Comments: No Comments
Virtually every regulatory agency (e.g., EPA, OSHA, FDA, USDA) and voluntary certification standard (e.g., ISO, GFSI, organic) has compliance requirements that call for companies to fulfill several common compliance activities. KTL has outlined eight compliance functions that can be instrumental in improving a company’s capability to comply. One very important compliance function involves records and document management.
Records provide documentation of what has been done related to compliance—current inventories, plans, management systems, training, inspections, and monitoring required for a given compliance or certification program. Each program typically has recordkeeping, records maintenance, and retention requirements specified by type. Having a good records management system is essential for maintaining the vast number of documents required by regulations and standards, particularly since some, like OSHA have retention cycles for as long as 30 years.
Moving Away from Paper Recordkeeping
Organizing and maintaining the records can create challenges—where to store them, security levels, remote and local accessibility, etc. Supply chain requirements can further add to the cumbersome workload of collecting, reviewing, and sharing documents and information.
Companies have been keeping records and documents in binders and file cabinets for years. And while that system can work, many dynamic tools are available to alleviate some of these challenges and support organizational decision-making. A document management system can help create:
- Process and document standardization
- Central and secure storage, organization, and access to documents and records locally or remotely
- Improved document searchability and accessibility
- Enhanced workflows for approving and completing tasks involving documents
- Easy access to documents for audits and clear audit trail, particularly for remote audits
- Version control and history
- Reduced paperwork
- Higher quality data due to reduced human error
- Improved collaboration
- Improved security of sensitive documents
All of which lead to consistent, efficient, and reliable compliance performance.
Transitioning Your Records
Transitioning from a paper-based recordkeeping system to an electronic document management system can seem overwhelming, particularly given the sheer volume of documents some organizations have. However, following a step-by-step approach—and considering the desired end product from the start—can help ensure that organizations end up with a system that will function well within the business context and provide ongoing compliance efficiency.
Step 1. Assess Current Documents and Processes
The first step is to identify where all your documents reside and how you are currently managing and organizing those documents. Additionally, an assessment of the documents themselves should be conducted to evaluate if they are still current, if they are in line with the processes and procedures they are intended to monitor, and if they are collecting all the required information.
Where are documents stored? What is electronic vs. paper? Are documents sorted by necessity, date, version, compliance area? What processes are currently in place for creating, managing, and storing documents? Where are the inefficiencies in adequately managing documents and records? If there are multiple systems, are they working together?
The goal of this step is to get a good handle on the current state of your documents and systems so you can move onto step 2, which will be to define the desired state of your document management system.
Step 2. Define Document Management System
Before building the system, you must define your ultimate desired end state. In a perfect world, how would the document management system operate? What parts and components would it have? How would things work together? At this point, you must consider the immediate need (i.e., document management) within the context of the overall business need. The idea is to align the document management system with any overall compliance management system (CMS). This requires a genuine understanding of both daily routines and the big picture.
Bring together key stakeholders to discuss their objectives, review the current state, and evaluate industry best practices. While it is necessary to get senior management buy-in and to understand the business needs, it is equally important to understand the routine activities and tasks of the people who will use the system in a daily basis. The system must be designed with all these users in mind—the end user entering data in the field, management who is reading reports and metrics, system administrator, office staff, etc.
Step 3. Gather Documents and Populate System
This step can involve significant resources depending on the volume of documents, so taking a phased approach can make it more manageable. It often makes sense to start where you already have processes and document storage systems in place that can be more easily transitioned into a new document management system to encourage user buy-in. Priorities should be set based on ease of implementation, compliance risk, business improvement, and value to the company.
Step 4. Determine Access and Train
The only way to ensure employees will correctly use the document management system is to provide adequate training. Define who needs access to the various parts of the system and what everyone’s roles and responsibilities are. Every employee who will touch the system should receive hands-on training to teach them how to correctly use the system to create efficiencies.
Step 5. Conduct an Annual Internal Audit and Document Review
Audits offer a systematic, objective tool to assess compliance across the workplace and to identify any opportunities for improvement. Audits may be used to capture regulatory compliance status, certification system conformance, adequacy of internal controls, potential risks, and best practices.
An internal audit of the document management system provides a valuable way to communicate performance to decision-makers and key stakeholders. This final step is an important one, because it will help ensure that:
- The organization is getting the most out of its document management system.
