FR Doc 05-17693

[Federal Register: September 7, 2005 (Volume 70, Number 172)]
[Rules and Regulations]
[Page 53063-53069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se05-7]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0081]
RIN 0910-AF47

Use of Materials Derived From Cattle in Human Food and Cosmetics

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule and request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the interim
final rule on use of materials derived from cattle in human food and
cosmetics published in the Federal Register of July 14, 2004. In the
July 14, 2004, interim final rule, FDA designated certain materials
from cattle, including the entire small intestine, as ``prohibited
cattle materials'' and banned the use of such materials in human food,
including dietary supplements, and in cosmetics. FDA is taking this
action in response to comments received on the interim final rule.
Information was provided in comments that persuaded the agency that the
distal ileum, one of three portions of the small intestine, could be
consistently and effectively removed from the small intestine, such
that the remainder of the small intestine, formerly a prohibited cattle
material, could be used for human food or cosmetics. We (FDA) are also
clarifying that milk and milk products, hide and hide-derived products,
and tallow derivatives are not prohibited cattle materials. Comments
also led the agency to reconsider the method cited in the interim final
rule for determining insoluble impurities in tallow and to cite instead
a method that is less costly to use and requires less specialized
equipment. FDA issued the interim final rule to minimize human exposure
to materials that scientific studies have demonstrated are highly
likely to contain the bovine spongiform encephalopathy (BSE) agent in
cattle infected with the disease. FDA believes that the amended
provisions of the interim final rule provide the same level of
protection from human exposure to the agent that causes BSE as the
original provisions.

DATES: The amendments to the interim final rule are effective October
7, 2005. Submit written or electronic comments on the amendments to the
interim final rule by November 7, 2005. The Director of the Office of
the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in 21 CFR 189.5 and 700.27 as of October 7, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2004N-
0081, by any of the following methods:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0081 and/or RIN number RIN 0910-AF47 in the subject line of your e-mail
message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, Food and Drug
Administration (HFA -305), 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm , including any personal

information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Effective Date and Opportunity for Public Comment'' heading of the
SUPPLEMENTARY INFORMATION in section IV of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number, 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: Rebecca Buckner, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.

SUPPLEMENTARY INFORMATION:

I. Background

On July 14, 2004, FDA issued an interim final rule entitled ``Use
of Materials Derived From Cattle in Human Food and Cosmetics'' (also
referred to as ``the interim final rule''), to address the potential
risk of BSE in human food and cosmetics (69 FR 42256, July 14, 2004).
In the interim final rule, FDA designated certain materials from cattle
as ``prohibited cattle materials'' and banned the use of such materials
in human food, including dietary supplements, and in cosmetics in
Sec. Sec. 189.5 and 700.27 (21 CFR 189.5 and 21 CFR 700.27). In the
interim final rule, FDA designated the following as prohibited cattle
materials: Specified risk materials (SRMs), the small intestine from
all cattle, material from nonambulatory cattle, material from cattle
not inspected and passed for human consumption, and mechanically
separated (MS)(Beef). The materials designated as SRMs were 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 of cattle 30 months and older, and the distal ileum of the
small intestine and tonsils from all cattle. The Food Safety and
Inspection Service (FSIS) of the United States Department of
Agriculture (USDA) designated the same list of materials as SRMs in its
rule entitled ``Prohibition of the Use of Specified Risk Materials for
Human Food and Requirements for the Disposition of Non-ambulatory
Disabled Cattle'' (69 FR 1862, January 12, 2004). In addition, FDA
provided an alternative standard for tallow in its interim final rule.
Tallow must be produced by either excluding prohibited cattle materials
or, if produced using prohibited cattle materials, must contain no more
than 0.15 percent insoluble impurities. Tallow derivatives were
exempted from

[[Page 53064]]

the provisions of FDA's interim final rule.
The comment period for the interim final rule closed on October 12,
2004. After reviewing comments received on the interim final rule, FDA
determined that it needed to make some changes and clarifications now,
rather than waiting until we could address all of the comments in a
final rule. We are amending or clarifying the interim final rule in the
following five areas:
1. Use of small intestine,
2. Status of milk and milk products,
3. Status of tallow derivatives,
4. Status of cattle hide, and
5. Testing method cited for determining the level of insoluble
impurities in tallow.
We are making these amendments to the interim final rule in part in
response to comments indicating uncertainty regarding the status of
certain products under the interim final rule and new information
regarding removal of the distal ileum.

