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Safety Assessment of Food Additives Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food.

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Presentation on theme: "Safety Assessment of Food Additives Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food."— Presentation transcript:

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3 Safety Assessment of Food Additives Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Advisory Committee Additives and Ingredients Subcommittee LATEX ALLERGY August 26-28, 2003

4 OVERVIEW Introduction Food & Drug Law Evaluation of Safety Natural Rubber Latex (NRL) Latex Allergy and Food Safety Conclusion

5 CFSAN’s Mission To promote and protect the public health by ensuring that: The food supply is safe and wholesome and cosmetics are safe Food and cosmetic products are honestly and accurately labeled

6 OFAS’s “Food Ingredients” Universe Direct Food Ingredients Color Additives GRAS Ingredients Foods/Ingredients produced using modern biotechnology Processing Aids Food Irradiation Equipment Food Packaging/Food Contact Substances Sweeteners; Preservatives; Fat; Nutrients; Texturizers (thickeners, Emulsifiers, etc.); Flavors To process food To inspect food In food, animal feed, drugs, cosmetics,medical devices(i.e. sutures and contact lenses) Antimicrobials(meat and poultry Processing); Defoamers; Ion exchange resins Enzymes; Fiber; Proteins; Lipids; Sugars; MSG; Antimicrobials; Phytosterols/stanols; Flavors; Infant formula ingredients Plants w/herbicide resistance or insect resistance, delayed ripening, etc.; often use GRAS concept Coatings (paper, metal, etc); New/recycled plastics including both polymers and monomers; Paper; Adhesives; Ingredients in Pkgs.(i.e. colorants, antimicrobials, antixoxidants, etc.);Packaging material for use during food irradiation,; Food packaging “formulations”

7 Food and Drug Law Federal, Food, Drug, and Cosmetic Act FFDCA Federal Food, Drug, And Cosmetic Act

8 FDA Authority FFDCA “The LAW”

9 OFAS & FFDCA Food Additive Provisions Sec. 409 Federal Food, Drug, And Cosmetic Act 409

10 Regulations LAW NOT  Food Additive

11 “PRE-MARKET” APPROVAL 1958 Food Additives Amendment of FFDCA Sec. 409

12 What is a Food Additive? The term ''food additive'' means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food;…. if such substance is not Generally Recognized As Safe, Sec. 201(s) FFDCA: Definition 21 CFR 170.3(e)(1)

13 What is a Food Additive? Sec. 201(s) FFDCA: Definition Any substance, that is reasonably expected to become a component of food as a result of its intended use, If such use in not Generally Recognized As Safe (GRAS) IN SHORT

14 Food and Drug Law Sec. 409 Unsafe Food Additives: the use of a food additive is unsafe, unless that use conforms to a regulation, notification, or exemption issued by FDA under Sec Sec. 402 Adulterated Food : a food is adulterated…if it is, or if it contains any food additive that is unsafe. Sec. 301 Prohibited Acts : the introduction or delivery into interstate commerce of any food that is adulterated or misbranded.

15 MOM’S Apple Pies Sweetner Unapproved Food Additive Adulterated Food Interstate CommerceFDA Enforcement Maryland  Virginia Food and Drug Law

16 New antioxidant “Unapproved” Antioxidant migrates Adulterated Food [A] Interstate Commerce FDA Enforcement Dave’s Candy Food and Drug Law

17 Why are food additives regulated? Unsafe Food Additive = Adulterated Food Unapproved Food Additive = Unsafe Food Additive Unapproved Food Additive = Adulterated Food

18 Food Drug & Cosmetic Act (As amended, 1958) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures Sec. 409 FFDCA

19 Food Drug & Cosmetic Act (As amended, 1958) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures Sec. 409 FFDCA

20 Food Drug & Cosmetic Act (As amended, 1958) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures Sec. 409 FFDCA

21 Standard of Review “Fair evaluation of the data …”

22 From the Senate Report on the “Food Additives Amendment of 1958” “The committee has endeavored to prescribe a new statutory criterion requiring that a high standard of fairness be observed in administrative rule-making under this bill. Personal attitudes or preferences of administrative officials could not prevail on the basis of being supported by substantial evidence picked from the record without regard to other evidence of probative value in the record.”

