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.

On October 18, 2021, the Environmental Protection Agency (EPA) announced its comprehensive Strategic Roadmap to tackle per- and polyfluoroalkyl substances (PFAS) contamination. The roadmap focuses on increasing investments in research, leveraging authorities to act now to restrict PFAS chemicals from being released, and accelerating cleanup of PFAS contamination.

Under this roadmap, more and more facilities are starting to be directly impacted by mitigation efforts and pending regulatory action. Just recently, EPA took the following actions to protect individuals and communities from the health risks posed by these “forever chemicals”.

Proposed Hazardous Substances Under Superfund

On August 26, 2022, EPA has issued a proposal to seek public comment on designating two of the most widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, aka Superfund). This proposal applies to perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including salts and structural isomers.

Like other PFAS, PFOA and PFOS can accumulate and persist in the human body for long periods of time. The intent of this rulemaking is twofold:

1. Increase transparency around releases of PFOA and PFOS; and
2. Help hold polluters accountable for cleaning up their contamination.

If finalized, the rulemaking would trigger reporting of PFOA and PFOS releases, providing the EPA with improved data and the option to require cleanups/recover cleanup costs. According to EPA, a release of PFOA, PFOS, or any other hazardous substance does not always add a site to the National Priorities List (NPL), necessitate cleanup, or result in an enforcement action.

EPA suggests this potential rulemaking would:

• Improve EPA, state, Tribal nation, and local community understanding of the extent and locations of PFOA and PFOS contamination throughout the country.
• Help communities avoid or reduce contact with these potentially dangerous chemicals.
• Encourage better waste management and treatment practices by facilities handling PFOA or PFOS.
• Potentially accelerate privately financed cleanups and mitigate potential adverse impacts.
• Allow EPA to recover cleanup costs from a potentially response party or require such a party to conduct the cleanup.
• Better protect public health.

EPA anticipates issuing an Advance Notice of Proposed Rulemaking in the next several weeks and will seek public comment once that is published.

Removal from Pesticide Products

On September 1, 2022, EPA proposed to remove 12 chemicals identified as PFAS from the current list of inert ingredients approved for use in pesticide products. Unlike active ingredients, inert ingredients are used to enhance pesticide effectiveness and product performance (e.g., extend shelf life, improve ease of application). EPA reviews safety information for inert ingredients before they can be included in a pesticide.

While these 12 PFAS are no longer used in any registered pesticides, EPA decided to remove the chemicals from the list of approved inert ingredients to prevent any further requested use in pesticide products.

EPA continues to evaluate pesticide active ingredients to determine if any meet the definition of PFAS or create other concerns.

Study on Leaching

In a recent study released on September 8, 2022, EPA confirmed that plastic containers made of fluorinated high-density polyethylene (HDPE) are likely to leach PFAS substances into pesticides and other liquid products that are stored in them. The data shows that the amount of PFAS that migrates into liquid products increases with storage time. This study further demonstrates the persistent and cumulative nature of PFAS.

Ongoing Challenges

KTL does not see the challenges associated with PFAS going away any time soon. If anything, we anticipate more facilities will be directly impacted by mitigation efforts and regulatory action to support the Strategic Roadmap, such as those outlined above. 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.

If you are facing challenges related to PFAS or would just like a fresh set of eyes to evaluate your current environmental risk level, please contact KTL. Our staff has hands-on experience assessing environmental risks and developing strategies to minimize them to the extent possible. Our team writes Emergency Response Plans and routinely works with Local Emergency Planning Committees (LEPCs) to coordinate emergency response efforts and exercises to keep communities informed and safe. In addition, we have a strong network of partners that can assist with testing and remediation strategies, when necessary.

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

Coulter Wood, CEM, CPEA, Senior Consultant

Coulter Wood, CEM, CPEA, is an is an environmental compliance and energy management leader with over 20 years of industry and consulting experience in providing expert regulatory and technical guidance, conducting energy and environmental compliance audits, leading corporate sustainability efforts and environmental capital expenditure projects, and managing energy sourcing and procurement. Coulter has extensive knowledge of state and federal environmental regulations. He has completed inspections and reports for emissions stack testing and Title V permitting, air emissions inventories, hazardous waste generation, storm water sampling, SPCC Plans, and NPDES authorizations and permits. He has also developed environmental and energy management systems. Coulter is a Certified Environmental Manager (CEM) and Certified Professional Environmental Auditor (CPEA). Coulter is based in Des Moines, Iowa. Read his full bio…

cwood@goktl.com | 507.208.9126

The Environmental Protection Agency’s (EPA) Risk Management Program (RMP) Rule is no stranger to change and controversy. Just what the RMP rule entails has been the subject of debate since EPA published the first RMP Amendments in January 2017. Since that time, rules related to RMP requirements have been published, petitioned, delayed, vacated, reissued, and reconsidered.

