[Federal Register Volume 59, Number 166 (Monday, August 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21279]
[[Page Unknown]]
[Federal Register: August 29, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Bovine-Derived Materials; Agency Letters to Manufacturers of FDA-
Regulated Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing the texts
of four letters it recently issued to manufacturers of FDA-regulated
products requesting that bovine-derived materials from certain cattle
not be used in the manufacture of FDA-regulated products intended for
humans or animals. FDA believes that bovine spongiform encephalopathy
(BSE), a neurological disease of bovine animals, is a concern in the
manufacture of FDA-regulated products. FDA believes that precautionary
measures will reduce potential risk of exposure to, or transmission of,
the agents that cause BSE in cattle. FDA is publishing the texts of the
four letters at the end of this document in addition to mailing them
directly to manufacturers.
FOR FURTHER INFORMATION CONTACT:
For dietary supplements and cosmetics: Elisa L. Elliot, Center for
Food Safety and Applied Nutrition (HFS-22), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-5140.
For medical devices: Kiki B. Hellman, Center for Devices and
Radiological Health (HFZ-113), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-7158.
For human drugs: Gayle R. Dolechek, Center for Drug Evaluation and
Research (HFD-335), Food and Drug Administration, 7520 Standish Pl.,
Rockville, MD 20855, 301-594-0104.
For biological products: Timothy W. Beth, Center for Biologics
Evaluation and Research (HFM-635), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.
For veterinary drugs: William C. Keller, Center for Veterinary
Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1722.
For animal feeds: John P. Honstead, Center for Veterinary Medicine
(HFV-222), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-594-1728.
For information on countries with BSE: Harvey Kryder, U.S.
Department of Agriculture, Animal and Plant Health Inspection Service,
Federal Bldg., rm. 757, 6506 Belcrest Rd., Hyattsville, MD 20782, 301-
436-7885.
SUPPLEMENTARY INFORMATION: FDA has recently issued four letters
requesting that bovine-derived materials from cattle that have resided
in, or originated from, countries designated by the U.S. Department of
Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS),
as countries where BSE exists, not be used in the manufacture of FDA-
regulated products intended for humans or animals. A letter dated
November 9, 1992, was issued to manufacturers of dietary supplements. A
letter dated December 17, 1993, was issued to manufacturers of human
drugs, biologics, and medical devices. (With respect to the December 17
letter, the agency has subsequently clarified that FDA does not object
to the use of bovine-derived materials from BSE-countries in the
manufacture of pharmaceutical grade gelatin at this time.) A letter
dated August 17, 1994, was issued to manufacturers of FDA-regulated
products for animals. A letter dated August 17, 1994, was issued to
manufacturers and importers of dietary supplements and cosmetics.
BSE is a neurological disease of bovine animals. USDA has
regulations that prohibit and restrict the importation of certain
animal products and animal byproducts from ruminants that have been in
countries where BSE exists. These countries are designated by USDA and
listed in 9 CFR 94.18.
The BSE agent is extremely resistant to traditional forms of
processing and sterilization. The disease was first identified in 1986.
Since that time, over 100,000 cattle in Great Britain have either died
or been destroyed as a result of BSE infection. At the present time,
BSE is not known to exist in the United States. The disease is not
known to be contagious by direct transmission.
BSE is a neurological disease classified as a transmissible
spongiform encephalopathy (TSE), and is similar to other TSE's such as
scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in humans. Its
continued spread within countries where BSE exists appears to be
through the use of feed containing protein and other products from
ruminants infected with BSE. In the United Kingdom, scrapie in sheep
has been epidemiologically associated with the occurrence of BSE in
cattle. Scrapie in sheep is known to have existed in Britain, Ireland,
France, and Germany for over 200 years and has been observed in the
United States and Canada for about 50 years. Because FDA cannot
positively rule out a direct association between scrapie and BSE, FDA
is proposing elsewhere in this issue of the Federal Register to
prohibit the use in ruminant feed of specified offal from adult sheep
and goats.
CJD is a rare neurological disease of humans that has similarities
to BSE in cattle. The cause of CJD is unknown except in a few cases of
specific genetic mutations and iatrogenic CJD in the case of CJD-
contaminated growth hormone injections, dura mater grafts, and corneal
transplants. Even though there is no direct evidence supporting an
association between BSE and human disease, FDA believes that it is
prudent to reduce any potential risk of human exposure to the BSE
agent.