23 House of Representatives, Report No. 2284, “Food Additives Amendment of 1958” Committee on Interstate & Foreign Commerce, 85 th Congress, 2 nd Session, July 28, 1958 “The committee feels that the Secretary’s findings of fact and orders should not be based on isolated evidence in the record, which evidence in and of itself may be considered substantial without taking account of the contradictory evidence of equal or even greater substance…”

24 Standard of Safety “Reasonable certainty of no harm”

25 Standard of Safety “Reasonable certainty of no harm”

26 Standard of Safety “Reasonable certainty of no harm”

27 Standard of Safety “Reasonable certainty of no harm”

28 Standard of Safety “Reasonable certainty of no harm”

29 Standard of Safety “Reasonable certainty of no harm” Commissioner David Kessler --- November 1995

30 Standard of Safety “Reasonable certainty of no harm”

31 Standard of Safety “Reasonable certainty of no Harm ” - Harm refers to Health Man or Animal What is Harm?

32 Standard of Safety “Reasonable certainty of no Harm ” What is Harm? - Harm refers to Health Man or Animal

33 Standard of Safety “Reasonable certainty of no Harm ” What is Harm? - Harm refers to Health Man or Animal

34 Standard of Safety Petitioner burden to demonstrate a “reasonable certainty of no harm” FDA Assessment

35 REASONABLE CERTAINTY OF NO HARM Legislative History of the FFDCA The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstance. H.R. Report, No. 2284, 85 th Congress (1958)

36 REASONABLE CERTAINTY OF NO HARM Legislative History of the FFDCA The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstance. H.R. Report, No. 2284, 85 th Congress (1958)

37 Section 409 Federal Food, Drug, And Cosmetic Act 409

38 Section 409 Requirements Any person may petition to establish safety

39 Food Additive Petition Review The Safety Decision It is NOT intended to ensure, nor is it possible to ensure, safety with absolute certainty: (“Reasonable Certainty of No Harm rather than “Certainty of No Theoretical Possibility of Harm”) Does NOT weigh risks and benefits It is NOT intended to enforce or limit consumer choices. What the evaluation is NOT:

40 Food Additive Petition Review The Safety Decision It DOES, in fact, ensure safety It IS a consensus decision made under uncertainty that provides a fair evaluation of all the data of record… -That must protect the public health -That will withstand scientific, procedural, and legal challenge from all sides

41 Safety Standard Approvals are Safety Based Only Reasonable Certainty of No Harm Harm refers to Health of Man or Animal Fair Evaluation of the Entire Record Benefits not weighed in Safety Decision Highlights

42 Key Players Consumer Safety Officer (CSO) Chemistry Toxicology Environmental CSO C T E

43 Data Requirements Identity Conditions of proposed use Intended technical effect Method for determining “quantity” Full reports of safety studies (data) Manufacturing methods Environmental information (NEPA) Sec. 409 FFDCA

44 Safety Evaluation A “full blown” exhaustive safety evaluation of all appropriate studies, with agency ownership of safety decision.

45 Safety Evaluation Estimation of Exposure Proposed Conditions of Use Concentration (safe) Level with no adverse effects observed toxicologically “ The dose makes the poison” “Key Determinant”

46 Technical Review FDA scientist review data and evaluate petitioner’s safety argument FDA communicates with petitioner to resolve any questions and/or additional data needs FDA review, documentation FDA reaches a scientific conclusion and makes a recommendation Key Players

47 FDA’s Action on the Petition Complete the review Establish a Regulation Deny the Petition Section 409 Requirements

48 Other Legal Requirements Objections and Public Hearings Judicial Review Amendment or Repeal of Regulations Section 409 Requirements

49 Amendment or Repeal IN Regulation OUT Regulation =

50 Legal Aspects of Food Additive Approvals Food Additives unsafe until FDA decision Regulations stipulate an identity, specifications and conditions of safe use Regulations do not provide specific product approvals Direct additives or Food-contact substance

