[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Proposed Rules]
[Pages 58570-58601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20196]
[[Page 58569]]
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Part III
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; Proposed Rule
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 /
Proposed Rules
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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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the agency's regulations to prohibit the use of certain cattle origin
materials in the food or feed of all animals. These materials include
the following: The brains and spinal cords from cattle 30 months of age
and older, the brains and spinal cords from cattle of any age not
inspected and passed for human consumption, the entire carcass of
cattle not inspected and passed for human consumption if the brains and
spinal cords have not been removed, tallow that is derived from the
materials prohibited by this proposed rule that contains more than 0.15
percent insoluble impurities, and mechanically separated beef that is
derived from the materials prohibited by this proposed rule. These
measures will further strengthen existing safeguards designed to help
prevent the spread of bovine spongiform encephalopathy (BSE) in U.S.
cattle.
DATES: Submit written or electronic comments by December 20, 2005.
Submit written comments on the information collection provisions by
November 7, 2005.
ADDRESSES: You may submit comments, identified by [Docket No. 2002N-
0273 or RIN 0910-AF46], by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). or Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6860, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Bovine Spongiform Encephalopathy
B. Current Animal Feed Safeguards in the United States
C. Risk of BSE in North America
D. Additional Measures Considered to Strengthen Animal Feed
Safeguards
1. Comments on November 6, 2002 Advance Notice of Proposed
Rulemaking (ANPRM)
2. Actions in Response to Washington State Case
3. Comments on July 14, 2004 ANPRM
II. Proposed Measures to Strengthen Animal Feed Safeguards
A. FDA Response to Comments to the 2004 ANPRM
B. Additional Measures to Further Strengthen Feed Protection
C. Basis for Proposing to Apply Additional Measures to All Animal
Food and Feed
D. Cattle Materials Proposed to be Prohibited From Use in All
Animal Food and Feed
E. Disposal of Cattle Materials Prohibited in Animal Feed
III. Description of Proposed Rule and Legal Authority
A. Definitions
B. Proposed Requirements
C. Proposed Recordkeeping and Access Requirements
D. Conforming Changes to 21 CFR 589.2000--Animal Proteins
Prohibited in Ruminant Feed
E. Legal Authority
IV. Analysis of Economic Impacts
A. Summary of Proposed Regulatory Impact Analysis
B. Need for Regulation
C. Benefits
D. Costs
E. Government Costs
F. Sensitivity Analysis
G. Regulatory Flexibility Analysis
V. Paperwork Reduction Act
VI. Environmental Impact
VII. Federalism
VIII. Comments
IX. References
I. Background
A. Bovine Spongiform Encephalopathy
BSE belongs to the family of diseases known as transmissible
spongiform encephalopathies (TSEs). In addition to BSE, TSEs also
include scrapie in sheep and goats, chronic wasting disease (CWD) in
deer and elk, and Creutzfeldt-Jakob disease (CJD) in humans. The agent
that causes BSE and other TSEs has yet to be fully characterized. The
most widely accepted theory in the scientific community is that the
agent is an abnormal form of a normal cellular prion protein. The
abnormal form of the prion protein is less soluble and more resistant
to heat degradation than the normal form. The abnormal prion does not
evoke any demonstrated immune response or inflammatory reaction in host
animals. BSE is diagnosed by postmortem microscopic examination of an
animal's brain tissue and by detection of the abnormal form of the
prion protein in an animal's brain tissue. There is currently no
available test to detect the disease in a live animal.
Since November 1986, there have been more than 180,000 confirmed
cases of BSE in cattle worldwide. Over 95 percent of all BSE cases have
occurred in the United Kingdom, where the epidemic peaked in 1992/1993,
with approximately 1,000 new cases reported
[[Page 58571]]
per week. In addition to the United Kingdom, the disease has been
confirmed in native-born cattle in 22 European countries and in some
nonEuropean countries, including Japan, Israel, Canada, and the United
States.
Epidemiological studies have characterized the outbreak of BSE in
the United Kingdom as a prolonged epidemic arising at various
locations, with all occurrences due to a common source, and have
suggested that feed contaminated by a TSE agent was the cause of the
disease outbreak (Ref. 1). The subsequent spread of BSE was associated
with the feeding of meat-and-bone-meal from rendered BSE-infected
cattle to non-infected cattle (Ref. 1). It appears likely that the BSE
agent was transmitted among cattle at an increasing rate by ruminant-
to-ruminant feeding until the United Kingdom ban on such practices went
into effect in 1988 (Ref. 2).
Agricultural officials in the United Kingdom have taken a series of
actions to eliminate BSE. These actions include making BSE a reportable
disease, banning mammalian meat-and-bone meal in feed for all food-
producing animals, prohibiting the inclusion of animals more than 30
months of age in the animal and human food chains, and destroying all
animals showing signs of BSE. As a result of these actions, most
notably the feed bans, the rate of newly reported cases of BSE in the
United Kingdom has decreased sharply and continues on a downward trend.
In 1996, a newly recognized form of the human disease CJD, referred
to as variant CJD (vCJD), was reported in the United Kingdom.
Scientific and epidemiological studies have linked vCJD to exposure to
the BSE agent, most likely through human consumption of beef products
contaminated with the agent. To date, approximately 150 probable and
confirmed cases of vCJD have been reported in the United Kingdom, where
there had likely been a high level of contamination of beef products.
It is believed that in the United States, where measures to prevent the
introduction and spread of BSE have been in place for some time, there
is far less potential for human exposure to the BSE agent. The Centers
for Disease Control and Prevention (CDC) leads a surveillance system
for vCJD in the United States. To date, CDC, has not detected vCJD in
any resident of the United States that had not lived in or traveled to
the United Kingdom for extended periods of time. In 2002, a probable
case of vCJD was reported in a Florida resident who had lived in the
United Kingdom during the BSE epidemic. Epidemiological data indicate
that the patient likely was exposed to the BSE agent before moving to
the United States.
B. Current Animal Feed Safeguards in the United States
In the Federal Register of June 5, 1997 (62 FR 30936) (the 1997
ruminant feed final rule), FDA published a final rule to provide that
animal protein derived from mammalian tissues is prohibited for use in
ruminant feed. Although BSE had not been identified in the United
States at that time, the 1997 ruminant feed final rule was put in place
to prevent the establishment and amplification of BSE in the United
States through animal feed and thereby minimize risk to humans and
animals. The 1997 ruminant feed final rule created a new Sec. 589.2000
(21 CFR 589.2000), Animal proteins prohibited in ruminant feed, and
established a system of controls to ensure that ruminant feed did not
contain animal protein derived from mammalian tissues. The 1997
ruminant feed final rule set out requirements for persons who
manufacture, process, blend, or distribute certain animal protein
products or ruminant feeds containing such products.
The 1997 ruminant feed final rule (Sec. 589.2000) prohibits the
use of mammalian-derived proteins in ruminant feed, with the exception
of certain proteins believed at that time not to pose a risk of BSE
transmission. These exceptions to the definition of ``protein derived
from mammalian tissues'' included: Blood and blood products; gelatin;
inspected meat products which have been cooked and offered for human
food and further heat processed for feed (such as plate waste and used
cellulosic food casings), referred to herein as ``plate waste'' milk
products (milk and milk protein); and any product whose only mammalian
protein consists entirely of porcine or equine protein. The 1997
ruminant feed final rule does not prohibit ruminant animals from being
fed processed animal proteins derived from nonmammalian species (e.g.,
avian or aquatic animals). The 1997 ruminant feed final rule permits
the manufacture of non-ruminant feed containing prohibited mammalian
protein and ruminant feed on the same premises, provided that separate
equipment is used in the production of ruminant feed or that documented
adequate clean-out procedures are used between production batches.
Following the discovery of a BSE positive cow in Washington State
in December 2003, FDA provided guidance on the use of materials from
BSE positive cattle. In Guidance for Industry, ``Use of Material from
BSE Positive Cattle in Animal Feed,'' published in the Federal Register
in September 2004 (69 FR 58448), FDA stated its view that under section
402(a)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 342(a)(5)), animal feed and feed ingredients containing
materials derived from a BSE-positive animal are considered adulterated
and should be recalled or otherwise removed from the marketplace.
C. Risk of BSE in North America
In April 1998, the United States Department of Agriculture (USDA)
contracted with the Harvard Center for Risk Analysis (HCRA) at Harvard
University and the Center for Computational Epidemiology at Tuskegee
University to conduct a comprehensive investigation of the BSE risk in
the United States. The report, (Ref. 3) widely referred to as the
Harvard Risk Assessment or the Harvard Study, is referred to in this
document as the Harvard-Tuskegee Study. The study was completed in 2001
and released by USDA. Following a peer review of the Harvard-Tuskegee
Study in 2002, the authors released a revised risk assessment in 2003
(Ref. 4).
The Harvard-Tuskegee Study reviewed available scientific
information related to BSE and other TSEs, assessed pathways by which
BSE could potentially occur in the United States, and identified
measures that could be taken to protect human and animal health in the
United States. The assessment concluded that the United States is
highly resistant to any proliferation of BSE, and that measures taken
by the U.S. Government and industry make the United States robust
against the spread of BSE.
The Harvard-Tuskegee Study concluded that the most effective
measures for reducing potential introduction and spread of BSE are as
follows: (1) The ban placed by USDA's Animal and Plant Health
Inspection Service on the importation of live ruminants and ruminant
meat-and-bone meal from the United Kingdom since 1989 and all of Europe
since 1997 and (2) the feed ban instituted in 1997 by FDA to prevent
recycling of potentially infectious cattle tissue. The Harvard-Tuskegee
Study further indicated that, if introduction of BSE had occurred via
importation of live animals from the United Kingdom before 1989,
mitigation measures already in place would have minimized exposure and
begun to eliminate the disease from the cattle
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population even assuming less than complete compliance with the feed
ban.
The Harvard-Tuskegee Study also identified pathways or practices
that, if addressed, would further decrease the already low risk of
spread BSE if it were introduced into the United States. These include
the following: (1) Failing to comply with FDA's ruminant feed
regulations that prohibit the use of certain proteins in feed for
cattle and other ruminants; and (2) rendering of animals that die on
the farm (considered the highest risk cattle), and then incorporating
(through illegal diversion or cross-contamination) the rendered product
in ruminant feed. The Harvard-Tuskegee Study's independent evaluation
of the potential additional risk mitigation measures predicts that a
prohibition against rendering of animals that die on the farm would
reduce potential new cases of BSE in cattle following a hypothetical
introduction of 10 infected animals by 80 percent (from 4.3 to 0.77
cases) as compared to the base case scenario, (i.e., present state of
the U.S. cattle population, along with government regulations and
prevailing agricultural practices, and an assumption of less than
complete compliance with the feed ban) (Ref. 4). Further, the study
evaluated the impact of a specified risk materials (SRMs) ban that
would prohibit high risk materials such as the brain, spinal cord,
vertebral column and animals that die on the farm, from inclusion in
human and animal food. The analysis predicts that this measure would
reduce potential new BSE cases in cattle following a hypothetical
introduction of ten infected animals by 90 percent (from 4.3 to 0.53
cases).
In 2003, following the detection of BSE in a native-born cow in
Canada, the HCRA evaluated the implications of a then-hypothetical
introduction of BSE into the United States (Ref. 5), using the same
simulation model developed for the initial Harvard-Tuskegee Study. The
results of this assessment were consistent with the conclusions of the
earlier study--namely, that the United States presents a very low risk
of establishing or spreading BSE should it be introduced.
On December 23, 2003, USDA announced that a dairy cow in Washington
State had tested positive for BSE. The results were confirmed on
December 25, 2003, by the Veterinary Laboratories Agency in Weybridge,
England. Immediately after the diagnosis was confirmed, USDA, FDA, and
other Federal and State agencies initiated an epidemiological
investigation (Ref. 6), and began working together to trace any
potentially infected cattle, trace potentially contaminated rendered
product, increase BSE surveillance, and take additional measures to
address risks to human and animal health. The epidemiological
investigation and DNA test results confirmed that the infected cow was
born and most likely became infected in Alberta, Canada, before
Canada's 1997 implementation of a ban on feeding mammalian protein to
ruminants.
On January 22 through 24, 2004, the Secretary of Agriculture
convened an international panel of experts on BSE. The panel, referred
to as the International Review Team (IRT), was asked to: (1) Assess the
epidemiological investigation conducted in response to the BSE case in
Washington State, (2) provide expert opinion about when the active
phase of the investigation should be terminated, (3) consider the
response actions of the United States to date, and (4) provide
recommendations about actions that could be taken to provide additional
meaningful human or animal health benefits in light of the North
American experience. The IRT provided its report on February 4, 2004.
In May 2004, USDA contracted with HCRA to update the BSE risk
assessment model to reflect its January 2004 rulemaking to prohibit
SRMs and certain other cattle material in human food. HCRA was also
asked to update the parameters in the model for compliance with FDA's
feed ban. HCRA was also asked to model the impact that the IRT
recommendation would have on the BSE risk to humans and cattle.
In December 2004, Canada announced that a third North American cow
tested positive for BSE. An ongoing epidemiologic investigation found
that this animal, an 8-year-old, nonambulatory dairy cow, originated in
Alberta, Canada and was born before the Canadian feed ban went into
effect in August 1997. Shortly thereafter, in January 2005, another cow
in Alberta was found to be positive for BSE. This case involved a beef
cow born in March 1998, 6 months after the Canadian feed ban went into
effect. Based on preliminary information, Canada believes that the most
likely source of infection in this animal was feed produced before
implementation of Canada's feed ban (Ref. 7).
In June 2005, USDA announced that a 12-year-old beef cow, born and
raised in Texas, was confirmed BSE positive. The BSE-positive cow most
likely became infected before FDA's implementation of the 1997 ruminant
feed final rule. It was determined that no part of the animal entered
the human food or animal feed chains.
D. Additional Measures Considered to Strengthen Animal Feed Safeguards
1. Comments on November 6, 2002, Advance Notice of Proposed Rulemaking
(ANPRM)
In the Federal Register of October 5, 2001 (66 FR 50929), FDA
announced its plan for an October 30, 2001 public hearing in Kansas
City, MO, to solicit comments from the public on the 1997 ruminant feed
regulation. Recognizing that new information had emerged since
publication of the feed rule in 1997, FDA requested comments on whether
changes to the rule or other additional measures were necessary (Ref.
8). Information obtained from the public hearing and from the Harvard-
Tuskegee Study was used in the publication of an ANPRM (2002 ANPRM) in
the Federal Register of November 6, 2002 (67 FR 67572). This ANPRM
sought comment from affected industries and the public on possible ways
to strengthen the 1997 ruminant feed regulation. The ANPRM specifically
asked for comments on a number of questions related to the following
five aspects of the BSE feed regulation: (1) Excluding brain and spinal
cord from rendered animal products, (2) prohibiting the use of poultry
litter in cattle feed, (3) assessing the improper use of pet food as a
feed for ruminants, (4) preventing cross-contamination, and (5)
eliminating the plate waste exemption.
The predominant view of those who submitted comments in response to
the ANPRM was that the BSE risk in the United States was low enough
that no new feed controls were needed. Most said that the current feed
ban provided more than adequate protection against BSE, that there was
no scientific justification for additional regulations, that compliance
with the 1997 ruminant feed final rule was extremely high, and that
over 19,900 USDA surveillance samples in 2002 alone failed to detect
BSE in U.S. cattle. They also cited the Harvard-Tuskegee Study
conclusion that existing control measures made the risk to U.S. cattle
and to U.S. consumers from BSE very low.
In the 2002 ANPRM, FDA said that the Harvard-Tuskegee Study
identified the removal of high-risk bovine tissues, such as brain,
spinal cord, intestine, and eyes, from human food and from rendered
material for all animal feed as a way to reduce the potential exposure
of cattle and humans to the BSE agent. The 2002 ANPRM then asked for
comments on the following three questions related to SRMs: (1) Should
high risk materials be excluded from rendered products?; (2) how
feasible would it be for the rendering industry
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to implement such an exclusion?; and (3) what will be the adverse and
positive economic, environmental, and health impacts from an exclusion?
Comments in support of an SRM ban included one comment from USDA
citing conclusions from the Harvard-Tuskegee Study that this action
would significantly reduce the amount of infectivity in the animal feed
chain, and would reduce risks resulting from ``leaks'' in the feed ban.
Other comments stressed the infectivity of these tissues, and the
recommendation by the World Health Organization (WHO) that countries
exclude these tissues from the animal and human food chain (Ref. 9).
Comments opposing an SRM ban said that the measure would be
redundant because the 1997 ruminant feed final rule already prohibits
this high-risk material in ruminant feed. Therefore, the ban would only
be beneficial if BSE were present in the United States and there were
significant non-compliance with the feed ban. The comments also cited
the conclusions of the Harvard-Tuskegee Study that the risks of BSE in
the United States are low. One comment said that restrictions on SRMs
in animal feed should be decoupled from restrictions for human food
because of the substantial reduction in infectivity obtained during
rendering. Another comment said that an SRM ban would give only the
perception of a risk reduction, not a real reduction, and that it would
send the message to our trading partners that our BSE risks are such
that more controls are needed. Australia asked that, if an SRM ban is
implemented, the ban not apply to Australia because of its widely
recognized status as a low-risk BSE country.
Numerous comments addressed the feasibility and the adverse
economic impacts of an SRM ban. One comment pointed out that it is not
feasible to remove central nervous system (CNS) tissue from decomposing
carcasses. Comments from a trade association said that an SRM ban would
require costly restructuring of facilities that would force many small
rendering plants out of business, depriving some parts of the country
access to rendering as a means of animal disposal. A June 2002 Sparks
Report estimated disposal costs of an SRM ban to be $54 million, based
on the assumption that the ban would apply to all cattle because of the
difficulty of determining the age of cattle at slaughter (Ref. 10).
According to an earlier 1996 Sparks Report, the cost of disposal of 1.7
billion pounds of CNS tissue and dead stock would exceed $400 million.
Another estimate for disposal was $50 million for the beef industry
alone. One comment said that feed costs account for 70 percent of
poultry production cost, and that renderers would pass on the costs of
excluding brains and spinal cords to the poultry industry.
Several comments mentioned the environmental impact of an SRM ban.
One comment stated that a total ban on SRMs in rendered animal products
would create a waste stream with no economic value. Another comment
said that a ban on SRMs would encourage improper disposal of dead stock
because there are no federal regulations on disposal of dead animals.
2. Actions in Response to Washington State Case
In response to the BSE case identified in Washington State, USDA
published an interim final rule in the Federal Register of January 12,
2004 (69 FR 1861), excluding high-risk tissues from human food. The
interim final rule prohibited the use of SRMs and certain other cattle
material in USDA-regulated human food. USDA defined SRMs as brain,
skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebra of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal
root ganglia (DRG) of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of cattle of all ages.
To ensure effective removal of the distal ileum, USDA requires that the
entire small intestine be removed and disposed of as inedible product.
In its January 12, 2004, interim final rule, USDA took the additional
step of making cattle that are unable to rise from a recumbent
position, referred to in this document as nonambulatory disabled
cattle, ineligible to be slaughtered for human consumption.
On January 26, 2004, FDA announced its intention to implement
additional measures to strengthen existing BSE safeguards for FDA-
regulated products. These measures included the issuance of an interim
final rule to implement additional measures related to animal feed. The
interim final rule would have implemented four specific measures
related to animal feeds. These measures included the elimination of the
exemptions for blood and blood products and ``plate waste'' from the
1997 ruminant feed rule, a prohibition on the use of poultry litter in
ruminant feed, and a requirement for dedicated equipment and facilities
to prevent cross-contamination.
However, on February 4, 2004, IRT released its report on measures
related to BSE in the United States. The report recommendations
included a somewhat different set of measures for reducing the risks
associated with animal feed than the measures FDA had announced that it
intended to implement through an interim final rule. Although FDA
believed its previously announced measures would serve to reduce the
already small risk of BSE spread through animal feed, the broader
measures recommended by the IRT, if implemented, could make some of the
previously announced measures unnecessary. FDA believed that additional
information was needed to determine the best course of action in light
of the IRT recommendations and decided to publish an ANPRM, which
requested comments on the recommendations of the IRT, as well as on
other measures under consideration to protect the animal feed supply.
Consistent with measures implemented by USDA to exclude high-risk
cattle tissues from human food (69 FR 1861), FDA published an interim
final rule on July 14, 2004 (69 FR 42255), prohibiting a similar list
of risk materials from FDA-regulated human food, including dietary
supplements, and cosmetics.
3. Comments on July 14, 2004, ANPRM
In the Federal Register of July 14, 2004 (69 FR 42287), FDA
published an ANPRM (2004 ANPRM) jointly with USDA in which FDA
announced its tentative conclusion that it should propose banning SRMs
in all animal feed. In this ANPRM, FDA asked for comment on this
measure and also on the IRT's recommendations to require dedicated
equipment or facilities for feed manufacture and transport, and its
recommendation to prohibit the use of all mammalian and poultry protein
in ruminant feed. Finally, FDA also asked for comment on the set of
measures that the agency had announced in January 2004. Comments
submitted in response to the 2004 ANPRM that relate to SRMs are
summarized in sections I.D.3a through I.D.3f by general topic area.
a. Need for SRM ban. As with the comments received in response to
the 2002 ANPRM, many comments questioned the need for an SRM ban at the
time of the 2004 ANPRM. Several comments argued that the comparison
made by the IRT between the BSE situations in Europe and the United
States is inappropriate. One reason given for the invalid comparison
was that there were an estimated 3 to 4 million undiagnosed BSE cases
in the United Kingdom, compared to two diagnosed cases in North America
in cattle born before feed restrictions were implemented. Another
comment said
[[Page 58574]]
that the United States did, in fact, learn from the European experience
and implemented controls early so that potential animal exposure to the
BSE agent in the United States remains exceedingly small compared to
the massive exposure in the United Kingdom. One comment submitted by
the agriculture department of a state with a large agriculture industry
said that its findings from 600 inspections do not support the premise
of the IRT's recommendation that an SRM ban is needed to address
problems of cross-contamination and on-farm misfeeding. The state
indicated that, in these inspections, it did not observe any prohibited
materials or feed containing prohibited materials on farms where
ruminant feeds were being mixed.
Other comments said that the reduction in risk obtained through an
SRM ban would be minimal, mostly citing the effectiveness of the
current firewalls in reducing BSE infectivity in the cattle population.
