Tag Archives: FSMA

Dave Cotto | Columbian’s Very Own Food Safety Expert

Meet Dave.

Dave Cotto is the Food Safety Specialist at Columbian. He manages the entire quality program at CLN, including all Food Safety, Food Defense, and HACCP Programs. He manages their inter-dependencies, their structure, their administration, and most importantly, the accountability related to those programs. Dave works hard to make sure that our customers are happy and their product is safe.

In fact, Dave was recently nominated by a customer for the Legendary Customer Service (LCS) Award and won it. You can read more about the nomination in our second quarter newsletter. His work defines LCS because of his diligence.  There are so many people in the organization who have no idea of the depth of knowledge that Dave holds because they might only see him out in the warehouse pulling samples for a customer quality audit. That’s just the tip of the iceberg.  He almost single-handedly keeps Columbian “in the game” with customers who require quality programs and auditing structures, and most people never even hear about him.

We decided that his hard work should be recognized, and his behind-the-scenes work should be spotlighted.

Q&A

  • Describe what your life is like when a customer shows up for an audit.

“Previously, I would have been super nervous. Today, I think our facilities are ‘food safety audit ready’. I am real comfortable. I think everyone is comfortable with the way our facilities look. Cosmetically, it’s excellent.”

  • What food safety certifications do you hold?

” Science of Food Manufacturing (AIB), Principles of Sanitation in Manufacturing (AIB), Principles of Warehouse Sanitation (AIB), Quality Assurance & HACCP (AIB), HACCP (AIB), FSPCA Preventive Controls for Human Foods (IFPI), SQF Food Safety Practitioner (NFS), PCQI training (IFPI).”

  • How did you get started in food safety?

“My previous employer had a mentoring program in place. During that process, I was exposed to sanitation and food safety. I was able to attend third party audits. That peaked my interest at that time, and I thought that this was something that I would like to do.”

  • What are some of the key differences you see between food safety in a manufacturing company vs. a logistics company?

“BIG difference. Manufacturing companies deal with exposed foods and all the risks that come with exposed foods. At a third-party warehouse, we are dealing with concealed foods. It’s very limited in the supply chain, but very important.

  • How long have you been working in food safety?

“I have been working in food safety for 29 years. I have been in the food business for 35 years. I started at Columbian in 2006.”

  • What regulatory agencies do you work with?

“Most of our facilities fall into the FDA jurisdiction. But, one or two facilities have the USDA come in because we have milk or egg byproducts in those warehouses.”

  • What’s your average day like?

*Laughs*
“It varies quite a bit. It depends on what is going on with the customer. There’s a lot of communication with the customer and myself.”

  • What teams at Columbian do you work with?

“I work with the Product Integrity Team mostly. I also work a lot with facility management. Depending on the issue, I could work with everyone and anyone.”

  • What’s your favorite part about your job?

“My favorite part of the job and I’m not kidding you… I like answering questions and I really like dealing with food safety procedures. I find it interesting.  What triggered a standard? Why do we have to implement that standard? I find that intriguing. My favorite part is problem-solving the root cause of an issue.”

  • Lastly, how did you become a Buckeye fan?

“Born and raised in Ohio.”

 

food safety

Dave’s diligence in tying our programs and actual practices together really keeps us in good standing with our customers. On a recent audit from our customer’s customer, they were asking many detailed questions and Dave was able to point to the policy, procedure, and written verification quickly and accurately. Our customer’s customer auditor was trying hard to find a chink in our armor, and Dave wouldn’t let it happen. We all were extremely impressed but even the auditor made the comment that ‘he could learn a thing or two from Dave’. -Jim Gadziemski, Vice President of Warehouse Operations

fsma

Sanitary Transportation Rule | Food Safety at Columbian

FSMAThe Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final. This rule is in place to advance the FDA’s efforts to protect foods from farm to table by making sure the food is safe during transportation. The rule institutes sanitary requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers included in transporting human and animal food. The FSMA rule authenticates requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers.

Since 2013, seven rules have been proposed regarding a modern, risk-based framework for food safety. This rule is intended to prevent practices during transportation that create food safety risks. There have been concerns about the need for new regulations to ensure that food is being transported in a safe manner since 2005 when there was an outbreak of illness due to human and animal food contamination. Some of these risks could be the failure to properly refrigerate food, inadequate cleaning of vehicles in between loads, and failure to properly protect food.fsma

Who is covered?

  • Shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.
    • Persons, e.g., shippers, in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.
  • The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.
  • Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.
    *Information gathered from The FDA 

Key Requirements

  • Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
  • Transportation operations:The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
  • Training:Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records:Maintenance of records of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred but does not exceed 12 months.
    *Information gathered from The FDA 

Waivers

The Sanitary Food Transportation Act (SFTA) allows the agency to waive the requirements of this FSMA rule if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest (FDA, 2017).

According to the FDA website, the FDA has published three waivers for businesses whose transportation operations are subject to Federal-State or local controls. They include:

  • Businesses that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when engaged in transportation operations involving bulk and finished Grade “A” milk and milk products.
  • Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
    • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
    • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as: delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s).
  • Businesses that are appropriately certified and are inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP), only when engaged in transportation operations involving molluscan shellfish in vehicles that are permitted by the State NSSP certification authority.

Click here to read more about the three waivers added to the final rule.

Compliance Dates

Recognizing that businesses, especially small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.

  • Small Businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule.
  • Other Businesses – a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.
    *Information gathered from The FDA 

Exempt from the Rule

  • Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
  • Transportation activities performed by a farm
  • Transportation of food that is transshipped through the United States to another country
  • Transportation of food that is imported for future export and that is neither consumed or distributed in the United States
  • Transportation of compressed food gasses (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
  • Transportation of human food by-products transported for use as animal food without further processing
  • Transportation of food that is completely enclosed by a container except for a food that requires temperature control for safety
  • Transportation of live food animals, except molluscan shellfish
    *Information gathered from The FDA

What does this mean for Columbian?

At Columbian, safety is our number one value. That being said, it is our highest priority to make sure that not only our employees are safe, but our customers and their products are safe as well. We specialize in food safety at Columbian and want to make sure that we are doing everything in our power to perform at the safest level.

At the warehouse level, Columbian’s role in the Sanitary Transportation Act is a small piece of the process, but vital to ensure that the food safety supply line is safe and suitable for further food processing at the manufacturing plants and distribution centers for finished products. Columbian does not transport bulk/open food. Temperature control in trailers is typically not an issue due to Columbian’s average length of haul.

Columbian’s primary role in the Sanitary Transportation Rule is to identify potential food safety risk at the point of receipt and in our trailer inspection processes.  This is done by obtaining regulatory standards, and customer requirements relating to refrigeration loads in the warehouse process product flow.  At this point, we know that we need clean trailers that are suitable for receiving and shipping of food grade materials from customer suppliers and to our customer designation sources.

fsmaTrailers that come into Columbian facilities must abide by our clean trailer rules. This process has been developed by Columbian’s food safety experts to ensure that trailers are clean before coming in contact with our facilities. Drivers are notified that their trailer will be rejected if it has any of the following:

  • Glass
  • Sharp, hard plastics
  • Holes
  • Infestation of any kind
  • Allergen contamination
  • Strong or unusual odors
  • Blood or blood stains

A refrigerated trailer (sometimes referred to as a reefer), on the other hand, is a different process because it involves handling sensitive perishable goods that require controlled temperatures. Refrigerated transportation is usually driven by our customer requirements, which coincide with national and international standards.  Once we have this information, we do the following:

Receiving

  • Provide training for our employees on the reefer process.
  • Confirm Security seals are attached the load
  • Check the reefer settings on the trailer before unloading product, and recording those temperature readings on inbound paperwork
  • Per customer or in-house procedures, we periodically check temperatures at designated points as we unload the trailer in order to ensure consistent temperature distribution throughout the trailer. The periodic temperature tests are also documented on the inbound paperwork.
  • As we unload, the driver visually inspects the product and trailer for defects that may compromise the product integrity.
  • All nonconforming issues to product condition, temperature, and trailer conditions (mentioned above), are rejected at this point in the receiving process and reported to the customer for remedial actions.

Outbound

  • Outbound loads follow the same process as inbound loads. However, there are two exceptions. First, we must make sure the temperature is preset and the temperature inside the trailer is at the customer’s required temperature before loading. Secondly, we do not periodically check temperatures as we load product on the trailer.

