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From: TSS ()
Subject: Prohibition of the Use of SRMs for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle USDA [Docket No. 03-025IFA]
Date: September 7, 2005 at 7:14 am PST


[Federal Register: September 7, 2005 (Volume 70, Number 172)]
[Rules and Regulations]
[Page 53043-53050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se05-1]


========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

[[Page 53043]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310 and 318

[Docket No. 03-025IFA]


Prohibition of the Use of Specified Risk Materials for Human Food
and Requirements for the Disposition of Non-Ambulatory Disabled Cattle

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
interim final rule, ``Prohibition of the Use of Specified Risk
Materials for Human Food and Requirements for the Disposition of Non-
Ambulatory Cattle,'' published in the Federal Register on January 12,
2004. The amendments permit beef small intestine, excluding the distal
ileum, to be used for human food, provided that such product is derived
from cattle that were slaughtered in an official establishment in the
United States or in a certified foreign establishment from a foreign
country that is eligible to export beef products to the United States.
Although the distal ileum is the only portion of the small intestine in
which BSE infectivity has been confirmed, the January 2004 interim
final rule requires that the entire small intestine of all cattle be
removed and disposed of as inedible. FSIS is taking this action based
on the Agency's evaluation of this issue and of the comments received
on the interim final rule, as well as comments received on an advance
notice of proposed rulemaking published in July 2004. FSIS has
concluded that the distal ileum can be effectively removed from the
rest of the small intestine. FSIS has determined that removal of the
distal ileum in accordance with the amendments in this document will
provide the same level of protection from human exposure to the BSE
agent as does the exclusion of the entire small intestine from the
human food supply.

DATES: This interim final rule is effective October 7, 2005. Comments
on this interim final rule must be received by November 7, 2005.

ADDRESSES: FSIS invites interested persons to submit comments on this
amended interim final rule. Comments may be submitted by any of the
following methods:
Mail, including floppy disks or CD-ROM's, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
Federal eRulemaking Portal: Go to http://www.regulations.gov.
Electronic mail: fsis.regulationscomments@fsis.usda.gov. Follow the online instructions

at that site for submitting comments.
All submissions received must include the Agency name and docket
number 03-025IFA.
All comments submitted in response to this amended interim final
rule, as well as research and background information used by FSIS in
developing this document, will be available for public inspection in
the FSIS Docket Room at the address listed above between 8:30 a.m. and
4:30 p.m., Monday through Friday. The comments also will be posted on
the Agency's Web site at http://www.fsis.usda.gov/regulations_&_policies/2005_Interim_&_Final_Rules_Index/index.asp
.


FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Deputy Assistant
Administrator, Office of Policy, Program, and Employee Development,
FSIS, U.S. Department of Agriculture, 1400 Independence Avenue, SW.,
Washington, DC 20250-3700, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

On January 12, 2004, FSIS issued a series of three interim final
rules to minimize human exposure to materials that scientific studies
have demonstrated contain the BSE agent in cattle infected with the
disease. FSIS issued the rules in response to the diagnosis on December
23, 2003, of BSE in an imported dairy cow in Washington State. The
animal had been imported from Canada. One of the rules, ``Prohibition
of the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-ambulatory Disabled Cattle'' (69 FR 1826,
January 12, 2004) (also referred to as ``the SRM interim final rule''
or ``the SRM rule''), among other things, designates certain materials
from cattle as SRMs, declares that SRMs are inedible, and prohibits the
use of these materials for human food (9 CFR 310.22(a) and 9 CFR
310.22(b)). The SRM rule also requires that establishments that
slaughter cattle, and establishments that process the carcasses and
parts of cattle, incorporate their procedures for the removal,
segregation and disposition of SRMs into their HACCP plans or
Sanitation SOPs or other prerequisite program (9 CFR 310.22(d)(1)).
The materials identified as SRMs in the FSIS SRM rule are the
brain, skull, eyes, trigeminal ganglia, spinal cord, 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 (DRG) of cattle 30 months of age and older, and the distal
ileum of the small intestine and tonsils from all cattle (9 CFR
310.22(a)). FSIS designated these materials as SRMs because they have
been found to contain BSE infectivity at some point during the disease
incubation period. Furthermore, the Agency determined that SRMs should
be declared as inedible because, as stated in the preamble to the SRM
rule, they present a sufficient risk of exposing humans to the BSE
agent so as to render them ``unfit for human food'' within the meaning
of section 1(m)(3) of the adulteration provisions of the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601(m)(3)). For a detailed explanation
of FSIS'' rationale for designating these tissues as SRMs, including
the supporting scientific studies, refer to the preamble to
``Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-ambulatory Disabled Cattle.''
FSIS designated the distal ileum from all cattle as an SRM because,
in cattle infected with BSE under experimental conditions, infectivity
was confirmed in

[[Page 53044]]

the distal ileum in the early stages of the disease. To ensure
effective removal of the distal ileum, FSIS requires that the entire
small intestine be removed and disposed of as inedible (9 CFR
310.22(a)(3)). However, in the preamble to the SRM rule, FSIS noted
that beef processors may be able to effectively remove the distal ileum
from the rest of the small intestine and requested comments on this
issue (69 FR 1862, 1869).
On July 14, 2004, the Food and Drug Administration (FDA) issued an
interim final rule, ``Use of Materials Derived From Cattle in Human
Food and Cosmetics'' (also referred to as ``the FDA rule'' or ``the
prohibited cattle materials rule''), that extends the measures to
prevent human exposure to the BSE agent issued by FSIS to FDA-regulated
human food and cosmetics (69 FR 42255). In its rule, FDA designates
certain materials from cattle as ``prohibited cattle materials'' and
prohibits the use of such materials for human food, including dietary
supplements, and cosmetics (21 CFR 189.5 and 21 CFR 700.27). Among the
materials designated as prohibited cattle materials by the FDA are
SRMs, the small intestine from all cattle, and material from cattle not
inspected and passed for human consumption. Materials that were
designated as SRMs in the FDA rule are the same as the materials
designated as SRMs by FSIS.
Although FDA designated the distal ileum of the small intestine
from cattle as an SRM, like FSIS, it prohibits the use of the entire
small intestine for human food. Consistent with the amendments to the
SRM interim final rule that FSIS is issuing in this document, FDA
intends to issue an amendment to its prohibited cattle materials rule
to permit, under certain circumstances, the manufacture and use of beef
casings derived from beef small intestine, excluding the distal ileum,
for human food and cosmetics.

