Update on Food Safety Modernization Act 2010 May 16, Dr. Bob Strong

Transcription

1 Update on Food Safety Modernization Act 2010 May 16, 2014 Dr. Bob Strong

2 Dr. Bob Strong Our Presenter Today Senior Consultant SAI Global Assurance Services Driving force behind our food safety operations in the areas of Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) and supplier assurance programs, including SAFE, SQF and BRC 44 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing. He is an often requested seminar speaker in the areas of GMP and HACCP Ph.D. and BSC in Chemistry and an accomplished food safety trainer for numerous food safety manager certification courses In addition, he is a GMP/HACCP instructor, a Lead Auditor trainer, and is also certified to consult on the Global Food Safety Initiative by SQF. He is certified in 20 product categories

3 Purpose Of This Webinar Provide an update on the implementation of FSMA Detailing which industries are exempt from the FSMA Review Section 106 Regulations to prevent intentional adulteration Review Section 111 Sanitary Transportation of Human and Animal Food Review Section 204 Processed food and produce traceability (Designation of High Risk Foods as it apples to records for traceability) Q&A

4 Food Safety Modernization Act (FSMA) 2010 Congress passed FSMA on December 20 th 2010 President Obama signed it into law on January 4 th, 2011 Congress sets the laws, FDA develops the regulations to fit with the laws and then enforces the laws. Initial timetable had a 3 year implementation plan with parts being implemented immediately and other parts gradually but FDA has not been able to meet this timeframe and it is now likely to be a 6-9 year implementation plan for most of the major proposed rules.

5 Food Safety Modernization Act (FSMA) 2010 Federal Judge from the US District Court in Northern California ruled in Spring of 2013 that FDA had to meet the following timetable. Regulations all had to be published by November 30 th, 2013 All comment periods have to be closed out by March 31 st, 2014 Final regulations need to be put into effect by June 30 th, 2015 Followed by a 3 year implementation plan for Industry

6 Food Safety Modernization Act 2010 Title 1 Title 2 Title 3 Title 4 Designed to improve capacity to prevent food safety problems Designed to improve capacity to detect and respond to food safety problems Designed to improve the safety of imported food Includes miscellaneous provisions

7 Food Safety Modernization Act 2010 Exempted Businesses FSMA does not apply to facilities regulated by USDA (meat, poultry and eggs) Also exempted are the following industries from any changes: Juice manufacturers Seafood processors Alcohol-related facilities Low acid canning (except to expand their Hazard Analysis) Small Businesses < $500,000 sales and 50% of their sales within 275 miles of their facility (Tester amendment) FDA is considering modified requirements for warehouses and having Preventive Controls only if they are storing refrigerated products.

8 Title 1 Sections Designed to prevent food safety problems Section 101* FDA access to your records Section 102 Registration and possible suspension by FDA Section 103* Preventive Controls (HACCP) Section 104 FDA hazard information Section 105 Produce food safety guidelines Section 106* Regulations to prevent intentional adulteration Section 107 Fee assessments by FDA Section 108 National agriculture and food defense strategy

9 Title 1 Sections Continued Section 109 Annual reporting by Secretary of Homeland Security Section 110 Building domestic capacity Section 111* Sanitary transportation regulations Section 112 Allergen education Section 113 New dietary ingredients Section 114 Post harvest processing of raw oysters guidance Section 115 Port shopping Section 116 Alcohol-related facilities

10 Title 2 Sections Improvements To Detect And Respond To Food Safety Problems Section 201 Allocation of funds to inspect food manufacturers and imported food Section 202 Laboratory accreditation Section 203 Laboratory food safety networking Section 204* Processed food and produce traceability Section 205 Enhance foodborne illness surveillance Section 206 Food seizures and recalls Section 207 Food detention regulation

11 Title 2 Sections Continued Section 208 EPA decontamination support Section 209 Training improvements for state, local and tribal food safety officials Section 210 Grants to state, local and tribal food safety officials Section 211 Reportable food registry improvements

12 Title 3 Sections Improving The Safety Of Imported Food Section 301 Importers to do risk verification on imported foods Section 302 Expedited review of imported foods by complying importers Section 303 Refusing admission to non-complying foods Section 304 Requiring notification of denial by other countries Section 305 Aid to foreign countries to improve their food safety

13 Title 3 Sections Continued Section 306 Requires imported food to be as safe as USA produced food (encourages foreign food processors to register with the FDA) Section 307 Third-party auditing of foreign food processors Section 308 Establish FDA offices in foreign countries Section 309 Prevention of food smuggling into the USA

14 Title 4 Sections Section 401 Appropriations for CFSAN and others Section 402 Whistleblower protection Section 403 Act does not apply to USDA inspected facilities Section 404 Requiring to be consistent with WTO Section 405 Determination of budgetary effects

15 Sections Update For the purpose of this update we are confining our webinar to the following 3 Sections of FSMA and an update on below 3 sections: Section 106 Intentional Adulteration of Foods Section 111 Sanitary Transportation of Human and Animal Food Section 204 Designation of High Risk Foods relative to recordkeeping for Traceability Updates on the following: Section 101 Records retention and availability Section 103 Preventive Controls update for Animal Feed Title 3 Prior Notice for Imported Foods.

