BSE and Cosmetics:BSE and Cosmetics:

FDA Risk Assessment and FDA Risk Assessment and Management Management Perspectives. Perspectives. Stanley R. Milstein, Ph.D., Office of Stanley R. Milstein, Ph.D., Office of Cosmetics and ColorsCosmetics and Colors

CFSAN-Australian Embassy CFSAN-Australian Embassy PresentationPresentation

December 7, 2006December 7, 2006

Cosmetic and Color Cosmetic and Color Additive Regulatory Additive Regulatory RequirementsRequirements Cosmetics:Cosmetics:

No Pre-Market Approval No Pre-Market Approval (Products and Ingredients) (Products and Ingredients)

Color Additives:Color Additives:Pre-Market ApprovalPre-Market Approval

OCAC’s Top Risk-Based OCAC’s Top Risk-Based Enforcement PrioritiesEnforcement Priorities

•Safety and Security RelatedSafety and Security Related Microbial contaminationMicrobial contamination

Illegal color additive useIllegal color additive use

Bovine Spongiform Encephalopathy (BSE)Bovine Spongiform Encephalopathy (BSE)

Bioterrorism/Counterterrorism (BT/CT)Bioterrorism/Counterterrorism (BT/CT)

BSE and FDA Oversight BSE and FDA Oversight of Cosmeticsof Cosmetics

OCAC has tracked the BSE OCAC has tracked the BSE epidemic since 1991. epidemic since 1991.

Cosmetics and BSE/v-CJDCosmetics and BSE/v-CJD >13,500 Cosmetic >13,500 Cosmetic

Ingredients in ICID-11Ingredients in ICID-11 Many Bovine Ingredients Many Bovine Ingredients

in Cosmetic Productsin Cosmetic Products Some Ingredients Some Ingredients

Subject to Other TSEs in Subject to Other TSEs in Cosmetics:Cosmetics: Antler Velvet, Deer Fat Antler Velvet, Deer Fat

(Cervidae) (Cervidae) Lanolin Derivatives Lanolin Derivatives

(Ovidae)(Ovidae) Mink Oil, Mink Fatty Mink Oil, Mink Fatty

Acid Derivatives Acid Derivatives (Mustela(Mustela))

Ingredients from the CTFA Cosmetic Ingredient Ingredients from the CTFA Cosmetic Ingredient Dictionary Dictionary

(6(6thth edition) that are from “Bovine” or “Animal” edition) that are from “Bovine” or “Animal” SourcesSources

88 Amniotic FluidAmniotic Fluid Fluid surrounding the cow embryo Fluid surrounding the cow embryo in utero.in utero.00 Aorta ExtractAorta Extract Extract derived from animal aorta.Extract derived from animal aorta.00 Brain ExtractBrain Extract Extract of bovine and porcine brains.Extract of bovine and porcine brains.0 0 Calf Blood ExtractCalf Blood ExtractExtract of calf blood.Extract of calf blood.0 0 Calfskin ExtractCalfskin Extract Extract of bovine skin.Extract of bovine skin.00 Calfskin HydrolysateCalfskin Hydrolysate Hydrolysate of calfskin, derived by acid, Hydrolysate of calfskin, derived by acid,

enzyme, enzyme, or other method of hydrolysis.or other method of hydrolysis.8787 CollagenCollagen Protein in cartilage and other connective tissue in Protein in cartilage and other connective tissue in

animals.animals.20 20 Collagen Amino AcidsCollagen Amino Acids The mixture of amino acids resulting from The mixture of amino acids resulting from

the the complete complete hydrolysis of collagen. It hydrolysis of collagen. It is characterized is characterized by containing a significant level of by containing a significant level of hydroxyproline.hydroxyproline.

00 ColostrumColostrum Fluid secreted by the mammary glands Fluid secreted by the mammary glands after the after the birth of an animal.birth of an animal.

00 Colostrum CreamColostrum Cream The oily, yellowish portion of colostrum (q.v.).The oily, yellowish portion of colostrum (q.v.).