II. Amendments and Clarifications to the Interim Final Rule

A. Prohibition on the Use of Small Intestine From All Cattle

In the interim final rule of July 14, 2004, FDA prohibited the use
of the entire small intestine in human food and cosmetics, even though
the agency (at the time the interim final rule was issued) only
considered, and currently only considers, the distal ileum portion of
the small intestine to be an SRM. As stated in the preamble to the
interim final rule, FDA prohibited the use of the entire small
intestine because at the time we believed: (1) It would be difficult to
distinguish one end of the small intestine from the other once it had
been removed from the animal; (2) there was a lack of international
agreement on how much of the small intestine should be removed to
ensure that the distal ileum is separated from the remainder of the
intestine; and (3) given the lack of international consensus on the
issue, a manufacturer or processor would not be able to document that
the distal ileum was adequately removed (69 FR 42256 at 42259). We
requested comments addressing our reasons for prohibiting use of the
entire small intestine and solicited specific information on whether
processors may be able to effectively remove just the distal ileum.
1. Comments Received
In response to the interim final rule, FDA received comments from
beef processors, the natural casing industry, the beef by-product
industry, and importers and exporters of natural casings and beef by-
products that requested that the agency amend its prohibited cattle
materials rule to prohibit only the distal ileum portion of the small
intestine for human food and cosmetics, rather than the entire small
intestine. As stated in the comments, infectivity has only been
confirmed 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 portion from the rest of the small
intestine.
Comments also described, in detail, examples of verifiable
procedures for the effective removal of the distal ileum portion of the
small intestine, which is made up of three sections: The duodenum, the
jejunum, and the 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 caecum at the
ileocecal orifice, and the ileum is separated from the jejunum at the
flange. According to the comments, the resulting segment 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 caecum. The
separation of the non-ileum sections of the small intestine from the
ileum is made at a point 36 to 80 inches from the caecum, leaving the
entire ileum of the small intestine attached to the caecum. According
to the comments, leaving the ileum attached to the caecum 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
caecum at the ileocecal orifice, leaving the caecum and the small
intestine for edible use.
Another comment noted that, prior to December 2003, Japan accepted
importation of beef casings from the United States on the basis of U.S.
government certified removal of the distal ileum from the small
intestine. The procedure required the removal of at least 80 inches of
the small intestine, measured from the junction of the ileum and the
caecum, to ensure removal of the distal ileum.
Several comments indicated that, because of the distinct shape of
the distal ileum of cattle, it is easy to verify the effective removal
of this portion of the small intestine. Furthermore, comments from the
natural casing industry stated that, because of the distal ileum's
physical properties, particularly the absence of a curve and an
irregular thick surface, the distal ileum is not useable as a natural
casing for sausage products. Thus, these comments noted, many slaughter
establishments in the United States and Canada have a policy of
removing the distal ileum from all cattle at the time of slaughter.
Furthermore, as stated by the comments, slaughter establishments in
Brazil, Argentina, and Uruguay, the three countries that are the major
exporters of natural casings to the United States, have all been able
to certify the removal of the distal ileum using achievable standards
when requested to do so by their U.S. customers.
In addition to comments requesting that only the distal ileum
portion of the small intestine be prohibited from use in human food and
cosmetics, we received comments stating that the entire small intestine
or both the small and large intestines should be considered SRMs.
Comments noted that the European Union (EU) identifies both the small
and large intestine as specified risk material and prohibits their use
in food. As stated in comments, this was done in the EU because BSE
infection is associated with absorption of the BSE agent from
contaminated feed and because it is not possible to prevent
slaughterhouse contamination of other intestinal areas with matter from
the ileum. Comments also cited a study showing that the myenteric
plexus of the distal ileum was positive when immunostained in naturally
infected and experimentally infected cattle. The comments noted that,
because the myenteric plexus runs throughout the intestine, the
possibility of infectivity in other sections of the intestine cannot be
discounted. Comments also noted that the International Review Team
(IRT), appointed to review BSE prevention measures in the United States
after the discovery of the BSE-positive cow in Washington State,
recommended that the SRM ban be amended to include the entire small and
large intestines.
2. Response to Comments
After considering the comments submitted on the removal of the
distal ileum, FDA has concluded that processors have the technology to
effectively remove the distal ileum portion from the rest of the small
intestine.
FDA believes that procedures to ensure effective removal of the
distal ileum require that at least 80 inches of

