22720 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 

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: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending 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 

entire carcass of bovine spongiform 

encephalopathy (BSE)-positive cattle; 

the brains and spinal cords from cattle 

30 months of age and older; the entire 

carcass of cattle not inspected and 

passed for human consumption that are 

30 months of age or older from which 

brains and spinal cords were not 

removed; tallow that is derived from 

BSE-positive cattle; tallow that is 

derived from other materials prohibited 

by this rule that contains more than 0.15 

percent insoluble impurities; and 

mechanically separated beef that is 

derived from the materials prohibited by 

this rule. These measures will further 

strengthen existing safeguards against 

BSE. 

DATES: This final rule is effective April 

27, 2009. The Director of the Office of 

the Federal Register approves the 

incorporation by reference in 

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

CFR part 51 of a certain publication in 

new 21 CFR 589.2001 effective April 27, 

2009. 

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.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

II. Comments on the Proposed Rule 

A. General Comments 

B. Comments on Proposed New 

§ 589.2001—Cattle Materials Prohibited 

in Animal Food or Feed 

C. Comments on Proposed Amendments to 

§ 589.2000—Animal Proteins Prohibited 

in Ruminant Feed 

III. Description of the Final Rule 

A. Definitions 

B. Requirements 

C. Recordkeeping and Access 

Requirements 

D. Changes to § 589.2000—Animal Proteins 

Prohibited in Ruminant Feed 

IV. Analysis of Economic Impacts 

A. Summary of Final Regulatory Impact 

Analysis 

B. Cost Effectiveness of Final Rule and 

Alternatives 

C. Need for Regulation 

D. Benefits 

E. Costs 

F. Government Costs 

G. Sensitivity Analysis 

H. Regulatory Flexibility Analysis 

V. The Small Business Regulatory 

Enforcement Fairness Act of 1996 

(SBREFA) 

VI. Paperwork Reduction Act of 1995 

VII. Environmental Impact 

VIII. Federalism 

IX. References 

I. Introduction 

BSE is a progressive and fatal 

neurological disorder of cattle that 

results from an unconventional 

transmissible agent. BSE belongs to the 

family of diseases known as 

transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. However, the 

distribution of infectivity in the body of 

the animal and mode of transmission 

differ according to the species and TSE 

agent. In addition to BSE, TSEs include, 

among other diseases, scrapie in sheep 

and goats, chronic wasting disease in 

deer and elk, and Creutzfeldt-Jakob 

disease in humans. 

The agent that causes BSE has yet to 

be fully characterized. The theory that is 

most accepted in the international 

scientific community is that the agent is 

an abnormal form of a normal protein 

known as cellular prion protein. The 

BSE agent does not evoke a traditional 

immune response or inflammatory 

reaction in host animals. BSE is 

confirmed by post-mortem microscopic 

examination of an animal’s brain tissue 

or by detection of the abnormal form of 

the prion protein in an animal’s brain 

tissues. The pathogenic form of the 

protein is both less soluble and more 

resistant to degradation than the normal 

form. The BSE agent is resistant to heat 

and to normal sterilization processes. 

BSE is not a contagious disease, and 

therefore is not spread through casual 

contact between animals. The 

possibility of maternal transmission 

(i.e., from a bovine dam directly to her 

offspring) was suggested by a 1997 

study conducted in the United 

Kingdom. However, subsequent studies 

have shown that it is unlikely that 

maternal transmission of BSE occurs at 

any epidemiologically significant level, 

if it occurs at all. Scientists believe that 

the primary route of transmission 

requires that cattle ingest feed that has 

been contaminated with a sufficient 

amount of meat and bone meal (MBM) 

from an infected animal. This route of 

transmission can be prevented by 

excluding potentially contaminated 

materials from ruminant feed. 

Scientific and epidemiological studies 

have linked variant Creutzfeldt-Jakob 

disease (vCJD) in humans to exposure to 

the BSE agent, most likely through 

human consumption of beef products 

contaminated with the agent. As of 

February 2007, 165 probable and 

confirmed cases of vCJD have been 

reported in the United Kingdom. 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. As of November 2006, 

CDC had detected two vCJD cases 

involving United States residents who 

were born and raised in the United 

Kingdom. A third case was confirmed 

by CDC in November 2006 and involved 

a United States resident living in 

Virginia who was born and raised in 

Saudi Arabia and had lived in the 

United States since 2005. This 

individual did not live in Europe at any 

time, and CDC has determined that this 

person was most likely infected from 

contaminated cattle products consumed 

as a child when living in Saudi Arabia. 

On December 23, 2003, the U.S. 

Department of Agriculture (USDA) 

diagnosed BSE in an adult cow in the 

United States that had been imported 

from Canada. Since then, USDA has 

confirmed two other cases of BSE in 

adult cows in the United States. One 

cow, which was diagnosed on June 24, 

2005, was born and raised in Texas. The 

other cow, which was diagnosed on 

March 15, 2006, had been on a farm in 

Alabama for less than a year. The Texas 

cow was 12 years old and the Alabama 

cow was determined to be more than 10 

years old. Therefore, both cows were 

born before FDA’s 1997 ruminant feed 

rule (62 FR 30936, June 5, 1997) was in 

place. 

Under USDA’s enhanced BSE 

surveillance program, 787,711 cattle 

were tested between June 1, 2004, and 

September 20, 2006. As previously 

noted, only two animals tested positive 

for BSE, one in Texas and one in 

Alabama. In September 2006, USDA 

transitioned to an ongoing surveillance 

plan under which approximately 40,000 

cattle are tested per year. 


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In the October 6, 2005, issue of the 

Federal Register (70 FR 58570), FDA 

published a proposed rule (the October 

2005 proposed rule) that would prohibit 

the use of certain cattle origin materials 

in the food or feed of all animals. The 

materials identified in the proposal 

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 have not been removed; (4) 

tallow that is derived from the materials 

prohibited by the proposed rule that 

contains more than 0.15 percent 

insoluble impurities; and (5) 

mechanically separated beef that is 

derived from the materials prohibited by 

the proposed rule. 

The preamble to the proposed rule 

contained information regarding BSE, 

including a summary of the current 

animal feed safeguards in the United 

States and the risk of BSE in North 

America, other options FDA considered 

for strengthening animal feed 

protections, and the reasons for 

proposing to exclude certain cattlederived risk materials from all animal 

food and feed. Also discussed in the 

preamble to the proposed rule was the 

Harvard Risk Assessment (referred to in 

the preamble to the proposed rule as the 

‘‘Harvard-Tuskegee Study’’), completed 

for USDA in 2001. The authors released 

a revised risk assessment in 2003. 

Among other things, the HarvardTuskegee Study identified pathways or 

practices that, if addressed, could 

further decrease the already low risk of 

the spread of BSE if it were introduced 

into this country. 

In mid-July 2006, USDA’s Food Safety 

and Inspection Service (FSIS) released a 

further revised Harvard Risk 

Assessment. Conducted in 2005, the risk 

assessment used an updated model to 

simulate the impact of measures 

adopted by USDA and considered by 

FDA in response to the detection of a 

BSE-positive cow in Washington State 

in December 2003. The 2005 study 

confirmed the original findings in the 

2001 Harvard-Tuskegee Study and 

noted that, with the protective measures 

in place in the United States in 2003, 

the introduction of BSE would result in 

limited spread, and the disease would 

be eliminated over time. Of the 

additional feed-related mitigation 

measures evaluated, the revised model 

predicted that removal of specified risk 

materials (SRMs) from all animal feed 

would result in a substantial reduction 

of any residual BSE disease agent not 

eliminated by the 1997 feed ban, 

because doing so eliminates 

transmissions resulting from crosscontamination and on-farm misfeeding. 

The current U.S. ruminant feed 

regulation (§ 589.2000 (21 CFR 

589.2000)) prohibits the use of certain 

mammalian-origin proteins in ruminant 

feed, but allows the use of these 

materials in feed for non-ruminant 

animals. While the prevalence of BSE in 

the United States is very much lower 

than in European countries with BSE, 

evidence from the European experience 

has demonstrated that, in countries with 

a high level of circulating BSE 

infectivity, measures on only ruminant 

feed were not sufficient to eliminate all 

transmission of BSE; new cases 

continued to be found in cattle born in 

the United Kingdom after 

implementation of a ruminant-toruminant feed ban. As stated in the 

proposed rule, these new cases were 

attributed to either cross-contamination 

during feed manufacture and transport, 

or to intentional or unintentional 

misfeeding on the farm. FDA believes 

that the presence of certain cattlederived risk materials in the nonruminant feed supply presents a 

potential source of exposure in the 

United States. Although in the United 

States, compliance with the 1997 

ruminant feed rule by the U.S. animal 

feed industry, i.e., renderers, protein 

blenders, and feed mills, has been very 

high, inspections of feed manufacturing 

firms have identified some instances of 

inadequate cleanout procedures, 

mislabeling, and recordkeeping 

deficiencies. 

As discussed in the preamble to the 

proposed rule, data from both naturally 

infected and experimentally infected 

cattle indicate that roughly 90 percent of 

BSE infectivity is contained in the brain 

and spinal cord, and only about 10 

percent of BSE infectivity is present in 

the retina, dorsal root and trigeminal 

ganglia, and the distal ileum (Ref. 1). 

The agency continues to believe that the 

1997 ruminant feed rule provides a 

strong primary line of defense against 

BSE transmission by prohibiting the use 

in ruminant feed of all materials with 

potential BSE infectivity. The additional 

measures taken in this final rule will 

further reinforce the existing rule by 

removing certain cattle-derived risk 

materials from all animal feed. This 

action greatly minimizes the residual 

BSE risks not eliminated by the 1997 

feed ban if cross-contamination of 

ruminant feed with non-ruminant feed, 

or diversion of non-ruminant feeds to 

ruminants, were to occur. 

As discussed in greater detail in 

section II of this document, FDA 

received numerous comments on its 

proposed rule. Based on these 

comments, the agency has made some 

modifications to this final rule. 

Specifically, a statement has been added 

setting forth the purpose of the new 

section, i.e., to prohibit the use of 

certain cattle origin materials in the 

food or feed of all animals to further 

reduce the risk of the spread of BSE 

within the United States. This change 

was made to clarify that the cattle 

materials prohibited by this rule are 

being prohibited from use in all animal 

food or feed because of their risk for 

transmitting BSE. This rule, however, 

should not be construed to mean that it 

is legal to use any portion of an animal 

that is adulterated under the Federal 

Food, Drug, and Cosmetic Act (the act) 

in animal food or feed. 

Under section 402(a)(5) of the act (21 

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

ingredients containing material derived 

from a BSE-positive animal are 

adulterated because they are in whole or 

in part the product of a diseased animal. 

The definition of cattle materials 

prohibited in animal feed (CMPAF) has 

been revised to include the entire 

carcass of BSE-positive cattle. This 

change was made to be consistent with 

the agency’s previous guidance entitled 

‘‘Use of Material from BSE-Positive 

Cattle in Animal Feed,’’ for which a 

notice of availability was published in 

the Federal Register of September 30, 

2004 (69 FR 58448). In that guidance, 

the agency made clear that it was not 

going to exercise enforcement discretion 

with regard to the use of BSE-positive 

cattle in animal food or feed. Therefore, 

this rule prohibits the use of BSEpositive cattle in all animal food or feed. 

Additional changes have also been 

made in this final rule to the definition 

of CMPAF. As defined in the proposed 

rule, CMPAF included the brains and 

spinal cords from cattle of any age not 

inspected and passed for human 

consumption (or the entire carcass, if 

brain and spinal cord were not 

removed). FDA explained in the 

preamble to the proposed rule its 

rationale for applying these 

requirements to cattle of any age. This 

rationale cited surveillance data 

showing that cattle not inspected and 

passed for human consumption were 

included in the population of cattle at 

highest risk of BSE, and noted that 

inspection programs were not in place 

in the rendering industry for verifying 

the age of dead cattle. However, given 

the challenges of removing the brain 

and spinal cord from this class of cattle, 

FDA specifically requested comment on 

this issue. 


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FDA has revised the definition of 

CMPAF in the final rule (proposed 

§ 589.2001(a)(iii) and new section 

589.2001(b)(iii)) to prohibit the use of 

the entire carcass of cattle not inspected 

and passed for human consumption that 

are 30 months of age or older from 

which brain and spinal cord have not 

been effectively removed or otherwise 

effectively excluded from animal feed. 

As a result, the rule now prohibits the 

use of the entire carcass of cattle not 

inspected and passed for human 

consumption unless: (1) The cattle are 

shown to be less than 30 months of age, 

or (2) the brains and spinal cords were 

effectively removed or effectively 

excluded from animal feed use. The 

final rule was further revised to require 

renderers to develop and maintain 

written procedures for determining the 

age of and/or removing the brain and 

spinal cord from, dead cattle, and to 

make the written procedures available 

for FDA inspection. FDA notes that, for 

cattle not inspected and passed that are 

diseased or that died otherwise 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: (1) The remaining material from 

cattle that are diseased or that die 

otherwise than by slaughter when the 

brain and spinal cord are effectively 

removed or effectively excluded from 

animal feed use and (2) the entire 

carcass from cattle that are diseased or 

that die otherwise than by slaughter if 

such cattle are shown to be less than 30 

months of age. 

FDA made these revisions based on 

comments indicating that it is feasible to 

put processes in place to age such cattle 

and that very little risk reduction is 

gained by excluding material from such 

cattle. FDA also received many 

comments that raised concerns about 

the environmental impacts of disposing 

of these animals by means other than 

rendering them for animal feed use. 

FDA noted in the preamble to the 

October 2005 proposed rule (70 FR 

58570) that European surveillance data 

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. However, FDA considered 

the level of risk reduction that might 

potentially be achieved by prohibiting 

materials from cattle that are not 

inspected and passed for human 

consumption and that are less than 30 

months of age. 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 

established by the final rule represent a 

secondary level of protection to address 

failures in compliance that may occur 

with the existing ruminant feed rule. 

After considering all of the previously 

mentioned factors, FDA determined that 

the proposed measure to prohibit 

materials from cattle that are not 

inspected and passed for human 

consumption and that are less than 30 

months of age is not necessary. 

Based on comments received, FDA 

has added a provision to this rule so 

that the agency may designate a country 

as not subject to the new requirements 

in this rule. As explained elsewhere in 

this document, a country seeking such 

a designation must submit a written 

request and include information about 

the country’s BSE case history, risk 

factors, measures to prevent the 

introduction and transmission of BSE, 

and any other relevant information. 

Lastly, for renderers handling cattle 

materials, this final rule provides, as did 

the proposed rule, that such renderers 

must establish and maintain records 

sufficient to demonstrate that material 

rendered for animal feed was not 

manufactured from, processed with, or 

does not otherwise contain CMPAF. 

Based on comments received regarding 

verification of CMPAF segregation in 

slaughter facilities, this final rule has 

been revised to clarify that the 

renderer’s records must also include 

documentation that establishments 

supplying cattle materials to the 

renderers have adequate procedures in 

place to effectively exclude CMPAF. 

These supplier-related records must 

include either certification or other 

documentation from the supplier that 

material supplied to the renderer does 

not include CMPAF or documentation 

of another method, acceptable to FDA, 

such as third-party certification, for 

verifying that suppliers have effectively 

excluded CMPAF from animal feed. 

II. Comments on the Proposed Rule 

FDA received more than 840 

comments on the proposed rule. They 

came from a wide variety of 

organizations, such as cattlemen, 

renderers, feed manufacturers, Federal 

agencies, State agriculture departments, 

trade associations, professional 

organizations, universities and research 

institutions, consumer organizations, 

and individuals. Many comments 

questioned the need for additional 

controls in light of the high compliance 

with FDA’s 1997 feed rule by the U.S. 

animal feed industry, coupled with the 

low prevalence of BSE in this country. 

Some comments took the opposing 

view, stating that more aggressive steps 

should be taken by FDA and that all 

ruminant-derived material should be 

prohibited in all animal feed. Some 

comments urged that all exemptions 

(e.g., plate waste and poultry litter) be 

removed from the regulations. Other 

comments asserted that the proposed 

rule was not scientifically based and 

should not be finalized. 

Many comments from industry raised 

concerns about the increased burden—

financial and otherwise—if the 

proposed rule is finalized. Some 

comments discussed the difficulty of 

ensuring complete removal of brain and 

spinal cord from dead cattle. Other 

comments expressed concerns about the 

increased volume of materials that 

would have to be disposed of through 

incineration, landfills, or other means. 

Potentially adverse environmental 

effects—and resultant adverse animal 

and public health consequences—from 

the increased volume of disposal 

materials were mentioned by several 

comments. Comments also expressed 

concerns about registration, 

certification, verification of segregation 

of CMPAF at slaughter establishments, 

recordkeeping, and record retention 

time. 

A description of the comments and 

FDA’s responses follows. 

A. General Comments 

1. Need for Additional BSE Safeguards 

(Comment 1) Many comments, in 

addressing the proposed rule generally, 

said that the current BSE feed regulation 

does not need to be strengthened. 

Reasons given for this position were the 

low prevalence of BSE in this country 

as shown by USDA’s surveillance 

results, the conclusion of the original 

Harvard Risk Assessment that the 

United States is resistant to BSE, and 

the effectiveness of the current ruminant 

feed rule (§ 589.2000) as evidenced by 

the high rate of industry compliance 

and the absence of BSE cases in cattle 

born after the 1997 ruminant feed rule. 

One comment said that FDA should 

develop a more accurate estimation of 

BSE risk to U.S. cattle by entering 

USDA’s most recent prevalence data 

into the Harvard Risk Assessment 

model. 

(Response) FDA agrees that the 

prevalence of BSE in the United States 

is very low, and that compliance with 

the current feed ban by the U.S. animal 

feed industry is at a high level. Though 

the situations are not directly 


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comparable, evidence from the 

European experience has demonstrated 

that BSE transmission can continue to 

occur even with a ruminant feed ban in 

place. FDA believes that eliminating the 

highest risk cattle-derived materials 

from the non-ruminant feed supply will 

further reduce the potential for cattle 

exposure to the BSE agent via crosscontamination of ruminant feed during 

feed manufacturing or transportation, or 

through on-farm misfeeding. As stated 

in the preamble to the proposed rule, 

without fully dedicated equipment, it 

may not be possible to completely 

prevent carryover of feed or feed 

ingredients even when cleanout 

procedures are in place. 

(Comment 2) One comment said that, 

because the cow found in Texas in June 

2005 did not test positive as a typical 

case of BSE, this case does not support 

the need for additional regulation. 

(Response) FDA is aware that the 

PrPSC (disease-specific prion protein) 

isolates from the Texas and Alabama 

cases are atypical in that they have 

characteristics on immunohistochemical 

and western blot analyses that 

distinguish them from the typical BSE 

isolate. Because the significance of these 

differences, particularly with respect to 

origin and transmissibility, is not yet 

clear, the agency believes the atypical 

nature of these two cases does not 

diminish the need to strengthen BSE 

feed controls. 

(Comment 3) Several comments said 

that the proposed rule was not based on 

the BSE situation in the United States, 

but rather on the situation in Europe 

where the incidence of BSE was 500- 

fold greater and control measures were 

instituted after BSE cases were 

identified. One comment also thought 

FDA might have developed its proposal 

based on the BSE situation in Japan. 

(Response) While the data from 

Europe and Japan on BSE provided the 

agency with important information to 

help develop our response to BSE, the 

agency based its decision on the BSE 

situation in the United States and 

believes that these measures are 

appropriate to the United States 

situation. The agency believes, however, 

that the early firewalls (prohibition on 

imports of animals and ruminant feed 

from countries with BSE and the 

ruminant feed ban) put in place in the 

United States makes it possible and 

appropriate to strengthen feed controls 

with measures that are still less 

expansive than those that would be 

appropriate in countries with higher 

BSE prevalence such as in European 

countries and Japan. The measures 

being implemented are commensurate 

with the BSE prevalence in the United 

States. 

(Comment 4) Several comments 

declared that the recommendations in 

the International Review Team’s (IRT) 

February 2005 report are not relevant to 

the development of this rule because 

they were not based on science, they do 

not reflect the difference in BSE risk 

between Europe and the United States, 

and they do not present an accurate 

understanding of the U.S. industry’s 

compliance with the existing BSE feed 

regulation. 

(Response) FDA agrees that not all of 

the IRT recommendations are 

appropriate for the U.S. situation. 

However, FDA is adopting the IRT 

recommendation to require the removal 

of certain cattle-derived risk materials 

from all animal feed. FDA believes that 

the level of compliance with the current 

ruminant feed rule by the U.S. animal 

feed industry is high, but believes that 

the additional measures provide a 

secondary level of protection to address 

failures in compliance that may occur 

with the existing ruminant feed rule. 

(Comment 5) One comment said that 

cross-contamination is not a problem 

because the BSE prevalence is so low in 

the United States. Another comment 

asked for the data the agency is relying 

on to show that cross-contamination 

and feeding errors need to be controlled, 

especially since the agency’s own 

statistics show the industry is in high 

compliance with the 1997 ruminant 

feed rule. 

(Response) FDA agrees that overall 

compliance with the 1997 ruminant 

feed rule by the U.S. animal feed 

industry has been high, but there have 

been instances of noncompliance with 

the rule that could have resulted in 

cattle being exposed to prohibited 

material through cross-contamination, 

mislabeling, or intentional or 

unintentional misfeeding. Information 

describing these instances of 

noncompliance was set forth in the 

preamble to the October 2005 proposed 

rule (70 FR 58570 at 58577). An updated 

summary of compliance information is 

provided in the References section of 

this document (Ref. 2). 

(Comment 6) A few comments asked 

FDA to recognize that the USDA 18- 

month surveillance snapshot may not be 

an accurate indication of BSE 

prevalence in the United States. 

Specifically, because the BSE cases to 

date are likely clustered in time and 

location, USDA’s surveillance results 

may underestimate the true risk. 

(Response) FDA stated in the 

preamble to the proposed rule that the 

detection of one BSE case in over 

418,000 samples analyzed under 

USDA’s enhanced surveillance program 

at the time of the publication of the 

proposed rule indicates that the 

prevalence of BSE is very low in the 

U.S. cattle population. FDA notes that 

USDA has conducted surveillance for 

BSE since 1990. A July 20, 2006, USDA 

report entitled ‘‘An Estimate of the 

Prevalence of BSE in the United States’’

supports FDA’s qualitative statement of 

a very low prevalence of BSE in the 

United States (Ref. 3). According to the 

report, a model developed in Europe 

was used to calculate U.S. BSE 

prevalence from two BSE cases detected 

in 735,213 samples collected over a 7- 

year period ending in March 2006. 

Results of this analysis support a 

conclusion that the prevalence of BSE in 

the U.S. cattle population is less than 

one infected animal per million adult 

cattle. 

FDA remains confident in the two 

models used by USDA. The most likely 

values calculated by these models for 

the estimated number of cases were 4 or 

7 infected animals out of 42 million 

adult cattle. USDA’s analysis was 

submitted to the scrutiny of a peer 

review process, and the expert panel 

agreed with the appropriateness of 

USDA’s assumptions and the factors it 

considered, as well as with the estimate 

of BSE prevalence. 

(Comment 7) One comment noted that 

the effectiveness of the feed ban, 

especially at the farm level, is not 

known. 

(Response) Inspection results indicate 

that compliance by U.S. animal feed 

industry is high. However, FDA agrees 

that it is very difficult to assess 

compliance with the ruminant feed rule 

at the farm level. FDA believes 

excluding certain cattle-derived risk 

materials from all animal feed channels 

will minimize any residual risks from 

on-farm misfeeding. 

(Comment 8) Two comments 

indicated that the agency’s feed control 

measures for ensuring compliance with 

the 1997 ruminant feed rule have been 

inadequate, citing a Government 

Accountability Office (GAO) study as 

evidence. 

(Response) FDA disagrees with these 

comments. FDA believes its 

enforcement activities are adequate for 

ensuring industry compliance with the 

1997 ruminant feed rule. The agency’s 

response to the GAO’s study can be 

found in Appendix VI of the GAO’s 

report (Ref. 4). 

(Comment 9) One comment 

speculated that, in some species, 

atypical BSE might be more pathogenic 

than typical BSE. 

(Response) FDA is not aware of any 

scientific evidence that atypical BSE is 


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more pathogenic than typical BSE. 

Therefore, the agency believes that the 

controls in this final rule are 

appropriate. 

(Comment 10) Several comments said 

the proposed rule will hamper BSE 

surveillance by reducing the number of 

cattle available for sampling. 

(Response) FDA has conferred with 

USDA on the development of this rule. 

Further, USDA’s transition from 

enhanced BSE surveillance to ongoing 

BSE surveillance places greater 

importance on collecting samples where 

clinical histories on sampled animals 

are more likely to be available, such as 

on farms and at diagnostic laboratories, 

and less importance on sampling at 

rendering plants where clinical histories 

are usually not available (Ref. 5). 

2. Other Approaches for Strengthening 

Feed Controls 

A number of comments recommended 

ways to strengthen feed controls that 

they believed would provide better 

protection than the measures proposed 

by FDA. 

(Comment 11) Several comments 

stated that the proposed rule does not go 

far enough, that it still allows materials 

derived from ruminant species to be fed 

to other species, and that it does not 

include any of the actions announced 

on January 26, 2004. Several comments 

suggested that no animal or mammalian 

products be allowed in cattle feed or in 

feed for any other food-producing 

animal species. One comment noted 

that, although the proposed rule is a 

small step in the right direction, it is 

inadequate to close the existing 

loopholes. Two comments stated that 

the proposal ignores some of the 

recommendations made by the IRT and 

other BSE experts. Several comments 

stated that the proposed rule would 

leave 10 percent of the potential 

infectivity in the feeding system. One 

comment stated that the 10-percent 

infectivity may represent 780 ID50 (ID50

is the amount of infective material that 

would result in a case of BSE in 50 

percent of the cattle that consumed it). 

Another comment remarked that distal 

ileum should be removed from animal 

feed, regardless of the disposal problems 

this could cause. In contrast, several 

comments were supportive of the 

agency’s reasoning behind the proposed 

rule. These comments stated that 

removal of brain and spinal cord from 

cattle 30 months of age and older is the 

single most important step that can be 

taken to prevent the amplification of 

BSE and thereby shorten the time it 

takes to eradicate any latent BSE 

infectivity that might be present but 

undetected in U.S. cattle. Some 

comments further noted that the 

proposal is consistent with the IRT 

recommendation regarding a staged 

approach to removing SRM from animal 

feed. 

(Response) The agency does not 

believe it is necessary, given the low 

prevalence of BSE in the United States, 

to prohibit all ruminant material from 

animal feed, nor is it necessary to 

prohibit all animal or all mammalian 

products in cattle feed. Our reasoning 

for deciding against the measures under 

consideration by FDA that were 

announced on January 26, 2004, and 

choosing instead to focus on certain 

cattle-derived risk materials was fully 

explained in the preamble to the 

October 2005 proposed rule (70 FR 

58570 at 58578). In deciding to prohibit 

brain and spinal cord only from cattle 

30 months of age or older, rather than 

the full list of SRMs, FDA 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 in this rule represent 

a secondary level of protection to 

address potential failures in compliance 

that may occur with the existing 

ruminant feed rule. FDA believes that 

the existing ruminant feed rule provides 

a strong line of defense by prohibiting 

the use in ruminant feed of protein 

derived from mammalian tissues. The 

additional measures in this final rule 

will further reinforce existing ruminant 

feed protection measures by removing 

the highest risk cattle-derived materials 

from all animal feed. 

(Comment 12) One comment stated 

that the agency’s proposal was too broad 

and asked that the rule be limited to 

removal of brain and spinal cord from 

dead and antemortem condemned cattle 

30 months of age or older. The comment 

said this would have captured the two 

BSE cases in Washington and Texas. 

(Response) FDA believes that the rule 

should apply to cattle slaughtered for 

human consumption as well as to cattle 

not inspected and passed for human 

consumption at antemortem inspection. 

Infected cattle that are over 30 months 

of age and in the preclinical stage of 

disease could pass antemortem 

inspection, yet still harbor significant 

levels of BSE infectivity in the brain and 

spinal cord. 