- The system and associated processes are operating as intended.
- Data can be used for trending and predictive analytics to better inform business decision-making.
- Ongoing opportunities for improvement in document organization and processes are identified and implemented.
- Efficiencies in business operations and overall compliance management—including remote access and remote auditing—are fully realized.
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:
- CCP Verification
- Overall Food Safety System Verification
- Food Safety System Validation
- 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.
The purpose of an inspection is for EPA to gather the appropriate information to determine whether the facility in question is in compliance with regulatory requirements. While inspections may happen after a significant environmental event or violation, EPA inspections are often a surprise to the facility as part of EPA’s overall compliance monitoring efforts. An inspection may be conducted on a single-media program or a specific environmental problem—or it may be an extensive multimedia event that covers all EHS compliance areas.
The frequency of these comprehensive multimedia inspections appears to be increasing. It is important that companies are prepared in the event they are faced with an EPA inspection. Preparation comes down to regularly evaluating the programs listed below to make sure records are complete, compliant, and easily accessible at all times. Note that this is not a comprehensive list; however, KTL’s experience assisting customers with preparing for and responding to EPA inspections has shown that these are areas the Agency tends to focus on.
1. Hazardous Waste Records
Do you have three (3) years of manifests and land disposal notifications readily available? Have you checked dates/signatures and final disposal information to make sure it is correct? Did you receive your return manifest within the required timeframe and, if not, did you file an exception report? Do you have waste characterizations?
2. Universal Waste
Are all containers closed, labeled, and dated? Are the words on the label compliant (i.e., “Universal Waste Lamps” vs. “Bad Bulbs”)? Do you have all disposal receipts readily available?
3. Used Oil
Are all containers closed and labeled as “Used Oil”? Do you have receipts from recycling activities? Did your transporter have an EPA ID number? Did the oil recycler test for PCB?
Are all employees responsible for a role in hazardous waste management trained and knowledgeable? Can they demonstrate compliance and competency if they are asked questions by an inspector? Have you addressed DOT training requirements? Are employees managing universal waste aware of their responsibilities?
5. Hazardous Waste Containers
Are all containers closed, labeled, and dated? Do you have a Satellite Accumulation Area (SAA), and is it properly labeled and managed? Are containers stored in the Central Accumulation Area (CAA) and properly managed? Does everyone working in the CAA have access to an emergency phone or way to alert emergency responders if there is a problem? Is there a spill kit that is appropriate for the hazardous waste type stored? Is the spill kit readily accessible in the CAA? Do you have records of weekly inspections (Small Quantity Generator (SQG) and Large Quantity Generator (LQG))?
Do you have three (3) years of reports and/or supporting documents for Tier II, TRI, and hazardous waste reporting? Do you have a current EPA Air Emissions Permit or documentation that demonstrates you are not required to have one? Are you required to have a Stormwater Pollution Prevention Plan (SWPPP) or a no exposure exclusion? Are you required to have a Spill Prevention, Containment and Countermeasure (SPCC) Plan? Are you preforming all activities and inspections required for your permits and plans?
If you have an inspection and there are findings, typically the next step in the process is for EPA to alert you with a Notification of Potential Findings. EPA will ask for your input and likely ask for additional data and documentation. If you find yourself in this situation, KTL strongly encourages you to seek expert assistance. If the responses to EPA are not made using “EPA compliance language,” there is a likelihood you may be offering more evidence to self-incriminate. This will allow EPA to then calculate multi-day penalty amounts that can add up very quickly. Once a company responds, it is difficult to dig out of such a hole.
EPA inspections, particularly in light of the challenges associated with COVID-19, are difficult to navigate. However, KTL’s experience has shown—even recently—that it is possible for businesses to proactively prepare for EPA inspections to reduce the likelihood of findings and/or penalties.
2.24.21 Webinar: Preparing for EPA Inspections in Iowa
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. Join KTL Senior Consultant and Iowa expert Becky Wehrman-Andersen and Senior Consultant Liz Hillgren, CHMM, CEA, for a one-hour webinar on 2.24.21 that will provide guidance on where to focus your attention to proactively prepare for an EPA inspection and reduce the likelihood of findings and/or penalties. Learn more and register now!