The purpose in issuing these four letters is to request that
bovine-derived materials from cattle that have resided in or originated
from USDA-designated BSE countries not be used in the manufacture of
FDA-regulated products intended for humans or animals. Meat (i.e.,
skeletal muscle) is not covered by these letters. For guidance on
importation of meat and other USDA-regulated products, refer to Title 9
of the Code of Federal Regulations.
The text of the November 9, 1992, letter to manufacturers of
dietary supplements follows:
November 9, 1992
Dear Manufacturer of Dietary Supplements:
In a series of recent meetings, representatives of the dietary
supplement industry have suggested that if FDA has concerns
involving dietary supplement products, it should communicate its
concerns directly to the industry. We agree that this is a
reasonable and appropriate suggestion. Therefore, I wish to bring a
matter of some importance to FDA to your attention. I would like to
share with you FDA's concerns regarding the marketing of certain
nutritional supplements. We have become aware that some supplements
contain brain, nervous tissue, or glandular materials from a variety
of animal species, including bovine (oxen, beef) and ovine (sheep)
species. We are concerned that some amount of these materials may
have come from countries experiencing Bovine Spongiform
Encephalopathy (BSE) in the case of bovine tissues, or scrapie in
the case of ovine tissues.
As you may know, BSE is an infectious neurologic disorder of
cattle, and is prevalent in certain parts of the world (``BSE
countries''). Scrapie is a spongiform encephalopathy of sheep, and
is a disease that is endemic in many parts of the world, including
the United States. It is believed that the rapid spread of BSE among
animals in Great Britain was caused by inadequately rendered,
scrapie agent-containing material being fed to cattle. Thus, it is
suggested that BSE is the clinical manifestation of scrapie in
cattle. It is further suggested that cattle became infected by the
orogastric route. Both scrapie and BSE are classified as
transmissible spongiform encephalopathies. The causal agent is
unknown, but suspected to be an agent known variously as ``prion,''
``virino,'' ``unconventional virus,'' or ``slow virus.'' That these
agents can infect across species, and infect primates, has been
demonstrated repeatedly in laboratory studies.
Although cases are rare, spongiform encephalopathies can affect
humans, most notably, Creutzfeldt-Jakob Disease (CJD). CJD is a rare
disease, its incidence being about 1 case per million population. It
is 100% fatal. Human-to-human transmission by iatrogenic means
(e.g., contaminated neurosurgical instruments, corneal and dura
mater implants, human growth hormone injections) has been
documented. The possibility of transmission of animal spongiform
encephalopathy agents to humans from consumption of animal brains
from a variety of species, such as squirrel, goat, sheep, and hogs,
and from consumption of sheep's eyeballs has been examined in the
past. Although proof of such dietary transmission is lacking, some
suspicions remain. The rarity of the disease, coupled with what is
believed to be a long onset time (median - 13 years), make more
precise epidemiological studies extremely difficult. Additionally,
there may be a genetic or other susceptibility in some individuals.
FDA has recently been involved in investigating a consumer
complaint involving a confirmed case of CJD. It is standard
procedure for FDA to follow-up on all consumer complaints involving
death or serious injury. In the course of this investigation, FDA
learned that the woman had taken a bovine tissue-containing dietary
supplement. Although, at the present there is no basis to conclude
that this supplement played any role in causing this disease, FDA
and NIH have decided that it is prudent to further investigate this
matter. Therefore, both agencies have begun to conduct cooperative
studies to determine whether nutritional supplements containing
brain, nervous tissue or glandular materials from bovine and ovine
species might be linked to human spongiform encephalopathies.
In 1991, the United States Department of Agriculture published a
rule (9 CFR 95.4) which prohibits imports of various tissues and
organs from ruminants in countries where BSE exists. Similar
prohibitions have been in place for scrapie for many years. The
concern addressed by the rules was that BSE - or scrapie-containing
materials may find their way into cattle or sheep in the U.S.
Nevertheless, FDA feels that the principle embodied in the USDA rule
is an appropriate standard for tissues, organs, glands, and
processed extracts from these articles insofar as they may be used
for human food, including in supplement form.
FDA is requesting that you investigate the source of your neural
and glandular tissue(s) or tissue extracts of bovine or ovine
species to determine if they are being produced in known BSE
countries or from flocks in which scrapie may be present. We would
recommend that you reformulate your products using neural or
glandular tissues that you are assured are BSE or scrapie free. We
suggest within the next two months, that you gather information and
determine the source of bovine or ovine materials used in your
product(s). If you use bovine-derived materials in your product(s),
we suggest that you develop a plan to assure, with a high degree of
certainty, that there is no possibility that materials of bovine
origin are being supplied by BSE countries, either directly or
indirectly. If you use ovine materials in your product(s), we
suggest that you also develop a similar plan for assuring that these
tissues are from scrapie-free animals. We fully recognize that there
is no proven link between BSE or scrapie, and human disease, but
given the devastating consequences of human spongiform
encephalopathies such as CJD, we believe that our request is a
prudent step at this time.
