![]() |
![]() |
![]() |
|
![]() |
[Federal Register: July 14, 2004 (Volume 69, Number
134)]
[Notices]
[Page 42255-42274]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
Department of Health and Human Services
Food and Drug Administration
21 CFR Parts 189 and 700
[Docket No. 2004N-0081] RIN-0910-AF47
Use of Materials Derived From Cattle in Human Food and
Cosmetics; and Recordkeeping Requirements for Human
Food and
Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle; Final Rule and Proposed Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
Summary: The
Food and
Drug Administration (FDA) is issuing
an interim final rule (interim final rule) to prohibit the use of certain cattle
material, to address the potential risk of
bovine spongiform encephalopathy (BSE), in human
food, including dietary supplements,
and cosmetics. Prohibited cattle materials include specified risk materials,
small intestine of all cattle, material from nonambulatory disabled cattle,
material from cattle not inspected and passed for human consumption, and
mechanically separated (MS)(Beef). Specified risk materials are the brain,
skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30
months and older; and the tonsils and distal ileum of the small intestine of all
cattle. Prohibited cattle materials do not include tallow that contains no more
than 0.15 percent hexane-insoluble impurities and tallow derivatives. FDA is
taking this action in response to the finding of an adult cow, imported from
Canada, that tested positive for BSE in the State of Washington. This action is
consistent with the recent interim final rule issued by the U.S. Department of
Agriculture (USDA) declaring specified risk materials and the carcasses and
parts of nonambulatory disabled cattle to be inedible, unfit for human
food, and prohibiting their use as
human food and requiring that the
entire small intestine be removed and disposed of as inedible. This action will
minimize human exposure to materials that scientific studies have demonstrated
are highly likely to contain the BSE agent in cattle infected with the disease.
Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD)
is likely caused by the consumption of products contaminated with the agent that
causes BSE. Also in this issue of the Federal Register, FDA is proposing 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 that the
food and cosmetics are in compliance
with this interim final rule.
DATES: The interim final rule is effective on July 14, 2004. Submit
written or electronic comments by October 12, 2004. The Director of the Office
of the Federal Register approves the incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 189.5
and 700.27 as of July 14, 2004.
ADDRESSES: You may submit comments, identified by Docket No. 2004N- 0081, by any of the following methods:
Instructions: All submissions received must include the agency name and Docket
No. or Regulatory Information Number (RIN) for this rulemaking. All comments
received will be posted without change to
http://www.fda.gov/dockets/ecomments, including any personal information
provided. For detailed instructions on submitting comments and additional
information on the rulemaking process, see section V in the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or comments
received, go to
http://www.fda.gov/dockets/ecomments and/or the Division of Dockets
Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for
Food Safety and Applied Nutrition
(HFS-306), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-1486.
SUPPLEMENTARY INFORMATION:
I. Background
On January 26, 2004, the Department of Health and Human Services announced new safeguards to strengthen existing firewalls against transmission of bovine spongiform encephalopathy (BSE) in the United States. This interim final rule, will protect the food and cosmetic supply from materials that may carry a risk of transmitting BSE. Consumption of products contaminated with agent that causes BSE has been linked to a human disease. The United States is currently protected from the spread of BSE by import controls, increased surveillance for the disease in the cattle population, FDA's 1997 ruminant feed regulation, and the United States Department of Agriculture's (USDA's) ban on specified risk materials and certain other cattle material in human food. This interim final rule complements USDA's ban for FDA-regulated human food and cosmetics.
A. Transmissible Spongiform Encephalopathies
Transmissible spongiform encephalopathies (TSEs) are fatal neurodegenerative disorders, which have been identified in humans and a number of animal species (e.g., cattle, sheep, goats, elk, deer, cats, and mink), but primarily in ruminants (cattle, sheep, elk, deer). TSEs are characterized by a long incubation period, then a shorter course of neurological symptoms, followed by death (Ref. 1). Postmortem histopathology of the brain tissue from humans and animals with TSEs is characterized by a sponge-like appearance of the brain and deposits of abnormal forms of certain cell-associated proteins (normal prion proteins) in the brain. In some TSEs, deposits of abnormal prion proteins are detected in other nervous and non-nervous tissues, such as the spinal cord, peripheral nerves, intestine, spleen, lymph nodes, and bone marrow (Refs. 2 to 6).
TSEs in humans include sporadic CJD, variant Creutzfeldt-Jakob disease (vCJD), Gerstmann-Straussler-Scheinker syndrome, kuru, fatal familial insomnia, and sporadic fatal insomnia (Ref. 7). Nonhuman TSEs include BSE in cattle, scrapie in sheep and goats, transmissible mink encephalopathy (TME) in mink, feline spongiform encephalopathy (FSE) in cats, and chronic wasting disease (CWD) in deer and elk (Ref. 7). Scrapie and CWD occur, and TME has occurred, in the United States. On December 23, 2003, USDA diagnosed BSE in an adult cow in the United States that had come from Canada.
The pathogenesis of TSEs is poorly understood. Resistance of TSE agents to physical and chemical treatments that would destroy most nucleic acids makes conventional micro-organisms, such as bacteria and viruses, less likely causes (Ref. 8). The prion theory suggests that the infectious agents of TSEs are abnormally folded forms of normal prion proteins, and is the most widely accepted explanation (Ref. 9). Normal prion protein genes are found widely in nature. In mammals, normal prion proteins are primarily expressed in neurons, but also can be found in other tissues in lower concentrations, depending on the mammalian species (Ref. 10). It is not well understood how the abnormal folding of prion proteins occurs, why hosts cannot efficiently dispose of or develop immunity to these proteins, and what factors cause some TSEs.
The current lack of an antemortem diagnostic test for TSEs in either humans or animals limits surveillance for these diseases, studies of disease pathogenesis, and other research efforts. Diagnosis is confirmed by special post-mortem examination of brain tissue by identification of abnormal prion proteins in advanced stages of the disease. At earlier stages of disease development, abnormal prion proteins may not yet be present or are undetectable in brain tissue. Presently, there are no effective treatments for TSEs, and all are invariably fatal (Ref. 1).
B. Bovine Spongiform Encephalopathy
BSE is a TSE of cattle with a long incubation
period (2 to 8 years), most likely acquired following consumption of an animal
product containing the infectious BSE agent (Refs. 11 and 12). The British
Ministry of Agriculture, Fisheries and Food (now known as the
Department for Environment, Food, and Rural Affairs) first
recognized BSE as a distinct disease in November 1986. The clinical signs of BSE
include behavioral, gait, and postural abnormalities. The disease usually
presents in cattle observed to have increased apprehension, increased reaction
to sound and touch, and a swaying gait. These signs are 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. 13).
Epidemiological studies have characterized the outbreak of BSE in the United
Kingdom as a prolonged epidemic arising at various locations, with all
occurrences due to a common source, and have suggested that feed contaminated by
a TSE agent was the cause of the disease outbreak (Ref. 14). The subsequent
spread of BSE, however, is associated with the feeding of meat-and-bone-meal
from rendered BSE- infected cattle to non-infected cattle (Ref. 14). It appears
likely that the BSE agent was transmitted among cattle at an increasing rate by
ruminant-to-ruminant feeding until the United Kingdom ban on such practices went
into effect in 1988 (Ref. 11). The United Kingdom instituted a
ruminant-to-ruminant feed ban to stop the cycle of infection, restrict the
geographic spread of the disease, and eliminate potential sources of new
infections. Since BSE was first identified in the United Kingdom, approximately
185,000 cattle have been diagnosed with the disease there (Ref. 15). The
precautionary slaughter of millions of British cows and increasingly stringent
prohibitions on certain animal feeding practices appear to have slowed, but not
eradicated, the BSE epidemic in the United Kingdom. In 1992 (the peak year of
the epidemic), there were over 35,000 cases of BSE in the United Kingdom; in
2003, there were approximately 458 cases (Ref. 15).
The measures used to control and prevent the spread of BSE in the United Kingdom
were too slowly developed or too poorly enforced to prevent the occurrence of
BSE in cattle in other countries to which the United Kingdom had shipped BSE-infected
cattle or cattle feed (Ref. 11). In addition to the United Kingdom, BSE has been
detected in non- imported cattle in Austria, Belgium, Canada, the Czech
Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan,
Liechtenstein, Luxembourg, the Netherlands, Poland, Portugal, the Republic of
Ireland, Slovakia, Slovenia, Spain, and Switzerland (Ref. 15). On December 23,
2003, USDA diagnosed a positive case of BSE in an adult Holstein cow, born in
Canada, in the State of Washington.
C. Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease
CJD is a sporadic disease of humans that exists throughout the world with an
annual incidence of approximately one case per million population (Ref. 9). The
highest death rates in the United States and the United Kingdom occur in
individuals between the ages of 60 and 70 (Ref. 16). Death generally occurs
after less than a year of progressive neurological deterioration (Ref. 9). Early
symptoms typically include changes in sleeping and eating patterns, followed by
inappropriate behavior and eventual dementia, lack of coordination, and
myoclonic spasms. CJD is always fatal (Ref. 16). The cause of sporadic CJD is
not fully understood, but genetic susceptibility may play a role (Ref. 9). CJD
has been inadvertently transmitted between humans during medical treatment or
diagnostic procedures via contaminated neurosurgical instruments, transplants of
dura mater and corneas, injection of pituitary extract, and cross-contamination
from medical personnel who handled tissues from patients with CJD (Ref. 9).
In April 1996, British scientists reported a previously undetected new variant
of CJD (vCJD) in young patients, with symptoms somewhat different from sporadic
CJD (Refs. 17 and 18). All cases of vCJD had histopathologic evidence of
spongiform changes in the brain, but also showed formation of ``florid'' plaques
(a core of amyloid protein with surrounding halos of vacuoles) not typically
seen in other forms of CJD (Ref. 9). Clinically, vCJD usually begins with a
psychiatric presentation, such as depression, anxiety, nightmares or
hallucinations. These symptoms are followed by memory impairment, then dementia
in the late stages. The clinical course may last up to 2 years before death
occurs (Ref. 19).
Because scientific evidence suggests that the presence and infectivity of
abnormal prion proteins in vCJD share some characteristics with those abnormal
prion proteins found in cattle with BSE, scientists have concluded that exposure
to the BSE agent is the most plausible explanation for the occurrence of vCJD
(Refs. 20 to 23). Monkeys (genetically the closest animal model to humans)
inoculated with samples of brain from BSE-infected cattle have been found to
develop a TSE that is histopathologically similar to vCJD (Ref. 24), as have
mice inoculated or fed with BSE-infected tissue (Ref. 25). Studies have shown
that abnormal prion proteins from vCJD patients are molecularly similar to
abnormal prion proteins from BSE-infected cattle, but different from abnormal
prion proteins from patients with CJD (Ref. 19). Although the exact route of
exposure is not known, most scientists believe that vCJD in humans is caused by
consumption of cattle products contaminated with the agent that causes BSE
(Refs. 16, 26, and 27).
Since 1996, approximately 150 probable and confirmed cases of vCJD have been
reported in the United Kingdom. In addition, one case of vCJD each has been
reported in Ireland and [[Page 42258]] Canada, both of which are believed to be
related to BSE exposure in the United Kingdom. The one reported case of vCJD in
the United States is also believed to be related to United Kingdom BSE exposure
(Ref. 10). In addition, there have been seven vCJD cases in France and one in
Italy (Ref. 10). Because the incubation period for vCJD in humans may range from
5 to 20 years, some epidemiological models have projected that many more
(600-3000) cases of vCJD caused by consumption of BSE- contaminated cattle
products may occur in the United Kingdom in the future (Ref. 28).
D. BSE Risk Assessments
In 1998, USDA asked the Harvard Center for Risk
Analysis (HCRA) and the Center for Computational Epidemiology at Tuskegee
University to evaluate United States measures to prevent the spread of BSE to
animals and humans if it were to occur in this country. The Harvard-Tuskegee
risk assessment (referred to below as the Harvard-Tuskegee study) was published
in November 2001, revised in 2003, and determined that the United States was
highly resistant to any proliferation of BSE or a similar disease (Ref. 29). The
risk assessment model also demonstrated that certain new control measures could
reduce the small risk even further.
The Harvard-Tuskegee study involved a probabilistic simulation model to
determine the consequences of introducing BSE into the U.S. cattle population.
This simulation indicated that, in a hypothetical situation in which 10 infected
cattle were imported into the United States, on average only four new cases of
BSE would arise, and the disease would be eliminated in 20 years. The
Harvard-Tuskegee study determined that these new cases of BSE would most likely
arise in the United States from incomplete compliance with FDA's ruminant feed
regulation (see III.A of this document), and also concluded that an epidemic of
BSE in this country resulting from scrapie, CWD, or another TSE is unlikely.
