Managing the complexities of a management system is challenging for any food and beverage company, particularly for the team tasked with implementing the system throughout the organization. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion.

In today’s “New Era of Smarter Food Safety,” having a common system to organize, manage and track compliance offers an ideal solution. Dynamic tools are becoming available—systems that can manage employee training, pest control, laboratory testing, supply chain management tools, regulatory compliance and certification requirements, etc.

Unfortunately, these systems are often not set up to “talk” to each other, leaving company representatives to navigate many systems, databases, folders, and documents housed in many different locations.

The Solution: Compliance Management Systems

An integrated compliance management system (CMS) is intended to bring all these tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.

Read KTL’s recent article and case study in Food Safety Tech about how a  CMS can be used to coordinate, organize, control, analyze, and visualize information to help organizations remain in compliance and operate efficiently.

Under the Toxic Substances Control Act (TSCA), certain manufacturers (including importers) must provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce. This is done through a Chemical Data Reporting (CDR) report. CDR is required for all chemical substances listed on the TSCA inventory, with some exceptions, as discussed below.

EPA uses CDR to collect basic exposure-related information, including information on the types, quantities, and uses of chemical substances produced domestically and imported into the United States. This data is important, because it allows the Agency to assess potential human health and environmental impacts of chemicals and to share up-to-date information with the general public on chemical risks.

Manufacturers and importers who work with chemicals must understand TSCA and CDR, how the rules apply, and what is required to ensure compliance.  

What Is CDR?

The CDR rule was originally issued under TSCA in the 1980s as the Inventory Update Reporting (IUR) rule. In 2011, EPA changed the name to CDR to recognize the changes in reporting requirements over the past several decades.

Today, CDR remains a means to collect information on basic chemical exposure, including types, quantities, and uses of chemicals produced domestically and imported to the United States. According to this rule, manufacturers and importers must report on production and use of chemicals in commerce if specified thresholds are met.

What Is TSCA?

TSCA was published in 1976 to provide EPA with the authority to require reporting, recordkeeping and testing requirements, and restrictions related to chemical substances. In 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21^st Century Act, which modernized and updated TSCA to include the following:

• Mandatory requirement and clear deadlines for EPA to evaluate existing chemicals
• Risk-based chemical assessments
• Increased public transparency for chemical information
• Consistent source of funding for EPA to carry out responsibilities

The CDR rule remains a key component of TSCA, as revised under the Lautenberg Chemical Safety Act.

Who Must Report under the CDR Rule?

The CDR rule applies to manufacturers and importers of chemicals who meet specified production volume thresholds:

• In general, the threshold is 25,000 lbs. or more of a chemical substance at any single site during any calendar year since the last principal reporting year.
• With respect to chemicals that are subject to certain TSCA actions, a reduced threshold of 2,500 lbs. may apply.

Are Any Chemicals Exempt from Reporting?

Certain types, manner of manufacture/import, or use of chemicals are exempt from CDR reporting (i.e., polymers, microorganisms, naturally occurring chemical substances, water, and certain forms of natural gas when manufacture (including import) of those chemical substances meets other reporting requirements).

It is important for facilities to assess whether they have chemicals that fall into the following categories, as outlined by EPA, which are all exempt from CDR:

• Chemicals manufactured or imported for non-TSCA uses are not required to be reported (e.g., pesticides are exempt from reporting under CDR by TSCA). If a portion of a manufacturer’s or importer’s production is not subject to TSCA (e.g., if the use is regulated by the Food and Drug Administration (FDA)), that portion will not be reported to CDR. Note that manufacturers may report downstream non-TSCA uses for their chemical.
• Generally, water and naturally occurring substances are exempt from CDR requirements. Three other groups of chemicals (i.e., polymers, microorganisms, and certain forms of natural gas) are also generally exempt. However, it is important to note that a particular polymer, microorganism, or form of natural gas may not be exempt if the chemical becomes the subject of certain TSCA actions (e.g., an enforceable consent agreement).
• Chemicals that are non-isolated intermediates, imported as part of an article, impurities, or byproducts destined for certain commercial uses are exempt from reporting.