Columbian always considers new rules and laws when creating new safety procedures. Columbian continues to strive for the safest environment for employees, customers, and product.

Click here to read more about the final rule on Sanitary Transportation of Human and Animal food.

Allergen Smart – Preparing for FSMA Changes


Allergen Smart - Preparing for FSMA

With the majority of recalls caused by undeclared allergens, the FDA focuses efforts of preventing cross-contact with new provisions in the Food Safety and Modernization Act (FSMA). Special thanks to Len Steed, Global Innovation Manager at AIB for contributing to this article.

The importance of food safety has a face, and a name. Debra Miller-Tossey, a grandmother of 8 and avid outdoorswoman living in Cadillac, Michigan, was diagnosed with Celiac disease in 2013. Celiac is an autoimmune response to the protein (gluten) found in grains like wheat, barley and rye, which causes the body to attack and damage the small intestine. “It was such a relief, I had been feeling sick for so long, and so worried it was cancer. It was just a relief to know it had a cause and could be managed.” Standard management of allergies and intolerances from foods such as milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish, is often strict avoidance, as even trace amounts can cause severe and even life threatening reactions called anaphylaxis. With an estimated 15 million Americans living with food allergies, the FDA, via the FSMA, is requiring documented controls to prevent undeclared allergens. Companies that produce and distribute food and beverage products will need to review the proposed 21 CFR 117 Good Manufacturing Practices (GMP) to ensure that existing prerequisite programs and Hazard Analysis Critical Control Points (HACCP) plans are effectively implemented to prevent recalls due to GMP deficiencies allowing for operational cross-contact and mislabeling.

Preventable Recalls: Undeclared and Allergen Cross Contact
The FDA Reportable Food Registry (RFR) collects data on Class 1 Recalls which is defined as ”…a reasonable probability that an article of food will cause a Serious Adverse Health Consequences or Death in Humans and Animals termed a (SAHCODHA) event. This data was used to track preventable recalls and incident patterns to help the FDA identify risk in the food chain which includes foods imported to the USA. Each year the RFR publishes a report titled “Targeting Inspection Resources and Identifying Patterns of Adulteration”. The fourth annual 2012-2013 report cites undeclared allergens as the largest reason for recalls accounting for 44% of all recalls. Food manufacturers and distributors will need to implement preventive controls as required by Section 103 Hazard Analysis and Risk Based Preventive Controls (HARPC) and the proposed GMPs.

HARPC Preventative Controls
The current GMP’s describe the methods, equipment and control procedures required for specific food sectors to prevent unsanitary conditions. The proposed change to the GMPs in 21 CFR 117 will require that companies re-examine their existing GMPs and decide if a process step, operational program or prerequisite program must be monitored similar to a HACCP Critical Control Point due to its importance to prevent a Class 1 SACODHA event. For those companies shipping product to the USA, the HARPC and proposed GMP requirement will be applicable under an additional FSMA rule called the Foreign Supplier Verification Program (FSVP). The final rule for HARPC and FSVP will be issued in August 30 2015 and October 31, 2015 respectively so the time to act is now.

For more information on how the FDA FSMA rules will affect your organization, the AIB has published an excellent resource, available here: http://www.columbianlogistics.com/AIB-FSMA-Ready

AIB International

Outstanding AIB Audit at Grandville, MI Warehouse

Columbian Logistics Network is please to announce it’s Grandville distribution center has passed it’s AIB International audit with a score of 960. The AIB International is a globally recognized non-profit that provides independent audit service, consulting, and educational programs in an effort to promote food safety across the food processing and distribution industries. The audit system for food distributors is composed of 5 categories:

  1. Operational Methods and Personnel PracticesAIB-International
  2. Maintenance for Food Safety
  3. Cleaning Practices
  4. Integrated Pest Management
  5. Adequacy of the Prerequisite and Food Safety Programs

Scores are determined by the number and type of ‘observations’ recorded by the auditor. “We are really proud of this score, it’s a great reflection of our commitment to providing our customers with the highest level of food safety.” Notes Jim Gadziemski, General Manager of Warehousing. Grandville facility manager Tami Binkowski would like to recognize the contributions of Dave Cotto, Food Safety Specialist, and Alisha Nettles, 1st shift warehouseman. “Their hard work and dedication really help make the audit process go seamlessly, and they are already planning on how to raise the score for next year!”.