BIOTECHNOLOGY FOCUS

Waste regulations can be difficult to understand, and it can be challenging to comply. Regulatory citations often seem like they are in a different language and the terminology used by inspectors can be confusing and difficult to decipher. Compliance often requires speaking not only the lab/industry language, but also the regulator’s language.

To get a true understanding of what regulations apply, it is important to start by asking two fundamental questions:

• What wastes does my company generate?
• What activities does my company carry out that are covered by waste requirements?

Through an evaluation of chemicals onsite, development of an inventory of both chemicals used and waste generated, and identification of processes to efficiently and effectively manage waste, businesses/labs can ensure they understand and meet their EHS regulatory obligations in the most efficient ways possible.

Environmental Protection Agency (EPA): Where Do You Start?

EPA regulates much of the waste generated by industry. Over the past ten years, the Agency has demonstrated an even stronger focus on labs. The most commonly cited EPA penalties under the Resource Conservation and Recovery Act (RCRA), which governs the disposal of solid and hazardous waste, have resulted from the items listed below:

• Dumping hazardous wastes down the drain
• Not having or having inadequate hazardous waste manifests
• Failing to properly train employees in hazardous waste management, handling, and emergency preparedness
• Lack of or improper labeling
• Open containers of hazardous waste onsite
• Failing to comply with hazardous waste generator regulations
• Improperly managing expired paints or spray paints
• Failing to have hazardous waste determinations on file
• Improper consolidation of waste from other nearby facilities
• Noncompliance with underground storage tank regulations

In order to avoid these citations, it is important to first understand your wastes. This is done through an EPA-required waste determination. In addition to reviewing chemicals that are used in processes and the different types of risk they present, a waste determination should evaluate all waste being generated by processes throughout the facility. The following waste streams are of particular regulatory concern, as they have strict regulatory requirements for their management and disposal.

Hazardous Waste
Hazardous wastes are found in a variety of processes in labs and in industry.  Solvents used to operate equipment, chemicals to conduct reactions and create products, maintenance chemicals, and new innovations are all potential sources of hazardous waste and should be included in a comprehensive waste determination.

The most frequently generated hazardous waste type in labs and in industry is flammable liquids. Chemicals such as acetone, toluene, xylenes, and methanol are commonly used flammable liquids that must be managed as hazardous waste. These wastes cannot be dumped down the drain without significant risk of fire, danger to personnel, and regulatory penalty. One of the first questions a regulator will ask in a lab or industrial process setting is to see waste containers. If a facility has chemicals but no waste containers, the regulators immediately jump to the conclusion that waste is not being managed correctly.

Other common hazardous waste streams found in labs and industry include toxic chemicals; corrosive acids and caustic bases; reactive chemicals, such as oxidizers and polymerizing chemicals; and chemicals that are radioactive. All of these are regulated by compliance agencies and require special management.

Examples of EPA regulations applying to labs include such things as identification of the amount of hazardous waste generated in a calendar month by a lab or in industry. The more hazardous waste generated, the more rigorous the EPA regulations.

Universal Waste
EPA also regulates a class of waste referred to as universal waste. Universal wastes are hazardous in their composition but can be recycled (e.g., fluorescent lightbulbs or lamps, CRTs and electronic waste, rechargeable batteries, and mercury-containing items). Failure to collect, label, store, and recycle these types of waste properly can also result in substantial threat of compliance penalty.

EPA regulators have focused on these waste streams as a source of penalty for the past decade. This is one of the most frequent citations issued to businesses. Although not as complex as the requirements for proper hazardous waste management, universal waste has nuances that a generator must be aware of to properly meet the regulatory requirements.

Biohazardous, Sharps, Pharmaceuticals, Unwanted Equipment, and Other Waste Types
Labs and industry have many additional sources of waste that are confusing and present head-scratching challenges as a waste determination is conducted. For example:

• If a facility wants to remove an outdated x-ray machine or electron microscope from service, what are the compliance requirements and is there a way to recycle it?
• If a lab process results in debris that is contaminated with bodily fluids, can they just be thrown in the trash? At what point are they considered “biohazardous?”