Comments Received on Procedures for Removal of the Distal Ileum

In response to the SRM rule, FSIS received several comments from
beef processors, the natural casing industry, the beef by-product
industry, and importers and exporters of natural casings and beef by-
products on the need to exclude the entire small intestine from the
human food supply. On July 14, 2004, APHIS, FSIS, and the Food and Drug
Administration (FDA) issued an Advance Notice of Proposed Rulemaking
(ANPR), ``Federal Measures To Mitigate BSE Risks: Considerations for
Further Action,'' (also referred to as the APHIS/FSIS/FDA ANPR) that
provided another opportunity for interested parties to comment on which
portions of the intestine of cattle should be removed to prevent
potentially infective material from entering the human food supply (69
FR 42287, 42296). The comment period for the APHIS/FSIS/FDA ANPR closed
on September 13, 2004.
Most of the comments submitted to the Agency on this issue
requested that FSIS amend the SRM rule to require the removal and
disposal of only the distal ileum and allow the remaining portion of
the small intestine to be used for human food. As stated by the
commenters, infectivity has been confirmed only in the distal ileum of
the small intestine of cattle infected with BSE under experimental
conditions, and the technology exists to effectively remove the distal
ileum from the rest of the small intestine. The commenters noted that,
before the issuance of the SRM rule, FSIS had approved a standard
operating procedure to certify the removal of the distal ileum from the
remaining portions of beef small intestine intended for export to
Japan. As stated by the commenters, the procedure approved by FSIS
requires the removal of at least 80 inches of the small intestine as
measured from the junction of the ileum and the cecum.
To further support their argument, several commenters provided a
detailed anatomical description of the small intestine of cattle, along
with pictures and diagrams of the anatomy of the small intestine, which
they asserted can be used to develop a model of certification of the
removal and disposal of the distal ileum. According to the commenters,
this description was developed with full scientific oversight and has
widespread support within the beef processing, casing, and beef by-
product industry.
Many commenters also described, in detail, examples of verifiable
procedures for the effective removal of the distal ileum. One procedure
described in the comments begins with the removal of the small
intestine from the abomasum. Under this procedure, the small intestine
is separated from the cecum at the ileocecal orifice, and the ileum is
separated from the jejunum at the flange. According to the commenters,
the resulting portion that contains the distal ileum would measure 36
to 72 inches in length depending on the age and size of the animal.
Another procedure described in the comments also begins with
removal of the small intestine from the abomasum, except that under
this procedure the small intestine remains attached to the cecum, and
the separation is made at a point 36 to 80 inches from the cecum,
leaving behind the remaining edible portions of the small intestine.
According to the commenters, leaving the ileum attached to the cecum at
this initial stage provides an easily verifiable point of reference for
on-line inspectors. The next step in this procedure is to separate the
36 to 80 inch portion of the intestine that contains the ileum from the
cecum at the ileocecal orifice, leaving the cecum and the large
intestine for edible use.
Another commenter described a procedure that uses a ``Small
Intestine Processing Machine'' that was developed in Japan
approximately 10 years ago specifically for the harvest of the jejunum
of the intestine for export to Japan. As presented by the commenter,
the Small Intestine Processing Machine strips the fat from, washes, and
then splits the jejunum lengthwise, and cuts the small intestine into
sections without leaving any part of the distal ileum attached. The
commenter stated that the harvest procedures using the Small Intestine
Processing Machine require that the uncoiled and untrimmed jejunum
portion of the small intestine be cut at least 72 cm or 30 inches from
the cecum end of the small intestine, which is equal to approximately
80 inches of the split, washed, and trimmed small intestine. According
to the commenter, this removal procedure exceeds the total length of
the distal ileum of the small intestine and includes a portion of the
jejunum as a precaution.
This same commenter stated that the harvest procedures for the
Small Intestine Processing Machine require that the entire intestinal
tract of the digestive system be laid out in full view prior to
starting the separation process, which makes accurate identification
and removal of the distal ileum possible. The commenter provided
pictures depicting the location of the distal ileum, cecum, and jejunum
portions of the small intestine and noted that as the distal ileum
joins the cecum, it is distinct from the jejunum, duodenum, and colon.
The commenter also explained that as the separation of the jejunum
(small intestine) is done by the Small Intestine Processing Machine,
the harvest is only completed between the initial cut on the cecum end
and the final cut adjacent to the duodenal jejunal flexure.
Several commenters indicated that because of the distinct shape of
the distal ileum of cattle, FSIS inspection program personnel could
easily verify the effective removal of this portion of the small
intestine. Furthermore, commenters from the natural casing

[[Page 53045]]

industry stated that because of its physical properties, particularly
the fact that it has no curve and an irregular thick surface, the
distal ileum is not useable as a natural casing for sausage products.
Thus, these commenters noted, many slaughter establishments in the
United States and Canada had a policy of removing the distal ileum from
all cattle at the time of slaughter prior to the effective date of the
SRM rule.
Furthermore, as stated by the commenters, prior to the effective
date of the SRM rule, slaughter establishments in Brazil, Argentina,
and Uruguay, the three countries that are the major exporters of
natural casings to the United States, had all been able to certify the
removal of the distal ileum using achievable standards when requested
to do so by their U.S. customers. One commenter submitted a CD-ROM on
``Details of Beef Casing Production in Brazil: Eliminating the Distal
Ileum,'' which, according to the commenter, demonstrates the distinct
appearance of the bovine ileum. The commenters also noted that Brazil,
Uruguay, and Argentina are countries that are generally recognized as
having a negligible BSE risk by the international community.

