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.

cGMPs – current Good Manufacturing Practices

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.

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 Update

The long awaited final rules for Preventative Controls are available, on time……. sort of.  The much anticipated final rules were due to be published August 30, 2015, by court mandate and with little aplomb, about noon eastern time on August 31, 2015 (cause the 30th was a Sunday) the rules were announced.  More accurately, the eventual publication of the rules was announced.

For those with little experience with Federal Government rule-making it came as another head scratching moment.  For those of us more experienced, we just sighed at business as usual and acknowledged all the more reason why this entire process is a bit frustrating.  What was announced yesterday is that the rules have been sent for publication in the Federal Register.  So, eventually, the rules will be published and we will get to read them – someday – depending upon size of the document….. Our government at work ladies and gentlemen.

Featured Announcements

August 31, 2015

The FDA has submitted the final preventive controls rules for human and animal food to the Federal Register for publication, as required by the court. Documents submitted to the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display. The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so. Please check back here for updates, which the agency will share as soon as the final rules are available via the Federal Register.

from www.fda.gov

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!

Food Safety Modernization Act & Animal Feed

The Food Safety Modernization Act, signed into law in 2011, has far reaching implications for both human and animal food manufacturers in the United States. Manufacturers of Animal Feed will be expected to meet the criteria set forth in the Preventative Controls for Animal Feeds which was originally published for comment in October 2013 and after revisions closed for comment on December 15, 2014. Publication of the Final Rule is anticipated in August, 2015. Based upon size, mills will have 1 – 3 years after the rule is finalized to implement the required programs.

Key provisions to the rule include:

  • Development of a food safety plan to address hazards associated with the manufacturing process
  • Implementation of a supplier process to ensure safety of raw materials
  • Registration of all mills as part of the FDA Bioterrorism Act
  • Small and Very Small Mill exemptions
  • Provisions for Economically Motivated Adulteration

Please check back often for updates on how these rules may affect you.