George Misko is a Partner at Keller and Heckman LLP George joined Keller and Heckman in Mr. Misko's practice focuses on food and drug matters

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2 George Misko is a Partner at Keller and Heckman LLP George joined Keller and Heckman in Mr. Misko's practice focuses on food and drug matters and environmental concerns, including pesticide regulation, right toknow laws, and toxic substance control regulations. Prior to joining Keller and Heckman, Mr. Misko was Senior Regulatory Counsel for the Chemical Specialty Manufacturers Association (now known as the Consumer Specialty Products Association), where he provided counsel on a broad range of environmental and health and safety issues. He currently writes a monthly column on regulatory issues for Food and Beverage Packaging magazine. George attended Catholic University of America where he received a B.A. and his J.D.

3 2009 PLACE Conference April 30, 2009 Columbus, OH Regulation of Antimicrobials in Food Packaging United States and the European Union Presented by: George G. Misko, Esq. Partner Keller and Heckman LLP Copyright 2009

4 Presentation Overview Discussion of FDA Regulation of Food-Contact Materials Application to Antimicrobials Discussion of EU Regulation of Antimicrobials in Food Contact Materials 4

5 Definition of a Food Additive A substance which, when used as intended, is reasonably expected to become a component of food, except GRAS and prior sanctioned substances ( 201(s)) Food additives must be the subject of a regulation or a food contact notification ( 409) 5

6 Definition of Food Contact Substance Any substance intended for use a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in food ( 409(h)(g)) Food Additive and Food Contact Substance definitions are not co-extensive 6

7 Premarket Clearance FOOD ADDITIVES REQUIRE FDA PREMARKET CLEARANCE Uncleared Food Additives are Automatically Unsafe and Adulterated 7

8 Three Types of Food Additives Direct Food Ingredients Secondary Direct Added to Food During Processing but Removed Indirect Food Packaging and Other Food Contact Materials 8

9 Definition of an Antimicrobial Subject to Two Statutory Schemes FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) FDCA (Food, Drug, and Cosmetic Act) FIFRA: Defines when registration is required FDCA: Defines who regulates safety Pesticide Chemical: EPA under Section 408 Pesticide Chemical Residue: EPA Under Section 408 Food additive: FDA under Section 409 9

10 Definition of an Antimicrobial FIFRA Regulations: Defines pest to exclude micro-organisims on processed food FDCA excludes as food additives pesticide chemicals (or residues) in RAC s or processed foods 10

11 Jurisdictional Authority over Antimicrobials Used Directly with Food FDA: Processed food; water used in processing facility EPA: RACs; water in contact with RAC s, provided not a food processing facility 11

12 Jurisdictional Authority over Antimicrobials in Food Packaging FDA: Nonfunctional Additives. Controls microorganisims in equipment and materials used in manufacture of food contact articles Slimicides in papermills Bacteriostats in latex emulsions No intended ongoing effect in the finished food contact article 12

13 Jurisdictional Authority over Antimicrobials in Food Packaging FDA: Material Preservatives. Incorporated into finished article to provide ongoing protection against discoloration, degradation, decomposition. No intended effect outside of the article itself No intended effect on the surface EPA would call this a treated article 13

14 Jurisdictional Authority over Antimicrobials in Food Packaging FDA: Sanitizing solutions and antimicrobials incorporated into packaging intended to have an effect on the food or extend the shelf life of the food. H 2 O 2 for asceptic packaging Silver zeolites for packaging films 14

15 Jurisdictional Authority over Antimicrobials in Food Packaging EPA: Sanitizing solutions used on permanent/semi-permanent food contact surfaces (but not packaging) Antimicrobials incorporated into permanent (semi-permanent food contact articles intended to have an on-going effect) Countertops Conveyor belts 15

16 FDA Regulation of Antimicrobials as Food Additives Direct Additive: Intended, ongoing preservative effect in food FAP required Labeling requirements Secondary Direct: Effect on food, but only during processing; no residue in food FAP or FCN No labeling required 16

17 FDA Regulation of Antimicrobials as Food Additives Indirect additives: Effect on packaging material itself either during processing or ongoing. FCN No labeling Subject to exemptions applicable to food contact articles 17

