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FDA FSMA Public Meeting (Part 2: Produce, Imports, and Intentional Adulteration)

This post is a continuation of a previously published blog regarding the Food Safety Modernization Act (FSMA) public meeting hosted by the U.S. Food and Drug Administration (FDA).  Read Part 1 for information about FDA’s general goals for FSMA implementation and plans of the Preventive Controls Team.

Produce Team

The Produce Team announced that they were working with the Produce Safety Alliance (PSA) and the Sprout Safety Alliance (SSA) to develop training on the regulatory requirements of the produce safety rule.  They said that regulator-specific training will introduce techniques needed to perform farm inspections and achieve consistency.

The Produce Team is also working with the National Association of State Departments of Agriculture (NASDA) to develop a voluntary on-farm assessment program.  FDA will conduct an assessment for volunteers before the compliance period is in effect to assist produce farmers with implementation of the produce rule.  The program will also inform FDA of the current state of the farm community.  Along with the assessment program, the Produce Team plans to have readily accessible technical assistance for farmers who need compliance assistance and technical support.

Later during a breakout session, the Produce Team asked for input from stakeholders. Suggestions included:

  • A database where farmers can access frequently asked questions, as well as information gathered from inspections regarding common mistakes and what  is often done well
  • Easily accessible training and opportunities to learn from other farmers
  • Letting farmers know in advance what date and for how long FDA will be inspecting their farm
  • A way to submit Food Safety Plans and other documentation in advance of an inspection in order to expedite the inspection process

FDA is expected to finalize its produce safety rule by October 31, 2015.

Imports Team

The Imports Team is working on the Foreign Supplier Verification Program (FSVP) rule.  The team said they were in the process of developing inspectional protocol for importers. The Imports Team expressed interest in establishing regional trading hubs so that regulator training could be delivered in a localized fashion.

During their breakout session, the Imports Team asked stakeholders what was most confusing or challenging about the FSVP rule.  Stakeholders expressed confusion about the exact responsibilities required by the FSVP rule and who was subject to those responsibilities.  They wanted to know the link between FSVP and other aspects of regulation, such as prior notice, registration, and Import Alerts.   Stakeholders expressed that:

  • FDA’s messages to industry should be in clear and simple language
  • Industry should have free access to training, specifically online training
  • Industry should have access to FDA-approved educational materials
  • Inspections should be consistent

FDA is expected to finalize the FSVP rule by October 31, 2015.  Under this rule, importers will be responsible for tracking the FDA compliance status of their foreign suppliers and their products and put programs in place to ensure food they import into the US meets the same standards as food manufactured in the United States.

Intentional Adulteration Team

The last team to present was the Intentional Adulteration Team.  They stated that their top priority was to establish training programs for regulators and industry. At their breakout session, stakeholders expressed a need for:

  • Clarification of what intentional adulteration is, as well as examples of intentional adulteration
  • A comprehensive training system for industry and regulators
  • Consistency in the development and implementation of training

FDA is expected to finalize its rule for intentional adulteration by May 31, 2016.

Common themes expressed at the FSMA public meeting from both FDA and stakeholders were easy-to-understand guidance, comprehensive and easily accessible training for both regulators and industry, and consistency in regulation.  Registrar Corp stays up-to-date on FDA regulations and will keep industry updated as FSMA implementation progresses.

Registrar Corp is an FDA consulting firm that helps food facilities comply with FDA regulations.  We can help facilities develop a Food Defense Plan that identifies measures to prevent intentional contamination of food products, as well as review an existing Food Defense Plan.  Registrar Corp also offers an online FDA Compliance Monitor that Importers can use to monitor the FDA compliance status of their suppliers.

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.