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
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.
Get to know our KTL team! This month, we are catching up with KTL SharePoint Specialist/Developer Jaime Stout. Jaime has over 20 years of experience developing holistic IT solutions that create a more robust and efficient environment. She is based in KTL’s Madison, WI office.
Tell us a little bit about your background—what are your areas of expertise?
Let’s just say I am not your average IT professional, but that is exactly what makes me so good at what I do! I am a creative problem solver with a knack for coming up with some pretty crazy solutions to any challenge handed to me, which is basically a long story short of how I ended up becoming a SharePoint Developer.
My background is in business. I have a graphic design degree and moved around the printing, publishing, and insurance industries before coming to KTL. In all these positions, I was challenged with creating systems to do things where an existing application didn’t already exist—some simple, like creating project tracking, inventory tracking or billing, and some more complex, like creating an online proofing system when the technology was still in its infancy—all working with no budget and only the software available.
SharePoint popped up on my radar about 14 years ago while working on a project where I wanted our print vendor system to match our internal system to create a more fluid user experience. I was simply told this was not possible, but I am not one to take no for an answer! I started digging into what was available to me within that company’s framework and discovered SharePoint. It has been a love story ever since.
When I first started working with SharePoint, I realized it worked very similarly to the applications I had learned in design school. By applying those same design principles, I was able to create the look and functionality within SharePoint to match the print vendor site and create a one-site experience, which was key to success on this project. I have been applying that theory ever since, with a focus on making applications work for the user rather than making the user work around the application.
What types of clients do you work with? What are the biggest issues you see them facing right now?
I work with any and all KTL clients—anyone who is looking for a paperless way to do business in a more efficient manner. The biggest issue I see my clients facing right now is too many applications and not enough solutions. A trend I have seen over the years for companies big and small is that they tend to pick single-focus solutions that don’t talk to each other to solve an immediate need rather than looking at the big picture need. As a result, they end up with all these different applications doing different things, and the data is basically useless.
One thing I try to focus on when we start any information management project is how we can consolidate however many systems the company is using to pull information so they talk to each other. It is important to figure out what other areas might be affected by the project, because what lies just below the surface is usually the first thing to cause issues. Data is very specific, but at the end of the day, it is still a human who enters it. Anywhere we can streamline processes provides a better chance of keeping data clean and useful.
What would you say is a highlight of your job?
What I love most about what I do is the challenge. I refuse to accept “it can’t be done” or “no” as an answer. The fact is that it almost always can be done. You just have to think outside the box, and then the opportunities become endless. One of the great challenges we get from our clients is creating systems that make their lives easier, and I love being the one to come up with those solutions. If you can stump me or challenge me with something I can’t figure out, you will be the first.
What do you like to do in your free time?
My two girls and my very spoiled dog Luna keep me pretty busy in my free time. In the winter, we are a hockey family, and life revolves around the ice. Even Luna goes to games—she is the unofficial team mascot. I am also a huge fan of adventures and traveling. We have been home a bit more than usual this past year, but we have also had the opportunity to really enjoy some great trips to Chicago and Hawaii with a little extra precaution.
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.
The Safe Quality Food (SQF) Program is a rigorous food safety and quality program. Recognized by the Global Food Safety Initiative (GFSI), the SQF codes are designed to meet industry, customer, and regulatory requirements for all sectors of the food supply chain. SQF certification showcases certified sites’ commitment to a culture of food safety and operational excellence in food safety management.
In May 2021, SQF will be releasing Edition 9 (SQF V9) to align the code with the latest GFSI benchmarking criteria, updated regulatory requirements, and scientific changes. According to the SQF Institute, SQF V9 is designed to help certified sites meet and exceed all industry, customer, and regulatory requirements so they can remain competitive across sectors. V9 is scheduled for implementation with audits beginning May 24, 2021.
The SQF V9 changes are broken down into two categories of changes:
- Development of Custom Codes for certain industry-specific sectors (livestock, animal feed, petfood, aquaculture, dietary supplements)
- Streamlined technical elements to reduce redundancy in the following sections:
- Site location and operation
- Food safety culture
- Chemical storage
- Personal hygiene
- GFSI benchmarking requirement updates, including changes to:
- Food safety culture requirements
- Internal laboratory requirements
- HACCP plan requirements for storage and distribution
- Remote activities requirements
- SQF stakeholder feedback updates, including changes to:
- Co-manufacturers’ requirements
- Ambient air testing requirement
- Audit scoring
New or updated concepts that present some of the greatest changes under SQF V9 include the following:
- Food Safety Culture Requirements: Senior leadership is required to lead and support a food safety culture within the site.
