KTL Principal Joe Tell was recently appointed to the Director’s Council of the Scripps Institution of Oceanography at University of California (UC) San Diego. Scripps is one of the most important centers for global earth science research and education in the world.

Director’s Council members are leaders in business, government, philanthropy, or the nonprofit sector. The Council meets formally twice per year to review the institution’s progress and to advise the Director in strategic planning for priorities, new directions, and high-level outreach.

Joe brings over 25 years of experience working with industrial, government, and institutional clients in operational and business risk management, process improvement, information management systems, and compliance assurance to his Director’s Council position. His expertise is focused on creating strategies for developing and implementing risk-based management systems that sustain the environment and public health, emphasize strong leadership commitment, and ensure cross-functional stakeholder engagement. Joe is particularly interested in making connections between the private sector, government agencies, and the NGO community to promote collaborative solutions to global environmental and health issues.

Scripps was founded as the Marine Biological Association of San Diego in 1903. The Institution leads research in climate change impacts and adaptation, resilience to hazards, conservation and biodiversity, oceans and human health, national security, and innovative technology to observe the planet.

A November 29, 2022, reader poll conducted by Quality Assurance & Food Safety Magazine identified the following top food safety concerns for 2023: 25% recalls, 25% traceability, 25% supplier/supply chain issues, 12% labor shortages, 12% something else.

Over the past few years, KTL has seen many of these concerns—and others—present challenges across the food industry.  We also recognize the opportunity some of these present when appropriately and proactively addressed. Here are some of the top food safety trends KTL is tracking in 2023—and some guidance to help you as you establish your food safety priorities.

Resource Constraints and Technology Solutions

Not surprisingly, one of the biggest challenges we have witnessed our clients grappling with is related to staffing, from turnover in the quality department to being understaffed in production. Employees are stretched thin and are carrying more responsibilities that they aren’t necessarily qualified to do, including food safety. Achieving and maintaining food safety compliance and Global Food Safety Initiative (GFSI) certification requires great management and expertise to ensure all aspects of a company’s technical compliance have been identified and are being actively handled. KTL has been working with more and more food safety and quality departments to fill these gaps—either with outsourced personnel or compliance efficiency tools—as companies look to recruit food safety staff.

Guidance:

• Invest in food safety training and education for all staff and start with the basics. Even experienced workers can benefit from refresher training to correct bad habits and build efficiencies.
• Develop a relationship with someone you trust to do things in your best interest. Use them to assess your operations, help you understand what regulations apply, identify gaps in your programs, and implement solutions to eliminate risks. Rely on them as a part of your team.
• Employ information technology (IT) solutions to create compliance efficiencies. A well-designed and executed compliance information management system brings IT and management systems together to coordinate, organize, control, analyze, and visualize information in such a way that helps organizations remain in compliance and operate efficiently. 
• Build a better food safety culture starting at the top and focusing on the details (see below).

Food Traceability

Without a doubt, food traceability is a hot topic with the Food and Drug Administration (FDA) publishing the Final Food Traceability Rule in November 2022. While the agency has had previous food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach—creating standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response. The compliance date for all entities subject to the updated recordkeeping requirements is January 21, 2025.

Guidance:

• The rule is complicated with unanswered questions about recordkeeping and FDA enforcement. Do what you can to understand your requirements. Review the Food Traceability List (FTL) and start building systems and processes now that address requirements for traceability lot codes, critical tracking events (CTEs), key data elements (KDEs), and recordkeeping.
• Having a good document/records management system will be essential for maintaining the vast number of documents required by the Food Traceability Rule. Such a system can help ensure process and document standardization; central and secure storage, organization, and access to documents and records; enhanced workflows for approving and completing tasks involving documents; and easy access to documents for audits and clear audit trail.

Food Safety Culture

Food safety culture continues to garner attention and visibility across the food industry, as it is being integrated more completely and significantly into many of the GFSI-benchmarked food safety certification standards. For example, BRCGS Issue 9, which was launched on August 1, 2022, emphasizes two core themes: building core competencies and developing food safety culture.  These actions are creating defined requirements, timelines, and measurements to create a culture that embraces food safety.

Guidance:

• Get senior leadership commitment in prioritizing food safety and quality.
• Assess current food safety program elements, identify improvements that are internally desirable and required, and implement those updates that will create a strong food safety culture.
• Put robust systems in place to ensure consistent commitment, communication, procedures, training, performance measurement, and trust.  

