Current Challenges of Technical Compliance in the U.S.:
Focus on Occupational Health & Safety and Environment
May 17, 2021 | 4 pm – 5 pm CT

Technical compliance regarding EHS has seen tremendous changes over the last couple of years and is likely to change even more in the foreseeable future. EHS regulatory enforcement will undoubtedly regain momentum in the next few years. Achieving and maintaining EHS compliance requires great management and expertise to ensure all aspects of a company’s technical compliance have been identified and are being actively managed.

KTL’s Sarah Burton will be joining Martin Mantz Compliance Solutions, our German alliance partner, to discuss the challenges of technical EHS compliance and to provide an up-to-date understanding of technical compliance in the U.S. today.

Don’t miss this free American Bar Association event on April 22, 2021 — Demonstrating Compliance in a Socially Distanced World: Virtual Auditing.

In the time of COVID-19, virtual auditing has become increasingly necessary and valuable to organizations as they seek to achieve environmental compliance while facing worldwide travel restrictions and remote work policies that have disrupted routine in-person audits. With this shift, comes the need for both regulated entities and regulators to develop new approaches and procedures to ensure the effectiveness of audits conducted remotely. Practitioners, including auditors and legal counsel, must consider new dynamics related to security, data protection, and audit integrity-on top of the usual audit considerations. This session will highlight some of these new challenges and provide real-world solutions to aid attendees form new practice skills to apply in the (virtual) field.

Panelists–including KTL’s Sarah Burton–will explore the new world of remote auditing, focusing on real-world solutions to the challenges that virtual auditing presents.

Register online.

Get to know our KTL team! This month, we are catching up with KTL Consultant and Data Science Specialist Will Brokaw. Will is an EHS Consultant with an extensive background in statistics and safety culture. He specializes in turning client data into usable information. Will is based in KTL’s Madison, WI headquarters. 

Tell us a little bit about your background—what are your areas of expertise?

My degrees are in psychology, then I taught statistics and research methods for a few semesters before moving to Madison. Kestrel was engaged in Human Factors work at the time, which was a good match with my background. I’ve since become involved mainly in various EHS projects for clients, including EHS auditing, statistics/data analysis, and SharePoint work.

What types of clients do you work with? What are the biggest issues you see them facing right now?

I see them facing many issues—upheaval caused by the pandemic, structural changes to companies (including layoffs), more aggressive enforcement of regulations with new administration.

What would you say is a highlight of your job?

The many wonderful people that I work with.

What do you like to do in your free time?

This is a hard question since we’ve all been trapped in our homes for the last year. I guess reading (fantasy for fiction and history for non-fiction) and listening to podcasts (The Dollop, Behind the Bastards, Knowledge Fight) and music have filled my time lately.

Read Will’s full bio.

Get to know our KTL team! This month, we are catching up with KTL Consultant Emily Watt. Emily works with multinational companies and government agencies to provide environmental, health, and safety (EHS) compliance and sustainability support. She is based in the Washington, DC metro area. 

Tell us a little bit about your background—what are your areas of expertise?

I studied International Relations and focused on Global Environmental Politics at American University in Washington, DC. I continued with French courses and picked up Brazilian Portuguese while studying in Rio de Janeiro, Brazil. Professionally, I’ve worked in both multinational corporations and small non-profit settings that overlap with U.S. government work.

I enjoy the facilitation of government programs internationally the most! My previous experience taught me a lot about implementing government programs, the associated challenges, and the opportunities for impact. It can be truly fulfilling work. However, I wanted my work to focus on environmentalism, which is how I ended up at KTL. In my current role, I work on global health programs, but I am also involved on a wide variety of U.S. environmental projects.

What types of clients do you work with? What are the biggest issues you see them facing right now?

I primarily work with U.S. government staff who manage global health programs. A project may have a wide scope of environmental impact. It can be difficult to home in on those impacts and identify specific mitigation measures that are needed for an activity, country, or region. When implementing a project to be sustainable for years to come, it is important to start off on the right foot and to continually self-assess. We are always looking through that lens and offering resources and guidance to create continual opportunities for improvement.

No matter the type of project I work on, it seems there is always a need for automation and organization. Whether there are too many people to train or too many documents to track, I have found that a well-equipped team and a solid Environmental Management System (EMS) to keep things on track are invaluable.

What would you say is a highlight of your job?

Variety keeps me on my toes! I enjoy working with different projects and people each day. There is a lot of variability and flexibility in the work KTL does, which allows for creative problem solving. I am always learning something new from my colleagues and clients—or from forging my own path through a problem. It is awesome to work with so many subject matter experts and to be a part of helping our clients achieve their greater goals.

What do you like to do in your free time?

Free time has been reimagined during COVID-19! I work from home regardless, so it is nice to take a walk outside to avoid the feeling of being in the same spot all day. I’ve prioritized being social with my friends through FaceTime or picnics in the park. I am teaching myself to cook, and I can be found staring at my houseplants hoping for them to grow.