- Additional Training Requirements: Training requirements are now defined for sampling and test methods, environmental monitoring, allergen management, food defense, and food fraud for all relevant staff.
- Labeling Requirements: Updates to Product Identification Section now emphasize labeling requirements and checks during operations and require the implementation of procedures to ensure label use is reconciled.
- Substitute SQF Practitioner: All sites are now required to have a designated substitute SQF Practitioner with HACCP training and competencies in maintaining the food safety plan and knowledge of the SQF Food Safety Code.
Planning for Change
For companies that are SQF-certified, now is the ideal time to assess current SQF program elements, identify improvements that are internally desirable and required by the new standard, and implement those updates that will make the SQF program more useful to the business. This can be done through a series of phases to ensure adoption throughout the organization.
Phase 1: SQF Assessment
An assessment should begin by reviewing the following:
- Existing SQF programs, processes, and procedures
- Existing document management systems
- Employee training tools and programs
This documentation review and program assessment will help to identify elements of the existing SQF program that are acceptable, those that show opportunities for improvement, and those that may be missing, including those needed for development and implementation to meet the requirements of SQF V9.
Phase 2: SQF Program Updates
The assessment will inform a plan for updating the SQF certification program, including major activities, key milestones, and expected outcomes. Development/update activities included on the plan may include the following:
- Updating current SQF programs, processes, and procedures with missing V9 requirements
- Developing new SQF programs, processes, and procedures for additional V9 requirements
- Updating training programs with any new and additional requirements
- Revising document register to align with SQF V9 numbering changes
- Updating records and forms with any new and additional requirements
- Updating Food Safety Policy to include new food safety culture requirements
When implementing program updates, leveraging existing management system and certification program elements and utilizing proven approaches can greatly streamline the process.
Phase 3: Training
To ensure staff are prepared to implement and sustain the updated SQF V9 program, training is important. This includes training for affected staff on applicable requirements; specific plans, procedures, and GMPs developed to achieve compliance; and the certification roadmap to prepare for future audits.
Following this plan now will help companies ensure they maintain their SQF certification when audits begin under SQF V9 in May 2021–and that certification matters when it comes to meeting customer and regulatory requirements, protecting the company brand, and keeping consumers safe.
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… email@example.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… firstname.lastname@example.org | 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… email@example.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… firstname.lastname@example.org | 773-456-5210
The Environmental Protection Agency (EPA) has provided generators of hazardous waste some options for managing unanticipated waste events and large-scale cleanouts that have not be acceptable in the past. Under the Hazardous Waste Generator Improvement Rule, episodic generation allows small quantity generators (SQGs) and very small quantity generators (VSQGs) of hazardous waste to maintain their generator status, even if they have an occurrence of waste generation that would normally push them into a higher generator status.
It is a fairly straightforward concept, in theory, that allows VSQGs and SQGs the flexibility to have one planned (e.g., regular maintenance, tank cleanouts, short-term projects, removal of excess chemical inventory, or chemical cleanouts) or unplanned (e.g., production process upsets, product recalls, accidental spills, acts of nature) event per year that creates an increase in the generation of hazardous wastes that exceeds quantity limits for the generator’s usual status.
If—or when—an episodic generation event occurs, there are very specific requirements that must be followed. KTL has assisted many companies through this process with great success, resulting in minimized risk, less threat of negative inspection results, and overall cleaner facilities. The case study below walks through an actual unplanned event and how the facility responded to maintain compliance with its SQG status.
Case Study: Episodic Generation Event
An Iowa company has a printing process that generates contaminated (used) solvent when it cleans its press and changes ink colors. Because the company generates more than 220 pounds (100 kilograms) but less than 2,200 pounds (1,000 kilograms) of hazardous waste per month, it is considered an SQG.
The company uses new and recycled solvent to formulate their inks for printing and to clean the press between printing runs. A distillation unit onsite is used to process used solvent for re-use in the processes.
