Presenting a live 90 ‐ minute webinar with interactive Q&A Food Safety Product Liability Claims Mastering the Standards for Fault, Causation and Damages in Foodborne Illness Litigation THURS DAY, JUNE 13, 2013 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: T d ’ f l f Lee N. S mith, S hareholder, Weintraub Tobin , S acramento, Calif. Felicity A. McGrath, Partner, Bonner Kiernan Trebach & Crociata , Washington, D.C. Jonathan M. Cohen, Partner, Gilbert , 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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Food Safety Management Act Rolls On and How It May Affect Food Liability Cases Liability Cases L E E N S M I T H L E E N . S M I T H W E I N T R A U B | T O B I N 4 0 0 C A P I T O L M A L L , S U I T E 110 0 S A CR A M E N T O , CA L I F O R N I A 9 5 8 14 S A CR A M E N T O , CA L I F O R N I A 9 5 8 14 9 16 - 5 5 8 - 6 0 0 0 L N S M I T H @ W E I N T R A U B . CO M
Abstract In January 2011 President Obama signed the Food Safety Modernization Act to provide greater security safety and Modernization Act to provide greater security, safety and accountability of food products in our supply chain. The new law involved many new requirements for industries that handle, process, package, and distribute food products. Since 2011, a k d di t ib t f d d t Si 2011 number of the more significant the rules have been promulgated, the two most significant for food processors, the Preventive Controls for Food Facilities and the Produce Safety Rule were C l f F d F ili i d h P d S f R l circulated for comment in early 2013 with an extended comment date of September 16, 2013. Many of these rules could impact Food Liability Law by changing industry standards and driving new contract requirements. 6
Agenda Food Safety Modernization Act (“FSMA”) Food Safety Modernization Act ( FSMA ) changed the status quo with respect to : FSMA Statute Effect on Food Liability What You Can Do to Manage Your Operations Better Under the Act 7
Food Safety Modernization Act (H.R. 2751) (H R 2751) Most expansive changes in food safety since Most expansive changes in food safety since the 1938 Act Sweeping new enforcement authorities S i f t th iti Exacting new food import requirements g Major new program activities for FDA/with corresponding budgetary issues corresponding budgetary issues 8
Significant FSMA Provisions Stronger Records Access Authority (FSMA § 101) g y ( § ) Mandatory Recall Authority (FSMA § 206) Increased Frequency of Inspections (FSMA § 201) Increased Frequency of Inspections (FSMA § 201) Whistleblower Protection (FSMA § 402) Foreign Facilities and Refusal of Inspection (FSMA § 306) Changes to Administrative Detention Standard (FSMA § 207) 9
Additional Changes Amendments to the Reportable Food Registry p g y (requiring more information and additional disclosure) (FSMA § 211) Suspension of Registration (FSMA § 102) S i f R i i (FSMA § 102) Preventative Controls (FSMA § 103) Produce Safety Rules (FSMA § 105) P d S f t R l (FSMA § 105) FDA Lab Accreditation (FSMA § 202) Traceability (FSMA § 204) Traceability (FSMA § 204) Major Changes to Regulation of Imports (FSMA §§ 301 302) (FSMA §§ 301,302) 10
Stronger Records Access Authority (FSMA § 101) (FSMA § 101) When “reasonable probability” of “serious adverse health consequences” consequences Now, includes records of other food affected in other food affected in similar manner Proper credentials and Proper credentials and written notice 11
RECALLS Prior to FSMA Prior to FSMA Prior to FSMA, recalls were voluntary and usually done at l t d ll d t the discretion of the parties; although the FDA could file for injunctive relief. j 12
What Was the Status Quo Before the New Act? Before the New Act? Recalls Class I Recalls: A situation in which there is a reasonable probability that A situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death. Class II Recalls: A situation in which use of or exposure to a volatile product may cause temporary or medically reversible d t t di ll ibl adverse health consequences or where the probably of serious adverse health consequences is remote. 13
What Was the Status Quo Before the New Act? (cont ) Before the New Act? (cont.) Recalls (cont.) ( ) Class III Recalls: A situation in which use of or exposure to a volatile A situation in which use of or exposure to a volatile product is not likely to cause adverse health consequences. 14
Mandatory Recall Authority (FSMA § 206) (FSMA § 206) Mandatory recall can be ordered by the FDA if there is a “reasonable probability” that an article of food is: Adulterated under section 402 or misbranded under section 403(w) and; Use of or exposure to such article will cause serious adverse health consequences or death to humans or adverse health consequences or death to humans or animals. Opportunity for voluntary recall within FDA appropriate pp y y pp p timing Hearing within two days of the order’s issuance 15
Increased Frequency of Inspections (FSMA § 201) (FSMA § 201) Immediate increased frequency of inspections Immediate increased frequency of inspections Once every 7, 5, 3 years Risk-based high-risk facilities first Risk-based, high-risk facilities first The higher the risk, the more inspections The higher the risk, the more inspections 16
Whistleblower Protection (FSMA § 402) (FSMA § 402) Protects employees from discharge, discrimination in p y g , compensation or conditions of employment with respect to: Providing information re: violation of FDA Act P idi i f ti i l ti f FDA A t 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” violation Remember to update Employee Handbooks to reflect this policy policy 17
Foreign Facilities and Refusal of Inspection (FSMA § 306) Inspection (FSMA § 306) If the FDA requests that it be q allowed to inspect a foreign facility, it must allow entry to U.S. inspector within 24 hours of requesting entry Or imported food from that facility will be refused that facility will be refused admission 18
Broader Authority to Detain Foods (FSMA § 207) (FSMA § 207) Administratively detain foods Administratively detain foods Lowers standard for FDA to detain foods 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 19
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 i t d f ilit h d t i “manufactured, processed, packed or held” “Requirement” “R i t” Report to FDA portal within 24 hours 20
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