FSMA Information & Compliance for Fuel Ethanol Producers

Transcription

1 FSMA Information & Compliance for Fuel Ethanol Producers Chad Poppe Compli Associates

2 About Compli Associates Compli Associates specializes in developing and managing practical and cost effective compliance solutions. Compli s regulatory experience spans the fuel, feed, pharmaceutical, and medical fields, resulting in a unique and well-rounded perspective on regulatory compliance. Compli also has extensive first-hand experience with ethanol production, creating a distinctive combination of regulatory compliance and real-world production.

3 Legal Disclaimer Every effort has been made to ensure the accuracy of the information being provided. However, Compli Associates does not guarantee or warrant the accuracy of any of the statements in this presentation, and Compli Associates shall not be liable for any individual s or entity s reliance on such information. Each individual or entity is responsible for its own compliance with federal, state, and local laws.

4 What is FSMA? Food Safety Modernization Act (FSMA) Enacted January 4, 2011 Last major change to food/feed law was 1938 Final Rules Published September 17, 2015 Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals

5 What is FSMA? FSMA gives the FDA more tools to monitor and control the food (both Human and Animal) safety of products within and outside the United States Increases the FDA s Recall Authority Increases the FDA s Inspection authority Requires Risk-Based Preventative Controls

6 What is FSMA? Three Main Components: 1) cgmps Current Good Manufacturing Practices 2) HARPC Hazards Analysis and Risk Based Preventative Controls 3) Sanitary Transportation

7 Who is Covered Under FSMA? Facilities that manufacture, process, pack or hold animal food and are required to register with FDA Applies to domestically produced and imported food for animals Ethanol Industry examples DDGS, Wet Distillers Grains, Corn Distillers Oil

8 Compliance Timeline Business Size cgmp Compliance Date Preventive Controls Compliance Date Businesses other than small and very small 1 year - Sept. 19, years - Sept. 18, 2017 businesses Small Business 2 years - Sept. 18, years - Sept. 17, 2018 a business employing fewer than 500 fulltime equivalent employees Very Small Business a business averaging less than $2.5 million per year, during the three-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale) 3 years - Sept. 17, years - Sept. 17, 2019 (except for records to support its status as a very small business, which you must start maintaining on Jan. 1, 2017)

9 Compliance Timeline Be aware that your customers will also need to meet the FSMA compliance rules, many of which will need to meet the earliest timeline (Sept, 2016) As a supplier, you are a part of your customers FSMA compliance program Therefore, market pressure will exist to push up the compliance timeline for all producers regardless of the FDA s business size criteria Evidence in the marketplace already for buyers of DDGS asking for compliance from DDGS producers

10 21 CFR 507 Subpart B cgmps Personnel Plant and grounds Sanitation Water supply and plumbing Equipment and utensils Plant operations Holding and distribution Holding and distribution of human food by-products for use as animal food First Compliance Deadline: Sept 19, 2016

11 21 CFR 507 Subpart C HARPC Food safety plan Hazard analysis Preventive controls Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control Provision of assurances required under (a)(2), (3), and (4) Recall plan Preventive control management components Monitoring Corrective actions and corrections Verification Validation Verification of implementation and effectiveness Reanalysis First Compliance Deadline: Sept 18, Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food Requirements applicable to a preventive controls qualified individual and a qualified auditor Implementation records required for this subpart

12 Sanitary Transportation Rules April 6, 2016 the FDA released the regulations for the Sanitary Transportation of Human and Animal Food Final Rule Who Is Covered Applies to shippers, receivers, loaders and carriers who transport food in the US by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce Requirements Vehicles and transportation equipment ensure that it does not cause the food that it transports to become unsafe Transportation operations Training Records

13 Sanitary Transportation - Compliance Dates Small Businesses Businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after April 6, 2016 (April 6, 2018) Other Businesses Businesses that are not small and are not otherwise excluded from coverage would have to comply one year after April 6, 2016 (April 6, 2017)

14 Effects on Ethanol Producers Fuel Ethanol Producers will need to put into place the policies, procedures, training, and documentation forms to ensure the production of safe high quality food for animals Collectively these procedures make up your Animal Food Safety Plan

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16 What is AFQA? AFQA was build by Compli Associates, the Program Registrar, operating under the direction of an Advisory Board composed of representatives from Fuel Ethanol Producers, Fuel Ethanol Industry Associations and Auditing Bodies

17 What is AFQA? A comprehensive, practical and costeffective quality assurance program to help Fuel Ethanol Producers with compliance Includes the necessary policies, procedures, and documentation forms and is designed to be your complete Animal Food Safety Plan

18 What is AFQA? Also includes a third party certification giving your facility a certificate of compliance to AFQA A certificate of compliance to AFQA also gives your customers an assurance of quality and helps satisfy their FSMA requirements

19 What does AFQA Provide? cgmps Procedures and Inspection Forms Personnel (Procedure and Inspection Form) Plant and grounds (Procedure and Inspection Form) Sanitation (Procedure and Inspection Form) Water supply and plumbing (Procedure and Inspection Form) Equipment and utensils (Procedure and Inspection Form) Plant operations (Procedure and Inspection Form) Mycotoxin Management (Procedure and Inspection Form) Holding and distribution (Procedure and Inspection Form)

20 What does AFQA Provide? Hazard Analysis and Risk Based Preventive Controls Allows for customization to individual facility needs Facility Registration Requirements Recall Plan Training Plan Verification Policy Reanalysis Policy Record Keeping Policy Transportation Inspection Procedure and Forms

21 What does AFQA Provide? Annual on-site audit verifying compliance to all sections Summary report of the findings of the annual audit and any related corrective actions Printed Certificate of Compliance (contingent upon meeting all the requirements of AFQA) Posting of the facility name on the Official Registrar AFQA website (contingent upon meeting all the requirements of AFQA) Free program updates that keep the AFQA program current and relevant to the changing regulatory landscape and needs of customers

22 How to Get Started? Contact Compli Associates for a program quote: Chad Poppe Compli Associates compli@compliassociates.com

23 More Information Chad Poppe Compli Associates