Thank you to those who joined us for our October FSMA Fridays session. We were joined by Rolando Gonzalez, Senior Director of Technical and Scientific Affairs and Eric Edmunds, Food Safety Director with The Acheson Group (TAG). Both Rolando and Eric shared great insights on the latest FSMA updates and current trends. This is Part 1 of a two part recap from the session. Click here for Part 2.
Unfortunately, Rolando’s audio was intermittent. Thankfully, he took the time to share his notes and thoughts, which we have included below. We would hate for the great information not be shared!
FSMA General Updates
September 18th, 2017 is the compliance date for the following (and we at TAG have certainly seen an increase in the number of companies seeking help to ensure alignment with these!):
- Small business – PC Human Food
- Small business – cGMP Animal Food
- Large business – PC Animal Food
A week ago, FDA released draft guidance on Animal Food cGMPs and the FSMA “Solely Engaged” exemptions. Let’s recall that draft status means that this represents the current thinking of the agency, but it is open for comments from the public (180-day period) and it is still non-binding to either the agency or companies, or in other words, companies can use alternate approaches to align with the expectations from the agency, but it is likely not to vary much from an eventual final rule around the topic.
- Animal Food cGMPs (50-page document) – aimed at helping animal food establishments determine if they are subject to the Current Good Manufacturing Practice (cGMP) requirements in the PCAF rule and provides explanation and recommendations for meeting those requirements, including a self-assessment tool towards the end of the document that facilities may use to evaluate their compliance with the cGMP requirements.
Rolando Gonzalez - FSMA “Solely Engaged” exemptions – first, remember that the “solely engaged” exemptions apply to the holding and transportation of RACs, storage of RACs (not including fruits and vegetables), storage of unexposed packaged food, and activities related to preparation of nuts and other commodities. The guidance (8-page document) discusses the “solely engaged” concept meaning that in order for a facility to be exempt from compliance with cGMPs and/or PC requirements, the entire facility needs to be “solely engaged” in the activity or activities that allowed them to qualify for those exemptions. If engaged in any other activities that are covered either under cGMPs or PC requirements, then the entire facility is covered by either the cGMP or PC requirements, or both, depending on what those activities are. There is a concise table at the end of the document that explains the four main different scenarios for applicability or exemption from compliance, along with some examples such as (direct text from the guidance doc):
- “A facility consisting of a grain elevator that holds grain RACs for human and animal food use and does not engage in any other activities covered by the cGMP or preventive controls requirements is exempt from the cGMP and preventive controls requirements in parts 117 and 507.”
- “A facility consisting of both a grain elevator that holds grain RACs for animal food use and a feed mill that manufactures animal food is not “solely engaged” in activities exempt from either the cGMP or preventive controls requirements. Therefore, the facility is subject to the cGMP and preventive controls requirements in part 507.”
Just this week, FDA released a FSMA compliance timeline document – a one-pager road map detailing key dates for compliance with the FSMA rules based on business size and specific components of the rules that may have different timelines.
Resources For Food Safety Plans
Now, for companies that might still be in need of help for putting together their food safety plan, are not sure of how aligned they are with FDA expectations, or simply have some specific questions, let’s remember that are resources available to ensure you meet those deadlines.
- Food Safety Plan Builder. This is a program that you download to your computer and it allows the user to enter information related to their food safety systems and obtain a food safety plan as the product.
Eric Edmunds
Feedback from some of our clients is that it can be laborious given the amount of details that you have to enter, and as with any other electronic tool, the product that you get out of it is as good as the information you put into it! A compliant food safety plan starts with a good hazard analysis and the Food Safety Plan Builder tool is not a substitute for the expertise and judgment from your PCQI. Also, there is also no guarantee that if you use it your food safety plan will be compliant with regulation, so it is just an additional tool to complement all other resources available. - The FDA FSMA Technical Assistance Network can answer questions via email.
- FSPCA – Food Safety Preventive Controls Alliance provides a variety of educational opportunities.
- Groups of experts such as TAG are always available to help you get there, from offering training to certifying your personnel as PCQI, to sometimes just even providing a fresh set of eyes with the broader view of how other companies are approaching similar challenges that you may encounter in the process!
Need Help Ensuring FSMA Compliance?
The TAG team can help you identify gaps and update your food safety and recall plans. For more information visit www.achesongroup.com.
Interested in learning how SafetyChain’s solutions are helping our customers reduce risk, control costs and ensure compliance? Contact us today!
