Whats Happening in Washington Whats happening in DC That Will - PDF document

2/1/2011 Virginia State Feed Meeting Discuss With You Today What’s Happening in Washington • What’s happening in DC That Will Affect Your Business • Food Safety Modernization Act (FSMA) Richard Sellers February 16, 2011 • What’s likely to happen Roanoke, Virginia 112 th Congress Priorities Lame Duck Session • Argument for shorter, hard deadline sessions Democrats: • GOP clearing decks for 112 th Congress Obama re-elected 2012 • Passed: Don’t-Ask-Don’t-Tell Win back majority START Treaty Ratified Food Safety Legislation Tax Pkg – Bush Tax Rates (24 months) & 2% more in your paycheck! 112th Congress Priorities Leadership Positioning Republicans & Conservative Democrats Obama – Will move to center (major issues)—ex. tax bill Understand 11/2 election message: Boehner – Consensus builder “All incumbents and White House - you have a two-year contract to deliver Reid & McConnell – Move past on our priorities or we will bounce you partisan politics out as quickly as your predecessors” 1

2/1/2011 Republican Agenda Food Safety Modernization Act “Law represents a sea change for food • Oversight Hearings- safety in America” –Dr. M. Hamburg, FDA Commissioner Amend, Revise, Repeal “Most significant change in FDA regulation • Spending Cuts , Deficit Reduction, of Feed since 1958” -AFIA Smaller Government New Laws Apply To Facility Registration • Biennially vs. One-Time (2012) All Ingredient Processing All Feed Manufacturing Pet Food • May be suspended by FDA—Suspended registration means plant shutdown Feed & Ingredient Imports Transportation Hazard Analysis & Preventive Controls New Fees: • Conduct Hazard Analysis • Foreign & Domestic Re-inspections • Develop & implement written preventive controls • Failure to comply with recall order plan: monitoring, verification, corrective actions, • Participation in voluntary qualified record keeping importer program • Regulations due 18 months (July 2012)—probably earlier! • Re-inspections at ports of entry • FDA may exempt or modify requirements for • Issuing export certifications for food facilities that are “solely engaged in the (not available previously, now $175) production of food for animals other than man” Immediate • 2

2/1/2011 Inspections: Traceability; Recordkeeping • Inspect registered Facilities according to • New recordkeeping requirements for risk profile designated high risk manufacturers (drug or premix products) • Minimum inspection once every 5 years >High Risk-within 5 years; every 3 years • Limitations include farms and “comingled >Low Risk-within 7 years; every 5 years raw agriculture commodities” • Regulations due 18 months (July 2012) • Regulations due 24 months (Jan 2013) • Records Access Mandatory Recall Authority • Reasonable belief that a particular article of food • Opportunity for voluntary recall is adulterated and possesses a threat of serious • May issue order to immediately recall if adverse health consequences or death to voluntary recall not completed humans or animals, FDA may have access to all • Must offer opportunity for informal hearing records relation to that article of food and any within 2 days of order issuance other article of food that the secretary believes • May only be ordered by FDA commissioner is likely to be affected in a similar manner. • Serious adverse health consequences, death… • Immediate • Deter copying – confidentiality of documents • Immediate Administrative Detention Third-Party Certifications • FDA has authority to administratively • FDA authority to accredit third-party detain an article of food if FDA has auditors to certify eligible foreign facilities- “reason to believe” that article is International SF/SF option adulterated or misbranded • System due 24 months (Jan 2013) • FDA has authority and has piloted • Rule in 120 days, effective 180 days accreditation of auditors of domestic food (July 2011) safety programs-Safe Feed/Safe Food 3

2/1/2011 Food Safety Transportation Act Import Requirements • Every US importer required to perform risk-based • Regulations on sanitary transportation of foreign supplier verification activities to verify food is not adulterated food (recordkeeping, ID prior to loads, • Regulations 24 months (Jan 2013) back hauling etc) • Foreign supplier verification program content specifics • Regulations 12 months (Jan 2012) • Regulations due 18 months (July 2012) • Establish a voluntary qualified importer program to expedite import process. Export facility must be certified by an accredited third-party auditor- International SF/SF option • Guidance 18 months (July 2012) Performance Standards Legislative Wins by AFIA • Review of relevant health data to determine • Mandatory regulatory recognition of feed vs. most significant food borne contaminants and human food facility regulation (four key sections) where appropriate, contaminant specific • No registration fees (House bill up to $150,000) performance standards • Follows Safe Feed/Safe Food process • Shall exempt or modify requirements for • Limited increase in records access facilities that are “solely engaged in production • Recognition and use of third-party certification of food for animals other than man” programs • Not less frequently than every two years • Export certification (required by many countries) What is AFIA Doing? What is AFIA Doing? • Formed Five Working Groups • Three charges: • Records/Registration • Review what has been enacted and what Hazard ID/Risk Management Plan it says. Performance Standards Tell AFIA what it should do (webcasts, Mandatory Recall and Administrative Detention reports, guidance documents, etc. Foreign Supplier Verification/Qualified Import Assist AFIA in preparing comments, Program webcasts, guidance documents, if needed. • Seven association committees are involved 4

2/1/2011 What Should You Do? What’s the Future? • Read the law or the legal memos • Massive work by FDA—it knows it cannot do it all • Read related e-mails from AFIA • Funding—House appropriators not • Take part in webcasts, read guidance expected to provide funding for the act documents, offer input to draft comments about your industry segment • We are urging FDA to collaborate with industry on guidance documents—we • Comply, comply, comply as best you can have the expertise. AFIA’s 4 Promises to Our Members… Thank you! Discussion 5