Substances Prohibited From Use in Animal Food or Feed, 58570-58601 [05-20196]

Agencies

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

[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Proposed Rules]
[Pages 58570-58601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20196]



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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: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://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 
https://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 https://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: burt.pritchett@fda.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Bovine Spongiform Encephalopathy
    B. Current Animal Feed Safeguards in the United States
    C. Risk of BSE in North America
    D. Additional Measures Considered to Strengthen Animal Feed 
Safeguards
    1. Comments on November 6, 2002 Advance Notice of Proposed 
Rulemaking (ANPRM)
    2. Actions in Response to Washington State Case
    3. Comments on July 14, 2004 ANPRM
II. Proposed Measures to Strengthen Animal Feed Safeguards
    A. FDA Response to Comments to the 2004 ANPRM
    B. Additional Measures to Further Strengthen Feed Protection
    C. Basis for Proposing to Apply Additional Measures to All Animal 
Food and Feed
    D. Cattle Materials Proposed to be Prohibited From Use in All 
Animal Food and Feed
    E. Disposal of Cattle Materials Prohibited in Animal Feed
III. Description of Proposed Rule and Legal Authority
    A. Definitions
    B. Proposed Requirements
    C. Proposed Recordkeeping and Access Requirements
    D. Conforming Changes to 21 CFR 589.2000--Animal Proteins 
Prohibited in Ruminant Feed
    E. Legal Authority
IV. Analysis of Economic Impacts
    A. Summary of Proposed Regulatory Impact Analysis
    B. Need for Regulation
    C. Benefits
    D. Costs
    E. Government Costs
    F. Sensitivity Analysis
    G. Regulatory Flexibility Analysis
V. Paperwork Reduction Act
VI. Environmental Impact
VII. Federalism
VIII. Comments
IX. References

I. Background

A. Bovine Spongiform Encephalopathy

    BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). In addition to BSE, TSEs also 
include scrapie in sheep and goats, chronic wasting disease (CWD) in 
deer and elk, and 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

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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

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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), FD