5 questions you’ll need to ask yourself before you’re ready for new FSMA regulations

Posted: 27 February 2017 | Mike Koeris | Founder at Sample6, | 2 comments

With the FDA’s new FSMA food safety regulations defining modern practice, here are five questions you must ask yourself before considering yourself compliant…


Now that the FDA Food Safety Modernization Act (FSMA) is the law of the land, it is essential for food processing plants to have plans and procedures in place that fully comply with the new rules and regulations.

USP launches new Food Fraud Database to support increased FDA food safety regulations

We asked Michael Koeris, Founder at Sample6 and to pose the 5 questions you must ask yourself before certainty that your plant or factory is compliant with the new regulations.

Even if your plant is already meeting basic FDA regulations, there’s more you must do in order to avoid noncompliance, protect your brand and meet the evolving demands of food safety.

If you haven’t already, it’s time to assess your food safety plan and ensure that your plant’s operations are in complete accordance with the new FSMA regulations and guidelines. There are five key areas to focus on, including Preventive Controls, Inspection and Compliance, Imported Food Safety, Response and Enhanced Partnership. To properly update your plant’s food safety plan and procedures, begin by asking the following questions.

Question 1: Does your plant have comprehensive preventive controls in place?

The main goal of FSMA is to bring food safety efforts into the 21st century by adopting proactive versus reactive measures. This means focusing on the early identification and prevention of issues associated with foodborne illness. That is why the preventive controls provision of FSMA is a top area of concern:

“For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.”

Even if your plant is already meeting basic FDA regulations, there’s more you must do…

In 2015, the FDA posted its final rules for preventive controls in both human and animal foods, requiring FDA-registered facilities to monitor for hazards and implement preventive controls to mitigate pathogens. These controls include product testing and environmental monitoring.

What steps is your plant taking to conduct efficient, proactive testing and monitoring?

Are you taking advantage of new technology that enables on-site pathogen detection?

It is not enough for plant managers to have a plan for taking corrective action on contaminated products; they must also have a strong preventive plan in place to identify pathogens in the production environment before they affect the product and/or leave the facility.

Question 2: Do you currently use all the inspection and compliance resources provided by the FDA?

In order for the ultimate goals of FSMA to be achieved, the FDA is tasked with ensuring that the food industry complies with the new rules and regulations — and that means conducting inspections:

“The legislation recognises that inspection is an important means of holding the industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.”

Your food processing plant can prepare for inspections by consulting all the resources provided by the FDA and utilising effective compliance and control software that enables you to:

  • Verify that you are in full compliance with all FSMA requirements
  • Present a virtual tour of your food safety plan with visualisation tools, corrective action reports and trending analysis
  • Demonstrate the improvements and accomplishments you have made to ensure that your plant is providing the safest food to the supply chain
  • Mitigate compliance risk to your organisation.

Question 3: Does your plant import food from outside the U.S?

If the answer is yes, you may be subject to the FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals:

“FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.”


FSMA regulations mandate that importers are responsible for:

  • Determining known or reasonably foreseeable hazards with each food
  • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
  • Conducting supplier verification activities
  • Conducting corrective actions

Question 4: What is your response plan if your plant has a recall?

Hundreds of food safety recalls take place each year, and the FDA can now invoke a mandatory recall if they detect a problem for which your company has not initiated a voluntary recall:

“For the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.”

Regardless of whether a recall happens through government mandate or voluntarily, it is crucial to have an effective, efficient response plan in place (and in writing) so that everyone knows what to do if/when one occurs. The plan should include:

  • Assigning a trusted manager to lead your efforts, and assembling a team of trained investigators, advisers and attorneys with relevant experience
  • Contacting your distributors and vendors
  • Detailing how you’ll collect and eliminate the returned food
  • Communicating with the public
  • Scouring your production facilities and storehouses for contaminants and other imperfections
  • Keeping careful records of everything your company does and sending status updates to the appropriate government agencies

Question 5: What does your plant do to help achieve public health goals?

Legislators understand that achieving these proactive food safety and public health goals requires an integrated effort between multiple agencies and partners:

“The legislation recognises the importance of strengthening existing collaboration among all food safety agencies — U.S. federal, state, local, territorial, tribal and foreign – to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.”

So, where does your facility fit into these efforts? Achieving safety goals — for both compliance reasons and business motives — starts with education.

It is important to stay up to date on actions your plant should be taking to protect the public from foodborne illness.

Read Michael’s original article here at…

Food Fraud 2017

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2 responses to “5 questions you’ll need to ask yourself before you’re ready for new FSMA regulations”

  1. Reece says:

    Is this not very similar to the HACCP regulations? Picture is very misleading to the general public. Red Meat is regulated by FSIS under USDA not by the FDA… am I wrong? Is there going to be an increase in how often the FDA regulated food processors are being inspected? Incomplete information on this article…. In my opinion.

    • Roy Manuell says:

      Thank you for your feedback and you were completely right about the choice of image which has been subsequently changed. Thanks.

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