Read Emily’s full bio.

To ensure a sound Hazard Analysis and Critical Controls Points (HACCP) Plan, companies must confirm the Plan is adequate for controlling food safety hazards through the process of validation and verification.

According to 9 CFR 417.4 a, “Every establishment shall validate the HACCP Plan’s adequacy in controlling the food safety hazards identified during the hazard analysis and shall verify that the Plan is being effectively implemented.” HACCP Principle 6—Establish Verification Procedures—further emphasizes the importance of establishing activities that determine the validity of the HACCP Plan and verify that the system is operating according to the Plan.

Based on these requirements, verification and validation seem quite similar. In practice, however, verification and validation are distinct functions that are both critical for compliance with U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) regulations. In short, verification is focused on the implementation of the plan, while validation is focused on its accuracy. You cannot validate a process until you verify the process is consistently following the plan and operating as intended. 

Validation: Proof the Plan Is Effective

Validation demonstrates and documents that the HACCP system works to address significant hazards​. It provides proof that the Plan is effective. The purpose of validation is to demonstrate that the HACCP system, as designed, will adequately control identified hazards to produce a safe, unadulterated product. Following completion of the hazard analysis and development of the HACCP Plan, establishments enter the 90-day period of initial validation, where the validity of the HACCP system is checked. Is the Plan working to achieve its intended goal?

Validation involves gathering data over time to confirm something is operating as intended. It relies heavily on using scientific data from journals; in-plant observations, measurements, and evaluations; and expert advice. According to the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), “Validation is the element of verification that focuses on collecting and evaluating scientific and technical information to determine if the HACCP Plan, when properly implemented, will effectively control the identified hazards.”

For example, validation of Critical Control Points (CCPs) may involve reviewing trends over the year, customer complaints, equipment issues, etc. to determine whether the process is working. To validate a temperature selected for heating food to remove harmful bacteria, a facility may cite scientific journals and studies.

Both USDA and FDA require validation of the food safety system to document scientific support for CCP or process preventive control critical limits. USDA further requires internal validation of the CCPs and critical operational parameters used in key prerequisite programs (PRPs). It is important companies use scientific evidence (e.g., microbiological test results, validation studies) to the extent possible to demonstrate hazards are effectively controlled.

Verification: Proof the Plan Is Followed as Written

Verification establishes the accuracy or truth of something—in other words, proof that the HACCP Plan is being followed as written. ​It answers the question, “Are we actually doing what we say we are going to do?” For example, if the Plan says that a food will be heated to a certain temperature to kill harmful bacteria, verification will test that the food actually reaches that temperature.

The purpose of verification is to confirm that the HACCP system is continually functioning as intended. Following the 90-day period of initial validation, monitoring and verification activities are performed to ensure the HACCP system continues to be implemented properly. These activities should be scheduled as needed (i.e., daily, weekly, monthly, quarterly, annually) and conducted by designated, trained employees.​

Regular audits of the HACCP Plan further ensure that it is being followed correctly. This is particularly important if any aspect of the company’s procedure, process, or ingredients has changed or a new product has been added to production.

HACCP Principle 6 outlines four elements for verification:

1. CCP Verification
2. Overall Food Safety System Verification
3. Food Safety System Validation
4. Regulatory Verification

In addition, both USDA and FDA require verification of the overall food safety system. USDA requires reassessments to be performed annually to verify the HACCP Plan. FDA requires reanalysis to be performed at least every three years to verify the Food Safety Plan.

There are some common verification activities to ensure food manufacturing facilities meet these requirements:

• Document review, including HACCP Plan and related policies, plans, Good Manufacturing Practices (GMPs), standard operating procedures (SOPs), equipment and product specifications, processing rates, inspection records, supplier information, etc.
• Facility walk-through to review operations and observe specific processes and equipment, as needed
• Evaluation of current Food Safety Management System (FSMS) elements
• Food Safety Plan review
• Review of PRPs (e.g., sanitation, allergen controls, traceability)
• Environmental monitoring and product testing
• Confirmation that the CCPs and other preventive controls are implemented and effective
• Direct observations of CCP monitoring activities
• Calibration of equipment

Validation and verification are important components of any food safety system. They provide proof that the HACCP Plan is not only effective, but also being followed and working as intended. Validation and verification ensure the Plan is a living, breathing document that is used daily to ensure the food safety system complies with both USDA and FDA regulations and, more importantly, works to prevents foodborne illness. 

Is your facility prepared for an EPA inspection?

EPA-contracted inspectors have been visiting facilities in Iowa. To date, we are aware of four inspections–all of which have been very comprehensive multimedia inspections. This is a trend that appears to be gaining momentum. Facilities must take the time now to regularly evaluate environmental programs to ensure records are compliant, easily accessible, and comprehensive. 

Join KTL Senior Consultant and Iowa expert Becky Wehrman-Andersen and Senior Consultant Liz Hillgren, CHMM, CEA, for a one-hour webinar that will provide guidance on where to focus your attention to proactively prepare for an EPA inspection and reduce the likelihood for any findings and/or penalties.

