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. 

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.

Growing Trend

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?

4. Training

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))?

6. Reporting

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?

Addressing Findings

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
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.

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.

Significant Changes

The SQF V9 changes are broken down into two categories of changes:

Structural 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
  • Specifications
  • Training

Technical Changes

• 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… 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

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.

Processing Breakdowns

During the first week of August, the company experienced two processing breakdowns that resulted in the unplanned generation of large quantities of hazardous waste:

1. A piece of production equipment malfunctioned and contaminated all the ink in the facility and the press with microscopic ceramic fragments.
2. 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.

Requirements

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.

Additional Details

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. 

When it comes to regulatory compliance, “hazardous” is an important term. Unfortunately, what is considered “hazardous” can be very confusing with the varying hazardous terms and definitions used across multiple regulatory agencies.

Overlapping Terminology

The fact is that different regulations have different definitions for similar terms, and these regulations are applied for different purposes. The same material can take on multiple descriptors—or not—depending on which regulations apply:

• Environmental Protection Agency (EPA) uses the term hazardous waste to protect human health and the environment (40 CFR 261 and 268).
• Department of Transportation (DOT) uses the term hazardous materials to ensure materials are managed safely in all modes of transport—air, road, marine, and rail (49 CFR 172).
• Occupational Safety and Health Administration (OSHA) uses the term hazardous substances and focuses on worker safety (29 CFR).

Sometimes, this terminology overlaps; sometimes it doesn’t. That is why it is critical to understand the differences between hazardous terms and to use each term appropriately—so you know what requirements apply.

EPA: Hazardous Waste

According to EPA, a hazardous waste is “a contaminated chemical or byproduct of a production process that no longer serves its purpose and needs to be disposed of in accordance with the EPA.”

Hazardous waste is generated from many sources, ranging from industrial manufacturing process wastes to batteries, and may come in many forms (e.g., liquids, solids, gases, and sludges). To determine whether a waste is considered “hazardous,” EPA has developed a flowchart identification process (pictured below).

EPA’s Resource Conservation and Recovery Act (RCRA) establishes the regulatory framework for managing hazardous waste. The degree of regulation that applies to each hazardous waste generator depends on the amount of hazardous waste produced.

Unless it is managed at the facility, hazardous waste generated must eventually be transported off site for disposal, treatment, or recycling. At this point, DOT regulations kick in for the transportation of freight, including the transport of RCRA hazardous waste.

DOT: Hazardous Material

DOT has the authority to regulate the transportation of hazardous materials under the Hazardous Materials Transportation Act (HMTA), which is overseen by the Pipeline and Hazardous Materials Safety Administration (PHMSA) division of DOT. A DOT hazardous material is defined as “a substance (gas, liquid, or solid) capable of creating harm to people, environment, and property.”

By definition, hazardous materials are capable of posing an unreasonable risk to health, safety, and property in commerce. This includes substances, wastes, marine pollutants, elevated temperature materials, and items included in DOT’s Hazardous Materials Table (HMT – 49 CFR 172.101) (e.g., laboratory chemicals, solvents, alcohol, acids, compressed gases, cleaners, pesticides, paints, infectious substances, radioactive materials). Note that anything excluded from the EPA’s Hazardous Waste Manifest requirements is not considered a hazardous waste by DOT when shipped but may be considered a hazardous material.  This is a tricky nuance but very important for shippers to understand. Correspondingly, DOT has rigorous training requirements.

