Document ID: FDA-2004-N-0188-0065
Agency: fda
Document Type: Rule
Title: Use of Materials Derived From Cattle in Human Food and Cosmetics
Posted Date: 2016-03-18T04:00Z

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Rules and Regulations]
[Pages 14718-14732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06123]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. FDA-2004-N-0188; (Formerly 2004N-0081)]
RIN 0910-AF47

Use of Materials Derived From Cattle in Human Food and Cosmetics

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; adoption of interim final rule as final with 
amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a 
final rule prohibiting the use of certain cattle material to address 
the potential risk of bovine spongiform encephalopathy (BSE) in human 
food, including dietary supplements, and cosmetics. We have designated 
the following items as prohibited cattle materials: Specified risk 
materials (SRMs), the small intestine from all cattle (unless the 
distal ileum has been removed), material from nonambulatory disabled 
cattle, material from cattle not inspected and passed, or mechanically 
separated (MS) (Beef). We are taking this action to minimize human 
exposure to certain cattle material that could potentially contain the 
BSE agent.

DATES: This final rule is effective on April 18, 2016.

FOR FURTHER INFORMATION CONTACT: Johnny Braddy, Center for Food Safety 
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1709.

SUPPLEMENTARY INFORMATION:

Executive Summary

A. Purpose of the Rule

    BSE is a fatal neurological disorder of cattle that has a long 
incubation period (2 to 8 years). It is transmitted when cattle ingest 
protein meal containing the BSE infectious agent. Cattle affected by 
BSE are usually apart from the herd and will show progressively 
deteriorating behavioral and neurological signs. Cattle will react 
excessively to noise or touch and will eventually stumble, fall, and 
experience seizures, coma, and death. Studies have linked variant 
Creutzfeldt-Jakob disease (vCJD) in humans to exposure to the BSE 
agent, most likely through human consumption of beef products 
contaminated with the BSE agent. There is no known treatment of vCJD, 
and it is invariably fatal.
    The final rule completes a rulemaking process that began with an 
interim final rule (IFR) in 2004 and was followed by IFRs in 2005 and 
2008. The final rule establishes measures to prohibit the use of 
certain cattle material in FDA-regulated human food and cosmetics to 
address the potential risk of BSE. Because the United States has had 
measures in place to prevent the introduction and spread of BSE, 
including those affirmed in this rule, the risk of human exposure to 
the BSE agent from FDA-regulated human food and cosmetics is 
negligible.

B. Legal Authority

    We are issuing these regulations under the adulteration provisions 
in sections 402, 409, 601, and under section 701 (21 U.S.C. 342, 348, 
361, and 371) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

C. Summary of the Major Provisions of the Rule

    The final rule provides definitions for prohibited cattle materials 
and prohibits their use in human food, dietary supplements, and 
cosmetics, to address the potential risk of BSE. We designate the 
following items as prohibited cattle materials: SRMs, the small 
intestine from all cattle unless the distal ileum has been properly 
removed, material from nonambulatory disabled cattle,

[[Page 14719]]

material from cattle not inspected and passed, or MS (Beef). We also 
confirm that milk and milk products, hides and hide-derived products, 
tallow that contains no more than 0.15 percent insoluble impurities, 
and tallow derivatives are not prohibited cattle materials. Further, we 
are amending the final rule to provide a definition of gelatin and to 
clarify that gelatin is not considered a prohibited cattle material 
under 21 CFR 189.5(a)(1) and 700.27(a)(1) as long as it is manufactured 
using the customary industry processes specified. Finally, we are 
finalizing the process for designating a country as not subject to BSE-
related restrictions applicable to FDA regulated human food and 
cosmetics. Specific requirements regarding record maintenance, 
retention, and accessibility, for manufacturers and processors of a 
human food or cosmetic product made with material from cattle were 
previously finalized (see 71 FR 59653).

D. Costs and Benefits

    This final rule reaffirms the provisions in the 2004 IFR, as well 
as the 2005 and 2008 amendments, to address the potential risk of BSE 
in human food including dietary supplements, and in cosmetics. As the 
final rule's coverage does not differ from the 2004 IFR and the 2005 
and 2008 amendments, no additional costs or benefits will accrue from 
this rulemaking.

Table of Contents

I. Introduction--what is BSE?
II. Background--what Is the history for this rulemaking?
III. What is the legal authority for this rulemaking?
IV. What comments did we receive? What are our responses?
    A. Definitions (Sec. Sec.  189.5(a) and 700.27(a))
    B. Requirements (Sec. Sec.  189.5(b) and 700.27(b))
    C. Records (Sec. Sec.  189.5(c) and 700.27(c))
    D. Adulteration (Sec. Sec.  189.5(d) and 700.27(d))
    E. Process for Designating Countries (Sec. Sec.  189.5(e) and 
700.27(e))
    F. Other Comments
V. Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Unfunded Mandatory Reform Act of 1995
VI. Environmental Impact, No Significant Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

I. Introduction--what is BSE?

    BSE is a progressive and fatal neurological disorder of cattle 
caused by an unconventional transmissible agent. BSE belongs to the 
family of diseases known as transmissible spongiform encephalopathies 
(TSEs). In the late stages of disease, all TSEs affect the central 
nervous system of infected animals. However, the distribution of 
infectivity in the body of the animal and mode of transmission differ 
according to the species and TSE agent. Other types of TSEs include 
scrapie in sheep and goats, chronic wasting disease in deer and elk, 
and Creutzfeldt-Jakob disease (CJD) in humans.
    BSE has a long incubation period (2 to 8 years), and is most likely 
transmitted when tissues from infected cattle are rendered and 
processed into protein meal, which is then used as an additive in 
livestock feed (Refs. 1 and 2). The clinical signs of BSE include 
behavioral, gait, and postural abnormalities. Cattle with the disease 
often present with increased apprehension, increased reaction to sound 
and touch, and a swaying gait. These signs may be accompanied by subtle 
changes in the normal behavior of the cow, such as separation from the 
herd while at pasture, disorientation, staring, and excessive licking 
of the nose or flanks. The disease progresses to stumbling and falling, 
and ends with seizures, coma, and death (Ref. 3).
    Scientific and epidemiological studies have linked vCJD in humans 
to exposure to the BSE agent, most likely through human consumption of 
beef products contaminated with the agent. In several cases that 
occurred in the United Kingdom (UK), it is believed that the persons 
became infected through transfusion of blood from an asymptomatic 
infected donor. There is no known treatment of vCJD, and it is 
invariably fatal (Ref. 4).
    As of June 2, 2014, vCJD has been identified in 229 patients from 
12 countries. One hundred seventy-seven probable and confirmed cases of 
vCJD have been reported in the UK, 27 in France, 5 in Spain, 4 in 
Ireland, 4 in the United States, 3 in the Netherlands, 2 in Portugal, 2 
in Italy, 2 in Canada, and one each from Japan, Saudi Arabia, and 
Taiwan (Ref. 5). In two of the four U.S. cases, exposure to the BSE 
agent is believed to have occurred while the individuals were residing 
in the UK. A third case was likely exposed while residing in Saudi 
Arabia. An investigation of the fourth case found that the patient's 
exposure to the BSE agent likely occurred before the patient moved to 
the United States (Ref. 5). In the United States, where measures to 
prevent the introduction and spread of BSE have been in place for some 
time, the risk of human exposure to the BSE agent is extremely low. 
Indeed, in May 2013, the World Organization for Animal Health (OIE) 
recognized the effectiveness of these mitigation measures and 
categorized the United States as negligible BSE risk, in accordance 
with Chapter 11.4 of the OIE Terrestrial Animal Health Code (Refs. 6 
and 7).

II. Background--what is the history for this rulemaking?

    In the Federal Register of July 14, 2004 (69 FR 42256), we issued 
an IFR entitled ``Use of Materials Derived From Cattle in Human Food 
and Cosmetics'' (also referred to as ``the 2004 IFR'') to prohibit the 
use of certain cattle material, to address the potential risk of BSE in 
human food, including dietary supplements, and cosmetics. The 2004 IFR 
designated the following items as prohibited cattle materials: SRMs, 
the small intestine from all cattle, material from nonambulatory 
disabled cattle, material from cattle not inspected and passed 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 (DRG) of cattle 30 months 
of age and older, and the tonsils and distal ileum of the small 
intestine from all cattle. These restrictions were codified at Sec.  
189.5, ``Prohibited cattle materials,'' and Sec.  700.27, ``Use of 
prohibited cattle materials in cosmetic products.'' The requirements in 
Sec. Sec.  189.5 and 700.27 are almost identical, except that the 
latter pertains only to cosmetic products.
    Previously, the Food Safety and Inspection Service (FSIS) of the 
U.S. Department of Agriculture (USDA) published an IFR in the Federal 
Register on January 12, 2004 (69 FR 1862) (FSIS IFR). The FSIS IFR 
prohibited certain cattle material from use in meat and meat products. 
The FSIS IFR designated the same items as SRMs as specified in FDA's 
2004 IFR. In the Federal Register of July 13, 2007, FSIS affirmed the 
FSIS IFR with amendments (72 FR 38700) (``2007 FSIS affirmation''). In 
the Federal Register of September 7, 2005 (70 FR 53063), we amended our 
regulations to permit the use of the small intestine of cattle in human 
food and cosmetics provided the distal ileum portion has been removed 
properly (also referred to as the ``2005 amendment''). The 2005 
amendment also clarified that milk and milk products, hides and hide-
derived products, and tallow derivatives are not prohibited cattle 
materials, and we provided for a different method for

[[Page 14720]]

determining impurities in tallow. FSIS also amended its regulations on 
September 7, 2005, to permit the use of the small intestine of cattle 
in human food provided the distal ileum is removed properly (70 FR 
53043).
    In the Federal Register of April 17, 2008 (73 FR 20785), we amended 
our regulations again to provide a process for designating certain 
countries as not subject to certain BSE-related restrictions (also 
referred to as the ``2008 amendment''). FSIS provided a similar 
country-specific exception from certain BSE restrictions covered in its 
regulations.
    We also published a notice in the Federal Register on March 4, 2013 
(78 FR 14012) (also referred to as the 2013 notice), reopening the 
comment period for the interim final rule. We invited comment on our 
assessment of recently published peer-reviewed scientific studies in 
which trace amounts of BSE infectivity were found in parts of the small 
intestines other than the distal ileum of cattle with both experimental 
and natural occurring BSE.
    In this rule, we are finalizing, with changes related to gelatin, 
the 2004 IFR, as amended in 2005 and 2008, to restrict certain cattle 
materials used in human foods and cosmetics that carry a risk of 
transmitting BSE. The final rule complements similar restrictions that 
apply to meat and meat products regulated by USDA.