One comment said that the Harvard-Tuskegee Study conclusion that an SRM
ban will reduce potential cattle exposure to BSE infectivity by 88
percent sounds more impressive than it really is. Reducing a very small
risk by 88 percent does not necessarily provide significant risk
reduction.
Finally, many comments questioned FDA's decision to ban SRMs from
animal feed before the results of USDA's enhanced BSE surveillance
program are known. USDA's one-time effort to test as many high-risk
cattle as possible was started on June 1, 2004, and was expected to be
completed by the end of 2005. One comment pointed out that the IRT's
recommendations for defining SRMs are predicated on the outcome of this
aggressive surveillance program.
In support of FDA's tentative conclusion that it should propose to
ban SRMs from all animal feed, many comments cited the conclusion of
the Harvard-Tuskegee Study that an SRM ban will provide additional risk
reduction, and also cited the recommendation of the IRT that SRMs
should be excluded from all animal feed, including pet food. One
comment said that an SRM ban would restore confidence in U.S. beef
exports.
b. Definition of SRMs. SRMs are typically defined as the tissues in
which BSE infectivity has been demonstrated in experimentally or
naturally infected animals. SRMs are further defined by the OIE
Terrestrial Animal Health Code based on the age of the animal and the
BSE risk status of a country. In the 2004 ANPRM, FDA asked how SRMs
should be defined for animal feed, specifically, if the SRM list should
be the same list as for human food. FDA also asked what information is
available to support having two different lists.
Comments from one organization included data from the Harvard-
Tuskegee Report on the relative infectivity of specific tissues. These
data were based on pathogenesis studies carried out in the United
Kingdom and showed the fraction of total infectivity of each tissue to
be: Brain 64.1 percent; spinal cord 25.6 percent; dorsal root ganglia
3.8 percent; trigeminal ganglia 2.6 percent; distal ileum 3.3 percent;
tonsil <0.1 percent; and eyes <0.1 percent. The comment used the data
to make the point that 90 percent of infectivity could be removed by
excluding only the brain and spinal cord. A different comment citing
the same data pointed out that the infectivity distribution represents
more than a worst case scenario because, in the pathogenesis study, the
BSE dose administered orally to calves was substantially greater than
would reasonably be expected under field conditions. This second
comment went on to point out that FDA's interim final rule on food and
cosmetics said that in cattle infected under field conditions, BSE
infectivity had been demonstrated only in the brain, spinal cord, and
retina of the eye at the end stages of the disease.
Many comments recommended that the human food list of SRMs be used
to define which SRMs should be excluded from animal feed. Several
comments recommended expanding the list beyond the human food list by
applying it to tissues from cattle 12 months of age or older, or to
tissues from all cattle. Others advocated eliminating bovine or animal
protein from ruminant feed altogether. Reasons given by the comments
for these recommendations were the large risk reduction that could be
achieved and the desirability of being consistent with the requirements
for human food.
Those who submitted comments in support of a more limited SRM list
mostly did so to minimize the volume of material that would require
nonfeed disposal. The comments stated that reducing this volume of
material that would require nonfeed disposal would lessen the adverse
impact of an SRM ban on the livestock, meat, and animal feed
industries. One company used the Harvard model to simulate three
different SRM scenarios and then submitted data showing that limiting
the SRM list to brain and spinal cord (while also prohibiting use of
dead stock and downers over 30 months of age), eliminating vacuum
rendering, and keeping the existing feed ban in place, achieved a risk
reduction equivalent to that obtained by banning the full human list of
SRMs.
The following are other suggestions provided in comments submitted
in response to the 2004 ANPRM for reducing the volume of SRM material
needing alternative disposal: (1) Allow the use of SRMs from animals
that test negative for BSE, (2) designate only the head as an SRM which
reduces by 64 percent the potential BSE infectivity in feed, (3) allow
the use of intestines from veal calves whose carefully controlled diets
consist of low-risk formulas, and (4) allow mechanically separated beef
from pet food plants to be used if SRMs are removed before meat is
mechanically separated from bones.
c. Cattle not inspected and passed for human consumption. The term
``cattle not inspected and passed for human consumption'' is used in
this document to mean cattle that were not inspected and passed for
human consumption by the appropriate regulatory authority. For the
purposes of this document, this term also includes nonambulatory
disabled cattle, i.e., cattle that could not rise from a recumbent
position or that could not walk, including, but not limited to, those
with broken appendages, severed tendons or ligaments, nerve paralysis,
fractured vertebral column, or metabolic conditions. This proposed
definition is consistent with the use of the terms ``inspected and
passed and nonambulatory disabled cattle'' as defined in USDA's interim
final rule on human food (69 FR 1862) and FDA's interim final rule on
human food and cosmetics (69 FR 42255). For the purposes of this
proposed rule, nonambulatory disabled cattle are included in the
definition of cattle not inspected and passed, since nonambulatory
disabled cattle cannot be passed for human consumption.
A number of questions were included in the 2004 ANPRM regarding the
use of materials from cattle not inspected and passed for human
consumption as previously defined. Comments received discussed both the
advantages and disadvantages of excluding these animals from being
rendered for use in animal feed.
Advantages mentioned included the additional risk reduction that
would be provided by the measure. A number of comments cited the
Harvard-Tuskegee Study, which showed that removing dead stock from the
feed chain would reduce potential exposure of cattle to the BSE agent
by 88 percent. However, other comments noted that such a ban would
result in dead stock being disposed of on the farm, impacting USDA's
surveillance program and
[[Page 58575]]
increasing environmental problems due to improper disposal of animal
carcasses. Concerns were also expressed about lack of infrastructure
for non-feed disposal of dead stock, and the serious economic impact of
diverting these animals to alternative disposal.
In response to the question in the 2004 ANPRM about effective
removal of SRMs from dead stock and nonambulatory disabled cattle,
several comments stated that such removal would not be economically or
technically feasible. Other comments stated that SRM material could be
effectively removed because there is no substantial difference between
the processing of dead and nonambulatory animals at rendering
facilities and the processing of healthy cattle at slaughter plants.
One other comment mentioned instances where some USDA-inspected
deboning facilities already remove SRMs from dead cattle at the request
of pet food manufacturers. This comment also said that, based on their
experience, SRMs can be removed from dead cattle in all but the hottest
months of the year when the rate of decomposition increases. Another
comment said that removing SRMs from dead stock may increase exposure
of plant employees to pathogens and zoonotic diseases.
One comment noted that the European experience has shown that
cattle at highest risk for BSE are dead cattle, downer cattle, and
ante-mortem condemned cattle over 30 months of age. This comment said
that, while it is possible to remove the meat from these carcasses for
use in pet food, they are not aware of any way of verifying the removal
of SRMs from dead and nonambulatory cattle (short of active government
oversight) that would allow this material to be rendered for use in
feeds for non-ruminant animals. Another comment suggested that as an
option for reducing the amount of material for disposal, dead stock
under 30 months of age be allowed to be rendered for feed use. This
comment also said that USDA could test dead stock over 30 months of
age, allowing material from negative animals to be used in feed.
d. Small intestine. The 2004 ANPRM also requested information to
evaluate the IRT recommendation that the entire intestine from cattle
of all ages should be excluded from the human and animal food chains.
With publication of its interim final rule on January 12, 2004, USDA
required that the entire small intestine be disposed of as inedible.
Likewise, FDA prohibited the use of the entire small intestine in FDA-
regulated human food and cosmetics, even though the agency only
considers the distal ileum portion of the small intestine to be a
specified risk material (69 FR 42259).
However, based on comments received in response to the FDA interim
final rule on human food and cosmetics, FDA concluded that processors
have the technology to effectively remove the distal ileum portion from
the rest of the small intestine. Thus, FDA amended the human food and
cosmetics interim final rule to state that the small intestine is not
considered prohibited cattle material if the distal ileum is removed by
a procedure that removes at least 80 inches of the uncoiled and trimmed
small intestine as measured from the caeco-colic junction and
progressing proximally towards the jejunum or by a procedure that the
establishment can demonstrate is equally effective in ensuring complete
removal of the distal ileum (70 FR 53063, September 7, 2005). This
amendment is consistent with USDA requirements (70 FR 53043, September
7, 2005).
Many comments in response to the 2004 ANPRM stated that inclusion
of the entire small intestine from cattle less than 30 months of age in
the list of prohibited material would double the volume of SRMs from
slaughter requiring alternative disposal while only marginally
decreasing infectivity. Several comments stated that only the distal
ileum should be included in the list of SRMs and noted that it is
easily identified for separation at slaughter.
One comment questioned the need to designate the intestinal tract
as SRM, pointing out that the distal ileum accounts for only 5 percent
of infectivity, which is reduced by two logs during rendering. Another
comment said that it was unnecessary to designate any portion of the
intestinal tract of cattle less than 30 months of age as SRM because
these animals were born 4 1/2 years after the feed ban was implemented,
and are therefore low risk animals. Several comments said that, if
packers can demonstrate a satisfactory technique, they should be
allowed to remove only the distal ileum rather than the entire small
intestine.
One comment expressing concern about the BSE risk associated with
bovine intestines said that research in the United Kingdom found
positive immunostaining for the resistant form of the prion protein
along the length of the intestine, which provides evidence that the
entire intestine should be considered SRM.
e. Infrastructure for alternative disposal. We received a number of
comments addressing the issue of disposal infrastructure. One comment
noted that the IRT recognized that an infrastructure was not in place
to dispose of SRM material and that the IRT had suggested that a staged
implementation may be necessary to allow this infrastructure to
develop. One comment said that before an SRM ban is implemented a
comprehensive plan for disposal of this material needs to be developed.
Another comment noted that in Texas, SRMs are considered special waste,
and that no landfill in the state is capable of accommodating a large
volume of this material. Additional comments indicated that this
concern was also true for other states, including Nebraska and Utah.
Two organizations submitted slaughter and cattle mortality data to
emphasize the amount of waste that would be generated by regulations
that would exclude this material from being rendered for use in animal
feed. One of these organizations said that it is deeply concerned that
FDA fails to recognize that a suitable disposal infrastructure does not
exist to deal with the very large quantities of SRMs that would be
generated on a daily basis. Its estimate for the volume of waste
generated from slaughter and cattle mortalities was 2 billion pounds
per year. The other organization submitted similar comments saying that
the U.S. system is currently unprepared to manage the waste disposal
challenges certain to arise if significant quantities of livestock
mortalities and slaughter byproducts require disposal by means other
than rendering. The comments further stated that the disposal and
environmental challenges resulting from the ban would be faced
immediately, but the solutions to these challenges would arise only
after significant time and financial investment across the livestock
sector. The comments also said that there is an absence of direct
regulatory control over alternative methods of disposing of the
enormous quantities of this unpleasant material.
Another comment suggested that renderers should be allowed to
dedicate lines to SRM material and SRM-free material within a single
facility. Equipment for receiving, grinding, cooking, processing, and
conveying could be dedicated lines, while the facility itself,
including the utilities, odor control, and wastewater treatment systems
be shared. Further, another comment suggested FDA work with the
rendering industry to develop cleanout procedures that would allow a
plant to process both SRMs and SRM-free material. These procedures
would be helpful to allow for seasonal deer rendering, for cleaning up
after accidental cross-contamination, and for
[[Page 58576]]
converting a facility back to SRM-free rendering.
One comment addressed the use of rendered SRM material as an
alternative fuel source for cement kilns, indicating that ruminant meat
and bone meal and fat are being used as a fuel source in Europe and
Japan. According to the comment, these materials burn efficiently, and
the heat from the kiln leaves virtually no organic residue.
f. Verification of SRM removal and SRM marking. One comment stated
that, in the absence of a practical test for verification of SRM
removal, the documentation required by HACCP plans should be sufficient
to show that SRMs at slaughter are excluded from animal feed channels.
Thus, inspections of records could be used to verify SRM removal. Also,
the comment stated that FDA can verify SRM removal by shifting
resources from inspections of thousands of feed mills and farms to the
much smaller number of slaughter plants and renderers.
One comment stated that rendering plants are capable of keeping raw
materials from various sources separated and capable of using
production, inventory, and shipping records to document the movement of
both SRM and SRM-free materials. Such management practices can be
verified by inspection, much like those conducted at USDA-inspected
cattle slaughter facilities. The comment went on to say that, if a
rendering plant is dedicated to rendering only SRMs, such a plant will
have to be inspected to determine how it disposes of SRMs.
Two comments suggested that raw or SRM-derived rendered materials
can be effectively marked using automatic dosage pumps to dispense
markers like glyceroltriheptanoate (GTH). GTH is a C7 synthetic fatty
acid not found in nature. A gas chromatography (GC) method for its
detection is available. Charcoal was mentioned as another potential
marker for use in rendered products.
II. Proposed Measures to Strengthen Animal Feed Safeguards
A. FDA Response to Comments to the 2004 ANPRM
FDA agrees with the numerous comments saying that it is important
to keep the BSE risk in the United States in proper perspective. FDA
acknowledges that the risk is likely low, and acknowledges that it is
inappropriate to compare the BSE situation in the United States to the
situation in Europe. However, FDA disagrees with comments concluding
that for these reasons no additional measures are needed. Even though
strong control measures have been put in place and compliance with the
current BSE feed regulation is high by renderers, protein blenders and
feed mills, the Agency is concerned, as discussed further below, about
such issues as the presence of high risk material in the non-ruminant
feed supply and cross-contamination of ruminant feed during the
rendering or feed manufacturing process. For example, without fully
dedicated equipment, it may not be possible to verify that there is
zero carryover of feed or feed ingredients in equipment, even where a
firm's cleanout procedures have been judged to be adequate. In
addition, resource constraints limit FDA's ability to assure full
compliance by all segments of the industry that are subject to the
current BSE feed regulation. For example, resources are not available
to the FDA and its state counterparts to fully verify compliance on
over 1 million farms where cattle are being fed.
FDA does not agree with comments that the agency should wait until
USDA completes its enhanced BSE surveillance program before deciding if
additional feed controls are needed. As stated in the July 2004 ANPRM,
FDA had tentatively decided based on clear evidence that the BSE agent
had been introduced into the North American animal feed supply, and
based on the recommendation of the IRT, that SRMs should be removed
from all animal feed. Results from the enhanced surveillance that was
being conducted concurrent with our rulemaking process indicated that
BSE had been introduced into the United States, but was present at a
very low level. These results reinforced FDA's decision that the
measures being proposed are appropriate.
With respect to the definition of SRMs, FDA agrees that prohibiting
the full list of SRMs would achieve greater risk reduction than
prohibiting a partial list, but also agrees with comments saying that
the infrastructure does not currently exist to handle the volume of
material that would require non-feed disposal if the full list of SRMs
were diverted from animal feed use. Therefore, FDA agrees that focusing
on brain and spinal cord is an effective approach for achieving
additional animal and public health protection while minimizing the
economic, environmental, and public health concerns associated with
disposal of the full list of SRMs. FDA, however, seeks comments on
whether a full SRM ban is warranted.
Comments were mixed on the feasibility of removing SRMs from dead
stock. FDA therefore concluded that some firms would elect to remove
SRMs and render the remainder of the carcass, and that this could
lessen difficulties associated with alternative disposal. FDA does not
agree that allowing test-negative animals to be rendered for animal
feed use is appropriate. Unlike Europe, rapid screening tests in the
United States have been used only for surveillance purposes. These
tests have not been used as food or feed safety tests because currently
available tests can detect BSE only in the late stages of disease.
Finally, although FDA agrees that vacuum rendering is less effective at
inactivating TSEs than atmospheric rendering, the Agency disagrees that
vacuum rendering should be prohibited. Modeling results submitted with
the comment showed that such a prohibition would result in an
additional one percent reduction in risk. In light of other measures
being proposed and the fact that few plants use vacuum rendering, FDA
does not believe that prohibiting this rendering process would
appreciably improve animal or public health protection.
B. Additional Measures to Further Strengthen Feed Protection
The United States and Canadian feed regulations implemented in 1997
were necessary because of uncertainty about whether BSE infectivity had
already been introduced into North America before new import
restrictions on live cattle and meat and bone meal from Europe were put
in place. It is now clear from the five North American BSE cases that
the BSE agent was introduced into the North American animal feed supply
at some point in time. While FDA continues to believe that compliance
with the feed regulation has provided strong protection against the
spread of BSE, the agency believes that the recent cases are an
indication that additional animal feed protections are needed to remove
residual infectivity that may be present in the animal feed supply. FDA
also believes that of all the options considered since publication of
the 2002 ANPRM, excluding the highest risk tissues from all animal feed
is the best approach to address the risks of BSE in the United States.
In the 2004 ANPRM, FDA announced its tentative conclusion that it
should propose a prohibition on the use of SRMs in all animal feed.
The decision to propose banning SRMs from all animal feed led to
the following questions: (1) Which material to exclude, (2) what
alternative disposal methods could be used, (3) what the economic and
environmental impacts of diverting material to alternative disposal
would be, and (4) how an SRM ban could be enforced. As the IRT
reported,
[[Page 58577]]
exclusion of large volumes of raw material is a massive burden for all
countries affected by BSE. FDA received valuable information pertaining
to these issues in comments submitted in response to the 2004 ANPRM.
In reaching a decision about what specific additional measures
should be proposed at this time, FDA considered the magnitude of the
BSE risk in the United States. While the recent North American cases
clearly show the BSE agent was introduced, the USDA enhanced BSE
surveillance program indicates that the prevalence of the disease in
the United States is very low. As of July 2005, USDA has tested over
418,000 high-risk cattle under its enhanced BSE surveillance program
(Ref. 11), and has found one positive animal in addition to the cow
identified in Washington State in December 2003. Therefore, FDA
believes that the additional measures being proposed are appropriate at
this time. The agency proposes to prohibit from use in all animal feed
the brains and spinal cords from cattle 30 months of age and older, the
brains and spinal cords from all cattle not inspected and passed for
human consumption, and the entire carcass of cattle not inspected and
passed for human consumption from which brains and spinal cords were
not removed. The agency also proposes to prohibit from use in all
animal feed mechanically separated beef and tallow that are derived
from materials prohibited by the rule. However, the rule proposes to
exempt tallow from this requirement if it contains no more than 0.15
percent insoluble impurities.
C. Basis for Proposing to Apply Additional Measures to All Animal Food
and Feed
The current U.S. ruminant feed regulation prohibits the use of
certain mammalian-origin proteins in ruminant feed, but allows the use
of these materials in feed for non-ruminant species. FDA believes that
the presence of high-risk materials in the non-ruminant feed supply
presents a potential risk of BSE to cattle in the United States.
European experience showed that, in countries with high levels of
circulating BSE infectivity, controls on only ruminant feed were not
sufficient to prevent further transmission of BSE. Until SRMs were
removed from all animal feed, a significant number of new cases
continued to be found in cattle born in the United Kingdom after
implementation of a ruminant-to-ruminant feed ban (Ref. 12). These new
cases were attributed to either cross-contamination during feed
manufacture and transport, or to intentional or unintentional
misfeeding on the farm.
The 1997 ruminant feed regulation requires feed manufacturers and
distributors that handle both ruminant feed and feed ingredients and
materials prohibited in ruminant feed to control cross-contamination by
either: (1) Maintaining separate equipment or facilities or (2) using
adequate clean-out procedures or other means adequate to prevent carry-
over of prohibited material into feed for ruminant animals. FDA has
been concerned about the adequacy of such clean-out procedures and
sought public comment on this issue in the 2002 ANPRM. Although many
firms using the clean-out option have written procedures in place,
evaluating their adequacy is difficult because of wide variation in
equipment and practices used by the feed industry, and because there is
currently no definitive test method to detect prohibited proteins.
Further increasing FDA's concerns about cross-contamination are
preliminary data from an unpublished study showing that the minimum
infectious dose for BSE may be lower than previously thought. Interim
results at approximately 5 years post exposure of an oral challenge
experiment have demonstrated transmission of BSE to 1 out of 15 animals
that received 0.01 gram of brain tissue from a BSE-infected animal
(Ref. 13). The lowest dose previously tested was 1.0 gram of brain
tissue which showed transmission of BSE in 7 out of 10 animals in the
trial group. This finding of a lower minimum infectious dose for BSE
would suggest that the risk from cross-contamination is greater than
previously thought. We seek comment on this interpretation of theses
interim results.
Instances of cattle being exposed to prohibited material through
noncompliance with the 1997 feed bans have been identified in both
Canada and the United States. The investigation by the Canadian Food
Inspection Agency of the BSE case identified in May 2003 found several
instances where cattle might have had access to non-ruminant feed
containing prohibited material. In the United States, FDA inspections
have identified situations where cattle could have been exposed to
material prohibited in ruminant feed as a result of ruminant feed being
contaminated with non-ruminant feed, or non-ruminant feed not being
properly labeled.
In fiscal year 2004 and the first half of fiscal year 2005, federal
and state inspections identified 41 instances (0.4 percent of
inspections) of cross-contamination or commingling problems in firms
that handle animal feeds containing prohibited mammalian protein (Ref.
14). During this same period, inspections identified 165 instances (1.7
percent of inspections) in which non-ruminant feeds containing
prohibited material were not properly labeled with the caution
statement ``Do Not Feed to Cattle or Other Ruminants''. Firms receiving
mislabeled feed would not be aware of the need to take steps to prevent
cross-contamination of ruminant feed with such products. Furthermore,
inspections during this period identified 604 instances (6.3 percent of
inspections) in which firms handling animal feeds containing prohibited
mammalian protein did not meet the recordkeeping requirements. These
instances involved a variety of recordkeeping deficiencies, including
not maintaining sales records for feeds received or distributed, not
establishing written protocols for avoiding commingling, and not fully
documenting clean-out measures utilized. Such deficiencies are
typically corrected by the involved firms without further action by the
agency. However, the occurrence of these deficiencies nonetheless
supports the need for additional measures to address concerns about the
presence of high-risk materials in the non-ruminant feed supply.
Without sales records, it is difficult to verify the source of feed or
feed ingredients or to track distributed feeds when conducting recalls
in response to known instances of product contamination. Without
appropriate documentation of procedures related to commingling or
cross-contamination, it is difficult to verify that workers are
informed of such procedures or that the procedures are adequate.
FDA has issued warning and untitled letters to firms addressing
noncompliance with the current ruminant feed ban regulation and a feed
manufacturer has been permanently enjoined in connection with
noncompliance with the current feed ban regulation.