Webinar: Preparing for EPA Inspections in Iowa

February 24, 2021 | 11:30 a.m. – 12:30 p.m. CT
Cost: $50*
Register Now!

Learning Objectives

During this webinar, we will focus on discussing, preparing for, and responding to the areas EPA tends to focus on in inspections: hazardous waste records, universal waste, used oil, training, hazardous waste containers, and reporting.

Our experts will address the following questions:

• How do I prepare for an inspection?
• What paperwork will be requested?
• What happens during a walk-through?
• What are my best options for fixing any problems?
• What happens after the inspection?
• What can I do now?

* Every facility registered for this webinar is eligible for a free 30-minute phone consultation with one of KTL’s EHS experts to help you understand current EHS regulatory requirements and inspection priorities. Offer valid until 3/31/21. 

January 20, 2021 | 11 am – 12 pm ET

Cost: FREE for members, $19 for nonmembers

Join KTL Senior Consultant Liz Hillgren and MichBio for a high-level overview of the EHS regulations that might be applicable to laboratories. The webinar will discuss typical lab regulatory challenges and provide an overview of the major requirements for OSHA, EPA, and DOT compliance, including plans, reporting, training, and programs.

KTL is pleased to announce the addition of the following individuals to our team.

Jessica Dykun, Senior Consultant

Jessica is a Senior Consultant with more than a decade of experience working in the food and beverage industry, with particular expertise in food safety and quality assurance (FSQA). Jessica has lent her expertise on a variety of KTL food projects over the past several years; we are happy to welcome her as a KTL employee. Jessica is certified in HACCP and Lean Six Sigma and as an FSSC Lead Auditor. Read her full bio… jdykun@kestreltellevate.com | 724-544-8416

April Greene, Consultant

April is an experienced EHS professional with a demonstrated history of working in the environmental services industry. She brings a strong chemistry and laboratory background to her work at KTL. She is particularly skilled in sustainability, data analysis, and analytical chemistry and has significant experience managing quality, facilities, safety, and regulatory compliance in a laboratory setting. Read her full bio… agreene@kestreltellevate.com | 608-799-2166

Samantha Hunt, Consultant

Samantha has a diverse background in the food and beverage industry, with particular expertise in food safety and quality assurance. Prior to joining KTL, she served in a variety of quality and lab management roles, with a specialized focus on beverage companies and fermentation science. Through her previous positions, Samantha has developed in-depth knowledge of FDA food safety regulations as they apply in laboratory, manufacturing, and packaging settings. Read her full bio… shunt@kestreltellevate.com | 828-470-8258

Erica Schein, Consultant

Erica has a strong background working in the food safety and quality control environment. She excels at researching and conducting programs to manage food safety requirements and ensure overall safety. Through her previous positions, Erica has developed in-depth knowledge of FDA and USDA regulations as they apply to a leading wholesale distribution center. She has in-the-field experience managing the daily operations of a highly effective and compliant food safety program. Read her full bio… eschein@kestreltellevate.com | 773-456-5210

Get to know our KTL team! This month, we are catching up with Senior Consultant Liz Hillgren. Liz brings over 20 years of environmental experience in both industry and consulting to the KTL team. She is based in Ann Arbor, Michigan.

Tell us a little bit about your background—what are your areas of expertise?

My background is in hazardous waste. I worked for transfer, storage, and disposal facilities (TSDFs) for 20 years. I have worked at a landfill, a stabilization facility, a fuel blender, a used oil recycler, and a wastewater treatment facility. I have managed technical groups but also customer service throughout my career in industry.

What types of clients do you work with? What are the biggest issues you see them facing right now?

My KTL customers are largely manufacturing facilities. Most of them are mid-sized, so they don’t always have tons of money—but they do have real regulatory issues.

What would you say is a highlight of your job?

I like to help my customers solve problems, because I feel like I am part of their team. I also like to learn new things—my job always has something new to think about.

What do you like to do in your free time?

I am a gardener, and I enjoy being outside. I live in an old house full of projects and potential. I like to sew. I just started beekeeping, so that is currently where all my time and money are spent!

Read Liz’s full bio.

NACD’s 2020 ChemEdge is making the shift to full virtual this year. The conference may look a little different, but it is still filled with all the critical knowledge and networking opportunities chemical distributors expect from ChemEdge.

ChemEdge 2020
Tuesday, September 1 – Thursday, September 3
Register Now!

As always, KTL will be an active participant in ChemEdge 2020. Be sure to join KTL Senior Consultant and Responsible Distribution Adviser Jake Taylor for the following presentations:

+ Digging Up the Roots! Root Cause Analysis Review and Exercise
Tuesday, September 1, 11:00 am-12:15 pm

+ OSHA Top 10 List
Wednesday, September 2, 9:00 am-10:00 am

We look forward to making the most of this virtual event and hope many of our clients and friends will be joining us at ChemEdge 2020 this September.