Use of Materials Derived From Cattle in Human Food and Cosmetics, 20785-20794 [08-1142]

Agencies

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

[Federal Register Volume 73, Number 75 (Thursday, April 17, 2008)]
[Rules and Regulations]
[Pages 20785-20794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1142]


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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 its 
regulations on the use of materials derived from cattle in human food 
and cosmetics. In these regulations, FDA has designated certain 
materials from cattle as ``prohibited cattle materials'' and has banned 
the use of such materials in human food, including dietary supplements, 
and in cosmetics. Prohibited cattle materials include specified risk 
materials (SRMs), the small intestine of all cattle unless the distal 
ileum is removed, material from nonambulatory disabled cattle, material 
from cattle not inspected and passed for human consumption, or 
mechanically separated (MS) (Beef). Specified risk materials include 
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 of age and older, and the 
tonsils and distal ileum of the small intestine of all cattle. FDA is 
amending its regulations so that FDA may designate a country as not 
subject to certain bovine spongiform encephalopathy (BSE)-related 
restrictions applicable to FDA regulated human food and cosmetics. A 
country seeking to be so designated must send a written request to the 
Director of FDA's Center for Food Safety and Applied Nutrition, 
including information about the country's BSE case history, risk 
factors, measures to prevent the introduction and transmission of BSE, 
and any other relevant information.

DATES: This interim final rule is effective July 16, 2008. Submit 
written or electronic comments on this interim final rule by July 16, 
2008. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by May 19, 2008 (see the ``Paperwork 
Reduction Act of 1995'' section of this document).

[[Page 20786]]


ADDRESSES: You may submit comments, identified by Docket No. 2004N-0081 
and RIN 0910-AF47, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously in the ADDRESSES portion of 
this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No. and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see 
section IV of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov 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-316), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 14, 2004 (69 FR 42256), FDA issued 
an interim final rule entitled ``Use of Materials Derived From Cattle 
in Human Food and Cosmetics'' (``the 2004 IFR'') to address the 
potential risk of BSE in human food and cosmetics. In the 2004 IFR, 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. These restrictions 
appear in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and 21 CFR 700.27) 
of FDA's regulations.
    The 2004 IFR designated the following as prohibited cattle 
materials: SRMs, the small intestine from all cattle, material from 
nonambulatory disabled cattle, material from cattle not inspected and 
passed for human consumption, or MS (Beef). SRMs include 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 of age and older, and the tonsils and 
distal ileum of the small intestine 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 
interim final 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 the Federal Register of September 7, 2005 (70 FR 53063), FDA 
amended the 2004 IFR to permit the use of the small intestine in human 
food and cosmetics provided the distal ileum portion of the small 
intestine has been removed. FDA also clarified that milk and milk 
products, hide and hide-derived products, and tallow derivatives are 
not prohibited cattle materials, and cited a different method for 
determining impurities in tallow. Also in the Federal Register of 
September 7, 2005 (70 FR 53043), FSIS published a similar amendment to 
its interim final rule, permitting the use of the small intestine in 
human food provided the distal ileum is removed.

II. Amendments to the Interim Final Rule's Provisions on Prohibited 
Cattle Materials

    In the 2004 IFR, FDA requested comment on whether materials from 
countries believed to be free of BSE should be exempt from the 
``prohibited cattle materials'' requirements. FDA further solicited 
comment on what standards it should apply in determining whether to 
exempt a country and how it should determine whether a country meets 
such standards (69 FR 42256 at 42263). FSIS requested similar comment 
on the issue of equivalence in applying its BSE requirements in an 
advance notice of proposed rulemaking (ANPR) entitled ``Federal 
Measures to Mitigate BSE Risks: Considerations for Further Actions,'' 
jointly published by USDA's Animal and Plant Health Inspection Service 
(APHIS) and FSIS, and FDA on July 14, 2004 (69 FR 42299-42300).

A. Comments Received

    In response to FDA's solicitation on this issue, FDA received 
comments from representatives of several foreign countries that export 
cattle materials or products derived from such materials into the 
United States and from several trade associations. The comments take 
issue with the uniform application of FDA's BSE-related measures to all 
human food and cosmetics imported into the United States, without 
regard to the BSE risk status of the originating country. Several 
comments state that their countries have a comprehensive range of 
control measures in place to prevent the entry and/or amplification of 
the BSE agent. These comments maintain that countries classified as 
BSE-free do not present a BSE risk and therefore should not be expected 
to comply with FDA's BSE-related restrictions. These comments further 
maintain that U.S. requirements are forcing establishments and firms in 
countries considered to be free of BSE to carry out costly and 
unnecessary measures that are not scientifically justified so that they 
can export cattle materials to the United States.
    These comments also state that providing an exemption from BSE-
related restrictions for countries classified as free of BSE would be 
consistent with guidelines established by the World Organization for 
Animal Health (referred to as ``OIE,'' based on its previous name, 
Office International des Epizooties), an international standard-setting 
body with 169 member countries, that publishes health standards for 
international trade in animal products. These comments state that the 
OIE recommends that countries restrict the importation of cattle 
material of potential concern on the basis of the BSE risk 
classification of the country or zone of origin. (See Terrestrial 
Animal Health Code, Ref. 1). These comments also point out that OIE 
recommends the removal of SRMs for imports from countries classified as 
minimal, moderate, and high risk for BSE but not for imports from 
countries with BSE-free status.\1\ Further, these comments

