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Is Your Allergen Mitigation Program FSMA Compliant?

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Allergen’s continue to be the top area for recalls within the U.S. Under FDA’s FSMA (Food Safety Modernization Act), allergens had been elevated as a Class I Recall. The expectation for raising this classification was that food manufacturers and processors would be more focused on their Preventative Controls, limiting the possible incidence, better managing potential allergen mis-haps, ultimately reducing Allergen Recalls. Unfortunately, evidence of fewer allergen recall incidents since FSMA implementation has not been realized. Additionally, FDA will be stepping up examination of Allergen programs on upcoming assessments.

Examining “why” there is a lack of reduction of allergen incidents still eludes Food Safety professionals. Most prevalent occurrence bucket are undeclared or mis-labeled allergens. However, the lack of progress for elimination of incidents leads to a larger issue, is there a robust Allergen Mitigation Plan in place that has been validated to address all possible mis-haps? The strength of a robust Allergen Mitigation Program, with multiple hierarchy of key elements are essential, providing needed fundamental checks and balances which are often overlooked.

This hierarchy focuses on highest risk areas first, then incorporates other stage or level concerns in descending order. The mitigation plan should also encompass every stage of the supply chain from processing start to packaging as a finished product. The critical stages of an Allergen Mitigation Program should be well documented and evaluate what are the risks at each step, ensuring remedies to minimize these potential hazards are in place.

There are five fundamental stages as follows:

Allergen Program Essential Stages

1.   Allergen Mapping-Ingredients: A Supplier questionnaire understanding key information such as allergens, sanitation program to eliminate allergens, if claims are made and validated, what certification programs are in place (e.g. Gluten-free, Organic, etc.), along with any other needed information to aid in providing clear labeling or processing steps in your operation should be first step to complete an Allergen Map. This map is a matrix which lays out all gathered supplier data on ingredients and potential allergens in your portfolio feeding into the document. The map should be unique to each facility within your organization.  

2.   Allergen Mapping-Formulae: Very similar to the ingredient matrix, this map now examines each formula by ingredient to highlight the allergen within that recipe. Again, each facility should be explicit on which allergens are present at that site.

3. Allergen Mapping-Process Zones: Mapping the processing facility for all possible aspects on moving and handling allergens in the production and storage zones is the next stage. Generally, an engineering plan of the process plant is used and must incorporate each process flow step at the site, preferably by line. Often, the map is color coded to reflect potential areas of cross-contact for raw and finished product areas as risks are different at each step. Solid walls or barriers, restricted travel routes and staging areas important to highlight. Often processors will utilize movable curtains for separation of allergen handling areas. These “magic” curtains are not sufficient barriers for cross-contact control. The use of color coding protective GMP ware is an excellent tool to manage people traffic to ensure team members are in the right areas, especially where temp employees are utilized.  

4.   Hazard Characterization: At this stage each facility needs to take a deep look at all considerations for the potential allergen(s) in your environment. Questions one should be focusing on: What it the physical nature of the allergen? Is it difficult to remove during ordinary sanitation or are other methods required? What level of processing does the allergen go through? Is the allergen spread through dust or present in the air? Do any employees handling this allergen have known allergies? Once each possible consideration is evaluated, the Allergen Plan should have the proper mitigation measure in place to address the hazard risk.

.5. Evaluate Control Measures: For this stage site must evaluate that the controls they have instituted are sufficient to mitigate the hazard risk potential. Typical steps to review include: Has planned scheduling of allergen runs worked to minimize risks? Are physical barriers or traffic patterns working? Is a dedicated plant, line or equipment sufficient? Are my cleaning programs adequate to eliminate the allergen? Have my employees been properly trained? Are my labeling checks acceptable to ensure there are no mis-haps on packaging? Has my validation program provided sufficient evidence my program is robust to control allergens in my environment?

Of course, there are many nuances to consider when developing a written Allergen Mitigation Program that aligns with FSMA for incorporating Preventative Controls. Like many other critical Food Safety programs, it is best to pull a cross-functional team with good understanding of each step to assist. Checking and doublechecking the five hierarchy stages should glean a robust plan that once validated should more than adequately meet FSMA compliance. 

Authored by Gina Reo

gina_reo@comcast.net   

https://www.ginareo.com/

February 25, 2019

FSMA Preventative Controls 101

Sanitary Design Drain Preventative Improvements for Aging Facilities

As most food organizations are well aware today FSMA, (Food Safety Modernization Act) has placed tremendous emphasis on manufacturers for Preventative Controls. Since FSMA became operative in 2016, FDA Investigators while visiting sites have been very focused on the new Preventative Control audits for enhanced GMP’s. In fact, the majority of #483’s issued were for basic GMP’s such as Sanitation, Pests, Building Design, Walls, Floors and Ceilings. Today, let’s focus on one area where particular attention continues to be overlooked in plants, especially in older facilities, drains. As you review aging facilities, you generally still see poorly maintained drains with chipped concrete or broken tiles, old cast iron units, trench drains or placement of drain in close proximity (often underneath) to food processing lines where aerosol contaminants or access for sanitation is nearly impossible to do effectively.

Additionally, the facility floors are frequently checkered with drains in numerous places no longer needed, due to lines that have long since been moved, many from a time when we used high powered water everywhere, hosing processing lines down and waste water volumes were of little concern.

FSMA Audit Challenges

Today, many food companies have smartly moved to minimizing water and understand the potential impact of increased risk for pathogen growth. Maintaining the sanitation program of numerous old drains is also time consuming, costly and burdensome for facilities to keep up, especially with new FSMA (EM) Environmental Monitoring Program recommendations for processors. If FDA investigators do perform swabbing when on site for an audit, they likely will incorporate drains. Drains are an excellent indicator of any microbial activity or potential resident organisms within the site.

Drain Program Preventative Improvements

Here are some strategies to bolster preventative improvement plans to minimize risks and costs associated with aging drains in food facilities:

1.   Assess condition and critically of needed drains in processing areas, consider closing off those no longer beneficial or problematic ones where “hot spots” may pose potential micro risk close to processing lines (if drain pipes suspected to be collapsed, camera evaluation study recommended)

2.   Balloon Diaphragm should be used where possible to close off drain in case future needs may change

3.   It is recommended to use only stainless steel, easy to clean drains. Do not use trench drains, possible harborage and aerosol risk. e.g. Tufco

4.   Perform cost analysis on sanitation labor hours, chemicals, water usage, waste water reduction, reduced downtime benefits and sampling swabs/hours for plant’s Environmental Monitoring on the current extensive on site drain maintenance vs. proposed slimmed down program focused on the critical few to reflect Cost of Quality Improvement for facility, project justification.

5.   Ensure SSOP’s (Sanitation Standard Operating Procedures) and EM Program updated reflecting new improvements.

6.   If using CAPA (Corrective and Preventative Action) analysis for Food Safety Plan under FSMA, be sure to show demonstrated enhancements.

Author Gina Reo

gina_reo@comcast.net   

https://www.ginareo.com/

Published November 1, 2018

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