18 Evaluating FDA Status 1. Is it Regulated (Subject of Regulation, Threshold of Regulation, or FCN)? 2. Is an Exemption Available? 3. Is FDA Approval A. Necessary or B. Desirable for Marketing? 4. Does the Product qualify for A. Food Contact Notification submission B. Threshold of Regulation C. Standard Petition Processing 18

19 Food Additive Clearances: Questions to Ask Does the regulatory clearance apply to your use? Do any limitations on food type exist? Do any limitations on temperature exist? 19

20 Exemptions and Exceptions From Food Additive Regulation Requirements No Migration GRAS 20

21 No Migration No migration exemption: A substance not reasonably expected to become a component of food is not a food additive Monsanto v. Kennedy: FDA must find a substance migrates into food in more than insignificant amounts to consider it a food additive 21

22 No Migration No migration What does no mean? 50 ppb, sometimes 10 ppb or less Modeling or Testing Self-determination 22

23 Generally Recognized as Safe (GRAS) Pre-1958 use scientific procedures or experience based on common use in food Post-1958 scientific procedures Scientific procedures published toxicological or other data generated by accepted means 23

24 Generally Recognized as Safe (GRAS) Some in Regulations (Parts 182, 184, 186), some not Self Determination Fluid Concept GRAS Notification Procedure 24

25 Functional Barrier Even More Exemptions Basic Resin Housewares 25

26 Food-Contact Notifications FCN program replaces petition process for food-contact substances Efficient Proprietary Effective Standard Food Additive Petition can still be required 26

27 FCN Process Drafting an FCN Key components of FCN include: Form 3480 (available at: ( Copies of relevant data/reports Comprehensive Toxicology Profile Environmental Assessment (if needed) 27

28 FCN Process Data Requirements General FCN data requirements Chemical identity/composition of FCS Manufacturing process Information on impurities and breakdown products Intended conditions of use Intended technical effect Migration data and reports 28

29 FCN Process Data Requirements General FCN data requirements (cont d) Estimation of exposure (Migration) x (food type factors) x (consumption factor) = EDI Plus other uses cumulative estimated dietary intake (CEDI) Some CEDI values are posted on FDA s website: Can request CEDI values from FDA 29

30 FCN Process Data Requirements General FCN data requirements (cont d) To conduct safety assessment, CEDI values are compared to available toxicity data on the FCS Toxicity data requirements (based on CEDI): 0.5 ppb: no toxicity testing required 0.5 ppb-50 ppb: 2 in vitro genotoxicity tests 50 ppb-1 ppm: 2 90-day studies plus an in vivo genotoxicity test >1 ppm: full 2-year study 30

31 FCN Process Data Requirements General FCN data requirements (cont d) Environmental Assessment is required unless the FCN is exempt under an applicable categorical exclusion, e.g.: <5% by weight of the finished article Repeated-use articles Food-contact coatings Substances already registered as pesticides under FIFRA 31

32 FCN Process Me Too FCNs FCNs are proprietary to the notifier, but others are not prohibited from filing an FCN for the same FCS Me too FCNs often require less data Obtain original FCN through FOIA Can often cross-reference technical effect, migration, and toxicology data contained in original FCN Must supply information on manufacturing process, impurities, specifications, etc. 32

33 Regulation of Antimicrobials for Food Packaging in the EU Basics: Only Plastics are subject to harmonized laws. Additives for Plastics in process of harmonization Paper, other packaging materials subject to Member country laws 33

34 Regulation of Antimicrobials in Plastic/Packaging in the EU Nonfunctional additive: Processing or product aids. No ongoing effect in finished article. Preservative in latex emulsions Subject to Plastics Directive Must be on positive list for plastics additives 34

35 Regulation of Antimicrobial in Plastic Packaging in the EU Surface biocides: Material preservatives intended to protect food hygiene No preservative effect in food, per se, but ongoing effect in packaging No authorization criteria yet accepted If agreed upon, likely to require labeling and efficacy data to approve Subject to active packaging requirements 35

36 Regulation of Antimicrobials in Plastic Packaging in the EU Surface Biocides: Antimicrobial in packaging intended to act as a preservative in food. Must be approved for direct addition to food 36

37 Thank You PRESENTED BY George G. Misko, Esq. Partner Keller and Heckman LLC Please remember to turn in your evaluation sheet... 37