Focus on Imports FDA Food Safety Modernization Act

Focus on Imports FDA Food Safety Modernization Act Clare Narrod, Joint Institute for Food Safety and Applied Nutrition, University of Maryland Standards Alliance Workshop on Standards to Support Small- and Medium-Sized Enterprises Lusaka, Zambia August 21, 2019

Food Safety Modernization Act v Signed into law January 2011 v v v Marks biggest change to our nation’s food laws in more than 70 years. Confirms industry’s primary role on food safety. Sets a standard of conduct. v Cornerstone v v Prevention is the focus. Science & Risk-based. v Will change business practices! ü ü ü • Growers Packinghouses Distributors Transporters Importers / Exporters Salmonella Listeria E. Coli O 157: H 7

FSMA “I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action. ” Margaret A. Hamburg, M. D. , Commissioner of Food and Drugs

Agenda • • • The public health imperative Why is the law needed? Provisions of the law; focus on imports New rules Implementation

The Public Health Imperative • Foodborne illness is a significant burden – About 48 million (1 in 6 Americans) get sick each year – 128, 000 are hospitalized – 3, 000 die • Immune-compromised individuals more susceptible – Infants and children, pregnant women, older individuals, those on chemotherapy • Foodborne illness is not just a stomach ache—it can cause life -long chronic disease – Arthritis, kidney failure

Why is the law needed? • Globalization – 15 percent of U. S. food supply is imported • Food supply more high-tech and complex – More foods in the marketplace – New hazards in foods not previously seen • Shifting demographics – Growing population (about 30%) of individuals are especially “at risk” for foodborne illness

Main Themes of the Legislation Prevention Inspections, Compliance, and Response Enhanced Partnerships Import Safety

Import Safety: Most Groundbreaking Shift • Current reliance on port-of-entry inspection cannot handle increase in imported food. • Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place • Requires food from abroad to be as safe as domestic

10 Import Safety Mandates Sec. 301. Foreign supplier verification program • Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U. S. requirements. Sec. 302. Voluntary qualified importer program • Allows for expedited review and entry; facility certification required Sec. 303. Certification for high-risk food imports • FDA has discretionary authority to require assurances of compliance for high-risk foods

Import Safety Mandates Sec. 304. Prior notice of imported food shipments • Requires information on prior refusals to be added to prior notice submission Sec. 305. Capacity building • FDA mandate to work with foreign governments to build food safety capacity Sec. 306. Inspection of foreign food facilities • Can deny entry if FDA access for inspection is denied Sec. 201. Targeting of inspection resources • Increased inspection of foreign as well as domestic facilities

Import Safety Mandates Sec. 307. Accreditation of third-party auditors • FDA can rely on accredited third parties to certify that foreign food facilities meet U. S. requirements Sec. 308. Foreign Offices of the Food and Drug Administration. • Establish offices in foreign countries to provide assistance on food safety measures for food exported to the U. S. Sec. 309. Smuggled Food • In coordination with Dept. Homeland Security, better identify and prevent entry of smuggled food

Import Provisions Work as a Whole Accreditation Body Accredits 3 rd parties Sec. 307 3 rd Party Certification Certify high-risk food imports Sec. 303 Foreign supplier verification program Foreign firms obtain 3 rd party certification as needed Sec. 301 Voluntary Qualified Importer Program Importer inspection and product certification enable expedited product entry Sec. 302

Enhanced Partnerships: Vital to Success International capacity building – Congress mandated FDA to work with foreign governments to build their food safety capacity – Allows FDA to rely more heavily on foreign government oversight – Capacity building helps to prevent problems before products reach the U. S. port of entry

Implementation Approach • • • Implementation already underway Coalition needed Transparency a priority Focus on public health protection Engage with stakeholders to help determine reasonable and practical ways to implement provisions

But, many challenges • Enormous workload - 50 new rules, guidance documents, Tight deadlines • Changes won’t appear overnight - Building new system will be a long-range process • Resources

FSMA implementation as a continuum • Phase 1: Set standards – Develop regulations, guidance, protocols for new administrative enforcement tools • Phase 2: Implement standards – Design strategies to implement standards – Fully develop and implement the standards • Phase 3: Monitor, evaluate, refresh • Stakeholder engagement throughout the process

