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Status/Update: FDA’s Rules for Produce Safety & Preventive Controls for Human Food. 8 th Annual Commissioner’s Food Safety Forum. Leanne L. Skelton Produce Safety Staff, Office of Food Safety, CFSAN, FDA on detail from Fruit & Vegetable Program, AMS, USDA. Background – Produce Safety.

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Status update fda s rules for produce safety preventive controls for human food

Status/Update:FDA’s Rules for Produce Safety & Preventive Controls for Human Food

8th Annual Commissioner’s Food Safety Forum

Leanne L. Skelton

Produce Safety Staff, Office of Food Safety, CFSAN, FDA

on detail from Fruit & Vegetable Program, AMS, USDA

Background produce safety
Background – Produce Safety

1998 Good Agricultural Practices Guidance

2008 Fresh-Cut Guidance

2009 Commodity Specific Guidances

Event/Issue Guidances

Existing authority under Food Drug & Cosmetics Act

Currently No Implementing Regulation

The rulemaking process it doesn t happen overnight
The Rulemaking Process; It Doesn't Happen Overnight

FDA proposes rule & requests comments

FDA considers comments & considers revising rule

FDA issues final rule setting dates for companies to comply

We are almost here for Produce & PCHF


Produce Safety Rule

Implementation & Compliance




Outreach technical assistance
Outreach & Technical Assistance

Public meetings


Listening sessions

Webinar invitations

Alliances for education

Guidance documents


  • Produce Safety Alliance


  • Sprouts Safety Alliance


  • Food Safety Preventive Controls Alliance



  • Consideration of alternative approaches

    • Raw manure use as a soil amendment

    • Water quality for water directly applied to the edible portion of crops

  • Study Facilitation

    • Development of research protocols that can be used various agro-ecological regions

  • Partnerships/Engagement

    • Western Center for Food Safety (FDA Center of Excellence)

    • USDA’s NIFA, ARS, and AMS

    • Land Grant Universities and Cooperative Extension

    • Industry (Center for Produce Safety, Commodity Groups, Trade Associations)

Inspection and compliance
Inspection and Compliance

Non-Traditional Strategy

  • “Educate Before We Regulate”

    • Robust Education and Outreach

    • Technical Assistance

  • Compliance Dates

    • At least 1 year for small business and At least 2 years for very small business after effective date.

  • Formulating a Compliance Strategy

    • With staff from across FDA disciplines

    • How to utilize existing efforts

Context fs ma sec 105 sec 103
Context -- FSMA Sec. 105 & Sec. 103

Produce Safety Regulation

Growing, harvesting, postharvest handling of produce (e.g., trimming, washing, grading)

Packing of produce, where exempt from BT Act registration

Preventive Controls Regulation for Human Food

Packing of produce, where subject to BT Act registration

Processing of produce (e.g., fresh-cut)

Warehousing, shipping, receiving of produce

Overarching principles standards fsma sec 105 standards for produce safety
Overarching Principles & StandardsFSMA Sec. 105 – Standards for Produce Safety

  • Prevention: A Cornerstone for Produce Safety

  • Requires FDA to set forth procedures, processes, and practices reasonably necessary to:

    • minimize the risk of serious adverse health consequences or death; and

    • prevent the introduction of know or reasonably foreseeable biological, chemical, and physical hazards

  • Provide sufficient flexibility to be applicable

    • to various types of entitiesengaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and

    • be appropriate to the scale and diversityof the production and harvesting of such commodities.

  • Take into consideration conservation and environmental practice standards and policies

Standards for produce safety
Standards for Produce Safety

  • Development of regulations and guidance

    • Includes knowledge and experiences from:

      • Inspections and investigations

      • Surveillance

        • Domestic and import field assignments findings

      • Scientific research findings

      • Previous public dockets

      • Stakeholder engagement

        • Farm Tours & Listening Sessions

        • FDA participation in association, scientific organization and other meetings

        • FDA public meetings and hearings

Preventive controls for human food what congress told fda to require relative to fresh produce
Preventive Controls for Human FoodWhat Congress told FDA to require relative to fresh produce

Under FSMA Sec 103 (Sec 418 of the FD&C Act) facilities are required to conduct a hazard analysis and implement preventive controls for identified hazards

Applies to businesses that are required to register under the BT Act of 2002 (Sec 415 of the FD&C Act [with some exemptions])

Outlines and Identifies components of HACCP (i.e., Process Control)

Defines Preventive Controls

Specifies what may be included in Preventive Controls

Pchf details
PCHF Details...

  • Exemptions…..

  • General Activities Outside the “Farm” Definition

  • Activities of “Mixed-type” Facilities that Would Make Them Subject to the PCHF

  • Is the “Mixed-type” facility subject to an exemption under PCHF?

  • Risk Analysis - what “low risk” activities & foods would be exempt for small & very small facilities?

Other related rulemaking activity
Other Related Rulemaking Activity

  • Sanitary Food Transportation Act

  • Foreign Supplier Verification Program

  • Voluntary Qualified Importer Program

  • Accreditation of 3rd Party Auditors

Next steps produce safety preventive controls for human foods
Next StepsProduce Safety & Preventive Controls for Human Foods

  • Comment

  • Public Meetings (and comment…)

  • Dates (and comment)

  • Research (and….)

  • Education & Outreach (and…)

  • Implementation & Compliance (…)