removed from these 

animals, FDA is proposing that the 

remaining material can still be used in 

animal feed. FDA notes that for cattle 

not inspected and passed that are 

diseased or that die other than by 

slaughter, the entire carcass of such 

animals is adulterated under section 

402(a)(5) of the act. FDA has 

traditionally exercised enforcement 

discretion with regard to the use of such 

animals in animal feed. For example, 

see Compliance Policy Guide 675.400. 

FDA intends to continue exercising 

such discretion for the use in animal 

feed of the remaining material from 

cattle that are diseased or that die other 

than by slaughter when the brain and 

spinal cord are removed. Because 

comments to the ANPRM were mixed 

on the feasibility of removing SRMs 

from cattle mortalities, FDA requests 

further comment on which tissues 

should be removed from this class of 

animals and the feasibility of removing 

them. 

In deciding to propose to allow these 

remaining materials to be used in 

animal feed, FDA considered the 

following: (1) brain and spinal contain 

about 90 percent of BSE infectivity (Ref. 

17), (2) surveillance data indicate the 

current risk of BSE to U.S. cattle is very 

low, (3) the existing ruminant feed rule 

provides strong protection against BSE, 

and (4) the new measures considered in 

this proposed rule represent a secondary 

level of protection to address failures in 

compliance that may occur with the 

existing ruminant feed rule. FDA 

believes that the existing ruminant feed 

rule provides the primary line of 

defense by prohibiting the use in 

ruminant feed of all material with 

potential BSE infectivity. If the brains 

and spinal cords are not removed from 

such animals, FDA proposes that all 

parts of ‘‘cattle not inspected and passed 

for human consumption’’ be prohibited. 

3. Mechanically-Separated Beef (MS) 

Mechanically-separated (MS) beef is a 

finely comminuted meat food product 

resulting from the mechanical 

separation and removal of most of the 

bone from attached skeletal muscle of 

cattle carcasses and parts of carcasses. 

This proposed definition of MS beef is 

consistent with, but not identical to, the 

definition of the term used by USDA in 

its 2004 interim final rule (69 FR 1862) 

prohibiting its use in human food and 

by FDA in its 2004 interim final rule (69 

FR 42255) prohibiting its use in human 

food, including dietary supplements 

and cosmetics. Those definitions 

provide that MS beef means a meat food 

product that meets the specification in 

9 CFR 319.5. This USDA regulation 

applies to MS beef for human food use. 

Because there is MS beef produced 

solely for animal feed use that would 

not fall within the USDA specification, 

the definition of MS beef as proposed in 

this rule is meant to refer to beef that is 

the product of the mechanical 

separation process, regardless of 

whether it meets the USDA 

specifications for MS species in 9 CFR 

319.5. The definition of MS beef is not 

meant to include product produced by 

Advanced Meat Recovery (AMR) 

systems used in the meat industry. 

Although MS beef was not considered 

in the 2002 ANPRM, 2004 ANPRM, or 

in the IRT report, FDA has included this 

material in this animal feed proposed 

rule to ensure that any such material 

that is used in animal feed is not 

contaminated with the other material 

prohibited by this proposed rule. A 

comment submitted in response to the 

2004 ANPRM said that FDA should 

allow mechanically separated beef to be 

used for pet food if SRMs are removed 

from material going into the mechanical 

deboning equipment that separates meat 

from bone, because some pet food 

operations are very similar to slaughter 

establishments and are capable of 

removing SRMs. 

Because the mechanical separation 

process may result in the contamination 

of the MS beef product with spinal cord, 

FDA proposes to designate MS beef as 

cattle materials prohibited in animal 

feed if it is derived from carcasses or 

parts of carcasses from which cattle 

materials prohibited in animal feed 

were not previously removed. 

4. Tallow 

Tallow is an animal-derived hard fat 

that has been heat processed; most 

tallow is derived from cattle. Any risk 

of BSE transmission from tallow is a 

result of protein that is present as an 

impurity in the tallow. Taylor et al. 

(Refs. 20 and 21) found, in rendering 

studies with abnormal prion protein, 

that the prion protein did not 

preferentially migrate into the fat 

fraction, but remained with the protein 

fraction. Therefore, there is no reason to 

believe that tallow is likely to contain 

unusually high amounts of prion 

protein as a constituent of the insoluble 

impurities fraction that remains in 

tallow after rendering. Taylor et al. 

(Refs. 20 and 21) also reported that the 

various rendering processes used for 

tallow production in the United 

Kingdom were sufficient to produce 

tallow that did not result in infection 

when injected into the brains of mice, 

even though the starting material was 

highly spiked with the scrapie agent. 

Wilesmith et al. (Ref. 22) noted that the 

geographical variation in the incidence 

of BSE in the United Kingdom was not 

consistent with the use of tallow in 

cattle feed and concluded that the most 

likely source of infection in cattle was 

BSE-contaminated meat and bone meal. 

The Office International des 

Epizooties (OIE), the world organization 

for animal health, categorizes tallow 

with insoluble impurities of no more 

than 0.15 percent as protein-free tallow. 

OIE guidelines recommend that tallow 

that meets this standard can be safely 

traded regardless of the BSE status of 

the exporting country (Ref. 23). FDA’s 

Transmissible Spongiform 

Encephalopathy Advisory Committee 

(TSEAC) considered the safety of tallow 

and tallow derivatives in 1998 (Ref. 24). 

Members of the committee indicated 

that tallow is a food with negligible or 

no risk of transmitting BSE to humans 

or animals. 

For the purposes of this proposed 

rule, tallow is defined as the rendered 

fat of cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. The 1997 ruminant 

feed final rule did not include tallow, 

fats, oils, and grease in the definition of 

animal proteins prohibited in ruminant 

feed because they are not proteins and 

were not considered to contain BSE 

infectivity. The agency said that 

infectivity studies conducted on some of 

these products (e.g., tallow) had 

demonstrated that they were at low risk 

of transmitting the TSE agent and; thus, 

it was unnecessary to restrict their use 

in ruminant feed (62 FR 30935). While 

the agency is not aware of any new 

scientific information suggesting that 

infectivity is present in tallow itself, the 

agency is concerned about potential BSE 

risks that tallow poses as a result of 

protein that is present as an impurity. 

These impurities may be of greater 

concern now because, as previously 

noted, new preliminary data suggest 

that the minimum infectious dose for 

BSE may be substantially lower than 

previously thought. We seek comment 

on this interpretation of the preliminary 

results. 

The agency is proposing to prohibit 

the use of tallow in animal food or feed 

that is derived from cattle materials 

prohibited in animal feed. However, the 

agency proposes to exempt from this 

requirement tallow that contains no 

58580 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

more than 0.15 percent insoluble 

impurities. The proposal would require 

that impurities be measured by the 

method entitled ‘‘Insoluble Impurities’’

(AOCS Official Method Ca 3a–46), 

American Oil Chemists’ Society, which 

is incorporated by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51, or another method 

equivalent in accuracy, precision, and 

sensitivity to A.O.C.S. Official Method 

Ca 3a–46. In response to the 2004 

ANPRM, comments were submitted to 

the agency requesting that the primary 

method for the impurity determination 

for tallow be one other than the method 

in the Food Chemicals Codex. 

Comments stated that the domestic 

tallow industry primarily uses a method 

of AOCS to measure insoluble 

impurities. In comparison to the Food 

Chemicals Codex method, comments 

stated that the AOCS method is less 

expensive, requires less solvent, and has 

lower solvent disposal costs. In 

addition, it does not require specialized 

equipment or supplies. FDA agrees with 

these comments, and proposes that the 

primary method for the impurity 

determination for tallow be the method 

from AOCS rather than the method in 

the Food Chemicals Codex. 

This proposed requirement for tallow 

would apply to all animal feed, 

including feed for ruminants. Since the 

existing ruminant feed rule § 589.2000 

(21 CFR 589.2000) does not include 

provisions relative to tallow, this 

proposal represents a new requirement 

for ruminant feed as well as for feed for 

non-ruminants. To make clear that this 

proposed requirement would apply to 

ruminant feed, FDA is proposing to 

amend § 589.2000 to include the tallow 

requirements. 

FDA is also proposing to exempt 

tallow derivatives from the 

requirements of this rulemaking. Tallow 

derivatives are produced by subjecting 

tallow to chemical processes 

(hydrolysis, transesterification, and 

saponification) that involve high 

temperature and pressure. FDA’s 

TSEAC considered tallow derivatives in 

1998 (Ref. 24), and determined that the 

rigorous conditions of manufacture are 

sufficient to reduce the BSE risk in 

tallow derivatives to insignificant levels. 

In addition, according to OIE guidelines 

tallow derivatives produced by 

hydrolysis, saponification, or 

transesterification using high 

temperature and pressure can be safely 

traded regardless of the BSE risk status 

of the country of origin (Ref. 23). 

E. Disposal of Cattle Materials 

Prohibited in Animal Feed 

FDA agrees with comments from the 

affected industry that a comprehensive 

plan would be needed to safely dispose 

of approximately 2.5 billion pounds of 

material if FDA decided to prohibit all 

dead stock and the full list of SRMs, as 

defined in the USDA interim final rule 

(69 FR 1862) and the FDA interim final 

rule (69 FR 42255), from being rendered 

for use in animal feed. The 2.5 billion 

pounds of cattle material includes 

approximately 1.4 billion pounds of 

material from cattle slaughtered for 

human consumption and 1.1 billion 

pounds of material from cattle not 

inspected and passed for human 

consumption that are currently being 

rendered for use in animal feed. FDA is 

concerned about the feasibility of 

establishing a new infrastructure to 

safely dispose of this large quantity of 

material, as well as the time it would 

take to implement these processes. 

Limiting the list of SRMs as proposed 

by this rule reduces the volume of 

slaughter byproducts that would require 

alternative disposal. First, this proposal 

does not require the diversion from use 

in animal feed the small intestine and 

tonsils from the 28 million head of 

cattle under 30 months of age that are 

slaughtered annually. Second, only the 

brain and spinal cord (weighing 1.3 

pounds per animal) rather than the 

head, spinal column, and small 

intestine, (weighing 88.5 pounds per 

animal) are diverted from the estimated 

7 million head of cattle over 30 months 

of age that are slaughtered annually in 

the U.S. FDA believes that this more 

limited amount of material from 

slaughter operations can be disposed of 

through landfill, incineration, or 

alkaline digestion. 

Based on comments received, FDA 

acknowledges that there is some 

uncertainty regarding the amount of 

material that will require alternative 

disposal as a result of the proposed 

requirements pertaining to cattle not 

inspected and passed for human 

consumption (i.e., dead stock and 

nonambulatory disabled cattle). FDA is 

including in this proposed rule the 

option to remove brain and spinal cord 

from cattle not inspected and passed for 

human consumption so that most of this 

material could continue to be rendered 

for use in animal feed. As previously 

noted, FDA intends to continue 

exercising enforcement discretion for 

the use in animal feed of the remaining 

material from cattle that are diseased or 

that die other than by slaughter when 

the brain and spinal cord are removed. 

As discussed in more detail in Section 

IV, Analysis of Economic Impacts, FDA 

acknowledges that while the proposed 

rule will result in additional material 

from these animals being disposed of by 

means other than rendering, FDA 

believes such increases will be modest. 

FDA seeks comment and further 

information on the feasibility of 

removing brain and spinal cord from 

cattle not inspected and passed for 

human consumption and on the impact 

of this proposed rule on the number of 

these cattle that would be disposed of 

by rendering. 

In summary, FDA believes that the 

measures proposed by this rule can be 

more feasibly implemented than a full 

SRM ban, and can add substantially to 

the protection provided by the current 

BSE feed regulation. With this 

approach, the resulting volume of 

material requiring special disposal 

would be manageable in the short term. 

This approach is also consistent with 

the advice of the IRT that a staged 

approach may be necessary in 

implementation of an SRM ban. Further, 

FDA believes that other feed controls 

that FDA previously considered, such as 

dedicated facilities, are not needed if 

these high-risk tissues are excluded 

from animal feed channels. Therefore, at 

this time FDA is not proposing 

rulemaking to address other feed control 

recommendations of the IRT or the 

additional planned measures 

announced by FDA on January 26, 2004. 

III. Description of Proposed Rule and 

Legal Authority 

FDA is proposing to establish a new 

§ 589.2001 (21 CFR 259.2001), Cattle 

materials prohibited in animal food or 

feed. While the existing § 589.2000 

outlines requirements related to 

ruminant feeds only, proposed 

§ 589.2001 outlines requirements 

intended to apply to food or feed for all 

animal species. The terms and 

requirements of proposed § 589.2001 are 

described in section IV.A of this 

document. 

A. Definitions 

The proposed § 589.2001(a) defines 

the following terms for the purposes of 

this regulation: 

(1) Cattle materials prohibited in 

animal feed includes: (i) the brains and 

spinal cords of cattle 30 months of age 

and older; (ii) the brains and spinal 

cords of cattle of any age not inspected 

and passed for human consumption; 

(iii) the entire carcass of cattle not 

inspected and passed for human 

consumption from which brains and 

spinal cords were not removed; (iv) 

mechanically separated beef that is 

derived from cattle materials prohibited 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58581 

under (i), (ii), or (iii) above; and (v) 

tallow that is derived from cattle 

materials prohibited under (i), (ii), or 

(iii) above. Tallow that is derived from 

cattle materials prohibited under (i), (ii), 

or (iii) above that contains no more than 

0.15 percent insoluble impurities and 

tallow derivatives are not considered 

cattle materials prohibited in animal 

feeds. 

(2) Cattle not inspected and passed 

for human consumption means cattle of 

any age that were not inspected and 

passed for human consumption by the 

appropriate regulatory authority. This 

term includes nonambulatory disabled 

cattle. Non-ambulatory disabled cattle 

are cattle that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. 

(3) Mechanically separated beef 

means a meat food product that is finely 

comminuted, resulting from the 

mechanical separation and removal of 

most of the bone from attached skeletal 

muscle of cattle carcasses and parts of 

carcasses. 

(4) Renderer means any firm or 

individual that processes slaughter 

byproducts, animals unfit for human 

consumption, or meat scraps. The term 

includes persons who collect such 

materials and subject them to minimal 

processing, or distribute them to firms 

other than renderers (as defined in 

paragraph (a)(1)) whose intended use for 

the products may include animal feed, 

industrial use, or other uses. The term 

includes renderers that also blend 

animal protein products. 

(5) Tallow means the rendered fat of 

cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. 

(6) Tallow derivative means any 

product obtained through initial 

hydrolysis, saponification, or transesterification of tallow; chemical 

conversion of material obtained by 

hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 

B. Proposed Requirements 

Proposed § 589.2001(b)(1) provides 

that no animal food or feed shall be 

manufactured from, processed with, or 

otherwise contain cattle materials 

prohibited in animal feed. Proposed 

§ 589.2001(b)(2) provides new 

requirements for renderers that handle 

cattle material prohibited in animal 

feed. Proposed § 589.2001(b)(3) provides 

new requirements for renderers that 

handle any cattle material. 

1. Proposed Requirements for Renderers 

That Manufacture, Process, Blend, or 

Distribute Cattle Materials Prohibited in 

Animal Feed 

The proposed § 589.2001(b)(2) 

requires that renderers that handle cattle 

materials prohibited in animal feed use 

separate equipment or containers to 

handle such material once it has been 

separated from other cattle materials. 

This requirement is intended to ensure 

that equipment used to manufacture, 

process, blend, store, or transport cattle 

materials prohibited in animal feed or 

products that contain or may contain 

cattle materials prohibited in animal 

feed do not serve as a source of crosscontamination for materials intended for 

animal feed. In addition, proposed 

§ 589.2001(b)(2) requires renderers that 

manufacture, process, blend, or 

distribute cattle materials prohibited in 

animal feed or products that contain or 

may contain cattle materials prohibited 

in animal feed must: (1) Label the 

prohibited materials in a conspicuous 

manner with the statement ‘‘Do not feed 

to animals’’; (2) mark the prohibited 

material with an agent that can be 

readily detected on visual inspection; 

and (3) establish and maintain records 

sufficient to track the prohibited 

materials to ensure such material is not 

introduced into animal feed, and make 

the records available for inspection and 

copying by FDA. These proposed 

requirements are intended to ensure that 

cattle materials prohibited in animal 

feed do not enter the animal feed chain 

and thus have no opportunity for 

inclusion in animal food or feed. FDA 

believes that such material must be both 

labeled and marked to ensure that it 

does not enter the feed channels since 

without such measures this material 

would be indistinguishable from cattle 

materials not prohibited by this 

proposed rule. Marking the material will 

provide a readily detectable method on 

visual examination by which all persons 

in the animal feed chain can be made 

aware that the a product is prohibited 

material or contains prohibited material. 

Marking also will serve as a way to 

make the status of the material known 

if, for some reason, the label ‘‘Do not 

feed to animals’’ is separated from the 

product. 

2. Proposed Requirements for Renderers 

that Manufacture, Process, Blend, or 

Distribute Any Cattle Materials 

Proposed § 589.2001(b)(3) requires 

that renderers that handle any cattle 

materials shall: (1) Establish and 

maintain records sufficient to 

demonstrate that material rendered for 

use in animal feed was not 

manufactured from, processed with, or 

does not otherwise contain, cattle 

materials prohibited in animal feed, (2) 

make copies of records available for 

inspection and copying by FDA, and (3) 

be in compliance with requirements 

under § 589.2000 regarding animal 

proteins prohibited in ruminant feed. 

C. Proposed Recordkeeping and Access 

Requirements 

The proposed recordkeeping 

requirements associated with this rule 

are focused on renderers because FDA 

believes this is the point at which cattle 

material prohibited in animal feed could 

enter the animal feed channel. 

