Renée Rioux, CADRE member
Being inspected by the federal government, no matter the branch, can be scary and intimidating. However, having gone through an APHIS inspection recently, I can promise that it is really not that bad! To set your mind at ease, here is a little run-down of what to expect during an APHIS inspection of your facility.
First of all, why are they inspecting in the first place? As we learned during our inspection, the main reason for these visits is ensure that you have the means to comply with the terms of your permit. PPQ 526 permits have strict regulations concerning pathogen storage and disposal. If you don’t have a functional autoclave or the means to lock up your regulated pathogens, then you will not be able to comply with the terms of your permit. Since these are issued by a government agency, non-compliance is sort of a big deal with penalties including fines and possible jail time. The inspections help to make sure that you will not end up having to deal with these penalties.
Obviously, every inspector is going to be different but we found ours to be very good-humored and informal. It was clear that he was not looking for a reason to not issue our permit. He just wanted to make sure we had everything needed to meet the terms of the permit. It helped greatly that the individual applying for the permit had been diligent in her preparation and sent detailed descriptions of our procedures, as well as photos of a number of items the reviewers had requested.
At the beginning of our inspection, all of our scientists who would be working with pests and pathogens met the inspector. He asked us a few general questions about the organisms we were planning to work with and types of experiments we were planning to conduct. He also allowed us the opportunity to ask any questions about the permit process that we had. This was nice because it offered us a chance to clarify a few questions we had about permits we already had in place.
We gave the inspector a tour of our laboratory and greenhouse facilities following the initial conversation. At this time, he took a more in-depth look at different pieces of our equipment. In particular, he checked the refrigerators and freezers that we use for storing pathogens and made sure that they could be locked. He also confirmed that we store our pathogens and pests separately from general lab items. He checked that both our autoclave and biosafety cabinets were in good working order and that they had valid inspections. We also needed to provide photos showing the inspection stickers on all of the autoclaves used for pathogens and pathogen-infected plant material.
Some of the items that could not be directly checked were discussed during our walk-through. These included the procedures for pathogen containment when moving between buildings and clean-up of pathogen-infected material following assays. We also spent time discussing the importance of autoclave testing. Although we had spore strips and used them occasionally, we did not have a strict testing protocol in place. The inspector’s comments helped us to create an autoclave log book and implement a plan for monthly spore vial testing to ensure that we are always in compliance with the terms of permits.
In the end, we had a couple items that were not quite up to snuff for the inspection. This was not a problem and did not get us into any kind of ‘trouble.’ We simply had to make the necessary changes, in this case it was having a soil trap installed on one of our lab sinks, and send photos documenting that this work had been completed. Once we sent in our documentation, we were good to go and our permit was accepted shortly thereafter.
All in all, the inspection was not only a pain free process but was also a great learning experience. I actually wish we had been inspected sooner because it would have helped us to streamline our application process and be more efficient. A couple of the main lessons we learned through this process that may be helpful for you to know are:
- Following directions helps greatly. The individual filling out our permits very carefully read each instruction and provided the exact answers to questions, photos, and other documentation that was needed. The inspector and others who worked with our permits were very appreciative of this (apparently applicants are not always this thorough). Though you do not want to be over-detailed, providing ample, accurate information makes the permit reviewer’s job easier and will, most likely, facilitate speedy approval of your permit.
- Keep good records of everything related to your pathogens. You do not want to risk losing track of something and having it jeopardize your permits. Records we keep include our autoclave log, a spreadsheet with all of our permits and their expiration dates so that we know when they need to be renewed, logs of infection experiments with start and end dates, and a monthly check-off sheet for the status of each pathogen in our collection that includes whether or not it is in storage, has active cultures, and is currently being used in experiments.
- Don’t be afraid to contact your APHIS representative. The permit application is not exactly intuitive, especially when you are new to the process. It is much easier to call APHIS and speak directly with someone to clarify your questions before submitting than to submit with incorrect or missing information and have to go through multiple iterations of the process.