Tag Archives: FSMA rules

FSMA, Food Safety Tech, FDA

FSMA Rule on Sanitary Transportation Finalized

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

FDA has finalized the FSMA rule Sanitary Transportation of Human and Animal Food. The rule establishes sanitary requirements for shippers, loaders, motor and rail vehicle carriers, and receivers involved in transporting human and animal food. The rule does not apply to exporters that ship food through the United States.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine in an agency press release.

The sanitary transportation rule puts forth requirements for the following:

  • Vehicles and transportation equipment, including design and maintenance
  • Transportation operations, including temperature control, preventing contamination between ready-to-eat food and raw food
  • Training of carrier personnel
  • Record maintenance, including written procedures, agreements and training

Those exempt from the rule include:

  • Food transportation shippers, receivers and carriers with less than $500,000 in annual revenue
  • Farms that perform transportation
  • Transport of compressed food gases and food contact substances
  • Transport of live food animals
  • Transport of human food byproducts for use as animal food without additional processing

Businesses must comply with the regulation one year following publication; smaller businesses (those with fewer than 500 employees and motor carriers with less than $27.5 million in annual receipts) have two years to comply.

Additional information is available on FDA’s website.

FSMA: What to Expect in 2015

By Aaron G. Biros
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Companies should start preparing for FSMA immediately, caution two food safety experts. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines. So are you prepared?

Two experts from The Acheson Group – Dr. David Acheson, and Melanie Neumann, in a recent FSMA Friday webinar, discussed what companies should expect from the FDA in 2015 and how they can adjust to comply with new rules as the final deadlines approach. FoodSafetyTech presents some excerpts:

With the FSMA comment deadline closed, what can we expect from FDA in terms of finalizing FSMA?

With the agency still answering questions and conducting FSMA related activities such as dealing with deadlines and proposals, we can expect to see the agency go silent on that. We have gone through multiple comment periods already so we should expect them to stick to their timeline of implementing rules.

What is FDA ultimately seeking to achieve with these rules?

When we look at where FDA is going in 2015, we need to look at what we should be doing in the private sector under FSMA’s prevention scheme. FDA is trying to require companies to think about preventative controls. It is about understanding where your risks are and using the appropriate controls. The main issue surfaces when regulators and suppliers have different senses of what appropriate controls really are. So, thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or importer, is going to be key in planning for the future.

When is it anticipated that the FSMA rules will be finalized?

Going from reactive to proactive and preventative strategies is the essence of FSMA’s effect on shifting the regulatory scheme. Therefore we should expect preventative control rules to come out first. We must put together a monitoring program and corrective actions in our food safety plan proactively. The FDA really wants to get these rules rolled out and enforced before the administration changes in 2016 with the next presidential election so we can safely assume they will try to stick to their published timelines (most proposed rules have a deadline in Fall 2015 with the latest in the spring of 2016).

What will some of the biggest challenges be for food and beverage companies as they begin to consider FSMA compliance?

The biggest challenges will deal with how to properly manage, store, and retrieve documentation. All the traceability data, information, and production and supplier documentation that is key in a recall should be readily presentable. Having all this data and documentation, being able to produce it quickly and turn it over to the on demand is the biggest hurdle. Companies need to leverage technology to manage this risk in documentation and data organization.

What should companies be doing now to begin to prepare for FSMA as we wait for the final rules?

Companies should start preparing for FSMA immediately. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines.

Supply chain risk control and environmental monitoring are new and challenging ventures. The behavior of FDA in the past few years have shown that any company that needs to comply with preventative control rules should really pay attention to their environmental monitoring program.

HAACP systems are likely to be fairly robust and will translate quickly, but environmental monitoring could be considered the Achilles’ heel. The other Achilles’ heel is the supply chain. This was in the original statute giving FDA the authority to require supply chain risk assessments and controls. This has resurfaced in the re-proposals, which is very reflective of the foreign supplier verification program. Look at what you know about your supply chain. The expectation will be that you control those risks.

The other challenge is FDA is expecting you to look more than one step upstream. If you are buying your ingredients from a distributor, it is your responsibility to institute preventative controls in environmental monitoring Companies need an organized central repository of all upstream, internal, and downstream documentation and data.

GFSI standards compare to the preventative control rules. The standards might be highly robust but that does not necessarily mean you comply with food defense and foreign supplier verification programs. Keep all that in mind when looking strategically toward 2016.

Summarized by Aaron Biros

Gary Nowacki, CEO, TraceGains, Inc.

How Can You Improve Your Supplier Qualification and Management?

By Food Safety Tech Staff
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Gary Nowacki, CEO, TraceGains, Inc.

Proposed rules under Food Safety Modernization Act are putting new demands on food and beverage companies for prevention-based risk controls. FSMA specifically addresses issues related to this for both foreign and domestic suppliers. This is going to mean either allocating more people and more time or coming up with modern ways to address these increasing and emerging demands.

Gary Nowacki, CEO at TraceGains, Inc. will address the topic of Supplier Qualification and Management at Food Safety Tech’s Food Safety Consortium to be held next month in Chicago. He will speak about how companies are struggling with managing up-stream supplier and ingredient risk and how they can both save time and be more in control of these challenges by using powerful tools and techniques.

Nowacki says that often companies have partial information on necessary documents: “Previously, companies might have felt ok about having at least certain data on their suppliers. That’s not enough under FSMA and the increasing demands of GFSI schemes, audits, and auditors.” By automating tasks that free up valuable human resources to focus on more complex issues, says Nowacki.

Giving an example, he says think about automatically sending out notices to suppliers who are non-compliant on certain information or documents so that a valuable resource doesn’t have to waste time calling or emailing the suppliers.

The role of desk audits

Another way to strengthen supplier relationships is by doing desk audits, the topic that Chris Petrlik-Siegel, Supplier Quality Manager at TIC Gums, will address at the Food Safety Consortium.

In a desk audit, the auditor checks to see if a supplier’s system as documented meets the requirements of the GFSI code under which they are certified. It also confirms if the concerned person has validated and verified the Food Safety Plans and Food Quality Plans. The Desk Audit can be conducted as an off-site or on-site activity and issues found during the Desk Audit will be documented as non-conformities. Depending on the number and type of non-conformities documented, the audit will move to the next phase – the Facility Audit – or not move forward until and critical and major non-conformities identified are properly corrected and corrective action is verified.

“Desk audits are a great way to check how ready you are to be audited. These take a lot less time than an on-site audit, and really help in preparing for the actual audit. Desk audits are more to establish or strengthen the partnership with the supplier rather than to work on an audit for the purpose of complying with regulations,” says Petrlik-Siegel.

She explains that many times, a food company visits a supplier to do an audit, and realizes that it’s a waste of time due to lack of preparedness of the supplier. “Now due to new rules being proposed under FSMA, as an end product supplier, we are responsible for the ingredients in the products, and all the products we are importing from foreign suppliers. So we rely on in-depth audits to ensure that our suppliers have robust systems and procedures in place, in addition to what we follow in-house,” describes Petrlik-Siegel.

So with 70 suppliers, each on an average supplying about 10 ingredients, the Quality Manager stresses on the importance of desk audits preparing you for the final site audits, and also for better compliance with FSMA rules. It’s often overwhelming to do a thorough audit in a matter of one or two days, so it helps to look at documentation and identify any gaps ahead of time, Petrlik-Siegel adds.

Listen to Nowacki and Petrlik-Siegel speak about Supplier Qualification and Management at the Food Safety Consortium. Click here for more information and to register.