Beyond EPA

Additional regulatory agencies that oversee lab and industry operations include the Occupational Safety & Health Administration (OSHA), Department of Transportation (DOT), Department of Homeland Security (DHS), fire department, and others depending upon the type of work being done, chemicals being used, and resulting end products. As with EPA, identifying the other regulations that apply can be quite challenging and overwhelming. For example:

• Under OSHA, evaluation of worker personal protective equipment (PPE), respiratory protection, safety equipment, including safety showers and eye wash stations, and fire extinguishers requires plans, inspections, and training of workers. These programs should be set up as best practice to protect employees.
• As discussed in our previous article, DOT is often forgotten about in labs; however, there are general DOT requirements for any entity receiving or shipping hazardous materials. Failure to have proper DOT training or to know how to properly ship can result in significant financial penalty.

The waste scenarios seen in labs and industry are countless, and each may hold associated regulatory compliance requirements. While this clearly presents business risks, it also provides a unique opportunity to create strategies to manage wastes more effectively and efficiently, improve safety, and reduce the potential costs of regulatory compliance.

BIOTECHNOLOGY FOCUS

Preparing products for shipment out and receiving raw materials in are both critical parts of the biotech lab/industry supply chain. In fact, managing transportation of these materials is an essential component of achieving operational success. Shipping hazardous waste that has resulted from product manufacturing or industrial processes is also vital to operations, as doing so helps to ensure compliance with regulations and minimize risks onsite.

Yet as important as hazardous waste transportation is in the biotech industry, some of the most overlooked regulations in industry are those requirements the Department of Transportation (DOT) has in place for “offering” (i.e., shipping or receiving) hazardous materials into commerce. Regardless of whether a company is shipping hazardous materials, receiving hazardous materials, or shipping hazardous waste, there are regulatory requirements that must be met to avoid substantial penalty and to maintain safe and compliant operations.

Training Requirements and Common Violations

The most significant DOT requirement related to waste relates to the DOT’s regulations for training, as enforced by the Pipeline and Hazardous Materials Safety Administration (PHMSA) division. PHMSA’s Hazmat Transportation Training requirements identify five areas that anyone offering (i.e., shipping or receiving) hazardous materials into commerce must be trained in to meet the General Awareness Hazardous Materials Regulatory (HMR) requirements (49 CFR 172.704).

One of the most common violations identified by both DOT and the Environmental Protection Agency (EPA) is failure of personnel signing hazardous waste manifests to have appropriate DOT training. A manifest tracks hazardous waste movement from your site to the proper destination (i.e., from “cradle to grave”). Each party that handles the waste signs the manifest and retains a copy for themselves. This ensures critical accountability in the transportation and disposal processes. If you are required to use a manifest for off-site shipments of hazardous waste, it is likely that you are required to have some form of hazardous waste training.

Training must be completed within 90 days of employment and must be refreshed at a minimum of every three years. Failure to meet this training requirement can result in substantial financial penalty. Perhaps even more important, lack of training may also impact the understanding of employees in how to correctly—and safely—perform their duties.

Penalties

The 2019 DOT HMR penalty amounts are as follows:

• The maximum civil penalty for a violation of hazardous materials transportation law (49 U.S.C. 5123(a)(1)) is $79,976 per day, per violation.
• For a violation that results in death, serious illness, severe injury, or substantial property damage, the fine is $186,610.
• The minimum penalty for a violation related to hazmat training (required once every three years for all hazmat employees per 49 CFR 172.704) is $481 per day, per violation.

Training and Resources

Training is key to compliance when it comes to shipping and receiving hazardous materials. Kestrel offers training with competency demonstration that meets the DOT Hazardous Materials General Awareness Training requirements. In a one-day seminar, participants:

• Learn all five required areas of compliance
• Develop understanding of various hazard classes and appropriate shipping requirements
• Practice identification of shipping names and use of the DOT Hazardous Materials Table in 49 CFR 172.101 as a reference for information
• Demonstrate competency and understanding through a written exercise at the completion of the class

Kestrel’s next offering of the 8-hour DOT Triennial General Awareness Training is being offered specifically for the biotech industry on Thursday, October 23 in Madison, Wisconsin. Register online.

