1 COMMISSIONER,FOOD SAFETYFOOD SAFETY FOR CHEFS FOOD SAFETY FOR CHEFS DR.MRINALINI DARSWAL COMMISSIONER,FOOD SAFETY GNCTD Monday, December 04, 2017

2 PLAN FOR PRESENTATION SALIENT POINTS- FSSAct,2006Sections/Rules/Regulations/Notifications Compliances required Procedures- enforcement related Rights of FBO Beyond the Act Challenges in Food Safety

3 PREAMBLE-FSSA An Act …..laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto.

4 WHAT IS FOOD? 3J FOOD IS WHAT IT IS NOT

5 WHAT IS IT NOT? animal feed,live animals unless they are prepared or processed for placing on the market for human consumption, plants, prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances :

6 IT IS…. any substance, whether processed, partially processed or unprocessed, which is intended for human consumption…… (BAN ON FOOD PRODUCTS CONTAINING TOBACCO AND NICOTINE)

7 WHAT IS COVERED UNDER THE FSS ACT (2006) FOOD" means any substance,whether processed, unprocessed, partially which processed intended or for is human consumption and includes primary food genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting

8 Who Comes Under The FSS ACT (2006) Every Food Business/ Operator

9 Who Does Not Come Under The(2006) FSS ACT

10 SAFE FOOD-which is not unsafeSection 3 (zz)- “unsafe food” means an article of food whose nature, substance or quality is so affected as to render it injurious to health- Poisonous or deleterious Filthy,putrid,rotten,decomposed,or diseased animal or plant substance Unhygienic processing-harmful

11 CONTD….. Substitution-inferior or cheaper substanceAddition of something not permitted Abstraction of constituents Coloured,flavoured,coatwd,powdered,polished-to conceal damage Coloring matter or preservatives-not specified Infected or infested with worms,weevils or insects Insanitary conditions Misbranded, sub-standard,extraneous matter pesticides or contaminants-excess

12 RISK S 3-zm to zq Risk-probability of an adverse effect on the health of consumers Risk analysis -Risk assessment- (i) hazard identification,(ii) hazard characterisation; (iii) exposure assessment, and (iv) risk characterisation -Risk communication -Risk management - evaluating policy alternatives…protection of health of consumers and for the promotion of fair trade practices….

13 Not a linear relationshipHazard vs. Risk Hazard Agent - chemical, physical, biological that could cause illness/death Risk Likelihood/probability of illness/death from exposure to a hazard; Exposure x consequence To begin, it is important to distinguish between “hazard” and “risk”. A hazard is the agent that could cause illness or death that we are concerned about. For example, we are concerned about Escherichia coli O157:H7 in ground beef. The hazard is the microbiological agent -- E. coli O157:H7. It is not the ground beef, which is the “vehicle” the agent is in. In contrast, risk is the likelihood or probability of illness or death from being exposed to a hazard. For example, the risk of illness from eating undercooked eggs contaminated with Salmonella Enteriditis in the U.S. is about 1 in a million. It is the probability of something “adverse” happening; in this case, foodborne illness. While this makes sense to a lot of you, most don’t think in these terms. An analogy that might be useful is the example of travelling by air plane. The “adverse outcome” you may be concerned about dying from injury as a result of being in an air plane crash due to engine failure. The hazard in this case is “engine failure.” The risk is “the likelihood or probability that you will die as a result of being aboard and air plane in which the engine fails during flight. If the engine fails and you are not aboard the plane, there is no risk to you. If you are aboard and the engine works fine, there is no risk (of dying) to you (at least by that means). The outcome: dying. The hazard: air plane engine failure. The risk: the likelihood or probability of death/injury as a result of air plane engine failure during flight. Not a linear relationship

14 Hazard vs. Risk Hazard Risk2,500 seriously ill per year in the U.S.; 1 in 5 cases result in death L. monocytogenes Approximately 3.5 illnesses per one million eggs consumed Salmonella Enteritidis To begin, it is important to distinguish between “hazard” and “risk”. A hazard is the agent that could cause illness or death that we are concerned about. For example, we are concerned about Escherichia coli O157:H7 in ground beef. The hazard is the microbiological agent -- E. coli O157:H7. It is not the ground beef, which is the “vehicle” the agent is in. In contrast, risk is the likelihood or probability of illness or death from being exposed to a hazard. For example, the risk of illness from eating undercooked eggs contaminated with Salmonella Enteriditis in the U.S. is about 1 in a million. It is the probability of something “adverse” happening; in this case, foodborne illness. While this makes sense to a lot of you, most don’t think in these terms. An analogy that might be useful is the example of travelling by air plane. The “adverse outcome” you may be concerned about dying from injury as a result of being in an air plane crash due to engine failure. The hazard in this case is “engine failure.” The risk is “the likelihood or probability that you will die as a result of being aboard and air plane in which the engine fails during flight. If the engine fails and you are not aboard the plane, there is no risk to you. If you are aboard and the engine works fine, there is no risk (of dying) to you (at least by that means). The outcome: dying. The hazard: air plane engine failure. The risk: the likelihood or probability of death/injury as a result of air plane engine failure during flight. 1 illness out of 600,000 consumed servings of ground beef (June – September) E. coli O157:H7