Are Any Manufacturers/Importers Exempt from Reporting?

EPA recently amended the definition of small manufacturer in 2020 in accordance with TSCA. This provides an exemption from reporting for manufacturers who meet the following criteria:

• Total sales during 2019 combined with those of the parent company (domestic or foreign) are less than $ 12 million; or
• Total sales during 2019 of the parent company (domestic or foreign) are less than $120 million and annual production volume of a qualifying chemical substance does not exceed 100,000 lbs. at any individual site. If the annual production volume of the chemical substance exceeds 100,000 lbs. at a site, the manufacturer is required to report for that particular site.

How Is the CDR Rule Different from Toxic Release Inventory (TRI) Rule?

CDR collects exposure-related information and requires manufacturers/importers to report industrial, commercial, and consumer use information for certain chemical substances on the TSCA inventory. TRI, on the other hand, is designed to track the management of certain toxic chemicals that might pose a threat to human health and the environment. Under TRI, regulated facilities must report on releases and waste management of specific chemical substances under the Emergency Planning and Community Right-to-Know Act (EPCRA).

How Often Must Data Be Reported?

Impacted manufacturers and importers must and submit information to the EPA every four (4) years. For chemical substances that trigger reporting, total annual production volume must be reported for each calendar year since the last principal reporting year. The 2020 submission reporting period was based on data for the calendar years 2016-2019. The next submission period will be 2024 for data collected from 2020-2023.

How Do Companies Submit CDR Data?

Companies subject to reporting must submit the required information using e-CDRweb, the CDR web-based reporting tool. To access this reporting tool, companies must register on EPA’s Central Data Exchange (CDX) system.

What Should I Do Now to Prepare?

The most recent submission period closed on January 29, 2021. To prepare your company for the 2024 submission:

• Keep records on production volume of imported and manufactured chemical substances.
• Follow EPA actions under TSCA to check if they have an impact on your reporting requirement.
• Make sure to submit your report within prescribed deadline; otherwise, you may be subject to EPA enforcement action.
• Visit the CDR website for program updates, announcements, and other guidance materials.

Spring is here…warmer temperatures, melted snow, anticipated rain, and, potentially, elevated flood warnings. Spring thaw is a critical time to evaluate potential runoff impacts from storm waters and to ensure compliance with regulatory requirements for storm water management.

Permit Requirements

According to the U.S. Environmental Protection Agency (EPA), “The National Pollutant Discharge Elimination System (NPDES) permit program addresses water pollution by regulating point sources that discharge pollutants into the waters of the United States.” NPDES permits are issued by states that have obtained EPA approval to issue permits or by EPA Regions in states without such approval.

Businesses with specific SIC/NAICS codes are required to have an NPDES permit or a No Exposure certification in place to help ensure protection of the nation’s surface waters. If a business is required to have an NPDES permit, they are also required to have a Storm Water Pollution Prevention Plan (SWPPP) for their site.

What Is a SWPPP?

A SWPPP is a site-specific, written document that is required to comply with a storm water general permit. The primary goal of the storm water permit program is to improve the quality of surface waters by reducing the number of pollutants potentially contained in the storm water runoff. The SWPPP describes:

• Potential sources of storm water pollution at the site
• Activities to control sedimentation and erosion
• Practices to reduce pollutants in storm water discharges from the site
• Procedures to comply with the terms of the general permit and Clean Water Act (CWA) requirements

SWPPPs are intended to be “living” documents that are updated to reflect changes at the site. With spring thaw and rains in the forecast, it is important to review the SWPPP and any Best Management Practice (BMP) strategies to ensure the site is effectively managing storm water and meeting permit and regulatory requirements.