FDA is also concerned about intentional and unintentional
misfeeding of non-ruminant feed to ruminants on the farm. Financial
incentives for intentional misfeeding could occur any time inexpensive
sources of prohibited protein are locally available to the feeder. The
use of salvaged pet food that contains ruminant meat and bone meal is
an example. There may be other incentives to intentionally feed non-
ruminant feed to cattle. For example, the Florida Department of
Agriculture and Consumer Services issued a statement cautioning against
the misuse of pet
[[Page 58578]]
food as feed for show cattle as a way to increase the shine in the
cattle coat (Ref. 15). Unintentional feeding could occur on the farm
from feeding ruminants and non-ruminant in close proximity to each
other. If intentional or unintentional uses occur, this proposed rule
would protect cattle by removing the highest risk material from the
non-ruminant feed being used in cattle feed. Assuring that misfeeding
does not occur on the farm is particularly difficult due to the large
number of cattle feeding operations in the United States, and FDA's
extremely limited resources to inspect these operations, which number
over 1 million.
Therefore, although overall compliance with the 1997 ruminant feed
rule has been high for renderers, protein blenders, and feed mills,
removal of the highest risk tissues from animal feed channels should
serve to address noncompliance with the rule that could result in
cattle exposure to prohibited material through cross-contamination,
mislabeling, or intentional or unintentional misfeeding.
D. Cattle Materials Proposed to be Prohibited From Use in All Animal
Food and Feed
1. Brain and Spinal Cord From Cattle 30 months of Age and Older
The USDA interim final rule published on January 12, 2004, provides
a full description of the scientific rationale for identifying the list
of tissues and selection of the 30-month age criterion used in its
definition of SRMs. FDA has adopted an identical definition of SRMs in
its interim final rule regarding FDA-regulated human food and
cosmetics. In the preamble of its July 14, 2004 interim final rule
regarding human food, including dietary supplements, and cosmetics, FDA
includes a detailed discussion of its rationale for the SRM definition.
As discussed in the preamble to the USDA and FDA interim final rules,
infectivity is not present in most tissues that harbor BSE infectivity
until more than 30 months after the animal was exposed to the agent.
Although the epidemiological and experimental data indicate that BSE
can develop in animals less than 30 months of age, the evidence
available to date indicates that this was a very rare occurrence, and
was associated with high levels of circulating infectivity at the peak
of the BSE epidemic in the United Kingdom. The agency continues to
believe that the rationale for the 30-month age criterion described
previously for human food and cosmetics is appropriate and proposes
that it be applied to animal feed as well.
In response to a question posed in the 2004 ANPRM as to which
tissues should be defined as SRMs for animal feed, FDA received
suggestions ranging from defining all animal protein as SRMs to
limiting the SRM definition to the head only. FDA considered
prohibiting from animal feed the same materials defined as SRMs that
are currently prohibited from use in food for humans, but decided that
proposing to require the removal of brain and spinal cord is the most
appropriate approach at this time.
In reaching the decision to propose to exclude only the brain and
spinal cord from animal feed, FDA considered information regarding the
tissue distribution of BSE infectivity. Under field conditions, BSE
infectivity has been found in the brain, spinal cord, and retina of the
eye in animals with clinical disease (Ref. 16). The Scientific Steering
Committee (SSC) of the European Union (Ref. 17) has also reported on
the proportion of total infectivity in various tissues.\1\ According to
the report, in an animal with clinical BSE, approximately 64 percent of
the infectivity is in the brain, 26 percent is in the spinal cord, 4
percent is in the dorsal root ganglia, 2.5 percent is in the trigeminal
ganglia, and 3 percent is in the distal ileum. The eyes are estimated
to contain less than 1 percent of the infectivity. Although available
data are limited on the distribution of tissue infectivity, data from
both naturally infected and experimentally infected cattle support the
finding that the brain and spinal cord are the tissues with the highest
level of infectivity.
---------------------------------------------------------------------------
\1\ A more recent report (Comer and Huntly, 2004, Journal of
Risk Research, 7, (5) 523-543) attributes 84.3 percent of
infectivity to brain and spinal cord and 9.6 percent to distal
ileum. We chose not to use the data from this more recent report
because its author (personal communications) explained that the
newer data suggesting that the level of infectivity in the distal
ileum at 6 to 18 months of age is higher than earlier estimates also
suggest that it is lower than earlier estimates at 32 months of age.
---------------------------------------------------------------------------
Because available data indicate that the brain and spinal cord
contain about 90 percent of BSE infectivity (Ref. 17), FDA believes
that the most appropriate course of action is to concentrate efforts on
excluding these highest risk tissues from animal feed. In deciding to
propose to prohibit brain and spinal cord only, rather than the same
list of materials previously defined as SRMs, FDA also considered the
following: (1) Surveillance data indicate the current risk of BSE to
U.S. cattle is very low, (2) the existing ruminant feed regulation
provides strong protection against BSE, and (3) the new measures
considered in this proposed rule represent a secondary level of
protection to address failures in compliance that may occur with the
existing ruminant feed rule. FDA believes that the existing ruminant
feed rule provides the primary line of defense by prohibiting the use
in ruminant feed of all material with potential BSE infectivity. The
measures proposed by this rule will effectively reinforce existing
ruminant feed protection measures by removing the tissues with the
highest infectivity from all animal feed. As a result, these measures
greatly minimize BSE risks if cross-contamination of ruminant feed with
non-ruminant feed, or diversion of non-ruminant feeds to ruminants,
were to occur.
2. Cattle Not Inspected and Passed for Human Consumption
As noted earlier in this document, the term ``cattle not inspected
and passed for human consumption'' includes cattle not inspected and
passed for human consumption by the appropriate regulatory authority as
well as nonambulatory disabled cattle.
European surveillance data indicate that cattle found dead or
culled onsite, where the carcass was submitted to rendering (fallen
stock), and cattle with health-related problems unfit for routine
slaughter (emergency slaughter) have a greater incidence of BSE than
healthy slaughter cattle. Surveillance data in the European Union in
2002 showed that there were 27.95 positive animals per 10,000 emergency
slaughter bovine animals tested and 6.15 positive animals per 10,000
fallen stock bovine animals tested compared to 0.31 positive animals
per 10,000 healthy slaughter animals tested (Ref. 18). In Switzerland,
the odds of finding a BSE case in fallen stock and emergency slaughter
cattle were found to be 49 and 58 times higher, respectively, compared
to the odds of finding a BSE case through passive surveillance (Ref.
19). These findings suggest that cattle not inspected and passed for
human consumption are more likely to test positive for BSE than healthy
cattle that have been inspected and passed for human consumption.
Because cattle not inspected and passed for human consumption are
included in the population of cattle at highest risk for BSE (Refs. 18
and 19), and processes are currently not established in the rendering
industry for verifying the age of such cattle through inspection, the
agency is proposing to define brains and spinal cords from all cattle
not inspected and passed for human consumption, regardless of age, to
be cattle materials prohibited in animal feed. As noted previously, the
[[Page 58579]]
term cattle not inspected and passed for human consumption is defined
in this proposed rule to include nonambulatory disabled cattle as
defined by FDA in its interim final rule on human food and cosmetics
and USDA in its interim final rule on human food. If the brains and
spinal cords are removed from these animals, FDA is proposing that the
remaining material can still be used in animal feed. FDA notes that for
cattle not inspected and passed that are diseased or that die other
than by slaughter, the entire carcass of such animals is adulterated
under section 402(a)(5) of the act. FDA has traditionally exercised
enforcement discretion with regard to the use of such animals in animal
feed. For example, see Compliance Policy Guide 675.400. FDA intends to
continue exercising such discretion for the use in animal feed of the
remaining material from cattle that are diseased or that die other than
by slaughter when the brain and spinal cord are removed. Because
comments to the ANPRM were mixed on the feasibility of removing SRMs
from cattle mortalities, FDA requests further comment on which tissues
should be removed from this class of animals and the feasibility of
removing them.
In deciding to propose to allow these remaining materials to be
used in animal feed, FDA considered the following: (1) brain and spinal
contain about 90 percent of BSE infectivity (Ref. 17), (2) surveillance
data indicate the current risk of BSE to U.S. cattle is very low, (3)
the existing ruminant feed rule provides strong protection against BSE,
and (4) the new measures considered in this proposed rule represent a
secondary level of protection to address failures in compliance that
may occur with the existing ruminant feed rule. FDA believes that the
existing ruminant feed rule provides the primary line of defense by
prohibiting the use in ruminant feed of all material with potential BSE
infectivity. If the brains and spinal cords are not removed from such
animals, FDA proposes that all parts of ``cattle not inspected and
passed for human consumption'' be prohibited.
3. Mechanically-Separated Beef (MS)
Mechanically-separated (MS) beef is a finely comminuted meat food
product resulting from the mechanical separation and removal of most of
the bone from attached skeletal muscle of cattle carcasses and parts of
carcasses. This proposed definition of MS beef is consistent with, but
not identical to, the definition of the term used by USDA in its 2004
interim final rule (69 FR 1862) prohibiting its use in human food and
by FDA in its 2004 interim final rule (69 FR 42255) prohibiting its use
in human food, including dietary supplements and cosmetics. Those
definitions provide that MS beef means a meat food product that meets
the specification in 9 CFR 319.5. This USDA regulation applies to MS
beef for human food use. Because there is MS beef produced solely for
animal feed use that would not fall within the USDA specification, the
definition of MS beef as proposed in this rule is meant to refer to
beef that is the product of the mechanical separation process,
regardless of whether it meets the USDA specifications for MS species
in 9 CFR 319.5. The definition of MS beef is not meant to include
product produced by Advanced Meat Recovery (AMR) systems used in the
meat industry.
Although MS beef was not considered in the 2002 ANPRM, 2004 ANPRM,
or in the IRT report, FDA has included this material in this animal
feed proposed rule to ensure that any such material that is used in
animal feed is not contaminated with the other material prohibited by
this proposed rule. A comment submitted in response to the 2004 ANPRM
said that FDA should allow mechanically separated beef to be used for
pet food if SRMs are removed from material going into the mechanical
deboning equipment that separates meat from bone, because some pet food
operations are very similar to slaughter establishments and are capable
of removing SRMs.
Because the mechanical separation process may result in the
contamination of the MS beef product with spinal cord, FDA proposes to
designate MS beef as cattle materials prohibited in animal feed if it
is derived from carcasses or parts of carcasses from which cattle
materials prohibited in animal feed were not previously removed.
4. Tallow
Tallow is an animal-derived hard fat that has been heat processed;
most tallow is derived from cattle. Any risk of BSE transmission from
tallow is a result of protein that is present as an impurity in the
tallow. Taylor et al. (Refs. 20 and 21) found, in rendering studies
with abnormal prion protein, that the prion protein did not
preferentially migrate into the fat fraction, but remained with the
protein fraction. Therefore, there is no reason to believe that tallow
is likely to contain unusually high amounts of prion protein as a
constituent of the insoluble impurities fraction that remains in tallow
after rendering. Taylor et al. (Refs. 20 and 21) also reported that the
various rendering processes used for tallow production in the United
Kingdom were sufficient to produce tallow that did not result in
infection when injected into the brains of mice, even though the
starting material was highly spiked with the scrapie agent. Wilesmith
et al. (Ref. 22) noted that the geographical variation in the incidence
of BSE in the United Kingdom was not consistent with the use of tallow
in cattle feed and concluded that the most likely source of infection
in cattle was BSE-contaminated meat and bone meal.
The Office International des Epizooties (OIE), the world
organization for animal health, categorizes tallow with insoluble
impurities of no more than 0.15 percent as protein-free tallow. OIE
guidelines recommend that tallow that meets this standard can be safely
traded regardless of the BSE status of the exporting country (Ref. 23).
FDA's Transmissible Spongiform Encephalopathy Advisory Committee
(TSEAC) considered the safety of tallow and tallow derivatives in 1998
(Ref. 24). Members of the committee indicated that tallow is a food
with negligible or no risk of transmitting BSE to humans or animals.
For the purposes of this proposed rule, tallow is defined as the
rendered fat of cattle obtained by pressing or by applying any other
extraction process to tissues derived directly from discrete adipose
tissue masses or to other carcass parts and tissues. The 1997 ruminant
feed final rule did not include tallow, fats, oils, and grease in the
definition of animal proteins prohibited in ruminant feed because they
are not proteins and were not considered to contain BSE infectivity.
The agency said that infectivity studies conducted on some of these
products (e.g., tallow) had demonstrated that they were at low risk of
transmitting the TSE agent and; thus, it was unnecessary to restrict
their use in ruminant feed (62 FR 30935). While the agency is not aware
of any new scientific information suggesting that infectivity is
present in tallow itself, the agency is concerned about potential BSE
risks that tallow poses as a result of protein that is present as an
impurity. These impurities may be of greater concern now because, as
previously noted, new preliminary data suggest that the minimum
infectious dose for BSE may be substantially lower than previously
thought. We seek comment on this interpretation of the preliminary
results.
The agency is proposing to prohibit the use of tallow in animal
food or feed that is derived from cattle materials prohibited in animal
feed. However, the agency proposes to exempt from this requirement
tallow that contains no
[[Page 58580]]
more than 0.15 percent insoluble impurities. The proposal would require
that impurities be measured by the method entitled ``Insoluble
Impurities'' (AOCS Official Method Ca 3a-46), American Oil Chemists'
Society, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, or another method equivalent in accuracy,
precision, and sensitivity to A.O.C.S. Official Method Ca 3a-46. In
response to the 2004 ANPRM, comments were submitted to the agency
requesting that the primary method for the impurity determination for
tallow be one other than the method in the Food Chemicals Codex.
Comments stated that the domestic tallow industry primarily uses a
method of AOCS to measure insoluble impurities. In comparison to the
Food Chemicals Codex method, comments stated that the AOCS method is
less expensive, requires less solvent, and has lower solvent disposal
costs. In addition, it does not require specialized equipment or
supplies. FDA agrees with these comments, and proposes that the primary
method for the impurity determination for tallow be the method from
AOCS rather than the method in the Food Chemicals Codex.
This proposed requirement for tallow would apply to all animal
feed, including feed for ruminants. Since the existing ruminant feed
rule Sec. 589.2000 (21 CFR 589.2000) does not include provisions
relative to tallow, this proposal represents a new requirement for
ruminant feed as well as for feed for non-ruminants. To make clear that
this proposed requirement would apply to ruminant feed, FDA is
proposing to amend Sec. 589.2000 to include the tallow requirements.
FDA is also proposing to exempt tallow derivatives from the
requirements of this rulemaking. Tallow derivatives are produced by
subjecting tallow to chemical processes (hydrolysis,
transesterification, and saponification) that involve high temperature
and pressure. FDA's TSEAC considered tallow derivatives in 1998 (Ref.
24), and determined that the rigorous conditions of manufacture are
sufficient to reduce the BSE risk in tallow derivatives to
insignificant levels. In addition, according to OIE guidelines tallow
derivatives produced by hydrolysis, saponification, or
transesterification using high temperature and pressure can be safely
traded regardless of the BSE risk status of the country of origin (Ref.
23).
E. Disposal of Cattle Materials Prohibited in Animal Feed
FDA agrees with comments from the affected industry that a
comprehensive plan would be needed to safely dispose of approximately
2.5 billion pounds of material if FDA decided to prohibit all dead
stock and the full list of SRMs, as defined in the USDA interim final
rule (69 FR 1862) and the FDA interim final rule (69 FR 42255), from
being rendered for use in animal feed. The 2.5 billion pounds of cattle
material includes approximately 1.4 billion pounds of material from
cattle slaughtered for human consumption and 1.1 billion pounds of
material from cattle not inspected and passed for human consumption
that are currently being rendered for use in animal feed. FDA is
concerned about the feasibility of establishing a new infrastructure to
safely dispose of this large quantity of material, as well as the time
it would take to implement these processes.
Limiting the list of SRMs as proposed by this rule reduces the
volume of slaughter byproducts that would require alternative disposal.
First, this proposal does not require the diversion from use in animal
feed the small intestine and tonsils from the 28 million head of cattle
under 30 months of age that are slaughtered annually. Second, only the
brain and spinal cord (weighing 1.3 pounds per animal) rather than the
head, spinal column, and small intestine, (weighing 88.5 pounds per
animal) are diverted from the estimated 7 million head of cattle over
30 months of age that are slaughtered annually in the U.S. FDA believes
that this more limited amount of material from slaughter operations can
be disposed of through landfill, incineration, or alkaline digestion.
Based on comments received, FDA acknowledges that there is some
uncertainty regarding the amount of material that will require
alternative disposal as a result of the proposed requirements
pertaining to cattle not inspected and passed for human consumption
(i.e., dead stock and nonambulatory disabled cattle). FDA is including
in this proposed rule the option to remove brain and spinal cord from
cattle not inspected and passed for human consumption so that most of
this material could continue to be rendered for use in animal feed. As
previously noted, FDA intends to continue exercising enforcement
discretion for the use in animal feed of the remaining material from
cattle that are diseased or that die other than by slaughter when the
brain and spinal cord are removed. As discussed in more detail in
Section IV, Analysis of Economic Impacts, FDA acknowledges that while
the proposed rule will result in additional material from these animals
being disposed of by means other than rendering, FDA believes such
increases will be modest. FDA seeks comment and further information on
the feasibility of removing brain and spinal cord from cattle not
inspected and passed for human consumption and on the impact of this
proposed rule on the number of these cattle that would be disposed of
by rendering.
In summary, FDA believes that the measures proposed by this rule
can be more feasibly implemented than a full SRM ban, and can add
substantially to the protection provided by the current BSE feed
regulation. With this approach, the resulting volume of material
requiring special disposal would be manageable in the short term. This
approach is also consistent with the advice of the IRT that a staged
approach may be necessary in implementation of an SRM ban. Further, FDA
believes that other feed controls that FDA previously considered, such
as dedicated facilities, are not needed if these high-risk tissues are
excluded from animal feed channels. Therefore, at this time FDA is not
proposing rulemaking to address other feed control recommendations of
the IRT or the additional planned measures announced by FDA on January
26, 2004.
III. Description of Proposed Rule and Legal Authority
FDA is proposing to establish a new Sec. 589.2001 (21 CFR
259.2001), Cattle materials prohibited in animal food or feed. While
the existing Sec. 589.2000 outlines requirements related to ruminant
feeds only, proposed Sec. 589.2001 outlines requirements intended to
apply to food or feed for all animal species. The terms and
requirements of proposed Sec. 589.2001 are described in section IV.A
of this document.
A. Definitions
The proposed Sec. 589.2001(a) defines the following terms for the
purposes of this regulation:
(1) Cattle materials prohibited in animal feed includes: (i) the
brains and spinal cords of cattle 30 months of age and older; (ii) the
brains and spinal cords of cattle of any age not inspected and passed
for human consumption; (iii) the entire carcass of cattle not inspected
and passed for human consumption from which brains and spinal cords
were not removed; (iv) mechanically separated beef that is derived from
cattle materials prohibited
[[Page 58581]]
under (i), (ii), or (iii) above; and (v) tallow that is derived from
cattle materials prohibited under (i), (ii), or (iii) above. Tallow
that is derived from cattle materials prohibited under (i), (ii), or
(iii) above that contains no more than 0.15 percent insoluble
impurities and tallow derivatives are not considered cattle materials
prohibited in animal feeds.
(2) Cattle not inspected and passed for human consumption means
cattle of any age that were not inspected and passed for human
consumption by the appropriate regulatory authority. This term includes
nonambulatory disabled cattle. Non-ambulatory disabled cattle are
cattle that cannot rise from a recumbent position or that cannot walk,
including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column, or
metabolic conditions.
(3) Mechanically separated beef means a meat food product that is
finely comminuted, resulting from the mechanical separation and removal
of most of the bone from attached skeletal muscle of cattle carcasses
and parts of carcasses.
(4) Renderer means any firm or individual that processes slaughter
byproducts, animals unfit for human consumption, or meat scraps. The
term includes persons who collect such materials and subject them to
minimal processing, or distribute them to firms other than renderers
(as defined in paragraph (a)(1)) whose intended use for the products
may include animal feed, industrial use, or other uses. The term
includes renderers that also blend animal protein products.
(5) Tallow means the rendered fat of cattle obtained by pressing or
by applying any other extraction process to tissues derived directly
from discrete adipose tissue masses or to other carcass parts and
tissues.
(6) Tallow derivative means any product obtained through initial
hydrolysis, saponification, or trans-esterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or
trans-esterification may be applied to obtain the desired product.
B. Proposed Requirements
Proposed Sec. 589.2001(b)(1) provides that no animal food or feed
shall be manufactured from, processed with, or otherwise contain cattle
materials prohibited in animal feed. Proposed Sec. 589.2001(b)(2)
provides new requirements for renderers that handle cattle material
prohibited in animal feed. Proposed Sec. 589.2001(b)(3) provides new
requirements for renderers that handle any cattle material.
1. Proposed Requirements for Renderers That Manufacture, Process,
Blend, or Distribute Cattle Materials Prohibited in Animal Feed
The proposed Sec. 589.2001(b)(2) requires that renderers that
handle cattle materials prohibited in animal feed use separate
equipment or containers to handle such material once it has been
separated from other cattle materials. This requirement is intended to
ensure that equipment used to manufacture, process, blend, store, or
transport cattle materials prohibited in animal feed or products that
contain or may contain cattle materials prohibited in animal feed do
not serve as a source of cross-contamination for materials intended for
animal feed. In addition, proposed Sec. 589.2001(b)(2) requires
renderers that manufacture, process, blend, or distribute cattle
materials prohibited in animal feed or products that contain or may
contain cattle materials prohibited in animal feed must: (1) Label the
prohibited materials in a conspicuous manner with the statement ``Do
not feed to animals''; (2) mark the prohibited material with an agent
that can be readily detected on visual inspection; and (3) establish
and maintain records sufficient to track the prohibited materials to
ensure such material is not introduced into animal feed, and make the
records available for inspection and copying by FDA. These proposed
requirements are intended to ensure that cattle materials prohibited in
animal feed do not enter the animal feed chain and thus have no
opportunity for inclusion in animal food or feed. FDA believes that
such material must be both labeled and marked to ensure that it does
not enter the feed channels since without such measures this material
would be indistinguishable from cattle materials not prohibited by this
proposed rule. Marking the material will provide a readily detectable
method on visual examination by which all persons in the animal feed
chain can be made aware that the a product is prohibited material or
contains prohibited material. Marking also will serve as a way to make
the status of the material known if, for some reason, the label ``Do
not feed to animals'' is separated from the product.
