Produce Food Safety Overview
Produce Food Safety Landscape

• FDA is the regulatory authority for the safety produce

• AMS serves as a partner agency in support of FDA Produce 

Safety efforts

• AMS supports the industry in meeting buyer industry and 

regulatory food safety requirements

• USDA provides food safety training and outreach support
USDA and FDA Working Relationship

• 2 Federal/National Departments

• Separate/Different Missions

• Memoranda of Understanding, pre 1975

• Food Safety Modernization Act, 2011

• USDA & FDA Cooperation & Coordination Workgroup

• Liaison position USDA to FDA, primarily FSMA-focused

• Government Review Process, ongoing

• Led by the Office of Management and Budget
Food Safety Modernization Act

• FSMA signed in 2011

• Seven Foundational Rules

• Preventive Controls for Human Food

• Preventive Controls for Animal Food

• Produce Safety Rule

• Foreign Supplier Verification Program

• Accredited Third Party Certification

• Sanitary Transportation

• Intentional Adulteration
Preventive Controls for Human Food
Produce Safety Rule
Produce Safety Rule

Materials created to determine if 

a business is subject to the 

Produce Safety Rule

Exemptions based on

• Sales

• Commodities

• End use/customer

https://www.fda.gov/media/94332/

download
Produce Safety Rule 

Inspections

Performed by:

• FDA inspectors

• FDA-trained state 

cooperators

Inspections began on 

large farms in 2018

Covid-19 resulted in 

changes in inspection 

activity for 2020
Additional Rulemaking/Guidance

• Posted in 2020/2021

• Produce Safety Rule translations

• Draft Traceability Rule

• Agricultural Water Treatment Development and Registration Protocol

• Information Collection on Rarely Consumed Raw list

• Awaiting Finalization

• Farm Definition

• Ag Water Requirements (Subpart E)

• Biological Soil Amendments of Animal Origin
USDA and FDA Outreach and 

Assistance to Industry

• USDA National Institute of Food & Agriculture, Food Safety 

Outreach Program

• https://nifa.usda.gov/food-safety-outreach-program

• Cooperative Agreements

• USDA Natural Resources Conservation Service

• Balancing conservation and food safety considerations

• FDA

• Cooperative Agreements

• Website postings and Stakeholder/Constituent Updates

• Guidance documents 

• Presentations, webinars, workshops

• USDA AMS

• Variety of on-going activities
USDA and FDA Outreach and 

Assistance to Industry

• USDA AMS

• Liaison Position

• Guidance Review and Development

• USDA GAP Audit Alignment

• Cooperative Agreement oversight and participation

• Produce Safety Alliance

• Local Foods

• Tribal
USDA GAP Audit Program
USDA GAP Audit Program
USDA and FDA Outreach and 

Assistance to Industry

• USDA AMS

• Liaison Position

• Guidance Review and Development

• USDA GAP Audit Alignment

• Cooperative Agreement oversight and participation

• Produce Safety Alliance

• Local Food Safety Collaborative

• Indigenous Food and Agriculture Initiative
Produce Safety Alliance

• Cooperative agreement 

between USDA, FDA, 

and Cornell

• Managed by USDA AMS

• Established in 2010

• Developed and 

maintains standardized 

curriculum for PSR

• Ensure effective 

training process

• Offer outreach, 

guidance, training, and 

technical assistance
Other Training Alliances for PSR

• Local Food Safety 

Collaborative

• Training, outreach, and 

education to local food 

producers

• National Farmers Union

• Alternate Curriculum

• Native American Tribal Center 

for Food Safety Outreach, 

Education, Training, and 

Technical Assistance

• Food safety training for Indian Country

• Indigenous Food and Agriculture Initiative 

(IFAI) at the University of Arkansas
Thank you

Audrey Draper

Liaison to FDA on Produce Safety Issues

Audrey.Draper@usda.gov

202-720-9136