(No. of products containing ingredient that have been voluntarily registered with FDA)(No. of products containing ingredient that have been voluntarily registered with FDA)

Ingredients from the CTFA Cosmetic Ingredient Ingredients from the CTFA Cosmetic Ingredient Dictionary Dictionary

(6(6thth edition) that are from “Bovine” or “Animal” edition) that are from “Bovine” or “Animal” SourcesSources

(Continued)(Continued)

00 Connective Tissue ExtractConnective Tissue Extract Extract of animal connective tissue.Extract of animal connective tissue.00 Cutaneous LysateCutaneous Lysate The end product of the controlled bacterial degradation of The end product of the controlled bacterial degradation of

animal cutaneous tissues. It consists of a complex mixture animal cutaneous tissues. It consists of a complex mixture of polypeptides and amino acids.of polypeptides and amino acids.

00 Cytochrome CCytochrome C A hemoprotein found in animal cells in the A hemoprotein found in animal cells in the mitochondrial mitochondrial protein-lipid complex.protein-lipid complex.

1010 ElastinElastin A fibrous protein found in the connective tissue A fibrous protein found in the connective tissue of animals.of animals.

00 FibronectinFibronectin A glycoprotein found in connective tissues, A glycoprotein found in connective tissues, basement basement membranes, in plasma and other body fluids.membranes, in plasma and other body fluids.

66 Glycoproteins Glycoproteins Conjugated proteins which contain carbohydrate. Conjugated proteins which contain carbohydrate. groups attached covalently to the polypeptide groups attached covalently to the polypeptide

chain.chain.00 GlycosaminoglycansGlycosaminoglycansA mixture of mucopolysaccharides derived from various A mixture of mucopolysaccharides derived from various

animal tissues.animal tissues.66 GlycosphingolipidsGlycosphingolipids Sphingolipids (q.v.) which contain a carbohydrate group Sphingolipids (q.v.) which contain a carbohydrate group

convalently attached to the sphingolipid backbone.convalently attached to the sphingolipid backbone.00 Heart ExtractHeart Extract Extract of animal heart tissue.Extract of animal heart tissue.

(No. of products containing ingredient that have been voluntarily registered with FDA)(No. of products containing ingredient that have been voluntarily registered with FDA)

Ingredients from the CTFA Cosmetic Ingredient Ingredients from the CTFA Cosmetic Ingredient Dictionary (6Dictionary (6thth edition) that are from “Bovine” or edition) that are from “Bovine” or

“Animal” Sources“Animal” Sources(Continued)(Continued)

0 0 Hydrolized Calf Ligaments/Liver/Skin Hydrolized Calf Ligaments/Liver/Skin Hydrolysate of young bovine liver and Hydrolysate of young bovine liver and skin derived by skin derived by acid, enzyme or other method acid, enzyme or other method of hydrolysis.of hydrolysis.

00 Hydrolized Calf SkinHydrolized Calf Skin Hydrolysate of calf skin, derived by acid, enzyme or Hydrolysate of calf skin, derived by acid, enzyme or other method of hydrolysis.other method of hydrolysis.

00 Hydrolized Spinal ProteinHydrolized Spinal Protein Hydrolysate of animal spinal cord protein, Hydrolysate of animal spinal cord protein, derived by derived by acid, enzyme or other method acid, enzyme or other method of hydrolysis.of hydrolysis.

1111 KeratinKeratin Protein derived from hair, wool, horn, nail, or other Protein derived from hair, wool, horn, nail, or other similar tissues in animals.similar tissues in animals.

00 Liver ExtractLiver Extract Extract of bovine livers.Extract of bovine livers.00 Liver HydrolysateLiver Hydrolysate Hydrolysate of animal liver, derived by acid, Hydrolysate of animal liver, derived by acid,

enzyme or enzyme or other method of hydrolysis.other method of hydrolysis.00 Mammalian HydrolysateMammalian Hydrolysate Hydrolysate of animal mammalian tissue, Hydrolysate of animal mammalian tissue,

derived by derived by acid, enzyme or other method acid, enzyme or other method of hydrolysis.of hydrolysis.

