Importing food for a trade show and not sure if you need an FSVP? In this post, we address the applicable exemption referencing current FDA guidance and regulation.
A master sanitation schedule defines your sanitation program. It is typically written in a table format. Each row addresses a specific area or piece of equipment while the columns layout the who, what, where when, how.
We recommend moving through your facility, room by room. Start with surfaces far away from food contact surfaces (FCS), like floors, walls and drains (known as zone 3 surfaces, or Z3), then surfaces close to FCS, like tables and racks (zone 2 surfaces, Z2) and finally, FCS (zone 1 surfaces, or Z1)). Once you have completed your master sanitation schedule, you can filter rows (based on frequency of cleaning) to create your sanitation logs and pre-op and post-op checklists.
The master sanitation schedule is used to establish a standard of cleaning, which can then be validated through a history of environmental testing results. When we find harmful microorganisms in our environment, you’ll want to re-evaluate the master sanitation schedule.
Other issues that may affect the performance of a sanitation program are:
Employee adherence to GMPs
Poor hygienic design of equipment and facility
Regular cleaning and sanitizing can only do so much!
Having difficulty getting started? Visit Food Safety Guides website or select a time to chat with consultant, Michael Kalish.
New to environmental monitoring? Don't have much money to spend or an internal laboratory? Well, you better sit down for this.
Regardless of company size, sampling and testing requires a significant investment of money, time and energy. So how much should you expect to spend? The answer is complicated, but our PEM Calculator is a good place to start.
Additional Costs to Consider When Preparing a PEM Estimate
Routine environmental testing (“Not For Cause”)
In FDA's draft guidance "Control of Listeria monocytogenes in Ready-To-Eat Foods", FDA recommends "that even the smallest processors collect samples from at least 5 sites of FCS (Food Contact Surfaces) and 5 sites of non-FCS (non-Food Contact Surfaces) on each production line for RTE foods" (p.36).
A minimum of 10 swabs at FDA's recommended weekly sampling frequency for high risk foods (i.e. foods that are capable of supporting Listeria growth) totals 520 swabs per year. If you're lucky, your lab may charge as little as $20/swab for Listeria species testing. Assuming you have one production line and find zero presence of Listeria species in your environment, the total annual cost of lab services (not including equipment and materials costs) is around $10,400.
The above is a very liberal estimate given:
Most companies may swab more than 10 surfaces per week
Companies are likely to face higher lab costs than $20/swab as well as ancillary expenses (e.g. equipment, materials, consulting and training fees)
The estimate does not factor in follow-up costs associated with a positive result (“For Cause” sampling, covered below)
Fire Fighting (“For Cause”) Sampling and Testing
When a sample tests positive (a result known as a “presumptive positive”), the company must:
Determine whether or not the positive indicates the real presence of the target organism at the swab site(s) or if it is a "false positive" (one must assume the result is positive unless proven otherwise); AND
If the target organism is assumed or demonstrated to be present, to take appropriate action, which can vary depending on the type of organism, surface, etc. In other words, you must have a plan for corrective action.
For Cause testing can increase expenses by orders of magnitude, so best to be prepared. To give you an idea of what For Cause testing entails, a good starting point is John Butts’ article “Seek & Destroy: Identifying and Controlling Listeria monocytogenes Growth Niches.”
Total Cost of Environmental Sampling (“For Cause” and “Not For Cause”):
So back to the original question: how much does a PEM program cost? It will depend on your product, facility, and numerous other factors. Two things are for sure:
Assume you will find positives
Sampling and crisis management (and crisis preparedness) come at a significant price tag, one which can be substantially diminished through due diligence and preparedness, but never eliminated.
Find a Laboratory
Looking for a lab or just trying to get quotes? Food Safety Guides put together a Google Map of the U.S.'s major food laboratories as well as a few local, ISO 17025 accredited labs. Click on the image below, then click sites near you to get contact information for the lab of your choice.
Clients keep asking me if I know of a good food lab, so I put together a Google Map of major U.S. food labs whose services include pathogen testing. Map includes large, corporately-managed labs and smaller, independently managed labs, so take your pick! Click on a flag to display contact information.
When I checked, all of the labs listed in the map were ISO 17025 accredited, but these accreditations have expirations so check with the lab to make sure their accreditation is current. Don't take my word for it! More labs to come, so bookmark and share. : )
Learn more: Tools & Tips for Estimating your Environmental Monitoring Costs
Need to estimate the cost of a Pathogen Environmental Monitoring (PEM) program? Use our handy dandy PEM Calculator! If you like it, please let us know and feel free to share : ) Scroll down for our 2-Step Instructions.
STEP 1: In Sampling Schedule table (top)Enter estimates for the number and type of samples (by zones, pathogen, indicator organism) per month.
STEP 2: Get cost/swab info from labs you may want to work with and plug into Pricing table.
That's it! Be aware that in addition to the cost of materials (e.g. swabs) and shipping costs (swabs submitted to a laboratory are generally shipped overnight), additional costs could result from:
- Follow-up testing to confirm a presumptive positive (labs have a rate for this)
- Multiplication of follow-up testing in response to a presumptive positive found in a composite swab*
- Multiplication of follow-up testing beyond an original swab site(s) to locate the source of a confirmed positive (this can be a very expensive and frightening goose chase)
We had a great time at this year's IAFP Annual Meeting re-connecting with colleagues and making new connections while navigating the dozens of symposia and professional development groups. And the cherry on top: we made it into IAFP's 2018 Recap video! (3:04 and 3:44)
Highly recommend attending this conference, exceptional opportunities to learn and grow professionally and expand one's network. Next year the Meeting is in Louisville, Kentucky. We can't wait.
