FDA & OSHA – New Reforms & Standards Affecting the Industry

1. FDA & OSHA – New Reforms & Standards Affecting the Industry Session Chairs: David Dickerson, Rick Fox

2. Jeff Barach, PhD– Barach Enterprises Jeffrey Barach, PhD is a food scientist that has been active in research and development, regulatory liaison activities, teaching, problem solving and trouble shooting. He routinely participates in planning, development and management of special projects and programs for the food industry on health and safety issues, production of foods, regulatory compliance issues and training. He is a subject matter expert (SME) on issues related to food safety modernization, biotechnology, food irradiation, nanotechnology and other new processing and testing technologies .

3. Danielle Gallo – Brady Corporation Danielle Gallo is a Senior Product Marketing Specialist for Brady Worldwide, Inc. She manages Brady’s safety and facility identification products for industry regulatory compliance and safety concerns. She is active in developing new products and solutions for the industry, as well as monitoring ever-changing regulations and global standards. Brady Worldwide, Inc. is an international manufacturer and marketer of complete solutions that identify and protect premises, products and people, including products in high-performance labels and signs, safety devices, printing systems and software, and precision die-cut materials.

4. FSMA Will Bring Added Demands on Food Safety Systems: Is Packaging Ready? Jeffrey Barach, Ph.D. TLMi Conference Chicago, IL September 5, 2013

5. Presentation Outline • FSMA Background • FSMA Current Status • Risk Assessment and Preventive Controls • Food Safety Plan • CPG Companies – Be Prepared • Packing/ Processing Companies- Be Proactive • Summary

6. Proposed Rules – cGMP & Preventive Controls Key Provisions • Reaffirms Industry’s Role in Food Safety • Prevention vs. Reaction • Risk-based Decisions Summary of Requirements • Conduct a Hazard Analysis and Assign Risk-based Preventive Controls • Develop a Written Food Safety Plan • Follow Updated cGMPs (Part 110 -> Part 117) • Compliance Based on Company Size (1-3 years)

7. FSMA Status Summary Today Tomorrow • Preventive Controls – Animals & Pets • FSVP • 3rd Party Accreditation • VQIP • Food Defense • Mandatory Recall Authority • Records Access • Preventive Controls - Human • Produce Safety • Traceability

8. FDA’s Proposed Timeline Filed with US District Court/ Northern CA – CFS & CEH vs. FDA; June 2013

9. Planning Ahead for FSMA The most significant food safety reform in 70 years. Focuses on the prevention of problems that could lead to foodborne illness or injury. √Be Prepared √Be Proactive

10. Get Started and Don’t Wait ! • FSMA is 85% HACCP- We Know HACCP! • FDA Needs to write 50 Rules & Guidance Documents • First Rules will be Proposed Rules and/or Draft Guidance • 120 Day + 120 DAY (8 Months!) Comment Period • Several Months for FDA to Respond to Comments • Final Rules and Guidance will Need to be Published • Implementation- many months • Compliance-will be years (2015?)

11. Be Prepared • Update Food Safety and Food Defense Plans • Hazard analysis • Preventive controls • Verification, including testing • Update Supply Chain Management Programs • Domestic • Foreign • Review Records Maintenance & Access Procedures • Routine • Under Bioterrorism Act

12. Be Proactive • Ensure Your Food Safety “Qualified Individual” is Engaged Now • Develop a Plan for Transition • GMP → “HACCP” → FSMA • HACCP → FSMA • Upgrade Capabilities – Invest for the Future • Record Keeping and Track/Trace • Validation of Processes • Allergen Management Programs

13. FSMA – Composition Overview

14. Food Safety Assurance Pyramid Total Management Commitment HACCP Education and Training Biological, Chemical, and Physical Hazards Food Temperature Control Cleaning and Sanitizing Personal Hygiene Pest Management Other PP’s HACCP FSMA Preventive Controls PrP’s Food Defense Produce Safety Graphic by Robert B. Gravani

15. HACCP – Hazard Analysis & Preventive Controls Covers 3 types of potential food safety hazards: Biological Chemical Physical • Hazards may be naturally occurring in food, contributed by environment, or generated by a mistake during processing • FSMA adds Radiologicalhazards

16. Sources of Hazards • Raw Materials and/or Ingredients Used in the Product • Activities Conducted at Each Step in the Process • Equipment Used to Make the Product • Packaging and Packaging Material • Storage and Distribution • Intended Use (Misuse) • Consumers of the Product (Population)

17. Food Safety Plans HACCP Plan FSMA – Food Safety Plan Domestic & Foreign Human Foods & Animal Foods (FDA) Seafood, Juice (FDA) Meat & Poultry (USDA)

18. FSMA: Building a Food Safety System Company ABC’s: Food Safety Plan Hazard Analysis Defines: Hazards and Preventive Controls Foundational Food Safety Programs (SOPs) General Controls: Prerequisite Type Programs GMPs, SSOP, Supplier Controls, Food Defense and Others Barach Enterprises LLC GRAPHIC by BARACH ENTERPRISES LLC