00 Mammary ExtractMammary Extract Extract of bovine mammary tissue.Extract of bovine mammary tissue.00 Marrow ExtractMarrow Extract Extract of bovine bone marrow.Extract of bovine bone marrow.00 Muscle ExtractMuscle Extract Extract of bovine muscle.Extract of bovine muscle.00 Neural ExtractNeural Extract Extract of bovine neural tissue.Extract of bovine neural tissue.

(No. of products containing ingredient that have been voluntarily registered with FDA)(No. of products containing ingredient that have been voluntarily registered with FDA)

Ingredients from the CTFA Cosmetic Ingredient Ingredients from the CTFA Cosmetic Ingredient Dictionary (6Dictionary (6thth edition) that are from “Bovine” or edition) that are from “Bovine” or

“Animal” Sources“Animal” Sources(Continued)(Continued)

00 Omental LipidsOmental Lipids Lipids obtained from bovine omentum.Lipids obtained from bovine omentum.

00 Ovarian ExtractOvarian Extract Extract derived from bovine ovaries.Extract derived from bovine ovaries.

77 Placental EnzymesPlacental Enzymes A mixture of enzymes obtained from an aqueous extract A mixture of enzymes obtained from an aqueous extract of animal placentas.of animal placentas.

31 31 Placental ExtractPlacental Extract Extract of animal placentas.Extract of animal placentas.

00 Placental LipidsPlacental Lipids A mixture of lipids from animal placentas.A mixture of lipids from animal placentas.

0 0 Placental ProteinsPlacental Proteins A mixture of proteins derived from animal placentas.A mixture of proteins derived from animal placentas.

00 Soluble ProteoglycanSoluble Proteoglycan Solubilized glycoproteins having a very high Solubilized glycoproteins having a very high carbohydrate carbohydrate content.content.

00 Spinal Cord ExtractSpinal Cord Extract An extract obtained from animal spinal cords.An extract obtained from animal spinal cords.

00 Spinal Lipid ExtractSpinal Lipid Extract An extract of animal spinal lipids.An extract of animal spinal lipids.

55 Spleen ExtractSpleen Extract An extract of bovine spleens.An extract of bovine spleens.

00 Testicular ExtractTesticular Extract An extract of bovine testicular tissue.An extract of bovine testicular tissue.

00 Thymus ExtractThymus Extract An extract of animal thymus.An extract of animal thymus.

(No. of products containing ingredient that have been voluntarily registered with (No. of products containing ingredient that have been voluntarily registered with FDA)FDA)

BSEBSE Issues for CosmeticsIssues for Cosmetics

– PossiblePossible vehicle for infection vehicle for infection Abraded skin, eye area, mucous Abraded skin, eye area, mucous

membranesmembranes

– Identification of ingredient sourcesIdentification of ingredient sources Risk Assessment: tissue, country of origin Risk Assessment: tissue, country of origin

• ““Safe-sourcing” from non-BSE countries; non-Safe-sourcing” from non-BSE countries; non-BSE herds in BSE or BSE-suspect countriesBSE herds in BSE or BSE-suspect countries

• Avoid “Co-mingling” and “cross-contamination” Avoid “Co-mingling” and “cross-contamination” • Use of SRMs and other “BSE-Risk Materials”Use of SRMs and other “BSE-Risk Materials”

Tallow and Tallow DerivativesTallow and Tallow Derivatives Gelatin and Gelatin DerivativesGelatin and Gelatin Derivatives

Specified Risk Specified Risk Materials (SRMs)Materials (SRMs) What are specified risk materials?What are specified risk materials?

