[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
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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