Phase 1: Standard Setting Regulation Final Rule Published Preventive Controls (Human Food) Sept 17, 2015 Preventive Controls (Animal Food) Sept 17, 2015 Produce Safety Nov 27, 2015 Foreign Supplier Verification Program Nov 27, 2015 Third Party Accreditation Nov 27, 2015 Sanitary Transportation April 5, 2016 Intentional Adulteration May 27, 2016

Produce Safety Rule v Sets standards for farm operations that grow, harvest, pack & hold produce for human consumption. v New on-farms standards for produce via an implementing regulation. v Routine on-farm regulatory compliance inspections. v Produce “farms” covered by the Produce Safety Rule: ü Farms growing produce ü Harvest operations ü On-farm packing houses ü Coolers

Preventive Controls for Human Food Rule (PCHF) v Sets standards for firms which manufacture, process, pack or hold human food. v Applies to FDA food facilities required register with FDA v Subparts of 21 CFR Part 117 B. Current Good Manufacturing Practice (c. GMP). C. Hazard Analysis and Risk-Based Preventive Controls (HARPC) G Supply-Chain Program v Produce businesses covered by the PCHF rule: ü Fresh-cut produce processors ü Off farm packing/re-packing & ripening operations ü Wholesalers ü Distributors

Foreign Supplier Verification Programs v Importers are now required to perform certain risk‐based activities to verify that food imported into the US has been produced with the same food safety standards that are required of US producers (Produce Rule & Preventive Controls Rule) v Requires FSVP consisting of: 1. Compliance Status Review 2. Hazard Analysis 3. Verification Activities 4. Corrective Actions 5. Periodic Reassessment of the FSVP 6. Importer Identification: (DUNS) 7. Recordkeeping v Verification Activities: onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure.

FSMA Sanitary Transport Rule Requires certain shippers, loaders, carriers and receivers, who transport food to be consumed or distributed in the United States, to take steps to prevent the contamination of food during transportation. v sanitary design and use of motor and rail vehicles implemented to protect food during transportation, v operational controls must be used during transportation, e. g. adequate temperature controls for safety (when required), v training of carrier personnel, and v recordkeeping to demonstrate compliance with the rule.

Phase 2: Promoting Compliance • Established an internal Phase 2 structure to operationalize each new rule: – Rules/Programs Workgroups (Preventive Controls, Produce, Import Controls, Intentional Adulteration) – Cross Cutting Workgroups (e. g. , IT, Metrics, Training) • • • Education, outreach and technical assistance for industry Training/technical assistance for regulators Data collection, analysis, updated IT Performance goals and metrics Inspections, compliance and enforcement

Education, Outreach, and Technical Assistance • Collaboration with industry, academia and researchers to provide training and educational materials to industry and regulatory officials • Formation of Training Alliances – Produce Safety Alliance – Food Safety Preventive Controls Alliance – Sprout Safety Alliance

Technical Assistance Network • Goal: to provides central, consistent sources of outreach and technical assistance for industry and regulators • Two phases: – Phase I: FSMA Rule Interpretation Questions – Phase II: Food Safety Regulatory Community

Technical Assistance Network • FDA At-a-Glance - “How to Submit a Question” • Submit inquiries via the web form or by mail • To submit a question, visit www. fda. gov/fsma and go to Contact Us • Common TAN questions posted

Inspections • Key Implementation Principles – Gain industry compliance, reduce the risk of foodborne illness – Not a “one size fits all approach” – Systems-based inspections, not observation focused – Interactive inspections

Compliance/Enforcement • Key Implementation Principles: – Develop and implement inspection / enforcement strategies that facilitate consistent decision making by regulators – Encourage industry to comply and make corrections on its own – Recognition that not all observations are equal relative to risk and potential for public health impact – Regulatory strategy that is dynamic

Accountability / Stakeholder Engagement • Key Implementation Principles: – Develop meaningful public health/performance metrics to measure success – Recognize the role of the marketplace in influencing and expanding industry compliance with FSMA rules – Work closely with industry, government agencies, academia, and other key stakeholders/partners

Stakeholder Engagement • Transparency Remains a Priority • Inclusive/Coalition Approach – Engage stakeholders to help determine reasonable and practical ways to implement provisions and concepts before rules become final. • Future: Partnerships/Collaboration Key – Establish mechanisms, including working with multiple partners, to foster industry understanding of final rules/guidance and encourage firms to comply and initiate any corrections on their own.

For More Information • Web site: http: //www. fda. gov/fsma • Subscription feature available • Send questions to FSMA@fda. hhs. gov 32