Other Comments on Removal of the Small Intestine

In addition to the comments that presented procedures for removing
the distal ileum, FSIS received other comments on whether the entire
small intestine from cattle should be excluded from the human food
supply. Some commenters, including members of the natural casing
industry, importers and exporters of natural casings and beef by-
products, and foreign countries that consider themselves to be ``BSE-
free,'' such as Australia, New Zealand, Uruguay, and Argentina,
suggested that FSIS consider a country's BSE risk status when
determining which portions of the intestine, if any, should be removed
and disposed of as inedible. Most of these commenters also requested
that FSIS exempt countries recognized as ``BSE-free'' or
``provisionally free'' by the international community from all
provisions of the SRM rule.\1\
---------------------------------------------------------------------------

\1\ The international guidelines established by the OIE have
been revised since FSIS issued the SRM interim final rule. The OIE
guidelines in the 2005 Terrestrial Animal Health Code provide for a
BSE ``negligible risk'' category instead of the ``BSE-free'' and
``provisionally free'' categories.
---------------------------------------------------------------------------

According to the commenters, a country's BSE-free risk status
provides the same level of protection from human exposure to the BSE
agent as does exclusion of SRMs and beef small intestine from the human
food supply in the United States. In addition, as noted by the
commenters, such an approach would be consistent with guidelines
established by the World Organization for Animal Health (the OIE),
which recommend that countries restrict the importation of beef small
intestines and other potentially infective materials on the basis of
the BSE risk classification of the region of origin.
FSIS' regulations governing the importation of meat and meat
products from foreign countries into the United States prohibit the
importation of any product that is adulterated or misbranded, or that
does not comply with the regulatory requirements that would apply to it
if it were a domestic product (9 CFR 327.3(a)). The FSIS import
regulations at 9 CFR 327.4(a) also require that fresh meat or fresh
meat by-products consigned to the United States from a foreign country
be accompanied by a foreign meat inspection certificate, signed by the
official authorized by the national foreign government to issue
inspection certificates for meat and meat by-products exported to the
Unites States, that certifies, among other things, that such products
are not adulterated or misbranded, and that such products have been
handled in a sanitary manner and are otherwise in compliance with
requirements equivalent to those in the FMIA and its implementing
regulations. The regulations, 9 CFR 327.3(a) and 9 CFR 327.4(a), make
clear that to be eligible for importation into the United States, meat
products from foreign countries must present no greater risk to human
health than products that were produced domestically in the United
States, and that to achieve the appropriate level of public health
protection, such products must comply with regulatory requirements
equivalent to those required by FSIS.
Thus, if FSIS were to exempt countries with a BSE-free risk status
(or negligible BSE risk under OIE guidelines) from some or all of the
provisions of the SRM rule, as requested by some of the commenters, any
products eligible for importation into the United States would be
required to comply with 9 CFR 327.3(a) and 9 CFR 327.4(a), i.e., they
could not be adulterated or misbranded, and would be required to comply
with requirements that are equivalent to those in the FSIS SRM rule. As
stated above, in response to the confirmation of BSE in the cow in
Washington State, FSIS currently considers the distal ileum and all
other SRMs from U.S. domestic cattle as adulterated under section
1(m)(3) of the FMIA. The Agency is evaluating whether it is appropriate
to consider these materials adulterated if they originate from a
country considered to have a BSE-free risk status. Until FSIS has an
opportunity to resolve this issue, the Agency has decided that all
materials designated as SRMs, including the distal ileum, should be
excluded from the human food supply, regardless of their country-of-
origin. FSIS will continue to evaluate the issue, and if the Agency
determines that an exemption is appropriate for countries considered to
have a BSE-free risk status or negligible BSE risk under OIE
guidelines, the Agency will take appropriate action.
Other commenters, including a private consultant, consumer advocacy
organization, and members of the restaurant industry, recommended that
FSIS expand the prohibition on the use of small intestine from cattle
for human food to include the entire intestine, both large and small.
Some of these comments noted that while certain sections of the
intestine were tested with no infectivity, not every section of the
intestine was subjected to the bioassay in the pathogenesis studies
conducted in the United Kingdom. One comment asserted that instead of
assuming that the untested section of the intestine are devoid of
infectivity, FSIS should err on the side of caution when it comes to
protecting public health.
Some comments, one of them citing an unpublished study, mentioned
that positive immunostaining has been identified along the length of
the intestine, providing evidence for the entire intestine to be
considered SRM under European Union regulations. To better understand
the implications of this finding FSIS contacted the commenter to obtain
more information on the study. The commenter explained that the
statement that positive immunostaining has been identified along the
length of the intestine was based on a misunderstanding of a report on
a published study.
The commenter clarified that there are published studies in which
positive immunostaining has been identified in the distal ileum portion
of the enteric nervous system (ENS) of naturally infected and
experimentally challenged cattle with BSE. However, the commenter
maintained that FSIS should designate the entire intestine, both large
and small, as SRM because the ENS runs through the length of the
intestinal tract and other areas of the ENS from naturally occurring
cases of BSE have not yet been examined for infectious prion staining.
Thus, stated the commenter, if other areas of the

