11/5/2019 Outcome and Learning from the Food Safety Modernization - - PDF document

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Outcome and Learning from the Food Safety Modernization Inspections

39th Annual Food Safety and Sanitation Workshop

Miriam Burbach, District Director/Program Division Director Office of Human and Animal Food Operations ‐ West U.S. Food & Drug Administration

November 6, 2019 | Portland, OR

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FDA Food Safety Modernization Act (FSMA)

• Intended to build a food safety system

for the future that makes modern, science‐ and risk‐based preventive controls the norm across all sectors of the food system.

• FSMA’s success depends on bringing

about high rates of compliance.

• FDA is committed to educating before

and while we regulate.

• FDA will engage and communicate to

international community that is consistent with domestic efforts.

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Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well‐being of the food system.

Response Prevention

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Seven Foundational Rules to implement FSMA

Title Description Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food (PCHIF) Requires that food facilities have safety plans that set forth how they will identify and minimize hazards Current Good Manufacturing Practices, Hazard Analysis, and Risk‐based Preventive Controls for Animals (PCAF) Establishes Current Good Manufacturing Practices and preventive controls for food for animals Foreign Supplier Verification Programs (FSVP) for Importers of Food for Human and Animals Importers will be required to verify that food imported into the United States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Establishes science‐based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms Accreditation of Third‐Party Certification Bodies to Conduct Food Safety Audits and to issue certifications Establishes a program for the accreditation of third‐party auditors to conduct food safety audits and issues certification of foreign facilities producing food for humans or animals Sanitary Transportation of Human and Animal Food Requires those who transport to use sanitary practices to ensure the safety of food Mitigation Strategies to Protect Food Against Intentional Adulteration Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large‐scale public harm 5

Compliance Dates 2019

January 2019 January 2019

Sprouts: Small businesses Sprouts: Small businesses

July 2019 July 2019

Intentional Adulteration: Large business Intentional Adulteration: Large business

September 2019 September 2019

‐Preventive Controls Animal Food ‐Qualified Facilities ‐Preventive Controls Animal Food ‐Qualified Facilities

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FSMA Implementation Updates

Ever increasing Preventive Controls Inspections: Human and Animal Food Began inspections of large businesses subject to PC Animal Food in October 2018 Produce Inspections by ORA Produce Safety Network Staff Sanitary Transportation Begin Intentional Adulteration in March 2020

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FSMA Implementation Updates

• Ever increasing Preventive Controls Inspections:

Human and Animal Food

• Began inspections of large businesses subject to

PC Animal Food in October 2018

• Produce Inspections by ORA Produce Safety

Network Staff

• Sanitary Transportation
• Begin Intentional Adulteration in March 2020

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Preventive Controls for Human Food

• FDA assignments issued since November 2016 for

inspections of businesses based on staggered compliance dates.

• Inspections (domestic and foreign) of businesses

subject to full requirements conducted by dedicated FDA staff who completed regulators and OJE training.

• Very small businesses subject to the applicable

preventive controls requirements in September 2018.

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Preventive Controls for Animal Food

• FDA conducted routine

inspections of facilities subject to CGMP of the PC AF rule since October 2017

• FDA began conducting

routine inspections of facilities subject to full requirements of the PC AF rule inspections in October 2018 of large businesses

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Regulators Training

In addition to Alliance Courses

• Preventive Controls for Human Food for

Regulators (FD254)

• Preventive Controls for Animal Food for

Regulators (VM220)

• Modernized GMP Inspections broadcast

(FD8000R)

• Sanitary Transportation Carriers Training

Module (FDA’s Public webpage)

• FSMA Chats; FSMA and PC Rule Readiness
• Training schedule available on ORA OTED web

page, Pathlore Learning Management System

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Qualified Facilities

• Business with average annual sales of

<$500,000 and at least half the sales to consumers or local retailers or restaurants (w/in same state or w/in 275 miles); or,

• Very small business (including any

subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, etc.

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Modified Requirements (Subpart D)

• Apply to a facility designated as a qualified facility.

– Self‐attestation must be submitted every two years, during the same timeframes as the facility is required to update its facility registration. – Guidance for Industry published May 2016.

• Apply for the storage of unexposed packaged food

that must be refrigerated for safety,

• Facilities will be inspected under modified

requirements, exempt from Subparts C and G.

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FDA‐Track Purpose

FDA‐TRACK is FDA's agency‐ wide performance management system that monitors analyzes and reports key performance data and projects for the Agency's program offices and cross‐ cutting initiatives

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About Food Track

Transparency – communicate FDA's story to internal

and external stakeholders.

Results – highlight office achievements and cross‐agency

initiatives that align with FDA’s public health mission.

Accountability – demonstrate FDA's contributions to office

and Agency priorities, plans and results.