[[Page 53065]]

the uncoiled and trimmed small intestine, as measured from the caeco-
colic junction and progressing proximally towards the jejunum, be
removed. We believe that these procedures ensure removal of the entire
distal ileum despite differences in length of the intestinal tract or
its segments between breeds or among animals of different sizes of the
same breed. An alternative removal procedure may be used if an
establishment can demonstrate that it is equally effective in ensuring
that the entire distal ileum is completely removed.
We do not agree with comments that stated that the entire small
intestine or both the small and the large intestine should be
designated as SRMs. Though the EU prohibits the entire intestine from
use in food, the data that we are aware of indicating infectivity along
the entire intestine is from other species, not from cattle infected
with BSE or other transmissible spongiform encephalopathies (TSEs)
(Refs. 1 to 6). Though the studies in other species represent the
distribution of infectivity in those species, they may not represent
the distribution of infectivity in cattle infected with BSE as
evidenced by studies with bovine tissue.
In cattle, infectivity has been found in the distal ileum in tissue
bioassay from cattle experimentally given BSE (Ref. 7; see discussion
in sections I. E and F of the interim final rule). In cattle
experimentally infected with BSE, positive Peyer's patches were found
by immunohistochemistry only in the distal ileum, and in cattle with
naturally occurring and experimental BSE, positive myenteric plexus
neurons were found only in the distal ileum (Ref. 8). The duodenum of
cattle experimentally given BSE has not demonstrated infectivity when
tested by mouse bioassay and has been negative for the presence of
abnormal prions when examined by immunohistochemistry during all stages
in the pathgenesis of the disease (Refs. 8 and 9). Few samples of
jejunum have been tested, but those that have been tested were negative
for the presence of abnormal prions when examined by
immunohistochemistry (Ref. 8). In a bioassay of tissues from cattle
with naturally-occuring BSE, no infectivity was found in the splanchnic
nerve, rumen, omasum, abomasum, proximal small intestine, proximal
colon, distal colon, and rectum, or even in the distal small intestine
(Ref. 9).
The study by Terry and others (Ref. 8) indicated that the myenteric
plexus of the distal ileum contained some abnormal prion protein in
neurons. This tissue extends throughout the small intestine, so we
cannot completely eliminate the possibility that infectivity might
exist in the jejunum or the duodenum. However, that same study found no
evidence of abnormal prion protein in the sections of the duodenum and
the jejunum examined. Therefore, it is likely that, if any infectivity
is present, it is at levels too low to present a public health risk. We
realize that the studies on tissue infectivity have limitations, but we
are not aware of evidence that intestine other than the distal ileum
harbors infectivity in cattle with BSE. If we become aware of data
indicating that other portions of the small intestine or the large
intestine in cattle harbor infectivity, we will take action appropriate
to the public health risk presented by the tissues.
We also do not agree that cross contamination of other parts of the
intestine with infectivity in the distal ileum is unavoidable in the
slaughterhouse. Comments provided several methods by which the distal
ileum can be consistently and effectively removed from the rest of the
small intestine without cross contamination during slaughter. We agree
that, if these methods are properly implemented, cross contamination
can be avoided.
Finally, we do not agree that we should require that the entire
intestine of all cattle be designated an SRM because the IRT
recommended it. As stated previously in this document, the agency does
not find that there is sufficient evidence to support designating the
entire intestine as an SRM.
Therefore, we are amending Sec. Sec. 189.5(a)(1) and 700.27(a)(1)
to reflect that small intestine is a prohibited cattle material unless
it meets the provisions of new Sec. Sec. 189.5(b)(2) and 700.27(b)(2).
New Sec. Sec. 189.5(b)(2) and 700.27(b)(2) state that small intestine
is not considered prohibited cattle material if the distal ileum is
removed by a procedure that verifiably 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.
These amendments to FDA's interim final rule are consistent with
amendments that USDA made to its interim final rule regarding use of
small intestine appearing elsewhere in this issue of the Federal
Register. FDA regulates stripped and cleaned casings derived from
bovine small intestine, and USDA's FSIS regulates unprocessed bovine
small intestine and ``meat food'' products made with beef casings. It
is important to note that natural beef casings and other FDA regulated
products derived from small intestine are also subject to FSIS
requirements when used in FSIS regulated products. Specifically, FSIS
will not permit natural casings derived from beef small intestine to be
used in meat food products unless the casings are derived from cattle
that have been inspected and passed in a U.S. official establishment or
in a certified foreign establishment.