15 SECTION 22 Genetically modified foods, organic foods, functional foods, proprietary foods, etc.“foods for special dietary uses or functional foods or nutraceuticals or health supplements” “genetically engineered or modified food” means food and food ingredients composed of or containing genetically modified or engineered organisms “organic food” means food products that have been produced in accordance with specified organic production standards; “proprietary and novel food” means an article of food for which standards have not been specified but is not unsafe:

16 SECTION 26 Responsibilities of the Food business operator.Satisfy requirements of the Act No sale of unsafe food Mis-branded, sub-standard, extraneous matter Without license Prohibited by notification No employment of person having infectious, contagious or loathsome disease

17 2. Responsible Industry:Culture of food industry Integrated controls: Farm to fork Regulatory compliance Commitment to continued learning and Proactive behaviour in responding to emerging food safety hazards

18 SECTION 27 Liability of the manufacturers, packers, wholesalers, distributors and sellers date of expiry unidentifiable manufacturer unhygienically stored or handled

19 SECTION 31 LICENSING AND REGISTRATIONNo person shall commence or carry on any food business except under a license Turnover-Rs.12 Lakhs pa- Self-declared Otherwise Registration There are two list for grant of a license 1. Central List- where the license is granted by the FSSAI (Food Safety and Standards Authority of India) given in Schedule 1 of the Licensing Regulation. 2. State List- All others Fee for Registration i- Rs. 100 per year. Fee for grant of License -Rs. 2,000 to Rs. 5,000 per year.

20 CHAPTER IX offences and penaltiesSection Offence Penalty ( Rs. Lakhs) Imprisonment 50 Penalty for selling food not of the nature or substance or quality demanded 5 - 51 Sub-standard food 52 Misbranded food 3 53 Misleading Ads 10 54 Extraneous matter One 55 Failure to comply directions of FSO 2 56 Unhygienic processing/manufacture 57 Possessing adulterant 2 to 10

21 CONTD….. section offence Penalty/fine Imprisonment 58Any other contravention 2 - 59 Unsafe food No injury one 6 months Non-grievous injury 3 One year Grievous injury 5 Six years Death 10 7 yrs to Life 60 Interfering with seized items 61 False information 3 months 62 obstructing/impersonating FSO One 63 No license 64 Subsequent offences Twice/one lakh daily/cancellation of license

22 CONTD…. Section Offence Fine Imprisonment 65Compensation for injury or death 1-5 lakhs Forfeiture of establishment/property 66 Offences by companies Nomination of Food safety in charge is must Connivance of Director, Manager,secretary etc.if proved is punishable 67 Import- Foreign trade Act/Customs Act

23 or witness if FBO declines signingSampling and Analysis of Food FOOD SAFETY OFFICER (FSO) samples seized by FSO FOOD BUSINESS OPERATOR FSO must pay FBO at rate sold to public Signature or thumb impression of FBO or witness if FBO declines signing Lifting the sample 4 samples or divide in 4 Parts Purchaser can lift sample(1+1) NABL Accredited Lab if FBO demands DO: 2 parts FOOD ANALYST State Health Lab 2+1 Analysis and prepare of 4 copies of report Appeal Analysis REFERRAL FOOD LABORATORY FBO DESIGNATED OFFICER FA Report RFL Report ADJUDICATION FSO FBO Appeal State Govt. to launch prosecution/penalty if sample is Unsafe, Substandard or Misbranded TRIBUNAL SPECIAL COURT

24 Naturally Occurring Toxic substancesAnalysis of Food Samples FSO/DO RFL Unfit Documentation Report Sample Fit Analysis for Microbiological Food additives Labeling Compliance parameters Quality Standards Pesticide Residues Physical Heavy Metal analysis Naturally Occurring Toxic substances Examination

25 REGULATIONS Licensing and registrationGeneral hygienic and sanitary practices Specific- Milk, Meat, catering- restaurants and hotels ( Part V) Packaging and Labeling Food product Standards Food Additives Prohibition on restriction of sales Contaminants, toxins and residues Lab and sample analysis

