2013 TLMI Technical Conference FDA & OSHA – New Reforms & Standards Affecting the Industry Session Chairs: David Dickerson, Rick Fox 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 . 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. 2013 TLMI Technical Conference FSMA Will Bring Added Demands on Food Safety Systems: Is Packaging Ready? TLMi Conference Chicago, IL September 5, 2013 Jeffrey Barach, Ph.D. 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 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 Riskbased Preventive Controls Develop a Written Food Safety Plan Follow Updated cGMPs (Part 110 -> Part 117) Compliance Based on Company Size (1-3 years) FSMA Status Summary Today • Mandatory Recall Authority • Records Access • Preventive Controls - Human • Produce Safety • Traceability Tomorrow • Preventive Controls – Animals & Pets • FSVP • 3rd Party Accreditation • VQIP • Food Defense FDA’s Proposed Timeline Regulation Proposed Rule Publication Final Rule Publication Preventive ControlsHuman Food January 16, 2013 May 1, 2014 Preventive ControlsAnimal Food August 31, 2013 May 1, 2014 Produce Safety January 16, 2013 May 1, 2014 Foreign Supplier Verification Program August 31, 2013 May 1, 2014 Accreditation of 3rd Party Auditors August 31, 2013 May 1, 2014 Food Defense August 31, 2013 May 1, 2014 Filed with US District Court/ Northern CA – CFS & CEH vs. FDA; June 2013 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 Proactive √ Be 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?) 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 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 FSMA – Composition Overview Food Safety Assurance Pyramid Total Management Commitment HACCP FSMA Preventive Controls Education and Training Biological, Chemical, and Physical Hazards Food Cleaning Temperature and Control Sanitizing Food Defense HACCP Personal Pest Hygiene Management Produce Safety Graphic by Robert B. Gravani PrP’s 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 Radiological hazards 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) Food Safety Plans Seafood, Juice (FDA) Meat & Poultry (USDA) Domestic & Foreign Human Foods & Animal Foods (FDA) FSMA: Building a Food Safety System Process Controls (CCPS) Hazard Analysis Defines: Hazards and Preventive Controls Parameters & Limits Monitoring Recall Plan Records Allergen Hazard Controls Verification Corrective Actions Sanitation Hazard Controls General Controls: Prerequisite Type Programs GMPs, SSOP, Supplier Controls, Food Defense and Others Barachby Enterprises LLC GRAPHIC BARACH ENTERPRISES LLC Company ABC’s: Food Safety Plan Foundational Food Safety Programs (SOPs) 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 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 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 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 Working Together on FSMA Ingredients Product Properties (Risk) Packaging Labeling Water Air/ Environment People Finished Product Processing & Controls Equipment Design & Cleaning Design Ideas – New and Retrofit Equipment If you can’t see it you can’t clean it! Provided by Triangle Package Machinery Co. 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 Find the Sanitary Design Problems… 1) 4-Bolt Ball Valve: Difficult to Clean and Disassemble 2) Capped Ferrule: Provides a Dead-end 3) 1” Drain Line is Dead-end Equipment Photos by Tom Fishlove, General Mills-Sanitation Center of Excellence Pack Expo 2012 Avoid a Ledge Where Product Can Build Up Equipment Support/Leveling Pads The Good and the Not So Good Internal Threads, O-Rings & Hygienic Finish Exposed Threads Example of Equipment with Tool-Less Disassembly -No Need to Use Tools that May be Misplaced or Lost 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 Your Resource for Packaging and Processing Innovation 31 Questions ? Contact: Jeff.barach@cox.net 703-242-9377 www.jbarach.com 2013 TLMI Technical Conference TLMI Technical Conference Danielle 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) 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. 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. 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 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 What is GHS? NFPA RTK - US Globally-Standardized GHS Std WHMIS Std – Canada HSID Std - Europe GHS Status in Americas 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 Europe & Around the Globe 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 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. 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 Analysis Office of Regulatory Analysis, 2011. 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 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 Written Hazard Communication Plan (continued) Model Hazard Communication Program 1. 2. 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. 