B. Status of Milk and Milk Products

The interim final rule provides that no human food or cosmetics
shall be manufactured from, processed with or otherwise contain,
prohibited cattle materials. Prohibited cattle materials include
material from cattle not inspected and passed for human consumption.
1. Comments Received
Several comments noted that milk and milk products could be viewed
as products that are not inspected and passed because milk is obtained
from live animals that do not undergo the same inspection as cattle
during slaughter. These comments noted that milk and milk products are
internationally recognized to present a negligible risk of transmitting
the agent that causes BSE and asked that we clarify the status of milk
and milk products under the interim final rule.
2. Response to Comments
The interim final rule applies to materials from cattle slaughtered
on or after the effective date and was not meant to apply to milk and
milk products, which come from live cattle. Therefore, we are amending
Sec. Sec. 189.5(a)(1) and 700.27(a)(1) to clarify that milk and milk
products are not included in the definition of ``prohibited cattle
materials.''

C. Clarification of the Classification of Tallow Derivatives

The interim final rule defines tallow and tallow derivatives and
states that prohibited cattle materials do not include tallow that
contains no more than 0.15 percent hexane-insoluble impurities and
tallow derivatives.
1. Comments Received
Several comments requested that we clarify whether the tallow used
as starting material for the tallow derivatives has to contain no more
than 0.15 percent insoluble impurities in order for the tallow
derivatives not to be included in the definition of ``prohibited cattle
materials.''

[[Page 53066]]

2. Response to Comments
The exemption of tallow derivatives from the definition of
``prohibited cattle materials'' does not depend on the source tallow
for the derivatives. For the reasons discussed in the preamble to the
interim final rule, tallow derivatives present a negligible risk of
transmitting the agent that causes BSE regardless of the source tallow.
Therefore, all tallow derivatives are exempt from the ban on the use of
prohibited cattle materials in human food and cosmetics.

