IA #17-04, REVISION, 5/20/03, IMPORT ALERT #17-04,"DETENTION WITHOUT PHYSICAL
EXAMINATION OF BULK SHIPMENTS OF HIGH-RISK BOVINE TISSUE FROM
BSE-COUNTRIES--BOVINE SPONGIFORM ENCEPHALOPATHY"
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
(NOTE: This import Alert contains guidance to FDA field
personnel only. It does not establish any requirements, or
create any rights or obligations on FDA or on regulated
entities.)
PRODUCT: Bulk shipments of high-risk bovine tissues and
tissue-derived ingredients (see Attachment A for a list of
affected products).
PRODUCT CODE: 17Y--99, meat and meat products, N.E.C.
53P--01, Bovine (bovine amniotic fluid), cosmetic raw
materials. (Review of EEPS entry data indicates that this
code may also be used for bovine placenta)
53P--02, Collagen, cosmetic raw materials
54G--01, Bovine, animal byproducts/extracts
54G--99, Animal byproducts/extracts, N.E.C.
PROBLEM: POISONOUS/DELETERIOUS SUBSTANCE - N.E.C. (PSNC)
OASIS CHARGE
CODES: DIET INGRE; INGRED FIL; COSMETIC; BSE FILTH; INSAN BSE.
PAC: 03819C for product codes 17Y--99, 54G--01,
54G--99
29002 for product codes 53P--01, 53P--02
PAF: MIC (microbiological hazards)
COUNTRIES: ALBANIA (AL), ANDORRA (AD), AUSTRIA (AT), BELGIUM (BE),
BOSNIA-HERZEGOVINA (BA), BULGARIA (BG), CANADA (CA), CROATIA
(HR), the CZECH REPUBLIC (CS), DENMARK (DK), the FEDERAL
REPUBLIC OF YUGOSLAVIA (YU), FINLAND (FI), FRANCE (FR),
GERMANY (DE), GREECE (GR), HUNGARY (HU), IRELAND, REPUBLIC
of (IE), ISRAEL (IL), ITALY (IT), JAPAN (JP), LEICHSTENSTEIN
(LI), LUXEMBOURG (LU), the former YUGOSLAV REPUBLIC OF
MACEDONIA (MK), MONACO (MC), NETHERLANDS (NL), NORWAY (NO),
OMAN (OM), POLAND (PL), PORTUGAL (PT), ROMANIA (RO), SAN
MARINO (SM), the SLOVAK REPUBLIC (SLOVAKIA) (SK), SLOVENIA
(SI), SPAIN (ES), SWEDEN (SE), SWITZERLAND (CH) UNITED
KINGDOM (Great Britain & Northern Ireland, and Falkland
Islands) (GB)
NOTE: The United States Department of Agriculture issued an
interim rule on January 6, 1998. The interim rule restricts
the importation of ruminants, meat and meat products from
ruminants, and certain ruminant products and byproducts not
only from countries and other regions in which BSE is known
to exist, but also from countries and other regions which,
because of import requirements less restrictive than those
that would be acceptable for import into the United States
and/or because of inadequate surveillance, present a
significant risk. Countries listed above are BSE affected
countries and/or have less restrictive import requirements
than those that would be acceptable in the U.S. The list of
countries may change and the Import Alert will be revised
accordingly.
MANUFACTURER/
SHIPPER: All, from the designated countries
MANUFACTURER/
SHIPPER I.D.#: N/A
CHARGES: As ingredients in dietary supplements, charge: "The article
is subject to refusal of admission pursuant to Section
801(a)(3) in that it appears to be for use as an ingredient
in a dietary supplement and appears to be or may be
otherwise unfit for food [Adulteration, Section 402(a)(3)]."
AND
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be for use as an
ingredient in a dietary supplement and may have 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 [Adulteration,
Section 402(a)(4)]."
As ingredients in cosmetics, charge: "The article is subject
to refusal of admission pursuant to Section 801(a)(3) in
that it appears to be for use as an ingredient in a cosmetic
product and appears to have or may have 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 [Adulteration, Section
601(c)."
If final disposition of the bulk lot is undetermined,
charge: "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be unfit
for food [Adulteration, Section 402(a)(3)]."
AND
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to have been prepared,
packed or held under insanitary conditions whereby it may
have been rendered injurious to health [Adulteration,
402(a)(4)]".