16 Sections Update For some additional information on other sections go to the SAI Global website and view the webinars: Food Safety Modernization Act 2010 What It Means To You Food Safety Modernization Act 2010 Update Jan 13 th 2014

17 Section 106 Regulations to prevent intentional adulteration of foods. Proposed rule issued 12/20/13 (170 pages) Comment period extended through 6/30/14 Intent is for companies to develop using a qualified individual a written food defense plan to protect against the intentional adulteration of food for the purpose of causing harm to the consumer. The plan should concentrate on: Actionable process steps Mitigation strategies Monitoring, corrective actions and verification

18 Section 106 Regulations to prevent intentional adulteration of foods. Who is exempt: Very small businesses (<$10M sales) You sold more than 50% of your sales to companies with <$10M sales Storage facilities (DCs etc.) except those with bulk liquid tanks Alcoholic beverage manufacturers Animal feed manufacturers and distributors

19 Section 106 Regulations to prevent intentional adulteration of foods. FDA has identified 4 key actionable types of areas: Bulk liquid receiving and loading Bulk liquid storage and handling Secondary ingredient handling Mixing and similar activities

20 Section 106 Regulations to prevent intentional adulteration of foods. FDA has identified 3 types of deliberate acts of contamination: Acts of Terrorism Disgruntled employees, consumers or competitors Economically motivated adulteration (i.e. melamine)

21 Section 106 Regulations to prevent intentional adulteration of foods. FDA key area Bulk liquid receiving and loading. Restrict access to loading areas Require sealing of tankers after loading Require at receiving a check of seals Require sealed bulk tanks at Supplier and Receiver Possibly requiring restricted access to loading and receiving areas

22 Section 106 Regulations to prevent intentional adulteration of foods. FDA key areas Bulk liquid storage and handling. Requiring restricted access to bulk tank storage rooms Locked rooms? Cameras? Sealed inlets?

23 Section 106 Regulations to prevent intentional adulteration of foods. FDA key areas Secondary ingredient handling. Ingredient rooms Pre-mix areas Adding rework

24 Section 106 Regulations to prevent intentional adulteration of foods. FDA key areas Mixing and similar activities. Mix kettles Blending operations Grinding operations Open processing points

25 Section 106 Regulations to prevent intentional adulteration of foods. FDA has identified the following requirements: Identify and implement focused mitigation strategies (Actionable process steps) Establish and implement procedures for monitoring these mitigation strategies Establish and implement corrective actions Verify that monitoring is being conducted Train supervisors assigned to actionable process steps Establish and maintain records

26 Section 106 Regulations to prevent intentional adulteration of foods. FDA asking for comments on using HACCP principles to develop the Food Defense plans Will call a control point a TACCP (Threat Assessment Critical Control Point) Identify more high risk processes easier to intentionally adulterate Examples of low risk foods Shell Eggs Most Whole Produce and Vegetables Game Meats (Whole or Cut but not ground or shredded) Peanuts and Tree Nuts (Raw, In-Shell) Sugar Cane and Sugar Beets

27 Section 106 Regulations to prevent intentional adulteration of foods. Effective dates 60 days after final rule is published Large companies then have 1 year to comply Small businesses (<500 FTE employees) have 2 years to comply Very small businesses (<$10M Sales) will have 3 years to comply

28 Section 111 Sanitary Transportation of Human and Animal Food Proposed rule was published on January 31 st, 2014 Comment period open until May 31 st, 2014 Public meetings were held: Chicago, Feb 27 th Anaheim, Mar 13 th College Park, MD, Mar 20 th Proposed rule published in Federal Register on 2/5/14 is 120 pages long

29 Section 111 Sanitary Transportation of Human and Animal Food Seventh and final rule of FSMA and builds on to the previously issued Sanitary Food Transportation Act of 2005 Has 5 major sections: 1. Vehicle and Transportation equipment 2. Transportation Operations 3. Information Exchange 4. Training 5. Records

30 Section 111 Sanitary Transportation of Human and Animal Food Who is exempt Shippers, receivers and carriers that have less then $500,000 total annual sales Transporting of raw agricultural commodities by farm vehicles Food being trans-shipped through US to another country. (i.e. Mexico to Canada) Food imported to be exported but not used or intended to be consumed in US Shelf stable foods that are completely enclosed in a container Transportation of compressed gases Transportation of live animals

31 Section 111 Sanitary Transportation of Human and Animal Food Vehicles and Transportation Equipment. The proposed rule will establish requirements for the design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become contaminated. Equipment includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading and unloading systems.