3. Container Labeling – Revise & Train 4. Safety Data Sheets (SDSs) – Revisions. Obtain & Train 5. Employee Training and Information – Update 6. Hazardous Non-routine Tasks 7. Informing Other Employers/Contractors 8. List of Hazardous Chemicals – Update Your Inventory 9. Chemicals in Unlabeled Pipes 10. Program Availability A copy of this program will be made available, upon request, to employees and their representatives. OSHA Model Hazard Communication Plan 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 Chemical Labels and Warnings 3. Labels & Warnings 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 GHS Pictograms Health Hazard Flame Exclamation Mark Carcinogen Mutagenicity Reproductive Toxicity Respiratory Sensitizer Target Organ Toxicity Aspiration Toxicity Flammable Pyrophorics Self-Heating Emits Flammable Gas Self-Reactive Organic Peroxides Irritant (skin and eye) Skin Sensitizer Acute Toxicity (harmful) Narcotic Effects Respiratory Tract Irritant Hazardous to Ozone Layer (Non Mandatory) Gas Cylinder Corrosion Exploding Bomb Gases Under Pressure Skin Corrosion / Burns Eye Damage Corrosive to Metals Explosives Self-Reactives Organic Peroxides Flame over Circle Skull and Crossbones Environment (Non Mandatory per OSHA) Oxidizers Acute Toxicity (Fatal or Toxic) Aquatic Toxicity GHS Pictograms Chemical/Physical Risks 1. Explosives 2. Flammables 3. Oxidizers 4. Gases Under Pressure 5. 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. Changes to the HazCom Label Six Elements of the GHS label format Hazard & Precautionary Statements Hazard Statements Physical (H200 series codification) – Appendix B H200 unstable explosive H221 flammable gas Health (H300) – Appendix A H300 fatal if swallowed H301 toxic if swallowed Environmental (H400) – EPA H400 Very toxic to aquatic life Precautionary Statements General (P100) – P102 Keep out of reach of children Prevention(P200) – P235 Keep cool Response (P300) – P380 Evacuate area Storage (P400) - P403 Store in a well-ventilated place Disposal (P500) – P502 Refer to manufacturer for information on recycling Federal Register 9_30_09 Benefits of a GHS-formatted Label Provides immediate visual reminders of hazards Past labels were inconsistent in terminology and visuals Standardized signal word, visuals, and hazard statements are in place Pictograms reinforce message presented in the text while enhancing communication for low-literacy users Precautionary statements provide useful steps to protect and prevent from chemical related injuries Example of Multi-Language Label GHS Label Layouts on Packaging Outer Packaging: Box with a flammable liquid transport label* Inner Packaging: Plastic bottle with GHS hazard warning label From GHS Purple Book. * Only the UN transport markings and labels are required for outer packaging. GHS Label Layouts on Packaging From GHS Purple Book Secondary Container Labeling What is it? – – “Secondary container” is defined as any container being used beyond the original manufacturer’s bottle that the chemical was shipped in This may include: Portable or working containers Storage bottles that are created for distribution of smaller amounts of the chemical Do I need to label it? What does it need to say? Portable/Working Containers – – YES! The only time it does not need to be labeled is if the container is intended only for the immediate use of the employee who performs the transfer The label needs to: Identity of the hazardous chemical Identify appropriate hazard warnings (words, pictures, symbols or a combination) Provide the employees with the specific information regarding the physical and health hazards of the hazardous chemicals NFPA 704 and HMIS Systems There are currently no plans to change the existing NFPA 704 and HMIS Systems and Classification These systems will still be used primarily to convey hazardous information to emergency first responders Classification Differences between NFPA and GHS HMIS/NFPA Hazard Ratings GHS Hazard Categories 0 = Minimal Hazard Category 1 = Severe Hazard 1 = Slight Hazard Category 2 = Serious Hazard 2 = Moderate Hazard Category 3 = Moderate Hazard 3 = Serious Hazard Category 4 = Slight Hazard 4 = Severe Hazard Category 5 = Minimal Hazard Where will I see those differences? The GHS hazard categories are displayed in the chemical’s Safety Data Sheet and not typically shown on the label Due to the significant change in classifications, it will be imperative to train employees on the change to ensure there is no confusion or conflicting information given Sample Chemical Label in Both Systems Sample Chemical Label in Both Systems Butanone Chemical Hazard Information in SDS Flammability Category 2 Flammability Category 3 *Information excerpted from Sigma Aldrich Butanone MSDS, revised 05/08/2012 Secondary Container Labels Best Practice: Label your secondary container chemicals with the same GHS format as the way they came into the facility Best Practice: Use a dual-labeled approach to where you show both your NFPA/HMIS