Environmental Focus

Food companies continue to see regulatory bodies—beyond FDA and USDA—taking much more interest in them. U.S. Environmental Protection Agency (EPA) multi-media inspections, enforcement actions, and large penalties for violations persist. EPA’s proposed Safer Communities by Chemical Accident Prevention (SCCAP) rule, which is intended to strengthen current Risk Management Plan (RMP) regulations, has the potential to create significant industry requirements in the future. Facilities that use anhydrous ammonia as refrigerant may be particularly vulnerable. In addition, EPA is investing resources in addressing per- and polyfluoroalkyl substances (PFAS) contamination. Many manufacturers, especially those in the food and beverage industry, are facing new concerns about whether and how to test for and remediate PFAS contamination.

Guidance:

• Evaluate your current environmental risk level and develop strategies to minimize risks to the extent possible. Proper usage strategies, a comprehensive environmental management system (EMS), and a forward-thinking Emergency Response Plan will remain vital tools for companies to effectively manage the associated risks
• Outline steps to improve performance and safe operations, including defining organizational roles and responsibilities.
• Streamline compliance methods and improve operational efficiencies by implementing IT solutions and compliance management systems that coordinate, organize, control, analyze, and visualize information.

Food Recalls

FDA took another step toward reducing the public’s exposure to the risks of foodborne illness on March 3, 2022, issuing its final guidance for voluntary recalls: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA’s guidance outlines the steps companies should take before a recall is mandated, including developing policies and procedures, establishing training, maintaining records, and initiating communications.

Guidance:

• Establish recall initiation procedures. Prepare, maintain, and document written procedures for initiating a recall to minimize delays and uncertainty when/if a voluntary recall becomes necessary.
• Identify and train appropriate personnel (and alternates) on recall-related responsibilities. The recall team should have a thorough understanding of recall procedures and their respective roles in carrying out a recall plan. Regular training, including mock recalls, helps ensure competency.
• Establish a recall communications plan to address communications with employees, FDA, supply chain, direct accounts, and the public, as necessary. Identify key contacts and develop draft templates that can be easily customized and distributed when needed.

Food Investments

We continue to see private equity firms investing heavily in food companies and, subsequently, in their food safety infrastructure. Any merger and acquisition (M&A) transaction, no matter the size or structure, can have a significant impact on the acquiring company—and food safety is a critical factor. Undertaking adequate due diligence is vital. It can lead to the discovery of regulatory inconsistencies that may lessen the value of an entire product line or business—and opportunities to make improvements. It can provide better insights into the risks and potential benefits of a transaction that will ensure a smoother, more effective, and sustainable business integration.

Guidance:

An assessment of the operations, production processes, equipment conditions, food safety management, quality, regulatory compliance, and all related documentation needs to be completed as part of any food-related acquisition. Prior to any acquisition, it is important to determine:

• Condition of operations (i.e., personnel, equipment, processes, facility) necessary to effectively meet existing performance standards.
• Level of food safety compliance to regulatory requirements and applicable voluntary industry certifications.
• Any potential high-level risks that would impact the transaction.

Cannabis

FDA is watching! The agency issued a number of warning letters in 2022 to companies that sell CBD-infused food and beverages and seems particularly concerned about food products that may appeal to children (e.g., cookies, gummies, etc.). While the regulatory framework for managing cannabis production is still unclear, this is a rapidly growing market, and we anticipate progress—whether at the state level or federal level—in the development and implementation of regulations and controls (e.g., Good Manufacturing Practices (GMPs), labeling requirements, etc.).

Guidance:

Several organizations have launched cannabis standards and certifications—often based on GFSI and GMPs—to improve the overall safety and quality of cannabis and cannabis-infused products in the market. Those getting involved in this rapidly growing industry need to assess operations, determine what standards might be appropriate, identify gaps in existing programs, prepare for potential regulatory action and/or certification opportunities, and implement solutions to eliminate risks.

Sustainable Food Management

According to a January 2023 article in Food Logistics Magazine, “By 2050, the Food and Agriculture Organization (FAO) estimates we will need to produce 60% more food to feed a world population reaching nearly 10 billion. Even if we hit that mark, 300 million people will still be grappling with food scarcity.” The regulatory community has identified a real need for addressing food waste and the lack of circularity in the food industry. Sustainable management of food involves “a systematic approach that seeks to reduce wasted food and its associated impacts over the entire lifecycle, starting with the use of natural resources, manufacturing, sales, and consumption, and ending with decisions on recovery of final disposal” (EPA). Watch for efforts to promote sustainable food management to expand to meet demand.

Guidance:

A thorough food and packaging assessment can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, reduce water and energy use and greenhouse gas (GHG) emissions associated with food production.

