FSMA 2018 Update

With the effective date of the Produce Safety Rule in January 2018 all 3 food and feed rules are now in use and members of our industry are working hard to implement the requirements and understand the impact to their business.  While the programs and requirements may seem daunting it is very likely that your current activities meet the requirements of your associated rule and, with some ongoing documentation and training, your facility can consistently prove compliance and meet FDA visit requirements when they occur.


Preventive Controls for Human Food

Any food manufacturer required to register for the Bioterrorism Act of 2002 must become compliant with this rule.  The initial compliance dates for large companies was September 2016 and passed without significant issue.  Smaller organizations were expected to become compliant in September 2017 and, as this was the bulk of manufacturers, more challenges were identified with regard to availability of training.  Overall compliance and education continues with moderate success.


Preventive Controls for Animal Feed

Published concurrent with the Preventive Controls Rule for Human Food, this rule impacts all pet food manufacturers and animal feed mills.  Large facilities were tasked with compliance in September 2016 and was met with recognition that the industry as a whole was working diligently but required addition assistance and training.  Recognizing this, FDA has deferred enforcement of many of the food safety requirements, focusing on education and outreach in lieu of punitive actions.  It is important to note that while enforcement may be delayed, expectation of compliance remains.


Produce Safety Rule

Published in January of 2016, the very largest of the those impacted by this rule were required to be compliant in January 2018.  Of the 3 industry sectors the fresh produce industry is by far the most diverse in size and scope.  From individual farm stands to wholesalers and distributors sites must understand the requirements of the rule and the documents necessary to prove compliance.  Understanding of farm site risks and environmental, wildlife and input effects is essential to ensuring your farm is meeting the rule requirements.

Food Safety Modernization Act (FSMA) – Implication for Feed Safety Enforcement

FSMA, which became law in January 2011, is designed to give FDA more authority to protect the safety of food for humans and animals. It gives FDA new authorities for addressing issues concerning the safety of food for animals and will ultimately change the overall enforcement actions taken by state and federal regulatory authorities.

Generally speaking, FSMA has four main themes: prevention; inspection, compliance, and response; import safety; and enhanced partnerships.

The prevention rules applying to animal food facilities are similar to Good Manufacturing Practices regulations currently in place for human food and for some aspects of the CGMPs for medicated feed. It is important to note that FDA is placing much emphasis on the different expectations between pet food manufacturers and animal feed mills.  The cGMP rules apply to personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, process and controls, and warehousing and distribution.

Other requirements of the regulations include:

  • Having written food safety plans
  • Conducting hazard analyses
  • Implementing controls to address hazards
  • Monitoring the controls to make sure they are effective, taking corrective action when a problem is discovered
  • Verifying that the corrective action was effective
  • Having a recall plan in place
  • Having a supplier approval and verification program

FSMA gives FDA new authority to require a mandatory recall if a firm with an unsafe food product fails to act quickly to voluntarily recall the product. It also gives FDA a more flexible standard for administratively detaining products that are potentially in violation of food safety requirements. And under FSMA, FDA will continue working with industry and other experts to develop programs for rapidly tracing domestic and imported food.

FSMA also extends to animal food ingredient imports. It gives FDA unprecedented authority to make sure that imported products meet U.S. standards. Under FSMA, importers are responsible for making sure that their foreign suppliers have adequate preventive controls in place to ensure the safety of their products.

September is Food Safety Month

September is Food Safety Month which leads us to consider the implications of food safety throughout the supply chain.  For the previous few years the emphasis has been shifting, or perhaps expanding is a better word, toward the farm.  We see more education, emphasis and visits being conducted at the farm – both animal and fruit and vegetable.  This is good but only 1/2 the battle.

When I first began HACCP training in my plants I would hold up a hot dog and explain – assume I am going to buy this at the store, leave it in my hot car for 8 hours while I visit my boyfriend, drop it on the floor as I remove it from the package and then eat it without heating.  If I become ill – who will be called to explain?

While a bit exaggerated that was, and essentially still is, a fact.  There is little to no emphasis placed on the consumers ability to keep safe – or render unsafe – the food that they eat.  Advocates stress that consumers must be able to buy and eat food with a confidence that it is safe.  This is true but the burden is also on them to take steps to keep the food safe.

I think September is a good time to share the FightBAC! information yet again.  The earlier and more often we stress the need for education for all the better we as an industry will be.


cGMP Implementation Deadline – September 2017

An important portion of FSMA to be implemented by animal feed mills is the application of cGMP’s consistent with the type of feed being manufactured.

Some things you should know:

  • The word ‘current’ indicates implementation of rules consistent with practices in place at the time of manufacture – meaning this is a living program requiring routine review and updating
  • When feed is manufactured under conditions less than these conditions it can be deemed adulterated by FDA
  • cGMPs are intended to provide a preventive approach to feed manufacture
  • Licensed medicated feed manufacture is subject to additional, more stringent cGMPs through sections 225.1 – 225.115 of the Code of Federal Regulations Title 21.


Each feed mill will have a unique program of cGMPs but all should be developed to ensure consistent control and documentation of the following:

  • Housekeeping requirements
  • Personnel training
  • Inventory control
  • Equipment cleaning
  • Preventative maintenance
  • Product labeling
  • Product trace and recall


If you’d like assistance in compiling your current Good Manufacturing Practices and a review of their adherence to FSMA requirements we’d be happy to help.

Is FSMA Going to Change under Trump?

With the inauguration of a new administration focused on reducing regulatory burden there has been much discussion about the potential effects on the Food Safety Modernization Act. Currently there has been no indication of any change of course by the FDA regarding ongoing implementation of the current programs but the rules are included in the list of items identified for review as part of the Reduced Regulatory Burden Initiative requested by the adminstration.