2. Proposed Requirements for Renderers that Manufacture, Process,
Blend, or Distribute Any Cattle Materials
Proposed Sec. 589.2001(b)(3) requires that renderers that handle
any cattle materials shall: (1) Establish and maintain records
sufficient to demonstrate that material rendered for use in animal feed
was not manufactured from, processed with, or does not otherwise
contain, cattle materials prohibited in animal feed, (2) make copies of
records available for inspection and copying by FDA, and (3) be in
compliance with requirements under Sec. 589.2000 regarding animal
proteins prohibited in ruminant feed.
C. Proposed Recordkeeping and Access Requirements
The proposed recordkeeping requirements associated with this rule
are focused on renderers because FDA believes this is the point at
which cattle material prohibited in animal feed could enter the animal
feed channel. Renderers, as defined in this proposed rule, receive
cattle materials from slaughter facilities or receive entire cattle
carcasses that were not inspected and passed for human consumption and
further process that material so that it may be used in animal feed.
FDA believes this is the critical control point in the feed and feed
ingredient processing channel at which the exclusion of cattle material
prohibited in animal feed must be documented. Once material is removed
from cattle and further processed, we may not be able to obtain the
information necessary to determine whether it is cattle material
prohibited in animal feed. There is currently no way to reliably test
feed or feed ingredients for the presence of the BSE agent or for the
presence of cattle materials prohibited in animal feed.
This proposed rule requires that no animal feed or feed ingredient
be manufactured from, processed with, or otherwise contain cattle
materials prohibited in animal feed. However, FDA does not believe it
is necessary for persons, other than renderers, that are involved in
the manufacture or processing of feed or feed ingredients to maintain
records documenting the exclusion of cattle materials prohibited in
animal feed. FDA believes, for the reasons cited previously, that it is
critical that such records be maintained at the point of the renderer.
However, FDA believes that requiring the maintenance of such records at
all manufacturing and processing points downstream would be redundant
and provide little additional information of value. FDA seeks comments
on the need to require that records be maintained by persons other than
renderers.
Because at this time there is no way to test reliably for the
presence of the BSE agent or the presence of the cattle materials
prohibited in proposed Sec. 589.2001(b)(1), renderers must depend
[[Page 58582]]
on records to ensure that the materials prohibited by this proposed
rule are excluded from material intended for use in animal feed and
that such material is appropriately disposed. Similarly, without
adequate records kept by renderers and access to the records by the
agency, FDA may not know whether renderers have complied with the
requirements. We are proposing in Sec. 589.2001(b)(2)(iv) that
renderers that manufacture, process, blend, or distribute cattle
materials prohibited in animal feed establish and maintain records
sufficient to demonstrate that such material was not introduced into
animal feed. Furthermore, we are proposing in Sec. 589.2001(b)(3)(i)
that renderers that manufacture, process, blend, or distribute cattle
materials establish and maintain records sufficient to demonstrate that
material rendered for use in animal feed was not manufactured from,
processed with, or does not otherwise contain, cattle materials
prohibited in animal feed.
Proposed Sec. 589.2001(d) requires that the records required by
this proposed rule be maintained for a minimum of 1 year. The 1-year
record retention period is consistent with the existing requirements
for ruminant feeds in 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. This is also considering the potentially long time
period from ingestion of the BSE agent in feed to manifestation of
clinical signs and lesions and the lack of a reliable estimate for the
latency period.
The proposed rule does not specify the types of records that would
need to be maintained in order to comply with the recordkeeping
requirements. The agency seeks comments on what type of records would
be appropriate and whether further detail is needed in the regulation
regarding specific record requirements such as the specific data
elements that must be included in such records.
D. Conforming Changes to Sec. 589.2000--Animal Proteins Prohibited in
Ruminant Feed
The requirements related to tallow in the proposed Sec. 589.2001
are intended to apply to all animal feed, including feed for ruminants.
Since the existing ruminant feed rule (Sec. 589.2000) does not include
provisions relative to tallow, this proposal represents a new
requirement for ruminant feed as well as for feed for non-ruminants.
Therefore, due to concerns about protein impurities present in tallow,
FDA is proposing to amend Sec. 589.2000 to include tallow in the
definition of ``protein derived from mammalian tissues'' and to add
language that excludes from the definition of ``protein derived from
mammalian tissues'' tallow containing no more than 0.15 percent
insoluble impurities and tallow derivatives as specified in proposed
Sec. 589.2001.
E. Legal Authority
FDA is issuing this proposed regulation on animal feed under the
food adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4),
(a)(5), 409, and 701(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 348, and
371(a)). The term ``food'' is defined to include articles used for food
``for man or other animals.'' See section 201 of the act (21 U.S.C.
321(f)). We note that the material that would be prohibited under this
proposed rule from use in animal feed continues to meet the definition
of food. Therefore, this material would be adulterated or misbranded
under the act based on violations of the proposed rule, as well as any
animal feed or feed ingredients that were manufactured from, processed
with, or otherwise contained, the prohibited material.
Under section 402(a)(3) of the act, a food is deemed adulterated
``if it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food.''
``Otherwise unfit for food'' is an independent clause in section
402(a)(3). The statute does not require that a food be filthy, putrid,
or decomposed for it to be ``otherwise unfit for food.'' In FDA's
interim final rule on the Use of Materials Derived from Cattle in Human
Food and Cosmetics (69 FR 42256 at 42264), we concluded that a food can
be ``otherwise unfit for food'' based on health risks, and sought
comments on that interpretation. Because of the possibility of
intentional or unintentional use of the materials that would prohibited
under this proposed rule in ruminant feed and the risk of BSE to
ruminants and humans from these materials, we have tentatively
concluded that these materials would be ``otherwise unfit for food''
under section 402(a)(3) of the act. We seek comment on this
interpretation.
Under section 402(a)(4) of the act, a food is deemed adulterated
``if it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health.'' The failure to ensure that
animal feed is prepared, packed, or held under conditions in which
cattle materials prohibited in animal feed under this proposed rule do
not contaminate animal feed would constitute an insanitary condition
whereby the feed may have been rendered injurious to health. Thus, this
insanitary condition would render the animal feed adulterated under
section 402(a)(4) of the act.
Under section 402(a)(5) of the act, food is deemed adulterated ``if
it is, in whole or in part, the product * * * of an animal which has
died otherwise than by slaughter.'' Some cattle are not inspected and
passed because they are diseased or have died before slaughter.
Material from these cattle that are diseased or that die otherwise than
by slaughter that is used as animal feed would render that feed
adulterated under section 402(a)(5) of the Act. FDA has traditionally
exercised enforcement discretion with regard to the use of such animals
in animal feed. For example, see Compliance Policy Guide 675.400. FDA
intends to continue exercising such discretion for the use in animal
feed of the remaining material from cattle that are diseased or that
die other than by slaughter when the brain and spinal cord are removed.
We are also relying on the adulteration provision in section
402(a)(2)(C)(i) of the act. Section 402(a)(2)(C)(i) deems a food
adulterated if it is or bears or contains a food additive that is
unsafe under section 409 of the act. Section 201(s) of the act, (21
U.S.C. 321(s)), defines as a food additive any substance whose intended
use results or may reasonably be expected to result in it becoming a
component of food unless, among other things, it is the subject of a
prior sanction (explicit approval for a specific use by USDA or FDA
before September 6, 1958), or is generally recognized as safe (GRAS).
Section 409 of the act provides that a food additive is unsafe unless
it and its use conform to a food additive regulation or an exemption
under section 409(j).
Prior sanctions are described in part 570 (21 CFR part 570). FDA is
not aware of any prior sanctions that relate to the present animal feed
use of the cattle material that would be prohibited in animal feed
under this proposed rule. Any person who intends to assert or rely on
such sanction is required to submit proof of the existence of the
applicable prior sanction. The failure of any person to come forward
with proof of such an applicable prior sanction in response to this
notice will constitute a waiver of
[[Page 58583]]
the right to assert or rely on such sanction at any later time.
A determination that a substance added directly or indirectly to a
food is GRAS, for its intended use is generally based on scientific
information regarding the composition of the substance, its use, method
of preparation, methods for detecting its presence in food, and
information about its functionality in food as determined by experts
qualified by scientific training and experience to evaluate the safety
of such a substance (Sec. 570.30). A substance added to food becomes
GRAS as a result of a common understanding about the substance
throughout the scientific community familiar with the safety of such
substances. The basis of expert views may be either scientific
procedures, or, in the case of a substance used in food before January
1, 1958, experience based on common use in food (Sec. 570.30(a)).
Substances that are GRAS based on use before January 1, 1958, must be
currently recognized as safe based on their pre-1958 use (See United
States v. Naremco, 553 F. 2d 1138 (8th Cir. 1977; compare United States
v. Western Serum, 666 F. 2d 335 (9th Cir. 1982)).
General recognition of safety based upon scientific procedures
requires the same quantity and quality of scientific evidence as is
required to obtain approval of a food additive regulation for the
ingredient (21 CFR 570.30(b)). (See United States v. Naremco, 553 F.2d
at 1143). A substance is not GRAS if there is a genuine dispute among
experts as to its recognition (An Article of Drug * * * Furestrol
Vaginal Suppositories, 294 F. Supp 1307 (N.D. Ga. 1968), aff'd 415 F.2d
390 (5th Cir. 1969)). It is not enough, in attempting to establish that
a substance is GRAS, to establish that there is an absence of
scientific studies that demonstrate the substance to be unsafe; there
must be studies that show the substance to be safe (United States v. An
Article of Food * * * CoCo Rico, 752 F.2d 11 (1st Cir. 1985)).
Conversely, a substance may be ineligible for GRAS status if studies
show that the substance is, or may be, unsafe, or if there is a
conflict in studies.
Expert opinion that cattle materials that would be prohibited in
animal feed under this proposed rule are GRAS would need to be
supported by scientific literature and other sources of data and
information, establishing that there is a reasonable certainty of no
harm from the material under the intended conditions of use. Expert
opinion would need to address topics such as whether BSE infectivity
can be detected, and whether it is reasonably certain that the BSE
agent will not be transmitted through cattle materials that would
prohibited in animal feed under this proposed rule. The burden of
establishing that a substance is GRAS is on the proponent of the
substance. (See CoCo Rico, supra.)
For the reasons discussed in other sections of this document, the
agency is tentatively concluding that cattle materials prohibited in
animal feed under this proposed rule are not GRAS by qualified experts
for use in animal food and, therefore, would be food additives. Section
402(a)(2)(C)(i) and (ii) of the act deems food adulterated ``if it is
or it bears or contains any food additive which is unsafe within the
meaning of section 409 * * * .'' Under section 409(a), a food additive
is unsafe unless a food additive regulation or an exemption is in
effect with respect to its use or its intended use. Therefore, in the
absence of a food additive regulation or an exemption, the cattle
materials that would be prohibited in animal feed under this proposed
rule would be adulterated under section 402(a)(2)(C)(i) of the act
because it bears or contains an unsafe food additive, and their
presence in animal feed would render the food adulterated.
Under section 701(a) of the act, FDA is authorized to issue
regulations for the act's efficient enforcement. The proposed
regulation would require measures to prevent animal food from being
unfit for food, being or bearing an unsafe food additive, being the
product of an animal that died otherwise than by slaughter. The
measures will also be required to prevent animal food from being held
under insanitary conditions whereby it may have been rendered injurious
to health. These proposed measures would allow for the efficient
enforcement of the act. Under the proposed regulations, renderers would
be required to establish and maintain records to track cattle materials
prohibited in animal feed to ensure that such material is not
introduced into animal feed and make such records available to FDA for
inspection and copying. Once material is removed from cattle, we may
not be able to obtain the information necessary to determine whether it
is prohibited cattle material. Because at this time there is no way to
test reliably for the presence of the BSE agent or the presence of the
cattle materials prohibited in proposed Sec. 589.2001(b)(1), renderers
must depend on records to ensure that their products do not contain
cattle materials prohibited from animal feed. In addition, without
adequate records, FDA cannot know whether renderers have complied with
the regulations that prohibit the use of certain cattle material in
rendered products intended for animal feed. For example, we would not
know from examination of a spinal cord whether the source animal was
over 30 months of age at the time of slaughter or whether the cattle
had been inspected and passed. Therefore, the proposed recordkeeping
and records access requirements are necessary for the efficient
enforcement of the proposed rule. Under the proposed rule, failure to
comply with the recordkeeping and records access requirements would
render the cattle material and any animal feed manufactured from,
processed with, or otherwise containing, the cattle material
adulterated under section 402(a)(4) of the act.
Furthermore, the proposed marking provision in Sec. 589.2001 is
necessary for the efficient enforcement of the act. Because there is
currently no reliable method to determine which cattle materials would
be the prohibited materials, marking is necessary to ensure compliance
with the proposed requirement that animal feed is not manufactured
from, processed with, or otherwise contains the prohibited cattle
materials. Under the proposed rule, failure to comply with this marking
requirement would render the cattle material and any animal feed
manufactured from, processed with, or otherwise containing, the cattle
material adulterated under section 402(a)(4) of the act.
FDA is issuing the proposed labeling requirement under sections
403(a)(1) and 201(n) of the act (21 U.S.C. 343(a)(1)). Section
403(a)(1) provides that a food is deemed misbranded if its labeling is
false or misleading in any particular. Section 201(n) provides that:
* * * in determining whether the labeling of a product is
misleading, there shall be taken into account (among other things)
not only representations made or suggested by statement, word,
design, device, or any combination thereof, but also the extent to
which the labeling * * * fails to reveal facts material in light of
such representations or material with respect to consequences which
may result from the use of the article to which the labeling * * *
relates under conditions of use prescribed in the labeling * * * or
under such conditions of use as are customary or usual.
The proposed rule would require cattle material prohibited in
animal feed to be labeled ``Do not feed to animals.'' We believe this
statement is material with respect to the consequences that may result
from the use of this material within the meaning of section 201(n) of
the act. As discussed in other sections of this document, the use of
the material
[[Page 58584]]
that would be prohibited under this proposed rule presents a risk of
BSE. Furthermore, there are no available definitive tests to detect
this material in feed. Therefore, under this proposed rule, the failure
to include this labeling statement would render the cattle material or
feed containing the prohibited cattle material misbranded under section
403(a)(1) of the act. We are also proposing that such statement be made
in a conspicuous manner. Under section 403(f) of the act, (21 U.S.C.
343(f)), a food is misbranded if ``any word, statement, or other
information required by or under authority of this Act to appear on the
label or labeling is not prominently placed thereon with such
conspicuousness * * * and in such terms as to render it likely to be
read and understood by the ordinary individual under customary
condition of purchase and use.'' Therefore, under the proposed rule,
the failure to include the statement ``Do not feed to animals'' in a
conspicuous manner would render the cattle materials or any feed
containing the cattle materials misbranded under section 403(f) of the
act.
IV. Analysis of Economic Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts, and equity).
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
FDA tentatively finds that the proposed rule does not constitute an
economically significant regulatory action as defined in Section
3(f)(1) of Executive Order 12866. We base this conclusion on both a
study of the impacts on industry of the proposed rule (on file at the
Division of Dockets Management (see ADDRESSES) conducted for FDA by the
Eastern Research Group (ERG)), a private consulting firm, and the
discussion in the remainder of this section (Ref. 25). The agency has
further tentatively determined that the proposed rule may have a
significant impact on a substantial number of small entities. This
proposed rule imposes no mandates on government entities, and would not
be expected to require the expenditure of over $115 million in any 1
year by the private sector. As such, no further analysis of anticipated
costs and benefits is required by the Unfunded Mandates Reform Act.
The following regulatory impact analysis begins with a summary of
the proposed rule and the expected benefits and costs. Next, in section
V.B of this document, we discuss the need for the regulation. In
section V.C, we discuss the benefits of the proposed rule, while in
section V.D, we discuss the costs. In section V.E, we discuss the costs
to the government. Finally, in section V.F, we discuss the regulatory
flexibility analysis.
A. Summary of Proposed Regulatory Impact Analysis
The proposed regulation would prohibit the use of certain cattle
materials in any animal feed. The cattle materials prohibited in animal
feed (CMPAF) would include the brain and spinal cord of all cattle 30
months of age or older, as well as the brain and spinal cord of cattle
not inspected and passed for human consumption regardless of age, the
entire carcass of cattle not inspected and passed if brain and spinal
cord is not removed (again, regardless of age), as well as other
materials. For the purposes of this proposed rule, the term ``cattle
not inspected and passed for human consumption'' includes nonambulatory
disabled cattle. Tallow derived from any of the prohibited materials
named previously would also be banned from use in animal feed unless it
contains no more than 0.15 percent insoluble impurities. MS beef from
any of the prohibited materials named above would be prohibited from
use in animal feed. Additional provisions of the proposed rule would
require renderers that handle cattle materials prohibited in animal
feed to use separate equipment or containers to handle this material
once it has been separated from other cattle materials. Such renderers
will also be required to follow certain procedures for labeling and
marking prohibited material and recordkeeping and records access.
The benefits of the proposed rule include the elimination of the
vast majority of the risk of spreading BSE to other cattle from
intentional or unintentional use of non-ruminant feed for ruminants or
cross-contamination of ruminant feed with non-ruminant feed or
ingredients intended for non-ruminant feed. FDA believes that the
proposed rule would effectively remove from use in non-ruminant feeds
those cattle tissues that account for approximately 90 percent of
potential BSE infectivity. Although the animal and public health
benefit associated with the additional BSE risk reduction is paramount,
the U.S. economy may also benefit from increased exports to the extent
that the proposed rule, if finalized, persuades foreign governments
that U.S. beef products are safe to import. Although we are unable to
quantify these benefits, they are potentially large, because the
expected loss of exports from the discovery of one infected cow in
Washington State in December 2003 amounted to approximately $3.4
billion in the first year (Ref. 26).
The total costs to industry of complying with the proposed rule
range from roughly $14 million to $24 million per year annualized over
10 years assuming a 7-percent discount rate (at a 3-percent discount
rate, the cost would range from $14 million to $23 million). These
estimated costs are the sum of the costs including: (1) The ban on the
use of certain tissues from cattle 30 months of age or older and cattle
not inspected and passed for human consumption in any animal feed and
(2) feed substitution costs. We discuss the proposed brain and spinal
cord prohibitions as direct costs to the affected firms (including
disposal costs, where applicable) and the firms' lost revenues from the
ban on these raw materials used in feed product inputs. Then, we
discuss the costs incurred by feed substitution costs. Table 1 of this
document shows a summary of these costs.
The proposed ban on the use of certain tissues from cattle 30
months of age or older and cattle not inspected and passed for human
consumption in any animal feed would require slaughterers and renderers
that process cattle 30 months of age or older and firms that process
dead, down, disabled, and diseased cattle to separate the CMPAF from
the remaining cattle offal that could still be used for animal feed. We
estimate that, for slaughterers, the separation of these materials from
cattle
[[Page 58585]]
30 months of age or older and cattle not inspected and passed for human
consumption regardless of age would require about $555,000 in one-time
capital costs (or $79,000 annualized at 7 percent and $65,000
annualized at 3 percent, over 10 years) (see table 1 of this document).
We estimate that the annual cost of the additional labor to separate
these CMPAF from other cattle offal is estimated to cost about $597,000
annually. Although compliance costs for these activities would be borne
initially by slaughterers, and are presented as such by ERG, a portion
of the costs are likely to be passed along to cattle producers and
consumers. For renderers, capital investments and labor for separation
and segregation of CMPAF would range from about $1.88 million to $4.65
million annually.
Our analysis does not project a specific disposal route for CMPAF
due to the uncertainty inherent in disposing of such low volumes of
material. Instead, it describes various disposal methods that may be
employed and estimated a $12 per 100 lbs. (cwt) of CMPAF disposal cost
(including transportation costs) for the low-cost end of the range of
disposal methods. The cost to dispose of the CMPAF is estimated to
range from $7.72 million to $9.97 million annually. Additional on-farm
disposal of dead and nonambulatory disabled cattle is expected to
increase compliance costs from about $1.02 million to $2.53 million
annually (including labor and equipment). The annual revenues foregone
from meat and bone meal (MBM) sales due to the prohibition of CMPAF in
animal feeds are estimated at $1.41 million to $2.78 million, and
foregone tallow sales are estimated at $1.37 million to $2.62 million.
This includes the value from CMPAF from cattle 30 months of age or
older and cattle not inspected and passed for human consumption
regardless of age, as well as from whole carcasses of cattle not
inspected and passed for human consumption that could not be rendered
due to this proposed rule.
We considered including a provision in this proposed rule that
would limit the use of all tallow in animal feed to that which contains
no more than 0.15 percent insoluble impurities, not just tallow derived
from the materials proposed to be prohibited in animal feed that
contains no more than 0.15 percent insoluble impurities. Analysis of
this alternative concluded that it would result in annualized costs of
about $1.78 million. These costs would consist of capital and operating
costs for polishing centrifuges that would be needed by a small segment
of independent renderers. We have not included a provision requiring
that all tallow meet the 0.15 percent limit in the proposal because the
CMPAF ban would effectively negate the risk of infectivity in non-
CMPAF-derived tallow. We invite public comments and data on the need
for, and impacts of, a provision that would require all tallow used in
animal feeds meet the 0.15 percent limit.
Table 1.--Total Costs ($ Millions)
------------------------------------------------------------------------
Annualized
Cost Item One-Time Cost Annual Costs Costs\1\
------------------------------------------------------------------------
Slaughter Facilities .............. .............. ................
------------------------------------------------------------------------
Capital Investments $0.56 N/A $0.08
------------------------------------------------------------------------
Labor .............. $0.60 $0.60
------------------------------------------------------------------------
Lost Value of MBM .............. $1.41--$2.76 $1.41--$2.78
(cattle 30 months of
age or older, cattle
not inspected and
passed)
------------------------------------------------------------------------
Lost Value of Tallow .............. $1.37--$2.62 $1.37--$2.62
(cattle 30 months of
age or older, cattle
not inspected and
passed)
------------------------------------------------------------------------
Disposal of cattle not .............. .............. ................
inspected and passed
------------------------------------------------------------------------
Labor .............. $0.12--$0.29 $0.12--$0.29
------------------------------------------------------------------------
Equipment .............. $0.9--$2.23 $0.9--$2.23
------------------------------------------------------------------------
Renderer Facilities .............. .............. ................