The following resources may also be helpful in understanding your hazardous waste transportation requirements:

• Commonly Shipped Undeclared Hazardous Materials
• PHMSA Hazmat Transportation Training Requirements

BIOTECHNOLOGY FOCUS

Biotech labs and industrial processes traditionally produce many different types of waste that can present significant waste management challenges. Identifying all the different waste sources in operations is not as easy as it sounds. For example, labs and industry may not fully take the time to evaluate the chemicals in reagents, and as a result, they can make errors in managing the associated waste—errors that present significant risk of regulatory penalty, unnecessary expenditures, or exposure to personnel.

However, as the following case study shows, appropriately identifying and managing wastes also presents opportunities for reduced risk, cost savings, and improved compliance.

Case Study in Waste

Recently, Kestrel assisted an industrial lab located in a large production facility with waste management concerns. An EPA inspection identified several negative findings with an estimated potential fine of $350,000. Kestrel assisted with penalty negotiations and development of waste management strategies.

Inventory and Risk Identification
As Kestrel worked to get the facility in compliance, the inventory and risk identification process uncovered one waste stream that contained small amounts of mercury in test vials. The lab had been comingling this waste stream with their vials of flammable solvent waste, resulting in large lab packs of waste that were expensive to dispose. A five-gallon bucket of vials cost them approximately $250 for disposal, and they were generating up to six buckets per month. While the process of comingling is not a compliance issue when handled as a hazardous waste, it is often an unnecessarily expensive way to manage non-hazardous waste.

Alternative Methods
A thorough evaluation of the reagent used indicated that there were alternative test methods that could be used to test for the same analyte. The lab was able to switch the mercury-containing reagent with a non-mercury-containing alternative. The cost for disposal of the five-gallon buckets dropped from $250 to $85 per bucket. Importantly, the testing methods were just as accurate and met the lab’s needs. This change minimized the risk of mercury exposure or a costly mercury cleanup event and resulted in a cost savings of approximately $1,000 per month.

Sustainable Strategies
Removal of the mercury-containing reagent was just one of many strategic improvements implemented at the lab based on the initial waste evaluation. Kestrel was able to develop strategies to resolve the remainder of the EPA findings. Based on the comprehensive compliance improvements, the EPA penalty was negotiated to a no-penalty ruling and the company did not have to pay any amount in fines. They have now operated for an additional two years with no EPA penalty, continued reduction in waste management costs, minimized risk to employees, and operated a more efficient and streamlined lab.

How About You?

Have you considered your operations and your waste streams? Ask yourself:

• Are there waste streams that you are paying too much to manage?
• Are there alternatives to the reagents or kits you are using that may minimize your risk and improve safety in your lab?
• Are there strategies that can make waste management simpler, more cost-effective, and more compliant that you could implement in your lab?

The interpretation of FSMA compliance for Dietary Supplement (DS) distributers and manufacturers has varied since the law was signed in 2011. As much of the food industry, including FDA, has sought to understand compliance requirements of the various FSMA rules, the DS industry has had even more to assess and determine due to its unique requirements relative to food. This is further complicated by the maturity of specific requirements for the supplement category of products being tested by industry and regulators.

Dual Level of Regulation

Early under FSMA, many DS companies struggled—and many continue to do so—with their compliance to FDA requirements due to their direct regulatory obligations as food and DS companies. Historically, the DS industry enforcement requirements fall under FDA Section 111 GMPs, which require more stringent control of the full production process than what is required for food only. This presents DS with a dual level of regulation, with the DS-specific regulation established years prior to FSMA. In fact, this regulation was well in-place at the signing of FSMA and the additional requirements, which include the 117 GMPs.

The more conservative approach to ensure compliance is to meet requirements under both the FSMA and FDA Food and Dietary statutes concurrently. Alternatively, companies may wait for more clarity on FSMA, as the final rules and compliance dates were pending due to the rulemaking time that was instituted during the rollout phase.

Challenges of Compliance

In meeting the Section 111 GMP requirements for the DS industry, there is significant complexity; however, if managed correctly, Section 111 does address many of the related FSMA requirements. Specific areas required by FSMA but not included in the DS requirements remain, including a complete Food Safety Plan, preventive controls, environmental monitoring, program management updates, and specific organizational roles of Preventive Controls Qualified Individual (PCQI), Qualified Auditor, and Qualified Sanitation Lead.

