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.

FSMA & cGMPs

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.

Food Safety Modernization Act

With the arrival of summer comes what should be the final laps for the Preventative Controls for Animal Feeds rule of the Food Safety Modernization Act. The FDA development group is indicating final rule publication by the end of August 2015 providing for some relaxing beach reading over Labor Day weekend.
As mentioned in prior articles, there will be ample time for implementation once the rules are made final. Overall I recommend that mills wait until the rule is read and digested before making any far-reaching changes to their programs. There are, however, a few things you can do to begin preparation and give yourself a head start. These things, regardless of the final rule, will serve to strengthen your existing food safety program and improve your business operation.
What can I do now?
• Develop a list of all your suppliers
• Obtain letters of guarantee for the ingredients you receive
• Review your pest control program. Update your map. Develop activity trends and address areas of concern
• Map your production process from receiving through storage indicating where items are added and which points are measured
• Review your employee-training program – what topics are currently covered, is your training up to date?

Only time will tell where we all end up but here’s to being prepared!

The ‘right’ thing to do

It’s the right thing to do.  How many times have we told ourselves that as we made a tough decision?  Buck up – it’s the right thing to do!  It’s an oft used phrase of our President as well.  He often pairs unpopular decisions with the comment.  Some one used it this week that made me pause… what does that really mean?  The right thing to do for whom?

In a food plant there are many competing priorities and a finite amount of funds – and everyone wants some.  Safety needs new ladders, maintenance is being asked to replace a packaging machine, food safety would like damaged floors resurfaced, wouldn’t it be nice to have an employee barbecue to celebrate the fourth of July?

How do you prioritize tight funds?  How do you send the message that food safety is important but you are going to install that packaging machine instead of resurfacing the floors?  How do you do what’s right by the Company as a whole and keep everyone motivated.  How do you counteract the ‘pounds out the door’ accusation?

My answer?  Honesty.  Explain.  Sometimes the right thing to do is the one that generates revenue.  How often have I said in order to make safe food you need to MAKE FOOD?  Something I fear is often not well communicated.  A good decision maker will collect the ideas, weigh the options and most importantly – explain the decision, ask about the risk, understand the decision they are making.

A good employee will honestly explain the risk.  Do you have to do this – yes/no?  What might happen if we don’t?  Be honest.  Proper management of company funds is on each of our heads.  It is our responsibility to ensure the sustainability of the organization.

So I implore you – make certain your are doing the right thing – not just labeling it the right thing to do.

FSMA Animal Feed Requirements

FDA has revised the Animal Feed requirements for FSMA implementation, resulting in approximately 2200 less mills being required to implement.  The summary of changes can be found here.

FSMA & Animal Feeds