D. Status of Human Food and Cosmetics Derived From Cattle Hide

The interim final rule provides that no human food or cosmetics
shall be manufactured from, processed with or otherwise contain,
prohibited cattle materials. Prohibited cattle materials include
products that have not been inspected and passed for human consumption.
Cattle hides, which are used as source material for collagen and
collagen casings, receive antemortem but not postmortem inspection in
most slaughter operations.
1. Comments Received
Several comments stated that the commenters did not believe that
FDA meant to designate all cattle hide and products derived from hide
as prohibited cattle material because they do not undergo postmortem
inspection. These comments also pointed out that antemortem inspection
is when BSE might be detected from the behavior or appearance of the
animal, while postmortem inspection is more useful for detecting cross
contamination among parts of the carcass. Comments indicated that risk
of cross contamination by other carcass parts is not relevant for the
hide because it is removed at the beginning of the slaughter process.
In addition, comments noted that cattle hide is internationally
recognized to be a tissue with a negligible risk of transmitting the
agent that causes BSE, and the World Organization for Animal Health
(OIE) recommends that it be freely traded regardless of the BSE risk
status of the exporting countries.
2. Response to Comments
We agree with these comments. It was not our intention to designate
all products derived from cattle hide as prohibited cattle materials
for use in human food and cosmetics. We also recognize that cattle hide
has been determined to be a tissue with negligible risk of transmitting
the agent that causes BSE and that the OIE recommends that it be freely
traded regardless of the BSE risk status of the exporting countries.
Therefore, we are exempting hides from the provisions of the interim
final rule and are amending Sec. Sec. 189.5(a)(1) and 700.27(a)(1) to
clarify that hides and hide-derived products are not included in the
definitions of ``prohibited cattle materials.'' Though we are exempting
hides from the provisions of the interim final rule, manufacturers and
processors must take precautions to avoid cross contamination of hides
and other nonprohibited cattle material with prohibited cattle material
during slaughter and processing. If hides are cross contaminated with
prohibited cattle material, they will be considered adulterated.

E. Method for Determining the Level of Insoluble Impurities in Tallow

Under the interim final rule (Sec. Sec. 189.5(a)(6) and
700.27(a)(6)), any raw materials may be used as the starting material
for tallow production as long as the resulting tallow contains no more
than 0.15 percent hexane insoluble impurities. The interim final rule
requires that the method for ``hexane-insoluble matter'' described in
the 5th edition of the Food Chemicals Codex (FCC) be used to measure
hexane-insoluble impurities in tallow. The interim final rule also
states that an alternative method may be used if it is equivalent to
the FCC method.
1. Comments Received
We received several comments requesting that we specify a different
method for measuring insoluble impurities in tallow. Comments stated
that the domestic tallow industry primarily uses a method of the
American Oil Chemists' Society (AOCS) to measure insoluble impurities.
In comparison to the FCC method, comments stated that the AOCS method
is less expensive, requires less solvent and has lower solvent disposal
costs, and does not require specialized equipment or supplies. These
comments requested that FDA approve the AOCS method for measuring
insoluble impurities.
2. Response to Comments
FDA agrees that the FCC method is more expensive, uses more
solvent, and requires more specialized equipment than other methods
currently used by industry. In response to comments and the information
we obtained about the various methods, we are amending the interim
final rule to cite the method for measuring insoluble impurities of the
AOCS (``Insoluble Impurities,'' AOCS Official Method Ca 3a-46) or a
method equivalent to it in accuracy, precision and sensitivity. The
AOCS method is currently used by the domestic tallow industry, uses
updated equipment, is less expensive to implement, and may be more
sensitive than the FCC method.
Reference to the AOCS method in the amended interim final rule does
not exclude use of the FCC method we cited in the interim final rule.
Any testing method may be used that is equivalent to the AOCS method.
Those wishing to use an alternate test are responsible for determining
that it is equivalent to the AOCS method cited in the interim final
rule as amended here; it is not necessary that FDA approve the use of
an alternate test.

III. Summary of Amendments to the Interim Final Rule

We are amending Sec. Sec. 189.5(a)(1) and 700.27(a)(1) to reflect
that small intestine is a prohibited cattle material unless it meets
the provisions of new Sec. Sec. 189.5(b)(2) and 700.27(b)(2). New
Sec. Sec. 189.5(b)(2) and 700.27(b)(2) state that 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.
We are amending Sec. Sec. 189.5(a)(1) and 700.27(a)(1) to specify
that milk and milk products and hides and hide-derived products are not
prohibited cattle materials.
Finally, we are amending Sec. Sec. 189.5(a)(6) and 700.27(a)(6) to
indicate that tallow, if it is sourced from unknown materials, must
contain not more than 0.15 percent insoluble impurities as determined
by the method ``Insoluble Impurities'' (AOCS Official Method Ca 3a-46),
AOCS, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46.