The Harvard-Tuskegee study estimated the number of cattle infectious doses that
might be available for human exposure, but it did not estimate the likelihood of
human disease from this exposure because the relationship between the two is not
known. According to the study, the estimated total infectivity available for
human exposure from the importation of 10 infected cattle is 35 cattle
infectious doses over 20 years. The Harvard-Tuskegee study determined that the
greatest sources of infectivity to consumers are direct consumption of cattle
brain and spinal cord and also meat from advanced meat recovery systems that
contains central nervous system tissue. The Harvard-Tuskegee study did not
address potential human exposure to the BSE agent through food
containing ingredients of cattle origin, such as gelatin, beef stocks, extracts,
and flavorings or cosmetics.
The Harvard-Tuskegee study identified three pathways that could lead to cattle
or human exposure to the BSE agent: (1) Noncompliance with FDA's ruminant feed
regulation prohibiting the use of certain proteins in feed for cattle and other
ruminants; (2) rendering of animals that die on the farm, and use (through
illegal diversion or cross-contamination) of the rendered product in ruminant
feed; and (3) the inclusion of high-risk tissues from cattle, such as brain and
spinal cord, in products for human oral consumption. Evaluation of potential
risk mitigation measures in the study found that a prohibition against rendering
of animals that die on the farm would reduce the potential cases of BSE
following hypothetical exposure by 82 percent. In addition, a ban on specified
risk materials (SRMs) including brain, spinal cord, and vertebral column from
inclusion in human and animal food would reduce potential BSE
cases in cattle by 88 percent and potential human exposure to BSE by 95 percent.
The Harvard- Tuskegee study also noted the value of ensuring that low-risk
cattle tissues are not cross-contaminated with high-risk tissue.
In 2003, after the discovery of a case of BSE in a cow in Canada, the USDA asked
HCRA to evaluate the implications of the hypothetical previous introduction of
BSE in the United States from Canada. The HCRA model indicated that the
potential for spread of BSE among cattle and the potential for human exposure to
BSE increase as the time period lengthens between the introduction of infected
Canadian cattle and FDA's issuance of the ruminant feed regulation in 1997
(i.e., there is more potential for spread of BSE if the infected cattle were
imported from Canada in 1990 versus 1996). In the worst case scenario involving
importation of five infected animals from Canada, BSE would be eliminated from
the United States with high probability by 2020 (Ref. 30).
E. Specified Risk Materials
1. List of Infective Tissues
Data on the distribution of BSE infectivity in tissues are incomplete, and there
are ongoing experiments with cattle to confirm and update earlier data (Refs. 2
to 6 and 31). In a pathogenesis study in which cattle tissues were assayed for
infectivity following intracerebral inoculation of tissues from cattle orally
exposed to the BSE agent, distal ileum and spinal cord were found to harbor
infectivity as early as 6 months post-inoculation for distal ileum and 32 months
post-inoculation for spinal cord (Refs. 3 and 4). In one experiment, cattle were
experimentally infected with BSE through consumption of the brains of cattle
with BSE. Infectivity in the tissues of the cattle consuming the brains was
evaluated by mouse bioassay. In the mouse bioassay, infectivity was detected in
brain, spinal cord, dorsal root ganglia (clusters of nerve cells attached to the
spinal cord that are contained within the bones of the vertebral column),
trigeminal ganglia (clusters of nerve cells connected to the brain that lie
close to the exterior of the skull), and distal ileum. All of the central
nervous system (CNS) tissues were found to be infective in animals 32 to 40
months after exposure to the BSE agent, which in some cases could be months
before anticipated onset of clinical signs of illness. This study was done with
relatively few animals (n=30), and the experimental conditions do not reflect
field conditions of disease transmission. Therefore, a second phase of the
experiment was initiated, and will continue for several more years, to determine
if any of the tissues that initially did not appear to be infective actually
contain low levels of infection. Preliminary results from this study have
indicated that tonsil, at 10 months after exposure, carries a low level of
infectivity (Ref. 31).
In cattle infected with BSE under field conditions, infectivity has been found
in the brain, spinal cord, and retina of the eye in animals with clinical
disease (Ref. 31). The Scientific Steering Committee of the European Union (Ref.
27) has reported on the proportion of total infectivity in various tissues. They
estimate that, in an animal with clinical disease, approximately 64 percent of
the infectivity is in the brain, 26 percent is in the spinal cord, 4 percent is
in the dorsal root ganglia, 2.5 percent is in the trigeminal ganglia, and 3
percent is in the distal ileum. The eyes are estimated to contain less than 1
percent of the infectivity.
Based on the information presented previously and consistent with the USDA's
regulation (69 FR 1862, January 12, 2004; discussed in section II of this
document), we have determined that the tissues with the highest risk of
harboring BSE infectivity (the SRMs) are [[Page 42259]] 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 animals 30 months and older,
and tonsil and distal ileum of cattle of all ages. Though the skull and the
vertebral column have not been shown to harbor BSE infectivity, they contain
tissues that have been shown to be infectious; therefore, we are including the
skull and the vertebral column in the list of SRMs. We are not including the
vertebrae of the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum as SRMs with the rest of the vertebral
column, because they do not contain spinal cord or dorsal root ganglia.
2. Animal Age at Which Tissues Become Infective
As discussed in the previous section, most tissues that harbor BSE infectivity
have been shown to do so in animals more than 30 months after exposure to the
agent. The exceptions are tonsils, which have been shown to harbor infectivity
at low levels at 10 months post- exposure, and the distal ileum, which has been
shown to harbor infectivity as early as 6 months post-exposure. In a study of
the BSE epidemic in the United Kingdom, Dealler and Lacey (Ref. 32) noted that
only 29 of 5,470 animals younger than 36 months of age developed BSE, with the
peak number of cases occurring between 48 and 60 months of age. At the height of
the BSE epidemic in the United Kingdom 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. 33). The youngest animal with a confirmed case
of BSE was 20 months old (Ref. 15).
Though animals younger than 30 months can develop BSE, it is a very rare
occurrence, based on epidemiological and experimental evidence. Therefore, we
have concluded that 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 should be considered SRMs only in cattle 30 months and older.
We are aware that there have been documented cases of BSE in animals younger
than 30 months, and that some tissues become infectious before the animal
exhibits clinical signs. As mentioned previously, during the height of the BSE
epidemic in the United Kingdom, a small number of animals younger than 30 months
showed signs of the disease. More recently, Japan has reported cases of BSE in
21- and 23-month-old animals, discovered during testing of animals presented for
slaughter. As the science and epidemiology on this issue develop, FDA may find
it necessary to modify the age period for SRM removal through future rulemaking.
Based on experimental evidence, we have concluded that the tonsil and distal
ileum of the small intestine of all cattle should be considered SRMs.
F. Small Intestine
To ensure effective removal of the distal ileum, USDA is requiring that the
entire small intestine be removed and disposed of as inedible product. FDA is
also prohibiting the use of the entire small intestine in FDA-regulated
food and cosmetics as prohibited cattle material. We are doing so
because: (1) It is difficult to distinguish one end of the small intestine from
the other once the organ has been removed from the animal, (2) there is no
international agreement on how much of the small intestine should be removed to
ensure that the distal ileum is separated from the upper part of the intestine,
and (3) there is no way for a manufacturer or processor to document that the
distal ileum was adequately removed since there is no international consensus on
the issue. USDA has solicited comment on whether processors may be able to
effectively remove just the distal ileum. FDA requests comment on this issue as
it affects FDA's rule.
G. Mechanically Separated (MS)(Beef)
MS(Species) is a standardized food defined by the USDA in 9 CFR
319.5 (see section IV.A of this document for definition of MS(Beef)). The
standard does not limit the amount of spinal cord and dorsal root ganglia that
can contaminate vertebral column used to produce the product. Consequently,
MS(Beef) may contain concentrated amounts of such tissues. Because we have
concluded that spinal cord, dorsal root ganglia and vertebral column are all
SRMs, we are designating MS(Beef) as a prohibited cattle material.
H. Nonambulatory Disabled Cattle
Experience has shown that nonambulatory disabled cattle (see section IV.A of
this document for definition) are the population at greatest risk for harboring
BSE. Surveillance data in the European Union in 2002 showed that there were 29
positive/10,000 tests for BSE among healthy-appearing cattle of all ages and 148
positive/10,000 tests for BSE among nonambulatory animals of all ages (Ref. 34).
In Switzerland, sampling of particular populations of cattle revealed that BSE-positive
animals were 49 to 58 times more likely to be found in the nonambulatory
population than in the population selected for passive slaughter surveillance
(Ref. 35). The Harvard-Tuskegee study estimated that, following importation of
10 infected cattle, a prohibition against rendering animals that die on the farm
(these animals are usually nonambulatory disabled) would decrease the number of
new cases of BSE by 82 percent.
Because typical clinical signs of BSE cannot always be observed in nonambulatory
disabled cattle, and because evidence has indicated these cattle are more likely
to have BSE than apparently healthy cattle, FDA is designating material from
nonambulatory disabled cattle as prohibited cattle materials.
I. Cattle Not Inspected and Passed for Human
Consumption
For cattle that are not inspected (see section IV.A of this document for
definition), there is no information as to their suitability for use in human
food and cosmetics in general, and as to their disease status
and potential for harboring BSE in particular. In addition, such cattle are
likely to have died on the farm or en route to slaughter, and these animals are
not eligible for inspection by the USDA. Therefore, these cattle are at higher
risk of harboring undetected BSE. For cattle that are inspected but not passed,
a regulatory authority (USDA or other) has made a determination that they are
not appropriate for use in human food. Such a determination may
be based, among other things, on evidence of a neurological disorder associated
with a higher risk of BSE. Moreover, material from cattle not inspected or
inspected and not passed for human consumption is prohibited from human
food by USDA. By requiring that material from cattle for use in
FDA-regulated human food and cosmetics be inspected and passed
for human consumption, we are minimizing the risk of exposure to the agent that
causes BSE, and extending the protections offered by the USDA or the appropriate
regulatory authority in other countries to FDA-regulated human food
and cosmetics.
J. BSE Testing for Food Safety Purposes
No practical antemortem tests for BSE exist. The currently available postmortem tests, although useful for disease surveillance (i.e., determining the rate of disease in the population of cattle), are not appropriate as food safety indicators. This is, in part, due to limitations on the existing testing methods, which rely on the use of brain tissue. Experimental evidence demonstrates that certain potentially infective tissues, such as distal ileum and tonsil, are the first tissues to accumulate infectivity in the incubation period, and this is prior to any infectivity being demonstrated in brain tissue (Refs. 3, 36, and 37). Therefore, tests conducted on brain tissue may not reflect accurately the potential infectivity in other tissues that develop infectivity earlier, such as distal lieum. Development of effective food safety indicators will require improved understanding of the pathogenesis of the disease and improved laboratory methods.
K. Dietary Supplements
Some dietary supplements contain cattle-derived materials (e.g., liver powder, brain, ovaries, eye tissue, mammary tissue, adrenal gland, hypothalamus) or substances derived from these tissues. On March 13, 2003 (68 FR 12158), FDA proposed current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. In the proposal, we recognized that animal-derived ingredients in dietary supplements present important public health and safety issues and that some dietary supplements contain material from cattle that may contain the infective agent that causes BSE. We also stated that, in the absence of broadly applicable or validated diagnostic tests available to manufacturers to identify BSE-infected animals or materials, the agency is considering whether to set forth specific requirements designed to prevent the use of materials derived from certain animals from regions that may present a risk of BSE. Further, in the proposal we sought comment, among other things, on whether we should include in the final rule specific requirements for manufacturing, packing, or holding all animal-derived dietary ingredients, including cattle-derived ingredients, whether or not they originate from areas with BSE. FDA will respond to those comments in a final dietary supplement CGMP rule and consistent with the provisions of this rule, which applies to all human food, including dietary supplements.
L. Cosmetics
Cosmetics may be made from a variety of
cattle-derived ingredients. Tallow derivatives, particularly fatty acids and
glycerin, are the predominant bovine ingredient used by the
cosmetic industry. Additionally, ingredients sometimes include albumin, brain
extract, brain lipid, cholesterol, fibronectin, sphingolipids, collagen,
keratin, and tallow. Cattle-derived ingredients serve many functions and may be
used as skin conditioning agents, emollients, binders, and hair and nail
conditioning agents.
There are several routes through which cosmetics contaminated with the agent
that causes BSE could transmit disease to humans. Transmission of the BSE agent
to humans through intact skin is not likely; however, cosmetics may be ingested
or applied to cut or abraded skin or to mucosal tissues, particularly in the
eye, which could provide direct routes for infection.
Although injection into the eye does not represent normal human contact with
cosmetics, experimental studies in animals may provide relevant information on
potential routes of exposure. In mice, intraocular injection of scrapie caused
infection along the optic nerve, which eventually spread into non-neural tissue
via the lymphatic system (Ref. 38). In addition to intraocular injection,
infectivity has been transmitted to animals via the conjunctiva of the eye
(mucosal tissue). Scott et al. (Ref. 39) found that scrapie was induced in 42
percent of rodents by dropping a high concentration of infectivity onto the
conjunctiva. Klitzman et al. (Ref. 40) suggested that kuru, a human TSE disease
found only among the Fore people of New Guinea, might have been transmitted by
rubbing infected human brain into eyes or cut skin, while handling and consuming
infected brain during funeral rituals.