(Comment 13) Numerous comments 

suggested that FDA prohibit the use of 

blood in animal feed. Reasons 

mentioned were that blood has been 

shown to contain TSE infectivity in 

several species, that vCJD has been 

found to be transmitted through blood, 

and that emboli created by stunning 

could carry infectivity. One comment 

said that, with more sensitive detection 

methods, BSE infectivity may be 

confirmed in blood. In contrast, 

numerous comments said FDA should 

continue to allow the use of blood in 

animal feed because there is no 

scientific basis for prohibiting blood in 

cattle feed and because calf health is 

dependent on colostrum supplements, 

which include blood products. One 

comment said that the chair of the IRT 

committee stated that blood does not 

transmit BSE. 

(Response) As explained in the 

preamble to the proposed rule, FDA is 

not prohibiting the use of blood and 

blood products in animal feed because 

we believe such a prohibition would do 

very little to reduce the risk of BSE 

transmission. Although TSE infectivity 

has been demonstrated experimentally 

in the blood (Ref. 6) of sheep and 

rodents (Ref. 7), species differences in 

the involvement of the lymphoreticular 

system in TSE diseases suggest that 

these findings cannot necessarily be 

extrapolated to cattle (Ref. 8). Studies 

using mouse and cattle bioassays have 

so far failed to detect BSE infectivity in 

bovine blood (Ref. 9). While FDA agrees 

that more sensitive detection methods 

might some day demonstrate BSE 

infectivity in bovine blood, the agency 

believes that it is highly unlikely that 

the BSE agent is present in blood of 

infected cattle at levels sufficient to 

transmit disease through oral 

administration of processed blood 

products. This conclusion is based on 

the inefficiency of the oral route of 

transmission relative to the intracerebral 

route, which was used in unsuccessful 

attempts to detect BSE infectivity in 

bovine blood. FDA believes that the 

prohibitions in this final rule make it 

unnecessary to also preclude the use of 

blood in animal feed. 

(Comment 14) A number of comments 

requested that poultry litter not be 

permitted to be fed to cattle, citing 

several reasons. One comment asked 

that FDA determine actual risk before 

deciding that poultry litter is not a risk 

factor. One comment stated that feces 

were infectious in rodents orally 

challenged with scrapie. Another 

comment noted that, in the United 

Kingdom, when cattle are orally 

challenged, the feces must be treated as 

medical waste for 1 month postchallenge. Another comment stated that 

TSE agents may be present in the 

porcine/poultry intestinal content, 

while still another comment stated that 

the 2001 World Health Organization/ 

Food and Agriculture Organization of 

the United Nations/World Organisation 

for Animal Health (OIE) Technical 


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Consultation concluded that digestive 

contents and fecal material from 

livestock or poultry being fed meat and 

bone meal (MBM) potentially 

contaminated with BSE should not be 

used as an ingredient in animal feed. 

(Response) In the preamble to the 

October 2005 proposed rule, FDA 

provided calculations submitted in 

comments to the advance notice of 

proposed rulemaking (ANPRM) that 

published in the Federal Register on 

July 14, 2004 (69 FR 42288), showing 

that a cow would need to consume a 

very large volume of poultry litter to 

ingest an infectious dose of BSE, 

assuming that the poultry feed spilled 

into the litter was formulated with MBM 

derived from a BSE-infected cow. Based 

on this analysis, FDA believes that the 

risk of cattle exposure to an infectious 

dose of BSE through poultry litter is 

low. The measures contained in this 

final regulation should reduce that risk 

even further because removing CMPAF 

from all animal feed prevents BSE 

infectivity from reaching poultry in the 

first place. 

(Comment 15) Several comments 

disagreed with the need for prohibiting 

poultry litter in cattle feed if FDA 

finalizes the proposed measures. Two 

comments said that there is no scientific 

basis for prohibiting poultry material in 

ruminant rations. Another comment 

pointed out that banning poultry litter 

would create significant disposal issues. 

(Response) As discussed in the 

response to the previous comment, 

because the rule prohibits the use of the 

highest risk cattle-derived materials in 

all animal feed, FDA agrees that it is not 

necessary to prohibit poultry litter from 

being fed to cattle. 

(Comment 16) Several comments 

recommended that dedicated facilities 

and equipment be required in order to 

prevent cross-contamination. One 

comment disagreed, stating that 

requiring dedicated facilities would 

force some renderers to discontinue 

operations. 

(Response) As explained in the 

preamble to the October 2005 proposed 

rule (70 FR 58570 at 58584), FDA fully 

expects this final rule to reduce 

substantially the remaining risk 

associated with cross-contamination, 

and therefore does not believe that the 

rule needs to also require dedicated 

facilities and equipment. 

(Comment 17) One comment 

suggested a ‘‘systems approach’’ as a 

substitute for the measures presented in 

the proposed rule. This approach, 

according to the comment, would 

prohibit the entire carcass (except 

skeletal muscle) of mature dead cattle 

and the brain and spinal cord of mature 

slaughter cattle from all animal feed. It 

would also prohibit the use of hypobaric 

(vacuum) rendering for processing 

inedible ruminant material. The 

commenter submitted modeling data 

obtained using the Harvard Risk 

Assessment model, which showed that 

this approach is as protective of animal 

and public health as a complete SRMs 

ban, while creating a much smaller 

disposal challenge. According to the 

modeling results, the ‘‘systems 

approach’’ and the full SRMs approach 

would reduce cases of BSE by 97 

percent and 99 percent, respectively. 

FDA’s proposed measures would reduce 

new cases by 40 percent to 63 percent, 

depending on the effectiveness of brain 

and spinal cord removal. The comment 

acknowledged that the ‘‘systems 

approach’’ would initially create 

disposal challenges, especially in the 

dairy sector, but that cost-effective 

carcass disposal methods could be 

implemented. 

(Response) The difference between 

the comment’s ‘‘systems approach’’ and 

the approach in this final rule is that the 

‘‘systems approach’’ would exclude the 

entire carcass of dead cattle 30 months 

of age or older rather than only the brain 

and spinal cord. As the comment 

acknowledges, eliminating the 

rendering option (other than disposal 

rendering) for disposal of all dead cattle 

30 months of age or older may create 

major disposal challenges in some 

regions of the country (see 

‘‘Environmental Assessment’’ for this 

final rule, Docket No. 2002N–0273). 

Modeling results submitted by the same 

commenter in response to the ANPRM 

showed that eliminating vacuum 

rendering contributed very little to the 

effectiveness of the ‘‘systems approach.’’

The agency believes that excluding 

brain and spinal cord from all cattle 30 

months of age or older, and not the 

complete list of SRMs, is the most 

appropriate course of action for the 

United States where the BSE prevalence 

is low and strong feed controls are 

already in place. 

(Comment 18) Citing the link of BSE 

cases in Alberta to hypobaric (or 

vacuum) rendering, one comment 

recommended that the use of hypobaric 

rendering be prohibited because it 

provides no TSE inactivation. 

(Response) FDA agrees that the cluster 

of BSE cases associated with a vacuum 

renderer in Alberta underscores the 

concern about the ability of this process 

to inactivate BSE infectivity. A major 

advantage of the measures in this final 

rule over other options considered is 

that they prevent the highest risk cattlederived materials from all animal feed, 

thereby reducing concerns about 

vacuum rendering. 

(Comment 19) One comment said that 

FDA should prohibit the use of 

mammalian protein in feed for food 

producing animals, and cited the 

following recent research to support this 

position: 

• Infectious dose may be smaller than 

previously thought: Attack rate studies 

in the United Kingdom have 

demonstrated transmission at a 0.001 

gram (g) dose (no reference), 10 times 

lower than the 0.01 g dose described by 

FDA in the proposal. 

• Repeated low dose exposure: A 

study in which scrapie was injected into 

mice (Jacquemot 2005) showed that 

repeated low doses caused scrapie when 

a single dose of the same size did not. 

A second study in which scrapie was 

administered orally to hamsters 

(Diringer 1998) showed a higher 

incidence of scrapie in hamsters 

receiving repeated doses than in 

hamsters receiving a single dose. 

• Additional organs may be 

infectious: Disease-specific prion 

protein (PrPsc) was found in the kidney, 

pancreas, and liver of scrapie infected 

mice when inflammation was induced 

in these organs (Heikenwalder 2005). 

Another study showed PrPsc in the 

urine of scrapie infected mice with 

kidney inflammation. A third study 

found PrPsc present in mammary glands 

of sheep with mastitis (Ligios 2005). 

• Interspecies barrier may be smaller 

than previously thought: Some studies 

have shown interspecies inoculation 

produced subclinical disease but not 

clinical disease, suggesting that 

previously assumed species barriers 

were not complete (Hill 2000). 

(Response) FDA is aware that BSE 

transmission has been demonstrated at 

a 0.001 g dose. FDA is also aware of the 

other recent scientific findings and 

considered this information as we were 

developing the final rule. The agency 

believes that the risks associated with 

repeated low dose exposure, infectivity 

in inflamed organs, and unapparent 

carriers of BSE infectivity are very low. 

The agency believes the risks of BSE 

infection are adequately addressed by 

the 1997 ruminant feed rule and this 

final rule, and that it is not necessary to 

prohibit all mammalian protein in feed 

for food-producing animals. 

(Comment 20) One comment noted 

that species which appear to be resistant 

may in fact be unapparent carriers and 

over time could become sources of the 

BSE agent. Another comment added that 

failure to detect infectivity in tissues of 

experimentally infected pigs and 

chickens might be due to insufficiently 

sensitive bioassay techniques. Another 


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comment suggested that because swine 

and poultry may be silent carriers, 

materials derived from swine and 

poultry should not be fed to cattle. 

(Response) These concerns were first 

addressed in the 1997 ruminant feed 

rule (62 FR 30936 at 30939). The agency 

has received no new information that 

would lead us to conclude that the 

additional measures suggested by these 

comments are needed to protect against 

BSE at this time. 

(Comment 21) Several comments said 

that FDA should remove the exemptions 

in the current feed rule, with the 

possible exception of the exemption for 

milk. 

(Response) As discussed in the 

preamble to the October 2005 proposed 

rule (70 FR 58570 at 58573), the agency 

considered eliminating certain of the 

current exemptions in the 1997 

ruminant feed rule. However, as further 

discussed in that preamble, given low 

levels of BSE prevalence and high 

compliance with the 1997 ruminant 

feed ban, the agency determined that 

prohibiting the highest risk cattlederived materials from all animal feed 

would be the most appropriate measure 

in the United States to further reduce 

the remaining risk of BSE infection not 

already addressed by the 1997 feed ban. 

Other responses to comments in the 

preamble to this final rule also discuss 

the agency’s reasons for not eliminating 

certain exemptions in the 1997 

ruminant feed rule. 

(Comment 22) Numerous comments 

suggested that the plate waste 

exemption be eliminated. Reasons cited 

were that plate waste could contain 

highly infectious material, FDA has not 

specified the reheating requirements 

sufficient to inactivate the agent, it 

could be a factor in the spread of 

scrapie, and it confounds feed testing. In 

contrast, one comment advised against 

eliminating the exemption, noting that 

potential infectivity in high risk 

material has already been removed from 

meat by USDA regulations. 

(Response) The exemption in the 1997 

ruminant feed rule is specifically for 

‘‘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)’’ (§ 589.2000(a)(1)). FDA 

disagrees that it is necessary to 

eliminate the plate waste exemption 

because, since 2004, human food has 

been required to be free of SRMs by 

USDA and FDA (69 FR 1862, January 

12, 2004 (affirmation of interim rule 72 

FR 38699, July 13, 2007), and 69 FR 

42256, July 14, 2004, respectively). 

3. International Trade Issues 

The agency received a number of 

comments about trade, particularly 

about international standards related to 

feed controls for the prevention of BSE. 

(Comment 23) One comment stated 

that FDA should not place more 

importance on trade considerations than 

on animal health, while another 

comment asserted that the proposed 

rule does not meet international 

standards, and therefore export markets 

may remain closed to U.S. products. In 

contrast, another comment stated that 

the proposed rule would satisfy trading 

partners and should help to reopen 

export markets. 

(Response) FDA’s mission is to 

promote and protect public health. The 

agency’s regulations are issued to 

achieve this mission. FDA is also aware 

of the international trade obligations of 

the United States and considers these 

obligations in rulemaking. FDA believes 

that this final rule, while based on its 

mission to promote and protect the 

public health, is consistent with 

international trade obligations. 

(Comment 24) One comment stated 

that the OIE recommends that feed and 

certain other commodities from 

controlled risk countries should not be 

traded if they contain protein from 

brains, eyes, spinal cord, skull, or 

vertebral column from cattle 30 months 

of age or older, or contain protein from 

the distal ileum or tonsils from cattle of 

any age. The comment added that if 

these commodities should not be traded 

internationally, then they should not be 

used domestically. 

(Response) The OIE guidelines 

described in the comment apply to meat 

products for human consumption and 

ruminant feed. They do not apply to all 

animal feed. FDA also notes that these 

risk materials are already prohibited 

from all ruminant feed. As discussed 

throughout the preamble to this final 

rule, FDA believes further prohibiting 

brain and spinal cord from cattle 30 

months of age and older in all animal 

food or feed is appropriate for the U.S. 

situation. 

(Comment 25) Several comments 

stated that FDA should harmonize its 

new BSE feed regulations with those 

proposed by Canada. One comment 

provided a recommendation on how the 

United States and Canadian feed 

regulations should be harmonized, 

suggesting that both countries prohibit 

dead and downer cattle and require the 

removal of brain and spinal cord from 

cattle 30 months of age and older at 

slaughter. In contrast, another comment 

stated that trade with Canada should be 

restricted because of inadequate feed 

controls and inadequate surveillance in 

Canada. 

(Response) The governments of the 

United States and Canada discussed the 

differences between their proposed 

regulations and considered options for 

aligning the two regulations. This led to 

a better understanding of each country’s 

situation. Having considered the 

circumstances related to each of the 

BSE-positive cows and the control 

systems in place in Canada and the 

United States, FDA has concluded that 

measures in the 1997 ruminant feed rule 

and in this final rule are the most 

appropriate for the situation in the 

United States. 

(Comment 26) Australia and New 

Zealand commented that they should 

not have to meet the proposed FDA 

requirements for exporting feed 

products to the United States because 

both countries have BSE-free status. 

Further, they stated that such 

requirements are contrary to World 

Trade Organization obligations under 

the Sanitary and Phytosanitary 

Agreement. 

(Response) As stated previously, FDA 

is aware of the international trade 

obligations of the United States and has 

considered these obligations throughout 

the rulemaking process for this 

regulation. In the preamble to FDA’s 

interim final rule on prohibiting the use 

of certain cattle materials in human food 

and cosmetics (69 FR 42256, July 14, 

2004), FDA requested comment on 

standards to apply when determining 

another country’s BSE status, providing 

an exemption for ‘‘BSE-free’’ countries, 

and how to determine that countries 

meet any standards that might be 

developed. On July 13, 2007, USDA’s 

FSIS published a final rule ‘‘Prohibition 

of the Use of Specified Risk Materials 

for Human Food and Requirements for 

the Disposition of Non-Ambulatory 

Disabled Cattle; Prohibition on the Use 

of Certain Stunning Devices Used to 

Immobilize Cattle During Slaughter’’

(also referred to as ‘‘the SRM final rule’’) 

(72 FR 38700), which affirmed, with 

changes, interim measures implemented 

by FSIS to minimize human exposure to 

materials that could potentially contain 

the BSE agent. One change that FSIS 

made in the SRM final rule was to 

exclude from the definition of SRMs 

materials from cattle from a country that 

can demonstrate that its BSE risk status 

can reasonably be expected to provide 

the same level of protection from human 

exposure to the BSE agent as prohibiting 

the use of SRMs for human food does in 

the United States. In the preamble to the 

SRM final rule, FSIS explained that 

those countries that believe that they are 

eligible to have materials from their 


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cattle excluded from the definition of 

SRMs should provide sufficient 

scientific evidence to support their 

claimed BSE risk status, and FSIS 

would then develop criteria to evaluate 

the equivalence request. FDA has 

decided to adopt a similar approach, 

and will allow a foreign country to seek 

a designation from FDA by which the 

restrictions otherwise applicable to 

animal feed would not apply to cattlederived material from that country. Any 

country seeking such a designation 

would have to provide sufficient 

scientific evidence to support its 

claimed BSE risk status. 

B. Comments on Proposed New 

§ 589.2001—Cattle Materials Prohibited 

in Animal Food or Feed 

1. Definition of Cattle Materials 

Prohibited in Animal Feed (CMPAF) 

FDA received numerous comments 

addressing the definition of ‘‘cattle 

materials prohibited in animal food or 

feed’’ (CMPAF) as set forth in proposed 

§ 589.2001(a). While some urged that all 

deads and downers, regardless of age, be 

included in the definition, others 

suggested that younger cattle be 

excluded from the definition because of 

science showing a lower infectivity risk 

in this group. 

(Comment 27) Numerous comments 

suggested that FDA exclude all deads 

and downers, regardless of their age, 

from the feed chain because they 

contain the highest level of infectivity 

and because the Harvard-Tuskegee 

Study showed reduction of the risk of 

BSE transmission when these two 

categories of animals were eliminated 

from the feed stream. Several comments 

said that infectivity could be present in 

tissues other than brain and spinal cord. 

Specifically mentioned was new 

research showing infectivity in 

peripheral nerves, both in one cow 

using a new bioassay technique 

(Buschmann and Groschup, 2005 (Ref. 

10)), and in a 94-month-old BSE 

infected cow in Japan using a western 

blot method. One comment said that 

subclinical infection could be present in 

cattle younger than 30 months of age. 

(Response) FDA disagrees that it is 

necessary to prohibit all cattle not 

inspected and passed for human 

consumption from all animal feed to 

prevent BSE infection. BSE has a long 

incubation period. Epidemiological data 

from the United Kingdom epidemic 

have demonstrated that, on average, 

cattle develop clinical signs 4 to 6 years 

after infection (Bradley 1991; Anderson 

1996 (Ref. 11)), though the incubation 

period can be longer or shorter than 4 

to 6 years. With BSE, as with other 

TSEs, the total amount of infectivity in 

an animal increases throughout the 

incubation period, reaching the highest 

load at the end, very close to the death 

of the animal. Infectivity is considered 

to increase exponentially after exposure, 

reaching 4.5 logs less than clinical cases 

by 50 percent of the incubation period, 

and 3 logs less than a clinical case at 70 

percent of the incubation period (Comer 

and Huntly, 2003 (Ref. 12)). Therefore, 

FDA assumes that the benefit shown in 

the Harvard-Tuskegee Study of 

excluding animals that die on the farm 

from the animal feed chain (77 percent 

reduction in mean number of new cases) 

is primarily attributable to excluding 

older deadstock. 

FDA does not believe that studies 

showing BSE infectivity in peripheral 

nerves are sufficient to justify 

prohibiting all cattle not inspected and 

passed from use in all animal feed to 

prevent BSE infection. In the 

Buschmann and Groschup study, the 

experimental mice used were 

approximately 10 times more sensitive 

than cattle to the BSE agent, and the 

donor cow was showing severe signs of 

late-stage clinical BSE. Furthermore, 

based on end-point titration, incubation 

time, and transmission rate, the 

infectivity levels in peripheral nerves 

are extremely low compared to levels in 

brain and spinal cord. The mice were 

injected both intracerebrally and 

intraperitoneally, which is much more 

efficient than the oral route of 

administration. Therefore, the agency 

believes that very little BSE risk 

reduction would be realized if this final 

rule prohibited all cattle not inspected 

and passed for human consumption 

from use in all animal feed. 

(Comment 28) Several comments 

suggested that deads and downers under 

30 months of age be allowed in nonruminant feed without brain and spinal 

cord removal, pointing out that no risk 

reduction is achieved by this 

requirement, and that age of deadstock 

could be verified by dentition, records, 

animal identification systems, or an 

onsite inspection. One comment said 

that FDA should provide guidance to 

renderers for procedures to verify age of 

cattle. 

(Response). FDA agrees that very little 

BSE risk reduction would be realized by 

prohibiting from animal feed all cattle 

less than 30 months of age that were not 

inspected and passed for human 

consumption and from which brain and 

spinal cord had not been removed. In 

the preamble to the October 2005 

proposed rule, the agency explained the 

rationale for the 30-month age criterion 

and stated that it should be applied in 

the animal feed context. However, the 

agency also explained that the decision 

to prohibit all cattle not inspected and 

passed for human consumption from 

which the brain and spinal cord were 

not removed from animal feed was 

based on the fact that procedures were 

currently not in place at rendering 

facilities to verify that firms were 

determining the age of cattle effectively 

(70 FR 58570 at 58578). Several 

comments suggested methods to 

determine the age of dead cattle, 

including animal identification systems, 

dairy herd records, dentition, body 

weight, or feed lot origin. 

Based on the limited scientific basis 

with regard to BSE risk reduction for 

prohibiting cattle not inspected and 

passed for human consumption less 

than 30 months of age and the 

comments suggesting ways to determine 

the age of such cattle, FDA has revised 

the definition of CMPAF in the final 

rule. The revised definition of CMPAF 

includes the entire carcass of cattle not 

inspected and passed for human 

consumption that are 30 months of age 

or older from which brains and spinal 

cords were not effectively removed or 

otherwise effectively excluded from 

animal feed. The final rule requires 

renderers to maintain written 

procedures if they remove brain and 

spinal cord from such cattle, or separate 

such animals based on whether or not 

they are 30 months of age or older. As 

suggested by one comment, FDA will 

issue separate guidance for industry on 

methods for determining the age of 

cattle. FDA will work with USDA to 

develop methods consistent with those 

of USDA. 

As FDA noted previously (70 FR 

58570 at 58579), section 402(a)(5) of the 

act states that a food shall be deemed to 

be adulterated if it is, in whole or in 

part, the product of a diseased animal or 

of an animal which has died otherwise 

than by slaughter. Since the category of 

cattle defined in this final rule as ‘‘cattle 

not inspected and passed for human 

consumption’’ are animals that already 

fall within the category of animals 

referred to in section 402(a)(5) of the act 

as ‘‘diseased animals or animals which 

died otherwise than by slaughter,’’ any 

animal feed derived from such animals 

would be considered adulterated. 

However, 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. With 

the implementation of this final rule, 

FDA will no longer exercise 

enforcement discretion over those 

materials prohibited by this regulation 

(i.e., CMPAF) that are derived from 

cattle not inspected and passed for 


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human consumption. FDA intends to 

continue exercising such discretion 

(relative to section 402(a)(5) of the act) 

for the use in animal feed of material 

derived from such cattle that are not 

defined as CMPAF. This includes (1) 

The remaining material from cattle not 

inspected and passed for human 

consumption when the brain and spinal 

cord are effectively removed or 

effectively excluded from animal feed 

use and (2) the entire carcass from cattle 

not inspected and passed for human 

consumption if such cattle are shown to 

be less than 30 months of age. 

(Comment 29) One comment asked 

that downer cattle not be allowed in 

animal feed. 

(Response) Under the final rule, to 

prevent BSE, cattle not inspected and 

passed for human consumption are 

prohibited from use in animal feed 

unless they are shown to be less than 30 

months of age or the brain and spinal 

cord are effectively removed or 

effectively excluded from animal feed. 

FDA originally included cattle of any 

age that were not inspected and passed 

for human consumption in the 

definition of CMPAF because: (1) 

European surveillance data suggested 

that cattle not inspected and passed for 

human consumption posed a higher risk 

for BSE and (2) we believed that 

processes were currently not established 

in the rendering industry for verifying 

the age of such cattle through 

inspection. However, FDA received 

comments on the feasibility of aging 

such cattle and on the relatively low 

risk reduction achieved by excluding 

such cattle if they were less than 30 

months of age. FDA considered these 

comments, surveillance data indicating 

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

very low, the strong feed protection 

provided by the existing ruminant feed 

rule, and the added secondary level of 

protection provided by the other 

provisions of this final rule. Based on 

these factors, FDA concluded that it was 

not necessary to include in the 

definition of CMPAF cattle not 

inspected and passed for human 

consumption that are under 30 months 

of age. 

(Comment 30) One comment 

requested that striated muscle from 

cattle that died otherwise than by 

slaughter be allowed to be harvested for 

use in non-ruminant feed. 

(Response) This final rule does not 

prohibit the use of cattle not inspected 

and passed for human consumption in 

animal feed if they are shown to be less 

than 30 months of age or if the brain and 

spinal cord are effectively removed or 

otherwise effectively excluded from 

animal feed. 4–D operations (plants that 

harvest skeletal muscle from dead, 

dying, diseased, or disabled cattle) that 

harvest skeletal muscle for such use as 

pet and mink food fall within the final 

rule’s definition of renderer and must 

have written procedures in place 

describing the aging methods and 

specifying how brain and spinal cord, or 

parts of carcasses containing brain and 

spinal cord, will be effectively removed 

or effectively excluded from animal 

feed. As discussed in more detail in the 

response to Comment 28, FDA notes 

that the use in animal feed of materials 

from cattle not inspected and passed for 

human consumption that are diseased 

or that die otherwise than by slaughter 

is the subject of enforcement discretion. 

(Comment 31) One comment from a 

foreign country requested that FDA 

clarify whether beef recovered by 

Advanced Meat Recovery (AMR) 

systems from vertebral column, from 

which spinal cord has been removed, is 

permissible in animal feed. 

(Response) This final rule does not 

prohibit in animal feed an AMR product 

derived from the vertebral column of 

cattle from which spinal cord has been 

removed prior to the AMR process, 

provided that the other requirements of 

the final rule are also met. 

2. Definition of Cattle Not Inspected and 

Passed for Human Consumption 

(Comment 32) Several comments 

stated that cattle carcasses and parts 

condemned on post-mortem inspection 

should not be considered CMPAF 

because some parts of the condemned 

carcass may have already been 

commingled with normal slaughter 

byproducts. The comments suggested 

that the definition ‘‘cattle not inspected 

and passed for human consumption’’ be 

changed to ‘‘cattle that do not pass antemortem inspection.’’

(Response) The agency did not intend 

for the purposes of this regulation that 

the carcasses of cattle condemned on 

post-mortem inspection be included in 

the definition of cattle not inspected 

and passed for human consumption. 

The agency intended this category of 

cattle to include cattle that had been 

presented to a slaughter establishment 

and rejected (did not pass ante-mortem 

inspection) as well as cattle that had not 

been presented to a slaughter 

establishment and, hence, were not 

subject to inspection by an appropriate 

regulatory authority. To clarify this, 

FDA is modifying the definition of 

‘‘cattle not inspected and passed for 

human consumption’’ in this final rule 

to mean ‘‘cattle that did not pass antemortem inspection by the appropriate 

regulatory authority. 

3. Restrictions on Tallow 

(Comment 33) One comment stated 

that the proposal is unclear as to 

whether the 0.15-percent insoluble 

impurity standard applies to all tallow 

or only to tallow derived from CMPAF. 

The comment requested that the tallow 

standard only apply to CMPAF-derived 

tallow. 

(Response) The final rule defines 

tallow as CMPAF if it is derived from: 

(1) BSE-positive cattle or (2) from other 

CMPAF material and contains insoluble 

impurities greater than 0.15 percent. 

The existing § 589.2000 has been 

changed to clarify that protein derived 

from mammalian tissues does not 

include tallow containing 0.15 percent 

or less insoluble impurities. The result 

of these changes is that tallow usage is 

more restrictive in ruminant feed than 

in feed for non-ruminants. All tallow 

that contains more than 0.15 percent 

insoluble impurities is prohibited in 

ruminant feed, but only tallow that 

contains more than 0.15 percent 

insoluble impurities and that is made 

from CMPAF is prohibited in the food 

or feed of all animals. 

(Comment 34) Five comments stated 

that tallow should be prohibited in 

animal feed. Two comments said that 

tallow should be entirely free of protein 

impurities. In contrast, another 

comment said that tallow from animals 

inspected and passed for human 

consumption with SRM removed should 

be allowed in animal feed without the 

0.15 percent restriction. 

(Response) The agency disagrees that 

all tallow should be prohibited in 

animal feed or that tallow should be free 

of impurities to be used in animal feed. 

