Are You Ge)ng Ready for FSMA? (Food Safety Moderniza9on Act)

Transcription

1 Are You Ge)ng Ready for FSMA? (Food Safety Moderniza9on Act) Chi Hee Kim Director, Worldwide Regulatory, Government and Industry Affairs Herbalife InternaAonal of America, Inc. October 28, 2014

2 A quote on FSMA FSMA will change the culture of how we do our business 2

3 Agenda Background Seven Proposed Rules Focus on Three Major Rules: Preven9ve Controls for Human (Current Good Manufacturing PracAce and Hazard Analysis and Risk- Based PrevenAve Controls for Human Food) Inten9onal Adultera9on Focused MiAgaAon Strategies to Protect Food against IntenAonal AdulteraAon Foreign Supplier Verifica9on Program (Foreign Supplier VerificaAon Programs (FSVP) for Importers of Food for Humans and Animals) Resource and Important Dates 3

4 Background: Why FSMA? 1 in 6 Americans (48 million people) get sick from food- borne illness per year 128,000 Americans are hospitalized per year 3,000 Americans die of foodborne diseases per year 4

5 Background: Why now? Complex food supply 15% of U.S. food supply is imported Imported from 150+ countries High- tech food manufacturing Ready- to- eat fresh produce salads Refrigerated foods Heat- and- serve foods New hazards in foods with the development of science Food cgmp is 25 years old and VERY broad 5

6 Background The FDA Food Safety ModernizaAon Act (FSMA): Shids the focus from reacang to contaminaaon to preven9on Gives FDA a congressional mandate for risk- based inspecaon of food processing faciliaes Burden is on all paracipants throughout the enare food system domes9cally and interna9onally 6

7 Background: Is it a new concept? No, what do we currently have? HACCP for juice (21CFR 120): effecave January 22, 2002 HACCP for fish & fishery products (21CFR 123): effecave December 18, 1997 Yes, recogniaon that a breakdown at any point on the farm- to- table spectrum can cause (1) harm to the health of consumers; (2) disrupaon; and (3) economic loss to the food industry. 7

8 Background: FSMA gives broad authority to FDA InspecAon of records Suspension of registraaon Expanded administraave detenaon Enhanced product tracing Mandatory recall 8

9 FSMA: Seven proposed rules Proposed Rule An9cipated Final Rule Implementa9on Date Preven9ve Controls Human Aug 30, 2015 Aug 30, 2016 Preven9ve Controls Animal Aug 30, 2015 Aug 30, 2016 Produce Safety Oct 31, 2015 Oct 31, 2016 Foreign Supplier Verifica9on Program Oct 31, 2015 Oct 31, 2016 Third Party Audit Accredita9on Oct 31, 2015 Oct 31, 2016 Sanitary Transport Mar 31, 2016 Mar 31, 2017 Inten9onal Contamina9on May 31, 2016 May 31,

10 PrevenAve Controls- Human HACCP on steroids Risk based Goal: Develop and implement a wrinen food safety plan that focuses on prevenang hazards for each food type manufactured in your registered facility and conanue on with records keeping This (21CFR117) will replace cgmp for food (21CFR110) Food safety plans must be reanalyzed every 3 years (minimum) 10

11 PrevenAve Controls- Human: Non- exempt vs. exempt Non- exempt: DomesAc and foreign faciliaes that manufacture, process, pack, or hold food for human consumpaon and register with FDA under secaon 415 of the FD&C Act Exempt: AcAviAes subject to HAACP requirements; Low- acid canned food requirements; Dietary supplements cgmp; Produce Safety; Very small size of company; or limited annual monetary value of sales (read details); Low risk on- farm acaviaes; FaciliAes solely engaged in storage of certain food 11

12 History of Food GMP Food GMP Development Timeline Date Milestone 1906 The Bureau of Chemistry passes the 1906 Pure Food and Drugs Act, prohibiang interstate commerce in misbranded and adulterated foods, drinks, and drugs 1933 FDA recommends revising the 1906 Pure Food and Drugs Act 1938 FDA passes the 1938 Federal Food, Drugs, and CosmeAcs Act, which provides idenaty and quality standards for food Mid 1960s FDA decides to clarify the FDCA through GMP regulaaons 1968 FDA proposes food GMP regulaaons 1969 FDA finalizes food GMP regulaaons Early 1970s FDA considers promulgaang industry- specific regulaaons Late- 1970s FDA decides to revise the general GMPs rather than adopang industry- specific GMPs 1986 FDA publishes revised food GMPs 2004 FDA announces effort to modernize food GMPs 2011 President Obama signs FSMA into law 12

13 PrevenAve Controls- Human: General approach 1. IdenAfy Hazard 2. Analyze Cause and effect 6. Training 7. Records keeping 8. Reanalysis 5. Review & Adjust through CorrecAve AcAon Document! 4. Monitor EffecAveness by verifying 3. Implement PrevenAve Controls 13