------------------------------------------------------------------------
Capital Investments $3.11-$7.67 $0.04--$0.11 $0.49--$1.20
------------------------------------------------------------------------
Labor .............. $1.40--$3.45 $1.40--$3.45
------------------------------------------------------------------------
Disposal of CMPAF from .............. $7.72--$9.97 $7.72--$9.97
cattle 30 months of
age or older, cattle
not inspected and
passed
------------------------------------------------------------------------
CMPAF Marking (High .............. $0.01 $0.01
Estimate)
------------------------------------------------------------------------
Recordkeeping/Labeling $0.10 $0.05 $0.06
------------------------------------------------------------------------
Feed Substitution .............. $0.30--$0.46 $0.30--$0.46
------------------------------------------------------------------------
Proposed Rule Total $3.76 $13.91--$22.5 $14.44--$23.75
Costs 6
------------------------------------------------------------------------
\1\ Annualized costs equal to annual costs plus one-time costs at 7
percent over 10 years. Using a 3 percent rate, annualized costs equal
$23,535,000.
FDA believes that this proposal, when evaluated in terms of its
incremental cost-effectiveness at reducing risks from BSE, is more
consistent with efficient science-based risk management than other
regulatory approaches that it identified in the 2004 ANPRM. This
proposal limits use of animal tissues for which infectivity is high
relative to
[[Page 58586]]
tissue weight. Weight is a key determinant of the incremental costs
from excluding tissues from rendering for animal feed. The approach
adopted in this proposal is likely to be relatively cost-effective
because it is directed primarily at those tissues for which infectivity
is likely to be high relative to control compliance costs.
In the 2004 ANPRM, FDA stated it was considering prohibiting a
larger list of cattle tissues (the full SRM list) from use in all
animal feeds. Under this option, SRMs would be defined as the skull,
brain, eyes, spinal cord, trigeminal ganglia, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum) and dorsal
root ganglia of all cattle over 30 months of age or older, including
the tonsils and distal ileum of all cattle regardless of age.
Additionally, this option would prohibit the small intestine of all
cattle, all material from nonambulatory disabled cattle, all material
from cattle that are not inspected and passed for human consumption,
and MS beef. Lastly, tallow derived from other prohibited materials and
containing more than 0.15 percent insoluble impurities would also be
prohibited from use in all animal feeds under this SRM option. As
detailed later in the analysis of alternatives, we have not included
all of these measures in this proposed rule because we believe the
proposed rule adequately addresses the risk from the presence of the
highest risk cattle material in the animal feed chain. We also note
that the proposed rule offers a more cost-effective approach to
achieving nearly the same level of protection against the spread of BSE
with regard to the presence of high-risk material in the non-ruminant
feed supply.
The approach described in the 2004 ANPRM is itself a refinement of
an approach announced early in 2004. In January 2004, shortly after
USDA reported finding a BSE-infected cow in Washington State, HHS
announced its intention to amend the current animal feed regulations by
adding several materials to the list of substances prohibited from use
in ruminant feed (Ref. 27). These materials included mammalian blood
and blood products; inspected meat products that have been cooked,
offered for human food, and then further heat-processed for feed (such
as plate waste and used cellulosic casings); and poultry litter.
Further, FDA planned to require establishments that manufacture,
process, blend, or distribute both products containing mammalian-
derived proteins and ruminant feed to use separate equipment or
facilities in their manufacture, processing and handling.
Preliminary analysis of the regulatory approach described in the
January 2004 announcement (Ref. 27) suggests that it is relatively less
effective in risk reduction compared to the CMPAF and SRM bans because
it would not remove the highest risk tissue (brain and spinal cord)
from animal feed channels. Instead, the approach described in the
January 2004 announcement would continue to allow the highest risk
cattle material in non-ruminant feed, but includes measures intended to
prevent cross-contamination of ruminant feed. Although we have not been
able to quantify the risk reduction associated with the approach
announced in January 2004, it is comparable in costs to the full SRM
ban described in the 2004 ANPRM. As a result we are not proposing it
here.
In developing this proposed rule we also considered other
alternatives (not included here), including combinations of bans of
various cattle tissues, from cattle of various ages (>30 months and <30
months) and various states (slaughtered for human food, deads,
downers). All of these resulted in costs over $100 million per year
with potential infective tissue reductions between 80 percent and 99
percent, when compared to the base case scenario.
Table 2 of this document lists the proposed rule (the CMPAF ban),
the SRM ban, and one of the options mentioned previously, namely a ban
on brain and spinal cord from slaughter cattle 30 months of age or
older, and a ban on the entire carcass of all dead and downed cattle.
The table lists both the expected costs of these options, and our best
estimate of the percent reduction in cattle tissues known to harbor BSE
infectivity. The proposed rule would reduce cattle oral ID50s (the
amount of infective material that would result in a case of BSE in 50
percent of the cattle that consumed it) that are available for use in
animal feed by about 90 percent as much as a ban on the full list of
SRMs (option 3), while imposing only 7 to 10 percent of the costs of
the SRM option (0.07 = $14 million/$195 million; 0.10 = $24 million/
$240 million). The second option would reduce the cattle oral ID50s by
more than 90 percent (a less than 10 percent increase over option 1),
but would impose costs that are about five to nine times greater than
option 1, though still only about 50 percent to 70 percent of the costs
of option 3. Based on the level of protection provided against the
spread of BSE and its cost-effectiveness, we believe the proposed rule
to be the most appropriate. FDA seeks further comment and scientific
and risk information on this analysis of additional regulatory options
for strengthening animal feed safeguards.
Table 2.--Cost-Effectiveness of Alternative Policies
------------------------------------------------------------------------
Option (Description of Banned Infectivity Annual Cost ($
Tissues/Materials) Reduction\1\ millions)
------------------------------------------------------------------------
CMPAF list from (1) Cattle 30 90% $14--$24
months or older, (2) deads,
(3) downers and (4), MS beef
if CMPAF not removed from
carcass, dedicated equipment/
container requirement;
tallow restriction (proposed
rule)
------------------------------------------------------------------------
Brain and spinal cord from >90% $115--$135\2\
cattle 30 months or older,
carcasses of all deads and
downs, MS Beef
------------------------------------------------------------------------
Full SRM list from cattle 30 >99% $195--$240
months or older, tonsils and
distal ileum from cattle of
all ages, carcass of all
deads and downers, MS beef,
tallow restriction
------------------------------------------------------------------------
\1\ Percent of ID50s from an infected animal that would be banned from
use in animal feed.
\2\ Detailed cost estimate of this alternative is not included in the
regulatory flexibility analysis section of this document.
[[Page 58587]]
B. Need for Regulation
Executive Order 12866 directs agencies to assess the need for any
significant regulatory action and an explanation of how the regulation
will meet that need. In this instance, FDA tentatively concludes that
private incentive systems for both suppliers and purchasers in markets
for cattle, rendering, and ruminant feed may inadequately address the
risk of BSE. This market failure is a result of inadequate information
being available to buyers of potentially infective animal feed. Because
of the risk of cross contamination during feed production and the risk
of inadvertently feeding non-ruminant feed to ruminants on an
integrated farm, buyers of ruminant and non-ruminant feed would likely
value a decrease in risk of BSE transmission if the market were able to
provide it. Buyers, however, have little information about the BSE
infectivity of feed because the costs to them of ascertaining
infectivity are very high and higher than the costs to the feed
producers. As a result, buyers may, without the current or proposed
feed rules, unknowingly buy feed contaminated with BSE because of the
presence of CMPAF.
The potential market failures created by the continued use of
materials that this proposed rule would eliminate are the same as in
the 1997 ruminant feed final rule. If feed purchasers could easily
identify the risk of the infective agent associated with products from
specific suppliers, they could more easily reduce these risks by
refusing to buy feed products derived from ruminants known to have
consumed prohibited CMPAF. Feed purchasers are unlikely to obtain the
information they need due to the long incubation period for BSE that
could lead to a suboptimal level of risk prevention by purchasers
during the incubation period. Ruminant producers have no way of knowing
whether a particular batch of feed or feed ingredients intended for
ruminants are free of potentially infective proteins due to the
possibility of CMPAFs being introduced through cross-contamination with
feed or feed ingredients intended for non-ruminants.
C. Benefits
The purpose of the proposed rule is to further reduce the risk of
BSE spreading within the cattle population. Reduced risk of BSE among
cattle also reduces human exposure to variant Cruetzfeldt-Jakob disease
(vCJD) believed to be caused by consumption of beef products
contaminated with the BSE agent as well as increases the potential for
exports by reducing foreign governments' concerns about the quality of
U.S. beef. In this section, we first address the reductions in the risk
of BSE to cattle in the United States and the corresponding protection
of human health from the major provisions of the proposal. We then
summarize the available evidence about the likely effect of this
proposed rule on U.S. exports of beef and other livestock products.
1. Risk Reduction
FDA estimates that banning CMPAFs from use in any animal feed would
effectively remove about 90 percent of any remaining potential
infectivity from possible spread through the feed system. To derive
this estimate of the risk reduction from the proposed CMPAF ban, we
assume that the number of new BSE cases is proportional to the amount
of all infectious material included in feed. Given this assumption, we
can estimate the percentage reduction in the risk of new BSE cases as
the percentage reduction in infectious material. A 1999 report by the
Scientific Steering Committee of the European Union suggests that the
brain and spinal cord constitute 89.7 percent of the total infective
load in a case of BSE (Ref. 28). This rule would prohibit use in all
animal feed of these tissues (CMPAFs) from cattle 30 months of age or
older and all cattle not inspected and passed for human consumption.
CMPAF, when taken from slaughtered cattle less than 30 months of age,
would not be prohibited from use in all animal feed because the
probability is very low that tissues from cattle of this age would
contain BSE infectivity. Thus, banning CMPAF would effectively remove
about 90 percent of total infectivity from animal feed. The absolute
level of animal health risk reduced by this rule would depend on the
number of infected animals in the United States and the extent to which
cattle get exposed to infected material.
The potential human exposure to infectious materials from consuming
beef is already small since USDA and FDA prohibit the use of certain
cattle materials, including SRMs, from human food. In its preliminary
analysis (Ref. 26), USDA modified the Harvard-Tuskegee model and
estimated that the two interim final rules issued in January 2004
reduced human exposure to infectious materials by an average of 80
percent. For example, USDA estimated if 5 BSE infected bulls were
introduced in 2003 and its control measures take effect in 2004,
consumers would be exposed to 4 animal ID50s between 2004 and 2020
compared to 18.5 animal ID50s without these measures (Ref. 26, Table
13). The estimate of percent reduction in exposure is insensitive to
the assumed number of infected animals introduced into the United
States. To the extent this rulemaking further reduces the likelihood of
the spread of BSE, it further reduces the already small likelihood of
human exposure to the infectious material.
Assessing the public health implications from estimates of the
human exposure to the BSE agent is difficult because there is no agreed
upon dose-response relationship between human exposure to cattle ID50s
and vCJD cases. Nonetheless, the experience of the United Kingdom
suggests that the BSE agent is many times less infective in humans than
in cattle. During the 1980s and 1990s, in the absence of preventive
control measures, millions of ID50s may have been available for
consumption by residents of the United Kingdom, since each cow with
clinical symptoms of BSE contains about 7,800 ID50s. The cumulative
number of definitive or probable vCJD cases identified in the United
Kingdom as of September 1, 2005, is 157 (Ref. 29). Thus, human exposure
to a few, or even a few dozen ID50s, may represent a relatively small
risk to public health. FDA solicits additional information on the dose
response relationship between ID50s and incidence of vCJD.
2. Increased Export Potential
A second major category of benefits pertains to the potential for
increased exports of U.S. cattle products to countries that have acted
to curtail exports since the discovery of the infected cow in
Washington State in December 2003. However, we are unable to quantify
the value of such increased exports, because of limits to the data and
resources available to us. We note however, that USDA assessed this
category of benefits in the interim final regulation that it issued in
January 2004. In its assessment, it concluded that ``the 2004 beef
export demand forecast has been reduced by 90 percent'' (Ref. 26, page
58). It reported that U.S. exports of beef, veal, and variety meats
amounted to $3.8 billion in sales in 2003, and exports of live cattle
resulted in an additional $63 million. The preventive measures
contained in this proposed rule are expected to increase the likelihood
that foreign governments ease some restrictions on imports of U.S. beef
products and cattle.
Another indirect and incomplete measure of the potential benefits
of this rule can be seen in measures of the commodities markets'
reactions to the discovery of BSE cases. When the first BSE case was
reported in Washington
[[Page 58588]]
State on December 23, 2003, beef prices had risen to record highs, but
were expected to decline in 2004. After the discovery of the BSE case,
the 5 area monthly weighted average steer price reported by USDA's
Agricultural Marketing Service declined by about 14 percent from
December 2003 to February 2004 (Ref. 30). By April 2004, the weighted
average monthly price appeared to recover much of the loss. Although
never fully reaching pre-BSE record levels, prices by mid-2004 appeared
to be close to what they would have been had the BSE-infected cow not
been identified. Such volatility in commodities markets may adversely
affect independent beef producers who are risk averse and have hedged
against such risks inadequately. To the extent that this proposed rule
would prevent the development of a BSE-infected cow in the U.S., it may
provide benefits to such beef producers by reducing their risk of
financial loss and the cost to them of insuring against such risks.
D. Costs
We address the costs to industry of complying with this proposed
regulation by considering in turn each of the individual provisions of
this proposal. The costs of this proposed rule can be estimated as the
sum of the costs of the different provisions.
FDA contracted with ERG to prepare an analysis of the impacts of
the ban or restriction on use of CMPAF in proposed
Sec. 589.2001. Additionally, ERG analyzed the likely impacts of
alternative options (on file at the Division of Dockets Management (see
ADDRESSES) and henceforth referred to as the Alternatives Report) (Ref.
31)). In particular, these alternatives include the following: (1) A
prohibition on the use of specified risk materials in animal feed, (2)
the requirement for the use of separate facilities or equipment by
those that process both mammalian protein prohibited in ruminant feed
and ruminant feeds, and (3) a ban on the use of blood and blood
products in ruminant feeds. The ERG analysis of this proposed rule
presents estimates of costs for the meatpacking or slaughtering,
rendering, and animal producer sectors. In addition, the ERG report
provides estimates of impacts on representative small firms in the
sectors that are impacted, to a significant degree, to fulfill
requirements of a regulatory flexibility analysis. In the development
of the Alternatives Report, ERG contacted establishments in the FDA
inspection database that were likely to be affected by these regulatory
options. Two separate telephone surveys were conducted, covering feed
mills, renderers, and agricultural product transporters (the latter
including trucking services at feed mills, renderers, and contract
haulers). In some cases, written questionnaires were provided to the
industry members. In addition, ERG used the services of industry
consultants and other contractors for their technical expertise. The
sector-specific surveys taken by ERG for the analysis of alternatives
were each administered to fewer than ten industry members. In its
development of the report on the proposed rule that would prohibit the
use of CMPAF in animal feed, ERG again contacted industry members it
had identified through its previous work on alternative policies, as
well as industry consultants and industry associations.
A study prepared for an industry association concluded that about
35 percent of cattle (42 percent by weight) not inspected and passed
for human consumption are currently rendered (Ref. 32). Our analysis
estimated the number of cattle at about 17 percent. Whereas our
analysis is based on other industry-supplied data that may be less
dated, the industry analysis is based on USDA/APHIS data, that while
older, resulted from several different USDA surveys.
The industry association's analysis differs from our analysis in
the following three ways: (1) The percentage of animals currently
rendered, (2) the number of animals, and (3) the weight of prohibited
cattle material from each animal. Because of these differences, it may
be potentially misleading to make a direct comparison of the findings
of the two analyses. For example, if we substitute industry's
percentages of animals currently rendered into our analysis, our
estimate increases from 17 percent to 33 percent, but not to the
industry association's estimate of 35 percent. The slight difference
between our findings and those of industry (i.e., 33 percent compared
to 35 percent) should be attributed to the difference in the number of
animals rendered in each individual category of cattle.
Aside from the percentage of cattle not inspected and passed for
human consumption currently rendered, the biggest source of variation
between the two estimates can be attributed to the assumptions about
the weight of CMPAF being rendered. The industry analysis assumed that
the entire carcass would be affected by the ban on cattle not inspected
and passed for human consumption. Discussions between ERG and industry
experts convince us that, in most cases, renderers can adequately
separate CMPAF from the other parts of a carcass. Adjusting the
industry analysis to include only CMPAF and to include the same number
of cattle as used in our analysis, decreases their estimate of the
percentage of tissues rendered from 42 to 33 percent. This contrasts to
our finding that only 17 percent of the volume of CMPAF from cattle not
inspected and passed for human consumption is currently rendered.
Nevertheless, we acknowledge the uncertainty in all of these
estimates. Due to the significance of this factor in estimating
compliance costs for this proposed rule, we have adopted the 42 percent
figure as the upper bound of the acceptable range and include cost
estimates using this factor, where appropriate, within the cost
methodology developed in the ERG analysis.
In general, the proposed ban on the use of CMPAF would impose three
types of costs. First, it requires firms to buy equipment and to
reallocate workers to change their production processes. This
requirement imposes direct costs. Second, it prohibits the use of CMPAF
by renderers who would use it to produce MBM and tallow. This
prohibition reduces the revenue to slaughterhouses that sell CMPAF.
Third, it also may oblige the buyers of MBM to turn to alternative
ingredients that may be more costly or nutritionally inferior.
Furthermore, prohibitions on the use of CMPAF in animal feeds can
impose additional disposal costs, insofar as a previously valuable
commodity is now turned into an undesirable by-product that requires
disposal. Thus, we assess the lost revenue, direct costs, additional
disposal costs, and feed substitution costs that may result from this
proposed rule.
1. Lost Value of CMPAF
The proposed rule would prohibit the use of CMPAF in all animal
feeds. Our analysis concluded that the proposed rule would cause
slaughtering operations to incur additional capital investment costs
and labor costs to modify and operate their plants in order to separate
CMPAF from the rest of the cattle offal. Further, we project the value
of the MBM and tallow based on historical prices, and discusses
possible CMPAF or MBM disposal options for the industry. We also
project the costs of additional disposal of on-farm dead and
nonambulatory disabled cattle, CMPAF marking costs, recordkeeping, and
labeling costs required by the proposal.
ERG used industry data to estimate the CMPAF quantities that would
be removed from cattle 30 months of age or
[[Page 58589]]
older slaughtered for human food and cattle not inspected and passed
for human consumption based on various factors including the age of the
cattle, size of slaughter plant (federal or state inspection
authority), and, for dead and nonambulatory disabled cattle of any age,
the type and size of animal (beef or dairy cattle). ERG also used
industry data on yield to project MBM and tallow production resulting
from the current level of CMPAF quantities. Using 4-year averages of
byproduct market prices ($180/ton for ruminant or mixed species MBM,
and $360/ton for tallow), the annual value of the MBM and tallow
originating from CMPAF is estimated at $976,000 and $794,000,
respectively. Using the high end of the range discussed previously, the
annual value of MBM and tallow would be $1,714,000 and $1,194,000,
respectively. Additionally, the annual value of the MBM and tallow from
the carcasses of deads and nonambulatory disabled cattle that would no
longer be collected by renderers (and would likely be disposed of on
the farm) is estimated by ERG at $430,000 and $576,000, respectively.
The high end of this range of costs is estimated at $1,064,000 for MBM
and $1,422,000 for tallow. The total value of the loss of MBM is
estimated to range from $1,406,000 to $2,777,000, and the total value
of the lost tallow is estimated to range from $1,370,000 to $2,616,000.
The cost of the proposed provision that restricts tallow based on an
impurity level is addressed in a later section of this analysis.
2. Direct Costs
There are 5 categories of direct costs, including: (1) Capital and
labor for slaughtering and rendering, (2) the tallow restriction, (3)
MS beef restriction, (4) CMPAF marking costs, and (5) labeling and
recordkeeping costs. We turn to each of these below.
a. Capital and labor costs--slaughtering and rendering. The
proposed rule would result in cattle slaughter operations separating
CMPAF and arranging for its disposal separate from other cattle offal.
This change in activity may be similar to the new activities required
by the 2004 USDA interim final rule, pertaining to the prohibition of
SRM for use in human food. It is likely, however, that SRM segregation
activities required under the 2004 USDA interim final rule that banned
SRM from use in human foods would differ to some extent from those that
would result from this proposed rule. The 2004 USDA interim final rule,
for example, would allow SRMs that are no longer available for human
consumption to go to rendering for processing into MBM and tallow for
use in feed for non-ruminant animal species. Under the FDA proposal,
the CMPAFs (which are a small subset by volume of SRMs) could not be
used in any animal feeds. Therefore, slaughterers would need to use
separate offal lines for offal of non-CMPAF-origin and offal of CMPAF-
origin.
For projected capital investment and labor, because of the
relatively small volume of CMPAF per plant, and current high rate of
brain and spinal cord removal, the rule should result in only modest
compliance costs. After consulting with slaughter operations, ERG
projected that all slaughter facilities would need additional offal
bins designated solely for CMPAFs. Additionally, modifications of
processes and procedures would be necessary for those slaughter
facilities that handle larger volumes of animals. These offal bin and
modification estimates ranged from only $150 for the smallest
facilities up to $15,000 for the two largest operations in the United
States. Aggregate one-time capital expenditures are estimated to be
about $555,000, or about $79,000 annually (based on a 7-percent
discount rate over 10 years).
Additional labor costs would be incurred at slaughtering facilities
to handle CMPAF segregation and disposal. ERG, using its discussion
with industry members, estimated that the smallest facilities would
incur no additional labor costs, while the level of additional labor
would range from only a few minutes at the next smallest facilities to
slightly more than one production worker at the largest establishments.
Based on the average pay for this worker of $20,420 (plus a 40 percent
increase for benefits), ERG estimated the additional labor costs for
this industry at $597,000. Per facility labor costs are expected to
range from $313 annually for the smallest plants to $30,000 annually
for the largest plants. Total capital and labor costs for slaughtering
facilities are estimated at $676,000 ($597,000 in labor costs plus
$555,000 annualized at 7 percent over 10 years; annualizing at 3
percent would reduce the cost by about $14,000 annually).