The challenge of compliance for the DS industry lies in these issues, but also in the variation of company types within the industry (i.e., distributers, manufacturers, suppliers, and the supply chain). For DS companies with many varying aspects, there can be significant variation in requirements due to the various supply chain components. This makes development more challenging based on the proper responsible party for the specifications and the final branded product for distribution. In addition, the situation of making dietary supplements and food in the same plant must be properly addressed. These all must comply with Section 111 requirements. If the Section 111 program ensures a well-qualified supplier program, this can be referenced as 117 compliance for FSMA. Unfortunately, many organizations have not formalized their written and documented programs, as required by Section 111, as well as under FSMA.

To complicate things more, the DS industry is still evolving with rapid expansion of companies, manufacturers, and distributers participating in broad and changing product types. Within the DS supply chain, the functions of product development, specification, manufacturing, operations, and the ultimate responsibility for the product and raw material stages is not easy to determine. This leaves the ultimate responsibility party to be identified—often with overlapped and shared levels of responsibility, from raw material sourcing to final manufacture. Correspondingly, it is vital for DS companies to maintain strict control of suppliers, customers, and product identification at each step of the manufacturing process.

Direct Compliance vs. Third-Party Certification

FSMA maintains its position of direct compliance to the regulations vs. the use of third-party certification for industry-legal interpretation. However, the decision to pursue third-party certification must be evaluated within this rapidly changing industry. Acceptance of these certifications is growing along with FSMA compliance. In fact, many major retail chains require global certification under the Global Food Safety Initiative (GFSI) standards. In line with this, programs must be further defined and developed to meet the GFSI requirements associated with the benchmarked standards (i.e., BRC, IFS, FSSC22000, SQF).

The need for DS companies to be certified to the GFSI through one of the standards will only continue as the distribution channels for DS products grow. These standards are necessary to provide structured requirements and to ultimately simplify the compliance process based on even more research and learning.

Keys to Success

With this rapid evolution of unique DS products, compliance and certification efforts must consider and meet the test of time. This may take several years to establish. DS companies operating under FSMA must make appropriate decisions in the development of their programs to provide evidence that programs and processes have been appropriately implemented.

Key to this is developing and maintaining a documented system with written programs and validation to Section 111 and Section 117 GMPs under FDA to meet all necessary requirements. Sufficient records must be maintained as evidence that programs have been implemented, verified, updated, and maintained as current at all times. Any exceptions addressed by Section 111 or Section 117 compliance must be confirmed and documented within this system. As just one example, in some cases Section 117 cites specific requirements, such as the protection of outside storage containers. If they do not exist, a company must identify this has been determined as an exception.

In addition, it is very important DS companies determine their compliance assessment process for FSMA. These determinations must be made relevant to the existing and verified Section 111 programs and requirements under Section 117. Decisions within any program for FSMA compliance must be clear, verified, and implemented so they can be inspected or audited with proper evidence.

Conducting an internal compliance audit can be a very helpful and important step in confirming all requirements are met and all documented programs and practices are verified and up to date. Any identified risks will lead to program non-conformity, which must be closed to meet the regulatory requirements of Section 111, Section 117, and GFSI, if appropriate. A failure in one compliance situation has the potential to create multiple non-conformances across three areas and, therefore, must be appropriately and quickly addressed.

Mapping Your Requirements

Ultimately, mapping the compliance process for both regulations—and possibly to GFSI certification requirements—must be made, along with a final register of documentation showing all requirements are being met. This requires not only time and resources of the identified qualified personnel, but this effort also must be supported by a well-founded Management Review process to ensure compliance in this rapidly evolving sector.

Biotechnology Focus

• Are you managing your waste correctly? 
• Are you disposing of your waste efficiently and cost-effectively? 
• Do you have a system to track your waste and sustain its management? 

Waste is one of those risks that is often overlooked at companies because it isn’t something core to operations. Unfortunately, if waste is incorrectly managed, there are regulatory compliance risks, exposure risks, and potential financial penalties that can impact your business.  

