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FDA FSMA Public Meeting (Part 1: General Goals & Preventive Controls)

The U.S. Food and Drug Administration (FDA) held a two-day public meeting to discuss their Food Safety Modernization Act (FSMA) implementation strategy.  The meeting took place on April 23 and 24, 2015.

Near the beginning of the meeting, Joann Givens, FDA ORA Acting Food and Feed Program Director, laid out some of the guiding principles for FSMA implementation.  Givens said that FDA plans to:

  • Work closely with government counterparts and other food safety system stakeholders
  • Invest in regulator training to promote consistent inspections and decision making
  • Facilitate and foster industry compliance with FSMA rules by creating commodity and sector specific guidance, education, outreach and technical assistance and by giving regulatory incentives for compliance.
  • Create targeted, risk-based inspection models with a wider range of sampling and testing activities
  • Engage FDA employees, key partners, and the public to determine ways to implement provisions before rule becomes final

Givens noted that the “one-fits-all” approach to inspections is over.  After Givens spoke, various FSMA working groups presented their plans to implement specific rules and held breakout sessions to obtain input and ideas from the public.

Preventive Controls Team

The Preventive Controls Team was the first group to present.  The team stated that their ultimate goal was the reduced risk of illness from foods subject to the preventive controls rules, along with more rapid and effective recall actions, reduced contamination of food, and increased implementation by industry.

Implementation plans that the Preventive Controls Team presented included:

  • To develop guidance documents to help industry identify significant hazards and develop preventive control strategies
  • To launch an internal technical assistance network that involves all food safety staff to help ensure consistent implementation in the field
  • To work with the Food Safety Preventive Controls Alliance (FSPCA) to develop and deliver basic preventive training to show industry and staff how to develop a food safety plan that will be acceptable to FDA
  • To stagger preventive controls regulator training throughout March 2016 and September 2018
  • To establish real-time contact with subject matter experts before and during an inspection
  • To rank violations as critical, major, or minor based on regulatory requirements and public health impact
  • To create a dynamic regulatory strategy through which different violations will trigger different regulatory responses and have different timeframes for corrective action

The Preventive Controls Team later held a breakout session where they asked stakeholders to give input on what type of outreach food and feed facilities will need and how FDA can best provide that outreach. Suggestions from stakeholders included:

  • Creating a “lite” version of the Food Safety Plan for small businesses
  • Hands on education for how to implement processes
  • Guidance as to what FDA will be looking for during an inspection
  • A mentoring program where large enterprises work with smaller enterprises
  • A peer reviewed risk and hazard analysis database where industry can share common hazards and solutions

Stakeholders also expressed the need for consistent and accessible technical assistance and training, and clear, simple outreach and instructions.

FDA is expected to finalize the preventive controls rules by August 30, 2015.  The rules will require most manufacturers of human and animal food to establish preventive controls for potential hazards that may occur and document the hazards and controls in a Food Safety Plan.  Once finalized, businesses will have between one and three years to comply, dependent on the size of the company.

Read Part 2 for more information from FDA’s FSMA Public Meeting, including presentations from the Produce, Imports, and Intentional Adulteration teams.  Registrar Corp is an FDA consulting firm that helps food facilities comply with FDA regulations.  We can help food facilities develop or review their Food Safety Plans, as well as conduct Mock FDA Inspections to help facilities prepare.  Registrar Corp follows FDA’s progress on the FSMA rules and will continue to inform the industry of any updates.

For questions about FSMA rules or other FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.