[[Page 20787]]

point out that the World Trade Organization Agreement on the 
Application of Sanitary and Phytosanitary Measures (the SPS Agreement) 
requires member countries to recognize regionalization of diseases and 
not put in place measures that are more trade restrictive than 
necessary to achieve public health goals.
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    \1\ At the time the comments were submitted, OIE classified 
countries for purposes of BSE into one of five categories: ``free,'' 
``provisionally free,'' ``minimal,'' ``moderate,'' and ``high 
risk.'' OIE subsequently revised its categories and now uses only 
three categories: ``negligible,'' ``controlled,'' and 
``undetermined'' risk. Countries previously categorized as ``BSE-
free'' or ``provisionally free'' are now categorized as having 
``negligible'' BSE risk.
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    Several of the comments also note that Canada and the European 
Union (EU) do not apply all of their BSE-related restrictions to 
countries recognized as BSE-free. For example, EU food and cosmetic 
regulations exclude countries that fall within the EU's lowest risk 
range of BSE risk categories from restrictions on the use of SRMs. 
Canada provides a similar exemption from its BSE-related restrictions 
for countries it considers to be free from BSE.\2\
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    \2\ Since these comments were submitted, Canada has adopted the 
OIE BSE risk categorization system of negligible, controlled, and 
undetermined risk. The EU is in the process of transitioning from 
its geographical BSE risk (GBR) system, which includes four levels 
of risk, to the OIE 3-tiered risk categorization system.
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    One comment suggests that in considering the BSE risk status of 
another country, FDA should refer to available country assessments 
already completed by USDA's APHIS in carrying out its BSE-related 
restrictions on imports of meat and edible products from ruminants 
(codified at 9 CFR 94.18), or otherwise rely on criteria provided by 
OIE for determining BSE-free countries. One comment recommends that if 
the assessment is conducted by U.S. authorities, it should be conducted 
by a single U.S. agency, preferably APHIS, given its prior experience 
in conducting this type of assessment.

B. USDA Amendment

    USDA's FSIS received similar comments in response to its interim 
final rule published on January 12, 2004, and the ANPR published July 
14, 2004, regarding the application of its BSE-related restrictions for 
imported products without taking into account a country's BSE risk 
status. Based in part on these comments, FSIS, in its affirmation of 
interim final rules with amendments published on July 13, 2007 (72 FR 
38699), amended its regulations to exclude from its definition of SRMs 
those materials from cattle that come from foreign countries that can 
demonstrate that their BSE risk status can reasonably be expected to 
provide the same level of protection from exposure to the BSE agent as 
does prohibiting the use of SRMs in the United States.

C. Response to Comments

    FDA agrees with the views expressed by the comments and has 
determined that it is not necessary for all BSE-related restrictions to 
apply to human food and cosmetics regardless of a country's BSE status. 
FDA's BSE-related restrictions for human food and cosmetics are 
intended to address the potential presence of BSE in a country's cattle 
population. SRMs are prohibited because they are the tissues most 
likely to harbor infectivity in cattle with BSE. The small intestine is 
prohibited unless the distal ileum portion of the small intestine, 
which is considered an SRM, is effectively removed. Material from 
nonambulatory disabled cattle are prohibited because evidence has 
indicated that this segment of the cattle population is more likely to 
have BSE than healthy-appearing cattle and the typical clinical signs 
of BSE having to do with gait and movement cannot be observed in 
nonambulatory cattle. MS (Beef) is included in the definition because 
it may contain concentrated amounts of the following SRMs: spinal cord, 
dorsal root ganglia, and vertebral column. Material from cattle not 
inspected and passed is prohibited because they are at higher risk of 
harboring undetected BSE.
    As described in the 2004 IFR, epidemiological evidence indicates 
that the BSE epidemic in the United Kingdom (U.K.) was a result of 
consumption of animal feed contaminated by the BSE agent. The spread of 
BSE outside the U.K. has been attributed to the export of BSE-
contaminated feed from the U.K. to other countries prior to the 
realization of the role of feed in transmitting the disease and the 
implementation of restrictions on such trade. However, a country may 
not have engaged in trade in animal feed with the U.K. or other 
affected countries, and it may have had preventive measures in place 
for a length of time adequate to make the chance remote that BSE 
currently is present in its national herds.
    Such a country may be able to demonstrate to FDA that its BSE case 
history, risk factors, and measures to prevent the introduction and 
transmission of BSE make certain BSE-related restrictions unnecessary. 
Not restricting cattle materials inspected and passed for human 
consumption from such a country to be used in human food and cosmetics 
is consistent with all applicable statutory standards. Further, this 
approach is consistent with OIE's recommendation that cattle materials 
from negligible risk countries not be restricted.
    Material from cattle not inspected and passed for human consumption 
will continue to be prohibited, regardless of the country of origin. We 
are retaining this provision as a universal requirement because the 
exception for designated countries in this amendment is predicated on 
application of a country's food safety controls, including inspection 
of source animals, to human food or cosmetics made with cattle 
materials and imported into the United States. It is critical to 
ensuring safety that, regardless of the country of origin, source 
cattle have been evaluated and determined appropriate for human 
consumption. In addition, applying this requirement universally is 
consistent with OIE recommendations, which recognize the importance 
that cattle pass antemortem and post-mortem inspections even in 
``negligible risk'' countries.
    Therefore, FDA is amending its regulations in Sec. Sec.  189.5 and 
700.27 to provide that FDA may designate a country as not subject to 
the restrictions applicable to human food and cosmetics manufactured 
from, processed with, or that otherwise contain SRMs, the small 
intestine of cattle, material from nonambulatory disabled cattle, or MS 
(Beef). Cattle materials inspected and passed from a designated country 
will not be considered prohibited cattle materials and their use will 
not render a human food or cosmetic adulterated. The amendment further 
provides that a country seeking to be so designated must send a written 
request to the Director of FDA's Center for Food Safety and Applied 
Nutrition, including information about a country's BSE case history, 
risk factors, measures to prevent the introduction and transmission of 
BSE, and other information relevant to determining whether SRMs, the 
small intestine of cattle (unless the distal ileum has been removed), 
material from nonambulatory disabled cattle, or MS (Beef) should be 
considered prohibited cattle materials.
    In its application, the requesting country will be expected to 
provide information to FDA on its BSE case history, including whether 
cattle in that country have tested positive for BSE, and if so, the 
circumstances and the country's response. In addition, FDA will review 
information that addresses the extent to which the requesting country 
has identified and taken into account relevant risk factors such as the 
following:
     Possible presence of BSE in indigenous and/or imported 
cattle;