IV. Effective Date and Opportunity for Public Comment

FDA provided the public with an opportunity to comment on the
issues raised by the interim final rule and addressed in this document.
These amendments to the interim final rule are in response to some of
those comments. These amendments to the interim final rule are
effective October 7, 2005. FDA invites public comment on these
amendments to the interim final rule. The comment period will be 60
days. The agency will consider modifications to these amendments to the
interim final rule based on comments made during

[[Page 53067]]

the comment period. Interested persons may submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding these amendments to the interim final rule. Submit a single
copy of electronic comments or two paper copies of any mailed comments,
except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
FDA will address other comments received in response to the interim
final rule and comments received in response to this amendment in
further rulemaking.

V. Executive Order 12866 and Regulatory Flexibility Act

FDA has examined the economic implications of this amendment to the
interim final rule as required by Executive Order 12866. Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including: Having an annual effect on the economy
of $100 million, adversely affecting a sector of the economy in a
material way, adversely affecting competition, or adversely affecting
jobs. A regulation is also considered a significant regulatory action
if it raises novel legal or policy issues. FDA has determined that this
amendment to the interim final rule is not an economically significant
regulatory action.
FDA has examined the economic implications of this amendment to the
interim final rule as required by the Regulatory Flexibility Act (5
U.S.C. 601-612). If a rule has a significant economic impact on a
substantial number of small entities, the Regulatory Flexibility Act
requires agencies to analyze regulatory options that would lessen the
economic effect of the rule on small entities. FDA has determined that
this amendment to the interim final rule does not have a significant
economic impact on a substantial number of small entities.
Bovine Small Intestine
The effect of amending the interim final rule will be that FDA
regulated human food and cosmetics may be manufactured from, processed
with, or otherwise contain small intestine if the distal ileum is
effectively removed. FDA regulates stripped and cleaned casings derived
from bovine small intestine, and USDA's FSIS regulates unprocessed
bovine small intestine and ``meat food'' products made with beef
casings. Very few, if any, FDA regulated foods use beef intestines or
beef casings as an ingredient. Therefore, the impact on FDA regulated
food industries as a result of this amendment to the final rule is
expected to be small. In the economic analysis of the interim final
rule, FDA did not estimate any opportunity costs for cattle
slaughterers or manufacturers that used beef small intestines and beef
natural casings in their products because the small intestine had
already been banned as human food by the FSIS interim final rule (69 FR
1862, January 12, 2004).
USDA's FSIS is amending its interim final rule to allow the use of
bovine small intestine, without the distal ileum, in USDA regulated
products. FDA's amendment will benefit those FSIS regulated
manufacturers who use beef casings; FDA's amendment again allows this
bovine material potentially to be used in FSIS regulated products. See
the FSIS interim final rule (69 FR 1862; January 12, 2004) and
accompanying analysis for the cost savings associated with the renewed
use of bovine small intestine in human foods products.
Tallow
FDA is amending the interim final rule to cite the AOCS method for
measuring insoluble impurities in tallow. The domestic tallow industry
primarily uses the AOCS method to measure insoluble impurities in
tallow, so this change to the rule will reduce the burden of having to
switch to a new measurement standard for many of the domestic tallow
manufacturers. In comparison to the FCC method cited by the interim
final rule, commenters stated that the AOCS method is less expensive
than the FCC method. Tallow producers do not have to use the AOCS
method if they use another method that is equivalent to the AOCS method
in accuracy, precision, and sensitivity. Tallow producers using nonAOCS
methods that can be validated will likely not switch methods and will
only bear the cost burden of validating that their method is equivalent
to the AOCS method. Tallow producers, who do not currently use the AOCS
method but decide to switch to the method as a result of this amendment
to the interim final rule, will pay a $50 fee to obtain the AOCS
copyrighted method.