Hazardous materials are legally defined by class, characteristic, and name:

• Class 1: Explosives
• Class 2: Gases
• Class 3: Flammable Liquid
• Class 4: Flammable Solids
• Class 5: Oxidizing Substances, Organic Peroxides
• Class 6: Poisonous (Toxic) and Infectious Substances
• Class 7: Radioactive Materials
• Class 8: Corrosives
• Class 9: Miscellaneous Dangerous Goods

OSHA: Hazardous Substance

Finally, OSHA defines a hazardous substance as “any substance or chemical that is a ‘health hazard’ or ‘physical hazard,’ including:

• Chemicals that are carcinogens, toxic agents, irritants, corrosives, sensitizers;
• Agents that damage the lungs, skin, eyes, or mucous membranes;
• Chemicals that are combustible, explosive, flammable, oxidizers, pyrophorics, unstable-reactive or water-reactive; and
• Chemicals which, in the course of normal handling, use, or storage, may produce or release dusts, gases, fumes, vapors, mists or smoke that may have any of the previously mentioned characteristics.”

Chemical hazards and toxic substances are addressed in several specific OSHA standards for general industry (29 CFR 1910 Subpart Z). OSHA’s Hazard Communication Standard (HCS – 29 CFR 1910.1200) is designed to ensure that information about chemical and toxic substance hazards in the workplace and associated protective measures is disseminated to workers and that the workers understand how to apply this knowledge to complete their job tasks safely.

Under HCS, manufacturers must provide a safety data sheet (SDS) for all hazardous substances they produce or import. The SDS conveys physical and health impacts, as well as procedures for exposures, spills, leaks, and disposal to employees and any downstream customers. Materials in transport must be properly labeled according to the HCS (i.e., flammable, explosive, radioactive), as well as meet DOT requirements.

In an additional OSHA program–Hazardous Waste Operations and Emergency Response (HAZWOPER)—all employees must be trained on emergency response, spill management, and risk minimization. This training covers:

• Code requirements​
• Hazard classes, risk identification, hazardous communication
• Site safety programs​
• Proper selection use of appropriate PPE and respiratory protection​
• Advanced spill management and emergency response procedures​
• Risk minimization, emergency management, and engineering controls​

The Overlap: An Example

Let’s see how these definitions come together in practice.

A DOT-regulated hazardous material that expires and becomes unusable might be regulated as a hazardous waste under EPA’s RCRA program. For example, if a company uses acetonitrile in their operations, when the company receives the acetonitrile as a product, it is transported to the company as a DOT Class 3 Flammable Liquid using a Bill of Lading as the shipping papers. If that same acetonitrile passes its expiration date and is unusable by the company, it must be shipped as a DOT Class 3 Flammable Liquid. 

Additionally, the generator (the company) must determine which waste codes are applicable. In this example, expired acetonitrile would have the waste code D001, indicating it is a flammable waste.  Because this was also an unused commercial chemical product, the expired acetone would have a waste code of U009 to comply with EPA hazardous waste regulations. Small and Large Quantity Generators (SQGs/LQGs) of hazardous waste would also have to ship the hazardous waste using a Hazardous Waste Manifest as the shipping paper versus a Bill of Lading.

A hazardous material or waste released to the environment in a quantity above a certain threshold, referred to as a Reportable Quantity, might be regulated as a hazardous substance for EPCRA reporting purposes. For example, if a tanker truck is delivering acetonitrile to the same facility, the acetonitrile is a hazardous material and meets the definition of a Class 3 Flammable Liquid. The Reportable Quantity for acetonitrile is 5,000 lbs. according to 49 CFR 172.102, Table 1. If the tanker truck is in an accident and 5,000 lbs. of acetonitrile spills (or is released to the environment), the trucking company must report the spill to the National Response Center to comply with EPA EPCRA regulations.

Importance of Training

As this example shows, there is much overlap between the different hazardous terminology and regulations—and getting it all correct is not always simple. This explains why rigorous training is required to meet compliance requirements for managing hazardous waste. OSHA, EPA, and DOT each have requirements for personnel who are working with chemicals, hazardous waste, or onsite emergency management activities:

• OSHA 1910.1200 (HazComm) requires all employees to be trained in label reading and SDS review for chemicals they may encounter in the workplace.
• OSHA 1910.120 (HAZWOPER) requires any employees who are in positions that may respond to chemical spills or emergencies onsite to be trained in chemical risk recognition, spill control basics, emergency response, and additional requirements depending on the level of response expected.
• DOT code (49 CFR 172.702) requires that any employee involved in the transportation (shipping or receiving) of hazardous materials must be trained and tested in general awareness, site-specific job functions, and transportation security.
• EPA code (40 CFR 266 and 273) requires that any employee taking part in chemical waste management (hazardous or universal) must be trained in proper waste disposal practices.