[[Page 20788]]

     Geographic origin of imported cattle;
     Materials used in the production of ruminant feed and feed 
ingredients; and
     Importation of ruminant feed and feed ingredients.
    FDA will consider information relating to the possible presence of 
BSE in indigenous and imported cattle in the requesting country as well 
as the requesting country's production and importation of ruminant feed 
and feed ingredients. With respect to imported cattle, relevant 
information includes the identification of any countries where imported 
cattle were born or raised and the dates any cattle were imported. With 
regard to ruminant feed, FDA will consider, among other things, how 
ruminant feed was produced in the requesting country, including what 
animal origin materials were allowed to be included. FDA will also 
consider whether ruminant feed and feed ingredients were imported, and 
if so, the source countries and dates of import.
    In addition to reviewing risk factors such as those identified 
previously, FDA will assess how the requesting country has addressed 
and managed any identified BSE risks through the implementation of 
appropriate measures to prevent the introduction and transmission of 
BSE. FDA will consider how long such preventive measures have been in 
place and whether they have been effectively carried out. Examples of 
preventive measures include the following:
     A prohibition on the use of ruminant feed that might carry 
a risk of transmitting the BSE agent;
     A prohibition on the importation of cattle and cattle-
derived products that might carry a risk of transmitting the BSE agent;
     Surveillance systems for BSE in cattle populations with 
appropriate examination of brain or other tissues collected for 
surveillance in approved laboratories;
     Mandatory notification and examination of all cattle 
showing signs consistent with BSE; and
     Protocols or other written procedures for investigating 
potential cases of BSE, including ability to trace former herdmates of 
BSE-positive animals.
    As part of its evaluation of feed restrictions, FDA will consider 
factors including whether appropriate feed restrictions are in place 
and the adequacy of enforcement of those restrictions (e.g., the 
frequency of facility inspections and level of compliance). FDA also 
will consider a requesting country's import controls for cattle 
material. Such consideration will include whether the country 
effectively monitors and controls potential pathways of SRMs and other 
potentially infective materials into its country from other countries 
for whom such controls are necessary.
    In addition, FDA will consider the requesting country's 
surveillance and monitoring efforts with respect to BSE. For example, 
FDA will evaluate the level at which the country performs surveillance 
and monitoring, whether tissue samples are collected and examined at 
approved laboratories, and whether recognized diagnostic procedures and 
methods are used, such as those procedures and methods provided in the 
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 
(Ref. 2).
    FDA also will consider whether the country has an ongoing program 
for notification and investigation of all cattle showing signs 
consistent with BSE. In evaluating such a program, FDA will consider, 
among other factors, whether notification and investigation are 
mandated, whether veterinarians, producers, and others involved in 
cattle production have been provided sufficient information about BSE, 
such as through an awareness program, and whether there are additional 
measures in place to stimulate reporting of suspect cattle, such as 
compensation or penalties.
    FDA also will consider a country's written procedures for 
investigating potential cases of BSE. Such a consideration will include 
whether the country has written procedures for the investigation of 
suspect animals and whether the country has the investigative 
capability to followup positive findings by tracing former herdmates of 
animals determined to be BSE positive. Finally, FDA also will consider 
any other information relevant to determining whether the country 
should be designated under Sec. Sec.  189.5(e) and 700.27(e).
    FDA and the USDA agencies, APHIS and FSIS, have different 
regulatory responsibilities with respect to preventing BSE and ensuring 
food safety. Further, it is not necessary or practical for one of the 
three agencies to conduct every evaluation of a country's BSE status, 
regardless of the purpose of the evaluation. FDA will, however, consult 
with APHIS and FSIS as part of its evaluation process. Further, FDA 
will take into consideration available risk assessments of other 
competent authorities in conducting its evaluation. Though it is not 
required, a previous BSE evaluation by USDA, OIE, or by another country 
or another competent authority, will be helpful to FDA in its review 
and may decrease the time needed for FDA to make a determination.
    Upon completion of its review, FDA will provide written 
notification of its decision to the applicant country, including the 
basis for the decision. FDA may impose conditions in granting a request 
for designation. Further, any designation granted under Sec.  189.5 or 
Sec.  700.27 will be subject to future review by FDA to ensure that the 
designation remains appropriate. As part of this process, FDA may ask 
designated countries to confirm that their BSE situation and the 
information submitted by them in support of their original application 
remain unchanged. Further, FDA may revoke a country's designation if 
FDA determines that it is no longer appropriate.
    FDA will provide further information on its evaluation process, the 
scope of the review, and the types of supporting information that it 
would find helpful in reviewing a country's submission at the time of 
the request.