51 Food Additive Regulations 21 CFR Parts General Provisions170 & 171 Direct Food Additive Regulations172 & 173 Indirect Food Additive Regulations Irradiation of Foods179 Substances permitted on interim basis180 Prior Sanctioned Substances181 GRAS Ingredients Prohibited Substances189 Title 21 CFR Rubber articles intended for repeat use

52 Food Drug & Cosmetic Act (As amended, 1958, 1997) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures -----As amended 1997(FDAMA)----- Defines “food contact substance”(FCS) Establishes a premarket notification program for FCSs

53 Food Drug & Cosmetic Act (As amended, 1958, 1997) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures -----As amended 1997(FDAMA)----- Defines “food contact substance”(FCS) Establishes a premarket notification program for FCSs

54 Food Drug & Cosmetic Act (As amended, 1958, 1997) Defines “food additive” w/GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures -----As amended 1997(FDAMA)----- Defines “food contact substance”(FCS) Establishes a premarket notification program for FCSs

55 What is a Food Contact Substance? (Section 409(h)(6) of the FFDCA) Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in food.

56 Food Contact Notifications Food Additive that is subject of an effective notification  Safe food additive

57 Brief Summary Food Additive Approvals Mechanism: FFDCA---Sec Necessary Tools Process: Safety Evaluation---Scientific review team Result: Regulations, notifications, and exemptions

58 Brief Summary Food Additive Approvals Petitioner is responsible for demonstrating safety FDA is responsible for –Conducting a full and fair evaluation of the data and information –Issuing a regulation if FDA scientists conclude the requested use is “SAFE” FDA Petitioner

59 Food Additive Regulations 21 CFR Parts General Provisions170 & 171 Direct Food Additive Regulations172 & 173 Indirect Food Additive Regulations Irradiation of Foods179 Substances permitted on interim basis180 Prior Sanctioned Substances181 GRAS Ingredients Prohibited Substances189 Title 21 CFR Rubber articles intended for repeat use

60 Natural Rubber Latex “NRL” § Chewing gum base § Adhesives § Pressure-sensitive adhesives § Resinous and polymeric coatings

61 Natural Rubber Latex “NRL” § Acrylic and modified acrylic plastics, semirigid and rigid § Cellophane § Closures with sealing gaskets for food containers § Rubber articles intended for repeated use

62 Natural Rubber Latex “NRL” 21 CFR (Feb. 1, 1963) Manufacture of Latex Food Service Gloves Acceptable “indirect” food additive---FCS FDA Position NRL currently “safe” food additive

63 Natural Rubber Latex “NRL” Exposure ---- Response Allergic Reactions Latex Proteins The Issues

64 Latex Allergy and Food Safety Problem: Food Mediated Latex Allergic Reactions

65 The Glove Barrier to Infectious Agents Food Contact Material Subject to the Law (FFDCA) Approval Intended Use Fair Evaluation Reasonable Certainty of No Harm Latex Allergy and Food Safety

66 Latex Allergenic Proteins Indicated in Food Mediated Allergic reactions Constituents of an Indirect Food Additive FFDCA (Sec. 409)---Food & Drug Law Evaluation---General Safety Standard Latex Allergy and Food Safety

67 Standard of Safety “Reasonable certainty of no harm”

68 Latex Allergy and Food Safety Food Mediated Latex Allergic Reactions How do we address the Problem

69 Latex Allergy and Food Safety Safety First FDA must operate under the Law (FFDCA) Approval --- Issuance of a Regulation Approvals are “safety” based only No explicit balancing of risks/benefits Amendment or Repeal --- Issuance of a Regulation Addressing the Problem

70 SUMMARY Sec. 409 FFDCA---Food Additive Provisions Review Process Fair Evaluation of the Data --- “Review” Reasonable Certainty of No Harm --- “Safety” NRL---21 CFR

71 CONCLUSIONS Evaluation of Safety Food and Drug Law Latex Allergy and Food Safety

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