VI. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for subsequent changes to the nonFDA Web sites after this document
publishes in the Federal Register.)
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. Wells, G. A. H., M. Dawson, S. A. C. Hawkins, et al.,
``Infectivity in the Ileum of Cattle Challenged Orally With Bovine
Spongiform Encephalopathy,'' Veterinary Record, 135: 40-41, 1994.
8. Terry, L. A., S. Marsh, S. J. Ryder, et al., ``Detection of
Disease-Specific PrP in the Distal Ileum of Cattle Exposed Orally to
the Agent of Bovine Spongiform Encephalopathy,'' Veterinary Record,
152: 387-392, 2003.
9. Scientific Steering Committee, European Commission, ``Update
on the Opinion of TSE Infectivity Distribution in Ruminant Tissues:
Initially Adopted by the Scientific Steering Committee at its
Meeting of January 10-11, 2002, and Amended at its Meeting of
November 7-8, 2002, Following the Submission of a Risk Assessment by
the German Federal Ministry of Consumer Protection, Food and
Agriculture and New Scientific Evidence Regarding BSE Infectivity
Distribution in Tonsils,'' accessed online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://europa.eu.int/comm/food/
fs/bse/scientific--advice08--en.html.

[[Page 53068]]

List of Subjects

21 CFR Part 189

Food additives, Food packaging, Incorporation by reference.

21 CFR Part 700

Cosmetics, Packaging and containers, Incorporation by reference.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
189 and 700 are amended as follows:

PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

0
1. The authority citation for 21 CFR part 189 continues to read as
follows:

Authority: 21 U.S.C. 321, 342, 348, 371.

0
2. Part 189 is amended by revising Sec. 189.5 to read as follows:
Subpart B--Prohibited Cattle Materials
Sec.
Sec. 189.5 Prohibited cattle materials.

Subpart B--Prohibited Cattle Materials

Sec. 189.5 Prohibited cattle materials.

(a) Definitions. The definitions and interpretations of terms
contained in section 201 of the Federal Food, Drug, and Cosmetic Act
(the act) apply to such terms when used in this part. The following
definitions also apply:
(1) Prohibited cattle materials means specified risk materials,
small intestine of all cattle except as provided in paragraph (b)(2) of
this section, material from nonambulatory disabled cattle, material
from cattle not inspected and passed, or mechanically separated
(MS)(Beef). Prohibited cattle materials do not include tallow that
contains no more than 0.15 percent insoluble impurities, tallow
derivatives, hides and hide-derived products, and milk and milk
products.
(2) Inspected and passed means that the product has been inspected
and passed for human consumption by the appropriate regulatory
authority, and at the time it was inspected and passed, it was found to
be not adulterated.
(3) Mechanically Separated (MS)(Beef) means a meat food product
that is finely comminuted, resulting from the mechanical separation and
removal of most of the bone from attached skeletal muscle of cattle
carcasses and parts of carcasses that meets the specifications
contained in 9 CFR 319.5, the regulation that prescribes the standard
of identity for MS (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise
from a recumbent position or that cannot walk, including, but not
limited to, those with broken appendages, severed tendons or ligaments,
nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk material means 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
of cattle 30 months and older and the tonsils and distal ileum of the
small intestine of all cattle.
(6) Tallow means the rendered fat of cattle obtained by pressing or
by applying any other extraction process to tissues derived directly
from discrete adipose tissue masses or to other carcass parts and
tissues. Tallow must be produced from tissues that are not prohibited
cattle materials or must contain not more than 0.15 percent insoluble
impurities as determined by the method entitled ``Insoluble
Impurities'' (AOCS Official Method Ca 3a-46), American Oil Chemists'
Society (AOCS), 5th Edition, 1997, incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method
equivalent in accuracy, precision, and sensitivity to AOCS Official
Method Ca 3a-46. You may obtain copies of the method from AOCS (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.aocs.org
) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be

examined at the Center for Food Safety and Applied Nutrition's Library,
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.