The OIE considers tallow with less than 

0.15 percent insoluble impurities to be 

protein-free. Further, OIE guidelines 

recommend that tallow meeting this 

standard is safe for use in animal feed, 

regardless of the exporting country’s 

BSE status. As explained in the 

proposed rule, the agency is concerned 

about protein impurities that may be 

present in tallow particularly now that 

an attack rate study in the United 

Kingdom has found that oral 

administration of a very low dose (1 

milligram (mg)) of BSE-infected brain 

produced disease in 1 of 15 calves 

receiving the dose. The agency sought 

comment on its proposed action, but no 

comments were received that provided 

a scientific basis for the agency to 

modify its position. Therefore, FDA has 

decided to prohibit all tallow containing 

more than 0.15 percent insoluble 

impurities from use in ruminant feed, 

but prohibit only tallow that contains 

more than 0.15 percent insoluble 


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impurities and is made from CMPAF 

from use in food or feed for other animal 

species. 

(Comment 35) Two comments said 

that, because no BSE risk is associated 

with the dirt, bone, and sand that 

comprise the impurities in tallow, the 

agency does not need to prohibit tallow 

containing more than 0.15 percent 

impurities. 

(Response) These comments imply 

that protein is not a component of 

tallow impurities. A 2001 report from a 

European Scientific Steering Committee 

stated that analysis of impurities in six 

tallow samples found that crude protein 

levels ranged from 5 percent to 16 

percent, assuming that all nitrogen in 

the impurities was of protein origin 

(Ref. 13). Since protein may be a 

component of tallow impurities, FDA 

believes that limiting tallow impurities 

to the OIE recommended level of 0.15 

percent is appropriate. 

4. Feasibility of Removing Brain and 

Spinal Cord 

(Comment 36) Many comments stated 

that brain and spinal cord cannot be 

removed completely from some dead 

cattle, and that the feasibility of removal 

depends on such things as condition of 

the carcass, size of the animal, worker 

skill, weather conditions, and distance 

between the production site and the 

rendering facility. Some comments 

submitted estimates of the percentage of 

dead animals from which brain and 

spinal cord could feasibly be removed. 

Those estimates ranged from as low as 

15 percent to as high as 54 percent. 

(Response) FDA acknowledges that 

removing brain and spinal cord from 

dead cattle may be difficult for the 

reasons mentioned, and that the agency 

may have overestimated the number of 

independent renderers that would 

choose to remove brain and spinal cord 

from dead cattle. However, FDA 

believes that, unless cattle not inspected 

and passed for human consumption are 

shown to be less than 30 months of age, 

the brain and spinal cord must be 

removed prior to use in animal food or 

feed to prevent BSE. As discussed in 

more detail in the response to Comment 

28, FDA notes that the use in animal 

feed of materials from cattle not 

inspected and passed that are diseased 

or that die otherwise than by slaughter 

is the subject of enforcement discretion. 

(Comment 37) FDA was asked to 

define what constitutes an ‘‘acceptable’’

level of brain/spinal cord removal. 

Another comment recommended that 

renderers maintain written procedures 

for processes used to remove brain and 

spinal cord and verify that such 

processes meet FDA standards for 

removal. 

(Response) During an inspection, FDA 

will review the adequacy of a firm’s 

written procedures for removal of brain 

and spinal cord and will verify that the 

firm is following its procedures and 

effectively removing all the brain and 

spinal cord or otherwise excluding it 

from animal feed use. 

(Comment 38) One comment said that 

custom-slaughter plants (not federally or 

State inspected) will need to remove the 

brain and spinal cord of all cattle, 

regardless of the animal’s age. 

(Response) Meat from cattle 

slaughtered under the custom-slaughter 

exemption is exclusively for the use by 

the owner of the animal, members of his 

or her household, and nonpaying guests 

and employees (Federal Meat Inspection 

Act, section 623(a)). Because such cattle 

are slaughtered without inspection by 

an appropriate regulatory authority, 

these animals would be considered 

cattle not inspected and passed for 

human consumption. The rule prohibits 

their use in animal feed if they are not 

shown to be less than 30 months of age 

or the brain and spinal cord are not 

effectively removed or effectively 

excluded from animal feed. 

(Comment 39) One comment stated 

that FDA should require firms that 

intend to render deadstock for use in 

animal feed to obtain a special permit 

and demonstrate to FDA’s satisfaction 

that they have implemented a system 

that is consistently effective in removing 

brain and spinal cord. 

(Response) This final rule requires 

that rendering firms maintain written 

procedures specifying how brain and 

spinal cord are effectively removed. The 

agency does not believe that requiring 

such firms to obtain a permit is 

necessary at this time. FDA believes that 

following its current approach of 

working collaboratively with its State 

counterparts to ensure compliance with 

BSE regulations will continue to be 

effective. 

5. Determining the Age of Cattle Not 

Inspected and Passed for Human 

Consumption 

(Comment 40) Two comments stated 

that dentition will not work for the 

process of determining the age of cattle 

and that an animal identification system 

is needed. 

(Response) The final rule has been 

revised to emphasize that firms are 

responsible for having processes in 

place to ensure cattle not inspected and 

passed for human consumption from 

which brain and spinal cord are not 

removed are shown to be less than 30 

months of age. If a firm is unable to 

determine the age of an animal, the 

brain and spinal cord must be removed 

in order for the remaining carcass to be 

used for animal feed and not violate the 

prohibitions in this final rule. As 

discussed in more detail in the response 

to Comment 28, FDA notes that the use 

in animal feed of materials from cattle 

not inspected and passed that are 

diseased or that die otherwise than by 

slaughter is the subject of enforcement 

discretion. 

Cattle under 30 months of age may be 

adequately identified through dentition. 

Veterinary texts and academic articles 

indicate that the second set of 

permanent incisors erupt when cattle 

are between 24 and 30 months of age. 

Thus, cattle would be considered to be 

30 months of age and older if at least 

one of the second set of permanent 

incisors has erupted. However, 

environmental or operational conditions 

could make aging by dentition difficult. 

Therefore, firms’ written procedures 

may need to include other means of age 

determination or adopt the default 

assumption that the animal is over 30 

months. 

6. Disposal of Prohibited Materials 

A significant number of comments 

were submitted pertaining to disposal 

problems that could be created if the 

proposed rule is finalized. These 

problems ranged from the financial 

burden created by collection fees to 

State and local regulations that restrict 

non-feed disposal of prohibited 

materials. 

(Comment 41) Numerous comments 

said that FDA underestimated the 

volume of material that will require 

alternative disposal when FDA’s 

proposed measures force renderers to 

increase collection fees or discontinue 

deadstock pickup. One comment said 

that as a result of the new regulation, 

pig, horse, and deer mortalities will no 

longer be picked up on discontinued 

routes. Another comment stated that 

farmers and dairymen will probably 

bury, compost, landfill, or dump 

carcasses to avoid the increased 

collection fee that renderers will charge. 

(Response) FDA agrees that renderers 

who continue to collect deadstock will 

likely increase collection fees to cover 

the costs of complying with the new 

requirements, and that we may have 

underestimated the impact that higher 

fees will have on deadstock collection. 

In the October 2005 proposed rule (70 

FR 585701 at 58592), we estimated that 

the 17 percent of dead cattle currently 

being collected would decrease by 3.5 

percent, and did not assume a decrease 

in the collection of dead animals of 

other species. The revised economic 


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impact analysis that accompanies this 

rule estimates that collection of calves 

and cattle will decline by 29.4 percent 

to 44.8 percent, with an additional 10- 

percent loss in rendering volume 

throughput to reflect a decrease in 

collection of dead animals of other 

species. Dead animals no longer 

collected should be disposed of in an 

environmentally and legally acceptable 

manner. 

(Comment 42) Some comments stated 

that rendering is the best disposal 

option and that burial, composting, and 

incineration are undesirable 

alternatives. One comment said that if 

SRMs and deadstock are diverted from 

animal feed use, FDA will no longer 

have control over this material. Another 

comment pointed out that it takes 14 

months to properly compost a 1500- 

pound (lb) cow. 

(Response) FDA believes this final 

rule appropriately controls materials to 

be rendered for animal feed. FDA 

intends to work with relevant local, 

State, and other Federal agencies 

concerning disposal issues. 

(Comment 43) Some comments stated 

that an infrastructure is not in place to 

provide alternative disposal in all areas 

of the country. Several comments said 

the rule will create a disposal crisis. 

One comment said that landfill 

operators and solid waste regulators are 

not prepared to deal with the magnitude 

of the disposal problem, and that some 

landfills will not accept dead animals or 

slaughter byproducts. Another comment 

said that they found no incinerators in 

their service area that would accept 

dead animals. One comment said that 

disposal rendering is feasible, but may 

not be locally available or that 

collection fees may be prohibitive. The 

last comment also said that alkaline 

hydrolysis digesters are not feasible, 

strict air pollution measures might 

preclude the use of incinerators, 

composting is prohibited in some areas, 

and land for burial is unavailable in 

densely populated areas. 

(Response) FDA recognizes that no 

single method of disposal is available or 

suitable in all regions of the country and 

acknowledges that the transition from 

rendering to other forms of disposal will 

be challenging in some parts of the 

country. The regulation will not become 

effective until 12 months after 

publication of this final rule, so that 

livestock producers, meat packers, 

renderers, and regulators have sufficient 

time to arrange for disposal of CMPAF 

using one or more of the alternatives 

mentioned or any other legal alternative. 

(Comment 44) A number of comments 

stated that, due to disposal restrictions 

at the State and local levels, a 

comprehensive disposal plan is needed 

before the proposed rule is 

implemented. Several comments said 

that FDA should consult with Federal, 

State, and local agencies, and with the 

affected industries, on environmentally 

safe disposal of deadstock. One 

comment said that neither FDA nor 

USDA has jurisdiction over on-farm 

disposal. Another comment said that 

USDA should use its broad animal 

health authority to lead a Federal 

agency task force on disposal. 

(Response) Non-feed disposal of 

carcasses and slaughter byproducts is 

primarily regulated by State and local 

agencies. Under certain circumstances, 

Federal agencies, such as the 

Environmental Protection Agency 

(EPA), may use their authorities to 

regulate disposal of this material. FDA 

consulted with EPA and participated in 

an industry sponsored roundtable in 

July 2006 to discuss practical solutions 

for non-feed disposal throughout the 

United States. FDA is ready to work 

with industry and other governmental 

agencies in identifying appropriate ways 

to dispose of CMPAF. 

(Comment 45) Some comments 

pointed out that Europe avoided 

massive disposal problems through 

government subsidies to the rendering 

industry for picking up and rendering 

prohibited material. Subsidies would 

help with disposal problems in the 

United States. 

(Response) FDA does not have 

authority to subsidize alternative 

disposal of CMPAF. 

(Comment 46) Several comments 

urged FDA to explore alternative ways 

to use CMPAF, such as in the 

production of biofuel. 

(Response) FDA welcomes innovative 

ways of disposing of animal byproducts, 

such as using them for the production 

of biofuels. The agency has participated 

in industry/government workshops that 

explored ideas for using deadstock and 

animal byproducts for the production of 

energy. The agency encourages 

environmentally sound, commercial 

uses of these materials so that the 

disposal burden is minimized. 

(Comment 47) One comment 

indicated that FDA should not expect a 

disposal-only rendering industry to 

develop if the proposed rule is 

implemented. 

(Response) FDA acknowledges that 

many factors, including the 

implementation of this final rule, play a 

role in determining whether facilities 

dedicated to disposal rendering may 

emerge in the marketplace. 

(Comment 48) One comment stated 

that prohibited brain and spinal cord 

material should not be diverted for use 

as fertilizer because the infectious agent 

can survive in soil and be recycled to 

cattle through crops. 

(Response) FDA is not aware of any 

data showing that BSE can be 

transmitted by this route. 

(Comment 49) One comment asked 

that the U.S. Government focus on 

research and on supporting the 

rendering industry’s development of 

alternative uses for animal byproducts. 

(Response) FDA agrees that 

alternative uses for animal byproducts 

need to be encouraged and studied 

further. 

7. Ensuring Appropriate Handling of 

Prohibited Material 

(Comment 50) Several comments 

addressed certification/registration of 

facilities handling cattle materials. One 

comment suggested that FDA should 

require annual certification to ensure 

that every facility handling cattle 

materials is in compliance with the rule. 

Another comment suggested registration 

of entities that handle prohibited cattle 

material, including renderers, farms that 

feed or mix feed for ruminants, and 

other parties that handle prohibited 

material, except where government 

inspection is already present (packerassociated renderers). 

(Response) The agency does not 

believe that requiring certification or 

registration of firms is necessary at this 

time. FDA believes that continuing its 

current approach of working 

collaboratively with its State 

counterparts to ensure compliance with 

BSE regulations will continue to be 

effective. 

(Comment 51) One comment asked 

whether written statements from 

slaughter and processing establishments 

would be acceptable to FDA as evidence 

that offal is free of prohibited material. 

One comment said that, due to liability 

concerns, renderers will be reluctant to 

accept material from plants that are not 

federally inspected. Two comments said 

that slaughter plants should be required 

to verify that raw materials sent for 

rendering into animal feed are free of 

prohibited cattle materials. 

(Response) The proposed rule 

provided that renderers that handle 

cattle materials must establish and 

maintain records sufficient to 

demonstrate that materials rendered for 

animal feed are not manufactured from, 

processed with, or does not otherwise 

contain CMPAF. The final rule has been 

revised to further clarify that renderers’

records must also include certification 

or other documentation from each 

supplier, or other documentation 

acceptable to FDA, that CMPAF has 

been excluded from materials to be 


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rendered for use in animal feed. 

Certification or other documentation 

from the supplier would be considered 

acceptable provided it includes a 

description of the supplier’s segregation 

procedures, documentation that the 

supplier confirms that its segregation 

procedures are in place prior to 

supplying any cattle material to the 

renderer, and records of the renderer’s 

periodic review of the suppliers’

certification or other documentation. 

Other methods acceptable to FDA, such 

as third-party certification, may also be 

used by renderers to document that 

suppliers have excluded CMPAF from 

material supplied to the renderer. 

(Comment 52) One comment asked 

that FDA clarify whether separate lines 

of equipment (barrels, room storage, 

pick-up vehicles) are required for 

handling SRM material. Another 

comment said the proposal’s 

requirement that facilities be dedicated 

may cause renderers to discontinue 

processing CMPAF. A third comment 

stated that equipment for processing 

and transportation of prohibited cattle 

materials should be specifically 

designated for such purposes only. A 

fourth comment suggested that 

renderers and slaughter plants should 

have verifiable separation and 

identification procedures in place. 

(Response) Under the final rule, 

renderers that provide a service to a 

slaughter plant by disposing of CMPAF 

must ensure that there is no crosscontamination, either through direct 

contact or via equipment surfaces, 

between CMPAF and animal feed or 

feed ingredients. In addition, CMPAF 

material is required to be marked and 

labeled ‘‘Do not feed to animals.’’

Renderers are responsible for ensuring 

that firms collecting such material on 

their behalf meet these requirements. 

8. Enforcement Issues 

FDA received many comments that 

addressed enforcement issues. 

Specifically, concerns were raised about 

an increased inspection burden, 

prohibited materials being illegally 

transported and dumped, and the need 

for agency guidance on recordkeeping. 

(Comment 53) Several comments said 

that additional resources will be needed 

to effectively enforce the new measures. 

One comment said that additional 

inspectors may be needed to ensure 

proper removal and disposal of the 

CMPAF. Two other comments said that 

increased inspectional presence will be 

necessary to ensure that firms comply 

with aging and brain and spinal cord 

removal requirements. 

(Response) FDA agrees that successful 

enforcement of the new measures will 

require an increased inspectional 

presence at firms that render cattle 

materials. Any reallocation of 

inspections needed to enforce this new 

rule should not affect the inspections of 

high-risk firms that are already being 

conducted to enforce the current 

ruminant feed rule. 

(Comment 54) One comment said the 

proposed rule creates too much of an 

inspectional burden with an over 

reliance on the examination of records. 

Another comment, in contrast, said that 

visual inspection by investigators 

ultimately cannot determine the 

presence or absence of the BSE agent. 

(Response) The agency considers both 

onsite observations of firms’ operations 

and examination of records to be 

important and valuable components for 

ensuring compliance with the new rule. 

Inspections are not intended to detect 

the presence of the BSE agent, but rather 

are intended to ensure that CMPAF are 

not used in animal feed. Records 

examination is intended to verify that 

firms maintain and follow written 

procedures and to facilitate tracking the 

receipt, processing, and distribution of 

CMPAF. 

(Comment 55) One comment stated 

that increases in renderer pick-up fees 

will result in illegal transportation and 

dumping of deads, downers, and 

CMPAF. 

(Response) FDA intends to vigorously 

enforce this new rule to ensure that 

CMPAF is not used in animal feed. FDA 

believes this final rule appropriately 

controls materials to be rendered for 

animal feed. FDA intends to work with 

relevant local, State, and other Federal 

agencies concerning disposal issues. 

(Comment 56) One comment said the 

proposal may cause independent 

renderers to stop accepting offal from 

red meat slaughter and processing 

establishments unless assurances are 

received that prohibited materials have 

been removed. Another comment cited 

a statement from a USDA OIG report 

saying that slaughter establishments are 

not adequately removing SRMs under 

current USDA regulations (Ref.14). The 

comment expressed concern that 

assurance cannot be provided for the 

removal of CMPAF from slaughter cattle 

under the proposed FDA regulation. 

(Response) As stated in the proposed 

rule, this final rule requires renderers to 

establish and maintain records 

sufficient to demonstrate that raw 

materials to be rendered for animal feed 

are free of CMPAF. The agency expects 

that, as a condition of collection, 

renderers will require beef slaughter 

establishments to provide sufficient 

documentation to enable the renderers 

to meet their obligation for establishing 

and maintaining records demonstrating 

CMPAF removal. As discussed above, 

this final rule clarifies that renderers’

records must include documentation, 

such as certification or other 

documentation from the supplier that 

material supplied to the renderer does 

not include CMPAF, or documentation 

of another method acceptable to FDA to 

verify that CMPAF has been segregated 

from slaughter byproducts that are to be 

rendered for animal feed use. 

(Comment 57) Several comments 

stated that renderers might not collect 

offal from 4–D plants and custom 

slaughter establishments because there 

is not routine government inspection of 

these operations to ensure removal of 

CMPAF. Several comments suggested 

that FDA require written certification of 

CMPAF removal. 

(Response) Because 4–D plants meet 

the definition of renderer, these firms 

are subject to the requirements of this 

rule. The final rule requires that 

renderers maintain written procedures 

for how they will remove brain and 

spinal cord from cattle not inspected 

and passed for human consumption 

and, if such cattle are to be rendered 

without brain and spinal cord removal, 

written procedures for how they will 

verify that such cattle are less than 30 

months of age. Rendering firms that 

collect material from a 4–D operation 

would have the responsibility of 

showing that CMPAF had been removed 

by the 4–D plant prior to collection, or 

that any CMPAF-containing material 

collected is not introduced into animal 

feed. 

With respect to custom slaughter, the 

final rule defines CMPAF to include 

certain cattle not inspected and passed 

for human consumption by the 

appropriate regulatory authority. Since 

the slaughter and processing of cattle in 

custom slaughter operations are not 

subject to inspection, the cattle handled 

by custom slaughter facilities would be 

considered not inspected and passed for 

human consumption. Therefore, cattle 

materials from custom slaughter 

establishments cannot be rendered for 

use in animal feed if the brain and 

spinal cord are not effectively removed 

from cattle that are 30 months of age or 

older. It is the renderer’s responsibility 

to establish and maintain records 

sufficient to demonstrate that material 

rendered for use in animal feed does not 

contain CMPAF. The final rule clarifies 

that these records must include 

certification or other documentation 

from the supplier demonstrating that 

adequate segregation procedures are in 

place at slaughter establishments, 

including custom slaughter 


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establishments, that supply cattle 

materials to the renderers. 

If renderers receive CMPAF for 

disposal, they are responsible for 

ensuring that it is excluded from animal 

feed. As discussed in more detail in the 

response to Comment 29, FDA notes 

that the use in animal feed of materials 

from cattle not inspected and passed for 

human consumption that are diseased 

or that die otherwise than by slaughter 

is the subject of enforcement discretion. 

(Comment 58) Numerous comments 

asked that FDA provide guidance on 

several aspects of the rule, such as 

proper recordkeeping, acceptable 

processes for removing brain and spinal 

cord from cattle not inspected and 

passed for human consumption, and 

separation and dedication of processing 

areas. 

(Response) FDA has specified in the 

final rule the recordkeeping requirement 

for renderers receiving raw materials 

from slaughter facilities. FDA will 

provide guidance as needed for meeting 

other requirements of the new rule. 

(Comment 59) One comment 

suggested that FDA require firms 

handling prohibited material to be 

registered. 

(Response) Pursuant to the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

facilities that manufacture, process, 

pack, or hold food for consumption in 

the United States must register with 

FDA. The agency does not believe that 

requiring additional registration of all 

firms handling prohibited material is 

necessary at this time. FDA believes that 

following its current approach of 

working collaboratively with its State 

counterparts to ensure compliance with 

BSE regulations will continue to be 

effective. 

(Comment 60) One comment 

suggested that FDA license firms 

handling prohibited cattle material just 

as it licenses feed mills that use 

Category II drugs as Type A medicated 

articles. 

(Response) The agency does not 

believe that requiring that firms be 

licensed is necessary at this time. FDA 

believes that continuing its current 

approach of working collaboratively 

with its state counterparts to ensure 

compliance with BSE regulations will 

continue to be effective. 

(Comment 61) Two comments 

questioned whether FDA has 

jurisdiction to inspect slaughter 

establishments to verify proper 

segregation of CMPAF. Another 

comment said it strongly opposes new 

FSIS inspectional activity to oversee 

CMPAF removal from animal feed. In 

addition, two comments said that the 

proposed rule amounts to an unfunded 

mandate requiring States to conduct 

additional inspections at slaughter 

establishments to ensure proper removal 

of CMPAF. 

(Response) Under this final rule, it is 

the responsibility of the renderer to 

ensure that material rendered for use in 

animal feed is free of CMPAF. FDA 

acknowledges that it does not conduct 

inspections in USDA-regulated 

slaughter establishments. Nevertheless, 

the agency believes that ensuring the 

segregation of CMPAF from other 

slaughter byproducts is pivotal to 

enhancing the safety of all animal feed. 

During inspections at rendering 

facilities, FDA intends to verify that 

renderers maintain records sufficient to 

demonstrate that material rendered for 

use in animal feed does not contain 

CMPAF. In response to comments 

regarding recordkeeping and the need 

for verification of the raw materials, the 

final rule has been revised to clarify that 

a renderer’s records must either include 

certification or other documentation 

from the supplier that material supplied 

to the renderer does not include 

CMPAF, or documentation of another 

method acceptable to FDA, such as third 

party certification, for verifying that 

suppliers have effectively excluded 

CMPAF. 

(Comment 62) Two comments stated 

that distribution records should be 

sufficiently detailed to allow for 

conducting trace forward and trace back 

investigations of prohibited cattle 

materials. 

(Response) As finalized herein, 

§ 589.2001(c)(2)(vi) (21 CFR 

589.2001(c)(2)(vi)) requires renderers 

that handle CMPAF to establish and 

maintain records sufficient to track 

CMPAF to ensure such material is not 

introduced into animal feed, and make 

the records available for inspection and 

copying by FDA. And under 

§ 589.2001(c)(3)(i), renderers that handle 

any cattle materials must 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, CMPAF, 

and make the copies available for 

inspection and copying by FDA. FDA 

expects to provide guidance, as needed. 

(Comment 63) One comment stated 

that renderers should maintain records 

on how they dispose of prohibited cattle 

material. 

(Response) The final rule requires 

renderers to maintain records sufficient 

to track CMPAF to ensure that the 

material was not introduced into animal 

feed. 

(Comment 64) Several comments 

suggested that instead of requiring that 

records be kept for 1 year, FDA should 

require that records be maintained for a 

longer time period. Suggestions ranged 

from 3 to 12 years. 

(Response) FDA does not consider it 

necessary to extend the recordkeeping 

requirement. As discussed in greater 

detail in the preamble to the October 

2005 proposed rule (70 FR 58570 at 

58582), FDA believes 1 year is 

appropriate, considering the amount of 

time the products will be in the animal 

feed production and distribution 

systems. 

9. Implementation of New Requirements 

(Comment 65) Several comments 

pointed out that time may be needed for 

implementation of the rule. Two 

comments suggested that it would take 

more than a year for renderers to 

develop dedicated rendering facilities or 

other types of disposal in California. 

Two other comments suggested a staged 

approach. 

(Response) FDA received numerous 

comments regarding the impacts of the 

proposed new requirements, 

particularly with respect to the 

separation and appropriate disposal of 

CMPAF. The analysis of economic 

impacts completed for this final rule 

estimates that slaughter and rendering 

facilities will incur substantial one-time 

capital costs in order to comply with the 

new requirements. Furthermore, this 

analysis indicates that a substantial 

component of the total cost of this rule 

is associated with the disposal of 

CMPAF. Based on comments received 

on the proposed rule and on FDA’s 

impact analysis completed for this final 

rule, FDA agrees that sufficient time 

will be needed to effectively implement 

the new requirements of this final rule 

including the development of alternate 

methods for disposing of CMPAF. FDA 

believes that 12 months should be a 

sufficient amount of time for the U.S. 

animal feed industry to come into 

compliance with this final rule. 

(Comment 66) Several comments said 

that instead of implementing new 

measures, FDA should provide 

additional resources to support 

compliance and enforcement of the 

current ban. Two comments stated that 

implementation of the new rule should 

not lessen enforcement of the current 

rule. 

(Response) The basis for the measures 

in this final rule was discussed in the 

preamble to the October 2005 proposed 

rule (70 FR 58570 at 58578). 

Implementation of this new rule should 

not diminish inspection and 

enforcement of the 1997 ruminant feed 


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rule at firms that handle prohibited 

mammalian protein. Current resources 

should allow for effective enforcement 

of both rules. 

(Comment 67) One comment said that 

rendering plants will need time to 

modify equipment and procedures 

before the rule is implemented. 

(Response) FDA understands that 

rendering plants will have to make a 

variety of modifications to comply with 

the final rule. For this reason, FDA has 

made the new rule effective 12 months 

from the date of publication. 

C. Comments on Proposed Amendments 

to § 589.2000—Animal Proteins 

Prohibited in Ruminant Feed 

The final rule amends § 589.2000 to 

exclude 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 

§ 589.2001(b)(6). FDA also received 

several comments related to other 

requirements in § 589.2000. 

(Comment 68) Three comments stated 

that salvaged pet foods, including 

distressed pet food, should be 

prohibited in cattle feed. 

(Response) Pet food containing 

prohibited mammalian protein is 

prohibited from use in ruminant feed by 

the 1997 ruminant feed rule. Pet food 

products sold or intended for sale as 

distressed or salvage items must be 

labeled with the statement ‘‘Do not feed 

to cattle or other ruminants’’ if they 

contain or may contain prohibited 

mammalian protein (see 

§ 589.2000(d)(4)). This final rule further 

reduces the risk that cattle could be 

exposed to the BSE agent through pet 

food because it requires the removal of 

certain cattle-derived risk materials 

from all animal feed. 

(Comment 69) Two comments 

requested that the current feed rule be 

revised to exempt firms that handle 

retail pet food from recordkeeping 

requirements. 

(Response) The 1997 ruminant feed 

rule requires firms to maintain records 

sufficient to track products containing 

prohibited mammalian protein. 

Exempting retail pet food distributors 

from recordkeeping requirements would 

diminish the ability of the agency to 

trace feed or feed ingredients that are 

adulterated under the 1997 ruminant 

feed rule. The agency intends to issue 

guidance that addresses what 

constitutes records sufficient to track 

prohibited protein associated with the 

sale of retail pet food. 

(Comment 70) One comment 

suggested that the current rule be 

revised to require feed labels that 

clearly, concisely, and accurately inform 

users about the source of animal protein 

ingredients in feeds. The comment said 

that requiring new feed ingredient 

definitions such as ‘‘non-ruminant 

derived animal proteins,’’ ‘‘ruminant 

derived animal proteins,’’ and ‘‘nonmammalian derived animal proteins’’

would be helpful. 