As the most recent action in the ongoing RMP saga, EPA proposed on August 31, 2022 to strengthen the RMP regulations with the Safer Communities by Chemical Accident Prevention (SCCAP) proposed rule.

RMP Background

RMP was promulgated in 1996 under the Clean Air Act (CAA) Section 112(r)(7) in 40 CFR Part 68. The goal of the RMP program is to prevent accidental releases of toxic substances that can cause serious harm to the public. To do this, the program requires subject facilities to develop and implement an RMP for their specific operations that:

• Identifies the potential effects of a chemical accident.
• Identifies steps the facility is taking to prevent an accident.
• Spells out emergency response procedures should an accident occur.

RMP covers 140 regulated toxic or flammable substances at approximately 11,740 facilities nationwide, including agricultural supply distributors, waste/wastewater treatment facilities, chemical manufacturers and distributors, food and beverage manufacturers, chemical warehouses, oil refineries, and other chemical facilities.  One area of industry that is highly impacted but frequently overlooked is facilities with ammonia refrigeration units that hold more than 10,000 lbs. of ammonia. This has become a focus for much recent EPA enforcement.

Proposed Amendments

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, environmental justice concerns, employee participation, and enhanced community notification.

Focus on Environmental Justice

In January 2021, President Biden signed Executive Order (EO) 13990, “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”.  EO 13990 directs Federal agencies to “immediately review, and take action to address, Federal regulations promulgated and other actions taken during the last four years that conflict with national objectives to improve public health and the environment; ensure access to clean air and water; limit exposure to dangerous chemicals and pesticides; hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; reduce greenhouse gas emissions; bolster resilience to the impacts of climate change; restore and expand our national treasures and monuments; and prioritize both environmental justice and employment.”

The proposed changes to RMP are an outgrowth of EO 13990 and a February 2022 Government Accountability Office (GAO) report recommending EPA amend the RMP rules to ensure that affected facilities are considering the risks associated with climate change.

According to EPA, RMP facility accidents occur more frequently in predominately minority communities. Persons of color make up 50% of those individuals living within one mile of RMP facilities; low-income individuals comprise 42% of those living within one mile of RMP facilities. Many of these communities live near multiple RMP facilities. These populations are particularly at risk of exposure if an accidental release at an RMP facility occurs.

In line with EO 13990, the intent of the SCCAP proposed rule is to further protect vulnerable communities from chemical accidents, especially those living near facilities with high accident rates. Proposed changes would require RMP-regulated facilities to better consider surrounding communities and the consequences of potential chemical accidents.

Deadlines

If finalized, the SCCAP rule will require RMP facilities to update their programs and plans to consider new data elements, prepare additional reports, and implement or update their notification procedures and field exercises to meet new deadlines:

• Three (3) years after effective date of final rule, facilities must implement provisions for:
  • New STAA
  • Incident investigation root cause analysis
  • Third-party compliance audit
  • Employee participation
  • Emergency response public notification
  • Exercise evaluation reports
  • Information availability information
• Four (4) years after effective date of final rule, RMP-regulated facilities must update and resubmit their Risk Management Plans with new and revised data elements.
• Facilities must comply with the revised emergency response field exercise frequency provision by March 15, 2027 or within 10 years of the date of an emergency response field exercise conducted between March 15, 2017 and the date of publication.

What’s Next

The SCCAP proposed rule is likely to be as controversial as its predecessors due to its potential impacts on RMP-regulated facilities across industries. Interested parties should take the time to submit comments by October 31, 2022 during the 60-day public comment period.

In the meantime, KTL will continue to follow and provide updates on the SCCAP proposed rule. KTL has experience working with a broad cross-section of industries impacted by RMP, particularly chemical companies. We have created RMP and General Duty Clause audit protocols and conducted audits and investigation/improvement programs following significant release events. In addition, our team provides Tier II and TRI reporting, writes plans for OSHA and Emergency Response, and routinely works with Local Emergency Planning Commissions (LEPCs) to coordinate emergency response efforts and exercises to keep communities informed and safe.

Regulatory enforcement-driven projects such as those related to RMP require skills in regulatory strategy, negotiations, expert analysis, presentations and testimony—and, equally important—trust and relationship building. KTL can work with companies to:

• Identify/understand/prioritize compliance risks
• Outline steps to improve performance and safe operations
• Define organizational roles and responsibilities
• Streamline compliance methods
• Plan and conduct required tabletop exercises and coordinate with local emergency response
• Implement, monitor, and continually improve performance