(7) Tallow derivative means any chemical obtained through initial
hydrolysis, saponification, or trans-esterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or
trans-esterification may be applied to obtain the desired product.
(b) Requirements.
(1) No human food shall be manufactured from, processed with, or
otherwise contain, prohibited cattle materials.
(2) 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.
(c) Records. Manufacturers and processors of human food that is
manufactured from, processed with, or otherwise contains, cattle
material must make existing records relevant to compliance with this
section available to FDA for inspection and copying.
(d) Adulteration.
(1) Failure of a manufacturer or processor to operate in compliance
with the requirements of paragraphs (b) or (c) of this section renders
human food adulterated under section 402(a)(4) of the act.
(2) Human food manufactured from, processed with, or otherwise
containing, prohibited cattle materials is unfit for human food and
deemed adulterated under section 402(a)(3) of the act.
(3) Food additive status. Prohibited cattle materials for use in
human food are food additives subject to section 409 of the act, except
when used as dietary ingredients in dietary supplements. The use or
intended use of any prohibited cattle material in human food causes the
material and the food to be adulterated under section 402(a)(2)(C) of
the act if the prohibited cattle material is a food additive, unless it
is the subject of a food additive regulation or of an investigational
exemption for a food additive under Sec. 170.17 of this chapter.

PART 700--GENERAL

0
3. The authority citation for 21 CFR part 700 continues to read as
follows:

Authority: 21 U. S. C. 321, 331, 352, 355, 361, 362, 371, 374.

0
4. Part 700 is amended by revising Sec. 700.27 to read as follows:

Sec. 700.27 Use of prohibited cattle materials in cosmetic products.

[[Page 53069]]

do not include tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and
milk and milk products.
(2) Inspected and passed means that the product has been inspected
and passed for human consumption by the appropriate regulatory
authority, and at the time it was inspected and passed, it was found to
be not adulterated.
(3) Mechanically Separated (MS)(Beef) means a meat food product
that is finely comminuted, resulting from the mechanical separation and
removal of most of the bone from attached skeletal muscle of cattle
carcasses and parts of carcasses that meet the specifications contained
in 9 CFR 319.5, the regulation that prescribes the standard of identity
for MS (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise
from a recumbent position or that cannot walk, including, but not
limited to, those with broken appendages, severed tendons or ligaments,
nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk material means 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
of cattle 30 months and older and the tonsils and distal ileum of the
small intestine of all cattle.
(6) Tallow means the rendered fat of cattle obtained by pressing or
by applying any other extraction process to tissues derived directly
from discrete adipose tissue masses or to other carcass parts and
tissues. Tallow must be produced from tissues that are not prohibited
cattle materials or must contain not more than 0.15 percent insoluble
impurities as determined by the method entitled ``Insoluble
Impurities'' (AOCS Official Method Ca 3a-46), American Oil Chemists'
Society (AOCS), 5th Edition, 1997, incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method
equivalent in accuracy, precision, and sensitivity to AOCS Official
Method Ca 3a-46. You may obtain copies of the method from the AOCS
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821. Copies

may be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.archives.gov/federal --register/code--of--federal--

regulations /ibr--locations.html.
(7) Tallow derivative means any chemical obtained through initial
hydrolysis, saponification, or trans-esterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or
trans-esterification may be applied to obtain the desired product.
(b) Requirements.
(1) No cosmetic shall be manufactured from, processed with, or
otherwise contain, prohibited cattle materials.
(2) 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.
(c) Records. Manufacturers and processors of cosmetics that are
manufactured from, processed with, or otherwise contain, cattle
material must make existing records relevant to compliance with this
section available to FDA for inspection and copying.
(d) Adulteration. Failure of a manufacturer or processor to operate
in compliance with the requirements of paragraph (b) or (c) of this
section renders a cosmetic adulterated under section 601(c) of the act.

Dated: August 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17693 Filed 9-6-05; 8:45 am]

BILLING CODE 4160-01-S