[[Page 53046]]

intestinal tract were subjected to immunostaining, one might expect to
find positive immunostaining in portions of the intestinal tract other
than the distal ileum. The commenter also noted that, although
immunostaining was attempted and found negative on sections of the
intestine other than the distal ileum of experimentally challenged
cattle, this study was extremely limited with regard to the testing of
tissues other than the distal ileum (i.e., tissues from 3 calves
sacrificed 6 months post-exposure).
Also, as stated by the comments, according to the E.U. Scientific
Steering Committee (SSC), intestine should be SRM because infection
from BSE comes from ingesting contaminated feed and slaughterhouse
contamination of other intestinal areas with matter from the ileum
cannot be avoided. Many of the comments also noted that the
International Review Team (IRT) appointed by the Secretary of
Agriculture in January 2004 to assess the U.S. Government's response to
the detection of BSE in the cow in Washington State recommended that
the SRM definition be adjusted to include the entire intestine, from
pylorus to anus, of all cattle.
After considering these comments, FSIS has not changed its
conclusion that, when the distal ileum is effectively removed, beef
small intestine that complies with the requirements of this interim
final rule presents no greater risk of introducing the BSE agent into
the human food supply than do other beef products permitted for use as
human food in the United States. As discussed below, this conclusion is
based on the information available to the Agency with regard to BSE
infectivity in the intestine of cattle, together with the availability
of procedures to effectively remove the distal ileum.
FSIS is not aware of any studies in which BSE infectivity has been
confirmed in any portion of the intestinal tract of cattle other than
the distal ileum. The animal studies of TSEs that indicate infectivity
along the entire intestinal tract that the Agency is aware of involve
animal species other than cattle (Ref. 1-6, available for viewing by
the public in the FSIS docket room). Although the data on TSEs in other
animal species may represent the distribution of infectivity in those
species, these data may not represent the distribution of infectivity
in cattle as evidenced by the studies discussed below.
The Agency recognizes that, based on the structure and function of
cells that make up the gastrointestinal tract of mammals, many areas
within the mammalian gastrointestinal tract could theoretically be
capable of harboring abnormal prions. TSE infectious agents that enter
susceptible animals through oral consumption of infectious material
appear to gain access to the CNS through the nerves that innervate the
gastrointestinal tract. Infection may involve a first step of
presentation to lymphatic tissues and may also occur by direct invasion
of nerve endings in the intestinal mucosa (Ref. 7, available for
viewing by the public in the FSIS docket room). Both gut-associated
lymphoid tissue (GALT) and ENS tissue are present throughout the
intestinal tract.
However, despite this theoretical risk, the only bovine GALT found
to be positive for BSE infectivity thus far has been in the Peyers
Patches of the distal ileum of calves infected with BSE under
experimental conditions. Two other GALT tissues from natural field
cases, spleen and mesenteric lymph nodes, have been subjected to mouse
bioassays and found to be non-infectious (Ref. 8, available for viewing
by the public in the FSIS docket room). Spleen and mesenteric lymph
node samples from experimentally dosed calves have also been subjected
to mouse bioassays with similar results.
A component of the ENS is the myenteric plexus that courses within
the length of the intestinal wall (Ref. 9, available for viewing by the
public in the FSIS docket room). Distal ileum sections of the intestine
from cattle that acquired natural field cases of BSE have been examined
for the presence of abnormal prion protien through immunostaining, and
the ganglion cells of the myenteric plexus were found to contain
abnormal prions in 9 out of 29 samples (Ref. 10, available for viewing
by the public in the FSIS docket room). Other areas of the ENS system
from naturally occurring cases of BSE have not yet been examined for
abnormal prion protein through immunostaining.
Gastrointestinal tissue from BSE field cases were subjected to and
found non-infective by mouse bioassay include a sample of the
splanchnic nerve, as well as samples of rumen, omasum abomasum,
proximal small intestine, distal small intestine, proximal colon,
distal colon, and rectum (Ref. 8, available for viewing by the public
in the FSIS docket room). From the U.K. pathogenesis studies, in which
calves were orally dosed with BSE-infectious materials, samples of
rumen, omasum, abomasum, duodenum, and spirial colon were found to be
non-infective by mouse bioassay (Ref. 11, available for viewing by the
public in the FSIS docket room). None of these samples have been
subjected to a cattle bioassay.
FSIS is aware of one small experiment in which immunostaining was
attempted on gastrointestinal tissue outside of distal ileum. The study
involved three calves that were orally infected with the BSE agent and
sacrificed six months later. In the study, immunostaining was negative
in all locations tested except for the Peyers Patches of the distal
ileum (Ref. 10, available for viewing by the public in the FSIS docket
room).
When it issued the SRM interim final rule, FSIS acknowledged that
available data on the development and distribution of tissue
infectivity in BSE infected cattle are incomplete and that additional
studies using cattle bioassays were being conducted to ensure that low
levels of infectivity that may not have been detected using mouse
bioassays are not missed (69 FR 1862, 1864-1865, January 12, 2005).
However, on the basis of the findings described above, FSIS has
concluded that bovine intestinal tissues other than the distal ileum
are either unlikely to contain BSE infectivity or contain infectivity
below the level of detection using the mouse bioassay. Furthermore,
FSIS has also concluded that, due to the availability of procedures to
remove the distal ileum, the fact that infectivity has been confirmed
only in the distal ileum has the most significant implications for
human health.
Thus, FSIS has determined that designating the distal ileum as SRM
is a prudent and appropriate measure to prevent human exposure to the
BSE agent in the United States. The Agency has also determined that it
is not necessary to designate the entire small intestine or the large
intestine as an SRM.
Future research that has been recommended by the European SSC
includes cattle bioassay and more sensitive prion detection testing of
many of the cattle tissues described above (Ref. 12, available for
viewing by the public in the FSIS docket room). Stored tissue is
available for this purpose in the United Kingdom. A pathogenesis study
underway in Germany will also provide tissue from cattle incubating BSE
for more definitive testing (Ref. 13, available for viewing by the
public in the FSIS docket room).
The Agency supports the need for the research being conducted with
regard to BSE and other TSEs. On March 18, 2005, the Secretary of
Agriculture announced that almost $2 million in funding has been
redirected to enhance research on BSE (``Johanns Announces