26 -GOOD MANUFACTURING PRACTICES FOR WHOLE PREMISESFOOD SAFETY AND STANDARDS (LICENSING AND REGISTRATION OF FOOD BUSINESSES), REGULATIONS 2011 Schedule 4 -Hygienic and Sanitary practices to be followed by Food Business operators Part-II -General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators applying for license Part - V Specific Hygienic and Sanitary Practices to be followed by Practices to be followed by Food Business Operators engaged in catering / food service establishments -GOOD MANUFACTURING PRACTICES FOR WHOLE PREMISES -GOOD FOOD HYGIENE PRACTICES

27 Product Specific requirementsFood grade packaging : Food grade as per BIS.  Label declaration • Name of Food List of Ingredients Nutritional information Declaration regarding Veg or Non veg Declaration regarding Food Additives Name and complete address of the manufacturer Net quantity Lot/Code/Batch identification Date of manufacture or packing Best Before and Use By Date FSSA(I) Logo &License/Registration Number Country of origin for imported food Instructions for use (if Necessary) Product Specific requirements  Restriction on advertisement • Super refined, Ultra refined etc.

28 Assume sample received from DO is a packet of Wheat AttaFOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011 PART 2.1: 2.2: 2.3: 2.4: 2.5: 2.6: 2.7: 2.8: 2.9: Dairy Products and Analogues Fats, Oils And Fat Emulsions Fruit & Vegetable Products Cereals & Cereal Products Meat and Meat Products Fish and Fish Products Sweets & Confectionery Assume sample received from DO is a packet of Wheat Atta Sweetening agents including Honey Salt, Spices, Condiments and Related Products 2.10: Beverages (Other than Dairy and Fruits & Vegetables based) 2.11: Other Food Product and Ingredients 2.12: Proprietary Food 2.13 Irradiation of Food CHAPTER 3 : SUBSTANCES ADDED TO FOOD Part 3.1: Food Additives

29 PART 2. 4: CEREALS AND CEREAL PRODUCTS 2.4.1: ATTA 2.4.2: MAIDA2.4.3: SEMOLINA (Suji or Rawa) 2.4.4: BESAN 2.4.5: PEARL BARLEY (Jau) 2.4.6: FOOD GRAINS 2.4: CORNFLOUR (Maize starch) 2.4.8: CORN FLAKES 2.4.9: CUSTARD POWDER 2.4.10: MACARONI PRODUCTS 2.4.11: MALTED AND MALT BASED FOODS 2.1.12: ROLLED OATS 2.1.13: SOLVENT EXTRACTED FLOURS 2.4.14: STARCHY FOODS BAKERY PRODUCTS 1. BISCUITS 2. BREAD

30 2.4.1 Specification for Atta

31

32

33

34 RIGHTS OF FBO Cost of sample to be paidAppeal against Food Analyst before DO- Referral Food Laboratory May ask for a sample to be sent to Referral food Lab FSO can be prosecuted for vexatious action u/s 39- Penalty of one Lakh Toll free number PGMS/

35 BEYOND THE ACT GST CODEX ALIMENTARIUS,WTOEuropean and FDA Standards-FSMA,2011 Chef as Local and Global Entrepreneur Chef as Culinary Brand Ambassador for the country Tourism and Hospitality Industry trends Clean Street Food Project Delhi-23,000 vendors trained and certified

36 Food Regulatory System FOOD LAWS (INDIA) BIS AGMARK PFA FSSA 2006 &Essentia Commodities Act FPO MMPO VOPO MANDATORY FSSA 2006 & RULES 2011 l FOOD LAWS (INDIA) COMPULSORY , , BIS VOLUNTARY AGMARK

37

38

39 10 AT 10 SWASTHA AAHAR SWASTHYA KA AADHARThe primary focus of the initiative is to engage with stakeholders and consumers to create food safety culture in the country. This bouquet of 10 initiatives focused on safe and nutritious food at home, school, workplace, religious places, in trains and railway stations, in restaurants and other places.