RECOMMENDING
OFFICE: CFSAN, DFPPE, Import Programs Branch (HFS-637)
REASON FOR\
ALERT: BSE has been identified in more than 100,000 cattle in the
United Kingdom and, to a much lesser extent, in several
other 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 presently
available. Current scientific information indicates that
the causative agent is extremely resistant to activation 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. (refer to 9 CFR 94.18). On
January 6, 1998, USDA issued an interim rule listing other
countries because of import requirements less restrictive
than those that would be acceptable for importation into the
U.S. and/or because of inadequate surveillance, which would
present a significant risk. USDA's regulations are intended
to protect livestock in the United States from contracting
TSEs and address known or strongly suspected modes of
transmission. 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:
o cosmetic products that are packaged and ready for
sale;
o bovine-derived materials intended for human
consumption as either finished dietary supplement
products or for use as ingredients in dietary
supplements; or
o human food (except meat, i.e., skeletal muscle).
In March 1996, the Spongiform Encephalopathy Advisory
Committee of the UK reported that 10 cases of CJD in the UK
are likely linked to exposure BSE before the UK ban in 1989.
The FDA has recommended that manufacturers who use bovine
by-products voluntarily investigate the geographic
source(s) of any bovine or bovine 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 considers further protective steps to be reasonable and,
in an August 17, 1994, letter (Attachment B), recommended
that manufacturers and importers of dietary supplements,
cosmetic products, and raw materials for these finished
product develop plans for ensuring, with a high degree of
certainty, that specific bovine-derived materials from
BSE-countries are not being used.
Attachment A is an expanded list of those tissues presenting
the highest known risk of infectivity, e.g., high-risk
tissue, which are the subject of this import alert.
Additional tissues may be added to this list as studies
warrant and this import alert will be revised accordingly.
FDA will be gathering information on the development of BSE
plans for all bovine - derived tissues and documenting the
use of high-risk tissue from BSE-countries during domestic
inspections under both the cosmetics and dietary supplements
compliance programs. Due to the difficulty in verifying the
presence of high-risk tissues in finished dietary
supplements or cosmetic products, this import alert is
limited to bulk lots of these tissues from BSE-affected or
at risk countries listed above. However, if during wharf
examinations or label reviews high-risk bovine tissues are
noted in the ingredients statement, districts should follow
the procedure in the Guidance section of this alert to
notify CFSAN.
The United States Department of Agriculture issued an
interim rule on January 6, 1998. The interim rule restricts
the importation of ruminants, meat and meat products from
ruminants, and certain ruminant products and byproducts not
only from countries and other regions in which BSE is known
to exist, but also from countries and other regions which,
because of import requirements less restrictive than those
that would be acceptable for import into the United States
and/or because of inadequate surveillance, present a
significant risk.
GUIDANCE: Districts may detain the shipment without physical
examination, if the high-risk bovine tissue or ingredient,
as listed in Attachment A, originated from one of the
following Countries: Albania, Andorra, Austria, Belgium,
Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic,
Denmark, the Federal Republic of Yugoslavia, Finland,
France, Germany, Greece, Hungary, Ireland, Israel, Republic
of, Italy, Japan, Leichtenstein, Luxembourg, the Former
Yugoslav Republic of Macedonia, Monaco, Netherlands, Norway,
Oman, Poland, Portugal, Romania, San Marino, the Slovak
Republic (Slovakia), Slovenia, Spain, Sweden, Switzerland
and United Kingdom. If an entry is detained and the importer
or manufacturer has not provided within sixty (60) days
documentation that establishes that the bovine derived
tissue used in the product came from BSE-free cattle or from
a non BSE affected or at risk country, districts should
attempt to determine the status of the entry and, where
possible, reach a final determination as to the entry. Sixty
(60) days should be ample time for an importer or
manufacturer to provide such documentation.
Districts may provide a copy of the Agency's August 17,
1994, letter (Attachment B) to importer's for their use in
developing plans to assure that future shipments of bovine
tissues are obtained from non-BSE countries.
Districts should be alert to entries of finished products
from BSE affected countries which contain high-risk bovine
tissues listed in the ingredients. When conducting field
examinations and/or label reviews of finished products, such
as dietary supplements or cosmetics that contain high-risk
bovine tissues, contact Rosemary Gary, CFSAN/Import Branch,
at 301-436-2413 with product identity, high-risk bovine
tissue used as ingredient, manufacturer/shipper, country of
origin, and importer of record and for further guidance.
For any issues and/or questions regarding science, science
policy, sample collection, analyses, preparation, analytical
methodology or confirmation tests, districts should contact
the Division of Field Science at 301-443-3320 or 443-3007.