Cut or abraded skin also has been proposed as a route for contracting TSE
diseases. The transmission of kuru through cut skin has been suggested and was
mentioned previously (Taylor et al. (Ref. 41) and Ingrosso et al. (Ref. 42))
demonstrated increased transmission of scrapie via oral mucosal tissue. In one
study, 100 percent of mice with experimentally damaged oral mucosal tissue
developed scrapie through ingestion of infected material, while only 71 percent
of mice with intact mucosa developed the disease (Ref. 41). In addition, Pammer
et al. (Ref. 43) and Sugaya et al. (Ref. 44) noted that epithelial cells,
dendritic cells, and keratinocytes (the primary cell types found in the
epidermis) have been found to contain infectious prion protein, indicating that
these cells are potential targets for peripheral infection with a TSE disease.
Use of BSE-contaminated cosmetics could provide a means of human infection via
several routes discussed previously. Many cosmetics are typically applied in the
area of the eye (mascara, eye brow pencil, eyeliner, eye lotion, and eye makeup
remover) and almost any cosmetic, including shampoo, can get into the eye via
eye rubbing or incorrect application. Any cosmetic product, but particularly
shaving creams and gels and lotions, may be applied to cut or abraded skin. Many
products may come in contact with mucosal tissue via rubbing. Cosmetics that are
ingested, such as lipstick, dentifrices, mouthwash, and breath fresheners, would
have the same route of infection as the feeding studies mentioned previously, if
the cosmetics were contaminated with the agent that causes BSE.
M. Tallow and Tallow Derivatives
Tallow is an animal-derived hard fat that has
been heat processed; most tallow is derived from cattle. Any risk of BSE
transmission from tallow is a result of protein that is present as an impurity
in the tallow. Taylor et al. (Refs. 45 and 46) found in rendering studies with
abnormal prion protein that the prion protein did not preferentially migrate
into the fat fraction, but remained with the protein fraction. Therefore, there
is no reason to believe that tallow is likely to contain unusually high amounts
of prion protein as a constituent of the insoluble impurities fraction that
remains in tallow after rendering. Taylor et al. (Refs. 45 and 46) also reported
that the various rendering processes used for tallow production in the United
Kingdom were sufficient to produce tallow that did not result in infection when
injected into the brains of mice, even though the starting material was highly
spiked with the scrapie agent. Wilesmith et al. (Ref. 47) noted that the
geographical variation in the incidence of BSE in the United Kingdom was not
consistent with the use of tallow in cattle feed and concluded that the most
likely source of infection in cattle was BSE- contaminated meat and bone meal.
The Office International des Epizooties (OIE), the international animal health
standard setting body, categorizes tallow with insoluble impurities of no more
than 0.15 percent as protein-free tallow and indicates that tallow that meets
this standard can be safely consumed by animals regardless of the starting
materials (Ref. 48). There is thought to be a 10- to 10,000-fold increase in the
amount of infectious material needed to cause illness in humans as compared with
cattle because of the species barrier, though the European Commission's
Scientific Steering Committee cautioned that this range is uncertain and in a
unlikely, but worst case scenario, the species barrier may not exist (Ref. 49).
FDA's Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC)
considered the safety of tallow and tallow derivatives in 1998 (Ref. 50).
Members of the Committee indicated that tallow is a food with
negligible or no risk of transmitting BSE to humans or animals.
Based on the research and the opinions noted previously, we are permitting
tallow to be used in human food and
cosmetics if it contains no more than 0.15 percent hexane-insoluble impurities
or otherwise complies with these regulations. We believe we are adequately
protecting human health by requiring a tallow standard for human
food and cosmetics that is as
protective as the standard recommended by OIE to prevent BSE in cattle.
Tallow derivatives are produced by subjecting tallow to chemical processes
(hydrolysis, trans-esterification, and saponification) that involve high
temperature and pressure. The TSEAC considered tallow derivatives in 1998 (Ref.
50) and determined that the rigorous conditions of manufacture are sufficient to
further reduce the BSE risk in tallow derivatives. In addition, the OIE also
recommends that derivatives of protein-free tallow be freely traded among
countries because they pose insignificant BSE risk to animals (Ref. 48). Because
we believe that tallow has negligible risk of transmitting BSE, and tallow
derivatives undergo additional processing, we do not believe that tallow
derivatives pose a risk of transmitting the agent that causes BSE to humans.
II. USDA Interim Final Rule
On January 12, 2004, in response to the diagnosis
of BSE in a cow in the United States, USDA published a series of interim final
rules including ``Prohibition of the Use of Specified Risk Materials for Human
Food and Requirements for the
Disposition of Non-Ambulatory Disabled Cattle'' (69 FR 1862). The rule declares
that SRMs are inedible and unfit for food
and prohibits their use as human food.
The rule designates the following as SRMs: 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. To ensure the
distal ileum is completely removed, the entire intestine must be removed and
disposed of as inedible. The rule also declares that MS(Beef) is unfit for
food and inedible. In addition, the
rule requires that all nonambulatory disabled cattle presented for slaughter be
condemned and not used in human food.
Furthermore, the rule requires that establishments that slaughter cattle or that
process the carcasses or parts of carcasses of cattle maintain daily records
sufficient to document the implementation and monitoring of procedures for
removal, segregation, and disposition of SRMs. Finally, the rule deems all
age-associated SRMs (all SRMs except tonsil and distal ileum) to be from animals
30 months or older unless an establishment can demonstrate that the materials
are from an animal that was younger than 30 months of age at the time of
slaughter.
In this interim final rule, FDA is extending similar protections to
FDA-regulated human food and
cosmetics. The USDA's interim final rule will reduce but will not, by itself,
eliminate the availability and use of prohibited cattle materials in domestic
and imported FDA-regulated human food
and cosmetics. Domestically, generally human
food that contains meat only in a relatively small proportion or that
historically has not been considered by consumers to be products of the meat
food industry (e.g., soup stock, beef
flavors and extracts, gelatin), is not produced under USDA inspection (see
definition of ``meat food product'' in
21 U.S.C. 601(j)) and may be physically available for use in FDA-regulated human
food and cosmetics. Further, even when
excluded from human food produced in
USDA-inspected establishments, prohibited cattle materials may leave the
establishments for inedible rendering or destruction. These materials, which
previously have not been explicitly prohibited in human
food and cosmetics by FDA, might then
be used in FDA-regulated human food or
cosmetics. For example, prohibited cattle materials leaving a USDA- inspected
facility might not be denatured sufficiently to preclude their use in
FDA-regulated human food and
cosmetics.
Under the Food Safety and Inspection
Services' (FSIS') rule, SRMs, small intestine from all cattle, and material from
nonambulatory disabled cattle must be designated as inedible. However, certain
products, such as gelatin and collagen (which are both covered by the provisions
of this rule) used in FDA-regulated human food
and cosmetics, have traditionally been produced from cattle material deemed
inedible by the USDA. Therefore, such a designation by the USDA may not be
enough to preclude use of prohibited cattle materials in FDA- regulated products
without additional regulation by FDA. Further, some cattle are not slaughtered
under continuous USDA inspection (e.g., some are sent directly to rendering).
Cattle material from these animals, such as brains or bones which include SRMs,
could end up as starting material for human
food, such as meat extracts or gelatin, respectively. Furthermore, if
prohibited cattle materials were used in FDA-regulated human
food or cosmetics, the rule would
facilitate FDA's ability to use the enforcement mechanisms of the Federal
Food,
Drug, and Cosmetic Act (the act) that apply to adulterated products
(e.g., seizure) to prevent human exposure to the prohibited cattle materials.
Imported products also may contain the types of materials prohibited by the
USDA, but which would not fall within the scope of the USDA's import regulations
either because of the nature of the products or their country of origin.
Specifically, although both FSIS and Animal and Plant Health Inspection Service
(APHIS) impose BSE- related prohibitions, these prohibitions collectively do not
cover all FDA-regulated human food and
cosmetics. FSIS' restrictions, contained in its interim final rule described
earlier in this document, do not apply to importation of dietary supplements,
cosmetics, and FDA- regulated human food
not considered to be ``meat food
products'' under the Federal Meat Inspection Act (21 U.S.C. 601(j)). APHIS' BSE-related
restrictions on imports do not cover gelatin for human use (beyond requiring a
permit) or cosmetics, and apply only to a limited number of countries (9 CFR
94.18).
III. FDA Actions on BSE
A. The FDA Ruminant Feed Regulation
In the Federal Register of June 5, 1997 (62 FR 30936), FDA published a
regulation that prohibits, with some exceptions, the use of protein derived from
mammalian tissues in feed for cattle and other ruminant animals (21 CFR
589.2000) (ruminant feed regulation). FDA published the ruminant feed regulation
because of findings that ruminants had been fed protein derived from animals in
which TSEs were found and that consumption of this protein may cause TSEs in
ruminants. The regulation was intended to prevent the establishment and
amplification of BSE in the United States and thereby minimize any risk to
animals and humans. FDA currently is considering changes to further strengthen
the regulation.
B. FDA Guidance
During the past decade, we have communicated with the public and manufacturers,
applicants, importers, and processors of FDA-regulated human
food and cosmetics about appropriate
steps to increase product safety and minimize the risk of products being
contaminated with the BSE agent. Most of our communications have been in the
form of letters and guidance to industry and import alerts.
November 1992--We wrote to manufacturers of dietary supplements to alert them to
the developing concern about TSEs in animals and CJD in humans and recommended
that they investigate the geographic sources of any
bovine and ovine material used in
their products. We suggested that manufacturers develop plans to ensure, with a
high degree of certainty, that bovine
and ovine materials used in their products were not from countries where BSE
exists (``BSE countries'' specified by USDA's APHIS in 9 CFR 94.18) or from
sheep flocks (foreign or domestic) infected with scrapie.
August 1994--We published a notice in the Federal Register (59 FR 44592, August
29, 1994) entitled ``Bovine-Derived
Materials; Agency Letters to Manufacturers of FDA-Regulated Products.'' The
notice published the November 1992 letter previously described and,
additionally, letters to manufacturers of FDA-regulated drugs, biologics, and
medical devices (December 1993), products for animals (August 17, 1994), and
manufacturers and importers of dietary supplements and cosmetics (August 17,
1994). The letter to the manufacturers and importers of dietary supplements and
cosmetics included our recommendation that firms manufacturing or importing
dietary supplements or cosmetics containing specific bovine
tissues ensure that the tissues do not come from cattle born, raised, or
slaughtered in BSE countries.
October 1994--We issued Import Alert 17-04, which allowed for the detention,
without examination, of bulk shipments of high-risk bovine
tissues and tissue-derived ingredients from BSE countries. When FDA issued
Import Alert 17-04 in 1994, the list of BSE countries included the United
Kingdom, France, Ireland, Oman, Switzerland, and Portugal. We have updated this
alert whenever APHIS has revised the list of countries in 9 CFR 94.18.
May 1996--We sent a letter to manufacturers and importers of dietary supplements
and cosmetics stating that FDA strongly believed that manufacturers should take
immediate and concrete steps to reduce the potential risk of human exposure to
the BSE infectious agent.
October 1997--We published a notice of availability (62 FR 52345, October 7,
1997) of a guidance for industry entitled ``The Sourcing and Processing of
Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform
Encephalopathy (BSE) in FDA-Regulated Products for Human Use.'' In the guidance
FDA recommends, among other things, that gelatin processors ensure that
slaughterhouses that supply cattle bones for gelatin production remove heads,
spines, and spinal cords as the first procedure following slaughter.
IV. Description of Interim Final Rule and Legal Authority
A. Definitions
In new Sec. Sec. 189.5(a) and 700.27(a) (21 CFR
189.5(a) and 21 CFR 700.27(a)) we are defining the following terms for the
purposes of this regulation:
1. Prohibited cattle materials means specified risk materials, small intestine
of all cattle, material from nonambulatory disabled cattle, material from cattle
not inspected and passed, or MS(Beef). The phrase ``prohibited cattle
materials'' includes all of the individual categories of materials and tissues
prohibited by this rulemaking. Prohibited cattle materials do not include tallow
that contains no more than 0.15 percent hexane-insoluble impurities and tallow
derivatives.
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. This definition is
consistent with the USDA's definition in 9 CFR 301.2.
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 USDA regulation that
prescribes the standard of identity for MS(Species). This definition of MS(Beef)
is consistent with the term as used by the USDA in its recent interim final rule
(69 FR 1862) prohibiting its use in human food.
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. This definition of nonambulatory disabled cattle
is consistent with the definition of nonambulatory disabled livestock in the
USDA's interim final rule (69 FR 1862) requiring that nonambulatory disabled
cattle be condemned and not used as human food.