40 ECONOMIC PROSPECTS AND TRENDS

41 China the Largest economy by 2030 but overtaken by India 2050Citibank research/IMF

42 With stagnant domestic markets, global majors want to swamp emerging marketsChina, Indian Sub-continent, Brazil, South Africa and ASEAN region will add twice of US food markets in the next ten years. (Yum in India $ 1 bn, Yum in China 6300 restaurants in 950 cities - Franchise model Focus on global technologies, local products Asian buying power in USA – 1 Tn $ Low income Economies have less concern for food safety

43 GROWTH 7% CAGR

44

45 Growth of Street food in key world markets2014 ( actual) 2015 ( E) 2016 2017 India 15,025.30 15,581.00 16,171.30 16,800.40 USA 12,275.80 12,505.60 12,763.30 13,047.10 Mexico 12,464.50 12,583.10 12,707.80 12,837.60 Brazil 8,154.30 8,775.00 9,480.80 10,108.60 China 8,258.10 8,555.70 8,831.10 9,073.10 Thailand 6,754.10 6,786.30 6,833.10 6,902.50 Venezuela 6,149.50 6,082.50 6,145.20 6,234.60 Singapore 4,165.00 4,208.90 4,245.40 4,274.10 Source: Euro monitor

46 NEW CONCERNS IN FOOD SAFETY

47 Concern for health and nutrition Some truth and severe mythsThe growing “No No” in Foods: GMO Free Lactose free Sugar free/ natural sugar only Organic only Caffeine free Local farm produced Non-refrigerated Peanut and tree nuts free Gluten free THE CHALLENGE OF FOCUSING ON COMMUNICATION OF SCIENCE BASED VALUE TO OVERCOME MYTHS ABOUT FOOD RELATED RISKS

48 What is Gluten and why is it Allergy for me?

49 Threats from global food movement and contaminationSurge in global food trade – 25% of global food production moves across the world. As food travels so too disease vectors, consequently enhancing the risk of food borne diseases. Global flow of products forces researchers to understand global needs and global regulations, not just local needs & local regulations. Global flow of products place researchers under serious pressure to redefine epidemiological, surveillance and food safety assessment parameters.

50 Growing threat of intentional contaminationMelamine, Peanut butter and Donot Dough contaminations triggers global debate on enterprise level food safety assessment process. Cost of failure any where too high to absorb for the whole world. ECONOMICALLY MOTIVATED ADULTERATION (EMA) ISSUE IN FOODS – COUNTERFEIT INGREDIENTS &FG – DRIVEN BY COST SAVING AND TARIFF REDUCTION GAME

51 FINALLY SELF REGULATION-HAND HOLDING AND FACILITATION-10 ON 10 INITIATIVE EASE OF DOING BUSINESS NECESSARY COMPLIANCES- TO STAY COMPETITIVE AS CONSUMERS ARE AWARE GLOBAL MARKET-COMPARATIVE ADVANTAGE

52 QUESTIONS PLEASE

53 HUNGRY???????? THANK YOU

54 SAFE WORDS TO REMEMBER HACCP-Hazard analysis and critical control points -systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. HARPC-Hazard Analysis and Risk based Preventive Controls GMP GSP ISO 22000

55 Receiving fresh vegetablesRefrigerated Storage Vegetable washing Peeling, dicing, cubing Water Filling Waste, non food use Heat Process Retail sales

56

57 Heightened Publicity Associated with Product Withdraws

58 Recall when ventures fail to comply is the utmost challengeFSSAI recall advisory When a Food Business Operator refuses to undertake a recall directed by the State Food Authority / Food Authority or where the State Food Authority / Food Authority has sufficient reasons to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing the State Food Authority/Food Authority will take appropriate action. The cost incurred by the State Food Authority / Food Authority for carrying out such actions will be recovered from the Food Business Operator responsible for such violation. (c)Vijay Vijayaraghavan, Cornell - Sathguru

59

60 Food Safety Modernization Act (FSMA) signed by President Obama in 2011 brings sweeping changes to the Federal Food, Drug and Cosmetic Act of 1938 FSMA holds both domestic and Imported Foods higher standards with emphasis on Hazard Analysis and Risk-based Preventive Controls (HARPC)

61 Import Safety MandatesSec Foreign supplier verification program (FSVP) All importers must establish FSVP and follow the regulations Requires importers to verify their foreign suppliers who must implement Hazard Analysis and Risk-based Preventive Controls (HARPC) that provide same level of public health protection as U.S. requirements (Not Adulterated/Misbranded) HACCP HARPC Used for selected foods All foods covered Food safety team Qualified Individual Terrorist acts not included Included

62 Types of produce associated with US outbreaks, 1996-2006 (N=71)Outbreaks associated with FDA/CFSAN-regulated foods: , Vierk et al., CFSAN, College Park, MD 62

63 US FDA-regulated foods linked to reported illnesses, 1996-2006 (N=23,428 illnesses)63

64 US FDA-regulated foods linked to reported illnesses, 1996-2006 (N=23,428 illnesses)64

65 Large Scale Production & Wide-spread Distribution1900’s Distribution Modern Distribution Small Serving local market (100’s of people) Quick turnover Large Serving the World (Millions of people)