III. Summary of Amendments to the Interim Final Rule

    FDA is amending its regulations in Sec. Sec.  189.5(a) and 
700.27(a) by revising the definition of ``prohibited cattle materials'' 
to exclude cattle materials inspected and passed for human consumption 
from a country designated by FDA under Sec.  189.5(e) or Sec.  
700.27(e). New Sec. Sec.  189.5(e) and 700.27(e) provide that a country 
seeking such a designation must send a written request to the Director, 
Office of the Center Director, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740-3835. Further, the request shall include 
information about a country's BSE case history, risk factors, measures 
to prevent the introduction and transmission of BSE, and other 
information relevant to determining whether SRMs, the small intestine 
of cattle (unless the distal ileum has been removed), material from 
nonambulatory disabled cattle, or MS (Beef) should be considered 
prohibited cattle materials. The new sections further provide that FDA 
shall respond in writing to any such request and that FDA may revoke a 
country's designation if FDA determines that it is no longer 
appropriate.

IV. Effective Date and Opportunity for Public Comment

    In the 2004 IFR, FDA solicited comment on whether materials from 
countries believed to be free from BSE should be exempt from the 
``prohibited cattle materials'' requirements. FDA

[[Page 20789]]

addresses the comments it received in this document. This amendment is 
effective on July 16, 2008. FDA invites public comment on the current 
amendment to the interim final rule; submit written or electronic 
comments on the interim final rule by July 16, 2008. The agency will 
consider modifications to the current amendment to the interim final 
rule based on comments made during the comment period. Interested 
persons may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.
    FDA will address other comments received in response to the 2004 
IFR and comments received in response to this document in further 
rulemaking.

V. Executive Order 12866 and Regulatory Flexibility Act

A. Interim Final Regulatory Impact Analysis

    FDA has examined the economic impacts of the interim final rule 
under 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 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 interim final rule is not a 
significant regulatory action as defined by Executive Order 12866.
1. Need for Regulation
    FDA agrees with FSIS and the international community that cattle 
materials imported from countries that can demonstrate that their BSE 
case history and their having in place effective measures to prevent 
the introduction and transmission of BSE may be such that they should 
not be subject to the same BSE-related restrictions applied to cattle 
materials imported into the United States from other countries. 
Restricting the importation of potentially infective materials on the 
basis of the BSE risk of the region of origin is more efficient than an 
approach that does not consider a country's circumstances regarding 
BSE.
    As comments on the 2004 IFR have noted, the World Trade 
Organization Agreement on the Application of Sanitary and Phytosanitary 
Measures (the SPS Agreement) requires member countries to recognize 
regionalization of diseases and not put in place measures that are more 
trade restrictive than necessary to achieve public health goals. Thus, 
the uniform application by FDA of BSE-related restrictions to all 
imports of food and cosmetic products into the United States without 
taking into account a country's BSE case history, risk factors, 
measures to prevent the introduction and transmission of BSE, and other 
relevant information means that other countries must implement costly 
and unnecessary measures that may not be scientifically justified. 
Providing this exception from certain requirements relating to human 
food and cosmetics for designated countries is more efficient in the 
sense that it achieves essentially the same protection of public health 
with fewer restrictions on the market for cattle-derived materials.
2. Interim Final Rule Coverage
    Foreign countries need to make formal application to FDA in order 
to be considered for this exception from the provision on prohibited 
cattle materials in Sec. Sec.  189.5 and 700.27. FDA will make a 
determination as to a country's request based on an evaluation that is 
carried out in consultation with the USDA's APHIS and FSIS. FDA will 
take into consideration relevant technical information provided by the 
requesting country with respect to its BSE case history, including 
whether cattle in that country have tested positive for BSE, and if so, 
the circumstance and the country's response. In addition, FDA will 
review information that addresses the extent to which the requesting 
country has identified and taken into account relevant risk factors 
such as the following:
     The possible presence of BSE in indigenous and/or imported 
cattle;
     Geographic origin of imported cattle;
     Materials used in the production of ruminant feed and feed 
ingredients; and
     Importation of ruminant feed and feed ingredients.
FDA will also assess how the requesting country has addressed and 
managed any identified BSE risks through the implementation of 
appropriate measures to prevent the introduction and transmission of 
BSE, such as the following:
     A prohibition on the use of ruminant feed that might carry 
a risk of transmitting the BSE agent;
     A prohibition on the importation of cattle and cattle-
derived products that might carry a risk of transmitting the BSE agent;
     Surveillance systems for BSE in cattle populations with 
appropriate examination of brain or other tissues collected for 
surveillance in approved laboratories;
     Mandatory notification and examination of all cattle 
showing signs consistent with BSE; and
     Protocol or other written procedures for investigating 
potential cases of BSE, including ability to trace former herdmates of 
BSE-positive animals.
Number of Countries Affected
    We do not know how many countries will take advantage of the option 
to petition FDA for a designation under Sec. Sec.  189.5(e) and 
700.27(e). According to information from the OIE, countries that are 
officially recognized as having a ``negligible BSE risk'' in accordance 
with the requirements of the OIE Terrestrial Animal Health Code (16th 
edition 2007) include the following: Australia, Argentina, New Zealand, 
Singapore, and Uruguay. Two countries, Iceland and Paraguay, are 
recognized as ``provisionally free''\3\ from BSE. For these two 
categories of countries, OIE does not recommend the removal of SRMs 
(Ref. 4).
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    \3\ The OIE ``provisionally free'' designation is in accordance 
with the 2004 edition (13th edition) of the Terrestrial Animal 
Health Code, and remains in effect for Iceland and Paraguay until 
May 2008. See Ref. 3.
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    Table 1 presents data from the U.S. International Trade Commission 
(Ref. 5) showing for 2006 the top 10 exporters of meat products\4\ and 
animal fats, oils, and by-products to the United States.
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    \4\ The data sorted by NAICS code does not allow for the 
separation of beef products that are imported from other imported 
meat products such as pork.