III. What is the legal authority for this rulemaking?

    We are issuing these regulations under the adulteration provisions 
in sections 402, 409, 601, and under section 701 of the FD&C Act.
    Under section 402(a)(3) of the FD&C Act, a food is deemed 
adulterated ``if it consists in whole or in part of any filthy, putrid, 
or decomposed substance, or if it is otherwise unfit for food.'' The 
term ``otherwise unfit for food'' in section 402(a)(3) of the FD&C Act 
does not require that a food be filthy, putrid, or decomposed for it to 
be ``otherwise unfit for food.'' A food can be ``otherwise unfit for 
food'' based on health risks. Further, the possibility of disease 
transmission to humans from exposure to prohibited cattle material, 
SRM, MS Beef, material from nonambulatory disabled cattle, and material 
from cattle not inspected and passed) may present a risk to human 
health. Under section 402(a)(3) of the FD&C Act, these materials are 
unfit for food. Under section 402(a)(4) of the FD&C Act, a food is 
adulterated ``if it has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health.'' The failure to 
ensure that food is prepared, packed, or held under conditions in which 
prohibited cattle materials do not contaminate the food constitutes an 
insanitary condition whereby it may have been rendered injurious to 
health and thus renders the food adulterated under section 402(a)(4) of 
the FD&C Act. Under section 402(a)(5) of the FD&C Act, food is deemed 
adulterated if it is, in whole or in part, the product of an animal 
which has died otherwise than by slaughter. Some cattle are not 
inspected and passed because they have died before slaughter. Material 
from cattle that die otherwise than by slaughter is adulterated under 
section 402(a)(5) of the FD&C Act. As further explained in the 2004 
IFR, prohibited cattle materials for use in human food are food 
additives subject to section 409 of the FD&C Act, except when used as 
dietary ingredients in dietary supplements. The use or intended use of 
any prohibited cattle material in human food, except for dietary 
ingredients in dietary supplements, causes the material and the food to 
be adulterated under section 402(a)(2)(C) of the FD&C Act.
    Under section 601(c) of the FD&C Act, a cosmetic is adulterated 
``if it has been prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health.'' The failure to ensure that a 
cosmetic is prepared, packed, or held under conditions in which 
prohibited cattle materials do not contaminate the cosmetic constitutes 
an insanitary condition whereby it may have been rendered injurious to 
health and, thus, renders the cosmetic adulterated under section 601(c) 
of the FD&C Act.
    Under section 701(a) of the FD&C Act, we may issue regulations for 
the efficient enforcement of the FD&C Act. A regulation that requires 
measures to prevent human food from being unfit for food, from being or 
bearing an unsafe food additive, from being the product of an animal 
that died otherwise than by slaughter, and to prevent human food and 
cosmetics from being held under insanitary conditions, allows for 
efficient enforcement of the FD&C Act.

IV. What comments did we receive? What are our responses?

    We received approximately 1,464 comments, each containing one or 
more issues, to the 2004 IFR, and approximately 20 comments, each 
containing one or more issues, to the 2005 and 2008 amendments, and 31 
comments to the 2013 notice. Animal welfare advocacy organizations, 
private consultants, consumer groups, foreign governments, Members of 
Congress, industry, and consumers submitted comments. Comments 
previously addressed in the 2005 and 2008 amendments, and comments 
addressing issues outside the scope of this rulemaking (e.g., those 
addressing potential concerns regarding diseases other than BSE; those 
addressing animal welfare concerns, which are covered in the Humane 
Methods of Slaughter Act of 1978 (7 U.S.C. 1901 et seq.) and 
administered by USDA); the prohibition of the use of materials from 
nonambulatory animals other than cattle (i.e., deer, elk, and sheep); 
and those responding to rules issued by other federal agencies will not 
be addressed in this document.
    To make it easier to identify the comments and FDA's responses, the 
word ``Comment,'' in parentheses, appears before the comment's 
description and the word ``Response,'' in parentheses, appears before 
FDA's response. Each comment is numbered to help distinguish between 
different comments. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value or 
importance.

A. Definitions (Sec. Sec.  189.5(a) and 700.27(a))

    Sections 189.5(a) and 700.27(a) state that the definitions and 
interpretations of terms in section 201 of the FD&C Act apply (21 
U.S.C. 321) and also define the following terms: ``prohibited cattle 
materials,'' ``inspected and passed,'' ``mechanically separated,'' 
``nonambulatory disabled cattle,'' ``specified risk material,'' 
``tallow,'' ``tallow derivative,'' and ``gelatin.'' Several comments 
pertained to our regulatory definitions, and we discuss those comments 
here.
1. ``Prohibited Cattle Materials'' (Sec. Sec.  189.5(a)(1) and 
700.27(a)(1))
    The 2004 interim final rule defined ``prohibited cattle materials'' 
as specified risk materials, small intestine of all cattle, material 
from nonambulatory disabled cattle, material from cattle not inspected 
and passed, or MS (Beef). The 2004 IFR also defined ``prohibited cattle 
material'' as not to include tallow that contains ``no more than 0.15 
percent hexane-insoluble impurities and tallow derivatives.'' The 2005 
amendment made an exception in the case of the small intestine such 
that the small intestine would not be considered prohibited cattle 
material if the distal ileum is removed by a

[[Page 14721]]

procedure that removes at least 80 inches of the uncoiled and trimmed 
small intestine in a manner specified in Sec.  189.5(b)(2) (or, in the 
case of Sec.  700.27, Sec.  700.27(b)(2)) and also changed ``hexane-
insoluble'' to ``insoluble'' in the definition of ``tallow.'' The 2005 
amendment also excluded hides and hide-derived products, and milk and 
milk products from the definition of ``prohibited cattle materials.'' 
The 2008 amendment provided that FDA may designate a country as not 
subject to certain BSE-related restrictions applicable to FDA regulated 
human food and cosmetics.
    We did not receive comments specific to the definition of 
``prohibited cattle materials at Sec. Sec.  189.5(a)(1) and 
700.27(a)(1), and we have finalized that portion of the definition 
without change.
a. Tallow, Tallow Derivatives, Gelatin, Hides and Hide-Derived 
Products, and Milk and Milk Products (Sec. Sec.  189.5(a)(1)(i) and 
700.27(a)(1)(i))
    (Comment 1) One comment supported the exclusion of hides and hide-
derived products from the definition of prohibited cattle materials but 
said that we need to address the possible cross-contamination of hides 
and other non-prohibited cattle materials with prohibited cattle 
materials during slaughter and processing.
    (Response 1) As noted in the 2005 amendment, manufacturers and 
processors must take precautions to avoid cross contamination of hides 
and other non-prohibited cattle material with prohibited cattle 
material during slaughter and processing (70 FR 53063 at 53066). 
Further, food establishments are subject to the current good 
manufacturing practice requirements (CGMPs) at 21 CFR part 110, and the 
failure to take adequate measures to prevent cross-contamination could 
result in insanitary conditions whereby the food may be rendered 
injurious to health and, therefore, adulterated under section 402(a)(4) 
of the FD&C Act.
    (Comment 2) While most comments found the clarification as to the 
allowable composition of tallow source material used in tallow 
derivatives in the preamble to the 2005 amendment helpful, one comment 
suggested that we revise the definition of ``prohibited cattle 
materials'' to state that: ``Prohibited cattle materials do not include 
tallow that contains no more than 0.15 percent insoluble impurities, 
tallow derivatives (regardless of the source of tallow), hides and 
hide-derived products, and milk and milk products.''
    (Response 2) We understand that the intent of the parenthetical 
``regardless of the source of the tallow'' is to make clear that the 
chemical processes (hydrolysis, transesterification, and 
saponification) involving high temperature and pressure are 
sufficiently rigorous even if the starting tallow is, for example, 
inedible tallow or tallow containing greater than 0.15 percent 
insoluble impurities. We agree that the processes to produce tallow 
derivatives are sufficiently rigorous, but believe that by excluding 
tallow derivatives, without the parenthetical, from the definition of 
prohibited cattle material, it is clear that we are excluding all 
tallow derivatives. Prohibited cattle material does not include tallow 
derivatives. We do not believe the parenthetical ``regardless of the 
source of tallow'' is needed.
    (Comment 3) One comment would revise the definition of prohibited 
cattle materials to emphasize the rigorousness of the processing 
involved in the production of tallow derivatives (i.e., 
transesterification or saponification) to minimize the risk of 
transmitting TSE agents. The comment was concerned that the ``lack of 
alignment'' between U.S. and non-U.S. requirements and guidance with 
respect to tallow derivatives will continue to affect the acceptance of 
U.S.-origin materials in non-U.S. markets.
    (Response 3) We decline to revise the definition as suggested by 
the comment. Our objective in developing our BSE regulations for human 
food and cosmetics, including these involving tallow derivatives, is to 
apply appropriate measures to safeguard life and health and be no more 
trade restrictive than necessary to achieve the food and cosmetic 
safety objective. As to the degree of processing involved in producing 
tallow derivatives, we addressed this subject in the preamble to the 
2004 IFR (69 FR 42256 at 42261) and discussed how tallow derivatives 
are produced by subjecting tallow to chemical processes (hydrolysis, 
transesterification, and saponification) that involve high temperature 
and pressure. We further noted in the 2004 IFR that FDA's Transmissible 
Spongiform Encephalopathy Advisory Committee (TSEAC) considered the 
safety of tallow and tallow derivatives in 1998 and ``determined that 
the rigorous conditions of manufacture are sufficient to further reduce 
the BSE risk in tallow derivatives'' (69 FR 42256 at 42261).
    We have revised the list of materials not considered prohibited 
cattle materials at Sec. Sec.  189.5(a)(1)(i) and 700.27(a)(1)(i) to 
include gelatin. To ensure that only gelatin derived from customary 
industry processes qualifies for this exclusion, Sec. Sec.  189.5(a)(8) 
and 700.27(a)(8) of the final rule provide that ``Gelatin means a 
product that has been obtained by the partial hydrolysis of collagen 
derived from hides, connective tissue, and/or bone bones of cattle and 
swine. Gelatin may be either Type A (derived from an acid-treated 
precursor) or Type B (derived from an alkali-treated precursor) that 
has gone through processing steps that include filtration and 
sterilization or an equivalent process in terms of infectivity 
reduction.''
    There has been increasing recognition based on scientific evidence 
as to the safety of gelatin for human use irrespective of the source 
materials from which it is made. For example, laboratory studies have 
indicated that gelatin manufacturing processes are capable of reducing 
inoculated BSE prion titers by at least six to eight orders of 
magnitude (Ref. 8). The OIE Code does not recommend any restrictions, 
regardless of the BSE status of a country, in trade of gelatin prepared 
from bones and intended for food, cosmetics, pharmaceuticals including 
biologicals, or medical devices, among other items (Ref. 9). A 2006 
scientific panel of the European Food Safety Authority (EFSA)--
reviewing a 2003 EFSA Scientific Steering Committee opinion--concluded 
that there was no support for prohibition of or restrictions on the use 
of skull and vertebrae of cattle that had passed ante mortem and post 
mortem inspections in the production of gelatin (Ref. 10). Based on 
this evidence, we conclude that gelatin manufactured from bovine raw 
materials using customary industry processes presents a negligible risk 
of transmitting the agent that causes BSE.
(b) Cattle Materials Inspected and Passed From Designated Countries 
(Sec. Sec.  189.5(a)(1)(ii) and 700.27(a)(1)(ii))
    (Comment 4) One comment supporting a mechanism to designate 
countries as not subject to certain BSE-related restrictions (provided 
under Sec.  189.5(a)(1)(ii)) expressed concerns that interested 
countries would need to go through separate application and evaluation 
processes at USDA and FDA for a country to receive a USDA and FDA-
granted designation. The comment requested that the application and 
evaluation procedures used by the different U.S. regulating agencies be 
streamlined to reduce the potential duplication of time and effort by 
the applying country.
    (Response 4) We understand the concern expressed by the comment.