Renderers would also incur additional capital and labor costs to
handle CMPAF segregation from cattle not inspected and passed for human
consumption. After consulting an equipment manufacturer, ERG projected
the cost of equipment purchases and installation for renderers based on
the size of the operation. These costs ranged from about $7,300 at the
smallest rendering operations to about $72,000 for the largest
operations. Total capital costs for renderers are estimated at $3.1
million (annualized at $442,000 over 10 years at a 7-percent discount
rate, or at $486,000 with a 10 percent maintenance cost included).
Using the upper end of the range of cattle not inspected and passed for
human consumption that are currently rendered, we estimate the capital
costs for renderers at about $7.67 million (annualized at $1.09 million
over 10 years at a 7 percent discount rate, or at $1.20 million with a
10 percent maintenance cost).
Renderer labor costs would also increase due to the CMPAF
separation, segregation and disposal. Using the same labor rates as
slaughterers, ERG projected that the additional labor would range from
slightly over $1,000 at the smallest facility to about $56,500 at the
largest facilities. The low end of the range of total incremental
payroll costs at renderers are estimated at about $1.4 million
annually. The high end of the range of annual labor costs is estimated
at $3.5 million. Although no labor overhead is included, we believe it
would be negligible because most facilities would hire less than one
additional laborer. Total capital and labor costs at rendering
establishments are projected to range from about $1.88 million to
$3,938,000 annually ($1.4 million to $3.5 million in labor costs plus
$486,000 in capital costs after annualizing at 7 percent over 10 years;
annualizing at 3 percent would reduce costs by about $78,000).
b. Tallow restriction. The proposed rule would ban the use of
tallow derived from the brains and spinal cords of cattle 30 months of
age or older, the brains and spinal cords of all cattle not inspected
and passed for human consumption, and the entire carcass of cattle not
inspected and passed for human consumption, if the brains and spinal
cords are not removed. An exception to this ban is provided for tallow
from these sources that has no more than 0.15 percent insoluble
impurities. We do not believe, however, that it would be economical for
renderers or tallow manufacturers to further process the brains and
spinal cords from these animals into tallow while complying with the
proposed equipment separation and tallow purification requirements. We
have, therefore, not included additional costs for this proposed
provision. The lost value of this tallow (and MBM) has already been
accounted for earlier in this analysis.
c. MS beef restriction. We do not project any compliance costs for
the proposed MS beef provision. The proposed rule would prohibit the
use of
[[Page 58590]]
MS beef from use in animal feeds if the brain and spinal cord of cattle
30 months of age or older, the brain and spinal cord of all cattle not
inspected and passed for human consumption, or the entire carcass of
cattle not inspected and passed for human consumption has not been
previously removed from the cattle material used to make MS beef. USDA
and FDA have already banned MS beef from use in human food. Through
contacts with industry members, the analysis projected that about 20
firms, about one-half of which are renderers, would be affected by this
proposed provision. These businesses, known as ``4D'' firms, collect
dead and downer (nonambulatory disabled) cattle and sell the meat to
pet food manufacturers, zoos and other animal feeding operations. The
number of pet food manufacturers using this MS beef as an input has
been declining in recent years, however, due to public perceptions
concerning pet food inputs. The analysis assumes many of these firms
use mechanical separation equipment as part of their operation. Census
data does not separately estimate the sales volume of red meat from 4D
animals and MS beef from 4D animals. ERG estimated the size of the
market at about $100 million per year, based on an industry contact.
Further, the analysis estimated that 75 percent of the value of this
product is generated from revenues unrelated to the animal or carcass
pick-up fees. Of this 75 percent, about 20 percent to 25 percent is
believed to represent MS beef sales. Industry contacts report that the
brain and spinal cords of dead and downer cattle are already removed
prior to any mechanical separation of muscle tissue, thereby negating
the need of further compliance efforts. We invite public comment and
analysis of the proposed rule's expected impact on 4D animals and
current 4D industry practices related to MS beef.
d. CMPAF marking costs. The proposed rule would require that
renderers that handle CMPAF or products containing CMPAF mark this
material or product so that it can be identified by visual inspection.
The analysis determined that the use of dyes would most likely be used
as the marking agent. Although the industry lacks experience with the
use of these dyes, it is believed to be a relatively simple process
that would be performed at the end of the rendering process. Using a
range of current dye costs, ERG estimated total industry compliance
costs of this requirement to be from about $1,700 to $13,000 per year.
At the high end of the range of cattle not inspected and passed for
human consumption, compliance costs of this provision would range from
about $2,200 to $16,000 per year.
e. Labeling and recordkeeping/access costs. The proposed rule would
require additional measures be taken by renderers that handle CMPAF or
products containing CMPAF to ensure that the prohibited materials are
not used in animal feed. The proposed requirements include labeling the
material ``Do not feed to animals'', establishing and maintaining
records sufficient to track cattle materials prohibited in animal feed
to ensure such material is not introduced into animal feed, and making
such records available to FDA. The proposed rule would also require
renderers that handle any cattle materials to establish and maintain
records sufficient to ensure that materials rendered for use in animal
feed do not contain CMPAF. ERG judged that the proposed labeling and
recordkeeping requirements would result in modest additional costs to
all renderers. Although past FDA rulemakings have shown that labeling
requirements can impose a substantial cost on industry, the analysis
assumed that this rulemaking's simple new labeling requirements
(applying primarily to bulk shipments) could be incorporated into
current labeling practices. We solicit comment on this assumption.
Likewise, any recordkeeping rules would only require incremental
administrative activities (to modify procedures and periodically review
and file) beyond current renderer recordkeeping requirements. Total
industry costs are estimated at about $62,000 annually (one-time costs
of $101,000 annualized at 7 percent over 10 years plus annual costs of
$48,000). We anticipate that records access costs would be negligible.
We invite public comment on the projected level of effort by industry
and estimated compliance costs of the proposed labeling and
recordkeeping/access requirements.
3. Disposal Costs
After separation from the material allowed to be used in animal
feed, an estimated 64.3 million lbs. of CMPAF would no longer be
rendered for use in animal feeds, and therefore would need to go to
disposal. The analysis identified five options for the disposal of
these SRMs. These options include landfilling of the CMPAFs without
rendering, rendering for disposal, disposal through alkaline hydrolysis
digesters, incineration, and composting. Due to the relatively small
volume of CMPAFs, rendering for disposal option would likely not be
economically viable. Contacts with industry members elicited various
responses concerning the disposal method that would be employed under
the CMPAF scenario. While landfilling the CMPAF may be a possibility in
some areas, other states do not allow the disposal of animal carcasses
in landfills. Our analysis concluded that landfilling would likely be
one of several methods used to dispose of the CMPAFs.
Based on industry information gathered for both this analysis (the
CMPAF option) and the Alternatives Report, ERG estimated the disposal
costs at $12 per 100 lbs. (cwt) of CMPAF. This is substantially higher
than its estimate in the Alternatives Report of the cost of SRM
disposal. Higher per cwt transportation costs (which are included in
the $12 per cwt estimate) are expected under the CMPAF scenario than
under the SRM alternative due to the much smaller volume of materials
requiring disposal under the CMPAF option. Other reasons for the higher
disposal cost rate include the uncertainty in the disposal methods that
will be used, and limited industry experience with at least some of
these methods. This led ERG to project a conservative estimate that
fully accounts for some uncertainty in cost factors. It is possible
that future industry efficiency in CMPAF disposal under any of the
disposal methods would lead to a reduction in projected $12 per cwt
disposal cost. Nevertheless, the 64.3 million lbs. of CMPAF that would
result under this proposed rule is estimated to result in $7.72 million
in disposal costs ($6.19 million to slaughterers and $1.53 million to
renderers). Using the 42 percent estimate of cattle not inspected and
passed for human consumption, we estimate that the 83.1 million lbs. of
CMPAF would result in disposal costs of about $9.97 million annually.
Cattle producers are also expected to incur additional disposal
costs for cattle not inspected and passed for human consumption in the
form of an increase in on-farm disposals. An increase in pick-up fees
for cattle not inspected and passed for human consumption due to the
slight loss in value of the rendered MBM would likely cause some of
these animals to be disposed of at a lower cost (than the pickup fee)
to the producer by burial on the farm. As previously discussed, our
analysis estimated that about 17 percent of all cattle not inspected
and passed for human consumption are currently rendered. Additionally,
it predicted that about 26,000 less cattle (0.6 percent of all cattle
not inspected and passed for human consumption, or about 3.5 percent of
all cattle not inspected and
[[Page 58591]]
passed for human consumption that are rendered) would be disposed of in
this manner, comprised of beef cows (no additional feedlot cattle
included) and cattle under 500 lbs (calves). ERG estimates of the
incremental labor and equipment cost of this activity sum to $1.02
million annually. Using the 42 percent estimate of cattle not inspected
and passed for human consumption and the same 3.5 percent relative
change in the reduction in renderer pick-ups of cattle not inspected
and passed for human consumption, we project that at the high end of
the range about 64,000 additional cattle would no longer be rendered,
at a disposal cost of about $2.53 million.
In forecasting the change in percentages to be disposed on-site,
the analysis considered in qualitative terms all factors in the formula
renderers use to determine whether they will make pickups. These
factors include the travel distance to the location and the expected
quantities of animals to be recovered at the location. All pickup
charges vary over time with the value of meat and bone meal and tallow,
so pickup patterns are subject to market-driven price changes that are
addressed in the agreements between renderers and dead animal
suppliers.
The analysis also considered that exclusions of prohibited
materials reduced the prospective value of the animals to be recovered.
Further, the potential latitude for renderers to increase fees was
considered, although renderers were fairly tentative in their own
forecasts of whether and how much they might increase pickup charges in
response to a potential new regulation.
ERG also considered that many relatively remote locations had
already been excluded from renderer pickups due to price and regulatory
changes over the past ten years. Thus, remaining pickup locations were
likely to have reasonably favorable characteristics, although
presumably some locations remained marginal in terms of the existing
market economics. The data in Table 2-1 of the ERG report (market
prices of rendered materials, and MBM and tallow yields) and data on
animal weights was used to consider the value of the dead animal to the
renderer.
The final forecast of the response in pickups is the judgment of
the apparent significance of the regulatory change to the economics of
the renderer pickups. Because the brain and spinal cord exclusion
affected a relatively small portion of the animal carcass for
nondecomposed animals, it followed that the effect on rendering
economics was similarly fairly modest. The analysis concluded that the
prohibition of these materials would not trigger wider, rippling
effects through the renderers' situation.
While there was considerable data about market prices for rendered
products and other aspects of pickup economics, data on the
distribution of relative costs among dead animal suppliers across the
United States was lacking. Such data would have been needed to make a
more rigorous forecast of the likely changes in rendering pickup
patterns. Given the dominating importance of local economic
considerations in rendering economics, even a national distribution of
such data would have been of uncertain value to the estimation process.
The industry association report (Ref. 32) (submitted in response to
the 2004 ANPRM seeking comment on a more restrictive full SRM ban in
animal feed) asserts that there would be no incentive to pick-up cattle
not inspected and passed for human consumption if it is banned from
animal feed absent exorbitant fees. While this proposed rule would not
ban all tissues from cattle not inspected and passed for human
consumption, we acknowledge some uncertainty in the response by
renderers in this area due to this proposed rule. We request comment on
the number and percent of cattle not inspected and passed for human
consumption that are currently rendered, as well as the expected number
of additional cattle that would be disposed of on farms or elsewhere
due to this proposed rule, and the costs of this activity.
4. Feed Substitution Costs
In both FDA's proposed and final rules concerning the prohibition
on the use of mammalian proteins in ruminant feeds in 1997, the agency
included the cost of feed that would be substituted for the MBM that
would be prohibited from use in ruminants. The same issue arises with
the proposed rule's creation of a list of CMPAFs that would be
prohibited from use in animal feeds. Animal feed manufacturers would
substitute other protein sources for the MBM that was previously
manufactured from CMPAF.
In the analysis prepared for the 1997 rule banning the use of
mammalian protein in ruminant feeds, the agency assumed a $31.76 per
ton price increase ($38.33 adjusted to expected 2005 dollars by the
average of general inflation from 1997 through 2004) for the substitute
material, in this case soybean meal, as well as additional minerals
that would be required to provide the same nutritional level as MBM. We
accept this as a conservative estimate of the long-term price
differential. The price differential between the two varies constantly
based on the weather, feed ingredient imports, slaughter rates, and
other factors. Since January 2004, soybean meal has been priced from
$58/ton below MBM to $55/ton above MBM (Ref. 33).
We cannot predict the future price differentials between the two
feed substitutes, but accept the previous number of $38.33/ton as a
reasonable current estimate. Applying this feed cost increase over the
7,800 tons of MBM that would not be created as a result of this
proposed regulation as calculated by ERG, results in $299,000 in
additional feed costs. Using the high end estimate of the number of
cattle not inspected and passed for human consumption that are
currently rendered, additional feed costs would amount to about
$457,000. We invite comment and data on the feed substitution costs
that this proposed rule would impose.
5. Distribution of Impacts of CMPAF From Cattle 30 Months of Age or
Older Slaughtered for Human Consumption and Cattle Not Inspected and
Passed for Human Consumption
ERG, primarily for the purposes of the Regulatory Flexibility
Analysis described in more detail below, estimated that a portion of
the costs to slaughterers will be passed through to consumers and
animal producers. Similarly, a portion of the costs to independent
renderers for handling CMPAF from cattle not inspected and passed for
human consumption will likely be passed back to ranchers, dairy
farmers, and feedlot operators by way of increased pickup or disposal
fees. We request public comment and data on the relative size and
distribution of the likely pass through of the impacts of this
rulemaking.
ERG also addressed the relative importance of the loss of MBM due
to the CMPAF prohibition to both integrated packer/renderers and
independent renderers. This analysis projected reductions of up to 0.2
percent of MBM production at independent renderers, while reductions of
less than 0.1 percent of MBM production would occur at integrated
slaughterers (packer/renderers)as the low impact estimates. Using the
high estimate of cattle not inspected and passed for consumption that
are currently rendered, we project a reduction of up to 0.4 percent of
MBM production at independent renderers. Independent renderers rely to
a greater extent on deadstock and, with the January 2004 USDA rule
banning the use of nonambulatory disabled cattle in
[[Page 58592]]
human food, also on nonambulatory disabled cattle as inputs to their
production process, while the integrated slaughterers do not.
E. Government Costs
The proposed rule may require the expenditure of additional funds
by the Federal government, but the increased expenditures are not
expected to be significant. The tissues that would be included on the
list of cattle materials prohibited in animal feed, due to this
proposed rule, may increase the number of inspections or the length of
time necessary to inspect an establishment to verify compliance with
the new proposed requirements. However, the number of establishments
inspected is not expected to substantially change as a result of this
proposed rule. All establishments that would be inspected for
compliance under proposed Sec. 589.2001 would already be subject to
Sec. 589.2000 or other federal rules. FDA has not estimated any
additional costs due to this based on the assumption that the
additional resources would not be significant. We invite comment on the
issue concerning additional government resources that would be required
by this proposed rule. ERG's discussions with industry members led to
the conclusion that no new rendering establishments will be constructed
and dedicated to disposal rendering as a result of the CMPAF ban.
Without additional renderer establishments subject to this or other FDA
regulations, FDA inspection efforts are not expected to noticeably
increase as a result of this proposed rule.
F. Sensitivity Analysis
Due to the previously described uncertainty concerning the
additional cattle not inspected and passed for human inspection that
would no longer be rendered as a result of this proposed rule, we have
included a sensitivity analysis around this cost factor. The ERG report
projected that an additional 0.6 percent of the current 17 percent of
cattle not inspected and passed for human consumption that are
currently rendered would not be rendered as a result of this rule and
would likely be buried on the farm or elsewhere (a relative reduction
of 3.5 percent (0.006/0.17) of the cattle not inspected and passed for
human consumption that are currently rendered). Table 3 estimates the
total costs of the proposed rule for various estimates including the
original 0.6 percent reduction in the number of cattle not inspected
and passed for human consumption that are rendered, as well as
reductions of 1 percent and 2 percent (representing relative reductions
of 5.8 percent (.01/.17) and 11.6 percent (.02/.17), respectively).
High end cost estimates (derived from the 42 percent estimate of the
number of cattle not inspected and passed for human consumption that
are currently rendered) for the same relative percent reductions are
also included.
If 42 percent of cattle not inspected and passed for human
consumption are currently rendered, and that implementation of this
proposal would cause an additional 2 percent of all cattle not
inspected and passed for human consumption not to be rendered, then the
total incremental costs of the rule would rise to about $36 million per
year. FDA solicits comment on the likely effect of this proposal on the
percent of cattle not inspected and passed for human consumption that
is not rendered and on the costs to society of the disposal methods
likely to be used as an alternative to rendering.
Table 3. Sensitivity Analysis
------------------------------------------------------------------------
Reduction in Percent of Cattle Not Inspected and Passed for Human
Consumption That are Rendered (Proposed Rule)
-------------------------------------------------------------------------
0.6% 1.0% 2.0%
------------------------------------------------------------------------
Total Costs $14.4--$23.7 $16.2--27.8 $19.8--$36.3
million million million
------------------------------------------------------------------------
G. Regulatory Flexibility Analysis
1. Small Business Impacts
The Regulatory Flexibility Act requires agencies to prepare a
regulatory flexibility analysis if a rule is expected to have a
significant impact on a substantial number of small entities. The
discussion in this section, as well as data and analysis contained in
sections two through four of the ERG report, constitute the agency's
compliance with this requirement.
One requirement of the Regulatory Flexibility Act is a succinct
statement of any objectives of the rule. As stated previously in this
analysis, with this proposed rule the agency intends to strengthen the
existing safeguards designed to help prevent the spread of BSE in U.S.
cattle, as well as further reduce any risk posed to humans from the
agent that causes BSE.
The Regulatory Flexibility Act also requires a description of the
small entities that would be affected by the proposed rule, and an
estimate of the number of small entities to which the proposed rule
would apply. Our analysis focused on renderers and animal slaughterers,
and to a lesser extent on 4D firms. Additionally, the Alternatives
report addresses possible impacts to small dairy farms from the blood
products alternative, and impacts to feed mills from the dedicated
equipment/facilities alternative (options summarized in the
alternatives section of this document).
Animal slaughterers would be classified in the North American
Industrial Classification System (NAICS) under code 311611--Animal
(Except Poultry) Slaughtering and renderers under NAICS code 311613--
Rendering and Meat Byproduct Processing. The Small Business
Administration (SBA) classifies slaughterers and renderers with less
than 500 employees as small businesses.
The ERG study estimated the number of small businesses that would
be affected by the proposed rule in its analysis of compliance costs.
The number of slaughterers and renderers affected by the CMPAF ban
(including recordkeeping/labeling and marking costs) were estimated at
689 and 141, respectively. This would include all federally inspected
slaughter plants and the all those renderers that handle mammalian
proteins that are currently prohibited in ruminant feed. Using U.S.
Census and USDA data, ERG then distributed the number of affected
entities in each business sector across the size classes of
establishments using the same proportions as those presented in the
total number of establishments. Using this distribution, it appears
that about 97 percent of slaughterer establishments and all renderer
establishments would be considered small businesses. However, the
existence of many multi-establishment rendering and slaughtering firms
would tend to overestimate the number of small businesses within each
sector. In fact, other Census data shows that only 79 percent of
rendering firms would be considered small businesses (Ref. 34).
Nevertheless, we believe that the number of affected small businesses
in
[[Page 58593]]
both sectors would still be considered substantial.
The CMPAF ban would primarily affect slaughterers and renderers.
ERG used its Small Business Impact Model (SBIM) to predict net income
and closure impacts for slaughterers and renderers by size of
establishment (for a full explanation of the SBIM, see section 4.2 of
the Alternatives report (included in the docket (Ref. 31)). The model
assumes there is no pass through of compliance costs. Although this is
a conservative assumption, smaller businesses in fact are probably less
able to pass through compliance costs than larger businesses in the
same industry, all other things equal. Under the no pass through
assumption, the model predicts moderate net income impacts that could
result in the closure of up to one slaughtering and one rendering
establishment. We acknowledge that net income impacts would likely be
higher under the higher estimate of the percent of cattle not inspected
and passed for human consumption that are currently rendered.
Our analysis for simplicity ignores any potential increases in MBM
prices that may ensue as a result of this proposed rule. In fact, some
modest price increases may occur as foreign demand for MBM increases in
response to reduced risk of BSE infectivity. Such price increases may
mitigate any reduction in net income of independent renderers.
ERG developed a separate market model to estimate the impact of a
CMPAF ban on beef prices and output. It implies that about 50 percent
of compliance costs will be passed on to consumers, 38 percent will be
passed back to cattle producers, and 12 percent will be incurred by
slaughterers. The model predicts that cattle producers would realize
only a 0.01 percent reduction in price for cattle, which would not be
considered a significant impact. Nevertheless, the agency acknowledges
the possibility of significant impacts on a substantial number of small
slaughterers and renderers.
The agency believes that the annual feed substitution costs (from
about $300,000 to $457,000) would not constitute a significant impact
when spread across the thousands of non-ruminant animal producers that
currently use ruminant protein in animal feeds. The agency requests
comments and additional data on the likely small business impacts on
slaughterers, renderers, beef cattle producers, dairy cattle producers,
or other animal producers and firms in related industries.
2. Analysis of Alternatives
We considered five other measures that are not included in this
proposed rule. These five measures, discussed in turn in the following
paragraphs, include: (1) A requirement that those facilities handling
both mammalian protein that is currently prohibited in ruminant feed
and ruminant feeds use dedicated facilities or equipment for each, (2)
a ban on the use of poultry litter in ruminant feeds, (3) a ban on the
use of blood and blood products in ruminant feeds, (4) a ban on the use
of plate waste in ruminant feeds, and (5) a ban on the use of a larger
list of SRM (using the USDA and FDA definition for human food) from all
animal feeds.
a. Dedicated facilities/equipment requirement. As mentioned
previously in this preamble, FDA considered requiring that those
facilities that process or otherwise handle both mammalian protein
currently prohibited in ruminant feed and prepare feed or feed
ingredients for ruminants use separate facilities or equipment in order
to prevent cross-contamination. This option was included in the public
announcement concerning agency intentions in January 2004. The proposed
rule's dedicated equipment requirement concerns the issue of cross-
contamination of CMPAFs with other cattle material once it has been
separated, whereas the requirement for dedicated equipment/facilities
under this option concerns cross-contamination of mammalian protein
currently prohibited in ruminant feeds and ruminant feeds under the
current mammalian to ruminant feed ban. Due to the large tonnage
difference between CMPAFs and all animal protein currently being
rendered, this alternative would result in larger industry impacts than
would the dedicated equipment requirement concerning CMPAFs alone.