Food Safety Verification Program (FSVP)

While not a new rule, FSVP remains a key focus as the surge in food demand and lack of supply has created an environment ripe for food fraud. FDA recently sent a number of warning letters to companies across the U.S. putting them on notice for not having FSVPs for a number of imported food products, a significant violation of compliance with FSVP regulations. On January 10, 2023, FDA issued its final FSVP guidance document to help importers comply with the FSVP regulation. It offers clarification on what foods/entities the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform FSVP activities.

Guidance:

• Assess your supplier approval/management program, focusing on the fundamental aspects of FSVP—those requirements that must be verified, recorded, and evident in documents supporting foreign shipments of food product(s) under the rule.
• Evaluate potential foreign suppliers’ performance and the risks posed by the food. Use FDA’s guidance document to determine and conduct appropriate foreign supplier verification activities.
• Implement a supplier approval and management system to improve coordination with and communication of approved suppliers; manage supplier requirements and supplier evaluations/approvals; and maintain all required documentation.
• Train your staff to have the knowledge needed to implement a successful FSVP that meets compliance requirements.

Set Your Goals for 2023

With these challenges simultaneously competing for attention—and with fewer resources to manage it all—companies need to assess priorities, needs, and requirements and create a plan for how to meet them. KTL suggests completing the following early in 2023:

• Get senior leadership commitment and invest in creating a food safety culture that prioritizes food safety and quality.
• Conduct a comprehensive food safety and quality gap assessment. This should be the starting point for understanding your regulatory and certification obligations and current compliance status—and for ensuring you are prepared to meet pending regulatory developments.
• Get your documentation in place. Update and/or develop the procedures, programs, and records you need to demonstrate compliance, and implement a reliable system to keep them organized and readily accessible.
• Leverage IT solutions to streamline compliance, manage certification requirements, and create business efficiencies.
• Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance.

Every year, we see a number of environmental, health, and safety (EHS) trends rise to the surface that have the potential to impact many industries. Some challenges and opportunities in EHS remain ongoing; some are just gaining traction with impacts yet to be known. Regardless, the start of a new year provides the opportunity to plan for EHS issues and trends on the horizon and prioritize efforts to ensure ongoing compliance.

Here are some of the top EHS trends KTL is keeping watch on in 2023—and some guidance to help you as you set your EHS strategy for the new year.

Resource Constraints and Technology Solutions

EHS personnel are being asked to manage a lot—and often in growing areas that may be outside their education, expertise, and/or experience. Resource constraints—particularly related to staffing—remain a significant concern across industry, and EHS is certainly not immune. Impacts from the “Great Resignation” of November 2021 and beyond continue to leave many companies without the resources needed to effectively manage EHS requirements.

Achieving and maintaining EHS compliance requires great management and expertise to ensure all aspects of a company’s technical compliance have been identified and are being actively handled. KTL has been working with more and more EHS departments to fill these gaps—either with outsourced personnel or compliance efficiency tools—as companies look to recruit EHS staff and meet compliance obligations.

Guidance:

• Develop a relationship with someone you trust to do things in your best interest, understanding that EHS should be a process of continuous improvement. Use them to help you understand what regulations apply. Let them help you prioritize your compliance plan. Use them to do your annual training. Rely on them as a part of your team.
• Employ information technology (IT) solutions to create compliance efficiencies. A well-designed and executed compliance information management system brings IT and management systems together to coordinate, organize, control, analyze, and visualize information in such a way that helps organizations remain in compliance and operate efficiently. A system like this will help provide operational flexibility, generate business improvement, and prepare organizations to address these and other EHS compliance challenges that will continue to surface. 

EPA Inspections and Enforcement

EPA intends to continue its enforcement path, holding environmental violators and responsible parties accountable. Significant investments are being made to enforce and ensure compliance with the nation’s environmental laws, including $213 million for civil enforcement efforts, $148 million for compliance monitoring efforts, and $69 million for criminal enforcement efforts. The Agency also has plans to improve inspections by sending 75% of EPA inspection reports to facilities within 70 days of inspection and conducting 55% of annual EPA inspections at facilities that affect communities with potential environmental justice (EJ) concerns (see more on EJ below).

Guidance:

• Design and maintain a safe facility to prevent accidental releases and minimize the consequences of accidental releases that do occur. Conduct a gap assessment to ensure the required processes and systems are functioning as intended.
• Establish a quick response internal inspection team that can evaluate all areas of risk in your facility to ensure you are in compliance, particularly at the time of inspection.
• Understand the hazards posed by chemicals at the facility and assess the impacts of a potential release. Complete a waste characterization for all hazardous and solid waste streams to make sure you are appropriately managing your universal waste and hazardous waste.
• Check your Emergency Response Plan to ensure it has identified emergency contacts for your facility and that the contacts are current. Coordinate with local emergency responders.