14 PrevenAve Controls- Human: Between now and Aug, 2016 Come up with a list of faciliaes that you register with FDA IdenAfy food types manufactured at each facility Develop wrinen hazard analysis for each food type: (1) idenafy and (2) analyze Develop wrinen prevenaon controls: - SanitaAon procedure, hygiene training, environmental monitoring program, food allergen control, recall plan, supplier verificaaon related to food safety Develop a wrinen procedures and the frequency with which they are to be performed for monitoring the implementaaon Develop a wrinen correcave acaon procedures Develop a wrinen verificaaon procedures Yes No 14

15 PrevenAve Controls- Human: Once implemented, record keeping starts Document monitoring of the prevenave controls Document correcave acaons Document verificaaon Document training for the qualified individual 15

16 PrevenAve Controls- Human: Triggers for reanalysis Other triggers for reanalysis of your food safety plans Ad Hoc CorrecAve AcAons When a PrevenAve Control is found to be ineffecave Whenever there is a significant change (e.g., supplier, facility, equipment, process, ingredients, etc.) Whenever you become aware of a new hazard (e.g.: recent outbreak, scienafic study, new technology) Upon noace by FDA 16

17 PrevenAve Controls- Human: Supplemental proposed rule (Sept 2014) 1. Farms that pack or hold from other farms not subject to the prevenave control rule 2. DefiniAon of a very small business proposed 3. Withdrawal of qualified exempaons process further clarified 4. Product tesang, environmental monitoring, and supplier controls 5. Economically moavated adulteraaon language 17

18 IntenAonal AdulteraAon Relates to condi9ons around the food process rather than physical or chemical parameters of the process Scope of the proposed rule Covered Acts intended to cause massive public health harm (insider and acts of terrorism) Goal: Develop and implement a wrinen food defense plan for vulnerable steps in food process to protect against intenaonal adulteraaon of food for each of your registered faciliaes (exempaons exist). Risk based and focused approach Not covered Acts intended to anack the reputaaon of a company, and not to cause public health harm Economically moavated adulteraaon intended to obtain economic gain, and not to cause public harm 18

19 History of Food Defense Policy 19

20 IntenAonal AdulteraAon: FaciliAes that are non- exempt vs. exempt Non- exempt Where vulnerable or key acavity types occur such as 1. Bulk liquid receiving and loading 2. Liquid storage and handling 3. Secondary ingredient handling 4. Mixing and similar acaviaes Exempt Packing, repacking, labeling, or relabeling of food where the container that directly contacts the food remains intact Holding of food, except the holding of food in liquid storage tanks Alcoholic beverages at certain alcohol- related faciliaes, and certain prepackaged food sold in limited quanaaes along with alcoholic beverage at the same faciliaes Manufacturing, processing, packing, or holding of food for animals AcAviAes that fall with the definiaon of farm and dairy farms TransportaAon carriers Qualified faciliaes (21CFR 121.3) 20

21 IntenAonal AdulteraAon: General approach You have a choice: (1) follow FDA s key acavity steps or (2) conduct your own vulnerability assessment 1. IdenAfy acaonable process steps 2. Develop focused miagaaon strategies 5. VerificaAon Document! 3. Monitor 6. Training 7. Records keeping 8. Reanalysis 4. CorrecAve acaon 21

22 IntenAonal AdulteraAon: FDA- idenafied key acaviaes It is likely that the contaminant will be introduced or distributed throughout food during: 1. Bulk liquid receiving and loading due to sloshing, movement, or turbulence 2. Liquid storage and handling when a liquid is contained in bulk storage tanks or in holding, surge, or metering tanks 3. Secondary ingredient handling steps such as staging, preparaaon, addiaon, or rework step 4. Mixing and similar ac9vi9es such as mixing, blending, homogenizing, or grinding 22

23 IntenAonal AdulteraAon: Between now and May 2017 Check to see if this rule applies to your registered facility Decide whether to use FDA idenafied key acavity types or your own vulnerability assessment Evaluate food types or producaon methods to see if the vulnerabiliaes (or key acavity types) and focused miagaaon strategies are similar Group food types or producaon method types with similar vulnerabiliaes (or key acavity types) Develop write acaonable process steps for each vulnerability or key acavity type Develop wrinen focused miagaaon strategies Develop wrinen procedures for monitoring Develop wrinen correcave acaon procedures Develop wrinen verificaaon procedures Yes No 23

24 IntenAonal AdulteraAon: Focused miagaaon strategy Examples of focused miagaaon strategies: 1. Bulk liquid receiving and loading: Control access to the receiving or loading area, conveyances, and equipment; Ensure adequate lighang in the receiving or leading area; Increase observaaon of the receiving or loading area Verify that seals on a shipping conveyance are intact prior to receiving or ader loading a bulk liquid Establish and implement a policy for driver check- in and idenaficaaon Inspect the shipping conveyance prior to loading bulk liquids Etc. 24

25 IntenAonal AdulteraAon: Frequency and triggers of reanalysis At least every 3 years Other triggers for reanalysis of your food defense plans Ad Hoc CorrecAve AcAons When a focused miagaaon strategy is found to be ineffecave Whenever there is a significant change made in the acaviaes conducted at a facility (e.g., new producaon line) Whenever you become aware of a new informaaon about potenaal vulnerabiliaes associated with the food operaaon or facility (e.g.: access to a paracular piece of equipment is greater than was thought to be) Upon noace by FDA 25

