FSMA: Produce Safety Rule 

- Implementation

Jennifer Thomas, Samir Assar, 

Fazila Shakir, Leanne Skelton

FDA/CFSAN and USDA/AMS

March 2015
FSMA Implementation

• Phase 1: Set standards

– Develop regulations, guidance, policy

• Phase 2: Implement standards

– Design strategies to implement standards

• Phase 3: Monitor, evaluate, refresh

• Stakeholder engagement throughout the 

process
Rule

2014

Dec 15

2015

Aug 30 Oct 31 2016 2017 2018 2019 2020 2021

Produce 

Safety

Preventive 

Controls 

Human

Preventive 

Controls

Animal

FSVP

Suppl. Prop. Final Large Small V. Small Water

Compliance Dates by Business Size
High-level FDA Oversight

Steering Committee

Import Controls Produce Safety Preventive Controls 

Human Food

Animal Food

Internal

Advisory Team

Phase 2: Governance

Sanitary 

Transportation

ORA, CFSAN, CVM and 

State representation.

Intentional 

Adulteration
FSMA Operational Strategy

• Provides a foundation for fully developing 

and implementing FSMA standards 

• Captures in broad, high-level terms our 

current thinking on strategy and guiding 

principles
FSMA Operational Strategy:

Produce Safety

• Broad, collaborative effort to foster 

awareness and compliance through 

guidance, education, and technical 

assistance
Key Principles

• Inspection, compliance functions 

specialized

• Invest in regulator training to promote 

consistent inspections, decision making

• Investigators and subject matter experts 

work together to drive compliance
Key Principles

• Robust data integration, analysis and 

information sharing

• Public health metrics

• Work closely with government 

counterparts and other food safety system 

stakeholders
Phase 2: Charge

• Develop a framework and multi-year 

implementation plan for ensuring compliance 

with regulations: 

• Inspections, compliance and enforcement

• Data collection, analysis, updated IT

• Performance goals and metrics

• Training for regulators 

• Education, outreach and technical assistance for industry
FDA Strategic Program Planning: 

5 Steps
Key Activities:

Skilled Workforce

• Build a workforce with specialized skill set 

focused on produce.

– Requires experienced regulatory personnel in 

field and HQ

– Staffing dependent upon overall production, 

risk-based commodity/practice assessments 

– Work closely with regulatory partners (USDA, 

states) and other stakeholders (cooperative 

extension). 
Key Activities:

Skilled Workforce

• Build a workforce with specialized skill set 

focused on produce.

– Comprehensive, Hands-On Regulator 

Training

• Include PSA core curriculum training requirement

• Regulator course with on-farm component

– Farm protocol and etiquette

• Continuing education
Key Activities:

Relationship Building

• Develop working relationships with farms

– Federal, state, academia, and farm 

partnerships

– Conduct inspections with expanded emphasis 

on education and outreach

• Pre-assessment program

– Develop an incentive program for compliance

– Develop a program to evaluate application of 

the rule to identify inconsistencies
Stakeholder Engagement

• Transparency Remains a Priority

• Next Phase: 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 to foster industry understanding 

of standards and encourage firms to comply and initiate 

any corrections on their own. 
Education, Outreach, and 

Technical Assistance for Industry

• Collaboration with industry, academia and 

researchers to provide training and 

educational materials to industry and 

regulatory officials

• Alliances

– Produce Safety Alliance

– Sprouts Safety Alliance

• FDA/NIFA grants
Internal Technical 

Assistance Network

Regulators and Industry
Joint GAPs Review Project

• USDA AMS, FDA CFSAN and ORA, and State partners

• Primary Goals

– Review GAPs materials & make recommendations for revisions

resulting in alignment with the FDA (final) Produce Safety Regulation

• Secondary Goals

– Gain better understanding the public health implications of common farming 

activities and operations via the perspective of FDA personnel;

– Gain a variety of farm-based experiences via USDA GAP audits;

– Provide examples, scenarios, and materials to be incorporated into training 

programs for both agencies; and

– Enhance the working relationships among both agencies and stakeholders
Thank you