In its Alternatives Report, ERG projects that this option would be
expected to reinforce the current trend in which increasing numbers of
feed mills discontinue the use of mammalian protein currently
prohibited in ruminant feeds in favor of porcine, avian, or plant-based
proteins. ERG estimates that only 124 out of more than 5,100 feed mills
and 41 out of 235 renderers currently produce ruminant feed or feed
ingredients and handle or process ruminant MBM. Based on its small
survey of feed mills, ERG estimates that only 27 of these feed mills
and 4 renderers would invest in dedicated facilities or equipment in
order to continue or begin to distribute both prohibited materials and
ruminant feeds or feed ingredients.
ERG consulted an agricultural architecture and engineering firm to
prepare cost estimates of investment in dedicated feed mill facilities.
Based on these estimates and discussions with feed mill operators, ERG
projects that no new mills would be constructed as dedicated facilities
to comply with this option, but rather currently operating or idle
mills would either be renovated or expanded as dedicated facilities, or
would handle a dedicated line of equipment. The annualized costs of
these investments for the 27 feed mills were estimated at $6.2 million
over 10 years at a 7-percent discount rate (at a 3-percent discount
rate over 10 years, the cost would be $5.1 million per year). The
effect on the ruminant MBM market caused by the discontinued use by
those that currently offer it in feeds but would choose not to invest
in dedicated facilities or equipment would be expected to be small.
ERG performed a similar survey of some of the 41 renderers that the
FDA inspection database showed as handling mammalian proteins currently
prohibited in ruminant feed and produce materials intended for use in
ruminant feed. The results of this survey indicate that very few
renderers intend to invest in dedicated facilities. Based on its small
sample, ERG predicts that only 4 renderers would do so. These were all
expected to currently have partial separation or dedication
capabilities in place. Based on discussions with renderer operators
through this and previous surveys, ERG predicts that the renderers that
invest in dedicated facilities would spend, on average, about $2
million each. The total cost of investment in dedicated facilities
would be $8 million. Annualizing this total over 10 years at a 7-
percent discount rate results in an annual cost of $1.14 million
($940,000 over 10 years at a 3-percent discount rate).
The dedicated facilities/equipment requirement would also extend to
the transportation services for mammalian proteins currently prohibited
in ruminant feed. Based on another survey of selected feed mills,
agricultural trucking companies and renderers concerning their current
transportation of products, ERG determined that agricultural
transporters would also incur costs as a result of this provision of
this option. The option implies that renderer delivery trucks that
carry prohibited MBM, including contract haulers providing this
service, would no longer be allowed to backhaul ruminant feed or
ruminant feed ingredients as part of its delivery routine. Due to this
[[Page 58594]]
change in service, ERG estimated a transportation cost increase of 40
to 80 percent for the 141 rendering facilities that process mammalian
protein currently prohibited in ruminant feed. Although most of these
renderers do not handle both mammalian protein currently prohibited in
ruminant feed and ingredients for feeds for ruminants, they rely on
transportation services (most likely contractor services) that
transport both materials, and thus would not be in compliance. These
transportation cost increases are projected to total $8 to $16 million
per year for the rendering industry.
Feed mills would also be expected to incur transportation cost
increases due to the prohibition under this option on backhauling
ruminant feeds in trucks that are used to deliver feeds with mammalian
proteins currently prohibited in ruminant feed. Since backhauling does
not occur as often in the delivery of feed due to shorter average
distances between feed mills and animal producers than from renderers
to feed mills, ERG predicted the transportation cost increases at 25 to
50 percent for feed mills. Based on ERG's calculation of the quantity
of feed that would be affected by the proposed rule (4.5 million tons)
and the average transportation cost per ton of feed ($12.66), total
transportation cost increases for feed mills were estimated to range
from $14.2 to $28.4 million per year. These costs would include the
amortized cost of capital equipment such as additional trucks, as well
as incremental operating and maintenance costs. These costs would be
incurred by about 200 feed mills. Again, this number is larger than the
number of mills that handle both mammalian proteins currently
prohibited in ruminant feed and ruminant feeds due to the additional
number of mills that would rely on contract feed haulers that handle
both materials. ERG acknowledges uncertainty in these estimates due to
possible changes in mill dedication patterns, the analysis of which
would have required additional geographic distribution data on feed
mills and feed types.
If CMPAFs are banned from use in all animal feeds as proposed in
this rule, the agency believes that a provision requiring dedicated
facilities or equipment for those handling mammalian proteins currently
prohibited in ruminant feed and preparing ruminant feeds would not be
necessary because this proposed rule is expected to reduce the number
of ID50s available for use in animal feeds by about 90
percent. Requiring separate facilities or equipment for mammalian
proteins currently prohibited in ruminant feed and ruminant feeds would
not be expected to significantly reduce the risk of feeding prohibited
proteins to ruminants, because nearly all of the potentially BSE
infective tissues would be unavailable for use in feeds for any animals
because of the CMPAF prohibition. Therefore, the risk is minimal that
the BSE agent would be present even if cross-contamination occurs
between mammalian protein intended for non-ruminant feed and ruminant
feeds. The agency requests comment and data on the need for a
requirement for dedicated facilities/equipment for those facilities
that handle both mammalian proteins currently prohibited in ruminant
feed and ruminant feed when a CMPAF ban also exists.
b. Poultry litter prohibition. The agency also considered a ban on
poultry litter in ruminant feed. Poultry litter contains bedding
material, spilled poultry feed, and manure, and is a waste by-product
of poultry production. Because poultry feed may contain mammalian meat
and bone meal currently prohibited in ruminant feed, there is a risk
that cattle fed poultry litter containing spilled poultry feed may be
exposed to prohibited meat and bone meal through that spilled poultry
feed.
This alternative would ban the use of poultry litter in all
ruminant feed. Its costs would be comprised of both substitution costs
for the replacement materials needed to provide an equivalent
nutritional value, and disposal costs if the poultry litter cannot be
used as an alternative product, such as fertilizer. The risk reduction
would be the elimination of the possibility of the spread of BSE
through the recycling of mammalian proteins currently prohibited in
ruminant feed back into cattle feed through poultry litter including
the spilled poultry feed containing prohibited mammalian proteins.
A preliminary risk assessment of poultry litter submitted to the
agency by an industry member predicted that in its worst-case scenario,
under the current ruminant feed ban rule, a cow would need to eat 70.1
tons of litter to be exposed to 1 ID50 (Ref. 35). FDA
modified some of the assumptions used in this risk assessment and
predicted what would happen if there was no mixing during the cleanout
process so that the spilled feed remained concentrated in a small
portion of the bedding. Under this scenario, a ruminant fed only
contaminated litter from under the poultry feeders must consume 3.4
tons to consume 1 ID50. This tonnage is still beyond the
volume a stocker steer would realistically consume under normal
circumstances due to its relatively short life. Similarly, dairy cows
would also not be expected to consume this amount since poultry litter
is not generally used in feed for lactating dairy cows. Because it
appears to pose only a small baseline risk of BSE for ruminants, FDA
currently believes that banning poultry litter from ruminant rations
would have little or no affect on the human risk while increasing the
environmental risks of its alternative disposal methods. FDA requests
comments on this issue.
Most poultry litter is not used as cattle feed. As an organic
source of nutrients for plants, it has been applied to farmland for
years. This practice, however, raised environmental concerns that
excess nitrogen and phosphorus could leach from the litter and
contaminate waterways. Since rumen microbes can efficiently metabolize
poultry litter, feeding litter to cattle provides an alternative use to
land application that benefits both poultry growers and cattle
producers. Where poultry and cattle operations overlap, poultry growers
are willing to sell litter at a price that exceeds the value of any
alternative use. Cattle producers obtain a feed ingredient for a lower
price than the next best alternative ingredient in the ruminant ration.
Banning the use of litter in ruminant feed will likely increase the
price of rations for ruminant producers and decrease revenues for
poultry producers. Moreover, if poultry producers must dispose of
unwanted litter, their operating costs would increase.
To analyze the impact of the ban on poultry litter on ruminant
producers, we calculated the per ton price of equivalent cattle rations
with and without poultry litter. Based on feed ingredient prices in
March 2004 and using equivalent cattle ration formulations recommended
by University of Georgia, rations with 38 percent to 53 percent poultry
litter average about $65 per ton (Ref. 36). Equivalent rations without
poultry litter average about $80 per ton, or about $15 per ton more
than the ration with poultry litter. The average cattle fed about 16.5
pounds of feed daily for 200 days consumes a total of 0.6 tons to 0.9
tons of litter, depending on the percentage of litter in the ration.
This suggests that the cost of feed will increase by about $25 per head
($15 per ton x 200 days per head x 16.5 pounds per day/2,000 pounds per
ton). The annual supply of poultry litter can potentially feed between
1.3 million (1.1 million tons of litter / 0.9 tons of litter
[[Page 58595]]
per cow) and 3.2 million cows (2 million tons of litter / 0.6 tons of
litter per cow). Thus the total cost of feed could increase from $32
million ($24.75 per cow x 1.3 million cows) to $80 million ($24.75 per
cow x 3.2 million cows).
Vertical integration in the poultry industry often results in
contract growers' contractual responsibility for litter management. For
many reasons, including regional distribution of poultry producers and
costly transportation, commodity markets do not handle poultry litter.
Some poultry producing states have taken the initiative to promote and
develop an infrastructure for litter markets, including programs to
match the producers and users of poultry litter; providing
transportation subsidies, or encouraging informal ``markets'' where
buyers and sellers can contact each other.
Alternative uses for poultry litter are being developed, but are
not widely available currently. With technology developed in the United
Kingdom, the nation's first poultry litter fired power plant is being
constructed in Missouri. Research is underway to convert litter into
activated carbons that can absorb environmental pollution.
In areas where cattle and poultry production overlap, banning
poultry litter from ruminant feed may require that growers store
litter, probably in deep stacking sheds, until alternative uses can be
identified. If it is not possible to store litter, however, growers may
need to dispose of surplus litter in landfills. To illustrate the cost
of a worst-case scenario, disposal of the entire 1.1 million to 2
million tons of litter would range from $44 million to $160 million
with disposal fees that range from $40 to $80 per ton.
Without alternative outlets for litter banned from ruminant feed,
the total short-run costs might range from $76 million to $240 million.
Contract growers and ruminant producers, many of whom are small
entities, would incur these costs. Although the poultry litter
alternative has not been included in the proposed rule, the agency
requests comment on the need for a poultry litter ban in ruminant feed
when a CMPAF ban in all animal feed also exists.
c. Blood and blood products prohibition. We also considered an
alternative that would have prohibited the use of blood and blood
products in ruminant feed. We did not include this option in this
proposed rule because we could not at this time show any BSE risk
reduction as a result of such a prohibition, and these products have
beneficial effects in ruminant feed. This option, if adopted, would
result in one-time direct costs of about $7 million (annualized at
$990,000 over 10 years at 7 percent) for relabeling, reformulation and
reregistration, as well as additional revenue losses for the product
manufacturers.
ERG identified and profiled the various blood and blood products
used in animal nutrition. These products include plasma-based
therapeutics and feed additives, premium blood-based feed additives and
commodity blood meal. The prohibition of blood and blood products would
result in some additional administrative costs to feed mills. It would
require some mills to reformulate the rations in feeds. Relabeling
efforts would also be required for some feeds, depending on whether the
current label identifies specific animal proteins or identifies
proteins under the broader term ``animal protein products.''
Additionally, some of these feeds would need to be reregistered with
state agencies due to their new labeling, resulting in additional
administrative cost to the mills.
ERG prepared cost estimates for each of these activities based on
FDA database information on feed ban inspections, data from industry-
sponsored reports, an industry journal, and Bureau of Labor Statistics
data. ERG estimated that about 2,300 feed mills offer some type of
blood-meal containing feeds, and that these mills have, on average,
about 44 feed mixes that would require reformulation due to their
containing blood meal or another ruminant protein that would no longer
be offered due to a dedicated facilities/equipment requirement. ERG
prepared this estimate assuming that both a blood product prohibition
and a dedicated facility/equipment requirement would be proposed.
Therefore, to the extent that the estimated 44 feed mixes represent not
those containing blood products but rather another ruminant protein
that would no longer be available if a dedicated facilities/equipment
requirement had been created, these costs will be overestimated. Based
on the various labor rates for mill employees, ERG estimated that
reformulation efforts would result in a one-time total cost of $2.85
million. Relabeling costs, including both printing plate preparation
and additional labor hours, are estimated to result in a one-time cost
of $2.77 million. Reregistration costs are projected to add another
one-time cost of $1.34 million. In total, these efforts would result in
a one-time cost of $6.96 million (average one-time costs per affected
mill would be about $3,000). Annualized over 10 years at a 7-percent
discount rate, this equates to $990,000 per year (see table 4 of this
document).
Table 4.--Administrative Costs
----------------------------------------------------------------------------------------------------------------
Cost Element One-Time Costs (Thousands) Annualized Costs\1\ (Thousands)
----------------------------------------------------------------------------------------------------------------
Reformulation $2,853 $406
----------------------------------------------------------------------------------------------------------------
Relabeling $2,771 $395
----------------------------------------------------------------------------------------------------------------
Reregistration $1,340 $190
----------------------------------------------------------------------------------------------------------------
Total Costs $6,963 $990
----------------------------------------------------------------------------------------------------------------
\1\Over 10 years at a 7 percent discount rate.
Along with the compliance costs mentioned previously, this option
would also result in the loss in value of the blood products
themselves. ERG's discussions with producers of plasma-based products
for therapeutic use led to the following conclusion. Most of these
products would not find an acceptable alternative market, or would do
so only at a steep price discount, due to their reduced efficacy when
used in animals other than cattle. Although ERG projected future market
volumes based on industry contacts, current sales of these products are
unavailable. Plasma-based feed additives and premium blood-based feed
additives are not as species-specific and could be shifted to use in
non-ruminant markets assuming a smaller decrease in price than would
likely occur with the therapeutic
[[Page 58596]]
products. These products, which could be shifted to use in non-ruminant
markets, may also incur higher transportation costs because fewer mills
would be expected to accept any mammalian proteins currently prohibited
in ruminant feed, that is if the dedicated facilities/equipment was
also required. Commodity ruminant blood meal, valued at about $41
million in 2003, would also be expected to lose value due to this
option. Porcine based blood meal would be expected to increase in
value. These losses have not been projected.
At this time, the agency does not have evidence that BSE is
transmitted to cattle via blood or blood products. Therefore, the
agency has not proposed that these products be banned from use in
ruminant feeds in this proposal. The agency requests further comment
and scientific information on the need to prohibit the use of blood and
blood products in ruminant feed.
d. Plate waste prohibition. This alternative would have eliminated
the current exemption of inspected meat products which have been cooked
and offered for human food, and further heat processed for feed
(commonly referred to as plate waste but also including used cellulosic
food casings) from the current definition of protein derived from
mammalian tissues. It would ban plate waste from use in ruminant feed.
As previously mentioned in the preamble to this proposed rule, the
agency requested comment on questions related to the use of plate waste
in ruminant feeds in the 2002 ANPRM. These questions focused on the
extent of plate waste use in ruminant feeds, the composition of plate
waste and its sources, plate waste processing techniques prior to its
inclusion in feed, and the adverse and positive impacts for excluding
plate waste from feed. Although the agency received many comments to
the 2002 ANPRM, they did not include estimates of usage or regulatory
impacts that were specific enough to form a foundation for a cost
analysis of this option. One comment stated that the amount of plate
waste used in ruminant feed was low. Another comment mentioned that
substantial tonnages were used in ruminant feed in at least one state.
A third comment stated that plate wastes from correctional facilities
in another state were used in ruminant feed. No additional data was
included to support these statements about the extent of plate waste
use in ruminant feed. One comment stated that there were six processors
of plate waste in the United States, but did not list these processors
or offer any estimate of the use or value of processed plate waste in
ruminant feed.
We tried to collect more information on the use of plate waste in
ruminant feed and any expected impacts from its ban in ruminant feed,
by contacting all those who commented to the ANPRM about plate wastes.
The comment that mentioned the use of plate waste from correctional
facilities offered additional anecdotal data about this practice in one
state, stating this practice was common in areas that had cattle or hog
farms located near correctional facilities. It is likely, though, that
because most or all of this plate waste is not currently further heat
processed for feed, it would not be exempt from the current feed ban as
defined in the 1997 ruminant feed final rule. No additional data on
actual volumes of plate waste was offered. Another state agriculture
agency that responded to the ANPRM, when contacted for further
information, also stated that very little, if any, plate waste was
further heat processed and used in ruminant feeds. Further, earlier
estimates of significant tonnages of plate waste being used in feeds
could not be verified by this agency through its investigators in the
field. The other comments did not respond to our attempts at further
contact.
We also requested the assistance of agency personnel with knowledge
of the ruminant feed industry in estimating the extent of use of plate
waste in ruminant feeds. Although these agency sources acknowledge that
the practice exists, we do not have any estimate of its prevalence on a
national level. According to these agency sources, since plate waste
(including used cellulosic food casings) is expected to have a
relatively low nutritional value when used as a supplement in ruminant
feeds, it would not be used in ruminant feed as a general rule. While
the agency acknowledges that some plate waste is currently used in
ruminant feeds, it cannot offer an estimate of this plate waste volume.
The agency acknowledges there would be incremental disposal costs and
alternative feed costs, due to a ban on the use of plate wastes in
ruminant feeds. However, the agency cannot reliably estimate these
costs at this time.
The agency has concluded that this additional measure would be
unnecessary given that measures already implemented by USDA and FDA to
prohibit SRMs from human food effectively eliminate BSE infectivity
from plate wastes. The agency requests further public comment on the
extent of plate waste use in ruminant feeds and the costs such a
prohibition would impose on any industry members.
e. SRM prohibition. A final alternative would prohibit the use of a
more extensive list of cattle materials in any animal feed. These
materials would include the following: (1) SRMs, (2) The small
intestine of all cattle, (3) material from cattle not inspected and
passed for human consumption (including nonambulatory disabled cattle),
(4) tallow containing more than 0.15 percent insoluble impurities if
derived from prohibited material, and (5) MS beef. SRMs would be
defined as the skull, brain, eyes, spinal cord, trigeminal ganglia,
vertebral column, (excluding the vertebrae of the tail, the transverse
processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum) and dorsal root ganglia of all cattle 30 months of age or
older, plus the tonsils and distal ileum of all cattle regardless of
age.
FDA stated in July 2004 that it was considering this alternative,
and ERG completed a cost analysis of this option. It is available at
the Division of Dockets Management (see ADDRESSES).
This alternative would require slaughterers to separate SRMs from
slaughter cattle, and require renderers and firms that process dead,
down, disabled, and diseased cattle (cattle not inspected and passed
for human consumption) to separate all material from such animals from
the remaining cattle offal produced for eventual use as animal feed. We
estimate that the separation of these SRMs and material from cattle not
inspected and passed for human consumption would require about $26.5
million in one-time capital costs (or $3.8 million annualized at 7
percent and $3.1 million annualized at 3 percent, over 10 years). We
estimate that the annual cost of the additional labor to separate SRMs
from other cattle offal is estimated to cost about $9.2 million
annually. The analysis projected that SRMs, instead of being rendered
for animal feed, would most likely be rendered for disposal, based on
the large amount of banned material this option would generate. To the
extent that some states would allow landfilling (another relatively low
cost disposal option), this analysis may overestimate compliance costs.
Although compliance costs for these activities would be borne initially
by slaughterers, and are presented as such by ERG, a portion of the
costs are likely to be passed through to cattle producers and
consumers. Annual rendering costs, which would include the value of the
MBM net of the value of the recovered tallow, would range from $24
million to $88 million at the low estimate of the number of cattle not
inspected and passed for human consumption that are currently rendered
[[Page 58597]]
to $31 million to $117 million at the high estimate. Additional SRM
transportation costs would be incurred to move SRMs and cattle not
inspected and passed for human consumption from slaughterers to
disposal renderers, and to move nonSRM offal a further distance to
another renderer due to their current renderer becoming a for-disposal-
only renderer. We estimate these to range from $22 million to $39
million at the low estimate of cattle not inspected and passed for
human consumption that are rendered to $33 million--$58 million at the
high estimate annually. Additionally, the estimated cost to dispose of
the resulting MBM is estimated at $8 million--$16 million at the low
estimate and $12 million -$24 million annually at the high estimate.
Total annualized costs of the prohibition of SRM, cattle not inspected
and passed for human consumption (as shown in table 4 of this document)
are estimated to range from $76 million to $161 million at the low end
of the estimates of cattle not inspected and passed for human
consumption that are rendered. Using the high estimate, annualized
costs would range from $102 million to $225 million. FDA expects MBM
disposal costs to decrease in the future with the development of
alternative markets for MBM of SRM-origin, but can offer no projections
of these cost reductions.
These cost estimates assume the development of a rendering industry
dedicated entirely to disposal. This industry would earn no fees from
selling rendered material, but would instead charge slaughterers and
cattle owners for the disposal of prohibited materials. Information
submitted to the agency implies that some independent rendering
establishments would be used as rendering for disposal, contingent upon
a volume of SRM products that would make disposal rendering profitable.
It may be possible that some geographic areas would be underserved by
disposal renderers due to the lack of availability of SRMs and cattle
not inspected and passed for human consumption, necessary to provide
the service at a charge that is lower than the cattle producers'
indirect cost of on-farm disposal of cattle not inspected and passed
for human consumption. Neither FDA nor ERG has the geographic data on
renderer locations and offal suppliers, or the financial data on
individual renderers necessary to predict the number or geographic
location of rendering establishments that will undertake SRM rendering
for disposal. Further discussion of the implications for the
development of a disposal rendering industry is available in the
environmental assessment of this proposed rule. We request comments and
data concerning the development of a rendering industry dedicated to
rendering for disposal only of SRM and cattle not inspected and passed
for human consumption.