Specified risk materials, from cattle Specified risk materials, from cattle 30 months and older30 months and older, , are the: are the:

brain brain skull skull eyes eyes trigeminal ganglia trigeminal ganglia spinal cord spinal cord vertebral column (excluding the vertebrae of the tail, vertebral column (excluding the vertebrae of the tail,

the transverse processes of the thoracic and lumbar the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) vertebrae, and the wings of the sacrum)

dorsal root ganglia. dorsal root ganglia. Specified risk materials from cattle of Specified risk materials from cattle of any ageany age are the: are the:

tonsils and tonsils and distal ileum of the small intestine. distal ileum of the small intestine.

Tallow – Cosmetic Tallow – Cosmetic FunctionsFunctions Definition: “Tallow is the fat Definition: “Tallow is the fat

derived from the fatty tissue of derived from the fatty tissue of sheep or cattle. It consists sheep or cattle. It consists primarily of fatty acid glycerides”primarily of fatty acid glycerides”– Skin conditioning agent-occlusiveSkin conditioning agent-occlusive– Bath soaps and detergentsBath soaps and detergents

FREQENCY OF USE BY CHEMICAL FREQENCY OF USE BY CHEMICAL NAMENAME

30 30 TallowTallow

11 11 Tallow Fatty AcidTallow Fatty Acid

4 4 Potassium TallowatePotassium Tallowate

103 103 Sodium TallowateSodium Tallowate

18 18 Tallow GlycerideTallow Glyceride

9 9 Tallow GlyceridesTallow Glycerides

120 120 Hydrogenated TallowHydrogenated Tallow

25 25 Hydrogenated Tallow GlycerideHydrogenated Tallow Glyceride

10 10 Hydrogenated Tallow GlyceridesHydrogenated Tallow Glycerides

1818 Hydrogenated Tallow-60 Myristyl Hydrogenated Tallow-60 Myristyl GlycolGlycol

33 Aluminum Hydrogenated Tallow Aluminum Hydrogenated Tallow GlutamateGlutamate

14 14 Dihydroxyethyl Tallow GlycinateDihydroxyethyl Tallow Glycinate

1212 DitallowdimoniumDitallowdimonium

13 13 Hydrogenated DitallowamineHydrogenated Ditallowamine

66 MEA-TallowateMEA-Tallowate

2121 PEG-15 Tallow PolyaminePEG-15 Tallow Polyamine

1919 PEG-2 Hydrogenated Tallow AminePEG-2 Hydrogenated Tallow Amine

122122 PEG-2 Tallow AminePEG-2 Tallow Amine

2929 PEG-5 Tallow AminePEG-5 Tallow Amine

8787 PEG-50 Tallow AmidePEG-50 Tallow Amide

4545 PEG-8 Hydrogenated Tallow AminePEG-8 Hydrogenated Tallow Amine

2424 PEG-8 Tallow AminePEG-8 Tallow Amine

44 Tallowdimonium Propyltrimonium Tallowdimonium Propyltrimonium DichlorideDichloride

55 Talloweth-60 Myristyl GlycolTalloweth-60 Myristyl Glycol

143143 Tallowtrimethylammonium ChlorideTallowtrimethylammonium Chloride

25922592 GlycerinGlycerin

2210 2210 Glyceryl DerivitivesGlyceryl Derivitives

Gelatin – Cosmetic Gelatin – Cosmetic FunctionsFunctions Definition: “Gelatin is a product obtained Definition: “Gelatin is a product obtained

by the partial hydrolysis of collagen by the partial hydrolysis of collagen derived from the skin, white connective derived from the skin, white connective tissue, and bones of animals…”tissue, and bones of animals…”– BinderBinder– Lytic AgentLytic Agent– Oral Health Care DrugOral Health Care Drug– Skin Conditioning AgentSkin Conditioning Agent– Hair Conditioning AgentHair Conditioning Agent– Viscosity Increasing Agent - AqueousViscosity Increasing Agent - Aqueous

Gelatin – 57 Cosmetic Product Gelatin – 57 Cosmetic Product Registrations Registrations {FDA VCRP Data, 21 CFR 720.4; May {FDA VCRP Data, 21 CFR 720.4; May 2003}2003}