5. Specified risk material (SRM) means the brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older, and the tonsils
and distal ileum of the small intestine of all cattle. This definition of SRMs
is the same as that used by the USDA in its interim final rule (69 FR 1862)
declaring SRMs to be inedible and prohibiting their use in human
food.
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 free of
prohibited cattle material or must contain not more than 0.15% hexane-insoluble
impurities determined by the method for ``hexane-insoluble matter,'' pp.
464-465, the Food Chemicals Codex, 5th
Ed. (2003), 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 the method in the Food
Chemicals Codex. You may obtain copies of the above-referenced method from the
Division of Dairy and Egg Safety (HFS-306), Center for
Food Safety and Applied Nutrition,
Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or you may examine a copy at the Center for
Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD, or at the Office of the
Federal Register, 800 North Capitol St., NW., Suite 700, Washington, DC.
7. Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of
material obtained by hydrolysis, saponification, or trans-esterification may be
applied to obtain the desired product.
B. Requirements for Prohibited Cattle Materials
USDA recently declared SRMs and MS(Beef) unfit
for food and inedible and prohibited
their use in human food. USDA also
required that all nonambulatory disabled cattle presented for slaughter be
condemned and not used in human food
and that small intestine of all cattle be removed and disposed of as inedible.
To ensure that the SRMs, small intestine of all cattle, MS(Beef), and material
from nonambulatory disabled animals are not incorporated into FDA-regulated
human food and cosmetics, we are
similarly prohibiting the use of SRMs, small intestine of all cattle, MS(Beef)
and material from nonambulatory disabled cattle in human
food and cosmetics. We are also
prohibiting material from cattle not inspected and passed. We are defining these
five categories of material as prohibited cattle materials.
Scientists believe that the human disease vCJD is likely caused by the
consumption of products contaminated with the agent that causes BSE. The
relationship between the agent that causes BSE and human cases of vCJD has been
described in section I.C of this document. Contamination of products with
infected cattle CNS tissue is believed to have led to the development of vCJD in
humans (Refs. 16, 26, and 27).
Currently, no practical method for testing products for the agent that causes
BSE is available and, therefore, we do not have a means of distinguishing
products that contain infectious material from products that do not. Consumers
also often are not able to determine which products contain prohibited cattle
materials and which products do not. For example, rendered products including
brain and spinal cord may become ingredients in soups, broths, meat flavors,
extracts, dietary supplements and cosmetics, where their presence may not be
indicated as such on the label. Furthermore, consumers have no way to determine
whether animal material in a human food
or cosmetic was sourced from nonambulatory disabled cattle or from cattle that
were not inspected and passed for human consumption.
In addition to being unable to test for infectious material in products, we also
do not know the infectious dose for humans. Despite widespread exposure in the
United Kingdom to BSE-contaminated meat products, only a very small percentage
of the exposed population has been diagnosed with vCJD to date. However, ongoing
experiments indicate that the infectious dose for cattle is very low. One gram
of affected cattle brain homogenate is sufficient to cause BSE in more than 50
percent of calves exposed by mouth. Five years after oral consumption of lower
doses of brain material, 2 of 15 calves fed 0.1 gram had developed BSE, and 1 of
15 fed 0.01 gram had developed the disease. This experiment is ongoing (Ref.
51). There is thought to be a 10- to 10,000-fold increase in the amount of
infectious material needed to cause illness in humans, as compared with cattle,
because of the species barrier (Ref. 49).
We know that consumption of contaminated material has caused illness in humans,
although we do not know the infectious dose, and we cannot test to determine
which products contain infectious material. Therefore, we have provided in Sec.
189.5(b) that no human food shall be
manufactured from, processed with, or otherwise contain prohibited cattle
materials, and in Sec. 700.27(b) that no cosmetic shall be manufactured from,
processed with, or otherwise contain, prohibited cattle materials.
FDA is applying these requirements for prohibited cattle materials to all
products or ingredients of products manufactured in the U.S. or imported into
the U.S. In an advanced notice of proposed rulemaking, entitled ``Federal
Measures to Mitigate BSE Risks: Considerations for Further Actions,'' published
by APHIS, FSIS, and FDA in this issue of the Federal Register, FSIS is seeking
comment on the issue of equivalence and BSE requirements. Likewise, FDA requests
comment on standards to apply when determining another country's BSE status,
providing an exemption for ``BSE-free'' countries, and how to determine that
countries meet any standards that might be developed. FDA intends to work with
USDA in developing a harmonized U.S. position on exempting other countries from
our respective requirements related to BSE.
C. Tallow and Tallow Derivatives
Tallow is defined in Sec. Sec. 189.5(a)(6) and 700.27(a)(6) 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 tissues.'' Tallow derivatives are defined in Sec. Sec.
189.5(a)(7) and 700.27(a)(7) as ``any chemical obtained through initial
hydrolysis, saponification, or trans-esterification of tallow or the chemical
conversion of material obtained by hydrolysis, saponification, or trans-esterification.''
For the reason described in section I.K of this document, we provide in Sec.
Sec. 189.5(a)(1) and 700.27(a)(1) that tallow with no more than a 0.15 percent
hexane-insoluble impurities and tallow derivatives are not considered prohibited
cattle materials under this rule. We are requiring in Sec. Sec. 189.5(a)(6) and
700.27(a)(6) that you measure the hexane-insoluble impurities in tallow by the
method for ``hexane- insoluble matter'' described in the 5th edition of the
Food Chemicals Codex (Institute of
Medicine, National Academies of Science) and incorporated by reference into this
rule or by another method that is at least equivalent in accuracy, precision and
sensitivity to the method described in the Food
Chemicals Codex, 5th edition. Tallow that contains more than 0.15 percent
hexane-insoluble impurities may be used if it complies with the requirements for
cattle materials in Sec. 189.5 for human food
and Sec. 700.27 for cosmetics.
We note that, regardless of its purity level, tallow to be used in human
food and cosmetics is subject to the
other provisions of the act and is adulterated, for example, if it has been
prepared, packed or held under insanitary conditions whereby it may have become
contaminated with filth (21 U.S.C. 342(a)(4)).
D. Records Access Requirements
We are requiring in Sec. Sec. 189.5(c) and
700.27(c) that manufacturers and processors of human
food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from cattle
must make existing records relevant to compliance with this rule available to
FDA for inspection and copying. We believe that records documenting the absence
of prohibited cattle materials in human food
and cosmetics are critical for manufacturers, processors, and FDA to ensure
compliance with the prohibitions on the use of prohibited cattle materials in
this interim final rule. Once material is removed from cattle, we may not be
able to obtain the information necessary to determine whether it is prohibited
cattle materials. There is currently no way to test reliably for the presence of
the BSE agent or for the presence of prohibited cattle materials. Therefore,
manufacturers and processors of human food
and cosmetics must depend on records from the suppliers of cattle material to
demonstrate that their supplier's cattle material does not contain prohibited
cattle materials.
The agency believes that recordkeeping and records access requirements are
necessary immediately. The agency, however, recognizes that recordkeeping
systems cannot be put into place immediately and, therefore, to include
recordkeeping requirements in this interim final rule could result in
manufacturers and processors immediately being in violation of the adulteration
provisions of the act with respect to human
food and cosmetics because of their failure immediately to establish
and maintain the necessary records as of the effective date of this interim
final rule. For that reason, we are proposing record establishment and
maintenance requirements in a separate rulemaking, rather than including them in
this interim final rule. Accordingly, in this issue of the Federal Register, we
are proposing to require that those manufacturers and processor establish and
maintain records to demonstrate compliance with this rule (see ``Recordkeeping
Requirements for Human Food and
Cosmetics Manufactured From, Processed With, or Otherwise Containing Material
from Cattle''). Although the agency is pursuing a separate rulemaking on
recordkeeping, we believe that some records may already be maintained that could
provide the agency with valuable compliance information before a final rule on
recordkeeping is issued as a result of the separate rulemaking. Therefore, we
are requiring in this interim final rule that FDA be able to access already
existing records that may demonstrate, or be relevant to, compliance with this
rule.
E. Scope of the Interim Final Rule
The prohibitions contained in Sec. 189.5 (b)
apply to all FDA- regulated human food,
except tallow and tallow derivatives. ``Human
food'' is ``food'' as that
term is defined in section 201(f) of the act (21 U.S.C. 321(f)), except for
animal food. Specifically, ``human
food'' is: (1) Articles used for
food or drink for man, (2) chewing
gum, and (3) articles used for components of any such article. ``Human
food'' includes, but is not limited
to, food additives, including
substances that migrate into food from
food packaging and other articles that
contact food, color additives, dietary
supplements and dietary ingredients, and infant formula.
The prohibitions contained in Sec. 700.27 (b) apply to all FDA- regulated
cosmetics. ``Cosmetic'' is defined in section 201(i) of the act (21 U.S.C.
321(i)) as
(1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced
into, or otherwise applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance, and (2)
articles intended for use as a component of any such articles; except that such
term shall not include soap.
In 21 CFR 701.20, FDA explains the criteria articles must meet to be considered
``soap'' under section 201(i) of the act.
F. Legal Authority
FDA is issuing these regulations under the
adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5),
601(c), and under section 701(a) of the act (21 U.S.C. 342(a)(2)(C), (a)(3),
(a)(4), (a)(5), 361(c), and 371(a)). Under section 402(a)(3) of the 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.''
``Otherwise unfit for food'' is an
independent clause in section 402(a)(3). It does not seem to require that a
food be filthy, putrid, or decomposed
for it to be ``otherwise unfit for food.''
We conclude that a food can be
``otherwise unfit for food'' based on
health risks. We seek comments on this interpretation. Because of the discovery
of a BSE positive cow in the United States and the possibility of disease
transmission to humans from exposure to material from infected cattle,
prohibited cattle materials (SRMs, small intestine of all cattle, MS(Beef),
material from nonambulatory disabled cattle, and material from cattle not
inspected and passed) may present a risk to human health. Under our
interpretation of section 402(a)(3), these materials are unfit for
food. Under section 402(a)(4) of the
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). Under section 402(a)(5) of the 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 these cattle that die otherwise
than by slaughter is adulterated under section 402(a)(5).
We are also relying on the food
additive provision in section 402(a)(2)(C) of the act. Any substance whose
intended use results or may reasonably be expected to result in it becoming a
component of food is a
food additive unless, among other
things, it is the subject of a prior sanction (explicit approval for a specific
use by USDA or FDA prior to September 6, 1958), or is generally recognized as
safe (GRAS). The regulations under 21 CFR 181.1(b) provide that, if scientific
data or information shows that the use of a prior-sanctioned ingredient may be
injurious to health and, thus, in violation of section 402 of the act, FDA can
prohibit use of the ingredient in food.
Prior sanctions are described in 21 CFR part 181. FDA is not aware of any prior
sanctions that relate to the present use of prohibited cattle materials.
However, to the extent any prior sanctions exist for the use of prohibited
cattle materials in food, they are
hereby revoked.
A determination that a substance added directly or indirectly to a
food is GRAS for its intended use is
generally based on specific information regarding the composition of the
substance, its use, method of preparation, methods for detecting its presence in
food, and information about its
functionality in food as determined by
experts qualified by scientific training and experience to evaluate the safety
of such a substance (21 CFR 170.35). A substance added to
food becomes GRAS as a result of a
common understanding about the substance throughout the scientific community
familiar with the safety of such substances. The basis of expert views may be
either scientific procedures, or, in the case of a substance used in
food prior to January 1, 1958,
experience based on common use in food
(Sec. 170.30(a)) (21 CFR 170.30(a)). Substances that are GRAS based on use prior
to January 1, 1958, must be currently recognized as safe based on their pre-1958
use (See United States v. Naremco, 553 F.2d 1138 (8th Cir. 1977); compare United
States v. Western Serum, 666 F.2d 335 (9th Cir. 1982)).
General recognition of safety based upon scientific procedures requires the same
quantity and quality of scientific evidence as is required to obtain approval of
a food additive regulation for the
ingredient (Sec. 170.30(b)). (See United States v. Naremco, 553 F.2d at 1143). A
substance is not GRAS if there is a genuine dispute among experts as to its
recognition (An Article of Drug * * *
Furestrol Vaginal Suppositories, 251 F. Supp 1307 (N.D. Ga. 1968), aff'd, 415
F.2d 390 (5th Cir. 1969)). It is not enough, in attempting to establish that a
substance is GRAS, to establish that there is an absence of scientific studies
that demonstrate the substance to be unsafe; there must be studies that show the
substance to be safe (United States v. An Article of
Food* * * CoCo Rico, 752 F.2d 11 (1st
Cir. 1985)). Conversely, a substance may be ineligible for GRAS status if
studies show that the substance is, or may be, unsafe, or if there is a conflict
in studies.
Expert opinion that prohibited cattle materials are GRAS would need to be
supported by scientific literature, and other sources of data and information,
establishing that there is a reasonable certainty of no harm from the material
under the intended conditions of use. Expert opinion would need to address
topics such as whether BSE infectivity can be detected and whether it is
reasonably certain that the BSE agent will not be transmitted through prohibited
cattle materials. The burden of establishing that a substance is GRAS is on the
proponent of the substance. (See CoCo Rico, supra).