[[Page 14722]]

However, as we explained in the 2008 amendment, FDA and USDA have 
different regulatory responsibilities with respect to preventing BSE 
and ensuring food safety (73 FR 20785 at 20788). While we have our own 
evaluation process, we will consult with USDA as part of this process 
(73 FR 20785 at 20788). Further, we will take into consideration 
available risk assessments of other competent authorities in conducting 
our evaluations (73 FR 20785 at 20788.). Although not required, a 
previous BSE evaluation performed by USDA's FSIS or Animal and Plant 
Health Inspection Service (APHIS), or by OIE, or by another country or 
competent authority, could be used by FDA as part of our review (73 FR 
20785 at 20788).
    (Comment 5) Several comments from the gelatin industry requested 
that gelatin be excluded from consideration as a prohibited cattle 
material. The comments noted that standard industry practice is to 
produce gelatin using raw materials from animals inspected and passed 
for human consumption, that SRMs and materials from nonambulatory 
disabled cattle are excluded, that the safety of gelatin is based on 
adherence to industry practices, as well as our CGMPs and USDA 
regulations, and that gelatin made from bovine raw materials undergoes 
manufacturing processes that inactivate possible BSE infectivity, 
citing studies by the European Commission (EC) and the Gelatine 
Manufacturers of Europe. Several comments noted that TSEAC reviewed 
these studies and concluded on July 17, 2003, that these studies 
``demonstrate a reduction in infectivity that is sufficient to protect 
human health.''
    (Response 5) We agree with the comments and have revised Sec. Sec.  
189.5(a)(1)(i) and 700.27(a)(1)(i) to include gelatin in the list of 
materials not considered ``prohibited cattle materials.'' We are making 
this change because gelatin manufactured according to customary 
industry processes present a negligible risk of transmitting the BSE 
agent and should not be considered ``prohibited cattle materials.''
    (Comment 6) Several comments took issue with an FDA statement 
appearing in the background section to the 2004 IFR that provided 
certain products, such as gelatin and collagen, ``have traditionally 
been produced from cattle material deemed inedible by the USDA'' (69 FR 
42256 at 42261). The comments pointed out that U.S. raw materials used 
to produce gelatin come from cattle that have been inspected and passed 
by USDA for human consumption and are produced in accordance with FDA 
and USDA regulations, and in accordance with applicable FDA human food 
CGMPs. These comments further noted that only safe raw materials are 
used to produce gelatin and that SRMs and materials from nonambulatory 
disabled cattle are excluded. One comment specifically requested that 
we publish a correction in the Federal Register clarifying that gelatin 
is not produced from inedible material.
    (Response 6) The quoted statement was included in a broader 
discussion explaining in part why we were extending similar protections 
to FDA-regulated human foods and cosmetics as USDA had already imposed 
in USDA-inspected facilities. We agree that gelatin is manufactured 
from raw materials that have been inspected and passed for human 
consumption.
    (Comment 7) Several comments requested that we clarify whether our 
gelatin guidance document published in 1997 (Ref. 11) will be revoked 
or revised in light of this regulation. The comments expressed concern 
that gelatin manufacturers would face an unnecessary regulatory burden 
depending on whether the product the gelatin is used in is a food 
product or dietary supplement, or a pharmaceutical product, or for 
other FDA-regulated uses. The comments also requested that we 
explicitly state that our gelatin guidance document is no longer 
applicable for products intended for oral consumption or cosmetic use 
by humans.
    (Response 7) This final rule supersedes the 1997 guidance with 
respect to human food and cosmetics. We intend to review the 1997 
guidance and will consider withdrawing or revising the guidance, as 
appropriate, consistent with this final rule.
2. ``Inspected and Passed'' (Sec. Sec.  189.5(a)(2) and 700.27(a)(2))
    The regulations define ``inspected and passed'' as meaning 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. We did not receive comments 
specific to our definition of ``inspected and passed,'' and we have 
finalized the definition without change.
3. ``Mechanically Separated (MS) (Beef)'' (Sec. Sec.  189.5(a)(3) and 
700.27(a)(3))
    The regulations define ``mechanically separated (MS) (beef)'' as a 
meat food product that is finely comminuted, resulting from the 
mechanical separation and removal of most bone from the attached 
skeletal muscle of cattle carcasses or parts of carcasses that meet 
certain USDA specifications. We did not receive comments specific to 
our definition of ``(MS) (Beef).''
    On our own initiative, we have revised the definition of 
``mechanically separated (MS) (Beef)'' to clarify that 9 CFR 319.5, 
which we cite in Sec. Sec.  189.5(a)(3) and 700.27(a)(3), refers to a 
USDA regulation. Thus, the final rule adds ``U.S. Department of 
Agriculture'' before ``regulation.''
4. ``Nonambulatory Disabled Cattle'' (Sec. Sec.  189.5(a)(4) and 
700.27(a)(4))
    The regulations define ``nonambulatory disabled cattle'' as cattle 
that cannot rise from a recumbent position or that cannot walk, 
including, but not limited to, cattle with broken appendages, severed 
tendons or ligaments, nerve paralysis, fractured vertebral column, or 
metabolic conditions.
    (Comment 8) One comment suggested that downer animals should be 
tested first for BSE and held pending the outcome of the testing before 
deciding to prohibit the use of material from nonambulatory disabled 
cattle in human food and cosmetics. If the test results are negative, 
then the carcass could be used for human food and cosmetics.
    (Response 8) This option is not feasible due to the limitations of 
currently available tests. No validated ante mortem test for BSE 
currently exists. Available post mortem tests, although useful for 
disease surveillance purposes in terms of determining the rate of 
disease in the population of cattle, are not appropriate as a safety 
indicator for human food or cosmetics because there is a potentially 
long period in the life of an infected animal where tests using the 
current methodology would not detect the disease (Refs. 12 through 14). 
This is due, in part, to limitations on existing testing methods, which 
rely on the use of post mortem brain tissue. Experimental evidence 
demonstrates that for cattle infected orally, certain potentially 
infective tissues (such as the distal ileum and tonsils) are the first 
tissues to accumulate infectivity in the incubation period and this 
infectivity occurs prior to any demonstrated infectivity in brain 
tissue (Refs. 12 through 14). Therefore, tests conducted on brain 
tissue may not accurately reflect the potential infectivity in other 
tissues that develop infectivity earlier, such as the distal ileum.
    As a result, we have finalized the definition of ``nonambulatory 
disabled cattle'' without change.
    (Comment 9) One comment stated that our restrictions relating to 
materials

[[Page 14723]]

