Substances Prohibited From Use in Animal Food or Feed, 22720-22758 [08-1180]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 81 (Friday, April 25, 2008)]
[Rules and Regulations]
[Pages 22720-22758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1180]



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Part VI





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 589



Substances Prohibited From Use in Animal Food or Feed; Final Rule

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

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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.

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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, e-mail: 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 Sec.  589.2001--Cattle Materials 
Prohibited in Animal Food or Feed
    C. Comments on Proposed Amendments to Sec.  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 Sec.  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 cattle-derived 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 Harvard-Tuskegee 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 cross-contamination and on-farm 
misfeeding.
    The current U.S. ruminant feed regulation (Sec.  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-to-ruminant 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 cattle-derived risk materials in the non-ruminant 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 BSE-positive 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 
Sec.  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 (Sec.  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 cross-contamination 
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

[[Page 22724]]

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 post-challenge. 
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

[[Page 22725]]

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 cattle-derived 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 (PrP\sc\) was found in the kidney, pancreas, and liver of 
scrapie infected mice when inflammation was induced in these organs 
(Heikenwalder 2005). Another study showed PrP\sc\ in the urine of 
scrapie infected mice with kidney inflammation. A third study found 
PrP\sc\ 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

[[Page 22726]]

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 cattle-derived 
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)'' (Sec.  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

[[Page 22727]]

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 cattle-derived 
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 Sec.  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 Sec.  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 non-ruminant 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

[[Page 22728]]

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 ante-mortem 
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 f