The following represent just some of the challenging waste situations facing biotech companies that must be addressed:  

• Chemical liquid waste going down the drain 
• Chemicals being evaporated up the hood 
• Biohazardous materials being thrown in the trash 
• Chemical spill cleanup materials that are being thrown in the trash 

Waste products such as these do not belong in standard trash and may hold either more value or more risk to the organization. For example, some wastes have continued value through recycling or repurposing. Conversely, other wastes may be regulated, requiring special disposal processes. Improperly disposing these regulated wastes (i.e., through standard trash) can create safety or environmental risks that may cost big dollars.  

How do you avoid making pricey mistakes?  

Methodical Approach

A methodical, analytical approach to characterizing and evaluating waste can substantially improve efficiencies when it comes to handling waste, and minimize the risks of improper waste management. Evaluation of waste streams (i.e., the type of waste generated and how/where it is generated) can help to identify:  

• Areas to improve efficiencies in waste management processes 
• Wastes that can be minimized and/or prevented to reduce disposal costs 
• Alternative strategies for disposal and waste management that may result in minimized inputs and lower cost of initial supplies  
• Regulatory requirements to avoid any potential penalties for non-compliance 

Let’s take the evaluation of waste solvent as one example. Companies frequently purchase large quantities of solvent and then end up paying for its disposal. Reviewing the type of solvent and how it is being used may reveal an alternative with the potential for significant savings, such as a bench–top distillation unit, which would provide for: 

• Lower upfront costs in the purchase of solvent 
• Lower costs in the disposal of hazardous waste solvent 
• Fewer risks and regulatory requirements associated with stocking less solvent   

Business Benefits

Strategic evaluation of one type of generated waste may also lead to significant business benefits beyond the waste itself. A thorough review of business and operational processes and the waste being generated creates the opportunity for a “bottom–to–top” evaluation of all regulatory compliance. And that can lead to potential savings that a business may not have previously identified. Review and understanding of wastes being generated within a lab or business often leads to the following program area discussions: 

• Review of EPA hazardous waste and opportunities to minimize or more cost-effectively manage this expensive waste stream. 
• Evaluation of compliance with EPA waste requirements to make sure waste is labeled, stored, disposed, and reported correctly. 
• Review of other waste streams, such as biohazardous, radiological, and universal waste streams, to assure they are being efficiently managed and in compliance with regulations. 
• Evaluation of how chemicals are being managed in accordance with regulatory requirements (e.g., EPA, OSHA, DOT). 
• Review of OSHA safety programs and discussions to ensure training, documentation, and procedures are in place to keep employees safe while meeting requirements for such programs as hazard communication, personal protective equipment (PPE), respiratory protection, safety showers, eye wash stations, fire extinguishers, confined space, energy control and emergency response planning. 
• Exploration of options for recycling and best practices that have the potential to significantly improve financial bottom line management and increase sustainability of lab operation. 

Strategy Going Forward

Effectively managing your waste really begins with a comprehensive review of operations. It is a process of understanding what you have, where it fits, and what you need to do with it to minimize risk, reduce costs, and ensure compliance. This process walks a company through the following basic questions:  

• What are my business processes? 
• What kind of waste does my company generate? 
• What waste regulations apply to my business? 
• How do I understand the potential impacts of my waste? 
• How do I come up with a strategy to effectively minimize waste and reduce cost while keeping employees safe? 
• How do I ensure that we efficiently and cost-effectively manage waste and compliance for the long run? 

Over the next several weeks, we will be answering each of these questions in a series of articles to help address some of the common—and often costly—mistakes related to waste management and to help ensure you are managing your wastes in the appropriate and most cost-effective ways possible. 

Kestrel is proud to provide our ongoing support for the manufacture, processing, and distribution of safe food. This fall, we look forward to joining our food industry friends and colleagues at a number of events to promote safe and quality food.

Food Safety Consortium

The Food Safety Consortium is a premiere event for food safety education and networking. The Consortium offers three days of informational sessions on topics including FSMA final rules, FDA inspections under FSMA, food defense, food recalls, new technology, hiring and retaining sanitation workers, building your food safety team, allergen management, proper use of sanitation chemicals, Prop 64, environmental monitoring, GFSI, and more.

• DATE: October 1-3, 2019
• LOCATION: Schaumburg, Illinois
• REGISTER NOW!