[[Page 53047]]

Expansion of BSE Research Program and Research Initiative to Improve
Food Safety,'' USDA press release no. 0097.05, March 18, 2005). The BSE
research funds, redirected by USDA's Agricultural Research Service,
will be used for newly funded BSE projects and facilities. Many of
these newly funded projects involve international collaboration with
researchers from the United Kingdom and other European countries. While
FSIS believes that the primary tissues of concern for spreading the BSE
agent have been identified, the Agency will use the results of futures
studies on BSE to further refine this determination and inform its
policies with regard to BSE.
FSIS disagrees with the comment that slaughterhouse contamination
of other intestinal areas with matter from the ileum cannot be avoided.
As discussed earlier in this document, the FSIS SRM interim final rule
requires that establishments develop, implement, and maintain written
procedures for the removal, segregation, and disposition of SRMs, and
that they incorporate these procedures into their HACCP plans,
Sanitation SOPs or other prerequisite programs (9 CFR 310.22(d)(1)).
These procedures must ensure that all SRMs, including the distal ileum,
are completely removed from the carcass, segregated from edible
products, and disposed of in an appropriate manner as prescribed by 9
CFR 314.1 and 9 CFR 314.3 (i.e., used for inedible rendering,
incinerated, or denatured). FSIS is responsible for ensuring the
adequacy and effectiveness of the establishment's procedures.
As stated throughout this document, FSIS has determined that beef
processors have the technology to effectively remove the distal ileum
from the intestine of cattle. Thus, the Agency has concluded that when
establishments incorporate their technologies for removing the distal
ileum into their HAACP plan or Sanitation SOP or other prerequisite
program, they will be able to effectively remove the distal ileum in a
manner that does not contaminate edible materials.

Amendments to SRM Interim Final Rule

After carefully evaluating this issue and the comments submitted on
the removal of the distal ileum, including the anatomical descriptions
and diagrams of the bovine small intestine, as well as the detailed
descriptions of the procedures for removal of the distal ileum, FSIS
has concluded that processors have the technology to effectively remove
the distal ileum from the rest of the small intestine. Therefore, FSIS
is amending the SRM interim final rule to permit for use as human food
beef small intestine, excluding the distal ileum, derived from cattle
slaughtered in official U.S. establishments or in certified foreign
establishments in countries listed by FSIS in 9 CFR 327.2(b) as
eligible to export meat products to the United States.\2\ This is a
requirement that all meat and meat food products must comply with to be
eligible for use as human food in the United States. In addition, FSIS
will not permit natural casings derived from beef small intestine,
excluding the distal ileum, to be used as containers of meat food
products unless the casings are derived from cattle that have been
inspected and passed in an official U.S. establishment or in a
certified foreign establishment.
---------------------------------------------------------------------------

\2\ Once a country is listed in 9 CFR 327.2(b) as eligible to
export meat and meat products to the United States, it must maintain
a meat inspection system that is equivalent to that of the United
States. If it does not, FSIS will not permit meat products from that
country to be imported into the United States. FSIS conducts audits
of eligible foreign countries meat inspection systems at least
annually.
---------------------------------------------------------------------------

9 CFR 327.1(b) of FSIS' import regulations provides that compliance
with the conditions of importation under FSIS' regulations does not
excuse the need for compliance with applicable requirements under other
laws, including the provisions in 9 CFR parts 94, 95, and 96 of APHIS'
regulations. Thus, under the amendments to the SRM interim final rule
described in this document, beef small intestine derived from cattle
that have been in countries listed by APHIS in 9 CFR 94.18(a) as
regions that present a risk of introducing BSE into the United States
will continue to be subject to importation restrictions established by
APHIS. APHIS' regulations at 9 CFR parts 94, 95, and 96 prohibit or
restrict the importation of beef products and by-products, as well as
casings (except stomachs), from cattle that have been in any of the
regions listed by APHIS in 94.18(a). FSIS and APHIS work closely
together to ensure that meat and meat products imported into the United
States comply with the regulatory requirements of both agencies. FSIS
and APHIS will continue to work together to ensure that the agencies
maintain a consistent policy with regard to the importation of beef
small intestines.
The amendments to the interim final rule also require that
establishments that process beef small intestine for human food have in
place procedures to ensure that the distal ileum is effectively
removed. As provided in 9 CFR 310.22(d)(1), the establishment must
incorporate these procedures into its HACCP plan or Sanitation SOPs or
other prerequisite program. FSIS has concluded that procedures that
require removal of at least 80 inches of the uncoiled and trimmed small
intestine as measured from the ceco-colic junction and progressing
proximally towards the jejunum comply with this requirement. The Agency
believes that this standard is sufficiently conservative to ensure
removal of the distal ileum despite differences in length of the
intestinal tract or its segments between breeds or variations from
animal to animal of the same breed. However, establishments may propose
alternative standards if they can demonstrate that such standards are
as effective as the standards described above in ensuring that the
entire distal ileum is completely removed.
APHIS' regulations prohibit or restrict the importation of most
ruminants and ruminant products, including beef intestines and casings,
from countries listed by APHIS as presenting a risk of introducing BSE
into the United States. As discussed above, to be eligible for
importation under FSIS' regulations, beef small intestine must comply
with both FSIS' and APHIS' import regulations.