Environmental Justice (EJ)

EPA’s Strategic Plan includes a goal that EJ and civil rights will be embedded into EPA’s programs, policies, and activities to reduce disparities in environmental and public health conditions. This focus on EJ has continued to gain momentum with a slew of additional significant actions taken in 2022 to further elevate EJ priorities and deliver on the Administration’s promises to advance justice and equity when it comes to ensuring clean air and water for all communities; safeguarding and revitalizing communities (i.e., Superfund and RCRA); and ensuring safety of chemicals through civil rights and compliance reviews, audits, and community outreach.

Guidance:

• Take the time to understand the communities where you operate—be informed, be prepared, and be proactive. Establish companywide priorities and goals and commit the appropriate resources to address EJ concerns.
• There are a number of EJ grants, funding, and other technical assistance available. EPA’s new Office of Environmental Justice and External Civil Rights is positioned to deliver new grants and technical assistance to meet EJ goals.

Sustainability and Climate Change

The Biden Administration previously committed to a net zero economy by 2050. EPA is focused on reducing greenhouse gas (GHG) emissions by promulgating rules to reduce pollution from the power sector, setting vehicle emission standards, and partnering with the public and private sectors communities (especially those underserved and disproportionally at risk) to increase energy efficiency in the residential, commercial, and industrial sectors. In addition, there is $100 million in grants to support efforts to reduce GHG emissions and increase resiliency in the nation’s infrastructure and $35 million to implement the American Innovation in Manufacturing Act to continue phasing out GHGs.

Guidance: 

• Conduct a lifecycle analysis (LCA) to identify and quantify the inputs and outputs in a process and use data to assess the potential environmental impacts across the lifecycle.
• Have an energy audit completed of your facilities.
• Get input from employees on what initiatives are important to them by enacting a sustainability committee or adding sustainability to your EHS agenda.

Safer Communities by Chemical Accident Prevention (SCCAP)

EPA proposed on August 31, 2022 to strengthen the Risk Management Program (RMP) regulations with the SCCAP proposed rule. The proposed SCCAP amendments include a number of requirements that were originally promulgated by the Obama Administration EPA in 2017 and subsequently rescinded during the Trump Administration in 2019, plus several new requirements considering impacts of climate change, EJ concerns, employee participation, and enhanced community notification. Proposed changes would require RMP-regulated facilities to better consider surrounding communities and the consequences of potential chemical accidents that could have significant impacts on industry requirements going forward.

Guidance:

• Identify/understand/prioritize your compliance risks and develop strategies to minimize them to the extent possible.
• Outline steps to improve performance and safe operations, including defining organizational roles and responsibilities. Plan and conduct required tabletop exercises and coordinate with Local Emergency Planning Committees (LEPCs) to ensure your plans work in practice.
• Streamline compliance methods and improve operational efficiencies by implementing IT solutions and compliance management systems that coordinate, organize, control, analyze, and visualize information.

PFAS Contamination

More and more facilities are going to be directly impacted by mitigation efforts and future regulatory action related to per- and polyfluoroalkyl substances (PFAS). PFAS contamination is an extremely complicated issue—and concern is mounting over its impacts and how to regulate these chemicals going forward. EPA has set aside $126 million to increase its understanding of human health and ecological effects of PFAS contamination, restrict its uses, and remediate PFAS that have been released. Over the course of 2022, EPA took several actions to further protect individuals and communities from the health risks posed by these forever chemicals and more is on the way.  

Guidance: 

• Evaluate your current environmental risk level and develop strategies to minimize risks to the extent possible. Proper usage strategies, a comprehensive environmental management system (EMS), and a forward-thinking Emergency Response Plan will remain vital tools for companies potentially dealing with PFAS to effectively manage the associated risks.
• Work with LEPCs to coordinate emergency response efforts and exercises to keep communities informed and safe.

Set Your Goals for 2023

With these trends toward more regulation, more enforcement, and more focus on EJ and sustainability—but with fewer resources to manage it all—companies need to accurately assess compliance requirements and create a plan for how to meet them. KTL suggests completing the following early in 2023:

• Get senior leadership commitment. It is often clear how an organization prioritizes EHS with little digging. Even with the best EHS personnel, the organization and its EHS system will only be as good as the top leadership and what is important to them.
• Conduct a comprehensive gap assessment to ensure you are meeting the requirements of all applicable EHS regulations. This should be the starting place for understanding your regulatory obligations and current compliance status.
• Perform a comprehensive onsite risk assessment with associated risk minimization planning and plan/conduct annual spill drills to practice emergency response for hazardous chemical incidents.
• Organize your records. Know what records you need. Document your inspections and your training. Develop standard operating procedures (SOPs) so people know what to do.
• Create an integrated management system (e.g., ISO 9001/14001/45001) by finding commonalities between the standards and leveraging pieces of each to develop a reliable system that works for your organization. Implement IT solutions to streamline compliance and create business efficiencies.
• Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance.

