The FDA has published these FAQ’s . Please read if you have any questions on registration. This process is also used to make required attestations for small facilities claiming to be “exempt” from FSMA otherwise known as a qualified facility.
Not to get “political” in these “overly political” times but, I will modify a quote from President Ronald Regan – “I am NOT from the Government, AND I AM here to help”.
It is my pleasure to return to CFD as a part-time consultant to support members and customers navigate the requirements of the FDA, as it relates to FSMA. As you may know, I returned to my previous position at a local non-profit as their Finance Manager, a little over a year ago. While I still hold this position as my full-time career, I have remained in touch with several members. I have helped a few by answering questions and assisting in the preparation and review of Feed Safety Plans. After discussion with the Board, Lon and Eric, I am reprising my role primarily updating the CFD FSMA website and publishing this newsletter. I am committed to keeping YOU up to date on all things FSMA by working with AFIA, staying connected via the FDA and focusing on your needs.
I hope you will take a moment to read through this update and reach out to me, so I know how to help moving forward…
I will pick up in 2020 where everything starts… with COVID-19. We all look forward to the day when our lives no longer revolve around this pandemic. As I read though the many industry updates over the last 6 months, COVID-19 looms large. As many parts of our world paused, agriculture pushed forward along with the first responders, medical professionals and other essential services. That is not to say there has been no impact to the industry. This industry has had more than its fair share of hard time but is uniquely positioned and steadfastly determined to weather this storm. Here is some valuable information I would like to share.
1.) Northeast Agribusiness and Feed Alliance (NEAFA) posted a webinar on stress management held on April 29th. If you have not seen it I recommend finding a quite corner, a cup of coffee, put your feet up and watch it. Kudos to NEAFA for addressing the social emotional health aspects of these times even before it was the buzz.
2.) AFIA (American Feed Industry Association) continues to be on the front lines of information dissemination from Washington. That has certainly been difficult during these times. As the pandemic has unfolded, there has been good and bad information shared. I am particularly impressed by a document published in collaboration by the FDA and OSHA. The Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic. It is a well thought out document with good guidance on protecting your employees and the safety of the food supply. This pandemic has been and continues to be an event that requires reanalysis of your Feed Safety Plan. COVID-19 is not transmissible through food. It is unlikely to be transmitted from contact surfaces. This does not mean it is not a threat to food safety. As outlined in the middle of page 11 through page 12, you must consider the very real impact the pandemic has had on supply chain interruptions and your trained workforce. Should you experience a case of COVID-19 in your workforce, your ability to produce feed could be significantly reduced and even eliminated should the virus spread to key employees. While hiring a temporary workforce is feasible, the lack of trained staff is a risk that needs to be well thought out. Page 13 – 15 details the 8 CGMP’s and things you should consider in mitigating the risk. If it hasn’t happened yet, and I hope it hasn’t, the latest increase in numbers nationally and locally should give you great pause.
3.) FDA Inspections were all but halted in March due to COVID-19. In July the FDA announced a plan to restart them and is working towards that end. In the next installment of this newsletter, I will provide an update on inspections held to date and what to expect moving forward.
4.) Last but certainly not least, a reminder… All Food Facilities (including animal food) must register as such with the FDA in even years between October 1 and December 31. As we stated in 2018, it remains CFD’s opinion that all CFD customers of pet, animal or human food products we sell are required to register. This Biennial registration renewal began back in 2012 so this should be the fifth time you have done so… but in these times with so much on our plates it begs a friendly reminder…
If this is your first time registering, click here for a list of information you will need to collect in order to do so.
In closing, I look forward to working with each and everyone of you. I am asking that you reach out to me with: Your questions. Your concerns. Your needs. If you need FSPCA Preventive Controls for Animal Food Training, we are open to holding a class in 2021. It could be for a certificate or a refresher. If you have completed your feed safety plan, I am open to reviewing and commenting on the plans. If you have not yet completed your plan, let me know what issues you are having in doing so. I AM here to help – Barbara Simeon (email@example.com)
All Food Facilities (including animal food) must register as such with the FDA in even years between October 1 and December 31. The FDA has published a small entity compliance guide to assist in this registration process. It is CFD’s opinion that all CFD customers of pet, animal or human food products we sell are required to register.
The following was posted on the FDA website today…Caution: Do not be complacent. Keep calm and keep busy. The announcement indicates an intention to delay inspections not compliance.
“Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explains what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PC Animal Food rule). Continue reading “FDA Announcements”
Action Required – FDA Biennial Registration due October 1, – December 31, 2016
The Bioterrorism Act of 2002 requires all Food (Human and Animal) facilities to register with the FDA. In 2011 FSMA changed the registration requirements from one-time registration to every two years in even years between Oct 1 and Dec 31. Failure to register is a federally prohibited act.
It has been CFD’s position that most members (and many customers) must register! Each facility under company ownership that has a different address requires registration. There are exceptions to the registration requirements. In the future the FDA will allow for cancelling registrations (#6 below) based on its verification that a facility is not required to register. If a member has any questions regarding the requirement to register, it may be safer to register and let the FDA exempt one or more of your facilities than to not register.
Between October 1, 2016 and December 31, 2016 go to: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm
During registration some of the information you will be required to provide includes the following:
- The e-mail address for the contact person of the domestic facility
- Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
- Updated food product category information, as determined appropriate by FDA in already-published guidance
Changes to the rule will be implemented in the coming years (there are many but these apply to our members):
- Unique Facility Identifier (UFI) – Will be assigned by the FDA and assist the FDA in verifying accuracy of site specific address, the FDA will verify the UFI prior to issuance of registration number or confirmation of registration. This will be implemented October 1, 2020.
- If you use a 3rd party to do your registration, the email of owner, operator, or agent in charge who authorized a third party to act on behalf of the facility will be required.
- Some previously optional fields are now mandatory. Such as preferred mailing address, emergency contact email address, type of activity.
- Electronic registration will be required as of January 4, 2020 (Changes to the waiver of electronic registration will also being made).
- Abbreviated Registration Renewal Process
- The FDA will have authority to cancel registrations in additional circumstances (such as: FDA independent verification that a facility is not required to register, facility address not updated in a timely manner, unauthorized registration submissions, registration expiration due to failure to renew.
- Requirement for immediate update to incorrect registration information
- Changes to activity types (such as Farm Mixed-Type Facility, Animal food warehouse/holding facility).
The FDA is preparing guidance on some of these changes and as more information is available we will provide updates!