SWPPP: Key Parts and Pieces

The SWPPP identifies potential sources of pollution that may reasonably be expected to affect the quality of storm water discharges associated with activity at the facility. The plan also describes the implementation of practices that are to be used to reduce those pollutants. The SWPPP, which should be prepared in accordance with good engineering practices, documents the following:

• Summarizes major activities conducted at the facility.
• Inventories exposed materials and summarizes storm water sampling requirements for the facility.
• Identifies potential source areas of storm water contamination and significant polluting materials.
• Identifies Best Management Practices (BMPs) for facility activities.
• Identifies impacts of BMPs.
• Identifies the individuals who will implement the SWPPP.
• Provides information on required storm water inspections.
• Discusses training requirements.
• Provides a means of recordkeeping for storm water-related documents at the facility.
• Provides a non-storm water discharge assessment.
• Summarizes storm water discharge regulatory applicability and implementation schedule.
• Fulfills the requirements of the General Permit issued to the facility.

SWPPP Development: Best Practices

EPA cites a number of common compliance problems associated with SWPPPs in its SWPPP guide.  Based on KTL’s experience, the following best practices can help ensure successful development of the SWPPP and implementation of the overall storm water pollution program to avoid those pitfalls.

1. Determine whether you need a SWPPP. Many facilities do not realize they need a SWPPP. Others may use a generic template to fulfill the need. To be effective, SWPPPs should be customized to address site-specific operations.
2. Implement control measures. The SWPPP identifies control measures for managing storm water. It is vital that those control measures outlined in the SWPPP are the control measures that are actually being used at the site. As operations change and control measures change, the SWPPP must be updated.
3. Keep a copy onsite. A copy of the SWPPP—hard copy or electronic—must be maintained onsite at all times in case of a regulatory inspection.
4. Authorize the SWPPP. A responsible facility representative must sign and authorize the current version of the SWPPP.
5. Identify and train your storm water pollution prevention team. The storm water pollution prevention team identified in the SWPPP must be current, familiar with the storm water program, and adequately trained on the program and their respective roles/responsibilities.
6. Collect representative visual assessment samples. Visual storm water samples collected from pooled areas onsite are not representative, as these areas tend to concentrate pollutants.
7. Cover dumpsters. This is a simple action that is often overlooked. Dumpsters from contract waste collection agencies must be appropriately sealed to prevent leaking oil or other contaminants. Check with your regulatory authority on what is required for outside dumpsters—even those for contractors.
8. Control outdoor storage. Keep outdoor storage to a minimum. Store only items specified in the SWPPP in the designated storage areas.
9. Maintain inspection and monitoring records. Facilities are required to maintain records of routine site inspections, visual assessments, monitoring results, and implementation of practices required in the permit.

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) issued a proposed rule to update the agency’s Hazard Communication Standard (HCS) to align with updates to the United Nations (UN) Globally Harmonized System of Classification and Labeling Chemicals (GHS), as well as those of Canada and other U.S. agencies.

According to OSHA, the agency “expects the proposed updates to the HCS will increase worker protections and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on labels and safety data sheets (SDS) for hazardous chemicals.”

HCS and GHS

The HCS was initially adopted by OSHA in 1983 to create a standardized approach for communicating about workplace hazards associated with hazardous chemical exposures. The standard requires chemical manufacturers and importers to classify the hazards of chemicals produced and/or imported to the U.S. and to communicate to employees about these chemicals through a hazard communication program, including labels and other forms of warning, SDS, and training.

Like HCS, the GHS is an international standard that was created as a “universally harmonized approach” to classifying chemicals and communicating hazard information. Warning pictograms that can be understood in any language are a key component of the GHS, in addition to universal standards for hazard testing criteria and SDS. The UN updates the GHS every two years, with the most recent updates in 2019 with Revision 8.

OSHA’s proposed HCS updates are the agency’s first since 2012 and are intended to address issues that have emerged since 2012, align with GHS Revision 7 and some provisions from GHS Revision 8, and enhance cooperation with international trading partners. Correspondingly, as part of OSHA’s proposed rule, the agency is evaluating whether it should establish a schedule for updating the HCS to coincide with GHS updates or maintain the status quo of updating when there are substantial changes to GHS requirements.