For the reasons discussed in section I of this document, the agency is declaring
that prohibited cattle materials are not GRAS by qualified experts for use in
human food and, therefore, are
food additives. Section 402(a)(2)(C)
of the act deems food adulterated ``if
it is, or it bears or contains, any food
additive which is unsafe within the meaning of section 409 * * *.'' Under
section 409(a) (21 U.S.C. 348(a)), a food
additive is unsafe unless a food
additive regulation or an exemption is in effect with respect to its use or its
intended use. As a result, because neither a
food additive regulation, nor an exemption, is in effect for prohibited
cattle materials intended for use in human food,
such materials, with the exception of dietary ingredients in dietary
supplements, are adulterated under section 402(a)(2)(C) of the act, and their
presence in food renders the
food adulterated.
Dietary supplements are considered food
under the act and are included in this rule. However, the
food additive definition in section
201(s)(6) of the act exempts from regulation as a
food additive ``an ingredient
described in paragraph (ff) in, or intended for use in, a dietary supplement.''
An ingredient described in section 201(ff) is a dietary ingredient. Therefore, a
dietary ingredient, within the meaning of section 201(ff), is not subject to
regulation as a food additive. FDA notes that, under this rule,
ingredients containing prohibited cattle materials, and dietary supplements
containing such ingredients, would be adulterated
food under section 402(a)(3) and
(a)(4) of the act, as unfit for food
and as food prepared, packed, or held
under insanitary conditions whereby it may have been rendered injurious to
health. Such dietary ingredients would also be adulterated under section
402(a)(5) of the act if sourced from an animal that died other than by
slaughter.
Under section 601(c) of the 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).
Under section 701(a) of the act, FDA is authorized to issue regulations for the
act's efficient enforcement. 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 act. The
regulations require that manufacturers and processors of human
food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from cattle
make existing records available to FDA for inspection and copying. Once material
is removed from cattle, we may not be able to obtain the information necessary
to determine whether it is prohibited cattle material. For example, we would not
know from examination of a spinal cord whether the source animal was over 30
months of age at the time of slaughter or whether it was inspected and passed.
Therefore, the records access requirement is necessary for the efficient
enforcement of this rule. Failure to comply with this rule's records access
requirement renders the affected food and cosmetics
adulterated under sections 402(a)(4) and 601(a) respectively.
V. Issuance of an Interim Final Rule, Immediate Effective Date, and Opportunity for Public Comment
We are issuing this rule as an interim final
rule, effective immediately, with an opportunity for public comment. Section
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B))
provides that, when an agency for good cause finds that notice and public
procedure are impracticable, unnecessary, or contrary to public interest, the
agency may issue a rule without providing notice and public comment. FDA has
determined that there is good cause under 5 U.S.C. 553(b)(3)(B) and 21 CFR
10.40(d) because the discovery of BSE in a cow in the United States requires
regulations in place immediately to impose restrictions on the use of cattle
material in human food and cosmetics
to further reduce the possibility of transmission of vCJD. Further, under 5
U.S.C. 553(d)(3), we find good cause to make the rule effective immediately. It
is imperative that we act quickly to impose these restrictions on the use of
cattle material in human food and
cosmetics to further reduce the possibility of transmission of vCJD and ensure
that there is consistent protection of the U.S.
food supply by imposing upon FDA-regulated products the same
restrictions related to BSE imposed upon USDA-regulated products.
FDA invites public comment on this interim final rule. The comment period on
this interim final rule will be 90 days. The agency will consider modifications
to this interim final rule based on comments made during the comment period.
Interested persons may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments regarding this interim final rule.
Submit a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
This interim final rule applies to human food
and cosmetics manufactured from, processed with, or that otherwise contain,
material from cattle slaughtered on or after its effective date. Human
food and cosmetics under the act
include their components and the rule applies to these components. FDA realizes
that it may be difficult, in certain instances, for manufacturers and processors
to comply immediately with all of the provisions of this interim final rule. We
may consider this in enforcing the rule.
FDA will address comments received and confirm or amend this interim final rule
in a final rule.
VI. Analysis of Economic Impacts of the Interim Final Rule Use of Materials Derived From Cattle in Food and Cosmetics
A. Interim Final Regulatory Impact Analysis
FDA has examined the economic implications of this interim final rule as required by Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this interim final rule is not an economically significant regulatory action.
1. Need for Regulation
The FSIS' interim final rule requires that specified risk materials, small
intestine from all cattle, tissue from nonambulatory disabled cattle, and
MS(Beef) not be used for human food.
Specified risk materials include the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse process of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older, and the tonsils
and distal ileum of the small intestine of all cattle. The FSIS interim final
rule requires that all of the prohibited materials be destroyed or sent to
inedible rendering.
FDA, in response to the finding of an adult cow that tested positive for BSE in
the State of Washington and to be consistent with the USDA in regulating cattle
products that could potentially transmit BSE, is issuing this interim final rule
for FDA-regulated food and cosmetics
that may contain cattle material of concern. Specifically, this interim final
rule regulates cattle materials that may be used in human foods (e.g., dietary
supplements, food additives, color
additives, infant formula) and cosmetics.
This interim final rule will not affect the incidence of BSE in cattle, which is
addressed in other FDA regulations. This interim final rule will serve as a
safeguard to reduce human exposure to the agent that causes BSE that may be
present in cattle-derived products from domestic and imported sources. If BSE-infected
cattle or cattle material is prevented from use in human
food by the requirements in this rule
(e.g., the requirement that cattle materials be sourced from inspected and
passed animals) this interim final rule will reduce human risk by reducing human
exposure to infectious materials (i.e., prohibited cattle materials).
2. Interim Final Rule Coverage
This interim final rule prohibits the use of ``prohibited cattle materials.''
These include SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse process of
the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root
ganglia of cattle 30 months and older (including rendering of these materials),
and the tonsils and distal ileum of the small intestine of all cattle), small
intestine of all cattle, tissue from nonambulatory disabled cattle, tissue from
cattle not inspected and passed for human consumption, and MS(Beef) in all
FDA-regulated human food and
cosmetics.
Under this interim final rule, tallow with no more than 0.15 percent
hexane-insoluble impurities or that meets the requirements of Sec. 189.5(b)
(human food) or Sec. 700.27(b)
(cosmetics) may be used in food or
cosmetics. In addition, tallow derivatives are exempt from the requirements of
this rulemaking. The provisions for tallow and tallow derivatives in this
interim final rule are in accordance with the best guidance from the OIE and
FDA's TSEAC. The interim final rule provides in Sec. Sec. 189.5(c) and 700.27(c)
that manufacturers and processors of human food
or cosmetics that are manufactured from, processed with, or otherwise contains
cattle material must make records relevant to compliance with this rule
available to FDA for inspection and copying.
3. Regulatory Options Considered
In response to the concern over BSE in food
and cosmetics, FDA considered three regulatory options:
No new regulation (baseline).
Prohibit the use of prohibited cattle materials in human
food and cosmetics and require access
to existing records relevant to determine compliance.
Prohibit the use of prohibited cattle materials in human
food and cosmetics and require
establishment, maintenance, and access to records demonstrating that prohibited
cattle materials are not used in human food
and cosmetics.
Option 1: No new regulation.We use this option as the baseline. By definition,
no costs and benefits are associated with the baseline.
Option 2: Prohibit the use of prohibited cattle materials in human
food and cosmetics and require access
to existing records relevant to determining compliance.
This option would prohibit the use of prohibited cattle materials in all
FDA-regulated food, including dietary
supplements, and cosmetics, and would require that manufacturers and processors
make existing records related to compliance with the rule available to FDA for
inspection and copying.
The prohibition would cover the same materials prohibited by the FSIS interim
final rule and also materials from cattle that are not inspected and passed for
human consumption. Because SRMs, small intestine of all cattle, nonambulatory
disabled cattle and MS(Beef) are subject to the USDA's disposition requirements
(e.g., destruction or rendering for purposes other than human
food), we assume that generally these
materials are not likely to be widely available for use in the manufacture of
FDA-regulated human food and cosmetics. The manufacturers and
processors of products currently using materials that are considered SRMs (e.g.,
the brain, skull, spinal cord) would presumably be able to continue to use these
ingredients, but exclusively from cattle younger than 30 months of age. The
manufacturers of FDA-regulated human food products that use
rendered material would continue to use rendered material that is the product of
edible rendering (e.g., edible tallow). The manufacturers and processors of
products using the tonsils and the small intestine of all cattle, material from
nonambulatory disabled cattle, material from cattle not inspected and passed for
human consumption, and MS(Beef) would need to find substitutes for these
ingredients. We assume that the recent USDA rulemaking has already led many of
these manufacturers to search for alternative ingredients.
We do not have adequate information to quantify the cost of ingredient switching
for human foods and request data on this subject. To the extent that this option
leads to increased use of alternative ingredients, exposure to prohibited cattle
materials will be reduced. Without a complete records requirement, however, the
incentives to ensure that alternative ingredients are used are reduced. Access
to existing records, as required by this option, would not increase the costs of
this interim final rule, but would be beneficial in ensuring that acceptable
cattle material is used in the manufacture of food and
cosmetics.
Manufacturers of cosmetics that currently use inedible rendered materials,
including tallow containing more than 0.15 percent hexane- insoluble impurities,
would have to find alternative ingredients. We assume that they would switch to
edible cattle rendered material, or perhaps non-cattle inedible rendering, to
continue production. While we do not have specific price information for all
cattle material, edible or inedible, used in cosmetics, we were able to
determine that prime edible tallow from cattle is 4 cents more per pound than
inedible tallow from cattle ($0.1575 per lb. vs. $0.1975 per lb.) (Ref. 52). In
comparison, the alternative fats white grease and yellow grease are less
expensive than even inedible tallow ($0.01 to $0.02 per lb. less), while lard is
more expensive than edible tallow ($0.06 more per lb.).
Because edible cattle material is more expensive than inedible material, the
costs for inputs into cosmetic production would increase for those producers
that currently use inedible cattle material and must switch to edible cattle
material. FDA does not have information on the specific number of ingredient
substitutions that will be made in cosmetics production as a result of this
interim final rule. We assume that the increased costs of edible cattle material
as an ingredient in cosmetic production would, at least in part, be passed along
to cosmetics' consumers in the form of higher prices for finished products. It
is unlikely that the price increases for the cosmetic inputs or for the finished
products would be large enough to substantially decrease the amounts of the
affected products sold. FDA requests comments on this assumption.
Even though FDA does not have a specific list of cosmetics that currently use
inedible rendering as an input in production, we do have information from the
year 2000 on the U.S. consumption of inedible tallow and greases used in soap,
lubricants, and fatty acids (Ref. 53). We expect that these three ingredients
represent a good portion of the inedible rendering that is used to produce
cosmetics.
Tallow is the generally accepted term for the rendered fat from ruminant
carcasses, while grease is a more generic term that could be used to describe
rendered pork fat (white grease), used restaurant grease (yellow grease), or
lower quality tallow (also called yellow grease). To estimate the portion of
inedible tallow from cattle in the inedible tallow and greases category, we
looked at the percentage of total production of inedible tallow and greases that
represented inedible tallow for the year 2000, and found that inedible tallow
represented 54 percent of the mixture.
Table 1 of this document shows the usage of inedible tallow and greases by
category (soap, lubricant, or fatty acid), the consumption that represents the
cattle portion of the material (inedible tallow) and the calculated additional
costs--about $18 million--of these potential cosmetic inputs. The cost of
cosmetic ingredient switching shown in table 1 represents an upper bound
estimate of costs. Some cosmetic products likely use tallow derivatives, exempt
from this rulemaking, or already use cattle-derived ingredients that are
considered edible. Because we do not have precise information on how many
cosmetic products use tallow with more than the maximum level of insoluble
impurities or other inedible cattle material as ingredients, we estimate the
costs of cosmetic ingredient switching to be between $0 and $18 million.
Table 1.--Inedible Tallow usage & Price Premium for Edible Tallow
U.S. Consumption of Inedible Tallow & Greases, 2000 |
lbs |
Consumption in lbs That represents Tallow Only | Price Premium for Edible Tallow = $0.04/lb |
Total inedible Tallow and greases usage | 3,654,200,000 | ........................... | ........................... |
Regulatory option 2 would decrease the likelihood
of human exposure to BSE in several ways. First, by making clear that prohibited
cattle material cannot be used in FDA-regulated human food and
cosmetics, option 2 would create an additional regulatory barrier, beyond
existing regulations, between consumers and food and cosmetics
potentially contaminated with BSE. Second, by deeming human food
and cosmetics manufactured from, processed with, or otherwise containing,
prohibited cattle materials to be adulterated, option 2 would clarify FDA's
ability to prohibit importation of prohibited cattle materials. Imported
products, such as gelatin, beef extracts, and dietary supplements, may contain
the types of materials prohibited by the USDA, but may not fall under the scope
of the USDA's import restrictions.
