Presenting a live 90 ‐ minute webinar with interactive Q&A Food Safety Claims: Products Liability Issues Mastering the Standards for Fault, Causation, and Damages in Foodborne Illness Litigation THURS DAY, DECEMBER 8, 2011 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Today s faculty features: Lee N. S mith, Partner, Stoel Rives , S acramento, Calif. Joseph J. Bottiglieri, Partner, Bonner Kiernan Trebach & Crociata , Washington, D.C. Jonathan M. Cohen, Partner, Gilbert , Washington, D.C. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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From Field to Fork The Food Safety Modernization Act P Presented by: t d b Lee N. Smith Stoel Rives LLP 500 Capitol Mall Ste 1600 Sacramento, CA 95814 , 5 December 8, 2011 ,
Abstract Abstract In January 2011 President Obama signed the Food Safety Modernization Act to drive greater security, safety and M d i ti A t t d i t it f t d accountability of food products in our supply chain. This new law will require many new requirements for industries q y q that handle, process and package and distribute food products. While not all provisions of this new law go into effect immediately there are certain provisions that effect immediately, there are certain provisions that require your immediate attention. This session will help you understand what you should be doing to prepare your facility for compliance and reap the intended rewards it f ilit f li d th i t d d d it offers. 6
Agenda Agenda • Food Safety Modernization Act (“FSMA”) changes the status quo with respect to – Recalls – Keeping records, and – Detentions • How to respond to FDA investigations • How to respond to recall or threatened recall p • Other steps you take to prevent or mitigate liability 7
Food Safety Modernization Act (H R 2751) (H.R. 2751) • Most expansive changes in food safety Most expansive changes in food safety since the 1938 Act • Sweeping new enforcement authorities • Sweeping new enforcement authorities • Exacting new food import requirements • Major new program activities for FDA 8
FSMA Scheduling Issues FSMA Scheduling Issues • Statutory provisions Statutory provisions are already in place although many of although many of the guidelines and regulations remain regulations remain to be drafted 9
What Was the Status Quo Before the New Act? B f th N A t? • Recalls – Class I Recalls: • A situation in which there is a reasonable probability that the use of or exposure to a violatile product will th t th f t i l til d t ill cause serious adverse health consequences or death. – Class II Recalls: • A situation in which use of or exposure to a violatile product may cause temporary or medically reversible adverse health consequences or where the probably adverse health consequences or where the probably of serious adverse health consequences is remote. 10
What Was the Status Quo B f Before the New Act? (cont.) th N A t? • Recalls (cont.) ( ) – Class III Recalls: • A situation in which use of or exposure to a violatile product is not likely to cause adverse health d i lik l d h l h consequences. 11
Mandatory Recall Authority (FSMA § 206) (FSMA § 206) • Mandatory recall ordered if “reasonable probability that an article of food is: – Food is adulterated under section 402 or misbranded under section 403(w) and; under section 403(w) and; – The use of or exposure to such article will cause serious adverse health consequences or death to humans or animals. • Opportunity for voluntary recall within FDA appropriate timing appropriate timing • Hearing within two days of the order’s issuance 12
FSMA Provisions Effective Now FSMA Provisions Effective Now • Stronger Records Access Authority (FSMA § 101) Stronger Records Access Authority (FSMA § 101) • Mandatory Recall Authority (FSMA § 206) • Increased Frequency of Inspections (FSMA § 201) q y p ( § ) • Whistleblower Protection (FSMA § 402) • Foreign Facilities and Refusal of Inspection g p (FSMA § 306) • Changes to Administrative Detention Standard (FSMA § 207) 13
Stronger Records Access Authority (FSMA § 101) (FSMA § 101) • When “reasonable When reasonable probability” of “serious adverse health consequences” • Includes records of other food affected in similar manner – NEW • Proper credentials and written notice 14
Increased Frequency of Inspections (FSMA § 201) (FSMA § 201) • Immediate increased Immediate increased frequency of inspections – Once every 7, 5, 3 y , , years • Risk-based – The higher the risk, the more inspections 15 1 5
Whistleblower Protection (FSMA § 402) (FSMA § 402) • Protects employees from discharge, discrimination Protects employees from discharge, discrimination in compensation or conditions of employment with respect to: – Providing information re: violation of FDC Act – Testifying, assisting or participating in a proceeding re: a violation re: a violation – Objecting to an “activity, policy, practice or assigned task” they “reasonably believe to be a violation” y y • Remember to update Employee Handbooks to reflect this policy 16
Foreign Facilities and Refusal of Inspection (FSMA § 306) I ti (FSMA § 306) • If the FDA requests that it q be allowed to inspect a foreign facility, it must allow entry to U.S. inspector within 24 hours of requesting entry f ti t • Or, imported food from th t f that facility will be refused ilit ill b f d admission 17
Broader Authority to Detain Foods (FSMA § 207) (FSMA § 207) • Administratively detain foods Administratively detain foods – Effective as of July 3, 2011 • Regulations being promulgated Regulations being promulgated • Lowers standard for FDA to detain foods – FDA only needs “A reason to believe” food is “adulterated or misbranded.” – Class I recall situation not required 18
Selected FSMA Provisions Effective Soon • Amendments to the Reportable Food Registry Amendments to the Reportable Food Registry (requiring more information and additional disclosure) (FSMA § 211) • Suspension of Registration (FSMA § 102) • Preventative Controls (FSMA § 103) • FDA Lab Accreditation (FSMA § 202) • Traceability (FSMA § 204) • Major Changes to Regulation of Imports (FSMA §§ 301,302) 19
Reportable Food Registry (RFR) Reportable Food Registry (RFR) • “Reportable Food” Reportable Food – “Reasonable probability” of “serious adverse health consequences to humans or animals” health consequences to humans or animals • “Responsible Party” – FDA-registered facility where product is FDA registered facility where product is “manufactured, processed, packed, or held” • “Requirement” Requirement – Report to FDA portal within 24 hours 20
Amendments to RFR (FSMA § 211) Amendments to RFR (FSMA § 211) • New “critical information” required • Within 18 months, FDA will require “consumer-oriented information” including – Description – Product ID codes – Contact information Contact information – Anything else FDA deems necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food 21
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