32 Section 111 Sanitary Transportation of Human and Animal Food Vehicles and Transportation Equipment. Problems with regard to cross-contamination or cross-contact could occur from Incorrect use of packing materials (i.e. using wood containers for raw meat and later for produce). Same hoses and/or pumps for delivering different allergens on same tanker. Same hoses for raw and R-T-E ingredients (Raw eggs and ice-cream mix). Pallets in bad condition splintering and/or projecting nails.

33 Section 111 Sanitary Transportation of Human and Animal Food Transportation operations. The proposed rule will establish requirements for the measures taken during transportation to include cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment so as to ensure no contamination or temperature abuse of products during transit. This includes the growth of spoilage bacteria (yeasts and lactobacilli) as well as pathogenic bacteria.

34 Section 111 Sanitary Transportation of Human and Animal Food Transportation operations. Ensuring adequate temperature controls Separation of foods requiring different temperature controls (Frozen and refrigerated) Separation of food from non-food items in the same load Poor quality pallets (i.e. cleanliness and condition) Pest free trailers Trailers and tankers in good physical shape

35 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. The proposed rule will establish requirements to exchange information between Carriers and Shippers/Receivers on: Prior cargoes Cleaning of bulk transportation equipment Temperature controls between Shipper, Carrier and Receiver on bulk loads and on trailer loads

36 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. Prior cargoes: Keeping a Log of loads and sharing that with customers. The FDA does not propose restricting what can be hauled only that cleaning be adequate between loads. Customers may want to restrict what carriers carry. (Cites the raw egg and ice cream mix incident). Waiving of information on the previous 3 loads can be implemented if tanker hauls only one ingredient and this agreement is in writing.

37 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. Cleaning of bulk transportation equipment. Wash tickets to be kept and shared with customers. (Unless cleaned at Shipper). Washing to include sanitizing, where necessary. (Wash station operator to apply a seal on access points to the tanker after cleaning). Where the same ingredient is hauled every time then a mutual agreement not to provide wash tickets can be put into effect but it needs to be in writing.

38 Section 111 Sanitary Transportation of Human and Animal Food Information exchange on required conditions. Proposed 1.908(b)(1) would require that the shipper specify to the carrier, in writing, all necessary sanitary requirements for the carrier's vehicle and transportation equipment, including any specific design requirements and cleaning procedures deemed necessary by the shipper, to ensure that the vehicle and equipment are in appropriate sanitary condition for the transportation of the food. Proposed 1.908(b)(1) would also provide that the information submitted by the shipper to the carrier is subject to the records requirements in proposed 1.912(a). Shipper is also required to visually inspect bulk tanker for cleanliness and condition before loading.

39 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. Temperature controls between Shipper, Carrier and Receiver on bulk loads and rail car and trailer loads. Need either an indicating thermometer and driver taking visual checks and recording results. Or Temp-Tale type of recorders or recording charts. No temperature monitoring required for thermally insulated bulk tankers.

40 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. Carrier has to communicate back to Shipper and to the Receiver, by a mutually agreed method, that TCS foods were transported under required temperature conditions. Carrier is relieved of this responsibility if: Shipper loads a temperature recording device in the trailer with their products. For short hauls, the Shipper is willing to accept loading temperatures and receiving temperatures as proof of temperature control during transit. Carrier will have to provide evidence that Shipper has agreed to this in writing if requested by Receiver.

41 Section 111 Sanitary Transportation of Human and Animal Food Information exchange. Temperature controls between Shipper, Carrier and Receiver on bulk loads and rail car and trailer loads. Shipper needs to specify in writing the pre-loading temperatures of the trailer to the Carrier and the Shipper is to confirm compliance. Receiver needs to specify in writing expected receiving temperature requirements for the products and the Receiver is to confirm compliance. For rail car loads Shipper takes responsibility for the Carrier in assuring Receiver of compliance.