PRIORITIZATION
GUIDANCE: III
FOI: No purging necessary
PREPARED BY: Linda Wisniowski, DIOP, 301-443-6553; Frank Sikorsky,
Rosemary Gary, DFPPE/Import Programs Branch, 301-436-2413
KEYWORDS: Bovine Spongiform Encephalopathy, BSE, High-Risk Tissue,
Animal, Glandular, Bovine
DATE LOADED
INTO FIARS: June 12, 2002
ATTACHMENT A
HIGH-RISK BOVINE TISSUE AND TISSUE-DERIVED INGREDIENTS
Adrenal gland
Bone marrow
Brain
Brain extract
Cerebellum
Cerebrospinal fluid
Cranial nerves
Colon (proximal and distal)
Dura mater
Eye
Hypothalamus
Ileum
Lymph nodes
Nasal mucosa
Olfactory bulb or gland
Pineal gland
Pituitary gland
Placenta
Spinal cord
Spleen
Suprarenal gland
Tonsil Attachment B
August 17, 1994
Food and Drug Administration
Rockville, MD 20857
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. 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:
. 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.
. 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 dietary
supplements 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,
/s/
Linda A. Suydam
Interim Deputy Commissioner for
Operations
May 9, 1996
TO MANUFACTURERS AND IMPORTERS OF DIETARY SUPPLEMENTS:
TO MANUFACTURERS AND IMPORTERS OF COSMETICS:
As the media have widely reported, the British government announced on March
20, 1996, that new information had been gathered about bovine spongiform
encephalopathy (BSE) in cattle that suggests a possible relationship between
BSE and ten cases of a newly identified form of Creutzfeldt-Jakob disease
(CJD), a similar fatal transmissible spongiform encephalopathy (TSE) in
humans. To serve our mutual interest in protecting public health, the Food
and Drug Administration (FDA) believes it is prudent to reiterate concerns we
have previously expressed on this issue.
BSE is a transmissible neurologic disorder of cattle and is prevalent in
certain parts of the world. This neurological disease is one of a number of
transmissible spongiform encephalopathies (TSE) known and is similar to other
TSEs such as scrapie in sheep and CJD in humans. It is believed that the
spread of BSE in cattle in some countries, particularly Great Britain, was
caused by the feeding of infected cattle and sheep tissues to cattle. While
transmission of the causative agent of BSE to humans has not been definitively
documented to date, inter-species transfer has been demonstrated (e.g., mice
can be infected by exposure to infected bovine tissues). Recent developments
in Great Britain raise serious questions regarding potential hazards of the
consumption of animal tissues containing the causative agent of BSE.
Although there is still no definitive evidence that the consumption of bovine
tissues that contain the transmissible agent for BSE cause CJD in humans, FDA
is concerned that appropriate measures to eliminate the use of bovine tissues
from BSE-countries be instituted industry-wide.
We strongly recommend that firms manufacturing or importing dietary
supplements which contain specific bovine tissues (see appendix A), including
extracts or substances derived from such tissues, take whatever steps are
necessary to assure themselves and the public that such ingredients do not
come from cattle born, raised, or slaughtered in countries where BSE exists.
FDA believes that immediate and concrete steps should be taken by
manufacturers to reduce the potential risk of human exposure to the infectious
agent which causes BSE in cattle.
The list of countries where BSE is known to exist is maintained by the U.S.
Department of Agriculture (USDA) and codified in Title 9, Code of Federal
Regulations, Part 94.18. The following is the current list:
USDA LIST OF COUNTRIES WHERE BSE EXISTS
(Current as of May 1996)
Great Britain (including Northern Ireland and the Falklands)
Switzerland
France
Republic of Ireland
Oman
Portugal
A range of research projects into the exact nature of both the BSE agent and
other TSE agents is ongoing. Available scientific information indicates that
these agents are extremely resistant to inactivation by normal disinfection or
sterilization procedures. A number of dietary supplement products use
bovine-derived tissues or extracts of such tissues as ingredients. These
ingredients include, for example, specific tissues and organs or their
extracts (e.g., liver powder, "orchic" extracts, ovaries, eye tissue, mammary
tissue), glandular powders or extracts (e.g., adrenal gland, thyroid gland),
or specific substances extracted from glands or tissues (e.g., melatonin
extracted from the pineal gland).
At a future date, we will contact you with guidance on how best to provide
assurance that your products do not contain potentially BSE-infected
materials.
We appreciate your attention to and cooperation in this matter. If you need
more information, please contact Dr. Elisa Elliot by telephone at (202)
205-5140.
Sincerely yours,
/s/
Michael A. Friedman, M.D.
Deputy Commissioner for Operations
EnclosureAppendix A
List of Tissues With Suspected Infectivity
Category I (High infectivity)
o brain
o spinal cord
Category II (Medium infectivity)
o ileum
o lymph nodes
o proximal colon
o spleen
o tonsil
o dura mater
o pineal gland
o placenta
o cerebrospinal fluid
o pituitary gland
o adrenal gland
Category III (Low infectivity)
o distal colon
o nasal mucosa
o sciatic nerve
o bone marrow
o liver
o lung
o pancreas
o 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.
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