As the Biden Administration enters its second year, agencies such as the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA) are preparing to take significant regulatory actions that will impact the cold chain.
On December 15, 2021, the Biden administration published its regulatory agenda, which outlines the plans of federal agencies across the government. The agenda includes proposals that will result in changes to several regulations impacting cold chain businesses. As a result, GCCA expects heavy rulemaking activity in 2022. Following are descriptions of some of the most significant regulations scheduled for action in 2022.
EPA Risk Management Program – “Accidental Release Prevention Requirements: Risk Management Program Under the Clean Air Act; Retrospection”
The EPA Risk Management Program (RMP) has been the subject of several rulemakings over the last five years. At the end of the Obama administration, the EPA published a final RMP rule known as the “2017 Amendments” that added compliance requirements for regulated facilities in areas such as emergency response planning, third-party audits and information sharing. The Trump administration executed a rulemaking to reconsider these amendments, resulting in a rule that rescinded many of the 2017 Amendments. The Biden administration is now considering further revisions to the RMP program. On January 20, 2021, Executive Order 13990, Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis (EO 13990), directed federal agencies to review existing regulations and take action to address priorities established by the new administration including bolstering resilience to the impact of climate change and prioritizing environmental justice. The EPA is considering developing a regulatory action to revise the current RMP regulations.
The proposed rule would address the administration’s priorities and focus on regulatory revisions completed since 2017. The proposed rule would also expect to contain a number of proposed modifications to the RMP regulations based in part on stakeholder feedback received from RMP public listening sessions held on June 16 and July 8, 2021. GCCA participated in these listening sessions and suggested the recently finalized reconsideration rule took appropriate action and that no further rulemaking is needed. The EPA currently plans to prepare a notice of proposed rulemaking that would provide the public an opportunity to comment on the proposal, and any regulatory alternatives that may be identified within the preamble to the proposed rulemaking. According to the regulatory agenda, the EPA is expected to issue a Notice of Proposed Rulemaking in September 2022 and complete a Final Rule by August 2023. GCCA has actively participated in previous RMP rulemakings and will continue to engage with the EPA and like-minded partners to communicate the industry’s positions on regulatory proposals and their potential impact on regulated entities.
EPA HFC Phase Down – “Restrictions on Certain Uses of Hydrofluorocarbons Under Subsection (i) of the American Innovation and Manufacturing Act”
The American Innovation and Manufacturing (AIM) Act, enacted on December 27, 2020, provides the EPA new authorities to address hydrofluorocarbons (HFCs) in three main areas: phasing down the production and consumption of listed HFCs, maximizing reclamation and minimizing releases of these HFCs and their substitutes in equipment (e.g., refrigerators and air conditioners), and facilitating the transition to next-generation technologies by restricting the use of HFCs in particular sectors or subsectors. Since enactment, the EPA has moved to implement the statute, including rulemaking in Fall 2021 that set the HFC baseline and schedule for phasing down consumption. The next step of the process will be establishing rules for various sectors and uses of HFCs. The regulatory agenda states that EPA is considering a rule that will restrict fully, partially, or on a graduated schedule, the use of HFCs in sectors or subsectors including the refrigeration, air conditioning, aerosol and foam sectors. The rule will also establish recordkeeping and reporting requirements and address other related elements of the AIM Act. The EPA is planning to publish a Notice of Proposed Rulemaking in June 2022. A Final Rule is currently scheduled for April 2023. This regulation has the potential to impact industrial refrigeration systems using HFCs. GCCA will continue to update members as the rulemaking process moves forward.
OSHA “Process Safety Management and Prevention of Major Chemical Accidents”
The Obama administration initiated a rulemaking to “modernize” the OSHA Process Safety Management (PSM) regulation in response to the explosion in West, Texas. OSHA went through a Request for Information and convened a panel under the Small Business Regulatory Enforcement Fairness Act to review potential impacts to regulated small businesses. The Trump Administration placed the rulemaking on the “long-term agenda” effectively pausing any further considerations. The Biden administration has since moved the rulemaking into the “pre-rule” stage and is planning to conduct a stakeholder meeting in 2022. After considering the input from the stakeholder meeting, OSHA is expected to develop a Notice of Proposed Rulemaking. OSHA rulemakings historically have taken multiple years to complete. GCCA has actively participated in this rulemaking from the beginning including having two GCCA members participate on the SBREFA panel. GCCA will continue to engage with OSHA throughout the process.
FDA FSMA Food Traceability Rule – “Requirements For Additional Traceability Records For Certain Foods”
The FDA Food Traceability rule would be a part of the food safety framework established through the Food Safety Modernization Act (FSMA). It represents the first new major regulation under FSMA in several years. According to the FDA, the regulation would help the agency rapidly and effectively identify recipients of higher-risk foods to prevent or mitigate foodborne illness outbreaks and credible address threats of serious adverse health consequences or death. At the core of the proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). FDA published a Proposed Rule in September 2020. GCCA submitted formal comments on the proposal and has been working with the agency and industry partners on the issue. FDA is subject to a judicial consent decree that requires the FDA to submit a final rule to the Office of the Federal Register by November 7, 2022. It is expected that FDA will complete this rulemaking by the deadline. The Biden regulatory agenda shows aggressive plans to advance a number of regulatory initiatives that could impact businesses across the cold chain in 2022. GCCA has been and will continue to be, closely engaged with the agencies to promote the interests of the cold chain as each of these rulemakings moves forward.
LOWELL RANDEL is Senior Vice President, Government and Legal Affairs at GCCA.
Busy Regulatory Outlook for 2022
GCCA expects heavy rulemaking activity to come.