Jurisdiction

Under section 1(j) of the FMIA, products from cattle that contain
meat or other portions of the carcass only in a relatively small
proportion or that historically have not been considered by consumers
as products of the meat food industry are not considered ``meat food
products'' subject to regulation by FSIS (21 U.S.C. 601(j)). Thus,
while unprocessed bovine small intestine is regulated by FSIS as a meat
food product, stripped and cleaned casings derived from the small
intestine of cattle have historically been regulated by FDA.
As discussed above, FSIS has decided to permit for use as human
food beef small intestine, excluding the distal ileum, derived from
cattle slaughtered in official U.S. establishments or in certified
establishments in foreign countries that FSIS considers eligible to
export meat and meat products to the United States. However, because
the amendments to the SRM interim final rule described in this document
are not intended to affect the regulatory authority of either FSIS or
FDA, jurisdiction over a product derived from small intestine will
continue to depend on whether the product is considered a meat food
product as defined in the FMIA. Thus, unprocessed beef small intestine
will continue to be regulated

[[Page 53048]]

by FSIS, and stripped and cleaned natural casing derived from bovine
small intestine will continue to be regulated by FDA.
However, although they are regulated by FDA, natural beef casings
are used as containers for certain meat food products. Therefore,
before FSIS applies the mark of inspection to a meat food product
encased in a natural beef casing derived from the small intestine, the
Agency will require that the establishment provide documentation that
demonstrates that the small intestine from which the casing was derived
complies with the requirements in the amendments to the SRM interim
final rule.

Small Business Considerations

One of the reasons that FSIS is at this time issuing these
amendments to the SRM interim final rule to allow the use of beef small
intestine, excluding the distal ileum, for human food is that the
Agency has received several comments in response to the SRM rule and
the APHIS/FSIS/FDA ANPR from small companies that manufacture sausages
and other products encased in natural beef casings, as well as from
manufacturers of ethnic foods, that indicate that the prohibition on
the use of the entire small intestine for human food is having an
adverse economic impact on small and very small businesses. As noted by
the commenters, beef round casings, which are derived from the small
intestine of cattle, are used in a wide assortment of sausage products,
as well as in specialty sausages. The commenters stated that processors
can substitute collagen casing for some types of sausage made from
natural beef rounds, but this generally results in a lower quality
product with a decreased market value.
Although some companies had stocks of natural casings from cattle
slaughtered prior to January 12, 2004, the date that the SRM interim
final rule went into effect, these companies have informed FSIS that
their existing supplies of natural beef casings will soon be exhausted.
Permitting the use of beef small intestine, excluding the distal ileum,
will relieve some of the economic burden that the prohibition on the
use of the entire small intestine for human food has imposed on these
small entities.

Summary of the Amendments

As discussed above, FSIS is amending the SRM interim final rule to
permit, under certain conditions, the use of beef small intestine,
excluding the distal ileum, for human food. As amended, 9 CFR
310.22(a)(3) will no longer require that establishments remove the
entire small intestine of all cattle and dispose of it as inedible.
Instead, it will specify the conditions under which the small intestine
from cattle is permitted to be used for human food. These conditions
were described in detail earlier in this document.
The regulations in 9 CFR 318.6(b)(1) provide that casings from
cattle may be used as containers of products provided the casings are
not derived from the small intestine. FSIS is amending paragraph (b)(1)
to permit casings from cattle that are derived from the small intestine
to be used as containers if the small intestine complies with the
requirements in 9 CFR 310.22(a)(3) as amended. The amendments to
paragraph (b)(1) also require that establishments that use casings
derived from the small intestine of cattle as containers for products
demonstrate, through documentation, that the small intestine from which
the casing was derived complies with the requirements in 9 CFR
310.22(a)(3) as amended.
9 CFR 318.6(b)(8) prohibits small intestine from cattle for use in
any meat food product or for edible rendering. FSIS is amending
paragraph (b)(8) to permit small intestine from cattle to be used in a
meat food product or for edible rendering if it complies with the
requirements in 9 CFR 310.22(a)(3) as amended.

Effective Date and Opportunity for Public Comment

Because FSIS has already provided the public with opportunities to
comment on the issues raised in this document (once in response to the
SRM interim final rule published on January 12, 2004 and again in
response to the APHIS/FSIS/FDA ANPR published on July 14, 2004), and
because the restrictions on the use of the small intestine for human
food are adversely affecting small businesses without providing any
public health benefits, the amendments to the SRM interim final
contained in this document will become effective before the comment
period closes. FSIS will consider any comments received during the
comment period for this amended interim final rule (see DATES above).
After that comment period closes, the Agency will publish another
document in the Federal Register. The document will include a
discussion of all comments received in response to the SRM interim
final rule, the APHIS/FSIS/FDA ANPR, and the amendments to the SRM
interim final rule described in this document. It will also include any
amendments to the SRM interim final rule made as a result of those
comments.

Executive Order 12866 and Regulatory Flexibility Act

These amendments to the January 12, 2004 interim final rule have
been determined to be significant and therefore, have been reviewed by
the Office of Management and Budget.
The interim final rule of January 12, 2004 (69 FR 1862) included a
Preliminary Regulatory Impact Analysis (PRIA) that was made available
for comment on April 7, 2004 (69 FR 18245). The PRIA indicated that
benefits of the SRM interim final rule were primarily those resulting
from the reduction in human exposure to BSE infectivity and the
restoration of beef exports. The PRIA estimated that designating beef
small intestines, including the distal ileum, from cattle of all ages
as a specified risk material did not result in a significant reduction
in potential human exposure to BSE. As discussed elsewhere in this
document, the distal ileum was designated as an SRM because BSE
infectivity has been demonstrated in the distal ileum after oral
exposure to the BSE agent. Although BSE infectivity was not
demonstrated in the remaining part of the small intestine, the interim
final rule required the removal of the entire small intestine to ensure
effective removal of the distal ileum. Therefore, this action does not
change the reduction in human exposure to BSE estimated in the PRIA.
The effect of amending the SRM interim final rule would be to
increase the supplies of beef small intestines and beef natural casings
manufactured from beef small intestine (beef casings) that do not
contain the distal ileum, and that, prior to the implementation of the
SRM rule, were used for human food. Although the SRM interim final rule
designated the distal ileum of all cattle as an SRM, to ensure
effective removal of the distal ileum, it required that the entire
small intestine be removed and disposed of as inedible. Thus, as a
result of the SRM rule, the supplies of beef small intestine and
natural casings derived from beef small intestine produced after the
effective date of the SRM rule were prohibited for use as human food.
One of the impacts on consumers of this prohibition of the use of
beef small intestine for human food has been the loss of food products
in marketplaces where the only suitable casings are beef casings. These
types of food products that typically use beef casings include sausages
such as salami, hard salami, thuringer, European-type sausages such as
braunschweiger, metwurst, and supressa, basterma, and Arabic sausages,
some pat[eacute]s, and a variety of