Renderers, as defined in this proposed 

rule, receive cattle materials from 

slaughter facilities or receive entire 

cattle carcasses that were not inspected 

and passed for human consumption and 

further process that material so that it 

may be used in animal feed. FDA 

believes this is the critical control point 

in the feed and feed ingredient 

processing channel at which the 

exclusion of cattle material prohibited 

in animal feed must be documented. 

Once material is removed from cattle 

and further processed, we may not be 

able to obtain the information necessary 

to determine whether it is cattle 

material prohibited in animal feed. 

There is currently no way to reliably test 

feed or feed ingredients for the presence 

of the BSE agent or for the presence of 

cattle materials prohibited in animal 

feed. 

This proposed rule requires that no 

animal feed or feed ingredient be 

manufactured from, processed with, or 

otherwise contain cattle materials 

prohibited in animal feed. However, 

FDA does not believe it is necessary for 

persons, other than renderers, that are 

involved in the manufacture or 

processing of feed or feed ingredients to 

maintain records documenting the 

exclusion of cattle materials prohibited 

in animal feed. FDA believes, for the 

reasons cited previously, that it is 

critical that such records be maintained 

at the point of the renderer. However, 

FDA believes that requiring the 

maintenance of such records at all 

manufacturing and processing points 

downstream would be redundant and 

provide little additional information of 

value. FDA seeks comments on the need 

to require that records be maintained by 

persons other than renderers. 

Because at this time there is no way 

to test reliably for the presence of the 

BSE agent or the presence of the cattle 

materials prohibited in proposed 

§ 589.2001(b)(1), renderers must depend 

58582 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

on records to ensure that the materials 

prohibited by this proposed rule are 

excluded from material intended for use 

in animal feed and that such material is 

appropriately disposed. Similarly, 

without adequate records kept by 

renderers and access to the records by 

the agency, FDA may not know whether 

renderers have complied with the 

requirements. We are proposing in 

§ 589.2001(b)(2)(iv) that renderers that 

manufacture, process, blend, or 

distribute cattle materials prohibited in 

animal feed establish and maintain 

records sufficient to demonstrate that 

such material was not introduced into 

animal feed. Furthermore, we are 

proposing in § 589.2001(b)(3)(i) that 

renderers that manufacture, process, 

blend, or distribute cattle materials 

establish and maintain records 

sufficient to demonstrate that material 

rendered for use in animal feed was not 

manufactured from, processed with, or 

does not otherwise contain, cattle 

materials prohibited in animal feed. 

Proposed § 589.2001(d) requires that 

the records required by this proposed 

rule be maintained for a minimum of 1 

year. The 1-year record retention period 

is consistent with the existing 

requirements for ruminant feeds in 

§ 589.2000(h). We believe that for the 

purposes of the recordkeeping 

requirements, 1 year is appropriate in 

light of the time that the products will 

be in the animal feed production and 

distribution systems. Extending the 

record retention period would have 

little practical value in determining the 

source of BSE in an animal. This is also 

considering the potentially long time 

period from ingestion of the BSE agent 

in feed to manifestation of clinical signs 

and lesions and the lack of a reliable 

estimate for the latency period. 

The proposed rule does not specify 

the types of records that would need to 

be maintained in order to comply with 

the recordkeeping requirements. The 

agency seeks comments on what type of 

records would be appropriate and 

whether further detail is needed in the 

regulation regarding specific record 

requirements such as the specific data 

elements that must be included in such 

records. 

D. Conforming Changes to § 589.2000— 

Animal Proteins Prohibited in Ruminant 

Feed 

The requirements related to tallow in 

the proposed § 589.2001 are intended to 

apply to all animal feed, including feed 

for ruminants. Since the existing 

ruminant feed rule (§ 589.2000) does not 

include provisions relative to tallow, 

this proposal represents a new 

requirement for ruminant feed as well as 

for feed for non-ruminants. Therefore, 

due to concerns about protein 

impurities present in tallow, FDA is 

proposing to amend § 589.2000 to 

include tallow in the definition of 

‘‘protein derived from mammalian 

tissues’’ and to add language that 

excludes from the definition of ‘‘protein 

derived from mammalian tissues’’

tallow containing no more than 0.15 

percent insoluble impurities and tallow 

derivatives as specified in proposed 

§ 589.2001. 

E. Legal Authority 

FDA is issuing this proposed 

regulation on animal feed under the 

food adulteration provisions in sections 

402(a)(2)(C), (a)(3), (a)(4), (a)(5), 409, 

and 701(a) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

342(a)(2)(C), (a)(3), (a)(4), (a)(5), 348, 

and 371(a)). The term ‘‘food’’ is defined 

to include articles used for food ‘‘for 

man or other animals.’’ See section 201 

of the act (21 U.S.C. 321(f)). We note 

that the material that would be 

prohibited under this proposed rule 

from use in animal feed continues to 

meet the definition of food. Therefore, 

this material would be adulterated or 

misbranded under the act based on 

violations of the proposed rule, as well 

as any animal feed or feed ingredients 

that were manufactured from, processed 

with, or otherwise contained, the 

prohibited material. 

Under section 402(a)(3) of the act, a 

food is deemed adulterated ‘‘if it 

consists in whole or in part of any 

filthy, putrid, or decomposed substance, 

or if it is otherwise unfit for food.’’

‘‘Otherwise unfit for food’’ is an 

independent clause in section 402(a)(3). 

The statute does not require that a food 

be filthy, putrid, or decomposed for it to 

be ‘‘otherwise unfit for food.’’ In FDA’s 

interim final rule on the Use of 

Materials Derived from Cattle in Human 

Food and Cosmetics (69 FR 42256 at 

42264), we concluded that a food can be 

‘‘otherwise unfit for food’’ based on 

health risks, and sought comments on 

that interpretation. Because of the 

possibility of intentional or 

unintentional use of the materials that 

would prohibited under this proposed 

rule in ruminant feed and the risk of 

BSE to ruminants and humans from 

these materials, we have tentatively 

concluded that these materials would be 

‘‘otherwise unfit for food’’ under section 

402(a)(3) of the act. We seek comment 

on this interpretation. 

Under section 402(a)(4) of the act, a 

food is deemed adulterated ‘‘if it has 

been prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health.’’ The failure to 

ensure that animal feed is prepared, 

packed, or held under conditions in 

which cattle materials prohibited in 

animal feed under this proposed rule do 

not contaminate animal feed would 

constitute an insanitary condition 

whereby the feed may have been 

rendered injurious to health. Thus, this 

insanitary condition would render the 

animal feed adulterated under section 

402(a)(4) of the act. 

Under section 402(a)(5) of the act, 

food is deemed adulterated ‘‘if it is, in 

whole or in part, the product * * * of 

an animal which has died otherwise 

than by slaughter.’’ Some cattle are not 

inspected and passed because they are 

diseased or have died before slaughter. 

Material from these cattle that are 

diseased or that die otherwise than by 

slaughter that is used as animal feed 

would render that feed adulterated 

under section 402(a)(5) of the Act. FDA 

has traditionally exercised enforcement 

discretion with regard to the use of such 

animals in animal feed. For example, 

see Compliance Policy Guide 675.400. 

FDA intends to continue exercising 

such discretion for the use in animal 

feed of the remaining material from 

cattle that are diseased or that die other 

than by slaughter when the brain and 

spinal cord are removed. 

We are also relying on the 

adulteration provision in section 

402(a)(2)(C)(i) of the act. Section 

402(a)(2)(C)(i) deems a food adulterated 

if it is or bears or contains a food 

additive that is unsafe under section 409 

of the act. Section 201(s) of the act, (21 

U.S.C. 321(s)), defines as a food additive 

any substance whose intended use 

results or may reasonably be expected to 

result in it becoming a component of 

food unless, among other things, it is the 

subject of a prior sanction (explicit 

approval for a specific use by USDA or 

FDA before September 6, 1958), or is 

generally recognized as safe (GRAS). 

Section 409 of the act provides that a 

food additive is unsafe unless it and its 

use conform to a food additive 

regulation or an exemption under 

section 409(j). 

Prior sanctions are described in part 

570 (21 CFR part 570). FDA is not aware 

of any prior sanctions that relate to the 

present animal feed use of the cattle 

material that would be prohibited in 

animal feed under this proposed rule. 

Any person who intends to assert or rely 

on such sanction is required to submit 

proof of the existence of the applicable 

prior sanction. The failure of any person 

to come forward with proof of such an 

applicable prior sanction in response to 

this notice will constitute a waiver of 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58583 

the right to assert or rely on such 

sanction at any later time. 

A determination that a substance 

added directly or indirectly to a food is 

GRAS, for its intended use is generally 

based on scientific information 

regarding the composition of the 

substance, its use, method of 

preparation, methods for detecting its 

presence in food, and information about 

its functionality in food as determined 

by experts qualified by scientific 

training and experience to evaluate the 

safety of such a substance (§ 570.30). A 

substance added to food becomes GRAS 

as a result of a common understanding 

about the substance throughout the 

scientific community familiar with the 

safety of such substances. The basis of 

expert views may be either scientific 

procedures, or, in the case of a 

substance used in food before January 1, 

1958, experience based on common use 

in food (§ 570.30(a)). Substances that are 

GRAS based on use before January 1, 

1958, must be currently recognized as 

safe based on their pre–1958 use (See 

United States v. Naremco, 553 F. 2d 

1138 (8th Cir. 1977; compare United 

States v. Western Serum, 666 F. 2d 335 

(9th Cir. 1982)). 

General recognition of safety based 

upon scientific procedures requires the 

same quantity and quality of scientific 

evidence as is required to obtain 

approval of a food additive regulation 

for the ingredient (21 CFR 570.30(b)). 

(See United States v. Naremco, 553 F.2d 

at 1143). A substance is not GRAS if 

there is a genuine dispute among 

experts as to its recognition (An Article 

of Drug *** Furestrol Vaginal 

Suppositories, 294 F. Supp 1307 (N.D. 

Ga. 1968), aff’d 415 F.2d 390 (5th Cir. 

1969)). It is not enough, in attempting to 

establish that a substance is GRAS, to 

establish that there is an absence of 

scientific studies that demonstrate the 

substance to be unsafe; there must be 

studies that show the substance to be 

safe (United States v. An Article of 

Food *** CoCo Rico, 752 F.2d 11 

(1st Cir. 1985)). Conversely, a substance 

may be ineligible for GRAS status if 

studies show that the substance is, or 

may be, unsafe, or if there is a conflict 

in studies. 

Expert opinion that cattle materials 

that would be prohibited in animal feed 

under this proposed rule are GRAS 

would need to be supported by 

scientific literature and other sources of 

data and information, establishing that 

there is a reasonable certainty of no 

harm from the material under the 

intended conditions of use. Expert 

opinion would need to address topics 

such as whether BSE infectivity can be 

detected, and whether it is reasonably 

certain that the BSE agent will not be 

transmitted through cattle materials that 

would prohibited in animal feed under 

this proposed rule. The burden of 

establishing that a substance is GRAS is 

on the proponent of the substance. (See 

CoCo Rico, supra.) 

For the reasons discussed in other 

sections of this document, the agency is 

tentatively concluding that cattle 

materials prohibited in animal feed 

under this proposed rule are not GRAS 

by qualified experts for use in animal 

food and, therefore, would be food 

additives. Section 402(a)(2)(C)(i) and (ii) 

of the act deems food adulterated ‘‘if it 

is or it bears or contains any food 

additive which is unsafe within the 

meaning of section 409***.’’ Under 

section 409(a), a food additive is unsafe 

unless a food additive regulation or an 

exemption is in effect with respect to its 

use or its intended use. Therefore, in the 

absence of a food additive regulation or 

an exemption, the cattle materials that 

would be prohibited in animal feed 

under this proposed rule would be 

adulterated under section 402(a)(2)(C)(i) 

of the act because it bears or contains an 

unsafe food additive, and their presence 

in animal feed would render the food 

adulterated. 

Under section 701(a) of the act, FDA 

is authorized to issue regulations for the 

act’s efficient enforcement. The 

proposed regulation would require 

measures to prevent animal food from 

being unfit for food, being or bearing an 

unsafe food additive, being the product 

of an animal that died otherwise than by 

slaughter. The measures will also be 

required to prevent animal food from 

being held under insanitary conditions 

whereby it may have been rendered 

injurious to health. These proposed 

measures would allow for the efficient 

enforcement of the act. Under the 

proposed regulations, renderers would 

be required to establish and maintain 

records to track cattle materials 

prohibited in animal feed to ensure that 

such material is not introduced into 

animal feed and make such records 

available to FDA for inspection and 

copying. Once material is removed from 

cattle, we may not be able to obtain the 

information necessary to determine 

whether it is prohibited cattle material. 

Because at this time there is no way to 

test reliably for the presence of the BSE 

agent or the presence of the cattle 

materials prohibited in proposed 

§ 589.2001(b)(1), renderers must depend 

on records to ensure that their products 

do not contain cattle materials 

prohibited from animal feed. In 

addition, without adequate records, 

FDA cannot know whether renderers 

have complied with the regulations that 

prohibit the use of certain cattle 

material in rendered products intended 

for animal feed. For example, we would 

not know from examination of a spinal 

cord whether the source animal was 

over 30 months of age at the time of 

slaughter or whether the cattle had been 

inspected and passed. Therefore, the 

proposed recordkeeping and records 

access requirements are necessary for 

the efficient enforcement of the 

proposed rule. Under the proposed rule, 

failure to comply with the 

recordkeeping and records access 

requirements would render the cattle 

material and any animal feed 

manufactured from, processed with, or 

otherwise containing, the cattle material 

adulterated under section 402(a)(4) of 

the act. 

Furthermore, the proposed marking 

provision in § 589.2001 is necessary for 

the efficient enforcement of the act. 

Because there is currently no reliable 

method to determine which cattle 

materials would be the prohibited 

materials, marking is necessary to 

ensure compliance with the proposed 

requirement that animal feed is not 

manufactured from, processed with, or 

otherwise contains the prohibited cattle 

materials. Under the proposed rule, 

failure to comply with this marking 

requirement would render the cattle 

material and any animal feed 

manufactured from, processed with, or 

otherwise containing, the cattle material 

adulterated under section 402(a)(4) of 

the act. 

FDA is issuing the proposed labeling 

requirement under sections 403(a)(1) 

and 201(n) of the act (21 U.S.C. 

343(a)(1)). Section 403(a)(1) provides 

that a food is deemed misbranded if its 

labeling is false or misleading in any 

particular. Section 201(n) provides that: 

* * * in determining whether the 

labeling of a product is misleading, there 

shall be taken into account (among other 

things) not only representations made or 

suggested by statement, word, design, device, 

or any combination thereof, but also the 

extent to which the labeling*** fails to 

reveal facts material in light of such 

representations or material with respect to 

consequences which may result from the use 

of the article to which the 

labeling*** relates under conditions of 

use prescribed in the labeling * * * or 

under such conditions of use as are 

customary or usual. 

The proposed rule would require 

cattle material prohibited in animal feed 

to be labeled ‘‘Do not feed to animals.’’

We believe this statement is material 

with respect to the consequences that 

may result from the use of this material 

within the meaning of section 201(n) of 

the act. As discussed in other sections 

of this document, the use of the material 

58584 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

that would be prohibited under this 

proposed rule presents a risk of BSE. 

Furthermore, there are no available 

definitive tests to detect this material in 

feed. Therefore, under this proposed 

rule, the failure to include this labeling 

statement would render the cattle 

material or feed containing the 

prohibited cattle material misbranded 

under section 403(a)(1) of the act. We 

are also proposing that such statement 

be made in a conspicuous manner. 

Under section 403(f) of the act, (21 

U.S.C. 343(f)), a food is misbranded if 

‘‘any word, statement, or other 

information required by or under 

authority of this Act to appear on the 

label or labeling is not prominently 

placed thereon with such 

conspicuousness*** and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary condition 

of purchase and use.’’ Therefore, under 

the proposed rule, the failure to include 

the statement ‘‘Do not feed to animals’’

in a conspicuous manner would render 

the cattle materials or any feed 

containing the cattle materials 

misbranded under section 403(f) of the 

act. 

IV. Analysis of Economic Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts, and equity). 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

FDA tentatively finds that the 

proposed rule does not constitute an 

economically significant regulatory 

action as defined in Section 3(f)(1) of 

Executive Order 12866. We base this 

conclusion on both a study of the 

impacts on industry of the proposed 

rule (on file at the Division of Dockets 

Management (see ADDRESSES) conducted 

for FDA by the Eastern Research Group 

(ERG)), a private consulting firm, and 

the discussion in the remainder of this 

section (Ref. 25). The agency has further 

tentatively determined that the 

proposed rule may have a significant 

impact on a substantial number of small 

entities. This proposed rule imposes no 

mandates on government entities, and 

would not be expected to require the 

expenditure of over $115 million in any 

1 year by the private sector. As such, no 

further analysis of anticipated costs and 

benefits is required by the Unfunded 

Mandates Reform Act. 

The following regulatory impact 

analysis begins with a summary of the 

proposed rule and the expected benefits 

and costs. Next, in section V.B of this 

document, we discuss the need for the 

regulation. In section V.C, we discuss 

the benefits of the proposed rule, while 

in section V.D, we discuss the costs. In 

section V.E, we discuss the costs to the 

government. Finally, in section V.F, we 

discuss the regulatory flexibility 

analysis. 

