How do I stay informed about what is happening at the FDA?

This question was asked at the CFD Nutrition and FSMA Conference in December. I get emails from several areas of the FDA. To signup for FDA email notifications, go to:

https://www.fda.gov/about-fda/contact-fda/get-email-updates

You will enter your email and create a password in order to make you selections and update them based on your changing professional interests… There is 27 Topic Areas to choose from. Including:

  • Animal Veterinary Health
  • Food & Nutrition
  • Guidance Documents
  • Recalls and Safety Alerts
  • News & Events

The other area relevant to our industry is OSHA. The following link allows you to read or sign up for OSHA QuickTakes – “OSHA’s online newsletter provides the latest news about enforcement actions, rulemaking, outreach activities, compliance assistance, and training and educational resources.”

https://www.osha.gov/quicktakes/

Do you need a refresher training?

Several of you have called to say that you have had inspections recently. Inspection activity has indeed resumed now that most COVID restrictions have been lifted.

  • Do you have questions following an inspection?
  • Do you need to update your Feed Safety Plan based on the requirement to do so at least every three years?
  • Do you need PCQI Refresher training?

The only Part 2 PCQI training of Animal Food through FSPCA is Virtual and costs $345 or more. If you are interested in attending a class in person at CFD, click here to put your name on a wait list. I would be happy to schedule a class in the coming months.

“I am NOT from the Government, AND I AM here to help” – Barbara Simeon

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… 

CLICK HERE TO RENEW FDA REGISTRATION

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 protected])

OSHA Safety Data Sheets (SDS)… formerly known as MSDS… what do employers need to do?

“The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), revised in 2012, requires that the chemical manufacturer, distributor, or importer provide Safety Data Sheets (SDSs) (formerly MSDSs or Material Safety Data Sheets) for each hazardous chemical to downstream users to communicate information on these hazards.” The link below is an OSHA publication that explains the 16 part form of an SDS and is an important training tool for users of these documents.

https://www.osha.gov/Publications/OSHA3514.html

Employer Responsibilities

Employers must ensure that the SDSs are readily accessible to employees for all hazardous chemicals in their workplace. This may be done in many ways. For example, employers may keep the SDSs in a binder or on computers as long as the employees have immediate access to the information without leaving their work area when needed and a back-up is available for rapid access to the SDS in the case of a power outage or other emergency. Furthermore, employers may want to designate a person(s) responsible for obtaining and maintaining the SDSs. If the employer does not have an SDS, the employer or designated person(s) should contact the manufacturer to obtain one.

How does CFD facilitate the collection of information?

Our website includes a link to SDS forms for most products we sell and we are working on updating this information for all products that require them. The following is an example of the location on our website:

As you approach the requirement to create a Feed Safety Plan one of the things you will need to do is to identify and address ingredient hazards. Collecting Product tags and SDS may be a way to satisfy two requirements in one. This is something you could start in the coming months in preparation for creating the plan.

 

OSHA FSMA Whistle Blower Protection

FSMA added to the list of 22 programs now afforded Whistleblower Protection by the US Department of Labor under OSHA.

AFIA wrote about this topic in a FSMA update last May, summarizing as follows:

Labor Department Issues New FSMA Rule to Protect Workers from Retaliation”

… On April 15, the Department of Labor issued a final whistleblower rule through its Occupational Safety and Health Administration. The rule implements an otherwise obscure provision of FSMA that some companies may overlook at their peril.

 

Spelling Out Steps for Processing a Complaint

Section 402 of FSMA spells out requirements aimed at ensuring workers across the supply chain–from manufacturers to retailers–are protected from retaliation by their employers for “blowing the whistle” on illegal activity. OSHA’s new rule spells out several things, including how employees should file complaints for retaliation, what steps companies and the government must take in response to a complaint and what the burden of proof is for bringing a successful action.

 

One of the most important aspects of the rule to keep in mind is that employees who file complaints under the new rule are protected if they have a “”reasonable belief,” which is defined in the new regulation as a “subjective, good faith belief and an objectively reasonable belief,”” the conduct they are complaining about violates the law.” (AFIA FSMA Update May 4, 2016)

 

An OSHA fact sheet on “Filing Whistleblower Complaints under the FDA Food Safety Modernization Act” can be found at https://www.osha.gov/Publications/OSHA3714.pdf