[[Page 20790]]



 Table 1.--Top 10 Countries Exporting Specified North American Industry
  Classification System (NAICS) Code Products to United States for 2006
NAICS 311611\1\--Meat Products (Excluding       Quantity (thousands of
 Poultry)                                            kilograms)\2\
������������������������������������������������������������������������
Canada                                        681,899
------------------------------------------------------------------------
Australia                                     376,585
------------------------------------------------------------------------
New Zealand                                   211,873
------------------------------------------------------------------------
Uruguay                                       103,305
------------------------------------------------------------------------
Brazil                                        83,897
------------------------------------------------------------------------
Denmark                                       46,652
------------------------------------------------------------------------
Mexico                                        35,553
------------------------------------------------------------------------
China                                         28,530
------------------------------------------------------------------------
Argentina                                     22,353
------------------------------------------------------------------------
Nicaragua                                     21,303
������������������������������������������������������������������������
NAIC 311613--Animal Fats, Oils, & By-                (thousands of
 Products                                            kilograms)\3\
������������������������������������������������������������������������
Canada                                        94,306
------------------------------------------------------------------------
New Zealand                                   32,550
------------------------------------------------------------------------
China                                         7,809
------------------------------------------------------------------------
Australia                                     6,807
------------------------------------------------------------------------
Brazil                                        6,589
------------------------------------------------------------------------
Mexico                                        2,130
------------------------------------------------------------------------
Colombia                                      1,826
------------------------------------------------------------------------
Germany                                       1,642
------------------------------------------------------------------------
Ecuador                                       1,149
------------------------------------------------------------------------
Japan                                         1,138
------------------------------------------------------------------------
\1\ The NAIC code 31161 covers the animal slaughtering and processing
  industry. The industry is composed of establishments that are
  primarily engaged in one or more of the following: (1) Slaughtering
  animals, (2) preparing processed meats and meat by-products, and (3)
  rendering and refining animal fat, bones, and meat scraps. The
  subcategory 311611 comprises those establishments primarily engaged in
  slaughtering animals (except poultry and small game). Establishments
  that slaughter and prepare meats are included in this classification.
  (Ref. 5) We use this data as an indicator of the countries that are
  most likely to petition FDA regarding their BSE status.
\2\ These figures do not include exports measured in ``clean yield
  kilograms'' and ``pieces.''
\3\ These figures do not include exports measured in ``grams,''
  ``liters,'' ``metric tons,'' and ``pieces.''

    We do not know how many countries might petition the FDA. However, 
taking into consideration the previous information on countries 
officially recognized as having a negligible BSE risk or being 
provisionally free of BSE under OIE, as well as the information in 
table 1 on countries that export large amounts of meat products and 
animal fats, oils, and byproducts to the United States, we are 
estimating for this analysis that 10 countries may be interested in 
petitioning FDA to be excepted from certain BSE-related restrictions 
applicable to human food and cosmetics. Our estimate is not intended to 
suggest that all of these countries would be able to qualify for a 
designation under Sec. Sec.  189.5(e) and 700.27(e).
3. Costs and Benefits of Exemption Provision
    Countries that petition the FDA to be designated as excepted from 
certain BSE-related restrictions applicable to human food and cosmetics 
may also petition USDA for exclusion from USDA's BSE-related 
requirements. Some of the costs to countries to petition FDA may be 
shared with costs to petition USDA because of similarities regarding 
how countries' products can qualify for the exceptions. Even so, we 
will outline here a potential scenario for calculating the costs of 
petitioning FDA for an exception from certain provisions of the 
agency's BSE regulations.
    a. Assumptions and costs associated with this interim final rule. 
We would expect countries that wish to petition FDA to be excepted from 
certain BSE-related restrictions applicable to human food and cosmetics 
to have already completed a risk assessment and put risk management 
strategies into place.\5\ Whether these risk assessment and mitigation 
strategies are sufficient for a country to be so designated by FDA will 
be determined on a case-by-case basis.
---------------------------------------------------------------------------