A. Summary of Proposed Regulatory 

Impact Analysis 

The proposed regulation would 

prohibit the use of certain cattle 

materials in any animal feed. The cattle 

materials prohibited in animal feed 

(CMPAF) would include the brain and 

spinal cord of all cattle 30 months of age 

or older, as well as the brain and spinal 

cord of cattle not inspected and passed 

for human consumption regardless of 

age, the entire carcass of cattle not 

inspected and passed if brain and spinal 

cord is not removed (again, regardless of 

age), as well as other materials. For the 

purposes of this proposed rule, the term 

‘‘cattle not inspected and passed for 

human consumption’’ includes 

nonambulatory disabled cattle. Tallow 

derived from any of the prohibited 

materials named previously would also 

be banned from use in animal feed 

unless it contains no more than 0.15 

percent insoluble impurities. MS beef 

from any of the prohibited materials 

named above would be prohibited from 

use in animal feed. Additional 

provisions of the proposed rule would 

require renderers that handle cattle 

materials prohibited in animal feed to 

use separate equipment or containers to 

handle this material once it has been 

separated from other cattle materials. 

Such renderers will also be required to 

follow certain procedures for labeling 

and marking prohibited material and 

recordkeeping and records access. 

The benefits of the proposed rule 

include the elimination of the vast 

majority of the risk of spreading BSE to 

other cattle from intentional or 

unintentional use of non-ruminant feed 

for ruminants or cross-contamination of 

ruminant feed with non-ruminant feed 

or ingredients intended for nonruminant feed. FDA believes that the 

proposed rule would effectively remove 

from use in non-ruminant feeds those 

cattle tissues that account for 

approximately 90 percent of potential 

BSE infectivity. Although the animal 

and public health benefit associated 

with the additional BSE risk reduction 

is paramount, the U.S. economy may 

also benefit from increased exports to 

the extent that the proposed rule, if 

finalized, persuades foreign 

governments that U.S. beef products are 

safe to import. Although we are unable 

to quantify these benefits, they are 

potentially large, because the expected 

loss of exports from the discovery of one 

infected cow in Washington State in 

December 2003 amounted to 

approximately $3.4 billion in the first 

year (Ref. 26). 

The total costs to industry of 

complying with the proposed rule range 

from roughly $14 million to $24 million 

per year annualized over 10 years 

assuming a 7-percent discount rate (at a 

3-percent discount rate, the cost would 

range from $14 million to $23 million). 

These estimated costs are the sum of the 

costs including: (1) The ban on the use 

of certain tissues from cattle 30 months 

of age or older and cattle not inspected 

and passed for human consumption in 

any animal feed and (2) feed 

substitution costs. We discuss the 

proposed brain and spinal cord 

prohibitions as direct costs to the 

affected firms (including disposal costs, 

where applicable) and the firms’ lost 

revenues from the ban on these raw 

materials used in feed product inputs. 

Then, we discuss the costs incurred by 

feed substitution costs. Table 1 of this 

document shows a summary of these 

costs. 

The proposed ban on the use of 

certain tissues from cattle 30 months of 

age or older and cattle not inspected and 

passed for human consumption in any 

animal feed would require slaughterers 

and renderers that process cattle 30 

months of age or older and firms that 

process dead, down, disabled, and 

diseased cattle to separate the CMPAF 

from the remaining cattle offal that 

could still be used for animal feed. We 

estimate that, for slaughterers, the 

separation of these materials from cattle 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58585 

30 months of age or older and cattle not 

inspected and passed for human 

consumption regardless of age would 

require about $555,000 in one-time 

capital costs (or $79,000 annualized at 

7 percent and $65,000 annualized at 3 

percent, over 10 years) (see table 1 of 

this document). We estimate that the 

annual cost of the additional labor to 

separate these CMPAF from other cattle 

offal is estimated to cost about $597,000 

annually. Although compliance costs for 

these activities would be borne initially 

by slaughterers, and are presented as 

such by ERG, a portion of the costs are 

likely to be passed along to cattle 

producers and consumers. For 

renderers, capital investments and labor 

for separation and segregation of 

CMPAF would range from about $1.88 

million to $4.65 million annually. 

Our analysis does not project a 

specific disposal route for CMPAF due 

to the uncertainty inherent in disposing 

of such low volumes of material. 

Instead, it describes various disposal 

methods that may be employed and 

estimated a $12 per 100 lbs. (cwt) of 

CMPAF disposal cost (including 

transportation costs) for the low-cost 

end of the range of disposal methods. 

The cost to dispose of the CMPAF is 

estimated to range from $7.72 million to 

$9.97 million annually. Additional onfarm disposal of dead and 

nonambulatory disabled cattle is 

expected to increase compliance costs 

from about $1.02 million to $2.53 

million annually (including labor and 

equipment). The annual revenues 

foregone from meat and bone meal 

(MBM) sales due to the prohibition of 

CMPAF in animal feeds are estimated at 

$1.41 million to $2.78 million, and 

foregone tallow sales are estimated at 

$1.37 million to $2.62 million. This 

includes the value from CMPAF from 

cattle 30 months of age or older and 

cattle not inspected and passed for 

human consumption regardless of age, 

as well as from whole carcasses of cattle 

not inspected and passed for human 

consumption that could not be rendered 

due to this proposed rule. 

We considered including a provision 

in this proposed rule that would limit 

the use of all tallow in animal feed to 

that which contains no more than 0.15 

percent insoluble impurities, not just 

tallow derived from the materials 

proposed to be prohibited in animal 

feed that contains no more than 0.15 

percent insoluble impurities. Analysis 

of this alternative concluded that it 

would result in annualized costs of 

about $1.78 million. These costs would 

consist of capital and operating costs for 

polishing centrifuges that would be 

needed by a small segment of 

independent renderers. We have not 

included a provision requiring that all 

tallow meet the 0.15 percent limit in the 

proposal because the CMPAF ban would 

effectively negate the risk of infectivity 

in non-CMPAF-derived tallow. We 

invite public comments and data on the 

need for, and impacts of, a provision 

that would require all tallow used in 

animal feeds meet the 0.15 percent 

limit. 

TABLE 1.—TOTAL COSTS ($ MILLIONS) 

Cost Item One-Time Cost Annual Costs Annualized Costs1

Slaughter Facilities 

Capital Investments $0.56 N/A $0.08 

Labor $0.60 $0.60 

Lost Value of MBM (cattle 30 months of age or 

older, cattle not inspected and passed) 

$1.41—$2.76 $1.41—$2.78 

Lost Value of Tallow (cattle 30 months of age or 

older, cattle not inspected and passed) 

$1.37—$2.62 $1.37—$2.62 

Disposal of cattle not inspected and passed 

Labor $0.12—$0.29 $0.12—$0.29 

Equipment $0.9—$2.23 $0.9—$2.23 

Renderer Facilities 

Capital Investments $3.11–$7.67 $0.04—$0.11 $0.49—$1.20 

Labor $1.40—$3.45 $1.40—$3.45 

Disposal of CMPAF from cattle 30 months of age or 

older, cattle not inspected and passed 

$7.72—$9.97 $7.72—$9.97 

CMPAF Marking (High Estimate) $0.01 $0.01 

Recordkeeping/Labeling $0.10 $0.05 $0.06 

Feed Substitution $0.30—$0.46 $0.30—$0.46 

Proposed Rule Total Costs $3.76 $13.91—$22.56 $14.44—$23.75 

1Annualized costs equal to annual costs plus one-time costs at 7 percent over 10 years. Using a 3 percent rate, annualized costs equal 

$23,535,000. 

FDA believes that this proposal, when 

evaluated in terms of its incremental 

cost-effectiveness at reducing risks from 

BSE, is more consistent with efficient 

science-based risk management than 

other regulatory approaches that it 

identified in the 2004 ANPRM. This 

proposal limits use of animal tissues for 

which infectivity is high relative to 

58586 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

tissue weight. Weight is a key 

determinant of the incremental costs 

from excluding tissues from rendering 

for animal feed. The approach adopted 

in this proposal is likely to be relatively 

cost-effective because it is directed 

primarily at those tissues for which 

infectivity is likely to be high relative to 

control compliance costs. 

In the 2004 ANPRM, FDA stated it 

was considering prohibiting a larger list 

of cattle tissues (the full SRM list) from 

use in all animal feeds. Under this 

option, SRMs would be defined as the 

skull, brain, eyes, spinal cord, 

trigeminal ganglia, 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 all 

cattle over 30 months of age or older, 

including the tonsils and distal ileum of 

all cattle regardless of age. Additionally, 

this option would prohibit the small 

intestine of all cattle, all material from 

nonambulatory disabled cattle, all 

material from cattle that are not 

inspected and passed for human 

consumption, and MS beef. Lastly, 

tallow derived from other prohibited 

materials and containing more than 0.15 

percent insoluble impurities would also 

be prohibited from use in all animal 

feeds under this SRM option. As 

detailed later in the analysis of 

alternatives, we have not included all of 

these measures in this proposed rule 

because we believe the proposed rule 

adequately addresses the risk from the 

presence of the highest risk cattle 

material in the animal feed chain. We 

also note that the proposed rule offers 

a more cost-effective approach to 

achieving nearly the same level of 

protection against the spread of BSE 

with regard to the presence of high-risk 

material in the non-ruminant feed 

supply. 

The approach described in the 2004 

ANPRM is itself a refinement of an 

approach announced early in 2004. In 

January 2004, shortly after USDA 

reported finding a BSE-infected cow in 

Washington State, HHS announced its 

intention to amend the current animal 

feed regulations by adding several 

materials to the list of substances 

prohibited from use in ruminant feed 

(Ref. 27). These materials included 

mammalian blood and blood products; 

inspected meat products that have been 

cooked, offered for human food, and 

then further heat-processed for feed 

(such as plate waste and used cellulosic 

casings); and poultry litter. Further, 

FDA planned to require establishments 

that manufacture, process, blend, or 

distribute both products containing 

mammalian-derived proteins and 

ruminant feed to use separate 

equipment or facilities in their 

manufacture, processing and handling. 

Preliminary analysis of the regulatory 

approach described in the January 2004 

announcement (Ref. 27) suggests that it 

is relatively less effective in risk 

reduction compared to the CMPAF and 

SRM bans because it would not remove 

the highest risk tissue (brain and spinal 

cord) from animal feed channels. 

Instead, the approach described in the 

January 2004 announcement would 

continue to allow the highest risk cattle 

material in non-ruminant feed, but 

includes measures intended to prevent 

cross-contamination of ruminant feed. 

Although we have not been able to 

quantify the risk reduction associated 

with the approach announced in 

January 2004, it is comparable in costs 

to the full SRM ban described in the 

2004 ANPRM. As a result we are not 

proposing it here. 

In developing this proposed rule we 

also considered other alternatives (not 

included here), including combinations 

of bans of various cattle tissues, from 

cattle of various ages (>30 months and 

<30 months) and various states 

(slaughtered for human food, deads, 

downers). All of these resulted in costs 

over $100 million per year with 

potential infective tissue reductions 

between 80 percent and 99 percent, 

when compared to the base case 

scenario. 

Table 2 of this document lists the 

proposed rule (the CMPAF ban), the 

SRM ban, and one of the options 

mentioned previously, namely a ban on 

brain and spinal cord from slaughter 

cattle 30 months of age or older, and a 

ban on the entire carcass of all dead and 

downed cattle. The table lists both the 

expected costs of these options, and our 

best estimate of the percent reduction in 

cattle tissues known to harbor BSE 

infectivity. The proposed rule would 

reduce cattle oral ID50s (the amount of 

infective material that would result in a 

case of BSE in 50 percent of the cattle 

that consumed it) that are available for 

use in animal feed by about 90 percent 

as much as a ban on the full list of SRMs 

(option 3), while imposing only 7 to 10 

percent of the costs of the SRM option 

(0.07 = $14 million/$195 million; 0.10 = 

$24 million/$240 million). The second 

option would reduce the cattle oral 

ID50s by more than 90 percent (a less 

than 10 percent increase over option 1), 

but would impose costs that are about 

five to nine times greater than option 1, 

though still only about 50 percent to 70 

percent of the costs of option 3. Based 

on the level of protection provided 

against the spread of BSE and its costeffectiveness, we believe the proposed 

rule to be the most appropriate. FDA 

seeks further comment and scientific 

and risk information on this analysis of 

additional regulatory options for 

strengthening animal feed safeguards. 

TABLE 2.—COST-EFFECTIVENESS OF ALTERNATIVE POLICIES

Option (Description of Banned Tissues/Materials) Infectivity Reduction1 Annual Cost ($ millions) 

CMPAF list from (1) Cattle 30 months or older, (2) deads, 

(3) downers and (4), MS beef if CMPAF not removed 

from carcass, dedicated equipment/container requirement; tallow restriction (proposed rule) 

90% $14—$24 

Brain and spinal cord from cattle 30 months or older, carcasses of all deads and downs, MS Beef >90% $115—$1352

Full SRM list from cattle 30 months or older, tonsils and 

distal ileum from cattle of all ages, carcass of all deads 

and downers, MS beef, tallow restriction 

>99% $195—$240 

1Percent of ID50s from an infected animal that would be banned from use in animal feed. 2 Detailed cost estimate of this alternative is not included in the regulatory flexibility analysis section of this document. 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58587 

B. Need for Regulation 

Executive Order 12866 directs 

agencies to assess the need for any 

significant regulatory action and an 

explanation of how the regulation will 

meet that need. In this instance, FDA 

tentatively concludes that private 

incentive systems for both suppliers and 

purchasers in markets for cattle, 

rendering, and ruminant feed may 

inadequately address the risk of BSE. 

This market failure is a result of 

inadequate information being available 

to buyers of potentially infective animal 

feed. Because of the risk of cross 

contamination during feed production 

and the risk of inadvertently feeding 

non-ruminant feed to ruminants on an 

integrated farm, buyers of ruminant and 

non-ruminant feed would likely value a 

decrease in risk of BSE transmission if 

the market were able to provide it. 

Buyers, however, have little information 

about the BSE infectivity of feed 

because the costs to them of ascertaining 

infectivity are very high and higher than 

the costs to the feed producers. As a 

result, buyers may, without the current 

or proposed feed rules, unknowingly 

buy feed contaminated with BSE 

because of the presence of CMPAF. 

The potential market failures created 

by the continued use of materials that 

this proposed rule would eliminate are 

the same as in the 1997 ruminant feed 

final rule. If feed purchasers could 

easily identify the risk of the infective 

agent associated with products from 

specific suppliers, they could more 

easily reduce these risks by refusing to 

buy feed products derived from 

ruminants known to have consumed 

prohibited CMPAF. Feed purchasers are 

unlikely to obtain the information they 

need due to the long incubation period 

for BSE that could lead to a suboptimal 

level of risk prevention by purchasers 

during the incubation period. Ruminant 

producers have no way of knowing 

whether a particular batch of feed or 

feed ingredients intended for ruminants 

are free of potentially infective proteins 

due to the possibility of CMPAFs being 

introduced through cross-contamination 

with feed or feed ingredients intended 

for non-ruminants. 

C. Benefits 

The purpose of the proposed rule is 

to further reduce the risk of BSE 

spreading within the cattle population. 

Reduced risk of BSE among cattle also 

reduces human exposure to variant 

Cruetzfeldt-Jakob disease (vCJD) 

believed to be caused by consumption 

of beef products contaminated with the 

BSE agent as well as increases the 

potential for exports by reducing foreign 

governments’ concerns about the quality 

of U.S. beef. In this section, we first 

address the reductions in the risk of BSE 

to cattle in the United States and the 

corresponding protection of human 

health from the major provisions of the 

proposal. We then summarize the 

available evidence about the likely 

effect of this proposed rule on U.S. 

exports of beef and other livestock 

products. 

1. Risk Reduction 

FDA estimates that banning CMPAFs 

from use in any animal feed would 

effectively remove about 90 percent of 

any remaining potential infectivity from 

possible spread through the feed system. 

To derive this estimate of the risk 

reduction from the proposed CMPAF 

ban, we assume that the number of new 

BSE cases is proportional to the amount 

of all infectious material included in 

feed. Given this assumption, we can 

estimate the percentage reduction in the 

risk of new BSE cases as the percentage 

reduction in infectious material. A 1999 

report by the Scientific Steering 

Committee of the European Union 

suggests that the brain and spinal cord 

constitute 89.7 percent of the total 

infective load in a case of BSE (Ref. 28). 

This rule would prohibit use in all 

animal feed of these tissues (CMPAFs) 

from cattle 30 months of age or older 

and all cattle not inspected and passed 

for human consumption. CMPAF, when 

taken from slaughtered cattle less than 

30 months of age, would not be 

prohibited from use in all animal feed 

because the probability is very low that 

tissues from cattle of this age would 

contain BSE infectivity. Thus, banning 

CMPAF would effectively remove about 

90 percent of total infectivity from 

animal feed. The absolute level of 

animal health risk reduced by this rule 

would depend on the number of 

infected animals in the United States 

and the extent to which cattle get 

exposed to infected material. 

The potential human exposure to 

infectious materials from consuming 

beef is already small since USDA and 

FDA prohibit the use of certain cattle 

materials, including SRMs, from human 

food. In its preliminary analysis (Ref. 

26), USDA modified the HarvardTuskegee model and estimated that the 

two interim final rules issued in January 

2004 reduced human exposure to 

infectious materials by an average of 80 

percent. For example, USDA estimated 

if 5 BSE infected bulls were introduced 

in 2003 and its control measures take 

effect in 2004, consumers would be 

exposed to 4 animal ID50s between 

2004 and 2020 compared to 18.5 animal 

ID50s without these measures (Ref. 26, 

Table 13). The estimate of percent 

reduction in exposure is insensitive to 

the assumed number of infected animals 

introduced into the United States. To 

the extent this rulemaking further 

reduces the likelihood of the spread of 

BSE, it further reduces the already small 

likelihood of human exposure to the 

infectious material. 