[[Page 53049]]

other food products largely sold in ethnic markets. Suitable
substitutes for beef casings do not exist or are generally inadequate
for some of these types of food products. For example, cellulosic,
collagen, fibrous, muslin or synthetic casings, or hog or sheep casings
are, in many cases, not adequate substitutes for beef natural casings
for use in producing some sausages, or some types of traditional ethnic
products. Another impact on consumers of this prohibition has been the
loss of food products in ethnic marketplaces where beef small
intestines were sold as variety meats, or food products were sold that
used beef small intestines as an ingredient of manufactured food
products or edible rendered food products. Suitable substitutes for
beef small intestines as variety meats do not exist or are generally
inadequate for some of these types of products.
The PRIA of the SRM interim final rule estimated that approximately
160 million pounds of small intestines, including the distal ileum,
were removed from the human food supply. The net revenue lost by
excluding the entire small intestine from the food supply, was
estimated to be an average of $27.6 million ($20.6 to $34.5 million)
per year for the food industry, after the implementation of the rule.
Of the $27.6 million in net annual revenue lost as a result of the
interim final rule, the PRIA estimated that an average of $16.6 million
($13.0 to $20.6 million) resulted from exclusion of the distal ileum
and an average of $10.9 million from the remaining parts of the small
intestine (see page 24 of the analysis). Therefore, this action is
estimated to restore an average of $10.9 million ($2.9 to $19.0
million) in net revenues lost as a result of the interim final rule.
In the PRIA, the Agency estimated, by survey, that approximately 47
federally-inspected establishments, that were primarily large
establishments, were affected by the value lost of beef small
intestines that were used for food products and to manufacture beef
casing. The amendment would allow some of these 47 establishments to
resume their sales of beef small intestines, beef casing, and food
products that use the imported beef casings. Thus, some of the 47
establishments or firms are expected to recover some of the value lost
through these new sales because of the amendment. The Agency is unable
to estimate the number of establishments that would resume the sales of
beef small intestines and their associated food products.
Also, the Agency is unable to estimate the number of establishments
that used beef casings in the production of meat products prior to the
implementation of the SRM interim final rule in January of 2004.
However, it believes that the number of domestic establishments
producing such products was small. As discussed elsewhere in this
document, the Agency has received comments from small companies that
indicate that the prohibition on the use of the entire small intestine
for human food is having an adverse economic impact on some small and
very small businesses. Most of these commenters are manufactures of
meat food products encased in natural beef casing. These amendments
will help to relieve some of this economic burden. However, FSIS is
unable to determine the number of small entities that will benefit from
this action.
The economic impact of the measure on manufacturers of casings
produced from other sources is not significant. The availability of
natural beef casings may reduce the demand for some cellulosic,
collagen, synthetic, or other types of casings. However, the reduction
is not expected to be significant, given the long-term trend in the use
of these types of non-natural casings.
Therefore, the Agency has determined that these amendments to the
interim final rule will not have a significant economic impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601).
The PRIA estimated that the SRM interim final rule would have a
minimal impact on U.S. meat production and beef prices paid by
consumers, because these products are a very small amount of total beef
production. Therefore, allowing the small intestine, excluding the
distal ileum, for use as human food as provided in this action will not
have a significant impact on the food industry and consumers.
The availability of these types of casing will reduce the demand
for some cellulosic, collagen, synthetic, or other types of casings.
However, the reduction is not expected to be significant, given the
long-term trend in the use of these types of non-natural casings.

Executive Order 12988

This amendment to the SRM interim final rule has been reviewed
under Executive Order 12988, Civil Justice Reform. In this interim
final rule: (1) All state and local laws and regulations that are
inconsistent with this rule will be preempted; (2) no retroactive
effect will be given to this rule; and (3) administrative proceedings
will not be required before parties may file suit in court challenging
this rule.

Paperwork Requirements

The SRM interim final rule included a paperwork analysis (61 FR
38862) prepared in accordance with the Paperwork Reduction Act. FSIS
has determined that the corrections and amendments in this rule do not
change any information collection burden hours.

Additional Public Notification

Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this amended interim final rule, FSIS will
announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Interim_&_Final_Rules_Index/index.asp.
The Regulations.gov Web site is the central

online rulemaking portal of the United States government. It is being
offered as a public service to increase participation in the Federal
government's regulatory activities. FSIS participates in
Regulations.gov and will accept comments on documents published on the
site. The site allows visitors to search by keyword or Department or
Agency for rulemakings that allow for public comment. Each entry
provides a quick link to a comment form so that visitors can type in
their comments and submit them to FSIS. The Web site is located at
http://www.regulations.gov/.

FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/

[[Page 53050]]

and allows FSIS customers to sign up for subscription options across
eight categories. Options range from recalls to export information to
regulations, directives and notices. Customers can add or delete
subscriptions themselves and have the option to password protect their
account.