Bath Preparations Bath Preparations 6 6

Hair Preparations Hair Preparations (Non-Coloring) (Non-Coloring) 1515

Makeup Preparations Makeup Preparations (Not Eye) (Not Eye) 5 5

Manicuring Manicuring Preparations Preparations 10 10

Shaving Shaving Preparations 1Preparations 1

Skincare Skincare Preparations Preparations 20 20

Gelatin – Cosmetic Gelatin – Cosmetic IngredientsIngredients Gelatin (57)*Gelatin (57)* Gelatin Keratin Amino Acid/Lysine Gelatin Keratin Amino Acid/Lysine

Hydroxypropyltrimonium Chloride (18)Hydroxypropyltrimonium Chloride (18)**

Gelatin/Lysine/Polyacrylamide Hydroxypropyltrimonium Gelatin/Lysine/Polyacrylamide Hydroxypropyltrimonium Chloride (0)*Chloride (0)*

* FDA Cosmetic Product Registrations (21 CFR 720.4, May 2003)* FDA Cosmetic Product Registrations (21 CFR 720.4, May 2003)

Regulatory Coverage of Regulatory Coverage of Ruminant Tissues and Ruminant Tissues and Tissue Derived IngredientsTissue Derived Ingredients Import Alert #17-04Import Alert #17-04 1994, 1996 “Letter to Manufacturers 1994, 1996 “Letter to Manufacturers

and Marketers of Dietary Supplements and Marketers of Dietary Supplements and Cosmetics’and Cosmetics’– Importers of cosmetic products should Importers of cosmetic products should

have procedures to assure that ruminant have procedures to assure that ruminant tissue and tissue-derived ingredients do tissue and tissue-derived ingredients do not come from cattle in countries where not come from cattle in countries where BSE occursBSE occurs

BSE/ v-CJD: OCAC Role In BSE/ v-CJD: OCAC Role In Process of BSE Risk Process of BSE Risk Analysis- IAnalysis- I

1992 – Education and Outreach1992 – Education and Outreach Intra-Agency OCAC-sponsored Seminar by CVM Intra-Agency OCAC-sponsored Seminar by CVM

Guidance to IndustryGuidance to Industry 1994,1996 – “Letters to Manufacturers of FDA-1994,1996 – “Letters to Manufacturers of FDA-

Regulated Products (Dietary Supplements and Regulated Products (Dietary Supplements and Cosmetics)”Cosmetics)”

FDA TSE Advisory Committee (TSEAC)FDA TSE Advisory Committee (TSEAC) OCAC Participation in FDA Inter-Center TSE OCAC Participation in FDA Inter-Center TSE

Working Group on Tallow (mid 1990s)Working Group on Tallow (mid 1990s) OCAC Presentation on Tallow to FDA-TSEAC OCAC Presentation on Tallow to FDA-TSEAC

(April 1998)(April 1998)

BSE/ v-CJD: OCAC Role In BSE/ v-CJD: OCAC Role In Process of BSE Risk Process of BSE Risk Analysis- IIAnalysis- II

Import Alert # 17-04 and Cosmetic Compliance Import Alert # 17-04 and Cosmetic Compliance Program (CPG 7829.001/ 7829.002) in Cosmetics Program (CPG 7829.001/ 7829.002) in Cosmetics “BSE-Firewall”“BSE-Firewall” Incorporate USDA/APHIS restrictions at 9 CFR 94.18 and Incorporate USDA/APHIS restrictions at 9 CFR 94.18 and

9 CFR 95.4 (1998 et. seq.) 9 CFR 95.4 (1998 et. seq.) Bovine Ingredients Usage Establishment Inspection (EI) Bovine Ingredients Usage Establishment Inspection (EI)