Assessing the public health 

implications from estimates of the 

human exposure to the BSE agent is 

difficult because there is no agreed upon 

dose-response relationship between 

human exposure to cattle ID50s and 

vCJD cases. Nonetheless, the experience 

of the United Kingdom suggests that the 

BSE agent is many times less infective 

in humans than in cattle. During the 

1980s and 1990s, in the absence of 

preventive control measures, millions of 

ID50s may have been available for 

consumption by residents of the United 

Kingdom, since each cow with clinical 

symptoms of BSE contains about 7,800 

ID50s. The cumulative number of 

definitive or probable vCJD cases 

identified in the United Kingdom as of 

September 1, 2005, is 157 (Ref. 29). 

Thus, human exposure to a few, or even 

a few dozen ID50s, may represent a 

relatively small risk to public health. 

FDA solicits additional information on 

the dose response relationship between 

ID50s and incidence of vCJD. 

2. Increased Export Potential 

A second major category of benefits 

pertains to the potential for increased 

exports of U.S. cattle products to 

countries that have acted to curtail 

exports since the discovery of the 

infected cow in Washington State in 

December 2003. However, we are unable 

to quantify the value of such increased 

exports, because of limits to the data 

and resources available to us. We note 

however, that USDA assessed this 

category of benefits in the interim final 

regulation that it issued in January 2004. 

In its assessment, it concluded that ‘‘the 

2004 beef export demand forecast has 

been reduced by 90 percent’’ (Ref. 26, 

page 58). It reported that U.S. exports of 

beef, veal, and variety meats amounted 

to $3.8 billion in sales in 2003, and 

exports of live cattle resulted in an 

additional $63 million. The preventive 

measures contained in this proposed 

rule are expected to increase the 

likelihood that foreign governments ease 

some restrictions on imports of U.S. beef 

products and cattle. 

Another indirect and incomplete 

measure of the potential benefits of this 

rule can be seen in measures of the 

commodities markets’ reactions to the 

discovery of BSE cases. When the first 

BSE case was reported in Washington 

58588 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

State on December 23, 2003, beef prices 

had risen to record highs, but were 

expected to decline in 2004. After the 

discovery of the BSE case, the 5 area 

monthly weighted average steer price 

reported by USDA’s Agricultural 

Marketing Service declined by about 14 

percent from December 2003 to 

February 2004 (Ref. 30). By April 2004, 

the weighted average monthly price 

appeared to recover much of the loss. 

Although never fully reaching pre-BSE 

record levels, prices by mid–2004 

appeared to be close to what they would 

have been had the BSE-infected cow not 

been identified. Such volatility in 

commodities markets may adversely 

affect independent beef producers who 

are risk averse and have hedged against 

such risks inadequately. To the extent 

that this proposed rule would prevent 

the development of a BSE-infected cow 

in the U.S., it may provide benefits to 

such beef producers by reducing their 

risk of financial loss and the cost to 

them of insuring against such risks. 

D. Costs 

We address the costs to industry of 

complying with this proposed 

regulation by considering in turn each 

of the individual provisions of this 

proposal. The costs of this proposed 

rule can be estimated as the sum of the 

costs of the different provisions. 

FDA contracted with ERG to prepare 

an analysis of the impacts of the ban or 

restriction on use of CMPAF in 

proposed 

§ 589.2001. Additionally, ERG 

analyzed the likely impacts of 

alternative options (on file at the 

Division of Dockets Management (see 

ADDRESSES) and henceforth referred to 

as the Alternatives Report) (Ref. 31)). In 

particular, these alternatives include the 

following: (1) A prohibition on the use 

of specified risk materials in animal 

feed, (2) the requirement for the use of 

separate facilities or equipment by those 

that process both mammalian protein 

prohibited in ruminant feed and 

ruminant feeds, and (3) a ban on the use 

of blood and blood products in 

ruminant feeds. The ERG analysis of 

this proposed rule presents estimates of 

costs for the meatpacking or 

slaughtering, rendering, and animal 

producer sectors. In addition, the ERG 

report provides estimates of impacts on 

representative small firms in the sectors 

that are impacted, to a significant 

degree, to fulfill requirements of a 

regulatory flexibility analysis. In the 

development of the Alternatives Report, 

ERG contacted establishments in the 

FDA inspection database that were 

likely to be affected by these regulatory 

options. Two separate telephone 

surveys were conducted, covering feed 

mills, renderers, and agricultural 

product transporters (the latter 

including trucking services at feed 

mills, renderers, and contract haulers). 

In some cases, written questionnaires 

were provided to the industry members. 

In addition, ERG used the services of 

industry consultants and other 

contractors for their technical expertise. 

The sector-specific surveys taken by 

ERG for the analysis of alternatives were 

each administered to fewer than ten 

industry members. In its development of 

the report on the proposed rule that 

would prohibit the use of CMPAF in 

animal feed, ERG again contacted 

industry members it had identified 

through its previous work on alternative 

policies, as well as industry consultants 

and industry associations. 

A study prepared for an industry 

association concluded that about 35 

percent of cattle (42 percent by weight) 

not inspected and passed for human 

consumption are currently rendered 

(Ref. 32). Our analysis estimated the 

number of cattle at about 17 percent. 

Whereas our analysis is based on other 

industry-supplied data that may be less 

dated, the industry analysis is based on 

USDA/APHIS data, that while older, 

resulted from several different USDA 

surveys. 

The industry association’s analysis 

differs from our analysis in the 

following three ways: (1) The percentage 

of animals currently rendered, (2) the 

number of animals, and (3) the weight 

of prohibited cattle material from each 

animal. Because of these differences, it 

may be potentially misleading to make 

a direct comparison of the findings of 

the two analyses. For example, if we 

substitute industry’s percentages of 

animals currently rendered into our 

analysis, our estimate increases from 17 

percent to 33 percent, but not to the 

industry association’s estimate of 35 

percent. The slight difference between 

our findings and those of industry (i.e., 

33 percent compared to 35 percent) 

should be attributed to the difference in 

the number of animals rendered in each 

individual category of cattle. 

Aside from the percentage of cattle 

not inspected and passed for human 

consumption currently rendered, the 

biggest source of variation between the 

two estimates can be attributed to the 

assumptions about the weight of 

CMPAF being rendered. The industry 

analysis assumed that the entire carcass 

would be affected by the ban on cattle 

not inspected and passed for human 

consumption. Discussions between ERG 

and industry experts convince us that, 

in most cases, renderers can adequately 

separate CMPAF from the other parts of 

a carcass. Adjusting the industry 

analysis to include only CMPAF and to 

include the same number of cattle as 

used in our analysis, decreases their 

estimate of the percentage of tissues 

rendered from 42 to 33 percent. This 

contrasts to our finding that only 17 

percent of the volume of CMPAF from 

cattle not inspected and passed for 

human consumption is currently 

rendered. 

Nevertheless, we acknowledge the 

uncertainty in all of these estimates. 

Due to the significance of this factor in 

estimating compliance costs for this 

proposed rule, we have adopted the 42 

percent figure as the upper bound of the 

acceptable range and include cost 

estimates using this factor, where 

appropriate, within the cost 

methodology developed in the ERG 

analysis. 

In general, the proposed ban on the 

use of CMPAF would impose three 

types of costs. First, it requires firms to 

buy equipment and to reallocate 

workers to change their production 

processes. This requirement imposes 

direct costs. Second, it prohibits the use 

of CMPAF by renderers who would use 

it to produce MBM and tallow. This 

prohibition reduces the revenue to 

slaughterhouses that sell CMPAF. Third, 

it also may oblige the buyers of MBM to 

turn to alternative ingredients that may 

be more costly or nutritionally inferior. 

Furthermore, prohibitions on the use of 

CMPAF in animal feeds can impose 

additional disposal costs, insofar as a 

previously valuable commodity is now 

turned into an undesirable by-product 

that requires disposal. Thus, we assess 

the lost revenue, direct costs, additional 

disposal costs, and feed substitution 

costs that may result from this proposed 

rule. 

1. Lost Value of CMPAF 

The proposed rule would prohibit the 

use of CMPAF in all animal feeds. Our 

analysis concluded that the proposed 

rule would cause slaughtering 

operations to incur additional capital 

investment costs and labor costs to 

modify and operate their plants in order 

to separate CMPAF from the rest of the 

cattle offal. Further, we project the value 

of the MBM and tallow based on 

historical prices, and discusses possible 

CMPAF or MBM disposal options for 

the industry. We also project the costs 

of additional disposal of on-farm dead 

and nonambulatory disabled cattle, 

CMPAF marking costs, recordkeeping, 

and labeling costs required by the 

proposal. 

ERG used industry data to estimate 

the CMPAF quantities that would be 

removed from cattle 30 months of age or 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58589 

older slaughtered for human food and 

cattle not inspected and passed for 

human consumption based on various 

factors including the age of the cattle, 

size of slaughter plant (federal or state 

inspection authority), and, for dead and 

nonambulatory disabled cattle of any 

age, the type and size of animal (beef or 

dairy cattle). ERG also used industry 

data on yield to project MBM and tallow 

production resulting from the current 

level of CMPAF quantities. Using 4-year 

averages of byproduct market prices 

($180/ton for ruminant or mixed species 

MBM, and $360/ton for tallow), the 

annual value of the MBM and tallow 

originating from CMPAF is estimated at 

$976,000 and $794,000, respectively. 

Using the high end of the range 

discussed previously, the annual value 

of MBM and tallow would be 

$1,714,000 and $1,194,000, respectively. 

Additionally, the annual value of the 

MBM and tallow from the carcasses of 

deads and nonambulatory disabled 

cattle that would no longer be collected 

by renderers (and would likely be 

disposed of on the farm) is estimated by 

ERG at $430,000 and $576,000, 

respectively. The high end of this range 

of costs is estimated at $1,064,000 for 

MBM and $1,422,000 for tallow. The 

total value of the loss of MBM is 

estimated to range from $1,406,000 to 

$2,777,000, and the total value of the 

lost tallow is estimated to range from 

$1,370,000 to $2,616,000. The cost of 

the proposed provision that restricts 

tallow based on an impurity level is 

addressed in a later section of this 

analysis. 

2. Direct Costs 

There are 5 categories of direct costs, 

including: (1) Capital and labor for 

slaughtering and rendering, (2) the 

tallow restriction, (3) MS beef 

restriction, (4) CMPAF marking costs, 

and (5) labeling and recordkeeping 

costs. We turn to each of these below. 

a. Capital and labor costs—

slaughtering and rendering. The 

proposed rule would result in cattle 

slaughter operations separating CMPAF 

and arranging for its disposal separate 

from other cattle offal. This change in 

activity may be similar to the new 

activities required by the 2004 USDA 

interim final rule, pertaining to the 

prohibition of SRM for use in human 

food. It is likely, however, that SRM 

segregation activities required under the 

2004 USDA interim final rule that 

banned SRM from use in human foods 

would differ to some extent from those 

that would result from this proposed 

rule. The 2004 USDA interim final rule, 

for example, would allow SRMs that are 

no longer available for human 

consumption to go to rendering for 

processing into MBM and tallow for use 

in feed for non-ruminant animal 

species. Under the FDA proposal, the 

CMPAFs (which are a small subset by 

volume of SRMs) could not be used in 

any animal feeds. Therefore, 

slaughterers would need to use separate 

offal lines for offal of non-CMPAF-origin 

and offal of CMPAF-origin. 

For projected capital investment and 

labor, because of the relatively small 

volume of CMPAF per plant, and 

current high rate of brain and spinal 

cord removal, the rule should result in 

only modest compliance costs. After 

consulting with slaughter operations, 

ERG projected that all slaughter 

facilities would need additional offal 

bins designated solely for CMPAFs. 

Additionally, modifications of processes 

and procedures would be necessary for 

those slaughter facilities that handle 

larger volumes of animals. These offal 

bin and modification estimates ranged 

from only $150 for the smallest facilities 

up to $15,000 for the two largest 

operations in the United States. 

Aggregate one-time capital expenditures 

are estimated to be about $555,000, or 

about $79,000 annually (based on a 7- 

percent discount rate over 10 years). 

Additional labor costs would be 

incurred at slaughtering facilities to 

handle CMPAF segregation and 

disposal. ERG, using its discussion with 

industry members, estimated that the 

smallest facilities would incur no 

additional labor costs, while the level of 

additional labor would range from only 

a few minutes at the next smallest 

facilities to slightly more than one 

production worker at the largest 

establishments. Based on the average 

pay for this worker of $20,420 (plus a 

40 percent increase for benefits), ERG 

estimated the additional labor costs for 

this industry at $597,000. Per facility 

labor costs are expected to range from 

$313 annually for the smallest plants to 

$30,000 annually for the largest plants. 

Total capital and labor costs for 

slaughtering facilities are estimated at 

$676,000 ($597,000 in labor costs plus 

$555,000 annualized at 7 percent over 

10 years; annualizing at 3 percent would 

reduce the cost by about $14,000 

annually). 

Renderers would also incur additional 

capital and labor costs to handle 

CMPAF segregation from cattle not 

inspected and passed for human 

consumption. After consulting an 

equipment manufacturer, ERG projected 

the cost of equipment purchases and 

installation for renderers based on the 

size of the operation. These costs ranged 

from about $7,300 at the smallest 

rendering operations to about $72,000 

for the largest operations. Total capital 

costs for renderers are estimated at $3.1 

million (annualized at $442,000 over 10 

years at a 7-percent discount rate, or at 

$486,000 with a 10 percent maintenance 

cost included). Using the upper end of 

the range of cattle not inspected and 

passed for human consumption that are 

currently rendered, we estimate the 

capital costs for renderers at about $7.67 

million (annualized at $1.09 million 

over 10 years at a 7 percent discount 

rate, or at $1.20 million with a 10 

percent maintenance cost). 

Renderer labor costs would also 

increase due to the CMPAF separation, 

segregation and disposal. Using the 

same labor rates as slaughterers, ERG 

projected that the additional labor 

would range from slightly over $1,000 at 

the smallest facility to about $56,500 at 

the largest facilities. The low end of the 

range of total incremental payroll costs 

at renderers are estimated at about $1.4 

million annually. The high end of the 

range of annual labor costs is estimated 

at $3.5 million. Although no labor 

overhead is included, we believe it 

would be negligible because most 

facilities would hire less than one 

additional laborer. Total capital and 

labor costs at rendering establishments 

are projected to range from about $1.88 

million to $3,938,000 annually ($1.4 

million to $3.5 million in labor costs 

plus $486,000 in capital costs after 

annualizing at 7 percent over 10 years; 

annualizing at 3 percent would reduce 

costs by about $78,000). 

b. Tallow restriction. The proposed 

rule would ban the use of tallow derived 

from the brains and spinal cords of 

cattle 30 months of age or older, the 

brains and spinal cords of all cattle not 

inspected and passed for human 

consumption, and the entire carcass of 

cattle not inspected and passed for 

human consumption, if the brains and 

spinal cords are not removed. An 

exception to this ban is provided for 

tallow from these sources that has no 

more than 0.15 percent insoluble 

impurities. We do not believe, however, 

that it would be economical for 

renderers or tallow manufacturers to 

further process the brains and spinal 

cords from these animals into tallow 

while complying with the proposed 

equipment separation and tallow 

purification requirements. We have, 

therefore, not included additional costs 

for this proposed provision. The lost 

value of this tallow (and MBM) has 

already been accounted for earlier in 

this analysis. 

c. MS beef restriction. We do not 

project any compliance costs for the 

proposed MS beef provision. The 

proposed rule would prohibit the use of 

58590 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

MS beef from use in animal feeds if the 

brain and spinal cord of cattle 30 

months of age or older, the brain and 

spinal cord of all cattle not inspected 

and passed for human consumption, or 

the entire carcass of cattle not inspected 

and passed for human consumption has 

not been previously removed from the 

cattle material used to make MS beef. 

USDA and FDA have already banned 

MS beef from use in human food. 

Through contacts with industry 

members, the analysis projected that 

about 20 firms, about one-half of which 

are renderers, would be affected by this 

proposed provision. These businesses, 

known as ‘‘4D’’ firms, collect dead and 

downer (nonambulatory disabled) cattle 

and sell the meat to pet food 

manufacturers, zoos and other animal 

feeding operations. The number of pet 

food manufacturers using this MS beef 

as an input has been declining in recent 

years, however, due to public 

perceptions concerning pet food inputs. 

The analysis assumes many of these 

firms use mechanical separation 

equipment as part of their operation. 

Census data does not separately 

estimate the sales volume of red meat 

from 4D animals and MS beef from 4D 

animals. ERG estimated the size of the 

market at about $100 million per year, 

based on an industry contact. Further, 

the analysis estimated that 75 percent of 

the value of this product is generated 

from revenues unrelated to the animal 

or carcass pick-up fees. Of this 75 

percent, about 20 percent to 25 percent 

is believed to represent MS beef sales. 

Industry contacts report that the brain 

and spinal cords of dead and downer 

cattle are already removed prior to any 

mechanical separation of muscle tissue, 

thereby negating the need of further 

compliance efforts. We invite public 

comment and analysis of the proposed 

rule’s expected impact on 4D animals 

and current 4D industry practices 

related to MS beef. 

d. CMPAF marking costs. The 

proposed rule would require that 

renderers that handle CMPAF or 

products containing CMPAF mark this 

material or product so that it can be 

identified by visual inspection. The 

analysis determined that the use of dyes 

would most likely be used as the 

marking agent. Although the industry 

lacks experience with the use of these 

dyes, it is believed to be a relatively 

simple process that would be performed 

at the end of the rendering process. 

