FSMA Information & Compliance for Fuel Ethanol Producers

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1 FSMA Information & Compliance for Fuel Ethanol Producers Compli Associates 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. 1

2 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 What is FSMA? FSMA gives the FDA more tools to monitor and control the food and feed safety of products both within and outside of the United States Increases the FDA s Recall Authority Increases the FDA s Inspection authority Requires Risk Based Preventative Controls 2

3 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 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) 3

4 Applicable Parts to Fuel Ethanol Producers 21 CRF Part 507 Current Good Manufacturing Practices, Hazard Analysis, and Risk based Preventative Controls for Food for Animals 21 CRF Part 507 Subpart A General Provisions Subpart B Current Good Manufacturing Practices (cgmps) Subpart C Hazard Analysis and Risk Based Preventative Controls (HARPC) Subpart D Withdrawal of a Qualified Facility Exemption Subpart E Supply Chain Program Subpart F Requirements Applying to Records That Must Be Established and Maintained 4

5 Subpart A General Provisions Applicability and status Definitions Qualifications of individuals who manufacture, process, pack, or hold animal food Exemptions Requirements that apply to a qualified facility Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food Applicability of this part to the holding and distribution of human food by products for use as animal food 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 Compli LLC and the AFQA Advisory Board have made every effort to ensure the accuracy of the information being provided, and said information is deemed reliable but is not guaranteed. Accordingly, Compli LLC and the AFQA Advisory Board shall not be liable for any individual s or entity s reliance on the information disseminated in the event the FDA disagrees or disapproves of this information, including (without limitation) through an FDA audit. 5

6 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 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 Subpart D Qualified Facility Exemption Circumstances that may lead FDA to withdraw a qualified facility exemption Issuance of an order to withdraw a qualified facility exemption Contents of an order to withdraw a qualified facility exemption Compliance with, or appeal of, an order to withdraw a qualified facility exemption Procedure for submitting an appeal Procedure for requesting an informal hearing Requirements applicable to an informal hearing Presiding officer for an appeal and for an informal hearing Timeframe for issuing a decision on an appeal Revocation of an order to withdraw a qualified facility exemption Final agency action Reinstatement of a qualified facility exemption that was withdrawn 6

7 Subpart E Supply Chain Program Requirement to establish and implement a supply chain program General requirements applicable to a supply chain program Responsibilities of the receiving facility Using approved suppliers Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) Conducting supplier verification activities for raw materials and other ingredients Onsite audit Records documenting the supply chain program Subpart F Requirements for Records Records subject to the requirements of this subpart General requirements applying to records Additional requirements applying to the food safety plan Requirements for record retention Use of existing records Special requirements applicable to a written assurance 7

8 Effects on Ethanol Producers Fuel Ethanol Producers will need to put into place the procedures (SOPs) to ensure the production of safe high quality food for animals. These procedures should be drafted in a manner that meets the requirements of FSMA. For Example: cgmp SOPs: Personnel Plant, Grounds and Sanitation Pest Control Water Supply and Plumbing Equipment and Utensils Plant Operations Preventative Control of Hazards Product Testing Program Warehousing and Distribution 8

9 For Example: An Animal Food Safety Plan that includes: Hazard Analysis Preventative Controls Supplier Verification Policy Recall Policy Procedures for Monitoring Corrective Action Verification Procedures Record Keeping Policy 9

10 What is AFQA? A quality assurance package that includes the necessary procedures (cgmps & Animal Food Safety Plan) The AFQA program can be supplied as a complete quality assurance package or you can order individual sections What is AFQA? A third party certification is also available 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 10

11 AFQA Timeline Compli, working together with an Advisory Board of ethanol production facilities and compliance and audit experts from SGS, has been working to develop the AFQA since October 2015 AFQA Timeline cgmp module is complete Hazard Analysis module is in progress expected to be complete by April Full AFQA program will be ready for deployment in May First compliance timeline is Sep,

12 Important Notice Each facility is responsible for compliance to the Federal Regulations. Compli and AFQA Advisory Board are working to provide the fuel ethanol industry the best and most appropriate set of tools to accomplish this task. Compli LLC and the AFQA Advisory Board make every effort to ensure the accuracy of the information being provided, and said information is deemed reliable but is not guaranteed. Accordingly, Compli LLC and the AFQA Advisory Board shall not be liable for any individual s or entity s reliance on the information disseminated in the event the FDA disagrees or disapproves of this information, including (without limitation) through an FDA audit. Questions Compli Associates compli@compliassociates.com 12