NR ARWH
AU Suydam,L.A.
TI IA #17-04, 10/19/95 - Revision, "Automatic detention of bulk shipments of high-risk bovine tissue from BSE-countries - bovine spongiform encephalopathy (BSE)", Attach A - 7/18/95, Attach B - 7/18/95, Appendix A - 7/18/95
QU Internet
IA http://www.fda.gov/ora/fiars/ora_import_ia1704.html
VT
Revision of this alert changes the text in the Guidance section. New information is designated by asterisks (***).
TYPE OF ALERT : AUTOMATIC DETENTION
(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
HARMONIZED CODE: 3001
PROBLEM: POISONOUS/DELETERIOUS SUBSTANCE - N.E.C. (PSNC)
PAC: 03819C
PAF CODE: MIC (microbiological hazards)
COUNTRIES: FRANCE (FR, 350), REPUBLIC OF IRELAND (IE, 470), OMAN (OM, 616), SWITZERLAND (CH, 855), UNITED KINGDOM (Great Britain & Northern, Ireland, and Falkland Islands) (GB, 925), PORTUGAL (PT, 735)
NOTE: These countries are BSE affected countries and the list may be subject to change. 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 (France, Republic of Ireland, Oman, Portugal and Switzerland). 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: United Kingdom, France, Republic of Ireland, Oman, Portugal and Switzerland - refer to 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. 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).
Documented transmission of the causative agents of BSE or scrapie to humans has not been reported to date. The FDA has recommended that manufacturers who use bovine by-products 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, in an August 17, 1994 letter (Attachment B), recommended that manufacturers and importers of dietary supplements, cosmetic products, and raw materials for these finished products 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-countries. FDA is not, at this time, recommending restrictions on the use of ovine-derived (sheep) materials since the epidemiological evidence now appears convincing that scrapie is not related to TSEs in humans.
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 six (6) following countries: United Kingdom, France, Republic of Ireland, Oman, Portugal and Switzerland. * 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 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. 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 and Frank Sikorsky, DFPPE/Import Programs Branch, 202-205-4606
DATE LOADED INTO FIARS: October 19, 1995
KEYWORDS: Bovine Spongiform Encephalopathy, BSE, High-Risk Tissue, Animal, Glandular, Bovine
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. 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:
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).
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 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)
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.
AD Linda A. Suydam, (Interim Deputy Commissioner for Operations)
PO Internet
SP englisch
OR Prion-Krankheiten 7