(Response) Section 589.2000 requires 

that feed products that contain or may 

contain prohibited mammalian protein 

be labeled with the caution statement 

‘‘Do not feed to cattle or other 

ruminants.’’ Part 501 (21 CFR part 501) 

contains most of the labeling 

requirements for animal feed. Under 

§ 501.4, ingredients must be listed on 

the product label by their common or 

usual name. Section 501.110 provides 

for the use of collective terms, such as 

‘‘animal protein products,’’ in lieu of 

listing each ingredient by its common or 

usual name. For FDA recommendations 

regarding the common or usual names 

for animal feed ingredients, see 

Compliance Policy Guide 7126.08. In 

response to the FDA Amendments Act 

of 2007, FDA intends to develop new 

regulations on processing and 

ingredient standards and ingredient 

definitions for all animal feed, and 

updated labeling standards for pet food. 

III. Description of the Final Rule 

A. Definitions 

Section 589.2001(a)(1) is being added 

to the final rule, and it sets forth the 

purpose of new § 589.2001, which is to 

prohibit the use of certain cattle origin 

materials in the food or feed of all 

animals to further reduce the risk of the 

spread of BSE within the United States. 

To address the BSE risk, 

§ 589.2001(b)(1) defines cattle materials 

prohibited in animal feed (CMPAF) to 

include the following: (1) The entire 

carcass of BSE-positive cattle; (2) the 

brains and spinal cords of cattle 30 

months of age and older; (3) the entire 

carcass of cattle not inspected and 

passed for human consumption that are 

30 months of age or older from which 

brains and spinal cords were not 

effectively removed or otherwise 

effectively excluded from animal feed; 

and (4) mechanically separated beef and 

certain tallow that is derived from 

materials prohibited by this rule. The 

definition of CMPAF does not include 

tallow derivatives or certain tallow that 

contains no more than 0.15 percent 

insoluble impurities. This definition 

differs from the proposed rule in that 

the entire carcass from BSE-positive 

cattle has been added to the definition. 

This was done to clarify that all 

materials from such animals are 

prohibited from use in animal feed. 

Further, the regulations were revised to 

exclude from the definition of CMPAF 

certain cattle that have not been 

inspected and passed for human 

consumption. Under the proposed rule, 

cattle that were not inspected and 

passed for human consumption were 

excluded from the definition of CMPAF 

if their brains and spinal cords were 

removed. The final rule was revised to 

indicate that such cattle are not 

considered CMPAF if the animals were 

shown to be less than 30 months of age, 

regardless of whether the brain and 

spinal cord have been removed. The 

regulations have also been revised to 

exclude from the definition of CMPAF 

certain cattle materials that originate 

from a country that has been designated 

by FDA as exempt from the 

requirements of this rule based on its 

BSE risk status. This exclusion is being 

added in response to comments and 

because the agency has determined that 

it is not necessary for all BSE-related 

restrictions to apply to animal feed 

regardless of a country’s BSE status. 

Epidemiological evidence indicates that 

the BSE epidemic in the United 

Kingdom (U.K.) was a result of 

consumption of animal feed 

contaminated by the BSE agent. The 

spread of BSE outside the U.K. has been 

attributed to the export of BSEcontaminated feed from the U.K. to 

other countries prior to the realization 

of the role of feed in transmitting the 

disease and the subsequent restrictions 

on such trade. FDA acknowledges that 

a country may not have engaged in 

commercial trade in animal feed with 

the U.K. or other affected countries, and 

it may have had preventive measures in 

place for a length of time adequate to 

make remote the chance that BSE is 

present in that country. 

Such a country may be able to 

demonstrate to FDA that its BSE case 

history, risk factors, and measures to 

prevent the introduction and 

transmission of BSE make certain BSErelated restrictions unnecessary with 

respect to cattle materials from that 

country. Allowing cattle materials from 

such a country to be used in nonruminant animal feed manufactured 

from, processed with, or otherwise 

containing CMPAF is consistent with 

OIE’s recommendation that other 

prohibited materials from negligible risk 

countries not be restricted. The process 

for seeking designation to be covered by 

this exclusion is set forth in 

§ 589.2001(f). 

In its application, the requesting 

country will be expected to provide 

information to FDA on its BSE case 

history, including whether cattle in that 


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country have tested positive for BSE, 

and, if so, the circumstances and the 

country’s response. In addition, FDA 

will review information that addresses 

the extent to which the requesting 

country has identified and taken into 

account relevant risk factors such as the 

following: 

• Possible presence of BSE in 

indigenous and/or imported cattle; 

• Geographic origin of imported 

cattle; 

• Materials used in the production of 

ruminant feed and feed ingredients; and 

• Importation of ruminant feed and 

feed ingredients. 

FDA will consider information 

relating to the possible presence of BSE 

in indigenous and imported cattle in the 

requesting country as well as the 

requesting country’s production and 

importation of ruminant feed and feed 

ingredients. With respect to imported 

cattle, relevant information includes the 

identification of any countries where 

imported cattle were born or raised and 

the dates any cattle were imported. With 

regard to ruminant feed, FDA will 

consider, among other things, how 

ruminant feed was produced in the 

requesting country, including what 

animal origin materials were allowed to 

be included. FDA will also consider 

whether ruminant feed and feed 

ingredients were imported, and if so, the 

source countries and dates of import. 

In addition to reviewing risk factors 

such as those identified previously, 

FDA will assess how the requesting 

country has addressed and managed any 

identified BSE risks through the 

implementation of appropriate measures 

to prevent the introduction and 

transmission of BSE. FDA will consider 

how long such preventive measures 

have been in place and whether they 

have been effectively carried out. 

Examples of preventive measures 

include the following: 

• A prohibition on the use of 

ruminant feed that might carry a risk of 

transmitting the BSE agent; 

• A prohibition on the import of 

cattle and cattle-derived products that 

might carry a risk of transmitting the 

BSE agent; 

• Surveillance systems for BSE in 

cattle populations with appropriate 

examination of brain or other tissues 

collected for surveillance in approved 

laboratories; 

• Mandatory notification and 

examination of all cattle showing signs 

consistent with BSE; and 

• Protocols or other written 

procedures for investigating potential 

cases of BSE, including ability to trace 

former herdmates of BSE-positive 

animals. 

As part of its evaluation of a 

requesting country’s feed restrictions, 

FDA will consider factors including 

whether appropriate feed restrictions 

are in place and the adequacy of 

enforcement of those restrictions (e.g., 

the frequency of facility inspections and 

level of compliance). FDA also will 

consider a requesting country’s import 

controls for cattle material. Such 

consideration will include whether the 

country effectively monitors and 

controls potential pathways of cattle 

materials and other potentially infective 

materials into its country from other 

countries for which such controls are 

necessary. 

In addition, FDA will consider the 

requesting country’s surveillance and 

monitoring efforts with respect to BSE. 

For example, FDA will evaluate the 

level at which the country performs 

surveillance and monitoring, whether 

tissue samples are collected and 

examined at approved laboratories, and 

whether recognized diagnostic 

procedures and methods are used, such 

as those procedures and methods 

provided in the OIE Manual of 

Diagnostic Tests and Vaccines for 

Terrestrial Animals (Ref. 15). 

FDA also will consider whether the 

requesting country has an ongoing 

program for notification and 

investigation of all cattle showing signs 

consistent with BSE. In evaluating such 

a program, FDA will consider, among 

other factors, whether notification and 

investigation is mandated, whether 

veterinarians, producers, and others 

involved in cattle production have been 

provided sufficient information about 

BSE, such as through an awareness 

program, and whether there are 

additional measures in place to 

stimulate reporting of suspect cattle, 

such as compensation or penalties. 

FDA also will consider a requesting 

country’s written procedures for 

investigating potential cases of BSE. 

Such a consideration will include 

whether the country has written 

procedures for the investigation of 

suspect animals and whether the 

country has the investigative capability 

to follow up positive findings by tracing 

former herdmates of animals 

determined to be BSE positive. Finally, 

FDA also will consider any other 

information relevant to determining 

whether the country should be 

designated under § 589.2001(f). 

FDA and the USDA agencies, APHIS 

and FSIS, have different regulatory 

responsibilities with respect to 

preventing BSE and ensuring food 

safety. Therefore, FDA cannot rely on 

the evaluations of APHIS and FSIS in 

making a determination on country 

designations. FDA will, however, 

consult with APHIS and FSIS as part of 

its evaluation process. In addition, FDA 

will take into consideration available 

risk assessments of other competent 

authorities in conducting its evaluation. 

Although it is not required, a previous 

BSE evaluation by USDA, OIE, or by 

another government or another 

competent authority, will be helpful to 

FDA in its review and may decrease the 

time needed for FDA to make a 

determination. 

Upon completion of its review, FDA 

will provide written notification of its 

decision to the requesting country, 

including the basis for the decision. 

FDA may impose conditions in granting 

a request for designation. Further, any 

designation granted under § 589.2001(f) 

will be subject to future review by FDA 

to ensure that the designation remains 

appropriate. As part of this process, 

FDA may ask designated countries to 

confirm that their BSE situation and the 

information submitted by them in 

support of their original application 

remain unchanged. Further, FDA may 

revoke a country’s designation if FDA 

determines that it is no longer 

appropriate. 

FDA will provide further information 

on its evaluation process, the scope of 

the review, and the types of supporting 

information that it would find helpful in 

reviewing a country’s submission at the 

time of the request. 

Section 589.2001(b)(2) defines cattle 

not inspected and passed for human 

consumption as cattle that did not pass 

antemortem inspection 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 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. The definition of cattle not 

inspected and passed for human 

consumption was revised to add the 

word ‘‘ante-mortem’’ to clarify that 

cattle referred to in this definition are 

those that did not pass (or were not 

subjected to) antemortem inspection. 

Section 589.2001(b)(3) defines 

mechanically separated beef as 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. 

Section 589.2001(b)(4) defines 

renderer to mean any firm or individual 

that processes slaughter byproducts, 

animals unfit for human consumption, 

or meat scraps. The term includes 


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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. 

Section 589.2001(b)(5) defines tallow 

to mean 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. 

Section 589.2001(b)(6) defines tallow 

derivative to mean 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. 

The definitions in § 589.2001(b)(3), 

(b)(4), (b)(5), and (b)(6) are unchanged 

from the proposed rule. 

B. Requirements 

Section 589.2001(c)(1) provides that 

no animal food or feed ingredient shall 

be manufactured from, processed with, 

or otherwise contain CMPAF. Section 

589.2001(c)(2) provides new 

requirements for renderers that handle 

CMPAF. Section 589.2001(c)(3) 

provides new requirements for 

renderers that handle any cattle 

material. 

1. Requirements for Renderers That 

Receive, Manufacture, Process, Blend, 

or Distribute CMPAF 

Section 589.2001(c)(2) of the final rule 

has been revised to include 

requirements for renderers that intend 

to render for use in animal feed cattle 

not inspected and passed for human 

consumption. If such cattle are to be 

rendered for animal feed, the renderer 

must ensure that the brain and spinal 

cord are effectively removed or 

otherwise effectively excluded from 

material rendered for use in animal 

feed. If such cattle are to be rendered 

without brain and spinal cord removal, 

the renderer must ensure that such 

animals are less than 30 months of age. 

In addition, written procedures must be 

maintained specifying the procedures 

used to ensure compliance with these 

requirements. 

As provided in the proposed rule, 

§ 589.2001(c)(2) of the final rule also 

requires that renderers that handle 

CMPAF 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 CMPAF or products that 

contain or may contain CMPAF do not 

serve as a source of crosscontamination. 

In addition, § 589.2001(c)(2) requires 

renderers that handle CMPAF or 

products that contain or may contain 

CMPAF to: (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 

requirements are intended to ensure that 

CMPAF 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 other 

cattle materials. 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 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. Requirements for Renderers That 

Receive, Manufacture, Process, Blend, 

or Distribute Any Cattle Materials 

Section 589.2001(c)(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, CMPAF; (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. 

These requirements are unchanged from 

the proposed rule. 

C. Recordkeeping and Access 

Requirements 

Section 589.2001(c)(2)(v) requires that 

renderers that receive, manufacture, 

process, blend, or distribute CMPAF 

establish and maintain records 

sufficient to demonstrate that such 

material was not introduced into animal 

feed and make them available to FDA 

for inspection and copying. 

Furthermore, § 589.2001(c)(3) requires 

that renderers that receive, manufacture, 

process, blend, or distribute any 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 CMPAF. 

Such records shall be considered 

sufficient to meet this requirement if 

they include documentation that 

establishments supplying cattle 

materials to the renderers have adequate 

procedures in place to effectively 

exclude cattle materials prohibited in 

animal feed. The exclusion of CMPAF 

by establishments supplying cattle 

materials to renderers must be 

demonstrated either by certification or 

other documentation provided by the 

supplier or by another method 

acceptable to FDA such as third-party 

certification. Certification or other 

documentation provided by the supplier 

is acceptable provided such records 

include a description of the supplier’s 

segregation procedures, documentation 

that the supplier confirms that such 

procedures are in place prior to 

supplying any cattle material to the 

renderer, and records of the renderer’s 

periodic review of its suppliers’

certification or other documentation. 

Copies of all records established and 

maintained by renderers must be made 

available for inspection and copying by 

FDA. 

In the preamble to the October 2005 

proposed rule (70 FR 58570 at 58581), 

FDA explained that these recordkeeping 

requirements were intended to ensure 

that no CMPAF would enter the feed 

channel. At that time, the agency 

explained that it did not believe it was 

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 CMPAF. 

The agency went on to state its belief 

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, however, 

sought comments on the need to require 

that records be maintained by persons 

other than renderers. The agency did 

not receive any comments on this point. 

Therefore, FDA is requiring that such 

records be established and maintained 

by renderers for the reasons explained 

in the preamble to the proposed rule. 

FDA also sought specific comments 

on what types of records would be 

appropriate for satisfying the 

recordkeeping requirements and 

whether further detail would be needed 


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in the regulation regarding specific 

record requirements. FDA received one 

comment asking whether written 

statements from slaughter and 

processing establishments would be 

acceptable to FDA as evidence that 

CMPAF has been removed. Several 

comments stated that slaughter plants 

should be required to verify that raw 

materials sent for rendering into animal 

feed are free of CMPAF. In addition, a 

few comments stated that the records 

should be detailed enough to allow trace 

forward and trace back as part of any 

investigation of prohibited cattle 

materials and asked that FDA provide 

guidance on proper recordkeeping. As 

discussed above, FDA has provided 

additional details about the 

recordkeeping requirements for 

renderers. Furthermore, as discussed in 

section II of the preamble, the agency 

plans to issue guidance, as needed, to 

assist renderers in complying with the 

recordkeeping and other requirements. 

Section 589.2001(e) provides that the 

records required by this final 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. In reaching 

this conclusion, the agency considered 

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. 

D. Changes to § 589.2000—Animal 

Proteins Prohibited in Ruminant Feed 

Section 589.2000(a)(1) has been 

amended 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 

§ 589.2001(b)(1)(v). As discussed in the 

preamble to the proposed rule, 

§ 589.2000 previously did not include 

tallow in the definition of protein 

derived from mammalian tissues. 

However, in light of concerns about 

protein impurities present in tallow, 

FDA has included tallow in the 

definition of protein derived from 

mammalian tissues unless it contains no 

more than 0.15 percent insoluble 

impurities. 

IV. Analysis of Economic Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 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). The 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

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 finalizing ‘‘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 $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. 

FDA finds that the final rule 

constitutes an economically significant 

regulatory action as defined in section 

3(f)(1) of Executive Order 12866 because 

the sum of the recurring costs and 

capital costs that could be incurred in 

1 year rounds to $100 million. We base 

this conclusion on both a study of the 

impacts on industry of the final rule 

(conducted for FDA by the Eastern 

Research Group (ERG), a private 

consulting firm (Ref. 16)) and the 

discussion in the remainder of this 

section. Under the requirements of the 

Regulatory Flexibility Act (RFA), the 

agency has determined that the 

regulation will have a significant impact 

on a substantial number of small 

entities. Therefore, the agency has 

prepared a final regulatory flexibility 

analysis in accordance with the RFA (5 

U.S.C. 604). The analysis can be located 

in section IV.H of this document. This 

final rule imposes no mandates on 

government entities, and does not 

require the expenditure of over $122 

million in any 1 year by the private 

sector. As such, further analysis of 

anticipated costs and benefits is not 

required by the Unfunded Mandates 

Reform Act. 

A. Summary of Final Regulatory Impact 

Analysis 

The existing rule, which provides the 

baseline for this analysis, prohibits the 

use of certain protein derived from 

mammalian tissues in ruminant feeds. 

This final rule expands this restriction 

to prohibit certain cattle-derived risk 

materials in all animal feeds. The final 

rule, which is very similar to the 

proposed rule, would define those 

CMPAF to include the brain and spinal 

cord of all cattle 30 months of age or 

older slaughtered for human 

consumption, as well as the brain and 

spinal cord of cattle not inspected and 

passed for human consumption 30 

months of age or older, the entire 

carcass of cattle not inspected and 

passed for human consumption 30 

months of age or older unless the brain 

and spinal cord have been effectively 

removed or effectively excluded from 

animal feed, as well as other materials. 

The final rule makes a notable change 

from the proposed rule by not defining 

as CMPAF the brain and spinal cord 

from cattle under 30 months of age that 

are not inspected and passed for human 

consumption. FDA has also revised the 

final rule to clarify that the records 

established and maintained by renderers 

that receive cattle materials to be 

rendered for use in animal feed must 

include certification or other 

documentation from the supplier, or 

other documentation acceptable to FDA, 

that material supplied to the renderer 

does not include CMPAF. For the 

purposes of this final rule, the term 

‘‘cattle not inspected and passed for 

human consumption’’ includes nonambulatory disabled cattle. The final 

rule prohibits tallow derived from BSEpositive cattle from use in animal feed 

and prohibits tallow derived from other 

CMPAF from use in animal feed unless 

it contains no more than 0.15 percent 

insoluble impurities. The final rule also 

prohibits mechanically separated (MS) 

beef derived from any of the CMPAF 

from use in animal feed. Additional 

provisions of the final rule would 

require renderers that handle CMPAF to 

use separate equipment or containers to 

handle this material once it has been 

separated from other cattle materials. 

Such renderers would also be required 

to follow certain procedures for labeling 

and marking CMPAF and recordkeeping 

and records access. 

The benefits of the final rule include 

the elimination of the vast majority of 

the risk not addressed by the 1997 

ruminant feed ban of spreading BSE to 

other cattle from intentional or 

unintentional use of non-ruminant feed 

for ruminants or cross-contamination of 


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Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 22737 

ruminant feed with non-ruminant feed 

or ingredients intended for nonruminant feed. The final rule would 

effectively remove from use in nonruminant feeds those cattle tissues that 

account for approximately 90 percent of 

potential BSE infectivity (Ref. 17). 

Although the animal and public health 

benefit associated with the additional 

BSE risk reduction is paramount, the 

U.S. economy may also benefit from 

regained market access in countries that 

remain fully or partially closed to U.S. 

beef and beef products to the extent that 

the final rule persuades foreign 

governments that more U.S. beef 

products are safe to import. Although 

we are unable to quantify the effects of 

this final rule on removing restrictions 

to foreign markets, the benefits are 

potentially large because the economy 

as a whole loses an annual surplus 

equal to about $58 million from the 

remaining restrictions. 

This final rule that prohibits the use 

of these materials in animal food or feed 

would impose four types of costs: 

Disposal costs, the opportunity cost of 

the MBM and tallow not produced, 

direct costs of new equipment and reallocated labor, and feed substitution 

costs. Total compliance costs of the final 

rule are estimated to range from about 

$64.4 to $80.9 million per year 

annualized over 10 years assuming a 7- 

percent discount rate; at a 3-percent 

discount rate, total compliance costs are 

estimated at $64.0 to $80.5 million per 

year. 

Compliance costs include those 

imposed by the rule’s prohibition on the 

use of certain tissues from cattle 30 

months of age or older slaughtered for 

human food and cattle 30 months of age 

and older not inspected and passed for 

human consumption in any animal feed 

as well as the cost to substitute other 

feed ingredients for those foregone from 

further processing of CMPAF. First, we 

discuss the brain and spinal cord ban as 

direct costs to the affected firms 

(including disposal costs, where 

applicable) and the social cost of the 

ban on the raw materials used in feed 

product inputs. Then, we discuss the 

feed substitution costs. Table 1 of this 

document shows a summary of these 

costs. 

The ban on the use of certain cattle 

materials in all animal feed from cattle 

30 months of age and older slaughtered 

for human consumption and cattle 30 

months of age and older not inspected 

and passed for human consumption 

would require renderers that process 

either materials from cattle 30 months of 

age and older slaughtered for human 

consumption or cattle not inspected and 

passed for human consumption 30 

months of age and older to separate the 

CMPAF from the remaining offal. 

Renderers may require slaughter 

facilities to separate such materials as a 

condition of collection. We estimate the 

one-time capital costs of such a 

requirement for slaughterers at about 

$2.1 million (Table 1, line 2) (or 

$299,000 annualized at 7 percent over 

10 years and $246,000 annualized at 3 

percent over 10 years). We estimate that 

the annual cost of the additional labor 

to separate this CMPAF from other 

cattle offal at about $972,000 (Table 1, 

line 3) (including maintenance on new 

equipment). Although compliance costs 

of these activities will be borne initially 

by slaughterers, a portion of the costs 

are likely to be passed along to cattle 

producers and consumers. For 

renderers, average annualized capital 

investment and labor costs for CMPAF 

separation and segregation are estimated 

at about $7.0 million (Table 1, lines 9 

and 10). 

Our analysis does not project a 

specific disposal route for CMPAF due 

to the variability of State and municipal 

laws for disposal of organic wastes. As 

it did for the proposed rule, our analysis 

of the final rule estimates a $12 per 100 

lbs (hundredweight (cwt)) of CMPAF 

disposal cost (including any 

transportation costs) from slaughter and 

rendering establishments. We estimate 

annual disposal costs for CMPAF from 

independent renderers at about $11.3 

million (Table 1, line 11) and from 

slaughterers at about $3.4 million (Table 

1, line 23). We expect that the disposal 

costs for slaughter CMPAF are 

immediately passed on to animal 

producers as lower prices for animals 

delivered to slaughter. Additional 

disposal costs to animal producers for 

other animals that would no longer be 

rendered as a result of this rule will 

range from $24.7 million to $35.7 (Table 

1, line 22) million annually. We 

estimate the social cost of the loss of 

MBM sales to range from $0.8 to $1.0 

(Table 1, lines 4 and 14) million and the 

social cost from lost tallow sales to 

range from $0.7 to $0.8 million (Table 

1, lines 5 and 15). These costs include 

the lost value from CMPAF from cattle 

30 months of age and older slaughtered 

for human consumption, cattle not 

inspected and passed for human 

consumption 30 months of age and 

older, as well as calves, cattle under 30 

months not inspected and passed for 

human consumption and other species 

that would no longer be rendered as a 

result of this rule. We judge the social 

cost of the loss of hide value resulting 

from this rule to range from $9.2 million 

to $13.7 million (Table 1, line 12) 

annually. The estimated cost of both 

creating and executing procedures for 

the aging of animals at greater or less 

than 30 months of age is $2.4 million 

(Table 1, lines 6 and 13) annually. To 

the extent some slaughter 

establishments already have aging 

procedures in place to comply with 

FSIS’ SRM rule, this amount may be an 

overestimate. 

The final rule, as in the proposed rule, 

requires that tallow derived from certain 

CMPAF contain no more than 0.15 

percent insoluble impurities. Even 

though the estimate of CMPAF is much 

larger in the final rule, because the 

amount handled directly by 

independent renderers would remain 

relatively small, we concluded that it 

would not be economical for renderers 

or tallow manufacturers to further 

process into tallow the brains and spinal 

cords from all cattle that have their 

brains and spinal cords removed while 

complying with the additional 

equipment separation and tallow testing 

and purification requirements. We 

therefore did not include any additional 

cost for this provision. 

TABLE 1.—TOTAL COSTS ($ MILLIONS) 1

Line Cost item One-time cost Annual costs Annualized 

costs 2

1 ............... Slaughter Facilities .............................................................................................. .......................... ........................ ........................

2 ............... Capital investments ............................................................................................. $2 .1 ........................ $0.30 

3 ............... Labor .................................................................................................................... .......................... $0.97 0.97 

4 ............... Social cost of lost MBM ....................................................................................... .......................... 0.04 0.04 

5 ............... Social cost of lost tallow ...................................................................................... .......................... 0.03 0.03 

6 ............... Creating/Performing cattle aging procedures ...................................................... .......................... 1.10 1.10 

7 ............... Subtotal—Slaughter Facilities ............................................................................. 2 .1 2.14 2.44 

8 ............... Renderer Facilities ............................................................................................... .......................... ........................ ........................


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22738 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 

TABLE 1.—TOTAL COSTS ($ MILLIONS) 1—Continued 

Line Cost item One-time cost Annual costs Annualized 

costs 2

9 ............... Capital investments ............................................................................................. 20 .25 3.04 5.92 

10 ............. Labor .................................................................................................................... .......................... 1.09 1.09 

11 ............. Disposal of CMPAF from cattle > 30 months ..................................................... .......................... 11.30 11.30 

12 ............. Value of cattle hides ............................................................................................ .......................... 9.16–13.69 9.16–13.69 

13 ............. Creating/Performing cattle aging procedures ...................................................... .......................... 1.28 1.28 

14 ............. Social cost of lost MBM ....................................................................................... .......................... 0.80–0.98 0.80–0.98 

15 ............. Social cost of lost tallow ...................................................................................... .......................... 0.64–0.78 0.64–0.78 

16 ............. Plant modification for tallow purification .............................................................. .......................... ........................ ........................

17 ............. Slaughter and renderer marking of CMPAF ........................................................ .......................... 0.02–0.06 0.02–0.06 

18 ............. Slaughter and renderer recordkeeping/labeling .................................................. 0 .30 0.21 0.27 

19 ............. Subtotal—Renderer Facilities .............................................................................. 20 .55 28.20–33.09 31.14–36.04 

20 ............. Animal Producer .................................................................................................. .......................... ........................ ........................

21 ............. Disposal of cattle > 30 months not inspected and passed, all other animals .... .......................... 24.70–35.70 24.70–35.70 

22 ............. Disposal of slaughter cattle CMPAF ................................................................... .......................... 3.38 3.38 

23 ............. Feed substitution ................................................................................................. .......................... 2.92–3.51 2.92–3.51 

24 ............. Subtotal—Animal Producers ............................................................................ .......................... 31.0–42.59 31.0–42.59 

25 ............. Final Rule Total Costs ..................................................................................... 22 .65 61.34–77.82 64.58–81.06 

1Totals may not sum due to rounding. 

2Annualized cost equal to annual cost plus one-time costs at 7 percent over 10 years. Using a 3-percent rate, annualized costs equal $63.99–

$80.48 million. 

B. Cost Effectiveness of Final Rule and 

Alternatives 

Compared with the final rule, we do 

not offer any alternative that would 

impose greatly lower costs. The only 

feasible lower-cost alternative that 

would reduce the risk of cross 

contamination would be to require 

separate facilities or equipment to 

produce ruminant and non-ruminant 

feed. 

Alternative 1—Dedicated Facilities and 

Equipment 

This alternative would strengthen 

FDA’s 1997 feed rule by preventing 

cross contamination of feed ingredients 

for ruminants with mammalian proteins 

currently prohibited from ruminant 

feed. To prevent cross contamination, 

this alternative would require dedicated 

equipment in those facilities producing 

or handling feed or feed ingredients for 

ruminants and mammalian proteins 

currently prohibited from ruminant 

feed. In the analysis of the alternatives 

to the proposed rule, ERG estimated that 

only independent renderers and feed 

mills would incur compliance costs for 

this dedicated facilities or equipment 

(70 FR 58593). It should be noted, 

however, that this requirement for 

dedicated facilities and equipment 

differs from the dedicated equipment 

requirement of the SRM ban 

(Alternative 3 in this document). Since 

the dedicated facilities and equipment 

option is analyzed here as a separate 

alternative (i.e. not as part of the SRM 

ban), the tonnage of rendered ruminants 

would not be reduced (without the SRM 

ban), and the resulting transportation 

costs would be larger than had the SRM 

ban been included as part of this 

alternative. 