26 Foreign Supplier VerificaAon Program Burden is on the importer (US owner of the food if there is one or the consignee if there is not a US owner at the Ame of entry or the US agent or representaave of the foreign owner or consignee at the Ame of entry) DefiniAon of foreign supplier: An establishment that grows, harvests, or manufactures/processes food (including animals) for export to the U.S Risk- based Goal: Develop a wrinen procedure for conduc9ng foreign supplier verifica9on ac9vi9es to provide assurances that foreseeable food safety risks have been idenafied through a hazard assessment process and are adequately controlled. 26

27 Foreign Supplier VerificaAon Program: Between now and October 2016 IdenAfy all the foods/dietary supplements/ingredients you are an importer* of (check for exempaons/paraal exempaons) Conduct and document food/supplier compliance status review of food and suppliers (warning leners, import alerts, etc.) Develop a wrinen procedure for conducang foreign supplier verificaaon acaviaes to provide assurances that hazards idenafied are adequately controlled (opaons 1 and 2) for each food Conduct hazard** analysis for each food Yes No * US owner of the food if there is one or the consignee if there is not a US owner at the Ame of entry or the US agent or representaave of the foreign owner or consignee at the Ame of entry **Hazards that are reasonably likely to occur 27

28 Foreign Supplier VerificaAon Program: OpAons 1 and 2 for hazards controlled/verified by foreign supplier FDA asked for comments on what the industry would prefer to use between two opaons, but ulamate it will be a single process of FDA s choosing SAHCODHA* hazards Other hazards - - Op9on 1 Op9on Importer must conduct an iniaal onsite audit to verify that those hazards are being adequately controlled Annual onsite audits Periodic onsite audiang Periodic or lot- by- lot sampling and tesang of the food Periodic review of the foreign supplier s food safety records Any other procedure established to be appropriate *SAHCODHA: serious adverse health consequences or death to humans or animals Periodic onsite audiang Periodic or lot- by- lot sampling and tesang of the food Periodic review of the foreign supplier s food safety records Any other procedure established to be appropriate 28

29 Foreign Supplier VerificaAon Program: Ongoing requirements Maintain a complete list of foreign suppliers Correc9ve ac9on: review complaints received concerning the foods they import, invesagate the cause or causes of adulteraaon or misbranding in some circumstances, take appropriate correcave acaons, and revise their FSVPs when they appear to be inadequate. Periodic reassessment of the FSVP: reassess every 3 years or sooner for new informaaon about potenaal hazards associated with the food as below Change to raw materials or the source of raw materials Product formulaaon Processing methods or systems Finished product distribuaon systems Intended use of the food Importer iden9fica9on at entry: name and DUNS number to CBP Records keeping 29

30 Foreign Supplier VerificaAon Program: ExempAons Exemp9ons: Importers of Juice, fish or fishery products Food for personal consumpaon; Alcoholic beverages; Food that is transshipped or re- exported; Food imported for research or evaluaaon purposes Very small importers or importers of food from very small foreign suppliers (< $500,000 in annual food sales) Establishments that merely hold or pack food for export to the U.S 30

31 Foreign Supplier VerificaAon Program: Dietary supplement (finished) importers Exempt from: ConducAng a hazard analysis, and VerificaAon except to verify supplier is complying with dietary supplement cgmps Not exempt from: Maintaining a list of foreign suppliers Performing compliance status review ConducAng supplier verificaaon ConducAng root cause invesagaaon and correcave acaons as needed Reassessing FSVP Ensuring importer idenaficaaon at Entry Maintaining records 31

32 Foreign Supplier VerificaAon Program: Low- acid canned food importers Exempt from: Microbiological hazard analysis Note exempt from: ConducAng hazard analysis (chemical, physical and radiological hazards) Maintaining a wrinen list of foreign suppliers Performing compliance status review ConducAng supplier verificaaon ConducAng root cause invesagaaon and correcave acaons as needed Reassessing FSVP Ensuring importer idenaficaaon at Entry Maintaining records 32

33 Foreign Supplier VerificaAon Program: Supplemental rule (Sept 2014) 1. Hazard analysis 2. Supplier verificaaon 3. Consistency with other proposed FSMA rules 33

34 Resources & important dates hnp:// Upcoming public meeang: Nov 13, 2014 on FSMA Supplemental NoAces of Proposed Rulemaking In person (Maryland) or Webcast: hnp:// FSMA- Nov13- DC/? source=govdelivery&utm_medium= &utm_source=govdelivery Closing date for public comment on supplemental noaces: December 15, 2014 Proposed Supplemental Rule for Produce Safety Proposed Supplemental Rule for PrevenAve Controls for Human Food Proposed Supplemental Rule for PrevenAve Controls for Animal Food Proposed Supplemental Rule for Foreign Supplier VerificaAon Programs (FSVP) 34

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