By Sonia Salas
The Food Safety Modernization Act (FSMA) expanded the U.S. Food and Drug Administration’s (FDA) inspectional authority and imposed many new requirements. Do you know what to do if a Produce Safety Rule (PSR) inspector knocks on your door?
PSR regulatory inspections are around the corner! They are set to begin in the spring of 2019. In most states (including Arizona, California, Colorado and New Mexico), inspections will be conducted by your state department of agriculture under a cooperative agreement with FDA.
Because prior notice to a company of an impending inspection is not required, you may not receive it. If an inspector contacts you to schedule an inspection, respond promptly as unresponsiveness will likely result in an unannounced inspection. Unless there is an urgent matter, inspectors will generally seek to inspect during normal business hours. In addition, an inspection has the weight of the law behind it; the inspector is specifically there to check for regulatory noncompliance. Noncompliance could lead to enforcement as simple as a follow-up inspection or as severe as operational shutdowns, penalties/fines, criminal investigations, and under the worst-case scenario, imprisonment.
PSR inspections will be prioritized based on operational size, where the operations are located, and which commodities are grown and/or handled. Inspections will involve verbal questions, records reviews and observations of covered activities. Record reviews will cover training, biological soil amendments of animal origin, food contact surface cleaning and sanitizing, water related records, and documentation related to exemptions that apply to your operation. PSR inspections represent new territory for growers and regulators and add uncertainty as to what to expect.
Being prepared in advance will go a long way to helping you feel confident when faced with your first PSR inspection. Fortunately, there are tools and resources available to accomplish this. There are three aspects you should consider: 1) assembling an inspection team, 2) requesting an On Farm Readiness Review (OFRR); and, 3) utilizing industry resources.
Assembling an inspection team
Having an inspection team and procedure in place is fundamental. An inspection team is commonly formed by a minimum two employees and it is best if headed by a senior level company representative. One person should be designated as the main contact and another one designated to take notes. An inspection team is responsible for greeting the inspector, participating in the opening conference, accompanying the food inspector during the inspection, providing documentation, answering questions and participating in the closing conference.
The inspection team should be familiar with the PSR requirements and be responsible for understanding your company’s policies, legal rights and responsibilities. This team should develop an inspection plan/procedure in writing and conduct drill inspections so that when an inspector shows up at your door, everyone knows what to do. Before an actual inspection takes place, an inspector should present credentials, a notice of inspection and discuss the nature of the inspection.
At the time of the inspection, the inspector will want to observe all activities conducted and performed on your operation that are covered by the PSR. If the inspector sees anything of concern, he or she should discuss it with you immediately and provide regulatory reference and scientific rationale to support such concerns. Any corrective actions that you commit to will be documented. At the end of the inspection, the inspector should summarize any discussions you had during the inspection, answer any questions you may have, discuss any follow-up steps, and provide your team with a copy of the inspection report. Western Growers has an Inspection Manual that provides information and suggested guidelines for members to follow during food regulatory inspections. This manual can be accessed at www.wga.com/resources
Self-Assessments and On-Farm Readiness Reviews
View preparing for a PSR inspection as an opportunity to conduct a self-audit of your food safety program activities, procedures, documentation, and record systems. WG has produced a PSR self-audit checklist along with an illustrated PS Rule Implementation Guide that is available to members on our website www.wga.com/fsma. This resource provides you with an opportunity to self-assess your operation.
Also, in 2017 the FDA released four guidance documents to help those subject to the PS Rule to establish and implement the required practices and procedures. These guidance documents culminated in the October 2018 release of a comprehensive Draft Guidance to Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce. This document is open for comments and we welcome your thoughts and careful review. Any comments can be submitted to us by March 30, 2019, or to the FDA by the comment deadline of April 22, 2019.
Industry guidance can assist you in assessing your operation. In addition, you could also request a non-regulatory On-Farm Readiness Review (OFRR). These are designed to help growers better understand what to expect from an actual PRS inspection. An OFRR is a voluntary, on-site assessment of your operation’s food safety and good agricultural practices coordinated by your state department of agriculture. OFRRs provide you with an opportunity to learn about the applicability of the rule to your operation and to ask questions. Western Growers has a dedicated OFRR website page that includes videos and additional information to better understand how OFRRs work and how to request one (www.wga.com/ofrr).
In conclusion, being prepared is a must to deal successfully with the upcoming PSR inspections. If you have assembled an inspection team, have inspection procedures in place and have assessed your operation regarding PSR requirements, you are better prepared ahead of any PSR inspection. Nevertheless, it is not too late if you have not addressed inspection preparedness. We encourage you to use tools and resources available to you. Please contact WG’s Science and Technology staff for assistance or if you have any questions about this matter.