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PROCESS EXPO with Special Food Safety Training

Kestrel will once again be joining FPSA at PROCESS EXPO, the nation’s largest trade show dedicated to bringing the latest technology and integrated solutions to all segments of the food and beverage processing and packaging industry.

• DATE: October 8-11, 2019
• LOCATION: Chicago, Illinois
• REGISTER NOW!

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SupplySide West with Featured Panel Discussion

SupplySide West is all about the science and strategy around the development of finished products that drive the global business economy. Learn about new trends from over 1,300 exhibitors and 140 hours of educational and conference programming. Don’t miss Kestrel’s Workshop: FSMA & Import Requirements for Food & Supplement Brands.

• DATE: October 15-19, 2109
• WORKSHOP DATE: October 16, 9 am – 12 pm
• LOCATION: Las Vegas, Nevada
• REGISTER NOW!

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We look forward to seeing you this fall. Contact us if you are interested in learning more about one of these events or setting up a time to meet!

On August 14, 2019, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) released a proposed rule to make several miscellaneous amendments to the Hazardous Materials Regulations (HMR) to ensure the safe and secure movement of hazardous materials to industry and consumers by all modes of transportation. This proposed rule is in response to numerous petitions submitted requesting PHMSA address a variety of provisions, including some on packaging, hazardous communication, and incorporation by reference documents. According to PHMSA, the amendments are intended to update, clarify, improve the safety of, or provide relief from various regulatory requirements in the HMR. The proposed amendments include:

• Adopting a phase-out schedule for certain railroad tank cars used to transport poisonous-by-inhalation materials
• Clarifying the cleaning standard for metal drums, including removing residual adhesive from labels
• Allowing the continued use of certain portable and mobile refrigerator systems commonly used in the produce industry
• Allowing for all waste materials to be managed in accordance with the lab pack exception whether they meet the definition of a hazardous waste per the U.S. EPA
• Incorporating an industry standard that can help to enhance the production of oil and gas wells
• Several additional proposed amendments derived from PHMSA’s petition for rulemaking process

EPA’s Hazardous Waste Generator Improvements Rule became effective on May 30, 2017, federally and in those states and U.S. Territories not authorized for RCRA (i.e., Iowa, Alaska, tribal lands and most of the territories). In the remainder of the states, the rule becomes effective when the state adopts it and adds it to their regulations. States were required to adopt more stringent revisions by July 1, 2019, which means the impacts of this rule should start to be realized across the country. The states are in various stages of adopting the regulation; check the status for your state.

For all intents and purposes, this is a good thing, as the Improvements Rule is designed to:

• Make the RCRA hazardous waste generator regulations easier to understand;
• Provide greater flexibility in how hazardous waste is managed to better fit today’s business operations; and
• Improve environmental protection.

Substantial Regulatory Revisions

The final rule includes over 60 revisions and new provisions to the hazardous waste generator program to make requirements more “user-friendly” in the end. Many of the revisions are technical corrections that address inadvertent errors in the regulations, remove obsolete programs, and clarify unclear citations. Some of the more substantial changes in the final rule, which states are required to adopt unless their requirements are more stringent, are outlined below.

Very Small Quantity Generators (VSQGs)

Conditionally exempt small quantity generators are now called very small quantity generators (VSQGs), and VSQG regulations are moved from 40 CFR 261.5 to 40 CFR 262. A VSQG generates less than 100 kg of hazardous waste in a month and may not accumulate more than 1,000 kg of hazardous waste.

Renotification for Small Quantity Generators (SQG)

The new rule now requires periodic renotification for SQGs every four years; SQGs were previously only required to notify once.

Waste Determinations

Any facility that generates waste needs to determine whether that waste is hazardous. According to the Improvements Rule, his waste determination must be made at the point of generation of the waste, prior to any dilution, mixing, and/or alteration.

Waste Consolidation

VSQGs are allowed to send hazardous waste to a large quantity generator (LGQ) to consolidate it before sending it to a RCRA-designated facility for management, under the condition that the facilities are under the control of the same person. Waste containers must be appropriately labeled (i.e., VSQG Hazardous Waste), and the LQG must notify the state of their participation.