On January 10, 2023, the U.S. Food and Drug Administration (FDA) issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

Part of the Food Safety Modernization Act (FSMA), FSVP establishes risk-based foreign supplier verification activities that importers of human and animal foods must follow to ensure their imports are not adulterated or misbranded and are produced in compliance with section 418 or 419 of the Food, Drug, and Cosmetic (FD&C) Act, as appropriate. The intent of FSVP is to hold importers accountable for verifying foreign suppliers are meeting U.S. food safety standards.

The new industry guidance document provides information to help importers comply with the FSVP regulation. It offers clarification on what foods/entities the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform FSVP activities. It also includes recommendations on the requirements to:

• Analyze the hazards in food.
• Evaluate a potential foreign supplier’s performance and the risk posed by the food.
• Determine and conduct appropriate foreign supplier verification activities.
• Meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

The final guidance document is available online.

KTL is pleased to welcome the newest member of our food safety team!

Anna Sauls, Senior Consultant

Anna Sauls is a food safety and quality professional with more than ten years of experience. Prior to joining KTL, she served as an industry trainer for food, beverage, and natural products. Anna has in-depth knowledge of FDA food safety regulations and a strong ability to effectively communicate and train others on meeting food safety and quality requirements. Her areas of expertise include 21 CFR, food safety hazards, Hazard Analysis and Critical Control Points (HACCP), current Good Manufacturing Practices (cGMPs), Preventive Controls for Human Foods, food defense, environmental monitoring, sanitation, auditing, and documentation. Anna is based in Candler, NC. Read her full bio…

asauls@goktl.com | 252.339.7583

In August 2013, President Obama signed Executive Order (EO) 13650, Improving Chemical Facility Safety and Security, with the objective to “improve the safety and security of chemical facilities and reduce the risks of hazardous chemicals to workers and communities.” A key element of EO 13650 involves modernizing federal policies, regulations, and standards.

The Order specifically calls on the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) to, among other things, review the Process Safety Management (PSM) and Risk Management Program (RMP) rules to determine if their covered hazardous chemical lists should be expanded.

Over nine years have passed since EO 13650 was issued, and the PSM/RMP modernization efforts are still underway. EPA’s most recent action on August 31, 2022 proposed to strengthen the RMP regulations with the Safer Communities by Chemical Accident Prevention (SCCAP) proposed rule. OSHA has yet to propose updates to the PSM rule, which has not been updated since its publication in 1992; however, the PSM rulemaking project is back on the Unified Agenda, and OSHA is working to make progress.

Progress on PSM

OSHA published the PSM standard (29 CFR 1910.119) in 1992 in response to several catastrophic chemical-release incidents. PSM requires employers to implement safety programs that identify, evaluate, and control highly hazardous chemicals. Unlike other standards, PSM is “performance-based” rather than prescriptive. It outlines 14 management system elements for controlling highly hazardous chemicals. Employers have the flexibility to tailor their PSM programs to the unique conditions at their facilities.

In response to EO 13650, OSHA published a Request for Information (RFI) in December 2013 and then completed a Small Business Advocacy Review Panel (SBAR) in June 2016. Following the SBAR, PSM was moved to the Long-Term Actions list on the Unified Agenda but was placed back on the Unified Agenda in Spring 2021.

Most recently, OSHA held an informal stakeholder meeting on October 12, 2022, to reengage stakeholders and solicit comments on the modernization topics mentioned in the RFI and SBAR panel report.

Potential PSM Changes

The PSM and RMP rules were written to complement each other. OSHA and EPA continue to coordinate as both agencies consider revisions to their respective rules. The Federal Register notice for OSHA’s stakeholder meeting lists the following potential changes to the scope of the current PSM standard that OSHA is considering:

• Clarifying the exemption for atmospheric storage tanks.
• Expanding the scope to include oil- and gas-well drilling and servicing.
• Resuming enforcement for oil and gas production facilities.
• Expanding PSM coverage and requirements for reactive chemical hazards.
• Updating and expanding the list of highly hazardous chemicals in Appendix A.
• Extending PSM requirements to cover dismantling and disposal of explosives and pyrotechnics.
• Clarifying the scope of the retail facilities exemption
• Defining the limits of a PSM-covered process.
• Including a definition of recognized and generally accepted as good engineering practices (RAGAGEP).
• Including a definition of critical equipment.
• Strengthening employee participation and including stop work authority.
• Requiring evaluation of updates to applicable RAGAGEP.
• Requiring continuous updating of collected information.
• Requiring formal resolution of Process Hazard Analysis team recommendations that are not utilized.
• Requiring safer technology and alternatives analysis.
• Requiring considering of natural disasters and extreme temperatures in their PSSM programs.
• Covering the mechanical integrity of any critical equipment.
• Better explaining equipment deficiencies.
• Clarifying organizational changes.
• Requiring root cause analysis.
• Requiring coordination of emergency planning with local emergency response authorities.
• Requiring third-party compliance audits.
• Developing a system for periodic review of and necessary revisions to their PSM management systems.
• Requiring the development of written procedures for all elements specified in the standard, and to identify records required by the standard along with a records retention policy.

What’s Next

While there is still much uncertainty regarding what potential changes may be made to the PSM standard—and when those changes could take effect—it is never too early for PSM-impacted facilities to consider the following:

• How might the potential changes listed above impact your business?
• What issues does your facility foresee with compliance?
• What systems, processes, procedures, plans, etc. does your facility need to ensure ongoing compliance?

KTL will continue to monitor developments with the PSM standard. As things progress, we can help you to:

• Identify/understand/prioritize your facility risks.
• Define organizational roles and responsibilities.
• Better manage documents and information to demonstrate compliance.
• Identify resources to help your facility comply with potential changes to the PSM standard.

On November 7, 2022, the Food and Drug Administration (FDA) submitted the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) to be published in the Federal Register. The Rule is scheduled to be published November 21, 2022, and will become effective 60 days after. The compliance date for all entities subject to the updated recordkeeping requirements is two years later—January 21, 2026.

Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency. Improving food traceability is a key objective for the FDA. The Administration has taken a number of actions over the past few years to put food traceability in the forefront, including establishing Tech-Enabled Traceability as a core element in the FDA’s New Era of Smarter Food Safety Blueprint and now, publishing the final Food Traceability Rule.

Summary of Key Elements

While FDA has had food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach. The objective of the rule is to “help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”

Key elements of the proposed Food Traceability Rule include the following:

• Food Traceability List (FTL): The FTL designates categories of high-risk foods that require additional recordkeeping to protect public health. The Agency created a risk-ranking model to identify the following high-risk foods for inclusion on the FTL: cheeses, shell eggs, nut butter, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fruits and vegetables (fresh cut), finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads. The rule establishes a process for FDA to update the FTL, as appropriate. Additions become effective one year after publication in the Federal Register; deletions would become effective immediately.
• Critical Tracking Events (CTEs) and Key Data Elements (KDEs): The rule requires tracking KDEs for five defined CTEs: growing, receiving, creating, transforming, and shipping. At each CTE, the responsible entity needs to record the traceability lot code and relevant KDEs specific to that activity. The traceability lot code is to be established by entities that originate, transform, or create food on the FTL. This identifier remains the same as the product moves through the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
• Traceability Program Records: Any entity that engages in production of a food on the FTL must create and maintain traceability program records, including a description of relevant reference records, list of foods on the FTL that are shipped, description of how traceability lot codes are assigned, and any other information needed to understand data. Records must be maintained as either original paper records, electronic records, or true copies. An electronic sortable spreadsheet must be provided to FDA within 24 hours during an outbreak, recall, or other threat to public health.

The final rule maintains several exemptions and partial exemptions included in the proposed rule. Some of these include excluding produce that is rarely consumed raw (RCR), certain farms and small originators, farms that sell directly to consumers, certain food produced and packaged on farms, small retail food establishments (RFEs), and others.

Meeting the Needs: Document Management

Over the next two years, those who manufacture, process, pack, or hold foods on the FTL will need to develop and implement the management systems required to fulfill the Food Traceability Rule’s recordkeeping requirements. And while these requirements only apply to foods on the FTL, FDA states that “they were designed to be suitable for FDA food products” and encourages the voluntary adoption of these practices industry-wide.

Having a good document/records management system is essential for maintaining the vast number of documents required by regulations and standards such as the Food Traceability Rule. Companies have been keeping records and documents in binders and file cabinets for years. 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 which, in the case of food traceability, will help to:

• Create standardization and harmonization across industry approaches.
• Reduce response time in a foodborne illness outbreak and, subsequently, the number of people impacted.
• Limit the overall scope of recalls.
• Improve communication and create stronger linkages through greater transparency throughout the supply chain.
• Eventually create end-to-end traceability.