The benefits of this interim 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.
If we define the baseline risk as the expected annual number of cases of vCJD
per year, then the annual benefits of prohibiting prohibited cattle materials
for use in foods and cosmetics would be: (baseline annual cases of vCJD - annual
cases of vCJD under FDA interim final rule) x (value of preventing a case of
vCJD).
An alternative way to characterize benefits is: Reduction in annual cases in
vCJD under FDA interim final rule x (value of preventing a case of vCJD)
We do not know the baseline expected annual number of cases, but based on the
epidemiology of vCJD in United Kingdom we anticipate much less than one case of
vCJD per year in the United States. Because the interim final rule will reduce
rather than eliminate risk of exposure to BSE infectious materials, the
reduction in the number of cases will be some fraction of the expected number.
The value of preventing a case of vCJD is the value of a statistical life plus
the value of preventing a year-long or longer illness that precedes certain
death for victims of vCJD. In a recent rulemaking regarding labeling of trans
fatty acids (68 FR 41433, July 11, 2003), we used a range of $5 to $6.5 million
for the value of a statistical life. The value of preventing a vCJD case would
be even higher because of the significant medical costs associated with the
illness (Ref. 54). We estimate that the value of preventing a single case of
vCJD ranges from $5.7 to $7.1 million. This estimate includes direct medical
costs, reduced ability of the ill person to function at home and at work, and
the cost of premature death.
As discussed earlier in this document, the Harvard-Tuskegee study has stated
that a ban on specified risk materials, including cattle brains, spinal cord and
vertebral column, from inclusion in human and animal
food would reduce the very few
potential BSE cases in cattle by a further 88 percent and potential human
exposure to infectivity in meat and meat products by a further 95 percent. This
interim final rule, in conjunction with the USDA's interim final rule, will help
achieve this reduction in potential human exposure. This interim final rule will
also reduce potential human exposure to BSE infection in human
food not covered by the
Harvard-Tuskegee study. For example, this interim final rule will help ensure
that a domestically produced or foreign-produced dietary supplement or
ingredient contains cattle material (e.g., brain) from animals of an appropriate
age.
Summary of Costs and Benefits of Interim Final Rule
The social cost of this interim final rule, which we approximate by multiplying the difference in ingredient prices by the pre-regulation quantity of ingredients, will be borne by producers and consumers of affected products. If demand is inelastic compared with supply, consumers will bear most of the social cost. If supply is inelastic compared with demand, producers will bear most of the social cost. The ready availability of alternatives for the prohibited ingredients, and the small number of products currently using them, implies that the social costs of this rule will likely be small for foods. The social costs for cosmetics will be greater. We estimate that the cost of ingredient switching for cosmetics will range from a lower bound of $0 to an upper bound of $18 million. The benefit of this interim final rule is that its requirements will--by reducing exposure to potentially infective materials--provide a safeguard against a case of vCJD occurring in humans if cattle infected with BSE enter the human food or cosmetic supply.
Option 3: Prohibit the use of prohibited cattle
materials in human food and cosmetics
and require establishment, maintenance, and access to records demonstrating that
prohibited cattle materials are not used in human
food and cosmetics.
Option 3, like option 2, prohibits the use of prohibited cattle materials in
human food, including dietary
supplements, and cosmetics. We explained in the discussion of option 2 that the
USDA's prohibitions are not sufficient, by themselves, to ensure that prohibited
cattle materials are not used in FDA-regulated
food and cosmetics. Therefore, FDA must be able to determine whether
prohibited cattle materials are used in the human
food and cosmetics it regulates.
Option 3 requires manufacturers and processors of FDA-regulated human
food and cosmetics manufactured from,
processed with, or otherwise containing cattle material to establish, maintain,
and provide access to records documenting that prohibited cattle materials are
not used in their products. Under this option, records would not be not required
for human food or cosmetics containing
tallow derivatives because tallow derivatives are not prohibited cattle
material. The marginal difference between options 2 and 3 presented in this
interim final rule is the requirements to establish and maintain records for
cattle-derived materials in Option 3. The requirement of records for
cattle-derived materials is the subject of an FDA proposed rulemaking published
elsewhere in this issue of the Federal Register. Thus, Option 3 of this interim
final rule represents the impacts of the requirements for the interim final rule
and for the proposed recordkeeping requirement. The impact of only the
recordkeeping requirement for cattle-derived materials used in
food and cosmetics is fully explained
elsewhere in this issue of the Federal Register.
Without these records, FDA may not be able to determine the age of cattle
material, such as brain or spinal cord, once it is separated from the source
animal. In addition, without records, the agency may not be able to determine
the inspectional status of the source animals. This regulatory option would
require that the manufacturer or processor retain records for 2 years after
using cattle material in food or cosmetics. Records must be
kept at the manufacturing or processing establishment or another reasonably
accessible location.
The costs of option 3 are the $0 to $18 million ingredient switching costs
calculated for option 2, plus the recordkeeping costs. We assume that some
records must be created for each shipment of materials from a slaughterhouse or
rendering facility to an FDA- regulated facility. We also assume that all
supporting information is known by the slaughter or rendering facility. The
USDA's interim final rule requires that establishments that slaughter cattle or
that process the carcasses or parts of carcasses of cattle maintain daily
records sufficient to document the implementation and monitoring of procedures
for removal, segregation, and disposition of SRMs.
Although most FDA-regulated human food
does not use a large quantity of cattle material, certain products contain
substantial amounts. Some fats and oils (e.g., oleo margarine and shortening)
use edible tallow and its derivatives; ice cream, yogurt, candies, flavorings,
marshmallows, and mayonnaise use gelatin; and some soups, mixed entrees, cake
mixes and pasta use a range of cattle material (Refs. 55 and 56).
Using establishment data from the FDA Small Business Model (which includes
information on all establishments in a manufacturing sector regardless of size)
(Ref. 57), FDA estimated that 132 establishments produce fats and oils, 181
establishments produce spreads, 127 establishments produce flavoring extracts,
40 establishments produce canned soups and stews, 625 establishments produce
non-chocolate candy, 88 establishments produce yogurt, and 451 establishments
produce ice cream. FDA cannot verify that all of these establishments actually
use cattle materials that fall under the jurisdiction of this interim final
rule; many may not. It is likely that all of the 132 establishments that produce
fats and oils currently use tallow derivatives, not tallow, so FDA assumes that
no records would be required to be kept by this establishment group. We assume
that only 25 percent of the establishments from the remaining production sectors
listed previously actually produce human food
that is manufactured from, processed with, or otherwise contains material from
cattle and therefore would be required to keep records under this option. We
include only 25 percent of the establishments in our estimates because most of
the manufacturers likely do not use cattle-derived ingredients in their
products. FDA requests comments on this assumption.
FDA research shows that 25 establishments with U.S. addresses supply
cattle-derived ingredients that are used in cosmetics (Ref. 58). These
cattle-derived ingredients include albumin, brain extract, brain lipids,
cholesterol and cholesterol compounds, fibronectin, sphingolipids, spleen
extract, tallow, and keratin and keratin compounds. FDA research also shows that
22 foreign establishments may export these cattle-derived ingredients to U.S.
cosmetic manufacturers. The U.S. cosmetic manufacturers would be required to
obtain records from the foreign establishments under this option. We therefore
include these foreign establishments when we estimate the recordkeeping costs of
the regulatory options in the interim final rule. Imported cosmetic products
represent about 10 to 20 percent of the cosmetics products on U.S. store shelves
(Refs. 59, 60, and 61). The burden of this interim final rule to foreign
cosmetics input suppliers and manufacturers will be less than the burden on
domestic cosmetics producers. The burden will be less for foreign cosmetics
manufacturers because Europe currently imposes some requirements similar to this
rule.
FDA does not have enough information on the types of cattle material used by the
47 domestic and foreign cosmetics establishments to know how often tallow
derivatives (exempt from the definition of prohibited cattle materials and,
therefore, exempt from the requirements under this option) are the only
cattle-derived ingredient used in these products. We estimate that 75 percent
(or 35) of the 47 cosmetics establishments would have to keep records for their
cattle- derived ingredients. We estimate that only 75 percent will keep records
because many cosmetics use tallow derivatives as their only cattle- derived
material and such materials are exempt from this rulemaking. FDA requests
comments on this assumption.
From FDA's dietary supplement database (Ref. 62), we are able to tell that there
are 162 dietary supplement brand names that use cattle material as ingredients
in their products. We assume that each brand name represents a facility that
produces multiple dietary supplement products containing cattle-derived
ingredients; therefore we assess recordkeeping costs for all 162 brand names. We
do not have information to determine if any of the dietary supplement
manufacturers use tallow derivatives (exempt from all requirements under this
option) as their only cattle-derived ingredient.
Recordkeeping Costs
The USDA's BSE interim final rule requires those establishments that slaughter
cattle or that process the carcasses or parts of carcasses of cattle maintain
daily records sufficient to document the implementation and monitoring of
procedures for removal, segregation, and disposition of SRMs. This USDA
requirement would reduce the startup costs of the recordkeeping required under
this option.
Recordkeeping costs include one-time costs and recurring costs. One-time costs
include the costs of designing records and training personnel in the maintenance
of the records. The recurring costs are the costs of ensuring that appropriate
records document the absence of prohibited cattle risk materials in human
food and cosmetics. The costs of
retaining records and planning for an FDA request for records access are
estimated to be zero. We estimate these costs to be zero becasue current
business practices already dictate that records for a second year is assumed to
be greater than the marginal cost of doing so. Although there is no specific
time period for providing records when requested, FDA notes that records
requestes costs are zero when FDA gives the records submitter 24 hours to
comply. These cost estimates are consistent with cost estimates used in FDA's
proposed recordkeeping requirements in ``Establishment and Maintenance of
Records Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002'' (68 FR 25188, May 9, 2003).
We assume that the one-time training burden incurred for each facility is the
equivalent of 1 month's on-the-job training or approximately 1/3 of an hour.
This time includes both the training required for personnel to learn how to
verify that shipments contain the appropriate records, and also the training
required for personnel to learn how to file and maintain those records. Given
current business practices, we know personnel are familiar with recordkeeping.
Therefore, the requirement to maintain additional records is expected to be
learned quickly. This training burden for recordkeeping is consistent with the
recordkeeping training burden in the analysis for the proposed recordkeeping
rule (68 FR 25188; May 9, 2003) and the records maintenance burden used in the
analysis of the Juice HACCP rule (66 FR 6138; January 19, 2001). Consistent with
the analysis conducted for the proposed recordkeeping rule (68 FR 25188; May 9,
2003), FDA assumes an hourly cost of an administrative worker, $25.10 per hour,
which has been doubled from $12.55 wage per hour to include overhead costs. This
cost, $25.10 per hour, applies to all labor costs.
We use the FDA Labeling Cost Model to estimate the one-time records design costs
per facility of $1,190 per stockkeeping unit (SKU) (Ref. 63). It is likely that
facilities using cattle-derived ingredients, whether the ingredients are for
human food or cosmetics, will take
advantage of their economies of scope and produce more than one product with
these ingredients. It is probable that each establishment has several SKUs
associated with products containing cattle-derived ingredients that will now
require recordkeeping. To account for additional products and SKUs we multiply
the record design costs per facility by 1.5 for a total design cost per facility
of $1,785 ($1,095 in labor costs and $690 in capital costs).
We multiplied the cost per product per SKU by 1.5 to account for the additional
records design required for the additional SKUs. The record design cost for the
first affected product or SKU will be more expensive than the marginal cost of
adding records for additional SKUs. This marginal cost of record design for
additional SKUs could be negligible or it could come close to doubling the
costs; we therefore pick 1.5, the midpoint of one and two, to be the cost
multiplier.
Consistent with the analysis conducted for the proposed recordkeeping rule
implementing the 2002 Bioterrorism Act, this record design cost is assumed to be
shared between two facilities--the upstream facility and the downstream
facility--as both will need to be involved in record production that meets the
needs of both the supplier and customer for the cattle-derived ingredient.
Unlike the Bioterrorism Act proposed recordkeeping rule, we do not have direct
information on all the facilities covered; we do not have data on the number of
slaughter plants or renderers that supply cattle material for human
food and cosmetic manufacturers and
processors under FDA jurisdiction. FDA does, however, have some information on
the number and type of downstream facilities that receive this material. Using
information on the number of human food
and cosmetic manufacturers that may use cattle-derived ingredients subject to
this interim final rule, we can account for the total shared records costs by
assuming that each food manufacturer
or processor facility listed in the table below procures ingredients from one
upstream slaughter plant or renderer. We assume each manufacturing facility
maintains an exclusive contractual relationship with one ingredient supplier for
calculation purposes. Even if multiple input suppliers are utilized by the
manufacturing facility, the marginal record set-up costs would decrease for
additional suppliers. Once the facility has learned what records are required,
it is less costly to keep records on additional input suppliers. FDA requests
comment on this assumption.
