[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Rules and Regulations]
[Pages 53063-53069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17693]


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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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#89efede8ede6eae2ecfdfac9e6eaa7efede8a7eee6ff"><span class="__cf_email__" data-cfemail="a2c4c6c3c6cdc1c9c7d6d1e2cdc18cc4c6c38cc5cdd4">[email protected]</span></a>. Include Docket No. 2004N-
0081 and/or RIN number RIN 0910-AF47 in the subject line of your e-mail 
message.
    <bullet> FAX: 301-827-6870.
    <bullet> 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://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://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://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://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://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.

    (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

[[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://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://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


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