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As Romaine lettuce is planted in Arizona, the FDA has overwhelmed the produce industry with draft guidance documents. When the Food Safety Modernization Act (FSMA) was signed in 2011, the importance of growing, harvesting and processing of fruits and vegetables was recognized as the start of food safety for the familiar term of farm-to-fork. One of FSMA’s foundational rules is the Produce Safety rule. Today we deviate from the traditional focus of the ConnectFood blog at the middle step of the Preventive Controls for Human Food rule to start at the very beginning where crops are grown.

As a Lead Instructor grounded in the latter rule, I have presented dozens of times the difference between a farm as a supplier and a food factory as a receiving facility. In the simple world of instruction those two are obvious. Consider a farm that harvests melons and then washes the melons. Is the location of washing considered a farm and under the Produce Safety rule or considered a receiving facility and under the Preventive Controls for Human Food rule? I don’t want to leave you hanging; I identify the washing facility as a receiving facility and subject to the Preventive Controls for Human Food rule. FDA has made my choice clearer with their guidance documents. Across the nation and internationally there are hundreds of examples of farms harvesting a crop and then another step being applied, before the fruits or vegetables reach a traditional food factory.

FDA has done a momentous job in publishing draft guidance for the farm and food industries. See my resources listed below. In keeping with starting at the beginning, key definitions are discussed here.

Supplier: the farm that grows the crop or raises the animal. A supplier to a food factory can in turn be a food factory, e.g., when a food factory purchases dried ingredients. For the purpose of discussion here, the supplier is a farm that grows a crop.

Receiving facility: food factory that receives the crop and registers with FDA as a facility that processes, manufactures, packs or holds food. The draft guidance documents are FDA’s current thinking on the definition of receiving facilities that handle crops. Facilities which in the past have been considered farms must now register as a food facility.

Farm mixed-type facilities: this is the location of the next step after harvesting, but before getting to a traditional food factory like a spaghetti sauce manufacturer. FDA looks at processing, packing and holding. For example, located conveniently to fields are packing houses. In our grocery stores, we find fruits and vegetables that have been washed and chilled, sorted and packed into wrapped trays, mesh bags or boxes. Those steps are considered processing. In the past, FDA has left farm mixed-type facilities as farms, and now FDA sees farm mixed-type facilities as receiving facilities under the enforcement of the Preventive Controls for Human Food rule. This is a big change and will cause hundreds of facilities to register as a food facility, implement a food safety plan, and have a trained Preventive Controls Qualified Individual (PCQI) to oversee food safety.

In my next blog post, read about different types of produce and exemptions from the rules.

Matthew Botos, CEO of ConnectFood, and the whole Expert Services team can guide you.

    “As with all food manufacturing we must focus on “basics done well”, this mean employee training and a focus on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs). The FDA has set a very good standard for all produce companies.” – Matthew Botos, CEO, ConnectFood

The folks at ConnectFood are here to help! Contact us.

Resources:
Guide to Minimize Food Safety Hazards of Fresh-cut Produce: Draft Guidance for Industry

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry, Draft Guidance

AT A GLANCE: KEY POINTS IN THE PRODUCE SAFETY RULE DRAFT GUIDANCE: CHAPTER 1: GENERAL PROVISIONS (SUBPART A)

FSMA Final Rule for Preventive Controls for Human Food

FSMA Final Rule on Produce Safety

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

Receiving is a critical operation within your company with great responsibilities.

  1. Receiving of raw materials potentially contaminated with pathogens
  2. Receiving of ingredients with known allergens
  3. Receiving of ingredients or packaging with a supply chain preventive control
  4. Prevention of intentional adulteration

Receiving personnel need access to records at Receiving. Do Receiving personnel have a tablet or computer to look up approved suppliers, specifications and other information? Stickers and placards should be readily available to label totes or pallets with QA hold, allergen, or other warnings. Receiving personnel must be properly trained in the receipt, labeling and handling of raw materials potentially contaminated with pathogens, ingredients with allergens, and ingredients or packaging with a supply chain preventive control.

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

The Preventive Controls for Human Food rule Subpart G details the requirements for supply chain preventive controls. With every receipt of an ingredient with a supply chain preventive control, bill of lading should be checked, along with the receipt of documentation of the absence of the hazard. The latter is needed, regardless of the same lot being repeated.

Receiving should have written SOPs for the inspection of vehicles for sanitary transport and receipt of materials in intact totes or on intact pallets. Not only are you concerned about determining if pests have accessed the ingredient, you are also preventing cross-contamination of pathogens and cross-contact of allergens. Within the written SOP, address the refusal of goods where the truck is unsanitary or when the packaging is compromised.

The Intentional Adulteration rule is effective in 2019, and Receiving plays a more direct role. Many of the steps taken now, like sealing of gaskets, will be documented to comply with the rule. The focus of the rule is on liquid ingredients and ingredients with the potential to cause widespread harm to public health. As you are implementing your food safety plans, consider incorporating measures designed to prevent intentional adulteration at Receiving.

Once an ingredient is accepted and properly labeled, Receiving may be responsible for notifying QA of a QA hold or for proper moving of ingredients to storage. Proper handling does not compromise the ingredient through cross-contamination or cross-contact. Another part of the Intentional Adulteration rule addresses the disgruntled employee. Start at Receiving and walk through the potential for an employee to have access to an ingredient or process, with the intent of widespread harm.

Receiving personnel play a key role in the safety of food. By providing the training and resources necessary for them to do their job well, you create a culture of food safety from the beginning.

Paperwork! Paperwork! And more paperwork! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.