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!

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.