Information on food producing
facilities in Table 2 represent U.S. facilities; dietary supplement numbers
account for both domestic and foreign facilities; cosmetics numbers account for
both domestic and foreign input suppliers.
Table 2.--First-Year Records Costs
Type of Product Using Cattle Material | Number of Facilities Estimated to Use Cattle Materials | Costs Per Facility for Designing Records | Costs Per Facility for Training (1/3 hour * $25.10 per hour) | Total Setup Costs |
Canned soups and stews | 10 | $1,785 | $8.37 | $17,934 |
Fats and oils | 0 | .................... | .................... | .................... |
Flavoring extracts | 32 | $1,785 | $8.37 | $57,388 |
Spreads | 45 | $1,785 | $8.37 | $80,702 |
Candy | 156 | $1,785 | $8.37 | $279,766 |
Yogurt | 22 | $1,785 | $8.37 | $39,454 |
Ice cream | 113 | $1,785 | $8.37 | $202,651 |
Dietary supplements | 162 | $1,785 | $8.37 | $290,526 |
Cosmetics | 35 | $1,785 | $8.37 | $62,768 |
Color additives | 0 | .................... | .................... | .................... |
Total | 575 | $1,785 | $8.37 | $1,031,189 |
The recurring recordkeeping cost is the cost of
ensuring that appropriate records document the absence of prohibited cattle
materials in human food and cosmetics.
The framework for estimating the amount of time required for FDA- regulated
facilities to ensure that the records for each shipment of materials is based on
the regulatory impact analysis of the proposed recordkeeping requirements in
``Establishment and Maintenance of Records Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002.'' In that analysis we
estimated that 30 minutes per week would be required to ensure that records on
each shipment to and from a facility contain adequate information of the
contents of the package, as well as adequate information on the transporter,
supplier, and receiver.
The recordkeeping requirements of this regulatory option will cover only a small
fraction of all ingredients used in the human
food and cosmetic manufacturing processes and only require that records
of cattle-derived ingredient origin from the input supplier be verified and
maintained by a food or cosmetic
manufacturer or processor. Because this recordkeeping requirement is less
complex than the recordkeeping requirements under the Bioterrorism Act and
affects fewer ingredients, we estimate the per facility burden to be about
one-half of the burden estimated for the Bioterrorism Act recordkeeping rule (68
FR 25188, May 9, 2003): 15 minutes per week, or 13 hours per year. FDA assumes
that this recordkeeping burden will be shared between two entities (i.e., the
slaughter plant and the manufacturer or processor of finished products
containing cattle-derived ingredients).
Table 3 shows the recurring recordkeeping costs for human
food and cosmetic manufacturers and
processors. As stated earlier, information on
food producing facilities in Table 3 represents U.S. facilities;
dietary supplement numbers account for both domestic and foreign facilities;
cosmetics numbers account for both domestic and foreign input suppliers.
Table 3.--Recurring Annual Records Costs
Type of Product (From Raw or Rendered Material That Needs Accompanying Documentation) | Number of Facilities | Annual Costs Per Facility of Ensuring That Appropriate Records Accompany Each Shipment Received (13 hours * $25.10/hour) | Total Recurring Annual Costs |
Canned soups and stews | 10 | $326.30 | $3,263 |
Fats and oils | 0 | .................... | .................... |
Flavoring extracts | 32 | $326.30 | $10,442 |
Spreads | 45 | $326.30 | $14,684 |
Candy | 156 | $326.30 | $50,903 |
Yogurt | 22 | $326.30 | $7,179 |
Ice Cream | 113 | $326.30 | $36,872 |
Dietary supplements | 162 | $326.30 | $52,861 |
Cosmetics | 35 | $326.30 | $11,421 |
Color additives | 0 | .................... | .................... |
Total | 575 | $326.30 | $187,625 |
The benefits of this option are the same as the benefits of option 2--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. With this option, however, requiring the establishment and maintenance of records provides an additional safeguard to prevent exposure to potentially infected materials.
B. Regulatory Flexibility Analysis
FDA has examined the economic implications of this interim final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a
significant economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires agencies to analyze regulatory options that
would lessen the economic effect of the rule on small entities. FDA does not
believe that this interim final rule will have a significant economic impact on
a substantial number of small entities.
For this interim final rule, the only cost is for those human
food and cosmetic facilities that will
need to switch to alternative ingredients. While
food facilities may incur search costs
as well as higher ingredient costs, the ready availability of alternatives for
prohibited ingredients, and the small number of products currently using them,
implies that these costs will be negligible for foods.
Cosmetic facilities are more likely than food
facilities to experience substantial ingredient switching costs as a result of
this interim final rule. As shown previously, we estimate that 35 cosmetics
establishments will be affected by this interim final rule. If ingredient
switching costs are closer to FDA's estimated upper bound of $18 million than to
the lower bound of 0, the average cost per establishment will be about $500,000.
We do not know if any of the affected establishments are small businesses. This
cost would, however, be a significant economic impact for small cosmetics
businesses. If the actual costs are closer to the lower bound, then the economic
impact will not be significant.
Because switching ingredients is the source of the reduction in exposure to
potentially infective materials, it is necessary to apply the rule's provisions
to all establishments equally. We have, however, allowed small businesses some
flexibility by not requiring the establishment and maintenance of records in
this interim final rule. In a companion rulemaking, we propose record
establishment and maintenance requirements and ask for comments on their effect
on small businesses.
C. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires cost-benefit and other analyses before any rulemaking if the rule would include a ``Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.'' The current inflation-adjusted statutory threshold is $115 million. FDA has determined that this interim final rule does not constitute a significant rule under the Unfunded Mandates Reform Act.
D. SBREFA Major Rule
The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law
104-121) defines a major rule for the purpose of congressional review as having
caused or being likely to cause one or more of the following: An annual effect
on the economy of $100 million or more; a major increase in costs or prices;
significant adverse effects on competition, employment, productivity, or
innovation; or significant adverse effects on the ability of U.S.-based
enterprises to compete with foreign-based enterprises in domestic or export
markets. In accordance with the Small Business Regulatory Enforcement Fairness
Act, the Office of Management and Budget (OMB) has determined that this interim
final rule is not a major rule for the purpose of congressional review.
VII. Paperwork Reduction Act Analysis
This interim final rule does not contain information collection provisions that
are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520). Therefore, clearance by OMB under the Paperwork Reduction Act
of 1995 is not required.
VIII. Environmental Impact Analysis
FDA has carefully considered the potential environmental effects of this interim
final rule and of three possible alternative actions. In doing so, the agency
focused on the environmental impacts of its action as a result of disposal of
unused cattle byproducts (e.g., dead animals and slaughter byproducts) that need
to be handled after the rule becomes effective.
The environmental assessment (EA) considered each of the alternatives in terms
of the need to provide maximum reasonable protection of human health without
resulting in a significant impact on the environment. The EA considered
environmental impacts related to landfill, incineration, composting, and land
burial. The additional waste that might result from the selected action would be
an extremely small amount compared to the total amount of waste generated by the
cattle industry.
The agency has concluded that the interim final rule will not have a significant
impact on the human environment, and that an environmental impact statement is
not required. FDA's finding of no significant impact (FONSI) and the evidence
supporting that finding, contained in an EA prepared under 21 CFR 25.40, may be
seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday. FDA invites comments and submission of data
concerning the EA and FONSI.
IX. Federalism
We have analyzed this interim final rule in accordance with the principles in
Executive Order 13132. We have determined that the interim final rule does not
contain policies that have substantial direct effects on the states, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, we have concluded that the interim final rule does not
contain policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement has not been
prepared.
X. References
1. Johnson, R.T. and Gibbs, C.J. 1998, ``Creutzfeldt-Jakob Disease and Related Transmissible Spongiform Encephalopathies,'' New England Journal of Medicine, 339 (27): 1994-2004.
2. Herzog, C, N. Sales, N. Etchegaray, et al., Tissue Distribution of Bovine Spongiform Encephalopathy Agent in Primates After Intravenous or Oral Infection, Lancet, 363 (9407): 422-28, 2004.
3. 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.
4. Wells, G.A.H., M. Dawson, S.A.C. Hawkins, et al., ``Infectivity in the Ileum of Cattle Challenged Orally With Bovine Spongiform Encephalopathy,'' Veterinary Record 135: 40-41, 1994.
5. Wells, G.A.H., S.A.C. Hawkins, R.B. Green, et al., ``Limited Detection of Sternal Bone Marrow Infectivity in the Clinical Phase of Experimental Bovine Spongiform Encephalopathy (BSE),'' Veterinary Record 144: 292-294, 1999.
6. Brown, K.L, D.L. Ritchie, P.A. McBride, et al., ``Detection of PrP in Extraneural Tissues,'' Microscopy Research Technique 50: 40-45.
7. Council for Agricultural Science and Technology, ``Transmissible Spongiform Encephalopathies in the United States,'' Task Force Report No. 136, 2000.
8. Prusiner, S.B., ``Prions,'' Proceedings of the National Academy of Sciences 95(23): 13363-83, 1998.
9. Prusiner, S.B., ``Shattuck Lecture-Neurodegenerative Diseases and Prions, `` New England Journal of Medicine 344 (20): 1516-1526, 2001.
10. Collins, S.J., V.A. Lawson, and C.L. Masters, ``Transmissible Spongiform Encephalopathies,'' Lancet 363 (9402): 51-61, 2003.
11. Collee, J.G. and R. Bradley,``BSE: A Decade on-Part I,'' Lancet 349: 636-41, 1997.
12. Anderson, R.M., C.A. Connelly, N.M. Ferguson, et al., ``Transmission Dynamics and Epidemiology of BSE in British Cattle,'' Nature 382: 779-788, 1996.
13. 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.
14. Kimberlin, R.H. and J.W. Wilesmith, ``Bovine Spongiform Eencephalopathy: Epidemiology, Low Dose Exposure, and Risks,'' Annals of the New York Academy of Sciences 724: 210-220, 1994.
15. Department for Environment, Food, and Rural Affairs, United Kingdom. 2004. BSE Home page, accessed online at http://www.defra.gov.uk/animalh/bse/index.html .
16. Brown, P., ``The Risk of Bovine Spongiform Encephalopathy (`mad cow disease') to Human Health,'' Journal of the American Medical Association 278 (12): 1008-1011, 1997.
17. Will, R.G., J.W. Ironside, M. Zeidler, et al., ``A New Variant of Creutzfeldt-Jakob Disease in the UK,'' Lancet347: 921-25, 1996.
18. Chazot, G., E. Broussolle, C.I. Lapras, et al. ``New Variant of Creutzfeldt-Jakob Disease in a 26-year-old French Man,'' Lancet 347: 1181, 1996.
19. Collinge, J., ``Prion Diseases of Humans and Animals: Their Causes and Molecular Basis,'' Annual Reviews in Neuroscience 24: 519-50, 2001.
20. Almond, J. and J. Pattison, ``Human BSE, '' Nature 389: 437- 38, 1997.
21. Scott, M.R., R. Will, J. Ironside, et al., ``Compelling Transgenetic Evidence for Transmission of Bovine Spongiform Encephalopathy Prions to Humans,'' Proceedings of the National Academy of Sciences 96 (26): 15137-142, 1999.
22. Hill, A.F., M. Desbruslais, S. Joiner, et al., ``The Same Prion Strain Causes vCJD and BSE,'' Nature 389: 448-450, 1997.
23. Collinge, J., ``Variant Creutzfeldt-Jakob Disease,'' Lancet 354: 317-323, 1999.
24. Lasmezas, C.I., J-G. Fournier, V. Nouvel, et al., ``Adaptation of the Bovine Spongiform Encephalopathy Agent to Primates and Comparison With Creutzfeldt-Jakob Disease: Implications for Human Health,'' Proceedings of the National Academy of Sciences 98 (7): 4142-4147, 2001.
25. Bruce, M.E., R.G. Will, J. W. Ironside, et al., ``Transmissions to Mice Indicate That `New Variant' CJD is Caused by the BSE Agent,'' Nature 389: 498-501, 1997.
26. Brown, P., R.G. Will, R. Bradley, et al., ``Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current Concerns,'' Emerging Infectious Disease 7 (1): 6-16, 2001.
27. Scientific Steering Committee, European Commission, ``Opinion of the Scientific Steering Committee on the Human Exposure Risk (HER) Via Food With Respect to BSE,'' accessed online at http://europa.eu.int/comm/food/fs/bse/scientific_padvice08_en.html .
28. Brown, P., ``Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease,'' British Medical Journal 322: 841-44, 2001.
29. Harvard Center for Risk Analysis, Harvard School of Public Health, ``Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States,'' accessed online at http://www.hcra.harvard.edu/pdf/madcow.pdf , 2003.
30. Harvard Center for Risk Analysis, Harvard School of Public Health, ``Evaluation of the Potential Spread of BSE in Cattle and Possible Human Exposure Following Introduction of Infectivity into the United States from Canada,'' accessed online at http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/text_wrefs.pdf , 2003.