As the Biden Administration enters its second year, agencies such as the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA) are preparing to take significant regulatory actions that will impact the cold chain.
On December 15, 2021, the Biden administration published its regulatory agenda, which outlines the plans of federal agencies across the government. The agenda includes proposals that will result in changes to several regulations impacting cold chain businesses. As a result, GCCA expects heavy rulemaking activity in 2022. Following are descriptions of some of the most significant regulations scheduled for action in 2022.
EPA Risk Management Program – “Accidental Release Prevention Requirements: Risk Management Program Under the Clean Air Act; Retrospection”
The EPA Risk Management Program (RMP) has been the subject of several rulemakings over the last five years. At the end of the Obama administration, the EPA published a final RMP rule known as the “2017 Amendments” that added compliance requirements for regulated facilities in areas such as emergency response planning, third-party audits and information sharing. The Trump administration executed a rulemaking to reconsider these amendments, resulting in a rule that rescinded many of the 2017 Amendments. The Biden administration is now considering further revisions to the RMP program. On January 20, 2021, Executive Order 13990, Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis (EO 13990), directed federal agencies to review existing regulations and take action to address priorities established by the new administration including bolstering resilience to the impact of climate change and prioritizing environmental justice. The EPA is considering developing a regulatory action to revise the current RMP regulations.
The proposed rule would address the administration’s priorities and focus on regulatory revisions completed since 2017. The proposed rule would also expect to contain a number of proposed modifications to the RMP regulations based in part on stakeholder feedback received from RMP public listening sessions held on June 16 and July 8, 2021. GCCA participated in these listening sessions and suggested the recently finalized reconsideration rule took appropriate action and that no further rulemaking is needed. The EPA currently plans to prepare a notice of proposed rulemaking that would provide the public an opportunity to comment on the proposal, and any regulatory alternatives that may be identified within the preamble to the proposed rulemaking. According to the regulatory agenda, the EPA is expected to issue a Notice of Proposed Rulemaking in September 2022 and complete a Final Rule by August 2023. GCCA has actively participated in previous RMP rulemakings and will continue to engage with the EPA and like-minded partners to communicate the industry’s positions on regulatory proposals and their potential impact on regulated entities.
EPA HFC Phase Down – “Restrictions on Certain Uses of Hydrofluorocarbons Under Subsection (i) of the American Innovation and Manufacturing Act”
The American Innovation and Manufacturing (AIM) Act, enacted on December 27, 2020, provides the EPA new authorities to address hydrofluorocarbons (HFCs) in three main areas: phasing down the production and consumption of listed HFCs, maximizing reclamation and minimizing releases of these HFCs and their substitutes in equipment (e.g., refrigerators and air conditioners), and facilitating the transition to next-generation technologies by restricting the use of HFCs in particular sectors or subsectors. Since enactment, the EPA has moved to implement the statute, including rulemaking in Fall 2021 that set the HFC baseline and schedule for phasing down consumption. The next step of the process will be establishing rules for various sectors and uses of HFCs. The regulatory agenda states that EPA is considering a rule that will restrict fully, partially, or on a graduated schedule, the use of HFCs in sectors or subsectors including the refrigeration, air conditioning, aerosol and foam sectors. The rule will also establish recordkeeping and reporting requirements and address other related elements of the AIM Act. The EPA is planning to publish a Notice of Proposed Rulemaking in June 2022. A Final Rule is currently scheduled for April 2023. This regulation has the potential to impact industrial refrigeration systems using HFCs. GCCA will continue to update members as the rulemaking process moves forward.
OSHA “Process Safety Management and Prevention of Major Chemical Accidents”
The Obama administration initiated a rulemaking to “modernize” the OSHA Process Safety Management (PSM) regulation in response to the explosion in West, Texas. OSHA went through a Request for Information and convened a panel under the Small Business Regulatory Enforcement Fairness Act to review potential impacts to regulated small businesses. The Trump Administration placed the rulemaking on the “long-term agenda” effectively pausing any further considerations. The Biden administration has since moved the rulemaking into the “pre-rule” stage and is planning to conduct a stakeholder meeting in 2022. After considering the input from the stakeholder meeting, OSHA is expected to develop a Notice of Proposed Rulemaking. OSHA rulemakings historically have taken multiple years to complete. GCCA has actively participated in this rulemaking from the beginning including having two GCCA members participate on the SBREFA panel. GCCA will continue to engage with OSHA throughout the process.
FDA FSMA Food Traceability Rule – “Requirements For Additional Traceability Records For Certain Foods”
The FDA Food Traceability rule would be a part of the food safety framework established through the Food Safety Modernization Act (FSMA). It represents the first new major regulation under FSMA in several years. According to the FDA, the regulation would help the agency rapidly and effectively identify recipients of higher-risk foods to prevent or mitigate foodborne illness outbreaks and credible address threats of serious adverse health consequences or death. At the core of the proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). FDA published a Proposed Rule in September 2020. GCCA submitted formal comments on the proposal and has been working with the agency and industry partners on the issue. FDA is subject to a judicial consent decree that requires the FDA to submit a final rule to the Office of the Federal Register by November 7, 2022. It is expected that FDA will complete this rulemaking by the deadline. The Biden regulatory agenda shows aggressive plans to advance a number of regulatory initiatives that could impact businesses across the cold chain in 2022. GCCA has been and will continue to be, closely engaged with the agencies to promote the interests of the cold chain as each of these rulemakings moves forward.
LOWELL RANDEL is Senior Vice President, Government and Legal Affairs at GCCA.
Source: https://www.gcca.org/busy-regulatory-outlook-2022
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