ERG determined that the prohibition on the use of tallow derived
from the list of cattle materials prohibited under this alternative
option that contains more than 0.15 percent hexane-insoluble impurities
would result in annualized costs estimated at $2. million. These costs
consist of capital and operating costs for polishing centrifuges that
would be needed by a small segment of independent renderers (further
analysis of this provision led ERG to reduce the estimated cost, as it
reported in its analysis of the proposed rule, to $1.78 million
annually). The loss in market value of both MS beef and muscle tissue
from cattle not inspected and passed for human consumption used in
animal feeds is projected at about $75 million. FDA acknowledges that
this last estimate is speculative because these sales cannot be
distinguished from other renderer sales in U.S. Census data. FDA
invites public comments and data on the impacts of the provisions that
would prohibit all tallow derived from the prohibited materials that
contains more than 0.15 percent insoluble impurities and all MS beef
from use in animal feeds. Total costs of this alternative are estimated
to range from $154.0 million to $242.6 million annually for the low
estimate of cattle not inspected and passed for human consumption.
Using the high estimate, total annualized costs are projected at $178
million to $302 million Table 5 of this document displays the costs
associated with this alternative.
Table 5.--Total Costs ($ Millions)\1\
------------------------------------------------------------------------
Annualized
Cost Item One-Time Cost Annual Costs Costs
------------------------------------------------------------------------
Capital Investments $27 N/A $4
------------------------------------------------------------------------
Labor ............... $9 $9
------------------------------------------------------------------------
Net Rendering ............... ($25-$88) to ($25-$88) to
Costs\2\ ($31-$117) ($31-$117)
------------------------------------------------------------------------
SRM Transportation ............... ($22-$39) to ($22-$39) to
($33-$58) ($33-$58)
------------------------------------------------------------------------
Disposal Costs ............... ($10-$18) to ($10-$18 to
($17-$29) ($17-$29)
------------------------------------------------------------------------
SRM Marking ............... ($0.02-$0.15) ($0.02-$0.15)
to ($0.03- to ($0.03-
$0.23) $0.23)
------------------------------------------------------------------------
Recordkeeping/ ............... $0.05 to $0.06 $0.05 to $0.06
Labeling
------------------------------------------------------------------------
Feed Substitution ............... $6-$7 $6-$7
------------------------------------------------------------------------
Subtotal--Codified ............... ($72-$161) to ($76-$165) to
SRM, Dead, Downer ($96-$220) ($100-$224)
Ban
------------------------------------------------------------------------
Tallow Restriction $11 $1 $2
------------------------------------------------------------------------
MS Beef Ban ............... $75 $75
------------------------------------------------------------------------
SRM Alternative Total ............... ............... ($153.0-$242)
Costs to ($178-$302)
------------------------------------------------------------------------
\1\ Low cost estimate ranges reflect lower estimate of cattle not
inspected and passed for human consumption. High cost estimate range
reflect high end of estimates of cattle not inspected and passed for
human inspection.
\2\ Has been reduced by the value of the tallow products recovered.
[[Page 58598]]
To assess the risk reduction from the SRM alternative in this
proposed rule, we use two distinct approaches. In the first approach,
we assume that the number of new BSE cases is proportional to the
amount of all infectious material included in feed. Given this
assumption, we can estimate the percentage reduction in risk as the
percentage reduction in infectious material.A report by the Scientific
Steering Committee of the European Union suggests that the tissues
designated as SRM (brain, spinal cord, trigeminal ganglia, dorsal root
ganglia, distal ileum, eyes) constitute at least 99.44 percent of the
total infective load (Ref. 29). These tissues (SRMs) from cattle 30
months of age and older, the tonsils and distal ileum of all cattle,
and all material from cattle not inspected and passed for human
consumption, would be prohibited from use in any animal feed under this
alternative. SRMs (except for tonsils and distal ileum which are
prohibited regardless of age of cattle), when taken from cattle less
than 30 months of age, would not be prohibited from use in all animal
feed because the probability is very low that tissues from cattle of
this age would contain BSE infectivity. FDA estimates, therefore, that
banning SRMs from use in any animal feed would effectively remove about
99 percent of any remaining infectivity from possible spread through
the feed system.
The second approach uses the Harvard-Tuskegee risk assessment
model, making adjustments to the infectivity pathways for cattle and
humans that would still be available even after the USDA interim final
rules concerning SRMs in human food and Advanced Meat Recovery (AMR)
systems became effective. FDA has updated the model to simulate the
introduction of five infected cattle into the United States. The model
was also updated to further reduction in the spread of BSE among cattle
and reduction in human exposure to cattle oral ID50s that
would result from a ban on SRMs in animal feeds. The USDA rule,
prohibiting the use of SRMs in human food as well as the FDA interim
final rule prohibiting the use of SRMs in human food and cosmetics, may
cause some offsetting increases in the amount of SRMs that enter non-
ruminant feeds; the proposed SRM ban would address this increase in
SRMs in animal feed. Under this second approach, we define risk
reduction as the reduction in human exposure that would result from the
ban on the use of SRM in any animal feed using the HCRA model. These
results show that prohibiting the use of SRMs in all animal feed would
effectively negate about 95 percent of the remaining risk of human
exposure to cattle oral ID50s. When considered as a
complementary measure to the USDA and FDA SRM bans for human food, the
estimate of overall human exposure reduction from those bans and the
SRM alternative is more than 99 percent.
The model does not take into account any additional risk reduction
from the restrictions on the use of tallow or MS beef in animal feeds.
While we believe these additional restrictions would likely further
reduce the risk to human health from BSE to a small degree, we cannot
quantify this risk reduction.
Compared to the proposed rule, this alternative would impose an
additional $171 million to $226 million in annual compliance costs. As
discussed earlier, we believe that this proposed rule provides the
appropriate level of protection against the spread of BSE in a cost-
effective manner.
V. Paperwork Reduction Act
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). A description of these provisions is given below with an
estimate of the annual recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Substances prohibited from use in animal food or feed.
Description: We are proposing to amend our regulations to prohibit
the use of certain cattle origin materials in the food or feed of all
animals. These materials include the following: (1) The brains and
spinal cords from cattle 30 months of age and older (2) the brains and
spinal cords from cattle of any age not inspected and passed for human
consumption, (3) the entire carcass of cattle not inspected and passed
for human consumption if the brains and spinal cords were not removed,
(4) MS beef that is derived from cattle from which prohibited materials
were not previously removed; and (5) tallow that is derived from cattle
materials prohibited in animal feed unless such tallow contains no more
than 0.15 percent insoluble impurities. These measures will further
strengthen existing safeguards designed to help prevent the spread of
BSE in U.S. cattle.
Description of Respondents: Rendering facilities, Medicated feed
manufacturers and distributors, livestock feeders.
Table 6.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Operation and
Recordkeepers Recordkeeper Records Recordkeeper Maintenance Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
589.2001(b)(2)(iv) and (b)(3)(i) 141 1 141 20 2,820 $47,940
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .............. .............. .............. .............. 2,820 ....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
The estimated recordkeeping burden is derived from agency resources
and discussions with affected industry. The recordkeeping requirement
in proposed Sec. 589.2001(b)(2)(iv) will apply to the limited number
of renderers who will handle prohibited bovine material. We estimate
that no more than 50 rendering firms will be involved in the handling
[[Page 58599]]
of this material. Although we may consider the distribution records
needed to comply with this proposed regulation ``usual and customary''
and thus not subject to PRA, we believe there will be burden associated
with setting up a system to assure such records are sufficient to
address the proposed recordkeeping requirement. Likewise, although we
may consider the records necessary to comply with proposed Sec.
589.2001(b)(3)(i) as ``usual and customary'' and not subject to PRA
burden accounting, we are including a burden estimate to cover
establishment of a system to assure existing receipt and manufacturing
records adequately address this proposed requirement.
In compliance with the PRA (44 U.S.C. 3507(d)), the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons are requested to submit written
comments on the information collection provisions to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB).
OMB is still experiencing significant delays in the regular mail,
including first class and express mail, and messenger deliveries are
not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
VI. Environmental Impact
The agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.
VII. Federalism
We have analyzed this proposed rule in accordance with the
principles in Executive Order 13132. We have determined that the
proposed rule does not contain policies that have substantial direct
effects on the states, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have tentatively concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.
VIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.
1. Kimberlin, R.H. and J.W. Wilesmith, ``Bovine Spongiform
Encephalopathy: Epidemiology, Low Dose Exposure, and Risks,'' Annals
of the New York Academy of Sciences, 724: 210-220, 1994.
2. Collee, J.G. and R. Bradley, ``BSE: A Decade on-Part I,''
Lancet, 349: 636-41, 1997.
3. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United
States,'' Harvard Center for Risk Analysis Internet Page (http://www.hcra.harvard.edu/pdf/madcow_report.pdf), 2001.
4. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United
States,'' Harvard Center for Risk Analysis Internet Page (http://www.hcra.harvard.edu/pdf/madcow.pdf), 2003.
5. Harvard Center for Risk Analysis, Harvard School of Public
Health, ``Evaluation of the Potential Spread of BSE in Cattle and
Possible Human Exposure Following Introduction of Infectivity into
the United States from Canada,'' accessed online at Harvard Center
for Risk Analysis Internet Page http://www.hcra.harvard.edu/pdf/canadian/Text_2003_09_05_-_with_refs.pdf, 2003.
6. U.S. Department of Agriculture, Animal and Plant Health
Inspection Service (USDA/APHIS), report of the epidemiological
investigation, ``A Case of Bovine Spongiform Encephalopathy (BSE) in
the United States,'' March 2004, USDA/APHIS Internet Page (http://www.aphis.usda.gov/lpa/issues/bse/BSE_tr_ban%20_ltr_enc_1.pdf).
7. Canadian Food Inspection Agency; BSE in North America; Latest
Information, (http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/situatione.shtml).
8. The transcripts of the October 30, 2001, public hearing on
BSE, are available at the Division of Dockets Management (refer to
Docket No. 01N-0423). The transcripts may also be obtained online at
FDA Internet Page (http://www.fda.gov/ohrms/dockets/dockets/01N-0423/01n0423.htm).
9. World Health Organization (WHO) Fact Sheet No. 113, Bovine
Spongiform Encephalopathy, revised Nov. 2002, WHO Internet Page
(http://www.who.int/mediacentre/factsheets/fs113/en/).
10. Livestock Mortalities: Methods of Disposal and Their
Potential Costs. Sparks Companies, Inc., McLean, VA, March 2002.
11. U.S. Department of Agriculture, Animal and Plant Health
Inspection Service, USDA's BSE Testing Program, USDA/APHIS Internet
Page (http://www.aphis.usda.gov/lpa/issues/bse_testing/index.html).
12. The BSE Inquiry Report, vol. 5, Animal Health, 1989-1996,
pp. 94-107, A committee report to MAFF, UK. BSE Inquiry Internet
Page (http://www.bseinquiry.gov.uk/).
13. Overview of the BSE risk assessments of the European's
Commission Scientific Steering Committee (SSC) and its TSE/BSE ad
hoc group, Adopted between September 1997 and April 2003, June 5,
2003, Europa Internet Page (http://europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf).
14. U.S. Food and Drug Administration, Center for Veterinary
Medicine, Summary of FDA Inspectional Findings and Recalls Involving
the Ruminant Feed Ban Regulation (21 CFR 589.2000) Conducted in
Fiscal Year 2004 and First Half of Fiscal Year 2005, September 2005.
15. Florida Department of Agriculture and Consumer Services and
Florida Cooperative Extension Service, Institute of Food and
Agricultural Services, brochure entitled ``The Misuse of Pet Food as
Feed for Show Cattle--Misconceptions and Realities.''
16. Scientific Steering Committee, European Commission, ``Update
on the Opinion of TSE Infectivity Distribution in Ruminant
Tissues,'' Initially adopted by the Scientific Steering Committee at
its meeting of January 10 and 11, 2002, and amended at its meeting
of November 7 and 8, 2002, following the submission of a risk
assessment by the German Federal Ministry of Consumer Protection,
Food and Agriculture and new scientific evidence regarding BSE
infectivity distribution in tonsils, Europa Internet Page (http://europa.eu.int/comm/foods/fs/bse/scientific_advice08_en.html).
17. SSC Opinion on The Human Exposure Risk (HER) via Food With
Respect to BSE, Adopted on 10 December 1999; (http://europa.eu.int/comm/food/fs/sc/ssc/out67_en.pdf).
18. Health and Consumer Protection Directorate-General, European
Commission, ``Report on the Monitoring and Testing of Ruminants for
the Presence of Transmissible Spongiform Encephalopathy (TSE) in
2002.''
19. Targeted Screening of High-Risk Cattle Populations for BSE
to Augment Mandatory
[[Page 58600]]
Reporting of Clinical Suspects, Preventive Veterinary Medicine 51:3-
16, 2001.
20. Taylor, D.M., S.L. Woodgate, and M.J. Atkinson, et al.,
``Inactivation of the Bovine Spongiform Encephalopathy Agent by
Rendering Procedures,'' Veterinary Record, 137: 605-610, 1995.
21. Taylor, D.M., S.L. Woodgate, A.J. Fleetwood, et. al., ``The
Effect of Rendering Procedures on Scrapie Agent,'' Veterinary
Record, 141: 643-649, 1997.
22. Wilesmith, J.W., G.A.H. Wells, M.P. Cranwell, et al.,
``Bovine Spongiform Encephalopathy: Epidemiological Studies,''
Veterinary Record, 123: 638-644, 1998.
23. Office International des Epizooties (OIE), Terrestrial
Animal Health Code, Bovine Spongiform Encephalopathy Chapter, 2005.
24. U.S. Department of Health and Human Services, Food and Drug
Administration (FDA), Transcript of meeting of the Transmissible
Spongiform Encephalopathies Advisory Committee, April 16, 1998, FDA
Internet Page (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf), 1998.
25. ``Economic Impacts of Proposed FDA Regulatory Changes to
Regulations of Animal Feeds Due to Risk of Bovine Spongiform
Encephalopathy,'' Contract No. 223-03-8500, Task Order 3, Eastern
Research Group, Lexington, MA, July 25, 2005.
26. ``Preliminary Analysis of Interim Final Rules and an
Interpretive Rule to Prevent the BSE Agent from Entering the U.S.
Food Supply,'' USDA, April 7, 2004, FSIS/USDA Internet Page (http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/frpubs/03-025n/bse_analysis.pdf).
27. Department of Health and Human Services press release. FDA
Internet Page (http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html).
28. European Union Scientific Steering Committee (EU SSC),
Opinion of December 10, 1999, of the Scientific Steering Committee
on the Human Exposure Risk (HER) via Food with Respect to BSE, p.
11, 2001.
29. United Kingdom Department of Health, 2005, Internet Page
(http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4118691&chk=0Yqdjc).).
30. U.S. Department of Agriculture, Agricultural Marketing
Service, Internet Page (http://www.ers.usda.gov/briefing/foodpricespreads/meatpricespreads/beef.xls)
31. ``Economic Impacts of Alternative Changes to the FDA
Regulation of Animal Feeds to Address the Risk of Bovine Spongiform
Encephalopathy,'' Contract No. 223-98-8002, Task Order 2, Eastern
Research Group, Lexington, MA, July 25, 2005.
32. ``An Economic and Environmental Assessment of Eliminating
Specified Risk Materials and Cattle Mortalities from Existing
Markets,'' Prepared for the National Renderers Association by
Informa Economics, Inc. Washington, D.C. http://www.renderers.org/economic_impact/index.htm
33. Feedstuffs, vol. 77, No. 3, p. 21, January 17, 2005.
34. U.S. Small Business Administration data at the U.S. Census
Bureau Internet Page (http://www.census.gov/csd/subsb/usalli01.xls).
35. North American Rendering Industry submission to docket
number 02N-0273, comment 30, February 3, 2004.
36. The University of Georgia, College of Agricultural and
Environmental Sciences, Cooperative Extension Service, AS-1
Newsletter, p. 5, January/February 2001.
List of Subjects in 21 CFR Part 589
Animal feeds, Animal foods, Food additives, Incorporation by
reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, the Food and
Drug Administration, it is proposed that 21 CFR part 589 be amended to
read as follows:
PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
1. The authority citation for 21 CFR part 589 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371.
2. Section 589.2000 is amended by revising paragraph (a)(1) and by
adding paragraphs (c)(4) and (e)(3) to read as follows:
Sec. 589.2000 Animal proteins prohibited in ruminant feed.
(a) * * *
(1) Protein derived from mammalian tissues means any protein-
containing portion of mammalian animals, excluding: Blood and blood
products; gelatin; tallow containing no more than 0.15 percent
insoluble impurities and tallow derivatives as specified in Sec.
589.2001; inspected meat products which have been cooked and offered
for human food and further heat processed for feed (such as plate waste
and used cellulosic food casings); milk products (milk and milk
proteins); and any product whose only mammalian protein consists
entirely of porcine or equine protein.
* * * * *
(c) * * *
(4) Renderers shall comply with all applicable requirements under
Sec. 589.2001.
* * * * *
(e) * * *
(3) Renderers shall comply with all applicable requirements under
Sec. 589.2001.
* * * * *
3. Section 589.2001 is added to read as follows:
Sec. 589.2001 Cattle materials prohibited in animal food or feed.
(a) Definitions--(1) Cattle materials prohibited in animal feed
include:
(i) The brains and spinal cords of cattle 30 months of age and
older;
(ii) The brains and spinal cords of cattle not inspected and passed
for human consumption as defined in paragraph (a)(2) of this section;
(iii) The entire carcass of cattle not inspected and passed for
human consumption from which brains and spinal cords were not removed;
(iv) Mechanically separated beef as defined in paragraph (a)(3) of
this section that is derived from materials specified in paragraphs
(a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this section; and
(v) Tallow as defined in paragraph (a)(5) of this section that is
derived from materials specified in paragraphs (a)(1)(i), (a)(1)(ii),
and (a)(1)(iii) of this section. Cattle materials prohibited in animal
feed do not include:
(A) Tallow derivatives as defined in paragraph (a)(6) of this
section and;
(B) Tallow as defined in paragraph (a)(5) of this section that is
derived from materials specified in paragraphs (a)(1)(i), (a)(1)(ii),
and (a)(1)(iii) of this section and that contains no more than 0.15
percent insoluble impurities. Insoluble impurities must be measured by
the method entitled ``Insoluble Impurities'' of the American Oil
Chemists' Society (Official Method Ca 3a-46), or another method
equivalent in accuracy, precision, and sensitivity to AOCS Official
Method Ca 3a-46. The Director of the Office of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain copies of the method from the
AOCS (http://www.aocs.org). Copies may be examined at the Center for
Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Cattle not inspected and passed for human consumption means
cattle of any age that were not inspected and passed for human
consumption by the appropriate regulatory authority. This term includes
nonambulatory disabled cattle. Nonambulatory disabled cattle are cattle
that cannot rise from a recumbent position or that cannot walk,
including, but not limited to, those with broken appendages, severed
tendons or
[[Page 58601]]
ligaments, nerve paralysis, fractured vertebral column, or metabolic
conditions.
(3) Mechanically separated beef means a finely comminuted meat food
product, resulting from the mechanical separation and removal of most
of the bone from attached skeletal muscle of cattle carcasses and parts
of carcasses.
(4) Renderer means any firm or individual that processes slaughter
byproducts, animals unfit for human consumption, or meat scraps. The
term includes persons who collect such materials and subject them to
minimal processing, or distribute them to firms other than renderers
(as defined in this paragraph) whose intended use for the products may
include animal feed, industrial use, or other uses. The term includes
renderers that also blend animal protein products.
(5) Tallow means the rendered fat of cattle obtained by pressing or
by applying any other extraction process to tissues derived directly
from discrete adipose tissue masses or to other carcass parts and
tissues.
(6) Tallow derivative means any product obtained through initial
hydrolysis, saponification, or trans-esterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or
trans-esterification may be applied to obtain the desired product.
(b) Requirements. (1) No animal feed or feed ingredient shall be
manufactured from, processed with, or otherwise contain, cattle
materials prohibited in animal feed as defined in paragraph (a)(1) of
this section.
(2) Renderers that manufacture, process, blend, or distribute
cattle materials prohibited in animal feed as defined in paragraph
(a)(1) of this section, or products that contain or may contain cattle
materials prohibited in animal feed, shall take the following measures
to ensure that materials identified in paragraph (b)(1) of this section
are not introduced into animal feed:
(i) Once cattle materials prohibited in animal feed have been
separated from other cattle materials, provide for measures to avoid
cross-contamination;
(A) Use separate equipment while handling cattle materials
prohibited in animal feed; or
(B) Use separate containers that adequately prevent contact with
animal feed, animal feed ingredients, or equipment surfaces;
(ii) Label the cattle materials prohibited in animal feed and
products that contain or may contain cattle materials prohibited in
animal feed in a conspicuous manner as follows: ``Do not feed to
animals'';
(iii) Mark the cattle materials prohibited in animal feed and
products that contain or may contain cattle materials prohibited in
animal feed with an agent that can be readily detected on visual
inspection; and
(iv) Establish and maintain records sufficient to track cattle
materials prohibited in animal feed to ensure such material is not
introduced into animal feed, and make the records available for
inspection and copying by the Food and Drug Administration.
(3) Renderers that manufacture, process, blend, or distribute any
cattle materials shall take the following measures to ensure that
materials identified in paragraph (b)(1) of this section are not used
in animal feed:
(i) Establish and maintain records sufficient to demonstrate that
material rendered for use in animal feed was not manufactured from,
processed with, or does not otherwise contain, cattle materials
prohibited in animal feed, and make the copies available for inspection
and copying by the Food and Drug Administration; and
(ii) Comply with all applicable requirements under Sec. 589.2000
regarding animal proteins prohibited in ruminant feed.
(c) Adulteration and misbranding. (1) Failure of a renderer to
comply with the requirements in paragraphs (b)(2)(i), (b)(2)(iii),
(b)(2)(iv), or (b)(3)(i) of this section will render the animal feed or
feed ingredients adulterated under section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the act).
(2) Animal feed or feed ingredients that are not in compliance with
paragraph (b)(1) of this section are adulterated under section
402(a)(2), 402(a)(3), or 402(a)(5) of the act.
(3) Animal feed or feed ingredients that are not in compliance with
the labeling requirements of paragraph (b)(2)(ii) of this section are
misbranded under section 403(a)(1) or 403(f) of the act.
(4) Failure of a renderer to comply with the requirements in
paragraph (d) of this section will render the animal feed or feed
ingredients adulterated under section 402(a)(4) of the act.
(d) Inspection; records retention. Records required to be made
available for inspection and copying by the Food and Drug
Administration, as required by this section, shall be kept for a
minimum of 1 year.
Dated: July 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20196 Filed 10-4-05; 1:00 pm]
BILLING CODE 4160-01-S