Using a range of current dye costs, ERG 

estimated total industry compliance 

costs of this requirement to be from 

about $1,700 to $13,000 per year. At the 

high end of the range of cattle not 

inspected and passed for human 

consumption, compliance costs of this 

provision would range from about 

$2,200 to $16,000 per year. 

e. Labeling and recordkeeping/access 

costs. The proposed rule would require 

additional measures be taken by 

renderers that handle CMPAF or 

products containing CMPAF to ensure 

that the prohibited materials are not 

used in animal feed. The proposed 

requirements include labeling the 

material ‘‘Do not feed to animals’’, 

establishing and maintaining records 

sufficient to track cattle materials 

prohibited in animal feed to ensure such 

material is not introduced into animal 

feed, and making such records available 

to FDA. The proposed rule would also 

require renderers that handle any cattle 

materials to establish and maintain 

records sufficient to ensure that 

materials rendered for use in animal 

feed do not contain CMPAF. ERG 

judged that the proposed labeling and 

recordkeeping requirements would 

result in modest additional costs to all 

renderers. Although past FDA 

rulemakings have shown that labeling 

requirements can impose a substantial 

cost on industry, the analysis assumed 

that this rulemaking’s simple new 

labeling requirements (applying 

primarily to bulk shipments) could be 

incorporated into current labeling 

practices. We solicit comment on this 

assumption. Likewise, any 

recordkeeping rules would only require 

incremental administrative activities (to 

modify procedures and periodically 

review and file) beyond current renderer 

recordkeeping requirements. Total 

industry costs are estimated at about 

$62,000 annually (one-time costs of 

$101,000 annualized at 7 percent over 

10 years plus annual costs of $48,000). 

We anticipate that records access costs 

would be negligible. We invite public 

comment on the projected level of effort 

by industry and estimated compliance 

costs of the proposed labeling and 

recordkeeping/access requirements. 

3. Disposal Costs 

After separation from the material 

allowed to be used in animal feed, an 

estimated 64.3 million lbs. of CMPAF 

would no longer be rendered for use in 

animal feeds, and therefore would need 

to go to disposal. The analysis identified 

five options for the disposal of these 

SRMs. These options include landfilling 

of the CMPAFs without rendering, 

rendering for disposal, disposal through 

alkaline hydrolysis digesters, 

incineration, and composting. Due to 

the relatively small volume of CMPAFs, 

rendering for disposal option would 

likely not be economically viable. 

Contacts with industry members elicited 

various responses concerning the 

disposal method that would be 

employed under the CMPAF scenario. 

While landfilling the CMPAF may be a 

possibility in some areas, other states do 

not allow the disposal of animal 

carcasses in landfills. Our analysis 

concluded that landfilling would likely 

be one of several methods used to 

dispose of the CMPAFs. 

Based on industry information 

gathered for both this analysis (the 

CMPAF option) and the Alternatives 

Report, ERG estimated the disposal 

costs at $12 per 100 lbs. (cwt) of 

CMPAF. This is substantially higher 

than its estimate in the Alternatives 

Report of the cost of SRM disposal. 

Higher per cwt transportation costs 

(which are included in the $12 per cwt 

estimate) are expected under the 

CMPAF scenario than under the SRM 

alternative due to the much smaller 

volume of materials requiring disposal 

under the CMPAF option. Other reasons 

for the higher disposal cost rate include 

the uncertainty in the disposal methods 

that will be used, and limited industry 

experience with at least some of these 

methods. This led ERG to project a 

conservative estimate that fully 

accounts for some uncertainty in cost 

factors. It is possible that future industry 

efficiency in CMPAF disposal under any 

of the disposal methods would lead to 

a reduction in projected $12 per cwt 

disposal cost. Nevertheless, the 64.3 

million lbs. of CMPAF that would result 

under this proposed rule is estimated to 

result in $7.72 million in disposal costs 

($6.19 million to slaughterers and $1.53 

million to renderers). Using the 42 

percent estimate of cattle not inspected 

and passed for human consumption, we 

estimate that the 83.1 million lbs. of 

CMPAF would result in disposal costs 

of about $9.97 million annually. 

Cattle producers are also expected to 

incur additional disposal costs for cattle 

not inspected and passed for human 

consumption in the form of an increase 

in on-farm disposals. An increase in 

pick-up fees for cattle not inspected and 

passed for human consumption due to 

the slight loss in value of the rendered 

MBM would likely cause some of these 

animals to be disposed of at a lower cost 

(than the pickup fee) to the producer by 

burial on the farm. As previously 

discussed, our analysis estimated that 

about 17 percent of all cattle not 

inspected and passed for human 

consumption are currently rendered. 

Additionally, it predicted that about 

26,000 less cattle (0.6 percent of all 

cattle not inspected and passed for 

human consumption, or about 3.5 

percent of all cattle not inspected and 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58591 

passed for human consumption that are 

rendered) would be disposed of in this 

manner, comprised of beef cows (no 

additional feedlot cattle included) and 

cattle under 500 lbs (calves). ERG 

estimates of the incremental labor and 

equipment cost of this activity sum to 

$1.02 million annually. Using the 42 

percent estimate of cattle not inspected 

and passed for human consumption and 

the same 3.5 percent relative change in 

the reduction in renderer pick-ups of 

cattle not inspected and passed for 

human consumption, we project that at 

the high end of the range about 64,000 

additional cattle would no longer be 

rendered, at a disposal cost of about 

$2.53 million. 

In forecasting the change in 

percentages to be disposed on-site, the 

analysis considered in qualitative terms 

all factors in the formula renderers use 

to determine whether they will make 

pickups. These factors include the travel 

distance to the location and the 

expected quantities of animals to be 

recovered at the location. All pickup 

charges vary over time with the value of 

meat and bone meal and tallow, so 

pickup patterns are subject to marketdriven price changes that are addressed 

in the agreements between renderers 

and dead animal suppliers. 

The analysis also considered that 

exclusions of prohibited materials 

reduced the prospective value of the 

animals to be recovered. Further, the 

potential latitude for renderers to 

increase fees was considered, although 

renderers were fairly tentative in their 

own forecasts of whether and how much 

they might increase pickup charges in 

response to a potential new regulation. 

ERG also considered that many 

relatively remote locations had already 

been excluded from renderer pickups 

due to price and regulatory changes over 

the past ten years. Thus, remaining 

pickup locations were likely to have 

reasonably favorable characteristics, 

although presumably some locations 

remained marginal in terms of the 

existing market economics. The data in 

Table 2–1 of the ERG report (market 

prices of rendered materials, and MBM 

and tallow yields) and data on animal 

weights was used to consider the value 

of the dead animal to the renderer. 

The final forecast of the response in 

pickups is the judgment of the apparent 

significance of the regulatory change to 

the economics of the renderer pickups. 

Because the brain and spinal cord 

exclusion affected a relatively small 

portion of the animal carcass for 

nondecomposed animals, it followed 

that the effect on rendering economics 

was similarly fairly modest. The 

analysis concluded that the prohibition 

of these materials would not trigger 

wider, rippling effects through the 

renderers’ situation. 

While there was considerable data 

about market prices for rendered 

products and other aspects of pickup 

economics, data on the distribution of 

relative costs among dead animal 

suppliers across the United States was 

lacking. Such data would have been 

needed to make a more rigorous forecast 

of the likely changes in rendering 

pickup patterns. Given the dominating 

importance of local economic 

considerations in rendering economics, 

even a national distribution of such data 

would have been of uncertain value to 

the estimation process. 

The industry association report (Ref. 

32) (submitted in response to the 2004 

ANPRM seeking comment on a more 

restrictive full SRM ban in animal feed) 

asserts that there would be no incentive 

to pick-up cattle not inspected and 

passed for human consumption if it is 

banned from animal feed absent 

exorbitant fees. While this proposed 

rule would not ban all tissues from 

cattle not inspected and passed for 

human consumption, we acknowledge 

some uncertainty in the response by 

renderers in this area due to this 

proposed rule. We request comment on 

the number and percent of cattle not 

inspected and passed for human 

consumption that are currently 

rendered, as well as the expected 

number of additional cattle that would 

be disposed of on farms or elsewhere 

due to this proposed rule, and the costs 

of this activity. 

4. Feed Substitution Costs 

In both FDA’s proposed and final 

rules concerning the prohibition on the 

use of mammalian proteins in ruminant 

feeds in 1997, the agency included the 

cost of feed that would be substituted 

for the MBM that would be prohibited 

from use in ruminants. The same issue 

arises with the proposed rule’s creation 

of a list of CMPAFs that would be 

prohibited from use in animal feeds. 

Animal feed manufacturers would 

substitute other protein sources for the 

MBM that was previously manufactured 

from CMPAF. 

In the analysis prepared for the 1997 

rule banning the use of mammalian 

protein in ruminant feeds, the agency 

assumed a $31.76 per ton price increase 

($38.33 adjusted to expected 2005 

dollars by the average of general 

inflation from 1997 through 2004) for 

the substitute material, in this case 

soybean meal, as well as additional 

minerals that would be required to 

provide the same nutritional level as 

MBM. We accept this as a conservative 

estimate of the long-term price 

differential. The price differential 

between the two varies constantly based 

on the weather, feed ingredient imports, 

slaughter rates, and other factors. Since 

January 2004, soybean meal has been 

priced from $58/ton below MBM to $55/ 

ton above MBM (Ref. 33). 

We cannot predict the future price 

differentials between the two feed 

substitutes, but accept the previous 

number of $38.33/ton as a reasonable 

current estimate. Applying this feed cost 

increase over the 7,800 tons of MBM 

that would not be created as a result of 

this proposed regulation as calculated 

by ERG, results in $299,000 in 

additional feed costs. Using the high 

end estimate of the number of cattle not 

inspected and passed for human 

consumption that are currently 

rendered, additional feed costs would 

amount to about $457,000. We invite 

comment and data on the feed 

substitution costs that this proposed 

rule would impose. 

5. Distribution of Impacts of CMPAF 

From Cattle 30 Months of Age or Older 

Slaughtered for Human Consumption 

and Cattle Not Inspected and Passed for 

Human Consumption 

ERG, primarily for the purposes of the 

Regulatory Flexibility Analysis 

described in more detail below, 

estimated that a portion of the costs to 

slaughterers will be passed through to 

consumers and animal producers. 

Similarly, a portion of the costs to 

independent renderers for handling 

CMPAF from cattle not inspected and 

passed for human consumption will 

likely be passed back to ranchers, dairy 

farmers, and feedlot operators by way of 

increased pickup or disposal fees. We 

request public comment and data on the 

relative size and distribution of the 

likely pass through of the impacts of 

this rulemaking. 

ERG also addressed the relative 

importance of the loss of MBM due to 

the CMPAF prohibition to both 

integrated packer/renderers and 

independent renderers. This analysis 

projected reductions of up to 0.2 percent 

of MBM production at independent 

renderers, while reductions of less than 

0.1 percent of MBM production would 

occur at integrated slaughterers (packer/ 

renderers)as the low impact estimates. 

Using the high estimate of cattle not 

inspected and passed for consumption 

that are currently rendered, we project 

a reduction of up to 0.4 percent of MBM 

production at independent renderers. 

Independent renderers rely to a greater 

extent on deadstock and, with the 

January 2004 USDA rule banning the 

use of nonambulatory disabled cattle in 

58592 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

human food, also on nonambulatory 

disabled cattle as inputs to their 

production process, while the integrated 

slaughterers do not. 

E. Government Costs 

The proposed rule may require the 

expenditure of additional funds by the 

Federal government, but the increased 

expenditures are not expected to be 

significant. The tissues that would be 

included on the list of cattle materials 

prohibited in animal feed, due to this 

proposed rule, may increase the number 

of inspections or the length of time 

necessary to inspect an establishment to 

verify compliance with the new 

proposed requirements. However, the 

number of establishments inspected is 

not expected to substantially change as 

a result of this proposed rule. All 

establishments that would be inspected 

for compliance under proposed 

§ 589.2001 would already be subject to 

§ 589.2000 or other federal rules. FDA 

has not estimated any additional costs 

due to this based on the assumption that 

the additional resources would not be 

significant. We invite comment on the 

issue concerning additional government 

resources that would be required by this 

proposed rule. ERG’s discussions with 

industry members led to the conclusion 

that no new rendering establishments 

will be constructed and dedicated to 

disposal rendering as a result of the 

CMPAF ban. Without additional 

renderer establishments subject to this 

or other FDA regulations, FDA 

inspection efforts are not expected to 

noticeably increase as a result of this 

proposed rule. 

F. Sensitivity Analysis 

Due to the previously described 

uncertainty concerning the additional 

cattle not inspected and passed for 

human inspection that would no longer 

be rendered as a result of this proposed 

rule, we have included a sensitivity 

analysis around this cost factor. The 

ERG report projected that an additional 

0.6 percent of the current 17 percent of 

cattle not inspected and passed for 

human consumption that are currently 

rendered would not be rendered as a 

result of this rule and would likely be 

buried on the farm or elsewhere (a 

relative reduction of 3.5 percent (0.006/ 

0.17) of the cattle not inspected and 

passed for human consumption that are 

currently rendered). Table 3 estimates 

the total costs of the proposed rule for 

various estimates including the original 

0.6 percent reduction in the number of 

cattle not inspected and passed for 

human consumption that are rendered, 

as well as reductions of 1 percent and 

2 percent (representing relative 

reductions of 5.8 percent (.01/.17) and 

11.6 percent (.02/.17), respectively). 

High end cost estimates (derived from 

the 42 percent estimate of the number 

of cattle not inspected and passed for 

human consumption that are currently 

rendered) for the same relative percent 

reductions are also included. 

If 42 percent of cattle not inspected 

and passed for human consumption are 

currently rendered, and that 

implementation of this proposal would 

cause an additional 2 percent of all 

cattle not inspected and passed for 

human consumption not to be rendered, 

then the total incremental costs of the 

rule would rise to about $36 million per 

year. FDA solicits comment on the 

likely effect of this proposal on the 

percent of cattle not inspected and 

passed for human consumption that is 

not rendered and on the costs to society 

of the disposal methods likely to be 

used as an alternative to rendering. 

TABLE 3. SENSITIVITY ANALYSIS

Reduction in Percent of Cattle Not Inspected and Passed for Human Consumption That are Rendered (Proposed Rule) 

0.6% 1.0% 2.0% 

Total Costs $14.4—$23.7 million $16.2—27.8 million $19.8—$36.3 million 

G. Regulatory Flexibility Analysis 

1. Small Business Impacts 

The Regulatory Flexibility Act 

requires agencies to prepare a regulatory 

flexibility analysis if a rule is expected 

to have a significant impact on a 

substantial number of small entities. 

The discussion in this section, as well 

as data and analysis contained in 

sections two through four of the ERG 

report, constitute the agency’s 

compliance with this requirement. 

One requirement of the Regulatory 

Flexibility Act is a succinct statement of 

any objectives of the rule. As stated 

previously in this analysis, with this 

proposed rule the agency intends to 

strengthen the existing safeguards 

designed to help prevent the spread of 

BSE in U.S. cattle, as well as further 

reduce any risk posed to humans from 

the agent that causes BSE. 

The Regulatory Flexibility Act also 

requires a description of the small 

entities that would be affected by the 

proposed rule, and an estimate of the 

number of small entities to which the 

proposed rule would apply. Our 

analysis focused on renderers and 

animal slaughterers, and to a lesser 

extent on 4D firms. Additionally, the 

Alternatives report addresses possible 

impacts to small dairy farms from the 

blood products alternative, and impacts 

to feed mills from the dedicated 

equipment/facilities alternative (options 

summarized in the alternatives section 

of this document). 

Animal slaughterers would be 

classified in the North American 

Industrial Classification System 

(NAICS) under code 311611—Animal 

(Except Poultry) Slaughtering and 

renderers under NAICS code 311613—

Rendering and Meat Byproduct 

Processing. The Small Business 

Administration (SBA) classifies 

slaughterers and renderers with less 

than 500 employees as small businesses. 

The ERG study estimated the number 

of small businesses that would be 

affected by the proposed rule in its 

analysis of compliance costs. The 

number of slaughterers and renderers 

affected by the CMPAF ban (including 

recordkeeping/labeling and marking 

costs) were estimated at 689 and 141, 

respectively. This would include all 

federally inspected slaughter plants and 

the all those renderers that handle 

mammalian proteins that are currently 

prohibited in ruminant feed. Using U.S. 

Census and USDA data, ERG then 

distributed the number of affected 

entities in each business sector across 

the size classes of establishments using 

the same proportions as those presented 

in the total number of establishments. 

Using this distribution, it appears that 

about 97 percent of slaughterer 

establishments and all renderer 

establishments would be considered 

small businesses. However, the 

existence of many multi-establishment 

rendering and slaughtering firms would 

tend to overestimate the number of 

small businesses within each sector. In 

fact, other Census data shows that only 

79 percent of rendering firms would be 

considered small businesses (Ref. 34). 

Nevertheless, we believe that the 

number of affected small businesses in 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58593 

both sectors would still be considered 

substantial. 

The CMPAF ban would primarily 

affect slaughterers and renderers. ERG 

used its Small Business Impact Model 

(SBIM) to predict net income and 

closure impacts for slaughterers and 

renderers by size of establishment (for a 

full explanation of the SBIM, see section 

4.2 of the Alternatives report (included 

in the docket (Ref. 31)). The model 

assumes there is no pass through of 

compliance costs. Although this is a 

conservative assumption, smaller 

businesses in fact are probably less able 

to pass through compliance costs than 

larger businesses in the same industry, 

all other things equal. Under the no pass 

through assumption, the model predicts 

moderate net income impacts that could 

result in the closure of up to one 

slaughtering and one rendering 

establishment. We acknowledge that net 

income impacts would likely be higher 

under the higher estimate of the percent 

of cattle not inspected and passed for 

human consumption that are currently 

rendered. 