FDA requests that you communicate your plan(s) to us once you
have developed them. We recognize that the steps you take to secure
the assurances you need from exporting countries may be difficult,
but we are certain you will agree with us that they are desirable.
If you need any additional information or guidance, please
contact Dr. Douglas L. Archer, Deputy director, Center for Food
Safety and Applied Nutrition at 202-205-4057. We appreciate you
cooperation and attention to this matter.
Sincerely,
Fred R. Shank, Ph.D.
Director
Center for Food Safety and Applied Nutrition
The text of the December 17, 1993, letter to manufacturers of
drugs, biological drugs, medical devices, and biological device
products follows:
December 17, 1993
TO: Manufacturers of FDA-regulated Products
The Food and Drug Administration (FDA, the Agency) is issuing
this letter to request that bovine-derived materials from cattle
which have resided in or originated from countries where Bovine
Spongiform Encephalopathy (BSE) has been diagnosed not be used in
the manufacture of FDA-regulated products intended for
administration to humans. We are advising you of our current
recommendations pertaining to the use of such bovine-derived
products.
FDA is providing the following information to explain why the
Agency thinks that an animal disease (such as BSE) may potentially
be a concern in the manufacture of FDA-regulated products intended
for administration to humans. BSE has been reported for more than
109,000 cattle in the United Kingdom [Fall, 1993 quarterly report of
the Ministry of Agriculture, Fisheries, and Food (MAFF)], and to a
much lesser extent in other European countries. This neurological
disease is a transmissible spongiform encephalopathy (TSE), and is
similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob
Disease (CJD) in humans. The spongiform encephalopathies are
uniformly fatal, and no rapid diagnostic test for infection in
living animals (or humans) is currently available. Iatrogenic
transmissions of CJD from both pituitary-derived human growth
hormone (somatotropin) and dura mater\1\ have been reported.
Research projects into the exact nature of both the BSE agent and
other spongiform encephalopathy agents, host range, patterns of
pathogenicity, and development of rapid antemortem diagnostic tests
are ongoing. Available scientific information indicates that these
agents are extremely resistant to inactivation by normal
disinfection or sterilization procedures. The list of countries
where BSE is known to exist (BSE-countries) is maintained by the
United States Department of Agriculture (USDA). Countries listed in
the Federal Register on December 6, 1991 (56 FR 63865 through 63870)
include France, Great Britain (includes the Falkland Islands),
Northern Ireland, the Republic of Ireland, Oman, and Switzerland.
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\1\Brown P, Preece MA, Will RG. ``Friendly fire in medicine:
hormones, homografts, and Creutzfeldt-Jakob disease''. Lancet
1992:340:24-27.
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While transmission of the causative agent of BSE to humans has
not been reported to date, FDA considers the recommendations below
to be prudent at this time to further reduce any potential risk of
exposure or transmission of a BSE-agent to humans by FDA- regulated
products.
The Agency notes that regulated products intended for
administration to humans and manufactured with bovine-derived
materials derived from cattle that have at any time been in BSE-
countries may be adulterated under Section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act (the Act), for drugs and
biological drug products; or Section 501(h) of the Act, for medical
devices and biological device products. The Agency is considering
rulemaking to restrict the use of bovine-derived materials from BSE-
countries. At this time, FDA recommends that bovine-derived
materials from BSE-countries not be used in the manufacture of FDA-
regulated products.
The Agency is providing the following suggestions to prevent the
use of bovine-derived materials from cattle which have resided in or
originated from BSE-countries. FDA recommends that manufacturers:
a. identify bovine-derived materials used in the regulated
product and identify all countries where the animals used for the
material have lived. This information may be provided to the
regulated-product manufacturer by the supplier of the bovine
product. The supplier may also provide the manufacturer with
appropriate veterinary regulatory inspection certification of
slaughter, as required by the country of origin of live animals.
b. maintain traceable records for each lot of bovine material
and each lot of FDA-regulated product using these materials. These
records should be part of the batch records, and available for FDA
inspection.
c. document the country of origin of the live animal source of
any bovine-derived materials used in the manufacture of the
regulated product. Documentation should be maintained for any new or
in-process lots of licensed, cleared, or approved products; products
pending clearance or approval; and investigational products intended
to be administered to humans. Such documentation should be a part of
the traceable records maintained in conjunction with batch
production records, and such information should be available for
review during FDA inspections.
d. maintain copies of the records identified above for FDA-
regulated products that are manufactured with bovine-derived
materials at foreign sites, or by the foreign manufacturers. The
U.S. firms responsible for marketing these products should be
responsible for these records. Manufacturers of products subject to
licensure should maintain records at the site of manufacture.