from nonambulatory disabled cattle should not apply to custom 
slaughtered animals.
    (Response 9) This final rule does not apply to custom slaughtered 
cattle because such cattle are for the owner's exclusive use and not 
for use in FDA regulated human food and cosmetics. FDA notes that, in 
our 2007 affirmation of our interim final rule with amendments, FSIS 
determined that it cannot permit the custom slaughter or preparation of 
products of nonambulatory disabled cattle for human food even if it is 
for the owner's exclusive use because FSIS considers the carcasses of 
these animals to be adulterated (72 FR 38700 at 38703 to 38704).
5. ``Specified Risk Material'' (Sec. Sec.  189.5(a)(5) and 
700.27(a)(5))
    The regulations define ``specified risk material'' as meaning 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. The definition also 
includes tonsils and distal ileum of the small intestine of all cattle 
as ``specified risk material.''
    In the Federal Register of March 4, 2013 (78 FR 14012), we reopened 
the comment period for the IFR due to new studies showing infectivity 
in parts of the small intestine other than the distal ileum. We noted 
that there were studies showing the presence of some infectivity in the 
proximal ileum, jejunum, ileocecal junction, and colon of cattle with 
BSE. We also noted that the infectivity levels reported in the studies 
were lower than the infectivity levels previously demonstrated for the 
distal ileum (78 FR 14012 at 14013). We put the studies into the 
administrative record and invited comment on them, and also said that 
we had tentatively concluded that the effect of these traces of 
infectivity on the risk of human or ruminant exposure to BSE in the 
United States is negligible (78 FR 14012). We tentatively concluded 
that ``requiring the removal of additional parts of the small intestine 
would not provide a measurable risk reduction compared to that already 
being achieved by removal of the distal ileum in all cattle and that it 
would be appropriate to finalize our interim final rule without 
changing any provisions related to the small intestine'' (78 FR 14012).
    (Comment 10) One comment asked whether the pituitary gland of 
cattle is considered an SRM and would have to be removed from the 
carcass when the brain is removed if the cattle is 30 months of age or 
older.
    (Response 10) The pituitary gland or hypophysis lies at the base of 
the brain, contacting the hypothalamus. Anatomically, it is considered 
part of the brain. Thus, the pituitary gland or hypophysis is 
considered an SRM in cattle 30 months or age or older and must be 
removed from the carcass when the brain is removed.
    (Comment 11) One comment requested that the vertebral column not be 
considered an SRM because the attached DRG as well as the loosely 
attached spinal cord, which are sources of BSE infectivity, can be 
safely separated and removed from the vertebral column. (In general 
terms, DRG are nerves attached to the spinal cord.) The comment did not 
submit any data in support of its position nor did it explain the 
method or methods for safely separating and removing the DRG from the 
vertebral column.
    (Response 11) We decline to revise the rule as suggested by the 
comment. While the vertebral column has not been shown to harbor BSE 
infectivity, it does contain tissues (i.e., DRG, spinal cord) that have 
been shown to be infectious. Technologies are not currently available 
to safely remove the DRG without removing part of the vertebral column 
(see 2007 FSIS affirmation, 72 FR 38700 at 38710). The 2007 FSIS 
affirmation also noted that while the DRG is located within the 
vertebral bones, it could potentially become dislodged during 
consumption of bone-in-beef products. Therefore, the vertebral column 
(excluding the vertebrae of the tail, the transverse processes of the 
thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 
30 months of age and older is included in the list of SRMs. We will 
reconsider this issue if technology becomes available to safely remove 
the DRG from the vertebral column, but we have finalized the definition 
of ``specified risk material'' without change.
    (Comment 12) One comment requested that we revise the definition of 
SRMs to include meat obtained from vertebral columns processed with 
Advanced Meat Recovery (AMR) systems because of the instances of DRG 
and spinal cord being detected in AMR products.
    (Response 12) We decline to revise the rule as suggested by the 
comment. USDA regulations, at 9 CFR 318.24, provide that vertebral 
columns of cattle 30 months of age and older (excluding the vertebrae 
of the tail, the transverse processes of the thoracic and lumbar 
vertebrae, and the wings of the sacrum) are SRMs and therefore cannot 
be used as source materials for AMR systems.
    (Comment 13) One comment stated that, although we noted that the 
OIE has not designated any intestinal sections other than the distal 
ileum as SRM, the OIE did not conduct a risk assessment to support that 
statement.
    (Response 13) We did not intend to imply that the OIE had conducted 
a risk assessment or studied the new research findings and published 
its conclusions about the significance to human health. We meant that 
the OIE had not added parts of the small intestine other than the 
distal ileum to its recommendations on commodities that should not be 
traded (Ref. 15).
    (Comment 14) Some comments recommended that the 30-month age 
cutoff, which provides a basis for designating certain cattle materials 
as SRMs, should be changed to a 12-month cutoff because of scientific 
uncertainty about how BSE spreads in cattle, and because the true 
prevalence of the disease in the United States is not fully known.
    (Response 14) We disagree with these comments. Experimental and 
epidemiological evidence have clearly linked transmission of BSE to 
using protein derived from BSE infected cattle as an additive in cattle 
feed. FDA's 1997 and 2008 BSE feed regulations prohibit this practice. 
Further, ongoing BSE surveillance conducted by USDA APHIS, which tests 
approximately 40,000 animals from the highest risk cattle population 
per year, shows that the prevalence in the United States is less than 
one case per million adult cattle in the United States (Ref. 16). We 
therefore believe that the 30-month cutoff is appropriate for the BSE 
risk status in the United States, as we first discussed in our 2004 IFR 
(69 FR 42256 at 42259-60).
    (Comment 15) One comment recommended that a 12-month cutoff for 
purposes of designating certain cattle materials as SRMs would be more 
prudent given the scientific uncertainty in fully understanding the 
possible ways that the BSE agent might infect humans.
    (Response 15) We disagree that an additional margin of safety in 
the age cutoff is needed because of scientific uncertainty about how 
humans are exposed to the BSE agent. The 30-month cutoff is 
internationally recognized and well supported by pathogenesis studies 
that were designed to determine the tissue distribution of the BSE 
agent as the disease progresses in BSE-infected cattle.
    (Comment 16) Several comments recommended that materials currently

[[Page 14724]]

designated as SRMs if they are from cattle 30 months of age and older 
should be considered SRMs regardless of the animal's age and should be 
prohibited from entering the food supply. According to the comment, a 
broad prohibition on the use of SRMs regardless of the animal's age 
would significantly reduce the need of determining the age of each 
animal, and thereby improve enforcement. Some comments pointed out 
that, in the absence of a national animal identification system, any 
determination of an animal's age is based typically on a physical 
assessment, and such an assessment can be subjective.
    (Response 16) We disagree that the full list of SRMs should be 
removed from all cattle to eliminate the need for aging the animals. 
Methods of aging allowed under FSIS regulations, such as documentation 
and dentition, are reliable for identifying cattle over 30 months of 
age.
    (Comment 17) One comment recommended that vertebral columns of 
cattle of all ages should be considered SRMs, not just vertebral 
columns of cattle 30 months of age and older, but the comment did not 
provide evidence or data to support the change.
    (Response 17) We disagree with this recommendation. As previously 
stated in Comment and Response 14, pathogenesis studies support a 30-
month cutoff in low BSE prevalence countries like the United States.
    (Comment 18) Several comments noted that available post mortem 
tests are capable of identifying the presence of the BSE agent only 
near the end of the animal's incubation period; therefore cattle 
younger than 30 months of age in the early stages of BSE that do not 
test positive for the disease may be harboring the BSE agent. The 
comments suggested that the definition of SRM not exclude certain 
materials from cattle younger than 30 months.
    (Response 18) We agree about the limitation of BSE test methods, 
but disagree that the limitations should influence the SRM definition. 
The 30-month cutoff is based on pathogenesis studies, not on diagnostic 
capabilities.
    (Comment 19) One comment supported a 12-month cutoff for 
classifying animal age-related SRMs due to uncertainty surrounding a 
published study that suggested that there may be another form of TSE in 
cattle, referred to as bovine amyloidotic spongiform encephalopathy 
(BASE).
    (Response 19) We do not agree that the 12-month cutoff is necessary 
for the BASE strain of BSE, also known as L-type BSE. FSIS pointed out 
in the 2007 FSIS affirmation that the available data on the BASE strain 
do not indicate that cattle with this form of BSE are more likely to 
contain higher levels of the infective agent early in the incubation 
period than cattle with the ``typical'' BSE strain (72 FR 38700 at 
38707). As FSIS concluded, additional study on the BASE form of BSE 
will be needed to determine its significance.
    (Comment 20) One comment recommended expanding the SRM definition 
to include the entire head of cattle 30 months of age and older. The 
comment also stated that cheek and head meat of cattle 12 months of age 
and older should be removed before the skull is fragmented or split, 
based on concerns that the head or cheek meat may contain central 
nervous system materials if the meat is not removed before the skull is 
fragmented or split. To support its arguments, the comment referred to 
a 2002 USDA FSIS paper that discussed the prohibition of cheek meat 
from cattle aged 24 months and older for human food if the meat is not 
removed before the skull is fragmented or split.
    (Response 20) We disagree that the entire head of cattle 30 months 
of age and older should be condemned because of concerns that head meat 
and cheek meat could be contaminated with central nervous system 
tissue. FSIS regulations (9 CFR 310.22(e)) require that establishment 
procedures for removal of SRMS at slaughter must address potential 
contamination of edible materials with specified risk materials. Such 
procedures would include taking steps to ensure that cheek meat, for 
example, is not cross-contaminated with brain matter or central nervous 
system matter.
    (Comment 21) One comment recommended using a 12-month cutoff for 
purposes of designating certain cattle materials as SRMs so that it 
would be consistent with the European Union (EU) standard 12-month 
cutoff period.
    (Response 21) We decline to revise the rule as suggested by the 
comment. The EU established its BSE requirements because of a small 
number of BSE cases detected in young animals. These cases are now 
believed to be the result of cattle being exposed to large exposure 
doses of the BSE agent at the height of their BSE outbreak, before 
appropriate mitigations were put in place to reduce high levels of BSE 
infectivity circulating in their cattle population. In contrast, early 
control measures were put in place in the United States to protect 
against the establishment and amplification of BSE in the U.S. cattle 
population.
    Further, the EC has published a roadmap for relaxing its BSE 
mitigations, including age cutoffs, because of the downward trend in 
BSE cases across the EU (Ref. 17).
    (Comment 22) Several comments supported using a 12-month cutoff for 
purposes of designating certain cattle materials as SRMs because cattle 
as young as 21 months have tested positive for BSE in the UK and Japan.
    (Response 22) We disagree with these comments. As discussed in the 
2004 IFR (69 FR 42256 at 42259), we are aware of documented cases of 
BSE in the UK in animals younger than 30 months of age. As noted in the 
2004 IFR (69 FR 42256 at 42259), at the height of the epidemic in the 
UK when thousands of animals were being diagnosed with BSE each year, 
fewer than 20 animals younger than 30 months were confirmed with the 
disease (Ref. 18). The youngest animal with a confirmed case of BSE was 
20 months old (Ref. 19). The occurrence of BSE in young animals in the 
UK was most likely the result of exposure to a high infective dose of 
the BSE agent at a young age.
    We also noted in the 2004 IFR the two reported cases of BSE in 21-
month and 23-month-old animals in Japan discovered during the testing 
of animals presented for slaughter (69 FR 42256 at 42259). FSIS 
addressed a similar comment in the 2007 FSIS affirmation (72 FR 38700 
at 38721) and concluded that the available evidence surrounding the two 
very young cases reported in Japan is insufficient to support any 
changes in FSIS's existing measures to prevent human exposure to the 
BSE agent. FSIS referred to a report by EFSA's Scientific Panel on 
Biological Hazards, which stated that ``it is unclear whether the very 
young cases [reported in Japan] were adequately identified and formally 
confirmed'' (Ref. 20). This same EFSA report concluded that these cases 
``seem to be epidemiologically peculiar as their cohort would have been 
expected to yield further cases.''
    (Comment 23) One comment said a 12-month age cutoff would be 
consistent with the International Review Team (IRT) recommendation that 
the brain, skull, spinal cord, and vertebral column of cattle over 12 
months of age be excluded from both human food and animal food chains 
unless aggressive surveillance shows that the BSE risk in the United 
States is minimal (Ref. 21).
    (Response 23) We decline to revise the rule in response to the 
comment. The IRT was convened at the request of the U.S. Secretary of 
Agriculture on December 30, 2003, to review the actions taken by the 
United States in response to the confirmation of BSE in an imported 
dairy cow in Washington State on December 23, 2003. The IRT recommended 
that, among other things,

