[Federal Register: April 25, 2008 (Volume 73, Number 81)]
[Rules and Regulations]
[Page 22719-22758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap08-8]
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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
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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 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 ante-mortem 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
Sec. 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
[[Page 22729]]
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
[[Page 22730]]
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 (packer-associated
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
[[Page 22731]]
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
cross-contamination, 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
[[Page 22732]]
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, Sec. 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 Sec. 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
[[Page 22733]]
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 Sec. 589.2000--Animal Proteins
Prohibited in Ruminant Feed
The final rule amends Sec. 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 Sec. 589.2001(b)(6). FDA also received several comments
related to other requirements in Sec. 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 Sec. 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 ``non-mammalian 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 Sec. 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 Sec. 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, Sec. 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 BSE-contaminated 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 BSE-related restrictions unnecessary
with respect to cattle materials from that country. Allowing cattle
materials from such a country to be used in non-ruminant 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
Sec. 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
[[Page 22734]]
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 Sec. 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 Sec.
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 Sec. 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, Sec. 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 cross-contamination.
In addition, Sec. 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 Sec. 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, Sec. 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 Sec. 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 Sec. 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 Sec.
589.2001(b)(1)(v). As discussed in the preamble to the proposed rule,
Sec. 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 non-ambulatory disabled cattle.
The final rule prohibits tallow derived from BSE-positive 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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ruminant feed with non-ruminant feed or ingredients intended for non-
ruminant feed. The final rule would effectively remove from use in non-
ruminant 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 partial