Our analysis for simplicity ignores 

any potential increases in MBM prices 

that may ensue as a result of this 

proposed rule. In fact, some modest 

price increases may occur as foreign 

demand for MBM increases in response 

to reduced risk of BSE infectivity. Such 

price increases may mitigate any 

reduction in net income of independent 

renderers. 

ERG developed a separate market 

model to estimate the impact of a 

CMPAF ban on beef prices and output. 

It implies that about 50 percent of 

compliance costs will be passed on to 

consumers, 38 percent will be passed 

back to cattle producers, and 12 percent 

will be incurred by slaughterers. The 

model predicts that cattle producers 

would realize only a 0.01 percent 

reduction in price for cattle, which 

would not be considered a significant 

impact. Nevertheless, the agency 

acknowledges the possibility of 

significant impacts on a substantial 

number of small slaughterers and 

renderers. 

The agency believes that the annual 

feed substitution costs (from about 

$300,000 to $457,000) would not 

constitute a significant impact when 

spread across the thousands of nonruminant animal producers that 

currently use ruminant protein in 

animal feeds. The agency requests 

comments and additional data on the 

likely small business impacts on 

slaughterers, renderers, beef cattle 

producers, dairy cattle producers, or 

other animal producers and firms in 

related industries. 

2. Analysis of Alternatives 

We considered five other measures 

that are not included in this proposed 

rule. These five measures, discussed in 

turn in the following paragraphs, 

include: (1) A requirement that those 

facilities handling both mammalian 

protein that is currently prohibited in 

ruminant feed and ruminant feeds use 

dedicated facilities or equipment for 

each, (2) a ban on the use of poultry 

litter in ruminant feeds, (3) a ban on the 

use of blood and blood products in 

ruminant feeds, (4) a ban on the use of 

plate waste in ruminant feeds, and (5) 

a ban on the use of a larger list of SRM 

(using the USDA and FDA definition for 

human food) from all animal feeds. 

a. Dedicated facilities/equipment 

requirement. As mentioned previously 

in this preamble, FDA considered 

requiring that those facilities that 

process or otherwise handle both 

mammalian protein currently prohibited 

in ruminant feed and prepare feed or 

feed ingredients for ruminants use 

separate facilities or equipment in order 

to prevent cross-contamination. This 

option was included in the public 

announcement concerning agency 

intentions in January 2004. The 

proposed rule’s dedicated equipment 

requirement concerns the issue of crosscontamination of CMPAFs with other 

cattle material once it has been 

separated, whereas the requirement for 

dedicated equipment/facilities under 

this option concerns crosscontamination of mammalian protein 

currently prohibited in ruminant feeds 

and ruminant feeds under the current 

mammalian to ruminant feed ban. Due 

to the large tonnage difference between 

CMPAFs and all animal protein 

currently being rendered, this 

alternative would result in larger 

industry impacts than would the 

dedicated equipment requirement 

concerning CMPAFs alone. 

In its Alternatives Report, ERG 

projects that this option would be 

expected to reinforce the current trend 

in which increasing numbers of feed 

mills discontinue the use of mammalian 

protein currently prohibited in 

ruminant feeds in favor of porcine, 

avian, or plant-based proteins. ERG 

estimates that only 124 out of more than 

5,100 feed mills and 41 out of 235 

renderers currently produce ruminant 

feed or feed ingredients and handle or 

process ruminant MBM. Based on its 

small survey of feed mills, ERG 

estimates that only 27 of these feed 

mills and 4 renderers would invest in 

dedicated facilities or equipment in 

order to continue or begin to distribute 

both prohibited materials and ruminant 

feeds or feed ingredients. 

ERG consulted an agricultural 

architecture and engineering firm to 

prepare cost estimates of investment in 

dedicated feed mill facilities. Based on 

these estimates and discussions with 

feed mill operators, ERG projects that no 

new mills would be constructed as 

dedicated facilities to comply with this 

option, but rather currently operating or 

idle mills would either be renovated or 

expanded as dedicated facilities, or 

would handle a dedicated line of 

equipment. The annualized costs of 

these investments for the 27 feed mills 

were estimated at $6.2 million over 10 

years at a 7-percent discount rate (at a 

3-percent discount rate over 10 years, 

the cost would be $5.1 million per year). 

The effect on the ruminant MBM market 

caused by the discontinued use by those 

that currently offer it in feeds but would 

choose not to invest in dedicated 

facilities or equipment would be 

expected to be small. 

ERG performed a similar survey of 

some of the 41 renderers that the FDA 

inspection database showed as handling 

mammalian proteins currently 

prohibited in ruminant feed and 

produce materials intended for use in 

ruminant feed. The results of this survey 

indicate that very few renderers intend 

to invest in dedicated facilities. Based 

on its small sample, ERG predicts that 

only 4 renderers would do so. These 

were all expected to currently have 

partial separation or dedication 

capabilities in place. Based on 

discussions with renderer operators 

through this and previous surveys, ERG 

predicts that the renderers that invest in 

dedicated facilities would spend, on 

average, about $2 million each. The total 

cost of investment in dedicated facilities 

would be $8 million. Annualizing this 

total over 10 years at a 7-percent 

discount rate results in an annual cost 

of $1.14 million ($940,000 over 10 years 

at a 3-percent discount rate). 

The dedicated facilities/equipment 

requirement would also extend to the 

transportation services for mammalian 

proteins currently prohibited in 

ruminant feed. Based on another survey 

of selected feed mills, agricultural 

trucking companies and renderers 

concerning their current transportation 

of products, ERG determined that 

agricultural transporters would also 

incur costs as a result of this provision 

of this option. The option implies that 

renderer delivery trucks that carry 

prohibited MBM, including contract 

haulers providing this service, would no 

longer be allowed to backhaul ruminant 

feed or ruminant feed ingredients as 

part of its delivery routine. Due to this 

58594 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

change in service, ERG estimated a 

transportation cost increase of 40 to 80 

percent for the 141 rendering facilities 

that process mammalian protein 

currently prohibited in ruminant feed. 

Although most of these renderers do not 

handle both mammalian protein 

currently prohibited in ruminant feed 

and ingredients for feeds for ruminants, 

they rely on transportation services 

(most likely contractor services) that 

transport both materials, and thus 

would not be in compliance. These 

transportation cost increases are 

projected to total $8 to $16 million per 

year for the rendering industry. 

Feed mills would also be expected to 

incur transportation cost increases due 

to the prohibition under this option on 

backhauling ruminant feeds in trucks 

that are used to deliver feeds with 

mammalian proteins currently 

prohibited in ruminant feed. Since 

backhauling does not occur as often in 

the delivery of feed due to shorter 

average distances between feed mills 

and animal producers than from 

renderers to feed mills, ERG predicted 

the transportation cost increases at 25 to 

50 percent for feed mills. Based on 

ERG’s calculation of the quantity of feed 

that would be affected by the proposed 

rule (4.5 million tons) and the average 

transportation cost per ton of feed 

($12.66), total transportation cost 

increases for feed mills were estimated 

to range from $14.2 to $28.4 million per 

year. These costs would include the 

amortized cost of capital equipment 

such as additional trucks, as well as 

incremental operating and maintenance 

costs. These costs would be incurred by 

about 200 feed mills. Again, this 

number is larger than the number of 

mills that handle both mammalian 

proteins currently prohibited in 

ruminant feed and ruminant feeds due 

to the additional number of mills that 

would rely on contract feed haulers that 

handle both materials. ERG 

acknowledges uncertainty in these 

estimates due to possible changes in 

mill dedication patterns, the analysis of 

which would have required additional 

geographic distribution data on feed 

mills and feed types. 

If CMPAFs are banned from use in all 

animal feeds as proposed in this rule, 

the agency believes that a provision 

requiring dedicated facilities or 

equipment for those handling 

mammalian proteins currently 

prohibited in ruminant feed and 

preparing ruminant feeds would not be 

necessary because this proposed rule is 

expected to reduce the number of ID50s 

available for use in animal feeds by 

about 90 percent. Requiring separate 

facilities or equipment for mammalian 

proteins currently prohibited in 

ruminant feed and ruminant feeds 

would not be expected to significantly 

reduce the risk of feeding prohibited 

proteins to ruminants, because nearly 

all of the potentially BSE infective 

tissues would be unavailable for use in 

feeds for any animals because of the 

CMPAF prohibition. Therefore, the risk 

is minimal that the BSE agent would be 

present even if cross-contamination 

occurs between mammalian protein 

intended for non-ruminant feed and 

ruminant feeds. The agency requests 

comment and data on the need for a 

requirement for dedicated facilities/ 

equipment for those facilities that 

handle both mammalian proteins 

currently prohibited in ruminant feed 

and ruminant feed when a CMPAF ban 

also exists. 

b. Poultry litter prohibition. The 

agency also considered a ban on poultry 

litter in ruminant feed. Poultry litter 

contains bedding material, spilled 

poultry feed, and manure, and is a waste 

by-product of poultry production. 

Because poultry feed may contain 

mammalian meat and bone meal 

currently prohibited in ruminant feed, 

there is a risk that cattle fed poultry 

litter containing spilled poultry feed 

may be exposed to prohibited meat and 

bone meal through that spilled poultry 

feed. 

This alternative would ban the use of 

poultry litter in all ruminant feed. Its 

costs would be comprised of both 

substitution costs for the replacement 

materials needed to provide an 

equivalent nutritional value, and 

disposal costs if the poultry litter cannot 

be used as an alternative product, such 

as fertilizer. The risk reduction would 

be the elimination of the possibility of 

the spread of BSE through the recycling 

of mammalian proteins currently 

prohibited in ruminant feed back into 

cattle feed through poultry litter 

including the spilled poultry feed 

containing prohibited mammalian 

proteins. 

A preliminary risk assessment of 

poultry litter submitted to the agency by 

an industry member predicted that in its 

worst-case scenario, under the current 

ruminant feed ban rule, a cow would 

need to eat 70.1 tons of litter to be 

exposed to 1 ID50 (Ref. 35). FDA 

modified some of the assumptions used 

in this risk assessment and predicted 

what would happen if there was no 

mixing during the cleanout process so 

that the spilled feed remained 

concentrated in a small portion of the 

bedding. Under this scenario, a 

ruminant fed only contaminated litter 

from under the poultry feeders must 

consume 3.4 tons to consume 1 ID50. 

This tonnage is still beyond the volume 

a stocker steer would realistically 

consume under normal circumstances 

due to its relatively short life. Similarly, 

dairy cows would also not be expected 

to consume this amount since poultry 

litter is not generally used in feed for 

lactating dairy cows. Because it appears 

to pose only a small baseline risk of BSE 

for ruminants, FDA currently believes 

that banning poultry litter from 

ruminant rations would have little or no 

affect on the human risk while 

increasing the environmental risks of its 

alternative disposal methods. FDA 

requests comments on this issue. 

Most poultry litter is not used as 

cattle feed. As an organic source of 

nutrients for plants, it has been applied 

to farmland for years. This practice, 

however, raised environmental concerns 

that excess nitrogen and phosphorus 

could leach from the litter and 

contaminate waterways. Since rumen 

microbes can efficiently metabolize 

poultry litter, feeding litter to cattle 

provides an alternative use to land 

application that benefits both poultry 

growers and cattle producers. Where 

poultry and cattle operations overlap, 

poultry growers are willing to sell litter 

at a price that exceeds the value of any 

alternative use. Cattle producers obtain 

a feed ingredient for a lower price than 

the next best alternative ingredient in 

the ruminant ration. Banning the use of 

litter in ruminant feed will likely 

increase the price of rations for 

ruminant producers and decrease 

revenues for poultry producers. 

Moreover, if poultry producers must 

dispose of unwanted litter, their 

operating costs would increase. 

To analyze the impact of the ban on 

poultry litter on ruminant producers, we 

calculated the per ton price of 

equivalent cattle rations with and 

without poultry litter. Based on feed 

ingredient prices in March 2004 and 

using equivalent cattle ration 

formulations recommended by 

University of Georgia, rations with 38 

percent to 53 percent poultry litter 

average about $65 per ton (Ref. 36). 

Equivalent rations without poultry litter 

average about $80 per ton, or about $15 

per ton more than the ration with 

poultry litter. The average cattle fed 

about 16.5 pounds of feed daily for 200 

days consumes a total of 0.6 tons to 0.9 

tons of litter, depending on the 

percentage of litter in the ration. This 

suggests that the cost of feed will 

increase by about $25 per head ($15 per 

ton x 200 days per head x 16.5 pounds 

per day/2,000 pounds per ton). The 

annual supply of poultry litter can 

potentially feed between 1.3 million (1.1 

million tons of litter / 0.9 tons of litter 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58595 

per cow) and 3.2 million cows (2 

million tons of litter / 0.6 tons of litter 

per cow). Thus the total cost of feed 

could increase from $32 million ($24.75 

per cow x 1.3 million cows) to $80 

million ($24.75 per cow x 3.2 million 

cows). 

Vertical integration in the poultry 

industry often results in contract 

growers’ contractual responsibility for 

litter management. For many reasons, 

including regional distribution of 

poultry producers and costly 

transportation, commodity markets do 

not handle poultry litter. Some poultry 

producing states have taken the 

initiative to promote and develop an 

infrastructure for litter markets, 

including programs to match the 

producers and users of poultry litter; 

providing transportation subsidies, or 

encouraging informal ‘‘markets’’ where 

buyers and sellers can contact each 

other. 

Alternative uses for poultry litter are 

being developed, but are not widely 

available currently. With technology 

developed in the United Kingdom, the 

nation’s first poultry litter fired power 

plant is being constructed in Missouri. 

Research is underway to convert litter 

into activated carbons that can absorb 

environmental pollution. 

In areas where cattle and poultry 

production overlap, banning poultry 

litter from ruminant feed may require 

that growers store litter, probably in 

deep stacking sheds, until alternative 

uses can be identified. If it is not 

possible to store litter, however, growers 

may need to dispose of surplus litter in 

landfills. To illustrate the cost of a 

worst-case scenario, disposal of the 

entire 1.1 million to 2 million tons of 

litter would range from $44 million to 

$160 million with disposal fees that 

range from $40 to $80 per ton. 

Without alternative outlets for litter 

banned from ruminant feed, the total 

short-run costs might range from $76 

million to $240 million. Contract 

growers and ruminant producers, many 

of whom are small entities, would incur 

these costs. Although the poultry litter 

alternative has not been included in the 

proposed rule, the agency requests 

comment on the need for a poultry litter 

ban in ruminant feed when a CMPAF 

ban in all animal feed also exists. 

c. Blood and blood products 

prohibition. We also considered an 

alternative that would have prohibited 

the use of blood and blood products in 

ruminant feed. We did not include this 

option in this proposed rule because we 

could not at this time show any BSE risk 

reduction as a result of such a 

prohibition, and these products have 

beneficial effects in ruminant feed. This 

option, if adopted, would result in onetime direct costs of about $7 million 

(annualized at $990,000 over 10 years at 

7 percent) for relabeling, reformulation 

and reregistration, as well as additional 

revenue losses for the product 

manufacturers. 

ERG identified and profiled the 

various blood and blood products used 

in animal nutrition. These products 

include plasma-based therapeutics and 

feed additives, premium blood-based 

feed additives and commodity blood 

meal. The prohibition of blood and 

blood products would result in some 

additional administrative costs to feed 

mills. It would require some mills to 

reformulate the rations in feeds. 

Relabeling efforts would also be 

required for some feeds, depending on 

whether the current label identifies 

specific animal proteins or identifies 

proteins under the broader term ‘‘animal 

protein products.’’ Additionally, some 

of these feeds would need to be 

reregistered with state agencies due to 

their new labeling, resulting in 

additional administrative cost to the 

mills. 

ERG prepared cost estimates for each 

of these activities based on FDA 

database information on feed ban 

inspections, data from industrysponsored reports, an industry journal, 

and Bureau of Labor Statistics data. ERG 

estimated that about 2,300 feed mills 

offer some type of blood-meal 

containing feeds, and that these mills 

have, on average, about 44 feed mixes 

that would require reformulation due to 

their containing blood meal or another 

ruminant protein that would no longer 

be offered due to a dedicated facilities/ 

equipment requirement. ERG prepared 

this estimate assuming that both a blood 

product prohibition and a dedicated 

facility/equipment requirement would 

be proposed. Therefore, to the extent 

that the estimated 44 feed mixes 

represent not those containing blood 

products but rather another ruminant 

protein that would no longer be 

available if a dedicated facilities/ 

equipment requirement had been 

created, these costs will be 

overestimated. Based on the various 

labor rates for mill employees, ERG 

estimated that reformulation efforts 

would result in a one-time total cost of 

$2.85 million. Relabeling costs, 

including both printing plate 

preparation and additional labor hours, 

are estimated to result in a one-time cost 

of $2.77 million. Reregistration costs are 

projected to add another one-time cost 

of $1.34 million. In total, these efforts 

would result in a one-time cost of $6.96 

million (average one-time costs per 

affected mill would be about $3,000). 

Annualized over 10 years at a 7-percent 

discount rate, this equates to $990,000 

per year (see table 4 of this document). 

TABLE 4.—ADMINISTRATIVE COSTS

Cost Element One-Time Costs (Thousands) Annualized Costs1 (Thousands) 

Reformulation $2,853 $406 

Relabeling $2,771 $395 

Reregistration $1,340 $190 

Total Costs $6,963 $990 

1Over 10 years at a 7 percent discount rate. 

