FSMA Produce Safety Rule Inspections Will Begin in 2019

Inspections of produce farms for compliance with the Food Safety Modernization Act Produce Safety Rule (PSR) are set to begin in July 2019. Passage of SB 331 in the Indiana General Assembly in 2018 gave the Indiana State Department of Health (ISDH) PSR enforcement authority in Indiana, making them the lead agency for inspections. SB 331 established no additional requirements beyond those of the federal rule.

The rollout of the inspection program will be staggered, to reflect the staggered compliance dates found in the PSR. During 2019, ISDH will be conducting inspections only on farms that have produce sales exceeding $25,000 and total food sales exceeding $500,000.

As inspections are rolled out, here are some things to remember:

  1. Prior to an inspection, growers will be contacted by ISDH by mail and by telephone. There will be no unannounced inspections. The inspectors will be as flexible as possible when setting up an inspection date and time.
  2. Most inspections across the U.S. will be conducted by state agencies. Those growers with operations in multiple states will be inspected by the lead agency in each state. The exception is Illinois, where FDA will be the lead agency for inspections. FDA has put considerable effort into insuring uniformity in application of the PSR across all the states. Inspections should be very similar regardless of the state where production is located and regardless of which agency is conducting the inspection.
  3. FDA Form 4056 will be used as a standard for inspections and will be used by FDA inspectors. This form will not be used by ISDH inspectors, who will be using a modified version of the document. Form 4056 may be used to give growers insight into what to expect during the inspection process. Form 4056 can be found at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM630765.pdf.
  4. Unlike audits, inspections will not utilize a point system. Growers will either be in compliance with the rule or not.

In advance of inspections, ISDH is offering On Farm Readiness Reviews for all produce growers. The On Farm Readiness Review is a FREE assessment of compliance with the PSR. Upon request, a team consisting of personnel from ISDH, Indiana State Department of Agriculture, and Purdue Extension will visit your farm and conduct the review. Upon completion of the review, you will be informed of where your farm is on the compliance spectrum and be advised concerning those aspects of compliance where you might improve. The whole process takes 2-3 hours. This is NOT an inspection and the service is completely confidential and free. Those interested in scheduling an On Farm Readiness Review should contact ISDH at (317) 476-0056 or email ProduceSafety@isdh.in.gov. For more information concerning the Produce Safety Rule and produce food safety, check out our website at www.SafeProduceIN.com.

Share This Article
It is the policy of the Purdue University that all persons have equal opportunity and access to its educational programs, services, activities, and facilities without regard to race, religion, color, sex, age, national origin or ancestry, marital status, parental status, sexual orientation, disability or status as a veteran. Purdue is an Affirmative Action Institution. This material may be available in alternative formats. 1-888-EXT-INFO Disclaimer: Reference to products in this publication is not intended to be an endorsement to the exclusion of others which may have similar uses. Any person using products listed in this publication assumes full responsibility for their use in accordance with current directions of the manufacturer.
Vegetable Crops Hotline - Department of Horticulture and Landscape Architecture 625 Agriculture Mall Dr. West Lafayette, IN 47907

© 2019 Purdue University | An equal access/equal opportunity university | Copyright Complaints | Maintained by Vegetable Crops Hotline

If you have trouble accessing this page because of a disability, please contact Vegetable Crops Hotline at guan40@purdue.edu.