19. Key Criteria for Food Equipment Sanitary Design • Minimize Surface Area to Clean • Parts and Assemblies Easy to Access and Inspect • Disassembly Can be Completed by Hand or With Simple Tools • Cleaning and Sanitizing Procedures Can be Repeated by All Responsible Employees

20. GMA Equipment Sanitary Design Checklist for Low-Moisture Foods Assist in evaluating compliance with the GMA Ten Principles for Sanitary Design for low-moisture foods • Satisfactory -All • Marginal – ½ Points • Unsatisfactory – No Points

21. Validation: Today & Tomorrow Traditionally, validation has encompassed scientific or technical support indicating a HACCP plan will effectively control targeted hazards (CCPs) As required by FSMA, FDA may expand the validation requirements to include more scientific and in-plant validation proof including validation of equipment, processes and programs

22. Opportunities with Equipment Manufacturers • Equipment Design and Construction • Sanitation Practices • Allergen Management • Environmental Monitoring • Temperature Monitoring • Validation • Scientific Support & In-plant Validation • Employee Training • Records and Traceability        

23. Working Together on FSMA Product Properties (Risk)  Packaging Ingredients Labeling Water  Air/ Environment People Equipment Design & Cleaning Finished Product  Processing & Controls 

24. Design Ideas – New and Retrofit Equipment If you can’t see it you can’t clean it! Provided by Triangle Package Machinery Co.

25. Key Criteria for Food Equipment Sanitary Design • Minimize Surface Area to Clean • Parts and Assemblies Easy to Access and Inspect • Disassembly Can be Completed by Hand or With Simple Tools • Cleaning and Sanitizing Procedures Can be Repeated by All Responsible Employees

26. Find the Sanitary Design Problems… • 4-Bolt Ball Valve: Difficult to Clean and Disassemble • Capped Ferrule: Provides a Dead-end • 1” Drain Line is Dead-end Equipment Photos by Tom Fishlove, General Mills-Sanitation Center of Excellence Pack Expo 2012

27. Avoid a Ledge Where Product Can Build Up

28. Equipment Support/Leveling Pads -The Good and the Not So Good Internal Threads, O-Rings & Hygienic Finish Exposed Threads

29. Example of Equipment with Tool-Less Disassembly -- No Need to Use Tools that May be Misplaced or Lost

30. Future Education & Technical Assistance • Alliances • FDA - National Technical Assistance Network & Information Center (Phone/Emails) • FDA Contract on Guidance • Deloitte and Touche • Institute of Food Technologists • Leavitt Partners • GMA – FSMA Manual & Webinars • Others

31. Your Resource for Packaging and Processing Innovation 31 31

32. Questions ? Contact: Jeff.barach@cox.net 703-242-9377 www.jbarach.com

33. TLMI Technical ConferenceDanielle Gallo OSHA’s modification of the Hazard Communication Standard (HCS) and it’s alignment with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

34. About the Presenter Brady Worldwide, Inc. is an international manufacturer and marketer of complete solutions that identify and protect premises, products and people, including products in high-performance labels and signs, safety devices, printing systems and software, and precision die-cut materials. Danielle Gallo is a Senior Product Marketing Specialist for Brady Worldwide, Inc. She manages Brady’s safety and facility identification products for industry regulatory compliance and safety concerns. She is active in developing new products and solutions for the industry, as well as monitoring ever-changing regulations and global standards.

35. Hazard Communication Standard Initially developed in 1983 to give employees a “right to know” Requires a comprehensive hazard evaluation and communication process Chemical manufacturers and importers must develop and provide a container label and a Material Safety Data Sheet (MSDS). Employers with employees exposed to hazardous chemicals must develop a hazard communication program including: Labels Access to SDSs Training on the workplace hazardous chemicals The previous HCS established requirements for minimum information that must be included on labels and SDSs, but did not provide specific language to convey the information or a format in which to provide it.

36. Background of GHS Why the need? Country-by-country, around the globe, hazard classification and communication laws are similar in purpose, but different enough to result in inconsistent hazard classification for similar products, and dissimilar looking labels and SDS. Need to harmonize and improve safety information and facilitate international trade through compatible classification methods, SDS and labels. NFPA RTK - US HSID Std - Europe WHMIS Std – Canada

37. Background of GHS United Nations Conference on Environment and Development (1992) mandated a globally harmonized chemical classification and labeling system Member States actively involved in creation: Unites States (OSHA representatives) Canada European Union Additional UN Members GHS was formally adopted in 2002 United Nations Committee of Experts on the Transport of Dangerous Goods Globally Harmonized System of Classification and Labeling of Chemicals Goal of GHS Written by the UN, the goal of the GHS is to harmonize differing workplace hazard classification and labeling systems across the world How GHS accomplishes that goal Harmonizes how hazardous substances and mixtures are classified Changes how hazard information is communicated (new pictograms and phrases) Streamlines the format of SDS and labels