    \5\ We assume such measures were necessary to continue marketing 
cattle products following the surge of BSE cases in the U.K. and the 
rulemakings that followed.
---------------------------------------------------------------------------

    b. Petition process. We assume petitions to FDA for this 
designation would include an already developed risk assessment or other 
technical information on the country's BSE situation, a detailed 
outline of risk mitigation strategies, and information on the country's 
cattle-derived products that are exported to the United States. The 
petition is assumed to take 80 hours per country for assembly of the 
information and the wage for a government employee earning a GS-14 step 
1 (Ref. 6) is used to estimate the costs. The cost of assembling a 
single petition is estimated to be about $5,400 (80 hours x $67.44 per 
hour including overhead). The petition will also be reviewed by higher 
level government managers before being sent to the FDA. We assume the 
wage for a high level government executive is a GS-15 step 3 (Ref. 6) 
and that they will spend 40 hours reviewing the petition. The cost of 
review by a government manager is estimated to be about $3,400 (40 
hours x $84.62 per hour including overhead). Thus, the total cost to 
each country to prepare and submit a petition to FDA to be considered 
for this designation would be about $9,000.
    c. Petition review by FDA. It will take FDA approximately 80 hours 
to review a petition. The cost of each petition review would be about 
$3,700 (80 hours x $45.65 per hour).\6\
---------------------------------------------------------------------------

    \6\ Pay for an employee earning a GS-13 step 7 adjusted to 
include locality pay for Washington D.C. and surrounding area (Ref. 
6).

     Table 2.--Total Cost of Initial Petition Application and Review
Petition Assembly and Review per Country         $9,000
------------------------------------------------------------------------
FDA Review per Petition                          $3,700
------------------------------------------------------------------------
Total Cost per Country                           $12,700
------------------------------------------------------------------------
Cost for 10 Countries                            $127,000
------------------------------------------------------------------------

    d. Petition success uncertainty. It is possible that some countries 
that petition the FDA to be designated as excepted from certain BSE-
related restrictions applicable to human food and cosmetics will not be 
successful. We do not know how likely it will be that countries with 
insufficient BSE risk assessment and mitigation strategies will 
petition the FDA.
    e. Future petitions to FDA. It is likely that those countries that 
currently sell a significant amount of cattle-derived material will be 
most interested in seeking possible relief under this change to FDA's 
prohibited cattle materials requirements. It is possible in the future, 
if new markets for cattle derived products develop, that other 
countries may want to petition FDA to be designated as not subject to 
certain BSE-related restrictions applicable to human food and 
cosmetics. We do not attempt to forecast new markets for cattle derived 
products here. We also do not attempt to forecast the frequency of, or 
estimate the costs associated with, FDA review in the future of 
successful petitions.
    f. Future review of successful petitions by FDA. Countries that 
successfully

[[Page 20791]]

petition the FDA to be designated as excepted from certain BSE-related 
restrictions applicable to human food and cosmetics will be subject to 
future review by FDA to ensure that their designation remains 
appropriate. As part of this process, FDA may ask designated countries 
to confirm that their BSE situation and the information submitted by 
them in support of their original application remain unchanged. FDA may 
revoke a country's designation if FDA determines that it is no longer 
appropriate.
    FDA has not yet determined the method by which the agency will 
conduct these future reviews. One possible method would be for FDA to 
send a letter to designated countries asking whether there has been a 
change in their status or circumstances relative to their BSE history, 
surveillance, import activities, or other relevant criteria and then 
compare any changed information with the information that was 
originally submitted. The OIE requires that countries it has recognized 
in regard to their BSE status ``should annually confirm during the 
month of November whether their status and the criteria by which their 
status was recognized have remained unchanged.'' In some cases, the FDA 
reviewer might rely on this information, if available, in conducting a 
future review of the country's designation.
    We assume it will take FDA and the designated country undergoing a 
review in the future about one third the time and effort it did when 
the original information was submitted. Thus, if the total cost to 
initially submit a petition and have it reviewed by FDA was $12,700, 
then a future review of the petition by FDA and the submitting country 
will cost about $4,200 (see Table 3).

         Table 3.--Cost of Future Review of Successful Petitions
Submission of Additional Information and         $3,000
 Response by Country
------------------------------------------------------------------------
FDA Review per Country                           $1,200
------------------------------------------------------------------------
Total Cost per Country                           $4,200
------------------------------------------------------------------------
Cost for 10 Countries                            $42,000
------------------------------------------------------------------------