42 Section 111 Sanitary Transportation of Human and Animal Food Training. The proposed rule will establish requirements for ½ day training of carrier personnel in the sanitary transportation practices and will include the documentation of this training. References training in: Personal hygiene for Drivers and the loading and unloading employees if product is exposed; (accessibility to do hand washing). Training in security. Not leaving products on docks after hours; In handling mixed loads so as to avoid crosscontamination. (i.e. hoses).

43 Section 111 Sanitary Transportation of Human and Animal Food Records. The proposed rule will establish the maintenance of written procedures and records by carriers and shippers related to transportation. Equipment cleaning. (Wash tickets, etc.) Prior cargoes. (Does not restrict any non-food or different types of foods being transported as long as adequate cleaning of the tankers). Temperature control. (Will need to have records to show loads stayed cold during entire transit, where applicable).

44 Section 111 Sanitary Transportation of Human and Animal Food Records. Training Records. For Shippers and Receivers should be based on cgmps. (Usually requires annual refresher training). For Carriers should include the date of the training, the type of training, and the person(s) trained. Records to be retained until 12 months after the trained employees cease their employment as a Carrier driver. Can keep records off-site after 6 months as long as they can be produced within 24 hours.

45 Section 111 Sanitary Transportation of Human and Animal Food Waivers. Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade "A" Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products. Food establishments holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.

46 Section 111 Sanitary Transportation of Human and Animal Food Compliance dates. Final rule will become law 60 days after publication. Compliance will be required within 12 months. Small businesses will get 24 months. Businesses other than motor carriers who are also not shippers and/or receivers with less than 500 persons. Carriers with less than $25.5 million in annual receipts.

47 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Issued on February 4 th Comments extended through 5/22/14 Designating high-risk foods based on the following factors: 1. Known food safety risks of a food including history and severity of foodborne illnesses using CDC data; 2. The likelihood the food has a high potential for microbiological or chemical contamination and its ability to support the growth of pathogens; 3. The point in the manufacturing process where the contamination is likely to occur; 4. The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; 5. The likelihood that consuming the food will result in a food borne illness; 6. The severity, health and economic, of a foodborne illness.

48 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring Criterion 1. Frequency of outbreaks and occurrence of illnesses 2. Severity of illness, taking into account illness duration, hospitalization and mortality 3. Likelihood of contamination 4. Growth potential/shelf life 5. Manufacturing process contamination probability/intervention 6. Consumption 7. Economic impact

49 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring Criterion #1 Frequency of outbreaks and occurrence of illnesses Must consider chemical and microbiological food safety hazards. Chemicals would include: Allergens Mycotoxins Pesticides Heavy metals

50 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring. Criterion #2 Severity of Illness Basis is % Hospitalization and % Mortality Criterion #3 Likelihood of Contamination Basis Known to Occur and Number of Recalls

51 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring. Criterion #3 Likelihood of Contamination Known to have occurred Frequency has occurred

52 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring. Criterion #4 Growth Potential/Shelf life Growth Potential Strong Likely growth at temperature at which the food is intended to be held and stored, including refrigeration and room temperature Moderate Some evidence that pathogens may grow Low No evidence that pathogens may grow Couple this with shelf life where longer shelf life can increase the risk.

53 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring. Criterion #5 Manufacturing Process Contamination Probability/Intervention High Recurring or frequent detection of contamination. Moderate Known history of contamination and sporadic detection of contamination Low Infrequent detection of contamination, or contamination introduced post manufacturing Couple this with steps taken to reduce contamination: Strong Control measures available and consistently applied Moderate Control measures available but lack of an adequate kill step Weak Lack of adequate control measures or poor implementation

54 Section 204 Designating High-Risk Foods for the purpose of recordkeeping related to Traceability Risk Model Criteria and Scoring. Criterion #6 Consumption 1-5% of population 5-10% of population >10% of population Criterion #7 Economic Impact Unknown or <$100K/year Lower K/year Medium 500K-10M/year Higher >10 M/year

55 Recent FDA Updates Waste products going to Animal Feed Record retention and availability Import notification Edition 3

56 Waste products going to Animal Feed. Questions raised by Brewers and Distillers about spent grains Comment period closed 3/31/14 FDA recognizes that Hazards will be minimal but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. Requires protection against physical and chemical contamination Quotes the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs.

57 Waste products going to Animal Feed. Final rules to be published late this summer. Final rule to be in effect by 8/30/15.

58 Records retention and availability. Applies to anybody who processes, packs, transports, distributes, receives, holds and imports human or animal food. Final rule was published on 4/4/14 Excludes Farms, Restaurants, USDA plants, Personal Consumption, Non-food packaging, Food contact packaging manufacturers but not users of this packaging materials.