References

1. Jeffrey, M., S. Ryder, S. Martin, et al., ``Oral Inoculation of
Sheep With the Agent of Bovine Spongiform Encephalopathy (BSE). 1.
Onset and Distribution of Disease-Specific PrP Accumulation in Brain
and Viscera,'' Journal of Comparative Pathology, 124: 280-289, 2001.
2. Bons, N., S. Lehmann, N. Nishida, et al., ``BSE Infection of the
Small Short-Lived Primate Microcebus Murinus,'' Comptes Rendus
Biologies, 325: 67-74, 2002.
3. Herzog, C., N. Sales, N. Etchegaray, et al., ``Tissue
Distribution of Bovine Spongiform Encephalopathy Agent in Primate After
Intravenous or Oral Infection,'' Lancet, 363: 422-428, 2004.
4. Jeffrey, M., I. Begara-McGorum, S. Clark, et al., ``Occurrence
and Distribution of Infection-Specific PrP in Tissues of Clinical
Scrapie Cases and Cull Sheep From Scrapie-Affected Farms in Shetland,''
Journal of Comparative Pathology, 127: 264-273, 2002.
5. Press, C. McL., R. Heggebo, A. Espenes, ``Involvement of Gut-
Associated Lymphoid Tissue of Ruminants in the Spread of Transmissible
Spongiform Encephalopathies,'' Advanced Drug Delivery Reviews, 56: 885-
899, 2004.
6. Heggebo, R., C. McL. Press, G. Gunnes, ``Distribution and
Accumulation of PrP in Gut-Associated and Peripheral Lymphoid Tissue of
Scrapie-Affected Suffolk Sheep,'' Journal of General Virology, 83: 479-
489, 2002.
7. Baird, A.W., D.P. Campion, L. O'Brien, D.J. Brayden, ``Oral
Delivery of Pathogens from the Intestine to the Nervous System,''
Journal of Drug Target, 12(2): 71-8, 2004.
8. Scientific Steering Committee. SSC Update of the Opinion on TSE
infectivity distribution in ruminant tissues (initially adopted on 10-
11 January 2002 and amended on 7-8 November 2002) following the
submission of (1) a risk assessment by the German Federal Ministry of
Consumer Protection, Food and Agriculture and (2) new scientific advice
regarding BSE infectivity distribution in tonsils. 2002. Health and
Consumer Protection Directorate-General (EC).
9. A.L.R. Findlay. Motility of the gastrointestinal tract of
ruminants. 98. Physiological laboratory, University of Cambridge. 2004.
10. Terry L.A., S. Marsh, S.J.Ryder, S.A. Hawkins, G.A. Wells, Y.I.
Spencer, ``Detection of Disease-Specific PrP in the Distal Ileum of
Cattle Exposed Orally to the Agent of Bovine Spongiform
Encephalopathy,'' Veterinary Record, 152(13): 387-92 2003.
11. Wells, G.A.H., M. Dawson, S.A.C. Hawkins, et al., ``Infectivity
in the Ileum of Cattle Challenged Orally to the Agent of Bovine
Spongiform Encephalopathy,'' Veterinary Record, 135: 40-41, 1994.
12. Scientific Steering Committee. SSC Opinion on BSE risk of the
bovine autonomic nervous system (Adopted by the Scientific Steering
Committee Meeting at its meeting of 6-7 March 2003. Health and Consumer
Protection Directorate-General (EC).
13. ProMED mail. BSE, ORAL CHALLENGE TRIAL 03). ProMED-mail 2004
20040524.1384. 2004.

List of Subjects

9 CFR Part 310

Animal diseases, Disposition of carcasses, Meat inspection, and
Post-mortem inspection.

9 CFR Part 318

Entry into official establishments, Food packaging, Meat
inspection, Reinspection and preparation of products.

0
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III as follows:

PART 310--POST-MORTEM INSPECTION

0
1. The authority citation for part 310 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


0
2. Paragraph (a)(3) of Sec. 310.22 is amended by removing the second
sentence and adding the following sentence and paragraphs (a)(3)(i) and
(ii) in its place:


Sec. 310.22 Specified risk materials from cattle and their handling
and disposition.

(a) * * *
(3) * * * The small intestine may be used for human food if:
(i) It is derived from cattle that were inspected and passed in an
official establishment in the United States or in a certified foreign
establishment in a country listed in 9 CFR 327.2(b) as eligible to
export meat and meat products to the United States and it is otherwise
eligible for importation under 9 CFR 327.1(b), and
(ii) 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 ceco-colic junction and progressing proximally towards the
jejunum or by a procedure that the establishment demonstrates is
effective in ensuring complete removal of the distal ileum.
* * * * *

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS

0
3. The authority citation for part 318 continues to read as follows:

Authority: 7 U.S.C. 38F, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.


0
4. Section 318.6 is amended to revise paragraphs (b)(1) and (b)(8) to
read as follows:


Sec. 318.6 Requirements concerning ingredients and other articles
used in preperation of products.

* * * * *
(b)(1) The only animal casings that may be used as containers of
product are those from sheep, swine, or goats. Casings from cattle may
be used as containers of products. However, if casings from cattle are
derived from the small intestine, the small intestine must comply with
the requirements in 9 CFR 310.22(a)(3). Establishments that use casings
derived from the small intestine of cattle as containers for products
must demonstrate, through documentation, that the small intestine from
which the casing was derived complies with the requirements in 9 CFR
310.22(a)(3).
* * * * *
(8) Intestines shall not be used as ingredients in any meat food
product for which a standard is prescribed in part 319 of this
subchapter and shall not be used in other products unless the products
are labeled in accordance with Sec. 317.8(b)(3) of this subchapter.
When small intestine from cattle is used in a meat food product or for
edible rendering, it must comply with the requirements in 9 CFR
310.22(a)(3).
* * * * *

Done at Washington, DC on: September 1, 2005.
Barbara J. Masters,
Administrator.
[FR Doc. 05-17683 Filed 9-6-05; 8:45 am]

BILLING CODE 3410-DM-P

http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-17683.htm

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