The Agency recommends that the information identified above be
obtained for all currently approved, cleared, or licensed products,
pending or approvable products, and investigational products.
Some manufacturers of FDA-regulated products may have already
provided some of this information in applications to the USDA for
permits to import certain animal products into the United States. In
some instances, copies of these applications and permits may contain
some of the information that the FDA is requesting. FDA suggests
that this information be documented, recorded, and maintained for
all bovine-derived products currently manufactured or marketed in
the U.S. This information should be available for FDA inspection.
If you have any questions regarding the above items please
contact the appropriate center as follows:
Center for Devices and Radiological Health: 301-594-4692 ext.
158
Center for Drug Evaluation and Research: 301-594-0054
Center for Biologics Evaluation and Research--contact the
Application Division in the CBER Office responsible for the
regulation of your product. These Offices are:
Office of Vaccines Research and Review 301-594-2090
Office of Therapeutics Research and Review 301-594-5109
Office of Blood Research and Review 301-594-2012
Regulated-product manufacturers are referred to the USDA for
current information and countries on the ``BSE-list''. Additional
information and regulations concerning bovine spongiform
encephalopathy (BSE) and affected animals may be obtained from the
open veterinary literature and the United States Department of
Agriculture (see 9 CFR 94.18).
Sincerely yours,
Jane E. Henney, M.D.
Deputy Commissioner for Operations
The text of the August 17, 1994, letter to manufacturers of FDA-
regulated products for animals follows:
August 17, 1994
To: Manufacturers of FDA-regulated products for animals
The Food and Drug Administration is issuing this letter to
request that bovine-derived materials from cattle which have resided
in, or originated from, countries designated as bovine spongiform
encephalopathy (BSE) countries by United States Department of
Agriculture (USDA), Animal and Plant Health Inspection Service, not
be used in the manufacture of FDA-regulated products (drugs and
feed) intended for animals. FDA believes that this action is
necessary to prevent the occurrence of BSE in U.S. cattle. Meat
(i.e., skeletal muscle) is not covered by this letter. For guidance
on importation of meat and other USDA-regulated products, refer to
Title 9 of the Code of Federal Regulations.
FDA is providing the following information to explain why the
Agency thinks that BSE may potentially be a concern in the
manufacture of FDA-regulated products intended for administration to
animals. BSE has been identified in more than 100,000 cattle in the
United Kingdom and to a much lesser extent in other European
countries. BSE has not been diagnosed in the U.S. This neurological
disease is a transmissible spongiform encephalopathy (TSE), and is
similar to other TSE's such as scrapie in sheep and Creutzfeldt-
Jakob Disease (CJD) in humans. The spongiform encephalopathies are
uniformly fatal and no rapid diagnostic test for infection in living
animals is currently available. A range of research projects into
the exact nature of both the BSE agent and other TSE agents, host
range, patterns of pathogenicity, and development of rapid ante
mortem diagnostic tests is ongoing. Available scientific information
indicates that these agents are extremely resistant to inactivation
by normal disinfection or sterilization procedures. The list of
countries where BSE is known to exist is maintained by the USDA and
codified in Title 9, Code of Federal Regulations, Part 94.18.
The Agency notes that products intended for animals and
manufactured with bovine-origin materials derived from cattle that
have, at any time, been in BSE countries may be adulterated under
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.
The Agency is considering rulemaking to restrict the use of bovine-
derived materials from BSE countries in the manufacture of FDA-
regulated products for animals. At this time, we request that
bovine-derived materials from BSE countries not be used in the
manufacture of FDA-regulated products intended for animals.
FDA considers the recommendations below to be prudent at this
time to further reduce any potential risk of exposure to, or
transmission of, a BSE agent to animals by FDA-regulated products.