31. Scientific Steering Committee, European Commission, ``Update on the Opinion of TSE Infectivity Distribution in Ruminant Tissues,'' Initially adopted by the Scientific Steering Committee at its meeting of January 10-11, 2002, and amended at its meeting of November 7-8, 2002, following the submission of a risk assessment by the German Federal Ministry of Consumer Protection, Food and Agriculture and new scientific evidence regarding BSE infectivity distribution in tonsils, accessed online at http://europa.eu.int/comm/food/fs/bse/scientific_advice08_en.html .
32. Dealler, S.F. and R.W. Lacey, ``Transmissible Spongiform Encephalopathies: The Threat of BSE to Man,'' Food Microbiology 7: 253-279, 1990.
33. Kimberlin, R.H., ``Bovine Spongiform Encephalopathy: An Appraisal of the Current Epidemic in the United Kingdom,'' Intervirology 35: 208-218, 1993.
34. Health and Consumer Protection Directorate-General, European Commission, ``Report on the Monitoring and Testing of Ruminants for the Presence of Transmissible Spongiform Encephalopathy (TSE) in 2002, accessed online at http://europa.eu.int/comm/food/food/biosafety/bse/annual_report_2002_en.pdf , 2003.
35. Doherr, M.G., D. Heim, R. Fatzer, et al., ``Targeted Screening of High-Risk Cattle Populations for BSE to Augment Mandatory Reporting of Clinical Suspects, Preventive Veterinary Medicine 51: 3-16, 2001.
36. 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.
37. 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): 10106-112, 2001.
38. Fraser, J.R.,``Infectivity in Extraneural Tissues Following Intraocular Scrapie Infection, Journal of General Virology 77: 2663- 68, 1996.
39. Scott, J.R., J. D. Foster and H. Fraser, ``Conjunctival Instillation of Scrapie in Mice Can Produce Disease,'' Veterinary Microbiology 34 (4): 305-309, 1993.
40. Klitzman R.L., M.P. Alpers, and D.C. Gajdusek, et al., ``The Natural Incubation Period of Kuru and the Episodes of Transmission in Three Clusters of Patients,'' Neuroepidemiology, 3 (1): 3-20, 1984.
41. Taylor, D.M., I. McConnell, and H. Fraser, ``Scrapie Infection Can Be Established Readily Through Skin Scarification in Immunocompetent but Not Immunodeficient Mice, '' Journal of General Virology 77: 1595-99, 1996.
42. Ingrosso, L., F. Pisani, and M. Pocchiari, ``Transmission of the 263K Scrapie Strain by the Dental Route,'' Journal of General Virology 80: 3043-47, 1999.
43. Pammer, J., W. Weninger, and E. Tschachler, ``Human Keratinocytes Express Cellular Prion-Related Protein in Vitro and During Inflammatory Skin Diseases,'' American Journal of Pathology 153: 1353-58,1998.
44. Sugaya, M., K. Nakamura, T. Watanabe, et al., ``Expression of Cellular Prion-Related Protein by Murine Langerhans Cells and Keratinocytes,'' Journal of Dermatology 28: 126-134, 2002.
45. Taylor, D.M., S.L. Woodgate, and M.J. Atkinson, et al., ``Inactivation of the Bovine Spongiform Encephalopathy Agent by Rendering Procedures,'' Veterinary Record 137: 605-10, 1995.
46. Taylor, D.M., S.L. Woodgate, A.J. Fleetwood, et. al., ``The Effect of Rendering Procedures on Scrapie Agent,'' Veterinary Record 141: 643-49,1997.
47. Wilesmith, J.W., G.A.H. Wells, M.P. Cranwell, et al., ``Bovine Spongiform Encephalopathy: Epidemiological Studies,'' Veterinary Record, 123: 638-44, 1998.
48. Office International des Epizooties, Terrestrial Animal Health Code, Bovine Spongiform Encephalopathy Chapter, accessed online at http://www.oie.int/eng/normes/MCode/A_00068.htm, 2003.
49. Scientific Steering Committee, European Commission, ``Oral Exposure of Humans to the BSE Agent: Infective Dose and Species Barrier,'' accessed online at http://europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf , 2000.
50. U.S. Department of Health and Human Services, Food and Drug Administration, Transcript of meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, April 16, 1998, accessed online at http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf , 1998.
51. Vossen, P., J. Kreysa, and M. Goll, Overview of the BSE-Risk Assessment of the European Commission's Scientific Steering Committee (SSC) and it TSE/BSE Ad Hoc Group, accessed online at http://europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf, 2003.
52. National Carlot Meat Report, Vol. 19, No. 29, http://www.ams.usda.gov/lsmnpubs/Meat.htm , February 11, 2004.
53. U.S. Production, Consumption, and Export of Rendered Products for 1998-2002, National Renderers Association, http://www.renderers.org/Statistics/index.htm .
54. Memorandum for the Record, The Costs of a Case of Variant Creutzfeldt-Jakob Disease (vCJD), 2004.
55. ``The Rest of the Cow,'' http://www.mad-cow.org/may99_late_news.html , May 20, 1999.
56. Mulvaney Kieran, ``The Rendering Industry, Big Business in By-Products,'' E Magazine, Vol. VII, No. IV, http://www.emagazine.com/july-august_1996/0796feat2sb2.html , July-August 1996.
57. ``Model for Estimating the Impacts for Regulatory Costs on the Survival of Small Businesses and its Application to Four FDA- Regulated Industries,'' Final Report, Eastern Research Group, July 2002.
58. CTFA International Buyer's Guide produced by the Cosmetics, Toiletries, and Fragrances Association (CTFA) found on the web at http://www.ctfa-buyersguide.org.
59. Memorandum of Telephone Conversation, Dr. Gerald McEwen, Cosmetic, Toiletry, and Fragrance Association, and Karen L. Carson, Food and Drug Administration, June 29, 2004.
60. United States International Trade Commission Interactive Tariff and Trade DataWeb, Essential Oils and Resinoids; Perfumery, Cosmetic or Toilet Preparations. Accessed online at http://dataweb.usitc.gov .
61. U.S. Census Bureau, 1997 Economic Census: Bridge Between NAICA and SIC Manufacturing. Accessed online at http://www.census.gov .
62. FDA Dietary Supplement Products With Animal Ingredients Database (DSPD-A), September 2002, RTI International, contractor-- FDA Contract Number 06673.013.
63. Muth, M.K., E.C. Gledhill, and S.A. Karns, FDA Labeling Cost Model, Final Report, RTI, Health, Social, and Economics Research, Research Triangle, NC, April 2002.
List of Subjects
21 CFR Part 189
Food additives, Food packaging, Incorporation by reference.
21 CFR Part 700
Cosmetics, Packaging and containers, Incorporation by reference.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 189 and 700 are amended as follows:
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
0
1. The authority citation for 21 CFR part 189 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
0
2. Part 189 is amended by redesignating subparts B and C as subparts C and D, respectively, and by adding a new subpart B to read as follows: Subpart B--Prohibited Cattle Materials
Sec. 189.5 Prohibited cattle materials.
Subpart B--Prohibited Cattle Materials
Sec. 189.5 Prohibited cattle materials.
(a) Definitions. The definitions and interpretations of terms contained in
section 201 of the Federal Food,
Drug, and Cosmetic Act (the act) apply
to such terms when used in this part. The following definitions also apply:
(1) Prohibited cattle materials means specified risk materials, small intestine
of all cattle, material from nonambulatory disabled cattle, material from cattle
not inspected and passed, or MS(Beef). Prohibited cattle materials do not
include tallow that contains no more than 0.15 percent hexane-insoluble
impurities and tallow derivatives.
(2) Inspected and passed means that the product has been inspected and passed
for human consumption by the appropriate regulatory authority, and at the time
it was inspected and passed, it was found to be not adulterated.
(3) Mechanically Separated (MS)(Beef) means a meat
food product that is finely
comminuted, resulting from the mechanical separation and removal of most of the
bone from attached skeletal muscle of cattle carcasses and parts of carcasses,
that meets the specifications contained in 9 CFR 319.5, the regulation that
prescribes the standard of identity for MS (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken
appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral
column or metabolic conditions.
(5) Specified risk material means the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils
and distal ileum of the small intestine of all cattle.
(6) Tallow means the rendered fat of cattle obtained by pressing or by applying
any other extraction process to tissues derived directly from discrete adipose
tissue masses or to other carcass parts and tissues. Tallow must be free of
prohibited cattle material or must contain not more than 0.15 percent
hexane-insoluble impurities as determined by the method for ``hexane-insoluble
matter,'' p. 465, in the ``Food
Chemicals Codex,'' 5th Ed. (2004), 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 the method in the
Food Chemicals Codex. You may obtain copies of the method from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418
(Internet address http://www.nap.edu) and the
Division of Dairy and Egg Safety (HFS-306), Center for
Food Safety and Applied Nutrition,
Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Copies may be examined at the Center for
Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741- 6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.
(7) Tallow derivative means any chemical obtained
through initial hydrolysis, saponification, or trans-esterification of tallow;
chemical conversion of material obtained by hydrolysis, saponification, or
trans-esterification may be applied to obtain the desired product.
(b) Requirements. No human food shall
be manufactured from, processed with, or otherwise contain, prohibited cattle
materials.
(c) Records. Manufacturers and processors of human
food that is manufactured from,
processed with, or otherwise contains, cattle material must make existing
records relevant to compliance with this section available to FDA for inspection
and copying.
(d) Adulteration. (1) Failure of a manufacturer or processor to operate in
compliance with the requirements of paragraphs (b) or (c) of this section
renders human food adulterated under
section 402(a)(4) of the act.
(2) Human food manufactured from,
processed with, or otherwise containing, prohibited cattle materials is unfit
for human food and deemed adulterated
under section 402(a)(3) of the act.
(3)Food additive status. Prohibited
cattle materials for use in human food
are food additives subject to section
409 of the act, except when used as dietary ingredients in dietary supplements.
The use or intended use of any prohibited cattle material in human
food causes the material and the
food to be adulterated under section
402(a)(2)(C) of the act if the prohibited cattle material is a
food additive, unless it is the
subject of a food additive regulation
or of an investigational exemption for a food
additive under Sec. 170.17 of this chapter.
PART 700--GENERAL
0
3. The authority citation for 21 CFR part 700
continues to read as follows:
Authority: 21 U. S. C. 321, 331, 352, 355, 361, 362, 371, 374.
0
4. Section 700.27 is added 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 act apply to such terms when used in this part. The following
definitions also apply:
(1) Prohibited cattle materials means specified risk materials, small intestine
of all cattle, material from nonambulatory disabled cattle, material from cattle
not inspected and passed, or MS(Beef). Prohibited cattle materials do not
include tallow that contains no more than 0.15 percent hexane-insoluble
impurities and tallow derivatives.
(2) Inspected and passed means that the product has been inspected and passed
for human consumption by the appropriate regulatory authority, and at the time
it was inspected and passed, it was found to be not adulterated.
(3) Mechanically Separated (MS)(Beef) means a meat food product
that is finely comminuted, resulting from the mechanical separation and removal
of most of the bone from attached skeletal muscle of cattle carcasses and parts
of carcasses that meet the specifications contained in 9 CFR 319.5, the
regulation that prescribes the standard of identity for MS (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken
appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral
column or metabolic conditions.
(5) Specified risk material means the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils
and distal ileum of the small intestine of all cattle.
(6) Tallow means the rendered fat of cattle obtained by pressing or by applying
any other extraction process to tissues derived directly from discrete adipose
tissue masses or to other carcass parts and tissues. Tallow must be free of
prohibited cattle risk material or must contain not more than 0.15 percent
hexane-insoluble impurities determined by the method for ``hexane-insoluble
matter,'' p. 465, in the ``Food
Chemicals Codex,'' 5th Ed. (2004), 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 the method in the
Food Chemicals Codex.. You may obtain copies of the method from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418
(Internet address http://www.nap.edu) and the
Division of Dairy and Egg Safety (HFS-306), Center for
Food Safety and Applied Nutrition,
Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Copies may be examined at the Center for
Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741- 6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.
(7) Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of
material obtained by hydrolysis, saponification, or trans-esterification may be
applied to obtain the desired product.
(b) Requirements. No cosmetic shall be manufactured from, processed with, or
otherwise contain, prohibited cattle materials.
(c) Records. Manufacturers and processors of cosmetics that are manufactured
from, processed with, or otherwise contain, cattle material must make existing
records relevant to compliance with this section available to FDA for inspection
and copying.
(d) Adulteration. Failure of a manufacturer or processor to operate in
compliance with the requirements of paragraph (b) or (c) of this section renders
a cosmetic adulterated under section 601(c) of the act.
Dated: July 8, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs,
[FR Doc. 04-15881 Filed 7-9-04; 11:00 am]
BILLING CODE 4160-01-S
![]() |
|