Reducing the Regulatory Burden

The FSMA rules establishes requirements for:
• A written food safety plan
• Hazard analysis
• Preventive controls
• Monitoring
• Corrective actions and corrections
• Verification
• Supply-chain program
• Recall plan

The majority of manufacturers of human and animal food will be required to implement cGMP and Food Safety programs in 2017.  Is your organization ready?  We can help!

Human Food versus Animal Feed

A common question these days from animal feed manufacturers is whether the FSMA regulation, and FDA themselves, understand the difference between human food and animal feed. There is justifiable concern that regulations are intended to move the animal feed industry toward the requirements of human food and most believe this is unwarranted.
We as industry are in the unique position to help our regulators understand what will and won’t work in the industry. The edict is to ensure the safe manufacture of the feed and you, as the manufacturer, can best determine how that is to be done.
There is no question that better tracking and documentation can be implemented. This will help us prove our case that best practices in the industry are designed to ensure safe manufacture. Only by stating, and proving, our case, can we instill in regulatory officials our responsible methods.
JW Safety has teamed with Ranck & Associates to offer their clients guidance to meet the requirements set forth in FSMA. Ranck & Associates is a full service management consulting firm specializing in food and feed manufacturing. They can offer a full program for FSMA compliance including a complimentary GAP analysis, training for both PCQI and mill employees and program development and ongoing assessment. Please contact us to begin planning your 2017 implementation.

The Time is Now!

September 19, 2016 marked the date for the first wave of FSMA implementation for the largest of the food and feed companies under FDA jurisdiction. We should finally begin to have clarity into some of the requirements and expectations of the overall management program.
To that end FDA has released a draft Guidance document for comment to help provide real life examples of program expectation. Joann Givens, Co-Chair of the FSMA Operations Team also took some time recently to provide a Q & A available on the FSMA Implementation website.

What happens next in terms of FDA enforcement of these new standards?

This is new territory for food and feed companies; it’s new territory for FDA too. For years we’ve been talking about the FSMA rulemakings and implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.
A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. FDA recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidance to come, about two dozen planned over the next few years. The expectation is for continued dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.
For those mills required to meet compliance in September 2017 now is the time to begin reviewing your existing programs and developing new procedures as necessary for compliance. A HACCP/Preventive Controls assessment will need to be completed to identify the hazards associated with your processes. Training will also need to be completed for the PCQI in your organization as well as all your employees responsible for manufacturing and handling.

HARPC – What To Include?

Still struggling to make the connection between your HACCP plan and the FDA mandated HARPC?

While some of the expectations are still a bit gray, and will be until we start to see enforcement from FDA, it is possible to take some active steps to bring your overall plan into compliance.  The stressed difference is HACCP can be considered reactionary versus HARPC as preventative – i.e. what do you need to do in advance to prevent an issue?

HARPC should be applied to the following programs:

  • Biological, chemical, physical and radiological hazards
  • Natural toxins, pesticides, drug residues, allergens, and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards.
  • Intentionally introduced hazards (including acts of terrorism)
  • Sanitation procedures at food surface contact points
  • Sanitation of utensils and equipment
  • Staff hygiene training
  • Environmental monitoring program
  • Food allergen control program
  • Recall plan
  • Current Good Manufacturing Practices (cGMPs)
  • Supplier verification activities

Dusting off these programs and appraising them from a different angle can help get you started and we’d be happy to help.  Feel free to contact us at info@ranckandassociates.com to discuss your organizational needs.


A basis for any food safety program is the implementation and documentation of Good Manufacturing Practices.  While the idea may seem intimidating at the onset, as you become more accustomed to the process you may find it of great benefit to your operation.

The Preventative Controls regulations require cGMPs for employees, facility, sanitation, water distribution, equipment and tools, operating conditions and storage/transport.  Written procedures and employee training on the expectations must be implemented as part of your compliance with the new rule.

Some examples of cGMP’s covering a facility would include handwashing requirements (employees), visitor policy (facility), SSOPs for cleaning equipment (sanitation), scheduled sequencing of product for hygiene or allergen considerations (operations) and color coding tools (equipment and tools).  In my work with plants and mills, I find that many of the expected processes are already in place however may not be documented as occurring.  With the implementation of the rule it will become important that these practices are documented and confirmed as occurring.  The adage to live by will be ‘if it’s not documented, it didn’t happen’.

If you’d like assistance in reviewing your existing programs and getting those best practices documented for your mill we’d love to help.  With over 25 years of food and feed manufacturing experience as well as extensive FDA and USDA knowledge, Ranck & Associates can help you implement a program that will quickly become how you do business instead of a cumbersome government program.  Please contact us if you would like to learn more about the FSMA services we offer.





The Time to Act is Now

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for both Human Food and Food for Animals was published in the Federal Register in September 2015 and with this action, the countdown to implementation has begun.  The first wave of facilities will be expected to have implementation complete no later than September 17, 2016 with smaller facilities to follow on September 17, 2017.

The rule establishes requirements in the following areas:

  • Personnel
  • Plant and grounds
  • Sanitation
  • Water supply and plumbing
  • Equipment and utensils
  • Plant operations
  • Holding and distribution
  • Holding and distribution of human food by-products for use as animal food

The rule establishes requirements for:

  • A written food safety plan
  • Hazard analysis
  • Preventive controls
  • Monitoring
  • Corrective actions and corrections
  • Verification
  • Supply-chain program
  • Recall plan

To ensure a thorough plan that meets all requirements you will want to make certain all the areas are touched upon and the requirements cover all aspects of your operation.

Please contact us if you would like to learn more about the FSMA services we offer.