Credibility – encourage the sharing of accurate, reliable

performance data to FDA stakeholders.

Knowledge‐sharing – enhance collaboration across

program offices and through the FDA.

The objectives of FDA‐TRACK can best be explained through its name:

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About the Food Safety Dashboard

This Food Safety Dashboard will monitor progress and performance towards achieving key outcomes

• ver time.

Having this data will help the agency identify trends in food safety, implement a risk‐informed planning and resource allocation framework, and modernize the agency’s food safety work in a way that will help achieve a new era of smarter food safety.

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Transparency ‐ FDA Data Dashboard

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FDA‐TRACK: Food Safety Dashboard

Outcomes:

• Increased Compliance by

Industry with PC Rule Requirements

– Track adoption of Food Safety Plans and PC HF Supply‐Chain Program – Track number of Inspections

• More rapid and effective

recall actions by facilities subject to the PC Rule

– Track number of recalls

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FDA Inspections ‐ FY2019 to date

Planned Accomplished* Human Food Modernized GMP Routine assigned 3746 Human Food PC (Full requirements) 400 (domestic) 100 (foreign) 722 Animal Food CGMP 304 297

*Data as of 10/8/2019. ORA OISM. **Conducted by CSO’s completing regulators course, includes On‐the‐Job Experience.

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FDA Inspections ‐ Overall

Op type Operations to date Assigned Operations % Completed Domestic 500 500 106% Foreign 201 150 134% Contract 182 231 79% Domestic + Contract 712 731 97% Total 913 881 104%

*Data as of 10/16/2019

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FDA Inspectional Decisions

Decision Domestic Inspections Foreign Inspections Contract % of Overall Total NAI ~200 ~100 ~75 ~45% OAI ~80 ~10% VAI ~200 ~80 ~100 ~45% VAI

*Data as of 10/16/2019

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Top 10 Common FDA Observations

PC Human Food (21 CFR 117)

• Hazard Analysis – Identification of Hazard, 21 CFR

117.130(a)(1)

• Food Safety Plan, 21CFR 117.126(a)(1)
• Preventive Controls – Identify, 21CFR 117.135(a)(1)
• Sanitation Controls Monitoring Proced, 21 CFR

117.145(a)

• Sanitation Controls Verif Procedures: Establish, 21

CFR 117.165(b)

• Pest Control, 21 CFR 117.35(c)
• Supply‐Chain Program Establish and Implement, 21

CFR 117.405(a)(1)

• Process Controls Monitoring Procedures: Establish,

21 CFR 117.145(a)

• Equipment and Utensils – Design and Maintenance,

21 CFR 117.40

• Allergen Controls Monitoring Proceed, 21 CFR

117.145(a)

• Sanitation Controls Procedures, 21 CFR

117.135(c)(3)

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Domestic Preventive Controls Inspections (Full Scope)

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Domestic Preventive Controls Inspections (Limited Scope)

24 www.fda.gov

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New Era of Smarter Food Safety

• New initiative supported by acting FDA

Commissioner Stephen Hahn and Deputy Commissioner of Food Policy and Response Frank Yiannas

• Public Meeting on Monday, October 21,

Rockville, MD

• Internal Working Groups to develop blue print

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Operational Field Activities: Successes

• FDA, State partners, and industry

participating alongside receiving consistent training.

• FDA Food Safety Staff learning

and working more closely together in the implementation of the Rules.

• Feedback from industry,

consumers, and state partners.

• More interaction from field with

industry and engagement from ORA senior management.

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Operational Field Activities: Challenges

• Longer inspection times and more

participants on inspections, partly due to OJE.

• Obtaining copies of Food Safety Plans

and other documents as informational rather than supporting evidence of violation or significant

• bservation.
• Continue inspections as outlined in

FDA’s Food Safety Work Plan. Other inspectional and sampling obligations as directed by Centers through directed assignments.

• Continue with environmental

sampling as directed or “for cause”.

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FDA Pilot: Two Tier Inspections

• Notice to Industry issued through

FDA’s website on 9/24/2018.

• Solicited businesses that

implement centrally‐developed supply‐chain program and recall plans. Tier 1 – FDA will assess adequacy Tier 2 – FDA will assess implementation

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What’s Next?

• FDA’s primary focus will continue to

be on education, training and technical assistance to help industry comply with the new requirements.

• Inspection approach will focus on

assessing the progress a company has made towards compliance and whether it is taking appropriate steps necessary to protect public health.

• Continue to have external

engagement with industry, consumer groups, and state regulatory partners. – Promote increased participation from state regulatory partners to ensure public health objectives of the new law are implemented.

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Have a FSMA Question? FDA Food Safety Modernization Act (FSMA) web site