Along with the compliance costs 

mentioned previously, this option 

would also result in the loss in value of 

the blood products themselves. ERG’s 

discussions with producers of plasmabased products for therapeutic use led 

to the following conclusion. Most of 

these products would not find an 

acceptable alternative market, or would 

do so only at a steep price discount, due 

to their reduced efficacy when used in 

animals other than cattle. Although ERG 

projected future market volumes based 

on industry contacts, current sales of 

these products are unavailable. Plasmabased feed additives and premium 

blood-based feed additives are not as 

species-specific and could be shifted to 

use in non-ruminant markets assuming 

a smaller decrease in price than would 

likely occur with the therapeutic 

58596 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

products. These products, which could 

be shifted to use in non-ruminant 

markets, may also incur higher 

transportation costs because fewer mills 

would be expected to accept any 

mammalian proteins currently 

prohibited in ruminant feed, that is if 

the dedicated facilities/equipment was 

also required. Commodity ruminant 

blood meal, valued at about $41 million 

in 2003, would also be expected to lose 

value due to this option. Porcine based 

blood meal would be expected to 

increase in value. These losses have not 

been projected. 

At this time, the agency does not have 

evidence that BSE is transmitted to 

cattle via blood or blood products. 

Therefore, the agency has not proposed 

that these products be banned from use 

in ruminant feeds in this proposal. The 

agency requests further comment and 

scientific information on the need to 

prohibit the use of blood and blood 

products in ruminant feed. 

d. Plate waste prohibition. This 

alternative would have eliminated the 

current exemption of inspected meat 

products which have been cooked and 

offered for human food, and further heat 

processed for feed (commonly referred 

to as plate waste but also including used 

cellulosic food casings) from the current 

definition of protein derived from 

mammalian tissues. It would ban plate 

waste from use in ruminant feed. 

As previously mentioned in the 

preamble to this proposed rule, the 

agency requested comment on questions 

related to the use of plate waste in 

ruminant feeds in the 2002 ANPRM. 

These questions focused on the extent of 

plate waste use in ruminant feeds, the 

composition of plate waste and its 

sources, plate waste processing 

techniques prior to its inclusion in feed, 

and the adverse and positive impacts for 

excluding plate waste from feed. 

Although the agency received many 

comments to the 2002 ANPRM, they did 

not include estimates of usage or 

regulatory impacts that were specific 

enough to form a foundation for a cost 

analysis of this option. One comment 

stated that the amount of plate waste 

used in ruminant feed was low. Another 

comment mentioned that substantial 

tonnages were used in ruminant feed in 

at least one state. A third comment 

stated that plate wastes from 

correctional facilities in another state 

were used in ruminant feed. No 

additional data was included to support 

these statements about the extent of 

plate waste use in ruminant feed. One 

comment stated that there were six 

processors of plate waste in the United 

States, but did not list these processors 

or offer any estimate of the use or value 

of processed plate waste in ruminant 

feed. 

We tried to collect more information 

on the use of plate waste in ruminant 

feed and any expected impacts from its 

ban in ruminant feed, by contacting all 

those who commented to the ANPRM 

about plate wastes. The comment that 

mentioned the use of plate waste from 

correctional facilities offered additional 

anecdotal data about this practice in one 

state, stating this practice was common 

in areas that had cattle or hog farms 

located near correctional facilities. It is 

likely, though, that because most or all 

of this plate waste is not currently 

further heat processed for feed, it would 

not be exempt from the current feed ban 

as defined in the 1997 ruminant feed 

final rule. No additional data on actual 

volumes of plate waste was offered. 

Another state agriculture agency that 

responded to the ANPRM, when 

contacted for further information, also 

stated that very little, if any, plate waste 

was further heat processed and used in 

ruminant feeds. Further, earlier 

estimates of significant tonnages of plate 

waste being used in feeds could not be 

verified by this agency through its 

investigators in the field. The other 

comments did not respond to our 

attempts at further contact. 

We also requested the assistance of 

agency personnel with knowledge of the 

ruminant feed industry in estimating the 

extent of use of plate waste in ruminant 

feeds. Although these agency sources 

acknowledge that the practice exists, we 

do not have any estimate of its 

prevalence on a national level. 

According to these agency sources, 

since plate waste (including used 

cellulosic food casings) is expected to 

have a relatively low nutritional value 

when used as a supplement in ruminant 

feeds, it would not be used in ruminant 

feed as a general rule. While the agency 

acknowledges that some plate waste is 

currently used in ruminant feeds, it 

cannot offer an estimate of this plate 

waste volume. The agency 

acknowledges there would be 

incremental disposal costs and 

alternative feed costs, due to a ban on 

the use of plate wastes in ruminant 

feeds. However, the agency cannot 

reliably estimate these costs at this time. 

The agency has concluded that this 

additional measure would be 

unnecessary given that measures 

already implemented by USDA and 

FDA to prohibit SRMs from human food 

effectively eliminate BSE infectivity 

from plate wastes. The agency requests 

further public comment on the extent of 

plate waste use in ruminant feeds and 

the costs such a prohibition would 

impose on any industry members. 

e. SRM prohibition. A final alternative 

would prohibit the use of a more 

extensive list of cattle materials in any 

animal feed. These materials would 

include the following: (1) SRMs, (2) The 

small intestine of all cattle, (3) material 

from cattle not inspected and passed for 

human consumption (including 

nonambulatory disabled cattle), (4) 

tallow containing more than 0.15 

percent insoluble impurities if derived 

from prohibited material, and (5) MS 

beef. SRMs would be defined as the 

skull, brain, eyes, spinal cord, 

trigeminal ganglia, 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 all 

cattle 30 months of age or older, plus 

the tonsils and distal ileum of all cattle 

regardless of age. 

FDA stated in July 2004 that it was 

considering this alternative, and ERG 

completed a cost analysis of this option. 

It is available at the Division of Dockets 

Management (see ADDRESSES). 

This alternative would require 

slaughterers to separate SRMs from 

slaughter cattle, and require renderers 

and firms that process dead, down, 

disabled, and diseased cattle (cattle not 

inspected and passed for human 

consumption) to separate all material 

from such animals from the remaining 

cattle offal produced for eventual use as 

animal feed. We estimate that the 

separation of these SRMs and material 

from cattle not inspected and passed for 

human consumption would require 

about $26.5 million in one-time capital 

costs (or $3.8 million annualized at 7 

percent and $3.1 million annualized at 

3 percent, over 10 years). We estimate 

that the annual cost of the additional 

labor to separate SRMs from other cattle 

offal is estimated to cost about $9.2 

million annually. The analysis projected 

that SRMs, instead of being rendered for 

animal feed, would most likely be 

rendered for disposal, based on the large 

amount of banned material this option 

would generate. To the extent that some 

states would allow landfilling (another 

relatively low cost disposal option), this 

analysis may overestimate compliance 

costs. Although compliance costs for 

these activities would be borne initially 

by slaughterers, and are presented as 

such by ERG, a portion of the costs are 

likely to be passed through to cattle 

producers and consumers. Annual 

rendering costs, which would include 

the value of the MBM net of the value 

of the recovered tallow, would range 

from $24 million to $88 million at the 

low estimate of the number of cattle not 

inspected and passed for human 

consumption that are currently rendered 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58597 

to $31 million to $117 million at the 

high estimate. Additional SRM 

transportation costs would be incurred 

to move SRMs and cattle not inspected 

and passed for human consumption 

from slaughterers to disposal renderers, 

and to move nonSRM offal a further 

distance to another renderer due to their 

current renderer becoming a fordisposal-only renderer. We estimate 

these to range from $22 million to $39 

million at the low estimate of cattle not 

inspected and passed for human 

consumption that are rendered to $33 

million—$58 million at the high 

estimate annually. Additionally, the 

estimated cost to dispose of the 

resulting MBM is estimated at $8 

million—$16 million at the low estimate 

and $12 million -$24 million annually 

at the high estimate. Total annualized 

costs of the prohibition of SRM, cattle 

not inspected and passed for human 

consumption (as shown in table 4 of this 

document) are estimated to range from 

$76 million to $161 million at the low 

end of the estimates of cattle not 

inspected and passed for human 

consumption that are rendered. Using 

the high estimate, annualized costs 

would range from $102 million to $225 

million. FDA expects MBM disposal 

costs to decrease in the future with the 

development of alternative markets for 

MBM of SRM-origin, but can offer no 

projections of these cost reductions. 

These cost estimates assume the 

development of a rendering industry 

dedicated entirely to disposal. This 

industry would earn no fees from selling 

rendered material, but would instead 

charge slaughterers and cattle owners 

for the disposal of prohibited materials. 

Information submitted to the agency 

implies that some independent 

rendering establishments would be used 

as rendering for disposal, contingent 

upon a volume of SRM products that 

would make disposal rendering 

profitable. It may be possible that some 

geographic areas would be underserved 

by disposal renderers due to the lack of 

availability of SRMs and cattle not 

inspected and passed for human 

consumption, necessary to provide the 

service at a charge that is lower than the 

cattle producers’ indirect cost of onfarm disposal of cattle not inspected and 

passed for human consumption. Neither 

FDA nor ERG has the geographic data 

on renderer locations and offal 

suppliers, or the financial data on 

individual renderers necessary to 

predict the number or geographic 

location of rendering establishments 

that will undertake SRM rendering for 

disposal. Further discussion of the 

implications for the development of a 

disposal rendering industry is available 

in the environmental assessment of this 

proposed rule. We request comments 

and data concerning the development of 

a rendering industry dedicated to 

rendering for disposal only of SRM and 

cattle not inspected and passed for 

human consumption. 

ERG determined that the prohibition 

on the use of tallow derived from the 

list of cattle materials prohibited under 

this alternative option that contains 

more than 0.15 percent hexaneinsoluble impurities would result in 

annualized costs estimated at $2. 

million. These costs consist of capital 

and operating costs for polishing 

centrifuges that would be needed by a 

small segment of independent renderers 

(further analysis of this provision led 

ERG to reduce the estimated cost, as it 

reported in its analysis of the proposed 

rule, to $1.78 million annually). The 

loss in market value of both MS beef 

and muscle tissue from cattle not 

inspected and passed for human 

consumption used in animal feeds is 

projected at about $75 million. FDA 

acknowledges that this last estimate is 

speculative because these sales cannot 

be distinguished from other renderer 

sales in U.S. Census data. FDA invites 

public comments and data on the 

impacts of the provisions that would 

prohibit all tallow derived from the 

prohibited materials that contains more 

than 0.15 percent insoluble impurities 

and all MS beef from use in animal 

feeds. Total costs of this alternative are 

estimated to range from $154.0 million 

to $242.6 million annually for the low 

estimate of cattle not inspected and 

passed for human consumption. Using 

the high estimate, total annualized costs 

are projected at $178 million to $302 

million Table 5 of this document 

displays the costs associated with this 

alternative. 

TABLE 5.—TOTAL COSTS ($ MILLIONS)1

Cost Item One-Time Cost Annual Costs Annualized Costs 

Capital Investments $27 N/A $4 

Labor $9 $9 

Net Rendering Costs2 ($25–$88) to ($31–$117) ($25–$88) to ($31–$117) 

SRM Transportation ($22–$39) to ($33–$58) ($22–$39) to ($33–$58) 

Disposal Costs ($10–$18) to ($17–$29) ($10–$18 to ($17–$29) 

SRM Marking ($0.02–$0.15) to ($0.03–

$0.23) 

($0.02–$0.15) to ($0.03–$0.23) 

Recordkeeping/Labeling $0.05 to $0.06 $0.05 to $0.06 

Feed Substitution $6–$7 $6–$7 

Subtotal—Codified SRM, Dead, Downer Ban ($72–$161) to ($96–$220) ($76–$165) to ($100–$224) 

Tallow Restriction $11 $1 $2 

MS Beef Ban $75 $75 

SRM Alternative Total Costs ($153.0–$242) to ($178–$302) 

1 Low cost estimate ranges reflect lower estimate of cattle not inspected and passed for human consumption. High cost estimate range reflect 

high end of estimates of cattle not inspected and passed for human inspection. 2 Has been reduced by the value of the tallow products recovered. 

58598 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

To assess the risk reduction from the 

SRM alternative in this proposed rule, 

we use two distinct approaches. In the 

first approach, we assume that the 

number of new BSE cases is 

proportional to the amount of all 

infectious material included in feed. 

Given this assumption, we can estimate 

the percentage reduction in risk as the 

percentage reduction in infectious 

material.A report by the Scientific 

Steering Committee of the European 

Union suggests that the tissues 

designated as SRM (brain, spinal cord, 

trigeminal ganglia, dorsal root ganglia, 

distal ileum, eyes) constitute at least 

99.44 percent of the total infective load 

(Ref. 29). These tissues (SRMs) from 

cattle 30 months of age and older, the 

tonsils and distal ileum of all cattle, and 

all material from cattle not inspected 

and passed for human consumption, 

would be prohibited from use in any 

animal feed under this alternative. 

SRMs (except for tonsils and distal 

ileum which are prohibited regardless of 

age of cattle), when taken from cattle 

less than 30 months of age, would not 

be prohibited from use in all animal 

feed because the probability is very low 

that tissues from cattle of this age would 

contain BSE infectivity. FDA estimates, 

therefore, that banning SRMs from use 

in any animal feed would effectively 

remove about 99 percent of any 

remaining infectivity from possible 

spread through the feed system. 

The second approach uses the 

Harvard-Tuskegee risk assessment 

model, making adjustments to the 

infectivity pathways for cattle and 

humans that would still be available 

even after the USDA interim final rules 

concerning SRMs in human food and 

Advanced Meat Recovery (AMR) 

systems became effective. FDA has 

updated the model to simulate the 

introduction of five infected cattle into 

the United States. The model was also 

updated to further reduction in the 

spread of BSE among cattle and 

reduction in human exposure to cattle 

oral ID50s that would result from a ban 

on SRMs in animal feeds. The USDA 

rule, prohibiting the use of SRMs in 

human food as well as the FDA interim 

final rule prohibiting the use of SRMs in 

human food and cosmetics, may cause 

some offsetting increases in the amount 

of SRMs that enter non-ruminant feeds; 

the proposed SRM ban would address 

this increase in SRMs in animal feed. 

Under this second approach, we define 

risk reduction as the reduction in 

human exposure that would result from 

the ban on the use of SRM in any animal 

feed using the HCRA model. These 

results show that prohibiting the use of 

SRMs in all animal feed would 

effectively negate about 95 percent of 

the remaining risk of human exposure to 

cattle oral ID50s. When considered as a 

complementary measure to the USDA 

and FDA SRM bans for human food, the 

estimate of overall human exposure 

reduction from those bans and the SRM 

alternative is more than 99 percent. 

The model does not take into account 

any additional risk reduction from the 

restrictions on the use of tallow or MS 

beef in animal feeds. While we believe 

these additional restrictions would 

likely further reduce the risk to human 

health from BSE to a small degree, we 

cannot quantify this risk reduction. 

Compared to the proposed rule, this 

alternative would impose an additional 

$171 million to $226 million in annual 

compliance costs. As discussed earlier, 

we believe that this proposed rule 

provides the appropriate level of 

protection against the spread of BSE in 

a cost-effective manner. 

V. Paperwork Reduction Act 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). A 

description of these provisions is given 

below with an estimate of the annual 

recordkeeping burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information. 

FDA invites comments on the 

following topics: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Substances prohibited from use 

in animal food or feed. 

Description: We are proposing to 

amend our regulations to prohibit the 

use of certain cattle origin materials in 

the food or feed of all animals. These 

materials include the following: (1) The 

brains and spinal cords from cattle 30 

months of age and older (2) the brains 

and spinal cords from cattle of any age 

not inspected and passed for human 

consumption, (3) the entire carcass of 

cattle not inspected and passed for 

human consumption if the brains and 

spinal cords were not removed, (4) MS 

beef that is derived from cattle from 

which prohibited materials were not 

previously removed; and (5) tallow that 

is derived from cattle materials 

prohibited in animal feed unless such 

tallow contains no more than 0.15 

percent insoluble impurities. These 

measures will further strengthen 

existing safeguards designed to help 

prevent the spread of BSE in U.S. cattle. 

Description of Respondents: 

Rendering facilities, Medicated feed 

manufacturers and distributors, 

livestock feeders. 

TABLE 6.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of Recordkeepers 

Annual Frequency per 

Recordkeeper 

Total Annual 

Records 

Hours per Recordkeeper Total Hours Operation and Maintenance Cost 

589.2001(b)(2)(iv) and 

(b)(3)(i) 141 1 141 20 2,820 $47,940 

Total 2,820 

The estimated recordkeeping burden 

is derived from agency resources and 

discussions with affected industry. The 

recordkeeping requirement in proposed 

§ 589.2001(b)(2)(iv) will apply to the 

limited number of renderers who will 

handle prohibited bovine material. We 

estimate that no more than 50 rendering 

firms will be involved in the handling 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58599 

of this material. Although we may 

consider the distribution records needed 

to comply with this proposed regulation 

‘‘usual and customary’’ and thus not 

subject to PRA, we believe there will be 

burden associated with setting up a 

system to assure such records are 

sufficient to address the proposed 

recordkeeping requirement. Likewise, 

although we may consider the records 

necessary to comply with proposed 

§ 589.2001(b)(3)(i) as ‘‘usual and 

customary’’ and not subject to PRA 

burden accounting, we are including a 

burden estimate to cover establishment 

of a system to assure existing receipt 

and manufacturing records adequately 

address this proposed requirement. 

In compliance with the PRA (44 

U.S.C. 3507(d)), the agency has 

submitted the information collection 

provisions of this proposed rule to OMB 

for review. Interested persons are 

requested to submit written comments 

on the information collection provisions 

to the Office of Information and 

Regulatory Affairs, Office of 

Management and Budget (OMB). 