“Far too many of our most disadvantaged Americans continue to live in communities where clean water clean air, and a healthy environment aren’t a reality.” ~ Senator Tom Carper, Chair of Senate Committee on Environment and Public Works (DE).

Environmental justice (EJ) seeks to provide “fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies” (U.S. Environmental Protection Agency – EPA).

Almost immediately upon taking office, the Biden-Harris Administration took swift and significant action to promote EJ efforts. Executive Order (EO) 13990 Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis and EO 14008 Tackling the Climate Crisis at Home and Abroad both direct federal agencies to develop EJ strategies to address the disproportionately high and adverse human health or environmental impacts of their programs on minority and/or low-income populations. The Justice40 Initiative has made it a goal that 40 percent of the overall benefits of certain federal investments are funneled to disadvantaged communities overburdened by pollution. And EPA’s FY 2022-2026 Plan added a fourth principal to support Biden’s Justice40 initiative—advance justice and equity—and states that “EJ and civil rights will be embedded into EPA’s programs, policies, and activities to reduce disparities in environmental and public health conditions.”

Growing Momentum

The focus on EJ continues to gain momentum with a slew of additional significant actions taken recently to further elevate EJ priorities and deliver on the Administration’s promises to advance justice and equity.

Inflation Reduction Act

On August 12, 2022, the Inflation Reduction Act (IRA) of 2022 passed. The IRA grants funding to EPA to help accelerate EJ efforts in the following areas.

New EPA Office of Environmental Justice and External Civil Rights 

On September 24, 2022, EPA announced a new national Office of Environmental Justice and External Civil Rights to help elevate EJ to the highest levels of government. According to EPA, this office will commit more than 200 staff in EPA headquarters and across 10 regions to help solve environmental challenges in underserved communities. The intent of this office is to:

• Improve EPA’s ability to incorporate equity, civil rights, and EJ principles and priorities into all EPA practices, policies, and programs.
• Support the fair treatment and meaningful involvement of all people in development, implementation, and enforcement of environmental laws, regulations, and policies.
• Engage communities with EJ concerns and increase support for community-led action through grants and technical assistance.
• Enforce federal civil rights laws that prohibit discrimination based on race, color, or national origin; sex; disability; or age by applicants for and recipients of EPA federal financial assistance.
• Provide services and expertise in alternative dispute resolution, environmental conflict resolution, consensus building, and collaborative problem solving.

The new office will ensure that implementation of the IRA’s funding programs meet the Justice40 Initiative. Office staff will also work with the Office of Land and Emergency Management to equitably carry out EPA’s final EJ Action Plan (see below).

Environmental Justice Action Plan for Land Protection and Cleanup Programs

September 30, 2022, EPA announced its finalized EJ Action Plan: Building Up Environmental Justice in EPA’s Land Protection and Cleanup Programs (EJ Action Plan). The plan outlines projects, tools, and practices to be applied to the Superfund, Brownfields, Emergency Response, Solid Waste Management, RCRA Corrective Action, and Underground Storage Tank (UST) programs to improve the quality of cleanups in communities with EJ concerns.

The EJ Action Plan is supported by Bipartisan Infrastructure Law investments, including $1 billion to initiate cleanup of 49 previously underfunded Superfund sites and accelerate cleanup at dozens of other sites.

EPA states four main goals for the EJ Action Plan:

1. Strengthen compliance with cornerstone environmental statutes by developing a “Good Governance” process and referral list to help address communities’ ongoing environmental concerns.
2. Incorporate EJ considerations during the regulatory development process by assessing impacts to pollution-burdened, underserved, and tribal communities when developing regulations and tools to identify, track, and consider the implications of EJ-related factors throughout the Superfund process.
3. Improve community engagement in rulemakings, permitting decisions, and policies by providing earlier and more frequent engagement with pollution-burdened and underserved communities and increasing technical support and risk communication resources.
4. Implement President Biden’s Justice40 Initiative through grant application resources and grant award decisions.

Improved Environmental Management

With EPA focused on more regulations, more enforcement, and improved climate change and EJ, environmental management needs to play an integral role in company strategy. Companies must take the time to be informed, be prepared, and be proactive. Establish companywide priorities and goals and commit the appropriate resources to ensure programs and systems are in place to achieve regulatory compliance and align with EPA’s priorities for the future.

If you would like help evaluating your current risk level and assessing your priorities, please contact KTL. 

The Occupational Safety and Health Administration (OSHA) is stepping up enforcement. On September 16, 2022, the U.S. Department of Labor (DOL) announced expanded criteria for placement in the OSHA Severe Violator Enforcement Program (SVEP) to strengthen enforcement, improve compliance with workplace safety standards (i.e., OSH Act), and reduce worker injuries and illnesses.