[[Page 14725]]

the brain, skull, spinal cord, and vertebral column of cattle over 12 
months be excluded from both the human food and animal food chains 
unless aggressive surveillance proves the BSE risk in the United States 
to be minimal (Ref. 22). As a follow up to the IRT report, USDA's APHIS 
conducted the aggressive surveillance and found the BSE prevalence in 
the United States to be minimal. Therefore, a 30-month cutoff is 
consistent with the recommendations of the IRT.
    (Comment 24) One comment noted that many countries have imported 
vast amounts of meat-and-bone meal from countries with BSE-infected 
cattle, some of which do not have adequate surveillance and other 
mitigations in place to prevent contamination of the animal feed and 
human food chains. The comment further noted that these countries may 
still serve as a source of disease, and if the entire intestine is not 
designated as SRM, BSE-infected bovine products could be imported and 
enter the U.S. food or feed supply.
    (Response 24) We disagree that the scenario described provides 
sufficient justification for designating the entire intestine as SRM. 
Our trading partners in cattle and cattle derived products are 
countries that have performed a BSE risk assessment, conducted the 
required level of BSE surveillance, and have the necessary BSE 
mitigations in place to meet OIE requirements for negligible or 
controlled risk status.
    (Comment 25) One comment stated that we should err on the side of 
caution when it comes to protecting public health and designate the 
entire length of the intestines as SRM. The comment noted that 
scientific research demonstrates that immunostaining was observed in 
the myenteric plexus of the distal ileum in both naturally infected and 
experimentally challenged cattle with BSE, so one cannot eliminate the 
possibility of infectivity in other sections because the myenteric 
plexus exists throughout the entire intestine. Another comment stated 
that even a trace of BSE infectivity is concern enough to prohibit the 
use of the jejunum, proximal ileum, ileocecal junction, and colon of 
cattle.
    (Response 25) We agree that it is reasonable to assume that 
increasingly sensitive detection methods could demonstrate that BSE 
infectivity is present anywhere along the intestinal tract, associated 
either with the enteric nervous system or lymphoreticular tissue. 
However, all available evidence to date shows that levels outside the 
distal ileum are much lower than levels in the distal ileum. As we 
explained in the 2013 notice, our tentative conclusion took into 
consideration not just the lower levels, but also the other safeguards 
in place in the United States, the sharp decline in the worldwide 
incidence of BSE, and the extremely low prevalence of BSE in the U.S. 
cattle population as indicated by USDA's BSE surveillance program (78 
FR 14012). This conclusion is consistent with the recommendation in the 
2009 EFSA Scientific Opinion that future consideration of risk 
associated with infectivity in the intestine take into account the BSE 
prevalence in cattle at that time (Ref. 18).
    (Comment 26) Comments from the Biological Hazards Unit of EFSA in 
response to FDA's 2013 notice reopening the comment period clarified 
EFSA's current thinking on BSE infectivity in bovine intestines. EFSA 
stated that it had concluded that BSE infectivity in the bovine ileum 
is found mainly in association with the lymphoid follicles, the ileal 
Peyer's patches (Refs. 23 through 25). The ileal Peyer's patches are 
aggregated into a long continuous structure called the ileocecal plate. 
The ileocecal plate extends the full length of the ileum, and may 
extend proximally into the jejunum. EFSA concluded that, when assessing 
the BSE infectious load potentially present in the intestines of BSE-
infected cattle, the ileocecal plate should be considered as the main 
contributor to BSE infectivity in the intestine.
    (Response 26) Since submitting comments to the 2013 notice, the 
EFSA Panel on Biological Hazards (BIOHAZ) published on May 13, 2014, a 
Scientific Opinion on BSE risk in bovine intestines and mesentery (Ref. 
25). This scientific opinion provides additional information about the 
distribution of intestinal lymphoid tissue with which BSE infectivity 
is associated in the early stages of disease. EFSA concluded that the 
BSE infectious load in the intestines is primarily associated with the 
lymphoid tissue making up the ileocecal plate. According to anatomical 
data presented in the report, the length of the ileocecal plate could 
reach four meters (157 inches), with considerable animal-to-animal 
variation, in cattle younger than 18 month of age, before the ileocecal 
plate starts to diminish in length as the animal ages. So, while 
studies to date show that infectivity levels outside the distal ileum 
are much lower than in the distal ileum, the anatomical data in the 
report show that in young cattle lymphoid tissue could extend two 
meters outside (proximal to) the distal ileum. This anatomical data 
does not alter our decision to leave the SRM definition unchanged. We 
believe that given the United States and worldwide BSE prevalence data, 
removal of prohibited cattle materials as required by this rule, 
together with the other effective BSE mitigations implemented by the 
U.S. government, provides the appropriate level of protection against 
human exposure to the BSE agent.
6. ``Tallow'' (Sec. Sec.  189.5(a)(6) and 700.27(a)(6))
    The regulations define ``tallow'' as 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 tissue. The definition also states that tallow 
must be produced from tissues that are not prohibited cattle materials 
and must not contain more than 0.15 insoluble impurities as determined 
by the method entitled ``Insoluble Impurities'' (AOCS Official Method 
Ca 3a-46, American Oil Chemists' Society (AOCS), 5th Edition, 1997, or 
another equivalent method.
    (Comment 27) One comment questioned the basis (i.e., underlying 
data) for selecting the 0.15 percent level as the allowable cutoff for 
insoluble impurities in tallow, but did not provide evidence or data to 
support changing the allowable level.
    (Response 27) We discussed the underlying research that provided 
the basis for permitting tallow to be used in human food and cosmetics 
if it contains no more than 0.15 percent insoluble impurities in the 
2004 IFR (69 FR 42256 at 42260 through 42261). In addition, the 0.15 
percent cutoff is consistent with the level used by the Office 
International des Epizooties (OIE) in the BSE chapter of the OIE 
Terrestrial Animal Health Code (Ref. 7). Therefore, we are not making 
any further changes with respect to using the 0.15 percent level as the 
allowable cutoff of insoluble impurities.
7. ``Tallow Derivatives'' (Sec. Sec.  189.5(a)(7) and 700.27(a)(7))
    The regulations define ``tallow derivative'' as any chemical 
obtained through initial hydrolysis, saponification, or 
transesterification of tallow. The definition also states that chemical 
conversion of material obtained by hydrolysis, saponification, or 
transesterification may be applied to obtain the desired product.
    We did not receive comments specific to our definition of ``tallow 
derivative,'' and we have finalized the definition without change.

[[Page 14726]]

8. ``Gelatin'' (Sec. Sec.  189.5(a)(8) and 700.27(a)(8))
    Our regulations at Sec. Sec.  189.5 and 700.27 mention, but do not 
define, ``gelatin.'' Thus, on our own initiative, we have decided to 
define gelatin as a product that has been obtained by the partial 
hydrolysis of collagen derived from hides, connective tissue, and/or 
bones of cattle and swine. Gelatin may be either Type A (derived from 
an acid-treated precursor) or Type B (derived from an alkali-treated 
precursor) that has gone through processing steps that include 
filtration and sterilization or an equivalent process in terms of 
infectivity reduction (Ref. 26).

