Food Safety Modernization Act

Transcription

1 Food Safety Modernization Act Leah Wilkinson Vice President, Public Policy and Education American Feed Industry Association (703)

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5 Who is AFIA? Represents the business, legislative and regulatory interests of the U.S. feed industry and its suppliers > 670 members AFIA members include: Feed Manufacturers Pet Food Manufacturers Ingredient Suppliers Integrators Equipment Manufacturers Renderers Industry Support Associations Educational Institutions Pharmaceuticals Media Membership= 75% of the commercial feed in the U.S. Membership = 70% of the non-grain ingredients Page 5

6 FSMA

7 FSMA Snap Shot Signed into law January 4, 2011 Result of several food safety incidents - Melamine - Spinach, peanut butter, eggs Identified by FDA as the most sweeping reform of food safety laws in more than 70 years - GOAL: Aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it Page 7

8 Food Safety Modernization Act Who s covered? Facilities that manufacture, process, pack or hold animals food and required to register with FDA under Bioterrorism Act Exemptions Farms as defined in Qualified facilities (very unlikely for animal food) Other specific exemptions Animal food means food for animals other than man and includes pet food, animal feed and raw materials and ingredients Page 8

9 Food Safety Modernization Act Farm as defined in 21 CFR part (b)(3): Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term farm includes: (i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. Utilize contract growers = not a farm = must register = FSMA Page 9

10 Complete Framework of FSMA for Animal Food Industry Preventive Controls for Animal Food (Part 507) - CGMPs - Hazard Analysis - Food Safety Plan Foreign Supplier Verification Program (FSVP) for Importers Sanitary Transportation of Human and Animal Food Accredited Third-Party Certification Page 10

11 What Does FSMA Require? Facilities that manufacture, process, pack or hold animal food must (includes retail): - Comply with CGMP requirements - Train Qualified Individuals Facilities that manufacture, process or pack must also: - Designate and train a Preventive Controls Qualified Individual - Conduct a Hazard Analysis - Develop a written Food Safety Plan to address the hazards identified Page 11

12 Status FDA Guidance Documents Need to finalize CGMP docs Comments due April-July for other guidance docs CGMP inspections underway Sanitary Transportation April 6, 2017 Foreign Supplier Verification May 30, 2017 First inspection in March Prepare for Sept. 17, 2018 Very small firms = CGMPs Small firms = hazard analysis and PCs Page 12

13 FSMA: CGMPs FDA Draft Guidance Documents to Date: - Draft GFI #235 - Current Good Manufacturing Practice Requirements for Food for Animals - Draft GFI #239 - Human Food By-Products for Use as Animal Food - Draft GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - Draft GFI Sanitary Transportation - Draft GFI Foreign Supplier Verification Page 13

14 AFIA FSMA Resources AFIA has resources available to members: - QI Training Video - PCQI Training Course - Hazard Analysis Scientific Literature Database - Training Webinars - Sample Food Safety Plan - FSMA update articles - Staff members available to answer questions Page 14

15 Free FSMA Webinars &i=21 Recordings available until Sept Page 15

16 FSMA Inspections and FDA FOIA Results

17 FDA CGMP Inspections FOIA 192 inspections performed and completed between Jan. 1 and Dec. 22, 2017 Inspections held in 35 states 64% feed/integrators; 10% pet food; 17% ingredients; 6% warehouses; 2% other 12 Form 483s were issued, 6 VAIs were issued, 5 were not classified; 1 was NAIs AFIA has copies of 483s issued Product type and geographic diversity continues Page 17

18 FDA CGMP Inspections by location Page 18

19 Inspection Activity What we ve learned so far: They usually do a thorough walk-thru of the plant Pest control seems to be a major focus Unlabeled containers and trash cans is a frequent observation They are asking to see QI training documentation They are asking about the PCQI and training Frequently, they are asking to see records for which they are not entitled to see The best preparation for an inspection is familiarity with the rule Page 19

20 FDA Hazard Analysis Inspection Plan Large firms compliance as of Sept Delayed inspections until Sept Small firms compliance Sept Inspections will start after Jan. 1, 2019 Will do CGMP and HA/PC inspections at same time May add in BSE inspection Sanitary transportation readiness questions Page 20

21 THANK YOU