59 Records retention Depends upon the perishability of the food product. Shelf-life Handler Transporter < 60 days 6 months 6 months 60 days - 6 months 12 months 12 months > 6 months 2 years 12 months Animal/Pet food 12 months 12 months

60 Records availability Within 24 hours of request by FDA Civil action if not kept or not made available

61 FSMA Title 3 Import Foods Prior Notification Requirement Edition 3 Issued March 2014 This contains answers to questions and comments received on many aspects To read these to and to Food and then to section called Spotlight

62 SAI Global Assurance Services SAI Global was founded in Headquarters in Australia Listed at the ASX: SAI (around $1 Billion market cap) Largest registrar in North America, 14,000+ registrations / 40,000+ globally SAI Global acquired QMI in 2008 QMI founded in 1984 as North America s first Registrar 30 years in North America SAI Global acquired the Supply Chain Certification Services business from Steritech in 2013 Americas Offices in Cleveland, Toronto, Montreal, Mexico City and Sao Paulo. Regional representatives covering all North, Central and South Americas Global Presence Clients in over 120 countries 500+ Auditors in North America 1,500+ Globally Diversified product sectors and customer base Accreditations: SCC, ANAB, EMA, UKAS, COFRAC, DAP, JAS-ANZ, IAOB, INN, ANSI, USDA Customer survey results 94% satisfaction (Americas) SQF Certification Body of the year BRC 5 Star Rating

63 Global Locations SAI Global Assurance Services Offices AUST RALIA BANGLADESH BRAZIL CANADA CHINA CZECH EGYPT FRANCE GEORGIA GERMANY INDIA INDONESIA IRELAND ITALY JAPAN KOREA LEBANON M EXICO NEW ZEALAND POLAND RUSSIA SOUTH AFRICA SPAIN SWEDEN TAIWAN THAILAND TUNISIE TURKEY UNITED KINGDOM UNITED STATES

64 Assurance Services Auditing Training & Improvement Solutions Consulting

65 Assurance Services Auditing Food Safety BRC SQF FSSC IFS HACCP Seafood Global GAP ISO Gluten free Animal welfare Global GAP Standards Global Aquaculture Alliance BAP Standards ASC Standards ASC Chain of Custody Environment Management System ISO 14001:2004 EMS Responsible Care -- RC & RCMS ISO BAN e-stewards Responsible Recycling (R2) Recycling Industry Operating Standard (RIOS) ISO Health & Safety Management System OHSAS 18001:2007 Packaging IFS PACsecure BRC Packaging SQF FSSC Quality Management System ISO 9001 QMS TS Automotive AS 9100, AS 9110, AS 9120 Aerospace Medical Devices ISO 13485: 2003 Forestry FSC SFI PEFC CoC CAN/CSA Z809 CERTFOR

66 Assurance Services Training & Improvement Solutions Public training On-site training elearning courses

67 Assurance Services Public training and improvement courses include: HACCP for Food Processors SQF Internal Auditing SQF Code Edition 7.2 Implementation Course SQF Advanced Practitioner BRC Standard for Food Safety Issue 6 Report Writing and Audit Techniques BRC Third Party Auditor Food Safety Issue 6 Course BRC Internal Auditor Course Understanding the Requirements for BRC Global Standard for Food Safety Issue 6 Allergen Management for Food Manufacturers Conducting and Leading Management System Audits Nonconformities and Root Cause Analysis for Food Safety

68 Upcoming Quality Training United States Anaheim, CA Atlanta, GA Baltimore, MD Boston, MA Charlotte, NC Chicago, IL Dallas, TX Houston, TX Los Angeles, CA Nashville, TN Orlando, FL St. Louis, MO Canada Calgary, AB Edmonton, AB Halifax, NS Montreal, QC Toronto, ON Ottawa, ON Vancouver, BC 10% Discount* Code: MAYFSMA10WEB *Valid for public training courses booked by July 31, 2014

69 Assurance Services SAI Global can offer on-site consulting including: On-site GAP analysis Management system implementation Kaizen Event HACCP program facilitation Program review & development Allergen program review and validation Product specification building

70 Assurance Services TRANSFER your certification today! Local auditors, Global reach: SQF BRC HACCP FSSC IFS ISO GMP Animal Welfare Packaging ISO 9001 ISO OHSAS 18001

71 Request more information on Training, Auditing, Consulting & Certification SAI Global Assurance Services

72 THANK YOU FOR ATTENDING

73 SAI Global Dr. Bob Strong Senior Consultant, SAI Global, Americas