Questionnaire Questionnaire

2001–2004: OCAC Representation on FDA-CFSAN 2001–2004: OCAC Representation on FDA-CFSAN Regulatory BSE InitiativesRegulatory BSE Initiatives CFSAN BSE Coordinating Committee CFSAN BSE Coordinating Committee Regulation and Guidance Development TeamsRegulation and Guidance Development Teams

BSE Emergency Response Plan (ERP) BSE Emergency Response Plan (ERP) BSE “Prohibited Cattle Materials” Proposal, Interim Final BSE “Prohibited Cattle Materials” Proposal, Interim Final

Rule (IFR), and Recordkeeping ProposalRule (IFR), and Recordkeeping Proposal

Industry InitiativesIndustry Initiatives

CTFA Board Policy Statement on CTFA Board Policy Statement on ‘‘Mad Cow DiseaseMad Cow Disease’ ’ (April 20, 2001)(April 20, 2001)Cosmetic products must not contain Cosmetic products must not contain

BSE-risk raw materials, as identified by BSE-risk raw materials, as identified by WHO as SRMs.WHO as SRMs.

Suppliers to certify bovine-derived Suppliers to certify bovine-derived ingredients free of risk materialsingredients free of risk materials

Tallow derivatives to be processed by Tallow derivatives to be processed by methods that assure they are safe.methods that assure they are safe.

BSE/ v-CJD: OCAC Role In BSE/ v-CJD: OCAC Role In Process of BSE Risk Analysis- Process of BSE Risk Analysis- IIIIII 2001-2003: OCAC Support to FDA Field 2001-2003: OCAC Support to FDA Field

Bovine Stem Cell Imports for ‘Cosmetic’ UseBovine Stem Cell Imports for ‘Cosmetic’ Use LOS-DO, CBERLOS-DO, CBER

2001-2004: OCAC International Outreach2001-2004: OCAC International Outreach Health Canada Risk Assessment (Focal Point Health Canada Risk Assessment (Focal Point

Research) Research) Guidance on BSE Risk Management Guidance on BSE Risk Management

KFDA (Korea)KFDA (Korea) MHLW (Japan)MHLW (Japan)

Bovine Spongiform Bovine Spongiform Encephalopathy (BSE)Encephalopathy (BSE) FDA BSE Emergency Response Plan FDA BSE Emergency Response Plan

Summary (12/24/03) Summary (12/24/03) FDA press release – “FDA Strengthens FDA press release – “FDA Strengthens

Existing Multiple Firewalls Against BSE Existing Multiple Firewalls Against BSE or ‘Mad Cow’ Disease” (1/26/04)or ‘Mad Cow’ Disease” (1/26/04)

Cosmetic Compliance Program (CPG 7829.001/ Cosmetic Compliance Program (CPG 7829.001/ 7829.002)7829.002)

Bovine Ingredients Usage Questionnaire During Bovine Ingredients Usage Questionnaire During Establishment Inspections (EI)Establishment Inspections (EI)

USDA/APHIS regulations at 9 CFR 94.18 and 9 USDA/APHIS regulations at 9 CFR 94.18 and 9 CFR 95.4CFR 95.4

USDA/APHIS list of “BSE Countries” USDA/APHIS list of “BSE Countries” (http://www.aphis.usda.gov)(http://www.aphis.usda.gov)

Use of Material Use of Material Derived From Cattle in Derived From Cattle in CosmeticsCosmeticsFederal Register, Vol. 69, No. 134, pgs. Federal Register, Vol. 69, No. 134, pgs.

42255-42274, July 14, 200442255-42274, July 14, 2004

Cosmetics shall not containCosmetics shall not contain “prohibited cattle material”“prohibited cattle material” SRMs, MS(Beef), ‘Non-Ambulatory Disabled SRMs, MS(Beef), ‘Non-Ambulatory Disabled

Cattle”, Cattle not Inspected and Passed Cattle”, Cattle not Inspected and Passed (USDA)(USDA)

Exemptions for Tallow (Exemptions for Tallow (≤0.15% “hexane-≤0.15% “hexane-insolubles) and Tallow Derivativesinsolubles) and Tallow Derivatives

2005 Amendments to 2005 Amendments to BSE Interim Final Rule BSE Interim Final Rule (IFR)(IFR) Federal Register, Vol. 70, No. 172, pgs. Federal Register, Vol. 70, No. 172, pgs.