To dedicate facilities, independent 

renderers would invest about $8 million 

in one-time costs and feed mills would 

invest about $43.2 million in one-time 

costs. Annualized over 10 years at 7 

percent, capital investment for 

dedicated facilities would equal about 

$7.3 million, or about $1.1 million for 

independent renderers and about $6.2 

million for feed mills. ERG forecast that 

this alternative would have little effect 

on MBM production, but would force 

firms to spend more to transport MBM 

because they could no longer backhaul 

ruminant feed in trucks used to 

transport feed containing mammalian 

proteins currently prohibited in 

ruminant feed (70 FR 58593 to 58594). 

In the analysis for the proposed rule, 

ERG estimated that dedicated 

equipment would increase 

transportation costs by $8 million to $16 

million for renderers and $14.2 million 

to $28.4 million for feed mills (70 FR 

58594). Accounting for ERG’s revised 

fuel costs (Ref. 16), the estimated costs 

for dedicated transportation equipment 

range from $14.6 million to $29.3 

million annually for renderers and from 

$22.5 million to $45.0 million annually 

for feed mills. The total estimated 

annualized compliance costs of this 

alternative range from $44.4 million to 

$81.6 million. 

This alternative addresses the 

problem of animal feed being crosscontaminated with prohibited 

mammalian protein in firms that 

manufacture animal feeds and also 

handle prohibited mammalian protein 

by requiring such firms to have 

dedicated facilities or equipment for 

animal feeds. The compliance costs of 

this alternative are similar to the costs 

of the final rule. In contrast to the final 

rule, however, this alternative would 

allow CMPAF with the highest BSE 

infectivity to remain in the animal feed 

supply, allowing potential exposure to 

BSE infectivity when cattle consume 

feed intended for other species through 

cross-contamination or misfeeding. We 

conclude, therefore, that the final rule 

more effectively reduces the risk from 

cross-contamination and misfeeding 

than this alternative to require 

dedicated facilities or equipment. Given 

the general similarity in compliance 

costs, we therefore judge this alternative 

to be less cost-effective than the final 

rule. 

Alternative 2—The Proposed Rule 

The proposed rule would require that 

the brain and spinal cord from all cattle 

30 months of age or older slaughtered 

for human consumption, and from all 

cattle not inspected and passed for 

human consumption of any age to be 

defined as CMPAF. The main difference 

between the proposed rule and the final 

rule is that the proposed rule would also 

define as CMPAF the brain and spinal 

cord of cattle under 30 months of age 

that were not inspected and passed for 

human consumption. Compared with 

the final rule, this alternative produces 

more tissue for disposal by deadstock 

renderers, increasing the compliance 

costs for independent renderers. 


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Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 22739 

1The enhanced Canadian feed ban exempts feed 

mills from the requirement for dedicated 

equipment. Although ERG included feed mills in its analysis of the SRM ban, we have excluded these 

costs from our analysis. 

However, these costs would be offset 

somewhat because, under the proposed 

rule, deadstock renderers would not 

need to determine the age of the animal. 

The annualized compliance costs for 

independent renderers would range 

from $34.9 million to $41.5 million. 

Similar to the final rule, livestock 

producers would likely pay higher 

prices for feed substitutes and on-farm 

disposal of deadstock. Annualized 

compliance costs for livestock 

producers would range from $36.4 

million to $51.9 million. Slaughterers 

would incur about $2.5 million in 

annualized costs. Table 2 of this 

document shows that, in total, the 

estimated annualized compliance costs 

for this alternative range from $73.8 

million to $95.9 million and exceed the 

annualized compliance costs of the final 

rule. 

Although this regulatory action would 

prohibit more material from animal feed 

than would the final rule, it would only 

add the brain and spinal cord of cattle 

not inspected and passed for human 

consumption under 30 months of age to 

the list of prohibited cattle material. 

Scientific evidence indicates that the 

probability that the brain and spinal 

cord from cattle under 30 months of age 

contains BSE infectivity is extremely 

low (Ref. 18). Consequently, this 

alternative is less cost-effective than the 

final rule because it cost $9.2 to $14.8 

million more without a commensurate 

reduction of risk. 

TABLE 2.—SUMMARY OF THE COMPLIANCE COSTS OF THE PROPOSED RULE 1

Cost item 

One-time 

costs 

($ million) 

Annual costs 

($ million) 

Annualized costs 2

($ million) 

Low estimate High estimate Low estimate High estimate 

Capital investments .............................................................. 26.2 ........................ ........................ 3.7 3.7 

Labor .................................................................................... ........................ 8.4 8.4 8.4 8.4 

Loss of net revenue ............................................................. ........................ 12.8 19.4 12.8 19.4 

Disposal costs ...................................................................... ........................ 44.9 59.9 44.9 59.9

Marking ................................................................................ ........................ 0.0 0.1 0.0 0.1 

Recordkeeping/Labeling ...................................................... 0.2 0.1 0.1 0.1 0.1 

Feed substitution .................................................................. ........................ 3.8 4.4 3.8 4.4 

Total costs .................................................................... 26.3 70.0 92.1 73.8 95.9 

1 Numbers may not sum due to rounding. 

2 Costs are annualized over 10 years at 7 percent. 

Alternative 3—The SRM Ban 

The third alternative we considered 

would prohibit the use of the full list of 

specified risk material (SRM) from 

animal feed and require the use of 

dedicated equipment by renderers. The 

scope of this alternative is similar to 

Canada’s 2006 enhanced feed rule and 

is the most restrictive regulatory action 

we considered.1 This alternative 

expands the list of prohibited material 

and would substantially increase the 

amount of prohibited material generated 

by regulatory action. It also requires that 

renderers have dedicated equipment 

used to process or transport protein 

prohibited from being fed to ruminants 

and to process or transport protein not 

prohibited from being fed to ruminants. 

In practice, some tissues that are not 

defined as SRM would be difficult to 

separate and are treated as SRM. Canada 

made a similar distinction in its 

enhanced feed rule. Thus, in addition to 

the material prohibited in the final rule, 

this alternative would prohibit from all 

animal feed: The skull, eyes, 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 cattle 30 

months of age and older, and the tonsils 

and distal ileum of all cattle. 

As shown in Table 3 of this 

document, the estimated annualized 

costs of this alternative range from 

$332.0 million to $344.7 million. 

Slaughterers would incur annualized 

costs of about $19.5 million in lost 

revenues and increased labor and 

capital costs. Independent renderers 

would incur from $42.9 million to $55.6 

million in annualized costs of lost 

revenues and increased labor and 

capital costs. Animal producers would 

incur about $12.7 million annually in 

feed substitution costs. Disposal costs 

for animals that would no longer be 

rendered as a result of the SRM ban and 

the disposal costs for slaughter SRM 

would account for the majority of the 

estimated annualized costs and equal 

about $257 million. Because most 

slaughterers can immediately pass 

disposal costs back to cattle producers 

by adjusting the prices they pay for 

slaughter animals, cattle producers 

would likely incur the entire cost of 

SRM disposal in the short run. ERG 

estimated that over time, markets would 

adjust to the impacts of an SRM ban and 

about 50 percent of the total incremental 

costs of this alternative would be passed 

on to consumers as higher beef prices, 

38 percent of the total incremental costs 

would be passed back to cattle 

producers as lower cattle prices and 12 

percent of the total incremental costs 

would be incurred by processors. 

Although this option would increase 

the material removed from animal feed 

when compared with the first 

alternative, the incremental reduction in 

the potential risk would not be 

commensurate with the costs as shown 

in Table 3 of this document. Thus, this 

regulatory alternative would be much 

less cost-effective than either the final 

rule or the proposed rule. 


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TABLE 3.—COMPLIANCE COSTS OF A FULL SRM BAN 1

Cost item 

One-time 

costs 

($ million) 

Annual costs 

($ million) 

Annualized costs 2

($ million) 

Low estimate High estimate Low estimate High estimate 

Capital investments .............................................................. 37.8 ........................ ........................ 5.4 5.4 

Labor .................................................................................... ........................ 12.7 12.7 12.7 12.7 

Loss of net revenue ............................................................. ........................ 35.8 35.8 35.8 35.8 

Transportation ...................................................................... ........................ 7.9 20.5 7.9 20.5 

Disposal costs ...................................................................... ........................ 257.0 257.0 257.0 257.0 

Marking ................................................................................ ........................ 0.6 0.6 0.6 0.6 

Recordkeeping/Labeling ...................................................... 0.2 0.1 0.1 0.1 0.1 

Feed substitution .................................................................. ........................ 12.7 12.7 12.7 12.7 

Total compliance costs ................................................. 38.0 326.6 339.3 332.0 344.7 

1 Numbers may not sum due to rounding. 2 Costs are annualized over 10 years at 7 percent. 

Summary of Regulatory Alternatives 

Table 4 of this document shows the 

annualized and incremental costs of 

each regulatory alternative considered. 

The safeguards put in place by the 1997 

ruminant feed rule have substantially 

reduced the potential risk that tissues 

infected with the agent that causes BSE 

could get into ruminant feed. The final 

rule further reduces the possible risk of 

cross contamination of ruminant feed 

with prohibited material. As explained 

previously, we have determined that the 

final rule is the most cost-effective 

action for reducing the potential risk 

that animal feed or feed ingredients 

intended for ruminants could contain 

the agent that causes BSE. 

TABLE 4.—COSTS OF ALTERNATIVE POLICIES

Alternative 

Annualized costs 1

($ million) 

Incremental annualized costs 

(from previous alternative) 

($ million) 

Low estimate High estimate Low estimate High estimate 

Separate facilities and equipment for renderers and feed mills .................. 44 .4 81.6 

Final rule ...................................................................................................... 64 .6 81.1 20.2 (0.5 ) 

Proposed rule .............................................................................................. 73 .8 95.9 9.2 14.8 

Full SRM ban; separate facilities and equipment for renderers .................. 332 344.7 258.2 248.8 

1 Costs are annualized over 10 years at 7 percent. 

C. Need for Regulation 

Executive Order 12866 directs 

agencies to assess the need for any 

significant regulatory action and to 

provide an explanation of how the 

regulation will meet that need. 

Comments on the October 2005 

proposed rule did not address the 

accuracy of the theoretical argument 

FDA put forth in the preamble to the 

October 2005 proposed rule related to 

private incentives and market failure (70 

FR 58570 at 58587). Therefore, FDA 

retains this argument here in the final 

rule. In this instance, FDA 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 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 final rule would eliminate are the 

same as described in the 1997 ruminant 

feed 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 processed 

CMPAF. Feed purchasers, however, are 

unlikely to obtain the information they 

need due to the long incubation period 

for BSE, which could lead to a 

suboptimal level of risk prevention by 

purchasers during the incubation 

period. Moreover, ruminant producers 

have no way of knowing whether a 

particular batch of feed or feed 

ingredients intended for ruminants is 

free of potentially infective proteins due 

to the possibility of CMPAF being 

introduced through cross-contamination 

with feed or feed ingredients intended 

for non-ruminants. 

D. Benefits 

FDA received few comments on the 

proposed rule that focused on the 

benefits section. One comment stated 

that the proposal was unnecessary 

because it addressed only a very small 

risk. FDA agrees that the risk is low but 

reiterates, as in the proposed rule, that 

by requiring removal of the highest risk 

cattle-derived materials from use in any 

animal feed, the final rule further 

reduces BSE risks not already addressed 

by the 1997 feed ban. 

The purpose of the final rule is to 

further strengthen existing safeguards 

against BSE in the United States. 

Reduced risk of BSE among cattle also 

reduces human risk of vCJD, which is 

believed to be caused by consumption 


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of beef products contaminated with the 

BSE agent. The final rule also increases 

the potential for exports by reducing 

foreign governments’ concerns about the 

safety 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 final rule on U.S. exports 

of beef and other livestock products. 

1. Risk Reduction 

FDA estimates that banning CMPAF 

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 ban on CMPAF, 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 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. This rule would prohibit use in all 

animal feed of these tissues from all 

cattle 30 months of age or older. Brain 

and spinal cord taken from cattle under 

30 months of age would not be defined 

as CMPAF, however, because the 

probability is extremely low that tissues 

from cattle of this age would contain 

BSE infectivity. Thus, banning CMPAF 

from animal feed 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 are exposed to infected material. 

The potential human exposure to 

infectious materials from consuming 

beef is already small, because USDA 

and FDA prohibit the use of certain 

cattle materials, including SRMs, from 

human food. The 2005 Harvard Risk 

Assessment that USDA’s Food Safety 

and Inspection Service made available 

to the public in July 2006 estimates that 

interim measures implemented by FSIS 

on January 12, 2004, and finalized on 

July 13, 2007, reduce potential human 

exposure to BSE infectivity by 99.6 

percent (see 69 FR 1862 and 72 FR 

38700). 

Assessing the public health 

implications from estimates of the 

human exposure to the BSE agent is 

difficult because there is no agreedupon relationship between human 

exposure to cattle ID50s (ID50 is the 

amount of infective material that would 

result in a case of BSE in 50 percent of 

the cattle that consumed it) and vCJD 

cases. 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, 

because each cow with clinical 

symptoms of BSE contains an average of 

about 7,800 ID50s. While the United 

Kingdom totaled over 183,000 cases of 

BSE (Ref. 19) through January 21, 2007, 

the cumulative number of definitive or 

probable vCJD cases identified in the 

United Kingdom as of February 2007 

was 165 (Ref. 20). Thus, the experience 

of the United Kingdom suggests that the 

BSE agent is many times less infective 

in humans than in cattle. 

2. Increased Export Potential 

A second major category of benefits 

largely accrues to U.S. cattle producers 

and reflects the potential for increased 

exports of U.S. beef and beef products 

to countries that have acted to curtail 

exports since the discovery of the 

infected cow in Washington State in 

December 2003. USDA assessed this 

category of benefits in the FSIS SRM 

interim final rule that it issued in 

January 2004. In its assessment, USDA 

concluded that ‘‘the 2004 beef export 

demand forecast has been reduced by 90 

percent’’ (Ref. 21). Foreign trade data 

shows that from 2003 to 2004, the 

quantity of beef, veal, and beef variety 

meat exported by the United States 

decreased by about 75 percent, whereas 

the value of these exports declined by 

about 80 percent (Ref. 22). According to 

USDA data, total U.S. exports of beef, 

veal, and variety meats amounted to 

$3.9 billion in sales in 2003, and exports 

of live cattle resulted in an additional 

$63 million. USDA reports that the 

value of total beef and veal exports for 

2006 amounted to $2 billion. In 2006 

prices, the decline in export value 

comes to $2.2 billion (= ($3.85 billion * 

1.09 [price adjustment]) ¥ $2 billion). 

The quantity exported fell from 

1,274,110 metric tons in 2003 to 653,205 

metric tons in 2006. Some export 

markets disappeared almost overnight: 

Exports of U.S. beef to Japan fell from 

375,452 metric tons in 2003 to 517 

metric tons in 2004; exports to South 

Korea fell from 246,595 metric tons in 

2003 to 144 metric tons in 2004. Exports 

have increased since 2006 but remain 

below 2003 levels. 

Numerous foreign governments have 

cited perceived weaknesses in the 1997 

feed ban as a justification for not fully 

opening their markets to U.S. beef and 

beef products. The preventive measures 

contained in this final rule may increase 

the likelihood that foreign governments 

ease some restrictions on imports of 

U.S. beef products and cattle. 

We cannot estimate the trade benefits 

of this final rule. We can estimate the 

net effect on social surplus of the 

continuing restrictions on beef exports, 

as well as the potential gain from 

removing those restrictions. To do so, 

we use a standard economic model of 

the effects of export restrictions on 

consumer and producer surplus. The 

closing of export markets, all else being 

the same, leads to a fall in exports and 

a rise in domestic consumption as more 

beef is sold on the domestic market (Ref. 

23). The forced sale to U.S. consumers 

increases consumer surplus and 

decreases producer surplus. Over time, 

the quantity produced in the domestic 

economy falls as well, as producers 

respond to the restrictions. If the trade 

restrictions on U.S. beef are removed, 

beef exports will increase, domestic 

consumption will decrease, and 

domestic production will increase. Once 

all adjustments are made to the 

withdrawal of the restrictions, we 

estimate the gain in social surplus to be 

about $105 million per year, with a 

range of $80 million to $120 million. 

We estimate the effects of the export 

restrictions using changes in beef prices 

and exports. Price changes in the U.S. 

market, however, are dominated by 

seasonal and trend effects, fluctuations 

in feed costs, and a host of other factors. 

These complications make it difficult to 

use actual beef price changes to estimate 

the effect of diminished exports on 

price. As an alternative to direct 

estimates of price changes, we impute 

the price effect by estimating the decline 

in domestic price needed to clear the 

market if beef intended for export is 

instead sold on the domestic market. 

Again, we do not estimate the actual 

change in price but the imputed 

contribution of the increased quantity of 

beef on average price. Our imputed 

price change draws on the price 

elasticity of demand for beef, which is 

the percentage change in the quantity of 

beef demanded divided by the 

percentage change in price. The 

estimates in the literature show the 

mean price elasticity of demand for beef 

is about ¥1.086, although the variance 

of the estimates is high (Ref. 24). 

To estimate the continued effect of the 

export restrictions and the potential 

gains from their removal, we assume 

that in their absence, the proportion of 

U.S. production exported would return 

to the 2003 level, 9.6 percent (Ref. 25). 

In 2006, the shortfall in beef exports 

compared with 2003 accounted for 


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about 5.2 (= 0.096 ¥ 0.044) percent of 

2003 beef production (Ref. 25). If we 

assume that the price elasticity of U.S. 

beef supply is about 0.5, removing the 

trade restriction would lead to 

responses on the supply about one-half 

as large as on the demand side, so 

domestic consumption would decline 

by 3.7 percent (= 0.035/(1 ¥ 0.044 ¥ 

0.017)). With a price elasticity of 

¥1.086 and a 3.7 percent decline in 

quantity demanded, we estimate the 

imputed price effect to be a rise of about 

3.4 percent (= 3.7 percent/1.086). 

The rise in social surplus can be 

approximated using the rise in price and 

the average value of exports in 2003 and 

2006. We estimate this gain to be about 

$105 million (= 1⁄2 * ($4.2 billion + $2.0 

billion) * 3.4 percent). This social 

surplus represents the continuing 

annual loss from the restrictions and the 

annual gain from their removal. 

The estimated gain in social surplus 

is highly sensitive to the assumptions 

made about the responses of domestic 

beef consumers and producers to the 

removal of export restrictions. Our base 

estimate of the gain in social surplus 

assumes that in the long-run, the 

changes in consumption are about twice 

as large as the change in production (the 

price elasticity of supply is about half as 

large as the price elasticity of demand 

in absolute value). If increased U.S. beef 

production accounts for one-half of the 

response to the removal of trade 

restrictions (the price elasticity of 

supply is about the same as the price 

elasticity of demand in absolute value), 

the gain in social surplus is about $80 

million per year. By contrast, if reduced 

consumption of beef in the United 

States accounts for three-fourths of the 

response to the removal of trade 

restrictions (the price elasticity of 

supply is about one-third the price 

elasticity of demand in absolute value), 

the gain in social surplus is about $120 

million per year. 

The estimates we present here are all 

based on a simplified model of the 

effects of trade restrictions. The 

estimates represent the gains from 

removing all remaining restrictions on 

beef exports, which will increase the 

world demand for U.S. beef. The 

estimates do not represent the gains 

from this final rule. The gains from this 

final rule would be estimated based on 

any relaxation of trade restrictions 

resulting from the rule. If other public 

and private policies reduce trade 

restrictions, then the potential gains 

from this rule would be correspondingly 

reduced. New safety events, such as 

more BSE cases, would also reduce the 

potential effects of this final rule on 

trade. We also expect that as time 

passes, the effects measured here will 

dissipate to be dominated by other 

changes in the world and domestic 

markets for beef. The social surplus 

estimated here would only be the shortterm benefit of this final rule if 

publication of this rule leads directly to 

the return of U.S. beef to its status in 

world markets before the discovery of 

the infected cow in Washington State in 

December 2003, assuming that no other 

policies or events intervene. 

E. Costs 

FDA has examined the numerous 

public comments that addressed the 

analysis of impacts section published 

with the proposed rule. Furthermore, 

FDA contracted with ERG to update the 

analysis it prepared for the proposed 

rule, taking into account the comments 

and data provided during the public 

comment period, as well as any other 

new or amended provisions that FDA 

made to the final rule. This section 

summarizes the ERG report on the final 

rule, responds to comments on the costs 

of the proposed rule, and describes the 

composition, size, and scale of 

economic activity for the various 

affected industry sectors that would be 

impacted by the final rule. 

The feasible regulatory alternatives to 

the final rule include the following: (1) 

Separate facilities and equipment for 

renderers and feed mills; (2) the 

proposed rule, which would prohibit 

the use of brain and spinal cord from 

cattle 30 months of age and older 

slaughtered for human consumption as 

well as from all cattle not inspected and 

passed for human consumption from 

animal feed; and (3) a full SRM ban in 

animal feed and separate facilities and 

equipment for renderers. The ERG 

report also includes estimates of 

impacts on small entities in the sectors 

that are impacted to a significant degree 

to fulfill requirements of a regulatory 

flexibility analysis. 

In the development of its final report 

on the brain and spinal cord 

prohibition, ERG reviewed the public 

comments to the rule that concerned the 

economic impacts of the proposed rule, 

focusing closely on the data and 

analysis included in a report prepared 

for and submitted by the National 

Renderers Association. ERG utilized the 

services of industry consultants and 

other contractors for their technical 

expertise, including contracting with an 

agricultural engineering firm to generate 

capital cost estimates for independent 

rendering operations. Additionally, ERG 

prepared and administered a small 

survey to independent renderers with 

additional questions about their 

operations, including logistics of animal 

pick-up services, days of operation, 

decomposition of deadstock, and their 

ability to comply with the rule. 

1. Public Comments on Costs 

One of the most comprehensive 

comments to the proposed rule was 

prepared by Informa Economics for the 

National Renderers Association entitled 

‘‘Economic Impacts of Proposed 

Changes to Livestock Feed Regulations’’ 

(Ref. 26). It concluded that the economic 

impact on renderers would far exceed 

the impacts that FDA estimated in the 

proposed rule, resulting in a significant 

economic burden of $127.7 million 

annually in direct economic impacts. 

Many of the individual comments or 

criticisms of our analysis of the 

proposed rule contained in the Informa 

report reflected other public comments 

from other individuals, companies, 

associations, and State governments. We 

have assembled similar comments 

together and will address them 

throughout the summary of the latest 

ERG analysis. 

Approximately $113 million of the 

$127.7 million (about 88 percent) of the 

direct costs in the 2005 Informa report 

represent the estimated deadstock 

collection fees that would be paid by 

livestock producers for picking up those 

deadstock that would still be rendered 

under the proposed rule. The Informa 

analysis assumes that the average 

individual pick-up fees that would be 

charged across the four cattle categories 

represent the costs that renderers would 

incur to remove the CMPAF from cattle 

not inspected and passed for human 

consumption, as well as costs to handle, 

process, and dispose of the material. 

The assumption, however, leads to an 

estimate of costs that represents not the 

expected marginal fee increases from 

the proposed rule, but rather the total 

pick-up fee that the animal producer 

would pay. Using only the marginal 

pick-up fee per cwt that would be 

imposed by this rule reduces the total 

cost from $112.7 million to $62.9 

million. The remainder of the original 

$112.7 million in fees ($49.8 million) 

represents costs that are currently 

incurred by the animal producers and 

are therefore not compliance costs of 

this rule. Further, the other 12 percent 

of the total direct costs represent the 

market value of the tallow and MBM 

that would be foregone due to this rule. 

Accounting for only the social costs of 

these lost revenues, estimated at the 

renderer’s net income rate of 5.65 

percent (use of net income as social cost 

is explained later in this document), 

reduces the $15.7 million to only about 

$0.89 million, a reduction of about 

$14.81 million. 


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This adjustment in estimated pick-up 

fee and MBM and tallow social cost 

losses reduces Informa’s total direct 

costs to about $63.1 million. This figure 

is actually below our final rule estimate 

of $64 million to $81 million, which 

includes a cost reduction from the 

exemption from the definition of 

CMPAF for cattle under 30 months not 

inspected and passed for human 

consumption. If, however, we were to 

include the upper end of the range of 

marginal fee increases from the Informa 

report (Informa’s $112.7 million cost 

represents only the lower bound of the 

data it presented), the range of the total 

direct costs from the Informa report 

(after accounting for the changes 

mentioned previously) would be $63.1 

million to $113.53 million. 

The Informa report also concludes 

that additional indirect costs for 

slaughter facilities to handle and 

dispose of CMPAF (which is not 

calculated separately in the report) and 

capital investments made by renderers 

to handle, process and dispose of 

CMPAF would likely result in a total 

cost exceeding $150 million annually. 

We agree that slaughtering facilities will 

incur additional capital costs, and ERG 

has increased its estimate from $676,000 

in the proposal to about $1.27 million 

annually in the final rule. The capital 

investments for renderers that are 

detailed in the Informa report 

(amounting to an annualized total of 

$11.3 million) are based on an 

assumption that 26 renderers would 

actually install additional equipment to 

render the CMPAF for disposal, which 

is 50 percent of the number that replied 

that they might consider installing such 

equipment. Those 26 rendering 

operations in question, however, would 

also have been included in the survey’s 

question on the expected increase in 

pick-up fees. The increase in pick-up 

fees, therefore, would account for these 

additional capital costs if they were 

indeed anticipated. The previously 

mentioned modifications to Informa’s 

calculations result in a significantly 

lower total cost for the final rule. 

Additionally, we disagree with 

Informa’s conclusion that, due to State 

and local prohibitions against its 

disposal in landfills, there is a high 

likelihood that all CMPAF would need 

to be rendered prior to disposal, 

although we agree that there is some 

uncertainty about the disposal methods 

that will be used throughout the United 

States. 

Various other comments focused on 

the general subject of increased costs to 

slaughterers and other meat processors 

for disposal of byproducts, the 

reduction in the value of the slaughtered 

animals, and the reduction in the 

profitability of renderers. Although 

almost none of these comments 

contained additional data to support 

these conclusions, ERG performed 

additional analyses of the relevant 

industries that largely support the main 

concerns expressed in these comments. 

Other comments stated that increased 

costs would be passed on to farmers. We 

agree that some compliance costs will 

be immediately passed on to farmers; 

ERG therefore concluded that animal 

producers would incur $28.1 million to 

$39.1 million in annual costs for 

alternative disposal of CMPAF from 

cattle slaughtered for human 

consumption and cattle not inspected 

and passed for human consumption 

(Table 1, lines 21 and 22). Other 

comments requested that we offer other 

economic incentives or remuneration in 

order to compensate renderers for 

converting operations to alternative 

disposal methods or for the cost of 

disposal, as has occurred in Europe. We 

did not consider subsidies as a policy 

option because FDA does not have this 

authority. Furthermore, the use of 

subsidies would not change the total 

social costs of the final rule, but rather 

transfer the costs to others. Likewise, 

the social cost does not change, as one 

comment suggested, if the number of 

cattle available for USDA’s BSE testing 

program decreases because the renderer 

refuses to waive pick-up fees. In this 

case, the social cost is transferred to the 

general public. 

We also received some comments that 

made claims about costs to individual 

States, such as the claim that the 

proposed rule would impose $10 

million in costs on California dairy 

farmers, feedlots, and beef cattle 

producers. While we cannot verify this 

estimate without additional data 

necessary to support such claims, we 

agree that the costs of this final rule will 

be proportionally heavier in states with 

large populations of affected cattle. 

One comment stated that removal of 

brain and spinal cord would reduce 

processing ability by 40 percent to 50 

percent, without providing supporting 

information. Another comment stated 

that FDA should focus on removal of 

SRMs from 4D and antemortem 

condemned animals greater than 30 

months, the cost of which would be 

from $64 million to $76 million, 

according to some industry estimates 

that were not disclosed. Without 

supporting information, we cannot 

respond directly to these comments. 

The ERG report, however, takes into 

account a number of public comments 

and changed many of its assumptions 

due to these public comments. 

In general, this final rule, which 

prohibits certain cattle-derived risk 

materials from all animal food or feed, 

would impose four types of costs: 

Disposal costs, lost revenue measuring 

the value of the MBM and tallow not 

produced, direct costs of new 

equipment and re-allocated labor, and 

feed substitution costs. 