We recommend that manufacturers:
a. Identify bovine-origin materials used in regulated products
for animals and identify all countries where the cattle used for the
material have lived. This information may be provided to the
regulated product manufacturer by the supplier of the bovine
material. The supplier may also provide the manufacturer with
appropriate veterinary regulatory inspection certification of
slaughter if already required by USDA for import from BSE countries
which verify the country of origin.
b. Maintain traceable records for each lot of bovine-derived
material and each lot of FDA-regulated products intended for animals
that are manufactured using these materials. These records should be
part of the batch records and available for FDA inspection.
c. Document the country of origin of the live animals for
bovine-origin materials used in the manufacture of any new or in-
process lots of FDA-regulated products intended for animals. Such
documentation should be a part of the traceable records maintained
in conjunction with batch production records and such information
should be available for FDA inspection.
d. Maintain copies of the appropriate records identified above
for FDA-regulated products intended for animals that are
manufactured with bovine-derived materials at foreign sites, or by
the foreign manufacturers. The U.S. firms responsible for marketing
these animal products should be responsible for these records.
Registered product manufacturers should maintain records at the site
of manufacture.
The Agency recommends that the information identified above be
obtained and maintained for all FDA-regulated products intended for
animals.
Some manufacturers of FDA-regulated products intended for
animals may have already provided some of this information in
applications to the USDA for permits to import certain bovine
materials into the U.S. In some instances, copies of these
applications and permits may contain some of the information
requested. We request that this information be documented, recorded,
and maintained for all bovine-origin materials for use in FDA-
regulated products intended for animals currently manufactured or
marketed in the U.S. This information should be available for FDA
inspection.
If you have any questions regarding the above items, please
contact the Center for Veterinary Medicine:
For Veterinary Drugs: Dr. William Keller, Director, Division of
Surveillance, HFV-210, 7500 Standish Place, Rockville, Maryland
20855, 301-594-1722
For Animal Feeds: Dr. John Honstead, Division of Animal Feeds,
HFV-222, 7500 Standish Place, Rockville, Maryland 20855, 301-594-
1728
Regulated product manufacturers are referred to the USDA for
current information and countries on its list of countries with BSE
in native animals. Additional information and regulations concerning
BSE and affected animals may be obtained from the USDA, Animal and
Plant Health Inspection Service (301-436-7830).
Sincerely yours,
Linda A. Suydam
Interim Deputy Commissioner for Operations
The text of the August 17, 1994, letter to manufacturers and
importers of dietary supplements and cosmetics follows:
August 17, 1994
To Manufacturers and Importers of Dietary Supplements:
To Manufacturers and Importers of Cosmetics:
The Food and Drug Administration (FDA) is recommending that
firms that manufacture or import dietary supplements and cosmetics
containing specific bovine tissues (see Appendix A) ensure that such
tissues do not come from cattle born, raised, or slaughtered in
countries where bovine spongiform encephalopathy (BSE) exists (BSE-
countries). Extracts of these tissues and ingredients derived from
these tissues are also of concern. The recommended actions are
precautionary measures to reduce potential risk of human exposure
to, or transmission of, the agent which causes BSE in cattle.
At this time, FDA is not extending the recommendation in this
letter to dairy products or gelatin, because available evidence does
not suggest transmission via these foods. Furthermore, meat (i.e.,
skeletal muscle) is not covered by this letter. For guidance on
importation of meat and other products regulated by the United
States Department of Agriculture (USDA), refer to Title 9 of the
Code of Federal Regulations.
The Agency is providing the following information to explain why
it believes that BSE may potentially be a concern with certain
dietary supplements and cosmetic products. BSE has been identified
in more than 100,000 cattle in the United Kingdom and, to a much
lesser extent, in several other countries. BSE has not been
diagnosed in the United States. This neurological disease is a
transmissible spongiform encephalopathy (TSE) and is similar to
other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease
(CJD) in humans. The spongiform encephalopathies are uniformly fatal
and no rapid diagnostic test for infection in living animals or
humans is presently available. Current scientific information
indicates that the causative agent is extremely resistant to
inactivation by normal disinfection or sterilization procedures. A
range of research projects into the exact nature of both the BSE
agent and other TSE agents, host range, patterns of pathogenicity,
and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of
certain tissues and organs from ruminants from countries where BSE
exists (BSE-countries; see 9 CFR 94.18). USDA's regulations are
intended to protect livestock in the United States from contracting
TSEs and address known or strongly suspected modes of transmission.
For the up-to-date listing of BSE-countries please contact USDA,
Animal and Plant Health Inspection Service (APHIS) at (301) 436-
7830.
