Equivalent Testing Methodologies for Agricultural Water
FDA announced their intent to re-examine subpart E to contemplate opportunities to simplify the rule. In the meantime, FDA has proposed to extend the compliance date for the ag water testing requirement by 2 years (this subpart of the rule already had extra time for compliance; this would be further extended by 2 years). In the meantime, FDA published eight additional test methods that can be used to quantify the amount of generic E. coli in agricultural water.
FDA has determined that the following methods are “scientifically valid” and “at least equivalent to the method of analysis in § 112.151(a) in accuracy, precision, and sensitivity. For more information and to see the equivalent methods, visit the FDA site.
Read an article on Agricultural Water written by Jennifer McEntire, Ph.D. United Fresh, and Jim Gorny, Ph.D., formerly PMA, in Food Safety Magazine’s August/September 2017 edition: Fixing FSMA’s Ag Water Requirements.
PSA Supplemental Slides for Agricultural Water
This PowerPoint includes a few slides that review the latest FDA announcements regarding the provisions in Subpart E that relate to agricultural water. Download the PowerPoint here.
Ag Water Webinar Recording Available
FSMA-related Agricultural Water Testing Requirements in the Produce Safety Rule have been a top concern for the fresh produce industry.
Now that FDA has made several announcements related to the Ag water testing provision, including delaying implementation of that part of the rule and identifying several test methods that are “scientifically valid” and “at least equivalent to the method of analysis in § 112.151 a, please join Dr. Jennifer McEntire, United Fresh VP of Food Safety and Technology for an insiders perspective. She’ll discuss FDA’s ag water extension timeline, the new and equivalent test methods and what this means for your operation. View a recording of the webinar here.
The Western Center for Food Safety contains links to tools (excel spreadsheets, app, online calculator for untreated surface water and untreated ground water) that can help you calculate the GM and STV and to determine if your water meets the criteria for appropriate application to produce before harvest.
Food Safety Plan Builder & Templates
Food Safety Plan Builder & Templates
The FDA released their Food Safety Plan Builder, a new software tool designed to help create a food safety plan. To freely download the Food Safety Plan Builder application, go to this link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm
*Note on the right hand side of the FDA webpage click on “Download the Food Safety Plan Builder Tool,” then fill out the info and hit “Proceed to Download.”
Access templates from the Food Safety Preventive Controls Alliance (FSPCA) you can use to develop your food safety plan. Select the downloadable Word versions so you can adapt them to fit your needs.
*Note that while FDA does not require a specific format, these were developed by the FSPCA, and are used during the Preventive Controls Qualified Individual Training course.
FSMA Compliance Dates and RegistrationImportant Note About Compliance Dates
FSMA Compliance Dates & Registration Information
United Fresh, in collaboration with a dozen other associations, recognizes the confusion around FSMA compliance dates and developed a document that suppliers and buyers can reference as affirmations of compliance are requested.
The purpose of this document is to explain why compliance dates are complicated (especially as related to the Foreign Supplier Verification Program), and why it is not possible to demonstrate compliance with the Produce Safety Rule prior to the regulatory compliance date due to FDA’s acknowledgement of potential changes to some provisions. It also addresses changes in FDA’s facility registration requirements.
FSMA Training Course Information
Looking for FSMA training courses? Click the links below to find information on the following programs:
Produce Safety Network
FSMA Resources For Wholesalers And Terminal Markets
GMP Responsibilities of Terminal Market Managers and Tenants
Terminal market vendors may need to work with market managers to make sure that Good Manufacturing Practices are met. Developed in concert with the USDA AMS and the National Association of Produce Market Managers, this short guide summarizes key GMP requirements that may cause confusion and uncertainty between terminal market managers and tenants. Download the document here.
Get Step-By-Step Instructions On Developing A Food Safety Plan
Have you gotten your copy of “How to Build a Food Safety Plan”? Developed with the support of the National Association of Perishable Agricultural Receivers (NAPAR), the publication walks wholesalers and distributors through the critical process of developing a food safety plan that complies with FDA regulations under the Food Safety Modernization Act (FSMA). It also includes templates developed by the Food Safety Preventive Controls Alliance that companies can use to develop and implement their food safety plans. The report is available to United Fresh Members for $100 and is $300 for non-members. Purchase your copy here.
FSMA Resources by USDA FAST Program
Spanish FSMA Resources by USDA FAST Program
General FSMA Questions
Produce Safety Rule vs Preventive Controls? The line for packinghouses and cooling operations is still blurry. Read this co-authored article by Dr. Jennifer McEntire and Dr. Jim Gorny (formally with PMA), talking about our proposed solution or view the FSMA 101 Presentation by Dr. Jennifer McEntire.
FDA has a YouTube video, “Produce Inspections for Regulators Virtual Produce Tour” intended for produce inspectors, regulators, growers, extension agents, and others interested in produce inspections conducted in accordance with the Produce Safety Rule.
Questions and Answers Regarding Food Facility Registration (Seventh Edition: Guidance for Industry) from the FDA.
FSVP Draft Guidance Summary (By Dr. Jennifer McEntire)