2. Disposal Costs 

For the proposed rule, ERG identified 

and discussed five options for disposal 

of CMPAF. These included landfilling 

of the CMPAF without rendering, 

rendering for disposal, disposal through 

alkaline hydrolysis digesters, 

incineration, and composting. The 

analysis concluded that landfilling 

would likely be one of the methods used 

to dispose of CMPAF, and that 

rendering for disposal would be 

unlikely due to the relatively small 

amount of CMPAF. The disposal cost 

estimate of the proposal was set at $12/ 

cwt, based on discussions with industry 

members and ERG’s other report on 

alternative regulatory options, including 

a full SRM prohibition. ERG concluded 

that the per cwt disposal cost would be 

higher than the full SRM prohibition 

disposal cost due to the lower volume 

of CMPAF for the brain and spinal cord 

prohibition as well as the uncertainty in 

disposal methods and unfamiliarity 

with some of the disposal methods in 

the industry. At this $12/cwt rate, 

disposal costs of the proposed rule for 

CMPAF from slaughter and render 

facilities were estimated at $7.72 

million. 

ERG also calculated the disposal costs 

of cattle not inspected and passed for 

human consumption that would no 

longer be rendered as a result of the 

proposed rule. This ban was expected to 

result in an increase in the number of 

on-farm disposals. For its analysis of the 

proposed rule, ERG estimated that 17 

percent of cattle not inspected and 

passed for human consumption were 

currently rendered. In addition, ERG 

had predicted that an additional 0.6 

percent of all cattle not inspected and 

passed for human consumption (or 3.5 

percent of all cattle not inspected and 

passed for human consumption that are 

currently rendered) would no longer be 

rendered due to the proposed rule. 

These animals were estimated to result 

in an increase in capital and labor costs 

for on-farm burial of about $1.02 

million. 

We received numerous public 

comments concerning the estimates on 

the rendering of cattle not inspected and 

passed for human consumption. Some 

were more specific than others, but the 

prevailing theme was that we had 


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significantly underestimated the 

number of cattle not inspected for 

human consumption that are currently 

rendered. In particular, the Informa 

report questioned the accuracy of the 

estimate that only 17 percent of cattle 

not inspected and passed for human 

consumption are currently rendered. In 

fact, FDA had included in the proposal 

a discussion of the uncertainty of its 

own estimate along with Informa’s 

previous estimate of this number at 

about 42 percent, and also incorporated 

this 42-percent estimate as the high end 

of the range of cost estimates for the 

proposal, where appropriate. Accepting 

Informa’s 2004 estimate that 42 percent 

of cattle not inspected and passed for 

human consumption were rendered, we 

modified the proposal’s disposal cost 

estimate for CMPAF from cattle 

slaughtered for human consumption 

and cattle not inspected and passed for 

human consumption that would 

continue to be rendered, from $7.72 

million to a range of $7.72 million to 

$9.97 million. Similarly, we modified 

the proposal’s disposal cost estimate for 

cattle not inspected and passed for 

human consumption that would no 

longer be rendered as a result of the 

proposed rule from $1.02 million to a 

range of $1.02 million to $2.5 million. 

In its analysis of the final rule, the 

ERG report uses the Informa survey data 

of renderers (conducted for its 

November 2005 report) and USDA data, 

which show that about 45 percent of 

cattle not inspected and passed for 

human consumption are currently 

rendered. We therefore base our cost 

estimates for the final rule solely on the 

45 percent figure, and do not include 

those based on the former range of 17 

percent to 42 percent. 

We also received many comments 

concerning the ERG estimate that about 

26,000 cattle not inspected and passed 

for human consumption (or 0.6 percent 

of all cattle not inspected and passed for 

human consumption) would no longer 

be rendered as a result of the rule. 

Informa’s 2005 results showed that 

renderers replied that, in total, about 67 

percent of cattle not inspected and 

passed for human consumption that are 

currently rendered would no longer be 

rendered due to the proposed rule. That 

is, 45 percent times 67 percent = 30 

percent of all cattle not inspected and 

passed for human consumption due to 

either renderer refusal to accept the 

animal or the producer’s refusal to pay 

a higher pick-up fee, would no longer be 

rendered. The final ERG report, relying 

on estimates it received from deadstock 

renderers and estimated price 

elasticities of deadstock to renderers, 

projects that pick-up charge increases 

would range from 25 percent to 50 

percent for all cattle under 30 months 

and 100 percent to 150 percent for cattle 

30 months of age or older. We note that 

one comment stated that California 

renderers would increase their pick-up 

fees by 50 percent. These higher pickup fees, coupled with expected closures 

of rendering plants handling about 10 

percent of these cattle, support ERG’s 

revised estimate that 29.4 percent to 

44.8 percent of currently rendered cattle 

not inspected and passed for human 

consumption will no longer be rendered 

as a result of this rule. We accept this 

estimate as well and include it in this 

analysis. The Informa estimate of 67 

percent may overstate the probability of 

an animal no longer being rendered 

because some of the carcasses that one 

renderer says will no longer be picked 

up by his company may still be picked 

up by another renderer. As a result of 

this and other changes in the final 

report, we estimate that the total amount 

of CMPAF would range from 610 

million to 733 million lbs, a significant 

increase from the 64 million lbs 

estimated in the proposed rule. 

Due to many public comments that 

FDA underestimated disposal costs in 

the proposed rule, ERG re-analyzed its 

methodology and assumptions 

concerning disposal in its report for the 

final rule. It reviewed various disposal 

technologies and a range of estimated 

costs for each based on literature 

compiled by researchers at Kansas State 

University, National Agricultural 

Biosecurity Center Consortium. The 

Kansas State University report presents 

a most likely representative estimate of 

costs, although it was derived from a 

graphic figure in the source document 

and thus contains some uncertainty. It 

also identified another disposal method 

that ERG had not considered in the 

proposed rule, namely that cattle would 

be left to decompose in the field or 

range without any additional treatment 

of the carcass. Some comments reflected 

the overall conclusions of the Kansas 

State University report, stating that 

incineration and composting are 

currently prohibitively expensive or 

complicated. One comment stated that 

burying CMPAF could be very 

expensive if a minimum of 4 hours rent 

for a backhoe is required, giving further 

support to the conclusion that when 

possible, these cattle would likely be 

left to decompose in the field. Several 

other comments questioned the 

availability of landfills for disposal of 

CMPAF. Another comment asked that 

we consult cost data in the 2004 

publication on carcass disposal 

technologies by the National 

Agricultural Biosecurity Center 

Consortium. Table 7 in that publication 

shows disposal costs per ton for various 

carcass disposal methods. For both 

burial and landfilling, it presents cost 

estimates that are below the estimates 

ERG uses in its analysis of this final rule 

(Ref. 27). 

Although many other comments 

questioned what they perceived to be 

low total disposal costs published in the 

proposed rule, the 2005 Informa survey 

reported an average disposal cost 

estimate of $11.51/cwt among those 

firms that indicated they would accept 

the CMPAF. Additionally, the Kansas 

State study reported 7 disposal options 

greater than $12/cwt and 4 options 

lower than $12/cwt. Accordingly, ERG 

has retained the overall average of $12/ 

cwt disposal cost for CMPAF (from 

brain and spinal cord removal) from 

independent rendering operations for 

the final rule. Some comments 

questioned the economic feasibility of 

using dedicated trucks to transport 

CMPAF to disposal or for further 

processing. We have in fact included 

these costs in our totals because in its 

analyses of disposal costs, ERG included 

the transportation costs in the $12 per 

cwt estimate. Further, the Informa 

survey of renderers (reporting that 

renderers expect disposal costs would 

average $11.51 per cwt.) based its 

questions on CMPAF as defined by the 

proposed rule, which would require 

separate transportation trucks or 

compartments. Based on this $12/cwt 

rate, we estimate that CMPAF disposal 

costs of the final rule for slaughter 

facilities will be $3.4 million (Table 1, 

line 22). 

Disposal costs for CMPAF removed at 

independent renderers are estimated 

using the same $12/cwt estimate used in 

the proposal (we explained the $12/cwt 

figure and public comments in detail 

earlier in the document). The Informa 

report and many other comments 

remarked that much more than just the 

brain and spinal cord would need to be 

removed from those cattle not inspected 

and passed for human consumption that 

were not too decomposed to undergo 

separation. Furthermore, comments 

stated that a significant number of them 

would be too decomposed to separate 

the brain and spinal cord. For both the 

proposed and final rule, ERG judged 

that from 1.3 lbs to 53.0 lbs of CMPAF 

would be removed from cattle 30 

months of age or older, but for the final 

rule it also included an allowance for 

the number of cattle 30 months of age 

or older not inspected and passed for 

human consumption that are picked up 

but that are too decomposed to undergo 

tissue separation. The Informa claim 


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that 54 percent of these animals being 

too decomposed to undergo tissue 

separation added significant weight to 

the volume of CMPAF that would be 

prohibited. Based on the aggregate 

weight of CMPAF removed, ERG 

estimated disposal costs at $11.3 million 

for the CMPAF that is removed by 

independent renderers and for the cattle 

not inspected and passed for human 

consumption that are picked up by 

renderers but are too decomposed to 

undergo tissue separation. 

For the disposal of the additional 

cattle not inspected and passed for 

human consumption that are no longer 

picked up for rendering, ERG adjusted 

the $12/cwt disposal cost for those 

carcasses that are likely to be buried on 

the farm. For on-farm burial, the most 

likely representative cost listed in the 

Kansas State University report was $6/ 

cwt. ERG increased this to an estimated 

$8/cwt to account for those farms where 

burial is less economical or less viable 

due to the absence of available land. 

The cattle carcasses were then 

distributed among the following four 

types: Calves, feedlot, cattle 30 months 

of age or older, and cattle under 30 

months. For its disposal cost 

calculations, ERG used only the 

incremental social cost, which is the 

difference between the disposal method 

and the existing charge for renderer 

pick-up cost (per cwt) as developed in 

the Informa report. For cattle 30 months 

of age or older not inspected and passed 

for human consumption, ERG calculated 

the incremental cost per cwt at $4.65 

($8.00/cwt minus the current $3.35/ 

cwt); for cattle under 30 months ERG 

calculated the incremental cost at $5.49 

($8.00/cwt minus the current $2.51/ 

cwt). For feedlot cattle, whose full 

disposal cost remains at $12/cwt 

because it is unlikely they would be 

buried at the producer site, ERG 

calculated the incremental cost at 

$10.24/cwt ($12.00/cwt minus the 

current $1.76/cwt). For calves, ERG 

assumed current pick-up charges to 

increase by $4.00/cwt, noting that their 

current reported pick-up fee exceeds 

$12/cwt. As a result, we estimate total 

disposal costs for the additional cattle 

not inspected and passed for human 

consumption to range from $22.0 

million to $33.0 million annually. 

To account for the additional tonnage 

of non-cattle species that died at the 

animal producer establishment and 

would no longer be rendered as a result 

of this rule as suggested by some 

comments, ERG added an additional 10 

percent of the cost of the midpoint in 

the range of total disposal costs for the 

combined calves, feedlot, cattle 30 

months of age or older, and cattle under 

30 months ($2.7 million) (Table 1, line 

21 adds $2.7 million to the disposal cost 

range of $22.0 to $33.0 million). We 

acknowledge additional uncertainty in 

this 10-percent estimate as we lack the 

data to present a more robust estimate. 

In sum, we find that the total disposal 

costs for slaughter establishments ($3.4 

million), renderers ($11.3 million), 

cattle not inspected and passed for 

human consumption that would no 

longer be picked up by renderers ($22.0 

million to $33.0 million), and other noncattle species ($2.7 million) will range 

from $39.4 million to $50.4 million. 

3. Lost Value of CMPAF and Hides 

For the proposed rule, ERG had 

calculated that the 64 million lbs. of 

CMPAF from both slaughter operations 

and from those cattle not inspected and 

passed for human consumption that 

would no longer be rendered would 

have yielded about 10,800 lbs. of MBM 

and 4,400 lbs. of tallow. Using historical 

byproduct prices, ERG had estimated 

the value of the MBM and tallow at $1.0 

million and $0.8 million. Accepting the 

2004 Informa estimate of a larger 

number of cattle currently rendered, we 

had included in the proposed rule an 

upper estimate of lost revenues of MBM 

at $1.7 million and tallow at $1.2 

million. 

The final rule differs from the 

proposed rule in that it exempts certain 

cattle-derived risk materials (brain and 

spinal cord from cattle under 30 months 

not inspected and passed for human 

consumption) from the definition of 

CMPAF. The final rule continues to 

prohibit the use of CMPAF in all animal 

feeds to prevent BSE. 

Both ERG’s 2004 report (relied upon 

for our analysis of the proposed rule) 

and the Informa report included the 

foregone revenues from MBM and 

tallow that would have been produced 

from the CMPAF as costs of the rule. 

This approach, however, overstates the 

true social cost of the rule because it 

includes value added from the use of 

capital and labor at rendering facilities 

that would not be used if the CMPAF 

goes to disposal without further 

rendering. A better estimate of social 

cost would include only the lost value 

attributable to the now-prohibited raw 

materials, or the difference in total cost 

between final products made with MBM 

or tallow from the CMPAF and the total 

cost of final products made with 

alternative raw materials. A more 

accurate estimate of the social cost of 

the rule would be the net income that 

would otherwise have been generated 

from the processing of CMPAF into 

MBM and tallow. For the final rule, ERG 

has estimated renderer average net 

income for both MBM and tallow at 5.65 

percent of their foregone sales, based on 

2002 Census of Manufacturers data. 

Marginal net income may be more 

appropriate because it takes into 

account the existence of fixed costs. The 

lack of detailed revenue and cost data 

for those independent renderers affected 

by the rule, however, prevents us from 

estimating the cost functions necessary 

for a measure of marginal net income. 

The significance of the difference 

between marginal and average net 

income is not likely to be large in this 

case, since the supplies of raw materials 

are highly elastic and the amount 

affected is a small fraction of all 

ingredients. Industry data show that 18 

percent of cattle 30 months of age or 

older are slaughtered for human 

consumption, thus requiring CMPAF 

removal. Consequently, ERG estimated 

the CMPAF removed at slaughterhouses 

to be about 28 million lbs. Using 

industry data on byproduct yields as 

well as historical averages prices for 

MBM and tallow of $180/ton and $360/ 

ton, ERG estimated the value of this 

foregone MBM at $0.6 million and 

tallow at $0.5 million. Using a 5.65 

percent net income rate, ERG estimated 

the social cost of the foregone MBM and 

tallow from slaughtered cattle at 

$64,000 per year (Table 1, lines 4 and 

5). 

Additionally, ERG estimated the value 

of the MBM and tallow foregone from 

the carcasses of the cattle not inspected 

and passed for human consumption that 

would no longer be collected by 

renderers as a result of this rule (and 

would likely be disposed of on the farm 

or elsewhere). This reduction in 

rendering would include those cattle 

not rendered due to the reduced 

quantity demanded for rendering 

services of cattle not inspected and 

passed for human consumption caused 

by the substantial expected increase in 

pick-up charges. In addition, fewer 

cattle will be rendered due to a number 

of rendering plant closures. Using 

various price elasticities of demand, 

ERG’s calculations forecast a 29.4 

percent to 44.8 percent reduction in the 

number of cattle not inspected and 

passed for human consumption that are 

picked up for rendering. Using industry 

averages of animal weights for cattle of 

different ages, ERG calculated the total 

weight of animals that would no longer 

be picked up for rendering at 489 

million lbs to 719 million lbs. Applying 

the yield rates of MBM and tallow for 

whole carcasses (25 percent for MBM, 

10 percent for tallow) results in MBM 

revenue losses ranging from $11.0 

million to $16.2 million, and tallow 


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revenue losses from $8.8 million to 

$12.9 million. Additional MBM and 

tallow revenue losses are estimated at 

$3.1 million and $2.5 million, 

respectively, for animals that were 

picked up by the renderer but were too 

decomposed to undergo tissue 

separation. Based on a 5.65 percent 

annual net income rate for both MBM 

and tallow, the resulting net income 

losses would range from $1.4 million to 

$1.8 million (Table 1, lines 14 and 15). 

Adding these losses to the net income 

loss from CMPAF derived from 

slaughterhouses results in total net 

income losses of $1.5 million to $1.8 

million annually. 

ERG also calculated the social cost of 

the hides that would be lost due to an 

increase in the number of cattle not 

inspected and passed for human 

consumption that would no longer be 

rendered as a result of this rule. The 

same assumptions and calculations that 

form the basis for the 29.4-percent to 

44.8-percent increase in cattle not 

inspected and passed for human 

consumption that would no longer be 

rendered as a result of this rule apply to 

loss of cattle hide value as well. ERG 

has taken the reduction in each of the 

four individual cattle categories (the 

total reduction ranges from 29.4 percent 

to 44.8 percent over all calves, feedlot, 

cattle 30 months of age or older, and 

cattle under 30 months), and applied 

the average market value of the hide for 

each to estimate the total hide value lost 

due to this rule at $9.16 million to 

$13.69 million. In this case, ERG 

concludes that the social cost would 

include almost the entire market value 

of the hide because the only value 

added to the process is a very small 

amount of labor required for hide 

removal. Because this value was not 

calculated and subtracted from the 

average market values, the previously 

mentioned total may slightly 

overestimate the social costs. 

4. Direct Costs 

In the proposed rule we reported five 

categories of direct costs, including: (1) 

Capital and labor costs for slaughtering 

and rendering, (2) the tallow restriction, 

(3) MS beef restriction, (4) marking 

costs, and (5) labeling and 

recordkeeping costs. For the final rule, 

we address these same costs as well as 

the cost of (6) creating procedures for 

training on, and actual administration 

of, the age determination process for 

cattle. 

a. Capital and labor costs for 

slaughtering and rendering. This final 

rule will result in cattle slaughter 

operations that separate CMPAF and 

arrange for its disposal separate from 

other cattle offal. FSIS’ regulations at 9 

CFR 310.22 prohibit SRMs for use as 

human food but do not prohibit these 

materials from being rendered into 

MBM and tallow for use in feed for nonruminant animals. Under this final rule, 

CMPAF from slaughterhouses (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 nonprohibited material-origin and offal of 

CMPAF-origin. 

For the proposed rule, we relied on 

the previous ERG report to project that 

slaughterers would incur annualized 

capital and labor costs that totaled 

$676,000 ($597,000 in annual labor 

costs plus $555,000 in capital costs 

annualized at 7 percent over 10 years). 

These costs included the additional 

offal bins that all slaughterers were 

expected to require, the modified 

procedures and processes for the larger 

slaughterers, and additional labor to 

segregate the CMPAF. Comments on the 

proposed rule did not offer specific 

costs for slaughterers but generally 

maintained that slaughterers would be 

affected. 

For the final rule, ERG revised its 

estimated number of USDA-inspected 

plants upward to 1,545 from 689, but 

revised the estimated number of cattle 

having CMPAF removed at slaughterers 

down from 100 percent to about 18 

percent due to the change in approach 

whereby only cattle 30 months of age or 

older would have CMPAF removed at 

slaughter. ERG estimated the resulting 

one-time capital expenditures of the 

final rule at $2.10 million (or $299,000 

annualized at 7 percent over 10 years). 

With the addition of maintenance costs 

of about $315,000 and labor costs of 

$656,000, ERG estimated the total 

annualized slaughter costs for capital 

and labor at about $1.27 million (Table 

1, lines 2 and 3), representing a small 

increase from the proposed rule. 

In the proposed rule, we concluded 

that renderers would also incur 

additional capital and labor costs to 

handle CMPAF segregation from cattle 

not inspected and passed for human 

consumption. ERG projected equipment 

purchases and installation at a one-time 

cost of $3.1 million (or $442,000 at 7 

percent over 10 years), as well as 

additional labor costs of $1.4 million 

annually. We used this cost as the low 

end of the range of costs, and used a 

figure 2.46 times greater as the upper 

end based on the 2004 Informa assertion 

that 42 percent of cattle not inspected 

and passed for human consumption 

were currently rendered, compared with 

ERG’s previous finding of this number 

at 17 percent. The proposed rule’s 

estimate for both renderer capital and 

labor costs was $1.9 million to $4.6 

million annually. Numerous public 

comments addressed the capital and 

labor costs to renderers. In general, the 

comments stated that FDA greatly 

underestimated the cost to renderers of 

removing brain and spinal cord from 

cattle not inspected and passed for 

human consumption. 

For the final rule, ERG reassessed the 

conclusions in its analysis of the 

proposed rule using the information 

provided in the 2005 Informa 

Economics report and presents final rule 

estimates that are substantially larger. 

ERG now estimates that there are 70 

deadstock renderers, including 25 very 

small renderers that were likely not 

included in the Informa survey’s result 

of 45 deadstock renderers. The 

estimated number is, however, a 

decrease from the proposed rule’s 

estimate of 141 independent renderers 

because it is now accepted that 

deadstock renderers are a small subset 

of independent renderers, and nondeadstock renderers would not incur 

these additional capital and labor costs. 

ERG contracted with an engineering 

firm to estimate the renovation of 

deadstock rendering facilities in order to 

remove CMPAF. The engineering firm 

created a detailed capital cost estimate 

for a deadstock renderer handling 150 

animals per day at about $600,000. ERG 

used this estimate as well as results of 

its discussions with other deadstock 

renderers to produce capital cost 

estimates across the range of deadstock 

renderers by size. The capital costs on 

a per plant basis have increased 

substantially for this final rule, most 

notably to account for the planning and 

construction of a separate structure for 

the removal of CMPAF. Whereas ERG 

had estimated one-time costs for capital 

improvements for renderers at $3.1 

million for the proposed rule (or 

$442,000 annualized at 7 percent over 

10 years), it estimated if all renderers 

initiated such renovations, the one-time 

costs for capital improvements for the 

final rule would be $32.2 million (or 

$4.6 million annualized at 7 percent 

over 10 years). The engineering 

estimates did not include a specific cost 

for construction permits, as one 

comment suggested would be needed, 

but the cost of construction permits 

would likely amount to a small part of 

the separate contingency costs that were 

included at $54,000 per rendering 

facility. 

ERG also increased its estimate of 

deadstock renderer labor costs on a per 

plant basis, due to further discussions 

with rendering facility managers. 

Whereas ERG estimated the additional 


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labor required for the proposed rule to 

range from 0.04 to 2.21 employees, it 

estimated the range for the final rule at 

0.17 to 8.00 employees. Due to the 

estimated reduction in the number of 

rendering plants that would undertake 

such renovations and additional hiring, 

ERG concluded that total labor costs 

would only increase by $1.4 million to 

$1.7 million. ERG also found that an 

additional maintenance cost estimated 

at 15 percent of aggregate capital costs 

would add another $4.8 million 

annually. Several comments on the 

proposed rule mentioned efficiency 

losses for renderers due to slower line 

speeds. We agree with the comment that 

this may be a possibility and have 

included additional labor costs, which 

would tend to offset those efficiency 

losses. 

Public comments and industry 

discussions with ERG indicate that 

many facilities would not undertake the 

capital improvements and additional 

labor necessary to renovate facilities and 

change their operating procedures. In its 

analysis of the final rule, ERG adjusted 

the total costs to account for the number 

of deadstock renderers that would not 

undergo these renovations, assuming 

that the expected decline in the 

percentage of renderers would equal the 

percentage reduction in material sent to 

rendering. To do this, ERG relied on 

renderers’ predictions (through direct 

discussions with renderers as well as in 

public comments) that they would 

require very large increases in pick-up 

fees. Some predicted that the pick-up 

fees would more than double. As a 

result, ERG estimated that the increase 

in fees would range from 100 percent to 

150 percent for cattle 30 months of age 

or older, and 25 percent to 50 percent 

for all other cattle. Using estimated 

price elasticities ranging from 0.25 for 

feedlot cattle to 0.6 for calves (Informa 

also suggests an inelastic demand for 

rendering services by many livestock 

producers), ERG calculated the total 

reduction in raw material going to 

rendering at 29.4 percent to 44.8 

percent, including an additional 10 

percent reduction for facilities that 

abandon deadstock rendering. The 29.4 

percent reduction in raw material going 

to rendering represent a decrease of 

549,000 from the current total number 

of 1,870,000 cattle rendered (549,000/ 

1,870,000 = 29.4 percent). This decrease 

is the combined decrease in numbers of 

calves, feedlot cattle, cattle 30 months 

or older, and cattle under 30 months. 

The number of calves going to rendering 

will decrease by 216,000, or 25 percent 

from the current number, 865,000 calves 

(865,000 times 25 percent = 216,000). 

The 25 percent decrease includes a 15 

percent decrease due to increased pickup fees (0.6 elasticity times 25 percent 

increased pick-up fees) plus a 10 

percent further reduction in non-cattle 

rendering due to plant closures. The 

number of feedlot cattle going to 

rendering will decrease by 27,000, or 6.3 

percent from the current number, 

424,000 feedlot cattle (424,000 times 6.3 

percent = 27,000). The 6.3 percent is the 

result of a 0.25 elasticity times a 25 

percent increase in pick-up fees. The 

number of cattle 30 months of age or 

older going to rendering will decrease 

by 281,000, or 60 percent from the 

current number, 469,000 cattle 30 

months of age or older (469,000 times 60 

percent = 281,000). The 60 percent 

decrease includes a 50 percent decrease 

due to increased pick-up fees (0.5 

elasticity times 100 percent increased 

pick-up fees) plus a 10 percent further 

reduction in non-cattle rendering due to 

plant closures. The number of cattle 

under 30 months of age going to 

rendering will decrease by 25,000, or 

22.5 percent from the current number, 

111,000 cattle under 30 months of age 

(111,000 times 22.5 percent = 25,000). 

The 22.5 percent decrease includes a 

12.5 percent decrease due to increased 

pick-up fees (0.5 elasticity times 25 

percent increased pick-up fees) plus a 

10 percent further reduction in noncattle rendering due to plant closures. 

The total reduction in cattle equals 

29.4 percent of the currently rendered 

number of cattle (549,000/1,870,000 = 

29.4 percent). The upper end of the 

range (44.8 percent) was calculated by 

the same method using the upper end 

range of factors. Using the midpoint of 

this 29.4-percent to 44.8-percent range, 

ERG predicted that about 37.1 percent of 

the renderers will not undergo these 

necessary capital renovations, thereby 

reducing the $32.2 million one-time cost 

to $20.25 million and the $11.2 million 

in annualized capital, maintenance, and 

labor costs to $7.0 million (Table 1, 

lines 9 and 10). Additionally, the 

number of cattle 30 months of age or 

older going to rendering would be 

reduced by 60 percent to 85 percent, 

thereby reducing the disposal costs to 

$11.3 million. Without the adjustment 

for these two factors, the annualized 

capital, operating, maintenance, and 

disposal costs for deadstock operators 

would be estimated at $52.4 million, not 

$18.4 million. 

b. Tallow restriction. The final rule 

would prohibit entirely the use of tallow 

derived from BSE-positive cattle and 

prohibit the use of certain other 

CMPAF-derived tallow unless it 

contains less than 0.15 percent 

insoluble impurities, as did the 

proposed rule. For the proposed rule, 

we concluded that it would not be 

economical for renderers or tallow 

manufacturers to further process the 

separated brains and spinal cords and 

other tissues from those cattle 

undergoing tissue separation into tallow 

while complying with the additional 

equipment separation and tallow testing 

and purification requirements. We 

therefore did not include any additional 

cost for this provision. We received one 

comment that stated that the capital 

investment for dedicated equipment to 

be used to produce tallow (that would 

then need to meet the purity 

requirements) would be substantial. We 

agree with this comment. The final rule 

contains an estimate of a much larger 

volume of CMPAF than the original 

estimate for the proposed rule. 

However, the amount of CMPAF that is 

handled directly by renderers is still a 

relatively small amount (because most is 

either on-farm disposal or other disposal 

of cattle not inspected and passed for 

human consumption), which would still 

not be economical to further process, 

due to the same equipment separation 

and tallow testing/purification 

requirements in this final rule. We have, 

therefore, not included additional costs 

for this provision. This analysis 

previously accounted for the net income 

lost on the value of this tallow and 

MBM. 

c. MS beef restriction. In the proposed 

rule, we predicted that there would not 

be any costs for the provision that 

would prohibit the use of MS beef in 

animal feeds if the brain and spinal cord 

of cattle 30 months of age or older or the 

brain and spinal cord of all cattle not 

inspected and passed for human 

consumption has not been previously 

removed from the cattle material used to 

make MS beef. ERG’s previous analysis 

concluded that the brain and spinal 

cord are already removed from the 

carcasses of dead cattle at the ‘‘4D’’

plants (independent renderers that 

collect dead and downer cattle and 

process the carcasses for red meat to be 

used for pet food manufacturers, zoos, 

and other animal feeding operations) 

that process them. 