Major Proposed Changes

The following proposed modifications to the HCS are intended to improve hazard communication so employees are more aware of the hazards associated with potential chemical exposure, while creating additional clarity and flexibility in requirements:

• Flexibility for bulk shipments of hazardous chemicals, including allowing labels to be included on immediate containers or with shipping papers, bills of landing (BOLs), or other electronic means that are immediately available to workers in printed form on the receiving end of the shipment.
• Options for labeling small containers when it is not feasible to use traditional pull-out labels, fold-back labels, or tags containing full information. This includes using just the product identifier, pictogram, signal word, chemical manufacturer’s name/phone number, and statement that full information is provided on the immediate outer package for containers less than or equal to 100 ml capacity. For those with a capacity of 3 ml or less, only the product identifier needs to be displayed.
• New requirements for updating labels on individual containers that have been released for shipment but are waiting future distribution. These shipments would not need to be relabeled; however, the chemical manufacturer/importer would need to provide the updated label for each individual container with each shipment.
• Updates to precautionary statements in every hazard class and category. OSHA is also proposing certain statements related to medical response be prioritized.
• Withholding of a chemical’s concentration range as a trade secret. In addition, OSHA is proposing to allow the use of prescriptive concentration ranges rather than actual concentration/concentration ranges (consistent with those required by Canada) when these are deemed trade secrets.
• New required information on SDS, including U.S. address/phone in Section 1, hazards associated with change in chemical’s physical form, identification of hazards that result from a chemical reaction, more information on physical and chemical properties (e.g., particle size), and more information on interactive effects.

Next Steps

OSHA is currently seeking public comment on the HCS proposed updates through April 19, 2021.

While many of OSHA’s proposed changes will provide additional flexibility to chemical manufacturers and importers, as well as alignment with GHS and international trading partners, the regulatory burden is not insignificant to those impacted. The fundamental structure of the HCS is not changing; however, the revisions will require companies to update SDS, labels, and training. All of this will take appropriate and resources to meet deadlines once any proposed updates are finalized.

View the Federal Register notice.

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

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

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

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

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

What would you say is a highlight of your job?

The many wonderful people that I work with.

What do you like to do in your free time?

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

Read Will’s full bio.

The International Featured Standards (IFS) are “uniform food, product, and service standards that ensure certified companies produce a product or provide a service that complies with customer specifications, while continually working on process improvement.”

There are currently six standards under IFS, including the most recent IFS Food Standard Version 7 (IFS Food V7), which was issued in October 2020. Recognized by the Global Food Safety Initiative (GFSI) as a benchmarked standard for auditing food manufacturers, IFS Food focuses on ensuring food safety and quality.

V7 Changes

The new IFS Food V7 reduces the number of requirements by 15% and provides additional clarity for auditors when performing an IFS assessment through the following changes:

• Risk-based and less prescriptive approach that allows for customized solutions for company-specific risks and hazards
• New wording that changes “audit” to “assessment” to create consistency with ISO/IEC 17065
• New structure that emphasizes onsite evaluation over documentation
• Better defined scoring system and a more clearly structured assessment report
• Unannounced assessments (every third certification)
• Checklist that aligns with the GFSI Benchmarking Requirements Version 2020, Food Safety Modernization Act (FSMA), and European Union (EU) regulations
• Incorporation of food safety culture into assessments

IFS Food V7 is scheduled for implementation with audits beginning March 1, 2021 and will become mandatory for all certified companies on July 1, 2021.

Focus on Food Safety Culture

One notable change with IFS Food V7 is the incorporation of food safety culture into requirements. This is in line with the addition of food safety culture into GFSI Benchmarking Requirements Version 2020. It also relates directly to one of the core elements of the U.S. Food & Drug Administration’s (FDA) New Era of Smarter Food Safety, which promotes food safety culture throughout the food system.

Per IFS, “Food safety culture refers to shared values, beliefs, and norms that affect mindset and behaviour toward food safety in, across, and throughout an organization.”