38. What is GHS? NFPA RTK - US Globally-Standardized GHS Std WHMIS Std – Canada HSID Std - Europe

39. United States – adopted by OSHA as of May 2012 Canada – Reviewing for development: Health Canada Policy and Programme Services Office is national coordinator. Currently reviewing GHS for incorporation into WHMIS Estimated changes to WHMIS occurring in Spring 2013 Mexico – Voluntary standard proclaimed: The first NAFTA member to adopt the GHS as a basis for national health & safety regulations Proclaimed a new voluntary standard, NMX-R-019-SCFI-2011 (June 4, 2011). NOM-018-STPS-2000 remains in force. Dual labeling & SDS’s result Companies importing/ exporting products to and from countries in Europe, Asia & South America are required to comply with both NOM 018-STPS-2000 & GHS ANIQ (Associacion Nacional de la Industria Quimica) requested authorization from the Labor Secretariat for an alternate procedure to comply with NOM 2000 through the GHS NMX-R Brazil – Implemented for substances: Pure substances (GHS classification, labeling & SDS) mandatory as of Feb 2011. Mixtures mandatory as of June 1, 2015 GHS Status in Americas

40. 27 EU Countries – Implemented under Regulation 1272/2008 CLP is mandatory for 4,500 SUBSTANCES as of December 1, 2010 CLP will be mandatory for all MIXTURES on June 1, 2015 2ND technical adaptation; Regulation 286/2011 Australia: Implemented (Dec. 2016 deadline) China: Implemented Japan: Implemented 67 countries globally - at least partially implemented: See UN website: http://live.unece.org/trans/danger/publi/ghs/implementation_e.html GHS Status in Europe & Around the Globe

41. OSHA’s Final Ruling on GHS OSHA has updated its Hazard Communication Standard (HCS) to align with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Modifications will reduce costs and burdens while protecting employers and employees. Modifications include: • Revised criteria for classification of chemical hazards • Revised and standardized labeling requirements • A specified format for safety data sheets • Requirements for employee training on labels and safety data sheets Based off of the 3rd revised edition of GHS.

42. Impact of GHS for U.S. Businesses 880,000 hazardous chemicals are currently used in the U.S. Hazard Communication affects 43 million American workers in over 5 million workplaces. GHS will prevent 500 injuries/illnesses and 43 deaths per year, equaling a total of $250 million in reduced health and safety risks. Costs per year will total $201 million dollars to comply with revisions to the HCS. Future net benefits are estimated at $556 million dollars per year. U.S. Dept. of Labor, OSHA, Directorate of Evaluation and AnalysisOffice of Regulatory Analysis, 2011.

43. 5 Main Requirements For a Complete Hazard Communication Program 1. Written Hazard Communication Plan 2. Chemical Inventory 3. Labels & Warnings 4. Safety Data Sheet Documents 5. Employee Training

44. Written Hazard Communication Plan 1. Written Hazard Communication Plan The starting point; your current plan: • Blueprint for implementation • Written plan that identifies how all requirements will be met, including: • labels and other forms of warning • safety data sheets (SDS) • employee information and training • Review your current plan with the revised, published rule in-hand OSHA Model Hazard Communication Plan

45. Written Hazard Communication Plan(continued) Model Hazard Communication Program • Company Policy • To ensure that information about the dangers of all hazardous chemicals used by (Name of Company) is known by all affected employees, the following hazardous information program has been established. • Container Labeling – Revise & Train • Safety Data Sheets (SDSs) – Revisions. Obtain & Train • Employee Training and Information – Update • Hazardous Non-routine Tasks • Informing Other Employers/Contractors • List of Hazardous Chemicals – Update Your Inventory • Chemicals in Unlabeled Pipes • Program Availability A copy of this program will be made available, upon request, to employees and their representatives. OSHA Model Hazard Communication Plan

46. Chemical Inventory 2. Chemical Inventory Review your chemical inventory: • Prepare list of chemicals • Survey the workplace for chemicals: • solids/liquids/gases/fumes • Check both the hazardous nature and potential for exposure • Check for updated SDS’s • New chemical receipts • Chemical purging • SDS management for both • Attach chemical list to written program *Your chemical inventory should be reviewed annually

47. Update the labels and warnings section of written program: Process and execution for container labeling Worn, missing and unreadable labels are replaced as needed Check secondary container labels for consistency with the: Revised HazCom regulation Revised labels on containers being received Label identities should link to the SDS & chemical inventories Check warning signs & labels for OSHA Subpart Z-Toxic & Hazardous Substances. Many may be revised; eg § 1910.1027 Cadmium Chemical Labels and Warnings 3. Labels & Warnings

48. GHS Pictograms

49. GHS Pictograms Chemical/Physical Risks Explosives Flammables Oxidizers Gases Under Pressure Corrosives Chemical Risks Pictograms Health Risks 1.Severe Toxics 2.Acute Toxics 3.Health Dangers 4.Corrosives Health Risks Pictograms Environmental Hazard Class* *OSHA does not regulate the Environmental Hazard Class, however the EPA is expected to incorporate this element of GHS into their standards.

50. Changes to the HazCom Label Six Elements of the GHS label format