u.s. fda food safety modernization act (fsma)face-cii.in/sites/default/files/2016/11thfood... ·...

U.S. FDA Food Safety Modernization Act (FSMA)

Dean Rugnetta, Deputy Director

U.S. FDA India Office

CII-11th Food Safety and Quality Summit, New Delhi

December 7, 2016

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Agenda 1. General Overview of FSMA 2. Preventive Controls for Human Food 3. Preventive Controls for Animal Food 4. Produce Safety 5. Foreign Supplier Verification Program 6. Third Party Certification 7. Sanitary Transportation 8. Intentional Adulteration 9. FDA FSMA Guidance 10. Food Safety Preventive Controls Alliance

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FMSA Overview

• Foodborne Illness in the United States

• The goal of FSMA is to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

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Preventive Controls for Human Food

• Facilities that manufacture, process, pack or hold human food must have a written food safety plan that outlines: o Hazard analysis

o Preventive controls

o Supply-chain program

o Recall plan

o Procedures for monitoring

o Corrective action procedures

o Verification procedures

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Preventive Controls for Animal Food

• Establish Current Good Manufacturing Practices (CGMPs)

• Hazard Analysis and Risk-Based Preventive Controls

o Each facility is required to implement a written food safety plan that focuses on preventing hazards in animal foods

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Produce Safety The focus is on conditions and practices identified as potential contributing factors for microbial contamination: • Agricultural water • Biological soil amendments of animal origin • Worker health and hygiene • Equipment, tools, buildings and sanitation • Domesticated and wild animals • Growing, harvesting, packing and holding activities • Sprouts requirements

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Foreign Supplier Verification Program

• Importers are responsible for: o Determining known or reasonably foreseeable hazards with

each food

o Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

o Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

o Conducting supplier verification activities

o Conducting corrective actions

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Third Party Certification

• Certifications will be used for two purposes:

o Facility certifications will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.

• Food or facility certifications will be used for admissibility of a food that FDA considers a potential risk to public health.

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Sanitary Transportation

• Vehicles and Transportation Equipment.

• Transportation operations must be conducted to prevent food from becoming unsafe during transport.

• Training

• Records

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Intentional Adulteration

• Food defense plan

– Vulnerability assessment

– Mitigation strategies

– Procedures for food defense monitoring

– Food defense corrective action procedures

– Food defense verification procedures

– Records

• Training

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For More Information

• Web site: www.fda.gov/fsma

• Subscription feature available

• To submit a question about FSMA, visit www.fda.gov/fsma and go to Contact Us

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Food Safety Preventive Controls Alliance

• FSPCA Technical Assistance Network using their web form at http://www.iit.edu/ifsh/alliance .

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U.S. FDA India Office US-FDA-INO@fda.hhs.gov

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