Informally, food safety culture can be thought of as “the way we do things around here” when it comes to food safety practices. An organization’s food safety culture is ultimately reflected in the way food safety is managed in the workplace. A strong food safety culture creates an atmosphere where everyone in the organization is aware of and helps to prevent any process and/or operational issues and deviations that my impact the safety and/or quality of their products.

Characteristics of a Strong Food Safety Culture

Per IFS Food V7, food safety culture should be driven by four primary elements:

• Communication about food safety policies and responsibilities
• Training
• Employee feedback
• Performance measurement

Best-in-class food safety cultures have robust systems in place to ensure that each of these elements, among others, is well-functioning and fully ingrained into the standard practices of the organization. KTL has found that organizations with strong food safety cultures typically exhibit many of the following attributes:

• Communication. Communication is most effective when it comprises a combination of top-down and bottom-up interaction. All levels of management (senior, middle, supervisory) are responsible for clearly communicating to the workers who carry out the company’s mission. It is equally important that workers provide feedback on a practical level about what’s working and what’s not.
• Commitment. When it comes to food safety, actions truly speak louder than words. A lack of commitment, as demonstrated by action (or lack thereof), comes across loud and clear to staff.
• Caring. Caring involves showing concern for the personal safety of individuals (employees and consumers), not just making a commitment to the overall idea of food safety.
• Cooperation.  Cooperation means working together to develop a strong food safety program. It means management seeks feedback from workers about food safety issues—and uses that feedback to make improvements.
• Coaching. Coaching each other—peer to peer, supervisor to employee, even employee to management—is an important way to keep everyone on track, generate constructive criticism, and foster a truly collaborative atmosphere regarding food safety.
• Procedures. There should be documented, clear procedures for every task. This not only prevents disagreement about what is required, it also shows commitment when things are put in writing.
• Training. Training is a more formal, documented process for ensuring that employees follow food safety processes and procedures and feel prepared to do their jobs.
• Tools. All equipment and tools should be in good repair and functioning as designed. Inadequate equipment/tools directly impact food safety/protection and indirectly impact perception of management commitment.
• Personnel. There must be enough qualified workers to perform each task. The company must not sacrifice food safety or quality because of being understaffed (i.e., requiring shortcuts/overtime to meet production goals).
• Trust. Trust in the food safety program, in senior management, and in each other is built when each of these characteristics is present and treated as a company-wide priority.

Planning for Change

For companies that are IFS-certified, now is the ideal time to assess current IFS Food program elements; identify improvements that are internally desirable and required by the new standard; and implement those updates that will create a strong food safety culture and make the IFS Food program more useful to the business. This can be done through a series of phases to ensure adoption throughout the organization.

• Phase 1: IFS Food Internal Assessment – Review existing IFS food programs, processes, and procedures; document management systems; and employee training tools and programs to identify those need areas in need of updates, development, and/or implementation to meet the requirements of IFS Food V7.
• Phase 2: IFS Food Program Updates – Based on the assessment, develop a plan for updating the IFS Food certification program, including major activities, key milestones, and expected outcomes. This may include updating/developing IFS Food programs, processes, procedures, and training with missing V7 requirements and incorporating new food safety culture requirements.
• Phase 3: Training – To ensure staff are prepared to implement and sustain the updated IFS Food V7 program, staff must be trained on applicable requirements; specific plans, procedures, and GMPs developed to achieve compliance; and the certification roadmap to prepare for future assessments.

Following this plan now will help companies ensure they maintain their IFS Food certification when assessments begin under IFS Food V7 in March 2021.

Resources

The IFS website has several comprehensive resources available to assist facilities and auditors in understanding the IFS Food V7 changes and requirements, including:

• IFS Food V7 Checklist vs. IFS Food V6.1 Checklist
• Comparison of IFS Food V7 vs. IFS Food V6.1 for All Parts of the Standard
• IFS Food V7 Assessment Guidelines
• IFS Food Doctrine

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:

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!