Episodic Generation

Episodic generation of hazardous waste occurs when a non-routine event (planned or unplanned) results in a smaller generator generating atypically larger amount of hazardous waste in a month, triggering more stringent regulations. Under the Improvements Rule, VSQGs and small quantity generators (SQGs) are allowed to maintain their existing generator category in the event they experience an episodic generation event. The Rule allows for one event per calendar year, with the potential to petition for a second. Generators must notify EPA/state agency 30 days prior to initiating a planned event or within 72 hours of an unplanned event. 

Enhanced Labeling

Previous RCRA program labeling regulations did not require waste generators to identify the hazards of wastes, which resulted in failure to communicate risks of wastes being transported, accumulated, or stored in different locations. Under the Improvements Rule, labeling and marking of containers and tanks must clearly indicate the hazards of the hazardous waste contained inside and include the words “Hazardous Waste” . 

Waste generators may use one of several established methods to indicate the waste hazards, including:

• DOT hazard communication consistent with 49 CFR part 172 subpart E (labeling) or subpart F (placarding)
• OSHA hazard statement or pictogram, as described in the OSHA Hazard Communication Standard in 29 CFR section 1910.1200
• NFPA code 704 chemical hazard label
• RCRA hazardous waste characteristic (i.e., ignitable, corrosive, reactive, toxic)

The labeling requirements for containers in the satellite accumulation areas and for containers in the central accumulation area are identical, with the additional requirement that containers in the generator’s central accumulation area are marked with the date that the satellite container was moved to the storage area or the date that waste was initially added to the container in the central accumulation area.

Note that marking containers with RCRA codes is required for SQGs and LQGs prior to sending hazardous waste off-site, per 40 CFR 262.32.

Emergency Response

Previous regulations required generators to make arrangements with Local Emergency Planning Commissions (LEPCs) for potential emergency situations. The Improvements Rule expands this to require documentation of these arrangements/efforts with the LEPCs. In addition, LQGs must prepare an executive summary of their contingency plans containing the information most critical for immediate response to an emergency situation. This Quick Reference Guide must contain the following eight elements:

• Types/names of hazardous waste and associated hazards
• Estimated maximum amounts of hazardous waste onsite
• Hazardous wastes requiring special treatment
• Map highlighting where hazardous wastes are generated, accumulated, and treated
• Map of facility and surroundings that identifies routes of access and evacuation
• Location of water supply
• Identification of onsite notification systems
• Name of emergency coordinator and contact information

Ensuring Compliance

Again, the final rule includes over 60 revisions and new provisions, and authorized states are required to adopt the more stringent portions of the rule and may choose to adopt the less stringent portions. It is important for facilities to:

1. Get a solid understanding of the rule for the states in which it operates. Regulations may vary from state to state.
2. Determine waste generator status to understand which requirements are applicable. VSQGs, SQGs, and LQGs have some different requirements due to their potential impacts on the environment.
3. Assess compliance with the new and revised provisions. Each facility should be assessed to compare existing efforts with updated regulatory requirements.
4. Create a plan to close any compliance gaps. In many cases, the rule offers flexibility to help facilities in their efforts to comply. There are alternatives facilities can and should explore to find solutions that offer the greatest economic and environmental benefits.

Note: EPA developed a workshop on the Hazardous Waste Generator Improvements Rule. The training is designed to explain the Rule’s provisions.

Compliance risk assessment helps to identify and assess risks related to applicable regulatory requirements. Internal and external events or conditions affecting the entity’s ability to achieve objectives must be identified, distinguishing between risks and opportunities. These risks are analyzed, considering the following:

• Size of the risk – where, how big, how often/many?
• Severity of the outcome – to what extent can it impact safety, environmental, operational, financial, customer relations, regulatory compliance?
• Likelihood/probability of each risk – how likely is the occurrence of a negative outcome, considering the maturity of existing controls?

Based on this assessment, management can prioritize risks, select appropriate risk responses (avoiding, accepting, reducing, sharing), and develop a set of actions to align with the entity’s risk tolerance/appetite. An acceptable level of residual risk is considered after selected improvements and controls are applied. From there, policies and procedures can be established and implemented to help ensure the risk responses are effectively communicated so operating managers and individuals can carry out their responsibilities.