The USDA regulations permit, under certain conditions, the
importation of some cosmetic ingredients (i.e., collagen, collagen
products, amniotic liquids or extracts, placental liquids or
extracts, serum albumin, and serocolostrum) derived from ruminants
from BSE-countries; see 9 CFR 95.4.
The USDA regulations do not apply to imports of:
* cosmetic products that are packaged and ready for sale;
* bovine-derived materials intended for human consumption as
either finished dietary supplement products or for use as
ingredients in dietary supplements; or
* human food (except meat, i.e., skeletal muscle).
While documented transmission of the causative agents of BSE or
scrapie to humans has not been reported to date, the FDA wrote to
manufacturers of dietary supplements in November 1992, alerting them
to the developing concern about TSEs in animals and CJD in man. That
letter recommended that manufacturers voluntarily investigate the
geographic source(s) of any bovine or ovine material used in their
products (generally neural or glandular tissue or tissue extracts).
The Agency also suggested that each manufacturer develop a plan ``to
assure, with a high degree of certainty,'' that such materials are
not from BSE-countries, as identified by USDA's APHIS, or from
scrapie-infected sheep flocks, either foreign or domestic.
FDA now considers further protective steps to be reasonable and
is restating and expanding its recommendation to manufacturers and
importers of dietary supplements and their ingredients, to develop
plans for ensuring, with a high degree of certainty, that specific
bovine-derived materials (see Appendix A) from BSE-countries are not
being used. The Agency is also recommending that manufacturers and
importers of cosmetic products and their ingredients develop the
same type of plans. FDA is not, at this time, recommending
restrictions on the use of ovine-derived materials in the
manufacture of dietary supplement and cosmetic products and
ingredients, as the epidemiological evidence now appears convincing
that scrapie is not related to TSEs in humans.
FDA believes it is prudent to expand its recommendation to
cosmetics and cosmetic ingredients because extracts of listed
tissues, e.g. sphingolipids isolated from brain tissue and extracts
of bovine placenta, are used in cosmetics. Additionally, FDA is
unaware of data demonstrating that processing techniques used in the
manufacture of cosmetics will inactivate TSE agents. Further, little
is known about the potential human risk of transmission from topical
application of cosmetics containing TSE agents to intact, broken or
abraded skin.
To assist manufacturers and importers whose products are within
the scope of this recommendation in developing their plans, the
following guidance is provided:
a. To ensure that bovine-derived materials (listed in Appendix
A) used in the product(s) are from non BSE-countries, identify all
countries where the animals used were born, raised or slaughtered.
The supplier of the bovine-derived materials should provide the
necessary records.
b. Maintain traceable records for each lot of bovine-derived
material and records of products containing the materials.
c. Maintain records for those products manufactured at foreign
sites or by foreign manufacturers which contain bovine-derived
materials.
The Agency recommends that manufacturers and importers of
dietarysupplements and cosmetic products and ingredients used in the
manufacture of these products develop their plans within the next
two months and notify the Agency, in writing, that their plans have
been developed. The designated contact is Dr. Elisa Elliot, Science
Policy Analyst, Executive Operations Staff, HFS-22, Center for Food
Safety and Applied Nutrition, FDA, 200 C Street, S.W., Washington,
DC, 20204 or FAX (202) 205-5025. FDA recommends that the plans be
implemented as soon after development as possible, and be available
for review by the Agency during inspections.
The Agency is continuing to examine all available information
about TSEs and will provide additional guidance as necessary. If you
need more information please contact Dr. Elliot by telephone at
(202) 205-5140.
We appreciate your attention to and cooperation in this matter.
Sincerely,
Linda A. Suydam
Interim Deputy Commissioner for Operations
Attachment
Appendix A
List of Tissues With Suspected Infectivity
Category I (High infectivity)
Brain
Spinal cord
Category II (Medium infectivity)
Ileum
Lymph nodes
Proximal colon
Spleen
Tonsil
Dura mater
Pineal gland
Placenta
Cerebrospinal fluid
Pituitary gland
Adrenal gland
Category III (Low infectivity)
Distal colon
Nasal mucosa
Sciatic nerve
Bone marrow
Liver
Lung
Pancreas
Thymus gland
List taken from ``Report of a WHO Consultation on Public Health
Issues Related to Animal and Human Spongiform Encephalopathies,''
World Health Organization, Office of International Epizootics,
Geneva, Switzerland, November 12-14, 1991.
Dated: August 19, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-21279 Filed 8-26-94; 8:45 am]
BILLING CODE 4160-01-F