53063-53069, September 7, 200553063-53069, September 7, 2005

NotNot considered ‘prohibited cattle material’ : considered ‘prohibited cattle material’ : Bovine Small Intestine – Distal Ileum; Bovine Small Intestine – Distal Ileum; Bovine hide or hide-derivatives, milk or milk products, Bovine hide or hide-derivatives, milk or milk products,

and tallow derivatives; and tallow derivatives;

AOCS (or equivalent) method OK to measure AOCS (or equivalent) method OK to measure insoluble impurities in tallowinsoluble impurities in tallow FCC method originally specified in IFR.FCC method originally specified in IFR.

ProposedProposed Record- Record-Keeping for Cosmetics Keeping for Cosmetics With Cattle MaterialWith Cattle Material

Federal Register, Vol. 69, No. 134, pgs. Federal Register, Vol. 69, No. 134, pgs. 42275-42285, July 14, 200442275-42285, July 14, 2004

Manufacturers must keep records and Manufacturers must keep records and make them available to FDAmake them available to FDA

Importers to electronically affirm at time Importers to electronically affirm at time of entry that those cosmetics with cattle of entry that those cosmetics with cattle material do not contain prohibited material do not contain prohibited materialmaterial

Record-KeepingRecord-Keeping

Effective - January 9, 2007Effective - January 9, 2007

(71 FR 59653, October 11, 2006)(71 FR 59653, October 11, 2006)

21 CFR 700.27(c)21 CFR 700.27(c) Manufacturers must keep records and Manufacturers must keep records and

make them available to FDAmake them available to FDA Importers to electronically affirm at Importers to electronically affirm at

time of entry that those cosmetics with time of entry that those cosmetics with cattle material do not contain cattle material do not contain prohibited materialprohibited material

FDA Export FDA Export CertificatesCertificates CTFA, ICMAD designated by CTFA, ICMAD designated by

FDA as “competent authority” FDA as “competent authority” for issuance of “BSE-free” for issuance of “BSE-free” certifications for industry certifications for industry firmsfirms

BSE Export Certificates

Cosmetics Guidance Cosmetics Guidance http://www.cfsan.fda.gov/~lrd/http://www.cfsan.fda.gov/~lrd/certific.htmlcertific.html

CTFA and ICMAD designated as “Competent CTFA and ICMAD designated as “Competent Authority” by FDA Authority” by FDA

BSE Risk AssessmentBSE Risk Assessment

Published by FDA-CFSAN as a notification to Published by FDA-CFSAN as a notification to WTO/TBT on July 14, 2004WTO/TBT on July 14, 2004

TransparencyTransparencyPublic posting to FDA-CFSAN WebsitePublic posting to FDA-CFSAN Website

http://www.cfsan.fda.gov/~comm/bse-http://www.cfsan.fda.gov/~comm/bse-ra.htmlra.html

Qualitative Risk AssessmentQualitative Risk Assessment Follows generally accepted framework Follows generally accepted framework

endorsed by Codex Alimentarius endorsed by Codex Alimentarius Commission, the U.S. National Academy of Commission, the U.S. National Academy of Sciences, and othersSciences, and others

BSE Risk Assessment: BSE Risk Assessment: FrameworkFramework Hazard IdentificationHazard Identification Exposure AssessmentExposure Assessment Hazard CharacterizationHazard Characterization

Dose/ Response AssessmentDose/ Response Assessment Risk CharacterizationRisk Characterization

BSE Risk AssessmentBSE Risk Assessment ConclusionsConclusions

vCJDvCJD – – may be caused by BSE “prions”may be caused by BSE “prions” Primary source of exposurePrimary source of exposure – – Ingestion of infected beefIngestion of infected beef Secondary routes of exposureSecondary routes of exposure – – Topical (abraded skin), Topical (abraded skin),