label alongside the GHS label Employers may choose to label workplace containers – With the same GHS label that is used to ship containers under the revised rule, – With label alternatives that meet the requirements for the standard National Fire Protection Association (NFPA) 704 Hazard Rating and the Hazardous Material Information System (HMIS) for labeling are considered acceptable for workplace containers – Information supplied on these labels must be consistent with the revised HCS (e.g. no conflicting hazard warnings or pictograms) Safety Data Sheets 4. Safety Data Sheet Documents Check your safety data sheets (SDSs) against your chemical inventory Do you have an (M)SDS for each chemical in your inventory? Do you have SDSs for other chemicals? Have duplicates and obsolete SDSs been removed? Contact chemical suppliers to receive or learn when they will begin supplying SDS’s according to the new format Are the SDSs readily accessible to employees? Safety Data Sheet Changes New SDS Order and Elements 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Identification of the substance or mixture and of the supplier Hazards identification Composition/information on ingredients First aid measures Firefighting measures Accidental release measures Handling and storage Exposure controls/personal protection Physical and chemical properties Stability and reactivity Toxicological information Ecological information** Disposal considerations** Transport information** Regulatory information** Other information including information on preparation and revision of the SDS GHS harmonization will standardize the order of SDS information for ease of use for employees along with improved accuracy of the information presented Previously know as Material Data Safety Sheets (MSDS), it is now referred to as Safety Data Sheets (SDS). The number of sections has been increased from a nine section format to 16 sections. **sections are not required in final rule but suggested by original U.N. GHS publication and may be added by employers So Who’s Responsible? Hazard Classification – Chemical manufacturers analyze existing formulations and re-classify products to new GHS standards Chemical Labels – Chemical manufacturers update primary container product labels to meet GHS standards and distribute upon purchase – Employers update secondary container labels and ensure all chemicals in the facility are clearly labeled and marked Safety Data Sheets (SDS) – Chemical manufacturers update all SDS to new 16-section format and distribute to customers – Employers ensure updated SDS are made available to all employees on-site Employee Training 5. Employee Training OSHA has not proposed to change training provisions under the HCS other than to initially train employees on new GHS elements. Minor revisions to the HCS on training: – Labels and SDSs must be adequately explained to employees. – Employees must understand standardized headings and sequence of SDS information. – Training on the standardized label elements must also be given. HCS training is meant to explain and reinforce information to the employees on areas of labels, SDSs, protective measures to be taken, and the understanding of chemical hazards in their workplace. Training is crucial! A study found employees did not understand 1/3 of the safety and health information with MSDSs, while 40% of individuals reading an MSDS had an overall difficulty understanding. General Elements of HazCom/GHS Training 1. Understanding the new Hazard Communication Standard 2. Understanding the Safety Data Sheet 3. Understanding Labels Pictograms Signal Words Hazard Statements Precautionary Statements 4. Understanding relationship of SDS and label 5. Understanding health information GHS Transition Timeframe December 1, 2015: Chemical distributors shipping product with updated SDS’s, and chemical labels December 1, 2013: Deadline to initially train employees on new label elements and SDS formats June 1, 2015: June 1, 2016: Chemical manufacturers reclassify chemicals, send SDS’s, and update chemical labels Full GHS Compliance: hazard communication program and workplace labeling updated Today 2013 2014 2015 2016 Getting Ready for GHS Take immediate action on: 1. 2. 3. 4. Staying alert for newly formatted SDS’s and capture them on file Update your chemical inventory Talk to our chemical supplies about their transition plans Chemical manufacturers and importers should begin preparing for/authoring GHS compliant SDS’s and labeling Coming up you will need to: 1. Be informed on regulation guidelines by December 1, 2013 2. Begin implementing GHS by the specified timeframe by December 1, 2013 3. Train your employees on GHS by December 1, 2013 In the future be prepared to: 1. Confirm that your secondary labeling system is GHS compliant. Use updated (GHS) labeling software to create and produce your labels by June 1, 2016 Hazard Communication and GHS What you need to know to prepare for the 2013 deadline