B. Requirements (Sec. Sec.  189.5(b) and 700.27(b))

    The regulations at Sec. Sec.  189.5(b)(1) and 700.27(b)(1) provide 
that no human food or cosmetic shall be manufactured from, processed 
with, or otherwise contain, prohibited cattle materials. We further 
clarify in Sec. Sec.  189.5(b)(2) and 700.27(b)(2) that the small 
intestine is not considered prohibited cattle material as long as the 
distal ileum is removed by a procedure that removes at least 80 inches 
of the small intestine or by another procedure that the establishment 
can show is equally effective at ensuring the distal ileum is 
completely removed.
    (Comment 28) One comment objected to the use of cattle materials in 
any products and believed that our ``published policy'' is much too 
lenient, but did not provide evidence or data to support this 
assertion.
    (Response 28) We disagree with the comment's broad generalization. 
In the absence of data or other information, we do not have a basis on 
which to evaluate the comment's assertion that our published policy is 
too lenient.
    (Comment 29) One comment questioned the validity of relying on the 
Harvard-Tuskegee study to support the restrictions being applied by 
this regulation to externally applied cosmetics. The comment also 
questioned whether the restrictions that cover materials derived from 
cattle not inspected and passed are predicated on unfounded assumptions 
with respect to potential infectivity.
    (Response 29) The Harvard-Tuskegee study does not specifically 
address potential human exposure to the BSE agent from cosmetics (69 FR 
42256 at 42258), so it was not relied on to support the restrictions 
applied by the 2004 IFR to externally applied cosmetics. However, we 
are concerned that cosmetics, because of the ways they are used, could 
serve as another potential route for BSE infectivity to enter the human 
system. We therefore conclude that the wide range of cattle-derived 
ingredients used in cosmetics should not contain prohibited cattle 
materials (Ref. 27).
    (Comment 30) One comment said that the United States should test 
every cow for TSEs, extend and enhance the feed ban, enhance 
surveillance and testing programs to test all cattle destined for human 
and animal consumption, ban all animal tissue in vaccines and 
nutritional supplements, and stop feeding ruminant and non-ruminant 
protein to all species.
    (Response 30) We disagree with the recommendation to change current 
U.S. BSE control measures. The mitigations currently in place in the 
U.S. adequately protect human and animal health from BSE. Testing 
cattle and enhancing surveillance and testing programs fall under the 
purview of USDA. USDA's surveillance strategy is to target testing on 
those animals in the cattle population where the disease is most likely 
to be found if it is present. USDA has concluded that this is the most 
effective way to meet OIE and domestic surveillance standards. USDA 
determined that a level of 40,000 samples per year from these targeted, 
high-risk cattle far exceeds the standards recommended by the OIE (Ref. 
16). With respect to animal feed restrictions, FDA's 1997 feed ban 
prohibited the use of ruminant protein in cattle feed, while the 2008 
enhanced feed ban prohibits the use of the highest risk cattle tissues 
in all animal feed. Lastly, we are not aware of scientific 
justification for banning all animal tissue in vaccines and nutritional 
supplements.
    (Comment 31) While many comments supported the use of material from 
nonambulatory disabled cattle, a few comments requested that these 
materials be prohibited regardless of the reason for the animal's 
condition (e.g., obesity, fatigue, stress, nerve paralysis, or physical 
injury such as a fractured appendage, severed tendon or ligament, or 
dislocated joint). Other comments were concerned that visual 
examination was not sufficient for determining whether an animal is 
safe to be slaughtered. Other comments thought the current prohibition 
involving nonambulatory disabled cattle is too broad in its 
application, particularly when applied to animals that are 
nonambulatory due to clear physical injuries, such as a broken limb.
    (Response 31) We decline to make changes to the rule regarding the 
prohibition on the use of cattle materials from nonambulatory disabled 
cattle in human food and cosmetics. As discussed in the 2007 FSIS 
affirmation, surveillance data from the EU indicate that cattle that 
cannot rise from a recumbent position are among the cattle that have a 
greater prevalence of BSE than healthy slaughter cattle, and the 
typical clinical signs of BSE may not always be observed when cattle 
are nonambulatory (72 FR 38700 at 38701 to 38706).
    (Comment 32) Several comments requested that SRMs be kept out of 
all cosmetics over which FDA has jurisdiction.
    (Response 32) Under Sec.  700.27, no cosmetic shall be manufactured 
from, processed with, or otherwise contain, prohibited cattle 
materials. This includes SRMs.
    (Comment 33) One comment stated that human consumption of any trace 
of BSE can be fatal, and that the use of materials derived from cattle 
should not be allowed in human food and cosmetics.
    (Response 33) We strongly disagree that cattle derived products 
should not be used in human food and cosmetics. The sharp decline in 
vCJD cases worldwide demonstrates that internationally recognized BSE 
mitigations that remove only specified risk materials are highly 
effective in protecting humans against BSE. (Refs. 4, 22, 28, and 29). 
We note that the World Health Organization (WHO), in the 2010 update to 
the WHO Tables on Tissue Infectivity Distribution in Transmissible 
Spongiform Encephalopathies (Ref. 30), stated that the amount of 
pathological prion or infectious agent detected by exquisitely 
sensitive assays may well fall below the threshold of transmissibility 
for humans, and that consideration also has to be given to the level of 
infectivity in tissue, the amount of tissue to which a person is 
exposed, and that oral exposure is a comparatively inefficient route of 
transmission.
    (Comment 34) One comment stated that one of the most important and 
still unanswered questions is the significance of atypical BSE with 
respect to human and animal health. The comment said that if the U.S. 
government considers atypical BSE to be a sporadic disease, at present 
there is no means to eliminate cases from the national herd, and thus 
the food supply. The comment noted that in atypical BSE the extent of 
infectivity in bovine tissue is unknown, and hence, it would be 
important to at least remove the tissues having infectivity in 
classical BSE cases.
    (Response 34) We agree with the comment's assertion that there are 
still unanswered questions about the

[[Page 14727]]

significance of atypical BSE with respect to human and animal health. 
We also agree that if atypical cases are sporadic, their occurrence 
will continue to be an ongoing rare event in our cattle population. 
However, based on the available science, we believe that the 
mitigations currently in place in the United States to protect against 
classical BSE are adequate to protect against atypical BSE. We note 
that this was also the conclusion of the OIE Scientific Commission for 
Animal Diseases. The February 2013 meeting report concluded that ``the 
ruminant-to-ruminant feed ban which mitigates the risk of classical BSE 
concurrently reduces the recycling of atypical BSE in the cattle 
populations of the controlled and negligible BSE risk countries within 
which it is applied.'' (Ref. 31).

C. Records (Sec. Sec.  189.5(c) and 700.27(c))

    In the 2004 IFR, FDA required that manufacturers and processors of 
human food and cosmetics that are manufactured from, processed with, or 
otherwise contain, cattle material must make existing records relevant 
to compliance available to FDA for inspection and copying. In a 
companion rulemaking at the same time, FDA proposed a rule entitled 
``Recordkeeping Requirements for Human Food and Cosmetics Manufactured 
From, Processed With, or Otherwise Containing Material from Cattle'' 
(69 FR 42275). The rule proposed to require that manufacturers and 
processors of human food and cosmetics that are manufactured from, 
processed with, or otherwise contain, material from cattle establish 
and maintain records sufficient to demonstrate the food or cosmetic is 
not manufactured from, processed, with, or does not otherwise contain, 
prohibited cattle materials. The records requirements were finalized in 
2006 and incorporated the requirement from the 2004 IFR that existing 
records relevant to compliance be made available to FDA (71 FR 59653).

D. Adulteration (Sec. Sec.  189.5(d) and 700.27(d))

    Under Sec.  189.5(d)(1), failure of a manufacturer or processor to 
operate in compliance with the requirements or records provisions 
renders human food adulterated under section 402(a)(4) of the FD&C Act. 
Under Sec.  700.27(d), failure of a manufacturer or processor to 
operate in compliance with the requirements or records provisions 
renders a cosmetic adulterated under section 601(c) of the FD&C Act. 
Further, under Sec.  189.5(d)(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 FD&C Act. Under Sec.  189.5(d)(3), 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 FD&C 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.
    We did not receive comments specific to the adulteration 
provisions, and we have finalized them without change.

E. Process for Designating Countries (Sec. Sec.  189.5(e) and 
700.27(e))

    Sections 189.5(e) and 700.27(e) establish a process for designating 
a country as not subject to certain 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.
    We did not receive comments specific to the process for designating 
countries, and we have finalized those aspects of the rule without 
change.

F. Other Comments

    Several comments addressed matters that were not specific to a 
particular provision in the IFRs. We address those comments here.
    (Comment 35) Several comments said that prohibiting the use of 
cattle materials from nonambulatory disabled cattle in human food and 
cosmetics also should apply to the use of such materials in animal food 
or feed.
    (Response 35) This final rule applies to the use of cattle 
materials in human food and cosmetics regulated by FDA. Our regulations 
in effect at the time of the 2004 IFR prohibited the use of certain 
protein from mammalian tissues in ruminant feed and have since been 
revised to prohibit the use of certain cattle-derived risk materials 
(e.g., the brains and spinal cords from cattle 30 months of age and 
older, as well as the entire carcass of cattle not inspected and passed 
for human consumption) in all animal feeds. In a feed rule published in 
the Federal Register on April 25, 2008 (73 FR 22720), FDA's Center for 
Veterinary Medicine (CVM) explained that, because of the low prevalence 
of BSE in the United States, it is not necessary to prohibit all 
ruminant material from animal feed, nor is it necessary to prohibit all 
animal or all mammalian products in cattle feed. (See 73 FR 22720 at 
22724, as well as similar discussion provided in the preamble to the 
earlier CVM proposal published in the Federal Register on October 6, 
2005 (70 FR 58570 at 58578).)
    (Comment 36) One comment stated that we do not truly know or 
understand the real risk to the public in regards to vCJD as caused by 
classical BSE. The comment said that based on results of an appendix 
tissue survey in the UK, the dose to infect humans may be much smaller 
than previously considered, and even small amounts of the BSE agent 
could infect humans resulting in a subclinical disease that may pose a 
risk to other people via blood transfusions, etc. According to the 
comment, this is justification for prohibiting the use of the entire 
intestine for human consumption or cosmetics.
    (Response 36) We are aware of the results of the appendix survey 
published October 15, 2013, in the British Medical Journal (Ref. 32). 
We agree that the survey results underscore the need for better 
understanding of BSE and vCJD. In the appendix survey, 32,441 archived 
appendix samples collected during surgical operations performed in the 
UK between 2000 and 2012 were analyzed for the presence of abnormal 
prion protein. Sixteen samples were positive for abnormal prions. We 
did not conclude from these findings that they provide the scientific 
justification to modify our SRM definition to include the entire 
intestine of cattle. As the article points out, the samples were 
collected after the large BSE epizootic in the United Kingdom that 
resulted in a substantial amount of BSE infectivity entering the human 
food supply. We continue to believe that the SRM definition we are 
finalizing is appropriate for managing the BSE situation risk in the 
United States.
    (Comment 37) One comment stated that FDA does not require reporting 
on CJD, so the United States is unable to track the incidence rate of 
the disease.
    (Response 37) Tracking the incidence of CJD and vCJD is the 
responsibility of the Center for Disease Control and Prevention (CDC). 
The CDC collaborates with the American Association of 
Neuropathologists, the National Prion Disease Pathology Surveillance 
Center, and State health departments to monitor the prevalence of human 
prion diseases in the United States (Ref. 33).
    (Comment 38) Several comments were from individuals who had 
suffered the loss of a loved one from sporadic CJD (sCJD) and were 
concerned about sCJD risks as well as vCJD risks. Many