The ERG report maintains that all or 

almost all 4D plants already remove the 

brain and spinal cord. To the extent that 

a small percentage of 4D plants might 

not remove these materials, we agree 

that there could be some additional 

compliance costs to this final rule but 

believe them to be small due to the 

small number of establishments. As 

such, we have slightly revised our 

previous conclusion that there would 

not be additional compliance costs as a 


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result of the MS beef provision of the 

final rule. 

d. Marking costs. The final rule, like 

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. For the 

proposed rule, ERG used various 

assumptions to characterize the cost of 

adding marker dyes to this material. It 

concluded with an estimate ranging 

from $1,700 to $13,000 annually for 

total industry compliance. Public 

comments on the proposed rule did not 

address the marking cost estimate. 

For the final rule, ERG used the same 

assumptions to calculate its estimate of 

marking costs, resulting in the same 

marking ranging from $0.11 to $0.78 per 

ton of CMPAF. In this case, though, ERG 

included as an upper bound estimate of 

marking costs the tonnage of MBM and 

tallow from cattle not inspected and 

passed for human consumption that 

would not be rendered for non-ruminant 

feed as a result of this rule. In effect, 

ERG has allowed for the possibility that 

the additional cattle that would not be 

rendered for feed as a result of this rule 

would be rendered for disposal instead. 

Taking this possibility into account 

provides for a worst-case scenario for 

marking costs. We now estimate the 

final rule marking costs to range from 

$18,000 to $64,000 annually, a relatively 

large increase from those of the proposal 

but a very small part of total compliance 

costs. 

e. Labeling, recordkeeping, 

certification, and access costs. The 

proposed rule would require that 

renderers that handle CMPAF or 

products that contain CMPAF ensure 

that the CMPAF are not used in animal 

feed. The proposed requirements 

included labeling for products with 

CMPAF that states ‘‘Do not feed to 

animals,’’ the establishment and 

maintenance of records sufficient to 

track CMPAF to ensure the materials are 

not introduced into animal feed, and 

making such records available to FDA. 

ERG judged that the proposed labeling 

requirements would impose only 

modest compliance costs since the 

labeling requirements (applying 

primarily to bulk shipments) could be 

incorporated into current labeling 

practices. ERG estimated total industry 

costs at about $62,000 annually (onetime costs of $101,000 annualized at 7 

percent over 10 years plus annual costs 

of $48,000). We did not receive any 

substantive public comments 

concerning the labeling and 

recordkeeping costs. 

For the final rule, ERG increased the 

hours needed for label design, 

production, and review, but did not 

revise hourly estimates for 

recordkeeping modification and review. 

In total, we estimate this labeling and 

recordkeeping provision to cost industry 

about $90,000 annually (a $165,000 onetime cost annualized at 7 percent over 

10 years plus $67,000 in annual costs). 

Additionally, the final rule has been 

revised to clarify that a renderer’s 

records must either include (1) 

certification or other documentation 

from the supplier that material supplied 

to the renderer does not include 

CMPAF, provided that it includes a 

description of the segregation 

procedures used, documentation that 

the supplier confirms that its 

segregation procedures are in place 

prior to supplying any cattle material to 

the renderer, and records of the 

renderer’s periodic review of the 

suppliers’ certification or other 

documentation; or (2) documentation of 

another method, acceptable to FDA, 

such as third party certification, for 

verifying that suppliers have effectively 

excluded CMPAF. 

Based on the levels of effort estimated 

for the 2007 dietary supplement cGMP 

final rule (72 FR 34752) requiring 

certification of procedures, FDA projects 

that the initial certification or other 

documentation of the suppliers’

procedures will require a 20-hour effort 

by a management level employee of an 

independent renderer. The Bureau of 

Labor Statistics (BLS) provides data on 

employee costs for management 

occupations classified within the North 

American Industrial Classification 

System (NAICS) code 311600—the 

animal slaughtering and processing 

industry (BLS data on individual 

occupations within NAICS code 

311613—rendering and meat product 

processing, is not available). We have 

adjusted the BLS wage data, including 

a 40 percent increase for benefits and 

adjusting for inflation in employment 

costs. FDA estimates the initial 

certification or other documentation of 

suppliers to an independent renderer to 

cost about $1,030 (annualized at $250 

per year over 10 years at a 7 percent 

discount rate). FDA estimates that the 

periodic review of the certification or 

other documentation to take 8 hours 

annually, resulting in a $412 annual 

cost. FDA expects daily recordkeeping 

to amount to 5 minutes per day for an 

administrative support employee. Using 

the BLS data, this recordkeeping cost is 

estimated at about $460 annually. Total 

annualized certification or other 

documentation costs per independent 

renderer establishment are estimated at 

about $1,125. 

FDA projects that the initial 

certification or other documentation of 

the internal system of a packer/renderer 

will require 6 hours for a management 

level employee. An additional 3 hours 

is expected to be expended each year for 

periodic review of the internal 

certification or other documentation. 

Packer/renderers will also be expected 

to incur recordkeeping costs estimated 

at about 5 minutes per day. Using the 

same BLS wage data as above, FDA 

projects annualized certification or 

other documentation costs per packer/ 

renderer establishment to be about $690. 

The total annualized costs of the new 

recordkeeping costs associated with the 

certification or other documentation of 

suppliers (slaughterers) for the 

estimated 125 independent renderers 

and 50 packer/renderers handling 

CMPAF is estimated at about $175,000. 

f. Animal age determination. The final 

rule does not include in the definition 

of CMPAF cattle not inspected and 

passed for human consumption under 

30 months of age. FDA originally 

included these cattle in the definition of 

CMPAF because of European 

surveillance data suggesting that cattle 

not inspected and passed for human 

consumption pose a higher risk for BSE, 

and due to concerns that processes were 

currently not established in the 

rendering industry for verifying the age 

of such cattle through inspection. 

However, FDA received comments on 

the feasibility of aging such cattle and 

on the relatively low risk reduction 

achieved by excluding such cattle. FDA 

considered these comments, 

surveillance data indicating the current 

risk of BSE to U.S. cattle is very low, the 

strong feed protection provided by the 

existing ruminant feed rule, and the 

added secondary level of protection 

provided by the other provisions of this 

final rule. Based on these factors, FDA 

concluded that it was not necessary to 

include in the definition of CMPAF 

cattle not inspected and passed for 

human consumption that are under 30 

months of age. 

The ERG report concludes that, in the 

absence of a national cattle 

identification system, deadstock 

renderers will need to make the 

judgments regarding age on an animalby-animal basis. Compliance costs for 

such a system would include 

administrative costs for the creation of 

procedures for employees to judge the 

age of animals, and training costs for 

educating employees on these 

procedures, as well as annual labor 

costs for the employees that administer 

the age determination process. 

ERG assumed that the cost of 

procedure development, normally a 


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one-time cost, would likely be revised 

annually as the industry moves toward 

a national cattle identification system. 

Additionally, ERG estimates that annual 

training times for non-clerical workers 

will be 4 hours for deadstock renderers 

and 2 hours for non-deadstock 

independent renderers. In addition, 1 

hour per year of supervisor time for 

employee training will be required for 

deadstock renderers and 0.5 hour for 

non-deadstock independent renderers. 

The total estimated costs to renderers of 

annual procedure development and 

updating and annual employee training 

will amount to about $491,000. For large 

slaughterers that also perform their own 

rendering, ERG estimated the costs of 

procedure development and employee 

training for slaughter animal age 

identification at $1.10 million annually. 

To the extent some slaughterers already 

have aging procedures in place to 

comply with FSIS’ SRM rule, this may 

be an overestimate. 

For the age determinations, ERG 

judged that the rendering truck drivers 

would make the actual age 

determinations at the animal producer 

site by reviewing the paperwork or 

using the dentition method. ERG judged 

that this procedure would not add to the 

total time an employee spends at each 

pick-up site. It therefore did not include 

additional compliance costs for the 

rendering truck driver. Review of these 

determinations and paperwork would 

be made at the rendering facility by 

supervisory personnel. ERG estimated 

total annual labor costs for the in-plant 

reviews of the age determination at 

about $790,000. Total annual costs for 

renderer age determination efforts are 

estimated at $1.28 million ($491,000 

plus $790,000). 

5. Feed Substitution Costs 

For the proposed rule, we included in 

the compliance costs the incremental 

cost for the feed ingredients that would 

be needed to replace the MBM in nonruminant animal feeds. Animal feed 

producers would be expected to 

substitute more costly protein sources 

for the MBM that was previously 

manufactured from CMPAF. In the 

analysis of the 1997 final rule 

prohibiting the use of mammalian 

proteins (with exceptions) from use in 

ruminant feeds, we calculated the cost 

to substitute MBM in a typical cattle 

ration. Assuming a $20 per ton price 

difference between MBM and a 

substitute feed ingredient, in this case 

soybean meal, we estimated that the 

reformulated cattle ration would cost an 

additional $31.76 per ton (including 

other ingredients). However, the prices 

of MBM and equivalent substitutes vary 

constantly based on weather, global 

markets, slaughter rates, and other 

factors. We have no other information 

on the types of rations or feed 

formulations that will be affected by this 

final rule. Consequently, we accept the 

cattle ration example as a conservative 

estimate of the long-term cost of feed 

substitution. 

Accordingly, for the October 2005 

proposed rule, we inflated the unit cost 

from $31.76 per ton to $38.33 per ton to 

account for inflation through 2005 and 

determined the tonnage of MBM that 

would no longer be processed from the 

CMPAF. Multiplying this total, 15.6 

million lbs, by $38.33 per ton resulted 

in about $300,000 in feed substitution 

costs for the proposed rule. Accounting 

for the high end of the range of animals 

currently rendered (as noted in the 2004 

Informa report) led to an upper end cost 

of about $450,000. 

We received one comment that the 

removal of ruminant proteins from nonruminant feed may increase the price of 

other protein sources, but it did not 

address the method used to account for 

feed substitution costs. We received 

many comments concerning the total 

amount of cattle byproducts that would 

no longer be made available for further 

processing for use in non-ruminant 

feeds. As noted previously in the 

section on disposal costs, ERG 

concluded that a much larger amount of 

cattle byproducts would no longer be 

available for this use. In total, the ERG 

calculations imply that the amount of 

MBM foregone from slaughterer and 

renderer CMPAF, as well as MBM that 

could have been produced from cattle 

not inspected and passed for human 

consumption that will no longer be 

rendered due to this rule, will range 

from 76,100 tons to 91,500 tons; a 

significant increase from the 7,800 tons 

estimated for the proposed rule. Based 

on the incremental feed substitution 

cost of $38.33 per ton of MBM, we 

estimate that long-term total feed 

substitution costs for the final rule will 

range from $2.92 million to $3.51 

million annually. 

F. Government Costs 

For the proposed rule, we concluded 

that there may be an increase in Federal 

fund expenditures for inspection 

activities, but did not expect it to be 

significant. The total number of 

establishments inspected was not 

expected to change substantially, as all 

establishments that would be inspected 

for compliance under § 589.2001 are 

already subject to § 589.2000 or other 

Federal rules. The additional materials 

that would be included as CMPAF may 

result in an increase in the number of 

inspections or the length of time 

necessary to inspect an establishment. 

We did not estimate the additional costs 

that would be required because we 

judged that the additional resources 

would not be substantial. ERG judged 

that no new rendering facilities would 

be constructed or dedicated to rendering 

for disposal due to the proposed rule, 

and thus our inspection activities would 

not noticeably increase. 

Country Designation 

The final rule contains a provision 

that was not included in the proposed 

rule. This provision exempts CMPAF 

from designated countries from the 

prohibition on its use in animal feed. A 

foreign country seeking this designation 

will submit a written request to FDA 

that includes (1) information about the 

country’s BSE case history, (2) risk 

factors, (3) measures to prevent the 

introduction and transmission of BSE, 

and (4) any other information relevant 

to determine how cattle materials from 

the country will be defined under 21 

CFR 589.2001(b)(1). FDA will respond 

to a country’s request in writing and 

may specify certain conditions when 

granting a request. Country designations 

will be subject to future review by FDA 

and can be revoked if a review shows 

that BSE-related restrictions are 

necessary. 

a. Number of countries affected. 

Although we do not know how many 

countries will submit a request to FDA 

for a designation under § 589.2001(f), 

we can use information from OIE and 

USDA to estimate the number of 

requests that might be submitted to the 

Center for Veterinary Medicine. 

According to the requirements of the 

OIE Terrestrial Animal Health Code 

(16th edition 2007), OIE officially 

recognizes five countries as having a 

‘‘negligible BSE risk,’’ including 

Australia, Argentina, New Zealand, 

Singapore, and Uruguay. In addition, 

OIE recognizes Iceland and Paraguay as 

‘‘provisionally free’’ from BSE. 

According to OIE recommendations, 

SRM removal is not a condition for 

importing fresh meat or meat products 

from a negligible risk country. Allowing 

animal feeds or animal feed ingredients 

containing CMPAF to be imported from 

designated countries is consistent with 

the lack of any restrictions on SRMs 

from negligible risk countries in the OIE 

guidelines. 

In addition to the countries 

recognized by OIE, a country exporting 

a large quantity of cattle products into 

the United States may submit a request 

for country designation to FDA. Table 1 

presents data from USDA’s Foreign 

Agricultural Service showing countries 


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that exported cattle products to the 

United States in 2006. Comparing the 

seven countries officially recognized by 

OIE as having a negligible BSE risk or 

being provisionally free of BSE and the 

countries listed in Table 5, 

approximately nine countries might 

submit a request. Because we are 

uncertain about the actual number of 

requests, for this analysis we estimate 

that 10 countries could submit a request 

to FDA to be exempted from CMPAF 

restrictions applicable to animal feed. 

Our estimate is not intended to suggest 

that all of these countries would qualify 

for a designation under § 589.2001(f). 

TABLE 5.—BOVINE PRODUCT IMPORTS

TO THE UNITED STATES (2006) 

Exporting country 

Percentage of 

imported bovine products 

Canada ................................. 31 

Australia ................................ 28 

New Zealand ........................ 17 

Uruguay ................................ 9 

Brazil ..................................... 7 

Argentina .............................. 2 

Nicaragua ............................. 2 

Mexico .................................. 1 

Costa Rica ............................ 1 

Other Countries .................... 2 

Source: USDA, Foreign Agricultural Service, 

HS 6-Digit Imports. Report for bovine product 

codes generated January 28, 2008 at http:// 

www.fas.usda.gov/ustrdscripts/USReport.exe. 

b. Cost of designation provision. We 

make certain assumptions concerning 

the effort to prepare and submit a 

request for country designation in 

preparation of these costs estimates. 

Because a country that submits a request 

to be designated as exempt from certain 

BSE-related restrictions for animal feed 

may also petition USDA for exclusion 

from USDA’s BSE-related requirements, 

we assume that a country wishing to 

submit a request to FDA to be 

designated as exempt from CMPAF 

restrictions has already completed a risk 

assessment and put risk management 

strategies into place. Whether these risk 

assessment and mitigation strategies are 

sufficient for a country to be so 

designated by FDA will be determined 

on a case-by-case basis. Moreover, we 

assume a request would include other 

technical information on the country’s 

BSE status, a detailed outline of risk 

mitigation strategies, and information 

on the country’s cattle-derived products 

that are exported to the United States. 

We assume that a foreign government 

employee earning the wage equivalent 

of a GS–14 step 1 would spend about 80 

hours to collect and prepare this 

information for each country submitting 

a request for country designation at an 

estimated cost of $5,395.20 (80 hours × 

$67.44 per hour including overhead). 

The request will also be reviewed by 

government managers before being 

submitted to the FDA. Assuming it takes 

a foreign government executive 40 hours 

to review the request, at a wage 

equivalent to a GS–15 step 3, it would 

cost approximately $3,384.80 (40 hours 

× $84.62 per hour including overhead) 

to review the request. Thus, the total 

cost to each country to prepare and 

submit a request to FDA to be 

considered for this designation would 

be about $8,780. Once the request is 

received by FDA, we estimate that it 

will take approximately 80 hours to 

review each request, at a cost of 

approximately $3,700 (80 hours × 

$45.65 per hour for an employee rated 

as a GS–13 step 7). Thus, as shown in 

Table 6, the total cost of an initial 

request is approximately $12,480. The 

estimated annual total for 10 requests 

would be $124,800, with FDA incurring 

about 29 percent of these costs and 

foreign governments incurring the 

remaining 71 percent. 

TABLE 6.—TOTAL COST OF THE INITIAL

REQUEST AND REVIEW

Collect information, Prepare 

and Submit the Request to 

FDA ................................... $8,780 

FDA Review per Request ..... 3,700 

Cost per Country .................. 12,480 

Total Cost for 10 Countries ............................ 124,800 

Countries that successfully request to 

be designated as exempt from CMPAF 

restrictions applicable to animal feed 

will be subject to annual review by FDA 

to ensure that their designation remains 

appropriate. As part of this process, 

FDA may ask designated countries to 

confirm that both their BSE status and 

the information submitted by them in 

support of their original application 

remain unchanged. FDA may revoke a 

country’s designation if FDA determines 

that it is no longer appropriate. 

FDA has not yet determined the 

method by which the agency will 

conduct these annual reviews. One 

possible method would be for FDA to 

send a letter to designated countries 

asking whether there has been a change 

in their status or circumstances relative 

to their BSE history, surveillance, 

import activities, or other relevant 

criteria, and then compare any changed 

information with the information in the 

original submission. The OIE requires 

that countries whose BSE status has 

been officially recognized ‘‘should 

annually confirm during the month of 

November whether their status and the 

criteria by which their status was 

recognized have remained unchanged.’’

In some cases, the FDA reviewer might 

rely on this information, if available, in 

conducting a future review of the 

country’s designation. 

For this analysis, we assume it will 

take FDA and the designated country 

about one-third the time and effort as 

the original request for country 

designation. Thus, if the total cost to 

submit the request and have it reviewed 

by FDA was $12,480, the annual review 

of the country designation by FDA and 

the submitting country will cost about 

$4,200 (see Table 7). 

TABLE 7.—COST OF ANNUAL REVIEW

OF COUNTRY DESIGNATION

Submission of Additional Information by the Designated Country ................. $3,000 

FDA Review of Information .. 1,200 

Cost per Designated Country 4,200 

Total Cost for Review 

(10 Countries) ............ 42,000 

It is likely that those countries that 

currently export to the United States a 

significant amount of cattle-derived 

material that contains CMPAF will be 

most interested in submitting a request 

for country designation. It is also 

possible that new markets for cattlederived products containing CMPAF 

could develop, providing an incentive 

for other countries to submit a request 

to FDA to be designated as exempt from 

CMPAF restrictions in animal feed. For 

this analysis, we do not attempt to 

forecast either new markets for cattlederived products containing CMPAF or 

the frequency and costs of future 

requests for country designations. 

G. Sensitivity Analysis 

For the proposed rule, we presented 

alternative ranges of costs that could be 

expected due to the uncertainty in 

certain cost factors. Specifically, we 

showed that total compliance costs 

would increase substantially (from a 

range of $14 million to $24 million to 

a range of $20 million to $36 million) 

if the number of cattle not inspected and 

passed for human consumption that 

would no longer be rendered as a result 

of this rule (or 3.4 percent of all cattle 

not inspected and passed for human 

consumption) increased to about 11.6 

percent of all cattle not inspected and 

passed for human consumption. This 

increase would be due to the much 

greater weight of the entire cattle carcass 

that would be disposed of compared 

with the weight of CMPAF from an 


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average cow slaughtered for human 

consumption or cow not inspected and 

passed for human consumption that had 

its CMPAF separated at the deadstock 

rendering facility. 

Public comments on the method used 

by both ERG and FDA have previously 

been presented. The common 

perception in comments, summarized 

here again, is that the analysis of the 

proposed rule considerably 

underestimated the number of cattle not 

inspected and passed for human 

consumption that would no longer be 

rendered. We have also previously 

shown that additional data, public 

comments, and discussion with 

industry and association members have 

led to an updated analysis that presents 

a significantly greater number of those 

animals that would no longer be 

rendered due to this final rule. The 

sensitivity analysis included in the ERG 

report on the final rule attempts to 

identify the most influential factors of 

the analysis, and the range of costs 

associated with varying the key 

assumptions. ERG finds the disposal 

cost rate for CMPAF to be particularly 

influential because it represents a large 

fraction of total costs. Specifically, its 

analysis shows that a 33-percent 

increase or decrease in the disposal cost 

per cwt of CMPAF results in a 

respective $18.1 million increase or 

decrease in the lower bound of total 

costs and a $23.7 million increase or 

decrease in the upper bound of total 

costs. The price of MBM and tallow 

does not have much effect on total costs. 

Similarly, the level of renderer capital 

costs do not appear to be significant 

because the amortization over 10 years 

results in a small annual cost compared 

to disposal costs. The elasticity 

estimates appear to have a more 

significant effect on total costs. A 

reduction in price elasticity of 50 

percent from the low estimate for each 

ruminant category would reduce the 

lower bound of total compliance costs 

by about 22 percent, while an increase 

in elasticity by 50 percent from the high 

estimate for each ruminant category 

would result in a 15 percent increase in 

the upper bound of total compliance 

costs. 

H. Final Regulatory Flexibility Analysis 

The Regulatory Flexibility Act 

requires an agency 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 of the 

final rule, as well as data and analysis 

contained in this rule’s regulatory 

impact analysis, and section three of the 

ERG report, constitutes our final 

regulatory impact analysis in 

compliance with section 604 of the 

Regulatory Flexibility Act. 

The Regulatory Flexibility Act 

requires that we present a succinct 

statement of a rule’s objectives. As 

stated previously in this analysis and 

unchanged from the proposed rule, the 

intent of this rule is to strengthen the 

safeguards designed to prevent the 

spread of BSE in U.S. cattle, as well as 

to reduce further any risk posed to 

humans from the agent that causes BSE. 

Other requirements of the Regulatory 

Flexibility Act are a description of the 

small entities that would be impacted 

by the final rule, an estimate of the 

number of small entities to which the 

rule would apply, a description of the 

projected reporting, recordkeeping (see 

Section VI. Paperwork Reduction Act of 

1995) and other compliance costs of the 

rule and the reason why any other 

significant alternatives considered by 

the agency were rejected. 

The ERG analysis concentrates on the 

effects of the rule on small renderers 

and small slaughterers, and to a lesser 

extent on small dairy farms. 

Slaughterers are classified in the North 

American Industrial Classification 

System (NAICS) under code 311611—

Animal (Except Poultry) Slaughtering, 

and renderers are classified under 

NAICS code 311613—Rendering and 

Meat Byproduct Processing (see Table 

8). The Small Business Administration 

(SBA) classifies both slaughterers and 

renderers with less than 500 employees 

as small businesses. 

TABLE 8.—TOTAL AND NUMBER OF AFFECTED ESTABLISHMENTS, BY SIZE IN SLAUGHTERING AND RENDERING

Employment size group 

NAICS 311611 

(slaughterers and renderers) 

NAICS 311613 

(rendering) 

Total number of 

establishments 

Estimated number 

of cattle slaughtering establishments a

Total number of 

establishments in 

2002 census 

Establishments affected by principal 

deadstock restrictions b

1 to 4 ........................................................................................ 1,132 1,132 30 0 

5 to 9 ........................................................................................ 229 229 25 0 

10 to 19 .................................................................................... 131 124 41 25 

20 to 49 .................................................................................... 134 7 72 22 

50 to 99 .................................................................................... 64 14 46 19 

100 to 249 ................................................................................ 66 6 13 3 

250 to 499 ................................................................................ 40 13 4 1 

500 to 999 ................................................................................ 20 7 0 0 

More than 1,000 ...................................................................... 53 13 0 0 

Total .................................................................................. 1,869 1,545 231 70 

a Cattle slaughterer distribution derived from federal and state slaughterer establishment count in USDA/NASS (2006). Establishments arrayed 

across size classes assuming that slaughter rates coincide with employment sizes. State slaughterers were assumed to be small and were 

added to the small size categories to match but not exceed the Census count of establishments. The distribution should be considered approximate. bThe employment size class of deadstock renderers was estimated by ERG and should be considered to be approximate. 

Source: ERG Report, Table 3–1, Page 3–2. 

The number of cattle slaughtering and 

rendering establishments expected to be 

impacted by the CMPAF ban is 1,545 

and 231, respectively. The majority of 

the impacts on renderers are expected to 

be incurred by the 70 deadstock 

renderers. Using both Census and USDA 

data, ERG distributed the slaughtering 

establishments across the size classes of 

establishments using the same 

proportions as those presented in the 

total number of establishments. This 

distribution shows that almost 99 

percent of slaughtering establishments 

would qualify as small businesses. 


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According to SBA data, over 97 

percent of all slaughtering firms would 

be considered small businesses, which 

would take into account multiestablishment firms. The SBA data also 

reports that 83 percent of all rendering 

firms would be considered small 

businesses. ERG concluded that it is 

likely that all 70 deadstock renderers 

have less than 500 employees and thus 

are considered small businesses. In 

summary, the number of affected small 

businesses in both sectors would be 

substantial. 

As in its analysis of the proposed rule, 

ERG used its Small Business Impact 

Model (SBIM) to predict net income and 

closure impacts on both slaughtering 

and rendering firms (Appendix A of the 

ERG report contains a technical 

explanation of the SBIM). The model, 

which assumes a partial cost passthrough of costs for slaughterers (animal 

producers would incur the disposal 

costs), predicts modest impacts on cattle 

slaughtering due to the small minority 

of cattle slaughtered for human 

consumption that are 30 months of age 

or older. The model predicts costs for 

the small slaughterers to range from 

under $100 for the smallest 

establishments slaughtering less than 

1,000 animals per year to about $7,100 

per establishment for those slaughtering 

300,000 to 500,000 cattle annually. 

Compliance costs as a percent of net 

income would range from less than 0.1 

percent to 2.1 percent for the small 

slaughter businesses. For all 

slaughterers, regardless of size, costs are 

expected to be significantly below 1 

percent of revenues. 

Costs for the deadstock renderers 

were estimated through the SBIM with 

two separate scenarios: One in which 

disposal costs are included and one in 

which they are not included. Disposal 

costs are not included under one 

scenario to reflect the likelihood that 

increased pick-up charges to animal 

producers will mostly offset the 

additional disposal costs. In this case, 

compliance costs for the smallest 

establishment ranged from an estimate 

of $97,000 to $122,000 ($153,000 to 

$180,000 including disposal costs). 

Compliance costs for the larger 

establishments ranged from $2.01 

million to $2.57 million ($3.23 million 

to $3.79 million including disposal 

costs). Compliance costs as a percent of 

net income ranged from 41 percent to 81 

percent across all deadstock renderer 

sizes (from 65 percent to 100 percent 

including disposal costs). The total 

number of rendering establishments 

expected to close (assuming only 

disposal costs are transferred to animal 

producers), using a net income 

assumption of 5.65 percent, ranged from 

12 to 16 facilities. If these disposal costs 

are not transferred, the model forecasts 

23 to 28 closures. Although all renderers 

contacted by ERG that were 

contemplating investing in capital to 

remove brain and spinal cord expected 

to charge substantially more in pick-up 

fees to recover these costs, some 

rendering plant closures are likely to 

result from this rule (Ref. 16, Section 

3.3). 

Small farms will incur compliance 

costs for the disposal of those animals 

that are no longer rendered due to either 

the increase in renderer pick-up fees or 

the termination of deadstock rendering 

services. ERG prepared a baseline 

enterprise dairy budget to demonstrate 

the relative size of the impacts of the 

final rule on a small (120-cow) dairy 

farm with about $300,000 in revenues. 

The SBA defines small dairy and beef 

cattle producers as those with revenues 

under $750,000, and USDA data shows 

the average dairy farm has about 110 

dairy cows (Ref. 28). The expected 

incremental compliance costs (from the 

ERG model) for disposal of the annual 

number of dead dairy cows and calves 

(assumed to be disposed of off-site at 

$12/cwt and $4/cwt, respectively) on an 

operation of this size is about $700, 

using the individual disposal rates for 

over 30-month cattle and calves. 