A deeper dive compliance program assessment may be performed for those risks that are identified as the company’s most significant.

Compliance Program Assessment

A compliance program assessment looks beyond “point-in-time” compliance to critically evaluate how the company manages compliance programs, processes, and activities, with compliance assurance as the ultimate goal. Capability, capacity, programs, and processes to comply are examined as part of this review. Conducting routine process and compliance audits are also key components of a compliance assurance program.

Compliance program assessment should follow a disciplined and consistent process, resulting in an effective program that guides alignment of activities to an integrated management system for sustained compliance and continuous improvement. An essential part of the assessment, audits capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices.

Compliance program assessment enables a company to define and understand:

• Compliance requirements and where regulated activities occur throughout the organization
• Current company programs and processes used to manage those activities and the associated level of program/process maturity
• Deficiencies in compliance program management and opportunities for improvement
• How to feed review recommendations back into elements of the management system to create a roadmap for sustaining and continually improving compliance

There are six phases associated with a compliance program assessment:

Phase 1 – Regulations, Requirements, and Applicability Analysis: Phase 1 focuses on identifying, organizing, validating, and understanding all of the requirements (legal or other) with which the company must comply. It provides an applicability analysis of the requirements to company operations by functional area and evaluates the associated risks. This stage engages representatives across the company who are responsible for activities subject to the requirements.

Phase 2 – Activities Analysis: This phase involves developing an inventory/profile of all company activities that may trigger the requirements identified in Phase 1. It asks the question, “What activities does the company carry out that are covered by the requirements?”

Phase 3 – Desired Compliance Program Standard: Establishing the company’s expectations for compliance program processes and controls—the desired condition—is essential. This “to-be” standard integrates management system principles into compliance program management. Programs should examine relative risks and ensure that risk-based priorities are being set.

Phase 4 – Actual Compliance Program Condition: In contrast to the desired standard identified in Phase 3, Phase 4 is about describing the company’s current compliance program. It defines how the company performs the activities outlined in Phase 3 (along with who, when, and where)—the “as-is” condition. This is done in the same framework as the desired standard in order to compare them in the next phase.

Phase 5 – Gap Analysis: The gap analysis compares actual compliance program management against the desired standard. It evaluates compliance program management processes, controls, and maturity to determine if they are good as is, need improvement, or are missing. These gaps and opportunities provide the basis for the improvement actions developed in Phase 6.

Phase 6 – Improvement Actions: Phase 6 moves the process along to developing action plans and an approach for ongoing management review that will guide the compliance program development and improvement activities. Compliance program management review is established at the end of this last phase. If there is a management system in place, program review information and action plan tracking can be integrated into that management system.

Outcomes

As a whole, this process will help companies evaluate the degree to which:

• Compliance goals and objectives are set and communicated by management.
• Hazards and risks are identified, sized, and assessed, including an inventory of activities subject to the compliance requirements and the relative risks.
• Existing controls are adequate and effective, recognizing, and addressing changed conditions.
• Plans are in place to address risks not adequately covered by existing controls.
• Plans and controls are resourced and implemented.
• Controls are documented and operationalized across functions and work units.
• Personnel know and understand the controls and expectations, and are engaged in their design and improvement.
• Controls are being monitored with appropriate metrics and compliance auditing and assurance.
• Information system is sufficient to support management system-required functions (e.g., document management and control, action tracking, notifications, training tracking, task calendaring, metrics reporting). Information dashboards can be used for reports to management.
• Deficiencies are being addressed by corrective/preventive action and are being tracked to completion.
• Processes, controls, and performance are being reviewed by management for ongoing improvement, including the maintenance and continual improvement of the integrated management system.

The Occupational Safety and Health Administration (OSHA) is joining businesses and organizations nationwide to recognize the importance and successes of workplace safety and health programs during Safe + Sound Week: August 12-18, 2019.

The week-long event encourages employers to implement workplace safety initiatives, and highlight workers’ contributions to improving safety. Businesses that incorporate safety and health programs can help prevent injuries and illnesses, reduce workers’ compensation costs, and improve productivity.

Participating in Safe + Sound Week can help get your program started, energize an existing one, or provide a chance to recognize your safety successes. Learn more about how to help plan and promote safety and health plans.