OMB is still experiencing significant 

delays in the regular mail, including 

first class and express mail, and 

messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974. 

VI. Environmental Impact 

The agency has carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management (see 

ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday. 

VII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles in 

Executive Order 13132. We have 

determined that the proposed rule does 

not contain policies that have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have tentatively concluded that the 

proposed rule does not contain policies 

that have federalism implications as 

defined in the Executive order and, 

consequently, a federalism summary 

impact statement is not required. 

VIII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register. 1. Kimberlin, R.H. and J.W. Wilesmith, 

‘‘Bovine Spongiform Encephalopathy: 

Epidemiology, Low Dose Exposure, and 

Risks,’’ Annals of the New York Academy of 

Sciences, 724: 210–220, 1994. 

2. Collee, J.G. and R. Bradley, ‘‘BSE: A 

Decade on-Part I,’’ Lancet, 349: 636–41, 1997. 

3. Harvard Center for Risk Analysis, 

Harvard School of Public Health, and Center 

for Computational Epidemiology, College of 

Veterinary Medicine, Tuskegee University, 

‘‘Evaluation of the Potential for Bovine 

Spongiform Encephalopathy in the United 

States,’’ Harvard Center for Risk Analysis 

Internet Page (http://www.hcra.harvard.edu/ 

pdf/madcow_report.pdf), 2001. 

4. Harvard Center for Risk Analysis, 

Harvard School of Public Health, and Center 

for Computational Epidemiology, College of 

Veterinary Medicine, Tuskegee University, 

‘‘Evaluation of the Potential for Bovine 

Spongiform Encephalopathy in the United 

States,’’ Harvard Center for Risk Analysis 

Internet Page (http://www.hcra.harvard.edu/ 

pdf/madcow.pdf), 2003. 

5. Harvard Center for Risk Analysis, 

Harvard School of Public Health, ‘‘Evaluation 

of the Potential Spread of BSE in Cattle and 

Possible Human Exposure Following 

Introduction of Infectivity into the United 

States from Canada,’’ accessed online at 

Harvard Center for Risk Analysis Internet 

Page http://www.hcra.harvard.edu/pdf/ 

canadian/Text_2003_09_05_-_with_refs.pdf, 

2003. 

6. U.S. Department of Agriculture, Animal 

and Plant Health Inspection Service (USDA/ 

APHIS), report of the epidemiological 

investigation, ‘‘A Case of Bovine Spongiform 

Encephalopathy (BSE) in the United States,’’

March 2004, USDA/APHIS Internet Page 

(http://www.aphis.usda.gov/lpa/issues/bse/ 

BSE_tr_ban%20_ltr_enc_1.pdf). 

7. Canadian Food Inspection Agency; BSE 

in North America; Latest Information, (http:// 

www.inspection.gc.ca/english/anima/ 

heasan/disemala/bseesb/situatione.shtml). 

8. The transcripts of the October 30, 2001, 

public hearing on BSE, are available at the 

Division of Dockets Management (refer to 

Docket No. 01N–0423). The transcripts may 

also be obtained online at FDA Internet Page 

(http://www.fda.gov/ohrms/dockets/dockets/ 

01N–0423/01n0423.htm). 

9. World Health Organization (WHO) Fact 

Sheet No. 113, Bovine Spongiform 

Encephalopathy, revised Nov. 2002, WHO 

Internet Page (http://www.who.int/ 

mediacentre/factsheets/fs113/en/). 

10. Livestock Mortalities: Methods of 

Disposal and Their Potential Costs. Sparks 

Companies, Inc., McLean, VA, March 2002. 

11. U.S. Department of Agriculture, Animal 

and Plant Health Inspection Service, USDA’s 

BSE Testing Program, USDA/APHIS Internet 

Page (http://www.aphis.usda.gov/lpa/issues/ 

bse_testing/index.html). 

12. The BSE Inquiry Report, vol. 5, Animal 

Health, 1989–1996, pp. 94–107, A committee 

report to MAFF, UK. BSE Inquiry Internet 

Page (http://www.bseinquiry.gov.uk/). 

13. Overview of the BSE risk assessments 

of the European’s Commission Scientific 

Steering Committee (SSC) and its TSE/BSE 

ad hoc group, Adopted between September 

1997 and April 2003, June 5, 2003, Europa 

Internet Page (http://europa.eu.int/comm/ 

food/fs/sc/ssc/out364_en.pdf). 

14. U.S. Food and Drug Administration, 

Center for Veterinary Medicine, Summary of 

FDA Inspectional Findings and Recalls 

Involving the Ruminant Feed Ban Regulation 

(21 CFR 589.2000) Conducted in Fiscal Year 

2004 and First Half of Fiscal Year 2005, 

September 2005. 

15. Florida Department of Agriculture and 

Consumer Services and Florida Cooperative 

Extension Service, Institute of Food and 

Agricultural Services, brochure entitled ‘‘The 

Misuse of Pet Food as Feed for Show Cattle—

Misconceptions and Realities.’’

16. Scientific Steering Committee, 

European Commission, ‘‘Update on the 

Opinion of TSE Infectivity Distribution in 

Ruminant Tissues,’’ Initially adopted by the 

Scientific Steering Committee at its meeting 

of January 10 and 11, 2002, and amended at 

its meeting of November 7 and 8, 2002, 

following the submission of a risk assessment 

by the German Federal Ministry of Consumer 

Protection, Food and Agriculture and new 

scientific evidence regarding BSE infectivity 

distribution in tonsils, Europa Internet Page 

(http://europa.eu.int/comm/foods/fs/bse/ 

scientific_advice08_en.html). 

17. SSC Opinion on The Human Exposure 

Risk (HER) via Food With Respect to BSE, 

Adopted on 10 December 1999; (http:// 

europa.eu.int/comm/food/fs/sc/ssc/ 

out67_en.pdf). 

18. Health and Consumer Protection 

Directorate-General, European Commission, 

‘‘Report on the Monitoring and Testing of 

Ruminants for the Presence of Transmissible 

Spongiform Encephalopathy (TSE) in 2002.’’

19. Targeted Screening of High-Risk Cattle 

Populations for BSE to Augment Mandatory 

58600 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 

Reporting of Clinical Suspects, Preventive 

Veterinary Medicine 51:3–16, 2001. 

20. Taylor, D.M., S.L. Woodgate, and M.J. 

Atkinson, et al., ‘‘Inactivation of the Bovine 

Spongiform Encephalopathy Agent by 

Rendering Procedures,’’ Veterinary Record, 

137: 605–610, 1995. 

21. Taylor, D.M., S.L. Woodgate, A.J. 

Fleetwood, et. al., ‘‘The Effect of Rendering 

Procedures on Scrapie Agent,’’ Veterinary 

Record, 141: 643–649, 1997. 

22. Wilesmith, J.W., G.A.H. Wells, M.P. 

Cranwell, et al., ‘‘Bovine Spongiform 

Encephalopathy: Epidemiological Studies,’’

Veterinary Record, 123: 638–644, 1998. 

23. Office International des Epizooties 

(OIE), Terrestrial Animal Health Code, 

Bovine Spongiform Encephalopathy Chapter, 

2005. 

24. U.S. Department of Health and Human 

Services, Food and Drug Administration 

(FDA), Transcript of meeting of the 

Transmissible Spongiform Encephalopathies 

Advisory Committee, April 16, 1998, FDA 

Internet Page (http://www.fda.gov/ohrms/ 

dockets/ac/98/transcpt/3406t2.pdf), 1998. 

25. ‘‘Economic Impacts of Proposed FDA 

Regulatory Changes to Regulations of Animal 

Feeds Due to Risk of Bovine Spongiform 

Encephalopathy,’’ Contract No. 223–03–8500, 

Task Order 3, Eastern Research Group, 

Lexington, MA, July 25, 2005. 

26. ‘‘Preliminary Analysis of Interim Final 

Rules and an Interpretive Rule to Prevent the 

BSE Agent from Entering the U.S. Food 

Supply,’’ USDA, April 7, 2004, FSIS/USDA 

Internet Page (http://www.fsis.usda.gov/ 

Frame/FrameRedirect.asp?main=/oppde/ 

rdad/frpubs/03–025n/bse_analysis.pdf). 

27. Department of Health and Human 

Services press release. FDA Internet Page 

(http://www.fda.gov/bbs/topics/news/2004/ 

hhs_012604.html). 

28. European Union Scientific Steering 

Committee (EU SSC), Opinion of December 

10, 1999, of the Scientific Steering 

Committee on the Human Exposure Risk 

(HER) via Food with Respect to BSE, p. 11, 

2001. 

29. United Kingdom Department of Health, 

2005, Internet Page (http://www.dh.gov.uk/ 

PublicationsAndStatistics/PressReleases/ 

PressReleasesNotices/fs/ 

en?CONTENT_ID=4118691&chk=0Yqdjc).). 

30. U.S. Department of Agriculture, 

Agricultural Marketing Service, Internet Page 

(http://www.ers.usda.gov/briefing/ 

foodpricespreads/meatpricespreads/beef.xls) 

31. ‘‘Economic Impacts of Alternative 

Changes to the FDA Regulation of Animal 

Feeds to Address the Risk of Bovine 

Spongiform Encephalopathy,’’ Contract No. 

223–98–8002, Task Order 2, Eastern Research 

Group, Lexington, MA, July 25, 2005. 

32. ‘‘An Economic and Environmental 

Assessment of Eliminating Specified Risk 

Materials and Cattle Mortalities from Existing 

Markets,’’ Prepared for the National 

Renderers Association by Informa 

Economics, Inc. Washington, D.C. http:// 

www.renderers.org/economic_impact/ 

index.htm 

33. Feedstuffs, vol. 77, No. 3, p. 21, January 

17, 2005. 

34. U.S. Small Business Administration 

data at the U.S. Census Bureau Internet Page 

(http://www.census.gov/csd/subsb/ 

usalli01.xls). 

35. North American Rendering Industry 

submission to docket number 02N–0273, 

comment 30, February 3, 2004. 

36. The University of Georgia, College of 

Agricultural and Environmental Sciences, 

Cooperative Extension Service, AS–1 

Newsletter, p. 5, January/February 2001. 

List of Subjects in 21 CFR Part 589 

Animal feeds, Animal foods, Food 

additives, Incorporation by reference. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, the Food and Drug 

Administration, it is proposed that 21 

CFR part 589 be amended to read as 

follows: 

PART 589—SUBSTANCES 

PROHIBITED FROM USE IN ANIMAL 

FOOD OR FEED 

1. The authority citation for 21 CFR 

part 589 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 348, 

371. 

2. Section 589.2000 is amended by 

revising paragraph (a)(1) and by adding 

paragraphs (c)(4) and (e)(3) to read as 

follows: 

§ 589.2000 Animal proteins prohibited in 

ruminant feed. 

(a) * * * 

(1) Protein derived from mammalian 

tissues means any protein-containing 

portion of mammalian animals, 

excluding: Blood and blood products; 

gelatin; tallow containing no more than 

0.15 percent insoluble impurities and 

tallow derivatives as specified in 

§ 589.2001; inspected meat products 

which have been cooked and offered for 

human food and further heat processed 

for feed (such as plate waste and used 

cellulosic food casings); milk products 

(milk and milk proteins); and any 

product whose only mammalian protein 

consists entirely of porcine or equine 

protein. 

* * * * * 

(c) * * * 

(4) Renderers shall comply with all 

applicable requirements under 

§ 589.2001. 

* * * * * 

(e) * * * 

(3) Renderers shall comply with all 

applicable requirements under 

§ 589.2001. 

* * * * * 

3. Section 589.2001 is added to read 

as follows: 

§ 589.2001 Cattle materials prohibited in 

animal food or feed. 

(a) Definitions—(1) Cattle materials 

prohibited in animal feed include: 

(i) The brains and spinal cords of 

cattle 30 months of age and older; 

(ii) The brains and spinal cords of 

cattle not inspected and passed for 

human consumption as defined in 

paragraph (a)(2) of this section; 

(iii) The entire carcass of cattle not 

inspected and passed for human 

consumption from which brains and 

spinal cords were not removed; 

(iv) Mechanically separated beef as 

defined in paragraph (a)(3) of this 

section that is derived from materials 

specified in paragraphs (a)(1)(i), 

(a)(1)(ii), and (a)(1)(iii) of this section; 

and 

(v) Tallow as defined in paragraph 

(a)(5) of this section that is derived from 

materials specified in paragraphs 

(a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this 

section. Cattle materials prohibited in 

animal feed do not include: 

(A) Tallow derivatives as defined in 

paragraph (a)(6) of this section and; 

(B) Tallow as defined in paragraph 

(a)(5) of this section that is derived from 

materials specified in paragraphs 

(a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this 

section and that contains no more than 

0.15 percent insoluble impurities. 

Insoluble impurities must be measured 

by the method entitled ‘‘Insoluble 

Impurities’’ of the American Oil 

Chemists’ Society (Official Method Ca 

3a–46), or another method equivalent in 

accuracy, precision, and sensitivity to 

AOCS Official Method Ca 3a–46. The 

Director of the Office of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain copies of the method from the 

AOCS (http://www.aocs.org). Copies 

may be examined at the Center for Food 

Safety and Applied Nutrition’s Library, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741–

6030, or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(2) Cattle not inspected and passed 

for human consumption means cattle of 

any age that were not inspected and 

passed for human consumption by the 

appropriate regulatory authority. This 

term includes nonambulatory disabled 

cattle. Nonambulatory disabled cattle 

are cattle that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Proposed Rules 58601 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. 

(3) Mechanically separated beef 

means a finely comminuted meat food 

product, resulting from the mechanical 

separation and removal of most of the 

bone from attached skeletal muscle of 

cattle carcasses and parts of carcasses. 

(4) Renderer means any firm or 

individual that processes slaughter 

byproducts, animals unfit for human 

consumption, or meat scraps. The term 

includes persons who collect such 

materials and subject them to minimal 

processing, or distribute them to firms 

other than renderers (as defined in this 

paragraph) whose intended use for the 

products may include animal feed, 

industrial use, or other uses. The term 

includes renderers that also blend 

animal protein products. 

(5) Tallow means the rendered fat of 

cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. 

(6) Tallow derivative means any 

product obtained through initial 

hydrolysis, saponification, or transesterification of tallow; chemical 

conversion of material obtained by 

hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 

(b) Requirements. (1) No animal feed 

or feed ingredient shall be manufactured 

from, processed with, or otherwise 

contain, cattle materials prohibited in 

animal feed as defined in paragraph 

(a)(1) of this section. 

(2) Renderers that manufacture, 

process, blend, or distribute cattle 

materials prohibited in animal feed as 

defined in paragraph (a)(1) of this 

section, or products that contain or may 

contain cattle materials prohibited in 

animal feed, shall take the following 

measures to ensure that materials 

identified in paragraph (b)(1) of this 

section are not introduced into animal 

feed: 

(i) Once cattle materials prohibited in 

animal feed have been separated from 

other cattle materials, provide for 

measures to avoid cross-contamination; 

(A) Use separate equipment while 

handling cattle materials prohibited in 

animal feed; or 

(B) Use separate containers that 

adequately prevent contact with animal 

feed, animal feed ingredients, or 

equipment surfaces; 

(ii) Label the cattle materials 

prohibited in animal feed and products 

that contain or may contain cattle 

materials prohibited in animal feed in a 

conspicuous manner as follows: ‘‘Do not 

feed to animals’’; 

(iii) Mark the cattle materials 

prohibited in animal feed and products 

that contain or may contain cattle 

materials prohibited in animal feed with 

an agent that can be readily detected on 

visual inspection; and 

(iv) Establish and maintain records 

sufficient to track cattle materials 

prohibited in animal feed to ensure such 

material is not introduced into animal 

feed, and make the records available for 

inspection and copying by the Food and 

Drug Administration. 

(3) Renderers that manufacture, 

process, blend, or distribute any cattle 

materials shall take the following 

measures to ensure that materials 

identified in paragraph (b)(1) of this 

section are not used in animal feed: 

(i) Establish and maintain records 

sufficient to demonstrate that material 

rendered for use in animal feed was not 

manufactured from, processed with, or 

does not otherwise contain, cattle 

materials prohibited in animal feed, and 

make the copies available for inspection 

and copying by the Food and Drug 

Administration; and 

(ii) Comply with all applicable 

requirements under § 589.2000 

regarding animal proteins prohibited in 

ruminant feed. 

(c) Adulteration and misbranding. (1) 

Failure of a renderer to comply with the 

requirements in paragraphs (b)(2)(i), 

(b)(2)(iii), (b)(2)(iv), or (b)(3)(i) of this 

section will render the animal feed or 

feed ingredients adulterated under 

section 402(a)(4) of the Federal Food, 

Drug, and Cosmetic Act (the act). 

(2) Animal feed or feed ingredients 

that are not in compliance with 

paragraph (b)(1) of this section are 

adulterated under section 402(a)(2), 

402(a)(3), or 402(a)(5) of the act. 

(3) Animal feed or feed ingredients 

that are not in compliance with the 

labeling requirements of paragraph 

(b)(2)(ii) of this section are misbranded 

under section 403(a)(1) or 403(f) of the 

act. 

(4) Failure of a renderer to comply 

with the requirements in paragraph (d) 

of this section will render the animal 

feed or feed ingredients adulterated 

under section 402(a)(4) of the act. 

(d) Inspection; records retention. 

Records required to be made available 

for inspection and copying by the Food 

and Drug Administration, as required by 

this section, shall be kept for a 

minimum of 1 year. 

Dated: July 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20196 Filed 10–4–05; 1:00 pm] 

BILLING CODE 4160–01–S