SVEP: Then and Now

The expanded criteria build off the original SVEP, which was first introduced on June 18, 2010, to focus OSHA’s resources on inspecting employers who continually expose workers to very serious dangers, even after being cited for them. This includes employers who have demonstrated indifference to OSH Act obligations by either “willfully or repeatedly violating federal health and safety laws or demonstrating refusal to correct previous violations” (i.e., failure to abate).

The changes enacted by OSHA in September 2022 are intended to broaden the SVEP’s scope and maximize the tools available to ensure employers comply with their legal obligation to provide safe and healthful workplaces. The new instructions “reflect the Biden-Harris administration’s commitment to ensuring OSHA has the tools it needs to ensure employers protect their workers or hold them accountable when they fail to provide safe and healthy workplaces,” explains Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health. He reinforces, “These changes to SVEP will hold a microscope to those employers who continue to expose workers to very serious dangers.”

This goes hand-in-hand with the Biden Administration’s recent efforts to make significant improvements in workplace safety protection for American workers through proposed increases in funding and significant increases to OSHA’s maximum penalties, as proposed in the original Build Back Better Act.

What’s Changing

The table below outlines how the SVEP criteria are changing from 2010 to 2022.

The final two updates included in the table above are intended to incentivize employers to fix problems quickly with solutions that ultimately work to transform the health and safety culture. The new SVEP instructions also add sample documents and guidance for specific situations to assist companies in complying.

Implementing a SHMS

Developing and implementing an SHMS is one of the best ways to help ensure a company does not end up in the SVEP. As stated in the table above, it is also a requirement for early removal from the SVEP. That is because a properly structured SHMS will get the processes, programs, and systems in place—and documented—to ensure the company is protecting employee safety and health and meeting OSH Act requirements.

OSHA requires the SHMS include the following Core Elements of the Safety and Health Program Recommended Practices:

• Management Leadership: Top management demonstrates a commitment to continuous improvement in safety and health, communicates that commitment to workers, provides adequate resources and support, and sets program expectations and responsibilities.
• Worker Participation: Workers understand their responsibilities and are involved in all aspects of the safety and health program, including setting goals, identifying reporting hazards, investigating incidents, communicating with management, and tracking progress.
• Hazard Identification and Assessment: Procedures are in place to continually identify workplace hazards and evaluate risks. Initial assessment of existing hazards, exposures, and control measures is followed by periodic inspections to identify new hazards; any incidents are also investigated to identify root causes.
• Hazard Prevention and Control: Employer and employees cooperate to identify and select methods for eliminating, preventing, or controlling workplace hazards according to the hierarchy of controls: engineering solutions, safe work practices, administrative controls, and personal protective equipment (PPE).
• Education and Training: Workers are trained to understand how the safety and health program works, how to recognize workplace hazards, and how to carry out their responsibilities under the program.
• Program Evaluation and Improvement: Processes are established to evaluate control measures for effectiveness, monitor program performance, verify program implementation, and identify opportunities to improve overall health and safety performance.
• Communication and Coordination for Host Employers, Contractors, and Staffing Agencies: Hosts commit to providing the same level of health and safety protection to all employees, communicating hazards present at the worksite, and resolving any conflicts that could impact safety or health.

Based on the plan-do-check-act cycle of continuous improvement, the SHMS should also include provisions for continually evaluating and improving program effectiveness and for OSHA’s review and evaluation. Finally, implementation must be verified by an independent third party (CSP, CIH, national union safety and health representative) subject to OSHA’s approval.

As usual, the best way to get ready for the increased enforcement is to understand the regulations and be prepared.

The Central region of APPA (CAPPA) is back hosting the 2022 Annual Conference in Lincoln, Nebraska this October–and KTL is looking forward to being part of the technical agenda this year! With the constant state of change in Higher Education, every interaction with students, faculty, staff and our business partners, vendor, etc. is important to improvement and growth in facilities. This year’s conference is filled with business and educational sessions to help support facilities management professionals in educational institutions.

KTL will be joining Southeast Missouri State University’s Autumn Gentry to present the following case study:

Using Microsoft 365 and SharePoint® to Manage EHS Compliance: University Case Study
October 10, 2022 | 11:00-11:55 a.m.

This presentation will discuss how educational facilities can use Microsoft 365 and SharePoint as a tool to manage EHS compliance programs. We will provide an overview of applicable EHS regulations, discuss how 365/SharePoint can be used to address university-specific needs, and provide a demonstration of Southeast Missouri State University’s “live” EHS management system.