4. Other Options Considered
    FDA considered the following options when examining the costs and 
benefits of this IFR.
Option 1--Do nothing.
    This option is the baseline for which the costs and benefits of 
other options are compared. The costs and benefits of this option have 
already been realized. Firms buying and selling cattle-derived 
materials in the United States and other countries have found 
alternatives to using products covered by the definition of prohibited 
cattle materials in the manufacture of their products.
Option 2--Amend definition of prohibited cattle materials (the chosen 
option).
    The costs and benefits of this option are outlined previously. The 
main benefit of this option is that it is more efficient than the 
current regulation because it achieves essentially the same protection 
of public health with fewer restrictions on the market for cattle-
derived materials. With this interim final rule, FDA can continue to 
prevent the potential introduction and transmission of BSE from cattle 
materials from non-designated countries, while at the same time 
reducing the restrictions on the market for cattle-derived materials 
from designated countries.
Option 3--Amend the definition of prohibited cattle materials to allow 
material from cattle not inspected and passed for human consumption for 
use in human food and cosmetics.
    This option is less stringent than option 2, which would reduce the 
costs of cattle-derived materials used in the manufacture of human food 
and cosmetics, but it would not provide the same public health benefits 
as options 1 and 2. Material from cattle not inspected and passed for 
human consumption has not been approved by a regulatory authority (USDA 
or other) and thus we cannot make the determination that, among other 
things, the cattle material is from an animal that was evaluated for a 
neurological disorder such as BSE. In requiring that material from 
cattle for use in FDA-regulated human food and cosmetics be inspected 
and passed for human consumption, we are minimizing the risk of 
exposure to the agent that causes BSE, and therefore maximizing the 
protection of public health from variant Creutzfeldt-Jakob disease, the 
human disease linked to consumption of BSE-infected cattle material.
5. Benefits
    Under this interim final rule, foreign countries would have the 
option of demonstrating (through information submitted to FDA) that 
their BSE case history, their identifying and taking into account 
relevant risk factors, their implementing appropriate measures to 
prevent the introduction and transmission of BSE, and any other 
relevant information shows that certain BSE-related restrictions, in 
their case, are unnecessary. Countries that successfully petition FDA 
would be able to again export human food and cosmetics to the United 
States without the removal of the following items:
     SRMs
     Small intestine (including the distal ileum)
     Material from nonambulatory disabled cattle
     MS (Beef)
6. Effect on Food Supply in the United States
    We expect this interim final rule amendment will increase the 
availability of certain cattle materials (and products containing those 
materials) for sale in the United States. The most significant gain in 
supply will probably occur from the increased availability of FDA-
regulated products that contain MS (Beef) and material from 
nonambulatory disabled cattle for use in human food regulated by FDA. 
Few, if any, human food or cosmetic products use SRMs as an ingredient, 
but to the extent that these materials are needed, they will again be 
available in the United States.

B. Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes 
certain requirements with respect to Federal rules that are subject to 
the notice and comment requirements of section 553(b) of the 
Administrative Procedure Act (5 U.S.C. 551 et seq.) and that are likely 
to have a significant economic impact on a substantial number of small 
entities. Unless an agency certifies that a proposed rule will not have 
a significant economic impact on a substantial number of small 
entities, section 603 of the RFA requires that the agency present an 
initial regulatory flexibility analysis at the time of the publication 
of the notice of proposed rulemaking describing the impact of the rule 
on small entities and seeking public comment on such impact. Because 
this rule is being issued as an interim final rule, the RFA does not 
apply and FDA is not required to either certify that the rule will not 
have a significant impact on a substantial number of small businesses 
or conduct an initial regulatory flexibility analysis. Also, FDA does 
not have information on how many small firms in foreign countries 
designated by the agency may benefit from this rule. Examining the 
effect this interim final rule has on small foreign firms is outside 
the scope of the RFA requirements.
    The extent to which small firms within the United States are 
affected by this rule is unknown. FDA

[[Page 20792]]

acknowledges that small U.S. businesses that use imported cattle 
materials in manufacture or for sale as final products will likely 
benefit from this rulemaking as costs of these inputs are expected to 
decrease as supply increases. Small U.S. firms that compete with 
foreign firms in order to supply cattle-derived inputs and products to 
U.S. business and markets may be adversely affected if foreign firms 
can more cheaply supply these materials and products. FDA seeks public 
comment on the question of whether such small U.S. businesses will be 
adversely impacted by this rule.

C. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rule making 
if the rule would include a ``Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $127 million, using the most current (2006) 
Implicit Price Deflator for the Gross Domestic Product. FDA has 
determined that this interim final rule does not constitute a 
significant rule under the Unfunded Mandates Reform Act.

VI. Paperwork Reduction Act of 1995

    This interim final rule contains information collection 
requirements that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The title, description, and respondent description of these 
provisions are shown in the following paragraphs with an estimate of 
the annual recordkeeping burden. Included in the estimate is the time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Petition To Be Designated as Not Subject to Certain BSE-
Related Restrictions Applicable to FDA Regulated Human Food and 
Cosmetics
    Description: 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, and then amended on September 7, 
2005. In the 2004 interim final rule and its amendments, 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. Prohibited cattle materials include 
SRMs, the small intestine of all cattle unless the distal portion of 
the ileum is removed, material from nonambulatory disabled cattle, 
material from cattle not inspected and passed for human consumption, 
and MS (Beef). SRMs include 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. Therefore, FDA is amending its regulations at Sec. Sec.  189.5 
and 700.27 to provide that FDA may designate a country as not subject 
to the restrictions applicable to human food and cosmetics manufactured 
from, processed with, or that otherwise contain SRMs, the small 
intestine of cattle, material from nonambulatory disabled cattle, or MS 
(Beef). The interim final rule, as amended, provides that these 
materials, when from cattle from a designated country, are not 
considered prohibited cattle materials, and their use does not render a 
human food or cosmetic adulterated. The amendment further provides that 
a country seeking to be so designated must send a written request to 
the Director of FDA's Center for Food Safety and Applied Nutrition, 
including information about a country's BSE case history, risk factors, 
measures to prevent the introduction and transmission of BSE, and other 
information relevant to determining whether SRMs, the small intestine 
of cattle (unless the distal ileum has been removed), material from 
nonambulatory disabled cattle, or MS (Beef) should be considered 
prohibited cattle materials.
    Description of Respondents: Countries with firms that would like to 
use SRMs, the small intestine of cattle, material from nonambulatory 
disabled cattle, or MS (Beef) in products exported to the United 
States.
Information Collection Burden Estimate
    FDA estimates the burden for this information collection as 
follows:

                         Table 4.--Estimated One-Time and Recurring Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of         No. of Responses       Total Annual        Hours per
  21 CFR Section      Respondents        per Respondent         Responses           Response        Total Hours
----------------------------------------------------------------------------------------------------------------
189.5 and                         10                     1                 10                 80             800
 700.27\2\
----------------------------------------------------------------------------------------------------------------
189.5(e) and                      10                     1                 10               26.4             264
 700.27(e)
----------------------------------------------------------------------------------------------------------------
Total one time burden                                                                                        800
----------------------------------------------------------------------------------------------------------------
Total recurring burden                                                                                       264
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information
  under this interim final rule.
\2\ One-time burden.

One Time Reporting Burden
    There will be a one time burden to countries that apply to FDA 
seeking to be designated as not subject to restrictions applicable to 
SRMs, the small intestine of cattle, nonambulatory disabled cattle, or 
MS (Beef). We estimate that each country that applies for an exclusion 
will spend 80 hours putting information together to submit to FDA. 
Table 4 row 3 of this document presents the one-time burden expected 
for countries who apply for the exclusion.
Recurring Burden

[[Page 20793]]

    Countries that successfully petition the FDA to be designated as 
excepted from certain BSE-related restrictions applicable to human food 
and cosmetics will be subject to future review by FDA to ensure that 
their designation remains appropriate. As part of this process, FDA may 
ask designated countries from time to time to confirm that their BSE 
situation and the information submitted by them in support of their 
original application remain unchanged. We assume it will take FDA and 
the designated country undergoing a review in the future about one 
third the time and effort it did when the information was submitted. 
Table 4 row 4 of this document presents the expected recurring burden.
    The information collection provisions of this interim final rule 
have been submitted to OMB for review. Interested persons are requested 
to fax comments regarding information collection by (see DATES), to the 
Office of Information and Regulatory Affairs, OMB. To ensure that 
comments on information collection are received, OMB recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.
    Prior to the effective date of this interim final rule, FDA will 
publish a notice in the Federal Register announcing OMB's decision to 
approve, modify, or disapprove the information collection provisions in 
this interim final rule. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

VII. Environmental Impact Analysis

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Federalism

    FDA has analyzed this interim final rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' FDA has determined that the interim final rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the interim 
final rule does not contain policies that have federalism implications 
as defined in the Executive order and, consequently, a federalism 
summary impact statement is not required.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web site after this document 
publishes in the Federal Register.)
    1. World Organization for Animal Health, Terrestrial Animal 
Health Code (2007), Chapter 2.3.13, Bovine Spongiform 
Encephalopathy. See also Appendix 3.8.4 (Surveillance for Bovine 
Spongiform Encephalopathy) and Appendix 3.8.5 (Factors to Consider 
in Conducting the Bovine Spongiform Encephalopathy Risk Assessment 
Recommended in Chapter 2.3.13). Accessed online at https://
www.oie.int/eng/normes/mcode/en_sommaire.htm.
    2. World Organization for Animal Health, Manual of Diagnostic 
Tests and Vaccines for Terrestrial Animals 2004 (updated 2006). 
Accessed online at https://www.oie.int/eng/normes/mmanual/A_
summry.htm.
    3. World Organization for Animal Health (OIE), Recognition of 
the Bovine Spongiform Encephalopathy Status of Member Countries, OIE 
Resolution No. XXIV, adopted by the International Committee of the 
OIE on May 22, 2007. See https://www.oie.int/eng/info/en_
statesb.htm?eld6, accessed August 30, 2007.
    4. United States International Trade Commission, Interactive 
Tariff and Trade Dataweb, https://dataweb.usitc.gov/, accessed April 
6, 2007.
    5. NAICS Association, https://www.naics.com/censusfiles/
NDEF311.HTM, accessed August 27, 2007.
    6. U.S Office of Personnel Management Salaries and Wages 2007 
General Schedule, https://www.opm.gov/oca/07tables/indexGS.asp, 
accessed on April 11, 2007.

List of Subjects

21 CFR Part 189

    Food additives, Food packaging.

21 CFR Part 700

    Cosmetics, Packaging and containers.

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, 381.

0
2. Section 189.5 is amended by revising paragraph (a)(1) and by adding 
paragraph (e) to read as follows:


Sec.  189.5  Prohibited cattle materials.

    (a) * * *
    (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 the following:
    (i) Tallow that contains no more than 0.15 percent insoluble 
impurities, tallow derivatives, hides and hide-derived products, and 
milk and milk products, and
    (ii) Cattle materials inspected and passed from a country 
designated under paragraph (e) of this section.
* * * * *
    (e) Process for designating countries. A country seeking 
designation must send a written request to the Director, Office of the 
Center Director, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, at the address designated in 21 CFR 5.1100. The 
request shall include information about a country's bovine spongiform 
encephalopathy (BSE) case history, risk factors, measures to prevent 
the introduction and transmission of BSE, and any other information 
relevant to determining whether specified risk materials, the small 
intestine of cattle except a