Making sure the right people get the right training will help ensure the organization understands hazardous terminology and correctly interprets the requirements related to hazardous substances the facility manufactures, uses, stores, or transports.

EPA’s Hazardous Waste Generator Improvements Rule became effective on May 30, 2017. This Rule is designed to make the RCRA hazardous waste generator regulations easier to understand; provide greater flexibility in how hazardous waste is managed; and improve environmental protection. The final rule includes over 60 revisions and new provisions to the hazardous waste generator program. 

One of these notable provisions, which impacts small quantity generators (SQG), is the requirement for SQGs to re-notify EPA or their state agency about their hazardous waste activities every four years. The first re-notification is due by September 2021. Since this is the first time EPA is requiring this of SQGs, many are not as aware of this specific re-notification requirement—and it is one that will impact many. 

Who’s an SQG?

Let’s take a step back and first define who is considered an SQG. According to EPA, SQGs are those facilities that generate more than 100 kilograms but less than 1,000 kilograms of hazardous waste per month. EPA cites the following major requirements for SQGs:

• SQGs may accumulate hazardous waste onsite for 180 days without a permit (or 270 days if shipping a distance greater than 200 miles).
  • The quantity of hazardous waste onsite must never exceed 6,000 kilograms.
  • SQG are limited to one episodic event per calendar year (40 CFR 262.230).
• SQGs must comply with the following requirements:
  • Hazardous waste manifest (40 CFR 262, subpart B)
  • Pre-transport (40 CFR 262.30-33)
  • Preparedness and prevention (40 CFR 262.16(b)(8) and (9)) 
  • Land disposal restriction (40 CFR 268)
  • Management of hazardous waste in tanks or containers (40 CFR 262.16(b)(2) and (3))
• There must always be at least one employee available to respond to an emergency. SQGs are not required to have detailed, written contingency plans.

And, starting in 2021, SQGs are required to re-notify EPA or their state environmental agency regarding their generator status at least every four years.

Re-notification Requirement

The intent of the re-notification requirement is to create a more accurate and complete count of the federal SQG universe, helping EPA and authorized states conduct oversight, enforcement, and planning. Ultimately, the data collected will allow EPA to identify those SQGs that are active and to remove those that are inactive from the database.

To meet the re-notification requirement, SQGs must complete and submit the Notification of RCRA Subtitle C Activities (i.e., Site Identification Form – also known as EPA Form 8700-12) or the state equivalent in full. The requirement for generators to re-notify whenever there is a change to the site contact, ownership, or type of RCRA Subtitle C hazardous waste activity conducted remains in place. Note: An SQG that submits a complete re-notification within the four years before an SQG renotification deadline would be considered in compliance with this provision.

Facilities can elect to fill out the paper form or may submit electronically via MyRCRAID, an electronic reporting system for submitting to the EPA Site Identification Form. Some states have their own forms that are equivalent to the Site Identification Form, also meeting the requirement of the regulation. In states where there is a more frequent re-notification or reporting requirement, the SQG should comply with its state deadline.

Ensuring Compliance

As generators consider this re-notification requirement and the other Hazardous Waste Generator Rule provisions, it is important to:

• Get a solid understanding of the rule for the state(s) in which the generator operates. Requirements, forms, frequency, etc. may vary from state to state and compared to EPA.
• Ensure the inventory of types and quantities of hazardous waste generated at the facility is current and documented.
• Review the Site Identification Form and determine what additional data needs to be gathered in advance of the September 2021 submittal deadline.

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.