Skip to main content
BusinessFood & Agribusiness

Everything Your Ohio Food Company Needs To Know About FSMA



As the owner or operator of an Ohio food company, it’s no secret that you wear many hats.

And one of those hats is the responsibility to stay up-to-date with the latest rules and regulations of the Food Safety Modernization Act.

At least I hope that’s one of your responsibilities…

Because if upper management isn’t focused on FSMA regulations – then who is?

But let’s admit that staying “up-to-date” with the constant changes of FSMA rules isn’t necessarily a walk in the park.

Day after day I’m talking with food companies across Ohio, and have found that one of their greatest challenges is FSMA compliance.

And that’s not because food safety isn’t a priority at their facilities…

Quite the opposite, in fact.

But what we’ve discovered is a lack of affordable (or even FREE) tools and resources that food companies can depend upon to learn the ins and outs of FSMA and ensure FSMA compliance.

Which is what prompted me to write this article.

And also prompted me to create this resource with more information on food safety, compliance and risk management.

Everything you need to know about FSMA.

Let’s break it down to the very basics: What is FSMA?

FSMA stands for the Food Safety Modernization Act, which was enacted in 2011 to improve the safety and security of the United States’ food supply.

In other words, the law focuses on preventing food contamination and foodborne illnesses.

Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die – all from foodborne diseases that are preventable.

The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy.

FSMA gives the U.S. Food and Drug Administration (FDA) greater authority to establish prevention-based controls across the food supply and conduct inspections of food producers.

In a nutshell, FSMA was enacted to accomplish three things:

  1. To expand oversight of imported products
  2. To improve the FDA’s response to food safety problems
  3. To enhance collaboration between food safety agencies

The FDA divides the elements of FSMA into five key areas:

  1. Preventive Controls which gives the FDA authority to institute proactive measures to minimize or prevent problems before they occur.
  2. Inspection and Compliance which are key tools for determining risks and enforcing that proper safety measures are taken.
  3. Imported Food Safety which ensures imported foods meet US safety standards.
  4. Response which means the FDA has mandatory recall authority to ensure a rapid response to a serious food safety problem.
  5. Enhanced Partnerships which is designed to improve training of state, local, territorial and tribe food safety officials.

Now, there’s some exemption rules for facilities that qualify as “small businesses” under FSMA. But these exemptions may not apply if your food business is linked to a foodborne illness outbreak.

Is my food business regulated by FSMA?

The industries that the FDA regulates under the law represent more than 80% of the consumer food supply in the US.

Meat, poultry and processed eggs are exempt from FSMA simply because they’re already regulated by the United States Department of Agriculture (USDA).

Which provisions will affect my food business?

There have been several provisions of FSMA that will directly affect many food companies, including yours;

  • The law has increased inspections of facilities to at least every seven years, with those that are deemed “high risk” inspected every three years.
  • The FDA has the power to mandate a food recall, whereas before it could only be negotiated or recommended by the FDA.
  • Food manufacturers that require additional inspections or a food recall may be subject to a fee designated by the FDA.
  • The FDA has the power to suspend a food manufacturing facility if a possible health risk is suspected.
  • The FDA will roll out new regulations for food production at least every two years based on the most significant food threats at that time.
  • Food processors will be required to prepare detailed food safety plans and tell the FDA what steps they are taking to keep their food safe at different stages of production. This information will be used to trace recalled foods.
  • New recordkeeping regulations will be imposed, and the FDA will have expanded access to these records for tracking purposes in the event of a potential public health risk.
  • FSMA allows for new regulations that prevent manufacturers from knowingly including illegal additives, chemicals or other substances to products.
  • The FDA may require certification or other forms of assurance for high-risk food imports, and can refuse to import food products that lack required certification.

What can my food company do to prevent food safety problems?

Develop a written hazard analysis plan.

This plan is designed to evaluate potential hazards that could affect food that is manufactured, processed, packed or even held at your facility, including biological and chemical hazards, natural toxins, pesticides and drug residues.

In addition to developing a written hazard analysis plan, you’re required to identify and implement preventive controls.

These preventive controls are intentionally developed to provide assurance that any hazards identified in your hazard analysis plan will be significantly reduced or prevented.

All of your controls must be documented in writing and your records must be kept for at least two years.

What’s detected during an FDA inspection?

FSMA calls for more frequent FDA facility inspections.

And if your food business is considered “high risk” you likely have received an initial FDA inspection since the FSMA was enacted in 2011. You can also expect to have a recurring inspection every three years.

The greatest risk you face when the FDA visits, is that they test and find a product that is deemed unsafe for your consumer.

The FDA has the power to mandate a recall of unsafe food if your company fails to acknowledge it and/or does not address it voluntarily.

If the FDA deems a product is unsafe, they may require access to all records regarding that article of food. Any person (excluding farms and restaurants) that manufactures, processes, packs, distributes, receives, holds or imports the potentially dangerous food must comply with the FDA’s request.

In conducting a recall, the FDA will notify the public through press releases, alerts and public notices.

They will also update their website to include a searchable database of food articles that are subject to recall.

Let’s just say… you want to do everything in your power to avoid a recall!

The FDA also has authority to suspend the registration of your food company if they determine that your food has reasonable probability of causing illness or death.

FSMA then requires a corrective action plan if your food company has been suspended and you seek to regain registration.

Bottom Line.

So here’s the bottom line.

While FSMA’s sole purpose is to improve the safety of the US food supply – there’s no doubt that the law has presented many challenges to your food business.

But that’s not to say it should hold you back.

Rather, it should keep you focused on developing and maintaining a safety culture within your facility – and perhaps subscribing to a few food safety organizations so you are informed on FSMA updates.

Next Step.

I’m Pat O’Neill, a Food and Agribusiness Recall Protection Specialist here at The O’Neill Group and I’d be happy to connect you with tools and resources that will help you maintain FSMA compliance.

Please call me at (330) 334-1561 or email me at to learn more about the tools and resources we have available for you.


This article was adapted from Zywave. This is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel or an insurance professional for appropriate advice.