[[Page 14728]]

comments said that, because the etiology of sCJD is unknown, FDA should 
take every precaution possible to eliminate human exposure to what 
could potentially be a causative agent of sCJD.
    (Response 38) Although sCJD and vCJD are both prion diseases of 
humans and are similar in many respects, the available scientific 
evidence does not support a conclusion that the BSE agent causes sCJD. 
Therefore, we believe that requiring removal of parts of the small 
intestines other than the distal ileum would not provide any additional 
protection against sCJD.
    (Comment 39) A comment inquired as to the impact of sequestration 
and budget cuts upon the availability of FDA inspectors in slaughter 
facilities to insure the proper removal of the distal ileum and keep 
the public safe.
    (Response 39) FDA does not inspect cattle slaughter facilities. 
They are inspected by USDA under the provisions of the Federal Meat 
Inspection Act (21 U.S.C. 601).
    (Comment 40) One comment requested that bovine blood-derived 
products, such as beef blood plasma and fibrinogen, be prohibited until 
it is more certain that such blood-derived products do not have the 
potential for transmitting TSEs to humans. While noting the current 
thinking that the lymphatic system is the primary route of infectivity 
for TSEs, the comment suggested that TSEs may be transmitted via the 
blood through cut or abraded skin and damaged oral mucosal tissue.
    (Response 40) We recognize that there are a number of animal 
species in which blood from TSE-infected animals have been shown to be 
capable of transmitting the TSE agent, and that there have been several 
cases in the UK of people acquiring vCJD after receiving transfusions 
of blood from donors who later were found to have vCJD. However, there 
is no evidence that blood from infected cattle can transmit the BSE 
agent to humans when the blood is incorporated into human food or 
cosmetics. Therefore, the final rule does not prohibit use of cattle 
blood or impose any special requirements on cattle blood materials that 
might be used in human food, including dietary supplements, and in 
cosmetics.
    (Comment 41) One comment said that the U.S. government issued an 
official communication that it has a longstanding system of 
interlocking safeguards against BSE that protects public and animal 
health in the United States and that the most important safeguard is 
the removal of SRM or the parts of an animal that would contain BSE 
should an animal have the disease from all animals presented for 
slaughter in the United States. The comment stated that this could lead 
the public to believe any tissue that may contain BSE infectivity is 
removed at slaughter and concluded that this is definitely not the case 
with certain parts of the intestine and potentially other tissue such 
as peripheral nerves.
    (Response 41) We understand the concern about how the message on 
the removal of SRM could be interpreted. We intend for the term SRM to 
mean the list of tissues identified in our final rule that must be 
removed from beef products for human consumption. We believe the 
official communication was correct that the United States has 
interlocking safeguards in place in addition to removal of specified 
risk material. These interlocking safeguards include a strong ruminant-
to-ruminant feed ban, an ongoing BSE surveillance program capable of 
detecting the disease at very low levels in the U.S. cattle population, 
and strict controls on imports of animals and animal products from 
countries at risk for BSE.
    (Comment 42) One comment expressed concern about the possibility of 
SRMs getting into the food supply through rendering.
    (Response 42) In edible rendering (applying the rendering process 
to edible tissues for use as human food) only materials from cattle 
sources that have been inspected and passed for human consumption and 
do not contain SRMs or other materials considered to be prohibited 
cattle materials may be rendered for use in human food and cosmetics. 
It is the responsibility of manufacturers and processors, including 
renderers, to take precautions to avoid cross contamination of non-
prohibited cattle material with prohibited cattle material during 
slaughter and processing. In this regard, manufacturers and processors 
of human food and cosmetics manufactured from, processed with, or that 
otherwise contain, material from cattle must maintain records 
sufficient to demonstrate that the human food and cosmetics are not 
manufactured from, processed with, or otherwise contain, prohibited 
cattle materials under Sec. Sec.  189.5(c)(1) and 700.27(c)(1). 
Further, food establishments are subject to the CGMP requirements in 
part 110, and failure to take adequate measures to prevent cross-
contamination could result in insanitary conditions whereby the food 
may be rendered injurious to health and, therefore, adulterated under 
section 402(a)(4) of the FD&C Act.

V. Regulatory Impact Analysis

A. Overview

Economic Analysis of Impacts
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us 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). We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule finalizes an existing IFR with no 
substantive changes, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any 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 $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This final rule reaffirms the provisions in the 2004 IFR, as well 
as the 2005 and 2008 amendments, to address the potential risk of BSE 
in human food including dietary supplements, and in cosmetics. As the 
final rule's coverage and requirements do not differ from the 2004 IFR 
and the 2005 and 2008 amendments, no additional costs or benefits will 
accrue from this rulemaking.
    The summary analysis of benefits and costs included in this 
document is drawn from the detailed IFR RIA (69 FR 42255 at 42265-
42271).

B. Comments on the IFR RIA

    We received two comments on our interim final regulatory impact 
analysis

[[Page 14729]]

and are declining to make changes to the RIA in the final rule.
    (Comment 43) One comment stated that our economic analysis appears 
to consider only the industries that are end users of cattle materials 
and to overlook industries that produce intermediate products. As a 
result, there is no mention of the rule's impact on manufacturers of 
collagen casings, gelatin, and other intermediate products.
    (Response 43) We disagree. We did estimate the impact of the 2004 
IFR (and amendments) to both producers of intermediate cattle-derived 
products and producers of cattle-derived end products (69 FR 42256 at 
42266). In the case of gelatin, depending on the product, we had 
information on cattle-derived materials manufactured by intermediate 
producers (i.e., input suppliers to cosmetics manufacturers) or 
information on end products that contained cattle-derived materials 
(i.e. foods). Whether our information was on intermediate manufacturers 
or end products, we estimated the impact of the 2004 IFR on both the 
upstream and downstream facilities.
    The final rule clarifies that gelatin was never considered a 
prohibited cattle material. This final rule defines ``gelatin'' to 
clarify that gelatin is not considered to be a prohibited cattle 
material as long as it is manufactured using the customary industry 
processes specified in the Gelatin Manufacturers Institute of America's 
(GMIA) Gelatin Manual.
    In the 2005 amendment to the 2004 IFR, we revised the definition of 
``prohibited cattle materials'' that appears at Sec. Sec.  189.5(a)(1) 
and 700.27(a)(1) to clarify that ``hides and hide-derived products'' 
are not to be considered prohibited cattle materials (70 FR 53063 at 
53066). Thus, collagen casings made from hides are not banned by this 
final rule, since the cattle hides from which they are made are not 
prohibited cattle materials.
    (Comment 44) One comment stated that the 2004 IFR does not consider 
the cost to gelatin producers of tracing cattle to their origin, nor 
does it consider that other cattle-derived ingredients from inedible 
rendering (i.e., tallow-derived products) are commonly used in 
cosmetics.
    (Response 44) The final rule does not require users of cattle 
material to certify from which animal a specific material was derived. 
Users of cattle-derived material must only maintain records sufficient 
to demonstrate that cattle derived material is not made from, processed 
with, or does not otherwise contain prohibited cattle materials. We 
included the costs of generating and keeping records on cattle-derived 
material in the BSE recordkeeping rule (71 FR 59653 at 59661).
    Our 2004 IFR analysis (69 FR 42256 at 42267) took into 
consideration the potential costs to cosmetic manufacturers to switch 
from inedible rendering to using edible tallow (and derivatives) in 
cosmetic products. We estimated in the 2004 IFR analysis that the cost 
of this change would range from $0 to $18 million.

C. Final Regulatory Impact Analysis

1. Need for Regulation
    This final rule reaffirms the provisions in the 2004 IFR, as well 
as the 2005 and 2008 amendments, to address the potential risk of BSE 
in human food including dietary supplements, and in cosmetics. As the 
final rule's coverage does not differ from the 2004 IFR and the 2005 
and 2008 amendments, no additional costs or benefits will accrue from 
this rulemaking.
2. Final Rule Coverage
    We have 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. We have designated the 
following items as prohibited cattle 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), and mechanically separated 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 DRG of cattle 30 months of age and older, and 
the tonsils and distal ileum of the small intestine from all cattle. 
These restrictions appear in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 
and 21 CFR 700.27). Milk and milk products, cattle hides and hide-
derived products, tallow that contains no more than 0.15 percent 
insoluble impurities, tallow derivatives (regardless of the tallow 
source), and gelatin are not prohibited cattle materials. In addition, 
we may designate a country as not subject to certain BSE-related 
restrictions following an evaluation of the country's BSE situation.
3. Costs of the Final Rule
    Because of the 2004 IFR and 2005 and 2008 amendments already in 
effect, manufacturers and processors of food and cosmetic products 
using bovine materials such as the brain, skull, and spinal cord are 
obtaining these ingredients exclusively from cattle younger than 30 
months of age. The manufacturers and processors of products that use 
the tonsils or the distal ileum of small intestine of cattle, material 
from nonambulatory disabled cattle, material from cattle not inspected 
and passed for human consumption, or MS (Beef) have found substitutes 
for those ingredients. To the extent that the 2004 IFR and 2005 and 
2008 amendments led to increased use of alternative ingredients or 
ingredients from cattle under the age of 30 months, exposure to 
potentially BSE-infected cattle materials was reduced.
    This final rule also clarifies that gelatin made from cattle-
derived material is not, and never was, considered a prohibited cattle 
material so long as it is manufactured using customary industry 
processes. If there remained in the marketplace any confusion as to the 
status of gelatin derived from cattle materials, the new definition 
provided by this final rule should remove that confusion.
4. Countries Requesting Designation
    To date, New Zealand and Australia have requested and received 
designation as not subject to certain FDA restrictions on cattle-
derived materials. No other countries have applied to the FDA for 
designation. In the 2008 amendment, we estimated that it would cost a 
country about $9,000 to assemble a petition package for us to consider, 
and it would cost us $3,700 to review each package (73 FR 20785 at 
20790). We did not receive any comments on these costs.
5. Benefits of the Final Rule
    The benefits of this final rule are the value of the public health 
benefits. The public health benefit is the reduction in the risk of the 
human illness associated with consumption of the agent that causes BSE. 
In the 2004 IFR and 2005 and 2008 amendments, we were unable to 
quantify the benefits of these rule-makings, but provided estimates of 
the illness burden that could be avoided if we reduced the potential 
exposure to BSE agents.
    In the 2004 IFR we estimated the benefits as the value of 
preventing a case of vCJD, the human illness that results from being 
infected from eating contaminated cattle-derived materials. (69 FR 
42256 at 42267) The cost of a case of vCJD is the value of a 
statistical life (VSL) plus the value of preventing a year-long or 
longer illness that precedes certain death for victims of

[[Page 14730]]

vCJD. In 2004 we estimated this value to be in the range of $5.7 to 
$7.1 million. Updating using a central estimate of $369,000 for the 
value of a statistical life year (VSLY) and a central estimate of $8.3 
million for VSL,\3\ results in a single case of vCJD being valued at 
about $10 million in 2013 dollars. This estimate included direct 
medical costs, reduced ability of the ill person to function at home 
and at work, and the cost of premature death.
---------------------------------------------------------------------------

    \3\ VSLY based on Aldy and Viscusi discussion paper 2007 (Ref. 
1). VSL is based on EPA National Center for Environmental Economics 
estimate of $7.4 million in 2006 dollars (Ref. 2).
---------------------------------------------------------------------------

    As we stated in the 2004 IFR, we do not know the baseline expected 
annual number of cases, but based on the epidemiology of vCJD in the 
UK, we anticipated much less than one case of vCJD per year in the 
United States. Because the IFR and amendments were expected to reduce, 
rather than eliminate, the risk of exposure to BSE infectious 
materials, the reduction in the number of cases was estimated to be an 
unknown fraction of the less than one case annually. We stated in the 
2004 IFR RIA that the IFR, in conjunction with USDA's requirements on 
cattle-derived materials, would help reduce a potential human exposure 
in the United States that was previously estimated at less than 1 
percent (69 FR 1862 at 1867).
    The benefits of this final rule have already been realized as the 
IFR has been in place since 2004. We do not estimate any additional 
benefits as a result of this finalizing this IFR.

