Consultants Update

1. Consultants Update Tom Badstubner Medical Gases Consultant Gases & Welding Distributors Association May 21, 2012 GAWDA Consultant's Forum Webinar

2. Discussion Topics • Am I a Food Producer? • Enforcement Authorities • FDA Food Gas Update • Food Registration (now and later) • Food Safety Modernization Act - • Key provisions • Lot numbers • Bulk qualification • Gas specifications and SOPs • Sample procedures and forms • Update to Medical Gas Safety Act GAWDA Consultant's Forum Webinar

3. Food Producer??? • Am I a food gas producer/warehouser? • CO2, Beer Gas for beverages • Nitrogen, argon and SO2 for wines • Hydrogen for fatty acids • Nitrogen for food packaging • Etc. GAWDA Consultant's Forum Webinar

4. Enforcement Authorities • Federal Food Enforcement • Laws • Regulations • Guidance • Enforcement Discretion • State Level Enforcement, Boards of Health GAWDA Consultant's Forum Webinar

5. Food Gas Update • Laws and Regulations • Federal Food, Drug and Cosmetic Act of 1938 (FFDCA), amended • Part 110 – Food Good Manufacturing Practices • Part 182 & 184 GRAS • CO2, SO2, N2, He, Propane, Butane • Public Health Security and Bioterrorism Preparedness Response Act of 2002 (BTA) • Registration, receiving/shipping records GAWDA Consultant's Forum Webinar

6. Food Gas Update • Sanitary Food Transportation Act of 2005 (SFTA) • FDA has authority to regulate the transportation of food • In 2010 the FDA began the rule making process • Did not anticipate unique aspects of food gases • FDA Food Safety Modernization Act of 2011 (FSMA) • Increases inspection, recall and compliance action authority GAWDA Consultant's Forum Webinar

7. Food Gas Update • Inspection activity • Mostly connected to drug inspections • Inspection focus... So far… • Raw material qualification • Be sure you have CoC, CoA or you have analyzed all bulk food gases (CO2, etc.) • Ambiguity among food inspectors about testing • Facility cleanliness & maintenance • Get a copy of the sample cleaning & maintenance log • Bakery model… inspectors really do not understand gases (pressurized systems, etc.) • Please call Tom when you are inspected • Latest information • Understand the evolving enforcement GAWDA Consultant's Forum Webinar

8. Food Registration • Required by Public Health Security and Bioterrorism Preparedness Response Act of 2002 (BTA) • Unevenly enforced at first, now clearly enforced • Production & warehouse locations • Easy to self-register • Email tom@asteriskllc.com for a one-page whitepaper with instructions GAWDA Consultant's Forum Webinar

9. Food Safety Modernization Act • Registration to begin from October to December of each even numbered year • Beginning in 2012 • May be an enhanced BTA registration… may be a new registration GAWDA Consultant's Forum Webinar

10. Food Safety Modernization Act • Food Safety Modernization Act (FSMA) - • Key provisions • Lot numbers • Bulk qualification • Gas specifications and SOPs GAWDA Consultant's Forum Webinar

11. FSMA – Key Provisions • Increased inspections activity • Preventive controls (HACCP) • Recall and compliance action authority • Suspension of registrations/fees • Foreign food producers GAWDA Consultant's Forum Webinar

12. FSMA – Shipment Records • See PDF: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm292746.htm • Covers the “immediate previous source and immediate subsequent recipients of food.” • Records requirements also apply to warehouse operations • Do not need to keep records of the distribution to “consumers” • “Vertically Integrated Companies” need not track distribution within branches… unless the food is transported by an outside company. • Two year record retention period .. even if the product is held longer than two years. Still keep records of shipment when it ships. GAWDA Consultant's Forum Webinar

13. FSMA – Lot Numbers • Track incoming and outgoing food shipments by lot or control number for repackaging operations – 1.345(a)(4) • Lot numbers not required to be tracked for distribution only operations – 1.337 1.345 GAWDA Consultant's Forum Webinar

14. Subpart J Establishment, Maintenance, and Availability of Records Sec. 1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? (a) If you are a nontransporter, you must establish and maintain the following records for all food you receive: (1) The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the nontransporterimmediate previous source, whether domestic or foreign; (2) An adequate description of the type of food received, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce); (3) The date you received the food; (4) For persons who manufacture, process, or pack food, the lot or code number or other identifier of the food (to the extent this information exists); (5) The quantity and how the food is packaged (e.g., 6 count bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) tank); and (6) The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate previous source (the transporter who transported the food to you). GAWDA Consultant's Forum Webinar

15. Are you a “Nontransporter”? Section 1.328 defines a nontransporter as a person who owns food or who holds, manufactures, processes, packs, imports, receives, or distributes food for purposes other than transportation. GAWDA Consultant's Forum Webinar

16. Bulk Qualification • All incoming bulk raw material must be “qualified” • Certificate of Conformance (CoC) • Certificate of Analysis (CoA) • Your own analysis • See sample SOPs for qualification forms GAWDA Consultant's Forum Webinar

17. Gas Specifications and SOPs • Sample Food SOPs are available email tom@asteriskllc.com • Includes procedures to support the latest regulations, enforcement and interpretations • Monthly GAWDA Food Gas Roundtables • First Friday of most months – 2:00 PM ET • Overflow capabilities • Recorded • Juliet@asteriskllc.comfor invitations GAWDA Consultant's Forum Webinar

18. Sample Procedures 2. Compliance 2.1 PART 110—Current Good Manufacturing Practices 2.2 GRAS—Generally Recognized As Safe Regulations 3. Products 3.1 Oxygen – Compressed 3.2 Oxygen – Liquefied 3.3 Nitrogen – Compressed 3.4 Nitrogen – Liquefied 3.5 Carbon Dioxide, High Pressure Cylinder 3.6 Carbon Dioxide, Liquid Container 3.6 Nitrous Oxide, High Pressure Cylinder 3.7 Food Gas Mixtures 3.7.1 - 25% Carbon Dioxide in Nitrogen – 300 3.7.2 - 20% Carbon Dioxide in Oxygen – 200 3.7.3 - 20% Carbon Dioxide in Oxygen – 250 3.7.4 - 20% Carbon Dioxide in Oxygen – 300 3.8 Argon – Compressed GAWDA Consultant's Forum Webinar

19. Sample SOP GAWDA Consultant's Forum Webinar

20. Medical Gas Modenization Act Updte • Accepted into the Prescription Drug User Fee Act (PDUFA) by the House and Senate • PDUFA must be passed this year • Includes: • Recognition (“approval”) for core medical gases and mixtures • Path to specific medical gas regulations • No additional fees • Some limited controversy about mixtures remains GAWDA Consultant's Forum Webinar

21. Contact Info Tom Badstubner • Office (508) 883-0927 • Cell (443)255-8984 • Fax (508) 883-3558 • Email tom@asteriskllc.com GAWDA Consultant's Forum Webinar