Hiring for FSMA (or GFSI)? Check out our recent article on top ten questions to ask for your job applicants!
Michael's most recent publication on Food Safety Magazine's website.
Each year, FDA dishes out hundreds of citations to food companies in the form of warning letters (Form 483s), and each subsequent year publishes the data on the FDA website. Want to see if a supplier of yours received a warning letter from FDA within the last ten years? Curious what the most commonly cited cGMP violation is? Chances are, you can find the answer on the FDA website.
According to FDA's FY2015 Inspections Citations, 6,116 human food cGMP citations were issued to 1,231 food facilities. The average number of citations per firm was 5, with 63% of firms receiving 5 citations or less, 88% of firms receiving less than 10 citations, and 99% of firms receiving less than 25 citations.
As seen in the chart to the left, citations involving regulations under the cGMP's "Sanitary Operations" totaled the most citations, accounting for 1,381 (22.6%) cGMP violations. Warehousing and distribution citations were negligible.
The most human food cGMP citations issued to a single company in FY2015 was 75. The next highest was 34.
Top 5 cGMP Violations
As shown in Table A below, (2) Sanitary Operations cGMP citations accounted for more than 50% of FY2015's most common cGMP violations and 16.5% of the total number of cGMP citations.
When considering how many facilities nationwide are built decades ago and many companies are slow to budget facility improvements (which can be cost-prohibitive and not necessarily have an immediate or direct impact on revenue), the top most cited cGMP violation makes sense. However, this number should be a warning to companies that are starting in or expanding into existing facilities, or building new facilities. It should encourage them to approach facility design not just as an opportunity to think long term in terms of capacity and scaling, but also with respect to creating a facility that is safer by design. Examples of "safer by design" includes installing hand sinks at entries into high risk processing areas and allowing space between equipment to permit easy access for cleaning.
Top cGMP citations by Section
Below are tables breaking out cGMP citations and frequency by section, starting with the section with the highest number of citations. I have excluded the Warehousing & Distribution table because the number of regulations and citations are so few.
#1 - Top 5 Sanitary Operations cGMP Citations
#2 - Top 5 Processes & Controls cGMP Citations
*Important Note: Citations issues under 21 CFR 110.80 consisted of the following:
#3 - Top 5 Plant & Grounds cGMP Citations
#4 - Top 5 Sanitary Facilities & Controls cGMP Citations
#5 - Top 5 Personnel cGMP Citations
#6 - Top 5 Equipment & Utensils cGMP Citations
- The data from FY2015 indicates that the most common cGMP violations involve sanitation failures, inadequate pest control, and failures by firms to design and maintain their facilities in order to ensure a sanitary environment.
- While citations involving sanitary operations failures totaled the most of any cGMP section, the number of citations by section was fairly evenly distributed for the top 4 cGMP sections, with personnel cGMP citations slightly behind.
- While 5 was the average number of citations per firm, FDA did not report the size of the companies it was inspecting in the data it provided. It may be safe to assume that small- and medium-size facilities had a higher average number of citations than large firms, which tend to dedicate larger budgets to food safety and more often conform with industry-set standards that go beyond regulatory requirements (e.g. Global Food Safety Initiative benchmark schemes, 3rd party audits).
- All effort should be made by companies to address all GMPs. A good starting point is by identifying weak points in a facility and investing in fixing the high priority issues first.
About the Data
Disclaimer: The data in this article is limited to what FDA publishes, which may be incomplete. In some data sets, only electronic submissions are made public while manual submissions are not. Limitations notwithstanding, it is the author's belief that these trends provide a valuable window into inspection trends by FDA and common cGMP issues facing food facilities.
The data for this article was downloaded directly from FDA's website and was filtered to focus exclusively on human food cGMP violations. The data can be accessed here.
If you are interested in digging deeper, you can obtain more information by diving directly into the warning letters. Here is a link to FDA's warning letter advanced search webpage.
About the Author
Charlie Kalish is Co-Founder of Food Safety Guides, a food safety and quality systems consulting firm headquartered in San Francisco and San Diego.
Charlie is an FSPCA Lead Instructor on multiple FSMA rules and a consultant and trainer to food companies across the United States and Australia. In addition to food safety, Charlie also consults and trains businesses on how to leverage cloud-based softwares and project management tools to streamline food safety plan development and implementation.
Food Safety Guides is partnering with UC San Diego Extension and food safety experts and industry leaders from around the U.S. to offer FREE monthly webinars to prepare small food businesses for the upcoming compliance deadline for FSMA's Preventive Controls for Human Food rule ("the PC Rule"). A "small business" is defined by FDA as a business that has 500 or less full-time employees, the compliance deadline is September 18, 2017.
Webinars will be held on the 1st of every month (or the 1st business day) from 10:00am - 11:00 AM PST. Topics will cover every aspect of the PC Rule, from who has to comply to pathogen environmental monitoring to nitty gritty details of supply chain control program requirements.
In addition to the free webinars, Food Safety Guides is offering additional low-cost webinars that provide even more FSMA guidance as well as FSPCA PCQI courses. For more information, click on the links below or visit our Events page.
Upcoming Webinars & Trainings
In my last review, I reviewed La Crosse Technology's dry probe. The focus of this post is FreshTemp's FreshSense Version 1.5, which uses wifi to relay a continuous stream of temperature data to the Cloud.