VI. Environmental Impact, No Significant Impact

    We have determined under 21 CFR 25.32(m) 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.

VII. Paperwork Reduction Act of 1995

    The collection of information provisions of this final rule are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520). The collections of information in Sec. Sec.  
189.5(e) and 700.27(e), added by the 2008 amendment, have been 
previously approved under OMB control number 0910-0623. This final rule 
does not revise the information collection requirements of Sec. Sec.  
189.5(e) and 700.27(e). Therefore we are not submitting this final rule 
to OMB as a revision of the information collection approved under OMB 
control number 0910-0623.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the 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 have concluded that the 
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 are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.)

1. Collee, J. G. and R. Bradley, ``BSE: A Decade On--Part I,'' The 
Lancet, 349:636-641, 1997.
2. Anderson, R. M., C. A. Donnelly, N. M. Ferguson, et al., 
``Transmission Dynamics and Epidemiology of BSE in British Cattle,'' 
Nature, 382:779-788, 1996.
3. Wells, G. A. H., A. C. Scott, C. T. Johnson, et al., ``A Novel 
Progressive Spongiform Encephalopathy in Cattle,'' Veterinary 
Record, 121:419-420, 1987.
4. HHS/CDC, ``vCJD (Variant Creutzfeldt-Jakob Disease'' (fact 
sheet), accessed online at http://www.cdc.gov/prions/vcjd/about.html.
5. University of Edinburgh, National CJD Research and Surveillance 
Unit, ``Variant CJD Cases Worldwide,'' accessed online at http://www.cjd.ed.ac.uk/documents/worldfigs.pdf.
6. Resolution No. 20, Recognition of the Bovine Spongiform 
Encephalopathy Risk Status of Member Countries, accessed online at 
http://www.oie.int/doc/ged/D12483.PDF.
7. Article 11.4 in the OIE Terrestrial Animal Health Code (2014), 
accessed online at http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm#article_bse.1.
8. Grobben A. H., P. J. Steel, D. M. Taylor, and R. A. Somerville, 
``Inactivation of the Bovine-Spongiform-Encephalopathy (BSE) Agent 
by the Acid and Alkaline Processes Used in the Manufacture of Bone 
Gelatin,'' Biotechnology and Applied Biochemistry, 39:329-338, 2004 
and Grobben, A. H., P. J. Steel, D. M. Taylor, R. A. Somerville, et 
al., ``Inactivation of the BSE Agent by Heat and Pressure Process 
for Manufacturing Gelatin,'' Veterinary Record, 157:277-289, 2005.
9. Article 11.4.15 in the OIE Terrestrial Animal Health Code (2014), 
accessed online at http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm#article_bse.15.
10. ``Quantitative Assessment of the Human and Animal BSE Risk Posed 
by Gelatine with Respect to Residual BSE Risk,'' European Food 
Safety Authority Journal, 312:1-29, 2006). Available at http://www.efsa.europa.eu/en/efsajournal/pub/312.
11. HHS/FDA, ``Guidance for Industry, The Sourcing and Processing of 
Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform 
Encephalopathy (BSE) in FDA-Regulated Products for Human Use,'' 
September 1997, accessed online at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125182.htm.
12. Wells, G. A. H., S. A. C. Hawkins, R. B. Green, et al., 
``Preliminary Observations on the Pathogenesis of Experimental 
Bovine Spongiform Encephalopathy (BSE): An Update,'' Veterinary 
Record, 142:103-106, 1998.
13. Lasmezas, C. I., J-P. Deslys, O. Robain, et al., ``Transmission 
of the BSE Agent to Mice in the Absence of Detectable Abnormal Prion 
Protein,'' Science, 275:402-405, 1997.
14. Race, R., A. Raines, G. J. Raymond, et al., ``Long-Term 
Subclinical Carrier State Precedes Scrapie Replication and 
Adaptation in a Resistant Species: Analogies to Bovine Spongiform 
Encephalopathy and Variant Creutzfeldt-Jakob Disease in Humans,'' 
Journal of Virology, 75(21):10106-10112, 2001.
15. Article 11.4.14 in the OIE Terrestrial Animal Health Code 
(2014), accessed online at http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm#article_bse.14.
16. USDA, APHIS, BSE Ongoing Surveillance Plan, July 20, 2006. 
Available at https://www.aphis.usda.gov/animal_health/animal_diseases/bse/downloads/BSE_ongoing_surv_plan_final_71406.pdf.
17. European Commission, the TSE Roadmap, July 15, 2005. Available 
at http://ec.europa.eu/food/food/biosafety/tse_bse/docs/roadmap_en.pdf.
18. Kimberlin, R. H., ``Bovine Spongiform Encephalopathy: An 
Appraisal of the Current Epidemic in the United Kingdom,'' 
Intervirology 35: 208-218, 1993.
19. Department for Environment, Food and Rural Affairs, UK, BSE 
Summary Statistics,'' August 2007 accessed online at: http://webarchive.nationalarchives.gov.uk/20130123162956/http:/www.defra.gov.uk/animalh/bse/statistics/bse/monthly_stats.pdf.
20. ``EFSA Panel on Biological Hazards (BIOHAZ) Scientific Opinion 
on BSE Risk in Bovine Intestines on Request from the European 
Commission,''

[[Page 14731]]

European Food Safety Authority Journal, vol. 1317, pp. 1-9 (2009).
21. CDC, BSE or Bovine Spongiform Encephalopathy, accessed online 
at: http://www.cdc.gov/prions/bse/prevalence.html.
22. USDA, The Secretary's Foreign Animal and Poultry Disease 
Advisory Committee's Subcommittee Report on Measures Relating to 
Bovine Spongiform Encephalopathy (BSE) in the United States, 
February 4, 2004.
23. Hoffmann C., M. Eiden, M. Kaatz, M. Keller, et al., 2011, ``BSE 
Infectivity in Jejunum, Ileum and Ileocaecal Junction of Incubating 
Cattle,'' Veterinary Research, 42, 21.
24. Terry, L. A., S. Marsh, S. J. Ryder, S. A. Hawkins, 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.
25. ``EFSA Panel on Biological Hazards (BIOHAZ),'' 2014 Scientific 
Opinion on BSE Risk in Bovine Intestines and Mesentery, European 
Food Safety Authority Journal, vol. 3554, pp. 1-98, (2014). http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/3554.pdf.
26. Gelatin Manufacturers of America, Gelatin Handbook, 2012.
27. FDA, Cosmetics: An Evaluation of the Risk of Variant 
Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein 
Used in Cosmetics, accessed online at: http://www.fda.gov/Cosmetics/ProductsIngredients/PotentialContaminants/ucm137012.htm.
28. European Centre for Disease Control and Prevention, Creutzfeldt 
Jakob Disease International Surveillance Network, CJD Surveillance 
Data 1993-2013, accessed online at: http://www.eurocjd.ed.ac.uk/surveillance%20data%201.html#vcjd-cases.
29. WHO, WHO Media centre, Variant Creutzfeldt-Jakob disease, Fact 
sheet N[deg] 180 Revised February 2012, accessed online at: http://www.who.int/mediacentre/factsheets/fs180/en/.
30. WHO, WHO Tables on Tissue Infectivity Distribution in 
Transmissible Spongiform Encephalopathies (2010 Update), available 
at: http://www.who.int/bloodproducts/tablestissueinfectivity.pdf.
31. Report of the Meeting of the OIE Scientific Commission for 
Animal Diseases, Paris, 4-8 February 2013, http://www.oie.int/doc/ged/D12361.PDF.
32. Gill, O. N., Y. Spencer, A. Richard-Loendt, C. Kelly, et al., 
``Prevalent Abnormal Prion Protein in Human Appendixes After Bovine 
Spongiform Encephalopathy Epizootic: Large Scale Survey,'' British 
Medical Journal 2013;347:f5675 doi: 10.1136/bmj.f5675 (published 15 
October 2013).
33. CDC, CDC Surveillance for vCJD, available at: http://www.cdc.gov/prions/vcjd/surveillance.html.

List of Subjects

21 CFR Part 189

    Food additives, Food packaging.

21 CFR Part 700

    Cosmetics, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, the 
interim final rule amending 21 CFR parts 189 and 700, which was 
published on July 13, 2004, at 69 FR 42255, and amended on September 7, 
2005, at 70 FR 53063, and amended on April 17, 2008, at 73 FR 20785, is 
adopted as a final rule with the following changes:

PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

0
1. The authority citation for 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) to read as 
follows:

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 FD&C Act) apply to such terms when used in this part. The 
following definitions also apply:
    (1) Prohibited cattle materials mean 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, gelatin, 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.
    (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 U.S. Department of Agriculture 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 of age 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 no 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 Food and Drug Administration's Main Library, 10903 New 
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039, 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.
    (8) Gelatin means a product that has been obtained by the partial 
hydrolysis of collagen derived from hides, connective tissue, and/or 
bone bones of cattle and swine. Gelatin may be either Type A (derived 
from an acid-treated precursor) or Type B (derived from an

[[Page 14732]]

alkali-treated precursor) that has gone through processing steps that 
include filtration and sterilization or an equivalent process in terms 
of infectivity reduction.
* * * * *

PART 700--GENERAL

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

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

0
4. Section 700.27 by is amended by revising paragraph (a) 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 FD&C Act) apply to such terms when used in this part. The 
following definitions also apply:
    (1) Prohibited cattle materials mean 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, gelatin, 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.
    (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 U.S. Department of Agriculture 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 of age 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 no 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 Food and Drug Administration's Main Library, 10903 New 
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039 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.
    (8) Gelatin means a product that has been obtained by the partial 
hydrolysis of collagen derived from hides, connective tissue, and/or 
bone bones of cattle and swine. Gelatin may be either Type A (derived 
from an acid-treated precursor) or Type B (derived from an alkali-
treated precursor) that has gone through processing steps that include 
filtration and sterilization or an equivalent process in terms of 
infectivity reduction.
* * * * *

    Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06123 Filed 3-17-16; 8:45 am]
 BILLING CODE 4164-01-P