Compliance costs of an operation of this 

size are estimated at 0.25 percent of 

revenues and 2.63 percent of net 

income. 

The effect of the annual feed 

substitution costs on small nonruminant animal operations is also 

expected to be minimal. The $2.9 to 

$3.5 million in additional costs would 

not be significant when spread over the 

thousands of non-ruminant animal 

producers that currently use ruminant 

protein in animal feeds. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

alternatives that would minimize any 

significant impact of a rule on small 

entities. For an analysis of the 

regulatory alternatives to this final rule, 

see section IV.B of this document. 

V. The Small Business Regulatory 

Enforcement Fairness Act of 1996 

(SBREFA) 

SBREFA (Pub. L. 104–121) defines a 

major rule for the purpose of 

congressional review as having caused 

or being likely to cause one or more of 

the following: An annual effect on the 

economy of $100 million or more; a 

major increase in costs or prices; 

significant adverse effects on 

competition, employment, productivity, 

or innovation; or significant adverse 

effects on the ability of U.S.-based 

enterprises to compete with foreignbased enterprises in domestic or export 

markets. In accordance with SBREFA, 

OMB has determined that this final rule 

is a major rule for the purpose of 

congressional review. 

VI. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that were 

submitted to OMB for review under the 

Paperwork Reduction Act of 1995 (the 

PRA) (44 U.S.C. 3501–3520). 

The title, description, and the 

respondent description of the 

information collection provisions are 

shown 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. 

Title: Substances Prohibited From Use 

in Animal Food or Feed 

Description: This final rule 

(§ 589.2001) prohibits the use of certain 

cattle origin materials in the food or 

feed of all animals. These materials 

include the following: (1) The entire 

carcass of BSE-positive cattle; (2) the 

brains and spinal cords from cattle 30 

months of age and older; (3) the entire 

carcass of cattle not inspected and 

passed for human consumption that are 

30 months of age or older from which 

the brains and spinal cords were not 

effectively removed or otherwise 

effectively excluded from animal feed; 

(4) mechanically separated beef that is 

derived from cattle materials prohibited 

by the rule; and (5) tallow that is 

derived from BSE-positive cattle and 

tallow that is derived from certain other 

materials prohibited by the rule 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. 

FDA has revised the final rule to 

include a statement of this purpose 

(§ 589.2001(1)). 

As discussed in section I of this 

document, FDA has revised the final 

rule to include a statement of purpose 

for the rule, specifically, to prohibit the 

use of certain cattle origin materials in 

the food or feed of all animals to help 

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

The final rule was also revised to 

require renderers to establish and 

maintain written procedures on aging 

animals to ensure that such animals are 

less than 30 months old if they are to 

be rendered for use in animal feed 

without brain and spinal cord removal. 


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Further, in response to concerns about 

ensuring effective removal of brain and 

spinal cord from animals 30 months of 

age or older, FDA has revised the final 

rule to require the establishment and 

maintenance of written procedures for 

ensuring that brain and spinal cord are 

effectively removed or effectively 

excluded from animal feed. As 

discussed in section I of this document, 

FDA has determined that it is the 

responsibility of the renderer to ensure 

that materials rendered for use in 

animal feed do not contain CMPAF. 

Therefore, the agency has explained in 

the final rule that a renderer’s records 

must either include certification or 

other documentation from the supplier 

that material supplied to the renderer 

does not include CMPAF, or 

documentation of another method, 

acceptable to FDA, such as third-party 

certification, for verifying that suppliers 

have effectively excluded CMPAF. Also, 

FDA is adding a provision to this rule 

so that it may designate a country as not 

subject to the CMPAF requirements of 

this rule (§ 589.2001(b)(1)(vi)). A 

country seeking such a designation must 

submit a written request and include 

information about the country’s BSE 

case history, risk factors, measures to 

prevent the introduction and 

transmission of BSE, and any other 

information relevant to determining 

whether the country should be subject 

to the requirements regarding CMPAF as 

discussed in greater detail in section I 

of this document. These are new 

collection of information requirements 

that have been added to the previous 

burden estimate set forth in the 

proposed rule. 

FDA believes that it has maximized 

the practical utility of this collection of 

information by not prohibiting certain 

cattle materials in animal food or feed, 

as long as the agency can be assured, 

through the establishment of written 

procedures, that brain and spinal cord 

were effectively removed or effectively 

excluded from animal feed or that the 

material was from cattle less than 30 

months of age. FDA believes it has 

minimized the burden to the rendering 

industry by not specifying the 

procedures to be followed so as to 

provide the latitude to establish 

procedures that can most efficiently be 

incorporated into rendering operations. 

Description of Recordkeeping for 

Respondents: Rendering facilities, 

medicated feed manufacturers and 

distributors, livestock feeders. 

TABLE 9.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR section Number of 

recordkeepers 

Annual 

frequency 

per recordkeeper 

Total annual 

records 

Hours per 

recordkeeper Total hours Operation and maint. costs 

589.2001(c)(2)(vi) and (c)(3)(i) ................ 175 1 175 20 3,500 $59,500 

589.2001(c)(2)(ii) ...................................... 50 1 50 20 1,000 17,000 

589.2001(c)(3)(i)(A) .................................. 175 1 175 26 4,550 80,580 

Total .................................................. ........................ ........................ ........................ ........................ 9,050 157,080 

The estimated recordkeeping burden 

is derived from agency resources and 

discussions with affected industry. As 

discussed in the Paperwork Reduction 

Act section of the October 2005 

proposed rule (70 FR 58570 at 58598), 

the recordkeeping requirement in 

§ 589.2001(c)(2)(vi) will apply to the 

limited number of renderers that will 

handle CMPAF. FDA estimates that no 

more than 50 of the approximately 175 

(based on current data) total 

independent rendering firms will be 

involved in the handling of this 

material. Although the agency may 

consider the distribution records needed 

to comply with this regulation ‘‘usual 

and customary’’ and thus not subject to 

the PRA, FDA believes there will be a 

burden associated with setting up a 

system to ensure such records are 

sufficient to address the recordkeeping 

requirement. Likewise, although FDA 

may consider the records necessary to 

comply with § 589.2001(c)(3)(i) as 

‘‘usual and customary’’ and not subject 

to PRA burden accounting, FDA is 

including a burden estimate to cover 

establishment of a system to ensure that 

existing receipt, manufacturing, and 

certification records adequately address 

this requirement. FDA estimates that the 

recordkeeping burden associated with 

§ 589.2001(c)(3)(i) would apply to the 

balance of the rendering firms not 

handling CMPAF. FDA solicited public 

comment on the estimated 

recordkeeping burden associated with 

§ 589.2001(b)(2)(iv) (§ 589.2001(c)(2)(vi) 

in the final rule) and § 589.2001(b)(3)(i) 

(§ 589.2001(c)(3)(i) in the final rule) of 

the proposed rule, but no comments 

were received. It was estimated that the 

operation and maintenance cost per 

renderer for complying with the records 

requirements of either of these sections 

would be $340. 

As discussed previously, FDA has 

revised the final rule to require the 

maintenance of certain written 

procedures if cattle not inspected and 

passed for human consumption are to be 

rendered for use in animal feed. The 

recordkeeping burden associated with 

the requirement to maintain written 

procedures (§ 589.2001(c)(2)(ii)) will 

apply to only those renderers that 

choose to render for use in animal feed 

cattle not inspected and passed for 

human consumption. Based on the 

expertise of FDA’s compliance staff who 

are knowledgeable about industry 

practices, FDA estimates that no more 

than 50 of the approximately 175 total 

independent rendering firms will be 

involved in the handling of this 

material. Furthermore, FDA estimates 

that the recordkeeping burden for this 

new requirement is similar to the 

burden that was previously estimated 

for § 589.2001(c)(2)(vi) and 

§ 589.2001(c)(3)(i). Therefore, FDA 

estimates that the cost per renderer for 

compliance with the new requirement 

for establishing and maintaining written 

procedures will be $340 per renderer, 

hence the new figure of $17,000 as 

shown in Table 9 of this document. 

Table 9 also reflects the estimated 26 

hours each renderer will need to satisfy 

the requirement under which renderers 

must maintain records from their 

supplier, certifying that materials 

provided were free of CMPAF. 

Description of Respondents for 

Reporting: As discussed earlier, the final 

rule includes a new provision that 

exempts CMPAF from designated 

countries from the prohibition on its use 

in animal feed (§ 589.2001(b)(1)(vi)). A 

foreign country seeking this designation 

will submit a written request to FDA 

that includes a variety of information 

about the country’s BSE status 

(§ 589.2001(f)). As discussed in section 

IV, FDA estimates that 10 countries 

could submit a request to FDA to be 

exempted from the CMPAF restrictions. 

FDA estimates the burden for this 


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information collection as shown in 

Table 10: 

TABLE 10.—ESTIMATED ONE-TIME AND RECURRING REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response Total hours 

§ 589.2001(b)(1) 2 ............................................................... 10 1 10 80 800 

§ 589.2001(f) ...................................................................... 10 1 10 26 .4 264 

Total one time burden ................................................ ........................ ........................ ........................ .......................... 800 

Total recurring burden ................................................ ........................ ........................ ........................ .......................... 264 

1There are no capital costs or operating costs associated with the collection of information under this final rule. 

2One-time burden. 

One-Time Reporting Burden 

There will be a one-time burden to 

countries that apply to FDA seeking to 

be designated as not subject to 

restrictions applicable to CMPAF. We 

estimate that each country that applies 

for an exclusion will spend 80 hours 

putting information together to submit 

to FDA. Table 10 row 1 of this 

document presents the one-time burden 

expected for countries that apply for the 

exclusion. 

Recurring Burden 

Countries that successfully petition 

FDA to be designated as exempt from 

certain BSE-related restrictions 

applicable to animal feed will be subject 

to future review by FDA to ensure that 

their designation remains appropriate. 

As part of this process, FDA may ask 

designated countries from time-to-time 

to confirm that their BSE situation and 

the information submitted by them in 

support of their original application 

remains unchanged. We assume it will 

take FDA and the designated country 

undergoing a review in the future about 

one third the time and effort it did when 

the information was submitted. Table 10 

row 2 of this document presents the 

expected recurring burden. 

The information collection provisions 

of this final rule have been submitted to 

OMB for review. Prior to the effective 

date of this final rule, FDA will publish 

a notice in the Federal Register, 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this final rule. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to a collection of information, unless 

that agency displays a currently valid 

OMB control number. 

VII. Environmental Impact 

In the ‘‘Environmental Impact’’

section of the preamble to the October 

6, 2005, proposed rule (70 FR 58570), 

FDA stated that it had carefully 

considered the potential environmental 

impact of this action and had 

determined that the proposed action 

would not have a significant impact on 

the human environment and that an 

environmental impact statement was 

not required. FDA’s finding of no 

significant impact and the evidence 

supporting that finding, contained in an 

environmental assessment, were placed 

on display in the public docket (Docket 

No. 2002N–0273). 

As discussed in section IV of the 

preamble to this final rule, the agency 

received many comments to the 

proposed rule that addressed the 

environmental effects of the proposed 

action, noting that the volume of 

material that would not be allowed in 

animal feed was much larger than 

originally estimated. As a result, FDA 

decided to perform a new 

environmental assessment that took into 

account the new information submitted 

in response to the proposed rule. 

Following a review of this new 

assessment, FDA again has made a 

finding of no significant impact. The 

evidence supporting that finding, 

contained in the new environmental 

assessment, may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. For ease of 

reference, the ‘‘Summary of 

Environmental Consequences’’ is 

reproduced below: 

‘‘The EA has examined the 

environmental consequences of 

prohibiting the use in animal feed of 

brain and spinal cord from cattle over 

30 months of age, and the carcasses of 

dead stock cattle that were either not 

age verified or from which brain and 

spinal cord were not removed. Our 

assessment indicates that, under this 

final rule, approximately 670 million 

pounds of cattle byproducts that would 

normally be recycled in animal feed will 

be diverted to other forms of disposal. 

In most areas of the country, this change 

in disposal patterns is not expected to 

have a large impact on the environment. 

In some areas of the country, however, 

adverse environmental impacts could be 

expected unless new disposal capacity 

is developed. To allow time for 

development of new methods of 

disposal, the agency is delaying 

implementation of this regulation for 12 

months. We assume that disposal of the 

materials prohibited in animal feed by 

the final rule will be disposed of in 

accordance with local, State, and 

Federal laws and regulations.’’

FDA received several comments on 

the proposed rule that addressed 

environmental concerns surrounding 

the residual effects of disposal of cattle 

byproducts. The comments and the 

agency’s responses are set forth in the 

following paragraphs. 

(Comment 71) Several comments said 

that FDA did not conduct an adequate 

environmental impact analysis for the 

proposed rule and improperly made a 

finding of no significant impact. 

Another comment said that the 

environmental assessment failed to 

consider alternative methods of disposal 

other than landfilling and rendering. A 

number of comments said that FDA 

underestimated the environmental 

impact resulting from improper 

composting and landfilling. 

(Response) In comments to the 

proposed rule, FDA received new 

information indicating that some of the 

assumptions used in the economic 

analysis may have been incorrect, 

especially those assumptions related to 

disposal of deadstock. The agency 

modified the assumptions based on this 

new information and considered all 

other relevant comments in completing 

a re-analysis of both the economic and 

environmental impacts of the proposed 

rule. After completing a new 

environmental assessment, the agency 

still concludes that the environmental 


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Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 22755 

impact is not significant, see revised 

environmental assessment in the public 

docket (Docket No. 2002N–0273). 

(Comment 72) Several comments said 

that animal and human health risks 

from non-feed disposal of deadstock are 

greater than the risks reduced by the 

proposed regulation. In contrast, one 

comment stated that, since the majority 

of cattle mortalities today are disposed 

of by means other than rendering and 

since this disposal does not appear to be 

causing disease outbreaks, the comment 

questioned the assertion by some that 

on-farm and alternative disposal will 

degrade public and animal health. 

Another comment stated that health 

concerns resulting from the proposed 

rule are being exaggerated for the 

purpose of preventing the rule from 

being finalized. 

(Response) The agency received no 

data in support of either position on the 

effects of non-feed disposal of CMPAF 

on animal or human health. 

(Comment 73) Several comments 

asked why FDA is not concerned about 

environmental exposure to the BSE 

agent through indiscriminant disposal 

of deadstock if the BSE infectious dose 

is really 10 mg or less and the agent 

remains infectious in soil. 

(Response) The agency believes that, 

based on the extremely low prevalence 

of BSE in this country and the absence 

of evidence that BSE is transmitted 

through soil and water, the risk of BSE 

transmission through exposure to the 

BSE agent in the environment is very 

low. 

(Comment 74) Several comments said 

that landfilling and burial will create 

problems of odor control, ground and 

surface water contamination, and 

disease caused by conventional 

pathogens. Other comments stated that 

the soil and geologic conditions in 

certain states are particularly unsuitable 

for carcass burial. 

(Response) FDA believes that odors 

and pathogens should not be significant 

problems when carcasses are properly 

buried, and in particular, when 

carcasses are landfilled. The agency 

acknowledges, however, that soil or 

geologic conditions in some parts of the 

country may not permit carcasses to be 

properly buried. In such areas, 

alternative disposal methods should be 

identified. The agency intends to allow 

sufficient time before the rule becomes 

effective to allow for the arrangement of 

disposal methods that are appropriate 

for local conditions. 

VIII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles in 

Executive Order 13132. FDA has 

determined that the final 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, the 

agency has concluded that the 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. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

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 addresses after this 

document publishes in the Federal 

Register.) 

1. Scientific Steering Committee, European 

Commission, ‘‘Opinion of the Scientific 

Steering Committee 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. 

2. 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 Years 2004–2007, 

April 2008. 

3. ‘‘An Estimate of the Prevalence of BSE in 

the United States,’’ U.S. Department of 

Agriculture, July 20, 2006, APHIS/USDA 

Internet page http://www.aphis.usda.

gov/peer_review/content/printable_

version/BSE_Prevalence_scientific_doc_

after.pdf. 

4. GAO Report No. 05–101, ‘‘Mad Cow 

Disease: FDA’s Management of the Feed 

Ban Has Improved, but Oversight 

Weaknesses Continue to Limit Program 

Effectiveness,’’ February 2005. 

5. ‘‘Bovine Spongiform Encephalopathy 

(BSE) Ongoing Surveillance Plan,’’ U.S. 

Department of Agriculture, Animal and 

Plant Health Inspection Service, July 20, 

2006, http://www.aphis.usda.gov/

newsroom/hot_issues/bse/downloads/

BSE_ongoing_surv_plan_final_

71406%20.pdf. 

6. Hunter, N., J. Foster, A. Chong, et al., 

‘‘Transmission of prion diseases by 

blood transfusion,’’ Journal of General 

Virology, 83: 2897–2905, 2002. 

7. Brown, P., L. Cervenakova, L.M. McShane, 

et al., ‘‘Further studies of blood 

infectivity in an experimental model of 

transmissible spongiform 

encephalopathy, with an explanation of 

why blood components do not transmit 

Creutzfeldt-Jakob disease in humans,’’

Transfusion, 39:1169–1178, November/ 

December, 1999. 

8. Scientific Steering Committee, European 

Commission, ‘‘The Implications of the 

Recent Papers on Transmission of BSE 

by Blood Transfusion in Sheep (Houston, 

et al., 2000; Hunter, et al., 2002),’’

adopted by the scientific steering 

committee at its meeting of September 12 

and 13, 2002, http://europa.eu.int/

comm/food/fs/sc/ssc/out280_en.pdf. 

9. Scientific Steering Committee, European 

Commission, ‘‘Opinion on the Safety of 

Ruminant Blood With Respect to TSE 

Risks,’’ adopted on April 13 and 14, 

2000, http://ec.europa.eu/food/fs/sc/ssc/

out74_en.pdf. 

10. Buschmann, A., and M. Groschup, 

‘‘Highly Bovine Spongiform 

Encephalopathy-Sensitive Transgenic 

Mice Confirm the Essential Restriction of 

Infectivity to the Nervous System in 

Clinically Diseased Cattle,’’ The Journal 

of Infectious Diseases, 192:934–42, 

September 1, 2005. 

11. Bradley, R., ‘‘Bovine Spongiform 

Encephalopathy (BSE)—the Current 

Situation and Research,’’ European 

Journal of Epidemiology, 7:532–544, 

1991. Anderson, R.M., et al., 

‘‘Transmission Dynamics and 

Epidemiology of BSE in British Cattle,’’

Nature, 382:779–788, 1996. 

12. Comer, P.J., and P.J. Huntly, ‘‘Exposure of 

the Human Population to BSE Infectivity 

Over the Course of the BSE Epidemic in 

Great Britain and the Impact of Changes 

to the Over Thirty Month Rule,’’ Over 

Thirty Month Rule (OTMR) Review 

Paper, June 2003. 

13. Scientific Steering Committee, European 

Commission, report of March 26 and 27, 

1998, updated June 24 and 25, 2001, 

‘‘Safety of Tallow Derived from 

Ruminant Tissues.’’

14. OIG Report No. 50601–10–KC [Bovine 

Spongiform Encephalopathy (BSE) 

Surveillance Program (Phase II) and 

Controls Over BSE Sampling, Specified 

Risk Materials, and Advanced Meat 

Recovery Products (Phase III)], January 

2006. 

15. World Organization for Animal Health, 

Manual of Diagnostic Tests and Vaccines 

for Terrestrial Animals 2004 (updated 

2006). Accessed online at http:// 

www.oie.int/eng/normes/mmanual/A_

summry.htm. 

16. ‘‘Economic Impacts of FDA Regulatory 

Changes Due to Risk of Bovine 

Spongiform Encephalopathy’’ (Final 

Report), Contract No. 223–03–8500, Task 

Order Number 8, Eastern Research 

Group, Inc., Lexington, MA, March 15, 

2007. 

17. European Union Scientific Steering 

Committee, 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. 

18. Scientific Steering Committee, European 

Commission, ‘‘Update of the Opinion on 

TSE Infectivity Distribution in Ruminant 

Tissues (initially adopted by the 


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22756 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 

Scientific Steering Committee at its 

meeting of 10–11 January 2002 and 

amended at its meeting of 7–8 November 

2002),’’ http://ec.europa.eu/food/fs/sc/

ssc/out296_en.pdf. 

19. United Kingdom, Department for 

Environment, Food and Rural Affairs, 

2007, http://www.defra.gov.uk/animalh/

bse/statistics/bse/yrbirth.html. 

20. United Kingdom, Department of Health, 

Monthly Creutzfeldt Jakob Disease 

Statistics, August 7, 2006, http:// 

www.gnn.gov.uk/environment/full

detail.asp?releaseID=219257&

newsareaID=2. 

21. ‘‘Preliminary Analysis of Final Rules and 

an Interpretive Rule to Prevent the BSE 

Agent from Entering the U.S. Food 

Supply,’’ U.S. Department of 

Agriculture, April 7, 2004, http://www.

fsis.usda.gov/Frame/Frame

Redirect.asp?main=http:// 

www.fsis.usda.gov/OA/news/2004/

bseregs040704.htm. 

22. USDA, Foreign Agricultural Service, U.S. 

Trade Internet System, FAS Agricultural 

Export Commodity Aggregations, Jan-Dec 

Annual Value and Quantities for the 

Total World Export of Beef & Veal (FR/ 

CH/FZ and PREP/PRES), and Beef 

Variety Meats. Query generated March 

27, 2008. Data source: Dept of 

Commerce, U.S. Census Bureau, Foreign 

Trade Statistics. (http://www.fas.usda.

gov/ustrade/USTExFAS.asp?QI=). 

23. Mathews, Kenneth H., Jr., Monte 

Vandemeer, and Ronald Gustafson, ‘‘An 

Economic Chronology of Bovine 

Spongiform Encephalopathy in North 

America,’’ Economic Research Service, 

USDA, June 2006 (http://www.ers.usda.

gov/Publications/LDP/2006/06Jun/

LDPM14301/). 

24. Economic Research Service, USDA, 

‘‘Beef—United States Elasticities,’’

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

Elasticities/). 

25. Economic Research Service, USDA, ‘‘U.S. 

Beef and Cattle Industry: Background 

Statistics and Information; U.S. Cattle 

and Beef Industry, 2002–2007,’’ (http:// 

www.ers.usda.gov/news/

BSECoverage.htm). 

26. ‘‘Economic Impacts of Proposed Changes 

to Livestock Feed Regulations,’’ Informa 

Economics, December 2005. 

27. ‘‘Carcass Disposal: A Comprehensive 

Review,’’ National Agricultural 

Biosecurity Center Consortium Carcass 

Disposal Working Group for the U.S. 

Department of Agriculture, Animal and 

Plant Health Inspection Service, Chapter 

9—Economic and Cost Considerations, p. 

18, August 2004. 

28. National Agricultural Statistics Service, 

U.S. Department of Agriculture, 

Agricultural Statistics 2006, p. VIII–3. 

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, 21 CFR part 589 is 

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 to prevent the 

transmission of bovine spongiform 

encephalopathy. 

(a) Purpose—The purpose of this 

section is to prohibit the use of certain 

cattle origin materials in the food or 

feed of all animals to further reduce the 

risk of the spread of bovine spongiform 

encephalopathy (BSE) within the United 

States. 

(b) Definitions—(1) Cattle materials 

prohibited in animal feed include: 

(i) The entire carcass of BSE-positive 

cattle; 

(ii) The brains and spinal cords of 

cattle 30 months of age and older; 

(iii) The entire carcass of cattle not 

inspected and passed for human 

consumption as defined in paragraph 

(b)(2) of this section that are 30 months 

of age or older from which brains and 

spinal cords were not effectively 

removed or otherwise effectively 

excluded from animal feed; 

(iv) Mechanically separated beef as 

defined in paragraph (b)(3) of this 

section that is derived from materials 

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

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

and 

(v) Tallow as defined in paragraph 

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

materials specified in paragraphs 

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

section. 

(vi) Cattle materials prohibited in 

animal feed do not include: 

(A) Tallow derivatives as defined in 

paragraph (b)(6) of this section; 

(B) Tallow as defined in paragraph 

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

materials specified in paragraphs 

(b)(1)(ii) and (b)(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’’

(AOCS Method Ca 3a–46), American Oil 

Chemists’ Society (AOCS), 5th Edition, 

1997, 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 AOCS Official Method Ca 

3a–46. You may obtain copies of the 

method from the AOCS (http:// 

www.aocs.org), 2211 W. Bradley Ave., 

Champaign, IL 61821. 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. 

(C) Materials as defined in paragraphs 

(b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (other than 

mechanically separated beef from the 

carcass of a BSE-positive cattle), and 

(b)(1)(v) of this section from cattle from 

a country that has been designated 

under paragraph (f) of this section. 

(2) Cattle not inspected and passed 

for human consumption means cattle 

that did not pass antemortem inspection 

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 

ligaments, nerve paralysis, fractured 


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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. 

(c) 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 

(b)(1) of this section. 

(2) Renderers that receive, 

manufacture, process, blend, or 

distribute cattle materials prohibited in 

animal feed as defined in paragraph 

(b)(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 prohibited as defined in 

paragraph (b)(1) of this section are not 

introduced into animal feed: 

(i) Exclude from use in animal feed 

the entire carcass of cattle not inspected 

and passed for human consumption as 

defined in paragraph (b)(2) of this 

section if: 

(A) The brain and spinal cord are not 

effectively removed from such cattle or 

the brain and spinal cord from such 

cattle are not otherwise effectively 

excluded from animal feed; and 

(B) Such cattle are 30 months of age 

or older. 

(ii) If renderers remove brain and 

spinal cord from cattle not inspected 

and passed for human consumption, or 

separate such animals based on whether 

or not they are 30 months of age or 

older, renderers must maintain adequate 

written procedures specifying how these 

processes are carried out. 

(iii) 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; 

(iv) 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’’; 

(v) 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 

(vi) 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 receive, 

manufacture, process, blend, or 

distribute any cattle materials shall take 

the following measures to ensure that 

materials prohibited as defined 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 copies of all records available for 

inspection and copying by the Food and 

Drug Administration. With respect to 

cattle materials obtained from 

establishments which have segregated 

cattle materials prohibited in animal 

feed, such records must demonstrate 

that establishments supplying cattle 

materials to the renderers have adequate 

procedures in place to effectively 

exclude cattle materials prohibited in 

animal feed; and these records shall be 

considered sufficient to meet this 

requirement if they include either: 

(A) Certification or other 

documentation from the supplier that 

material supplied to the renderer does 

not include cattle materials prohibited 

in animal feed; such certification or 

documentation is acceptable, provided 

that it includes a description of the 

segregation procedures used, 

documentation that the supplier 

confirms that its segregation procedures 

are in place prior to supplying any cattle 

material to the renderer, and records of 

the renderer’s periodic review of the 

suppliers’ certification or other 

documentation; or 

(B) Documentation of another method 

acceptable to FDA, such as third-party 

certification, for verifying that suppliers 

have effectively excluded cattle 

materials prohibited in animal feed. 

(ii) Comply with all applicable 

requirements under § 589.2000 

regarding animal proteins prohibited in 

ruminant feed. 

(d) Adulteration and misbranding. (1) 

Failure of a renderer to comply with the 

requirements in paragraphs (c)(2)(i) 

through (c)(2)(iii), (c)(2)(v) and (c)(2)(vi), 

or (c)(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 (c)(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 

(c)(2)(iv) 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 (e) 

of this section will render the animal 

feed or feed ingredients adulterated 

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

(e) 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. 


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(f) Process for designating countries. 

A country seeking designation must 

send a written request to the Director, 

Office of the Center Director, Center for 

Veterinary Medicine, at the address 

designated in § 5.1100 of this chapter. 

The request shall include information 

about that country’s BSE case history, 

risk factors, measures to prevent the 

introduction and transmission of BSE, 

and any other information relevant to 

determining whether the cattle materials 

from the requesting country do or do not 

meet the definitions set forth in 

paragraph (b)(1) of this section. FDA 

shall respond in writing to any such 

request and may impose conditions in 

granting any such request. Any grant by 

FDA of such a request under this 

paragraph will be subject to future 

review by FDA and may be revoked if 

FDA determines that the granted request 

is no longer appropriate. 

Dated: April 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1180 Filed 4–23–08; 8:45 am] 

BILLING CODE 4160–01–P 


sroberts on PROD1PC70 with RULES