During the first week of August, the company experienced two processing breakdowns that resulted in the unplanned generation of large quantities of hazardous waste:
- A piece of production equipment malfunctioned and contaminated all the ink in the facility and the press with microscopic ceramic fragments.
- Within the same week, the distillation unit had a thermocouple malfunction, and the used solvent began to accumulate.
These dual challenges resulted in a large generation event of excess contaminated waste ink and used solvent. The facility surpassed the SQG hazardous waste threshold quantities. An event such as this falls under the category of an unplanned episodic generation event. The company determined it needed to conduct an episodic generation cleanup event and set a goal of disposing of all hazardous waste by the end of August.
Steps to Compliance
As a first step, the company notified the EPA by phone within 72 hours of the event. The company also completed the initial notification form required by EPA requesting a one-time episodic event that would increase their generator status to LQG for the month and submitted it. Then, they began the coordination for disposal with the disposal facility and the transporter.
The facility disposed of all contaminated ink and solvent generated the first week of August by August 27 (within the 60-day requirement). During this time, the presses were flushed, the distillation unit was repaired, the facility began production, and the solvent recycling process resumed.
After all waste was disposed from the property, the company completed the final notification form for the EPA and returned to SQG generation levels by September 1. All manifests, land disposal notifications, and documentation are retained in an episodic generation file onsite. Additionally, KTL assisted in the development of a comprehensive overview document that explained all aspects of the episodic event so any future inspections would be completed with little question or concern about the event.
An event such as the one described in this case study is a prime example of an unplanned episodic generation event. Accordingly, the facility was required to respond. Among the most significant requirements the facility had to satisfy to maintain its SQG status include:
- Notifying the EPA within 72 hours after an unplanned event (or at least 30 days before a planned event) using EPA Form 8700-12.
- Obtaining an EPA ID number (if the generator does not already have one) BEFORE initiating the shipment of generated waste.
- Completing the event and shipping the episodic waste off site within 60 days of starting the event, whether planned or unplanned, using a hazardous waste manifest, hazardous waste transporter, and RCRA-designated facility.
- Completing and maintaining records onsite for three years after the completion date of the episodic event.
It is important to note some additional details about episodic generation that are important for VSQGs and SQGs to know and understand:
- Typically, a generator is only allowed to have one episodic event per year, whether planned or unplanned; however, the generator may petition the EPA or state for a second event, provided the second event is the opposite type (i.e., planned vs. unplanned). The petition must include:
- Reason for and nature of the event
- Estimated amount of hazardous waste being managed
- How the hazardous waste will be managed
- Estimated length of time needed to complete the management, not to exceed 60 days
- Information regarding the previous episodic event (e.g., nature of the event, planned or unplanned, how the generator complied)
- An episodic event cannot last more than 60 days beginning on the first day episodic hazardous waste is generated and concluding on the day the hazardous waste is removed from the generator’s site. If the hazardous waste is not off site within 60 days, then it must be counted toward the generator’s monthly generation levels.
- The following are NOT considered episodic events and would impact overall generator status:
- Increased waste related to increased production
- An accident or spill due to operator error, abuse, or lack of maintenance (i.e., irresponsible management of hazardous waste/materials)
- Any activity that is part of the normal course of business
- Discovering at the end of the month that the monthly generation thresholds have been exceeded
- Short-term generation differs from episodic generation. A short-term generator is an entity that does not normally generate hazardous waste but has a one-time, non-recurring, temporary event (typically less than 90 days) unrelated to normal operational activities. Short-term generators are not relieved of any regulatory requirements tied to the volume of hazardous waste generated and must meet all generator requirements for the level of generator (i.e., notification, manifesting, reporting, contingency planning, and training).
The episodic waste provision allows SQGs and VSQGs to avoid the increased burden of a higher generator status when generating episodic waste—provided it is properly managed. In the past, this wasn’t an option, unless states provided special exception. Now it is part of EPA’s objective to provide greater flexibility in how hazardous waste is managed through the Hazardous Waste Generator Improvements Rule. If your company is interested in exploring a plant-wide chemical cleanup or experiences a production challenge that results in the generation of hazardous waste at a rate that is higher than your generator status allows, KTL can provide the expertise necessary to guide you through the episodic generation process.