Ocular, or Oral/Buccal potentially possible, even if unlikely Ocular, or Oral/Buccal potentially possible, even if unlikely Dose/Response (cattle)Dose/Response (cattle) - - Small doses still infectious but Small doses still infectious but

require longer incubation periods require longer incubation periods Species Barrier Species Barrier - - Human = ca. 10Human = ca. 101 1 – 10– 104 4 (cattle)(cattle) Quantitative Risk Assessment Quantitative Risk Assessment - - difficult due to much difficult due to much

“Uncertainty” in assumptions and available data “Uncertainty” in assumptions and available data Risk ManagementRisk Management

Effectiveness of cosmetic manufacturing proceses for Effectiveness of cosmetic manufacturing proceses for inactivating BSE prions is unknown inactivating BSE prions is unknown Best control of risk through cosmetics is to avoid and control Best control of risk through cosmetics is to avoid and control exposure to high-risk cattle raw materials used in the exposure to high-risk cattle raw materials used in the manufacture of cosmetics.manufacture of cosmetics.

Recent BSE Cases in North Recent BSE Cases in North America: America: January 23, 2006; March 13, January 23, 2006; March 13, 20062006 Dairy cow, 6-7 yrs old, Dairy cow, 6-7 yrs old,

Alberta, Canada Alberta, Canada Beef cow, > 10 yrs old, Beef cow, > 10 yrs old, State of Alabama State of Alabama

FDA and USDA Notified FDA and USDA Notified

by CFIA (Canadian Cow)by CFIA (Canadian Cow) No part of either No part of either

infected cow entered infected cow entered human food or animal human food or animal feed chainfeed chain

FDA evaluating any FDA evaluating any ‘next steps’ through ‘next steps’ through ORA and CVM.ORA and CVM.

v-CJD Cases in the U.S.v-CJD Cases in the U.S.

Tracked by CDC and FDATracked by CDC and FDA Few in number, generally non-resident or Few in number, generally non-resident or

resident-alienresident-alien 200 cases worldwide; 3 cases in U.S.200 cases worldwide; 3 cases in U.S. November 28, 2006November 28, 2006 - Latest case reported by - Latest case reported by

CDC is young Saudi Arabian adult, resident in CDC is young Saudi Arabian adult, resident in U.S. resident since late 2005, living in Virginia.U.S. resident since late 2005, living in Virginia.

Other cases: UK (164), France (21), Republic Other cases: UK (164), France (21), Republic of Ireland (4), the Netherlands (2), Canada (1), of Ireland (4), the Netherlands (2), Canada (1), Italy (1), Japan (1), Portugal (1), Saudi Arabia Italy (1), Japan (1), Portugal (1), Saudi Arabia (1), and Spain (1). (1), and Spain (1).

FDA Export FDA Export CertificatesCertificates Guidance Guidance Cosmetics Cosmetics

http://www.cfsan.fda.gov/~lrd/certific.html

CTFA, ICMAD designated by CTFA, ICMAD designated by FDA as “competent authority”FDA as “competent authority”

CFSAN-OCAC Address CFSAN-OCAC Address InformationInformation How To Find Us:How To Find Us:

OCAC Management: OCAC Management: CFSAN (HFS-100, 101)CFSAN (HFS-100, 101) University Station (CPK2)University Station (CPK2) 4300 River Road, College Park MD 207404300 River Road, College Park MD 20740 Phone: 301 436-1130Phone: 301 436-1130 Fax: 301 436-2975Fax: 301 436-2975 E-Mail: E-Mail: stanley.milstein@fda.hhs.govstanley.milstein@fda.hhs.gov Additional Locators: Additional Locators: CFSAN Website:CFSAN Website: http://www.cfsan.fda.gov/~dms/cos-toc.htmlhttp://www.cfsan.fda.gov/~dms/cos-toc.html